Pigfen 40 mg/g Granules for Pigs

Composition

Each g contains

Active substance:

Fenbendazole 40 mg

Excipients:

For the full list of excipients see section 6.1

6.1 List of excipients

Maize Starch

Pregelatinised starch

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Pharmaceutical form

Granules Off-white to light yellow granules.

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Pharmacological properties

Pharmacotherapeutic group: Anthelmintics, benzimidazoles and related substances, fenbendazole

ATC Vet Code: QP52AC13

5.1 Pharmacodynamic properties

Fenbendazole is an anthelmintic belonging to the benzimidazole-carbamate group. It acts by interfering with the energy metabolism of the nematode.

Fenbendazole inhibits the polymerisation of tubulin to microtubules. This interferes with essential structural and functional properties of the cells of helminths, such as formation of cytoskeleton, formation of the mitotic spindle and the uptake and intracellular transport of nutrients and metabolic products.

5.2 Pharmacokinetic particulars

Fenbendazole is only partly absorbed after oral administration and is then metabolised in the liver. Body clearance of fenbendazole in serum after intravenous administration to pigs at a dose rate of 1 mg/kg was 1.36 L/h/kg, volume of distribution at steady state was 3.35 L/kg and the mean residence time was 2.63 hours.

After oral administration at a dose rate of 5 mg/kg the peak plasma concentration of fenbendazole was 0.07µg/ml, the Tmax was 3.75 hours and the mean residence time was 15.15 hours. The bioavailability was 27.1 %. Oxfendazole was the major plasma metabolite i.e 2/3 of the total AUC.

Fenbendazole and its metabolites are distributed throughout the body and high concentrations can be found in the liver.

The elimination of fenbendazole and its metabolites occurs primarily via the faeces (>90%) and to a small extent in the urine and milk.

Fenbendazole is metabolised to its sulphoxide, then to sulphone and amines.

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Target species

Pigs

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Indications

Treatment of pigs infected with Ascaris suum (adult, intestinal and migrating larval stages) susceptible to fenbendazole.

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Dosage

Oral use.

The veterinary medicinal product is only intended for the treatment of individual pigs on farms where a small number of pigs are to receive treatment.

To be mixed with a small quantity (20%) of the daily feed ration and administered prior to offering the remaining feed.

The treated feed must be prepared daily just before administration to the animals.

Pigs to be treated should be separated and treated individually.

May be administered to pigs using the following dosage regimens:

- Single dose of 5 mg fenbendazole (corresponding to 125 mg of the veterinary medicinal product) per kg bodyweight (migrating larval, intestinal larval and adult stages);

- 0.72 mg fenbendazole (corresponding to 18 mg of the veterinary medicinal product) per kg bodyweight per day for 7 consecutive days (intestinal larval and adult stages);

- 0.36 mg fenbendazole (corresponding to 9 mg of the veterinary medicinal product) per kg bodyweight per day for 14 consecutive days (intestinal larval and adult stages).

To ensure a correct dosage, body weight should be determined as accurately as possible.

The intake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of fenbendazole may need to be adjusted accordingly.

The use of suitably calibrated measuring equipment is recommended.

Partly-consumed feed must be disposed of with other waste feed and not given to other animals.

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Contraindications

Do not use in cases of hypersensitivity to the active substance, to other benzimidazoles or to any of the excipients.

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Adverse reactions

None known.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for use in animals

None.

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

Embryotoxic effects cannot be excluded. Pregnant women must take extra precautions when handling this veterinary medicinal product.

This veterinary medicinal product may be toxic to humans after ingestion.

Accidental ingestion of the veterinary medicinal product should be avoided.

In case of accidental ingestion, rinse mouth with plenty of clean water, seek medical advice immediately and show the package leaflet or the label to the physician.

This veterinary medicinal product may cause eye irritation and skin sensitisation.

Avoid contact with skin and/or eyes.

Personal protective equipment consisting of goggles, impervious gloves and a disposable half-mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN 140 with a filter to EN 143 should be worn when handling the veterinary medicinal product.

In case of skin and/or eye contact, immediately rinse with plenty of water.

Wash hands after use.

Special precautions for the protection of the environment

The veterinary medicinal product should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.

Other precautions

Not applicable

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

Can be used during pregnancy.

The safety of the veterinary medicinal product has not been established during lactation. Use only according to the benefit-risk assessment by the responsible veterinarian.

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Interactions

Exacerbation of paracetamol hepatotoxicity by fenbendazole cannot be excluded.

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Overdose

The veterinary medicinal product administered as a single 25 mg fenbendazole/kg dose for three consecutive days did not produce any clinically apparent adverse reactions in pigs.

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Special 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.

• Under dosing, which may be due to underestimation of body weight, misadministration of the veterinary medicinal product, or lack of calibration of the dosing device (if any).

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

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Withdrawal period

Meat and offal: 4 days.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

Polyethylene/aluminium foil/polyethylene terephthalate zipper bags of 0.250 kg, 0.500 kg and 1 kg.

Not all pack sizes may be marketed.

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Storage

Veterinary medicinal product as packaged for sale: no special storage precautions.

After first opening of the immediate packaging: do not store above 25°C.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 3 months.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

The veterinary medicinal product should not enter water courses as fenbendazole may be dangerous for fish and other aquatic organisms.

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 30282/5014

9 DATE OF FIRST AUTHORISATION

16 September 2015

10 DATE OF REVISION OF THE TEXT

December 2023

PROHIBITION OF SALE, SUPPLY AND/OR USE

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Approved 04 May 2024

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Registration holder

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

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