Moxodex 1 mg/ml Oral Solution for Sheep

Composition

Each ml contains:

Active substance:

Moxidectin 1.00 mg

Excipients:

Clear colourless to yellowish solution.

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Pharmacological properties

4.1 ATCvet code: QP 54 AB 02

4.2 Pharmacodynamics

Moxidectin is a parasiticide active against a wide range of economically important internal and external parasites and is a second generation macrocyclic lactone of the milbemycin family. Its principal mode of action is interfering with neuromuscular transmission of the GABA (gamma amino butyric acid)-gated or glutamate-gated chloride channels. Moxidectin stimulates the release of GABA and increases its binding to the postsynaptic receptors. The net effect is to open the chloride channels on the postsynaptic junction to allow the inflow of chloride ions and induce an irreversible resting state. This results in flaccid paralysis and eventual death of parasites exposed to the drug.

4.3 Pharmacokinetics

Moxidectin is absorbed after oral administration with peak plasma levels around 13 hours after dosing and is eliminated slowly with a t ½ of approximately 7 days. The drug is distributed throughout the body tissues but due to its lipophilicity the target tissue is fat where concentrations are 10 to 20 times higher than those found in other tissues. Moxidectin undergoes limited biotransformation by hydroxylation. The only significant route of excretion is the faeces.

Environmental properties

Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance. In particular, in acute and chronic toxicity studies with algae, crustaceans and fish, moxidectin showed toxicity to these organisms, yielding the following endpoints:

EC50: the concentration which results in 50% of the test species individuals being adversely affected, i.e. both mortality and sub-lethal effects.

NOEC: the concentration in the study at which no effects are observed.

This implies that when allowing moxidectin to enter water bodies, this may have a severe and lasting impact on aquatic life. To mitigate this risk, all precautions for use and disposal must be adhered to.

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Target species

Sheep.

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Indications

For the treatment and prevention of mixed infections of sheep with parasites sensitive to moxidectin

Adult and/or immature gastro-intestinal nematodes:

- Haemonchus contortus (including inhibited larvae)

- Teladorsagia circumcincta (including inhibited larvae)

- Teladorsagia trifurcata

- Trichostrongylus axei (including inhibited larvae)

- Trichostrongylus colubriformis

- Trichostrongylus vitrinus

- Nematodirus battus

- Nematodirus spathiger

- Nematodirus filicolis (adults only)

- Strongyloides papillosus (larval stages only)

- Cooperia curticei (adults only)

- Cooperia oncophora

- Oesophagostomum columbianum

- Oesophagostomum venulosum (adults only)

- Chabertia ovina

- Trichuris ovis (adults only)

Adult respiratory tract nematode:

- Dictyocaulus filaria

The product has a persistent effect in preventing reinfection:

for 5 weeks by Teladorsagia circumcincta and Haemonchus contortus

for 4 weeks by Oesophagostomum columbianum

Clinical trials, after experimental and natural infection, have shown that the product is effective against certain benzimidazole resistant strains of:

Haemonchus contortus

Teladorsagia circumcincta

Trichostrongylus colubriformis

Cooperia curticei

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Dosage

Oral use.

Should be given as a single oral drench of 1 ml/5 kg live bodyweight, equivalent to 200 μg moxidectin/kg live bodyweight, using any standard drenching equipment.

To ensure a correct dosage, body weight should be determined as accurately as possible; accuracy of the dosing equipment should be checked.

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Contraindications

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

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Adverse reactions

None known.

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:

None known.

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

- Avoid direct contact with skin and eyes.

- Personal protective equipment consisting of impermeable rubber gloves should be worn when handling the veterinary medicinal product.

- In the event of eye contact, flush the eye with copious amounts of clean water and seek medical advice immediately and show the package leaflet or the label to the physician.

- Wash hands or any exposed area after use.

- Do not smoke, eat or drink when handling this product.

Special precautions for the protection of the environment:

Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance; therefore, exposure of the environment to moxidectin must be limited to the extent possible. Treatments should be administered only when necessary and should be based on faecal egg counts or evaluation of the risk of infestation at the animal and/or herd level.

Like other macrocyclic lactones, moxidectin has the potential to adversely affect non-target organisms:

• Faeces containing moxidectin excreted onto pasture by treated animals may temporarily reduce the abundance of dung feeding organisms. Following treatment of sheep with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of 4 days and may decrease dung fly abundance during that period. It has been established in laboratory tests that moxidectin may temporarily affect dung beetle reproduction; however, studies with incurred residues indicate no long-term effects. Nevertheless, in case of repeated treatments with moxidectin (as with products of the same anthelmintic class) it is advisable not to treat animals every time on the same pasture to allow dung fauna populations to recover.

• Moxidectin is inherently toxic to aquatic organisms including fish. The product should be used only according to the label instructions. Based on the excretion profile of moxidectin when administered as the oral formulation to sheep, treated animals should not have access to watercourses during the first 3 days 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, lactation and fertility:

Moxidectin has been shown to be safe for use in pregnant, lactating and breeding animals. Can be used during pregnancy and lactation and in breeding animals.

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Interactions

The effects of GABA agonists are increased by moxidectin.

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Overdose

Symptoms have not been observed at less than 5 times the recommended dose. They are manifested as transient salivation, depression, drowsiness and ataxia 8 to 12 hours post-treatment. Treatment is not generally necessary, and recovery is generally complete within 24 to 48 hours. There is no specific antidote.

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Special warnings

Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:

- Too frequent and repeated use of anthelmintics from the same class, over an extended period of time

- Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any).

- Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

Resistance to macrocyclic lactones has been reported in Teladorsagia in sheep in a number of countries. In 2018, throughout Europe, multiple resistance of Teladorsagia circumcincta to moxidectin, levamisole, benzimidazole and ivermectin were reported. Moxidectin resistant Haemonchus contortus and Trichostrongylus colubriformis were also described. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of parasites, local history of treatments and recommendations on how to use the product under sustainable conditions to limit further selection for resistance to antiparasitic compounds.

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Withdrawal period

Meat and offal: 14 days.

Milk: 5 days.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

White HDPE flexi containers containing 1 L, 2.5 L, 3 L and 5 L of product. The containers are closed with an aluminium foil seal and polypropylene tamper-evident caps.

The product is marketed in a cardboard outer carton.

Not all pack sizes may be marketed.

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Storage

Keep the container in the outer carton in order to protect from light. Do not store above 25 °C.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 18 months.

Shelf life after first opening the immediate packaging: 6 months.

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Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

The veterinary medicinal product should not enter water courses as 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 08749/4089

8 DATE OF FIRST AUTHORISATION

24 July 2018

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

April 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).

Gavin Hall Approved: 28 April 2026

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Registration holder

Chanelle Pharmaceuticals Manufacturing Ltd

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