Land: Indonesia
Språk: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LIVE REASSORTANT HUMAN-BOVINE ROTAVIRUS TYPE G1, LIVE REASSORTANT HUMAN-BOVINE ROTAVIRUS TYPE G2, LIVE REASSORTANT HUMAN ROTAVIRUS TYPE G3, LIVE REASSORTANT HUMAN ROTAVIRUS TYPE G4, LIVE REASSORTANT HUMAN-BOVINE ROTAVIRUS TYPE P1
ORGANON PHARMA INDONESIA TBK - Indonesia
LIVE REASSORTANT HUMAN-BOVINE ROTAVIRUS TYPE G1, LIVE REASSORTANT HUMAN-BOVINE ROTAVIRUS TYPE G2, LIVE REASSORTANT HUMAN ROTAVIRUS TYPE G3, LIVE REASSORTANT HUMAN ROTAVIRUS TYPE G4, LIVE REASSORTANT HUMAN-BOVINE ROTAVIRUS TYPE P1
2,2 X 10 PANGKAT 6 IU /2,8 X 10 PANGKAT 6 IU /2,2 X 10 PANGKAT 6 IU /2,0 X 10 PANGKAT 6 IU /2,3 X 10
CAIRAN ORAL
DUS, 10 POUCH @ 1 TUBE @ 2 ML
MERCK SHARP & DOHME CORP. - United States of America
2021-08-05
_ _ SOLUTION FOR ORAL ADMINISTRATION ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT, MSD) I. THERAPEUTIC CLASS RotaTeq is a live, oral liquid pentavalent vaccine which protects against rotavirus gastroenteritis. II. COMPOSITION ACTIVE INGREDIENTS Each 2 mL dose contains the following human-bovine rotavirus reassortants: G1, G2, G3, G4, and P1A[8]. The minimum dose levels of the reassortants are as follows: G1 2.2 X 10 6 infectious units G2 2.8 X 10 6 infectious units G3 2.2 X 10 6 infectious units G4 2.0 X 10 6 infectious units P1A[8] 2.3 X 10 6 infectious units The reassortants are propagated in Vero cells using standard tissue culture techniques in the absence of antifungal agents. INACTIVE INGREDIENTS The reassortant are suspended in a buffered stabilizer solution. Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80 and also culture media. There are no preservatives or thimerosal present. III. INDICATIONS RotaTeq is an oral pentavalent vaccine indicated for the prevention of rotavirus gastroenteritis in infants and caused by the serotypes G1, G2, G3, G4, and G-serotypes that contain P1A[8] (e.g., G9). RotaTeq may be administered as early as six weeks of age. DISETUJUI OLEH BPOM: 18/10/2023 ID EREG100373VR12300309 _ _ IV. DOSAGE AND ADMINISTRATION FOR ORAL USE ONLY. NOT FOR INJECTION. Posology The vaccination series consists of three ready-to-use liquid doses of RotaTeq administered orally to infants. The first dose of RotaTeq should be administered at 6 to 12 weeks of age; the subsequent doses should be administered at a minimum interval of 4 weeks between each dose. There are no restrictions on the infant’s consumption of food or liquid, including breast milk, either before or after vaccination with RotaTeq. RotaTeq may be given to pre-term infants according to their chronological age. If for any reason an incomplete dose is administered (e.g., infant spits or regurgitates the vaccine), a replacement dose is not recommended, since Les hele dokumentet