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Date: Saturday, May 4, 2024 4:46

Release 2.26
Rabisin
 
Species: Cats, Dogs
Therapeutic indication: Immunological veterinary medical products: For dogs, For cats
Active ingredient: Vaccine Antigens
Product:Rabisin
Product index: Rabisin
Incorporating:
Qualitative and quantitative composition

Each 1 ml dose of vaccine contains:
Active substance:
Inactivated rabies virus, G52 strain ≥ 2.09 log10 OD50* and ≥ 1 IU**
Adjuvant: Aluminium (as hydroxide) 1.7 mg
Excipients: Excipient q.s. 1 ml
* when batch control is performed with an in vitro ELISA test
** when batch control is performed according to Ph. Eur. monograph 451
For the full list of excipients, see below.
Pharmaceutical form
Suspension for injection.
Clinical particulars
Target species
Dogs and cats.
Indications for use
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 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 product to animals
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.
Adverse reactions
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.
Interactions
Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Boehringer Ingelheim’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 vaccine when used with any other product except the products mentioned above. A decision to use this vaccine before or after any other 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
No other signs than those described under Adverse reactions have been observed after the administration of an overdose of vaccine.
Pharmaceutical particulars
Excipients
GMEM medium, Protein hydrolysates, Salts.
Major incompatibilities
Do not mix with any other product.
Shelf life
Shelf life of the product as packaged for sale: 36 months. Use immediately after opening.
Special precautions for storage
Store between +2 °C and + 8 °C, protected from light. Do not freeze.
Immediate packaging
Single dose vial and 10 x 1 dose vials.
Disposal
Any unused product or waste materials derived from such products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 08327/4150
Significant changes
Legal category
Legal category: POM-V
GTIN
GTIN description:Rabisin single dose vial
GTIN:3661103036098
GTIN description:Rabisin 10 x 1 dose vial
GTIN:3661103036036