Fipratix Spot-on Solution 4 Pipettes 6.6ml 402mg Approx

NAME
FIPRATIX

PHARMACOTHERAPEUTIC CATEGORY
Topical ectoparassicides.

ACTIVE PRINCIPLES
Fipronil, permethrin.

EXCIPIENTS
Benzyl alcohol, Diethyl glycol, Monoethyl ether, Butylhydroxyanisole, Butylhydroxytoluene.

INDICATIONS
In dogs, to be used against flea and / or tick infestations, when a repellent (anti-bite) activity against flea bites and / or mosquitoes is also required. Fleas: for the treatment and prevention of flea infestations (Ctenocephalides spp.). Fleas on dogs are killed within 24 hours of treatment. One treatment determines, for four weeks, a persistent efficacy against infestation with other adult fleas. The product can be used as part of a treatment strategy for the control of Flea Allergic Dermatitis (FAD) when this has been previously diagnosed by the veterinarian. Ticks: Treatment of Ixodes ricinus tick infestations. One treatment determines, for four weeks, a persistent acaricidal efficacy against tick infestation (Ixodes ricinus, Dermacentor reticulatus and Rhipicephalus sanguineus). If ticks of some species (Dermacentor reticulatuse Rhipicephalus sanguineus) are present when the product is applied, not all are killed within 48 hours of treatment. Phlebotomes and mosquitoes: one treatment determines a repellent activity (anti-sting) against fl ebotomes (Phlebotomus perniciosus) and mosquitoes (Culexpipiens, Aedes aegypti) for four weeks.

CONTRAINDICATIONS / SECONDARY EFFECT
Do not use in case of hypersensitivity to the active substances or to any of the excipients. Do not use on rabbits and cats where possible adverse reactions may occur up to the death of the animal. Do not use in sick animals (ie systemic diseases, fever.) Or convalescent inanimals.

USE / ROUTE OF ADMINISTRATION
Topical.

DOSAGE
The minimum recommended dose is 6.7 mg of fipronil / kg body weight and 60 mg of permethrin / kg bodyweight 1.5-4 kg: Fiprotix percani of very small size (toys). Body weight 4-10 Kg: Fiprotix for small dogs. Body weight 10-20 Kg: Fiprotix for medium-sized dogs. Body weight 20-40 Kg: Fiprotix for large breed dogs. Body weight 40-60 Kg: Fiprotix for giant breed dogs. For dogs> 60 kg an appropriate combination of pipettes should be used. Method of administration: Remove the pipette from the blister. Hold the pipette upright. Shake the narrow part of the pipette to ensure that the contents are inside the main part of the pipette. Break the seal at the top of the spot-on pipette along the marked line. Part the fur of the animal until the skin is visible. Place the tip of the pipette directly against the uncovered skin and gently squeeze several times to empty the contents in two to four different points, depending on the body weight, on the animal's back. As an indication for dogs weighing less than 20 kg the product must be applied in two points, while in dogs weighing more than 20 kg apply the product in 2-4 points. The use of the product must be based after the confirmation of the infestation or risk of infestation, by fleas and / or ticks or when a repellent activity (anti-feeding) against sand flies and / or mosquitoes is also necessary. Depending on the degree of ectoparasitic infestation, it is advisable to repeat the treatment. The interval between 2 treatments should not be less than 4 weeks.

STORAGE
Store below 30 degrees C. Store in the original package to protect from light.

WARNINGS
The veterinary medicinal product remains effective after exposure to sunlight or if the animal gets wet after a rain. Avoid shampooing or immersion of the animal in water of treated animals as this can reduce the duration of the activity. A dog with fleas may exhibit an allergic reaction to flea saliva called Flea Allergic Dermatitis (FAD). If the dog develops red skin, itches and bites, or scratches itself excessively and is restless and annoyed, check if it is affected by DAP. To reduce re-infestation from new fleas, it is recommended that all dogs in a household be treated. Other animals living in the same location must be treated with a suitable product. Animal fleas often infest the animal's basket, kennels and resting areas, such as carpets and furnishing fabrics that must be treated, in case of massive infestation and at the beginning of control measures, with a suitable insecticide and passing vacuum cleaner regularly. In any case it can be a meal from single ticks or bites from single sand flies or mosquitoes. For this reason, if the conditions are unfavorable, the transmission of infectious diseases by these parasites cannot be excluded. Studies have shown anti-sting effects for 4 weeks against sand flies and mosquitoes. Therefore in case of short-term travel (less than 4 weeks) in endemic areas it is recommended to apply the treatment immediately before the expected exposure. For longer exposure periods (ie animals living in endemic areas or staying there for longer than 4 weeks) the treatment program should be based on local epidemiological information. Animals must be carefully weighed before treatment. The safety of the product has not been established in dogs less than 12 weeks of age or weighing less than 1.5 kg. Care should be taken to prevent the contents of the pipette from coming into contact with the eyes or mouth of the dogs to be treated. In particular, oral intake due to application site exacerbation by the treated animal and / or animals in contact should be avoided. This product is extremely toxic to cats and could be fatal due to the peculiar physiology of cats, which is unable to metabolise certain compounds including permethrin. In case of accidental skin exposure, wash the cat with shampoo or soap and immediately consult a veterinarian. To prevent cats from being accidentally exposed to the product, keep treated dogs away from cats after treatment until the application site is dry. It is important to avoid cats licking the application site of a dog treated with this product. If this happens, consult a veterinarian immediately. Do not use on rabbits and cats. Unless indicated by the veterinarian, this product must not be used in sick or debilitated animals. Special precautions to be taken by the person administering the veterinary medicinal product to animals: The product may cause neurotoxicity. The product can be harmful if swallowed. Avoid ingestion including hand-mouth contact. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. The product can cause irritation to the eyes and irritation of the mucous membranes. Therefore, avoid contact of the product with the mouth or eyes including accidental hand-mouth and hand-eye contact. In case of accidental contact of the product with the eyes, immediately and thoroughly wash the eyes with water. If eye irritation persists, seek medical advice and show the package leaflet or the label to the physician. Avoid contact with skin. If the product comes into contact with the skin, immediately wash the exposed skin with soap and water. Wash hands thoroughly after use. Do not smoke, drink or eat while applying the veterinary medicinal product. People with known hypersensitivity (allergy) to fipronil, permethrin or any of its components should avoid contact with the veterinary medicinal product, which, in some individuals, on very rare occasions, can cause irritation of the respiratory tract and skin reactions. Treated animals should not be touched and adults and children should not be allowed to play with treated animals until the application site is dry and for approximately 12 hours after application of the product. It is therefore recommended that animals be treated during the early evening or late afternoon in order to minimize possible contact with treated animals. Only on the day of treatment the treated animals should not be allowed to sleep with the owners, especially children. Store in the original packaging. In order to prevent children from coming into contact with the pipettes used, dispose of them immediately and appropriately. For veterinary use only. Other precautions: Fipronil and permethrin can adversely affect aquatic organisms. Dogs should not be allowed to swim in streams for 2 days after application. The product can have negative effects on painted surfaces or other paintings or furnishings in the home. Allow the application site to dry before allowing contact with such materials. Overdose: In healthy puppies of 12 weeks of age treated 3 times at 3 week intervals safety has been demonstrated with doses up to 5 times the maximum recommended dose. The risk of developing adverse reactions may however increase with overdose, therefore animals should always be treated, according to body weight, with the correct size pipette. Incompatibility: none known.

WAITING TIME
Not relevant.

TARGET SPECIES
Dogs.

INTERACTIONS
None known.

SIDE EFFECTS
Transient skin reactions at the application site (pruritus, erythema) and widespread pruritus have been reported after use. Transient behavioral changes (such as hyperactivity / agitation) or vomiting have been observed. In case of licking, transient hypersalivation may be observed.

PREGNANCY AND BREASTFEEDING
Laboratory studies with fipronil and permethrin did not reveal any teratogenic or embryotoxic effects. However, no studies have been performed with the product in pregnant or lactating bitches. The use in pregnancy and lactation should therefore only be made after a risk / benefit assessment.