White to off-white powder for solution for fish treatment containing 1000 mg/g tricaine methanesulphonate.

For use in an immersion bath for sedation, immobilisation and anaesthesia of fish for: vaccination, transportation, weighing, tagging, clipping, stripping of brood stock, blood-sampling and surgical procedures.

For use in ornamental fish or their development stages, and breeding and juvenile stages of fish.

An aqueous solution of the product is used in an immersion bath for sedation, immobilisation and anaesthesia of fish, both ornamental and those intended for human consumption.

A number of factors influence the efficacy and safety of the product, including concentration of the drug in water, duration of exposure, previous exposures to the drug, temperature, oxygen content and density of biomass. Because of these variable factors it is strongly recommended that a test of the selected drug concentration and exposure time is conducted with a small group of representative fish before large numbers are medicated. This is especially important when water temperature is at the upper or lower ends of the normal temperature ranges for the species being treated. The product should be dissolved in water of the same composition and characteristics as that to which the fish are accustomed. As the product has good aqueous solubility, it may be added directly to the container. Effects on the fish should be monitored as the product is gradually introduced.

Before anaesthesia or prolonged sedation, fish should be fasted for 12 to 24 hours. During treatment they should be stocked at a density not exceeding 80 g/litre. To minimize damage and loss when medicated for long periods for transport etc. the level of sedation should allow fish to maintain their equilibrium and swimming position. Aeration should be provided unless sedation, or anaesthesia, is of short duration. In anaesthesia loss of reflexes takes place in one to fifteen minutes after immersion, depending upon concentration employed. Narcotised fish should be removed from medicated water and returned to their normal environment as soon as possible, when recovery will take between one and thirty minutes.

The following examples of dose rates and exposure times are based on laboratory and field experience:

The product should not be used in the following tropical fish species: Apistogramma (Mikrogeophagus) ramirez, Balantiocheilos melanopterus, Etroplus suratensis, Melanotaenia maccullochi, Monodactylus argenteus, Phenacogrammus interruptus and Scatophagus argus.

Do not use in cases of known hypersensitivity to the active substance.

Do not exceed the dose recommended for each category of fish.

Brood stock anaesthetised for stripping should be immersed in unmedicated water immediately before collection of eggs or milt to avoid significant direct contact of either with the product.

As solutions of the veterinary medicinal product are slightly acidic, the use of phosphate or imidazole buffer has been proposed to reduce stress.

In case of overdose, remove fish immediately to aerated water of the same composition and temperature that is free from anaesthetic. Overdose or prolonged exposure to the product may cause respiratory failure and death.

In order to protect the environment, used solution must either be filtered using activated charcoal filters prior to dilution in the effluent to be discharged from the farm or it must be transferred to a holding tank filled with water with subsequent controlled release for dilution in the effluent to be discharged from the farm. See further information section.

Fish must not be slaughtered for human consumption during treatment. Fish may be slaughtered for human consumption only after 70 degree days after the last treatment.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the doctor.

People with known hypersensitivity to tricaine mesilate (tricaine methanesulphonate) should avoid contact with the veterinary medicinal product.

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

Do not create dust when handling the powder or preparing the anaesthetic solution. In case of accidental inhalation of dust, move to fresh air and if breathing is affected, seek medical advice immediately and show the doctor the product label. In situations where dust is created when handling the powder, wear a disposable half mask respirator conforming to European Standard EN 149, or a non-disposable respirator to European Standard EN 140 with a filter to EN 143.

Avoid contact with skin and eyes. In case of accidental contact, immediately wash the affected area with plenty of clean running water. If irritation persists, seek medical advice.

Do not eat, drink or smoke whilst handling the product.

Wash hands after use.

Store in the original container. Store in a dry place. Keep the container tightly closed in order to protect from moisture. Protect from direct sunlight.

This veterinary medicinal product does not require any special temperature storage conditions.Shelf life after dilution or reconstitution according to direction: 24 hours.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Keep out of the sight and reach of children.

For animal treatment only.

Available in tubs containing 25g, 100g, 250g, or 1000g of product. Not all pack sizes may be marketed.

Tricaine methanesulphonate has been used successfully at lower concentrations in conjunction with several other anaesthetics. No adverse interaction with other pharmaceuticals has been established.

Filtration of used solution through an activated charcoal filter will ensure that the concentration of spent tricaine methanesulphonate in discharge water does not exceed 1 µg/L. Spent carbon filters should be disposed of in accordance with local requirements

Transfer of used solution to a holding tank filled with water and controlled release for dilution in the effluent will ensure that the concentration of spent tricaine methanesulphonate in discharge water does not exceed 1 µg/L when releasing the solution from the holding tank at flow rates calculated in the table below (1,000L and 50,000L holding tanks). Discharge flows for different sized holding tanks can be calculated as shown in the 50,000L column.

UK (GB): Vm 11003/4014

UK (NI): Vm 11003/4014