Do not use in animals less than 100 kg bodyweight or greater than 500 kg.
Do not inject the veterinary medicinal product by the 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 the “Dosage and administration” section above.
Not to be mixed with other veterinary medicinal products before administration.
In order to prevent abscesses, a strict aseptic technique is recommended. CYDECTIN 10% LA for Cattle has been formulated specifically for subcutaneous injection in the 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 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.
Cattle:
Rare (1 to 10 animals / 10,000 animals treated): | Injection site swelling1,2 Depression 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 disappears without treatment within 14 days after administration, may persist up to 5 weeks (<5% of cases) or longer (very rare occasions).
In case of hypersensitivity reactions, 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 its local representative or the national competent authority via the national reporting system. See also the package leaflet for respective contact details.
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;
- Under-dosing which may be due to underestimation of bodyweight, misadministration of the veterinary medicinal 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.
Withdrawal period
Meat and offal: 108 days.
Milk: Not authorised for use in animals producing milk for human consumption. Do not use in pregnant animals which are intended to produce milk for human consumption within 80 days of expected parturition.
The withdrawal period is based solely on a single injection at the ear site of injection. Avoid direct contact with skin and eyes.
Operator warnings
Avoid direct contact with skin and eyes.
Wash hands after use.
Do not smoke, drink or eat while handling the veterinary medicinal product.
Take care to avoid self-injection.
Advice to Medical Practitioners in case of accidental self-injection: Treat symptomatically.
Other precautions regarding impact on 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.