MMR II VACCINE

Страна: Малайзия

Език: английски

Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активна съставка:

LIVE ATTENUATED MEASLES VIRUS; LIVE ATTENUATED RUBELLA VIRUS; LIVE ATTENUATED MUMPS VIRUS

Предлага се от:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Международно Name):

LIVE ATTENUATED MEASLES VIRUS; LIVE ATTENUATED RUBELLA VIRUS; LIVE ATTENUATED MUMPS VIRUS

Броя в опаковка:

1Units Units

Произведено от:

MERCK SHARP & DOHME B.V.

Листовка

Not Applicable

Данни за продукта

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