Moxiclear 40 mg + 10 mg Spot-on Solution for Small Dogs

Composition

Each 0.4 ml pipette contains:

Active substances:

Imidacloprid 40 mg

Moxidectin 10 mg

Excipients:

A clear colourless to yellow solution with light opalescence.

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Pharmacological properties

4.1 ATCvet code:

QP54AB52.

4.2 Pharmacodynamics

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the veterinary medicinal product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post- synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages (L3, L4) of Dirofilaria immitis. It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.

4.3 Pharmacokinetics

After topical administration of the veterinary medicinal product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 4 to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed systemically and is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

Environmental properties

See sections 3.5 and 5.5.

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Target species

Dogs (≤ 4 kg)

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Indications

For dogs suffering from, or at risk from, mixed parasitic infections:

• For the treatment and prevention of flea infestation (Ctenocephalides felis),

• the treatment of biting lice (Trichodectes canis),

• the treatment of ear mite infestation (Otodectes cynotis), sarcoptic mange (caused by Sarcoptes scabiei var. canis),

• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),

• the treatment of circulating microfilariae (Dirofilaria immitis),

• the treatment of cutaneous dirofilariosis (adult stages of Dirofilaria repens)

• the prevention of cutaneous dirofilariosis (L3 larvae of Dirofilaria repens),

• the reduction of circulating microfilariae (Dirofilaria repens),

• the prevention of angiostrongylosis (L4 larvae and immature adults of Angiostrongylus vasorum),

• the treatment of Angiostrongylus vasorum and Crenosoma vulpis,

• the prevention of spirocercosis (Spirocerca lupi),

• the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala, adults of Toxascaris leonina and Trichuris vulpis).

The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

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Dosage

Spot-on use.

Dosage schedule for dogs:

The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 2.5 mg/kg bodyweight moxidectin, equivalent to 0.1 ml/kg bodyweight the veterinary medicinal product for dogs.

To ensure a correct dosage, body weight should be determined as accurately as possible.

The treatment schedule should be based on individual veterinary diagnosis and on the local epidemiological situation.

Flea treatment and prevention (Ctenocephalides felis)

One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine the veterinary medicinal product treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The veterinary medicinal product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.

Treatment of biting lice (Trichodectes canis)

A single dose of the veterinary medicinal product should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

Treatment of ear mite infestation (Otodectes cynotis)

A single dose of the veterinary medicinal product should be administered. Loose debris should be gently removed from the external ear canal at each treatment. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.

Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis)

A single dose of the veterinary medicinal product should be administered twice 4 weeks apart.

Prevention of heartworm disease (D. immitis) and cutaneous dirofilariosis (D. repens)

Dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with the veterinary medicinal product, the advice provided in section 3.5 should be considered.

For prevention of heartworm disease and cutaneous dirofilariosis, the veterinary medicinal product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis and D. repens larvae) are present. The veterinary medicinal product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with the veterinary medicinal product must be given within 1 month of the last dose of the former medication.

In non-endemic areas there should be no risk of dogs having heartworm. Therefore, they can be treated without special precautions.

Treatment of microfilariae (D. immitis)

The veterinary medicinal product should be administered monthly for two consecutive months.

Treatment of cutaneous dirofilariosis (skin worm) (adult stages of Dirofilaria repens)

The veterinary medicinal product should be administered monthly for six consecutive months.

Reduction of microfilariae (D. repens)

The veterinary medicinal product should be administered monthly for four consecutive months. Efficacy against adult worms has not been shown. Adult worms may continue to produce microfilariae.

Treatment and prevention of Angiostrongylus vasorum

A single dose of the veterinary medicinal product should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.

In endemic areas regular 4 weekly application will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.

Treatment of Crenosoma vulpis

A single dose of the veterinary medicinal product should be administered.

Prevention of Spirocerca lupi:

The veterinary medicinal product should be administered monthly.

Roundworm, hookworm and whipworm treatment (Toxocara canis, Ancylostoma caninum, Uncinaria stenocephala, Toxascaris leonina and Trichuris vulpis).

In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non- endemic for heartworm, the veterinary medicinal product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.

Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.

Method of administration

For external use only. Do not remove the pipette from the sachet until ready to use. Remove the pipette from the outer sachet using scissors or fold along diagonal line to expose nick; tear back at nick.

Hold the pipette upright. Tap the narrow part of the pipette to ensure the contents remain within the main body of the pipette. Twist or snap back the tip.

For dogs up to 25 kg:

With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin.

For dogs of more than 25 kg:

For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some of the veterinary medicinal product to run down the animal’s side.

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Contraindications

Do not use in puppies under 7 weeks of age.

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

Do not use in dogs classified as Class 4 for heartworm disease as the safety of the veterinary medicinal product has not been evaluated in this animal group.

For cats, the corresponding veterinary medicinal product for cats, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.

For ferrets: Do not use the presentation for dogs. Only the corresponding veterinary medicinal product for small cats and ferrets (0.4 ml) must be used.

Do not use on canaries.

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Adverse reactions

Target species: Dogs.

Common (1 to 10 animals / 100 animals treated): Cough1, Tachypnoea1, Dyspnoea1, Vomiting1, Diarrhoea1, Inappetence1, Lethargy1

Rare (1 to 10 animals / 10,000 animals treated): Vomiting2, Hypersensitivity

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Application site greasy fur2, Application site hair loss2, Application site itching2, Application site reddening2, Pruritus3, Neurological signs (e.g. ataxia, muscle tremor)4, Hypersalivation5, Behavioural disorders (e.g. agitation)6, Lethargy6, Inappetence6

1 These signs are common in heartworm positive dogs with microfilaraemia, and there is a risk of gastrointestinal signs and severe respiratory signs that may require prompt veterinary treatment.

2 Disappears without further treatment.

3 Transient.

4 If the animal licks the application site after treatment. Mostly transient.

5 If the animal licks the application site immediately after treatment. Not a sign of intoxication; disappears within minutes.

6 Caused by a sensation at the application site. Correct application will minimise licking of the application sites.

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:

The treatment of dogs weighing less than 1 kg should be based on a risk-benefit assessment.

There is limited experience on the use of the veterinary medicinal product in sick and debilitated animals, thus the veterinary medicinal product should only be used based on a risk-benefit assessment for these animals.

Care should be taken that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals. Do not allow recently treated animals to groom each other. When the veterinary medicinal product is applied in 3 to 4 separate spots (see section 4.9), specific care should be taken to prevent the animal licking the application sites.

This veterinary medicinal product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the veterinary medicinal product as described under section 4.9; in particular, oral uptake by the recipient and/or other animals in close contact should be prevented.

The safety of the veterinary medicinal product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore, the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit risk assessment by the treating veterinarian.

Although experimental overdosage studies have shown that the veterinary medicinal product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the veterinary medicinal product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of the veterinary medicinal product has not been evaluated when administered on the same day as an adulticide.

Imidacloprid is toxic for birds, especially canaries.

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

Avoid contact with skin, eyes or mouth.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

In case of accidental spillage onto skin, wash off immediately with soap and water. If the veterinary medicinal product accidentally gets into eyes, they should be thoroughly flushed with water.

If skin or eye symptoms persist, or the veterinary medicinal product is accidentally swallowed, seek medical advice immediately and show the package leaflet or label to the physician.

Do not ingest. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the veterinary medicinal product with caution.

In very rare cases the veterinary medicinal product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation). In very rare cases the veterinary medicinal product may cause respiratory irritation in sensitive individuals.

In order to prevent children from getting access to pipettes, keep the pipette in the original packaging until ready for use and dispose of used pipettes immediately. After application do not stroke or groom animals until the application site is dry. 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.

Special precautions for the protection of the environment:

The veterinary medicinal product should not enter water courses as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.

Other precautions:

The solvent in the veterinary medicinal product may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

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:

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

Use only accordingly to the benefit-risk assessment by the responsible veterinarian.

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Interactions

During treatment with the veterinary medicinal product no other antiparasitic macrocyclic lactone should be administered. No interactions between the veterinary medicinal product and routinely used veterinary medicinal products or medical or surgical procedures have been observed.

Safety of the veterinary medicinal product when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.

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Overdose

Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse events or undesirable clinical signs.

Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse events or undesirable clinical signs.

The veterinary medicinal product was administered to puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.

After accidental oral ingestion or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may occur in very rare cases.

Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse events, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40 % of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10 % of the recommended dose produced no adverse effects.

Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse events.

In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial.

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Special warnings

Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the veterinary medicinal product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the veterinary medicinal product.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Therefore, the use of this veterinary medicinal product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.

The use of the veterinary medicinal product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time (see also sections 3.2 and 3.9).

The veterinary medicinal product has not been shown to have an adulticidal effect against D. repens. Efficacy against adult Dirofilaria repens has not been tested under field conditions.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

0.4 ml clear pipette with a film composed of 3 layers: a polypropylene/COC, solvent free lacquer laminate and a copolymer of polyethylene/EVOH/polyethylene. The pipettes are sealed within a child resistant 4-ply foil sachet composed of LDPE/nylon/aluminium foil/polyester film and presented in an outer box.

Package Sizes:

Pipettes are presented in cardboard boxes containing 1, 2, 3, 4, 6, 9, 12, 21 or 42 pipettes. Each pipette is individually sealed in a foil sachet.

Not all pack sizes may be marketed.

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Storage

Do not store above 25 °C.

Store in the original package in order to protect from light and moisture.

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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

Medicines should not be disposed of via wastewater.

The veterinary medicinal product should not enter water courses as imidacloprid and moxidectin 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.

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Additional information

Vm 02000/4437

8 DATE OF FIRST AUTHORISATION

24 May 2018

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

March 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

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

Approved: 19 June 2025

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Registration holder

Norbrook Laboratories Limited

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