Pigfen 40 Mg/G Granules For Pigs
AN: 00179/2014
Issued: September 2015
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
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. |
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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:
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 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.
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.
Amounts to be administered and administration route
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Pigfen administered as a single 25 mg fenbendazole/kg dose for three consecutive days did not produce any clinically apparent adverse reactions in pigs.
Withdrawal periods
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 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.
6. PHARMACEUTICAL PARTICULARS
List of excipients
Maize Starch
Pregelatinised starch
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: 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
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