M-M-R II SERBUK INJEKSI 0,5 ML

Country: Индонезија

Језик: Индонежански

Извор: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Активни састојак:

MUMPS VIRUS VACCINE, LIVE; POLYRIBOSYL RIBITOL PHOSPHATE; RUBELLA VIRUS VACCINE LIVE ATTENUATED

Доступно од:

MERCK SHARP & DOHME PHARMA - Indonesia

INN (Међународно име):

MUMPS VIRUS VACCINE, LIVE; POLYRIBOSYL RIBITOL PHOSPHATE; RUBELLA VIRUS VACCINE LIVE ATTENUATED

Дозирање:

0,5 ML

Фармацеутски облик:

SERBUK INJEKSI

Јединице у пакету:

DUS, 1 VIAL @ 0,5 ML + 1 VIAL PELARUT @ 0,7 ML

Произведен од:

MERCK SHARP & DOHME - Netherlands

Датум одобрења:

2018-12-28

Карактеристике производа

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
WI-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 infectious 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
sorbitol (14.5 mg), sodium
phosphate, sucrose (1.9 mg), hydrolyzed gelatin (14.5 mg), recombinant
human 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.
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
284
triple
seronegative
children,
11 months
to
7
years
of
age,
demonstrated that M-M-R II is highly immunogenic and generally well
tolerated. In these
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