Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
Ambirix, suspension for injection in pre-filled syringe.
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
| Pharmaceutical Form |
|---|
|
Suspension for injection. Ambirix is a turbid white suspension. |
1 dose (1 ml) contains:
Hepatitis A virus (inactivated)1,2 720 ELISA Units.
Hepatitis B surface antigen3,4 20 micrograms.
1 Produced on human diploid (MRC-5) cells
2 Adsorbed on aluminium hydroxide, hydrated 0.05 milligrams Al3+
3 Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
4 Adsorbed on aluminium phosphate 0.4 milligrams Al3+
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Hepatitis A, inactivated vaccine |
Inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, highly purified, formalin inactivated, and then adsorbed onto amorphous aluminum hydroxyphosphate sulphate. |
|
| Hepatitis B, purified antigen |
Hepatitis B vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg). Hepatitis B vaccine has been recognized as the first anti-cancer vaccine because it can prevent primary liver cancer. |
| List of Excipients |
|---|
|
Sodium chloride For adjuvants, see section 2. |
1 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl).
Pack sizes of 1 and 10 pre-filled syringes with or without needles and pack size of 50 pre-filled syringes without needles.
Not all pack sizes may be marketed.
GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
PLGB 19494/0259
Date of first authorisation: 01/01/2021
| Drug | Countries | |
|---|---|---|
| AMBIRIX | Austria, Estonia, Croatia, Ireland, Lithuania, Netherlands, Poland, United Kingdom |
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