Versifel Cvr
Revised: August 2014
AN. 00201/2014
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versifel CVR
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of Versifel CVR (1 ml) contains the following
Active substances:
Live attenuated feline enteritis (panleucopaenia) virus (FPV), Snow Leopard strain, minimum titre: 103.0CCID50*
Live attenuated feline rhinotracheitis virus (FVR), strain FVRm, minimum titre: 105.0CCID50*
Live attenuated Calicivirus (FCV), strain F9, minimum titre: 105.5CCID50*
*Cell culture infectious dose-50
Solvent:
Water for injection.
For a full list of excipients, see Section 6.1.
PHARMACEUTICAL FORM
Lyophilisate and solvent for solution for injection.
CLINICAL PARTICULARS
Target species
Cats from 9 weeks of age.
Indications for use, specifying the target species
Active immunisation of cats to reduce mortality and clinical signs of disease caused by feline enteritis (panleucopaenia) virus, to reduce clinical signs of disease caused by feline rhinotracheitis virus and to prevent clinical signs of disease and reduce infection caused by feline calicivirus.
Onset of immunity occurs by approximately 3 weeks after the last dose of the Basic Vaccination Scheme.
The duration of immunity is at least 12 months.
Contraindications
Unhealthy animals should not be vaccinated.
Special warnings for each target species
The feline panleucopaenia virus and the feline calicivirus vaccinal strains may be shed from vaccinated animals for a number of days following vaccination. However, due to the low pathogenicity of these strains, it is not necessary to keep vaccinated animals separated from non-vaccinated animals.
Moderate to high levels of maternally derived antibodies (MDA) may interfere with the response to vaccination.
Special precautions for use
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, wash the area immediately with water. If symptoms develop, seek medical attention showing a copy of the product literature.
Adverse reactions (frequency and seriousness)
On rare occasions,transient increases in rectal temperature, transient lameness and transient lethargy may be observed as well as soft painless swellings (<1 cm average) may occur in the first 24 hours after vaccination, which may be evident as painlesshard nodules for up to 21 days after dosing.
On very rare occasions, an anaphylactic reaction may occur which may require appropriate symptomatic treatment (eg adrenaline).
When Versifel CVR and Leukocell 2 are administered simultaneously, incidence of local reactions may be increased.
Use during pregnancy, lactation or lay
Do not use in pregnancy.
Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy from the concurrent administration of this vaccine with any other except Leukocell 2 (inactivated feline leukaemia vaccine by Zoetis). 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.
Amounts to be administered and administration route
Reconstitute the lyophilisate fraction aseptically with the complete contents of the solvent provided. Shake and immediately inject the contents of the vial subcutaneously 1 ml per dose.
Basic vaccination
In cats aged nine weeks and over, two injections of Versifel CVR, 3 to 4 weeks apart will stimulate full active immunity.
Re-vaccination
A single 1 ml dose is required on an annual basis.
If simultaneous immunisation against feline leukaemia virus (FeLV) is required, Versifel CVR can be reconstituted with Leukocell 2 (inactivated, adjuvanted sub-unit FeLV vaccine) in place of the solvent, using the reconstitution method described above. Once mixed, the vaccines should be injected immediately via the subcutaneous route.
Do not use chemically sterilised syringes or needles, as these might affect the effectiveness of the vaccine.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No reactions other than those listed in Section 4.6 are observed after an overdose administration.
Withdrawal period
Not applicable.
IMMUNOLOGICAL PROPERTIES
Vaccination induces the active immunity in healthy cats against feline infectious enteritis (panleucopaenia) and respiratory disease due to feline rhinotracheitis virus and calicivirus.
ATCVet Code:QI06AD04
PHARMACEUTICAL PARTICULARS
List of excipients
Neomycin
Gentamycin
Incompatibilities
Do not mix with any other veterinary medicinal product except the solvent provided for reconstitution or Leukocell 2 (inactivated, adjuvanted sub-unit FeLV vaccine).
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years
Shelf-life after reconstitution: use immediately.
Special precautions for storage
Store and transport between +2°C and +8°C. Do not freeze.
Nature and composition of immediate packaging
The lyophilisate component and the solvent component are filled in 1 monodose glass vials Type I (Ph. Eur.). Both have a rubber stopper fulfilling Ph. Eur. requirements and an aluminium cap.
Cartons contain25 glass vials of 1 monodose containing the lyophilisate component and 25 glass vials of 1 ml containing the solvent.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Dispose of waste materials by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.
MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
London
EC4A 3AE
MARKETING AUTHORISATION NUMBER
Vm:42058/4163
DATE OF FIRST AUTHORISATION
Date:12 February 2010
DATE OF REVISION OF THE TEXT
Date:August 2014
Approved: 08/08/2014
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