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Canigen L4 (Inactivated Leptospira strains:L. interrogans...) – Summary of product characteristics - QI07AB01

Updated on site: 08-Feb-2018

Medication name: Canigen L4
ATC: QI07AB01
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

Canigen L4 suspension for injection for dogs

2.QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose of 1 ml contains:

 

 

Active substances:

 

 

Inactivated Leptospira strains:

 

U1

- L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000)

3550-7100

- L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni

290-1000

U1

(strain Ic-02-001)

 

U1

- L. interrogans serogroup Australis serovar Bratislava (strain As-05-073)

500-1700

- L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)

650-1300

U1

1 Antigenic mass ELISA units.

 

 

Excipient:

 

 

 

Thiomersal

0.1 mg

 

 

For the full list of excipients, see section 6.1.

3.PHARMACEUTICAL FORM

Suspension for injection.

Colourless suspension.

4.CLINICAL PARTICULARS

4.1Target species

Dogs.

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

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.

4.3Contraindications

None.

4.4Special warnings for each target species

None.

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

Avoid accidental self-injection or contact with the eyes. In case of ocular irritation seek medical advice immediately and show the package leaflet or the label to the physician.

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 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 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 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.

4.9Amounts 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.

(*) 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

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 PARTICULARS

6.1List of excipients

Thiomersal

Sodium chloride

Potassium chloride

Disodium phosphate dihydrate

Potassium dihydrogen phosphate

Water for injections

6.2Major incompatibilities

Do not mix with any other veterinary medicinal products except those mentioned in section 4.8.

6.3Shelf life

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.

Pack sizes:

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

The Netherlands

8.MARKETING AUTHORISATION NUMBER(S)

EU/2/15/183/001-003

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

Not applicable

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