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Canigen L4
Canine leptospirosis vaccine (inactivated)


PACKAGE LEAFLET:

Canigen L4 suspension for injection for dogs


  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 batch release:


    Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer

    The Netherlands


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Canigen L4 suspension for injection for dogs


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


    Each dose of 1 ml contains:


    Active substances:

    Inactivated Leptospira strains:

    • L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000) 3550-7100 U1

    • L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)

      290-1000 U1

    • L. interrogans serogroup Australis serovar Bratislava (strain As-05-073) 500-1700 U1

    • L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005) 650-1300 U1


      1 Antigenic mass ELISA units. Colourless suspension.


  4. INDICATION(S)


    For active immunisation of dogs against:

    • L. interrogans serogroup Canicola serovar Canicola to reduce infection and urinary excretion

    • L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection and urinary excretion

    • L. interrogans serogroup Australis serovar Bratislava to reduce infection

    • L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection and urinary excretion


      Onset of immunity: 3 weeks. Duration of immunity: 1 year.


  5. CONTRAINDICATIONS


    None.


  6. ADVERSE REACTIONS

    A mild and transient increase in body temperature (≤ 1°C) has been observed very commonly in clinical studies for a few days after vaccination, with some pups showing less activity and/or a reduced appetite. A small transient swelling at the site of injection (≤ 4 cm), which can occasionally be firm and painful on palpation, has been observed very commonly in clinical studies. Any such swelling will either have disappeared or be clearly diminished by 14 days post-vaccination.

    Clinical signs of immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia, or

    immune-mediated polyarthritis have been reported in very rare cases. A transient acute hypersensitivity reaction may occur in very rare cases. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening. If such reactions occur, appropriate treatment is recommended.


    The frequency of adverse reactions is defined using the following convention:

    • very common (more than 1 in 10 animals treated displaying adverse reaction(s))

    • 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


    Dogs.


  8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION


    Subcutaneous use.


    Administer two vaccinations of 1 dose (1 ml) of vaccine with an interval of 4 weeks to dogs from 6 weeks of age onwards.


    Vaccination scheme:


    Basic vaccination: The first vaccination can be administered from 6 to 9(*) weeks of age and the second vaccination from 10 to 13 weeks of age.

    Revaccination: Dogs should be re-vaccinated annually with one dose (1 ml) of vaccine.


    (*) In case of high level of maternally derived antibodies, first vaccination is recommended at 9 weeks of age.


  9. ADVICE ON CORRECT ADMINISTRATION


    Before use, ensure that the vaccine is at room temperature (15 °C – 25 °C).


  10. WITHDRAWAL PERIOD(S)


    Not applicable.


  11. SPECIAL STORAGE PRECAUTIONS

    Keep out of the sight and reach of children.


    Store in a refrigerator (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. Shelf life after first opening the immediate container: use immediately.


  12. SPECIAL WARNING(S)


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


    Special precautions to be taken by the person administering the veterinary medicinal product to animals:

    Avoid accidental self-injection or contact with the eyes. In case of eye contact, rinse the eye(s) with water. In case of self-injection or ocular irritation, seek medical advice immediately and show the package leaflet or the label to the physician.


    Pregnancy:

    Can be used during pregnancy.


    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 other than those mentioned in section “Adverse Reactions” were observed after the administration of a double dose of vaccine. However, these reactions may be more severe and/or last longer. For example, local swelling, which can be up to 5 cm in diameter and which may take over 5 weeks to completely disappear, may be observed at the site of injection.


    Incompatibilities:

    Do not mix with any other veterinary medicinal products.


  13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY


    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


    ).


  15. OTHER INFORMATION


Pack sizes:

Plastic box with 10 vials of 1 ml (1 dose). Plastic box with 50 vials of 1 ml (1 dose).


Not all pack sizes may be marketed.


In vitro and in vivo data in non-target species suggests that the vaccine may provide a degree of cross-protection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.


For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.


België/Belgique/Belgien:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

France/ Frankrijk/Frankreich Tel: + 33 (0) 4 92 08 73 00

Lietuva:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Prancūzija,

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


Република България:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Франция

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

Luxembourg/Luxemburg:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

France,

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


Česká republika:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Francie,

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

Magyarország:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros, Franciaország,

Teл: + 33 (0) 4 92 08 73 00


Danmark:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Frankrig,

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

Malta:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Franza,

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


Deutschland:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Frankreich,

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

Nederland:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Frankrijk,

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


Eesti:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros, Prantsusmaa,

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

Norge:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros, Frankrike,

Tlf: + 33 (0) 4 92 08 73 00


Ελλάδα:

VIRBAC,

Österreich:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Γαλλία,

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


España:

VIRBAC ESPAÑA S.A.,

Angel Guimerá 179-181,

ES-8950 Esplugues de Llobregat


France: VIRBAC France, 13ème rue – L.I.D., FR-06517 Carros,

service-conso@virbac.fr


Hrvatska:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Francuska,

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


Ireland:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

France,

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


Ísland:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Frakkland,

Sími: + 33 (0) 4 92 08 73 00


Italia:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Francia,

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


Κύπρος:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Γαλλία,

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


Latvija:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros, Frankreich,

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


Polska:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Francja,

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


Portugal:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

França,

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


România:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Franţa,

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


Slovenija:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Francija,

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


Slovenská republika:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros, Francúzsko,

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


Suomi/Finland:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros, Ranska/Frankrike,

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


Sverige:

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros, Frankrike,

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


United Kingdom (Northern Ireland):

VIRBAC,

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

Francija,

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

1ère avenue 2065 m – L.I.D., FR-06516 Carros,

France,

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