Fipralone Topical Spray 1 Bottle 100ml 2.5mg/ml

NAME
FIPRALONE

PHARMACOTHERAPEUTIC CATEGORY
Ectoparasiticides for topical use.

ACTIVE PRINCIPLES
Fipronil 2.5 mg / ml.

INDICATIONS
Treatment of flea infestations (Ctenocephalides spp.) In dogs and cats, ticks (Ixodes ricinus, Rhipicephalus sanguineus) in dogs and cats; biting lice of dogs (Trichodectes canis) and cats (Felicola subrostratus). The product can be used as part of the strategic treatment for the control of flea allergy dermatitis (FAD). The insecticidal efficacy against new adult flea infestations persists for up to 2 months in cats and up to 3 months in dogs, depending on the severity of the environmental infestation. The medicine has a persistent acaricidal efficacy for up to 4 weeks against lice, in relation to the level of environmental infestation.

CONTRAINDICATIONS / SECONDARY EFFECT
Do not use on sick (systemic diseases, fever, etc.) or convalescent animals. Do not use on rabbits, as adverse reactions and even death can occur. Do not use in case of hypersensitivity to the active substance or to any of the excipients.

USE / ROUTE OF ADMINISTRATION
Topical.

DOSAGE
The pump delivers 0.5ml (100ml bottle) or 1.5ml (250ml bottle) or 3ml (500ml bottle) of spray per delivery. In order to wet the hair up to the skin, apply 3 or 6 ml per kg bodyweight, (from 7.5 to 15mg of active ingredient per kg bodyweight), depending on the length of the hair. This dosage can be achieved with 6-12 pumps per application per kg bodyweight of the 100ml pack, or 2-4 applications of the 250ml pack or 1-2 applications for the 500ml pack. According to the length of the hair: the 100 ml pack allows 4-8 treatments for a 4 kg bodyweight cat or 3 treatments for a 10 kg dog. The 250 ml package allows 2-4 treatments for a 20 kg dog. The 500 ml pack allows 2-4 treatments for a 40 kg dog. Method of administration: spray against the grain, holding the dog; large jet for the back in an upright position; large jet for the chest and belly, in a sitting or lying position; narrow jet for legs and skin folds in an upright position; put the product on a muzzle glove. Spray over the entire surface of the animal's body from a distance of 10-20 cm. Spray against the grain and make sure that the entire body surface is evenly wet. Rub the hair especially in animals with long hair to bring the product into direct contact with the skin. For the treatment of the head or of young or nervous animals, the application can be made on a glove and pass it against the grain on the hair. Leave to dry naturally. Do not dry with towels.

STORAGE
Highly flammable. Do not store above 25 degrees C. Protect from direct sunlight. Do not use after the expiry date stated on the bottle. Shelf life after first opening the container: 1 year.

WARNINGS
Avoid direct contact with the animal's eyes. Do not spray directly on areas with broken skin. Allow treated animals to dry in a well-ventilated room first. Do not lock pets indoors or in pet carriers until the skin is completely dry. In the absence of specific data on safety and efficacy, the product is not recommended for the treatment of other species apart from dogs and cats. When used as part of a strategic program for the treatment of Flea Allergic Dermatitis, monthly application to allergic patients and other dogs and cats in the group is recommended. For optimal effectiveness, it is not recommended to bathe or shampoo animals in the 2 days before or after applying the product. Baths or shampoos up to 4 times in two months have not shown significant effects on the residual efficacy of the product. Monthly treatments are recommended when applying more frequent shampoos. Treatments of kennels, beds, carpets and pillows with appropriate insecticides will help in the reduction of environmental infestation and will improve the duration of the protection against re-infestation. For optimal control of flea infestations in the presence of mixed groups of animals, all dogs and cats in the family / group should be treated with an appropriate insecticide. It is important to ensure that animals do not lick each other after treatment. There may be a tick attack. For this reason, the transmission of infectious diseases cannot be completely excluded if conditions are unfavorable. The product is not suitable for the direct treatment of the environment. Keep treated animals away from fire or heat sources and surfaces that could be damaged by the alcohol contained in the spray, for at least 30 minutes after treatment and until the hair is completely dry. The product is toxic to aquatic organisms. Dogs should not be allowed to immerse themselves in streams for 2 days after application. Special precautions for those administering the product to animals: the product can cause irritation to the mucous membranes and eyes. Therefore, contact of the product with the mouth or eyes should be avoided. Animals and operators with known hypersensitivity to insecticide or alcohol must avoid contact with the product. Avoid the content coming into contact with your fingers. If this happens, wash your hands with soap and water. In case of accidental contact with the eyes, wash the eyes immediately and abundantly with water. Treated animals should not be touched until the coat has dried. It is therefore recommended that animals are not treated during the day, but could be treated in the early evening, newly treated animals should not sleep with their owners and in particular with children. Spray on animals in an open place or in a well-ventilated room. Do not breathe in the spray. Do not eat, drink or smoke while using the product. Wear rubber or PVC gloves when handling animals. It is recommended to wear a waterproof apron for clothing protection. If clothing gets very wet with the product, it should be removed and washed before putting it back on. Remove gloves after use and wash hands with soap and water. Wash contaminated skin immediately with soap and water. People with known hypersensitivity or asthma may be particularly sensitive to the product. Do not use the product if you have had a previous reaction to the product. Treatment of groups of animals: good ventilation is particularly important in environments where a group of animals must be treated. Treat animals outdoors, or reduce vapor saturation by moving animals away from the treatment site as the alcohol evaporates and ensure the room is well ventilated between individual treatments. Also, make sure that the place where animals are left to dry is well ventilated and avoid housing multiple recently treated animals in the same space. This medicinal product is toxic to aquatic organisms. Dogs should not be allowed to immerse themselves in streams for 2 days after application. Overdose: the risk of adverse reactions may 'increase in case of overdose. In case of overdose, initiate symptomatic treatment.

WAITING TIME
Not relevant.

TARGET SPECIES
Dogs, cats.

SIDE EFFECTS
In case of licking, a short period of hypersalivation may be observed mainly due to the nature of the excipients. Among the extremely rare suspected adverse reactions, after use, transient skin reactions at the application site such as pruritus and alopecia have been reported. After use, hypersalivation, reversible neurological symptoms (hyperesthesia, depression, nervous symptoms), vomiting or respiratory symptoms have been exceptionally reported.

PREGNANCY AND BREASTFEEDING
Laboratory studies using fipronil have shown no evidence of teratogenic effects in rats and rabbits. The medicine is well tolerated by puppies following the treatment of lactating bitches. There are no data available on the safety of the product on pregnant or lactating bitches or cats, therefore use only according to the benefit / risk assessment.