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Leucofeligen FeLV/RCP

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Summary for the public


What is Leucofeligen FeLV/RCP?

Leucofeligen FeLV/RCP is a vaccine for cats. It is available as two vials, one containing a white powder pellet and one containing a liquid. The powder contains live attenuated (weakened) feline viruses: feline calicivirus (strain F9),viral rhinotracheitis virus (strain F2) and feline panleucopenia virus (strain LR 72). The liquid contains a protein of feline leukaemia virus (FeLV). The contents of the two vials are mixed together before use to make up a suspension for injection.


What is Leucofeligen FeLV/RCP used for?

Leucofeligen FeLV/RCP is used to vaccinate cats from eight weeks of age against the following diseases:

  • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus);
  • feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus);
  • feline panleucopenia (a serious illness causing bloody diarrhoea caused by a parvovirus);
  • feline leukaemia (an illness affecting the immune system caused by a retrovirus).

The vaccine helps to reduce the signs of these diseases. It can also help to reduce excretion of feline viral rhinotracheitis viruses, to prevent a fall in white blood cell counts in feline panleucopenia and to prevent FeLV remaining in the blood.

Leucofeligen FeLV/RCP is given to kittens as two injections under the skin. The first injection is given when the kitten is about eight weeks old, and the second three/four weeks later.

Afterwards, cats need a booster injection every year.


How does Leucofeligen FeLV/RCP work?

Leucofeligen FeLV/RCP is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. Leucofeligen FeLV/RCP contains small amounts of the three types of weakened virus listed above and protein from the FeLV called ‘envelope p45 protein’. The FeLV protein used in the vaccine is not extracted from viruses but is made in a bacterium using ‘recombinant DNA technology’.

When a cat is given the vaccine, the immune system recognises the weakened viruses and the FeLV proteins as ‘foreign’ and makes antibodies against them. In the future, the cat’s immune system will be able to produce antibodies more quickly when it is exposed to the viruses. The antibodies will help to protect against the diseases caused by these viruses. When exposed to any of these viruses later in life, the cat will either not become infected or have a much less serious infection. The vaccine also contains an ‘adjuvant’ (a compound containing aluminium) to stimulate a better protective immune response.


How has Leucofeligen FeLV/RCP been studied?

Because Leucofeligen FeLV/RCP is made up of two vaccines that have been available in the European Union (EU) since the 1980s (Feligen RCP and Leucogen), the company used data from studies carried out with these vaccines to support the use of Leucofeligen FeLV/RCP. Leucofeligen FeLV/RCP has been examined in two main ‘field’ studies involving kittens aged eight to nine weeks. The main measure of effectiveness was the presence of antibodies against the viruses in the vaccinated kittens’ blood. Further studies were carried out under laboratory conditions to confirm the other benefits of vaccination.


What benefit has Leucofeligen FeLV/RCP shown during the studies?

The studies showed that Leucofeligen FeLV/RCP provided protection against the diseases listed above. In addition, it reduced the excretion of feline viral rhinotracheitis viruses, prevented a fall in white blood cell counts in feline panleucopenia and prevented FeLV from remaining in the blood.


What is the risk associated with Leucofeligen FeLV/RCP?

A temporary small nodule (hard swelling) may appear at the site of injection. This usually resolves on its own within three to four weeks. This reaction is reduced after subsequent injections. In rare cases, there may be pain on being touched, sneezing or conjunctivitis (eye inflammation). These resolve without any treatment. The temporary usual signs following vaccination, such as increased temperature, apathy (listlessness) and digestive problems such as abdominal discomfort may also be seen following vaccination. For a full list of all side effects reported with Leucofeligen FeLV/RCP, see the Package Leaflet.

Leucofeligen FeLV/RCP should not be used in pregnant cats. Its use is not recommended in cats nursing kittens.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

In case of accidental self-injection seek medical advice immediately and show the Package Leaflet or the label to the doctor.


Why has Leucofeligen FeLV/RCP been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Leucofeligen FeLV/RCP exceed the risks for the active immunisation of cats from eight weeks of age against the diseases listed above. The Committee recommended that Leucofeligen FeLV/RCP be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Leucofeligen FeLV/RCP

The European Commission granted a marketing authorisation valid throughout the European Union, for Leucofeligen FeLV/RCP to Virbac S.A. on 25 June 2009. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Leucofeligen FeLV/RCP
EMEA Product number: EMEA/V/C/000143
Active substance: Live Feline Calicivirus (strain F9), Live Feline Viral Rhinotracheitis virus (strain F2), Live Feline Panleucopenia virus, purified p45 FeLV-envelope antigen
INN or common name: Adjuvanted vaccine against feline calicivirosis, feline viral rhinotrachieitis, feline panleucopenia and feline leukaemia
Species: Cats
ATCvet Code: QI06AH07
Marketing Authorisation Holder: Virbac S.A.
Revision: 1
Date of issue of Market Authorisation valid throughout the European Union: 25/06/2009
Contact address:
Virbac S.A.
1ère Avenue 2065 M
06516 Carros
France



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF THE VETERINARY MEDICINAL PRODUCT
    LEUCOFELIGEN FeLV/RCP lyophilisate and solvent for suspension for injection for cats
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Per dose of 1 ml:
    Lyophilisate:
    Active substances:
    Live attenuated Feline Calicivirus (strain F9)
    10 4.6 -10 6.1 CCID 50 *
    Live attenuated Feline Viral Rhinotracheitis virus (strain F2)
    10 5.0 -10 6.6 CCID 50 *
    Live attenuated Feline Panleucopenia virus (strain LR 72)
    10 3.7 -10 4.5 CCID 50 *
    * Cell Culture Infectious Dose
    Excipient:
    Stabilizing buffer containing gelatin
    to 1.3 ml before
    freeze-drying
    Solvent:
    Active substance:
    Minimum quantity of purified p45 FeLV-envelope antigen
    102 µg
    Adjuvants:
    3% aluminium hydroxide gel expressed as mg Al
    10 µg
    Excipient:
    Buffered isotonic solution to
    1 ml
    For a full list of excipients, see section 6.1
    3.
    PHARMACEUTICAL FORM
    Lyophilisate and solvent for suspension for injection.
    Visual aspect :
    Lyophilisate: White pellet
    Solvent: Opalescent liquid
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Cats
    2
    Purified extract of Quillaja saponaria
    1 mg
    4.2 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 primary vaccination for the panleucopenia 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.
    4.3 Contraindications
    None.
    4.4 Special warnings
    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.
    4.5 Special precautions for use
    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.
    4.6 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.
    4.7 Use during pregnancy, lactation or lay
    Do not use in pregnant cats.
    Use is not recommended during lactation.
    3
    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.
    4.9 Amounts to be administered and administration route
    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.
    4.10 Overdose (symptoms, emergency procedures, antidotes)
    No adverse reactions were observed after an overdose administration (10 doses of lyophilisate
    and 2 doses of solvent) of the veterinary medicinal product other than those mentioned in
    section 4.6 except local reactions that can last longer (5 to 6 weeks at the most).
    4.11 Withdrawalperiod
    Not applicable.
    5.
    IMMUNOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Live and inactivated viral vaccines
    ATCvetcode: 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.
    4
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Lyophilisate :
    Gelatin
    Potassium hydroxyde
    Lactose monohydrate
    Glutamic acid
    Potassium dihydrogen phosphate
    Dipotassium phosphate
    Solvent :
    Sodium chloride
    Disodium phosphate anhydrous
    Potassium dihydrogen phosphate
    Aluminium hydroxide
    Quillaja saponaria
    6.2 Incompatibilities
    In the absence of compatibility studies, this veterinary medicinal product must not be mixed
    with other 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 after reconstitution.
    6.4. Special precautions for storage
    Store and transport refrigerated (2C – 8C)
    Do not freeze.
    Protect from light.
    6.5 Nature and composition of immediate packaging
    Lyophilisate:
    3 ml type-1 glass vial containing freeze-dried attenuated live viral components with a butyl
    elastomer stopper.
    Solvent:
    A 3 ml-glass vial containing the adjuvanted liquid, with a 13 mm-diameter butyl elastomer
    stopper and set with an aluminium capsule.
    Box of 10 lyophilisate vials and 10 solvent vials.
    Box of 50 lyophilisate vials and 50 solvent vials.
    Not all pack sizes may be marketed.
    6.6 Special precautions for the disposal of unused veterinary medicinal product or
    waste materials derived from the use of such products
    Any unused veterinary medicinal product or waste materials derived from such veterinary
    medicinal products should be disposed of in accordance with local requirements.
    5
    7.
    MARKETING AUTHORISATION HOLDER
    Virbac
    1ère avenue – 2065 m – L.I.D.
    06516 Carros Cedex France
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/09/097/001
    EU/2/09/097/002
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    25/06/2009
    10 DATE OF REVISION OF THE TEXT
    16/12/2010
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency http://www.ema.europa.eu /.
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    6
    ANNEX II
    A.
    MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE
    SUBSTANCE(S) AND MANUFACTURING AUTHORISATION
    HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
    B.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION REGARDING SUPPLY OR USE
    C.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
    D.
    STATEMENT OF THE MRLs
    7
    A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
    BATCH RELEASE
    Name and address of the manufacturer(s) of the biological active substance(s)
    PP MANUFACTURING CORPORATION
    175 crossing Boulevard Suite 200, Framingham, Massachusetts 01702, USA
    Virbac
    1ère avenue – 2065 m – L.I.D., 06516 Carros Cedex France
    Name and address of the manufacturer(s) responsible for batch release
    Virbac
    1ère avenue – 2065 m – L.I.D., 06516 Carros Cedex France
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    To be supplied only on veterinary prescription.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    Not applicable.
    D. STATEMENT OF THE MRLs
    Not applicable.
    8
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    9
    A. LABELLING
    10
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    Box of 10 lyophilisate vials and 10 solvent vials
    Box of 50 lyophilisate vials and 50 solvent vials
    1.
    NAME OF THE VETERINARY MEDICINAL PRODUCT
    LEUCOFELIGEN FeLV/RCP lyophilisate and solvent for suspension for injection for cats.
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per dose of 1 ml
    Lyophilisate:
    Active substances:
    Live attenuated Feline Calicivirus (strain F9),
    10 4.6 -10 6.1 CCID 50
    Live attenuated Feline Viral Rhinotracheitis virus (strain F2),
    10 5.0 -10 6.6 CCID 50
    Live attenuated Feline Panleucopenia virus (strain LR 72),
    10 3.7 -10 4.5 CCID 50
    Excipient: Stabilizing buffer containing gelatine
    Solvent:
    Active substance: Minimum quantity of purified p45 FeLV-envelope antigen, 102 µg
    Adjuvants: 3% aluminium hydroxide gel, Purified extract of Quillaja saponaria
    Excipient: Buffered isotonic solution
    3.
    PHARMACEUTICAL FORM
    Lyophilisate and solvent for suspension for injection.
    4.
    PACKAGE SIZE
    Box of 10 lyophilisate vials and 10 solvent vials
    Box of 50 lyophilisate vials and 50 solvent vials
    5.
    TARGET SPECIES
    Cats
    6.
    INDICATION(S)
    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.
    11
     
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Subcutaneous use
    8.
    WITHDRAWAL PERIOD
    Not applicable
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use
    10. EXPIRY DATE
    EXP {month/year}
    Use immediately after reconstitution
    11. SPECIAL STORAGE CONDITIONS
    Store and transport refrigerated (2C – 8C)
    Do not freeze.
    Protect from light
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription
    14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Virbac. 1ère avenue – 2065 m – L.I.D., 06516 Carros Cedex France
    12
     
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/09/097/001
    EU/2/09/097/002
    17. MANUFACTURER’S BATCH NUMBER
    Lot {number}
    13
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING
    UNITS LYOPHILISATE VIAL
    1.
    NAME OF THE VETERINARY MEDICINAL PRODUCT
    LEUCOFELIGEN FeLV/RCP, lyophylisate for suspension for injection for cats
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    1 dose
    4.
    ROUTE(S) OF ADMINISTRATION
    SC use
    5.
    WITHDRAWAL PERIOD
    Not applicable.
    6.
    BATCH NUMBER
    Lot {number}
    7.
    EXPIRY DATE
    EXP {month/year}
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    Ad. us. vet.
    14
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING
    UNITS SOLVENT VIAL
    1.
    NAME OF THE VETERINARY MEDICINAL PRODUCT
    LEUCOFELIGEN FeLV/RCP solvent for suspension for injection for cats
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    1 dose of 1 ml
    4.
    ROUTE(S) OF ADMINISTRATION
    Subcutaneous use
    5.
    WITHDRAWAL PERIOD
    Not applicable
    6.
    BATCH NUMBER
    Lot {number}
    7.
    EXPIRY DATE
    EXP {month/year}
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    15
     
    B. PACKAGE LEAFLET
    16
    PACKAGE LEAFLET FOR
    LEUCOFELIGEN FeLV/RCP lyophilisate and solvent 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 for the batch release:
    Virbac, 1 ère avenue – 2065 m – L.I.D., 06516 Carros Cedex France
    2.
    NAME OF THE VETERINARY MEDICINAL PRODUCT
    LEUCOFELIGEN FeLV/RCP lyophilisate and solvent for suspension for injection for cats
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER
    INGREDIENT(S)
    Per dose of 1ml:
    Lyophilisate:
    Active substances:
    Live attenuated Feline Calicivirus (strain F9):
    10 4.6 -10 6.1 CCID 50 *
    Live attenuated Feline Viral Rhinotracheitis virus (strain F2):
    10 5.0 -10 6.6 CCID 50 *
    Live attenuated Feline Panleucopenia virus (strain LR 72):,
    10 3.7 -10 4.5 CCID 50 *
    * Cell Culture Infectious Dose
    Excipient:
    Stabilizing buffer containing gelatin: to
    1.3 ml before freeze-drying
    Solvent:
    Active substance:
    Minimum quantity of purified p45 FeLV-envelope antigen:
    102 µg
    Adjuvants:
    3% aluminium hydroxide gel expressed as mg Al:
    1 mg
    Purified extract of Quillaja saponaria:
    10 µg
    Excipient:
    Buffered isotonic solution to
    1 ml
    Visual aspect:
    Lyophilisate: White pellet
    Solvent: Opalescent liquid
    4.
    INDICATION(S)
    For active immunisation of cats from eight weeks of age against :
    - feline calicivirosis to reduce clinical signs
    17
    - 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 primary vaccination for the panleucopenia and leukaemia
    components, and 4 weeks after the primary vaccination for the calicivirus and rhinotracheitis
    virus components.
    The duration of immunity is one year after the primary vaccination for all components.
    5.
    CONTRAINDICATIONS
    None.
    6.
    ADVERSE REACTIONS
    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 (eye inflammation) 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 (listlessness), digestive
    disturbances (abdominal discomfort).
    In case of anaphylactic shock, appropriate symptomatic treatment should be administered.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7.
    TARGET SPECIES
    Cats
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF
    ADMINISTRATION
    Subcutaneous use (under the skin).
    Administer subcutaneously (under the skin) 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.
    18
    9.
    ADVICE ON CORRECT ADMINISTRATION
    Reconstitute one dose of lyophilisate with one dose of solvent, shake gently and administer
    immediately.
    10. WITHDRAWAL PERIOD
    Not applicable.
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    Store and transport refrigerated (2C – 8C)
    Do not freeze.
    Protect from light
    Do not use after the expiry date stated on the label after EXP
    Use immediately after reconsitution
    12. SPECIAL WARNING(S)
    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.
    In case of anaphylactic shock, appropriate symptomatic treatment should be administered
    Special precautions to be taken by the person administering the product to animals
    In case of accidental self-injection, seek medical advice immediately and show the package
    leaflet or the label to the physician.
    Use during pregnancy, lactation or lay
    Do not use in pregnant cats. Use is not recommended during lactation.
    Interactions with other medicinal products
    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
    No adverse reactions were observed after an overdose administration (10 doses of lyophilisate
    and 2 doses of solvent) of the veterinary medicinal product other than those mentioned in
    section 4.6 except local reactions that can last longer (5 to 6 weeks at the most).
    19
    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.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    16/12/2010
    Detailed information on this product is available on the website of the European Medicines
    15. OTHER INFORMATION
    Lyophilisate:
    3 ml type I glass vial containing freeze-dried attenuated live viral components stopped with a butyl
    elastomer stopper.
    Solvent:
    3 ml-glass vial with a 13 mm-diameter butyl elastomer stopper and set with an aluminium capsule.
    Box of 10 lyophilisate vials and 10 solvent vials
    Box of 50 lyophilisate vials and 50 solvent vials
    Not all pack sizes may be marketed
    For any information about this veterinary medicinal product, please contact the local
    representative of the marketing authorisation holder.
    België/Belgique/Belgien
    VIRBAC BELGIUM S.A.
    Rue de la station 17
    B-1300 WAVRE
    Tel: 32 (0) 10 47 06 35
    Luxembourg/Luxemburg
    VIRBAC BELGIUM S.A.
    Rue de la station 17
    B-1300 WAVRE
    Tel: 32 (0) 10 47 06 35
    Република България
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Magyarország
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Česká republika
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Malta
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    20
    Danmark
    VIRBAC Danmark A/S
    Profilvej 1
    6000 Kolding
    Tel: 45 2219 1733
    Nederland
    VIRBAC NEDERLAND BV
    Hermesweg 15
    NL-3771 ND-Barneveld
    Tel: 31 (0) 342 427 100
    Deutschland
    VIRBAC Tierarzneimittel GmbH
    West Rögen 20
    D-23843 Bad Oldesloe
    Tel: 49 (4531) 805 555
    Norge
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Eesti
    OÜ ZOOVETVARU
    Pärnasalu 31
    ET -76505 Saue/Harjumaa, ESTONIA
    Tel: + 372 6 709 006
    E-mail: margus@zoovet.ee
    Österreich
    VIRBAC Österreich GmbH
    Hildebrandgasse 27
    A-1180 Wien
    Tel: 43 (0) 1 21 834 260
    Ελλάδα
    VIRBAC HELLAS A.E.
    23 rd Klm National Road Athens-Lamia
    145 65 Agios Stefanos
    Athens - GREECE
    Tel: +30 210 6219520
    E-mail: info@virbac.gr
    Polska
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    España
    VIRBAC ESPAÑA S.A.
    ES-8950 Esplugues de Llobregat
    (Barcelona).
    Tél. : + 34 93 470 79 40
    Portugal
    VIRBAC DE Portugal
    LABORATÓRIOS LDA
    P-2080 Almeirim
    Tel: (351) 243 570 500
    France
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    E-mail: dar@virbac.fr
    România
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Ireland
    C&M Veterinary Distributors Limited
    IE-Limerick
    Tel: 353 61 314 933
    Slovenija
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Ísland
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Slovenská republika
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Italia
    VIRBAC SRL
    Via dei Gracchi 30
    I-20146 Milano
    Tel: 39 02 48 53 541
    Suomi/Finland
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    21
    Κύπρος
    GEO. PAVLIDES & ARAOUZOS LTD
    25-27 Dimostheni Severi, 1080
    CY-1080 Nicosia - CYPRUS
    Τηλ: + 357 22456117
    E-mail: theodosiou.vet@gpa.com.cy
    Sverige
    VIRBAC S.A.
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Latvija
    OÜ ZOOVETVARU
    Pärnasalu 31
    ET - 76505 Saue/Harjumaa, ESTONIA
    Tel: + 372 6 709 006
    E-mail: margus@zoovet.ee
    United Kingdom
    VIRBAC Ltd
    UK-Suffolk IP30 9 UP
    Tel: 44 (0) 1359 243243
    Lietuva
    OÜ ZOOVETVARU
    Pärnasalu 31
    ET - 76505 Saue/Harjumaa, ESTONIA
    Tel: + 372 6 709 006
    E-mail: margus@zoovet.ee
    22


    Source: European Medicines Agency


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