Sheep.

For the treatment and prevention of infections caused by:

− Adult and immature gastro-intestinal nematodes

∙ Haemonchus contortus (including inhibited larvae)

∙ Ostertagia (Teladorsagia) circumcincta (including inhibited larvae)

∙ Ostertagia (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 veterinary medicinal product has a persistent effect in preventing reinfection:

∙ for 5 weeks by Ostertagia (Teladorsagia) circumcincta and Haemonchus contortus

∙ for 4 weeks by Oesophagostomum columbianum

None.

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

infection based on its epidemiological features, for each flock.

Repeated use for an extended period, particularly when using the same class of substances,

increases the risk of resistance development. Within a flock, maintenance of susceptible

refugia is essential to reduce that risk. Systematically applied interval-based treatment and

treatment of a whole flock should be avoided. Instead, if feasible, only selected

individual animals or subgroups should be treated (targeted selective treatment). This should be

combined with appropriate husbandry and pasture management measures. Guidance for each

specific flock should be sought from the responsible veterinarian.

Multiple resistance of Teladorsagia circumcincta to moxidectin, levamisole, benzimidazole and ivermectin was reported throughout Europe. Moxidectin-resistant Haemonchus contortus and Trichostrongylus colubriformis were also described. Therefore, the use of this veterinary medicinal product should take into account local information about susceptibility of the target parasites, where available. Additionally, use should be based on local history of treatments and recommendations on how to use the veterinary medicinal product under sustainable conditions to limit further selection for resistance to antiparasitic compounds. These precautions are especially important when moxidectin is being used to control resistant strains.

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

. Haemonchus contortus

. Ostertagia circumcincta

. Trichostrongylus colubriformis

. Cooperia curticei

It is recommended to further investigate cases of suspected resistance, using an appropriate

diagnostic method (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. Confirmed resistance should be reported to the marketing authorisation holder or to the competent authorities.

Not applicable.

− Avoid direct contact with skin and eyes.

− Wash hands after use.

− Do not smoke or eat when using this veterinary medicinal product.

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

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 flock 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 veterinary medicinal 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 veterinary medicinal 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 veterinary medicinal 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.

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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.

The safety of moxidectin was established during pregnancy, lactation and in breeding bulls.

The effects of GABA agonists are increased by moxidectin.

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.

Underdosing could result in ineffective use and may favour resistance development.

To ensure administration of a correct dosage, body weight should be determined as accurately as possible. If animals are to be treated collectively, reasonably homogeneous groups should be set up, and all animals of a group should be dosed at the rate corresponding to the heaviest one.

Accuracy of the dosing should be thoroughly checked. Do not mix with other products.

Symptoms generally do not occur 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.

Not applicable

Meat and offal: 14 days.

Milk: 5 days.