Verorab

Verorab

vaccine, rabies

Manufacturer:

Sanofi Pasteur

Distributor:

Zuellig
Full Prescribing Info
Contents
Inactivated purified rabies vaccine prepared on vero cell line.
Description
The active substance is: After reconstitution, 1 dose (0.5 mL) contains: Rabies virus*, WISTAR Rabies PM/WI38 1503-3M strain (inactivated) ≥2.5 IU**.
*Produced in VERO cells.
**Quantity measured according to the NIH test against the international standard.
The other ingredients are: Powder*: maltose, 20% human albumin solution, Basal Medium Eagle (mixture of mineral salts, vitamins, dextrose and amino-acids including L-Phenylalanine), water for injections.
*Composition of the powder before the freeze-drying step.
Solvent: sodium chloride, water for injections.
Action
Pharmacotherapeutic group: rabies vaccines. ATC code: J07BG01.
Indications/Uses
VERORAB is indicated for the prevention of rabies in children and adults. It can be used before or after exposure to the rabies virus, as a primary vaccination or as a booster dose.
Pre-exposure rabies prevention (pre-exposure vaccination): Pre-exposure vaccination should be offered to subjects at high risk of contamination by the rabies virus.
All those at permanent risk, such as the personnel of diagnostic, research or production laboratories working with the rabies virus, should be vaccinated. Immunity should be maintained by booster doses (see How to use VERORAB under Dosage & Administration).
Vaccination is also recommended for the following categories, given the frequency of exposure to risk: Veterinarians and veterinarians' assistants, animal handlers (including those manipulating bats) and forest warden (gamekeepers), taxidermists.
People in contact with potentially rabid animal species (such as dogs, cats, skunks, raccoons and bats).
Adults and children living in or traveling to enzootic areas.
Post-exposure rabies prevention (post-exposure vaccination): Vaccination should be initiated immediately at the slightest risk of rabies contamination. It must imperatively be performed in a rabies centre under medical supervision.
Post-exposure treatment includes local non-specific treatment of the wound, vaccination and passive immunisation with rabies immunoglobulins. The treatment should be adapted to the nature of the contact or of the wound, the condition of the animal and the patient's rabies vaccination status (see How to use VERORAB under Dosage & Administration).
Local treatment of the wound must be performed in all cases.
Dosage/Direction for Use
Always use this medicine exactly as the doctor or pharmacist has told to. Check with the doctor or pharmacist if the patient is not sure. One dose consists in the administration of 0.5 mL of vaccine via the intramuscular route.
Pre-exposure vaccination: Three doses of 0.5 mL of VERORAB are administered at D0, D7 and D28 for primary vaccination. The dose scheduled at D28 can be administered at D21.
Booster doses and regular serological tests, to assess the subjects' seroconversion status, are recommended. The frequency of booster doses and serological tests is indicated in Table 1.
Each booster dose consists in the administration of one dose of 0.5 mL. (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 immunisation with rabies immunoglobulins. 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 tetanus treatment and an antibiotherapy in order to prevent the development of infections other than rabies.
Vaccination: Post-exposure vaccination must be performed under medical supervision, only in a rabies centre and as soon as possible following exposure. (See Tables 2 and 3.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Vaccination of non-immunised subjects (subjects who did not receive pre-exposure vaccination): Essen regimen.
Five doses of 0.5 mL of VERORAB are administered at D0, D3, D7, D14 and D28.
Zagreb regimen (schedule 2-1-1).
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.
Whatever the regimen used, vaccination must not be discontinued unless made possible by the animal's health status (see Table 3).
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 package leaflet of the rabies immunoglobulins used.
When possible, the vaccine should be administered contra-laterally to the immunoglobulins administration sites.
For immunodeficient subjects, in the case of Category II exposure (WHO Classification, see Table 2), rabies immunoglobulins should also be administered concomitantly with the vaccine.
Vaccination of subjects already immunised (full pre-exposure vaccination confirmed): If pre-exposure vaccination was perfomed less than 5 years before (cell culture rabies vaccine): two booster doses are administered at DO and D3. Rabies immunoglobulins are not necessary.
This does not apply to immunodeficient subjects.
If pre-exposure vaccination was perfomed more than 5 years before, if it 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-immunised subjects previously).
If the patient is immunodeficient, a full post-exposure treatment should also be started (see Vaccination of non-immunised subjects previously).
Use in children: VERORAB can be administered to children and to adults using the same posology.
Method of administration: The vaccine is administered by 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.
If the Zagreb regimen is used, one dose should be administered in each deltoid muscle (left and right) in adults at D0, then one dose at D7 and D21.
VERORAB must not be injected in the buttocks region.
The vaccine must not be injected via the intravascular route.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist or nurse.
Contraindications
Pre-exposure vaccination: If the patient is allergic to the active substance or any of the other ingredients of this medicine, listed in Description.
If the patient developed an allergic reaction during a previous injection of this medicine or of any vaccine with the same composition.
If the patient is feverish or if has an acute disease (in this case, it is preferable to postpone vaccination).
Post-exposure vaccination: Given the fatal outcome of the declared rabies infection, there are no contraindications to post-exposure vaccination.
Special Precautions
As with all vaccines, VERORAB may not protect 100% of people vaccinated.
VERORAB must not be administered via the intravascular route; make sure the needle does not penetrate a blood vessel.
Use with caution if the patient is allergic to polymyxin B, to streptomycin or to neomycin (present in trace amounts in the vaccine) or to any antibiotic of the same group.
As with all injectable vaccines, appropriate medical treatment and supervision must be readily available in case of a rare anaphylactic reaction after vaccine administration.
Serological tests (assay of neutralising antibodies using the RFFIT - Rapid Fluorescent Focus Inhibition Test - method) should be performed regularly, see Table 1 under Dosage & Administration.
When the vaccine is administered to subjects with a known decreased immunity (immunodeficiency), due to a suppressive disease or to a concomitant immunosuppressive treatment, a serological test should be performed 2 to 4 weeks after vaccination, see How to use VERORAB under Dosage & Administration.
VERORAB should be administered with caution to subjects with a decreased platelet level (thrombocytopenia) or clotting disorders, because of the risk of bleeding that may occur during intramuscular administration. Talk to the doctor, pharmacist or nurse before using VERORAB.
Driving and using machines: Post-vaccination dizziness was frequently reported. This can temporarily affect the ability to drive or use machines.
Use In Pregnancy & Lactation
Pregnancy: One animal toxicity study on reproduction and development, led with another inactivated rabies vaccine produced in VERO cells, did not evidence any deleterious effects on female fertility and on pre- and post-natal development.
Clinical use of rabies vaccines (inactivated "WISTAR Rabies PM/Wl38 1503-3M strain") during a limited number of pregnancies did not show any malformative or foetotoxic effects to date. Given the seriousness of the disease, vaccination should be performed during pregnancy, in compliance with the usual vaccination schedule, in case of high risk of contamination.
Breast-feeding: This vaccine can be used during breast-feeding.
If the patient is pregnant or breast-feeding, think may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before using this medicine.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Increase in size of lymph nodes (adenopathy, lymphadenopathy).
Allergic skin reaction as skin rash with itching (urticaria, pruritus), swelling (cedema). Allergic reaction with respiratory disorders (dyspnoea, angioedema). Anaphylactic reaction, serum sickness-like reaction.
Headache (cephalalgia), dizziness, somnolence.
Abdominal pain, nausea, diarrhoea, vomiting.
Muscular pain (myalgia), joint pain (arthralgia).
At the injection site: pain, erythema (redness) and induration, haematoma, swelling (oedema) and itching (pruritus).
Fever (hyperthermia), shivering, malaise, influenza-like syndrome.
Convulsions, encephalopathy.
Sudden hearing decrease or loss.
Fatigue (asthenia).
In infants born very prematurely (at or before 28 weeks of gestation), respiratory pauses may occur during 2 to 3 days after vaccination.
Reporting of side effects: If the patient get any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed in this monograph.
By reporting side effects the patient can help provide more information on the safety of this medicine.
Drug Interactions
Corticosteroids and immunosuppressive treatments may interfere with the production of antibodies and lead to vaccination failure, see Precautions.
Rabies immunoglobulins and vaccine must never be combined in the same syringe or administered at the same site.
VERORAB must not be mixed with other medicinal products or other vaccines.
Tell the doctor or pharmacist if the patient is taking, have recently taken or might take any other medicines.
Caution For Usage
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).
Storage
Store in a refrigerator (2°C-8°C). Do not freeze.
Store in the original outer package, protected from light.
After reconstitution, the vaccine must be used immediately.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help to protect the environment.
ATC Classification
J07BG01 - rabies, inactivated, whole virus ; Belongs to the class of rabies viral vaccines.
Presentation/Packing
Inj [vial + syringe (diluent)] 0.5 mL x 1's, [vial + amp (diluent)] 0.5 mL x 5's.
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