Moximed

Composition
1 ml Moximed, spot on solution for dogs, contains imidacloprid 100 mg and moxidectin 25 mg.

Each dose (pipette) contains:

Excipients: Benzyl alcohol; butylhydroxytoluene and propylene carbonate.

Target species
Dogs.
Indications for use
For dogs with mixed parasitic infections or at risk of developing such an infection:

Treatment and prevention of flea infestation (Ctenocephalides felis)

Treatment of mange lice infestation (Trichodectes canis)

Treatment of ear mites (Otodectes cynotis), sarcoptic mange (caused by Sarcoptes scabiei var. canis), demodicosis (caused by Demodex canis)

Prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis)

Treatment of circulating microfilariae (Dirofilaria immitis)

Prevention of cutaneous heartworm disease (L3 larvae of Dirofilaria repens)

Treatment of cutaneous heartworm disease (adult stage of Dirofilaria repens)

Reduction of circulating microfilariae (Dirofilaria repens)

Prevention of angiostrongylosis (L4 larvae and adults immatures of Angiostrongylus vasorum)

Treatment of infestation with Angiostrongylus vasorum and Crenosoma vulpis

Prevention of spirocerciasis (Spirocerca lupi)

Treatment of gastrointestinal nematode infestations (L4 larvae, immatures and adults of Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala, adults of Toxascaris leonina and Trichuris vulpis)

Can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).

Treatment of infections with Eucoleus (synonym Capillaria) boehmi (adults)

Treatment of eyeworm infections (adults of Thelazia callipaeda)

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 with heartworm disease class 4 as the safety of the veterinary medicinal product has not been evaluated in this group of animals.

Special warnings

Special warnings:

Short-term contact of the animal with water, once or twice between monthly treatments, is unlikely to 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 product.

Frequent, repeated use of an anthelmintic may lead to the development of resistance of parasites to that class of anthelmintic. Therefore, the decision to use this veterinary medicinal product should be based on an individual case assessment and on local epidemiological information on the susceptibility of the target species, in order to limit the possibility of selection of resistant strains.

The use of the veterinary medicinal product should be based on a confirmed diagnosis of mixed infestation (or risk of infestation, in case of prophylactic use) at the same time (see also sections 4 and 8).

Efficacy against adult Dirofilaria repens has not been tested under field conditions.

Special precautions for safe use in the target species:

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

There is limited experience with the use of the veterinary medicinal product in sick and debilitated animals, therefore it should only be used after a benefit-risk assessment in these animals.

Do not administer the product into the mouth, eyes or ears of the animal.

The contents of the pipette or the applied dose should not come into contact with the eyes or mouth of the treated animal and/or other animals. Do not allow recently treated animals to lick each other. When the product has been applied to 3-4 different sites (see “Recommendations on correct administration”), take extra care to ensure that the animal does not lick the application sites.

The veterinary medicinal product contains moxidectin, which belongs to the group of macrocyclic lactones, therefore special care should be taken in Collie or Bobtail (Old English Sheepdog) breeds, similar breeds and their crossbreeds to properly administer the product (as described in “Recommendations on correct administration”), in particular oral ingestion by the treated animal and/or other animals in direct contact with it should be prevented.

The veterinary medicinal product should not be discharged into watercourses as it may affect aquatic organisms: moxidectin is very toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.

The safety of the veterinary medicinal product has only been evaluated in dogs with heartworm class 1 or 2 (laboratory studies) and in a few dogs with heartworm class 3 (field studies), therefore use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit-risk assessment by the veterinarian.

Although experimental overdose studies have shown that the veterinary medicinal product can be safely administered to dogs infested with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs over 6 months of age living in areas endemic for heartworm disease should be tested for adult heartworm infestation before treatment with the product. On veterinary advice, the infected dog should be treated with an adulticide to eliminate 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 to birds, particularly 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 while using the veterinary medicinal product.

Wash hands thoroughly after use.

After application, do not pet or groom animals until the application site is dry.

In case of accidental skin contact, wash immediately with soap and water.

To prevent children from accessing the pipettes, keep the pipette in its original packaging until ready for use, then safely dispose of used pipettes.

Recently treated animals should not sleep in the same bed as their owners, especially children.

People with known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the veterinary medicinal product with caution. In very rare cases, it may cause skin sensitization or transient skin reactions (e.g. numbness, irritation or burning sensations).

In very rare cases, the veterinary medicinal product may cause respiratory tract irritation in susceptible individuals.

In case of accidental contact with eyes, rinse thoroughly with plenty of water.

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

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

Special precautions for environmental protection:

The veterinary medicinal product should not be allowed to enter water courses as it may harm aquatic organisms: moxidectin is very toxic to aquatic organisms.

Pregnancy and lactation:

Use is not recommended during pregnancy and lactation.

Fertility:

Do not use in breeding animals.

Interaction with other veterinary medicinal products and other forms of interaction:

During treatment, other antiparasitic drugs of the macrocyclic lactone group should not be used.

No interactions have been observed between this product and other commonly used veterinary medicinal products or medical and surgical procedures.

The safety of the veterinary medicinal product has not been evaluated when administered on the same day as an adulticide for the elimination of adult heartworms.

Overdose:

A dose of up to 10 times the recommended dose has been tolerated by adult dogs without adverse effects or undesirable clinical signs. A dose of 5 times the minimum recommended dose, applied weekly for 17 weeks, has been evaluated in dogs over 6 months of age and tolerated without adverse effects or undesirable clinical signs. The veterinary medicinal product has been administered to puppies at 5 times the recommended dose every 2 weeks for 6 treatments and no serious safety concerns have been reported. Transient mydriasis, salivation, vomiting and transient tachypnea have been observed.

Following accidental oral ingestion or overdose, neurological signs (mostly transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, decreased pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may occur in very rare cases. Collie dogs sensitive to ivermectin have tolerated up to 5 times the recommended dose repeated at monthly intervals without adverse effects, but the safety of weekly administration has not been evaluated in these dogs. Severe neurological signs have been observed when 40% of the unit dose was administered orally. Oral administration of 10% of the recommended dose has not produced any adverse effects. Dogs infested with adult heartworms have tolerated without adverse effects a dose of up to 5 times the recommended dose, every 2 weeks for 3 treatments. In case of accidental oral ingestion, symptomatic treatment should be administered. There is no specific antidote. The use of activated charcoal may be beneficial.

Major incompatibilities:

None known.

Adverse events

The use of this veterinary medicinal product may cause transient pruritus in dogs. Vomiting may rarely occur. Transient local skin sensitivity reactions, such as pruritus, hair loss, greasy fur, erythema at the application site, have been reported in very rare cases. These symptoms disappear without treatment.

In very rare cases, neurological signs (mostly transient), such as ataxia (lack of coordination) and muscle tremors may be observed (see section “Overdose”).

The veterinary medicinal product has a bitter taste. Occasionally, if the animal licks the application site immediately after treatment, hypersalivation may occur. This is not a sign of intoxication and disappears within a few minutes without treatment. Correct application of the veterinary medicinal product reduces the possibility of licking the application site.

In very rare cases, the veterinary medicinal product may cause a sensation at the application site leading to transient behavioural changes such as lethargy, agitation and inappetence.

A field study has shown that dogs with heartworm disease with microfilariae are at risk of developing severe respiratory signs (coughing, tachypnea, dyspnea) which may require immediate veterinary treatment. In the study, these reactions were common (seen in 2 out of 106 dogs treated). Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs.

Dosage for each species, routes of administration and methods of administration

For external use only.

Dosage regimen:

The minimum recommended dose is 10 mg imidacloprid/kg body weight and 2.5 mg moxidectin/kg body weight, equivalent to 0.1 ml Moximed/kg body weight.

The treatment regimen should be based on the individual veterinary diagnosis and the local epizootic situation.

Treatment and prevention of flea infestation (Ctenocephalides felis)

A single treatment prevents further flea infestation for 4 weeks. Pupae in the environment may hatch for 6 weeks or more after initiation of treatment, depending on climatic conditions. Therefore, treatment with Moximed should be carried out concurrently with environmental disinfestations to interrupt the life cycle of fleas present in the environment. This may lead to a more rapid reduction of the flea population in the household. The veterinary medicinal product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.

Treatment of infestation with mange lice (Trichodectes canis)

A single dose should be administered. A follow-up veterinary examination is recommended 30 days after treatment, as some animals may require repeat treatment.

Treatment of ear mites (Otodectes cynotis)

A single dose should be administered. Loose debris should be gently removed from the external ear canal with each treatment. A follow-up veterinary examination is recommended 30 days after treatment, as some animals may require repeat treatment. Do not apply directly into the ear canal.

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

A single dose should be administered, 2 times, 4 weeks apart.

Treatment of demodicosis (caused by Demodex canis)

A single dose every 4 weeks for 2 to 4 months is effective against Demodex canis and results in significant improvement of clinical signs, particularly in mild to moderate cases. However, severe cases may require longer and more frequent treatment. To obtain the best results in severe cases, on the recommendation of the veterinarian, Moximed can be applied once a week and for a longer period of time. In all cases it is essential that the treatment is continued until the skin scraping is negative at least 2 times consecutively, the scraping being carried out at an interval of one month.

Treatment should be discontinued in dogs in which no improvement or reduction in the number of parasites has been observed after 2 months of treatment. Alternative treatment should be administered. Seek the advice of the veterinarian. Since demodicosis is a disease caused by various factors, it is also recommended to treat all associated diseases appropriately, when possible.

Prevention of heartworm disease (D. immitis) and skin worm disease (D. repens)

For the prevention of heartworm disease, the veterinary medicinal product should be applied at regular monthly intervals during the time of year when mosquitoes (intermediate hosts that carry and transmit D. immitis larvae) are present. The veterinary medicinal product can be administered throughout the year. The first dose can be administered after the first possible exposure to mosquitoes, but not more than one month after this exposure. Treatment should be continued at regular monthly intervals until 1 month after the last exposure to mosquitoes. In order to establish a treatment routine, it is recommended to administer the treatment on the same day or on the same date of the month. When replacing another heartworm prevention product in a heartworm prevention programme, the first treatment with Moximed should be administered within 1 month of the last dose of the previously administered product. In non-endemic areas there should be no risk of heartworm infection in dogs. Therefore, they can be treated without special precautions.

For the prevention of cutaneous heartworm disease, the veterinary medicinal product should be applied at regular monthly intervals during the period of the year when mosquitoes (intermediate hosts that carry and transmit D. repens larvae) are present. The veterinary medicinal product can be administered throughout the year or at least 1 month before the first possible exposure to mosquitoes. Treatment should be continued at regular monthly intervals until 1 month after the last exposure to mosquitoes. In order to establish a treatment routine, it is recommended to administer the treatment on the same day or on the same date of the month.

Treatment of microfilariae (D. immitis)

The veterinary medicinal product should be administered monthly for 2 consecutive months.

Treatment of cutaneous heartworm disease (adult stage of Dirofilaria repens)

The veterinary medicinal product should be administered monthly for 6 consecutive months.

Treatment and prevention of Angiostrongylus vasorum infestation

A single dose should be administered. A follow-up veterinary examination is recommended 30 days after treatment, as some animals may require 

repeated treatment. In endemic areas, regular monthly administration will prevent angiostrongylosis and infestation with Angiostrongylus vasorum.

Treatment of Crenosoma vulpis infestation

A single dose should be administered.

Prevention of spirocerciasis (Spirocerca lupi)

The veterinary medicinal product should be administered monthly.

Treatment of roundworm, hookworm and whipworm infestations (Toxocara canis, Ancylostoma caninum, Uncinaria stenocephala, adults of Toxascaris leonina and Trichuris vulpis)

In areas endemic for heartworm disease, monthly treatment can significantly reduce the risk of reinfestation with roundworm, hookworm and whipworm. In non-endemic areas, 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 infestations caused by Uncinaria stenocephala.

Treatment of infections with Eucoleus (synonym Capillaria) boehmi (adults)

The veterinary medicinal product should be administered monthly for 2 consecutive months. It is recommended to prevent self-coprophagy between the 2 treatments to prevent possible reinfestation.

Treatment of eyeworm infections (adult Thelazia callipaeda)

A single dose should be administered.

Recommendations for correct administration

Hold the pipette upright, gently tap the narrow end of the pipette so that all its contents remain at the bottom. Break off the pre-cut tip of the pipette along the marked line.

For dogs up to 25 kg: With the dog in an upright position, make a path between the shoulder blades so that the skin is visible. Apply only to healthy skin, if possible. Place the tip of the pipette on the skin and by repeated pressing empty its contents.

For dogs over 25 kg: For easy application the dog should be in an upright position. The entire contents of the pipette should be applied evenly in 3-4 points along the spine, from the shoulders to the base of the tail. At each point, remove the fur so that the skin is visible. Apply only to healthy skin. Place the tip of the pipette on the skin and squeeze gently to empty some of its contents directly onto the skin. Be careful not to apply too much of the product at one point to prevent the veterinary medicinal product from running down the sides of the animal.

Withdrawal periods

Not applicable.

Special precautions for storage

Keep out of the sight and reach of children.

Store in the original package.

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

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

Shelf life after first opening the immediate packaging: use immediately.

Special precautions for disposal

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

Use the return systems for unused veterinary medicinal products or waste materials derived from such veterinary medicinal products, in accordance with local requirements and national collection systems. These measures should help to protect the environment.

Ask your veterinarian or pharmacist for information on how to dispose of medicines no longer required.