Bob Martin Clear Plus 268 mg/ 241.2 mg Spot-on Solution for Large Dogs

Composition

Each pipette of 2.68 ml contains:

Active substances:

Fipronil 268.00 mg

(S)-methoprene 241.20 mg

Excipients:

Butylhydroxyanisole (E320) 0.536 mg

Butylhydroxytoluene (E321) 0.268 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 and ticks (Dermacentor reticulatus, 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 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.

Peak fipronil plasma concentrations are slowly attained (mean tmax approximately 101 h), and decline slowly (mean terminal half-life approximately 154 h, highest values are observed for males).

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 haircoat 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.

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Target species

Dogs.

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Indications

For the treatment of dogs weighing 20 kg to 40 kg bodyweight

- 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 persist 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 a persistent acaricidal efficacy for up to 4 weeks against ticks.

- Treatment of infestations with biting lice (Trichodectes canis).

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Dosage

One pipette of 2.68 ml per dog weighing over 20 kg and up to 40 kg, corresponding to a minimum recommended dose of 6.7 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.

Method of administration:

Weigh the dog first and ensure that correct product is used for the weight of the dog.

Thermoformed pipettes:

1. Bob Martin Clear Plus must be applied at 2 points, at the base of the back of the dog’s head and between the shoulder blades. If the dog 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 dog’s coat until the skin is visible. Place the tip of the pipette directly against the skin and squeeze gently. Apply approximately half the pipette at one point and half at the second point

Polypropylene pipettes

1. Bob Martin Clear Plus must be applied at 2 points – at the base of the back of the dog’s head and between the shoulder blades. If the dog 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 dog’s coat until the skin is visible. Place the tip of the pipette directly against the skin and squeeze gently. Apply approximately half the pipette at the base of the back of the dog’s head and half between the dog’s shoulder blades. Squeeze the pipette several times to ensure dosing is complete.

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 puppies less than 8 weeks 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. This product is specifically developed for dogs. Do not use in cats and ferrets, as this could lead to overdosing.

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

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Adverse reactions

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.

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

Do not overdose.

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).

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Warnings

Special precautions for use in animals

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.

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.

Other precautions

Fipronil and (S)-methoprene may adversely affect aquatic organisms. Dogs should not be allowed to swim in watercourses for 2 days after application.

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Use during pregnancy, lactation or lay

The product can be used 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

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.

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Special warnings

Bathing/immersion in water within 2 days after application of the product and more frequent bathing than once a week should be avoided, as no study has been performed to investigate how this affects the efficacy of the product. Emollient shampoos can be used prior to treatment, but reduce the duration of protection against fleas to approximately 5 weeks when used weekly after application of the product. Weekly bathing with a 2% chlorhexidine medicated shampoo did not affect efficacy against fleas during a 6 week long study.

There may be an attachment of a few 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.

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 2.68 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 2.68 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 52797/5016

9 DATE OF FIRST AUTHORISATION

21 August 2018

10 DATE OF REVISION OF THE TEXT

October 2025

Gavin Hall Approved: 23 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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