Sign Out
ROTAVAC 5D is pinkish yellow colored sterile liquid oral use, may contain white suspended particles, in the final container of the product. Vigorous shaking/mixing, does not dissolve the particles.
Rotavirus Vaccine (Live Attenuated, Oral) is a monovalent vaccine containing suspension of live attenuated rotavirus 116E prepared in Vero cells. Rotaviruses are double-stranded RNA virus of the genus Reoviridae. Rotaviruses are classified in a dual classification system based on two proteins on the surface of the virus into G and P types. Based on this nomenclature, Rotavirus 116E is classified as G9P[11]. A single human dose of ROTAVAC 5D is 0.5 mL containing not less than [NLT] 105.0 FFU [Focus Forming Unit] of live rotavirus 116E.
Composition: Each dose of 0.5 mL contains: Vero cell derived Rotavirus 116E bulk, Live attenuated NLT 105.0 FFU, Neomycin Sulphate BP 15 μg, Kanamycin Acid Sulphate BP 15 μg, Sucrose BP 0.25 gms, Trehalose BP 2.5 mg, Lactalbumin Hydrolysate (LAH) 2.5 mg, Human Albumin BP 0.35%, Potassium Di-Hydrogen Orthophosphate BP 1.65 mg, Di-Potassium Hydrogen Orthophosphate BP 10 mg, Trisodium Citrate Dihydrate BP 7.75 mg, Water for Injections BP q.s.
pH range: 6.50 to 7.50.
Excipients/Inactive Ingredients: Neomycin Sulphate, Kanamycin Acid Sulphate, Sucrose, Trehalose, Lactalbumin Hydrolysate (LAH), Human Albumin, Potassium Di-Hydrogen Orthophosphate, Di-Potassium Hydrogen Orthophosphate, Trisodium Citrate Dihydrate.
Continue with Google