Rotavac 5D Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Per 0.5 mL Live attenuated rotavirus 116E vaccine (vero cell derived) not <10⁵ FFU

Indications/Uses

Active immunization of infants ≥6 wk for prevention of gastroenteritis due to rotavirus infection.

Click to view Rotavac 5D detailed prescribing information

Dosage/Direction for Use

3-dose regimen: 1st dose should begin at the age of 6 wk w/ at least 4 wk interval between doses. Vaccination course should be completed by the age of 8 mth (34 wk), up to 24 mth.

Click to view Rotavac 5D detailed prescribing information

Overdosage

View Rotavac 5D overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Babies w/ severe combined immunodeficiency disease; history of intussusception/intestinal malformations predisposing to intussusception; ongoing gastroenteritis.

Click to view Rotavac 5D detailed prescribing information

Special Precautions

Not to be injected. May not provide complete protection against rotavirus induced gastroenteritis or gastroenteritis due to other pathogens. May delay vaccination in case of acute infection or febrile illness. Infants who are immune-compromised; infected w/ HIV or w/ chronic gastroenteritis; in close contact w/ immune-deficient persons. Assess symptoms suggestive of intussusception eg, continuous vomiting, blood in stools & abdominal lump or distention. Not to be administered to adults including pregnant women.

Click to view Rotavac 5D detailed prescribing information

Use In Pregnancy & Lactation

Click to view Rotavac 5D detailed prescribing information

Adverse Reactions

Fever, cough, crying. Diarrhea.

Click to view Rotavac 5D detailed prescribing information

Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Rotavac 5D detailed prescribing information

Storage

View Rotavac 5D storage conditions for details to ensure optimal shelf-life.

Description

View Rotavac 5D description for details of the chemical structure and excipients (inactive components).

Action

View Rotavac 5D mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J07BH01 - rota virus, live attenuated ; Belongs to the class of rota virus diarrhea viral vaccines.

Thai FDA Category

Presentation/Packing

Form

Rotavac 5D oral liqd ≥100,000 FFU

Packing/Price

((multidose)) 2.5 mL x 1's; ((singe-dose)) 0.5 mL x 10 × 1's

Rotavac 5D

rotavirus vaccine

Manufacturer:

Bharat Biotech

Distributor:

Biogenetech

Marketer:

Biogenetech