Zerofen Vet.
PACKAGE LEAFLET
Name and Address of the Marketing Authorisation Holder and of the Manufacturing Authorisation Holder Responsible for Batch Release if different
Marketing Authorisation Holder and Manufacturer for Batch Release: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland.
Name of the Veterinary Medicinal Product
Zerofen vet. 4% Oral powder for Swine
Statement of the active substance(s) and other ingredient(s)
Active Substance: Fenbendazole 40mg/g
Excipient: Lactose Monohydrate
Indication(s)
Zerofen vet. 4% oral powder is a broad spectrum anthelmintic for the treatment of pigs infected with nematodes of the gastro-intestinal tract:
Red stomach worms; Hyostrongylus rubidus (mature and immature stages)
Nodular worms; Oesophagostomumspp.(mature and immature stages)
Eel worms; Ascaris suum (mature stages)
Use during pregnancy and lactation
Since benzimidazoles may possess embryotoxic effects, restrictive use in the first stages of pregnancy is recommended.
Contraindications
None known
Adverse Reactions
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. Intolerance to lactose is seen in animals who lack the intestinal enzyme lactase, which can lead to diarrhoea, abdominal discomfort, distension and flatulence.
Target Species
Pigs from the age of weaning.
Dosage for each species, route(s) and method of administration
Zerofen vet. should be administered orally mixed with feed.
The normal dose rate is 5 mg of fenbendazole per kg bodyweight, given as a single dose, which corresponds to 1.2 g of powder per10 kg bodyweight.
Calibrated scales should be used in order to weigh accurate dosing amounts.
To ensure administration of a correct dose, body weight should be determined as accurately as possible.
For use in individual pigs on farms where only a small number of pigs are to receive the medicine.
The product should be mixed thoroughly to achieve a homogenous and stable mixture.
It has to be ensured that the calculated dose is completely taken up by the animals. Consideration must be given to pigs whose daily feed intake is reduced or restricted.
Advice on Correct Administration
Zerofen vet. 4% powder is not intended for medicated feed manufacturing. It should not be administered in the drinking water.
WithdrawAl Period
Meat and offal: 3 days.
Special Storage Precautions
Keep in the original container. Keep the container tightly closed.
Use before expiry date, as printed on the packaging.
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:
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Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
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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 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”.
Because of possible sensitisation and contact dermatitis, direct skin contact and inhalation should be avoided. When handling, suitable protective equipment such as rubber gloves and filtering masks should be used. Hands should be washed after handling the finished feed. Product is harmful if swallowed.
Special Precautions for the disposal of unused product or waste materials, if any
Any unused veterinary medicinal products or waste materials derived from such medicinal products should be disposed of in accordance with local requirements.
Date on which the Package Leaflet was last Approved
2014-04-24
Other Information
This pharmaceutical is active against immature and mature forms of red stomach worms and nodular worms and against mature forms of eel worms. Fenbendazole is a benzimidazole compound that kills the parasites. Fenbendazole interacts with the energy metabolism of the parasite by inhibition of the glucose uptake.
Packaging sizes: 500g, 1kg, 2.5 kg, 5 kg and 10kg.
Not all pack sizes may be marketed