EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/312188/2015

EMEA/V/C/004079

EPAR summary for the public

Canigen L4

Canine leptospirosis vaccine (inactivated)

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.

What is Canigen L4 and what is it used for?

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.

How is Canigen L4 used?

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

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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.

How does Canigen L4 work?

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.

What benefits of Canigen L4 have been shown in studies?

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.

What are the risks associated with Canigen L4?

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.

Why is Canigen L4 approved?

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.

Other information about Canigen L4

The European Commission granted a marketing authorisation valid throughout the EU for Canigen L4 on 3 July 2015.

The full EPAR for Canigen L4 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. For more information about treatment with Canigen L4, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

This summary was last updated in May 2015.

Canigen L4 EMA/312188/2015