AMFLEE 50 mg spot-on solution for cats
1 pipette (0.50 ml) contains:

Active substance:
Fipronil 50 mg


Other substances:
Butylhydroxyanisole (E320) 0.10 mg
Butylhydroxytoluene (E321) 0.05 mg


Spot-on solution.
Yellowish liquid.


Target species
kitten


Indications for use, specifying target species

Treatment and prevention of flea (Ctenocephalides felis) and tick (Rhipicephalus spp., Dermacentor spp., Ixodes spp.) infestations in cats.

Treatment and control of flea allergy dermatitis (FAD) in cats.
Prevention and treatment of hematophagous lice infestations Felicola subrostratus in cats.


Contraindications

As no studies have been conducted to confirm the safety of the product for that age/weight segment in kittens, the product should not be administered to kittens less than 8 weeks of age or weighing less than 1 kg.
Do not administer the product to sick animals (systemic diseases, fever) or to those in convalescence.
Do not administer the product to rabbits due to the risk of serious adverse reactions or even death.


Special warnings for each target species
Avoid contact of the product with the eyes of animals.


Special precautions for use

i) Special precautions for use in animals
Ticks on animals should be removed before using the product to reduce the risk of communicable diseases.
It is important to ensure that the product is applied in a protected area where the animal cannot lick it and animals should be avoided from licking each other after treatment.
There are no data on the efficacy of the product after bathing/shampooing in cats. However, based on information on the efficacy of the product in dogs shampooed two days after application of the product, bathing cats is not recommended for two days after application of the product.
Ticks may appear sporadically. Thus, it is impossible to completely rule out disease infection under adverse conditions. As a rule, ticks will die within 24 - 48 hours after infestation without feeding on the animal's blood.
Pet fleas frequently invade their bedding, where animals sleep and rest, places that should be regularly treated with appropriate insecticides and cleaned with a vacuum cleaner in case of massive infestations or when applying preventive measures.

ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
The product may cause irritation of mucous membranes and eyes. Therefore, avoid contact of the product with the mouth and eyes.
Animals or people with known hypersensitivity to insecticides or alcohol should avoid contact with Amflee spot-on solution. Avoid direct hand contact with the product. In case of accidental contact, wash hands with soap and water.

In case of contact with eyes, rinse thoroughly with clean water.

Wash hands after use.

Do not touch treated animals and do not let children play with them until the application site of the product has dried. Therefore, it is not recommended to apply the treatment during the day but in the evening before going to bed, and animals should not be allowed to sleep with their owners, especially children.

Do not smoke, drink or eat while applying the product.


Adverse reactions (frequency and severity)
If animals lick themselves, short-term hypersalivation may occur, mainly due to the excipients. Among the extremely rare suspected adverse reactions, transient skin reactions at the application site (hair discoloration and loss, itching and erythema) and general itching with alopecia may be observed. Exceptionally, reversible neurological symptoms (hyperaesthesia, depression, nervousness), hypersalivation or vomiting have been observed after use.

Avoid overdose.


Use during pregnancy, lactation or laying

The safety of the product has been demonstrated in breeding, pregnant and lactating females, receiving doses three times higher than the therapeutic dose.

Amflee spot-on solution can be applied to breeding and pregnant females, as well as lactating females.


Interactions with other medicinal products or other forms of interaction

They don't know each other.


Amounts to be administered and route of administration

Due to the lack of clinical tests conducted on the safety of the product, the minimum interval between applications is 4 weeks.

Amounts to administer:

Apply the contents of a single-dose 0.5 ml pipette to the skin between the shoulders.

Route of administration:

External application to the skin.

Method of administration:

Remove a pipette from the packaging. Hold the pipette upright with the tip pointing upwards and unscrew the pipette cap. With the other end of the cap removed, pierce the seal of the pipette. Remove the animal’s hair from the midline between the shoulders to expose the skin. Place the tip of the pipette on the skin and squeeze the tube several times to empty directly onto the skin.
One dose will provide protection against flea infestation for a period of 5 weeks.
The product is effective against ticks for 2 weeks.


Overdose (symptoms, emergency procedures, antidotes), as appropriate
Laboratory studies on the safety of the product in cats or kittens over 8 weeks of age and weighing around 1 kg, which received monthly doses 5 times higher than the recommended dose, for 6 consecutive months, demonstrated that there were no undesirable effects.

However, the risk of adverse reactions increases with overdose (see section 4.6).
Itching may occur after treatment.
Overdosing causes hair clumping at the application site. However, this clumping will disappear after 24 hours of application.


Waiting time

That's not the case.


Pharmacodynamic properties

Fipronil is an insecticide/acaricide of the phenylpyrazole group. It acts directly on arthropods by interacting with ligands of chloride ion channels, especially those regulated by the neurotransmitter gamma-aminobutyric acid (GABA), thus blocking the pre- and postsynaptic transport of chloride ions across cell membranes. This leads to uncoordinated activities of the central nervous system and the death of insects and mites.
Amflee spot-on solution contains the active ingredient fipronil, which has a unique mechanism of action against fleas and ticks. Amflee spot-on solution accumulates in the lipid component of the skin and hair follicles and is continuously eliminated on the skin and hair, ensuring persistent activity.


Pharmacokinetic features

The total amount of fipronil absorbed through the skin after topical application of Amflee spot-on solution is negligible.
After application of the Amflee spot-on solution, fipronil spreads through the concentration gradient in the skin and hair of animals from the application site to peripheral areas (lumbar, groin area). Fipronil is not absorbed and thus not metabolized in the body.

The concentration of fipronil in animal hair decreases reaching a concentration of 1 µg/g 2 months after administration.


List of excipients

Butylated hydroxytoluene (E321)
Butylated hydroxyanisole (E320)
Ethanol (96%)
Polysorbate 80
Povidone K25
Diethylene glycol monoethyl ether


incompatibility

They don't know each other.


Validity period

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.


Special precautions for storage

Does not require special storage conditions.
Product compliance information Product compliance information Product safety Manufacturer information Personal information Product safety information

Currently, product safety information is not available.

Manufacturer information

Currently, manufacturer information is not available.

Responsible person information

Currently, information about the person responsible is not available.

\n

Presentation type: Pipette

Action: Ticks, Fleas, Lice

Pieces Set: 1 piece

Cat Weight: No

\n

Quantity: 1 Pipette