Target species
Cats.
Indications for use, specifying the target species
Treatment and prevention of flea infestations (Ctenocephalides felis) on cats. One application prevents flea infestation for one month. It also prevents the multiplication of fleas by inhibiting flea emergence in the environment of the cat for 3 months.
Contraindications
Do not use in cats or kittens weighing less than 0.6 kg. Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
All cats within the household should be treated. Dogs in the household should only be treated with a veterinary medicinal product authorised for use in that species. Fleas can infest the cat’s basket, bedding and regular resting areas such as carpets and soft furnishings. In case of massive flea infestation and at the beginning of the control measures, these areas should be treated with a suitable insecticide and then vacuumed regularly. The impact of shampooing on the efficacy of the veterinary medicinal product has not been evaluated.
In case of suspicion of dermatitis (itch and skin irritation), seek veterinary advice
Special precautions for use
Special precautions for use in animals
The safety of the product has not been established in cats younger than 7 weeks or weighing less than 0.6 kg (see Contraindications).
After accidental ingestion of the product, transient reactions such as salivation, abnormal faeces and emesis may occur, however these should resolve without treatment within 4 hours. Care should be taken to apply the dose to an area where the animal cannot lick it off (see amounts to be administered and administration route), and to ensure that animals do not groom each other immediately following treatment. Care should be taken to ensure that the contents of the spot-on applicator, or the applied dose, do not come into contact with the eyes of the cat to be treated and/or any other animals.
No studies have been performed in sick or convalescent cats, therefore use in these cats should be based on the benefit-risk assessment of a veterinarian
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to dinotefuran, pyriproxyfen or dimethyl sulfoxide should avoid contact with this veterinary medicinal product.
The veterinary medicinal product is irritating to the eyes and skin.
To avoid adverse reactions:
•Wash hands thoroughly and immediately after use.
•Avoid contact with the skin, eyes or mouth.
•In case of accidental spillage onto skin, wash off immediately with soap and water.
•If the veterinary medicinal product accidentally gets into the eyes, they should be rinsed with water immediately, with the eyelids open, and for a sufficient length of time.
•Treated animals must not be handled for at least eight hours after application of the product. It is therefore recommended to treat the animal in the evening.
•Treated animals should not be allowed to sleep with their owners, especially children, on the day of treatment.
•Used applicators should be disposed of immediately and not left within the sight or reach of children.
If skin or if eye irritation persists, or in case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
Slight scales, transient erythema and alopecia can be observed in rare cases, which usually disappear spontaneously without treatment. Transient neurological signs such as muscle tremors or lethargy may occur very rarely and in particular after application site licking. Transient cosmetic effects such as wet hair and a white dry residue may occur at the application site very rarely and may persist up to 7 days; however, these effects are usually not noticeable after 48 hours. These changes do not affect the safety or the efficacy of the veterinary medicinal product. Other application site disorders such as erythema, pruritus, lesions and inflammation may occur very rarely. Hyperactivity and tachypnoea may occur very rarely
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in adult female cats. Use only accordingly to the benefit/risk assessment by the responsible veterinarian. Laboratory studies with each of the components, dinotefuran or pyriproxyfen, in rats and rabbits have not produced any evidence of maternotoxic, teratogenic or foetotoxic effects. In rats, dinotefuran has been shown to cross the blood-milk barrier and is excreted in the milk.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
Dosage:
The minimum recommended dose is 42.3 mg dinotefuran/kg bodyweight and 4.23 mg pyriproxyfen/kg bodyweight.
The treatment dose range is 42.3 to 705 mg dinotefuran/kg bodyweight (bw) and 4.23 to 70.5 mg pyriproxyfen/kg bodyweight (bw) for cats of 0.6 kg to 10 kg bodyweight.
Method and route of administration:
Spot-on use. Care should be taken to apply the veterinary medicinal product only onto intact (undamaged) cat's skin.
Treatment schedule:
Following a single administration, the veterinary medicinal product will prevent flea infestation for one month and prevent further flea multiplication by inhibiting flea emergence in the environment of the cat for 3 months. The need to re-treat cats which are likely to be re-infested, and the time interval between such treatments, should be based on an assessment by a veterinarian.
How to apply: Remove the spot-on applicator from the pack.
Step 1: Hold the applicator upright, placing fingers below the larger disk as shown.
Step 2: With the other hand, press downwards on the smaller disk until the 2 disks meet evenly. This will pierce the seal.
Step 3: The cat should be standing or in a comfortable position for easy application. At the base of cat’s head, part the hair until the skin is visible. Apply the veterinary medicinal product slowly with the tip of the applicator on the skin. Avoid superficial application to the cat’s hair.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No clinically important adverse reactions were observed in healthy kittens aged 7 weeks or more, topically treated 7 times at 2 week intervals and with up to 4 times the highest recommended dose except transient oedema or dry skin at the application site.
Withdrawal period(s)
Not applicable