Xn HARMFUL

Oxidising Agent

Corrosive

Do not attempt to administer the product unless you have been fully trained to handle and use the product, and are fully aware of operational and safety procedures.

This product can cause skin, eye and respiratory irritation.

Avoid breathing in product fumes, and avoid contact with skin and eyes.

Wear personal protective equipment whilst handling this product, consisting of chemically resistant headgear, face shield or safety goggles, chemically resistant PVC acid suit / oilskins, chemically resistant PVC gloves (with cuff under suit) and safety rubber wellington boots (with suit over boots).

Before commencing handling of this product ensure a supply of fresh water and preferably eye wash solutions are available.

Wash hands after use.

In case of accidental exposure to the product, immediately soak all clothing with copious volumes of water, from a water supply, remove any contaminated clothing and thoroughly clean the contaminated clothing before re-using.

In case of accidental contact with eyes, rinse immediately with plenty of clean running water and seek medical advice.

After contact with skin, wash immediately with plenty of water.

In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).

In case of accidental ingestion of the product, seek medical attention immediately showing the physician the product label.

iii

Other precautions

Depending on regional requirements, the user may need to apply for and obtain consent for discharge. Check with the relevant regional legislative body e.g. SEPA in Scotland.

The most important mechanism for removal of hydrogen peroxide in coastal waters is dilution and degradation which are increased by water movements including the flushing effects in sea lochs. Do not use at times of slack water as poor dilution and dissociation of residuals may occur. After treatment care should be taken to provide sufficient water exchange through the net to dilute residual hydrogen peroxide. The wash from a boat’s propeller may be used to increase water exchange in cases where low water exchange rates cannot be avoided. These measures will help to prevent possible adverse effects on aquatic life.

Do not allow concentrated product to contaminate wood, paper, grass or any other combustible materials as this may cause fire.

A water hose or other plentiful water supply should be available to dilute any spills and leaks of the product.

Do not return any product to original container.

Use clean and vented containers to retain any spilled product.

4.6

Adverse reactions (frequency and seriousness)

Adverse reactions with the product are rare.

Any cellular damage to the gill during treatment is transient and reparable. See Section 4.3.

However, common signs that an adverse reaction is occurring include: fish losing equilibrium and possibly sinking, and fish becoming hyperactive which may as a result of increased Hydrogen Peroxide concentrations or increasing fish stress levels.

Measures to treat fish undergoing adverse reactions are detailed in section 4.5.

4.7

Use during pregnancy, lactation or lay

Not applicable.

4.8

Interaction with other medicinal products and other forms of interaction

Hydrogen peroxide should not interact with other medicaments as it is not systemic and is purely a physical treatment. If fish are stressed due to over handling or disease, any form of lice treatment would produce further stress. However, this may be less detrimental than the lice burden.

Where medicaments have been given and gill function may be compromised, hydrogen peroxide should not be administered.

Refer to section 4.5 for further information.

4.9

Amount(s) to be administered and administration route

For external use only.

As the volume of water enclosed within the tarpaulin, temperature and duration of treatment impact on efficacy, the dosing instructions and regimen should be adhered to.

By total enclosure method at a concentration of approximately 1500 mgl^-1 as hydrogen peroxide for a maximum of 20 minutes contact.

Infested fish should be bathed in 1500 mgl^-1 hydrogen peroxide for a period of between 15 and 20 minutes. The contact time being dependent on the final concentration of hydrogen peroxide. The contact time should be decreased as water temperature exceeds 14°C.

The product is administered by the total enclosure method in which the fish cage net is raised to an approximate depth, e.g. 2 m. Then a tarpaulin is drawn beneath the net to produce the treatment bath. When this procedure has been accomplished, checks should be made to ensure that fish do not become trapped within folds of the net. Sufficient oxygen diffusers should be placed in the treatment enclosure to support the number and size of fish present. Oxygen should now be applied to the system.

Care should be taken when setting the tarpaulin so as not to unduly reduce the volume of the treatment bath. If fish treatment densities are too high, scaling and hyperactivity may occur. A suggested maximum treatment density would be 150 kgm^-3 but this would be dependent on fish size, year class etc. Fish must not be fed for at least 24 hours prior to treatment.

If nets are heavily fouled, care should be taken when using hydrogen peroxide. Bottle weights should be applied around the periphery of the treatment bath to prevent flotation of the net. These should be applied before commencing treatment.

The estimated volume of the product to produce the treatment concentration of approximately 1500 mgl^-1 hydrogen peroxide should now be administered using safe and compatible dosing equipment.

To achieve an effective concentration of 1500 mgl^-1 in a cage, you will need approximately 2.6 litres of the product for every metre cube of water to be treated.

The following steps should be followed before any treatment commences.

Samples of water should be taken at several points to assess the concentration of the treatment solution using the simple titration test method provided.

If the treatment concentration is found to be low, sufficient hydrogen peroxide should be added to achieve the treatment concentration.

The required volume of produce to be added may be estimated from the following table:

If treatment concentration is high, the contact time may be reduced or the tarpaulin should be dropped. A contact time of between 15-20 minutes should prove sufficient for effective removal of lice.

Measurement of the concentration of hydrogen peroxide in solution should be continued during the treatment and after the tarpaulin has been removed to ensure efficient dispersion has occurred.

During the treatment, fish must be observed for any signs of atypical behaviour. If fish appear distressed, e.g. losing equilibrium or becoming hyperactive during the treatment, remove the tarpaulin and lower the net. Reference should be made to section 4.5.

After treatment ensure that residual hydrogen peroxide is dispersed in the local vicinity as quickly as possible, perhaps using the wash of a boat propeller.

Merckoquant 110011 teststicks (Graduations: 0.5-2-5-10-25 mg/l) or Reflectoquant teststicks Merck 116974 (Range 0.2 – 20 mg/l) or similar commercially available test kits may be used to monitor low levels of residual hydrogen peroxide.

Methods of analysis, advice on test kits, dosing equipment and product handling, and Safety Data Sheets for the product are available from the supplier.

A second application may be required (dependent on routine lice monitoring), to ensure the removal of previously surviving chalami, which will have moulted through to pre-adult stages. Care should be taken not to allow a build up of mature lice as resettlement of copepodids could occur.

Where possible, treatments should be conducted during periods of high tidal flow to ensure good dispersal of residual hydrogen peroxide and dislodged lice. This will minimise any possible resettlement of lice.

4.10

Overdose (symptoms, emergency procedures, antidotes), if necessary

An overdose situation may occur by two methods:

In this event refer to contraindications and warnings.

Strong solutions of hydrogen peroxide produce irritation and ‘burning’ of skin and

mucous membranes or gills.

Emergency procedures: remove tarpaulins immediately and flush hydrogen peroxide

from the cage using the wash from a boat.

4.11

Withdrawal period(s)

Meat: zero days

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:

Dermatological; antiseptics and disinfectants

ATC Vet Code:

QD08AX01

5.1

Pharmacodynamic properties

Water containing hydrogen peroxide may diffuse into the body of the lice or be drawn into the gut by normal biological processes, e.g. feeding. Once within the body of the louse, dissociation to of the hydrogen peroxide in to oxygen and water may cause temporary or permanent disruption to internal structures, causing the parasite to detach from the host.

Resistance to hydrogen peroxide has been reported on one farm after fish were treated with hydrogen peroxide regularly (41 treatments) over a 6 year period. The proposed mechanisms of resistance were genetic selection of individuals with a cuticle that provides a barrier to penetration by hydrogen peroxide or the presence of detoxifying enzymes.

5.2

Pharmacokinetic properties

Absorption

As hydrogen peroxide is administered typically as a 20 minute bath treatment, absorption by the host is considered to be negligible.

Distribution

Not applicable.

Biotransformation

The possibility of any biotransformation is small, due to the unlikelihood of absorption occurring, and hydrogen peroxide being broken down by catalase and other enzymes. These may be considered as natural routes of detoxification and would occur very rapidly.

Elimination

As above, break down of any hydrogen peroxide residual would be enzymic. Excretion of hydrogen peroxide would not occur.

5.3

Environmental properties

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Disodium dihydrogen diphosphate (Na₂H₂P₂O₇)

Nitric acid (HNO₃)

Demineralised Water

6.2

Incompatibilities

Keep away from acids, alkalis, reducing agents and metal salts.

6.3

Shelf life

10 months

6.4

Special precautions for storage

Store in closed original container.

Do not return product to original container.

Store in a secure place and out of reach of children

Do not store above 25°C. Protect from direct sunlight. Store away from heat sources.

Do not store containers on rafts at sea.

6.5

Nature and composition of immediate packaging

Single use Intermediate Bulk Containers (IBCs) of 1100 Kg.

Reusable stainless steel ISO-containers of 22,900 Kg or 26, 000 Kg.

6.6

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

Harmful to aquatic life. Do not contaminate water courses or confined inlets with concentrated product as high concentrations may be deleterious to some marine species. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7

MARKETING AUTHORISATION HOLDER

Solvay Chemicals International S. A.

Rue de Ransbeek 310

B-1120 Brussels

Belgium

8.

MARKETING AUTHORISATION NUMBER

Vm 31011/4000

9.

DATE OF FIRST AUTHORISATION

19 December 2012

10.

DATE OF REVISION OF THE TEXT

August 2015