 INDIRAB™ is a Chromatographically Purified Vero Cell Rabies Vaccine developed from virus strain obtained from CDC (Centres for Disease Control & Prevention), Atlanta, USA and derived from the original Pitmen Moore strain to capture the virulence. Chromatographically Purified INDIRAB™ is free from all harmful viruses and adventitious agents capable of causing tumors. With the superior technology, Chromatographically Purified INDIRAB™ is safe with no chance of egg protein allergy, antibiotic allergy and bird flu transmission, seen with chick & duck embryo rabies vaccines.
Composition
One dose of Lyophilized Vaccine contains:
Purified ß Propiolactone Inactivated Rabies virus 2.5 I.U.*
(Prepared on Vero cells; PM strain of Rabies virus) of one immunizing dose.
Thiomersal as preservative ……… 0.01%
Maltose ………………………………………… up to 1 immunizing dose
Human Serum albumin ……………… up to 1 immunizing dose
* Such that the Protective Power is greater than or equal to 2.5 I.U. before and after heating at +370C for 4 weeks.
Diluent: 0.3% Sodium Chloride Solution …………………… 0.5 ml
Indications
Pre- Exposure prophylaxis:
This vaccination is specially recommended for high risk professionals' e.g. veterinarians, animal care personnel, hunters, doctors, rabies laboratory personnel, production personnel, army personnel, postmen and children who are exposed to the risk of rabies.
Post exposure prophylaxis:
Treatment of subjects bitten by suspicious/ rabid animals.
Dosage
Dose for Children and Adult is 0.5 ml
Vaccination Schedule
The vaccination schedule should be adapted according to the category of exposure and the subject's rabies immune status.
Pre-exposure Vaccination
This vaccine is recommended for the prevention of rabies in subjects at a high risk of exposure.
All subjects at a permanent risk, such as diagnostic, research and production laboratory staff working on rabies virus, should be vaccinated.
1st Dose
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Zero Day
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2nd Dose
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Day 7
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3rd Dose
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Day 28
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1st Booster Dose
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1 year later
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Booster Dose
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Every 5 years
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Post Exposure Vaccination
After confirmed or suspected exposure, vaccination must be started immediately.
The treatment is instituted according to the type of wound / exposure and the status of the animal.
First aid treatment
The treatment of wounds is very important and must be performed promptly after the bite. It is recommended first to wash the wound with large quantities of water and soap or detergent and then apply 70% alcohol / tincture of iodine.
Post exposure vaccination must be administered under medical supervision.
Category |
Type of contact with a suspect rabid domestic or wild animal or animal unavailable for observation |
Recommended Treatment |
| I |
Touching or feeding of animal, licks on intact skin, contact with animal but definitely not with its saliva |
None; if reliable case history is available.
In case of doubts vaccinate on D0, D7, D28. |
| II |
Nibbling of uncovered skin, minor scratches, superficial bites (except on head, neck, shoulder girdle, arms or hands) or abrasions without bleeding, licks on broken skin |
Administer vaccine immediately on D0, D3, D7, D14, D28 and D90 (optional)
Stop treatment if animal remains healthy throughout the observation period of 10 days or if animal is killed humanely and found to be negative by appropriate laboratory techniques. |
| III |
Single or multiple major trans dermal bites / scratches especially on head, face, neck, shoulder girdle, arms or hands or contamination of mucous membrane with saliva (i.e. licks on broken skin) |
Administer rabies immunoglobulin / antirabies serum and vaccine immediately on D0, D3, D7, D14, D28 and D90 (optional)
Stop treatment if animal remains healthy throughout the observation period of 10 days or if animal is killed humanely and found to be negative by appropriate laboratory techniques. |
Vaccination of non-immunized subjects against rabies:
The schedule includes 0.5ml injections on D0, D3, D7, D14, D28 and D90 (Optional) Table Category I, II & III
In the case of category III exposure (see Table-2), rabies immunoglobulin / Rabies immunserum must be administered in association with the vaccine.
Additional passive immunization on day 0 is required with:
Human rabies immunoglobulin (HRI) 20 I.U./kg of body weight or equine rabies immunoglobulin 40 I.U./kg of body weight.
The vaccine should be injected on the side opposite the immunoglobulin administration sites.
In enzootic areas, the severity of certain exposures due to the severity of the lesions and/or location (proximity of the central nervous system), a late consultation or immunodeficiency of the subject may justify, depending on the case 2 injections on D0.
Vaccination of subjects already immunized against Rabies:
If vaccine administered in less than 5 years of exposure (cell culture rabies vaccine): Then 2 injections on D0, D3 are recommended.
If vaccine administered in >5 years of exposure or incomplete vaccination: 6 injections D0, D3, D7, D14, D28 and D90 (optional) with administration of immunoglobulin if required.
In practice, if the last booster dose was administered over 5 years previously or if the vaccination is incomplete, the subject is considered to have an uncertain vaccination status.
Mode of Administration
To reconstitute the vaccine, transfer content of diluent into the lyophilized vial and shake thoroughly until the powder is completely suspended. The solution should be homogenous, clear and free from particles. Withdraw the solution in a syringe.
The vaccine must be injected immediately after reconstitution and the syringe must be destroyed after use.
The vaccine is administered by the intramuscular route only in the deltoid in adults and in the antero-lateral region of the thigh muscle in children. Do not inject in the gluteal region.
Contraindications
This vaccine must not be used in the following cases:
Pre-exposure
- severe febrile infection, acute disease, progressive chronic disease (it is preferable to postpone vaccination).
- known hypersensitivity to any of the ingredients of the vaccine.
Post-exposure
- No contraindications to post-exposure treatment, because rabies is a lethal disease, any contraindication to exposure treatment should be considered carefully before disqualifying an individual for anti rabies treatment.
If there is any doubt, it is essential to consult your doctor.
Special Warnings
Do not inject by the intravascular route: make sure that the needle does not enter a blood vessel.
Immunoglobulins and rabies vaccine must not be associated in the same syringe or injected at the same site.
Keep out of the reach of children.
Drug and other Interactions
Corticosteroids and immunosuppressive treatment may interfere with antibody production and cause vaccine failure.
In order to avoid possible interactions between several medicinal products any other ongoing treatment should be systematically reported to your doctor. If any contraindications exist the risk of prophylactic vaccination should be weighed against those of a possible infection and if necessary, the vaccination should be carried out taking appropriate precautions.
Pregnancy Breast Feeding
Pregnancy is not a contraindication to rabies vaccination.
For the vaccination of subjects at a high risk of contamination, the benefit/risk ratio must be assessed before administering the injection.
During pregnancy and lactation, it is recommended to ask your doctor for advice before using the vaccine.
Additional Information
Wound should not be sutured for 7 days but any case, RIG should always be administered before suturing. Antibiotics can be prescribed and the tetanus vaccination status should be checked and if needed institute antitetanus procedures. In case of severe bites (Category III) half of the calculated dose of rabies immunoglobulin should preferably be injected intra-gluteally and rest of the immunoglobulin should be infiltrated deep into the wound and around the wound. Sensitivity to heterologous (equine) immunoglobulin must be determined before it is administered.
Rabies immunoglobulin should not be administered more than once or at higher doses than the recommended dose since there is a risk that this may interfere with antibody induction after vaccination.
Side Effects
- Minor local reactions: pain, erythema, oedema, pruritus and induration at the injection point.
- Systemic reactions: moderate fever, shivering, fainting, asthenia, headaches, dizziness, arthralgia, myalgia, gastro-intestinal disorders (nausea, abdominal pains).
- Exceptional cases of anaphylactic reactions are observed.
Storage
Do not use the vaccine after Expiry date.
Store between +2oC to +8oC
Do not Freeze. Keep out of the reach of Children.
Presentation
Pack contains one vial of Lyophilized vaccine, Diluent and Disposable Syringe with needle.
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