Berirab

/ Genmedix

Posology
Post-exposure prophylaxis consists of a regimen of one dose of immunoglobulin and full courses of rabies vaccination. Rabies immunoglobulin and the first dose of rabies vaccine should be given as soon as possible after exposure. Additional doses of rabies vaccine should be given according to official guidelines or the manufacturer’s instruction.
Rabies prophylaxis exclusively with simultaneous vaccination: recommended dose of rabies immunoglobulin is 20 IU Berirab per kg body weight (bw).
Because of the risk of interference with antibody production related to vaccination, neither the dose should be increased nor repeat rabies immunoglobulin be given even if the onset of the simultaneous prophylaxis is delayed.
Method of administration: Human rabies immunoglobulin should be administered via the intramuscular route.
Do not use solutions which are cloudy or contain residues (deposits/particles).
Berirab is a ready-for-use solution and should be administered at body temperature.
Of the total quantity of rabies immunoglobulin, as much as possible should be
instilled deeply into and around the wound. The remainder is to be injected i.m.
preferably into the vastus lateralis muscle with the patient lying down.
If comparatively large total volumes are required, it is advisable to administer them in divided doses at different sites. This applies in the case of doses above 2 ml for children up to 20 kg bw and doses above 5 ml for persons above 20 kg bw.
Do not inject intravenously !
In case of simultaneous prophylaxis the immunoglobulin and the vaccine should be administered at contralateral sites of the body.
The immunoprophylaxis should be carried out immediately even in case that
suspicion is not clarified if the animal was infected. Wounds should not be primary sewed. Parts of the body that are possibly contaminated and all wounds are to be cleaned immediately with soap or detergent, washed well with water and treated with 70% alcohol or iodine tincture; this is also true for contamination with vaccine solution from vaccination baits.
In the presence of a coagulation disorder, in the case of which intramuscular
injections are contraindicated, Berirab may be given sub-cutaneously. Afterwards the injection site should be compressed with a swab.
However, it should be noted that there are no clinical efficacy data to support
administration by the subcutaneous route.

Post-exposure prophylaxis of rabies infection after
● exposure to scratches, bites or other injuries caused by a suspected rabid animal
● mucous membrane contamination with infectious tissue or saliva of a suspected rabid animal
● contact of mucous membranes or newly skin injury with rabies live attenuated
vaccine e.g. vaccination baits.
Human rabies immunoglobulin must always be used in combination with a rabies vaccine.
National and/or WHO guidelines regarding protection against rabies should be
observed.

Because of the life-threatening risk due to rabies, there are no contraindications to the administration of rabies immunoglobulin.

See prescribing information for full details.

In rare cases the following adverse reactions may occur:
● allergic reactions including fall in blood pressure, dyspnoea, cutaneous
reactions (flush, urticaria), in isolated cases reaching as far as anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration of immunoglobulins.
● generalized reactions such as chills, fever, headache, malaise, nausea, vomiting, arthralgia and moderate back pain.
cardio-vascular reactions particularly if the product is inadvertently injected
intravascularly (e.g. tachycardia, bradycardia, sweating, hypotension, vertigo)
Local reactions: At the injection site local pain, tenderness or swelling can be observed in rare cases.

Vaccinations with live attenuated virus vaccines: Immunoglobulin administration may impair the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella vaccines for a period of up to three months. After administration of Berirab an interval of at least three months
should elapse before vaccination with live virus vaccines. In the case of measles, this impairment may persist for up to four months. Therefore, patients receiving measles vaccine should have their antibody status checked.
Interference with serological testing: It has to be considered that when serological test results are interpreted, the transitory rise of passively transferred antibodies after immunoglobulin injection may result in misleading positive test results.
Passive transmission of antibodies to erythrocyte antigens, e.g., A, B and D may
interfere with some serological tests for red cell allo-antibodies (e.g. Coombs test).
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, diluents or solvents.

The safety of Berirab for use in human pregnancy has not been established in
controlled clinical trials. Long lasting clinical experience with immunoglobulins does indicate that no harmful effects on the course of pregnancy, on the foetus or the neonate are to be expected.