Fipralone Spot-on Solution 4 Pipettes 0.5ml 50mg Cats

NAME
FIPRALONE 50 MG SPOT-ON SOLUTION FOR CATS

PHARMACOTHERAPEUTIC CATEGORY
Topical ectoparassicides.

ACTIVE PRINCIPLES
Each 0.5 ml pipette contains: 50 mg fipronil.

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

INDICATIONS
For the treatment of flea (Ctenocephalides spp.) And tick (Dermacentor reticulatus) infestations. The product has a persistent insecticidal efficacy for up to 5 weeks against fleas (Ctenocephalidesfelis). The product has a persistent activity for up to 2 weeks against ticks (Rhipicephalus sanguineus, Ixodes ricinus, Dermacentorreticulatus). If ticks of some species (Rhipicephalus sanguineus, Ixodes ricinus) are present, when administering the product, not all ticks could be killed within the first 48 hours of application but could be killed within a week. The product can be used as part of the strategic treatment for the control of flea allergy dermatitis (FAD) when this has been previously diagnosed by the veterinarian.

CONTRAINDICATIONS / SECONDARY EFFECT
In the absence of available data, do not use in kittens younger than 2 months or weighing less than 1 kg. Do not use on sick animals (ie systemic diseases, fever ...) or in 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
For external use only. Administer by topical application to the skin 1 pipette of 0.5 ml per animal. Method of use. Thermoformed pipettes: hold the pipette upright. Shake the narrow part of the pipette to ensure that the contents are within the widest part of the pipette. Break the seal at the top of the spot-on pipette along the marked line. Part the cat's fur until the skin is visible. Place the tip of the pipette directly against the uncovered skin and gently squeeze a few times to empty the contents. Repeat the operation at one or two different points on the cat's back, preferably at the base of the head and between the shoulder blades. Pipette the polypropylene: remove the pipette from the blister pack. Hold the pipette upright, unscrew and pull off the cap. Turn the cap over and place the other end on the pipette again. Screw the cap to break the seal, then remove the cap from the pipette. Part the cat's fur until the skin is visible. Place the pipette tip directly against uncovered skin and gently squeeze a few times to empty the contents. Repeat the operation at one or two different points on the cat's back, preferably at the base of the head and between the shoulder blades. It is important to make sure that the product is applied to an area where the animal cannot lick it and to make sure that the animals do not lick each other after the treatment. Care must be taken in order to avoid excessive moistening of the hair with the product as this will cause a sticky appearance of the hair at the point of application. However, if this happens, it will disappear within 24 hours after application. White deposits may be present at the application site for up to 48 hours after application. Treatment program For optimal control of flea and / or tick infestations the treatment program can be based on the local epidemiological situation. In the absence of safety studies, the minimum interval between treatments is 4 weeks.

STORAGE
Store at temperatures below +30 degrees C. Store in a dry place. Store in the original packaging. Do not remove from blister until use.

WARNINGS
Cat fleas often also infest the pet's kennel, beds or rest areas such as carpets and pillows, in case of massive infestations, they must be treated at the beginning of the implementation of control measures, with appropriate insecticides and cleaned regularly. The product does not prevent the attack of ticks on animals. If the animal has been treated prior to exposure to ticks they will be killed in the first 24-48 hours after the attack. This will happen before the meal is completed, reducing but not excluding the risk of disease transmission. Once dead, the ticks will fall off the animals, any remaining ticks can be easily removed by pulling them lightly. It is advisable to avoid frequent baths or shampoos because the maintenance of the effectiveness of the product in these cases has not been tested. There are no data on the effect of baths or shampoo on the efficacy of the product in cats. However, based on the information available for dogs, shampooing an hour prior to treatment does not affect the effectiveness of the product against fleas. When used as part of a strategic program for the treatment of Flea Allergic Dermatitis, monthly application is recommended for allergic patients and other cats in the family. For optimal control of flea infestation in the presence of promiscuous groups of animals, all dogs and cats in the family / group should be treated with an appropriate insecticide. Avoid contact with animals' eyes. In case of accidental contact with the eyes, wash the eyes immediately and abundantly with water. Do not apply the product on wounds or broken skin. Special precautions for 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 must be avoided. In case of accidental contact with the eyes, wash immediately and abundantly with water. If eye irritation persists seek medical advice and show the package leaflet or the label to the doctor. Do not drink, eat or smoke during application. Avoid the content coming into contact with your fingers. If this happens, wash your hands with soap and water. Wash hands after use. Do not drink, eat or smoke during application. People with known hypersensitivity to fipronil or excipients should avoid contact with the veterinary medicinal product. Animals or operators with known hypersensitivity to fipronil or to any of the excipients should avoid contact with the veterinary medicinal product. Treated animals should not be touched until the application site has dried, children should not be allowed to play with treated animals until the application site has dried. It is therefore recommended that animals are not treated during the day, but should be treated in the early evening, and that newly treated animals should not sleep with their owners and in particular with children. Other precautions: the alcoholic excipient can have adverse effects on painted, varnished or other surfaces of the house or furniture. Overdose: No adverse reactions were observed in safety studies in cats and kittens 2 months of age or older or weighing approximately 1 kg, treated with 5 times the recommended dose (therapeutic daily dose administered for 5 consecutive days ) for 3 consecutive months except for itching and vomiting which occurred only once. The risk of adverse reactions may 'increase in case of overdose.

WAITING TIME
Not relevant.

TARGET SPECIES
Cats.

INTERACTIONS
None known.

SIDE EFFECTS
If there is 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 (squamous, local alopecia, pruritus, erythema) general pruritus and alopecia have been reported. After use, hypersalivation, reversible neurological symptoms (hyperesthesia, depression, nervous symptoms) and vomiting have been exceptionally reported.

PREGNANCY AND BREASTFEEDING
Laboratory studies using fipronil have shown no evidence of teratogenic or embryotoxic effects. No studies have been performed with this product in pregnant or lactating cats. Use only in accordance with the benefit / risk assessment by the responsible veterinarian.