Fipralone Duo Spot-on Solution 4 Pipettes 1.34ml 134mg

NAME
FIPRALONE DUO 134 MG / 40 MG SPOT-ON SOLUTION FOR MEDIUM SIZE DOGS

PHARMACOTHERAPEUTIC CATEGORY
Topical ectoparassicides. Associations.

ACTIVE PRINCIPLES
Each 1.34 ml pipette contains: fipronil 134 mg, pyriproxyphene 40 mg.

EXCIPIENTS
Butylated hydroxyanisole E320, butylated hydroxytoluene E321, diethylene glycol monoethyl ether.

INDICATIONS
Treatment of flea infestations alone or in association with ticks. For the treatment and prevention of flea infestations (Ctenocephalides spp.). The treatment prevents further infestation for 7 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). One treatment has persistent acaricidal efficacy for 2 weeks Ixodes ricinus and 4 weeks against Dermacentor reticulatus Rhipicephalus sanguineus. If ticks of some species (Dermacentor reticulatus, Rhipicephalus sanguineus) are present when administering the product, 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.

SAFETY IN REF. SPECIES
No adverse reactions were observed in safety studies in the target species in puppies aged 10 weeks, treated with 5 times the recommended dose 3 times at 4 week intervals and with the maximum recommended dose 6 times at 4 week intervals. . The risk of adverse reactions (see section 4.6) may increase in case of overdose, therefore animals should always be pipetted according to body weight.

USE / ROUTE OF ADMINISTRATION
Topical.

DOSAGE
Spot-on use. Apply 1 pipette of 1.34 ml per dog weighing between 10 kg and 20 kg corresponding to the minimum recommended dose of 6.7 mg fipronil / kg bodyweight and 2 mg pyriproxyphene / kg bodyweight. appropriate combination of 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 dog's coat 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 operations in one or two different points of the dog's back to avoid removal or a more superficial application to the coat, especially in large dogs. Drip-saving system (the product is released only by pressing the body of the pipette). A pipette constitutes a treatment, with the possibility of repeating the administration on a monthly basis. For optimal control of flea and / or tick infestations, the treatment program can be based on the local epidemiological situation.

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

WARNINGS
Shampooing or direct immersion of the animal in water after treatment can reduce the duration of the activity. The product remains active against fleas for 5 weeks when the dog is subjected to monthly washing after treatment. Repeated immersions in water in 2 times after application of the product do not affect the adulticidal activity against fleas and the relative effectiveness in preventing the development of adult fleas from eggs. The influence of water immersion or shampoo on the dog on the efficacy of the product against ticks has not been evaluated. At the beginning of the control measures, in case of infestation, the pet beds, bedding and regular 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. The transmission of infectious tick-borne diseases cannot be completely ruled out if conditions are unfavorable. Immediate efficacy has been demonstrated against Ixodes ricinus, indicating that ticks of this species are killed within 48 hours of product application. If ticks of Dermacentor reticulatus or Rhipicephalus sanguineus are present when the product is applied, these ticks may not be killed within the first 48 hours. Once dead, 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. Animals must be carefully weighed before treatment. In the absence of safety data, the product should not be used in puppies less than 10 weeks of age and / or weighing less than 2 kg. Care should be taken to avoid the contents of the pipette coming into contact with the eyes or mouth of the treated dogs. In particular oral uptake due to application site licking from treated animals or animals in contact should be avoided. Do not apply the product on wounds or damaged skin. It is important to make sure that the product is applied to a dry area where the animal cannot lick itself and to pay attention so that the animals do not lick each other after the treatment. In the absence of further safety studies, do not repeat the treatment at intervals of less than 4 weeks. The use of the product has not been studied in sick and debilitated dogs. Special precautions for administering the product to animals: the product may cause neurotoxicity. The product can be harmful if ingested. Avoid contact with skin and mouth. Avoid ingestion including hand-to-mouth contact. Do not smoke, drink or eat during application. Wash hands after use. 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 the original packaging until ready for use and discard used pipettes immediately. In case of accidental skin contact, rinse with water. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the product label to the physician. Other precautions: Fipronil and pyriproxyphene can adversely affect aquatic organisms. Dogs should be prevented from accessing waterways for 48 hours after treatment. The product may have adverse effects on household, painted or other painted or furniture surfaces. Allow the application site to dry before allowing contact with such materials.

WAITING TIME
Not relevant.

TARGET SPECIES
Dogs (10-20 kg).

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 accumulated experience with these active substances among the drug forms, 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 bitches. The safety of the veterinary medicinal product during pregnancy and lactation has not been established. Use or according to benefit / risk assessment.