Patient leaflet - Leucofeligen FeLV/RCP
B. PACKAGE LEAFLET
PACKAGE LEAFLET
LEUCOFELIGEN FeLV/RCP lyophilisate and suspension for suspension for injection for cats
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for the batch release:
VIRBAC
1ère avenue 2065 m LID
06516 Carros
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
LEUCOFELIGEN FeLV/RCP lyophilisate and suspension for suspension for injection for cats
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Per dose of 1 ml:
Lyophilisate :
Active substances:
| Live attenuated feline calicivirus (strain F9): | 104.6–106.1ccid50* |
| Live attenuated feline viral rhinotracheitis virus (strain F2): | 105–0–106–6 CCID50* |
| Live attenuated feline panleucopenia virus (strain LR 72): | 103.7–104.5 CCID50* |
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* Cell culture infectious dose 50%.
Excipient:
| Stabilizing buffer containing gelatin: to | 1.3 ml before freeze-drying |
Suspension :
Active substance:
| Minimum quantity of purified p45 FeLV-envelope antigen: | 102 ^g |
Adjuvants:
| 3% aluminium hydroxide gel expressed as mg Al3+: | 1 mg |
| Purified extract of Quillaja saponaria : | 10 ^g |
Excipient:
| Buffered isotonic solution to | 1 ml. |
Visual aspect:
Lyophilisate: White pellet.
Suspension: Opalescent liquid.
4.
INDICATION(S)
For active immunisation of cats from eight weeks of age against:
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– feline calicivirosis to reduce clinical signs,
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– feline viral rhinotracheitis to reduce clinical signs and viral excretion,
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– feline panleucopenia to prevent leucopenia and to reduce clinical signs,
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– feline leukaemia to prevent persistent viraemia and clinical signs of the related disease.
The onset of immunity has been demonstrated from:
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– 3 weeks after the first injection of primary vaccination for the calicivirus component
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– 3 weeks after the primary vaccination for the panleucopenia and leukaemia components
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– 4 weeks after the primary vaccination for the rhinotracheitis virus components.
After the primary vaccination course, the duration of immunity lasts for one year for all components.
Following a first booster vaccination one year after the primary vaccination course, a duration of immunity of 3 years has been demonstrated for the leukaemia component.
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5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
A moderate and transient local reaction (<2 cm) is commonly observed after the first injection. This local reaction could be a swelling, an oedema or a nodule and resolves spontaneously within from 3 to 4 weeks at the most. After the second injection, and subsequent administrations, this reaction is markedly reduced.
The transient signs following vaccination such as hyperthermia (lasting 1 to 4 days), apathy and digestive disturbances may also be commonly observed,
Pain at palpation, sneezing or conjunctivitis may be noted in rare cases. This resolves without any treatment.
Anaphylactic reactions have been reported in very rare cases. In case of anaphylactic shock, appropriate symptomatic treatment should be administered.
Febrile limping syndrome reactions may occur very rarely in kittens, as reported in the literature after the use of any vaccine containing a Feline Calicivirus component.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reactions)
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Cats
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Subcutaneous use (under the skin).
Administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Primary vaccination:
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– first injection in kittens from 8 weeks of age
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– second injection 3 or 4 weeks later.
Maternally derived antibodies, especially those against feline panleucopenia virus, 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.
Re-vaccinations:
Following a first booster vaccination one year after the primary vaccination course, subsequent vaccinations can be performed at intervals of three years for the leukaemia component.
In this case, since annual revaccination is required for calicivirus, rhinotracheitis virus and panleucopenia virus components, a single dose of FELIGEN RCP can be used annually.
The vaccine can be used as a booster for kittens or cats previously vaccinated with FELIGEN RCP and LEUCOGEN separately.
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9. ADVICE ON CORRECT ADMINISTRATION
Reconstitute one dose of lyophilisate with one dose (1ml) of suspension, shake gently and administer immediately.
10.
WITHDRAWAL PERIOD(S)
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after
EXP.
Shelf life after reconstitution according to directions: use immediately.
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12. SPECIAL WARNING(S)
Special warnings for each target species:
Vaccinate healthy animals only.
Maternally derived antibodies, especially those against feline panleucopenia virus, can negatively influence the immune response to vaccination.
Special precautions for use in animals:
De-worming at least 10 days prior to vaccination is recommended.
Only feline leukaemia virus (FeLV) negative cats should be vaccinated. Therefore, a test for presence of FeLV before vaccination is recommended.
The feline calicivirus and feline panleucopenia virus vaccine strains can spread. It has been demonstrated that this spread did not cause adverse reactions on non-vaccinated cats.
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.
Pregnancy and lactation:
Do not use in pregnant cats. The 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.
Overdose (symptoms, emergency procedures, antidotes):
No adverse reactions were observed after an overdose administration (10 doses of lyophilisate and 2 doses of suspension) of the veterinary medicinal product other than those mentioned in section 6 except local reactions that can last longer (from 5 to 6 weeks at the most).
Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this product is available on the website of the European Medicines Agency ().
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15. OTHER INFORMATION