Before Using VERORAB: Intradermal route.
Do not use VERORAB: Intradermal route (Pre-Exposure and Post-Exposure Vaccination): The Intradermal route must not be used in the following instances: individuals receiving long term corticosteroid or other immunosuppressive therapy or chloroquine, immunocompromised individuals, individuals, particularly children, with severe wounds, especially to the head and neck or presenting late for consultation.
Pre-Exposure Vaccination via intradermal route: Primary-vaccination: As according to WHO, VERORAB may be given intradermally (0.1 ml dose on day 0, D7 and D21 or D28).
However, intramuscular injections are preferable if antimalarial chemoprophylaxis (e.g. chloroquine) is being used concurrently or there is a possibility of an immune-compromised state (antibody response may be impaired if the intradermal method is used).
Post-exposure vaccination via intradermal route: Intradermal schedule: This vaccine is of sufficient potency to allow its safe use in the WHO recommended intradermal post-exposure regimen in countries where relevant national authorities have approved the intradermal route for rabies post-exposure treatment.
If VERORAB is administered by the intradermal route, the following instructions and warnings must be strictly adhered to.
Dosage and administration for intradermal route: One intradermal dose comprises 0.1 ml of reconstituted vaccine, i.e. 1/5 of the intramuscular dose. For Verorab, the administration schedule recommended by WHO is: Non-immunized individuals: The 2-site intradermal regimen (known as updated Thai Red Cross regimen, 22202) prescribes 1 injection of 0.1 ml at 2 sites on days 0, D3, D7, and D28.
Fully immunized individuals: 2 injections on D0, D3. This schedule should not apply to immunocompromised patients.
The intradermal (ID) injection may be used as an alternative, on upper or forearm. The intradermal (ID) injection is not approved by all national authorities.
Special Precautions for the Intradermal Route: It is essential that intradermal administration of VERORAB be carried out only by medical staff trained in this technique in order to ensure that the vaccine is delivered intradermally and not subcutaneously. For the intradermal route a sterile syringe with fixed needle (insulin type) is preferred. Correct intradermal injection should result in a raised papule with an "orange peel" (peau d'orange) appearance.
If the vaccine is injected too deeply into the skin, and a pa pule is not seen, the needle should be withdrawn and reinserted nearby. If there is a complete failure to inject intradermally at more than half of the multiple injection sites, an extra intradermal dose should be given in the opposite site.
Special Storage Conditions for the Intradermal Route: VERORAB does not contain a preservative; therefore, great care must be taken to avoid contamination of reconstituted vaccine. Vaccine may be used up to 8 hours after reconstitution provided it is maintained at 2°C to 8°C. Unused vaccine must be discarded after 8 hours.
Using aseptic technique, a dose of vaccine may be withdrawn from a vial and the remainder used for another patient provided that the vial is stored in a refrigerator between +2°C and +8°C. A new sterile needle and syringe must be used to withdraw and administer each dose of vaccine for each patient to avoid cross infection.
The following information is intended for healthcare professionals only: Injection-schedule recommendations should be followed scrupulously.
To reconstitute the vaccine: Take the cap off the vial of powder.
Inject the content of the prefilled syringe of solvent into the vial of powder.
Shake gently in order to obtain a homogenous vaccine suspension. The reconstituted vaccine appears as a limpid homogenous liquid.
Withdraw 0.5 mL of suspension and inject immediately.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
This medicinal product is subject to medical prescription (List I).