Asperix

Main information

  • Trade name:
  • Asperix Vet, 49.5 % w/ w Hydrogen Peroxide Concentrate for Solution for Fish Treatment
  • Pharmaceutical form:
  • Concentrate for solution for fish treatment
  • Prescription type:
  • POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Asperix Vet, 49.5 % w/w Hydrogen Peroxide Concentrate for Solution for Fish Treatment
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Salmon (Atlantic)
  • Therapeutic area:
  • Ectoparasiticide

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 47367/4000
  • Authorization date:
  • 15-01-2018
  • Last update:
  • 19-01-2018

Summary of Product characteristics: dosage, interactions, side effects

Issued: January 2018

AN: 00986/2016

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

ASPERIX Vet, 49.5 % w/w hydrogen peroxide concentrate for solution for fish

treatment

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

49.5 % w/w Hydrogen Peroxide

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Concentrate for solution for fish treatment.

The solution is a clear, colourless liquid.

4.

CLINICAL PARTICULARS

4.1

Target species

Atlantic salmon (Salmo salar)

4.2

Indications for use, specifying the target species

For the treatment of salmon suffering from infestation with motile (pre-adult to adult)

sea lice, Lepeophtheirus salmonis or Caligus spp, prior to the stage where serious

tissue damage occurs.

4.3 Contraindications

Do not exceed the recommended concentration of hydrogen peroxide.

Do not use at high water temperatures.

Extreme care should be taken if using hydrogen peroxide at water temperatures

above 14°C. If treatment is unavoidable, hydrogen peroxide concentration and

contact time should be reduced. If signs of atypical behaviour, e.g. fish losing

equilibrium or hyperactivity are observed, treatment should be stopped immediately.

Do not use in fish with a mean weight of less than 200 g.

Do not treat fish which are showing clinical signs of previous gill damage.

Page 1 of 10

Issued: January 2018

AN: 00986/2016

An assessment of gill condition and the possibility of other stressors e.g. algal

blooms should be made before commencement of treatments.

Do not use in stressed fish.

4.4

Special warnings for each target species

Repeated use of the same chemotherapeutic agent may encourage the

development of resistance to the agent.

4.5

Special precautions for use

Special precautions for use in animals

If problems occur when raising nets or setting the tarpaulin extending the time that

fish are constricted within the treatment bath, extra care should be taken as fish may

be unduly stressed prior to hydrogen peroxide addition.

In the event that fish begin to lose their equilibrium and possibly begin to sink during

treatment with hydrogen peroxide, tarpaulins must be removed immediately.

Residual hydrogen peroxide should be flushed from the cage using the wash from a

boat.

Oxygen sparges should remain in the cage even if they are not used during

treatment. This provides the ability to agitate moribund fish preventing them settling

on the floor of the net. Affected fish should recover after a short period when nets

may be dropped to their full extent.

If during treatment with hydrogen peroxide fish become hyperactive, this may be

indicative of increased hydrogen peroxide concentrations or that fish have become

unduly stressed.

Hydrogen peroxide concentration may be tested with a suitable test method and

dissolved oxygen should be monitored to prevent an oxygen crash occurring. In the

event that the hydrogen peroxide and dissolved oxygen concentration are normal but

hyperactivity persists, treatment should be stopped. This should prevent a

subsequent oxygen crash and minimise scaling of fish.

The nets should be partially lowered to increase the volume of water available to the

fish and hydrogen peroxide residuals should be flushed away using the wash from a

boat. These actions should relieve any undue stress to the fish.

The activity of the fish should be allowed to return to normal before the nets are

completely dropped.

Page 2 of 10

Issued: January 2018

AN: 00986/2016

Special precautions to be taken by the person administering the veterinary medicinal

product to animals

Harmful

Corrosive

Oxidising Agent

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. Hydrogen peroxide is corrosive.

This product is harmful if swallowed or if inhaled and may cause respiratory irritation.

Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.

Avoid contact with skin and eyes. This product may cause skin irritation and serious

eye damage.

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 boots (with suit over boots).

Before commencing handling of this product ensure a supply of fresh water and

preferably eye wash solutions are available.

IN CASE OF INHALATION: Remove person to fresh air and keep comfortable for

breathing. If you feel unwell SEEK IMMEDIATE MEDICAL ATTENTION by calling a

physician or National Poisons Information Centre.

IN CASE OF ACCIDENTAL EYE CONTACT: Rinse immediately with plenty of clean

water for several minutes. SEEK IMMEDIATE MEDICAL ATTENTION by calling a

physician or National Poisons Information Centre. Remove any contact lenses, if

easy to do so and continue rinsing eyes.

IN CASE OF ACCIDENTAL SKIN CONTACT: Immediately remove any

contaminated clothing. Wash the exposed skin immediately with water and seek

medical advice if irritation persists. Thoroughly clean the contaminated clothing by

soaking with plenty of water before re-using.

IN CASE OF ACCIDENTAL INGESTION: Seek medical attention immediately and

show the package leaflet or the label to the physician.

Always wash hands with soap and water directly after use.

Page 3 of 10

Issued: January 2018

AN: 00986/2016

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 mechanisms 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 through the net to

dilute residual hydrogen peroxide. The water 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,

Page 4 of 10

Issued: January 2018

AN: 00986/2016

hydrogen peroxide should not be administered.

Refer to section 4.5 for further information.

4.9

Amounts 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

By total enclosure method at a concentration of approximately 1500 mg/L as

hydrogen peroxide for a maximum of 20 minutes contact.

Infested fish should be bathed in 1500 mg/L 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 approximately 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 kg/

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 the

treatment.

The estimated volume of the product to produce the treatment concentration of

approximately 1500 mg/L hydrogen peroxide should now be administered using safe

and compatible dosing equipment.

To achieve an effective concentration of 1500 mg/L in a cage, approximately 2.6

litres of the product will be needed for every metre cube of water to be treated.

The following steps should be followed before treatment commences.

1.Assess the water volume to be treated in m

Page 5 of 10

Issued: January 2018

AN: 00986/2016

2.Multiply the water volume by 2.55 to obtain the volume in litres of product

required to achieve a concentration of 1500 mg/L hydrogen peroxide.

3.Add the product to the cage using dedicated dosing equipment.

4.Once the addition is completed, a sample of the treated water should be taken

and analysed immediately to obtain the confirmation of concentration in the

cage.

Samples of water should be taken at several points to assess the concentration

of the treatment solution using a suitable test method.

If the treatment concentration is found to be low, sufficient hydrogen peroxide

should be added to achieve the treatment concentration.

The required volume of product to be added may be estimated from the

following table:

Locate the concentration as measured on assay in the row across the

top.

Proceed down this column to reach the row associated with the initial

estimated volume.

The resulting figure gives the additional volume to be added to the pen.

Page 6 of 10

Issued: January 2018

AN: 00986/2016

Estimated

water

volume

Volume

ASPERIX

Vet to

add (L)

Additional volume ASPERIX Vet to add in litre if reading

is (mg/L)

1000

1200

1300

1400

1019

1091

1019

1164

1082

1237

1146

1310

1003

1210

1382

1058

1273

1455

1114

1910

2183

1671

1273

1000

2546

2910

2228

1698

1273

2000

5093

5821

4456

3395

2546

1273

3000

7639

8731

6684

5093

3820

1910

1175

5000

12732

14551

11141

8488

6366

3183

1959

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 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

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.

Page 7 of 10

Issued: January 2018

AN: 00986/2016

Commercially available test kits may be used to monitor low levels of residual

hydrogen peroxide.

A second application may be required (dependent on routine lice monitoring), to

ensure the removal of previous surviving chalimi, 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:

1.Addition of too much hydrogen peroxide to the treatment bath producing a

higher concentration than recommended.

In this event refer to contraindications and warnings.

2.Extended contact period above the recommended 15-20 minutes. This may be

due to the poor dispersion of hydrogen peroxide after treatment.

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 disinfectant

ATCvet 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 of the hydrogen peroxide to oxygen

and water may cause temporary or permanent disruption to internal structures,

causing the parasite to detach from the host.

Reduced sensitivity of sea lice has been reported after repeated use of hydrogen

peroxide. The proposed mechanisms of resistance were genetic selection of

Page 8 of 10

Issued: January 2018

AN: 00986/2016

individuals with cuticle that provides a barrier to penetration by hydrogen peroxide or

the presence of detoxifying enzymes. The requirements of national resistance

monitoring programmes should be followed.

5.2

Pharmacokinetic particulars

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 enzymatic.

Excretion of hydrogen peroxide would not occur.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Disodium dihydrogen diphosphate

Nitric acid

Deionised water

6.2

Incompatibilities

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

6.3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 12 months

6.4

Special precautions for storage

Store in the 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

Protect from direct sunlight. Store away from heat sources.

6.5

Nature and composition of immediate packaging

Reusable stainless steel ISO-container with the capacity of 25 m

(25 000 litres).

Page 9 of 10

Issued: January 2018

AN: 00986/2016

6.6

Special precautions for the disposal of unused veterinary medicinal

product or waste materials derived from the use of such products

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 product should be disposed of in accordance with local

requirements.

7.

MARKETING AUTHORISATION HOLDER

Evonik Resource Efficiency GmbH

Rellinghauser Straße. 1-11

D-45128 Essen

Germany

8.

MARKETING AUTHORISATION NUMBER

Vm 47367/4000

9.

DATE OF FIRST AUTHORISATION

15 January 2018

10.

DATE OF REVISION OF THE TEXT

January 2018

Approved: 15/01/2018

Page 10 of 10