Krajina: Tanzánia
Jazyk: angličtina
Zdroj: Tanzania Medicinces & Medical Devices Authority
Live Attenuated Rotavirus Vaccine
Serum Institute of India Pvt. Ltd. (SIIPL), INDIA
Infectious bursa disease
Live Attenuated Rotavirus Vaccine
10^5.6 FFU/serotype
Lyophilized powder for reconstitution
Serum Institute of India Private Limited, INDIA
Physical description: Pinkish to yellowish-White mass; Local technical representative: JILICHEM (T) Limited (5053)
Registered/Compliant
2021-11-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rotavirus Vaccine, Live Attenuated, (Oral) (Freeze-Dried) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2.5 mL contains: Live Attenuated Bovine-Human Rotavirus Reassortant [G1, G2, G3, G4 and G9]* ≥ 10 5.6 FFU / serotype. Reconstitute with Diluent for Rotavirus Vaccine. Diluent is a sterile solution (Citrate Bicarbonate Buffer) prepared using 9.6 mg/mL citric acid and 25.6 mg/mL sodium bicarbonate. * Grown on vero cells. Excipient(s) with known effect Eagle's MEM (Minimum Essential Medium with Hank's Salts, Glutamine and Sodium bicarbonate). Sucrose and Glycine. The vaccine is supplied along with a 2.5 mL vial for one dose and 5 mL vial for two doses of buffered diluent. This vaccine contains no preservatives. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilized powder to be reconstituted with buffered diluent for oral administration. Description: Pinkish to yellowish white mass. Appearance: Pinkish to yellowish liquid when reconstituted with diluent and may contain inherent product aggregates. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rotavirus Vaccine, Live Attenuated, (Oral) is indicated for active immunization of healthy infants from the age of 6 weeks for the prevention of gastroenteritis due to rotavirus infection when administered as a 3-dose series. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ROTAVIRUS VACCINE, LIVE ATTENUATED (ORAL) IS FOR ORAL ADMINISTRATION ONLY AND MUST _ _NOT BE INJECTED_. _DOSAGE:_ Rotavirus Vaccine, Live Attenuated (Oral) should be administered as a 3-dose regimen, 4 weeks apart, beginning at 6 weeks of age. Based on recommendations from the World Health Organization, if the routine childhood immunizations are initiated later than 6 weeks of age and/or at a longer dose interval than 4-weeks, Rotavirus Vaccine, Live Attenuated (Oral) can still be administered, by itself or concomitantly with DTP, inactivated poliovirus vaccine (IPV), oral poliovirus vaccine (OPV), H. Prečítajte si celý dokument