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

Composition

Each 0.4 ml pipette contains:

Active substances:

Imidacloprid 40.0 mg

Moxidectin 10.0 mg

Excipients:

Clear yellow to brownish solution.

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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 inmammals.

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 of Dirofilaria immitis (L1, L3, L4) and Dirofilaria repens (L1, L3). 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.

The veterinary medicinal product has a persistent action and protects dogs for 4 weeks after a single application against re-infection with the following parasites: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus vasorum.

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 throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat. It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.

The T ½ in dogs is about 28.4 days.

Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in dogs.

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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

• The veterinary medicinal product is only indicated when use against fleas and one or more of the other target parasites is indicated at the same time.

• 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), demodicosis (caused by Demodex 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 Eucoleus (syn. Capillaria) boehmi (adults),

• the treatment of the eye worm Thelazia callipaeda (adults),

• 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.

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

Dosage schedule:

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

For treatment or prevention of infestations with the parasites indicated for use of this veterinary medicinal product, the need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle.

Dogs weighing over 4 kg bodyweight: use the appropriate Prinovox spot-on solution for dogs

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 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 should be administered twice 4 weeks apart.

Treatment of demodicosis (caused by Demodex canis)

The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases. Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, the veterinary medicinal product can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.

As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.

Prevention of heartworm disease (D. immitis)

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, 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 larvae) are present. The veterinary medicinal product may be administered throughout the year. The first dose may be given after first possible exposure to mosquitoes, but not more than one month after this exposure. 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.

Prevention of cutaneous dirofilariosis (skinworm) (D. repens)

For prevention of 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. 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.

Treatment of microfilariae (D. immitis)

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

Treatment of cutaneous dirofilariosis (skinworm) (adult stages of Dirofilaria repens)

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

Reduction of microfilariae (skinworm) ( D. repens)

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

Treatment and prevention of Angiostrongylus vasorum

A single dose 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 monthly applications will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.

Treatment of Crenosoma vulpis

A single dose should be administered.

Prevention of spirocercosis (Spirocerca lupi)

The veterinary medicinal product should be administered monthly.

Treatment of Eucoleus (syn. Capillaria) boehmi (adults)

The veterinary medicinal product should be administered monthly for two consecutive months. It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.

Treatment of the eye worm Thelazia callipaeda (adults)

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

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.

Remove one pipette from the package. Then hold the pipette in an upright position, and twist and pull off the cap. Reverse the cap and use it to twist and remove the seal from the pipette, as shown.

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.

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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 product has not been evaluated in this animal group.

Do not use in cats., Instead, the corresponding “Prinovox for cats” product (0.4 or 0.8 ml), which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used for cats.

Do not use in ferrets. Only “Prinovox for small cats and ferrets” (0.4 ml) must be used for ferrets.

Do not use on canaries.

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Adverse reactions

Dogs:

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

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

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, Behavioural disorder (e.g. Agitation, Inappetence, Lethargy)³, Hypersalivation⁴, Neurological signs (e.g. Ataxia, Muscle tremor)⁵, Pruritus⁶

1 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 Disappear without further treatment.

3 Transiently noted and related to sensation at application site.

4 This is not a sign of intoxication and disappears within minutes without treatment.

Correct application will minimise licking of the application site.

5 Most are transient.

6 Transient

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 animals weighing less than 1 kg should be based on a benefit-risk 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 benefit-risk assessment for these animals.

Do not apply in the mouth, in the eyes or the ears of the animal.

Care should be taken that the veterinary medicinal product is not ingested by animals and does not come into contact with the eyes or mouth of the recipient and/or other animals.

Consider carefully the correct application method described in section 3.9, especially that the veterinary medicinal product should be applied at the base of the skull in order to minimise the risk for the animal to lick the veterinary medicinal product.

Do not allow recently treated animals to groom each other. Do not allow treated animals to come into contact with untreated animals until the application site is dry. When the veterinary medicinal product is applied in 3 to 4 separate spots (see section 3.9), 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 Collie or Old English Sheep dogs and related breeds or crossbreeds, to correctly administer the veterinary medicinal product as described under section 3.9; 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

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.

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

Ingestion of the veterinary medicinal product is harmful. In order to prevent children getting access to pipettes, keep the pipette in the original packaging until ready for use and dispose of used pipettes immediately.

After application, treated animals should not be handled, especially children, until the application site is dry. This can be ensured by treating animals in the evening. Do not allow recently treated animals to sleep with owners, especially children. Avoid contact with skin, eyes or mouth.

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 the label to the physician.

Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

Special precautions for the protection of the environment:

Moxidectin fulfils the criteria for a persistent, bioaccumulative and toxic substance; therefore, exposure of the environment to moxidectin should be minimised as much as possible. 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.

See also section 5.5.

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

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

Pregnancy and lactation:

The use is not recommended during pregnancy and lactation.

Fertility:

Do not use in breeding animals.

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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 effects 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 effects 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 effects, 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 effects.

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.

The possibility that other animals in the same household can be a source of re-infection with fleas, mites, gastrointestinal nematodes, heartworm and/or lungworm should be considered, and these should be treated as necessary with an appropriate product.

Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the veterinary medicinal product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each individual animal.

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

None known.

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Immediate packaging

White polypropylene pipette for single use closed with white polypropylene screw cap. Pipettes are packed in polyvinyl chloride and aluminium foil blisters. Each pipette contains 0.4 ml of solution.

Pack sizes:

Cardboard box containing blister packs with 1, 2, 3, 4, 6 or 21 pipettes.

Not all pack sizes may be marketed.

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Storage

Do not store above 25 °C.

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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 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 00879/5091

8 DATE OF FIRST AUTHORISATION

17 December 2014

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

December 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.

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Registration holder

Elanco Europe Ltd

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