Pyceze

Introduction

Company name: Novartis Animal Health UK Ltd

Address: Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

Telephone: 01276 694402

Fax: 01276 694403

Presentation

A clear fluid bath additive containing Bronopol BP 50% w/v for administration to holding water containing farmed, fertilized salmonid eggs, Atlantic Salmon or Rainbow Trout

Uses

The product is indicated for:

- the treatment and control of fungal infections (Saprolegnia spp) in farmed, fertilized salmonid eggs.

- reduction and control of fungal infections (Saprolegnia spp) in farmed Atlantic salmon and Rainbow Trout.

Dosage and administration

Eggs:

Treat once daily at 50mg Bronopol/litre (1ml product /10 litres incubator water) for

30 minutes, as necessary, commencing 24 hours after fertilisation

Efficacy data indicates that the product must be correctly administered.

The correct amount of product per volume of incubator should be measured and mixed with a small volume of incubator water prior to addition to the incubator. Undiluted product in direct contact may damage the surface of plastic troughs.

Use only the measuring cylinder provided to measure out the correct amount of product. After use, rinse the measuring cylinder carefully and add the rinsings back into the incubator water.

Flow rates to the incubator must be such that a complete exchange of the incubator water is achieved in 30 minutes or less, following the end of the treatment period.

It is essential that the fish eggs be exposed to a homogeneous concentration of Pyceze throughout the treatment period. This can be achieved by ensuring there is continual water movement in the incubator during the treatment period by following the recommendations below for either re-circulation or continuous addition depending on your choice of application. It is important to maintain the flow rate in the incubator during the treatment period to that normally used on the farm to prevent any physical damage to the sensitive eggs.

Use the following equations to calculate the amount of product required, depending on your choice of application. It is recommended that you do not change the configuration of your system. The treatment time may appear longer than 30 minutes – this is to allow time for the product to disperse so that each egg receives the correct dose for the correct time. Treat daily.

Re-circulation

(dose = 1ml per 10 litres water = 50mg bronopol/litre)

Total treatment dose is added to the system over the time it takes for the water to circulate once through the system (Administration Time) to achieve proper mixing. Circulation of the medicated water is then continued for the treatment time of 30 minutes

Administration Time (mins) = volume ÷ flow

where:

volume = incubator and pipework volume in litres

flow = flow rate in litres per minute

Dose of Pyceze(ml)=volume÷10

where:

volume = incubator and pipework volume in litres and includes the volume of water Pyceze is diluted in for administration to incubator Administration

Volume).

Add the dose of Pyceze during the calculated Administration Time, and then circulate for 30 minutes. The flow of unmedicated water should then resume.

Continuous addition

(dose = 1ml per 10 litres water = 50mg bronopol/litre)

Treatment is added to the system over the time it takes for the water already in the system to achieve the correct dose level. Addition of the medicated water is then continued for the treatment time of 30 minutes.

Administration Time (mins) = (volume÷ flow) + 30

where:

volume = incubator and pipework volume in litres

flow = flow rate in litres per min.

Dose of Pyceze (ml)=[(flow×time10]+volume÷10)

where:

flow = flow rate in litres per min

time = administration time in minutes

volume = volume of water used to dilute Pyceze in litres for administration to inflow of incubator (Administration Volume)

Add the dose of Pyceze during the calculated Administration Time, leaving the in-flow water flow unchanged.

A laminated instruction card is provided to illustrate these calculations.

If appropriate to the farm management system, dead eggs should be removed on a regular basis to avoid these becoming a source of further fungal infection.

Fish:

Treat once daily at 20mg Bronopol/litre (1 ml product/25 litres water) for 30 minutes daily, for up to 14 consecutive days. Use the equation below to calculate the amount of product required.

Dose of Pyceze (ml) = Treatment Volume (litres) ÷ 25

After 30 minutes treatment time resume the unmedicated water flow to the treatment unit.

Efficacy data indicates that the product must be correctly administered.

Using the 500ml measuring jug (provided with the 5 litre pack) add the required volume of product to a bucket containing a suitable volume of water (e.g., 5, 10 or 20 litres) from the treatment bath. Mix the bucket contents thoroughly and after stopping the water flow add to the treatment bath at several positions, spreading the treatment around the treatment bath as much as possible to aid mixing. After use, rinse the measure and the bucket carefully and add the rinsings back into the treatment bath.

Undiluted product in direct contact may damage the surface of plastic tanks.

Flow rates to the treatment unit must be such that a complete exchange of the water is achieved in 60 minutes or less following the end of the treatment period.

It is recommended that oxygen be diffused into the treatment unit throughout the treatment period to maintain an oxygen level above 7mg/litre and to ensure adequate mixing of the product.

Movement of the fish and oxygen diffusion during treatment will ensure mixing of the product through the treatment water. The treatment unit volume may be reduced to limit the amount of product used. Care should be taken when doing this not to unduly stress the fish by lack of space or oxygen availability.

For treatment of freshwater cages the net should be raised to a depth of 1 to 2 metres depending on the biomass of the fish. The cage to be treated should then be surrounded by an impervious tarpaulin to completely isolate it. Oxygen should be supplied and treatment carried out as above. Once the 30 minutes treatment time is completed the tarpaulin should be removed and the nets lowered to the original depth.

Treat daily for up to 14 consecutive days. It may be appropriate to reduce the frequency of treatment where challenge is less severe, depending on advice from the prescribing veterinary surgeon

Contra-indications, warnings, etc

Do not use in smolting Atlantic salmon or Rainbow Trout alevins as studies have indicated increased toxicity at this stage

Special precautions for use

Data appears to demonstrate that Pyceze, once diluted in a fixed volume of water may be degraded by prolonged or repeated exposure to high intensity ultra-violet light. Degradation of Pyceze may alter its toxicity profile. It is therefore recommended that Pyceze treated water is not passed repeatedly through ultra-violet sterilizing filters.

Irritating to eyes, lungs and skin.

Wear suitable protective clothing, impermeable gloves (0.3mm nitrile rubber) and face shield when using the product. After contact with the skin, wash immediately and - in case of contact with the eyes - rinse immediately with plenty of water and seek medical advice. Do not smoke, drink or eat when using the product and wash hands carefully after use.

Environmental warnings

This formulated product is designed for the treatment and control of fungal infections in farmed salmonid eggs and reduction and control of fungal infection in Atlantic Salmon and Rainbow Trout, following dilution and water borne administration. However, at levels greater than the treatment dose, the product could be harmful to other aquatic life.

Do not contaminate surface waters or ditches with product, diluted product or used container. Do not re-use the container or measuring cylinder for any other purpose.

Any unused product and containers should be disposed of in accordance with national requirements.

A discharge consent is required for release of this product into the aquatic environment. This must be obtained, prior to use of the product, from the Environment Agency, Scottish Environment Protection Agency or equivalent authority.

Withdrawal period

Not to be used in eggs intended for human consumption.

Meat: Zero

Pharmaceutical precautions

Close container after use.

Do not store above 25°C.

Store in the original container.

Protect from light.

Use only under veterinary direction.

For animal treatment only.

Keep out of reach of children.

Accurate measurement of the dose can be achieved using the measuring cylinder provided.

Legal category

POM-V

Packaging Quantities

1 litre, 5 litre

Marketing authorisation number

Vm 18343/4000.