Canigen L4
Authorised
This medicine is authorised for use in the European Union
Canine leptospirosis vaccine (inactivated)
MedicineVeterinaryAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Canigen L4. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Canigen L4.
For practical information about using Canigen L4, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Canigen L4 is a veterinary vaccine used to vaccinate dogs from six weeks of age to protect against leptospirosis caused by one of four specific types of Leptospira bacteria. In dogs, leptospirosis can cause bleeding, hepatitis (inflammation of the liver) and jaundice (yellowing of the skin and eyes) or nephritis (kidney inflammation). The bacteria are spread via the urine of infected animals. For some strains of Leptospira, the vaccine also reduces the excretion (shedding) of the bacteria into the urine by the infected dogs, thereby reducing the risk of transmission.
This vaccine is the same as Nobivac L4, which is already authorised in the European Union (EU). The company that makes Nobivac L4 has agreed that its scientific data can be used for Canigen L4 (‘informed consent’).
Canigen L4 contains four types of inactivated (killed) Leptospira strains: L. interrogans serogroup Canicola serovar Portland-vere, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, L. kirschneri serogroup Grippotyphosa serovar Dadas.
Canigen L4 is available as a suspension for injection and can only be obtained with a prescription. The vaccine is given to dogs as two injections, four weeks apart, under the skin. The first injection can be given from six to nine weeks of age and the second four weeks later. When puppies are known to have high levels of maternally derived antibodies (special type of proteins, received from the mother in the milk, that help the body to fight infection), it is recommended that the first vaccination is given at nine weeks of age. A single ‘booster’ injection should be given every year to maintain the vaccine’s effect.
Protection starts three weeks after vaccination and lasts one year.
Canigen L4 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. The strains of Leptospira bacteria in Canigen L4 are killed (inactivated) so that they do not cause disease. When Canigen L4 is given to dogs the animals’ immune system recognises the bacteria as ‘foreign’ and makes defences against them. In the future, if the animals are exposed to these Leptospira bacteria the immune system will be able to respond more quickly. This will help protect them against leptospirosis.
The company has presented data from both laboratory and field studies to establish the safety and effectiveness of the vaccine, including how long it took for the dogs to be fully protected and how long the vaccine could provide protection.
The studies showed that the vaccine reduces infection with Leptospira and excretion of the bacteria into the urine. They also showed that the vaccine is safe to give to pregnant bitches.
A mild and temporary increase in body temperature (1°C or less) may occur for a few days after vaccination, with some puppies showing less activity and/or a reduced appetite. A small, temporary swelling may occur at the injection site, which will either disappear or reduce in size within two weeks after vaccination. An occasional temporary, acute (short-term) hypersensitivity (allergic) reaction may occur.
The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Canigen L4’s benefits are greater than its risks and recommended that it be approved for use in the EU.
The European Commission granted a marketing authorisation valid throughout the EU for Canigen L4 on 3 July 2015.
For more information about treatment with Canigen L4, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Product information
Latest procedure affecting product information: IB/0009
07/07/2021
Product details
- Name of medicine
- Canigen L4
- Active 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 As-05-073); L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
- International non-proprietary name (INN) or common name
- Canine leptospirosis vaccine (inactivated)
- Species
- Dogs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI07AB01
Pharmacotherapeutic group
- Immunologicals for canidae
- Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
Therapeutic indication
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.
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