Mandatory Legal Text

Seresto® collar for cats and dogs: Two compositions: One collar for cats and dogs up to 8 kg body weight (38 cm length) and one collar for dogs over 8 kg body weight (70 cm length) contains 10 % imidacloprid and 4.5 % flumethrin as active substances; excipients: titanium dioxide and iron oxide black. Indications for use:

Cats: For the treatment and prevention of flea (Ctenocephalides felis) infestation for 7 to 8 months. 
Protects the animal’s immediate surroundings against flea larvae development for 10 weeks.
Seresto can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
The product has persistent acaricidal (killing) efficacy (Ixodes ricinus, Rhipicephalus turanicus) and repellent (anti-feeding) efficacy against tick infestations (Ixodes ricinus) for 8 months. It is effective against larvae, nymphs and adult ticks. Ticks already on the cat prior to treatment may not be killed within 48 hours after collar application and may remain attached and visible. Therefore, removal of ticks already on the cat at the time of application is recommended. The prevention of infestations with new ticks starts within two days after application of the collar.

Dogs: For the treatment and prevention of flea (Ctenocephalides felis, C. canis) infestation for 7 to 8 months. 
Protects the animal’s immediate surroundings against flea larvae development for 8 months.
Seresto can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
The product has persistent acaricidal (killing) efficacy against tick infestations (Ixodes ricinus, Rhipicephalus sanguineus, Dermacentor reticulatus) and repellent (anti-feeding) efficacy against tick infestations (Ixodes ricinus, Rhipicephalus sanguineus) for 8 months. It is effective against larvae, nymphs and adult ticks.
Ticks already on the dog prior to treatment may not be killed within 48 hours after collar application and may remain attached and visible. Therefore, removal of ticks already on the dog at the time of application is recommended. The prevention of infestations with new ticks starts within two days after application of the collar.
The product provides indirect protection against the transmission of the pathogens Babesia canis vogeli and Ehrlichia canis from the tick vector Rhipicephalus sanguineus, thereby reducing the risk of canine babesiosis and canine ehrlichiosis for 7 months.
Reduction of the risk of infection with Leishmania infantum via transmission by sand flies for up to 8 months.
For treatment of biting/chewing lice (Trichodectes canis) infestation. 

Contraindications: Do not treat kittens less than 10 weeks of age. Do not treat puppies less
than 7 weeks of age. Do not use in case of hypersensitivity to the active substances or to any of the
excipients. 

Special precautions for use: The product is water resistant; it remains effective if the animal becomes wet. However, prolonged, intense exposure to water or extensive shampooing should be avoided as the duration of activity may be reduced. Studies show that monthly shampooing or water immersion does not significantly shorten the 8 months efficacy duration for ticks after redistribution of the active substances in the coat whereas the product’s flea efficacy gradually decreased, starting in the 5th month. The influence of shampooing or water immersion regarding the transmission of canine leishmaniosis has not been examined.
Keep the bag with the collar in the outer packaging until use.
As with any veterinary medicinal products, do not allow small children to play with the collar, or to put it into their mouths. Pets wearing the collar should not be allowed to sleep in the same bed as their owners, especially children. Imidacloprid and flumethrin are continuously released from the collar to the skin and fur whilst the collar is being worn. The product may cause hypersensitivity reactions in some people. People with known hypersensitivity (allergy) to the ingredients of the collar should avoid contact with the veterinary medicinal product. 
The product may cause skin, eye and respiratory irritation in some people in very rare cases. In case of eye irritation, flush eyes thoroughly with cold water. In case of skin irritation, wash the skin with soap and cold water. If symptoms persist it is recommended to seek medical advice and show the package leaflet or the label to the physician. Immediately dispose of any remnants or cut-offs of the collar. Wash hands with cold water after fitting the collar. 

Adverse reactions: In rare cases behavioural disorders that may include hiding, vocalization, hyperactivity, excessive licking and/or grooming or scratching at the application site may be observed in animals that are not used to wearing collars on the first few days after fitting. Aggression after collar application was reported in very rare cases. Ensure that the collar is fitted correctly.
Application site reactions such as pruritus, erythema and hair loss may occur. These have been reported as rare in dogs and uncommon in cats and usually resolve within 1 to 2 weeks . In single cases, a temporary collar removal may be recommended until the symptoms have disappeared.
In very rare cases in dogs and rare cases in cats, application site reactions such as dermatitis, inflammation, eczema, lesions or haemorrhage may occur and in these instances, collar removal is recommended.
In dogs in rare cases neurological symptoms as ataxia, convulsions and tremor may occur. In these
cases collar removal is recommended.
Also, in rare case in dogs and cats, slight and transient reactions as depression, change of food intake, salivation, vomiting and diarrhoea might occur initially. As in other topical applications, allergic contact dermatitis might occur in hypersensitive animals.
Laboratory studies with either flumethrin or imidacloprid in rats and rabbits have not produced any effects on fertility or reproduction and showed no teratogenic or foetotoxic effects. However, the safety of the veterinary medicinal product has not been established in target animals during pregnancy and lactation, and in the absence of available data, the product is therefore not recommended in pregnant and lactating bitches or queens. 
No interaction with other medicinal products and other forms of interaction are known. Due to the nature of the collar, overdosage is unlikely and signs of overdosage are not to be expected. An overdosage of five collars around the neck was investigated in adult cats and dogs for an 8-month period and in 10-week-old kittens and 7-week-old puppies for a 6-month period and no other adverse effects were observed. In the unlikely event of oral uptake of the collar, mild gastrointestinal signs (e.g., loose stool) may occur. 

Disposal: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. This product should not enter water courses as it may be dangerous for fish and other aquatic organisms

Withdrawal period: Not applicable. 

Marketing authorization holder: Local Bayer affiliates 

All information presented is based on the European Summary of Product Characteristics (SPC; status 07/2020); Registration conditions, incl prescription status may vary country by country – please check your registered local SPC / Product Information for full information.

Off