Precautions and warnings

There is a chance of an immune reaction (called an immune complex reaction) occurring 2 to 21 days after booster doses of the HDCV (human rabies vaccine). Symptoms can include joint pain, arthritis, nausea, tiredness, swelling, fever, and vomiting. Use caution for patients who have bleeding disorders, are taking blood thinners, or have a weakened immune system. Do not use this vaccine in people who have already been diagnosed with rabies. Post-exposure rabies prevention should be started as soon as possible after a likely exposure, no matter how much time has passed, as long as the person does not yet show symptoms of rabies. The vaccine can be given during pregnancy and breastfeeding.

Drug Interactions

Taking immunosuppressant medications at the same time as vaccines may make the vaccines less effective.

Contraindications

**Before Exposure:**
Do not give the rabies vaccine to people who have a high fever, a serious infection, a sudden illness, ongoing serious health problems, or known allergies to the rabies vaccine or any of its ingredients.

**After Exposure:**
There is no reason to avoid post-exposure rabies treatment, even if there are usual contraindications, because rabies is a deadly disease. Any possible reasons not to treat should be considered very carefully before deciding not to give anti-rabies treatment.

Mode of actions

The rabies vaccine is made from a virus that has been inactivated (killed), and it helps protect people against rabies. It can be given before possible exposure to the virus (preventive) or after someone has been exposed. If the vaccine is given after exposure, it is usually given together with rabies immunoglobulins, because it takes about 7 to 10 days for the body to produce protective antibodies after receiving the vaccine.

Dosage & Administration

Adult: 1 ml for children and adults:

a) Pre-exposure immunization Primary-vaccination: According to the WHO recommendations 1 injection by the intramuscular route on days D0, D7, D21 or D28, followed by a booster dose one year later. Boosters Thereafter, one injection every 5 years or when the titre is found to be less than 0.5 I.U./ml.

b) Post-exposure treatment Intramuscular schedule:
Non-vaccinated individuals: Treatment consists of 5 injections. Intramuscular injections to be given on Day 0, D3, D7, D14 and D28 subsequent to contact with an animal confirmed or suspected of being rabid. In case of severe (WHO category 3) wounds, immunoglobulin should be administered as soon as possible.

Fully vaccinated individuals: If vaccine administered in less than 5 years of exposure (cell culture rabies vaccine): 2 injections on D0, D3. If vaccine administered in more than 5 years of exposure or incomplete vaccination: 5 injections on D0, D3, D7, D14 and D28 with administration of immunoglobulin if required. Post exposure vaccination must be administered on the basis of severity under medical supervision.

Intradermal schedules: One intradermal (ID) dose is comprised of 0.1 ml.
WHO Modified Thai Red Cross (2-2-2-0-2) schedule: Day 0: 2 injections each of 0.1 ml at separate sites, Day 3: 2 injections each of 0.1 ml at separate sites, Day 7: 2 injections each of 0.1 ml at separate sites, Day 28: 2 injections each of 0.1 ml at separate sites.

To reconstitute the vaccine, transfer content of supplied diluent into the vial containing freeze-dried preparation. Do not shake. After reconstitution the solution should be homogeneous, clear and free from any particles. Vaccine must be injected immediately after reconstitution and the syringe should be destroyed after use.

Pregnancy & Lactation

Although animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in pregnant women, but during pregnancy, this medicine can be used just when definitely required despite potential risks.

Mothers with a newborn baby who have used this drug during the last 3 months of pregnancy may seldom create symptoms including drowsiness, muscle stiffness or shakiness, feeding or breathing troubles, constant crying. If you notice any of these symptoms of your baby's particularly during their first month, tell the doctor immediately.

This medicine passes into breast milk. Talk to your doctor before breastfeeding.

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