SII Measles and Rubella Virus Vaccine live.Attenuated(Freeze-Dried) 10 doses

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

measles, live attenuated; rubella, live attenuated

Tilgjengelig fra:

SM PHARMACEUTICALS SDN. BHD.

INN (International Name):

measles, live attenuated; rubella, live attenuated

Enheter i pakken:

10 dose vial x50vial Vials

Produsert av:

SERUM INSTITUTE OF INDIA PRIVATE LIMITED

Informasjon til brukeren

Not applicable

Preparatomtale

Item Code number: Colour: Pantone 2665C and 072CDimensions: 123 x 247 mmProduct: Reason for issue: Shelf Life text revisedCustomer: EXPORTS - MALAYSIASpecification No.: Artwork made to: 100% QUALITY
CONTROLPACKAGING
DEVELOPMENTREGULATORY
AFFAIRSQUALITY
ASSURANCEE:\Packaging artworks as on 090212\Artworks SII Pvt Ltd 231015\Insert\Malaysia\MR insert.cdr Rev. on : 28.02.18Supercedes Item Code: 20011159/1Specification: Two colour printing on maplito paper (bible)
not less than 40 gsm.MEDICAL
DEPARTMENT MEASLES AND RUBELLA VACCINE
Live, Attenuated (Freeze-Dried)20011159/2
SiiDESCRIPTION
The vaccine is prepared from the live, attenuated strains of Edmonston-Zagreb measles virus and
Wistar RA 27/3 rubella virus. Both measles and rubella viruses are propagated on human diploid cells
(HDC). The vaccine is lyophilized and is provided with diluent. The product has the appearance of a
yellowish-white dry cake. The vaccine meets the requirements of WHO when tested by the methods
outlined in WHO, TRS 840(1994).
POTENCY
Each single human dose when reconstituted in a volume of 0.5 ml contains not less than 1000 CCIDof
50
measles virus and 1000 CCID of rubella virus.
50
INDICATIONS
For active immunization against measles and rubella in infants, children, adolescents and young
adults at risk. Immunization of susceptible non-pregnant adolescent and adult females is indicated if
certain precautions are observed (see CONTRAINDICATIONS).The vaccine can be safely and
effectively given simultaneously with DTP, DT, TT, Td, BCG, Polio vaccine (OPV and IPV), Haemophilus
influenzae type b, Hepatitis B, Yellow fever vaccine and vitamin A supplementation.
APPLICATION AND DOSAGE
The vaccine should be reconstituted only with the entire diluent supplied (Sterile water for injection)
using a sterile syringe and needle. With gentle shaking the dried cake is easily dissolved. After
reconstitution the vaccine should be used immediately. A single dose of 0.5 ml should be administered
by deep subcutaneous injection into the anterolateral aspect of up