M-M-R II VACCINE

Šalis: Singapūras

kalba: anglų

Šaltinis: HSA (Health Sciences Authority)

Veiklioji medžiaga:

MEASLES VIRUS (MORE ATTENUATED ENDER'S STRAIN) (LIVE); MUMPS VIRUS (JERYL LYNN STRAIN) (LIVE); RUBELLA VIRUS (WISTAR RA 27/3 STRAIN) (LIVE)

Prieinama:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC kodas:

J07BD52

Dozė:

min 1000 CCID50/0.5 ml

Vaisto forma:

INJECTION, POWDER, FOR SOLUTION

Sudėtis:

MEASLES VIRUS (MORE ATTENUATED ENDER'S STRAIN) (LIVE) min 1000 CCID50/0.5 ml; MUMPS VIRUS (JERYL LYNN STRAIN) (LIVE) min 12500 CCID50/0.5ml; RUBELLA VIRUS (WISTAR RA 27/3 STRAIN) (LIVE) min 1000 CCID50/0.5 ml

Vartojimo būdas:

SUBCUTANEOUS

Recepto tipas:

Prescription Only

Pagaminta:

Merck Sharp & Dohme LLC

Autorizacija statusas:

ACTIVE

Leidimo data:

1988-06-24

Pakuotės lapelis

SG-IPC-V205C-I-032014 
INTERNATIONAL PHYSICIANS CIRCULAR 
Injection 
M-M-R
® II 
(MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE) 
WORLDWIDE PRODUCT LABELING 

MRL 
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), sodium chloride, hydrolyzed gelatin (14.5 mg),
recombinant human albumin 
(0.3 mg), fetal bovine serum (<1ppm), 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 infant

Prekės savybės

SG-IPC-V205C-I-022020
INTERNATIONAL PHYSICIANS CIRCULAR
INJECTION
M-M-R II®
(MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE)
WORLDWIDE PRODUCT LABELING
MRL
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