Pays: Indonésie
Langue: indonésien
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 50 VIAL @ 20 DOSIS + PELARUT
2022-11-25
Item Code number: Colour: Pantone Process Blue C and Pantone 072 C Dimensions: 123 x 247 mm Product: Reason for issue: Text revised Customer: Indonesia Specification No.: Artwork made to: 100% QUALITY CONTROL PACKAGING DEVELOPMENT REGULATORY AFFAIRS QUALITY ASSURANCE File Name: E:\Packaging artworks as on 090212\Artworks SII Pvt Ltd 231015\Insert\Indonesia\BCG Vaccine 4 folds, Indonesia Final.cdr Date: 07.10.17 035 5205/8/F3 Supercedes Item Code: MEDICAL DEPARTMENT BCG VACCINE Specification: To be printed on bible 40 gsm. paper 20011954/3 20011954/2 “On medical prescription only” Reg. No.: DKI1340300144A1 Imported by : PT Bio Farma (Persero) Jl. Pasteur No. 28, Bandung, Indonesia SII BCG VACCINE (Freeze-Dried) DESCRIPTION BCG Vaccine is a live freeze-dried vaccine derived from attenuated strain of _Mycobacterium bovi_s (Bacillus Calmette Guerin Moscow strain 361- I) used for the prevention of tuberculosis. The freeze-dried vaccine is white and crystalline in appearance. It contains Sodium Glutamate as stabilizer. The vaccine meets the requirements of W.H.O. when tested by the methods outlined in W.H.O., TRS. 979 (2013). COMPOSITION Live, attenuated BCG Vaccine (Bacillus Calmette Guerin Strain) 5 5 Each 0.1 ml contains between : 2 x 10 and 8 x 10 C.F.U. Reconstitute with Sodium Chloride Injection Dose : 0.05 ml, Intradermal for infants under one year old. : 0.1 ml, Intradermal for children over one year of age and adult. RECONSTITUTION Tap the vaccine vial gently so as to get the white and crystalline vaccine powder at the bottom of the vial. BCG vaccine vial of 20 doses (0.05 ml) for infants under one year old /10 doses (0.1 ml) for children over one year of age and adult to be reconstituted by adding the entire content of the supplied container of diluent (Sodium Chloride Injection). Carefully invert the vial a few times to resuspend freeze dried BCG. Gently swirl the vial of resuspended vaccine before drawing up each subsequent dose. The resulting suspension should be homogenous, slightly opaque and colourl Lire le document complet