Home page Home page
AstraZeneca

Vepacel
Prepandemic influenza vaccine (H5N1) (whole virion, inactivated,prepared in cell culture)

Package leaflet: Information for the user VEPACEL suspension for injection

Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)


image This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.


Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.


Sodium chloride Water for injections Polysorbate 80.

What VEPACEL looks like and contents of the pack


VEPACEL is presented as a suspension for injection in multidose vial (10 doses of 0.5 ml per vial) in pack size of 20 vials.


The suspension is clear to opalescent.


Marketing Authorisation Holder


Ology Bioservices Ireland LTD Wilton Park House

Wilton Place Dublin 2

D02P447

Ireland


Manufacturer


Baxter AG Uferstrasse 15

A-2304 Orth/Donau Austria


This leaflet was last revised in


Medicinal product no longer authorised

eu/.


---------------------------------------------------------------------------------------------------------------------------


The following information is intended for healthcare professionals only:


Multidose vial (10 doses of 0.5 ml per vial)

The vaccine should be allowed to reach room temperature before use. Shake before use. After shaking, the vaccine is a clear to opalescent suspension.

Prior to administration, visually inspect the suspension for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vaccine.


The vaccine should not be administered intravascularly.


Any unused vaccine or waste material should be disposed of in accordance with local requirements. After first opening, the vial is to be used within a maximum of 3 hours.

Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.