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Date: Thursday, July 2, 2020 11:20

Description: vet004
Release 6.413
Seresto Flea and Tick Control collar
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs, For cats
Active ingredient: Flumethrin, Imidacloprid
Product:Seresto® Flea and Tick Control 1.25 g + 0.56 g, collar for cats
Seresto® Flea and Tick Control 1.25 g + 0.56 g, collar for small dogs ≤ 8 kg
Seresto® Flea and Tick Control 4.50 g + 2.03 g, collar for large dogs > 8 kg
Product index: Seresto Flea and Tick Control collar
Presentation
A grey, odour-free collar containing the following active substances:
Seresto Flea and Tick Control 1.25 g + 0.56 g, collar for cats: 38 cm (12.5 g) containing 1.25 g imidacloprid and 0.56 g flumethrin
Seresto Flea and Tick Control 1.25 g + 0.56 g, collar for small dogs ≤ 8 kg: 38 cm (12.5 g) containing 1.25 g imidacloprid and 0.56 g flumethrin
Seresto Flea and Tick Control 4.50 g + 2.03 g, collar for large dogs > 8 kg: 70 cm (45 g) containing 4.5 g imidacloprid and 2.03 g flumethrin
The collar also contains Titanium dioxide (E 171) and Iron oxide black (E 172) as excipients.
Uses
For cats use Seresto Flea and Tick Control 1.25 g + 0.56 g, collar for cats
For dogs ≤ 8 kg use Seresto Flea and Tick Control 1.25 g + 0.56 g, collar for small dogs ≤ 8 kg
For dogs > 8 kg use Seresto Flea and Tick Control 4.50 g + 2.03 g, collar for large dogs > 8 kg
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.
The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD), where this has been previously diagnosed by a veterinary surgeon.
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. If you are unsure how to safely remove ticks from your animal, seek professional guidance. The prevention of infestations with new ticks starts within two days after application of the collar.
Dogs:
For the treatment (Ctenocephalides felis) 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.
The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD), where this has been previously diagnosed by a veterinary surgeon.
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. If you are unsure how to safely remove ticks from your animal, seek professional advice. 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.
For treatment of biting/chewing lice (Trichodectes canis) infestation.
Dosage and administration
Cutaneous use. One collar per animal to be fastened around the neck.
Cats receive one collar of 38 cm length.
Small dogs up to, and including, 8 kg body weight receive one Seresto collar for dogs ≤ 8kg of 38 cm length.
Dogs above 8 kg receive one Seresto collar for dogs > 8 kg of 70 cm length.
For external use only.
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.
Fitting the collar to the cat (see diagram)
Description: h-724
Fitting the collar to the dog (see diagram)
Description: h-726
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 puppies and kittens are rapidly growing.
Cats: This collar is designed with a safety-closure mechanism.
Use During Pregnancy and Lactation
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.
Contra-indications, warnings, etc
Do not treat kittens less than 10 weeks of age.
Do not treat puppies less than 7 weeks of age.
Do not use in the case of known hypersensitivity to the active substances or to any of the excipients.
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.
Ideally, the collar should be applied before the beginning of the flea or tick season.
As with all long-term 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 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.
In rare cases mild behavioural disorders that may include scratching at the application site 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.
Mild application site reactions such as pruritus (itchiness), erythema (redness) and hair loss may occur. These have been reported as uncommon in cats and rare in dogs and usually resolve 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 very rare cases in dogs and rare cases in cats, application site reactions such as dermatitis, inflammation, eczema or lesions may occur and in these instances, collar removal is recommended
In rare cases in dogs neurological symptoms such as ataxia, convulsions and tremor may occur. In these cases collar removal is recommended.
Also, in rare case in cats and dogs, 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.
The frequency of possible adverse effects is defined using the following convention:
very common (affects more than 1 animal in 10)
common (affects 1 to 10 animals in 100)
uncommon (affects 1 to 10 animals in 1,000)
rare (affects 1 to 10 animals in 10,000)
very rare (affects less than 1 animals in 10,000)
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 month period, and in 7 week old puppies and 10 week old kittens for a 6 month period and no other adverse effects were observed than those already described in this section.
In the unlikely event of the animal eating the collar mild gastrointestinal symptoms (e.g. loose stool) may occur.
User Safety
Keep the bag with the collar in the outer packaging until ready to use.
Immediately dispose of any remnants or off‑cuts of the collar (see Dosage and administration section).
Do not allow children to play with the collar, or to put it into their mouths.
Imidacloprid and flumethrin are continuously released from the collar onto the 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 product.
The product may cause skin, eye and respiratory irritation in some people in very rare cases. Pets wearing the collar should not be allowed to sleep in the same bed as their owners, especially children.
Wash hands with cold water after fitting the collar.
Special Precautions for 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.
Pharmaceutical precautions
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years.
This veterinary medicinal product does not require any special storage conditions.
Legal category
Legal category: NFA-VPS
Packaging quantities
Tin containing one single 38 cm or 70 cm polyvinyl chloride-based collar packed into a PETP/PE bag.
Further information
Pharmacotherapeutic group: ectoparasiticides, insecticides and repellents, pyrethrins and pyrethroids, Flumethrin combinations. ATCvet code: QP53AC55
Imidacloprid is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it can be classified as a chloronicotinyl nitroguanidine. Imidacloprid is active against larval flea stages, adult fleas and lice. In cats, activity against C.felis starts immediately after application of the collar. In dogs, activity against C. felis starts immediately after application of the collar whereas adequate efficacy against C. canis starts within one week after application of the collar. In addition to the indications listed under the 'Uses' section, an activity against Pulex irritans fleas has been demonstrated.
Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.
Flumethrin is an ectoparasiticide of the synthetic pyrethroid group. According to current knowledge the synthetic pyrethroids interfere with the sodium channel of nerve cell membranes, resulting in a delay in repolarisation of the nerve and finally killing of the parasite. In studies on structure-activity relationship of a number of pyrethroids, interference with receptors of a certain chiral conformation was noted thereby causing a selective activity on ectoparasites. No anti-cholinesterase activity was noted with these compounds. Flumethrin is responsible for the product’s acaricidal activity and also prevents production of fertile eggs by its lethal effect on female ticks. In an in-vitro study 5 to 10 % of Rhipicephalus sanguineus ticks exposed to a sublethal dose of 4 mg flumethrin/L laid eggs which had a modified appearance (shrivelled, dull and dry) indicating a sterilising effect.
In addition to the indications listed under ‘Uses’ section, activity has been demonstrated in cats against Ixodes hexagonus and the non-European tick species Amblyomma americanum and in dogs against I. hexagonus, I. scapularis and the non-European tick species Dermacentor variabilis and the Australian paralysis tick I. holocyclus. 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 cats, indirect protection against the transmission of Cytauxzoon felis (transmitted by Amblyomma americanum ticks) has been shown in one laboratory study in a small number of animals at one month after treatment, thereby reducing the risk of diseases caused by this pathogen under the conditions of this study. In dogs, in addition to the pathogens listed under 'Uses' section, indirect protection against the transmission of Babesia canis canis (by Dermacentor reticulatus ticks) has been shown in one laboratory study at day 28 after treatment, and indirect protection against the transmission of Anaplasma phagocytophilum (by Ixodes ricinus ticks) has been shown in one laboratory study at 2 months after treatment, thereby reducing the risk of diseases caused by these pathogens under the conditions of these studies.
Data of two clinical field studies performed in Leishmania infantum endemic areas indicate a significant reduction in the risk of Leishmania transmission by sand flies in treated dogs compared to non-treated dogs, while the efficacy of the product in the prevention of sandfly bites has not been established. The influence of shampooing or water immersion regarding the transmission of canine leishmaniosis has not been examined.
The collars were able to improve the Sarcoptes scabiei infestation in pre-infested dogs leading to a full cure after three months.
Cats and Dogs: 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.
Marketing Authorisation Number
Seresto Flea and Tick Control 1.25 g + 0.56 g, collar for cats: Vm 00010/4217
Seresto Flea and Tick Control 1.25 g + 0.56 g, collar for small dogs ≤ 8 kg: Vm 00010/4218
Seresto Flea and Tick Control 4.50 g + 2.03 g, collar for large dogs > 8 kg: Vm 00010/4219
Significant changes
GTIN
GTIN description:Seresto Flea and Tick Control 1.25 g + 0.56 g, collar for cats
GTIN:04007221050490
GTIN description:Seresto Flea and Tick Control 1.25 g + 0.56 g, collar for small dogs ≤ 8 kg
GTIN:04007221050483
GTIN description:Seresto Flea and Tick Control 4.50 g + 2.03 g, collar for large dogs > 8 kg
GTIN:04007221050476