Rabavert: Uses, Side Effects and Dosage

What RabAvert is used for:

RabAvert is indicated for: the active immunization of individuals of all age groups to prevent rabies. The product is used before rabies virus exposure (pre-exposure) in selected populations and also immediately after exposure (post-exposure) in all individuals.

What is rabies and your immediate action:

Rabies is an acute fatal disease caused by the rabies virus. The rabies virus can infect any mammal, including dogs, cats, skunks, bats, foxes, coyotes, raccoons, and other mammals. Human exposure to rabies virus most commonly occurs through bites from rabies-infected animals or, contamination of scratches, abrasions or cuts of skin or mucous membranes by saliva or other potentially infectious material, such as the brain tissue of a rabid animal or rabies virus-containing materials. The typical clinical signs of rabies in humans often do not appear until several weeks to months after exposure to rabies virus. This incubation period can range from a few days to several years. Once the typical clinical signs of rabies start, survival is extremely rare, with death usually occurring within a few days. Currently, there is no treatment to prevent death once the typical clinical signs of rabies have developed. However, rabies can be effectively prevented if appropriate medical measures are taken promptly after exposure. Vaccination is a primary method of preventing rabies. If you are bitten by a mammal or exposed to material containing or suspected containing rabies virus through an injury or even skin/mucosal contact, you should immediately seek medical attention for risk assessment even if you have previously received pre-exposure vaccination or has previously exposed to rabies virus.

How RabAvert works:

RabAvert stimulates your immune system to create antibodies against the rabies virus and therefore help protect you if exposed to rabies. Multiple shots are required for effective protection.

The ingredients in RabAvert are:

Medicinal ingredient: Inactivated rabies virus (Flury LEP)

Non-medicinal ingredients: Disodium edetate, hydrogen chloride, polygeline, potassium-L-glutamate, sodium chloride, sucrose, trometamol, water for injection.

Residues from the manufacturing process: Amphotericin B, chlortetracycline, human serum albumin, neomycin, and ovalbumin.

RabAvert comes in the following dosage form(s):

RabAvert is available as:

• 1 vial of lyophilized powder containing a single dose; and,
• 1 disposable pre-filled syringe of sterile diluent for RabAvert (1 mL), with two identical needles.

RabAvert has at least 2.5 IU of rabies antigen.

Do not use RabAvert for pre-exposure vaccination if:

• You have a history of anaphylaxis to the vaccine or any of the vaccine components including the container as it is a contraindication to the pre-exposure vaccination with this vaccine.
• You have an acute infection. The presence of a minor infection, such as a cold, should not require postponement of the pre-exposure vaccination, but talk to your doctor or nurse first.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RabAvert. Talk about any health conditions or problems you may have, including if you:

• Have a weakened immune system because of an illness that supresses your immune system or are in treatment with radiation therapy, antimalarials, corticosteroids, or other immunosuppressive agents.
• Are allergic to this drug or its ingredients or components of the container.
• Have fainted with a previous injection. Fainting can occur following, or even before, any needle injection.

• Are or think you may be pregnant, you may still be given rabies vaccine if you have had, or are likely to have had, contact with the virus. If the risk of contact with the virus is thought to be considerable, your doctor will advise you whether to have rabies vaccine now or to wait.

• Are breastfeeding. You can receive RabAvert if the risk of contact with the virus is thought to be considerable. Your doctor will advise you.

Warnings you should know about:

• With the use of RabAvert anaphylaxis and neuroparalytic events such as encephalitis, transient paralysis and Guillain-Barré-Syndrome, have been reported to be temporally associated.
• Before deciding to discontinue immunisation the patient’s risk of developing rabies must be carefully considered
• You must not use RabAvert subcutaneously and/or intradermally.
• Do not inject intravascularly.

As with all vaccines, RabAvert may not fully protect all people who are vaccinated.

If you have been exposed to the rabies virus through contact with animals, you should get the vaccine regardless of any other illnesses you may have.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with RabAvert:

• Drug interactions with RabAvert include: Radiation therapy, antimalarials, corticosteroids, other immunosuppressive agents, and immunosuppressive illnesses can interfere with the development of active immunity after vaccination and may diminish the protective efficacy of the vaccine
• RabAvert can be given at the same time as other vaccines. A different injection site will be used for each type of vaccine.
• You may also need to be given an injection of antibodies against rabies (called “rabies immunoglobulin”). If so, the rabies immunoglobulin injection will be given in different limbs.

How to take RabAvert:

RabAvert will be given to you by a healthcare professional in a healthcare setting. The usual dose of RabAvert is intramuscular (IM) injection of 1.0 mL each.

To adults and children 2 years of age and above, RabAvert is given into the deltoid muscle.

To small children and infants (below 2 years of age), RabAvert is given into the anterolateral zone of the thigh.

Usual dose:

A. Primary Immunization (Pre-exposure vaccination)

• Immunocompetent (healthy and functional) individual:

  • Conventional: one injection on each of Days 0, 7 and 21 (or 28)
  • If rapid immunization is required: one injection on each of Day 0 and Day 7
• Immunocompromised (weakened immune system) individual: one injection on each of Days 0, 7 and 21 (or 28)

B. Booster Immunization

• The booster dose is one injection given intramuscularly when your rabies antibody level falls below a specific level (0.5 IU/mL) anytime after vaccination in order to maintain an adequate immune response for prevention against rabies.

C. Post-Exposure Prophylaxis

• A complete course of immunization consists of the administration of rabies immunoglobulin (RIG) on Day 0 followed by injections of RabAvert:

  • Immunocompetent individual: one injection on each of:

    • Day 0, 3, 7 and 14 or
    • Day 0, 3, 7, 14 and 28
  • Immunocompromised person: one injection on each of Days 0, 3, 7, 14 and 28

D. Post-Exposure Prophylaxis of Previously Immunized Healthy Persons

• When rabies exposure occurs in a previously vaccinated individual, then that individual should receive two IM doses of RabAvert:

  • One dose immediately and one 3 days later.
  • Human Rabies Immunoglobulin (RIG) should not be given in these cases.

Overdose:

Missed dose:

Please refer to your physician in case of a missed vaccination.

Possible side effects from using RabAvert:

These are not all the possible side effects you may have when taking RabAvert. If you experience any side effects not listed here, tell your healthcare professional.

RabAvert cannot cause rabies because it does not contain any live virus.

Side effects reported can be:

• Very common (these may affect more than 1 in 10 people);
• Common (these may affect up to 1 in 10 people);
• Uncommon (these may affect up to 1 in 100 people);
• Rare (these may affect up to 1 in 1,000 people); or,
• Very rare (these may affect less than 1 in 10,000 people).

In very rare cases, neurological events such as those in the 7 Warnings and Precautions section above and other severe conditions affecting the brain and nerves have been reported in temporal association with administration of RabAvert. Consult your physician if you experience any of these mentioned cases.

Your risk of developing rabies must be carefully considered, however, before deciding to discontinue immunization.

The most commonly occurring adverse reactions are injection-site reactions such as: swelling and pain; flu-like symptoms such as: fatigue, fever, headache, dizziness, weakness; and rash that may also be: red, lumpy, itchy (very common); injection-site redness, abdominal pain, lymph node swelling, muscle pain and general discomfort, joint pain, nausea, vomiting, diarrhea, and decreased appetite (common).

In rare cases, chills and sweating, circulatory reactions such as: hot flush; visual disturbance, tingling or numbness of skin, pain in limbs, feeling faint, fainting, and hypersensitivity have been reported.

Serious allergic reactions are rare after receiving a vaccine. These reactions may include:

• difficulty in breathing,
• blue discolouration of the tongue or lips,
• swelling of the face and neck or elsewhere
• low blood pressure causing collapse and shock.

When these signs or symptoms occur, they usually develop very quickly after the injection is given; consult a doctor immediately.

Once initiated, rabies prophylaxis should not be interrupted or discontinued because of local or mild general adverse reactions to rabies vaccine. Usually, such reactions subside within a few days and may be successfully managed with anti-inflammatory and fever reducing agents.

This is not a complete list of side effects. If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Storage:

RabAvert should be stored protected from light at 2°C to 8°C. After reconstitution, the vaccine is to be used immediately. The vaccine may not be used after the expiration date given on package and container.

If you want more information about RabAvert:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website www.bnvaccines.ca; or by calling 1-833-203-7933.

Imported by Accuristix, 100 Vaughan Valley Blvd., Vaughan, ON, L4H 3C5, Canada.

Date of Authorization: 2026-10-28

Trademarks are owned by Bavarian Nordic A/S.