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Species: Dogs Therapeutic indication: Immunological veterinary medical products: For dogs Active ingredient: Vaccine Antigens Product:Canigen L4 suspension for injection for dogs Product index: Canigen L4 suspension for dogs
Active substances: Inactivated Leptospira strains: - L. interrogans serogroup Canicola serovar Portlandvere (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. Excipient: Thiomersal 0.1 mg
Colourless suspension for injection
Dogs
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
none
none
Special precautions for use in animals: Vaccinate only healthy animals. Special precautions to be taken by the person administering the veterinary medicinal product to animals: None.
A mild and transient increase in body temperature (≤ 1°C) may occur for a few days after vaccination, with some pups showing less activity and/or a reduced appetite. A small transient swelling (≤ 4 cm), which can occasionally be firm and painful on palpation, may be observed at the site of injection. Any such swelling will either have disappeared or be clearly diminished by 14 days post-vaccination. In very rare cases, 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. 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 displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Can be used during pregnancy
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Canigen series from the same marketing authorisation holder (or national subsidiary) containing canine distemper virus strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain 154 and/or canine parainfluenza virus strain Cornell components for subcutaneous administration where authorised. The product information of the relevant Canigen vaccines should be consulted before administration of the mixed product. When mixed with these Canigen vaccines, the demonstrated safety and efficacy claims for Canigen L4 are no different from those described for Canigen L4 alone. When mixed with Canigen vaccines containing canine parainfluenza virus strain Cornell at annual revaccination, it has been established that there is no interference with the anamnestic response induced by the injectable canine parainfluenza virus component. Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with vaccines of the Canigen series from the same marketing authorisation holder (or national subsidiary) containing Bordetella bronchiseptica strain B-C2 and/or canine parainfluenza virus strain Cornell components for intranasal administration where authorised. 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 any other veterinary medicinal product therefore needs to be made on a case by case basis.
Subcutaneous use. Before use, allow the vaccine to reach room temperature. 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. For simultaneous use with Canigen vaccines where authorised: 1 dose of a Canigen vaccine from the same marketing authorisation holder (or national subsidiary) containing canine distemper virus strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain 154 and/or canine parainfluenza virus strain Cornell components should be reconstituted with 1 dose (1 ml) of Canigen L4. The mixed vaccines should be administered by subcutaneous injection.
No adverse reactions other than those mentioned in section 4.6 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.
Not applicable
To stimulate active immunity in dogs against L. interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang. In vitro and in vivo data in non-target species suggest that the vaccine may provide a degree of cross-protection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Thiomersal Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Do not mix with any other veterinary medicinal products except those mentioned above.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life after first opening the immediate packaging: 10 hours Shelf life after reconstitution of Canigen vaccines: 45 min
Store in a refrigerator (2°C – 8°C). Do not freeze. Protect from light.
Type I glass vial of 1 ml (1 dose) or 10 ml (10 doses) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap. Pack sizes: Box with 10 or 50 vials of 1 ml (1 dose). Box with 1 vial of 10 ml (10 doses). Not all pack sizes may be marketed.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
EU/2/15/183/001-003
03/07/2015
Nil
Legal category: POM-V
GTIN description:Canigen L4 vaccine for dogs 50 dose GTIN:8713184139658 GTIN description:Canigen L4 vaccine for dogs 10 dose GTIN:8713184139641
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