البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
measles, live attenuated; rubella, live attenuated
SM PHARMACEUTICALS SDN. BHD.
measles, live attenuated; rubella, live attenuated
50x1dosevial Vials
SERUM INSTITUTE OF INDIA PRIVATE LIMITED
Not applicable اقرأ الوثيقة كاملة
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 اقرأ الوثيقة كاملة