Fipralone Spot-on Soluz 4 Pipettes 0.67ml 67mg Dogs From 2 To

NAME
FIPRALONE 67 MG SMALL SIZE DOGS

PHARMACOTHERAPEUTIC CATEGORY
Ectoparasiticides for topical use.

ACTIVE PRINCIPLES
Fipronil.

EXCIPIENTS
Butylhydroxyanisole E320 0.134 mg; Butylhydroxytoluene E321 0.067 mg.

INDICATIONS
For the treatment of flea (Ctenocephalides spp.) And tick (Dermacentor reticulatus) infestations. The insecticidal efficacy against new flea infestations persists for up to 8 weeks. The product has persistent acaricidal efficacy for up to 4 weeks against ticks (Rhipicephalus sanguineus, Ixodes ricinus, Dermacentor reticulatus). killed within 48 hours of first application but within one week. The product can be used as part of the strategic treatment for the control of flea allergic dermatitis (FAD), when this has been previously diagnosed.

CONTRAINDICATIONS / SECONDARY EFFECT
In the absence of available data, do not use in puppies younger than 2 months or weighing less than 2 kg. Do not use on sick animals (eg systemic diseases, fever ...) or convalescing. Do not use on rabbits, as adverse reactions and even death may occur. This product is specifically developed for dogs. Do not use in cats, as overdoses may occur. Do not use in case of hypersensitivity to the active substance or to any of the excipients.

USE / ROUTE OF ADMINISTRATION
Topical.

DOSAGE
Administer by topical application on the skin according to the live weight as follows: 1 pipette of 0.67 ml per dog weighing more than 2 kg and up to 10 kg. Mode ': 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 tip of the pipette directly against uncovered skin and gently squeeze a few times to empty the contents. Repeat the operation in one or two different places on the dog's back. 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 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. 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. Overdose: No adverse reactions were observed in safety studies in target species in puppies of 2 months of age, in dogs weighing approximately 2 kg, treated with the therapeutic dose for 5 consecutive days. The risk of adverse reactions may 'increase in case of overdose. Incompatibility: none known.

STORAGE
Store below 30 degrees C. Store in a dry place.

WARNINGS
Shampooing one hour before treatment does not affect the effectiveness of the flea product. Baths or immersions in water within 2 days after applying the product should be avoided. Weekly immersion in water for 1 minute reduces the persistence period of insecticidal efficacy against fleas by one week. 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 completion of the meal, 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. Dog fleas often also infest the pet's kennel, beds or rest areas such as carpets and cushions which, in the event of massive infestations, must be treated at the beginning of the implementation of control measures, with appropriate insecticides and cleaned regularly. When used as part of a strategic program for the treatment of Flea Allergic Dermatitis, monthly application is recommended for allergic patients and other dogs in the family. For optimal control of flea infestations in the presence of mixed groups of animals, all dogs and cats in the family / group should be treated with an appropriate insecticide. Animals must be carefully weighed before treatment. Avoid contact with the eyes of the animals. In case of accidental contact with the eyes, immediately and abundantly rinse the eyes with water. 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. Do not apply the product on wounds or broken skin. Special precautions for the person administering the product: 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 the eyes immediately and abundantly with water. If eye irritation persists seek medical advice and show the package leaflet or the label to the physician. 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. 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: Fipronil may be hazardous to aquatic organisms. Dogs should not be allowed to immerse themselves in streams for 2 days after application. The product 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 target species in puppies of 2 months of age, in dogs weighing approximately 2 kg, treated with the therapeutic dose for 5 consecutive days. The risk of adverse reactions may 'increase in case of overdose. Incompatibility: None known.

WAITING TIME
Not relevant.

TARGET SPECIES
Dogs.

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, transient skin reactions at the application site (skin discoloration, local alopecia, pruritus, erythema) general pruritus and alopecia have been reported after use. After use, hypersalivation, reversible neurological symptoms (hyperesthesia, depression, nervous symptoms), vomiting and respiratory symptoms have been exceptionally reported.

PREGNANCY AND BREASTFEEDING
Laboratory studies using fipronil have shown no evidence of teratogenic or embryotoxic effects. The safety of the product has not been demonstrated on pregnant or lactating bitches. Use only according to the benefit / risk assessment.