Fipratix*4pip 2,20ml 134+1200m

NAME
FIPRATIX 134 MG / 1200 MG SPOT-ON SOLUTION FOR MEDIUM SIZE DOGS

PHARMACOTHERAPEUTIC CATEGORY
Topical ectoparassicides.

ACTIVE PRINCIPLES
Each 2.20ml pipette contains: Fipronil 134.2mg, Permethrin 1199.0mg.

EXCIPIENTS
Butylhydroxyanisole (E320), butylhydroxytoluene (E321), benzyl alcohol (E1519), diethylene glycol monoethyl ether.

INDICATIONS
In dogs, to be used against flea and / or tick infestations, when a repellent (anti-sting) activity against sand flies and / or mosquitoes is also necessary. Fleas: For the treatment and prevention of flea infestations (Ctenocephalides spp.) Fleas on dogs are killed within 24 hours of treatment. One treatment prevents infestation with new adult parasites for four weeks. 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: One treatment prevents tick infestation for four weeks (Ixodes ricinus, Dermacentor reticulatus and Rhipicephalus sanguineus). If ticks are present when the product is applied, not all ticks are killed within the first 48 hours, but they can be killed in a week. The treatment indirectly reduces, for 4 weeks after application, the risk of transmission of diseases transmitted by infected ticks for 4 weeks (canine babesiosis). Phlebotomes and Mosquitoes: One treatment determines a repellent (anti-sting) activity against sand flies (Phlebotomus perniciosus) and mosquitoes (Culex pipiens, 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 in convalescent animals.

USE / ROUTE OF ADMINISTRATION
Topical.

DOSAGE
Spot-on use. The minimum recommended dose is 6.7 mg of fipronil / kg body weight and 60 mg of permethrin / kg bodyweight. 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 a dog 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. Treatment program: 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, the responsible veterinarian may recommend repeating 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 your dog develops red skin, itches and bites, or scratches excessively and is restless and annoyed, you should seek the advice of a veterinarian to diagnose if he has DAP. To reduce re-infestation from new fleas, it is recommended to treat all dogs in a household. 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 which must be treated, in case of massive infestation and at the beginning of control measures, with a suitable insecticide and passing regularly the vacuum cleaner. In any case there 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 four weeks against sand flies and mosquitoes. Therefore in chaos 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 that live in endemic areas or stay there for longer periods) 4 weeks long) the treatment schedule should be based on local epidemiological information. Animals should be carefully weighed prior to treatment. Product safety has not been established in dogs less than 12 weeks of age or weighing less than 12 weeks. 1.5 kg. Care should be taken to avoid the contents of the pipette coming into contact with the eyes or mouth of dogs to be treated. In particular, oral intake due to licking of the application site by the animal treated by animals in contact should be avoided.This product is extremely toxic to cats and could be fatal due to pecu liar physiology of cats, which is unable to metabolize 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 prevent cats from 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. Special precautions to be taken by the person administering the veterinary medicinal product to animals: the product can 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 may cause eye irritation and mucosal irritation. Therefore, avoid contact of the product with the mouth or eyes including accidental hand, mouth and 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, wash the exposed skin immediately 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 one 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. On the day of treatment alone, treated animals should not be allowed to sleep with their 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. iii) 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.

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. Studies have not been performed with the product in pregnant or lactating bitches. Use during pregnancy and lactation only on risk / benefit assessment.