PROQUAD® ( Measles Mumps Rubella AND Varicella (OkaMerck) Virus Vaccine Live MSD) LYOPHILIZED 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; LIVE ATTENUATED VARICELLA OKA STRAIN 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; LIVE ATTENUATED VARICELLA OKA STRAIN VIRUS

Броя в опаковка:

1 Units

Произведено от:

MERCK SHARP & DOHME B.V.

Данни за продукта

1
LOCAL PRODUCT CIRCULAR
LPC-PQDR-I-ref-082021b
PROQUAD
®
[MEASLES, MUMPS,
RUBELLA AND VARICELLA (OKA/MERCK) VIRUS VACCINE LIVE]
REFRIGERATOR
-
STABLE FORMULATION
I. THERAPEUTIC CLASS
ProQuad
®
is a c
ombined
attenuated
live virus vaccine
containing
measles, mumps, rubella,
and varicella viruses. ProQuad is a sterile
lyophilized
preparation
of (1) the
components
of M-
M-R II*
(Measles,
Mumps and Rubella Virus Vaccine Live): Measles Virus Vaccine Live, a
more
attenuated
line of measles virus, derived from Enders'
attenuated
Edmonston
strain and
propagated in chick embryo cell culture; Mumps Virus Vaccine Live, the
Jeryl Lynn™ (B level)
strain of mumps virus propagated in chick embryo cell culture; Rubella
Virus Vaccine Live, the
Wistar RA 27/3 strain of live a
ttenuated
rubella virus
propagated
in WI-38 human diploid lung
fibroblasts;
and
(2)
Varicella
Virus
Vaccine
Live
(Oka/Merck),
the
Oka/Merck
strain
of
varicella-
zoster virus propagated in MRC
-5 cells (
hereafter referred to as VARIVAX
*).
II. COMPOSITION
IIA. ACTIVE INGREDIENTS
ProQuad,
when
reconstituted
as
directed,
is
a
sterile
preparation
for
subcutaneous
administration. Each 0.5
-
mL dose contains not less than 3.00 log
10
TCID
50
(50% tissue culture
infectious dose) of measles virus; 4.30 log
10
TCID
50
of mumps virus; 3.00 log
10
TCID
50
of
rubella virus; and a minimum of 3.99 log
10
PFU (plaque-forming units) of
Oka/Merck
varicella
virus.
IIB. INACTIVE INGREDIENTS
Each 0.5-mL dose of the vaccine contains no more than 20 mg of
sucrose, 11 mg of
hydrolyzed gelatin, 2.5 mg of urea, 2.3 mg of sodium
chloride,
16 mg of sorbitol, 0.38 mg of
monosodium
L-
glutamate,
1.4 mg of sodium
phosphate,
0.25 mg of
recombinant
human
albumin, 0.13 mg of sodium bicarbonate, 94 mcg of
potassium
phosphate,
58 mcg of
potassium chloride; residual
components of MRC
-5 cells including DNA and protein; 5 mcg of
neomycin,
bovine serum albumin (0.5 mcg), and other buffer and media
ingredients.
The
product contains no
preservative
. This product contains trace
quantities
of