Felocell CVR is for vaccination of healthy cats as an aid in preventing feline viral rhinotracheitis (FVR).
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Availability date: 03/13/2014
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of Felocell CVR (1 ml) contains the following:
Live attenuated feline enteritis (panleucopaenia) virus (FPV), Snow Leopard strain, minimum titre: 103.0 CCID50*
Live attenuated feline rhinotracheitis virus (FVR), strain FVRm, minimum titre: 105.0 CCID50*
Live attenuated Calicivirus (FCV), strain F9, minimum titre: 105.5 CCID50*
*Cell culture infectious dose-50
Water for injection.
For full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate and solvent for solution for injection.
4. CLINICAL PARTICULARS
4.1 Target species
Cats from 9 weeks of age.
4.2 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
The duration of immunity is at least 12 months.
Unhealthy animals should not be vaccinated.
4.4 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.
4.5 Special precautions for use
i. Special precautions for use in animals
ii. 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.
4.6 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 painless hard nodules for up to 21days after dosing.
On very rare occasions, an anaphylactic reaction may occur which may require appropriate symptomatic treatment (eg adrenaline).
When Felocell CVR and Leukocell 2 are administered simultaneously, incidence of local reactions may be increased.
4.7 Use during pregnancy, lactation or lay
Do not use in pregnancy.
4.8 Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrates that this vaccine can be
administered concurrently with Leukocell 2 (Pfizer's inactivated feline leukaemia vaccine). No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product 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.
4.9 Amounts to be administered and administration route
Reconstitute the freeze-dried vaccine aseptically with the complete contents of the diluents provided. Shake and immediately inject the contents of the vial subcutaneously 1 ml per dose.
In cats aged nine weeks and over, two injections of Felocell CVR, 3 to 4 weeks apart will stimulate full active immunity.
A single 1 ml dose is required on an annual basis.
If simultaneous immunisation against feline leukaemia virus (FeLV) is required, Felocell CVR can be reconstituted with Leukocell 2 (inactivated, adjuvanted sub-unit FeLV vaccine) in place of the diluent, 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No reactions other than those listed in Section 4.6 are observed after an overdose administration.
4.11 Withdrawal period(s)
5. 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.
ATC Vet Code – QI06AD04
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Do not mix with any other veterinary medicinal product except the diluent provided for reconstitution or Leukocell 2 (inactivated, adjuvanted sub-unit FeLV vaccine).
6.3 Shelf life
After reconstitution - use immediately.
6.4. Special precautions for storage
Store and transport the freeze-dried component and the diluent between 2°C and 8°C. Do not freeze.
6.5 Nature and composition of immediate packaging
The freeze-dried component and the liquid 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 contain 25 glass vials of 1 monodose containing the freeze-dried component and 25 glass vials of 1 ml containing the diluent.
6.6 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.