Summary of medicine characteristics - Canigen L4
SUMMARY OF PRODUCT CHARACTERISTICS
-
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Canigen L4 suspension for injection for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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 290–1000 U1
(strain Ic-02–001)
-
- 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.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection.
Colourless suspension.
4. CLINICAL PARTICULARS4.1 Target species
Dogs.
-
4.2 Indications for use, specifying the target species
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.
4.3 Contraindications
None.
-
4.4 Special warnings for each target species
Vaccinate healthy animals only.
-
4.5 Special precautions for use
Special precautions for use in animals
Not applicable.
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.
-
4.6 Adverse reactions (frequency and seriousness)
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).
-
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy.
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.
Before use, ensure that the vaccine is at room temperature (15 °C – 25 °C).
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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
-
4.11 Withdrawal period
Not applicable.
-
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for Canidae, inactivated bacterial vaccine.
ATCvet code QI07AB01.
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.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Sodium chloride
Potassium chloride
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal products.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 21 months.
Shelf life after first opening the immediate packaging: use immediately.
6.4. Special precautions for storage
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Protect from light.
-
6.5 Nature and composition of immediate packaging
Type I glass vial of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
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.
-
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
Intervet International B.V.
Wim de Korverstraat 35
5831 AN Boxmeer
The Netherlands
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/15/183/001–002
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 03/07/2015.
Date of last renewal: 24/04/2020.