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Date: Friday, April 19, 2024 22:18

Description: MSD-AH
Release 5.60
Nobivac® Rabies Suspension for injection
 
Species: Cats, Dogs, Ferrets
Therapeutic indication: Immunological veterinary medical products: For dogs, For cats, For ferrets
Active ingredient: Vaccine Antigens
Product:Nobivac® Rabies Suspension for injection
Product index: Nobivac® Rabies
Incorporating:
Qualitative and quantitative composition
Each 1 ml dose contains:
Active substance:
Inactivated rabies virus strain Pasteur RIV: ≥ 0.95 AIU* equivalent to ≥ 2 IU**
* Batch control is performed with an in vitro potency test according to Ph. Eur. monograph 451.
AIU = rabies antigenic mass AlphaLISA International Units.
** Corresponding potency in the in vivo mouse challenge test according to Ph. Eur. Monograph 451.
Adjuvant:
Aluminium phosphate: 0.60 - 0.88 mg Al3+
Excipients:
Thiomersal (preservative): 0.1 mg
For the full list of excipients see section Pharmaceutical particulars
Pharmaceutical form
Suspension for injection.
Light yellow/orange to slightly red/purple with a whitish sediment.
Clinical particulars
Target species
Dogs and cats.
Indications for use
For the active immunisation against rabies to reduce clinical signs and mortality.
Onset of immunity: an adequate serological response (≥ 0.5 IU) has been demonstrated 2 to 3 weeks after vaccination.
Duration of immunity: 3 years.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
The vaccine may not be effective in animals incubating the disease at the time of vaccination.
Some animals may be immunologically incompetent and fail to respond to vaccination. A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.
Special precautions for use
The presence of maternal antibodies can interfere with the response to vaccination.
This product should not be administered for at least one month following the administration of hyperimmune serum (anti-serum) or immunosuppressant drugs.
Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration.
Operator warnings
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse Reactions
Transient local reactions such as non-painful diffuse to firm swellings of approximately 1 cm in diameter may be observed for up to 3 weeks after subcutaneous vaccination.
A transient acute hypersensitivity reaction - with signs that may include, facial oedema, vomiting, pruritus or diarrhoea - may occur shortly after vaccination in very rare cases. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening with additional signs like dyspnoea, collapse, ataxia, muscle tremor and convulsion. If such reactions occur appropriate treatment is recommended.
Clinical signs of immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia or immune-mediated polyarthritis have been reported in very rare cases.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy and lactation
Can be used during pregnancy in dogs. There are no laboratory data on use during pregnancy in other species, but on basis of field experience, such use is expected to be safe.
Interactions
Safety and efficacy data are available which demonstrate that Nobivac Rabies can be mixed and administered with vaccines in the Nobivac range containing one or more of the following components: live canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza or live feline viral rhinotracheitis virus, feline calicivirus and feline panleucopenia virus.
Safety and efficacy data are available which demonstrate that Nobivac Rabies can be administered on the same day but not mixed with Nobivac vaccines containing canine Leptospira interrogans serogroups Canicola and Icterohaemorrhagiae antigens.
No information is available on the safety and efficacy of this vaccine 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 made on a case by case basis.
Amount to be administered and administration route
Administer a dose of 1 ml irrespective of the size, species or breed of animal.
Intramuscular or subcutaneous route.
Sterile equipment should be used for administration. Avoid contamination of vaccine with traces of chemical sterilising agents. Do not use chemicals such as disinfectant or spirit to disinfect the skin prior to inoculation.
Primary course and booster vaccination in dogs and cats
Primary vaccination age* 12 weeks or older
Booster vaccination every 3 years
*The primary vaccination may be administered at an earlier age, but a second dose must then be administered at the age of 12 weeks.
Minimum vaccination age in dogs and cats: 4 weeks.
Further information
Limited safety data for ferrets are available from monitoring post vaccination reactions. Ferrets can be vaccinated subcutaneously from 12 weeks of age. An adequate serological response (≥ 0.5 IU) has been demonstrated 1 month after vaccination.
Ferrets should receive a booster vaccination every 18 months.
Overdose
No effects other than those in section "Adverse reactions".
Withdrawal period
Not applicable.
Pharmacological particulars
ATCVet code: QI07A A02
The vaccine contains inactivated antigens to stimulate active immunity against rabies.
Pharmaceutical particulars
Excipients:
Aluminium phosphate
Disodium hydrogen phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Thiomersal
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal products apart from those listed in section "Interactions".
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 4 years.
Special precautions for storage
Store in a refrigerator (2 °C - 8 °C). Do not freeze.
Immediate packaging
Type I glass vial closed with rubber stopper and aluminium cap.
Package sizes:
Cardboard box with 1 x 1 ml vials
Cardboard or plastic (PET) box with 10 x 1 ml or 50 x 1 ml vials.
Not all presentations may be marketed.
Disposal
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Number
UK: Vm 01708/4325
Significant changes
Date of the first authorisation or date of renewal
25 October 2010.
Date of revision of the text
December 2021.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Pet Travel Scheme (PETS)
Animals intended for vaccination under the Pet Travel Scheme (PETS) must be identified by a permanent numbered microchip. This microchip number must be recorded on the pet passport/vaccination record of the animal at the time of rabies vaccination.
Health regulations and requirements in certain countries specify that animals must be revaccinated annually against rabies.
Prior to any international travel with pets, or travel to and from Northern Ireland, always check rabies vaccination requirements of destination countries well in advance of the planned departure dates.
Legal category
Legal category: POM-V
GTIN
GTIN description:Nobivac Rabies 1x1ds:
GTIN:08713184115232,
GTIN description:Nobivac Rabies 10x1ds:
GTIN:08713184144935