Land: Indonesia
Språk: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LIVE ATTENUATED MEASLES VIRUS (SCHWARZ STRAIN), LIVE ATTENUATED MUMPS VIRUS (RIT4385 STRAIN), LIVE ATTENUATED RUBELLA VIRUS (RA27/3 STRAIN), LIVE ATTENUATED VARICELLA ZOSTER VIRUS (OKA STRAIN)
SMITHKLINE BEECHAM PHARMACEUTICALS - Indonesia
LIVE ATTENUATED MEASLES VIRUS (SCHWARZ STRAIN), LIVE ATTENUATED MUMPS VIRUS (RIT4385 STRAIN), LIVE ATTENUATED RUBELLA VIRUS (RA27/3 STRAIN), LIVE ATTENUATED VARICELLA ZOSTER VIRUS (OKA STRAIN)
LEBIH BESAR DARI ATAU SAMA DENGAN 10 PANGKAT 3.0 CCID_50 /LEBIH BESAR DARI ATAU SAMA DENGAN 10 PANGK
SERBUK INJEKSI + PELARUT
DUS, 1 VIAL + 1 PREFILLED SYRINGE PELARUT @ 0,5 ML + 2 JARUM
GlaxoSmithKline Biologicals SA - Belgium
2022-04-05
ERS_leaPRItetinj_MA Transfer SBP to GWI (Project Rinjani)_circ1_24Jan22 Page 1 of 8 PRIORIX-TETRA MEASLES, MUMPS, RUBELLA AND VARICELLA VACCINE Powder and solvent for solution for injection QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 mL) contains: Live attenuated measles virus 1 (Schwarz strain) not less than 10 3.0 CCID 50 3 Live attenuated mumps virus 1 (RIT 4385 strain, derived from Jeryl Lynn strain) not less than 10 4.4 CCID 50 3 Live attenuated rubella virus 2 (Wistar RA 27/3 strain) not less than 10 3.0 CCID 50 3 Live attenuated varicella virus 2 (Oka strain) not less than 10 3.3 PFU 4 1 produced in chick embryo cells 2 produced in human diploid (MRC-5) cells 3 Cell Culture Infective Dose 50% 4 Plaque forming units The powder is white to slightly pink. The solvent is clear and colourless. CLINICAL INFORMATION INDICATIONS _PRIORIX-TETRA_ is indicated for active immunisation in subjects from the age of 12 months up to 6 years of age inclusive against measles, mumps, rubella and varicella (see also “_Warnings and Precautions)._ DOSAGE AND ADMINISTRATION Posology Subjects from the age of 12 months up to 6 years of age should receive 2 doses of _PRIORIX-TETRA_ to ensure optimal protection against measles, mumps, rubella and varicella (see _Pharmacodynamics_). It is preferable to respect an interval of at least 6 weeks between doses. In no circumstances should this interval be less than 4 weeks. Alternatively, and in accordance with applicable official recommendations*: - A single dose of _PRIORIX-TETRA_ may be administered to children who have already received a single dose of another measles, mumps and rubella (MMR) vaccine and/or a single dose of another varicella vaccine**. - A single dose of _PRIORIX-TETRA_ may be administered followed by a single dose of another measles, mumps and rubella (MMR) vaccine and/or a single dose of another varicella vaccine. _* Applicable official recommendations may vary regarding the interval between doses of measles, mumps_ _and rubella and of Les hele dokumentet