Finished product reference
Rotavirus Vaccine, Pentavalent, Live
Powder, for Suspension · Oral · 5 mL
- List code
- 52997
- Pharmacologic class
- Vaccine (live rotavirus, pentavalent, oral)
What it is and how it works
Contains five live human–bovine reassortant rotaviruses expressing human G1, G2, G3, G4 and P1A[8] antigens. After oral administration they replicate in the intestine and induce protective immunity against rotavirus gastroenteritis.
Indications
Active immunisation of infants from 6 weeks of age for prevention of gastroenteritis due to rotavirus infection.
Dosage and administration (summary)
Given orally as a three-dose course, the first dose between 6 and 12 weeks of age with at least 4 weeks between doses, preferably completed by 20–22 weeks and no later than 32 weeks of age.
Contraindications
Hypersensitivity to a previous dose or component; history of intussusception or uncorrected congenital gastrointestinal malformation predisposing to it; severe combined immunodeficiency.
Warnings and precautions
There is a small increased risk of intussusception, mainly within 7 days after the first dose; carers should seek urgent advice for symptoms suggesting it. Postpone in acute febrile illness, diarrhoea or vomiting; vaccine virus may be shed in stools, so hand hygiene is advised.
Storage and supply
Store at 2–8 °C; do not freeze; protect from light.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.