Seresto Collar Cat | 38 cm

Seresto is an innovative collar that protects cats up to 8 months against fleas and ticks. Seresto contains the active ingredients imidacloprid and flumethrin. The Seresto collar protects against both adult fleas and flea larvae during 7-8 months. The protections against ticks lasts 8 months. In addition, Seresto also has a repelling effect against ticks. The repelling effect prevents ticks to feed on your cat, thereby reducing the risk of tick-borne diseases. Furthermore, Seresto reduces the risk of infection with Leishmania infantum through transmission by sandflies up to 8 months. Seresto does not work against mites.

The collar is for external use only, water resistant and odorless. Due to the special ‘polymer matrix’ in the collar, the largest concentration of active substances is located inside the collar and the concentration on the outside of the collar is relatively low. The Seresto collar is therefore very safe to use. Seresto is therefore also safe for other animals and children. The active ingredient is not located on the outside of the band, but adheres to the sebum layer of the skin. Therefore the collar is considered safe. This has also been confirmed by a series of safety studies among users. The animal can be stroked safely after applying the collar. Make sure that a child does not hold the collar for more than 15-20 minutes.

Seresto can be used on kittens from 10 weeks. Note: kittens are growing fast, so loosen the band on time.

When fitting the collar, it is important to remove remnants of the plastic connectors on the inside of the collar. Then attach the collar around your cat's neck, and make sure there is room enough to allow you to slip two fingers between the collar and the neck. Then slide the excess part of the collar through the loop and cut off this piece (leaving 2 cm). After the application of the collar, the active ingredients will distribute over the rest of the body.

Seresto for cats
Length: 38 cm
Contains: 1.25 gram imidacloprid en 0.56 gram flumethrin

Use during pregnancy, lactation and kittens

Seresto collars should not be used in pregnant and lactating cats, in kittens less than 10 weeks and hypersensitivity to one of its ingredients.

Adverse reactions

Scratching at the application site can be observed during the first days after application in animals that are not used to wearing a collar. Mild skin reactions like itching, redness and hair loss may occur at the application site. In very rare cases, more serious skin reactions as dermatitis, inflammation, eczema or lesions can occur. In these cases is it recommended to remove the collar. In rare cases Seresto can also cause mild and transient reactions like depression, change of food intake, salivation, vomiting and diarrhoea.

PACKAGE LEAFLET

Seresto 1.25 g + 0.56 g, collar for cats and dogs ≤ 8 kg

1.       NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Bayer Animal Health GmbH
51368 Leverkusen
Germany

[or national subsidiary(ies), respectively]

Manufacturer for the batch release:

KVP Pharma + Veterinär Produkte GmbH

Projensdorfer Str. 324, 24106 Kiel

Germany

2.       NAME OF THE VETERINARY MEDICINAL PRODUCT

Seresto 1.25 g + 0.56 g, collar for cats and dogs ≤ 8 kg         [AT, BE, CY, DE, DK, EL, ES, FI, FR, IE, IS, IT, LU, NL, NO, PT, SE, UK]

Foresto 1.25 g + 0.56 g, collar for cats and dogs ≤ 8 kg         [BG, CZ, EE, HU, LT, LV, PL, RO, SK, SI]

Imidacloprid

Flumethrin

3.       STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

One grey, odour free collar of 38 cm (12.5 g) contains 1.25 g imidacloprid and 0.56 g flumethrin as active substances.

Excipients: Titanium dioxide (E 171), Iron oxide black (E 172), Dibutyladipate, Propylene glycol dicaprylocaprate, Epoxidised soybean oil, Stearic acid, Polyvinyl chloride

4.         INDICATION(S)

Cats:

For the treatment and prevention of flea (Ctenocephalides felis) infestation for 7 to 8 months. Efficacy against fleas starts immediately after application of the collar.

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) (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.

Ideally, the collar should be applied before the beginning of the flea or tick season.

Dogs:

For the treatment and prevention of flea (Ctenocephalides felis) infestation for 7 to 8 months. Efficacy against fleas starts immediately after application of the collar.

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.

For treatment of biting/chewing lice (Trichodectes canis) infestation.

Ideally, the collar should be applied before the beginning of the flea or tick season.

5.         CONTRAINDICATIONS

Do not treat kittens less than 10 weeks and puppies less than 7 weeks of age.

Do not use in case of known hypersensitivity to the active substances or to any of the excipients.

6.       ADVERSE REACTIONS

Occasionally slight pruritus and/or erythema may be observed in animals that are not used to wearing collars on the first few days after fitting. Ensure that the collar is not fitted too tightly.

Slight hair loss and mild skin reactions may occur at the application site, which usually recover within 1 to 2 weeks without the need for collar removal. In single cases, a temporary collar removal may be recommended until the symptoms have disappeared.

In cats, initially, slight and transient reactions as depression, change of food intake, salivation, vomiting and diarrhoea might occur in rare cases. As in other topical applications, allergic contact dermatitis might occur in hypersensitive animals.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

7.       TARGET SPECIES

Cats, Dogs (≤ 8 kg)

8.       DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Cats and small dogs up to 8 kg body weight receive one collar of 38 cm length.

Dogs above 8 kg receive one Seresto collar for dogs > 8 kg of 70 cm length.

Cutaneous use. One collar per animal to be fastened around the neck. For external use only.

9.       ADVICE ON CORRECT ADMINISTRATION

Remove collar from protective bag directly before use. Unroll collar and make sure that there are no remnants from the plastic connectors inside the collar. Adjust the collar around the animal's neck without tightening it too tight (as a guide, it should be possible to insert 2 fingers between the collar and the neck). Pull excess collar through the loop and cut off any excess length extending beyond 2 cm.

The collar should be worn continuously for the 8 month protection period and should be removed after the treatment period. Check periodically and adjust fit if necessary, especially when kittens/puppies are rapidly growing.

This collar is designed with a safety-closure mechanism. In the unlikely event of a cat being trapped, the cats own strength is sufficient to widen the collar to allow for quick release.

10.     WITHDRAWAL PERIOD

Not applicable.

11.     SPECIAL STORAGE PRECAUTIONS

Keep out of the reach and sight of children.

This veterinary medicinal product does not require any special storage conditions.

Do not use after expiry date stated on the bag and outer box.

12.     SPECIAL WARNING(S)

Ticks will be killed and fall off the host within 24 to 48 hours after infestation without having had a blood meal, as a rule. An attachment of single ticks after treatment cannot be excluded. For this reason, a transmission of infectious diseases by ticks cannot be completely excluded if conditions are unfavourable.

As in all longterm topical products, periods of excessive seasonal hair shedding may lead to transient slight reduction of efficacy by loss of hair-bound portions of the active ingredients. Replenishment from the collar starts immediately so that full efficacy will be re-established without any additional treatment or collar replacement.

For optimum control of flea problems in heavily infested households it may be necessary to treat the environment with a suitable insecticide.

The product is water resistant; it remains effective f 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.

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.

Due to the nature of the collar overdosage is unlikely and signs of overdosage are not to be expected.

An overdosage of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period and no other adverse effects were observed than already described in section “adverse reactions”.

In the unlikely event of the animal eating the collar mild gastrointestinal symptoms (e.g. loose stool) may occur.

Special precautions for persons administering Seresto to animals:

Keep the bag with the collar in the outer packaging until use.

As with any veterinary medicinal product, 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.

People with known sensitivity to the ingredients of the collar should avoid contact with the collar.

Immediately dispose of any remnants or cut-offs of the collar (see section “advice on correct administration”).

Wash hands with cold water after fitting the collar.

13.     SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

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.

14.     DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

15.     OTHER INFORMATION

Pack size: one collar

Both active ingredients are slowly and continuously released in low concentrations from the polymer matrix system of the collar towards the animal. Both actives are present in the cat’s or dog’s haircoat in acaricidal/insecticidal concentrations during the entire efficacy period. The active substances spread from the site of direct contact over the entire skin surface. Target animal overdose and serum kinetic studies have established that imidacloprid reached the systemic circulation transiently while flumethrin was mostly not measurable. Oral absorption of both active substances is not relevant for the clinical efficacy.

Activity against fleas starts immediately after application of the collar. In addition to the indications listed above an activity against Ctenocephalides canis and Pulex irritans fleas has been demonstrated.

The product provides repellent (anti-feeding) activity against the claimed ticks, thus preventing repelled parasites from taking a blood meal and thereby indirectly aids in the reduction of the risk of Vector-Borne Disease transmission. In addition to the indications listed above activity has been demonstrated in cats against Ixodes hexagonus and the non-European tick species Amblyomma americanum as well as in dogs against I. hexagonus I. scapularis and the non-European tick species Dermacentor variabilis and the Australian paralysis tick I. holocyclus.

The collars were able to improve the Sarcoptes scabiei infestation in pre-infested dogs leading to a full cure after three months.