Verorab

Verorab Dosage/Direction for Use

vaccine, rabies

Manufacturer:

sanofi pasteur

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Posology: One dose consists in the administration of 0.5 mL of vaccine via the intramuscular route.
The intradermal (ID) route may be used as an alternative. One intradermal dose consists of 0.1 mL of reconstituted vaccine, i.e. 1/5 of the intramuscular dose.
The vaccination schedule should be adapted according to the circumstances of vaccination and the subject's rabies immunity status (see Tables 1 and 2).
Pre-exposure vaccination: Three doses of VERORAB are administered at D0, D7 and D28 for primary vaccination. The dose scheduled at D28 can be administered at D21.
The doses are administered either by IM or ID route. The Intradermal route must not be used for immunocompromised individuals (see Contraindications). 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).
Booster doses and regular serological tests, to assess the subjects' seroconversion status, are recommended. The frequency of booster doses and tests is indicated in Table 1.
Each booster dose consists in the IM administration of one dose of 0.5 mL.
VERORAB can be administered as a booster injection after primary vaccination with a cell culture rabies vaccine (a rabies vaccine prepared in VERO cells or prepared in human diploid cells (HDCV)). (See Table 1.)

Click on icon to see table/diagram/image

For immunodeficient subjects, a serological test should be performed 2 to 4 weeks after vaccination. If the test result shows antibody titers strictly below 0.5 IU/mL, an additional injection is justified.
Post-exposure vaccination: Post-exposure treatment includes local non-specific treatment of the wound, vaccination and passive immunization with rabies immunoglobulins if necessary. The treatment should be adapted to the nature of the contact or of the wound (see Table 2), the condition of the animal (see Table 3) and the patient's rabies vaccination status.
First aid: local treatment of the wound: Local treatment of all bites and scratches is very important and must be performed immediately.
First aid recommendations include immediate flushing out of the wound for at least 15 minutes with water and soap, detergent, povidone iodine or any other substance with a proven destructive action on the rabies virus. If no soap or antiviral agents are available, the wound should be extensively flushed out with water.
If necessary, the treatment can be supplemented by the administration of a prophylactic tetanus treatment and an antibiotherapy in order to prevent the development of infections other than rabies.
Vaccination: (See Table 2 and Table 3.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Post-exposure vaccination must be performed by appropriately trained medical staff, and as soon as possible following exposure.
Vaccination of non-immunized subjects (subjects who did not receive pre-exposure vaccination): Essen regimen: Five doses of 0.5 mL of VERORAB are administered by IM route at D0, D3, D7, D14 and D28.
Or;
Zagreb regimen (schedule 2-1-1): IM administration of four doses of 0.5 mL of VERORAB: one dose administered in the right deltoid region and one dose administered in the left deltoid region at D0, then one dose administered in the deltoid region at D7 and D21 (see Method of administration for the administration site in young children under Dosage & Administration).
Or;
The 2-site intradermal regimen (known as updated Thai Red Cross regimen, 2-2-2-0-2), which prescribes 1 injection of 0.1 mL at 2 sites on days 0, D3, D7, and D28. The Intradermal route must not be used for immunocompromised individuals (see Contraindications).
Whatever the regimen used, vaccination must not be discontinued unless made possible by the animal's health status.
Whatever the regimen used, rabies immunoglobulins should be administered at D0 concomitantly with the vaccine, in case of category III exposure (WHO classification, see Table 2). The rabies immunoglobulins posology is as follows: Human rabies immunoglobulins 20 IU/kg of body weight; Equine rabies immunoglobulins 40 IU/kg of body weight.
For more information, please see the Summary of Characteristics of the rabies immunoglobulins used.
When possible, the vaccine should be administered contra-laterally to the immunoglobulins administration sites.
For immunodeficient subjects, in case of Category II exposure (WHO Classification, see Table 2), rabies immunoglobulins should also be administered concomitantly with the vaccine.
Vaccination of subjects already immunized (full pre-exposure vaccination confirmed): If pre-exposure vaccination was performed with cell culture rabies vaccine, two booster doses are administered at D0 and D3 by IM route. Rabies immunoglobulins are not necessary. This schedule should not apply to immunocompromised patients (see Vaccination of nonimmunized subjects as previously mentioned).
If pre-exposure vaccination is incomplete or in case of doubt, the subject's vaccination status is not considered as complete and a full post-exposure treatment should be started (see Vaccination of non-immunized subjects as previously mentioned).
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.
Paediatric population: VERORAB can be administered to children and to adults using the same posology.
Method of administration: Precautions to be taken before handling or administering the medicinal product.
The vaccine is administered via the intramuscular route, generally in the anterolateral region of the thigh muscle until the age of 12 months and in the deltoid muscle after this age.
The intradermal (ID) injection may be used as an alternative, in upper arm or forearm.
Do not inject in the buttocks region.
Do not inject via the intravascular route.
For instructions on reconstitution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.
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