Medine.co.uk

Rabisin

Revised: September 2014

AN: 01289/2013


SUMMARY OF PRODUT CHARACTERISTICS


NAME OF THE VETERINARY MEDICINAL PRODUCT


RABISIN


QUALITATIVE AND QUANTITATIVE COMPOSITION


Active substances:

Each 1-ml dose of vaccine contains

Rabies virus glycoproteins 1 IU


Adjuvant:

Aluminium (as hydroxide) 1.7 mg


Excipients:

Excipient q.s. 1 ml


For full list of excipients, see section 6.1.


PHARMACEUTICAL FORM


Suspension for injection.


CLINICAL PARTICULARS


Target species


Dogs and cats.


Indications for use, specifying the target species


For active immunisation of dogs and cats, to reduce mortality and clinical signs due to rabies infection.

Immunity has been demonstrated 1 month after primary vaccination, and has been shown to persist up to the first booster dose, (1 year after primary vaccination) and up to 3 years following booster vaccination.


Contra-indications


None.


Special warnings for each target species


Do not vaccinate unhealthy animals.


Special precautions for use including special precautions to be taken by the person administering the medicinal product to animals


Special precautions for use in animals


Where a dog or a cat was vaccinated before 12 weeks of age, the primary vaccination scheme should be completed by an injection given at 12 weeks of age or older.


Special precautions to be taken by the person administering the veterinary medicinal product to the animals


In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.


Adverse reactions (frequency and seriousness)


Vaccination may sometimes induce a local reaction, as a small and transient swelling at the injection site (usually 2 – 3 cm diameter, persisting mostly up to 2 weeks, rarely up to 4 weeks).

Vaccination may exceptionally induce an anaphylactoid (hypersensitivity) reaction. In such a case, symptomatic treatment should be provided.


Use during pregnancy, lactation or lay


Can be used during pregnancy.


Interaction with other medicinal products and other forms of interaction


Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Merial’s PUREVAX non-adjuvanted vaccines for cats.

In the case of products administered parenterally, the products should be given at different sites.

No information is available on the safety and efficacy of this vaccination when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.


Amounts to be administered and administration route


Inject one dose of 1 ml subcutaneously according to the following schedule:


Primary vaccination: 1 injection from 12 weeks of age,

Booster vaccination: 1 year after primary vaccination, then at intervals of up to 3 years.


UK Pet Travel Scheme (PETS): Animals intended for vaccination under the UK Pet Travel Scheme (PETS) must be identified by a permanently numbered microchip. The microchip number must be recorded on the pet passport or official third country veterinary certificate at the time of rabies vaccination.


Overdose (symptoms, emergency procedures, antidotes), if necessary


No other signs than those described under section 4.6 have been observed after the administration of an overdose of vaccine.


Withdrawal periods


Not applicable.


IMMUNOLOGICAL PROPERTIES


Inactivated vaccine in adjuvant against rabies.

After administration, the vaccine stimulates active immunity against rabies.


ATCVet Code: QI07AA02


PHARMACEUTICAL PARTICULARS


List of excipients


GMEM medium

Protein hydrolysates

Salts


Incompatibilities


Do not mix with any other veterinarymedicinalproduct.


Shelf-life


Shelf-life of the veterinary medicinal product as packaged for sale: 36 months.

Use immediately after opening.


Special precautions for storage


Store between +2C and + 8C, protected from light. Do not freeze.


Nature and composition of immediate packaging


Type I glass vials with butyl-elastomer closure.


Package sizes:

Bottle (glass) of 1 dose of suspension, box of 1 bottle

Bottle (glass) of 1 dose of suspension, box of 10 bottles

Bottle (glass) of 1 dose of suspension, box of 100 bottles


Not all pack sizes may be marketed.


Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate


Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.


MARKETING AUTHORISATION HOLDER


Merial Animal Health Ltd

PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex

CM19 5TG


MARKETING AUTHORISATION NUMBER


Vm:08327/4150


DATE OF FIRST AUTHORISATION


Date:28 October 2005


DATE OF REVISION OF THE TEXT


Date:September 2014


ANY OTHER INFORMATION REQUIRED BY THE SECRETARY OF STATE


Not applicable.


04 September 2014

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