Land: Indonesië
Taal: Indonesisch
Bron: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
MEASLES VIRUS VACCINE LIVE ATTENUATED; RUBELLA VIRUS VACCINE LIVE ATTENUATED
BIO FARMA - Indonesia
MEASLES VIRUS VACCINE LIVE ATTENUATED; RUBELLA VIRUS VACCINE LIVE ATTENUATED
5 DOSIS
CAIRAN INJEKSI
DUS, 50 VIAL @ 5 DOSIS + DUS, 50 AMPUL PELARUT @ 2,5 ML
SERUM Institute - India
2019-06-24
DESCRIPTION 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 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 50 of measles virus and 1000 CCID of rubella virus. 50 INDICATIONS For active immunization against measles and rubella in children age 9 months – 16 years old. The vaccine can be given simultaneously with IPV, Yellow fever vaccine and Rotavirus vaccine. APPLICATION AND DOSAGE The vaccine should be reconstituted only with the entire diluent supplied (Sterile water for injections) 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 upper thigh in toddlers and upper arm in older children. If the vaccine is not used immediately then it should be stored in the dark at 2-8ºC for no longer than 6 hours. Any opened container remaining at the end of a session (within six hours of reconstitution) should be discarded. The vaccine vial monitor (see figure), for this type of vaccine is attached to the vial cap and should be discarded when the vaccine is being reconstituted. The diluent supplied is specially designed for use with the vaccine. Only this diluent must be used to reconstitute the vaccine. Do not use diluents from other types of vaccine or for MR vaccine from other manufacturers. Water for injections must NOT be used for this purpose. Using an incorrect diluent may result in damage to the vaccine and/or serious reactions to those receiving the vaccine. Diluent must n Lees het volledige document