1. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER AND THE MANUFACTURER RESPONSIBLE FOR RELEASE OF THE BATCH IN THE EEA, IF DIFFERENT

The Marketing Authorization Holder and the manufacturer responsible for the release of the batch of the medicinal product.

Zoetis Belgium SA

rue Leid Berniat, 1

1348 Louvain-la-Neuve

BELGIUM

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Versifel CVR, lyophilisate and diluent for the preparation of an injectable suspension for cats

3. ACTIVE (-IOS) AND OTHER SUBSTANCES

One dose of vaccine (1 ml) contains:

active ingredients:

at least 10 3.0 CCID50* of the live attenuated strain of feline panleukopenia virus Snow Leopard,

live attenuated strain of feline rhinotracheitis virus FVRm at least 10 5.0 CCID50,

live attenuated strain F-9 of feline calicivirus at least 10 5.5 CCID50;

CCID50* - Infectious dose for 50% of cell cultures.

Excipients up to 1 ml.

4. INDICATIONS

For healthy cats from 9 weeks of age for immunization of cats to reduce mortality and clinical manifestations of infectious enteritis (panleukopenia), reduce clinical signs of infectious rhinotracheitis and reduce clinical signs and manifestations of the disease caused by calicivirus.

Onset of immunity: immunity to all components of the vaccine is formed approximately 3 weeks after

the last doses of primary vaccination.

Duration of immunity: at least 12 months.

5. CONTRAINDICATIONS

Do not vaccinate sick cats.

6. ADVERSE REACTIONS

Rarely in the first 24 hours. After vaccination, transient increase in rectal temperature, lameness and apathy, as well as a soft, painless swelling (on average < 1 cm), which may persist as a painless, hard nodule for up to 21 days after vaccination, may occur.

In very rare cases, anaphylactic reactions may occur, which should be treated symptomatically (e.g., with

adrenaline).

The frequency of adverse reactions is determined according to the following scheme:

- very common (adverse reactions occurred in more than 1 in 10 animals during one course of treatment),

- common (more than 1, but less than 10 per 100 animals),

- uncommon (more than 1, but less than 10 per 1,000 animals),

- rare (more than 1, but less than 10 animals per 10,000),

- very rare (less than 1 per 10,000 animals, including isolated cases).

If you notice any serious effects or other effects not mentioned in this leaflet, you should inform your veterinarian.

7. TARGET ANIMALS

Cats (from 9 weeks of age).

8. DOSAGE, ROUTES AND METHODS OF ADMINISTRATION FOR EACH SPECIES.

The lyophilisate of the vaccine should be aseptically mixed with the diluent, shaken and immediately administered subcutaneously at 1 ml.

Basic vaccination

Cats should be vaccinated for the first time at 9 weeks of age and older, twice every 3-4 weeks.

Revaccination

Revaccination is required once a year.

If rabies immunization is required at the same time, Versigard Rabies vaccine (an inactivated monovalent vaccine containing the rabies virus strain Vnukovo-32) can be used to dilute the lyophilisate instead of the diluent. Prepare the vaccine as described above and immediately administer the prepared vaccine subcutaneously.

9. INSTRUCTIONS FOR CORRECT USE

Do not use chemically sterilized syringes and needles as this may reduce the effectiveness of the vaccine.

10. DISCLAIMER

Not suitable.

11. SPECIAL STORAGE INSTRUCTIONS.

Keep out of reach of children.

Store and transport cool (2-8 ℃).

Do not freeze.

Protect from light.

12. SPECIAL INSTRUCTIONS

Special instructions for use in specific target animal species.

Do not vaccinate cats under 1 month of age. after completion of corticosteroid treatment.

Feline panleukosis virus and the vaccine strain of calicivirus can be transmitted from vaccinated animals to unvaccinated animals. However, due to the low pathogenicity of these strains, it is not necessary to differentiate between vaccinated and unvaccinated animals.

Moderate or high levels of maternal antibodies may interfere with the response to the vaccine.

Special precautions for persons administering the medicinal product to animals.

In case of accidental injection, seek medical advice immediately and show the leaflet or label of this veterinary medicinal product.

Fertility

Do not use during pregnancy.

Interaction with other medicinal products and other forms of interaction

Safety and efficacy studies have shown that this vaccine can be mixed with Versiguard Rabies vaccine.

Incompatibilities

Do not mix with other veterinary medicinal products except the diluent or Versiguard Rabies (inactivated liquid monovalent rabies vaccine). 

ntva).

13. SPECIAL PROVISIONS FOR DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE, IF NECESSARY

Discarded waste should be decontaminated by boiling, burning or immersion in a suitable disinfectant approved by the competent authority.

14. OTHER INFORMATION

For veterinary use only.

Sale to veterinarians only.

Pharmacotherapeutic group: Live viral vaccines for cats.

The vaccine promotes the formation of active immunity against infectious enteritis (panleukopenia), infectious rhinotracheitis and feline calicivirus.