Amflee 50 mg solution for dripping for cats, 6 pcs

Upute za korištenje Amflee 50 mg solution for dripping for cats, 6 pcs

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Important notes (compulsory information):

Amflee® 50 mg solution for dripping for cats. Active substance: Fipronil. Areas of application: for the treatment and prevention of a flea (ctenocephalides spp) and ticks (Dermacentor reticulatus, ixodes ricinus) in cats.

For risks and side effects read the leaflet and ask your vet or pharmacist.


LEAFLET: INFORMATION FOR THE USER

Amflee® 50 mg solution for dripping for cats

1. Name and address of the admission holder and, if different, the manufacturer responsible for the batch release

TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven
Germany

2. Designation of the veterinary medicinal product

Amflee® 50 mg solution for dripping for cats
Fipronil

3. Active substance (E) and other ingredients

1 pipette (0.5 ml) contains:
Active substance:
Fipronil 50 mg

Other ingredients:
Butylhydroxyanisol (E320) 0.10 mg, butylhydroxytoluene (E321) 0.05 mg

Pale yellow to yellow, clear solution.

4. Field of application (E)

For the treatment and prevention of a flea (ctenocephalides spp) and ticks (Dermacentor reticulatus, ixodes ricinus) in cats. The veterinary medicinal product has a persistent insecticidal effect of up to 4 weeks against fleas (Ctenocephalides Felis), an acaricidal effect of up to 4 weeks against IXodes Ricinus and up to a week against Dermacentor reticulatus and Rhipicephalussanguineus. If tickets (Rhipicephalus sanguineus) are available on the animal at the time of the veterinary medicinal product, all ticks may be killed within the first 48 hours, but only within a week. The veterinary medicinal product can be part of a treatment plan for the control of FlohalerGiedermatitis (FAD) Unless previously diagnosed by a veterinarian.

5. Contraindications

Do not use in cat puppies who are younger than 2 months and / or weigh less than 1 kg, as there are no investigations. Do not apply to patients (eg systemic diseases, fever ...) or convalescent animals. Do not apply to rabbits because side effects can occur with death. Do not use in a known hypersensitivity to the active ingredient, dimethylsulfoxide or any of the other ingredients.

6. Side effects

When the animal licks the solution, saliva flow can occur for a short time. The extremely rare side effects on the application include temporary skin reactions on the application site (shed, local hair loss, itching, skin extraction) and general itching or hair loss. In exceptional cases, after application, increased salivation, reversible neurological symptoms (hypersensitivity, depression, nervous symptoms) or vomiting were observed. If you notice side effects, especially those that are not listed in the leaflet on your beast, share them with your veterinarian or pharmacist.

7. Target type (s)

Cats

8. Dosage for each species, type and duration of the application

Administration and dosage:
Only for external use. Topical application on the skin: 1 Pipette with 0.5 ml per animal.

Type of application:

1. Release the pipette from the film packaging. Hold the pipette upright, turn the cap and remove the cap.
2. Turn the cap and put it back on the pipette with the other end. Press the cap and turn until the closure breaks. Then remove the cap from the pipette.
3. The fur of the animal cane between the shoulder blades, so that the skin becomes visible.
4. Put the pipette tip on the skin and press the pipette several times to empty the content as possible to 2 (one on the skull base and a second 2 to 3 cm further) directly on the skin.

The coat should be cleverand the veterinary medicinal product is applied to the skin. Temporary changes in the hair dress (clumped, greasy coat and / or deposits in the coat) can occur at the application site. They usually disappear within 24 hours.

9. Notes for the right application

For optimal control of the flea and / or tick infestation, the treatment plan should take into account the local epidemiological conditions. Due to lack of security studies, a treatment interval of 4 weeks should not be undershot.

10. Wait

Not applicable.

11. Special storage instructions

Keep medicines inaccessible to children. Keep in original container to protect the content from light and moisture. Do not take advantage of the film packaging until use. The veterinary medicinal product should be at room temperature for about one hour before administration (over 14 ° C) be kept. You must no longer apply the veterinary medicinal product according to the expiry date specified on the container and outer wrapping.

12. Special warnings

Fleas of pets often infested the basket, warehouses and the usual resting sites such as rugs and upholstered furniture. With massive infestation and at the beginning of the fighting measure, therefore, these places should be treated with a suitable insecticide and sucked off regularly. The veterinary medicinal product does not prevent ticks affecting the animal. When the animal was treated in front of an infestation, the tick is killed in the first 24 - 48 hours after infestation. The killing is usually carried out in front of the bloodseys, so that the risk of a tie-transferable disease can not be completely excluded. As soon as the ticks are killed, they generally fall from the animal, remaining ticks can be removed with a gentle train. Investigations on the influence of bathing / shampooing on the efficacy of the veterinary medicinal product in cats are not available. But there are investigations in dogs that suggest that a weekly immersion in water for a minute reduces the period of persistent insecticidal effect against fleas by 1 week. For optimal control of the flea problem in a household with several animals, all dogs and cats should be treated with a suitable insecticide. As part of a treatment plan against Flohalerwiedermatitis, monthly applications are recommended for the allergic animal and other household cats. Avoid contact with the eyes of the animal. If the veterinary medicinal product accidentally reaches the eyes, they must be rinsed immediately and thoroughly with water. Do not apply the veterinary medicinal product to wounds or skin lesions. The animals must be balanced precisely before the treatment. In compatibility studies on cats and cat puppies at the age of 2 months and older and with a couple weight of about 1 KG, after application of five times recommended dose, no side effects were observed once a month over three consecutive months. However, the risk of side effects can increase in the event of overdose (see section 6). Laboratory tests with Fpronil did not give any evidence of teratogenic or embryotoxic effects. No studies were carried out with this veterinary medicinal product for carrying and tensive cats. Therefore, an application during pregnancy and lactation should only be carried out after appropriate benefit risk assessment by the attending veterinarian.

Special precautions for the user:
This veterinary medicinal product can cause irritation of the mucous membrane and the eyes. Therefore, the contact with mouth or eyes should be avoided. If the veterinary medicinal product accidentally reaches the eyes, they must be rinsed immediately and thoroughly with water. If the eye irritation persists, a doctor must be consulted without delay and to show the package leaflet or the label. Avoid contact with the skin. If the veterinary medicinal product accidentally reaches the skin, it must be washed immediately with water and soap. Wash hands after use. Do not eat, drink or smoke during use.

Persons with known hypersensitivity to Fpronil or dimethyl sulfoxide or one of the other ingredients should avoid contact with the veterinary medicinal product. Avoid direct contact with treated animals as long as the application site is still moist. Children must be kept away from the treated animal during this time. It is therefore recommended not to treat animals during the day, but in the early evening. Freshly treated animals should not sleep with the owners, especially children. Keep the pipettes in the original packaging and dispose of used pipettes immediately.

13. Special precautions for disposal of non-used medicines or waste materials, if necessary

Unused veterinary medicinal products are preferably to be dispensed with pollutant collection points. For joint disposal with household waste, ensure that no misuse of this waste can be done. Veterinary medicinal products must not be disposed of with the waste water or the sewer. Fipronil must not get into waters as it can be a threat to water organisms.

14. Approval date of the leaflet

February 2015

15. Further information

White pipette made of polypropylene, with a closure cap made of polyethylene or polyoxymethylene. Each 0.5 ml pipette is packed in a triple sheath of LD-polyethylene / terephthalate / aluminum. Packs of 1, 3, 6, 10, 20 or 30 pipettes. There may not be all pack sizes on the market. If further information about the veterinary medicinal product is desired, please contact the local representative of the authorization holder.

Source: Information of the leaflet
Status: 02/2016