assets.publishing.service.gov.uk · All listed warnings must be adhered to. ... Potassium chloride...

Administration can be oral, topical, or for aquarium animals only, via water

All listed warnings must be adhered to. VMD/L4/ENF/013/C - #716729v14 – revised 04/06/2018

Active ingredient

Species

Aquarium animals Cage Birds Ferrets Homing pigeons Rabbits Small Rodents Terrarium animals

Allowed

Admin route

Allowed Admin route

Allowed Admin route

Allowed Admin route

Allowed Admin route

Allowed Admin route

Allowed Admin route

1, 3 Pentidiamine

Via

water

1,3

Dihydroxybenzol

Via

water

1-Chloro-2,2,5,5-

tetramethyl-4-

imidazolidinone

(N-Halamine)

Via

water

2-Phenoxyethanol

Via

water



5-Nitro-1, 3-

thiazol-2-ylazan

Via

water

Oral

9-aminoacridine-

hydrochloride

Via

water

Acetic Acid

Via

water

Acriflavine

Via

water,

Topical

Acriflavine

(neutral)

Via

water

Acriflavine

Hydrochloride

Via

water

Acriflvine chloride

Via

water



Alginic Acid

Oral Oral

Allantoin

Via

water

Aloe Vera

Via

water,

Topical

Alpha

Tocopherols

(Vitamin E)

Oral

Oral Oral Oral Oral Oral

Aminoacridine

Hydrochloride

Via

water

Aminobenzoic

Acid Oral

Amprolium

Oral



Amprolium

Hydrochloride Oral Oral Oral

Aneurine HCl

Oral

Antifoam

Via

water

Aqueous Iodine

Solution Oral

Ascorbic Acid

(Vitamin C) Oral

Oral


Azadirachtin

Via

water

Azamethiphos

Via

water

Bee propolis

Topical



Benzalkonium

Chloride

Via

water,

Topical

Topical Topical Topical Topical Topical Topical

Benzimidazole

CAS:51-17-2

Via

water

Benzyldodecyl-bis

-(2-hydroxyethyl)

ammonium

chloride

Via

water

Biotin

Oral Oral

Oral

Bis(4-

dimethylaminophe

nyl)phenylmethliu

mhydroxide

Via

water

Bromhexine

Oral



with

warning

Bronopol

Via

water

Calciferol

Oral

Calcium Acetate

Oral

Calcium

Gluconate

Oral

Oral Oral Oral Oral

Calcium

Pantothenate Oral

Calcium pidolate

Oral

Oral

Carmellose

Topical



Carnidazole

Oral

Carnitine

Oral

Oral

Cetraria islandica

extract (Cetrarin)

Via

water

Chloramine

Topical Topical Topical

Chloramine T

Via

water

Cholecalciferol

(Vitamin D3)

Oral


Choline

Oral

Oral

Choline Chloride

Oral



Citric Acid

Via

water

Clazuril

Oral

Clove Oil

Via

water

Coal Tar Solution

Topical

Compound

benzoin tincture Topical

Copper

Oral

Oral

Copper Chloride

with

warning

Via

water



Copper EDTA

with

warning

Via

water

Copper Sulphate

with

warning

Via

water

Copper Sulphate

Pentahydrate

with

warning

Via

water

Crucifers

Oral

Cyanocobalamin

(vitamin B12) Oral

Oral

Oral



Cypermethrin

with

warning

Topical

with

warning

Topical

with

warning

Topical

with

warning

Topical

with

warning

Topical

with

warning

Topical

Dextrose

monohydrate

Oral


Dicalcium

Phosphate Oral

Diclazuril

Topical Oral Topical Topical Oral

Didecyldimethyla

mmonium

chloride

with

warning

Topical

with

warning

Topical

with

warning

Topical

with

warning

Topical

with

warning

Topical

with

warning

Topical

with

warning

Topical

Diflubenzuron

Via

water



Dimeticone


Dimetridazole

with

warning

Via

water

with

warning

Oral

Di-n-butyl-tin-

oxide

Via

water

Doramectin

with

warning

Oral

Topical

D-Panthothenic

Acid (Vitamin B5)

Oral

Oral

d-Phenothrin

Topical



Emamectin

Benzoate

with

warning

Via

water,

Oral

Enilconazole

with

warning

Topical

Enterococcus

faecium DSM

10663/NCIMB

10415 E1707

Oral


Enterococcus

faecium DSM

10663/NCIMB

10415 EC No 13

Oral




Ethacridine

lactate

Via

water

Ethacridinlactat

Oral

Oral

Ethanol

Via

water,

Topical

Ethopabat

with

warning

Oral

with

warning

Oral

Ethyl

butylacetylaminop

ropionate

with

warning

Topical

with

warning

Topical Topical



Eprinomectin

with

warning

Topical

Eucalyptus Oil

Topical

Fenbedazole

Oral


Fipronil

with

warning

Topical

Flubendazole

Via

water

Oral Oral

Folic Acid

Oral Oral

Oral



Formaldehyde

Via

water

Formalin

Via

water

Fructo-

oligosaccharide Oral Oral

Garlic

Oral

Gelatin

Topical

Glucose

Oral

Oral

Glycerine

Topical

Harakeke Phormi

um tenax (D-

Via

water



xylose and D-

glucuronic acid) -

Plant extract

Hexamethylparao

saniline (Crystal

Violet/Gentian

Violet)

with

warning

Via

water

Ichammol

Topical

Imidacloprid


Immunoglobulin

IgA

Oral

Immunoglobulin

IgG

Oral



Immunoglobulin

IgM

Oral

Inositol

Oral

Ipecacuanha

tincture

Oral

Iron

Oral

Oral

Ivermectin

with

warning

Topical

with

warning

Topical

with

warning

Oral

&

Topical

with

warning

Topical

with

warning

Topical

with

warning

Topical

Kahikatea

Dacrycarpus

Via

water



dacrydioides

(Podocarpic acid

and other

diterpinoids) -

Plant Extract

Kanuka (White

Manuka) Kunzea

ericoides (Alpha

pinea) - Plant

extract

Via

water

Kaolin

Oral


Kawakawa

Macropiper

excelsum

(Myristicin) - Plant

extract

Via

water



Koromiko hebe

slicifolia and Hebe

stricta (Tannins) -

Plant Extract

Via

water

Levamisole

Via

water

Oral

Oral Oral

Levamisole

hydrochloride

Via

water

Oral

Oral

Linalool

Via

water

Lufenuron

with

warning

Via

water

Oral Oral Oral

Lycine

Oral

Oral



Magnesium

sulphate

Via

water

Oral


Malachite Green

with

warning

Via

water,

Topical

Malachite Green

carbinol

hydrochloride

with

warning

Via

water

Malachite Green

Oxalate

with

warning

Via

water

Mamaku Cyathea

Medullaris - Plant

extract

Via

water



Manganese

Oral

Oral

Manuka Leptospe

rmum scoparium

(Beta triketones

including

leptospermone,

poly phenolic

compounds

including tannin

ellagic acid) -

Plant extract

Via

water

Mebendazole

Oral

Menadione

(Vitamin K3) Oral

Oral

Oral



Methionine

Oral

Oral

Methoprene

Topical Topical Topical Topical

Methylene Blue

Via

water,

Topical

Miconazole

Topical

with

warning

Topical

with

warning

Topical

with

warning

Topical

Monodicalcium

Phosphate Oral

Monoproplyene

Glycol

Via

water,

Topical



Montmorillonite

Oral,

Via

water

Moxidectin

with

warning

Topical

with

warning

Oral

&

Topical

Niclosamide

Via

water

Oral

Oral

Nicotinamide

(Vitamin B3)

Oral

Oral

Nicotinic Acid

Oral

Nitroscanate

Via

water



Oxfendazole

Oral

Oral

Oxibendazole

Oral

Oral

Pantothenic Acid

(vitamin B5) Oral

Pectin

Topical Oral


Permethrin

Cis:Trans 25:75

with

warning

Topical Topical

with

warning

Topical

with

warning

Topical

with

warning

Topical

Phenol

Via

water

Phenoxyethanol

Via

water



Pimenta

racemosa (West

Indian Bay Oil)

Via

water

Piperazine

Oral

Piperazine Citrate

Via

water

Oral

Oral Oral Oral Oral

Piperazine

phosphate Oral

Piperonyl

butoxide

Topical Topical

with

warning


Plant Extract:

Harakeke Phormi

um tenax (D-

Via

water



xylose and D-

glucuronic acid)

Plant Extract:

Kahikatea

Dacrycarpus

dacrydioides

(Podocarpic acid

and other

diterpinoids)

Via

water

Plant Extract:

Kanuka (White

Manuka) Kunzea

ericoides (Alpha

pinea)

Via

water

Plant Extract:

Koromiko hebe

slicifolia and Hebe

stricta (Tannins)

Via

water



Plant extract:

Mamaku Cyathea

Medullaris

Via

water

Plant Extract:

Manuka Leptospe

rmum scoparium

(Beta triketones

including

leptospermone,

poly phenolic

compounds

including tannin

ellagic acid)

Via

water

Plant Extract:

Pohutakawa Metr

osideros excelsa

(Ellagic and Gallic

acid)

Via

water



Plant

Extract:Kawakaw

a Macropiper

excelsum

(Myristicin)

Via

water

Plant

Extract:Puriri Vite

x lucens

(Flavonoid c-

glycoside, beta-

carotene)

Via

water

Pohutakawa Metr

osideros excelsa

(Ellagic and Gallic

acid) - Plant

extract

Via

water

Polyhexanide

Oral

Topical Topical Topical Topical Topical



Polyvinylpyrrolido

ne (Povidone)

Via

water

Potassium

chloride

Oral


Potassium

Permanganate

Via

water

Povidone iodine

with

warning

Topical

with

warning

Topical

with

warning

Topical

with

warning

Topical

with

warning

Topical

with

warning

Topical

Praziquantel

Via

water

Oral

Topical

Oral

Topical

Oral Oral

Topical

Oral Oral

Proflavine

hemisulphate

Via

water

Propolis

Oral,

Topical



Puriri Vitex lucens

(Flavonoid c-

glycoside, beta-

carotene) - Plant

Extract

Via

water

PVP Iodine

Topical

Pyrantel

embonate

Oral

Pyrethrins

Oral Topical Topical Topical

Pyrethrum Extract

B.P

with

warning

Topical

Pyrethrum liquid

extract Topical Topical Topical



Pyrethrum

powder Topical Topical Topical

Pyridoxine HCl

(vitamin B6) Oral Oral Oral

Pyriproxyfen


Quinine

bisulphate

Via

water

Quinine

hydrochloride

dihydrate

Via

water

Quinine Sulphate

Via

water

Rafoxanide

Via

water

with

warning



Retinol Palmitate

(vitamin A)

Via

water

Oral Oral

Oral Oral Oral Oral

Riboflavin

(vitamin B2)

Via

water

Oral Oral

Oral Oral Oral

Ronidazole

with

warning

Oral

with

warning

Oral

with

warning

Oral

Silver Colloid

Via

water

Silver Proteinate

Via

water

S-methoprene


Sodium

bicarbonate Oral Oral



Sodium Chloride

Via

water

Oral Oral

Oral Oral Oral Oral

Sodium Chlorite

Via

water

Sodium Perborate

tetrahydrate

Via

water

Sodium

Propionate Oral

Sodium

Thiosulphate

Via

water

Squill Elixir

Topical

Strong Silver

Proteinate

Via

water

Surgical Spirit

Topical



Tabebuia

avellanedae

extract

Via

water

Tea Tree Oil

(Melaleuca Oil)

Via

water

Oral

Thiamine (Vitamin

B1) Oral Oral

Tocopherol

acetate (vitamin

E)

Oral Oral Oral

Treonine

Via

water

Oral Oral

Tricaine

methanesulfonate

with

warning

Via

water



Trisodium citrate

Oral Oral Oral Oral Oral Oral

Tryptophan

Oral Oral

Zinc

Oral

Zinc Oxide

Topical

Zinc Sulphate

Via

water

Active Conditions on inclusion

Bromhexine Products containing Bromhexine should include the following warning on the packaging/ product literature: Bromhexine is a mucolytic to be used as an adjunctive therapy. It has no activity against bacterial, viral or other causes of respiratory disease. Birds displaying symptoms of respiratory disease may deteriorate rapidly and should be examined by a veterinary surgeon.

Copper Products containing Copper should include an appropriate warning since copper can be toxic to fish.

Cypermethrin Products containing Cypermethrin should include the following on the product literature: Extremely dangerous to fish and aquatic life. Do not use spray in areas containing aquaria, fish tanks and bowls. Do not contaminate aquaria, fishbowls, ponds or waterways with the product.



Didecyldimethylammonium

chloride

Products containing Didecyldimethylammonium chloride may only be marketed for the use as a wound irrigation and skin decontamination

solution.

Dimetridazole Products containing Dimetridazole should include a warning that the product is not to be used in animals intended for human consumption.

Doramectin Products containing Doramectin must include the following on the product literature: “Do not use in animals other than those indicated. Serious reactions, including deaths, have been reported in dogs (especially Collies, Old English Sheep Dogs and related breeds), tortoises and turtles treated with products containing the active substance.”

Emamectin Benzoate

Products containing Avermectins must include the following on the product literature: “Do not use in animals other than those indicated. Serious reactions, including deaths, have been reported in dogs (especially Collies, Old English Sheep Dogs and related breeds), tortoises and turtles treated with products containing the active substance.”

Enilconazole Products containing Enilconazole must contain the following warning on the packaging: "If signs of disease persist beyond 7 days, or reappear, then advice must be sought from a veterinary surgeon".

Eprinomectin Products containing Eprinomectin must include the following on the product literature: “Do not use in animals other than those indicated. Serious reactions, including deaths, have been reported in dogs (especially Collies, Old English Sheep Dogs and related breeds), tortoises and turtles treated with products containing the active substance.”

Ethopabat The active Ethopabat is approved for use in combination with Amprolium. It must be clear on the packaging that it is a supplementary active which improves the coccidiostatic activity of amprolium.

Ethyl

butlacetylaminopropionate

Products containing Ethyl butlacetylaminopropionate must include the following on the product literature the statement "If signs of disease persist or appear consult a veterinary surgeon."

Fipronil Products containing Fipronil should include a contraindication for the use of the product in rabbits on their packaging, labels and package leaflets.

Fructo-oligosaccharide Not for use in degus

Hexamethylparaosaniline (Crystal Violet/Gentian Violet)

Products containing Hexamethylparaosaniline must be appropriately labelled to give information (1) on the hazards (including potential for cancer) and risks of handling the substance (2) on minimising exposure and advice on what to do in the event of accidental exposure (3) on the environmental hazards and how to dispose of unused substance and treated water.

Ivermectin 1. Products containing Ivermectin must include the following on the product literature: “Do not use in animals other than those indicated. Serious reactions, including deaths, have been reported in dogs (especially Collies, Old English Sheep Dogs and related breeds), tortoises and



turtles treated with products containing the active substance.” 2. Do not use in tortoises or turtles.

Lufenuron The following warning should be included in the product literature: For use in fish only. May be harmful to aquatic invertebrates.

Malachite Green Products containing Malachite Green must be labelled in accordance with CLP Regulations and have child-resistant closures.

Miconazole Products containing miconazole must contain the following warning: "If signs of disease persist beyond 7 days, or reappear, then advice must be sought from a veterinary surgeon".

Moxidectin The following user safety warnings and disposal advice should be added to the labelling/ product literature: Avoid direct contact with skin and eyes. The use of protective gloves is recommended. Wash hands or any exposed area after use. Do not smoke, drink or eat while handling this product. In the event of eye contact, flush the eye with copious amounts of clean water and seek medical advice. The product should not enter water courses as it is dangerous to fish and aquatic life. The labelling/product literature should include the following prudent use warnings: Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy: - Too frequent and repeated use of anthelmintics from the same class, over an extended period of time - Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any). ‘Do not use in animals other than those indicated. Moxidectin can be toxic to Collies, Old English Sheep dogs and related breeds and crossbreeds. Ensure that these animals do not come into contact with the product and especially that they do not lick/drink the product.’

Piperonyl Butoxide Products containing Piperonyl Butoxide must include the warning "Harmful to fish. Cover or remove all fish bowls and aquaria before use. Do not contaminate ponds, waterways or ditches with the product."

Permethrin Spot on topical treatments containing Permethrin must contain the following prominently on the packaging: A cat symbol with a cross or line drawn through it; and the words “Caution: Extremely poisonous to cats. It is important that cats do not come into contact with this product as it could kill them”.

Povidone iodine Products containing Povidone iodine must contain the following warning " Not to be used on open wounds at a concentrations above 1%"



Pyrethrum Extract B.P Products containing Pyrethrum Extract B.P must include the warning "Harmful to fish. Cover or remove all fish bowls and aquaria before use. Do not contaminate ponds, waterways or ditches with the product."

Rafoxanide Products containing rafoxanide should include 1) an appropriate warning since rafoxanide can be toxic to some species of fish and juvenile fish.’ The exact wording of the warning is to be

decided by the individual company based on knowledge of their own product (for example, you suggested to include for your own product a warning not to treat fish below the age of 3 months and Loricariids or Coridoras if the concentration is 0.04mg/l or more.)

2) 2) the environmental safety warning - : ‘Dangerous to aquatic life. Do not contaminate water courses or confined inlets with the product, or from discharges from treated tanks, as any such exposure may be deleterious to some aquatic species. Any unused product or waste materials derived from such product (such as water or sediment removed from the tank during cleaning) should be disposed of in accordance with local requirements.’

Ronidazole Products containing Ronidazole must include a warning that the product is not to be used in animals intended for human consumption.

Tricaine methanesulfonate 1) Products containing Tricaine methanesulfonate may be indicated for mild sedation and also for “euthanasia of diseased fish”. 2) The products must include the following warning on the product literature:

Do not use with the following tropical fish species: Apistogramma (Mikrogeophagus) ramirez, Balantiocheilos melanopterus, Etroplus suratensis, Melanotaenia maccullochi, Monodactylus argenteus, Phenacogrammus interruptus and Scatophagus argus.

3) The following user safety warnings should be added to product literature:

Impermeable rubber gloves should be worn when handling the veterinary medicinal product.

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 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 package leaflet or the label to the physician.

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.

assets.publishing.service.gov.uk · All listed warnings must be adhered to. ... Potassium chloride...

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Transcript of assets.publishing.service.gov.uk · All listed warnings must be adhered to. ... Potassium chloride...