देश: इंडोनेशिया
भाषा: इंडोनेशियाई
स्रोत: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LIVE ATTENUATED MYCOBACTERIUM BOVIS (BACILLUSS CALMETTE GUERIN STRAIN)
BIO FARMA - Indonesia
LIVE ATTENUATED MYCOBACTERIUM BOVIS (BACILLUSS CALMETTE GUERIN STRAIN)
0.75 MG
SERBUK INJEKSI
DUS, 1 DUS @ 10 VIAL @ 0,75 MG (10 DOSIS DEWASA) + 1 DUS @ 10 VIA...
AJ VACCINE A/S - Denmark
2021-06-17
CONFIDENTIAL Page 1 of 7 09-Nov-2020 Final BCG Vaccine AJV Summary of Product Characteristics SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BCG Vaccine AJV, powder and solvent for suspension for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.1 mL) for adults and children aged 12 months and over contains: _Mycobacterium bovis_ (_M. bovis_) Bacillus Calmette-Guerin (BCG), Danish strain 1331, live attenuated, 2-8 x 10 5 CFU. After reconstitution, 1 dose (0.05 mL) for infants under 12 months of age contains: _M. bovis_ BCG, Danish strain 1331, live attenuated_,_ 1-4 x 10 5 CFU. This is a multidose container. See Section 6.5 for the number of doses per vial. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for suspension for injection. White crystalline powder (might be difficult to see due to the small amount in the vial). The solvent is a colourless solution without any visible particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Active immunisation against tuberculosis. BCG Vaccine AJV is to be used according to official national recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: _Adults, adolescents and children aged 12 months or more: _ \jor ILIVaccines DISETUJUI OLEH BPOM : 17 MEI 2021 EREG100409VR12100075 CONFIDENTIAL Page 2 of 7 09-Nov-2020 Final BCG Vaccine AJV Summary of Product Characteristics A dose of 0.1 mL of the reconstituted vaccine is injected strictly by the intradermal route. _Infants under 12 months of age:_ A dose of 0.05 mL of the reconstituted vaccine is injected strictly by the intradermal route. National recommendations should be consulted regarding the need for tuberculin testing before administration of BCG Vaccine AJV. Method of Administration: The injection site should be clean and dry. If antiseptics (such as alcohol) are applied to swab the skin, they should be allowed to evaporate completely before the injection is given. BCG Vaccine AJV must be administered पूरा दस्तावेज़ पढ़ें