Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
MEASLES VIRUS ENDERS EDMONSTON STRAIN (LIVE, ATTENUATED); MUMPS VIRUS JERYL LYNN™ (LEVEL B) STRAIN (LIVE, ATTENUATED); RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED); VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED)
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
J07BD54
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
MEASLES VIRUS ENDERS EDMONSTON STRAIN (LIVE, ATTENUATED); VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED); RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED); MUMPS VIRUS JERYL LYNN™ (LEVEL B) STRAIN (LIVE, ATTENUATED)
S.C, I.M
Required
MERCK SHARP & DOHME LLC, USA
MEASLES, COMBINATIONS WITH MUMPS, RUBELLA AND VARICELLA, LIVE ATTENUATED
ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella, and varicella in individuals from 12 months of age to 12 years of age.ProQuad can be administered to individuals from 9 months of age under special circumstances: outbreak situations, or travel to a region with high prevalence of measles.
2020-10-31
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ProQuad ® powder and solvent for suspension for injection in a pre-filled syringe. Measles, mumps, rubella and varicella vaccine (live). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, one dose (0.5 mL) contains: Measles virus 1 Enders’ Edmonston strain (live, attenuated) ......... not less than 3.00 log 10 TCID 50 * Mumps virus 1 Jeryl Lynn™ (Level B) strain (live, attenuated) .... not less than 4.30 log 10 TCID 50 * Rubella virus 2 Wistar RA 27/3 strain (live, attenuated) ................ not less than 3.00 log 10 TCID 50 * Varicella virus 3 Oka/Merck strain (live, attenuated) ..................... not less than 3.99 log 10 PFU** *50% tissue culture infectious dose **plaque-forming units ( 1 ) Produced in chick embryo cells. ( 2 ) Produced in human diploid lung (WI-38) fibroblasts. ( 3 ) Produced in human diploid (MRC-5) cells. The vaccine may contain traces of recombinant human albumin (rHA). This vaccine contains a trace amount of neomycin. See section 4.3. Excipient(s) with known effect The vaccine contains 16 milligrams of sorbitol per dose. See section 4.4. For the full list of excipients, see section 6.1. _ _ _ _ 3. PHARMACEUTICAL FORM Powder and solvent for suspension for injection in a pre-filled syringe. Before reconstitution, the powder is a white to pale yellow compact crystalline cake and the solvent is a clear colourless liquid. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella, and varicella in individuals from 12 months of age to 12 years of age. 2 ProQuad can be administered to individuals from 9 months of age under special circumstances: outbreak situations, or travel to a region with high prevalence of measles (see sections 4.2, 4.4, and 5.1). 4.2 Posology and method of administration Posology ProQuad should be used in accordance to official recommendations. • Individuals 12 months of age to 12 years of age Individual Đọc toàn bộ tài liệu