Do not use in animals less than 100 kg bodyweight or greater than 500 kg.
Do not inject the product by intravascular route. Intravascular injection may result in ataxia, paralysis, convulsions, collapse and death. To prevent any intravascular injection, carefully follow the administration procedure described in item “Amounts to be administered and administration route.”
Do not use in cases of hypersensitivity to the active substance or any of the excipients.
Special warnings
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 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 and/or herd.
Repeated use for an extended period, particularly when using the same class of substances, increases the risk of resistance development. Within a herd, maintenance of susceptible refugia is essential to reduce that risk. Systematically applied interval- based treatment and treatment of a whole herd 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 herd should be sought from the responsible veterinarian.
Underdosing may result in ineffective use and may favour resistance development; therefore, underestimation of bodyweight and misadministration of the product must be avoided (see section 3.9. Administration routes and dosage).
The use of this product should take into account local information about susceptibility of the target parasites, where available.
It is recommended to further investigate cases of suspected resistance, using an appropriate diagnostic method (e.g. Faecal Egg Count Reduction Test). Confirmed resistance should be reported to the marketing authorisation holder or to the competent authority.
Where the results of tests strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.
In the absence of risk of co-infection, a narrow spectrum product should be used.
Special precautions for use
Special precautions for safe use in the target species:
In order to prevent abscesses, a strict aseptic technique is recommended. The veterinary medicinal product has been formulated specifically for subcutaneous injection in dorsal surface of the ear of cattle and must not be given by any other route of administration or to any other species.
To avoid possible secondary reactions by the death of Hypoderma larvae in the spine or the oesophagus of animals, it is recommended to administer a veterinary medicinal product effective against Hypoderma larvae after the end of fly activity and before the larvae reach their resting sites. Consult your veterinary surgeon on the correct timing of this treatment.
Immunity to nematodes depends on adequate exposure to infection. Although not normally the case, circumstances could occur in which anthelmintic control measures might increase the vulnerability of cattle to re-infection. Animals may be at risk towards the end of their first grazing season, particularly if the season is long, or in the following year if they move onto heavily contaminated pasture. In such instances, further control measures may be necessary.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
This product can cause skin and eye irritation. Avoid direct contact with skin and eyes.
Do not smoke, drink, or eat while handling the product. Wash hands after use.
If accidental skin contact occurs, wash the affected area with soap and water.
If accidental eye exposure occurs, immediately rinse the eyes thoroughly with water If skin or eye irritation persists, seek medical attention.
Take care to avoid self-injection.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Advice to medical practitioners: In case of accidental self-injection: Treat symptomatically.
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
cattle with the veterinary medicinal product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period more than 4 weeks 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, field studies 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 injectable formulation, treated animals should not have access to watercourses during the 10 days after treatment.
Adverse Events
Cattle:
Rare (1 to 10 animals / 10,000 animals treated): | Injection site swelling1,2 Depression and ataxia |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site abscess2 |
1immediate or delayed, may further develop into injection site abscesses, frequency tends to be higher in heavier animals.
2generally disappear without treatment within 14 days after administration, although may persist up to 5 weeks (<5% of cases) or longer (very rare occasions). In case of hypersensitivity reactions, a symptomatic treatment should be applied.
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.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy. Note section Contraindications and section Withdrawal periods.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Reactions at the injection site have to be expected more frequently and severe depending on the injected volume. Systemic clinical signs of overdoses are consistent with the mode of action of moxidectin. These clinical signs are manifested as transient salivation, depression, drowsiness and ataxia 24 to 36 hours post-treatment. The systemic clinical signs usually disappear within 36 to 72 hours without treatment. At doses >3 times the recommended dose divided on both ears, the systemic clinical signs included recumbency, muscle tremor, ruminal tympany and dehydration, which were resolved after treatment with fluids. The systemic clinical signs can last for a few days to ten days. There is no specific antidote.
Interaction with other medicinal products and other forms of interaction
The effects of GABA agonists are increased by moxidectin.