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Date: Wednesday, April 30, 2025 12:32

Description: Virbac 2013
Release 2.235
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
Incorporating:
Presentation
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 1 ml:
Lyophilisate:
Active substances:
Live attenuated feline calicivirus (strain F9) 104.6–106.1 CCID50*
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*
* Cell culture infectious dose 50%.
Suspension:
Active substance:
Minimum quantity of purified p45 FeLV-envelope antigen 102 μg
Adjuvants:
3% aluminium hydroxide gel expressed as mg Al3+ 1 mg
Purified extract of Quillaja saponaria 10 μg
Excipients:
Qualitative composition of excipients and
other constituents
Lyophilisate:
Gelatin
Potassium hydroxide
Lactose monohydrate
Glutamic acid
Potassium dihydrohgen phosphate
Dipotassium phosphate
Water for injections
Sodium Chloride
Disodium phosphate
Suspension:
Sodium chloride
Disodium chloride
Potassium dihydrogen phosphate
Water for injections
Aluminium hydroxide gel
Visual appearance:
Lyophilisate: White color.
Suspension: Opalescent liquid.
Uses
Target species
Cats
Indications for use, specifying the target species
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 panleucopenia 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 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.
Duration of immunity:
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.
Dosage and administration
Subcutaneous use.
Reconstitute one dose of lyophilisate with one dose of solvent, shake gently and administer immediately.
Administer subcutaneously one dose (1ml) 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, 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-vaccination
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 calcivirus, rhinotracheitis virus and panleucopenia virus components, a single dose of Feligen RCP can be used annually.
This vaccine can be used as a booster for kittens or cats previously vaccinated with FELIGEN RCP and LEUCOGEN separately.
Contra-indications, warnings, etc
Contraindications
None
Special warning 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.
Adverse events
Cats:
Common
(1 to 10 animals / 100 animals
treated):
Injection site reaction1, Injection site swelling1,
Injection site oedema1, Injection site nodule1.
Hyperthermia2,3, Apathy3
Digestive tract disorder3.
Rare
(1 to 10 animals / 10,000
animals treated):
Injection site pain4, 5,
Sneezing5,
Conjunctivitis5.
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Anaphylaxis6.
Febrile limping syndrome reactions7.
1A moderate and transient local reaction (<2 cm) is observed after the first injection and resolves spontaneously within 3 to 4 weeks at the most. After the second injection, and subsequent administrations, this reaction is markedly reduced.
2Lasting 1 to 4 days.
3Transient signs.
4At palpation.
5This resolves without any treatment.
6In case of anaphylactic shock, appropriate symptomatic treatment should be administered.
7May occur very rarely in kittens, as reported in the literature after the use of any vaccine containing a Feline Calicivirus component.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
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.
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).
Withdrawal period(s)
Not applicable.
Pharmaceutical precautions
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after reconstitution: use immediately.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
Legal category
Legal category: POM-V
Packaging quantities
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.
Further information
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.
Marketing Authorisation Number
GB
VM 05653/5013
UK(NI):
EU/2/09/097/001-002
Significant changes
GTIN
GTIN description:Leucofeligen FeLV/RCP (10 doses)
GTIN:3597133056204
GTIN description:Leucofeligen FeLV/RCP (50 doses)
GTIN:3597133056211