SUMMARY OF PRODUCT CHARACTERISTICS

Pigfen40 mg/g granules for pigs.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 g contains

Active substance

Fenbendazole 40 mg

Other substances

For the full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Granules

Off-white to light yellow granules.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs.

4.2 Indications for use, specifying the target species

Treatment of pigs infected with Ascaris suum (adult and migrating larval stages)

4.3 Contra-indications

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

4.4 Special warning for each target species

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:

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.

4.5 Special precautions for use

i. Special precautions for use in animals

None

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

This product may cause eye irritation and skin sensitisation.

Avoid contact with skin and/or eyes.

When handling or mixing, care should be taken to avoid direct contact with the skin and eyes, and inhalation of dust, by wearing goggles, impervious gloves and adisposable half-mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN 140 with a filter to EN 143.

Wash hands after use.

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

iii 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

The product can be safely administered to pregnant animals.

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.

4.8 Interaction with other medicinal products and other forms of interaction

Exacerbation of paracetamol hepatotoxicity by fenbendazole cannot be excluded.

For oral administration.

The 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 the daily feed ration.

The dose is 5 mg fenbendazole per kg bodyweight (12.5 g of the product/100 kg bodyweight) to be administered as a single dose.

Bodyweight should be determined as accurately as possible to avoid under- dosing.

For accurate dosing use a suitably calibrated measuring device.

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

Meat and offal: 4 days.

5. PHARMACOLOGICAL PROPERTIES

Anthelmintics, benzimidazole derivatives – fenbendazole.

ATCvet Code: QP52AC13

5.1 Pharmacodynamic properties

Fenbendazole is an anthelmintic 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

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 T_max 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.

6. PHARMACEUTICAL PARTICULARS

Maize Starch

Pregelatinised starch

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: 2 years.

Shelf life after first opening the immediate packaging: 3 months.

6.4 Special precautions for 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.

6.5 Nature and composition of 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.

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

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

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

8. MARKETING AUTHORISATION Number

Vm30282/4023

9. Date of first AUTHORISation

16 September 2015

10. Date of Revision of text

September 2015

Approved: 16/09/2015