Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: AJ Vaccines A/S, 5 Artillerivej, DK-2300 Copenhagen S, Denmark
BCG Vaccine AJV, powder and solvent for suspension for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for suspension for injection. White crystalline powder (might be difficult to see due to the small amount of powder in the vial). The solvent is a colourless solution without any visible particles. |
After reconstitution, 1 dose (0.1 ml) for adults and children aged 12 months and over contains: Mycobacterium bovis BCG (Bacillus Calmette-Guerin), Danish strain 1331, live attenuated, 2-8 × 105 cfu.
After reconstitution, 1 dose (0.05 ml) for infants under 12 months of age contains: Mycobacterium bovis BCG (Bacillus Calmette-Guerin), Danish strain 1331, live attenuated, 1-4 × 105 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.
| Active Ingredient | Description | |
|---|---|---|
| BCG vaccine |
BCG vaccine is an immunostimulating agent. It has anti-tumor activity, but the exact mechanism of action is not known. |
| List of Excipients |
|---|
|
Powder: Sodium glutamate Solvent: Magnesium sulphate heptahydrate |
Powder in amber Type I glass vial with bromobutyl stopper and aluminium cap; 1 ml of solvent in Type I glass vial with a chlorobutyl stopper and an aluminium cap.
Packages of 1, 5, 10 vials and a 1 vial presentation including 1 unidose injection kit (one polypropylene syringe and two injection needles (one long for adding solvent and one short for intradermal injection)).
One vial of reconstituted vaccine contains 1 ml, corresponding to 10 doses for adults and children aged 12 months and over (0.1 ml) or 20 doses for infants under 12 months of age (0.05 ml).
Not all pack sizes may be marketed.
AJ Vaccines A/S, 5 Artillerivej, DK-2300 Copenhagen S, Denmark
PL 46796/0001
Date of first authorisation: 9 September 2002
Date of latest renewal: 26 October 2007
| Drug | Countries | |
|---|---|---|
| BCG VACCINE AJV | Estonia, Finland, France, New Zealand, Poland, United Kingdom |
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