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Date: Tuesday, April 23, 2024 7:50

Description: MSD-AH
Release 5.93
Panacur® Equine Granules 22.2% w/w
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for horses
Active ingredient: Fenbendazole
Product:Panacur® Equine Granules 22.2% w/w
Product index: Panacur® Equine Granules 22.2% w/w
Withdrawal notes: Not to be used in horses intended for human consumption.
Incorporating:
Qualitative and quantitative composition
Fenbendazole 22.222% w/w
For a full list of excipients, see section “Pharmaceutical Particulars”.
Pharmaceutical form
Granules. A white to yellowish-white granular powder.
Clinical particulars
Target species
Horses and other equines.
Indications for use
A broad spectrum anthelmintic for the treatment and control of adult and immature roundworms of the gastro-intestinal tract in horses and other equines.
Panacur effectively treats and controls the following roundworm infections: Large strongyles (adults and migrating larval stages of S.vulgaris; adults and tissue larval stages of S. edentatus)
Adult and immature small strongyles (Cyathostomes) (benzimidazole susceptible) including encysted mucosal 3rd and 4th stage larvae; it is also effective against inhibited 3rd stage larvae (encysted) in the mucosa.
Adult and immature Oxyuris spp., Strongyloides spp. and Parascaris equorum.
Panacur also has an ovicidal effect on nematode eggs.
Contraindications
None known.
Special warnings 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:
(i) Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
(ii) 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.
Resistance to fenbendazole has been reported in cyathostomes in horses. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
Special precautions for use
Assess bodyweight as accurately as possible before calculating the dosage.
Operator warnings
Direct contact with the skin should be kept to a minimum. Avoid inhalation of granule dust. Wash hands after use.
Adverse reactions
None known.
Use during pregnancy or lactation
Pregnant mares and young foals may be safely treated with fenbendazole at therapeutic dosage levels.
Interactions
None known.
Amounts to be administered and administration route
Routine treatment: Administer orally 5 g Panacur Equine Granules per 150kg bodyweight. (= 7.5mg fenbendazole/kg bodyweight)
Practical dosage recommendations:
Up to 150 kg: 5 g
151 to 300 kg: 10 g
301 to 450 kg: 15 g
451 to 600 kg: 20 g
601 to 750 kg: 25 g
751 to 900 kg: 30 g
Panacur Equine Granules sachet packs each contain 10.2 g granules and can be used as follows:
Foals and ponies up to 300 kg bodyweight: 1 sachet
Thoroughbreds and other breeds of horses up to 600 kg bodyweight: 2 sachets
Heavy hunters, heavy draft horses: 3 sachets
Donkeys: 1 sachet
Increased dosing for specific infections.
Five day course:
For the treatment and control of migrating larval stages of large strongyles and encysted mucosal 3rd and 4th stage larvae and inhibited 3rd stage small strongyle larvae (encysted) in the mucosa, administer 5 g Panacur Equine Granules per 150 kg bodyweight daily for 5 days.
(= 7.5 mg fenbendazole/kg bodyweight daily for 5 days).
Single dose treatments:
For the treatment and control of encysted mucosal stages of small strongyles, administer 20 g Panacur Equine Granules per 150 kg bodyweight.
(= 30 mg fenbendazole/kg bodyweight).
For the treatment and control of migrating stages of large strongyles, administer 40 g Panacur Equine Granules per 150 kg bodyweight.
(= 60 mg fenbendazole/kg bodyweight).
Diarrhoea caused by Strongyloides westeri in two to three week old suckling foals should be treated with Panacur 10% Suspension at a dose rate of 25 ml per 50 kg bodyweight.
(= 50 mg fenbendazole per kg bodyweight).
Panacur Equine Granules should be sprinkled onto concentrate or grain feed and the full dosage given as one administration.
To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked.
Recommended dosing programme
All horses should be routinely wormed with the single dose of Panacur Equine Granules every 6-8 weeks.
Treatment of encysted mucosal dwelling larvae should ideally be done in the autumn (late October/November) and again in the Spring.
However, for horses who fail to maintain condition or bought-in horses with unknown worming history, the treatment can be given at any time of the year.
Overdose
Benzimidazoles are unlikely to cause any reactions in the target species.
Withdrawal periods
Not to be used in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation.
Pharmacological particulars
ATCvet code: QP52AC13
Pharmacodynamic properties
Fenbendazole is an anthelmintic belonging to the benzimidazole carbamates group. It acts by interfering in the energy metabolism of the nematode. The anthelmintic efficacy is based on inhibition of the polymerisation of tubulin to microtubuli. The anthelmintic affects both adult and immature stages of gastro-intestinal and respiratory nematodes.
Pharmacokinetic particulars
Fenbendazole is only partly absorbed from the intestine and reaches maximum plasma concentration 6 (4-8) hours after oral administration.
Fenbendazole is metabolised mainly by enzymes of the cytochrome P -450 system in the liver. The major oxidative metabolite is fenbendazole sulfoxide which is further metabolised to fenbendazole sulfone.
Fenbendazole and its metabolites are distributed throughout the body but highest concentrations are found in the liver.
Fenbendazole and its metabolites are detectable in the plasma only during the first 48 hours following drug administration at a single dose rate of 10 mg fenbendazole/kg bodyweight.
Administration of fenbendazole at a dose rate of 10 mg/kg bodyweight daily for five consecutive days lead to accumulation of fenbendazole during the multiple dosing period whereas the concentrations of its two metabolites show only a slight increase. After the last administration on day 5, all three compounds are eliminated from blood very rapidly, within two or three days.
The elimination of fenbendazole and its metabolites occurs primarily via the faeces.
Pharmaceutical particulars
Excipients
Lactose monohydrate,
Povidone 2500,
Maize starch.
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 36 months.
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Immediate packaging
Pack A: A 10 g low density polyethylene/aluminium foil/paper laminated sachet with heat sealed closure, contained in a secondary cardboard box, consisting of either 10 or 100 sachets per box.
Disposal
Dangerous to fish and aquatic life. Do not contaminate ponds, waterways or ditches with the product or used container.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4424
Significant changes
Date of the first authorisation or date of renewal
29 January 1993.
Date of revision of the text
December 2020
Any other information
For animal treatment only. Keep out of sight and reach of children.
Legal category
Legal category: POM-VPS
GTIN
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