Summary of medicine characteristics - Leucofeligen FeLV/RCP
SUMMARY OF PRODUCT CHARACTERISTICS
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
LEUCOFELIGEN FeLV/RCP lyophilisate and suspension for suspension for injection for cats
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 1 ml:
Lyophilisate:
Active substances:
104.6–106.1 CCID50*
105.0–106.6 CCID50*
103.7–104.5 CCID50*
Live attenuated feline calicivirus (strain F9)
Live attenuated feline viral rhinotracheitis virus (strain F2)
Live attenuated feline panleucopenia virus (strain LR 72) * 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:
Excipient:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate and suspension for suspension for injection.
Visual aspect:
Lyophilisate: White color.
Suspension: Opalescent liquid.
4. CLINICAL PARTICULARS4.1 Target species
Cats
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4.2 Indications for use, specifying the target species
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, – 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 – 3 weeks after the primary vaccination for the panleucopenia and leukaemia components, – 4 weeks after the primary vaccination for the rhinotracheitis virus component.
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.
4.3 Contraindications
None.
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4.4 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.
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4.5 Special precautions for use
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.
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4.6 Adverse reactions (frequency and seriousness)
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: – very common (more than 1 in 10 animals treated displaying adverse reactions) – 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).
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4.7 Use during pregnancy, lactation or lay
Do not use in pregnant cats.
The use is not recommended during lactation.
4.8 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.
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4.9 Amounts to be administered and administration route
Subcutaneous use.
Reconstitute one dose of lyophilisate with one dose of suspension, shake gently and administer immediately.
Administer subcutaneously one dose (1ml) 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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 4.6 except local reactions that can last longer (from 5 to 6 weeks at the most).
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4.11 Withdrawal period(s)
Not applicable.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: immunologicals for Felidae, live and inactivated viral vaccines for cats.
ATCvet code: QI06AH07.
Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia.
The vaccine contains the purified p45 FeLV-envelope antigen, obtained by genetic recombination of the E. coli strain. The antigenic suspension is adjuvanted with an aluminium hydroxide gel and with a purified extract of Quillaja saponaria.
For the leukaemia component, protection against persistent viraemia is observed in 73% of cats 3 weeks after their first vaccine injection.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Lyophilisate:
Gelatin
Potassium hydroxide
Lactose monohydrate
Glutamic acid
Potassium dihydrogen phosphate
Dipotassium phosphate
Water for injections
Sodium chloride
Disodium phosphate anhydrous
Suspension:
Sodium chloride
Disodium phosphate anhydrous
Potassium dihydrogen phosphate
Aluminium hydroxide gel
Quillaja saponaria
Water for injections
6.2 Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after reconstitution: use immediately.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
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6.5 Nature and composition of immediate packaging
Lyophilisate:
A type I glass vial containing one dose of freeze-dried attenuated live viral components with a butyl elastomer stopper.
Suspension:
A type I glass vial containing one dose (1 ml) of the adjuvanted liquid vaccine, with a 13 mm-diameter butyl elastomer stopper and set with an aluminium capsule.
Plastic or cardboard box of 10 lyophilisate vials and 10 suspension vials.
Plastic or cardboard box of 50 lyophilisate vials and 50 suspension vials.
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
VIRBAC
1ère avenue 2065 m LID
06516 Carros
FRANCE
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/09/097/001–002
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25/06/2009.
Date of last renewal: 06/06/2014.