ORAL PASTE
COMPOSITION
Fenbendazole 187.5mg
Excipient q.s.p 1.0 g
PHARMACEUTICAL PROPERTIES
Fenbendazole is a benzimidazole anthelmintic. It acts by interfering with the energy metabolism of nematodes. Its anthelmintic efficacy is based on the inhibition of the polymerization of tubulin into microtubules. Destruction of the microtubular network often leads to disaggregation and cell death. Fenbendazole is metabolized to oxfendazole. These two molecules are known for their anthelmintic activity, and for having a reversible metabolism.
Fenbendazole has ovicidal, larvicidal and adulticidal action, and shows activity against gastrointestinal nematodes, lungworms and tapeworms.
After oral administration, absorbed fenbendazole is metabolised in the liver to fenbendazole sulphoxide, sulphone and amines. The half-life of fenbendazole in serum after oral administration of the recommended dose is 10 hours. In general, the elimination of fenbendazole and its metabolites takes place mainly via the faeces (>90%) and, to a lesser extent, in the urine and in the milk.
TARGET SPECIES
Horses.
IMDICATIONS
In horses, treatment of infestations with the following parasites:
- Gastrointestinal nematodes (adults and L4 larvae): Strongylus spp. ; Parascaris equorum; Oxyurus equi; Cyathostomum spp. ; Cylicocyclus spp. ; Strongyloides westeri.
- Lungworms (adults and L4 larvae): Dictyocaulus arnfieldi.
ADMINISTRATION AND DOSAGE
- In horses: 7.5 mg of fenbendazole per kg of body weight, in single oral administration, i.e. 4 g of paste per 100 kg of body weight.
- Severe Strongyloides westeri infestations in foals: 50 mg of fenbendazole per kg bodyweight, single oral administration, i.e. one 24 g applicator for a foal weighing 90 kg bodyweight.
The paste is administered orally, in the absence of any food, by introducing the end of the applicator into the interdental space and depositing the required quantity of paste at the base of the tongue. The plunger of the applicator has a graduated rod that allows the dose to be adjusted to the weight of the animal.
CONTRAINDICATIONS AND INTERACTIONS
- Do not use in animals with known hypersensitivity to the active ingredient.
- Do not use if resistance to benzimidazoles is suspected.
SIDE EFFECTS
If the doses are respected, no side effects are observed in the target species.
PRECAUTIONS FOR USE
Precautions for use in animals:
- Body weight should be assessed as accurately as possible before calculating the dose.
- Resistance to all benzimidazoles can develop during frequent and repeated use of an antiparasitic from this family.
Special precautions to be taken by the person administering the medicinal product:
- Avoid direct contact with the skin. Wash hands well after use. Wearing impermeable gloves is advised when using the drug.
- In case of accidental ingestion, consult a doctor immediately.
USE IN CASE OF PREGNANCY AND LACTATION
- In laboratory animals, fenbendazole like a number of other benzimidazoles causes a reduction in the functions of the male reproductive system and has embryotoxic and teratogenic properties.
- Safety in mares during pregnancy and lactation has been studied. The use of the specialty in mares during pregnancy and lactation does not pose any particular problem.
WITHDRAWAL PERIOD
- Meat and offal: 8 days.
- Milk: Do not use in dairy females whose milk or its derivatives are intended for human consumption.
STORAGE CONDITIONS
- Unopened container: Keep the product in the original packaging, protected from light and at a temperature < 25°C.
- After opening the bottle: Immediate use after opening.
PHARMACEUTICAL FORM AND PRESENTATION
Oral paste.
Case of a 24g syringe. Box of 10 syringes of 24g each.