Rotavirus Vaccine, Live Attenuated (Oral) (Freeze-Dried) Serum Institute of India

Rotavirus Vaccine, Live Attenuated (Oral) (Freeze-Dried) Serum Institute of India

vaccine, rotavirus

Manufacturer:

Serum Institute of India

Distributor:

Masu
Concise Prescribing Info
Contents
Live attenuated bovine [human rotavirus reassortant (G1, G2, G3, G4 & G9) ≥ 105.6 FFU/serotype]
Indications/Uses
Active immunization of healthy infants 6 wk for prevention of gastroenteritis due to rotavirus infection.
Dosage/Direction for Use
Contraindications
Hypersensitivity. Infants w/ history of uncorrected congenital malformation of the GI tract & intussusception. Severe combined immunodeficiency disease.
Special Precautions
Do not administer parenterally. Immunocompromised infants (eg, infected w/ HIV or chronic gastroenteritis) & those in close contact w/ immunodeficient persons. Delay administration in acute infection or febrile illness. Carefully evaluate for symptoms suggestive of intussusception. Not for adults including women of childbearing age, pregnant or lactating.
Adverse Reactions
Fever, irritability, decreased appetite, decreased activity level, vomiting & diarrhea.
Drug Interactions
Immunosuppressive therapy (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs & corticosteroids) may reduce the immune response to vaccines.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BH02 - rota virus, pentavalent, live, reassorted ; Belongs to the class of rota virus diarrhea vaccines.
Presentation/Packing
Form
Rotavirus Vaccine, Live Attenuated (Oral) (Freeze-Dried) Serum Institute of India oral vaccine
Packing/Price
(diluent + 1 adapter and 2 syringe) 5 mL x 1's; (diluent + 1 adapter and syringe) 2.5 mL x 1's
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