| Posology The recommended single intramuscular dose is 1 ml in all age groups. Whenever possible according to vaccine availability, it is recommended that one type of cell culture vaccine should be used throughout the course of pre- or post-exposure immunisation. However, adherence to the recommended schedules is of critical importance for post-exposure prophylaxis, even if another type of cell culture vaccine has to be used. PRE-EXPOSURE PROPHYLAXIS Primary immunisation In previously unvaccinated persons, an initial course of pre-exposure prophylaxis consists of three doses (each of 1 ml) administered on days 0, 7 and 21 or 28. Booster doses The need of intermittent serological testing for the presence of antibody ≥ 0.5 IU/ml (as assessed by the Rapid Focus-Fluorescent inhibition Test) and the administration of booster doses should be assessed in accordance with official recommendations. The following provides general guidance: • Testing for neutralising antibodies at 6-month intervals is usually recommended if the risk of exposure is high (e. g. Laboratory staff working with rabies virus).• In persons who are considered to be at continuing risk of exposure to rabies (e.g. veterinarians and their assistants, wildlife workers, hunters), a serological test should usually be performed at least every 2 years, with shorter intervals if appropriate to the perceived degree of risk.• In above mentioned cases, a booster dose should be given should the antibody titre fall below 0.5 IU/ml.• Alternatively, booster doses may be given at official recommended intervals without prior serological testing, according to the perceived risk. Experience shows that reinforcing doses are generally required every 2-5 years.Rabipur may be used for booster vaccination after prior immunisation with human diploid cell rabies vaccine.POST-EXPOSURE PROPHYLAXIS Post-exposure immunisation should begin as soon as possible after exposure and should be accompanied by local measures to the site of inoculation so as to reduce the risk of infection. Official guidance should be sought regarding the appropriate concomitant measures that should be taken to prevent establishment of infection (see also section 4.4). Previously fully immunised individuals For WHO exposure categories II and III, and in category I cases where there is uncertainty regarding the correct classification of exposure (see Table l below), two doses (each of 1 ml) should be administered, one each on days 0 and 3. On a case by case basis, schedule A (see Table 2 below) may be applied if the last dose of vaccine was given more than two years previously. Table 1: Immunisation schedules appropriate to different type of contact, exposure and recommended post-exposure prophylaxis (WHO 2004)
Category | Type of contact with a suspect or confirmed rabid domestic or wilda)
animal, or animal unavailable for testing | Type of exposure | Recommended post-exposure prophylaxis | I | Touching or feeding of animals Licks on intact skin Touching of inoculated animal lure with intact skin | None | None, if reliable case history is available. In case of unreliable case history, treat according to schedule A (see Table 2). | II | Nibbling of uncovered skin Minor scratches or abrasions without bleeding Touching of inoculated animal lure with skin damaged | Minor | Administer vaccine immediatelyb) Stop treatment if animal remains healthy throughout an observation period of 10 daysc)
or if animal is proven to be negative for rabies by reliable laboratory using appropriate diagnostic techniques In case of uncertainty and/or exposure in a high-risk area, administer active and passive treatment as in schedule B (see Table 2). | III | Single or multiple transdermal bites or scratches, licks on broken skin Contamination of mucous membrane with saliva (i.e. licks) Exposure to batsd) Touching of inoculated animal lure with mucous membrane or fresh skin wound | Severe | Administer rabies immunoglobulin and vaccine immediatelyb)
as in schedule B (see Table 2). Stop treatment if animal remains healthy throughout an observation period of 10 daysc)
or if animal is proven to be negative for rabies by reliable laboratory using appropriate diagnostic techniques |
a) Exposure to rodents, rabbits and hares seldom, if ever, requires specific anti-rabies post-exposure prophylaxis. b) If an apparently healthy dog or cat in or from a low-risk area is placed under observation, the situation may warrant delaying initiation of treatment. c) This observation period applies only to dogs and cats. Except in the case of threatened or endangered species, other domestic and wild animals suspected as rabid should be humanely killed and their tissues examined for the presence of rabies antigen using appropriate laboratory techniques. d) Post-exposure prophylaxis should be considered when contact between a human and a bat has occurred unless the exposed person can rule out a bite or scratch, or exposure to a mucous membrane. Individuals unimmunised or with uncertain immune status Depending on the WHO category as in Table l, treatment according to schedules A or B (see Table 2 below) may be required for previously unimmunised persons and for those who have received fewer than 3 doses of vaccine or who have received a vaccine of doubtful potency. Table 2: Post-exposure prophylaxis of subjects with no or uncertain immune status
Schedule A Active immunisation after exposure is required | Schedule B Active and passive immunisation after exposure are required | One injection of Rabipur i.m. on days: 0, 3, 7, 14, 28 (5-doses schedule) Or One dose of Rabipur is given into the right deltoid muscle and one dose into the left deltoid muscle on day 0, and one dose is applied into the deltoid muscle on days 7 and 21 (2-1-1 regimen). In small children the vaccine is to be given into the thighs. | Give Rabipur as in schedule A + l × 20 IU/kg body weight human rabies immunoglobulin* concomitantly with the first dose of Rabipur. If HRIG is not available at the time of the first vaccination it must be administered not later than 7 days after the first vaccination |
* Observe manufacturer's instructions regarding administration Immunocompromised patients and patients with a particularly high risk of contracting rabies For immunocompromised patients, those with multiple wounds and/or wounds on the head or other highly innervated areas, and those for whom there is a delay before initiation of treatment, it is recommended that: - The days 0, 3, 7, 14 and 28 immunisation regimen should be used for these cases -Two doses of vaccine may be given on day 0. That is, a single dose of 1 ml vaccine should be injected into the right deltoid and another single dose into the left deltoid muscle. In small children, one dose should be given into the anterolateral region of each thigh. Severely immunosuppressed patients may not develop an immunologic response after rabies vaccination. Therefore, prompt and appropriate wound care after an exposure is an essential step in preventing death. In addition, rabies immune globulin should be administered in all immunosuppressed patients experiencing Category II and Category III wounds. In immunocompromised patients, the neutralising antibody titre should be measured 14 days after the first injection. Patients with a titre that is less than 0.5 IU/ml should be given another two doses of vaccine simultaneously and as soon as possible. Further checks on the antibody titre should be made and further doses of vaccine should be administered as necessary. In all cases, the immunisation schedule must be followed exactly as recommended, even if the patient does not present for treatment until a considerable time has elapsed since exposure. Method of Administration The vaccine should be given by intramuscular injection into the deltoid muscle, or into the anterolateral region of the thigh in small children. It must not be given by intra-gluteal injection. Do not administer by intravascular injection (see Section 4.4). | |