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AstraZeneca

Leucogen
Feline leukaemia vaccine (inactivated)


PACKAGE LEAFLET:

LEUCOGEN 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 – L.I.D., 06516 Carros Cedex

    France


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    LEUCOGEN suspension for injection for cats


  3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)


    Per dose of 1 ml:


    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:

    Buffered isotonic solution to 1 ml. Opalescent liquid.


  4. INDICATION(S)


    Active immunisation of cats from eight weeks of age against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.


    The onset of immunity has been demonstrated from 3 weeks after the primary vaccination. After the primary vaccination course, the duration of immunity lasts for one year.

    Following a first booster vaccination one year after the primary vaccination course, a duration of immunity of 3 years has been demonstrated.


  5. CONTRAINDICATIONS


    None.

  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.


    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)

    • uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

    • rare (more than 1 but less than 10 animals in 10,000 animals treated)

    • 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.


  7. TARGET SPECIES


    Cats


  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:

    • first injection in kittens from eight 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.


    Re-vaccinations:

    Following a first booster vaccination one year after the primary vaccination course, subsequent vaccinations can be performed at intervals of three years.


  9. ADVICE ON CORRECT ADMINISTRATION


    Shake the vial gently before use.


  10. WITHDRAWAL PERIOD(S)


    Not applicable.

  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 first opening the container: use immediately.


  12. SPECIAL WARNING(S)


    Special warnings for each target species: Vaccinate healthy animals only.


    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.


    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:

    Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with FELIGEN CRP and FELIGEN RCP. No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after another 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 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:

    Do not mix with any other veterinary medicinal product except FELIGEN RCP or FELIGEN CRP.


  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

    Detailed information on this product is available on the website of the European Medicines Agency ().


  15. OTHER INFORMATION


Immediate packaging:

Type I glass vials containing one dose (1 ml) of the vaccine closed with a 13 mm-diameter butyl elastomer stopper and aluminium capsule.


Plastic or cardboard box of 10 vials. Plastic or cardboard box of 50 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.


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België/Belgique/Belgien VIRBAC Belgium NV Esperantolaan 4

3001 Leuven

Tel: +32-(0)16 387 260

Lietuva

VIRBAC

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1ère avenue 2065 m LID 06516 Carros

Prancūzija

Tel: +33-(0)4 92 08 73 00


Република България

VIRBAC

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1ère avenue 2065 m LID 06516 Carros

Франция

Teл: +33-(0)4 92 08 73 00

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Luxembourg/Luxemburg VIRBAC Belgium NV Esperantolaan 4

3001 Leuven Belgique / Belgien

Tel: +32-(0)16 387 260


Česká republika

VIRBAC

image

1ère avenue 2065 m LID 06516 Carros

Francie

Tel: +33-(0)4 92 08 73 00

Magyarország

VIRBAC HUNGARY KFT

Szent Istvàn krt.11.II/21. HU-1055 Budapest

Teл: +36703387177


Danmark

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VIRBAC Danmark A/S Profilvej 1

6000 Kolding Danmark

Tel: +45 75521244

Malta

VIRBAC

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1ère avenue 2065 m LID 06516 Carros

Franza

Tel: + 33-(0)4 92 08 73 00


Deutschland

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VIRBAC Tierarzneimittel GmbH Rögen 20

DE-23843 Bad Oldesloe Tel: +49-(4531) 805 111

Nederland

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VIRBAC Nederland BV Hermesweg 15

NL-3771 ND-Barneveld Tel : +31-(0)342 427 127


Eesti

VIRBAC

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1ère avenue 2065 m LID 06516 Carros Prantsusmaa

Tel: +33-(0)4 92 08 73 00

Norge

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VIRBAC Danmark A/S Profilvej 1

DK-6000 Kolding Danmark

Tel: + 45 75521244

Ελλάδα

VIRBAC HELLAS Α.Ε.

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13o χλμ Ε.Ο. Αθηνών - Λαμίας EL-14452, Μεταμόρφωση Τηλ: +30 2106219520

Österreich

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VIRBAC Österreich GmbH Hildebrandgasse 27

1180 Wien Österreich

Tel: +43-(0)1 21 834 260


España

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VIRBAC España SA Angel Guimerá 179-181

ES-08950 Esplugues de Llobregat (Barcelona) Tel. : + 34-(0)93 470 79 40

Polska

VIRBAC Sp. z o.o.

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ul. Puławska 314

PL 02 - 819 Warszawa

Tel.: + 48 22 855 40 46


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France VIRBAC France 13e rue LID

FR-06517 Carros

Tél : +33-(0)805 05 55 55

Portugal

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VIRBAC de Portugal Laboratórios LDA R.do Centro Empresarial

Ed13-Piso 1- Esc.3 Quinta da Beloura PT-2710-693 Sintra

Tel: + 351 219 245 020


Hrvatska

VIRBAC

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1ère avenue 2065 m LID FR-06516 Carros Francuska

Tel: + 33-(0)4 92 08 73 00

România

VIRBAC

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1ère avenue 2065 m LID FR-06516 Carros

Franţa

Tel: + 33-(0)4 92 08 73 00


Ireland

VIRBAC

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1ère avenue 2065 m LID FR-06516 Carros

France

Tel: + 33-(0)4 92 08 73 00

Slovenija

VIRBAC

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1ère avenue 2065 m LID FR-06516 Carros FRANCIJA

Tel: + 33-(0)4 92 08 73 00


Ísland

VIRBAC

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1ère avenue 2065 m LID FR-06516 Carros Frakkland

Tel: + 33-(0)4 92 08 73 00

Slovenská republika

VIRBAC

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1ère avenue 2065 m LID FR-06516 Carros Francúzsko

Tel: + 33-(0)4 92 08 73 00


Italia

VIRBAC SRL

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Via Ettore Bugatti, 15 IT-20142 Milano Tel: + 39 02 40 92 47 1

Suomi/Finland

VIRBAC

image

1ère avenue 2065 m LID

FR-06516 Carros

Puh/Tel: + 33-(0)4 92 08 73 00


Κύπρος

VIRBAC HELLAS Α.Ε.

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13o χλμ Ε.Ο. Αθηνών - Λαμίας EL-14452, Μεταμόρφωση Τηλ.: +30 2106219520

Sverige

VIRBAC Danmark A/S Filial Sverige

c/o Incognito AB

Box 1027

SE-171 21 Solna

Tel: +45 75521244

Latvija

VIRBAC

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1ère avenue 2065 m LID FR-06516 Carros Francija

Tel: +33-(0)4 92 08 73 00

United Kingdom (Northern Ireland)

VIRBAC

image

1ère avenue 2065m LID FR-06516 Carros France

Tel: + 33-(0)4 92 08 73 00