Amflee Combo Spot On Solution for XLarge Dogs over 40kg.
A combination spot on containing Fipronil and S-Methoprene effective against fleas, ticks, biting lice and flea larvae and eggs. Amflee Combo prevents environmental flea burden. New innovative pipette for ease of use and compliance
Dogs over 40 kg
Indications for use, specifying the target species:
For the treatment of dogs, dosage defined by bodyweight grouping - To be used against infestations with fleas, alone or in association with ticks and/or biting lice.
- Treatment of flea infestations (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persists for 8 weeks. Prevention of the multiplication of fleas by inhibiting the development of eggs (ovicidal activity) and larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas for eight weeks after application.
- Treatment of tick infestations (Ixodes ricinus, Dermacentor variabilis,
Dermacentor reticulatus, Rhipicephalus sanguineus). The product has persistent acaricidal efficacy for up to 4 weeks against ticks.
- Treatment of infestations with biting lice (Trichodectes canis).
The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD), where this has been previously diagnosed by a veterinary surgeon.
In the absence of available data, the product should not be used on puppies less than 8 weeks old and/or weighing less than 2 kg.
Do not use on sick (e.g. systemic diseases, fever) or convalescent animals.
Do not use in rabbits due to a risk of adverse reactions or even death.
This product is specifically developed for dogs. Do not use in cats and ferrets, as this could lead to overdosing.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species:
Bathing/immersion in water within 2 days after application of the product and more frequent bathing than once a week should be avoided, as no study has been performed to investigate how this affects the efficacy of the product. Emollient shampoos can be used prior to treatment, but reduce the duration of protection against fleas to approximately 5 weeks when used weekly after application of the product. Weekly bathing with a 2% chlorhexidine medicated shampoo did not affect efficacy against fleas during a 6 week long study.
There may be an attachment of a few ticks. For this reason a transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.
Fleas from pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furnishings which should be treated, in case of massive infestation and at the beginning of the control measures, with a suitable insecticide and vacuumed regularly.
Special precautions for use:
i) Special precautions for use in animals
Avoid contact with the animal's eyes.
It is important to make sure that the product is applied to an area where the animal
cannot lick it off and to make sure that animals do not lick each other following treatment.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals:
This product can cause mucous membrane, skin and eye irritation. Therefore, contact of the product with mouth, skin and eyes should be avoided.
People with a known hypersensitivity to insecticides or alcohol should avoid contact with the product. Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and water.
After accidental ocular exposure the eye should be rinsed carefully in clean water.
Wash hands after use.
In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.
Do not smoke, drink or eat during application.
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 that animals are not treated during the day, but should be treated during the early evening, and that recently treated animals are not allowed to sleep with owners, especially children.
iii) Other precautions
Dogs should not be allowed to swim in watercourses for 2 days after application.
Adverse reactions (frequency and seriousness):
Among the very rare suspected adverse reactions, transient skin reactions on the application site (skin discoloration, local hair loss, itching, redness) and general itching or hair loss have been reported after use. Excessive salivation, reversible nervous signs (increased sensitivity to stimulation, depression, other nervous signs), vomiting or respiratory symptoms have also been observed after use.
In the case of licking the administration site, a brief period of excessive salivation may be observed due mainly to the nature of the carrier.
Do not overdose.
Use during pregnancy, lactation or lay:
Can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction:
Amounts to be administered and administration route:
Route of administration and dosage:
External use only, spot-on use..
Administer by topical application to the skin; one pipette of 4.02 ml (402 mg fipronil + 361.8 mg (S)-methoprene) per dog weighing over 40 kg. This corresponds to a minimum recommended dose of 6.7 mg/kg for fipronil and 6 mg/kg for (S)- methoprene, by topical application to the skin. In the absence of safety studies the minimum treatment interval is 4 weeks.
Method of administration:
1. Remove the pipette from its packaging. Hold the pipette in an upright position, twist and pull the cap off.
2. Turn the cap around and place the other end of the cap back on the pipette. Push and twist the cap to break the seal, then remove the cap from the pipette.
3. Part the coat on the back of the animal at the base of the neck in front of the shoulder blades until the skin is visible. Place the tip of the pipette onto the skin and squeeze the pipette several times to empty its contents completely and directly onto the skin in one spot.
Temporary changes to the coat (clumped/greasy hair) may be noted at the application site.
Overdose (symptoms, emergency procedures, antidotes), if necessary:
No adverse effects were observed in target animal safety studies in 8 week-old puppies, growing dogs and dogs weighing about 2 kg treated once at five times the recommended dose. The risk of experiencing adverse effects may however increase when overdosing, so animals should always be treated with the correct pipette size according to bodyweight..
List of excipients
Ethanol 96 per cent
Diethylene glycol monoethyl ether
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Special precautions for storage:
Store in the original package in order to protect from light and moisture.
This veterinary medicinal product does not require any special temperature storage conditions.
Nature and composition of immediate packaging:
White polypropylene unit-dose pipette with polyethylene or polyoxymethylene closure with spike packaged into laminated triplex bag composed of polyester, aluminium and polyethylene.
Cardboard box containing 1, 3, 6, 10, 30 pipettes.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal product should be disposed of in accordance with local
requirements. Fipronil and S-methoprene may adversely affect aquatic organisms.
Do not contaminate ponds, waterways or ditches with the product or empty container.
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