מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LIVE ATTENUATED MEASLES VIRUS; LIVE ATTENUATED RUBELLA VIRUS; LIVE ATTENUATED MUMPS VIRUS
MERCK SHARP & DOHME (MALAYSIA) SDN BHD
LIVE ATTENUATED MEASLES VIRUS; LIVE ATTENUATED RUBELLA VIRUS; LIVE ATTENUATED MUMPS VIRUS
1Units Units
MERCK SHARP & DOHME B.V.
Not Applicable קרא את המסמך השלם
S-LPC-V205C-I-022020B LOCAL PRODUCT CIRCULAR MALAYSIA Injection M-M-R II ® (MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE) M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) is a live virus vaccine for vaccination against measles (rubeola), mumps and rubella (German measles). M-M- R II is a sterile lyophilized preparation of (1) ATTENUVAX (Measles Virus Vaccine Live, MSD), a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; (2) MUMPSVAX (Mumps Virus Vaccine Live, MSD), the Jeryl Lynn (B level) strain of mumps virus propagated in chick embryo cell culture; and (3) MERUVAX II (Rubella Virus Vaccine Live, MSD), the Wistar RA 27/3 strain of live attenuated rubella virus propagated in W1 - 38 human diploid lung fibroblasts. The reconstituted vaccine is for subcutaneous administration. “When reconstituted as directed, the dose for injection is 0.5 mL and contains not less than 1,000 CCID 50 (50% cell culture infecti ous dose) of measles virus; 12,500 CCID 50 of mumps virus; and 1,000 CCID 50 of rubella virus. Each dose of the vaccine is calculated to contain s orbitol (1 4.5 mg), sodium phosphate, sucrose (1.9 mg), hydrolyzed gelatin (14.5 mg), recombinant albumin ( ≤ 0.3 mg), fetal bovine serum (<1 ppm), other buffer and media ingredients and approximately 25 mcg of neomycin.” The product contains no preservative. Sorbitol and hydrolyzed gelatin are added as stabilizers. CLINICAL PHARMACOLOGY Measles, mumps, and rubella are three common childhood diseases, caused by measles virus, mumps virus (paramyxoviruses), and rubella virus (togavirus), respectively, that may be associated with serious complications and/or death. For example, pneumonia and encephalitis are caused by measles. Mumps is associated with aseptic meningitis, deafness and orchitis; and rubella during pregnancy may cause congenital rubella syndrome in the infants of infected mothers. Clinical studies of 279 triple seronegative children, 11 months to 7 years קרא את המסמך השלם