Bob Martin Clear Plus 50 mg/ 60 mg Spot-on Solution for Cats and Ferrets

Composition

Each pipette of 0.5 ml contains:

Active substances:

Fipronil 50.00 mg

(S)-methoprene 60.00 mg

Excipients:

Butylhydroxyanisole (E320) 0.10 mg

Butylhydroxytoluene (E321) 0.05 mg

For the full list of excipients, see section 6.1.

6.1 List of excipients

Butylhydroxyanisole (E320)

Butylhydroxytoluene (E321)

Ethanol

Polysorbate 80 (E433)

Povidone

Diethylene glycol monoethyl ether

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Pharmaceutical form

Spot-on solution.

Clear amber solution.

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Pharmacological properties

Pharmacotherapeutic group: Ectoparasiticides for topical use incl. insecticides. ATC vet code: QP53AX65.

The product is an insecticidal and acaricidal solution for topical use, containing an association of an adulticidal active ingredient, fipronil, in combination with an ovicidal and larvicidal active ingredient, (S)-methoprene.

5.1 Pharmacodynamic properties

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, ticks (Dermacentor variabilis, Rhipicephalus sanguineus, Ixodes ricinus) 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 treated animals with the immature stages of fleas.

5.2 Pharmacokinetic particulars

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 cats in comparison to intravenous dosing of fipronil or (S)-methoprene alone. This established absorption and other pharmacokinetic parameters under conditions mimicking clinical practice. The topical application, with additional potential oral exposure from licking, resulted in overall systemic absorption of fipronil (18%) with a mean maximum concentration (Cmax) of approximately 100 ng/ml fipronil and 13 ng/ml of fipronil sulfone in plasma.

Peak fipronil plasma concentrations are rapidly attained (mean tmax approximately 6 h) and decline with a mean terminal half-life of approximately 25 h.

Fipronil is slightly metabolised to fipronil sulfone in cats.

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

Both (S)-methoprene and fipronil, together with its major metabolite, are well-distributed in the haircoat of cats 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 59 days after dosing. Parasites are killed through contact rather than by systemic exposure.

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

The pharmacokinetic profile of the product has not been investigated in ferrets.

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Target species

Cats and ferrets.

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Indications

In cats:

-To be used against infestations with fleas, alone or in association with ticks and/or biting lice.

-Elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persists for 4 weeks. Prevention of the multiplication of fleas by inhibiting the development of eggs (ovicidal activity), larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas for six weeks after application.

-Elimination of ticks (Ixodes ricinus, Dermacentor variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus) The product has a persistent acaricidal efficacy for up to 2 weeks against ticks (based on experimental data).

-Elimination of biting lice (Felicola subrostratus).

In ferrets:

-To be used against infestations with fleas, alone or in association with ticks.

- Elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy against new infestations with adult fleas persists for 4 weeks. Prevention of the multiplication of fleas by inhibiting the development of eggs (ovicidal activity), larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas.

- Elimination of ticks (Ixodes ricinus,). The product has a persistent acaricidal efficacy for 4 weeks against ticks (based on experimental data).

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Dosage

One pipette of 0.5 ml per cat, corresponding to a minimum recommended dose of 5 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.

One pipette of 0.5 mL per ferret corresponding to a dose of 50 mg for fipronil and 60 mg for (S)-methoprene per ferret, by topical application to the skin.

The minimum treatment interval is 4 weeks.

Method of administration:

Thermoformed pipettes:

1. Bob Martin Clear Plus must be applied at 2 points, at the base of the back of the cat’s head and between the shoulder blades. If the pet is wearing a collar remove it first so that it does not restrict application.

2. Remove a single pipette from the pack. To open, hold the pipette upright and snap off the tip.

3. Part your pet’s coat until the skin is visible. Place the tip of the pipette directly against the skin and squeeze gently. Apply approximately half of the pipette at one point and half at the second point. Avoid applying onto the fur and do not rub into the skin as this will reduce the product’s performance.

Polypropylene pipettes

1. Bob Martin Clear Plus must be applied at 2 points – at the base of the back of the pet’s head and between the shoulder blades. If the pet is wearing a collar remove it first so that it does not restrict application.

2. Remove a single pipette from the pack. Hold the pipette upright and snap off the top section of the cap opening the pipette.

3. Part your pet’s coat until the skin is visible. Place the tip of the pipette directly against the skin and squeeze gently. Apply approximately half of the pipette at one point and half at the second point. Avoid applying onto the fur and do not rub into the skin as this will reduce the product’s performance.

Apply to an area where the animal cannot lick it off and do not allow pets to lick each other after treatment.

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

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Contraindications

In the absence of available data, the product should not be used on kittens less than 8 weeks old and/or weighing less than 1 kg. The product should not be used on ferrets less than 6 months old.

Do not use on sick (e.g. systemic diseases, fever) or convalescent animals. Do not use in rabbits, as adverse reactions with even mortality could occur. In absence of studies, the use of the product is not recommended in non-target species.

Do not use in known cases of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

Do not overdose.

Cats:

Among the very rare suspected adverse reactions, transient skin reactions on the application site (scaling, 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) or vomiting have also been observed after use.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If licking occurs, a brief period of excessive salivation may be observed due mainly to the nature of the carrier .

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Warnings

Special precautions for use in animals

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.

No data on the effect of bathing/shampooing on the efficacy of the product in cats and ferrets are available. However, based on information available for dogs shampooed as from 2 days after application of the product, it is not recommended to bath animals within 2 days after application of the product.

There may be an attachment of single 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.

The potential toxicity of the product for kittens of less than 8 weeks of age in contact with a treated queen is not documented. Special care should be taken in this case.

Animals should be weighed accurately prior to treatment.

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

Keep pipettes in original packaging until ready to use.

This product can cause mucous membrane, skin and eye irritation. Avoid contents coming into contact with your mouth, skin and eyes.

If skin contact does occur, wash it off quickly and thoroughly with soap and water. In case of accidental eye contact, immediately and thoroughly flush the eyes with clean water.

If the product is accidentally swallowed, or irritation of the eye persists, seek medical advice and show the packaging to the physician.

Do not smoke, drink or eat during application.

People with a known hypersensitivity (allergy) to insecticides or alcohol should avoid contact with the product.

Treated animals should not be handled until the application site is dry; in particular, 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 during the early evening.

Recently treated animals should not be allowed to sleep with owners, especially children.

Wash hands thoroughly after use with soap and water.

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Use during pregnancy, lactation or lay

Cats:

The product can be used during pregnancy.

For treatment during the lactating period, see section 4.5).

Ferrets:

Laboratory studies in cats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of the veterinary medicinal product has not been established in ferrets during pregnancy and lactation.

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Interactions

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

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Overdose

The risk of experiencing adverse effects may increase with overdosing (see section 4.6).

In cats No undesirable effects were observed in target animal safety studies in cats and kittens aged 8 weeks and older and weighing about 1 kg treated once a month at five times the recommended dose for six consecutive months.

Itching may occur following treatment.

Overdose application of the product will cause a sticky appearance of hairs at the treatment spot. However, should this occur, it will disappear within 24 hours post application.

In ferrets In ferrets aged 6 months and older and treated once every 2 weeks for four treatments, at five times the recommended dose, body weight loss was observed in some animals.

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Special warnings

Avoid the contact with the animal’s eyes.

When treating infestations of parasites, all in-contact animals should be treated with an appropriate product at the same time.

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Withdrawal period

Not applicable.

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Incompatibilities

None known.

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Immediate packaging

Thermoformed pipettes

Dark blue Thermoformed single-dose pipettes containing an extractable volume of 0.5 ml comprising a white laminate lidding film (polypropylene/ white colored cyclic-olefin-copolymer/polypropylene / polyethylene / ethylene vinyl alcohol / polyethylene) and a laminate film (polyethylene/ ethylene vinyl alcohol / polyethylene / polypropylene / blue colored cyclic-olefin- copolymer / polypropylene).

The pipettes are packaged in a clear PVC blister closed by heat sealing with a PET/aluminium foil and placed in a carton box or blister card.

Polypropylene pipettes White opaque polypropylene single-dose tubes containing an extractable volume of 0.5 ml packaged in a clear PVC blister closed by heat sealing with aluminium foil and placed in a carton box or blister card.

Blister cards or boxes of 1, 2, 3, 4, 5 or 6 tubes.

Not all pack sizes may be marketed.

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Storage

Do not store above 25°C.

Store in the original package.

Store in a dry place.

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Shelf life

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

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Disposal of unused product

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 should not enter water courses as this may be dangerous for fish or other aquatic organisms.

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Additional information

Vm 52797/5018

9 DATE OF FIRST AUTHORISATION

21 August 2018

10 DATE OF REVISION OF THE TEXT

October 2025

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Registration holder

Pets Choice Limited

Brentwood House

Lower Philips Road

Whitebirk Industrial Estate

Blackburn

Lancashire

BB1 5UD

United Kingdom

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