Incepta Pharmaceuticals Ltd.
Rabix-VC is indicated for To prevent Rabies virus
Precautions and warnings
Possibility of immune complex reaction 2-21 days after booster doses of HDCV (Human diploid cell cultures rabies vaccine); symptoms include arthralgia, arthritis, nausea, malaise, angioedema, fever and vomiting. Caution when used in patients with bleeding disorders, patients on anticoagulant treatment, severely immunocompromised patients. Not to be used in patients with confirmed diagnosis of rabies. Postexposure prophylaxis may be started regardless of the length of time from likely exposure, as long as clinical signs of rabies infection are not present. Pregnancy, lactation.
Minor local reactions like pain, erythema, oedema, pruritus and induration at the injection site and lasting to 24-48 hours. Moderate fever, shivering, fainting, asthenia, dizziness, respiratory manifestations (dyspnoea, wheezing), fever, abdominal pain, vomiting and allergic skin reactions (urticaria, rash, itching).
Concurrent use with immunosuppressants may reduce the efficacy of vaccines.
Severe fever, febrile infection, acute disease, progressive chronic diseases. Known hypersensitivity reactions to rabies vaccine or any of its components.
No contraindication to post-exposure treatment, because rabies is lethal disease, any contraindication to exposure, treatment should be considered carefully before disqualifying an individual for anti-rabies treatment.
Mode of actions
Rabies vaccine is an inactivated virus vaccine that is used for active immunisation against rabies. It can be used for pre- and post-exposure immunisation. For post-exposure immunisation, it is often used in conjunction with rabies immunoglobulins as it takes about 7-10 days for the specific antibodies to develop.
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
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks