देश: इंडोनेशिया
भाषा: इंडोनेशियाई
स्रोत: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LIVE ATTENUATED RECOMBINANT JAPANESE ENCEPHALITIS VIRUS
AVENTIS PHARMA - Indonesia
LIVE ATTENUATED RECOMBINANT JAPANESE ENCEPHALITIS VIRUS
4.0-5.8 LOG PFU
SERBUK INJEKSI
DUS, 1 VIAL @ 0,5 ML + 1 VIAL PELARUT NaCl @ 0,5 ML + 1 SYRINGE +...
GOVERNMENT PHARMACEUTICAL ORGANIZATION - MERIEUX BIOLOGICAL PRODUCTS CO., LTD. - Thailand
2020-04-18
KSF/XXXXXX ---.---.--- IMOJEV® POWDER AND DILUENT* FOR SUSPENSION FOR INJECTION JAPANESE ENCEPHALITIS VACCINE (LIVE, ATTENUATED) * 0.4% Sterile Sodium chloride solution (IMOJEV®) * 0.9% Sterile Sodium chloride solution (IMOJEV®Multidose) COMPOSITION After reconstitution, one dose (0.5 mL) contains: Live, attenuated, recombinant Japanese encephalitis virus*: 4.0 - 5.8 log PFU** * Propagated in Vero cells ** Plaque Forming Unit LIST OF EXCIPIENTS Powder Mannitol, Lactose monohydrate, Glutamic acid, Potassium hydroxide, Histidine, Human Serum Albumin Diluent Sodium chloride, Water for injections No adjuvant or antimicrobial preservative is added PHARMACEUTICAL FORM Powder and diluent for suspension for injection The powder is a white to creamy white homogeneous cake which might be retracted from the sides of the vial. The diluent is a clear solution. After reconstitution, IMOJEV® is a colourless to amber suspension. THERAPEUTIC INDICATION Imojev is indicated for prophylaxis of Japanese encephalitis caused by the Japanese encepha- litis virus, in subjects from 9 months of age and over. POSOLOGY AND ADMINISTRATION Posology Primary Vaccination: Subjects 9 months of age and over one 0.5 mL single injection of the reconstituted vaccine. Booster - Paediatric population Paediatric population (up to 18 years of age): If a long term protection* is required, one 0.5 mL dose of IMOJEV® should be given as a booster dose after primary vaccination. The booster dose should be given preferably 12 months after primary vaccination and can be given up to 24 months after primary vaccination. One 0.5 mL dose of Imojev can also be given as a booster vaccination in children who were previously given an inactivated Japanese encephalitis vaccine for primary vaccination, in accordance with the recommended timing for the booster of the inactivated Japanese encephalitis vaccine. *Immunity is maintained at a high level at least 4 years after the booster dose when the vaccine used for primary vaccination is JE-CV (Imojev). - Adult populatio पूरा दस्तावेज़ पढ़ें