SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Amflee 134 mg spot-on solution for medium dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 pipette (1.34 ml) contains:

Active substance:

Fipronil 134 mg

Excipients:

Butylhydroxyanisole (E320) 0.27 mg

Butylhydroxytoluene (E321) 0.13 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Spot-on solution.

Light yellow to yellow, clear liquid.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Treatment of flea (Ctenocephalidesspp.) and tick (Dermacentorreticulatus)infestations.

For treatment of Trichodectes canis biting lice infestations on dogs. Most lice are killed within 2 days.

Insecticidal efficacy against new infestations with adult fleas persists for up to 8 weeks.

The product has a persistent acaricidal efficacy for up to 3 weeks against Ixodes ricinusandup to4 weeks against Rhipicephalussanguineusand Dermacentor reticulatus. If ticks of some species (Ixodes ricinus, Rhipicephalus sanguineus) are present when the product is applied, all the ticks may not be killed within the first 48 hours.

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.

Do not use on puppies less than 2 months old and/or weighing less than 2 kg in the absence of available data.

Do not use on sick (e.g. systemic diseases, fever…) or convalescent animals.

Do not use in rabbits, as adverse reactions and even death could occur.

This product is specifically developed for dogs. Do not use in cats, as this could lead to overdosing.

Do not use in cases of hypersensitivity to the active substance, dimethyl sulphoxide or to any of other excipients.

4.4 Special warnings for each target species

Bathing/immersion in water within two days after application of the product should be avoided. After weekly immersions in water for one minute the period of persistent insecticidal efficacy against fleas was 7 weeks.

The product does not prevent ticks from attaching to the animals. If the animal has been treated prior to exposure to the ticks, the ticks will be killed in the first 24-48 hours after attachment. This will usually be prior to engorgement, minimising but not excluding the risk of transmission of diseases. Once dead, ticks will often drop off the animal, but any remaining ticks may be removed with a gentle pull.

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.

When used as part of a strategy for the treatment of flea Allergy Dermatitis, monthly applications to the allergic patient and to other dogs in the household are recommended.

For optimal control of flea infestation in multi-pet household, all dogs and cats in the household should be treated with a suitable insecticide.

4.5 Special precautions for use

i) Special precautions for use in animals

Animals should be weighed accurately prior to treatment.

Avoid contact with the animal's eyes. In the case of accidental eye contact, immediately and thoroughly flush the eyes with water.

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.

Do not apply the product on wounds or damaged skin.

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

This product can cause mucous membrane and eye irritation. Therefore, contact between the product and the mouth or eyes should be avoided.

In the case of accidental eye contact immediately and thoroughly flush the eyes with water. If eye irritation persists seek medical advice and show the package leaflet or the label to the physician.

Do not smoke, drink or eat during application.

Avoid contents coming into contact with the fingers. If this occurs, wash off immediately with soap and water.

Wash hands after use.

People with a known hypersensitivity to fipronil or dimethyl sulphoxide or other 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 that animals are not treated during the day, but should be treated during the early evening, and that recently treated animals should not be allowed to sleep with owners, especially children.

Keep pipettes in the original packaging and dispose of used pipettes immediately.

iii) Other precautions

Fipronil may adversely affect aquatic organisms. Dogs should not be allowed to swim in water courses for 2 days after application.

4.6 Adverse reactions (frequency and seriousness)

If licking occurs, a brief period of hypersalivation may be observed.

Among the extremely rare suspected adverse reactions, transient cutaneous reactions on the application site (skin discoloration, local alopecia, pruritus, erythema) and general pruritus or alopecia have been reported after use. Exceptionally, hypersalivation, reversible neurologic symptoms (hyperesthesia, depression, nervous symptoms), vomiting or respiratory symptoms have been observed after use.

Laboratory studies using fipronil have not shown any evidence of teratogenic or embryotoxic effect. Studies have not been carried out with this product in pregnant and lactating bitches. Use in pregnancy and lactation only in accordance with professional veterinary advice and a benefit/risk assessment.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Route of administration and dosage:

External use only.

Administer by topical application to the skin according to the bodyweight as follows:

1 pipette of 1.34 ml per dog weighing over 10 kg and up to 20 kg bodyweight.

Method of administration:

Remove the pipette from the triplex bag. Hold the pipette in an upright position, twist and pull the cap off. 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. Spread the animal hairs in the area between the shoulder blades to make the skin visible. Put the tip of the pipette onto the skin and press the unit-dose pipette several times to empty its contents directly onto the skin at one or two spots.

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.

The hair should be parted and the product applied to the skin. Temporary changes to the coat (clumped/greasy hair and/or deposits on the hair) may be noted at the application site.

Treatment schedule:

For optimal control of flea and/or tick infestation the treatment schedule can be based on the local epidemiological situation.

In the absence of safety studies, the minimum treatment interval is 4 weeks.

4.10 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 (see section 4.6) may however increase when overdosing, so animals should always be treated with the correct pipette size according to bodyweight.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Ectoparasiticides for topical use.

ATC vet code: QP53AX15

5.1 Pharmacodynamic properties

Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. It acts by inhibiting the GABA complex, binding to the chloride channel and thereby blocking pre-and post-synaptic transfer of chloride ions across cell membranes. This results in uncontrolled activity of the central nervous system and death of insects or acarids.

Fipronil exhibits an insecticidal and acaricidal activity against fleas (Ctenocephalidesspp.), ticks (Rhipicephalusspp., Dermacentorspp., Ixodesspp., including Ixodes ricinus) and lice (Trichodectes canis) in the dog. Ticks will usually be killed within 48 h after contact with Fipronil, however if ticks of some species (Ixodes ricinus, Rhipicephalus sanguineus) are already present when the product is applied, all of the ticks may not be killed within the first 48 hours. Fleas will be killed within 24 hours.

5.2 Pharmacokinetic particulars

Fipronil is mainly metabolised to its sulfone derivative (RM1602), which also possesses insecticidal and acaricidal properties. The concentrations of fipronil on the hair decrease with time.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Butylhydroxyanisole (E320)

Butylhydroxytoluene (E321)

Polysorbate 80

Povidone K25

Dimethyl sulfoxide

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 36 months.

6.4. Special precautions for storage

Store in the original containerin order to protect from lightand moisture. Do not remove from bag until required for use.

The product should be maintained at room temperature (above 14°C)for approximately one hour prior to administration.

6.5 Nature and composition of immediate packaging

White polypropylene pipette closed with either a polyethylene or polyoxymethylene cap. Each pipette is packed in a polyethylene terephthalate/aluminium/low density polyethylene triplex bag.

Box containing 1, 3, 6, 10, 20 or 30 pipettes.

Not all pack sizes may be marketed.

6.6 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 products should be disposed of in accordance with local requirements.

Fipronil may adversely affect aquatic organisms. Do not contaminate ponds, waterways or ditches with the product or empty container.

7. MARKETING AUTHORISATION HOLDER

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

8. MARKETING AUTHORISATION NUMBER

Vm 01656/4088

9. DATE OF FIRST AUTHORISATION

27 May 2015

10. DATE OF REVISION OF THE TEXT

May 2015

Approved: 27/05/2015