Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Adult Dosage

Administer by intramuscular injection. The vaccine should be administered into the deltoid region.

Adults, Elderly and Children

Prophylaxis:

Three injections each of 1 millilitre given on days 0, 7 and 28. A single reinforcing dose should be given at two or three year intervals to those at continued risk.

If, for whatever reason, it has not been possible to give a full course of three injections, it is probable that, in the majority of subjects, two doses may be adequate to confer protection, provided these were given four weeks apart. Subjects receiving only two injections who remain at continued risk should receive a reinforcing dose 6-12 months later, with further reinforcing doses given at two to three year intervals.

Treatment

(i) In persons known to have adequate prophylaxis:

In the event of contact with a suspected rabid animal, two further boosters should be given on day 0 and on day 3 to 7.

(II) In persons with no, or possibly inadequate, prophylaxis:

The first injection of rabies vaccine should be given as soon as possible after the suspected contact (day 0) and followed by five further doses on days 3, 7, 14, 30 and 90. The use of Human Rabies Immunoglobulin on day 0 should be considered, but only in persons with no adequate prophylaxis. The treatment schedule may be stopped if the animal concerned is found conclusively to be free of rabies.

Child Dosage

Contra Indications

Pre Exposure

Known systemic hypersensitivity reaction to any component of Rabies Vaccine BP or after previous administration of the vaccine or a vaccine containing the same components as Rabies Vaccine BP.

Vaccination must be postponed in case of febrile and/or acute disease.

Post Exposure

Since declared rabies infection generally results in death, there are no contraindications to post exposure vaccination.

Special Precautions

In subjects with a history of allergy there may be an increased risk of side-effects and this possibility should be taken into account.

As with all vaccines, appropriate facilities and medication such as epinephrine (adrenaline) should be readily available for immediate use in case of anaphylaxis or hypersensitivity following injection.

The vaccine may contain traces of neomycin and betapropiolactone which are used during the manufacturing process. Caution must be exercised when the vaccine is administered to subjects with hypersensitivity to betapropiolactone, neomycin, and other antibiotics of the same class

Rabies Vaccine BP should not be administered to patients with bleeding disorders such as haemophilia or thrombocytopenia, or to persons on anticoagulant therapy unless the potential benefit clearly outweighs the risk of administration. If the decision is taken to administer Rabies Vaccine BP in such persons, it should be given with caution with steps taken to avoid the risk of haematoma formation following injection.

Interactions

Corticosteroids and immunosuppressive treatments may interfere with antibody production and cause the failure of the vaccination. It is therefore advisable to perform a neutralising antibody assay 2 – 4 weeks after the last injection.

Administration of an additional dose should be considered if the antibody titre is less than 0.5 IU/ml (using an RFFIT analysis – Rapid Fluorescent Focus Inhibition Test).

Adverse Reactions

Adverse reaction information is derived from clinical trials and worldwide post- marketing experience.

Two randomised controlled trials where Rabies Vaccine BP has been studied in both children (n=199) using pre-exposure schedule (3 doses, IM) and adults (n=124) using the post exposure schedule (5 doses, IM) have been selected to represent safety clinical data.

Within each system organ class the adverse reactions are ranked under headings of frequency, using the following convention:

Very common ( >1/10)

Common ( >1/100, <1/10)

Uncommon ( >1/1000, <1/100)

Not known (cannot be estimated from the available data because only reported post marketing and not in clinical trials)

The most frequent adverse reactions are injection site pain and headache.

These reactions have been associated with the presence of betapropiolactone-altered human albumin (including the production of IgE antibodies in the vaccine).

Allergic reactions occurred more frequently among persons receiving booster than primary vaccination. 

Manufacturer

Drug Availability

Updated