Canigen L4 (Inactivated Leptospira strains:L. interrogans...) – Summary of product characteristics - QI07AB01
Updated on site: 08-Feb-2018
|Medication name:||Canigen L4|
|Substance:||Inactivated Leptospira strains:L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000); L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001); L. interrogans serogroup Australis serovar Bratislava (strain A|
|Manufacturer:||Intervet International B.V.|
- 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- 3. PHARMACEUTICAL FORM
- 4. CLINICAL PARTICULARS
- 4.1 Target species
- 4.2 Indications for use, specifying the target species
- 4.3 Contraindications
- 4.4 Special warnings for each target species
- 4.5 Special precautions for use
- 4.6 Adverse reactions (frequency and seriousness)
- 4.7 Use during pregnancy, lactation or lay
- 4.8 Interaction with other medicinal products and other forms of interaction
- 4.9 Amounts to be administered and administration route
- 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
- 4.11 Withdrawal period
- 5. IMMUNOLOGICAL PROPERTIES
- 6. PHARMACEUTICAL PARTICULARS
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBER(S)
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
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:
Inactivated Leptospira strains:
- L. interrogans serogroup Canicola serovar
- L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni
- L. interrogans serogroup Australis serovar Bratislava (strain
- L. kirschneri serogroup Grippotyphosa serovar Dadas (strain
1 Antigenic mass ELISA units.
For the full list of excipients, see section 6.1.
Suspension for injection.
4.2Indications 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
-L. interrogans serogroup Australis serovar Bratislava to reduce infection
-L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection and urinary
Onset of immunity: 3 weeks.
Duration of immunity: 1 year.
4.4Special warnings for each target species
4.5Special precautions for use
Special precautions for use in animals
Vaccinate healthy animals only.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
4.6Adverse 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
In very rare cases, clinical signs of
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).
4.7Use during pregnancy, lactation or lay
Can be used during pregnancy.
4.8Interaction 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 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
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.
4.9Amounts to be administered and administration route
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.
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
(*) 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 at room temperature (15°C - 25°C) before they are administered by subcutaneous injection.
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
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
6.1List of excipients
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
Do not mix with any other veterinary medicinal products except those mentioned in section 4.8.
Shelf life of the veterinary medicinal product as packaged for sale: 21 months. Shelf life after first opening the immediate container: 10 hours.
Shelf life after reconstitution of Canigen vaccines according to directions: 45 mins.
6.4Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Protect from light.
6.5Nature and composition of immediate packaging
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.
Plastic box with 10 or 50 vials of 1 ml (1 dose).
Cardboard box with 1 vial of 10 ml (10 doses).
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 product should be disposed of in accordance with local requirements.
7.MARKETING AUTHORISATION HOLDER
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer
8.MARKETING AUTHORISATION NUMBER(S)
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 03/07/2015
10 DATE OF REVISION OF THE TEXT
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