Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: GlaxoSmithKline Biologicals s.a., rue de lInstitut 89, B-1330 Rixensart, Belgium
Adjupanrix suspension and emulsion for emulsion for injection.
Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted).
| Pharmaceutical Form |
|---|
|
Suspension and emulsion for emulsion for injection. The suspension is a colourless light opalescent liquid. The emulsion is a whitish to yellowish homogeneous milky liquid. |
After mixing, 1 dose (0.5 ml) contains:
Split influenza virus, inactivated, containing antigen* equivalent to: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14) 3.75 micrograms**.
* propagated in eggs
** haemagglutinin (HA)
This vaccine complies with the WHO recommendation and EU decision for the pandemic.
AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
The suspension and emulsion vials once mixed form a multidose container. See section 6.5 for the number of doses per vial.
Excipient with known effect:
The vaccine contains 5 micrograms thiomersal (see section 4.4).
For the full list of excipients see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Influenza, inactivated, split virus |
|
| List of Excipients |
|---|
|
Suspension vial: Polysorbate 80 Emulsion vial: Sodium chloride (NaCl) For adjuvants, see section 2. |
One pack containing:
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml).
GlaxoSmithKline Biologicals s.a., rue de l’Institut 89, B-1330 Rixensart, Belgium
EU/1/09/578/001
Date of first authorisation: 19 October 2009
Date of latest renewal: 31 July 2019
| Drug | Countries | |
|---|---|---|
| ADJUPANRIX | Austria, Estonia, Croatia, Ireland, Lithuania, Poland, Singapore |
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