Target Species
Dogs.
Indications for use, specifying the target species
For the treatment of dogs weighing 2 to 10 kg bodyweight.
To be used against infestations with fleas, alone or in association with ticks and/or biting lice.
•Treatment of flea infestations (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persist for 8 weeks. Prevention of the multiplication of fleas by inhibiting the development of eggs (ovicidal activity) and larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas for eight weeks after application.
•Treatment of tick infestations (Ixodes ricinus, Dermacentor variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus). The product has a persistent acaricidal efficacy for up to 4 weeks against ticks.
•Treatment of infestations with biting lice (Trichodectes canis).
Contraindications
In the absence of available data, the product should not be used on puppies less than 8 weeks old and/or weighing less than 2 kg.
Do not use on sick (e.g. systemic diseases, fever) or convalescent animals.
Do not use in rabbits, as adverse reactions with even mortality could occur. In the absence of studies, the use of the product is not recommended in non-target species.
This product is specifically developed for dogs. Do not use in cats and ferrets, as this could lead to overdosing.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
Bathing/immersion in water within 2 days after application of the product and more frequent bathing than once a week should be avoided, as no study has been performed to investigate how this affects the efficacy of the product. Emollient shampoos can be used prior to treatment, but reduce the duration of protection against fleas to approximately 5 weeks when used weekly after application of the product. Weekly bathing with a 2% chlorhexidine medicated shampoo did not affect efficacy against fleas during a 6 week long study.
Dogs should not be allowed to swim in watercourses for 2 days after application (See section, Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products)
There may be an attachment of a few ticks. For this reason a transmission of infectious diseases cannot be completely excluded if conditions are unfavorable.
Fleas from pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furnishings which should be treated, in case of massive infestation and at the beginning of the control measures, with a suitable insecticide and vacuumed regularly.
Special precautions for use
Special precautions for use in animals
Avoid contact with the animal’s eyes.
It is important to make sure that the product is applied to an area where the animal cannot lick it off and to make sure that animals do not lick each other following treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product can cause mucous membrane, skin and eye irritation. Therefore, contact of the product with mouth, skin and eyes should be avoided. In case of accidental eye contact, immediately and thoroughly rinse the eyes with clean water. If eye irritation persists seek medical advice and show the package leaflet or the label to the physician. If contact with the skin occurs, wash hands with soap and water.
People with a known hypersensitivity to insecticides or alcohol should avoid contact with the veterinary medicinal product.
Wash hands after use.
Ingestion of the product is harmful. Prevent children getting access to the pipettes and discard the used pipettes immediately after applying the product. In case of accidental ingestion of product, seek medical advice immediately.
Treated animals should not be handled until the application site is dry, and children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended that animals are not treated during the day, but should be treated during the early evening, and that recently treated animals are not allowed to sleep with owners, especially children.
Adverse reactions (frequency and seriousness)
Among the very rare suspected adverse reactions, transient skin reactions on the application site (skin discoloration, local hair loss, itching, redness) and general itching or hair loss have been reported after use. Excessive salivation, reversible nervous signs (increased sensitivity to stimulation, depression, other nervous signs), vomiting or respiratory symptoms have also been observed after use.
The frequency of adverse reactions is defined using the following convention:
•very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If licking occurs, a brief period of excessive salivation may be observed due mainly to the nature of the carrier .
Do not overdose.
Use during pregnancy, lactation or lay
The product can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interactions
None known.
