Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2014 Publisher: Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom Tel: +44 (0)20 8957 2200 Fax: +44 (0)20 8957 2608 Email: info@bpl.co.uk
Post-exposure prophylaxis of rabies infection in persons after exposure to scratches, bites or other injuries including mucous membrane contamination with infectious tissue, such as saliva, caused by a suspected rabid animal.
Human Rabies Immunoglobulin must always be used in combination with a rabies vaccine.
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 instructions.
Rabies prophylaxis exclusively with simultaneous vaccination: recommended dose of rabies immunoglobulin is 20 IU/kg body weight.
If vaccine is given but treatment with human rabies immunoglobulin is delayed, human rabies immunoglobulin should still be given up to seven days after starting the course of vaccine.
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).
The volume of solution that needs to be administered to give 500 IU is stated on the label.
Human rabies immunoglobulin should be administered via the intramuscular route.
If a large volume (>2mL for children or >5 mL for adults) is required, it is recommended to administer this in divided doses at different sites.
The immunoglobulin and the vaccine should be administered at two different sites of the body.
The wound should be cleaned with soap and disinfectant.
Injections of the immunoglobulin should preferably be administered in the bitten site. The immunoglobulin should be carefully infiltrated in the depth of and around the wound. Any remainder should be injected intramuscularly at a site distant from that used for the rabies vaccine.
If intramuscular administration is contraindicated (bleeding disorders), the injection can be administered subcutaneously. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.
Consequences of an overdose are not known.
Stored at 2°C-8°C: 2 years.
Stored at 25°C: 1 week.
Human Rabies Immunoglobulin should be stored in the original container at 2°C to 8°C. Storage for up to one week at ambient temperatures (25°C) in the original container is not detrimental. DO NOT FREEZE.
Store in the original vial. Keep vial in the outer carton in order to protect from light.
Neutral borosilicate glass vial (type I Ph.Eur.) with overseal consisting of a halobutyl rubber wad (type I Ph.Eur.), clear lacquered aluminium skirt and flip-off polypropylene cap.
The product should be brought to room or body temperature before use.
The colour can vary from colourless to pale-yellow and is either clear or slightly opalescent. Do not use solutions that are cloudy or have deposits.
Any used product or waste material should be disposed of in accordance with local requirements.
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