Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
BCG vaccine(Bacillus Calmette Guerin Strain)
Serum Institute of India Pvt. Ltd.
J07AN01
BCG vaccine(Bacillus Calmette Guerin Strain)
between 2x10^5 and 8x10^5 CFU/0,1ml
powder lyophilized for solution for injection
(50) 10/20 dose glass vial/ (50/5x10/) sodium chloride 0.9% 1ml ampoules with solvent in blister, (300/6 box/)(50) 10/20 dose gl
Prescription
Registered
2017-10-23
Sii Sii DESCRIPTION BCG Vaccine is a live freeze-dried vaccine derived from attenuated strain of Mycobacterium bovis (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 re-suspend freeze dried BCG. Gently swirl the vial of re-suspended vaccine before drawing up each subsequent dose. The resulting suspension should be homogenous, slightly opaque and colourless. The reconstituted suspension may occasionally show clumps, which is normal characteristic of Mycobacterium bovis. Avoid vigorous shaking which may enhance/aggrevate clumps formation. Reconstitute only with diluent provided by manufacturer. Using an incorrect diluent may result in damage to the vaccine and / or serious reactions to those receiving the vaccine. Use immediately after reconstitution. If the vaccine is not used immediately then it must be stored in the dark at 2 - 8 º C for no longer than 6 hours (1 immunisation session). Any opened vial remaining at the end of a vaccination session (within six hours of reconstitution) must be discarded. The vaccine vial monitor for this type of vaccine i Прочитать полный документ
SERUM INSTITUTE OF INDIA PVT. LTD. BCG VACCINE (FREEZE DRIED), 1 ML (0.05 ML X 20 DOSE/0.1 ML X 10 DOSE) SPC Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT BCG Vaccine (Freeze Dried), 1 ml (0.1 ml x 10 dose / 0.05 ml x 20 dose) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BCG Vaccine is a live freeze-dried vaccine derived from attenuated strain of _Mycobacterium bovis_. (Bacillus Calmette Guerin 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). BCG vaccine (Freeze-Dried)-10/20 doses, contains of a lyophilized powder and a diluent for reconstitution (Sodium Chloride Injection B.P. (0.9% w/v), 1 ml). COMPOSITION Live, attenuated BCG Vaccine (Bacillus Calmette Guerin Strain) Each 0.1 ml contains between : 2 x 10 5 and 8 x 10 5 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. 3. PHARMACEUTICAL FORM Freeze-dried powder for injection (Supplied with diluent separately i.e. sodium chloride injection B.P. (0.9% w/v), 1 ml in USP Type-1 glass ampoules) 4. CLINICAL DATA 4.1. THERAPEUTIC INDICATIONS BCG vaccine should be given routinely to all infants at risk of early exposure to tuberculosis. This vaccine should be given soon after the child is born. BCG administered early in life provides high level of protection particularly against severe forms of childhood tuberculosis and tubercular meningitis. In countries with low prevalance of tuberculosis, BCG vaccination should be restricted to high risk groups such as hospital personnel and tuberculin negative contacts of known cases of tuberculosis. The vaccine can be given simultaneously with DTP, DT, TT, Measles, Polio, Hepatitis B, Haemophilus influenzae type b, yellow fever vaccines and vita Прочитать полный документ