VetUK Imidacloprid Flea Treatment for Dogs 10 - 25 Kg. 250 mg Spot-on Solution

Composition

Each 2.5 ml pipette contains:

Active substance:

Imidacloprid 250 mg

Excipients:

Clear yellow to slightly brownish solution.

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Pharmacological properties

4.1 ATCvet code: QP53AX17

4.2 Pharmacodynamics

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to a group of chloronicotinyl compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine.

The substance has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS). The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptor sites and the postulated poor penetration through the blood/brain barrier in mammals, it has virtually no effect on the mammalian CNS. The minimal pharmacological activity in mammals is supported by safety studies involving systemic administration of sub-lethal doses to rabbits, mice and rats.

In further studies, in addition to the adulticide flea efficacy of imidacloprid, a larvicidal flea efficacy in the surroundings of the treated pet has been demonstrated. Larval stages in the pet’s surroundings are killed following contact with a treated animal.

4.3 Pharmacokinetics

The product is indicated for cutaneous administration. Following topical application in dogs, the solution is quickly distributed over the animal. Acute dermal studies in the rat and target animal overdose and serum kinetic studies have established that systemic absorption is very low, transient and not relevant for the clinical efficacy. This has been further demonstrated by a study in which fleas were not killed after having fed on previously treated animals once the animal’s skin and fur had been cleaned of all active material.

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Target species

Dogs.

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Indications

For the prevention and treatment of flea infestations and for the treatment of biting lice (Trichodectes canis) on dogs from 10 kg to less than 25 kg body weight. Fleas on dogs are killed within one day following treatment. One treatment prevents further flea infestation for four weeks.

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Dosage

This product is for external use only and should not be administered orally. Animals should be weighed accurately prior to treatment.

Dosage and Treatment Schedule

Re-infestation from emergence of new fleas in the environment may continue to occur for six weeks or longer after treatment is initiated. More than one treatment may therefore be required, depending on the level of fleas in the environment. To aid in environmental challenge, the additional use of a suitable environmental treatment against adult fleas and their developing stages is recommended.

The product remains effective if the animal becomes wet, for example after swimming or exposure to heavy rain.

However, in cases of frequent swimming or bathing re-treatment may become necessary, depending on the presence of fleas in the environment. In these cases do not re-treat more frequently than once weekly.

In cases of biting louse infestation, a further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Method of administration:

Apply only to undamaged skin. Hold the pipette upright. Tap the narrow part of the pipette to ensure the contents remain within the main body of the pipette. Snap back the tip. With the dog in the standing position, part the coat between the shoulder blades until the skin is visible.

Place the tip of the pipette on the skin and squeeze the pipette several times to empty its contents completely and directly onto the skin in one spot.

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

Correct application will minimise the opportunity for the animal to lick the product.

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Contraindications

Do not treat unweaned puppies of less than 8 weeks of age.

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

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Adverse reactions

Dogs:

Very rare (<1 animal / 10 000 animals treated, including isolated reports):

Agitation

Hypersalivation1

Disorientation, Neurological signs (e.g. Depression, Incoordination, Tremor)

Application site reaction (e.g. Hair loss, Itching, Reddening of the skin, Skin lesion)

1 May occur if the dog licks the application site immediately after treatment due to the bitter taste. This is not a sign of intoxication and disappears within some minutes without treatment.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

If signs of disease persist or appear, consult a veterinary surgeon.

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

This product can cause mucous membrane, skin and eye irritation.

Therefore, contact of the product with mouth, skin and eyes should be avoided. This product contains benzyl alcohol and may cause skin sensitisation or transient skin reactions in rare cases (for example, irritation, tingling).

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

Do not smoke, drink or eat during application.

If contact with the skin occurs, wash hands with soap and water.

If the product gets into eyes, the eyes should be thoroughly rinsed with clean water. If skin or eye irritation persists, or the product is accidentally swallowed, seek medical advice.

Do not stroke, groom or 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.

Dispose of used pipettes immediately.

Wash hands after use.

Special precautions for the protection of the environment:

Imidacloprid is toxic to aquatic organisms. To avoid adverse effects on aquatic organisms, treated dogs should not be allowed to enter surface water for 48 hours after treatment.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

No primary embryotoxic, teratogenic or reproductive toxic effects have been observed during the studies with imidacloprid on rats and rabbits. Studies on pregnant and lactating bitches together with their offspring are limited.

Evidence so far suggests that no adverse effects are to be expected in these animals. Consult your veterinary surgeon before using in pregnant or nursing animals.

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Interactions

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

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Overdose

No adverse clinical signs were produced by either individual doses of up to 200 mg/kg body weight (five to eight times the therapeutic dose), daily treatments at 100 mg/kg body weight for five consecutive days or weekly treatments at five times the maximum dose rate for eight consecutive weeks.

In rare cases of overdose or licking of treated fur, nervous system disorders (such as twitching, tremors, ataxia, mydriasis, miosis, lethargy) can occur.

Poisoning following inadvertent oral uptake in animals is unlikely. In this event, treatment should be symptomatic under veterinary medical attention. There is no known specific antidote but administration of activated charcoal may be beneficial.

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Special warnings

This product is for topical use and should not be administered orally.

Care should be taken to avoid the contents of the pipette coming into contact with the eyes or mouth of the recipient animal.

Do not allow recently treated animals to groom each other.

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Withdrawal period

Not applicable.

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Incompatibilities

None known.

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Immediate packaging

A white pipette composed of a heat-formed shell of composed of a polypropylene/cyclic olefin copolymer/polypropylene layer and a polyethylene/ethylene vinyl alcohol/polyethylene layer.

Box with 1, 2, 3, 4, 6 pipettes in individual foil sachets.

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

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Disposal of unused product

Medicines should not be disposed of via wastewater.

The veterinary medicinal product should not enter water courses as Imidacloprid may be dangerous for fish and other aquatic organisms.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

Do not contaminate ponds, waterways or ditches with the product or empty containers.

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Additional information

Vm 39787/5032

8 DATE OF FIRST AUTHORISATION

02 July 2019

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

December 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product not subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved: 01 December 2025

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Registration holder

EU Pharmaceuticals Ltd

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