Moxamid 400 mg/100 mg spot-on solution for extra-large dogs XL

Homepage Products Veterinary products Moxamid 400 mg/100 mg spot-on solution for extra-large dogs XL

Active substances:

One pipette (4,0 ml) contains:

Active substances:

Imidaclopridum          400 mg

Moxidectinum            100 mg

Excipients:

Butylhydroxytoluen   4,0 mg

Benzylalkohol            3228 mg

PHARMACEUTICAL FORM

Spot-on solution

Clear yellow to brownish solution

CLINICAL PARTICULARS

Target species

Dogs 25-40 kgs

Indications for use, specifying the target species

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

• 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 product can be used as part of a treatment strategy for flea allergy

dermatitis (FAD).

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 on canaries.

Special warnings for each target species

Brief contact of the animal with water on one or two occasions between monthly

treatments is unlikely to significantly reduce the efficacy of the product. However,

frequent shampooing or immersion of the animal in water after treatment may reduce

the efficacy of the product.

The use of the product should be based on the confirmed diagnosis of mixed

infection (or risk of infection, where prevention applies) at the same time

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

Special precautions for use

Special precautions for use in animals

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 product in sick and debilitated animals,

thus the 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 product is not ingested by animals and 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. Do not allow treated

animals to come into contact with untreated animals until the application site is dry.

When the product is applied in 3 to 4 separate spots, specific care

should be taken to prevent the animal licking the application sites.

Moxamid 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.

Imidacloprid is toxic for birds, especially canaries.

 

Avoid contact with skin, eyes or mouth. Do not eat, drink or smoke during application.

Wash hands thoroughly after use.

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

In case of accidental spillage onto skin, wash off immediately with soap and water.

People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin

should administer the product with caution. In very rare cases the product may cause

skin sensitisation or transient skin reactions (for example numbness, irritation or

burning/tingling sensation).

In very rare cases the product may cause respiratory irritation in sensitive individuals.

If the product accidentally gets into eyes, they should be thoroughly flushed with

water.

Adverse reactions

Often (1 - 10 dogs  / 100 dogs):	Cough, tachypnoe, dyspnoe, vomiting, diarrhea, anorexia, lethargy
Uncommon (1 - 10 dogs / 10 000 dogs):	Vomiting
Rare (<1 dog / 10 000 dogs, including sporadic reports):	Local skin reaction (pruritus, alopecia, seborrhea, erythema)2 Neurological signs (ataxia, muscle tremor)3 Behavioral changes (letargy, restlesness, inappetence)
Unknown frequency	Puritus Salivation

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. Therefore, the use of the product is not

recommended in animals intended for breeding or during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction

During treatment with Moxamid no other antiparasitic macrocyclic lactone should be

administered.

Safety of Moxamid when administered on the same day as an adulticide to remove

adult heartworms has not been evaluated.

Amounts to be administered and administration route

Dosage schedule:

The recommended minimum doses are 10 mg/kg body weight imidacloprid
and 2.5 mg/kg body weight moxidectin, equivalent to 0.1 ml/kg body weight.

Body weight [kg]	Size of pippete	Volume [ml]	Imidaclopride [mg/kg b.w.]	Moxidectin [mg/kg b.w.]
25-40 kgs	MOXAMID for large dogs	4,0	10–25	2,5–6,25

 

   Dogs > 40 kgs  - suitable pipettes combination

 

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. The 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 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.

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. 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.

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.

For prevention of heartworm disease, the 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 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. 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 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 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.

Treatment of microfilariae (D. immitis)

Moxamid should be administered monthly for two consecutive months.

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

Moxamid should be administered monthly for six consecutive months.

Reduction of microfilariae (skin worm) (D. repens)

Moxamid 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 product should be administered monthly.

 

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

The 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 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 nonendemic

for heartworm, the 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

Hold the tube with the neck up and tap the neck several times with your finger. Gently break off the tip with a twisting motion.

On a standing dog, spread the fur between the shoulder blades so that the skin is visible. Apply to intact skin. Place the tip of the tube on the skin and apply the contents directly to the skin by repeatedly squeezing the tube

Overdose (symptoms, emergency procedures, antidotes), if necessary

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 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.

Withdrawal period(s)

Not applicable.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiparasitic products, insecticides and repellents,

macrocyclic lactones, milbemycins.

Pharmacodynamic properties

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 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 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 drug 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.

Pharmacokinetic particulars

After topical administration of the 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.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Special precautions for storage

Do not store above 30 °C.

Pack sizes: 1 or 3 single-dose pipettes.

All pack sizes may not be available on the market