FIPRON 2.5 mg/ml cutaneous spray, solution
Treatment and prevention of flea attack and associated allergies to flea bite. Treatment and prevention od louse and tick attacks.
|type of preparative:||Antiparasitics|
|target species animals:||Cat, Dog|
1 ml contains:
Active substance: Fipronilum 2.5 mg
Cutaneous spray, solution
Indications for use, specifying the target species:
Treatment and prevention of flea attack and associated allergies to flea bite. Treatment and prevention of louse and tick attacks.
Do not use in kittens 8 weeks of age or younger. Do not use in puppies 3 days of age or younger.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in target animal species other than as specified.
Parasites can develop resistance to any group of ectoparasiticides after frequent, repeated use of the active substance from the same group.
Special precautions for use:
Special precautions for use in animals
The product must not be inhaled. Protect the animal's eyes. Prevent the animals from mutual licking until the product has fully dried. Washing of the animals 48 hours prior to the treatment and 48 hours after the treatment is not recommended.Individual ticks may stick to the animal. Therefore, infectious disease transmission cannot be ruled out in unfavourable conditions.
Avoid underdosing due to incorrect assessment of the animal's live weight or to incorrect administration of the drug.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not eat, drink or smoke while handling the product.
Protective gloves should be worn when handling this veterinary medicinal product. Harmful when inhaled. Systemic effects (such as respiratory complaints, tremor, excitability, increased irritability, weakness, nausea) may occur. The treatment should be performed in well ventilated areas.
Avoid contact of the package content with the skin and/or mucosa of the person providing the treatment. Wash your hands with soap and water after application. Remove contaminated clothing which is in direct contact with skin.
This product may cause irritation of the mucosa and eyes. Protect your eyes against contact with the product.
In case of contact with the eyes, rinse the eyes immediately with plenty of water and seek medical advice. If health problems arise, seek medical attention and show the package leaflet or label.
Do not handle the animals treated and do not allow children to play with the animals until the applied product has dried. To this end, it is recommended that the product be applied to the animals in the evening rather than during the day and that the animals should not be allowed to sleep with humans, with children in particular.
No sensitization induced by Fipronil has been demonstrated in sensitization tests. Persons with known hypersensitivity to Fipronil or to any of the excipients as well as persons with convulsive disorders (epilepsy) should be cautious when handling the product.
Avoid swallowing the product. In case of inadvertent use seek medical attention immediately. Show the doctor the package insert or label.
Class II inflammable material!
Isolated cases of skin reactions of various intensity such as itching and/or inflammatory irritation in sensitive animals have been reported.
Use during pregnancy, lactation or lay:
Laboratory studies performed on mice and rats have or not demonstrated any adverse effects on reproduction or any foetotoxic or teratogenic effects of Fipronil applied in therapeutic doses. Application of the product has no effect on the lactation of the target animal species either. Application of the product has no effect on the fertility of the target animal species.
Interaction with other medicinal products and other forms of interaction:
Amounts to be administered and administration route:
Generally, the dose is 7.5 mg of fipronil per kg of the animal's body weight, i.e. in practice 3 ml of the product or 6 squeezes of the application pump per kg of the animal's body weight when using the 100ml packaging or 2 squeezes of the cap per kg of the animal's body weight when using the 250ml packaging. This dose may be increased up to a double in dependence on the animal's hair length, i.e. to 15 mg of Fipronil per kg of the animal's body weight, in practice up to 12 squeezes of the application pump per kg of the animal's body weight when using the 100ml packaging or 4 squeezes per kg of the animal's body weight when using the 250ml packaging. Exact dosage is necessary to ensure an optimal effect and duration of action. Consult your veterinary surgeon if necessary.
Spray the whole animal's body from a 10-20 cm distance against the direction of the hair/fur. Usually, a brush or comb is used simultaneously. All hair/fur should be moisturized uniformly with the product so the preparation can penetrate as far as the skin. For the treatment of the head and skin around the eyes, spray the product onto a wet glove and rub it carefully into the hair/fur. Avoid spraying into the eyes.
Allow the product to dry at normal ambient temperature.
Since no safety studies are available, do not apply the product more frequently than once in 4 weeks.
Overdose (symptoms, emergency procedures, antidotes), if necessary:
Excitability, aggressiveness and even spasms may appear in animals that have swallowed large amounts of fipronil. Administration of diazepam or lorazepam (or phenobarbital) is recommended in such cases. Corticosteroids and ß2 – sympatomimetics are recommended in the event of respiratory problems.
Not intended for food-producing animals.
Fipronil is an insecticide/acaricide derived from 1-N-pyrazole. In the central nervous system of arthropods, Fipronil interacts with gamma-aminobutyric acid (GABA), whereupon the presynaptic and postsynaptic transfer of chloride ions through the cell membranes of neurons is blocked. This results in non-coordinated activity of the central nervous system and subsequent death of the animal. Fipronil kills insects and mites by contact or after ingestion. Fipronil exerts an adulticide effect, mild ovocide effect and larvicide effect, also in species resistant to pyrethroids, organophosphates and carbamates.
After topical application, Fipronil is sparingly absorbed by the dogs' and cats' skin and the concentration gradient of the product in the subcutaneous tissue spreads from the site of application to the periphery. In dogs, the product penetrates partially into the body fluids and is subsequently metabolised. The main metabolic product is the sulphonate derivative RM 1602, which also exerts insecticide and acaricide effects. No absorption through the skin into the systemic circulation occurs in cats.
Shelf-life of the veterinary medicinal product in an intact package: 2 years
Special precautions for storage:
Store below 25°C. Protect from frost.
Nature and composition of immediate packaging:
1 x 100 ml, 1 x 250 ml.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products:
The product is toxic to bees, fish and birds. Do not contaminate watercourses. Do not allow dogs or cats treated with the product to swim in watercourses containing fish during 12 hours after the treatment.
All unused veterinary medicinal product and/or waste arising from this product should be disposed of in compliance with local regulations.
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