SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Curofen50 mg/g oral powderforpigs

[Fendoral 50 mg/g oral powder for pigs (Belgium)]

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each g contains:

Active substance:

Fenbendazole 50 mg

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral powder.

Awhitepowder.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs.

4.2 Indications for use, specifying the target species

Forthetreatment ofbenzimidazolesusceptiblematureand immature(L₄) forms ofthefollowing nematodes of thegastrointestinal and respiratory tracts ofpigs:

Hyostrongylus rubidus (red stomach worm)

Oesophagostomumspp. (nodularworms)

Ascaris suum(eel worm)

Trichuris suis (whip worm)

Metastrongylus apri (Lungworm)

4.3 Contraindications

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species

Careshouldbetakentoavoidthefollowingpracticesbecausetheyincreasetheriskofdevelopmentofresistanceand could ultimately resultin ineffectivetherapy:

• 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).

Suspected clinical cases ofresistanceto anthelmintics should befurtherinvestigated using appropriatetests (e.g.Faecal Egg CountReduction Test). Wheretheresultsofthetest(s)strongly suggest resistanceto aparticularanthelmintic, an anthelminticbelonging to anotherpharmacological class and having adifferent modeofaction should beused.

4.5 Special precautions for use

Special precautions for use in animals

Not applicable.

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

This product may cause hypersensitivity (allergy) reactions. People with known hypersensitivity to fenbendazole should avoid contact with the veterinary medicinal product.

Avoid skin contact when handling 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, including impervious gloves and a face-mask. It is recommended to use either 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 all exposed skin after use.

Other Precautions

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

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Theproduct can beused in pregnant or lactating sows.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

For oral administration by adding to small quantities of feed for immediate consumption by individual pigs.

Individual Treatment – single dose

The recommended therapeutic dose is 5 mg fenbendazole per kg bodyweight as a single dose individual treatment which is equivalent to 1g of product per 10kg bodyweight or 5g of product per 50 kg bodyweight or 20g of product per 200 kg bodyweight.

To ensure the correct dosage and to avoid possible under-dosing, the bodyweight and the amount of product to be administered should be determined as accurately as possible. To accurately measure the correct amount of product, a suitably calibrated weighing scale should be used.

The recommended amount of veterinary medicinal product should be added to a small quantity of the estimated daily amount of food for each individual animal in a bucket or a similar container and mixed thoroughly prior to being offered for immediate consumption.

Medicated feed should be freshly prepared before administration.

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

Dosing table:

Pig Bodyweight (kg)	Amount (g) of product
50 kg	5g
100 kg	10g
150 kg	15g
200 kg	20g

For use in individual pigs on farms where only a small number of pigs are to receive the veterinary medicinal product. Larger groups should be treated with medicated feeding stuff manufactured using an appropriate anthelmintic premix.

Treatment for specific infections

For the treatment of Trichuris suis, it is recommended that the dosage is divided and administered over seven days.

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

None known.

4.11 Withdrawal period

Meat and offal: 6 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anthelmintics, benzimidazole derivatives – fenbendazole.

ATCvet code: QP52AC13.

5.1 Pharmacodynamic properties

Fenbendazole is an anthelmintic (wormer) belonging to the benzimidazole-carbamate group. It acts by binding to beta-tubulin, thereby inhibiting the polymerisation of tubulin to microtubules and subsequently interfering with energy metabolism.

5.2 Pharmacokinetic particulars

Fenbendazoleis poorly solublein waterand consequently is poorly absorbed when administered orally. The main breakdown products arethesulphoxide(oxfendazole)and sulphone.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

GlucoseMonohydrate

Colloidal anhydrous silica

6.2 Incompatibilities

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

6.3 Shelf life

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

Shelf life after first opening the immediate packaging: 28 days

6.4. Special precautions for storage

Store in a dry place.

Store in the original container in order to protect from light.

6.5 Nature and composition of immediate packaging

200 g and 1kg bag composed of clear low density polyethylene (LDPE) laminated with metallised polyester.

1 kg bag composed of clear low density polyethylene (LDPE).

5 x 200g LDPE laminated bags in a cardboard box

1 kg LDPE laminated bag

1 kg LDPE bag inside a white polypropylene container

Not all pack sizes may be marketed

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. The product should not enter water courses as this may be dangerous for aquatic organisms.

7. MARKETING AUTHORISATION HOLDER

Univet Ltd.

Tullyvin

Cootehill

Co. Cavan

Ireland

8. MARKETING AUTHORISATION NUMBER

Vm 05150/4004

9. DATE OF FIRST AUTHORISATION

04 December 2015

10. DATE OF REVISION OF THE TEXT

December 2015

Approved: 04 December 2015