Rabies vaccine suspension for injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Single dose vial of lyophilised vaccine and single dose syringe of diluent containing freeze-dried rabies virus
Drugs List
Therapeutic Indications
Uses
Rabies - prophylaxis
Rabies - prophylaxis after exposure
Prophylactic immunisation against rabies.
Treatment of patients following suspected rabies contact.
For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.
https://www.gov.uk/government/publications/rabies-the-green-book-chapter-27
Dosage
Adults
Pre-exposure prophylaxis:
In previously unvaccinated persons, the manufacturer recommends an initial course consisting of three doses (each of 1 ml) administered on days 0, 7 and 28 (the Green Book advises that the third dose may be given on day 21 instead of day 28 if there is insufficient time before travel - unlicensed schedule).
All those at regular and continuing risk should receive a single reinforcing dose one year after the primary course was completed. Further doses should be at 3 to 5 yearly intervals thereafter. In subjects constantly at risk from rabies, it is recommended that 3 to 6 monthly monitoring of serum rabies antibody concentration is carried out. If the titre is below 0.5 iu/millilitre another single dose (1 ml) should be given as a reinforcing dose.
For those at intermediate risk or travelling again to an affected area without access to medical care, a reinforcing dose should be given from 10 years after completion of the primary course.
Post-exposure prophylaxis:
Post-exposure prophylaxis against rabies depends on the level of risk in the country, the nature of exposure, and the individual's immunity. Follow local guidelines on when vaccination is needed. Begin vaccination as soon as possible following wound care and first aid treatment.
The indication for post-exposure vaccination with or without rabies immunoglobulin depends on the type of contact with the rabid animal as categorised by the World Health Organisation (WHO 2010):
- Category I - Touching or feeding animals, licks on intact skin.
- Category II - Minor scratches or abrasions without bleeding, licks on broken skin and nibbling of uncovered skin.
- Category III - Single or multiple transdermal bites or scratches, contamination of mucous membrane with saliva from licks, exposure to bats.
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.
The manufacturer recommends one injection of 1ml administered on days 0, 3, 7, 14, 30 (five doses).
The Green Book permits one injection of 1ml administered on days 0, 3, 7, 14, and 28 (five doses).
Category I - No treatment is required if case history is reliable (if case history unreliable see category II).
Category II - Vaccinate according to the dose schedules above (except when there is uncertainty and/or exposure in a high risk area - see below).
Category III and Category II (when there is uncertainty and/or exposure in a high risk area) exposure, patient should be vaccinated according to the dose schedule above and also receive human rabies immunoglobulin (HRIG). Using a single dose of 20 iu/kilogram of body weight of HRIG, infiltrate as much as possible around the bite wound. Administer any remaining solution by intramuscular injection into the anterolateral thigh (remote from vaccination site). Please note that the recommended dose of human rabies immunoglobulin should not be increased or repeated as it may interfere with antibody formation during rabies vaccination. If the vaccine is given but HRIG treatment is delayed, HRIG can be administered up to seven days after the vaccine. Continue vaccination until course is complete.
Immunocompromised patients, patients at thigh risk or delayed treatment
For immunocompromised patients, individuals with HIV infection, 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, extra care or treatments may be required. Specialist advice should be sought.
Wound care is essential, vaccination (as above) and administration of HRIG in all Category II and Category III exposure is recommended.
Fully immunised individuals
Those who have previously received full pre- or post- exposure immunisation including necessary booster immunisations after exposure or re-exposure. Category I - No treatment is required if case history is reliable (if case history unreliable see category II).
Category II or III exposure - Administer one injection (1 ml) on days 0 and 3 (manufacturer allows up to day 7). 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.
Elderly
(See Dosage; Adult)
Children
(See Dosage; Adult)
Administration
The manufacturer advises that the vaccine should be given by intramuscular injection into the deltoid region.
It is suggested that administration may be to the anterolateral thigh in infants.
In patients with bleeding disorders, vaccines may be given by deep subcutaneous injection (unlicensed route).
Contraindications
None known
Precautions and Warnings
Febrile disorder
Breastfeeding
Haemophilia
Immunodeficiency syndromes
Pregnancy
Thrombocytopenia
Contains human albumin
May contain trace amounts of betapropiolactone
May contain trace amounts of neomycin
Have adrenaline injection ready for use in case of anaphylaxis
Monitor antibody titre in immunocompromised patients
When administering the primary immunisation series to very premature infants (less than 29 weeks) respiratory monitoring should be considered for 48-72 hours due to the risk of apnoea. Infants with a previous history of respiratory immunity should be watched closely. The benefit of vaccination in this group of infants is high and should not be withheld or delayed.
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, preferably intragluteally (the Green Book recommends administration into anterolateral thigh).
Pregnancy and Lactation
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 (Shaefer 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 (shaefer 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/ ).
Lactation
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 (shaefer 2007). The UK Drugs in Lactation Advisory Service classify both inactivated and live attenuated vaccines generally as substances that may be administered to a breastfeeding mother.
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
Side Effects
Abdominal pain
Allergic skin reactions
Anaphylaxis
Angioedema
Apnoea
Arthralgia
Asthenia
Bruising at injection site
Chills
Convulsions
Diarrhoea
Dizziness
Dyspnoea
Encephalitis
Erythema at injection site
Guillain-Barre syndrome
Headache
Induration (injection site)
Injection site reactions
Local pain (injection site)
Lymphadenopathy
Malaise
Myalgia
Nausea
Neuropathy
Oedema
Paraesthesia
Paresis
Pruritus
Pyrexia
Rash
Serum sickness-like reactions
Urticaria
Vomiting
Wheezing
Overdosage
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 ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).
Further Information
Last Full Review Date: July 2013
Reference Sources
BNF for Children (2012-2013) Pharmaceutical Press, London.
British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.
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.
Summary of Product Characteristics: Rabies Vaccine BP. Sanofi Pasteur MSD Limited. Revised september 2012.
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: July 22, 2013
World Health Organisation fact sheet no.99 Rabies. Dated July 2013
Available at: https://www.who.int/mediacentre/factsheets/fs099/en/index.html
Last accessed: July 22, 2013
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: July 22, 2013
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