Fipralone Duo*4pip 50mg/60mg G

NAME
FIPRALONE DUO 50 MG / 60 MG SPOT-ON SOLUTION FOR CATS

PHARMACOTHERAPEUTIC CATEGORY
Topical ectoparassicides. Associations.

ACTIVE PRINCIPLES
Each 0.5 ml pipette contains: 50 mg fipronil, 60 mg pyriproxyphene.

EXCIPIENTS
Butylhydroxyanisole E320, butylhydroxytoluene E321, diethylene glycol and ethyl ether.

INDICATIONS
Treatment of flea infestations alone or in association with ticks. For the treatment and prevention of flea infestations (Ctenocephalides felis); one treatment prevents further infestation for 5 weeks. Prevention of flea multiplication by preventing eggs from developing into adult fleas for 12 weeks after application. For the treatment of tick infestations (Ixodes ricinus and Rhipicephalus turanicus). One treatment determines a persistent acaricidal efficacy for a week. If ticks are present at the time of application, not all ticks could be killed within 48 hours.

CONTRAINDICATIONS / SECONDARY EFFECT
Do not use in rabbits, as adverse reactions and even death may occur. Do not use in case of known hypersensitivity to the active substance or to any of the excipients.

USE / ROUTE OF ADMINISTRATION
Topical.

DOSAGE
Spot-on use. For a 6 kg cat, apply 1 pipette of 0.5 per animal corresponding to the minimum recommended dose of 8.3 mg fipronil / kg body weight and 10 mg pyriproxyphene / kg body weight. recommended dose of 1 ml, which can be administered with two 0.5 ml pipettes. Instructions for use Remove the pipette from the blister pack. 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 hair in the back area until the skin is visible. Place the pipette tip directly against the skin and gently squeeze a few times to empty the contents in one or two places. Make sure the solution is only applied to healthy skin and avoid superficial applications on cat fur or removal. Drip-saving system (the product is released only by pressing the body of the pipette). For optimal control of flea and / or tick infestations the treatment program can be based on the local epidemiological situation. However, in the absence of further safety studies, do not repeat the treatment at intervals of less than 4 weeks.

STORAGE
Store at a temperature not exceeding +30 degrees C. Store in a dry place. Store the blister in the original package in order to protect it from light.

WARNINGS
The bath of the fur of the animals with water 2 hours before the treatment and twice during the efficacy period of the product, indicated against fleas, (with an interval of 2 weeks against adult fleas or four weeks against the larval stages) was evaluated in two laboratory tests. Confirming that wetting the fur of animals as described does not affect the efficacy of the product. The influence of a shampoo on the efficacy of the product has not been evaluated. If a cat needs a shampoo it is advisable to do it before applying the veterinary medicinal product. At the beginning of the control measures, in the case of infestation, the kennels of the animals, the bedding of the kennel and the rest areas such as carpets and furnishing fabrics must be treated, with a suitable insecticide and regularly cleaned with a vacuum cleaner. To reduce the presence of fleas in the environment, all animals living in the same home area should be treated with a product suitable for flea control. The product does not prevent the attack of ticks on animals. If the animal has been treated before exposure to ticks they will be killed in the first 48 hours after the attack. This will happen before the meal is completed, reducing but not excluding the risk of disease transmission. Once they die, the ticks will fall off the animals. Any remaining ticks will need to be carefully removed making sure that their portion of the mouthparts does not remain in the skin. For external use only. Do not administer orally. Animals must be carefully weighed before treatment. The safety of the product has not been evaluated in cats less than 10 weeks of age and / or weighing less than 1 kg. Avoid contact with animals' eyes. In case of accidental contact with eyes, wash with water. Care should be taken to apply the product correctly as described. Do not apply the product on wounds or damaged skin. It is important to make sure that the product is applied on a dry area where the animal cannot lick itself and pay attention so that the animals do not lick each other after the treatment. debilitated. Use in sick or debilitated animals only in accordance with the benefit / risk assessment. In the absence of further safety studies, do not repeat the treatment at intervals of less than 4 weeks. Special precautions for those administering the product to animals: the product can cause neurotoxicity. The product can be harmful if ingested. Avoid ingestion including hand-to-mouth contact. Avoid contact with skin and mouth. Do not smoke, drink or eat during application. Wash hands after use.In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the product label to the physician.In case of accidental contact with skin, rinse with water. Treated animals should not be touched until the application site is dry, and children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended that animals not be treated during the day, but should be treated during the early evening, and that newly treated animals should not be allowed to sleep with their owners, especially children. Keep pipettes in their original packaging until ready for use and discard used pipettes immediately. Other precautions the product can have adverse effects on painted or varnished surfaces or other surfaces of the house or furniture. Wait until the application site is dry before allowing contact with such materials. Overdose: No adverse reactions were observed in safety studies in cat and kitten species at 10 weeks, treated with 5 times the recommended dose for 3 consecutive times with a 4-week interval and treated with the maximum recommended dose 6 times at an interval of 4. weeks. The risk of adverse reactions can 'increase in case of overdose, therefore animals should always be treated with the correct dose according to the weight of the same.

WAITING TIME
Not relevant.

TARGET SPECIES
Cats.

INTERACTIONS
None known.

SIDE EFFECTS
Transient aesthetic effects such as a wet appearance or a slight appearance of dandruff may occur at the application site. According to the experience accumulated with these active substances among the pharmaceutical forms spots, temporary skin reactions at the application site (squamosis, local alopecia, itching, erythema, discolouration of the skin) and general itching or alopecia can be observed after use. In very rare cases, hypersalivation, reversible neurological symptoms (hyperesthesia, depression, nervous symptoms), respiratory symptoms or vomiting may occur.

PREGNANCY AND BREASTFEEDING
Laboratory studies using fipronil and pyriproxyphene have shown no evidence of teratogenic or embryotoxic effects. No studies have been performed with this product in pregnant or lactating cats. The safety of the veterinary medicinal product during pregnancy and lactation has not been established. Use or according to benefit / risk assessment.