Spot on solution, light yellow to yellow clear liquid. Presented in pipettes, individually wrapped in foil and cardboard boxes of 3 pipettes.

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).

EXTERNAL USE ONLY. Administer by topical application to the skin.

Dosage

2-10 kg: 1 x 0.67ml pipette

10-20 kg: 1 x 1.34ml pipette

20-40 kg: 1 x 2.68 pipette

40-60 kg: 1 x 4.02ml pipette

60 kg plus +: 1 x 4.02ml pipette and an appropriate smaller pipette

Administration:

Temporary changes to the coat (clumped/greasy hair and/or deposits on the hair) may be noted at the application site.

Duration of treatment:

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.

Can be used during pregnancy and lactation.

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 case of hypersensitivity to the active substance or to any of the excipients.

Do not apply on wounds or damaged skin.

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

Do not use in any other non-target species.

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.

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.

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.

Keep pipettes in original packaging until ready to use.

Dogs should not be allowed to swim in watercourses for 2 days after application.

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.

Interactions - Do not use simultaneously with other flea products which are applied directly on to the animal.

Environmental Safety
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 containers.

Store in the original container in order to protect from light and 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.

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

1, 3 and 6 pipette packs

Not all pack sizes may be marketed

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Pharmacotherapeutic group: Ectoparasiticides for topical use.

ATCvet code: QP53AX65

Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. It acts by interacting with ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA), 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 acarines. Fipronil kills fleas within 24 hours and ticks (Dermacentor reticulatus, Dermacentor variabilis, Rhipicephalus sanguineus, Ixodes scapularis, Ixodes ricinus, Haemaphysalis longicornis, Haemaphysalis flava, Haemaphysalis campanulata) and lice within 48 hours post-exposure.

(S)-Methoprene is an insect growth regulator (IGR) of the class of compounds known as juvenile hormone analogues that inhibit the development of immature stages of insects. This compound mimics the action of juvenile hormone and causes impaired development and death of the developing stages of fleas. The on-animal ovicidal activity of (S)-methoprene results from either direct penetration of the eggshell of newly laid eggs or from absorption through the cuticle of the adult fleas. (S)-methoprene is also effective in preventing flea larvae and pupae from developing, which prevents contamination of the environment of the treated animals with the immature stages of fleas.

Studies of metabolism of fipronil have demonstrated that the major metabolite is the sulfone derivative of fipronil.

(S)-methoprene is extensively degraded into carbon dioxide and acetate that are subsequently incorporated into endogenous materials.

The pharmacokinetic profiles after topical application of fipronil and (S)-methoprene in combination were studied in dogs in comparison to intravenous dosing of fipronil or (S)-methoprene alone. This established absorption and other pharmacokinetic parameters. The topical application resulted in low systemic absorption of fipronil (11%) with a mean maximum concentration (Cmax) of approximately 35 ng/ml fipronil and 55 ng/ml of fipronil sulfone in plasma. Fipronil is extensively metabolised to fipronil sulfone after topical administration.

Plasma concentrations of (S)-methoprene were below the limit of quantitation (20 ng/ml) in dogs after topical application.

Both (S)-methoprene and fipronil, together with its major metabolite, are well-distributed in the hair/coat of a dog within one day after application. The concentrations of fipronil, fipronil sulfone and (S)-methoprene in the hair/coat decrease with time and are detectable for at least 60 days after dosing. Parasites are killed through contact rather than systemic exposure.

No pharmacological interaction between fipronil and (S)-methoprene was noted.

Fleascreen Combo Spot On for Dogs Small Vm 01656/4125

Fleascreen Combo Spot On for Dogs Medium Vm 01656/4126

Fleascreen Combo Spot On for Dogs Large Vm 01656/4127

Fleascreen Combo Spot On for Dogs Extra Large Vm 01656/4157