ERVEBO Solution for injection Ref.[27940] Active ingredients: Ebola vaccine

Ervebo should be administered by a trained healthcare worker.

Posology

Individuals 18 years of age or older: one dose (1 mL) (see section 5.1).

The need for a booster dose has not been established.

Paediatric population

The safety, immunogenicity and efficacy of Ervebo in children aged 1 to 17 years have not yet been established (see sections 4.8 and 5.1).

Method of administration

For precautions to be taken before administering the vaccine, see section 4.4.

For precautions regarding thawing, handling and disposal of the vaccine, see section 6.6.

Ervebo should be administered by the intramuscular (IM) route. The preferred site is the deltoid area of the non-dominant arm or in the higher anterolateral area of the thigh. Do not inject the vaccine intravascularly. No data are available for administration via the subcutaneous or intradermal routes.

Cover the vaccination injection site or any vesicles with an adequate bandage (e.g. any adhesive bandage or gauze and tape) that provides a physical barrier to protect against direct contact (see sections 4.4 and 5.3). The bandage may be removed when there is no visible fluid leakage.

The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.

No cases of overdose have been reported.

3 years.

Store and transport frozen at -80°C to -60°C.

After thawing, the vaccine should be used immediately; however, in-use stability data have demonstrated that once thawed, the vaccine can be stored for up to 14 days at 2°C to 8°C prior to use. At the end of 14 days, the vaccine should be used or discarded. Upon removal from the freezer, the product should be marked with both the date that it was taken out of the freezer and also a new discard date (in place of the labelled expiry date). Once thawed, the vaccine cannot be re-frozen.

Keep the vial in the outer carton in order to protect from light.

Solution for 1 dose in a vial (type I glass) with a stopper (chlorobutyl) and a flip-off plastic cap with aluminium seal.

Pack size of 10 vials.

• The vaccine is stored frozen at -80°C to -60°C and should be removed from the freezer and thawed in less than 4 hours until no visible ice is present. Do not thaw the vial in a refrigerator as it is not guaranteed that the vial will thaw in less than 4 hours. The thawed vial should then be gently inverted several times prior to withdrawal with the syringe. The vaccine should appear as a colourless to slightly brownish-yellow liquid with no particulates visible. Discard the vaccine if particulates are present.
• Withdraw the entire content of the vaccine from the vial using a sterile needle and syringe.

If feasible, the waste liquid from eye washes should be collected and decontaminated before discarding into the drain.

Any unused vaccine or waste material should be disposed in compliance with the institutional guidelines for genetically modified organisms or biohazardous waste, as appropriate.

If breakage/spillage were to occur, disinfectants such as aldehydes, alcohols and detergents are proven to reduce viral infection potential after only a few minutes.