Ecozole 4% w/w Premix for Medicated Feeding Stuff

Composition

Active substance:

Each 1g contains

Fenbendazole 0.04g

Excipient(s):

For a full list of excipients, see section 6.1.

6.1 List of excipients

Lactose monohydrate

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Pharmaceutical form

Premix for Medicated Feeding Stuff

A white to off white powder.

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Pharmacological properties

ATC vet code: QP52AC13

5.1 Pharmacodynamic properties

A broad spectrum anthelmintic from the benzimidazole group. Benzimidazoles bind to nematode tubulin, a protein necessary for the formation and viability of microtubules. This occurs primarily in absorptive intestinal cells resulting in a complete absence of microtubules in the intestinal cells of the nematode, which means that these cells cannot absorb nutrients, a consequent reduction in glycogen and effective starvation of the parasites. Structural differences have been shown to exist between tubulin from mammalian and helminth sources, thus resulting in the preferential toxicity of fenbendazole to the helminth and not to the host. Fenbendazole may also inhibit energy production in helminths by inhibition of glucose uptake and glycogen breakdown.

5.2 Pharmacokinetic particulars

Fenbendazole is only partially absorbed following oral administration. The absorbed fenbendazole is metabolised to the active compound, oxfendazole (sulfoxide) and the sulfone. In pigs, a significant proportion of the dose of fenbendazole is excreted unchanged in the faeces, and a very small proportion in the urine.

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Target species

Pigs.

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Indications

A broad spectrum anthelmintic for the treatment of pigs infected with mature and immature forms of nematodes of the gastro-intestinal and respiratory tracts:

Hyostrongylus rubidus (Red Stomach worm)

Oesophagostomum sp. (Nodular worms)

Ascaris suum (large roundworm)

Trichuris suis (Whipworm)

Also effective in the contol of Metastrongylus apri (Lungworm).

An ovicidal effect on nematode eggs.

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Dosage

A manufacturer who is approved to incorporate directly at any concentration, veterinary medicinal products or premixtures containing such products must be responsible for mixing when incorporation is less than 2kg per tonne for final feed.

To be administered orally, mixed with feed. The dose rate for administration is 5 mg fenbendazole per kg bodyweight. The product may be administered to pigs either as a single dose or by divided dosage over 7 days. It may also be administered to sows over 14 days.

For the treatment of infections with Trichuris and for control of Metastrongylus apri the dose of 5 mg/kg should be divided and spread over 7 days.

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Contraindications

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

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Adverse reactions

None known

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Warnings

(i) Special precautions for use in animals

When preparing medicated feed for pigs which are to be administered over a number of days, to ensure thorough dispersion a pre-mix should be prepared first. Once mixed, this should then be incorporated with the remaining feed.

The product can be incorporated into pelleted feed preconditioned with steam at a temperature not greater than 75°C.

Only to be incorporated by a manufacturer who are approved to mix at a rate of below 2 kg per tonne of final feed.

(ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals

Incorporating into the feed must be performed by a suitably approved manufacturer.

Impervious gloves must be worn when handling this product or feed containing this product.

When handling or mixing, care should be taken to avoid direct contact with the skin and inhalation of any dust by wearing protective clothing, rubber gloves and 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.

Wash hands and exposed skin after handling medicated feedstuffs.

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Use during pregnancy, lactation or lay

Ecozole 4% Powder can be safely used during pregnancy and lactation.

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Interactions

None known.

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Overdose

Benzimidazoles have a wide safety margin.

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Special warnings

None.

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Withdrawal period

Meat and offal: 3 days

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Incompatibilities

None known.

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Immediate packaging

The product is presented in pack sizes of 500 g, 1 kg and 10 kg packed into low density polyethylene bag in a polypropylene tub closed with polypropylene push fit cap.

Not all pack sizes may be marketed.

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Storage

Store in a dry place.

Do not store above 25°C.

The product will remain stable in the finished feed for 12 months.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after incorporation into finished feed: 12 months.

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Disposal of unused product

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

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Additional information

Vm 08749/5109

9 DATE OF FIRST AUTHORISATION

06 July 1995

10 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

October 2025

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Registration holder

Chanelle Pharmaceuticals Manufacturing Ltd

Loughrea

Co. Galway

H62 FH90

Ireland

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