Fulstan

Fulstan may be available in the countries listed below.

Ingredient matches for Fulstan

Falecalcitriol

Falecalcitriol is reported as an ingredient of Fulstan in the following countries:

• Japan

International Drug Name Search

Finasterida J. Neves

Finasterida J. Neves may be available in the countries listed below.

Ingredient matches for Finasterida J. Neves

Finasteride

Finasteride is reported as an ingredient of Finasterida J. Neves in the following countries:

• Portugal

International Drug Name Search

Boltin

Boltin may be available in the countries listed below.

Ingredient matches for Boltin

Tibolone

Tibolone is reported as an ingredient of Boltin in the following countries:

• Spain

International Drug Name Search

Acetan

Acetan may be available in the countries listed below.

Ingredient matches for Acetan

Lisinopril

Lisinopril is reported as an ingredient of Acetan in the following countries:

• Austria

International Drug Name Search

Diovenor

Diovenor may be available in the countries listed below.

Ingredient matches for Diovenor

Diosmin

Diosmin is reported as an ingredient of Diovenor in the following countries:

• Algeria


• France


• Tunisia


• Venezuela

International Drug Name Search

Evigen

Evigen may be available in the countries listed below.

Ingredient matches for Evigen

Tocopherol, α-

Tocopherol, α- is reported as an ingredient of Evigen in the following countries:

• Turkey

International Drug Name Search

Sulfadimetoxina

Sulfadimetoxina may be available in the countries listed below.

Ingredient matches for Sulfadimetoxina

Sulfadimethoxine

Sulfadimetoxina (DCIT) is also known as Sulfadimethoxine (Rec.INN)

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Vancomycin HCL Abbott

Vancomycin HCL Abbott may be available in the countries listed below.

Ingredient matches for Vancomycin HCL Abbott

Vancomycin

Vancomycin hydrochloride (a derivative of Vancomycin) is reported as an ingredient of Vancomycin HCL Abbott in the following countries:

• Thailand

International Drug Name Search

Dolos

Dolos may be available in the countries listed below.

Ingredient matches for Dolos

Mefenamic Acid

Mefenamic Acid is reported as an ingredient of Dolos in the following countries:

• Indonesia

International Drug Name Search

Bicillin L-A Suspension

Pronunciation: PEN-i-SIL-in G BEN-za-theen
Generic Name: Penicillin G Benzathine
Brand Name: Bicillin L-A

Do not inject Bicillin L-A Suspension in or near an artery or vein. It should only be injected into muscle. There have been reports of serious side effects, including death, when Bicillin L-A Suspension has been injected into a vein.

Bicillin L-A Suspension is used for:

Treating some types of infections caused by certain bacteria.

Bicillin L-A Suspension is a penicillin antibiotic. It works by interfering with the formation of the bacteria's cell wall while it is growing. This weakens the cell wall and kills the bacteria.

Do NOT use Bicillin L-A Suspension if:

• you are allergic to any ingredient in Bicillin L-A Suspension or to other penicillins


• you are taking a tetracycline antibiotic

Contact your doctor or health care provider right away if any of these apply to you.

Before using Bicillin L-A Suspension:

Some medical conditions may interact with Bicillin L-A Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have diarrhea or a stomach infection, especially in children 9 years old or younger


• if you have diabetes

Some MEDICINES MAY INTERACT with Bicillin L-A Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Probenecid because it may be increase the risk of Bicillin L-A Suspension's side effects


• Chloramphenicol or tetracyclines because they may decrease Bicillin L-A Suspension's effectiveness


• Anticoagulants (eg, warfarin) or methotrexate because their actions and the risk of their side effects may be increased by Bicillin L-A Suspension


• Anticoagulants (eg, warfarin), chloramphenicol, or oral contraceptives (birth control pills) because their effectiveness may be decreased by Bicillin L-A Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bicillin L-A Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Bicillin L-A Suspension:

Use Bicillin L-A Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Bicillin L-A Suspension is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Bicillin L-A Suspension at home, a health care provider will teach you how to use it. Be sure you understand how to use Bicillin L-A Suspension. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Bicillin L-A Suspension works best if it is given at the same time each day.


• Shake well before each use. Store Bicillin L-A Suspension in the refrigerator. Do not freeze.


• Bicillin L-A Suspension should not be injected into or near an artery or vein. Bicillin L-A Suspension should be injected into muscle, preferably in the upper outer portion of the buttocks. In children, Bicillin L-A Suspension should be injected into the thigh.


• To clear up your infection completely, use Bicillin L-A Suspension for the full course of treatment. Keep using it even if you feel better in a few days.


• If you miss a dose of Bicillin L-A Suspension, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Bicillin L-A Suspension.

Important safety information:

• Bicillin L-A Suspension may cause dizziness, drowsiness, or blurred vision. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take Bicillin L-A Suspension if you have had a severe allergic reaction to a penicillin antibiotic (eg, amoxicillin, ampicillin) or a cephalosporin antibiotic (eg, cefaclor, cephalexin, cefuroxime, cefadroxil). A severe allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness. Ask your health care provider if you are unsure if you are allergic to Bicillin L-A Suspension.


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Diabetes patients - Bicillin L-A Suspension may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Bicillin L-A Suspension. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Use Bicillin L-A Suspension with caution in the ELDERLY; they may be more sensitive to its effects.


• Use Bicillin L-A Suspension with caution in NEWBORNS; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Bicillin L-A Suspension while you are pregnant. Bicillin L-A Suspension is found in breast milk. If you are or will be breast-feeding while you use Bicillin L-A Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Bicillin L-A Suspension:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Pain, swelling, or bleeding at the injection site; mild diarrhea; worsening of arthritis.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; blood in urine; bloody stools; chest pain; chills; extreme tiredness; fainting; fast heartbeat; fever; flushing with lightheadedness or fainting; hallucinations; headache; itching; muscle pain; nausea; pounding in the chest; rapid breathing; seizures; severe diarrhea; stomach pain/cramps; vaginal irritation or itching; vomiting; worsening of skin lesions.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Bicillin L-A side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms of may include diarrhea; nausea; vomiting.

Proper storage of Bicillin L-A Suspension:

Store Bicillin L-A Suspension in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Dispose of properly after use. Keep Bicillin L-A Suspension, as well as needles, syringes, or other materials, out of the reach of children and away from pets.

General information:

• If you have any questions about Bicillin L-A Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Bicillin L-A Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Bicillin L-A Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Bicillin L-A resources

• Bicillin L-A Side Effects (in more detail)
• Bicillin L-A Use in Pregnancy & Breastfeeding
• Bicillin L-A Drug Interactions
• Bicillin L-A Support Group
• 2 Reviews for Bicillin L-A - Add your own review/rating

Compare Bicillin L-A with other medications

• Actinomycosis
• Anthrax
• Anthrax Prophylaxis
• Aspiration Pneumonia
• Bacterial Infection
• Clostridial Infection
• Congenital Syphilis
• Cutaneous Bacillus anthracis
• Deep Neck Infection
• Diphtheria
• Endocarditis
• Fusospirochetosis, Trench Mouth
• Joint Infection
• Leptospirosis
• Lyme Disease, Arthritis
• Lyme Disease, Carditis
• Lyme Disease, Erythema Chronicum Migrans
• Lyme Disease, Neurologic
• Meningitis
• Meningitis, Meningococcal
• Meningitis, Pneumococcal
• Neurosyphilis
• Otitis Media
• Pneumonia
• Prevention of Perinatal Group B Streptococcal Disease
• Rat-bite Fever
• Rheumatic Fever Prophylaxis
• Skin Infection
• Strep Throat
• Syphilis, Early
• Syphilis, Latent
• Tertiary Syphilis
• Tonsillitis/Pharyngitis
• Upper Respiratory Tract Infection

Saphris

In the US, Saphris (asenapine systemic) is a member of the drug class atypical antipsychotics and is used to treat Bipolar Disorder, Post Traumatic Stress Disorder, Schizoaffective Disorder and Schizophrenia.

US matches:

• Saphris

Ingredient matches for Saphris

Asenapine

Asenapine maleate (a derivative of Asenapine) is reported as an ingredient of Saphris in the following countries:

• United States

International Drug Name Search

Dacarbazina

Dacarbazina may be available in the countries listed below.

Ingredient matches for Dacarbazina

Dacarbazine

Dacarbazina (DCIT) is known as Dacarbazine in the US.

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana

Click for further information on drug naming conventions and International Nonproprietary Names.

Doss-Relief

Generic Name: docusate (DOK ue sate)

Brand Names: Calcium Stool Softener, Colace, Correctol Softgel Extra Gentle, D-S Caps, Diocto, Doc-Q-Lace, Docu, Docu Soft, Doculase, Docusoft S, DocuSol, DOK, DOS, DSS, Dulcolax Stool Softener, Enemeez Mini, Fleet Sof-Lax, Kao-Tin, Kaopectate Stool Softener, Kasof, Phillips Stool Softener, Silace, Sur-Q-Lax

What is Doss-Relief (docusate)?

Docusate is a stool softener. It makes bowel movements softer and easier to pass.

Docusate is used to treat or prevent constipation, and to reduce pain or rectal damage caused by hard stools or by straining during bowel movements.

Docusate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Doss-Relief (docusate)?

You should not use docusate if you are allergic to it, or if you have a blockage in your intestines. Do not use docusate while you are sick with nausea, vomiting, or stomach pain. Do not take mineral oil while using docusate, unless your doctor tells you to.

Ask a doctor or pharmacist before using docusate if you are on a low-salt diet, if you are pregnant or breast-feeding, or if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.

What should I discuss with my healthcare provider before using Doss-Relief (docusate)?

You should not use docusate if you are allergic to it, or if you have a blockage in your intestines. Do not use docusate while you are sick with nausea, vomiting, or stomach pain. Do not take mineral oil while using docusate, unless your doctor tells you to.

Ask a doctor or pharmacist if it is safe for you to take docusate:

• 
  

  if you are on a low-salt diet; or

  
  


• 
  

  if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.

  
  

It is not known whether docusate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether docusate 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. Do not give this medication to a child younger than 2 years old without the advice of a doctor.

How should I use Doss-Relief (docusate)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take docusate tablets or capsules with a full glass of water. Drink plenty of liquids while you are taking docusate. Do not crush, chew, or break a docusate capsule. Swallow it whole.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Mix the liquid with 6 to 8 ounces of milk, fruit juice, or infant formula and drink the mixture right away.

Do not take docusate rectal enema by mouth. It is for use only in your rectum. Wash your hands before and after using docusate rectal enema.

Try to empty your bowel and bladder just before using the enema.

Twist off the applicator tip. Lie down on your left side with your knees bent, and gently insert the tip of the enema applicator into the rectum. Squeeze the tube to empty the entire contents into the rectum. Throw away the tube, even if there is still some medicine left in it.

After using docusate, you should have a bowel movement within 12 to 72 hours. Call your doctor if you have not had a bowel movement within 1 to 3 days.

Do not use docusate for longer than 7 days unless your doctor has told you to. Overuse of a stool softener can lead to serious medical problems. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since docusate is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting or stomach pain.

What should I avoid while using Doss-Relief (docusate)?

Avoid using laxatives or other stool softeners unless your doctor has told you to.

Avoid using the bathroom just after using docusate enema.

Doss-Relief (docusate) 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 docusate and call your doctor at once if you have a serious side effect such as:

• 
  

  rectal bleeding or irritation;

  
  


• 
  

  numbness or a rash around your rectum;

  
  


• 
  

  severe diarrhea or stomach cramps; or

  
  


• 
  

  continued constipation.

  
  

Less serious side effects may include:

• 
  

  mild diarrhea; or

  
  


• 
  

  mild nausea.

  
  

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 Doss-Relief (docusate)?

There may be other drugs that can interact with docusate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Doss-Relief resources

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

• Docusate Professional Patient Advice (Wolters Kluwer)


• Colace MedFacts Consumer Leaflet (Wolters Kluwer)


• Diocto Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Docusate Salts Monograph (AHFS DI)


• Dostinex Monograph (AHFS DI)


• Enemeez Mini Enema MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Doss-Relief with other medications

• Constipation

Where can I get more information?

• Your pharmacist can provide more information about docusate.

See also: Doss-Relief side effects (in more detail)

Granudoxy

Granudoxy may be available in the countries listed below.

Ingredient matches for Granudoxy

Doxycycline

Doxycycline monohydrate (a derivative of Doxycycline) is reported as an ingredient of Granudoxy in the following countries:

• Argentina


• France


• Luxembourg

International Drug Name Search

Levium

Levium may be available in the countries listed below.

Ingredient matches for Levium

Levomepromazine

Levomepromazine maleate (a derivative of Levomepromazine) is reported as an ingredient of Levium in the following countries:

• Germany

International Drug Name Search

Mesterolone

In some countries, this medicine may only be approved for veterinary use.

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

G03BB01

CAS registry number (Chemical Abstracts Service)

0001424-00-6

Chemical Formula

C20-H32-O2

Molecular Weight

304

Therapeutic Categories

Anabolic

Androgen

Chemical Name

Androstan-3-one, 17-hydroxy-1-methyl-, (1α,5α,17ß)-

Foreign Names

• Mesterolonum (Latin)
• Mesterolon (German)
• Mestérolone (French)
• Mesterolona (Spanish)

Generic Names

• Mesterolone (OS: BAN, DCIT, USAN)
• Mestérolone (OS: DCF)
• SH 60723 (IS)
• SH 723 (IS: Schering)
• Mesterolon (PH: Ph. Eur. 6)
• Mesterolone (PH: BP 2010, Ph. Eur. 6)
• Mestérolone (PH: Ph. Eur. 6)
• Mesterolonum (PH: Ph. Eur. 6)

Brand Names

• Infelon
  Caprifarmindo, Indonesia



• Proviron
  Bayer, Austria; Bayer, Belgium; Bayer, Spain; Bayer, Italy; Bayer, Turkey; Bayer Animal Health, Luxembourg; Bayer Schering, Australia; Bayer Schering, Greece; Bayer Schering, South Africa; Schering, Burkina Faso; Schering, Benin; Schering, Brazil; Schering, Central African Republic; Schering, Congo; Schering, Cote D'ivoire; Schering, Chile; Schering, Cameroon; Schering, Colombia; Schering, Czech Republic; Schering, Dominican Republic; Schering, Algeria; Schering, Ethiopia; Schering, Gabon; Schering, Georgia; Schering, Hungary; Schering, Israel; Schering, Sri Lanka; Schering, Madagascar; Schering, Mali; Schering, Mauritania; Schering, Mauritius; Schering, Mexico; Schering, Niger; Schering, Oman; Schering, Peru; Schering, Philippines; Schering, Poland; Schering, Portugal; Schering, Serbia; Schering, Senegal; Schering, Chad; Schering, Togo; Schering-Plough, Indonesia



• Pro-Viron
  Bayer, United Kingdom; Schering, Malta



• Pro-Viron (veterinary use)
  Schering-Plough Veterinary, United Kingdom



• Provironum
  Bayer, Vietnam; German Remedies, India; Schering, Singapore; Schering, Thailand



• Vistimon
  Jenapharm, Taiwan

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Diclofenac GMP

Diclofenac GMP may be available in the countries listed below.

Ingredient matches for Diclofenac GMP

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Diclofenac GMP in the following countries:

• Venezuela

International Drug Name Search

Unifed

In the US, Unifed (pseudoephedrine systemic) is a member of the drug class decongestants and is used to treat Nasal Congestion.

US matches:

• Unifed Liquid


• Unifed

Ingredient matches for Unifed

Pseudoephedrine

Pseudoephedrine hydrochloride (a derivative of Pseudoephedrine) is reported as an ingredient of Unifed in the following countries:

• Oman

Triprolidine

Triprolidine hydrochloride monohydrate (a derivative of Triprolidine) is reported as an ingredient of Unifed in the following countries:

• Oman

International Drug Name Search

Nisom

Nisom may be available in the countries listed below.

Ingredient matches for Nisom

Nimodipine

Nimodipine is reported as an ingredient of Nisom in the following countries:

• Colombia

International Drug Name Search

Diclobru

Diclobru may be available in the countries listed below.

Ingredient matches for Diclobru

Diclofenac

Diclofenac is reported as an ingredient of Diclobru in the following countries:

• Georgia

International Drug Name Search

Cliad

Cliad may be available in the countries listed below.

Ingredient matches for Cliad

Chlordiazepoxide

Chlordiazepoxide is reported as an ingredient of Cliad in the following countries:

• Indonesia

Clidinium

Clidinium Bromide is reported as an ingredient of Cliad in the following countries:

• Indonesia

International Drug Name Search

Devincal

Devincal may be available in the countries listed below.

Ingredient matches for Devincal

Piracetam

Piracetam is reported as an ingredient of Devincal in the following countries:

• Spain

Vincamine

Vincamine is reported as an ingredient of Devincal in the following countries:

• Spain

International Drug Name Search

Morphine HCl EG

Morphine HCl EG may be available in the countries listed below.

Ingredient matches for Morphine HCl EG

Morphine

Morphine hydrochloride (a derivative of Morphine) is reported as an ingredient of Morphine HCl EG in the following countries:

• Luxembourg

International Drug Name Search

Riomet

In the US, Riomet (metformin systemic) is a member of the drug class non-sulfonylureas and is used to treat Diabetes - Type 2, Female Infertility, Insulin Resistance Syndrome and Polycystic Ovary Syndrome.

US matches:

• Riomet


• Riomet Solution

Ingredient matches for Riomet

Metformin

Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Riomet in the following countries:

• Myanmar


• United States

International Drug Name Search

Minims Lignocaine & Fluorescein

Minims Lignocaine & Fluorescein may be available in the countries listed below.

Ingredient matches for Minims Lignocaine & Fluorescein

Fluorescein

Fluorescein sodium (a derivative of Fluorescein) is reported as an ingredient of Minims Lignocaine & Fluorescein in the following countries:

• Ireland


• New Zealand


• South Africa

Lidocaine

Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Minims Lignocaine & Fluorescein in the following countries:

• Ireland


• New Zealand


• South Africa

International Drug Name Search

Clopran

Clopran may be available in the countries listed below.

Ingredient matches for Clopran

Clomipramine

Clomipramine hydrochloride (a derivative of Clomipramine) is reported as an ingredient of Clopran in the following countries:

• Taiwan

Metoclopramide

Metoclopramide hydrochloride (a derivative of Metoclopramide) is reported as an ingredient of Clopran in the following countries:

• Oman

International Drug Name Search

Gesicox

Gesicox may be available in the countries listed below.

Ingredient matches for Gesicox

Meloxicam

Meloxicam is reported as an ingredient of Gesicox in the following countries:

• Vietnam

International Drug Name Search

L S 50 Water Soluble

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for L S 50 Water Soluble

Lincomycin

Lincomycin hydrochloride monohydrate (a derivative of Lincomycin) is reported as an ingredient of L S 50 Water Soluble in the following countries:

• United States

Spectinomycin

Spectinomycin sulphate tetrahydrate for veterinary use (a derivative of Spectinomycin) is reported as an ingredient of L S 50 Water Soluble in the following countries:

• United States

International Drug Name Search

Tapros

Tapros may be available in the countries listed below.

Ingredient matches for Tapros

Leuprorelin

Leuprorelin is reported as an ingredient of Tapros in the following countries:

• Indonesia

Tafluprost

Tafluprost is reported as an ingredient of Tapros in the following countries:

• Japan

International Drug Name Search

Retin

Retin may be available in the countries listed below.

Ingredient matches for Retin

Tretinoin

Tretinoin is reported as an ingredient of Retin in the following countries:

• Czech Republic

International Drug Name Search

Loperamida Merck

Loperamida Merck may be available in the countries listed below.

Ingredient matches for Loperamida Merck

Loperamide

Loperamide is reported as an ingredient of Loperamida Merck in the following countries:

• Portugal

International Drug Name Search

Hypren

Hypren may be available in the countries listed below.

Ingredient matches for Hypren

Ramipril

Ramipril is reported as an ingredient of Hypren in the following countries:

• Austria

International Drug Name Search

Neuomil

Neuomil may be available in the countries listed below.

Ingredient matches for Neuomil

Maprotiline

Maprotiline hydrochloride (a derivative of Maprotiline) is reported as an ingredient of Neuomil in the following countries:

• Japan

International Drug Name Search

Pfizer-E

Pfizer-E may be available in the countries listed below.

Ingredient matches for Pfizer-E

Erythromycin

Erythromycin is reported as an ingredient of Pfizer-E in the following countries:

• Ethiopia

International Drug Name Search

Etilmorfina

Etilmorfina may be available in the countries listed below.

Ingredient matches for Etilmorfina

Ethylmorphine

Etilmorfina (DCIT) is also known as Ethylmorphine (BAN)

International Drug Name Search

Glossary

BAN	British Approved Name
DCIT	Denominazione Comune Italiana

Click for further information on drug naming conventions and International Nonproprietary Names.

Tripta

Tripta may be available in the countries listed below.

Ingredient matches for Tripta

Amitriptyline

Amitriptyline hydrochloride (a derivative of Amitriptyline) is reported as an ingredient of Tripta in the following countries:

• Myanmar


• Singapore

International Drug Name Search

Venlagamma

Venlagamma may be available in the countries listed below.

Ingredient matches for Venlagamma

Venlafaxine

Venlafaxine hydrochloride (a derivative of Venlafaxine) is reported as an ingredient of Venlagamma in the following countries:

• Germany


• Slovakia

International Drug Name Search

Alfuzosin Teva

Alfuzosin Teva may be available in the countries listed below.

Ingredient matches for Alfuzosin Teva

Alfuzosin

Alfuzosin is reported as an ingredient of Alfuzosin Teva in the following countries:

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Dermofix

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Sertaconazole

Sertaconazole nitrate (a derivative of Sertaconazole) is reported as an ingredient of Dermofix in the following countries:

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• Portugal


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Theracough

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Guaifenesin

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Cleanxate

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Flavoxate

Flavoxate hydrochloride (a derivative of Flavoxate) is reported as an ingredient of Cleanxate in the following countries:

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Dentosedina

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Benzocaine

Benzocaine is reported as an ingredient of Dentosedina in the following countries:

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Procaine

Procaine hydrochloride (a derivative of Procaine) is reported as an ingredient of Dentosedina in the following countries:

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Amlodipine

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Rotarix

rotavirus vaccine, live

Dosage Form: oral applicator
FULL PRESCRIBING INFORMATION

Indications and Usage for Rotarix

Rotarix® is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies (14.3)]. Rotarix is approved for use in infants 6 weeks to 24 weeks of age.

Rotarix Dosage and Administration

Reconstitution Instructions for Oral Administration

For oral use only. Not for injection.

Reconstitute only with accompanying diluent. Do not mix Rotarix with other vaccines or solutions.

	Remove vial cap and push transfer adapter onto vial (lyophilized vaccine).
	Shake diluent in oral applicator (white, turbid suspension). Connect oral applicator to transfer adapter.
	Push plunger of oral applicator to transfer diluent into vial. Suspension will appear white and turbid.
	Withdraw vaccine into oral applicator.
	Twist and remove the oral applicator.
Ready for oral administration.	Do not use a needle with Rotarix. Not for injection.

Recommended Dose and Schedule

The vaccination series consists of two 1-mL doses administered orally. The first dose should be administered to infants beginning at 6 weeks of age. There should be an interval of at least 4 weeks between the first and second dose. The 2-dose series should be completed by 24 weeks of age.

Safety and effectiveness have not been evaluated if Rotarix were administered for the first dose and another rotavirus vaccine were administered for the second dose or vice versa.

In the event that the infant spits out or regurgitates most of the vaccine dose, a single replacement dose may be considered at the same vaccination visit.

Infant Feeding

Breast-feeding was permitted in clinical studies. There was no evidence to suggest that breast-feeding reduced the protection against rotavirus gastroenteritis afforded by Rotarix. There are no restrictions on the infant’s liquid consumption, including breast-milk, either before or after vaccination with Rotarix.

Dosage Forms and Strengths

Rotarix is available as a vial of lyophilized vaccine to be reconstituted with a liquid diluent in a prefilled oral applicator.

Each 1-mL dose contains a suspension of at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated human G1P[8] rotavirus after reconstitution.

Contraindications

 4.1 Hypersensitivity

 A demonstrated history of hypersensitivity to any component of the vaccine.

 Infants who develop symptoms suggestive of hypersensitivity after receiving a dose of Rotarix should not receive further doses of Rotarix.

Gastrointestinal Tract Congenital Malformation

History of uncorrected congenital malformation of the gastrointestinal tract (such as Meckel’s diverticulum) that would predispose the infant for intussusception.

 4.3 Severe Combined Immunodeficiency Disease

  Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive Rotarix. Postmarketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered live, oral rotavirus vaccines and later identified as having SCID [see Adverse Reactions (6.2)].

Warnings and Precautions

Gastrointestinal Disorders

Administration of Rotarix should be delayed in infants suffering from acute diarrhea or vomiting.

Safety and effectiveness of Rotarix in infants with chronic gastrointestinal disorders have not been evaluated. [See Contraindications (4.2).]

Altered Immunocompetence

Safety and effectiveness of Rotarix in infants with known primary or secondary immunodeficiencies, including infants with human immunodeficiency virus (HIV), infants on immunosuppressive therapy, or infants with malignant neoplasms affecting the bone marrow or lymphatic system have not been evaluated.

Shedding and Transmission

Rotavirus shedding in stool occurs after vaccination with peak excretion occurring around day 7 after dose 1. Live rotavirus shedding was evaluated in 2 studies among a subset of infants at day 7 after dose 1. In these studies, the estimated percentages of recipients of Rotarix who shed live rotavirus were 25.6% (95% Confidence Interval [CI]: 10.2, 41.1) and 26.5% (95% CI: 15.5, 37.5), respectively. Transmission of virus was not evaluated. There is a possibility that the live vaccine virus can be transmitted to non-vaccinated contacts. The potential for transmission of vaccine virus following vaccination should be weighed against the possibility of acquiring and transmitting natural rotavirus.

Intussusception

Following administration of a previously licensed oral live rhesus rotavirus-based vaccine, an increased risk of intussusception was observed.1 The risk of intussusception with Rotarix was evaluated in a pre-licensure safety study (including 63,225 infants) conducted in Latin America and Finland. No increased risk of intussusception was observed in this clinical trial following administration of Rotarix when compared with placebo. [See Adverse Reactions (6.1).]

  Interim postmarketing safety data from a study conducted in Mexico among a birth cohort of infants suggest an increased risk of intussusception in the 31-day period following administration of the first dose of Rotarix. In this study, within the 31-day period after the first dose, most cases of intussusception occurred in the first 7 days. [See Adverse Reactions (6.2).]

In worldwide passive postmarketing surveillance, cases of intussusception have been reported in temporal association with Rotarix [see Adverse Reactions (6.2)].

Post-Exposure Prophylaxis

Safety and effectiveness of Rotarix when administered after exposure to rotavirus have not been evaluated.

Adverse Reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. As with any vaccine, there is the possibility that broad use of Rotarix could reveal adverse reactions not observed in clinical trials.

Solicited and unsolicited adverse events, serious adverse events and cases of intussusception were collected in 7 clinical studies. Cases of intussusception and serious adverse events were collected in an additional large safety study. These 8 clinical studies evaluated a total of 71,209 infants who received Rotarix (N = 36,755) or placebo (N = 34,454). The racial distribution for these studies was as follows: Hispanic 73.4%, white 16.2%, black 1.0%, and other 9.4%; 51% were male.

Solicited Adverse Events: In 7 clinical studies, detailed safety information was collected by parents/guardians for 8 consecutive days following vaccination with Rotarix (i.e., day of vaccination and the next 7 days). A diary card was completed to record fussiness/irritability, cough/runny nose, the infant’s temperature, loss of appetite, vomiting, or diarrhea on a daily basis during the first week following each dose of Rotarix or placebo. Adverse events among recipients of Rotarix and placebo occurred at similar rates (Table 1).

Table 1. Solicited Adverse Events Within 8 Days Following Doses 1 and 2 of Rotarix or Placebo (Total Vaccinated Cohort)

	Dose 1		Dose 2
	Rotarix	Placebo	Rotarix	Placebo
	N = 3,284	N = 2,013	N = 3,201	N = 1,973
	%	%	%	%
Fussiness/irritabilitya	52	52	42	42
Cough/runny noseb	28	30	31	33
Feverc	25	33	28	34
Loss of appetited	25	25	21	21
Vomiting	13	11	8	8
Diarrhea	4	3	3	3

Total vaccinated cohort = all vaccinated infants for whom safety data were available.

N = number of infants for whom at least one symptom sheet was completed.

aDefined as crying more than usual.

bData not collected in 1 of 7 studies; Dose 1: Rotarix N = 2,583; placebo N = 1,897; Dose 2: Rotarix N = 2,522; placebo N = 1,863.

cDefined as temperature ≥100.4°F (≥38.0°C) rectally or ≥99.5°F (≥37.5°C) orally.

dDefined as eating less than usual.

Unsolicited Adverse Events: Infants were monitored for unsolicited serious and non-serious adverse events that occurred in the 31-day period following vaccination in 7 clinical studies. The following adverse events occurred at a statistically higher incidence (95% CI of Relative Risk excluding 1) among recipients of Rotarix (N = 5,082) as compared with placebo recipients (N = 2,902): irritability (Rotarix 11.4%, placebo 8.7%) and flatulence (Rotarix 2.2%, placebo 1.3%).

Serious Adverse Events (SAEs): Infants were monitored for serious adverse events that occurred in the 31-day period following vaccination in 8 clinical studies. Serious adverse events occurred in 1.7% of recipients of Rotarix (N = 36,755) as compared with 1.9% of placebo recipients (N = 34,454). Among placebo recipients, diarrhea (placebo 0.07%, Rotarix 0.02%), dehydration (placebo 0.06%, Rotarix 0.02%), and gastroenteritis (placebo 0.3%, Rotarix 0.2%) occurred at a statistically higher incidence (95% CI of Relative Risk excluding 1) as compared with recipients of Rotarix.

Deaths: During the entire course of 8 clinical studies, there were 68 (0.19%) deaths following administration of Rotarix (N = 36,755) and 50 (0.15%) deaths following placebo administration (N = 34,454). The most commonly reported cause of death following vaccination was pneumonia, which was observed in 19 (0.05%) recipients of Rotarix and 10 (0.03%) placebo recipients (Relative Risk: 1.74, 95% CI: 0.76, 4.23).

Intussusception: In a controlled safety study conducted in Latin America and Finland, the risk of intussusception was evaluated in 63,225 infants (31,673 received Rotarix and 31,552 received placebo). Infants were monitored by active surveillance including independent, complementary methods (prospective hospital surveillance and parent reporting at scheduled study visits) to identify potential cases of intussusception within 31 days after vaccination and, in a subset of 20,169 infants (10,159 received Rotarix and 10,010 received placebo), up to one year after the first dose.

No increased risk of intussusception following administration of Rotarix was observed within a 31-day period following any dose, and rates were comparable to the placebo group after a median of 100 days (Table 2). In a subset of 20,169 infants (10,159 received Rotarix and 10,010 received placebo) followed up to one year after dose 1, there were 4 cases of intussusception with Rotarix compared with 14 cases of intussusception with placebo [Relative Risk: 0.28 (95% CI: 0.10, 0.81)]. All of the infants who developed intussusception recovered without sequelae.

Table 2. Intussusception and Relative Risk With Rotarix Compared With Placebo

Confirmed Cases of Intussusception	Rotarix	Placebo
	N = 31,673	N = 31,552
Within 31 days of diagnosis after any dose	6	7
Relative Risk (95% CI)	0.85 (0.30, 2.42)
Within 100 days of dose 1a	9	16
Relative Risk (95% CI)	0.56 (0.25, 1.24)

 CI = Confidence Interval.

aMedian duration after dose 1 (follow-up visit at 30 to 90 days after dose 2).

Among vaccine recipients, there were no confirmed cases of intussusception within the 0- to 14-day period after the first dose (Table 3), which was the period of highest risk for the previously licensed oral live rhesus rotavirus-based vaccine.1

Table 3. Intussusception Cases by Day Range in Relation to Dose

	Dose 1		Dose 2		Any Dose
Day Range	Rotarix	Placebo	Rotarix	Placebo	Rotarix	Placebo
	N = 31,673	N = 31,552	N = 29,616	N = 29,465	N = 31,673	N = 31,552
0-7	0	0	2	0	2	0
8-14	0	0	0	2	0	2
15-21	1	1	2	1	3	2
22-30	0	1	1	2	1	3
Total (0-30)	1	2	5	5	6	7

Kawasaki Disease: Kawasaki disease has been reported in 18 (0.035%) recipients of Rotarix and 9 (0.021%) placebo recipients from 16 completed or ongoing clinical trials. Of the 27 cases, 5 occurred following Rotarix in clinical trials that were either not placebo-controlled or 1:1 randomized. In placebo-controlled trials, Kawasaki disease was reported in 17 recipients of Rotarix and 9 placebo recipients [Relative Risk: 1.71 (95% CI: 0.71, 4.38)]. Three of the 27 cases were reported within 30 days post-vaccination: 2 cases (Rotarix = 1, placebo = 1) were from placebo-controlled trials [Relative Risk: 1.00 (95% CI: 0.01, 78.35)] and one case following Rotarix was from a non-placebo-controlled trial. Among recipients of Rotarix, the time of onset after study dose ranged 3 days to 19 months.

Postmarketing Experience

The risk of intussusception with Rotarix has been evaluated in a hospital-based Postmarketing Active Surveillance Study (PASS) in a birth cohort of infants in Mexico. An interim analysis of this study suggests an increased risk of intussusception in the 31-day period following administration of the first dose of Rotarix [Relative Risk: 1.8 (99% CI: 1.0, 3.1)]. In this study, within the 31-day period after the first dose, most cases of intussusception occurred in the first 7 days.

Applying the relative risk observed from the interim analysis of the PASS in Mexico to estimates of background rates of intussusception in the US would approximate 0 to 4 additional cases of intussusception hospitalizations per 100,000 vaccinated infants within the 31 days after the first dose. In the first year of life, the background rate of intussusception hospitalizations in the US is approximately 34 per 100,000 infants.2

Worldwide passive postmarketing surveillance data also suggest that most cases of intussusception reported following Rotarix occur in the 7-day period after the first dose.

The following adverse events have been reported since market introduction of Rotarix. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination with Rotarix.

Gastrointestinal Disorders: Intussusception (including death), hematochezia, gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID).

Blood and Lymphatic System Disorders: Idiopathic thrombocytopenic purpura.

Vascular Disorders: Kawasaki disease.

General Disorders and Administration Site Conditions: Maladministration.

Drug Interactions

Concomitant Vaccine Administration

In clinical trials, Rotarix was administered concomitantly with US-licensed and non-US-licensed vaccines. In a US coadministration study in 484 infants, there was no evidence of interference in the immune responses to any of the antigens when PEDIARIX® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined], a US-licensed 7-valent pneumococcal conjugate vaccine (Wyeth Pharmaceuticals Inc.), and a US-licensed Hib conjugate vaccine (Sanofi Pasteur SA) were coadministered with Rotarix as compared with separate administration of Rotarix.

Immunosuppressive Therapies

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to Rotarix. [See Warnings and Precautions (5.2).]

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Rotarix. It is also not known whether Rotarix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Pediatric Use

Safety and effectiveness of Rotarix in infants younger than 6 weeks or older than 24 weeks of age have not been evaluated.

The effectiveness of Rotarix in pre-term infants has not been established. Safety data are available in pre-term infants (Rotarix = 134, placebo = 120) with a reported gestational age ≤36 weeks. These pre-term infants were followed for serious adverse events up to 30 to 90 days after dose 2. Serious adverse events were observed in 5.2% of recipients of Rotarix as compared with 5.0% of placebo recipients. No deaths or cases of intussusception were reported in this population.

Rotarix Description

Rotarix (Rotavirus Vaccine, Live, Oral), for oral administration,  is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus strain is propagated on Vero cells. After reconstitution, the final formulation (1 mL) contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus.

The lyophilized vaccine contains amino acids, dextran, Dulbecco’s Modified Eagle Medium (DMEM), sorbitol, and sucrose. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, sodium hydrogenocarbonate, and phenol red.

In the manufacturing process, porcine-derived materials are used. Porcine circovirus type 1 (PCV-1) is present in Rotarix. PCV-1 is not known to cause disease in humans.

The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach.

Rotarix contains no preservatives.

The tip cap and the rubber plunger of the oral applicator contain dry natural latex rubber. The vial stopper and transfer adapter are latex-free.

Rotarix - Clinical Pharmacology

Mechanism of Action

Prior to rotavirus vaccination programs, rotavirus infected nearly all children by the time they were 5 years of age. Severe, dehydrating rotavirus gastroenteritis occurs primarily among children aged 3 to 35 months.3 Among children up to 3 years of age, approximately 16% of cases before 6 months of age result in hospitalization.4

The exact immunologic mechanism by which Rotarix protects against rotavirus gastroenteritis is unknown [see Clinical Pharmacology (12.2)]. Rotarix contains a live, attenuated human rotavirus that replicates in the small intestine and induces immunity.

Pharmacodynamics

Immunogenicity: A relationship between antibody responses to rotavirus vaccination and protection against rotavirus gastroenteritis has not been established. Seroconversion was defined as the appearance of anti-rotavirus IgA antibodies (concentration ≥20 U/mL) post-vaccination in the serum of infants previously negative for rotavirus. In 2 safety and efficacy studies, one to two months after a 2-dose series, 86.5% of 787 recipients of Rotarix seroconverted compared with 6.7% of 420 placebo recipients and 76.8% of 393 recipients of Rotarix seroconverted compared with 9.7% of 341 placebo recipients, respectively.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Rotarix has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Clinical Studies

Efficacy Studies

The data demonstrating the efficacy of Rotarix in preventing rotavirus gastroenteritis come from 24,163 infants randomized in two placebo-controlled studies conducted in 17 countries in Europe and Latin America. In these studies, oral polio vaccine (OPV) was not coadministered; however, other routine childhood vaccines could be concomitantly administered. Breast-feeding was permitted in both studies.

A randomized, double-blind, placebo-controlled study was conducted in 6 European countries. A total of 3,994 infants were enrolled to receive Rotarix (n = 2,646) or placebo (n = 1,348). Vaccine or placebo was given to healthy infants as a 2-dose series with the first dose administered orally from 6 through 14 weeks of age followed by one additional dose administered at least 4 weeks after the first dose. The 2-dose series was completed by 24 weeks of age. For both vaccination groups, 98.3% of infants were white and 53% were male.

The clinical case definition of rotavirus gastroenteritis was an episode of diarrhea (passage of 3 or more loose or watery stools within a day), with or without vomiting, where rotavirus was identified in a stool sample. Severity of gastroenteritis was determined by a clinical scoring system, the Vesikari scale, assessing the duration and intensity of diarrhea and vomiting, the intensity of fever, use of rehydration therapy or hospitalization for each episode. Scores range from 0 to 20, where higher scores indicate greater severity. An episode of gastroenteritis with a score of 11 or greater was considered severe.5

The primary efficacy endpoint was prevention of any grade of severity of rotavirus gastroenteritis caused by naturally occurring rotavirus from 2 weeks after the second dose through one rotavirus season (according to protocol, ATP). Other efficacy evaluations included prevention of severe rotavirus gastroenteritis, as defined by the Vesikari scale, and reductions in hospitalizations due to rotavirus gastroenteritis and all cause gastroenteritis regardless of presumed etiology. Analyses were also done to evaluate the efficacy of Rotarix against rotavirus gastroenteritis among infants who received at least one vaccination (total vaccinated cohort, TVC).

Efficacy of Rotarix against any grade of severity of rotavirus gastroenteritis through one rotavirus season was 87.1% (95% CI: 79.6, 92.1); TVC efficacy was 87.3% (95% CI: 80.3, 92.0). Efficacy against severe rotavirus gastroenteritis through one rotavirus season was 95.8% (95% CI: 89.6, 98.7); TVC efficacy was 96.0% (95% CI: 90.2, 98.8) (Table 4). The protective effect of Rotarix against any grade of severity of rotavirus gastroenteritis observed immediately following dose 1 administration and prior to dose 2 was 89.8% (95% CI: 8.9, 99.8).

Efficacy of Rotarix in reducing hospitalizations for rotavirus gastroenteritis through one rotavirus season was 100% (95% CI: 81.8, 100); TVC efficacy was 100% (95% CI: 81.7, 100) (Table 4). Rotarix reduced hospitalizations for all cause gastroenteritis regardless of presumed etiology by 74.7% (95% CI: 45.5, 88.9).

Table 4. Efficacy Evaluation of Rotarix Through One Rotavirus Season

	According to Protocola		Total Vaccinated Cohortb
	Rotarix	Placebo	Rotarix	Placebo
Infants in Cohort	N = 2,572	N = 1,302	N = 2,646	N = 1,348
Gastroenteritis cases
Any severity	24	94	26	104
Severec	5	60	5	64
Efficacy estimate against RV GE
Any severity	87.1%d		87.3%d
(95% CI)	(79.6, 92.1)		(80.3, 92.0)
Severec	95.8%d		96.0%d
(95% CI)	(89.6, 98.7)		(90.2, 98.8)
Cases of hospitalization due to RV GE	0	12	0	12
Efficacy in reducing hospitalizations due to RV GE	100%d		100%d
(95% CI)	(81.8, 100)		(81.7, 100)

RV GE = rotavirus gastroenteritis; CI = Confidence Interval.

aATP analysis includes all infants in the efficacy cohort who received two doses of vaccine according to randomization.

bTVC analysis includes all infants in the efficacy cohort who received at least one dose of vaccine or placebo.

cSevere gastroenteritis defined as ≥11 on the Vesikari scale.

dStatistically significant vs. placebo (P <0.001).

A randomized, double-blind, placebo-controlled study was conducted in 11 countries in Latin America and Finland. A total of 63,225 infants received Rotarix (n = 31,673) or placebo (n = 31,552). An efficacy subset of these infants consisting of 20,169 infants from Latin America received Rotarix (n = 10,159) or placebo (n = 10,010). Vaccine or placebo was given to healthy infants as a 2-dose series with the first dose administered orally from 6 through 13 weeks of age followed by one additional dose administered at least 4 weeks after the first dose. The 2-dose series was completed by the age of 24 weeks of age. For both vaccination groups, the racial distribution of the efficacy subset was as follows: Hispanic 85.8%, white 7.9%, black 1.1%, and other 5.2%; 51% were male.

The clinical case definition of severe rotavirus gastroenteritis was an episode of diarrhea (passage of 3 or more loose or watery stools within a day), with or without vomiting, where rotavirus was identified in a stool sample, requiring hospitalization and/or rehydration therapy equivalent to World Health Organization (WHO) plan B (oral rehydration therapy) or plan C (intravenous rehydration therapy) in a medical facility.

The primary efficacy endpoint was prevention of severe rotavirus gastroenteritis caused by naturally occurring rotavirus from 2 weeks after the second dose through one year (ATP). Analyses were done to evaluate the efficacy of Rotarix against severe rotavirus gastroenteritis among infants who received at least one vaccination (TVC). Reduction in hospitalizations due to rotavirus gastroenteritis was also evaluated (ATP).

Efficacy of Rotarix against severe rotavirus gastroenteritis through one year was 84.7% (95% CI: 71.7, 92.4); TVC efficacy was 81.1% (95% CI: 68.5, 89.3) (Table 5).

Efficacy of Rotarix in reducing hospitalizations for rotavirus gastroenteritis through one year was 85.0% (95% CI: 69.6, 93.5); TVC efficacy was 80.8% (95% CI: 65.7, 90.0) (Table 5).

Table 5. Efficacy Evaluation of Rotarix Through One Year

	According to Protocola		Total Vaccinated Cohortb
	Rotarix	Placebo	Rotarix	Placebo
Infants in Cohort	N = 9,009	N = 8,858	N = 10,159	N = 10,010
Gastroenteritis cases
Severe	12	77	18	94
Efficacy estimate against RV GE
Severe	84.7%c		81.1%c
(95% CI)	(71.7, 92.4)		(68.5, 89.3)
Cases of hospitalization due to RV GE	9	59	14	72
Efficacy in reducing hospitalizations due to RV GE	85.0%c		80.8%c
(95% CI)	(69.6, 93.5)		(65.7, 90.0)

RV GE = rotavirus gastroenteritis; CI = Confidence Interval.

aATP analysis includes all infants in the efficacy cohort who received two doses of vaccine according to randomization.

bTVC analysis includes all infants in the efficacy cohort who received at least one dose of vaccine or placebo.

cStatistically significant vs. placebo (P <0.001).

Efficacy Through Two Rotavirus Seasons

The efficacy of Rotarix persisting through two rotavirus seasons was evaluated in two studies.

In the European study, the efficacy of Rotarix against any grade of severity of rotavirus gastroenteritis through two rotavirus seasons was 78.9% (95% CI: 72.7, 83.8). Efficacy in preventing any grade of severity of rotavirus gastroenteritis cases occurring only during the second season post-vaccination was 71.9% (95% CI: 61.2, 79.8). The efficacy of Rotarix against severe rotavirus gastroenteritis through two rotavirus seasons was 90.4% (95% CI: 85.1, 94.1). Efficacy in preventing severe rotavirus gastroenteritis cases occurring only during the second season post-vaccination was 85.6% (95% CI: 75.8, 91.9).

The efficacy of Rotarix in reducing hospitalizations for rotavirus gastroenteritis through two rotavirus seasons was 96.0% (95% CI: 83.8, 99.5).

In the Latin American study, the efficacy of Rotarix against severe rotavirus gastroenteritis through two years was 80.5% (95% CI: 71.3, 87.1). Efficacy in preventing severe rotavirus gastroenteritis cases occurring only during the second year post-vaccination was 79.0% (95% CI: 66.4, 87.4). The efficacy of Rotarix in reducing hospitalizations for rotavirus gastroenteritis through two years was 83.0% (95% CI: 73.1, 89.7).

The efficacy of Rotarix beyond the second season post-vaccination was not evaluated.

Efficacy Against Specific Rotavirus Types

The type-specific efficacy against any grade of severity and severe rotavirus gastroenteritis caused by G1P[8], G3P[8], G4P[8], G9P[8], and combined non-G1 (G2, G3, G4, G9) types was statistically significant through one year. Additionally, type-specific efficacy against any grade of severity and severe rotavirus gastroenteritis caused by G1P[8], G2P[4], G3P[8], G4P[8], G9P[8], and combined non-G1 (G2, G3, G4, G9) types was statistically significant through two years (Table 6).

Table 6. Type-Specific Efficacy of Rotarix Against Any Grade of Severity and Severe Rotavirus Gastroenteritis (According to Protocol)

	Through One Rotavirus Season			Through Two Rotavirus Seasons
	Number of Cases			Number of Cases
	Rotarix	Placebo	% Efficacy	Rotarix	Placebo	% Efficacy
Type Identifieda	N = 2,572	N = 1,302	(95% CI)	N = 2,572	N = 1,302