Web PLR Article Directory Cook Islands: May 2012

Thursday, May 31, 2012

Alramucil

Generic Name: psyllium (SIL ee um)

Brand Names: Fiberall, Genfiber, Hydrocil, Konsyl, Konsyl Orange Sugar-free, Konsyl-D, Konsyl-Orange, Laxmar, Laxmar Orange, Laxmar Sugar Free, Metamucil, Metamucil Berry Burst Smooth Texture Sugar Free, Metamucil Orange Coarse Milled Original Texture, Metamucil Orange Smooth Texture, Metamucil Orange Smooth Texture Sugar Free, Metamucil Unflavored Coarse Milled Original Texture, Metamucil Unflavored Smooth Texture Sugar Free, Natural Fiber Therapy, Perdiem Fiber Powder, Reguloid, V-Lax

What is Alramucil (psyllium)?

Psyllium is a bulk-forming fiber laxative. Psyllium works by absorbing liquid in the intestines and swelling to create a softer, bulky stool that is easier to pass.

Psyllium is used to treat occasional constipation or bowel irregularity. Psyllium may also be used to treat diarrhea and may help lower cholesterol when used together with a diet low in cholesterol and saturated fat.

Psyllium may also be used for other purposes not listed in this product guide.

What is the most important information I should know about Alramucil (psyllium)?

Laxatives may be habit-forming if they are used too often or for too long. This can lead to damage of intestinal nerves or muscle tissues. Do not take psyllium for longer than directed on the label or prescribed by your doctor. You should not take this product if you are allergic to psyllium, or if you have trouble swallowing, a sudden change in bowel habits that lasts longer than 2 weeks, severe nausea, vomiting, or stomach pain, or if you have ever had a skin rash while taking psyllium.

Also talk with your doctor before using psyllium if you have a colostomy or ileostomy, rectal bleeding, or a blockage in your intestines.

Stop using psyllium and call your doctor at once if you have choking or trouble swallowing, severe stomach pain or cramping, nausea or vomiting, constipation that lasts longer than 7 days, rectal bleeding, or itchy skin rash. Do not take psyllium for longer than 7 days in a row unless your doctor has told you to.

What should I discuss with my healthcare provider before taking Alramucil (psyllium)?

trouble swallowing;

a sudden change in bowel habits that lasts longer than 2 weeks;

severe nausea, vomiting, or stomach pain; or

if you have ever had a skin rash while taking psyllium.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this product. Before you take psyllium, tell your doctor if you have:

a colostomy or ileostomy;

rectal bleeding; or

a blockage in your intestines.

Psyllium products may contain sugar, sodium, or artificial sweeteners. This may be of concern to you if you have diabetes, high blood pressure, or phenylketonuria (PKU). Check the product label if you have any of these conditions.

FDA pregnancy category B. Psyllium is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether psyllium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Alramucil (psyllium)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Psyllium is intended to be used for a short time only.

Take psyllium with a full glass (at least 8 ounces) of water or another liquid. Taking psyllium without enough liquid may cause it to swell in your throat and cause choking. Drinking plenty of fluids each day while you are taking psyllium will also help improve bowel regularity.

The psyllium wafer must be chewed before you swallow it.

Do not swallow psyllium powder dry. It must be mixed with liquid. Place the psyllium powder into an empty glass and add at least 8 ounces of water or other liquid such as fruit juice. Stir this mixture and drink all of it right away.

If the powder and liquid mixture is too thick, add more liquid. After drinking the entire mixture, add a little more liquid to the same glass, swirl gently and drink right away to make sure you get the entire dose of psyllium.

Psyllium may be only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

It may take up to 3 days of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 2 or 3 days of treatment.

Do not take psyllium for longer than 7 days in a row unless your doctor has told you to. Store psyllium at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, and stomach pain. Using a laxative too often or for too long may cause severe medical problems involving your intestines.

What should I avoid while taking Alramucil (psyllium)?

Avoid taking other oral (by mouth) medications within 2 hours before or after you take psyllium. Bulk-forming laxatives can make it harder for your body to absorb other medications, possibly making them less effective.

Avoid breathing in the dust from psyllium powder when mixing. Inhaling psyllium dust may cause an allergic reaction.

If you take psyllium as part of a cholesterol-lowering treatment plan, avoid eating foods that are high in fat or cholesterol. Your treatment will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Alramucil (psyllium) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using psyllium and call your doctor at once if you have a serious side effect such as:

choking or trouble swallowing;

severe stomach pain, cramping, nausea or vomiting;

constipation that lasts longer than 7 days;

rectal bleeding; or

itchy skin rash.

Less serious side effects may include:

bloating; or

minor change in your bowel habits.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Alramucil (psyllium)?

Tell your doctor about all other medications you use, especially:

a blood thinner such as warfarin (Coumadin); or

demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

This list is not complete and there may be other drugs that can interact with psyllium. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Alramucil resources

Alramucil Side Effects (in more detail)
Alramucil Use in Pregnancy & Breastfeeding
Alramucil Drug Interactions
Alramucil Support Group
0 Reviews for Alramucil - Add your own review/rating

Konsyl Powder MedFacts Consumer Leaflet (Wolters Kluwer)

Metamucil MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Alramucil with other medications

Constipation
Dietary Fiber Supplementation
Irritable Bowel Syndrome

Where can I get more information?

Your pharmacist can provide more information about psyllium.

See also: Alramucil side effects (in more detail)

Tuesday, May 29, 2012

Dermol 500 Lotion

1. Name Of The Medicinal Product

DERMOL™ 500 LOTION

2. Qualitative And Quantitative Composition

Benzalkonium Chloride 0.1% w/w; Chlorhexidine Dihydrochloride 0.1% w/w; Liquid Paraffin 2.5% w/w; Isopropyl Myristate 2.5% w/w.

Excipient : Cetostearyl Alcohol 5.0% w/w.

3. Pharmaceutical Form

White, non-greasy cutaneous emulsion.

4. Clinical Particulars

4.1 Therapeutic Indications

An antimicrobial emollient for the management of dry and pruritic skin conditions, especially eczema and dermatitis. The lotion is suitable for direct application, and for use as a soap substitute.

4.2 Posology And Method Of Administration

For adults, children and the elderly: For application to the skin: apply the lotion to the affected areas as required. Massage into the skin, until absorbed. For use as a soap substitute: use as a cleanser in the bath or shower, or for other toiletry purposes, instead of ordinary soap or shower gel.

4.3 Contraindications

Do not use in cases of known sensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Avoid contact with the eyes. The excipient cetostearyl alcohol may on rare occasions give rise to local skin reactions (e.g. contact dermatitis) in sensitive people.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No special precautions.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Although the lotion has been specially formulated for use on dry or problem skin, in the unlikely event of a reaction discontinue treatment. These reactions are very rare (<1/10,000, based on spontaneous reporting) and may be irritant or allergic in nature. Reactions have been observed occasionally when used excessively as a leave-on application in areas of folded skin such as the anogenital area.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC code : D02 AX, emollients and protectives.

Bacteria (especially Staphylococcus aureus) are implicated in the pathogenesis of inflammatory dry skin conditions such as atopic eczema or dermatitis. Dermol 500 Lotion contains 5% of emollient oils in a non-greasy aqueous lotion which also contains the well-known and effective antiseptics benzalkonium chloride and chlorhexidine dihydrochloride. Its antimicrobial properties assist in overcoming infection, whether from Staph. aureus, the pathogen which often complicates eczema and associated pruritus, or secondary infection caused by scratching.

Massaged into the skin, the emollients, liquid paraffin and isopropyl myristate, permit rehydration of dry skin by forming an occlusive barrier within the skin surface, thus reducing drying from evaporation of water that diffuses from the underlying layers.

5.2 Pharmacokinetic Properties

The active ingredients are presented in an aqueous lotion and so are readily absorbed into the stratum corneum when the product is gently massaged over the areas of dry skin. The antiseptic ingredients are in intimate contact with the skin, and as they are in solution, their availability is optimal.

5.3 Preclinical Safety Data

No special information.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Cetostearyl Alcohol; Cetomacrogol 1000; Phenoxyethanol; Purified Water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

30 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Replace cap after use.

6.5 Nature And Contents Of Container

Plastic 500 ml bottle with a white pump dispenser. Supplied as an original pack (OP).

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

8. Marketing Authorisation Number(S)

00173/0051.

9. Date Of First Authorisation/Renewal Of The Authorisation

23 June 2009.

10. Date Of Revision Of The Text

March 2010.

Monday, May 28, 2012

Azmax Twisthaler

Generic Name: mometasone (Inhalation route)

moe-MET-a-sone FURE-oh-ate

Commonly used brand name(s)

In the U.S.

Asmanex Twist

In Canada

Asmanex Twisthaler

Azmax Twisthaler

Available Dosage Forms:

Powder

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Mometasone

Uses For Azmax Twisthaler

Mometasone is used to help prevent the symptoms of asthma and improve breathing in patients 4 years of age and older. When used regularly every day, inhaled mometasone decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Inhaled mometasone belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.

This medicine is available only with your doctor's prescription.

Before Using Azmax Twisthaler

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mometasone in children 4 years of age and older. However, safety and efficacy have not been established in children younger than 4 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mometasone in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of mometasone

This section provides information on the proper use of a number of products that contain mometasone. It may not be specific to Azmax Twisthaler. Please read with care.

Inhaled mometasone is used to prevent asthma attacks. It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.

Inhaled mometasone is used with a special inhaler that comes with patient directions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses and be used at the same time each day, as ordered by your doctor.

To use the Twisthaler®:

Take the Twisthaler® out of the pouch before you use it for the first time.

Write down the date on the cap label when you first open the foil pouch. The medicine is good for only 45 days once the pouch is opened.

The Twisthaler® has a small window on the side with numbers showing. This is the dose counter. It keeps track of how many more times you can use the inhaler before you need to open a new one. When the dose counter reaches "00", the Twisthaler® will lock itself. If the dose counter is not working correctly, do not use the Twisthaler® and return it to your pharmacy or doctor.

Remove the cap while it is in upright position to make sure you get the right amount of medicine with each dose.

Hold the Twisthaler® upright and twist the cap in a counterclockwise direction to open it. The dose counter should change to a lower number when you take off the cap. The arrow on the Twisthaler® should be pointing to the dose counter.

To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.

Breathe in through your mouth as deeply as you can until you have taken a full deep breath.

Take the Twisthaler® out of your mouth. Hold your breath for about 10 seconds, then breathe out slowly.

Do not breathe out into the inhaler.

Wipe the mouthpiece dry with a cloth or tissue. Do not wash it with water. Put the cap back on right away and twist it in a clockwise direction. You should hear a "click" when the cap is fully closed.

Gargle and rinse your mouth with water after each dose; this will help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For inhalation dosage form (aerosol powder):
- For preventing an asthma attack:
  - For patients who have received inhaled corticosteroids and bronchodilators:
    - Adults, teenagers, and children 12 years of age and older—One puff once a day, in the evening. Each puff contains 220 micrograms (mcg) of mometasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 440 mcg per day.
    - Children 4 to 11 years of age—One puff once a day, in the evening. Each puff contains 110 mcg of mometasone.
    - Children younger than 4 years of age—Use and dose must be determined by your doctor.
  - For patients who have received oral corticosteroids:
    - Adults, teenagers, and children 12 years of age and older—Two puffs two times a day, in the evening. Each puff contains 220 micrograms (mcg) of mometasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 880 mcg per day.
    - Children 4 to 11 years of age—One puff once a day, in the evening. Each puff contains 110 mcg of mometasone.
    - Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away the inhaler when the dose counter is at "00" or 45 days after you opened the package. Ask your pharmacist, doctor, or health caregiver about the best way to dispose of the used inhaler and any leftover medicine.

Precautions While Using Azmax Twisthaler

If you will be using this medicine for a long time, it is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you or your child have white patches in the mouth or throat; or pain when eating or swallowing.

You should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Make sure you understand how to use the short-acting inhaler. Talk to your doctor if you need instructions.

Talk with your doctor or get medical care right away if:

Your or your child's symptoms do not improve after using this medicine for 2 weeks or if they become worse.

You or your child have a big decrease in your peak flow when measured as directed by your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Your doctor may want you to carry a medical identification (ID) card stating that you or your child are using this medicine. The card will say that you may need additional medicine during an emergency, a severe asthma attack or other illness, or unusual stress.

Using too much of this medicine for a long period of time can cause problems with your adrenal gland. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or weight loss.

Follow your doctor's directions carefully if you are switching from an oral corticosteroid to this medicine.

This medicine may decrease bone mineral density when used for a long time. Low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

This medicine may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you or your child are having a cough, difficulty with breathing, shortness of breath, or wheezing after using this medicine. Use a short acting inhaler right away to treat your symptoms.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Azmax Twisthaler Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

cold or flu-like symptoms

congestion

cough

dryness or soreness of the throat

Less common

Abdominal or stomach pain

diarrhea

fever or chills

loss of appetite

lower back or side pain

nausea

Rare

White patches inside the nose or mouth

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty with moving

discouragement

feeling sad or empty

headache

increased abdominal or stomach pain and cramping during menstrual periods

irritability

lack of appetite

loss of interest or pleasure

muscle or joint pain

muscle pain or stiffness

nasal burning and irritation

stomach discomfort following meals

stuffy or runny nose

tiredness

trouble concentrating

trouble sleeping

unexplained runny nose or sneezing

upset stomach

Less common

Accidental injury

bladder pain

bloated

bloody mucus or unexplained nosebleeds

bloody or cloudy urine

chest congestion

difficult, burning, or painful urination

excess air or gas in stomach or intestines

frequent urge to urinate

full feeling

general feeling of discomfort or illness

lower back or side pain

menstrual changes

passing gas

post-procedure pain

shivering

sweating

unusual tiredness or weakness

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Azmax Twisthaler resources

Azmax Twisthaler Use in Pregnancy & Breastfeeding
Azmax Twisthaler Drug Interactions
Azmax Twisthaler Support Group
9 Reviews for Azmax Twisthaler - Add your own review/rating

Compare Azmax Twisthaler with other medications

Asthma, Maintenance
Hay Fever
Nasal Polyps

Thursday, May 24, 2012

Avelox

Generic Name: moxifloxacin (Oral route)

mox-i-FLOX-a-sin hye-droe-KLOR-ide

Oral route(Tablet)

Fluoroquinolones, including moxifloxacin hydrochloride, are associated with an increased risk of tendinitis and tendon rupture in all ages. Risk further increases with age over 60 years, concomitant steroid therapy, and kidney, heart, or lung transplants. Fluoroquinolones, including moxifloxacin hydrochloride, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid in patients with known history of myasthenia gravis .

Commonly used brand name(s)

In the U.S.

Avelox

Available Dosage Forms:

Tablet

Therapeutic Class: Antibiotic

Chemical Class: Moxifloxacin

Uses For Avelox

Moxifloxacin is used to treat bacterial infections in many different parts of the body.

Moxifloxacin belongs to the class of medicines known as fluoroquinolone antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Before Using Avelox

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of moxifloxacin in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of moxifloxacin in the elderly. However, elderly patients are more likely to have age-related heart problems, or develop severe tendon problems (including tendon rupture), which may require caution in patients receiving moxifloxacin.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Cisapride

Dronedarone

Mesoridazine

Pimozide

Sparfloxacin

Thioridazine

Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acarbose

Acetohexamide

Acetophenazine

Alfuzosin

Amiodarone

Amitriptyline

Amoxapine

Apomorphine

Arsenic Trioxide

Asenapine

Astemizole

Azithromycin

Benfluorex

Bretylium

Chloroquine

Chlorpromazine

Chlorpropamide

Ciprofloxacin

Citalopram

Clarithromycin

Clomipramine

Clozapine

Crizotinib

Dasatinib

Desipramine

Disopyramide

Dofetilide

Dolasetron

Dothiepin

Doxepin

Droperidol

Erythromycin

Ethopropazine

Flecainide

Fluconazole

Fluphenazine

Gatifloxacin

Gemifloxacin

Gliclazide

Glimepiride

Glipizide

Gliquidone

Glyburide

Granisetron

Guar Gum

Halofantrine

Haloperidol

Ibutilide

Iloperidone

Imipramine

Insulin

Insulin Aspart, Recombinant

Insulin Glulisine

Insulin Lispro, Recombinant

Lapatinib

Levofloxacin

Lofepramine

Lopinavir

Lumefantrine

Mefloquine

Metformin

Methadone

Methotrimeprazine

Miglitol

Moricizine

Nilotinib

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Ondansetron

Opipramol

Paliperidone

Pazopanib

Perflutren Lipid Microsphere

Perphenazine

Pipotiazine

Posaconazole

Procainamide

Prochlorperazine

Promazine

Promethazine

Propafenone

Propiomazine

Protriptyline

Quetiapine

Quinidine

Quinine

Ranolazine

Salmeterol

Saquinavir

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

Sunitinib

Telavancin

Telithromycin

Terfenadine

Tetrabenazine

Thiethylperazine

Tolazamide

Tolbutamide

Toremifene

Trazodone

Trifluoperazine

Triflupromazine

Trimeprazine

Trimipramine

Troglitazone

Vandetanib

Vardenafil

Vemurafenib

Voriconazole

Warfarin

Aluminum Carbonate, Basic

Aluminum Hydroxide

Aluminum Phosphate

Betamethasone

Corticotropin

Cortisone

Cosyntropin

Deflazacort

Dexamethasone

Didanosine

Dihydroxyaluminum Aminoacetate

Dihydroxyaluminum Sodium Carbonate

Fludrocortisone

Fluocortolone

Hydrocortisone

Iron

Magaldrate

Magnesium Carbonate

Magnesium Hydroxide

Magnesium Oxide

Magnesium Trisilicate

Methylprednisolone

Paramethasone

Prednisolone

Prednisone

Rifampin

Sucralfate

Triamcinolone

Zinc

Interactions with Food/Tobacco/Alcohol

Proper Use of Avelox

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Swallow the tablet whole with a glass of water. Do not split, crush or chew it. This medicine may be taken with or without food.

Take this medicine at the same time each day.

Drink plenty of fluids with this medicine to help prevent some unwanted effects.

If you are taking aluminum or magnesium-containing antacids, iron supplements, multivitamins, didanosine (Videx®), sucralfate (Carafate®), or zinc, do not take them at the same time that you take this medicine. It is best to take these medicines at least 4 hours before or 8 hours after taking moxifloxacin. These medicines may keep moxifloxacin from working properly.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

For oral dosage form (tablets):
- For infections:
  - Adults—400 milligrams (mg) once a day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Avelox

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If you have low potassium levels in the blood, moxifloxacin may increase your risk of having a fast, slow or irregular heartbeat; loss of consciousness; or fainting spells. If these symptoms occur, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you take this medicine.

Moxifloxacin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without checking first with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Tell your doctor right away if you start having numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be symptoms of a condition called peripheral neuropathy.

Moxifloxacin may rarely cause inflammation (tendinitis) or tearing of a tendon (the cord that attaches muscles to bones). This can occur while you are taking the medicine or after you finish taking it. The risk of having tendon problems may be increased if you are over 60 years of age, are using steroid medicines (eg, dexamethasone, prednisolone, prednisone, or Medrol®), have severe kidney problems, have a history of tendon problems (eg, rheumatoid arthritis), or if you have received an organ transplant (eg, heart, kidney, or lung). Stop using this medicine and check with your doctor right away if you have sudden pain or swelling in a tendon after exercise (eg, ankle, back of the knee or leg, shoulder, elbow, or wrist), bruise more easily after an injury, or are unable to bear weight or move the affected area. Refrain from exercise until your doctor says otherwise.

Moxifloxacin may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. If these reactions are especially bothersome, check with your doctor.

Some people who take moxifloxacin may become more sensitive to sunlight than normal. Exposure to sunlight, even for brief periods of time, may cause severe sunburn, or skin rash, redness, itching, or discoloration. When you begin using this medicine:

Stay out of direct sunlight, especially between the hours of 10 AM and 3 PM, if possible.

Wear protective clothing, including a hat and sunglasses.

Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some people may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.

Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Avelox Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Abdominal or stomach cramps

abdominal or stomach tenderness

black, tarry stools

bleeding gums

blisters

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

blurred vision

bone pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain

chills

clay-colored stools

cough

crying

dark urine

diarrhea, watery and severe, which may also be bloody

difficult or labored breathing

difficulty with moving

difficulty with swallowing

discouragement

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

excessive muscle tone

fainting

fast, irregular, pounding, or racing heartbeat or pulse

feeling of unreality

feeling of warmth or heat

feeling sad or empty

fever

flushed, dry skin

flushing or redness of the skin, especially on the face and neck

fruit-like breath odor

headache

hyperventilation

increased hunger

increased sensitivity of the skin to sunlight

increased thirst

increased urination

irregular heartbeat recurrent

irritability

itching

joint pain, stiffness, or swelling

lack of coordination

loss of appetite

loss of interest or pleasure

lower back, side, or stomach pain

mood or mental changes

muscle aching or cramping

muscle pains or stiffness

muscle tension or tightness

nausea or vomiting

nervousness

noisy breathing

pain

pain in the pelvis

pain, warmth, or burning in the fingers, toes, and legs

painful or difficult urination

painful, swollen joints

pale skin

palpitations

pinpoint red spots on the skin

pounding in the ears

problems with speech or speaking

problems with vision or hearing

quick to react or overreact emotionally

rapid weight gain

rapidly changing moods

redness or other discoloration of the skin

restlessness

seeing, hearing, or feeling things that are not there

seizures

sensation of the skin burning

sense of detachment from self or body

severe sunburn

shakiness in the legs, arms, hands, or feet

shortness of breath

skin rash

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sweating

swelling of the feet or lower legs

swelling or puffiness of the face

swollen glands

tightness in the chest

tingling of the hands or feet

tiredness

trouble concentrating

trouble sleeping

troubled breathing with exertion

unexplained weight loss

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

vomiting of blood

wheezing

yellow eyes or skin

Incidence not known

Blistering, peeling, or loosening of the skin

change in the ability to see colors, especially blue or yellow

difficulty in chewing or talking

double vision

drooping eyelids

eye pain

general feeling of tiredness or weakness

hives

hoarseness

irregular or slow heart rate

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

muscle weakness

no blood pressure or pulse

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red, irritated eyes

red skin lesions, often with a purple center

severe headache

severe tiredness

stomach pain, continuing

stopping of heart

unconsciousness

unusual behavior, such as disorientation to time or place, failure to recognize people, hyperactivity, or restlessness

Rare

Acid or sour stomach

bad, unusual, or unpleasant (after) taste

belching

burning feeling in the chest or stomach

change in sense of smell

change in taste

changes in vision

continuing ringing or buzzing or other unexplained noise in the ears

difficulty having a bowel movement (stool)

excess air or gas in the stomach or intestines

fear or nervousness

feeling of constant movement of self or surroundings

full feeling

general feeling of discomfort or illness

hearing loss

heartburn

impaired vision

indigestion

itching of the vagina or genital area

lack or loss of strength

loss of memory

pain during sexual intercourse

passing of gas

problems with memory

redness, swelling, or soreness of the tongue

sensation of spinning

sleepiness or unusual drowsiness

sleeplessness

sore mouth or tongue

stomach discomfort, upset, or pain

swelling or inflammation of the mouth

thick, white vaginal discharge with no odor or with a mild odor

unable to sleep

vaginal yeast infection

white patches in the mouth or on the tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Avelox side effects (in more detail)

More Avelox resources

Avelox Side Effects (in more detail)
Avelox Dosage
Avelox Use in Pregnancy & Breastfeeding
Drug Images
Avelox Drug Interactions
Avelox Support Group
96 Reviews for Avelox - Add your own review/rating

Avelox Monograph (AHFS DI)

Avelox Consumer Overview

Avelox MedFacts Consumer Leaflet (Wolters Kluwer)

Avelox Prescribing Information (FDA)

Avelox I.V.

Compare Avelox with other medications

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Tuesday, May 22, 2012

Prestim Tablets

Prestim Tablets

10 mg timolol maleate

2.5 mg bendroflumethiazide

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If you experience any side effect and this becomes serious, tell your doctor or pharmacist.

In this leaflet:

1. What Prestim is and what it is used for

2. Before you take Prestim Tablets

3. How to take Prestim Tablets

4. Possible side effects

5. How to store Prestim Tablets

6. Further information

What Prestim Is And What It Is Used For

Prestim Tablets are a combination of two medicines, one slows your heart rate and the other increases water removal from your body.

Prestim tablets are used to treat raised blood pressure.Your doctor has prescribed these tablets for you because your blood pressure is too high.

Before You Take Prestim Tablets

Do not take Prestim Tablets if you:

Are allergic (hypersensitive) to timolol maleate, bendroflumethiazide, any of the other ingredients of Prestim (these are listed in section 6, “Further Information”), or any medicine known as a thiazide diuretic.

Have bronchial asthma or a chronic lung disease.

Have a history of wheezing or asthma.

Have serious kidney problems.

Have difficulty urinating.

Have uncontrolled heart failure, a very slow heart rate, other heart problems or a certain type of angina called Prinzmetal’s angina.

Have low blood pressure or problems with your blood circulation.

Have a condition affecting your adrenal glands called phaeochromocytoma.

Have a condition that causes acidity of the blood called metabolic acidosis.

Are taking medicines used for relieving depression such as lithium, monoamine oxidase inhibitors (e.g. selegiline, moclobedine) and tricyclic antidepressants (e.g. amitriptyline, lofepramine).

Are pregnant, or think that you might be pregnant.

Take special care with Prestim Tablets

Tell your doctor before you start treatment if you have or have had in the past one of the following problems or if you develop any of these during treatment:

Suffer from diabetes, low blood sugar levels (hypoglycaemia), heart, liver or kidney problems.

Suffer from an overactive thyroid gland.

Psoriasis (this is a skin disease with thickened patches of red skin, often with silvery scales).

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines.

In particular, tell your doctor if you are taking any of the following:

Any other medicines for high blood pressure or heart problems such as: lignocaine, verapamil, disopyramide, tocainide, diltiazem, quinidine, amiodarone, clonidine, digitalis glycosides, reserpine, hydralazine, guanethidine, dihydropyridine derivatives (e.g. nifedipine) and any of the medicines known as class I antiarrhythmic agents.

Medicines used for treating depression (e.g. lithium, tricyclic antidepressants and monoamine oxidase inhibitors) or other mental problems (e.g. phenothiazines).

Medicines known as barbiturates, used to treat sleeping disorders.

An anti-ulcer medicine called cimetidine.

An antibiotic called rifampicin.

Medicines known as prostaglandin synthetase inhibitors (e.g. ibuprofen, aspirin).

Medicines known as sympathomimetic agents used for asthma (e.g. salbutamol), to stimulate your heart (e.g. isoprenaline) and in some cough and cold preparations.

Medicines for treating diabetes (e.g. insulin or oral anti-diabetic medicines).

Medicines that work by reducing the amount of important chemicals; adrenaline and catecholamines, that are involved in nerve function (e.g. reserpine).

If you are going to have surgery

If you are going to have an operation in hospital or going to the dentist, tell the doctor at the hospital or the dentist that you are taking Prestim Tablets.

Certain anaesthetics should not be used with these tablets (e.g. ether, cyclopropane, trichloroethylene). You should not be given a local anaesthetic combined with adrenaline while you are taking Prestim Tablets.

Taking Prestim Tablets with food and drink

You should avoid excessive alcohol consumption while taking Prestim.

Pregnancy and breast-feeding

Tell your doctor before you take any tablets if you are pregnant or breast-feeding. Also, tell your doctor if you become pregnant during treatment.

Do not take Prestim tablets if you are pregnant.

Your doctor will decide if you should take Prestim while you are breast-feeding.

Driving and using machines

This medicine may cause tiredness or dizziness as a side effect.

Therefore you should be careful if you are going to drive or operate machinery.

How To Take Prestim Tablets

Always take Prestim exactly as your doctor has told you.You should check with your doctor or pharmacist if you are not sure.

The usual dose can vary from 1 to 4 tablets.

You can take the tablets as a single dose in the morning or in two doses, one in the morning and the other in the evening.

Prestim Tablets should be swallowed whole with water.

If you take more Prestim Tablets than you should

If you or anyone else accidentally take more than the recommended dose of these tablets, call your doctor straight away or go to your nearest hospital casualty department.

If you forget to take Prestim

If you forget to take your tablet(s), take the next dose as normal.

Do not take a double dose to make up for forgotten tablet(s).

If you stop taking Prestim

Keep taking the Prestim Tablets for as long as your doctor tells you to. Do not stop taking them without consulting your doctor first. If it is right for you to stop taking Prestim then your doctor will probably reduce the dose gradually since it is important not to stop suddenly.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Prestim Tablets Side Effects

Like all medicines, Prestim can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience severe abdominal pain and vomiting or you notice inflammation of your blood vessels (e.g. veins).

Tell your doctor if you notice a skin rash and/ or your eyes feel dry. Your doctor may decide to change your treatment. If you have a skin rash, this may be associated with an increased sensitivity to sunlight.

Tell your doctor if you have any of the side effects mentioned below and you are concerned:

Upset stomach, dizziness, tiredness, depression, weakness, sleeplessness, breathing difficulties, a slow heart beat or other heart problems.

You may also experience tired or painful muscles, feel thirsty and pass less urine than normal.

If you are short sighted this may get worse.

Some side effects will not normally be noticed. These include an increase in blood sugar and sugar in the urine (particularly in people who are diabetic), changes in levels of some substances in the blood, such as decrease in potassium or an increase in urea, and changed blood cells. Your doctor may therefore need to do some tests.

Tell your doctor or pharmacist if you notice any side effects not listed in this leaflet, or if any of these effects become serious.

How To Store Prestim Tablets

Keep out of the reach and sight of children.

Store Prestim Tablets below 25°C.

Do not use Prestim after the expiry date which is stated on the bottle label and outer carton after the text “EXP“. The expiry date refers to the last day of that month.

Medicines must not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.

Further Information

What Prestim contains

Active substance:
Timolol maleate and bendroflumethiazide. Each tablet contains 10 mg of timolol maleate and 2.5 mg
of bendroflumethiazide.

Other ingredients:
Microcrystalline cellulose, starch and magnesium stearate.

What Prestim looks like and contents of the pack

Prestim Tablets are white, flat and oval with “ ” imprinted on one side and a break-mark on the other.

Prestim comes in bottles of 30 tablets.

Marketing Authorisation Holder

Meda Pharmaceuticals Ltd.

Skyway House

Parsonage Road

Takeley

Bishop’s Stortford

CM22 6PU

United Kingdom

Manufacturer

Labiana Pharmaceuticals S.L.U.

Casanova 27-31

08757- Corbera de Llobregat (Barcelona)

Spain

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in July 2010.

34842E0EU-D00

562103V4130UK00

Sunday, May 20, 2012

White Liniment BP (White Embrocation BP)

1. Name Of The Medicinal Product

White Liniment BP (White Embrocation BP)

2. Qualitative And Quantitative Composition

Turpentine Oil BP 25.0% v/v

3. Pharmaceutical Form

Liniment

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of rheumatism, lumbago, sciatica and sprains.

4.2 Posology And Method Of Administration

Applied directly to the skin.

Apply 2 or 3 times a day, as required. Rub thoroughly into the affected parts.

This product is suitable for use by adults and the elderly but is not recommended for children under 12 years, except under a doctor's instruction.

4.3 Contraindications

Sensitivity to turpentine oil

4.4 Special Warnings And Precautions For Use

For external use only.

Avoid broken or inflamed skin.

Keep all medicines away from children.

Keep away from the eyes and other sensitive areas.

If symptoms persist seek medical advice.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Use of all medicines should be avoided if possible during pregnancy and lactation. No information is available regarding safety of use of this product in the above condition.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

May cause irritation. Absorption of large amounts may cause some of the effects of poisoning with turpentine oil.

4.9 Overdose

In case of accidental ingestion the symptoms will be those of turpentine poisoning, local burning and gastro-intestinal upset, coughing and choking, pulmonary oedema, excitement, coma, fever, tachycardia, liver damage, haematuria and albuminuria.

15ml of turpentine oil may be fatal to children (equivalent to 60ml of white liniment).

The stomach should be emptied by emesis or by aspiration and lavage. Suitable supportive measures should be taken.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Turpentine is applied externally in liniments as a counter-irritant and rubefacient.

5.2 Pharmacokinetic Properties

No information available.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Oleic Acid BP, Ammonium Chloride BP, Ammonia Solution Strong BP, Purified Water BP.

6.2 Incompatibilities

None known.

6.3 Shelf Life

200ml	36 months
500ml	36 months

6.4 Special Precautions For Storage

Store below 25°C.

Do not allow to freeze.

6.5 Nature And Contents Of Container

200ml Plain round amber glass bottle with plastic cap or white 28mm cap with tamper evident band and EPE Saranex liner.

500ml Amber glass winchester bottle with plastic cap or white 28mm cap with tamper evident band and EPE Saranex liner.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Thornton and Ross Limited

Linthwaite Laboratories

Huddersfield

HD7 5QH

8. Marketing Authorisation Number(S)

PL 00240/6440R

9. Date Of First Authorisation/Renewal Of The Authorisation

18^th May 1998

10. Date Of Revision Of The Text

17/08/2004

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable

Wednesday, May 16, 2012

HyperHEP B S/D

hepatitis b immune globulin (human)

Dosage Form: injection
Hepatitis B Immune Globulin

(Human)

HyperHEP B S/D

Solvent/Detergent Treated

HyperHEP B S/D Description

Hepatitis B Immune Globulin (Human) — HyperHEP BTM S/D treated with solvent/detergent is a sterile solution of hepatitis B hyperimmune immune globulin for intramuscular administration; it is preservative-free and latex-free. HyperHEP B S/D is prepared by cold ethanol fractionation from the plasma of donors with high titers of antibody to the hepatitis B surface antigen (anti-HBs). The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. HyperHEP B S/D is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. HyperHEP B S/D is then incubated in the final container for 21–28 days at 20–27°C. Each vial or syringe contains anti-HBs antibody equivalent to or exceeding the potency of anti-HBs in a U.S. reference hepatitis B immune globulin (Center for Biologics Evaluation and Research, FDA). The U.S. reference has been tested against the World Health Organization standard Hepatitis B Immune Globulin and found to be equal to 220 international units (IU) per mL.

The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for HyperHEP B S/D has been validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1), was chosen as the relevant virus for blood products; Bovine Viral Diarrhea Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Human Herpes viruses and other large enveloped DNA viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation. Significant removal of model enveloped and non-enveloped viruses is achieved at two steps in the Cohn fractionation process leading to the collection of Cohn Fraction II: the precipitation and removal of Fraction III in the processing of Fraction II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III.

Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.

Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.(22–25)

Studies of the HyperHEP B S/D manufacturing process demonstrate that TSE clearance is achieved during the Pooled Plasma to Effluent III Fractionation Process (6.7 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.

HyperHEP B S/D - Clinical Pharmacology

Hepatitis B Immune Globulin (Human) provides passive immunization for individuals exposed to the hepatitis B virus (HBV) as evidenced by a reduction in the attack rate of hepatitis B following its use.(1-6) The administration of the usual recommended dose of this immune globulin generally results in a detectable level of circulating anti-HBs which persists for approximately 2 months or longer. The highest antibody (IgG) serum levels were seen in the following distribution of subjects studied: (7)

DAY	% OF SUBJECTS
3	38.9%
7	41.7%
14	11.1%
21	8.3%

Mean values for half-life were between 17.5 and 25 days, with the shortest being 5.9 days and the longest 35 days.(7)

Cases of type B hepatitis are rarely seen following exposure to HBV in persons with preexisting anti-HBs. No confirmed instance of transmission of hepatitis B has been associated with this product.

In a clinical study in eight healthy human adults receiving another hyperimmune immune globulin product treated with solvent/detergent, Rabies Immune Globulin (Human), HyperRABm S/D, prepared by the same manufacturing process, detectable passive antibody titers were observed in the serum of all subjects by 24 hours post injection and persisted through the 21 day study period. These results suggest that passive immunization with immune globulin products is not affected by the solvent/detergent treatment.

Indications and Usage for HyperHEP B S/D

Recommendations on post-exposure prophylaxis are based on available efficacy data and on the likelihood of future HBV exposure for the person requiring treatment. In all exposures, a regimen combining Hepatitis B Immune Globulin (Human) with hepatitis B vaccine will provide both short- and long-term protection, will be less costly than the two-dose Hepatitis B Immune Globulin (Human) treatment alone, and is the treatment of choice.(8) HyperHEP B S/D is indicated for post-exposure prophylaxis in the following situations:

Acute Exposure to Blood Containing HBsAg

After either parenteral exposure, e.g., by accidental “needlestick” or direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident) involving HBsAg-positive materials such as blood, plasma or serum. For inadvertent percutaneous exposure, a regimen of two doses of Hepatitis B Immune Globulin (Human), one given after exposure and one a month later, is about 75% effective in preventing hepatitis B in this setting.

Perinatal Exposure of Infants Born to HBsAg-positive Mothers

Infants born to HBsAg-positive mothers are at risk of being infected with hepatitis B virus and becoming chronic carriers.(5,8-10) This risk is especially great if the mother is HBeAg-positive.(11-13) For an infant with perinatal exposure to an HBsAg-positive and HBeAg-positive mother, a regimen combining one dose of Hepatitis B Immune Globulin (Human) at birth with the hepatitis B vaccine series started soon after birth is 85%–95% effective in preventing development of the HBV carrier state.(8,14) Regimens involving either multiple doses of Hepatitis B Immune Globulin (Human) alone or the vaccine series alone have 70%–90% efficacy, while a single dose of Hepatitis B Immune Globulin (Human) alone has only 50% efficacy.(8,15)

Sexual Exposure to an HBsAg-positive Person

Sex partners of HBsAg-positive persons are at increased risk of acquiring HBV infection. For sexual exposure to a person with acute hepatitis B, a single dose of Hepatitis B Immune Globulin (Human) is 75% effective if administered within 2 weeks of last sexual exposure.(8)

Household Exposure to Persons with Acute HBV Infection

Since infants have close contact with primary care-givers and they have a higher risk of becoming HBV carriers after acute HBV infection, prophylaxis of an infant less than 12 months of age with Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated if the mother or primary care-giver has acute HBV infection.(8)

Administration of Hepatitis B Immune Globulin (Human) either preceding or concomitant with the commencement of active immunization with Hepatitis B Vaccine provides for more rapid achievement of protective levels of hepatitis B antibody, than when the vaccine alone is administered.(16) Rapid achievement of protective levels of antibody to hepatitis B virus may be desirable in certain clinical situations, as in cases of accidental inoculations with contaminated medical instruments.(16) Administration of Hepatitis B Immune Globulin (Human) either 1 month preceding or at the time of commencement of a program of active vaccination with Hepatitis B Vaccine has been shown not to interfere with the active immune response to the vaccine.(16)

Contraindications

None known.

Warnings

HyperHEP B S/D is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Talecris Biotherapeutics, Inc. [1-800-520-2807].

The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.

HyperHEP B S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immune globulin preparations. Epinephrine should be available.

In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Hepatitis B Immune Globulin (Human) should be given only if the expected benefits outweigh the risks.

Precautions

General

HyperHEP B S/D should not be administered intravenously because of the potential for serious reactions. Injections should be made intramuscularly, and care should be taken to draw back on the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel. Intramuscular injections are preferably administered in the deltoid muscle of the upper arm or lateral thigh muscle. The gluteal region should not be used as an injection site because of the risk of injury to the sciatic nerve.(17) An individual decision as to which muscle is injected must be made for each patient based on the volume of material to be administered.

Laboratory Tests

None required.

Drug Interactions

Although administration of Hepatitis B Immune Globulin (Human) did not interfere with measles vaccination,(18) it is not known whether Hepatitis B Immune Globulin (Human) may interfere with other live virus vaccines. Therefore, use of such vaccines should be deferred until approximately 3 months after Hepatitis B Immune Globulin (Human) administration. Hepatitis B Vaccine may be administered at the same time, but at a different injection site, without interfering with the immune response.(16) No interactions with other products are known.

Pregnancy Category C

Animal reproduction studies have not been conducted with HyperHEP B S/D. It is also not known whether HyperHEP B S/D can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HyperHEP B S/D should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

Adverse Reactions

Local pain and tenderness at the injection site, urticaria and angioedema may occur; anaphylactic reactions, although rare, have been reported following the injection of human immune globulin preparations.(19)

Overdosage

Although no data are available, clinical experience with other immunoglobulin preparations suggests that the only manifestations would be pain and tenderness at the injection site.

HyperHEP B S/D Dosage and Administration

Acute Exposure to Blood Containing HBsAg(15)

Table 1 summarizes prophylaxis for percutaneous (needlestick or bite), ocular, or mucous-membrane exposure to blood according to the source of exposure and vaccination status of the exposed person. For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure (its value beyond 7 days of exposure is unclear). If Hepatitis B Immune Globulin (Human) is indicated (see Table 1), an injection of 0.06 mL/kg of body weight should be administered intramuscularly (see PRECAUTIONS) as soon as possible after exposure and within 24 hours, if possible. Consult Hepatitis B Vaccine package insert for dosage information regarding that product.

Table 1. (adapted from (20) ) Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure
	Exposed Person
Source	Unvaccinated	Vaccinated
* Hepatitis B Immune Globulin (Human), dose 0.06 mL / kg IM. † HB Vaccine dose 20 μg IM for adults; 10 μg IM for infants or children under 10 years of age. First dose within 1 week; second and third doses, 1 and 6 months later. ‡ Less than 10 sample ratio units (SRU) by radioimmunoassay (RIA), negative by enzyme immunoassay (EIA).
HBsAg-Positive	1. Hepatitis B Immune Globulin (Human) x1 immediately*	1. Test exposed person for anti-HBs.
	2. Initiate HB Vaccine Series†	2. If inadequate antibody,‡ Hepatitis B Immune Globulin (Human) (x1) immediately plus HB Vaccine booster dose, or 2 doses of HBIG,* one as soon as possible after exposure and the second 1 month later.

Known Source (High Risk)	1. Initiate HB Vaccine Series	1. Test Source for HBsAg only if exposed is vaccine nonresponder; if source is HBsAg-positive, give Hepatitis B Immune Globulin (Human) x1 immediately plus HB Vaccine booster dose, or 2 doses of HBIG,* one as soon as possible after exposure and the second 1 month later.
Known Source (High Risk)		2. Test source for HBsAg. If positive, Hepatitis B Immune Globulin x 1
Low Risk HBsAg-Positive	Initiate HB Vaccine series	Nothing required.
Unknown Source	Initiate HB Vaccine series within 7 days of exposure	Nothing required.

For persons who refuse Hepititis B Vaccine, a second dose of Hepatitis B Immune Globulin (Human) should be given 1 month after the first dose.

Prophylaxis of Infants Born to HBsAg and HBeAg Positive Mothers

Efficacy of prophylactic Hepatitis B Immune Globulin (Human) in infants at risk depends on administering Hepatitis B Immune Globulin (Human) on the day of birth. It is therefore vital that HBsAg-positive mothers be identified before delivery.

Hepatitis B Immune Globulin (Human) (0.5 mL) should be administered intramuscularly (IM) to the newborn infant after physiologic stabilization of the infant and preferably within 12 hours of birth. Hepatitis B Immune Globulin (Human) efficacy decreases markedly if treatment is delayed beyond 48 hours. Hepatitis B Vaccine should be administered IM in three doses of 0.5 mL of vaccine (10 μg) each. The first dose should be given within 7 days of birth and may be given concurrently with Hepatitis B Immune Globulin (Human) but at a separate site. The second and third doses of vaccine should be given 1 month and 6 months, respectively, after the first. If administration of the first dose of Hepatitis B Vaccine is delayed for as long as 3 months, then a 0.5 mL dose of Hepatitis B Immune Globulin (Human) should be repeated at 3 months. If Hepatitis B Vaccine is refused, the 0.5 mL dose of Hepatitis B Immune Globulin (Human) should be repeated at 3 and 6 months. Hepatitis B Immune Globulin (Human) administered at birth should not interfere with oral polio and diphtheria-tetanus-pertussis vaccines administered at 2 months of age.(15)

Sexual Exposure to an HBsAg-positive Person

All susceptible persons whose sex partners have acute hepatitis B infection should receive a single dose of HBIG (0.06 mL/kg) and should begin the hepatitis B vaccine series if prophylaxis can be started within 14 days of the last sexual contact or if sexual contact with the infected person will continue (see Table 2 below). Administering the vaccine with HBIG may improve the efficacy of postexposure treatment. The vaccine has the added advantage of conferring long-lasting protection.(8)

Table 2. (adapted from (21) ) Recommendations for Postexposure Prophylaxis for Sexual Exposure to Hepatitis B
HBIG*		Vaccine
Dose	Recommended timing	Dose	Recommended timing
* HBIG = Hepatitis B Immune Globulin (Human) † IM = intramuscularly ‡ The first dose can be administered the same time as the HBIG dose but at a different site; subsequent doses should be administered as recommended for specific vaccine.
0.06 mL/kg IM†	Single dose within 14 days of last sexual contact	1.0 mL IM†	First dose at time of HBIG* treatment‡

Household Exposure to Persons with Acute HBV Infection

Prophylactic treatment with a 0.5 mL dose of Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated for infants <12 months of age who have been exposed to a primary care-giver who has acute hepatitis B. Prophylaxis for other household contacts of persons with acute HBV infection is not indicated unless they have had identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive hepatitis B vaccine.(8)

Hepatitis B Immune Globulin (Human) may be administered at the same time (but at a different site), or up to 1 month preceding Hepatitis B Vaccination without impairing the active immune response from Hepatitis B Vaccination.(16)

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Administer intramuscularly. Do not inject intravenously.

Hepatitis B Immune Globulin (Human) — HyperHEP B™ S/D is supplied in a syringe with an attached UltraSafe® Needle Guard for your protection and convenience, as well as in vials. Please follow instructions below for proper use of syringe and UltraSafe® Needle Guard.

Directions for Syringe Usage

Remove the prefilled syringe from the package. Lift syringe by barrel, not by plunger.

Twist the plunger rod clockwise until the threads are seated.

With the rubber needle shield secured on the syringe tip, push the plunger rod forward a few millimeters to break any friction seal between the rubber stopper and the glass syringe barrel.

Remove the needle shield and expel air bubbles. [Do not remove the rubber needle shield to prepare the product for administration until immediately prior to the anticipated injection time.]

Proceed with hypodermic needle puncture.

Aspirate prior to injection to confirm that the needle is not in a vein or artery.

Inject the medication.

Keeping your hands behind the needle, grasp the guard with free hand and slide forward toward needle until it is completely covered and guard clicks into place. If audible click is not heard, guard may not be completely activated. (See Diagrams A and B)

Place entire prefilled glass syringe with guard activated into an approved sharps container for proper disposal. (See Diagram C)

A number of factors could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

How is HyperHEP B S/D Supplied

HyperHEP B S/D is supplied in a 0.5 mL neonatal single dose syringe with attached needle, a 1 mL single dose syringe with attached needle and a 1 mL and a 5 mL single dose vial. HyperHEP B S/D is preservative-free and latex-free.

NDC Number	Size
13533-636-03	0.5 mL syringe
13533-636-02	1 mL syringe
13533-636-01	1 mL vial
13533-636-05	5 mL vial

STORAGE

Store at 2–8°C (36–46°F). Do not freeze. Do not use after expiration date.

CAUTION

Rx only

U.S. federal law prohibits dispensing without prescription.

REFERENCES

Grady G F, Lee VA : Hepatitis B immune globulin — prevention of hepatitis from accidental exposure among medical personnel. N Engl J Med 293(21):1067–70, 1975.

Seeff LB, Zimmerman HJ, Wright EC, et al: Efficacy of hepatitis B immune serum globulin after accidental exposure. Lancet 2(7942):939-41, 1975.

Krugman S, Giles JP: Viral hepatitis, type B (MS-2-strain). Further observations on natural history and prevention. N Engl J Med 288(15):755-60, 1973.

Current trends: Health status of Indochinese refugees: malaria and hepatitis B. MMWR 28(39):463-4; 469-70, 1979.

Jhaveri R, Rosenfeld W, Salazar JD, et al: High titer multiple dose therapy with HBIG in newborn infants of HBsAg positive mothers. J Pediatr 97(2):305–8, 1980.

Hoofnagle JH, Seeff LB, Bales ZB, et al: Passive-active immunity from hepatitis B immune globulin. Ann Intern Med 91(6):813-8, 1979.

Scheiermann N, Kuwert EK: Uptake and elimination of hepatitis B immunoglobulins after intramuscular application in man. Dev Biol Stand 54:347-55, 1983.

Recommendations of the Immunization Practices Advisory Committee (ACIP): Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination. Appendix A: Postexposure Prophylaxis for Hepatitis B. MMWR 40(RR-13):21-25, 1991.

Stevens CE, Beasley R P, Tsui J, et al: Vertical transmission of hepatitis B antigen in Taiwan. N Engl J Med 292(15):771-4, 1975.

Shiraki K, Yoshihara N, Kawana T, et al: Hepatitis B surface antigen and chronic hepatitis in infants born to asymptomatic carrier mothers. Am J Dis Child 131(6):644-7, 1977.

Recommendation of the Immunization Practices Advisory Committee (ACIP): Immune globulins for protection against viral hepatitis. MMWR 30(34):423-8; 433-5, 1981.

Okada K, Kamiyama I, Inomata M, et al: e antigen and anti-e in the serum of asymptomatic carrier mothers as indicators of positive and negative transmission of hepatitis B virus to their infants. N Engl J Med 294(14):746-9, 1976.

Beasley R P, Trepo C, Stevens CE, et al: The e antigen and vertical transmission of hepatitis B surface antigen. Am J Epidemiol 105(2):94-8, 1977.

Beasley R P, Hwang LY, Lee GCY, et al: Prevention of perinatally transmitted hepatitis B virus infections with hepatitis B immune globulin and hepatitis B vaccine. Lancet 2(8359): 1099-102, 1983.

Recommendation of the Immunization Practices Advisory Committee (ACIP): Recommendations for protection against viral hepatitis. MMWR 34(22):313–35, 1985.

Szmuness W, Stevens CE, Olesko WR, et al: Passive-active immunisation against hepatitis B: immunogenicity studies in adult Americans. Lancet 1:575–77, 1981.

Recommendations of the Immunization Practices Advisory Committee (ACIP): General recommendations on immunization. MMWR 38(13):205-14; 219-27, 1989.

Beasley R P, Hwang LY: Measles vaccination not interfered with by hepatitis B immune globulin. Lancet 1:161, 1982.

Ellis E F, Henney CS: Adverse reactions following administration of human gamma globulin. J Allerg 43(1):45-54, 1969.

Recommendations of the Immunization Practices Advisory Committee (ACIP): Update on Adult Immunization. Table 9. Recommendations for postexposure prophylaxis for percutaneous or permucosal exposure to hepatitis B, United States. MMWR 40(RR-12):70, 1991.

Recommendations of the Immunization Practices Advisory Committee (ACIP): Update on Adult Immunization. Table 10. Recommendations for postexposure prophylaxis for perinatal and sexual exposure to hepatitis B, United States. MMWR 40(RR-12):71, 1991.

Stenland CJ, Lee DC, Brown P, et al. Partitioning of human and sheep forms of the pathogenic prion protein during the purification of therapeutic proteins from human plasma. T ransfusion 2002. 42(11):1497-500.

Lee DC, Stenland CJ, Miller JL, et al. A direct relationship between the partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins. T ransfusion 2001. 41(4):449-55.

Lee DC, Stenland CJ, Hartwell RC, et al. Monitoring plasma processing steps with a sensitive Western blot assay for the detection of the prion protein. J Virol Methods 2000. 84(1):77-89.

Cai K, Miller JL, Stenland CJ, et al. Solvent-dependent precipitation of prion protein. Biochim Biophys Acta 2002. 1597(1):28-35.

Talecris Biotherapeutics, Inc.

Research Triangle Park, NC 27709 USA

U.S. License No. 1716

08938829

(Rev. May 2008)

PACKAGE LABEL

Hepatitis B

Immune

Globulin

(Human)

HyperHEP B™ S/D

Solvent/Detergent

Treated

1 mL Sterile Solution

NDC 13533-636-01

Talecris

BIOTHERAPEUTICS

The patient and physician

should discuss the risks and

benefits of this product.

One Single Dose Vial

FOR INTRAMUSCULAR

INJECTION ONLY. DO NOT

GIVE INTRAVENOUSLY

No preservative

For complete dosage and

administration information,

read enclosed package insert.

Store at 2-8°C (36-46°F).

Do not freeze.

If the shrink band is absent or

shows any sign of tampering,

do not use the product and

notify Talecris Biothera-

peutics, Inc. immediately.

Not returnable for credit or

exchange.

Rx only

CAUTION: U.S. federal law

prohibits dispensing without

prescription.

Hepatitis B Immune Globulin

(Human) is a sterile solution

of immunoglobulin containing

15%-18% protein stabilized

with 0.21-0.32 M glycine. The

pH is adjusted with sodium

carbonate.

The potency is equivalent to or

exceeds that of the U.S. Food

and Drug Administration Ref-

erence Hepatitis B Immune

Globulin. The U.S. reference

has been tested against the

World Health Organization

standard Hepatitis B Immune

Globulin and found to be equal

to 220 international units (IU)

per mL.

08907792

Talecris Biotherapeutics, Inc.

Research Triangle Park,

NC 27709 USA

U.S. License No. 1716

NDC 13533-636-01

Hepatitis B Immune

Globulin (Human)

HyperHEP B™ S/D 1 mL

Solvent/Detergent Treated                    The patient and

Talecris                                 physician should discuss

Biotherapeutics, Inc.                 the risks and benefits

RTP, NC 27709                    of this product. Dosage &

U.S. License No. 1716         Administration: See insert.

Lot

Exp.

HyperHEP B S/D
hepatitis b immune globulin (human) injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	13533-636
Route of Administration	INTRAMUSCULAR	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Human Hepatitis B Virus Immune Globulin (Human Hepatitis B Virus Immune Globulin)	Human Hepatitis B Virus Immune Globulin	220 [iU] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Glycine

Product Characteristics
Color	YELLOW (Clear liquid, colorless to pale yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	13533-636-01	1 mL In 1 VIAL, GLASS	None
2	13533-636-02	1 mL In 1 SYRINGE, GLASS	None
3	13533-636-03	.5 mL In 1 SYRINGE, GLASS	None
4	13533-636-05	5 mL In 1 VIAL, GLASS	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA101146	10/09/1996

Labeler - TALECRIS BIOTHERAPEUTICS, INC. (839731507)

Establishment
Name	Address	ID/FEI	Operations
TALECRIS BIOTHERAPEUTICS HOLDINGS CORP		611019113	MANUFACTURE

Revised: 10/2010TALECRIS BIOTHERAPEUTICS, INC.

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1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container

6.6 Special Precautions For Disposal And Other Handling

7. Marketing Authorisation Holder

8. Marketing Authorisation Number(S)

9. Date Of First Authorisation/Renewal Of The Authorisation

10. Date Of Revision Of The Text

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