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Canigen L4 (Inactivated Leptospira strains:L. interrogans...) – Package leaflet - 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.

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:

3550-7100 U1

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

- L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni

290-1000 U1

(strain Ic-02-001)

500-1700 U1

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

- 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.

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.

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).

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.

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.

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: 10 hours.

Shelf life after reconstitution of Canigen vaccines according to directions: 45 mins.

12.SPECIAL WARNING(S)

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.

Pregnancy:

Can be used during pregnancy.

Interaction 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.

Overdose (symptoms, emergency procedures, antidotes):

No adverse reactions other than those mentioned in section 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.

Incompatibilities:

Do not mix with any other veterinary medicinal products except the above mentioned vaccines.

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

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).

15.OTHER INFORMATION

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.

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.

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