Finished product reference
Rotavirus Vaccine, Monovalent, Live
Solution · Oral · 5 dose
- List code
- 53445
- Pharmacologic class
- Vaccine (live attenuated rotavirus, monovalent, oral)
What it is and how it works
Contains a live attenuated human rotavirus strain (G1P[8]) that replicates in the intestine and induces protective immunity, including cross-protection against other common serotypes. It prevents severe rotavirus gastroenteritis in infants.
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 two-dose course, the first dose from 6 weeks of age with at least 4 weeks between doses, completed according to the product licence (preferably before 16 weeks and no later than 24 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 severe abdominal pain, persistent vomiting, blood in stools or abdominal swelling. Postpone in acute febrile illness, diarrhoea or vomiting; vaccine virus is shed in stools, so hand hygiene is advised, especially near immunocompromised contacts.
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.
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.
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