Krka Amflee spot-on 67mg - antiparasitic solution for dogs from 2 to 10kg

Product Description

Antiparasitic indicated for the treatment of flea and tick infestations in dogs.

Indications

Amflee Spot-On is a veterinary medicinal product indicated for the treatment of infestations by Trichodectes canis, a dog-biting louse. Most lice are killed within two days. The insecticidal efficacy against new infestations by adult fleas persists for up to 8 weeks. The veterinary medicinal product has persistent acaricidal efficacy for up to 3 weeks against Ixodes ricinus and up to 4 weeks against Rhipicephalus sanguineus and Dermacentor reticulatus. If ticks of certain species (Ixodes ricinus, Rhipicephalus sanguineus) are present when the veterinary medicinal product is applied, not all ticks may be killed within the first 48 hours.
The veterinary medicinal product may be used in combination with other products. be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD), when this has been previously diagnosed by the veterinarian.

Directions for use and Dosage

Route of administration and dosage:
For external use only.
Administer by topical application to the skin according to body weight as follows:

Directions for use

1. Remove the pipette from the sachet a triple layer;
2. Hold the pipette upright, twist and remove the cap;
3. Turn the cap inside out and replace it on the pipette;
4. Press and twist the cap to break the seal, then remove the cap from the pipette;
5. Part the animal's fur between the shoulder blades until the skin is visible;
6. Place the tip of the pipette on the skin and squeeze the single-dose pipette several times to empty the contents directly onto the skin in one or two places.

Warnings

It is important to ensure that the veterinary medicinal product is applied to an area that the animal cannot lick and that animals do not lick each other after treatment. The fur should be parted and the veterinary medicinal product should be applied to the skin. At the application site,
transient coat changes (clumps/greasy hair and/or deposits on the hair) may be observed. For optimal control of flea and/or tick infestations, the treatment program may be based
on the local epidemiological situation.
In the absence of safety studies, the minimum interval between treatments is 4 weeks. Keep out of the sight and reach of children.
Store in the original package in order to protect the veterinary medicinal product from light and moisture. Do not remove from the pouch until ready for use.
Before application, the veterinary medicinal product should be kept at room temperature (above 14°C) for approximately one hour.

Special warnings

Special warnings for each target species

Bathing/immersion in water within 2 days of application of the veterinary medicinal product should be avoided. Following weekly immersion in water for one minute, the insecticidal efficacy against fleas persists for 7 weeks. The veterinary medicinal product does not prevent tick attachment to animals. If the animal was treated before exposure to ticks, they will be killed within 24–48 hours after attachment. This generally occurs before the animal finishes feeding, reducing but not eliminating the risk of disease transmission. Once dead, ticks often detach from the animal, but any remaining ones can be removed by gently pulling them. Fleas on animals often infest the animal's bedding, blankets, and usual resting areas, such as carpets and soft furnishings. In the event of massive infestations and at the beginning of control measures, these should be treated with a suitable insecticide and regularly vacuumed. When used as part of a strategy for the treatment of Flea Allergy Dermatitis, monthly applications are recommended for allergic patients and other dogs and cats in the household should be treated with an appropriate insecticide. For optimal control of flea infestations in a multi-pet household, all animals in the household (e.g., dogs, cats, ferrets, rabbits) should be treated with an appropriate insecticide.

Special precautions for use in animals

Animals should be accurately weighed before treatment.
Avoid contact with the animal's eyes. In case of accidental contact with the eyes, rinse immediately with plenty of water.
It is important to ensure that the veterinary medicinal product is applied to an area that the animal cannot lick and that animals do not lick each other after treatment. Do not apply the veterinary medicinal product to wounds or broken skin.
Fipronil may be harmful to aquatic organisms. Dogs should not be allowed to swim in watercourses for two days after application.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

This veterinary medicinal product may cause irritation to mucous membranes and eyes. Therefore, contact between the veterinary medicinal product and the mouth or eyes should be avoided. In case of accidental contact with eyes, rinse immediately with plenty of water.
If eye irritation persists, seek medical advice and show the package leaflet or the label. Do not smoke, drink, or eat during application.
Avoid contact of the contents with your fingers. If this occurs, wash your hands immediately with soap and water. Wash hands after use.
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 handled 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 not to treat animals during the day, but rather in the early evening, and not to allow recently treated animals to sleep with their owners, especially children. Keep pipettes in the original container and dispose of used pipettes immediately.

Contraindications

In the absence of available data, do not use in puppies under 2 months of age and/or weighing less than 2 kg. Do not use in sick (e.g. systemic diseases, fever, etc.) or convalescent animals. Do not use in rabbits, as they may cause allergic reactions. Adverse reactions and even death may occur. This veterinary medicinal 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, dimethyl sulfoxide, or any of the excipients.

Side effects

If the animal licks itself, a short period of hypersalivation may be observed.
Among the very rare suspected adverse reactions, transient skin reactions at the application site (skin discoloration, local alopecia, itching, erythema) and general itching or alopecia have been reported after use.
In very rare cases, hypersalivation, reversible neurological symptoms (hyperesthesia, depression, nervous symptoms), vomiting, or respiratory symptoms have been observed after use. The frequency of adverse reactions is defined using the following conventions:

• Very common (more than 1 in 10 animals treated displaying adverse reactions during the course of one treatment)
• Common (more than 1 but less than 10 animals in 100 animals treated);
• Uncommon (more than 1 but less than 10 animals in 1,000 animals treated);
• Rare (more than 1 but less than 10 animals in 10,000 animals treated);
• Very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you experience any side effects, even those not already mentioned in this leaflet, or you think that the medicine has not worked, please tell your doctor. Veterinary.

Overdose

In safety studies in the target species, no adverse reactions were observed in 8-week-old puppies, growing dogs, and dogs weighing approximately 2 kg, treated once with doses five times the recommended dose. However, the risk of adverse reactions (see paragraph 6) may increase in case of overdose, therefore animals should always be treated with the correct pipette dosage based on body weight.

Pregnancy and lactation

Laboratory studies using fipronil have shown no evidence of teratogenic or embryotoxic effects. The safety of the veterinary medicinal product has not been established in breeding, pregnant, or lactating bitches. Use only in accordance with the benefit/risk assessment by the responsible veterinarian.

Format

3 single-dose pipettes of 0.67 ml