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Date: Wednesday, May 22, 2024 20:15

Release 2.224
AMX® 10 mg/ml Concentrate for Solution for Fish Treatment
 
Species: Fish
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For fish
Active ingredient: Deltamethrin
Product:AMX® 10 mg/ml Concentrate for Solution for Fish Treatment
Product index: AMX Concentrate
Fish - meat: 5 degree days
Incorporating:
Presentation
AMX 10 mg/ml concentrate for solution for fish treatment is a slightly opaque, pale yellow liquid containing Deltamethrin 10 mg/ml.
Uses
For treatment of adult and pre-adult sea lice (Lepeophtheirus salmonis) on Atlantic salmon (Salmo salar) and Rainbow trout (Oncorhynchus mykiss).
Dosage and administration
Delousing should be performed in a well-boat or in a sea-cage with a raised net enclosed by a tarpaulin. This is to ensure proper control of the treatment volume and the treatment dosage and to reduce the amount of AMX® used and the environmental exposure. Calculate the water volume as exactly as possible to ensure correct dosing.
Treatment dose
0.2 ml AMX® per m3 (1000 l) sea water in the treatment unit. This corresponds to 2 μg deltamethrin/litre sea water in the treatment volume.
Treatment volume
For tarpaulin bath treatments, the dosage is calculated according to the actual volume of the treatment unit (tarpaulin volume).
For well-boat treatments, the dosage is calculated according to the actual volume of the treatment unit .
Treatment period
30 minutes
Advice on correct administration
The product should be brought to room temperature before use in order to flow more easily out of the bottle. Shake the bottle well before use. Calculate the volume in the treatment unit and the AMX® dose. Use a suitable container and dilute the calculated quantity of AMX® in sea water. Diluting the product in a large volume of sea water will ensure better dispersion and thereby the efficacy of the treatment. After a short period of stirring, the diluted solution must be spread evenly throughout the treatment unit. It is recommended to use a pump with low or moderate pressure to further improve an even dispersion. Do not disperse under high pressure as this may cause atomising and/or foaming.
All fish should be oxygenated during treatment. Ensure that the oxygen level is above 7 mg/l before the treatment is initiated and that it is kept above 7 mg/l during the entire duration of the treatment.
Avoid treatment if large amounts of organic material are present in the sea water, or if the sea-cage is overgrown, as this may reduce efficacy of the treatment. Overgrowth of algae on the sea-cages/nets may prevent water exchange after treatment. This may extend the exposure period and increase risk of intoxication of fish.
Treatment should not be carried out unless some degree of water current is present. Without a current the exposure period may be extended and increase the risk of overdosing. If water currents are low at the time of removal of the tarpaulin the use of an artificial water-current (e.g. a boat motor propeller) is recommended in order to speed up the water exchange in the treatment unit.
Dead sea lice may remain on fish for a few days after the treatment (depending on water temperature).
AMX® does not prevent reinfestation with sea lice after treatment. The treatment may be repeated if reinfestation with sea lice occurs, but a period of at least 14 days should elapse between treatments.
Contra-indications, warnings, etc
Contraindications
Do not use on fish with infectious diseases, as treatment against sea lice may aggravate the clinical signs and increase mortality.
Adverse reactions
The fish tend to move closer to the surface during treatment and increased restlessness and jumping frequency are observed. Occasional mortalities have also been observed after treatment with the recommended treatment regimen. Miscalculation of the treatment volume (overdosing), extended exposure of treatment period or low water temperature may increase the frequency of adverse reactions or signs of intoxication.
Special warnings for target species
At water temperatures below 6°C, the product's safety margin is reduced. Extra precautionary measures should be exercised if treatments are performed at low water temperatures. The efficacy of this medicinal product declines with water temperatures below 6°C. Lack of efficacy and reduced sensitivity to deltamethrin has been observed. Suboptimal treatment regimen and frequent treatments as well as the use of pyrethroids only for sea lice treatment, can induce reduced sensitivity in the sea lice with lack of efficacy as a possible consequence.
The risk of intoxication may increase in fish with severe skin lesions.
Symptoms of overdosing are equilibrium problems, behavioural disturbances, gasping for air in the water, alteration in pigmentation and mortalities. If any of these symptoms occur, the treatment should be terminated and unmedicated sea water let in. If the fish are treated in a raised net enclosed in a tarpaulin, the tarpaulin should be removed and the net released to normal depth immediately. In order to speed up water exchange in the treatment unit such cases, an artificial water-current can be applied (e.g. by using a boat motor propellor).
The acute toxicity of deltamethrin in fish is high. The toxicity is affected by the dose, exposure period and the water temperature. Signs of intoxication have been seen in laboratory trials with doses 5 times the recommended dose at 30 minutes exposure and doses 3 times the recommended dose at 60 minutes exposure. Experience from clinical use of the product indicates that lower doses and/or other exposure conditions may also cause signs of intoxication.
Use in broodstock
Use only in accordance with the benefit/risk assessment by the responsible veterinarian because reproductive toxicity has not been established in the target species.
Environmental precautions
The substance is toxic to crustaceans and should not be used in sea farms where crabs or lobsters are kept in close vicinity of the treated sea-cages (<200m), or when local water currents increase the likelihood of exposure.
To prevent toxic effects on local aquatic organisms and to prevent toxic waste of deltamethrin to be washed into the littoral zone, bath treatment should be performed on an outgoing tide, or during periods with a local outgoing current.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.
Withdrawal period
5 degree days for treated Atlantic salmon. 5 degree days for treated Rainbow trout.
Operator warnings
Wear protective clothing (i.e. cotton overalls and nitrile rubber or neoprene gloves (0.3mm thick)) and disposable face mask when handling the product, tarpaulins and nets of treated cages.
Avoid contact with the skin, eyes, nose and mouth. If clothing becomes contaminated remove without delay and wash skin thoroughly with soap and water. Change out of protective clothing and wash hands thoroughly after using the product. Launder protective clothing before re-use.
Do not smoke, eat or drink when handling the product.
The product is of low hazard by oral and dermal routes. Inhalation of the product may cause irritation to the mucous membranes and respiratory tract. Skin exposure may cause transient sensations (tingling, numbness), which disappear after a few hours. Obtain medical advice if symptoms persist.
All equipment that has been in contact with the product should be thoroughly cleaned after completion of treatment.
The product may cause harm to the unborn child. Pregnant women should therefore be extra careful when handling the product.
Pharmaceutical precautions
Protect from frost.
Shelf-life after first opening the immediate packaging is 9 months. Dilute immediately before use, discard any unused solution. Do not use product if the expiry date has passed.
Keep out of the sight and reach of children.
For animal treatment only.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. This formulated product is designed for treatment of fish. However, at levels greater than the treatment dose, the product could be harmful to fish and aquatic life. Do not contaminate surface waters or ditches with the product or used containers.
Legal category
Legal category: POM-V
Packaging quantities
Aluminium bottle with tamper evident black polypropylene screw cap containing 250 ml or 1000 ml of concentrate (10 mg/ml deltamethrin).
Not all pack sizes may be marketed.
Further information
Nil
Marketing Authorisation Number
UK (GB): Vm 21714/4004
UK (NI): Vm 21714/4004
Significant changes