Rabies vaccine solution for injection
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Powder and solvent for solution for injection containing freeze-dried rabies virus
This product has been produced on purified chick embryo cells.
Rabies - prophylaxis
Rabies - prophylaxis after exposure
For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.
Prophylaxis before exposure to rabies
In previously unvaccinated persons, an initial course consists of three doses (each of 1 ml) administered on days 0, 7 and 21 or 28.
The need of intermittent serological testing for the presence of antibody greater than or equal to 0.5 IU/millilitre and the administration of booster doses should be assessed in accordance with official recommendations.
Individuals who are at continuous risk should have their antibody levels tested every 6 months. Reinforcing doses of vaccine should be given if antibody levels fall below 0.5 IU/millilitre.
For those at frequent risk, a single reinforcing dose of vaccine should be given 1 year after the primary course has been completed. Reinforcing doses are generally required every 2 to 5 years.
Routine boosting is not recommended for those at infrequent risk. For individuals such as travellers, boosting with a single dose of vaccine can be considered in those who have had a primary course over 10 years ago and are travelling again to a high risk area.
Treatment after exposure to rabies
Follow local guidelines on when vaccination is needed. Begin vaccination as soon as possible following first aid treatment.
Unimmunised or incompletely immunised individuals
This includes those who have been immunised by the intradermal route (unlicensed route) or have received fewer than 3 doses of vaccine or whose last dose of vaccine was given more than 2 years previously.
Administer one injection (1 ml) on days 0, 3, 7, 14, and 28 or 30 (five doses in total).
Or one dose 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.
The indication for post-exposure vaccination with or without rabies immunoglobulin depends on the type of contact with the rabid animal:
Category I - touching or feeding animals; licks on intact skin; contact of intact skin with secretions or excretions of a rabid animal or human case.
Category II - nibbling of uncovered skin; minor scratches or abrasions without bleeding.
Category III - single or multiple transdermal bites, scratches or licks on broken skin; contamination of mucous membrane with saliva (i.e. licks); exposure to bats.
Category I - no treatment is needed if case history is reliable.
Category II - administer vaccine immediately. Stop treatment if animal remains healthy throughout an observation period of 10 days, or if proven to be negative for rabies by a reliable laboratory using appropriate diagnostic techniques.
Category III - administer rabies vaccine immediately, and rabies immunoglobulin, preferably as soon as possible after initiation of post-exposure prophylaxis. Rabies immunoglobulin can be injected up to 7 days after first vaccine dose administration. Stop treatment if animal remains healthy throughout an observation period of 10 days or is proven to be negative for rabies by reliable laboratory using appropriate diagnostic techniques.
Immunocompromised patients, patients at high risk due to multiple wounds and/or wounds to head/highly innervated areas, and patients for whom there was a delay in starting treatment
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, the manufacturer recommends that the days 0, 3, 7, 14 and 28 immunisation regimen should be used.
Alternatively, two doses 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 should be given into the left deltoid. In small children, one dose should be given into the anterolateral region of each thigh. This would result in a total of 6 doses.
Rabies immunoglobulin should be administered in all immunosuppressed patients experiencing WHO category II and category III wounds.
The neutralising antibody titre should be measured 2 to 4 weeks (preferably on day 14) 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 antibody titre should be made and additional doses of vaccine should be administered as necessary.
Specialist advice should be sought for individuals with HIV infection or who are immunosuppressed.
Fully immunised individuals
Those who have previously received full pre- or post- exposure immunisation including necessary booster immunisations after exposure or re-exposure.
Administer one injection (1 ml) on days 0 and 3. Administration of human rabies immunoglobulin is not required.
For information regarding the necessity for ongoing treatment after observation of the infecting animal, consult specialist guidelines.
(See Dosage; Adult)
(See Dosage; Adult)
The vaccine should be given by intramuscular injection into the deltoid muscle, or into the anterolateral region of the thigh in small children.
In patients with bleeding disorders, vaccines may be given by deep subcutaneous injection (unlicensed route).
It is not necessary to maintain intervals between rabies and other vaccines, but different administration sites should be used for each.
Precautions and Warnings
Postpone immunisation if there is active or suspected infection
Impaired response possible in immunocompromised patients
May contain trace amounts of amphotericin
May contain trace amounts of chlortetracycline
May contain trace amounts of neomycin
Do not mix with other vaccines in the same syringe
Have adrenaline injection ready for use in case of anaphylaxis
Inject other vaccines at different sites
Resuscitation facilities must be immediately available
Monitor antibody titre in immunocompromised patients
Follow national immunisation guidelines
After contact with animals which are suspected carriers of rabies, it is essential to observe the following procedures:
Immediate wound treatment
Immediately cleanse the wound for 15 minutes with soap and flush thoroughly with water. Then treat the wound with a suitable disinfectant e.g. alcohol (70%) or iodine solution. Where possible, bite injuries should not be closed with a suture as may increase risk of introduction of virus to nervous system. The WHO recommends wound cleaning even if long delay in presentation.
Tetanus vaccination and rabies immunoglobulin administration
Prophylaxis against tetanus should be implemented when necessary.
In cases of indicated passive immunisation, as much of the recommended dose of human rabies immunoglobulin (HRIG) as anatomically feasible should be applied as deeply as possible in and around the wound. Any remaining HRIG should be injected intramuscularly at a site distant from the vaccination site (the Green Book recommends administration into anterolateral thigh).
There have been reports of encephalitis and Guillain-BarrÃ© syndrome occurring after the use of rabies vaccines. Corticosteroids used to treat adverse reactions such as these may inhibit the development of immunity to rabies. The risk of developing rabies should be carefully considered, before deciding to discontinue immunization.
Pregnancy and Lactation
Use rabies vaccine with caution in pregnancy.
Rabies vaccine has not been studied in animal models. There is no firm evidence of harm to the foetus resulting from its use in pregnancy. Case reports (from various rabies vaccine types) generally indicate an uncomplicated course of pregnancy, foetal and infant development (Schaefer 2007, Briggs 2011).
The vaccine may be used for pre-exposure prophylaxis during pregnancy if it is considered that the potential benefit outweighs any possible risk to the foetus.
Since rabies is an illness with fatal consequences, a pregnant woman must always be simultaneously immunised (actively and passively) following a bite from an animal suspected to be rabid (Schaefer 2007).
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password at ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).
Use rabies vaccine with caution in breastfeeding.
There are no breastfeeding data on rabies vaccine. Since it is an inactivated rabies virus, it is not expected to pose a threat to the infant if it were to appear in the milk (Schaefer 2007). The UK Drugs in Lactation Advisory Service states that rabies vaccine is compatible with breastfeeding.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Erythema at injection site
Induration (injection site)
Injection site reactions
Local pain (injection site)
Swelling (injection site)
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: November 2015
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Immunisation against infectious disease - the Green Book, April 2013.
Available at: https://www.gov.uk/government/publications/rabies-the-green-book-chapter-27
Last accessed: 19 November 2015
Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 19 November 2015.
Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 19 November 2015.
Summary of Product Characteristics: Rabipur. Novartis Vaccines. Revised December 2009.
Summary of Product Characteristics: Rabipur pre-filled syringe. GlaxoSmithKline UK. Revised May 2016.
UK Drugs in Lactation Advisory Service.
Available at: https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Last accessed: 19 November 2015
World Health Organisation fact sheet no.99 Rabies. Dated September 2015
Available at: https://www.who.int/mediacentre/factsheets/fs099/en/index.html
Last accessed: 19 November 2015
World Health Organisation Rabies Pre and Post-exposure prophylaxis in humans. Dated June 2010
Available at: https://www.who.int/rabies/PEP_prophylaxis_guidelines_June10.pdf
Last accessed: 19 November 2015
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