Amflee 134 mg solution for dripping for medium dogs, 6 pcs

Instructions for use for Amflee 134 mg solution for dripping for medium dogs, 6 pcs

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Important notes (compulsory information):

Amflee® 67/134/268/402 mg Solution for dripping for dogs. Active substance: Fipronil. Applications: To treat a flea (Ctenocephalides spp.) And tick infestation (Dermacentor reticulatus). To treat hair lures (trichodeces canis) in dogs.

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


LEAFLET: INFORMATION FOR THE USER

Amflee® 67/134/268/402 mg solution for dripping for dogs

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

Admission holder:
TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven
Germany

Manufacturer responsible for the batch value:
TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven
Germany

2. Designation of the veterinary medicinal product

Amflee® 67/134/268/402 mg solution for dripping for dogs
Fipronil

3. Active substance (E) and other ingredients

Each single dose (pipette) contains:

Single dose	Active ingredient	Strength	Other ingredient butylhydro-xyanisol (E320)	Other ingredient butylhydro-xytoluene (E321)
Amflee 67 mg	Fipronil	67 mg	0.134 mg	0,067 mg
Amflee 134 mg	Fipronil	134 mg	0.27 mg	0.13 mg
Amflee 268 mg	Fipronil	268 mg	0.54 mg	0.27 mg
Amflee 402 mg	Fipronil	402 mg	0.80 mg	0.40 mg

Pale yellow to yellow, clear solution.

4. APPLICATION AREAS)

To treat a flea (ctenocephalides spp) and tick infestation (Dermacentor reticulatus). For the treatment of hairlingen (Trichodectes Canis) in dogs. Most hairlings are killed within 2 days. The insecticidal effect against a renewed infestation with adult fleas is maintained up to 8 weeks. The veterinary medicinal product has a persistent acaricidal effect of up to 3 weeks against IXodes Ricinus and up to 4 Weeks against Rhipicephalus Sanguineus and Dermacentor reticulatus. If certain types of ticks (Ixodes Ricinus, Rhipicephalus sanguineus) are already present at the animal at the time of the veterinary medicinal product, all ticks may not be killed within the first 48 hours. The veterinary medicinal product can be used as part of a treatment plan for controlling Flohalerwiedermatitis (FAD), unless they have been diagnosed by a veterinarian.

5. Contraindications

Do not use at puppies who are younger than 2 months and / or weigh less than 2 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. This veterinary medicinal product has been specially developed for dogs. Do not apply to cats, as this can lead to overdose. 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 (hyperesthesia, depression, nervous symptoms), vomiting or respiratory symptoms were observed. Fall of them you side effects, especially those that are not listed in the leaflet, discontinue with your animal, share them with your veterinarian or pharmacist.

7. Target type (s)

dog

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

Administration and dosage:
Only for external use.

Topical application on the skin according to the body weight, as follows:

Dogs	Number of pipettes	Pipette volume	Power
over 2 kg and up to 10 kg	1 Pipette	0.67 ml	67 mg
over 10 kg and up to 20 kg	1 Pipette	1.34 ml	134 mg
over 20 kg and up to 40 kg	1 Pipette	2.68 ml	268 mg
40 kg and up to 60 kg	1 Pipette	4.02 ml	402 mg
over 60 kg	1 Pipette + corresponding smaller pipette	4.02 ml + corresponding combination	402 mg + corresponding combination

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 contents as far as possible at 1 or 2 digits directly on the skin.

9. Notes for the right application

It is important to ensure that the veterinary medicinal product is applied at a location where the animal can not lick it and also that the animals can not face each other after treatment. The coat should be curled and the veterinary medicinal product is applied directly to the skin. Temporary changes in the hair dress (clumped, lubricious coat and / or deposits in the fur) can occur at the application site. For optimal control of a flea And / or tick infestation should take into account the treatment plan 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

Bathing / immersion in water within two days of the application of the veterinary medicinal product should be avoided. After weekly immersion in water for a minute, the persistent insecticidal effect was against fleas at 7 weeks. The veterinary medicinal product does not prevent ticks affecting the animal. When the animal was treated in front of an infestation, the ticks are killed in the first 24 - 48 hours after the infestation. The killing is usually carried out in front of bloodseys, so that the risk of a tie-transferable disease can be reduced but 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. 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. As part of a treatment SPlanes against FlohalerGiedermatitis are recommended monthly applications for the allergic animal and other household dogs. For optimal control of the flea problem in a household with several animals, all dogs and cats should be treated with a suitable insecticide. The animals must be balanced precisely before the treatment. 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. It is important to ensure that the veterinary medicinal product is applied at a location where the animal can not lick it and also that the animals can not face each other after treatment. Do not apply the veterinary medicinal product to wounds or skin lesions. Laboratory tests with Fpronil did not give any evidence of teratogenic or embryotoxic effects. No studies with this veterinary medicinal product were carried out on carrying and bundling bitches. Therefore, an application during pregnancy and lactation should only be carried out after appropriate benefit risk assessment by the attending veterinarian. In compatibility studies at puppies at the age of 8 weeks, adolescent dogs and dogs weighing about 2 kg no side effects were observed after a single application of five times recommended dose. However, the risk of side effects (see section 6) can increase in the event of overdose, so the animals should always be treated with the correct pipette size according to the body weight. Fipronil must not get into waters as it can be a threat to water organisms. Dogs may not be bathed in open waters for 2 days after treatment.

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 medic.
inal 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. Do not eat, drink or smoke during use. 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. Persons with known hypersensitivity to Fpronil or dimethylsulfoxide or any 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 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 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