SII MEASLESMUMPS & RUBELLA VACCINE LIVE ATTENUATED (FREEZE-DRIED) 10 DOSES

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

Caesalpinia sappan; LIVE ATTENUATED MEASLES VIRUS

Dostępny od:

SM PHARMACEUTICALS SDN. BHD.

INN (International Nazwa):

Caesalpinia sappan; LIVE ATTENUATED MEASLES VIRUS

Sztuk w opakowaniu:

0.5ml mL

Wyprodukowano przez:

SERUM INSTITUTE OF INDIA PRIVATE LIMITED

Ulotka dla pacjenta

Not applicable

Charakterystyka produktu

SERUM INSTITUTE OF INDIA PVT. LTD. Item Code number: Colour: Pantone 220C and 072CDimensions: 123 x 247 mm
Product: Reason for issue: Shelf Life text revisedCustomer: MalaysiaSpecification No.: Artwork made to: 100% QUALITY
CONTROLPACKAGING
DEVELOPMENTREGULATORY
AFFAIRSQUALITY
ASSURANCEFile name: E:\Packaging artworks as on 090212\Artworks SII Pvt Ltd 231015\Insert\Malaysia\MMR insert.cdr Date : 28.02.18Supercedes Item Code:Specification: To be printed on bible paper 40 gsm.MEDICAL
DEPARTMENT
20013694/1035 5205/8/F3
Sii MEASLES, MUMPS AND RUBELLA VACCINE Live, Attenuated (Freeze-Dried)
Vaccinum morbillorum, parotitidis et
rubeolae vivum lyophilisatumDESCRIPTION
The vaccine is prepared from the live, attenuated strains of Edmonston-Zagreb measles virus, Leningrad-Zagreb
(L-Z) mumps virus and Wistar RA 27/3 rubella virus. The measles and rubella viruses are propagated on human
diploid cells (HDC) and the mumps virus is grown on chick fibroblasts from SPF eggs (Specific pathogen free
eggs). The vaccine is freeze-dried and is provided with diluent. The product has the appearance of yellowish-
white dry cake. The vaccine meets the requirements of W.H.O. when tested by the methods outlined in W.H.O.,
TRS 840 (1994).
POTENCY
Each single human dose when reconstituted in a volume of 0.5 ml contains not less than 1000 CCID of measles
50
virus, 5000 CCID of mumps virus and 1000 CCID of Rubella virus. In addition, the freeze-dried vaccine when
5050
stored at 37ºC for 7 days shows no loss in potency (less than 1.0 log loss in virus titres).
10
INDICATIONS
For active immunization against measles, mumps and rubella in children from 12 months to 10 years of age.
Second dose of MMR is usually advocated any time before the age of 6 years (elementary school entry
4-6 years).In children above 10 years, adolescents and adults, Measles and Rubella (MR) vaccine is
recommended. Revaccination may seroconvert primary failures or boost antibody titres of previously
vaccinated individuals whose titers have declined. The Advisory Committee