Amflee Spot-On Pesticide Cats 3 Pipettes

NAME:

AMFLEE 50 MG SPOT-ON SOLUTION FOR CATS

PHARMACOTHERAPEUTIC CATEGORY:

Topical ectoparassicides.

ACTIVE PRINCIPLES:

1 pipette (0.5 ml) contains: 50 mg fipronil.

EXCIPIENTS:

Butylhydroxyanisole (E320), Butylhydroxytoluene (E321), Polysorbate 80, Povidone K25, Dimethyl sulfoxide.

INDICATIONS:

Treatment and prevention of flea (Ctenocephalides spp.) And tick (Dermacentor reticulatus, Ixodes ricinus) infestations in cats.

The product has persistent insecticidal efficacy for up to 4 weeks against fleas (Ctenocephalides spp.) And acaricidal efficacy for up to 4 weeks against Ixodes ricinus and up to 1 week against Dermac entor reticulatus and Rhipicephalus sanguineus.

If ticks of the species Rhipicephalus sanguineus are present when applying the product, not all ticks could be killed within the first 48 hours, but they could be killed within a week.

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.

CONTRAINDICATIONS / SECONDAR EFFECT:

In the absence of available data, the product must not be used in kittens younger than 2 months and / or weighing less than 1 kg.

Do not use in sick (for example, systemic diseases, fever ...) or convalescent animals.

Do not use in rabbits, as adverse actions and even death can occur.

Do not use in case of hypersensitivity to the active substance, to dimethyl sulfoxide or to any of the excipients.

USE / ROUTE OF ADMINISTRATION:

Topical.

DOSAGE:

For external use only.

Administer 1 pipette of 0.5 ml per animal by topical application on the skin.

How to use: remove the flap from the triple layer bag.

Hold the pipette upright, twist and remove the cap.

Turn the cap back and place it back on the pipette.

Press and twist the cap to break the seal, then remove the cap from the pipette.

Part the fur of the animal in the area between the shoulder blades until the skin is visible.

Place the tip of the pipette on the skin and press gently to empty the contents on the skin, preferably in two points, one at the base of the head and the other 2-3 cm further back.

It is important to ensure that the product is applied to an area that the animal cannot lick and that the animals do not lick each other after the treatment.

The hair must be separated and the product applied to the skin.

Transient coat changes (bundled / greasy hair and / or coat deposits) may be found at the application site, which usually disappear within 24 hours.

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 in the original package to protect it from light and humidity.

Do not remove from bag until use.

Before application, the product must be kept at room temperature (above 14 degrees C) for about an hour.

WARNINGS:

Fleas present in animals often infest the kennel, blankets and the usual areas where the animal rests such as carpets and furnishing fabrics which, in case of massive infestations and at the beginning of control measures, must be treated with a special insecticide and regularly cleaned with a vacuum cleaner.

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 to 8 hours after the attack.

Typically, this occurs before the meal is complete, reducing but not excluding the risk of disease transmission.

Once dead, ticks often detach from the animal, but the remaining ones can be removed by pulling lightly.

No information is available on the effect of baths / shampoos on the efficacy of the product in cats.

However, based on the information available to dogs, one minute weekly immersion in water reduces the persistence period of insecticidal efficacy against fleas by one week.

For optimal flea infestation control in a multi pet home, all dogs and cats in the home should be treated with a suitable insecticide.

When used as part of a strategy for the treatment of Flea Allergic Dermatitis, monthly applications are recommended to allergic patients and other cats in the home.

Avoid contact with the animal's 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 damaged skin.

The souls must be weighed carefully before treatment.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: This product may cause irritation to the mucous membranes and eyes.

Therefore contact between the product and the mouth or eyes should be avoided.

In case of accidental contact with the eyes, immediately wash the eyes with plenty of water.

If eye irritation persists, seek medical advice and show the package leaflet or the label to the physician.

Avoid the content coming into contact or with your fingers.

If this happens, wash your hands immediately with soap and water.

Wash hands after use.

Do not smoke, drink or eat during application.

People with known hypersensitivity to fipronil or dimethyl sulfoxide 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 and children should not be allowed to play with treated animals until the application site has dried.

It is therefore recommended not to treat animals during the day, but in the evening and not to allow recently treated animals to sleep with their owners, especially with children.

Keep pipettes in the original container and dispose of used pipettes immediately.

Overdose: In the safety studies in the target species, no adverse reactions were observed in cats and kittens aged 2 months or older or weighing approximately 1 kg, treated once monthly with 5 times the dose. recommended dose for 3 consecutive months.

The risk of adverse reactions occurring may however increase in case of overdose.

WAITING TIME:

Not relevant.

TARGET SPECIES:

Cats.

INTERACTIONS:

None known.

SIDE EFFECTS:

If the animal licks itself, a short period of hypersalivation may be observed.

Among extremely rare suspected adverse reactions, transient skin reactions at the site of application (squamous, local alopecia, pruritus, erythema) and general pruritus or alopecia have been reported after use.

Hyper salivation, reversible neurological symptoms (hyperesthesia, depression, nervous symptoms) and vomiting were exceptionally observed after use.

PREGNANCY AND BREASTFEEDING:

Laboratory studies using fipronil have shown no evidence of teratogenic or embryotoxic effects.

Studies have not been conducted with this product in pregnant or lactating cats.

During pregnancy and lactation use only according to a benefit / risk assessment.