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Date: Wednesday, August 5, 2020 8:09

Description: MSD-AH
Release 4.4
Panacur Equine Oral Paste 18.75 % w/w
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for horses
Active ingredient: Fenbendazole
Product:Panacur® Equine Oral Paste 18.75 % w/w
Product index: Panacur Equine Oral Paste
Withdrawal notes: Not for use in horses intended for human consumption.
Qualitative and quantitative composition
Each 24g syringe contains:
Active substance(s)
Fenbendazole: 18.75 % w/w
Excipient(s)
Methyl Parahydroxybenzoate: 0.17 % w/w
Propyl Parahydroxybenzoate: 0.016 % w/w
For full list of excipients, see section "Pharmaceutical Particulars".
Pharmaceutical form
Oral paste.
A white to light grey homogenous paste.
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 also has an ovicidal effect on nematode eggs.
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).
Benzimidazole susceptible adult and immature small strongyles (Cyathostomes), including encysted mucosal 3rd and 4th stage larvae; it is also effective against encysted inhibited 3rd stage larvae in the mucosa.
Adult and immature Oxyuris spp.,Strongyloides spp. and Parascaris equorum.
Contra-indications
None.
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:
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.
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. Wear impermeable rubber gloves while administering the product. Wash hands after use.
Adverse reactions
None known.
Use during pregnancy, lactation or lay
Pregnant mares and 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, 1 Syringe per 600 kg bodyweight
(= 7.5 mg fenbendazole/kg bodyweight)
Practical dosage recommendations:
Weight
Type
Routine treatment
Up to 100 kg
Miniature ponies
Syringe mark 100 kg
101-300 kg
Donkey, Shetland and other small
ponies, foals
Syringe mark 300 kg (½ syringe)
301-400 kg
Dartmoor, New Forest, Welsh etc
Syringe mark 400 kg
401-500 kg
Light hunter, Arabs etc.
Syringe mark 500 kg
501-600 kg
Thoroughbreds
1 syringe
601 kg and over
Heavy hunters, draught horses
1 syringe +
additional 100 kg
syringe marks for each extra 100 kg bodyweight
Increased dosing for specific infections:
Five day course:
For the treatment and control of migrating and tissue larval stages of large strongyles, encysted mucosal 3rd and 4th stage small strongyle larvae and encysted inhibited 3rd stage small strongyle larvae in the mucosa, administer 1 syringe per 600 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 1 syringe per 150 kg bodyweight.
(= 30 mg fenbendazole/kg bodyweight)
For the treatment and control of migrating stages of large strongyles administer 1 syringe per 75 kg bodyweight.
(= 60 mg fenbendazole/kg bodyweight)
For the treatment and control of Strongyloides westeri in sucking foals administer 1 syringe per 90 kg bodyweight.
(= 50 mg fenbendazole/kg bodyweight)
Panacur Equine Paste should be administered orally by squeezing the paste from the syringe onto the back of the tongue. No dietary control is required before or after treatment.
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 Paste every 6-8 weeks.
Treatment of encysted inhibited and encysted mucosal dwelling larvae should be performed in the autumn (ideally late October/November) and again in the spring (ideally in February). 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 have a high margin of safety.
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
Pharmacodynamic properties
Fenbendazole is an anthelmintic belonging to the benzimidazole carbamate group
(ATCvet code: QP52AC13).
Fenbendazole 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 properties
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
Methyl Parahydroxybenzoate, Propyl Parahydroxybenzoate, Propylene Glycol, Apple and Cinnamon Flavour, Carbomer 980, Glycerol (85%),
Sorbitol (70%, crystalising), Sodium Hydroxide and Water Purified.
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Do not store above 25 °C. Protect from direct sunlight.
Immediate packaging
A 24 g, white, opaque, high density polyethylene, graduated oral syringe with a low density polyethylene plunger and plunger head. The closure is a white, opaque, low density polyethylene cap (push-fit).
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 Number
Vm 01708/4439
Significant changes
Date of the first authorisation or date of renewal
29 January 1993
Date of revision of the text
May 2013.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Panacur PA FLAV 10x24gr
GTIN:08713184042347