Leucofeligen FeLV/RCP

Leucofeligen FeLV/RCP

Species: Cats Therapeutic indication: Immunological veterinary medical products: For cats Active ingredient: Vaccine Antigens Product:Leucofeligen FeLV/RCP Product index: Leucofeligen FeLV/RCP

Presentation

Per dose of 1 ml: Lyophilisate: Active substances: Live Feline Calicivirus (strain F9) 104.6 -106.1 CCID50* Live Feline Viral Rhinotracheitis virus (strain F2) 105.0 -106.6 CCID50* Live Feline Panleucopaenia virus (strain LR 72) 103.7 -104.5 CCID50* * Cell Culture Infectious Dose Minimum quantity of purified p45 FeLV-envelope antigen 102 microgrammes Adjuvants: 3% aluminium hydroxide gel expressed as mg Al 1 mg Purified extract of Quillaja saponaria 10 microgrammes

Uses

For active immunisation of cats from eight weeks of age against:

• feline calicivirosis to reduce clinical signs.
• feline viral rhinotracheitis to reduce clinical signs and viral excretion.
• feline panleucopaenia to prevent leucopenia and to reduce clinical signs.
• feline leukaemia to prevent persistent viraemia and clinical signs of the related disease.
• Onset of immunity: 3 weeks after the primary vaccination for the panleucopaenia and leukaemia components, and 4 weeks after the primary vaccination for the calicivirus and rhinotracheitis virus components.
• Duration of immunity: one year after the primary vaccination for all components.

Dosage and administration

Subcutaneous use. Reconstitute one dose of lyophilisate with one dose of solvent, shake gently and administer immediately. Administer subcutaneously one dose of the veterinary medicinal product according to the following regimen of vaccination. Primary vaccination: - first injection in kittens from 8 weeks of age - second injection 3 or 4 weeks later. Maternally derived antibodies can negatively influence the immune response to vaccination. In such cases where maternally derived antibodies are expected, a third injection may be appropriate from 15 weeks of age. Revaccination: Annual Can be used as a booster for kittens or cats previously vaccinated with FELIGEN RCP and LEUCOGEN separately.

Contra-indications, warnings, etc

The feline calicivirus and feline panleucopenia virus vaccinal strains can spread. It has been demonstrated that this spread did not cause adverse reactions on non-vaccinated cats. Maternally derived antibodies, especially those against feline panleucopenia virus, can negatively influence the immune response to vaccination.

Special precautions for use in animals

• Vaccinate only healthy animals.
• De-worming at least 10 days prior to vaccination is recommended.
• Only FeLV negative cats should be vaccinated. Therefore, a test for presence of FeLV before vaccination is recommended.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions (frequency and seriousness)

After the first injection, a moderate and transient local reaction (<2 cm) could occur (oedema, swelling, nodule). This reaction resolves spontaneously within 3 to 4 weeks at the most. After the second injection, and subsequent administrations, this reaction is markedly reduced. In rare cases, pain at palpation, sneezing or conjunctivitis may be noted, that resolves without any treatment. The transient usual signs following vaccination may also be observed, such as: hyperthermia (lasting 1 to 4 days), apathy, digestive disturbances. In case of anaphylactic shock, appropriate symptomatic treatment should be administered.

Use during pregnancy, lactation or lay

Do not use in pregnant cats. Use is not recommended during lactation.

Interaction with other medicinal products and other forms of interaction

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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. In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other medicinal products.

Pharmaceutical precautions

Keep out of the reach and sight of children. Store and transport refrigerated (2°C – 8°C) Do not freeze. Protect from light. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

Legal category: POM-V

Packaging quantities

Box of 10 lyophilisate vials and 10 solvent vials. Box of 50 lyophilisate vials and 50 solvent vials.

Further information

Nil

Marketing Authorisation Number

EU/2/09/097/001 EU/2/09/097/002

GTIN

GTIN description:Leucofeligen FeLV/RCP (10 doses) GTIN:3597133056204 GTIN description:Leucofeligen FeLV/RCP (50 doses) GTIN:3597133056211