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Date: Saturday, January 22, 2022 0:12

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Release 3.61
Embotape Oral Paste 40% w/w
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for horses
Active ingredient: Pyrantel Embonate
Product:Embotape Oral Paste 40% w/w
Product index: Embotape Oral Paste 40% w/w
Withdrawal notes: Not to be used on animals 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.
Qualitative and quantitative composition
Active Substance Per Syringe
Pyrantel embonate 11.4g
Pharmaceutical form
Pale yellow to buff coloured paste for oral administration.
Clinical particulars
Target species
Horses and ponies.
Indications for use
Pyrantel embonate is a broad spectrum anthelmintic. Pyrantel embonate is indicated for use in the horse for the control and treatment of adult infections of large and small strongyles, Pinworms, Roundworms, Tapeworms.
Pyrantel embonate has a broad spectrum of activity, including activity against:
Large strongyles: Stronglylus vulgaris, S. edentatus, S. equinus.
Small strongyles:Trichonema spp. (Cyathostomes), Triodontophorus spp.
Pinworms: Oxyuris equi, Probstmayria vivipara.
Large roundworms: Parascaris equorum.
Tape worms: Anoplocephala perfoliata.
Contra-indications
Not for use in foals less than 4 weeks of age.
Contraindicated in known sensitivity to pyrantel and in severely debilitated animals.
Special warnings for target species
Care should be taken to avoid the following practices because they increase the risk of development of resistence and could ultimately result in ineffective therapy:
Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
Underdosing, which may be due to underestimation of weight or misadministration of the product..
Suspected clinical cases of resistence 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 pyrantel has been reported in cyathostomes in horses (widespread in the USA and Canada). 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 resistence to anthelmintics.
Special precautions for use in animals
The same syringe should only be used to dose two animals if they are both healthy and are either running together, or are on the same premises and in direct contact with each other.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Direct contact with the skin should be avoided.
Wash hands and any other parts of the body which comes into contact with the product after use.
Avoid handling the product if you know you are hypersensitive to pyrantel.
Adverse reactions
Pyrantel embonate is safe for horses and ponies of all ages, including foals over 4 weeks old, pregnant mares and stallions. Impaction of the small intestine may occur in foals infected with high numbers of Parascaris equorum. Symptoms (colic) may be seen as soon as 30 minutes after treatment.
Use during pregnancy, lactation or lay
Embotape is safe to give to pregnant and lactating mares provided the recommendations are followed.
Interactions
Combined administration of pyrantel and levamisole or piperazine is not recommended.
Amounts to be administered and administration route
Control and treatment of Strongyles, Oxyuris and Parascaris:
Embotape should be used at a dose rate of 19 mg pyrantel embonate per kg bodyweight. The prescribed amount of Embotape is deposited on the tongue of the animal and the animal allowed to swallow. The complete contents of one syringe contains 11.4g pyrantel embonate (6 graduated doses of 1.9g) in 28.5g paste and is sufficient for the treatment of 600kg bodyweight. Each graduation of the syringe is sufficient for the treatment of 100kg body-weight.
Control and treatment of Anoplocephala (Tapeworm):
Embotape should be used at a dose rate of 38mg pyrantel embonate per kg bodyweight (i.e. twice the dose used for stronglyes). The need for re-treatment may vary, but if considered necessary, should be carried out after an interval of 6 weeks.
To ensure administration of a correct dose, body weight should be determined as accurately as possible.
Overdose
Pyrantel embonate is of low oral toxicity. Oral doses of up to 2000mg/kg bodyweight in mice and rats and 1000mg/kg in dogs have produced no evidence of toxicity.
Pyrantel embonate, at dosages of up to 60mg/kg bodyweight (20 times the standard therapeutic dose) had no adverse effects on horses, ponies or foals. Monitoring included haematological parameters, and serum cholinesterase and glutamic oxaloacetic transaminase levels.
Withdrawal periods
Not to be used in horses and ponies 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
ATC vet code QP52AF02.
Pyrantel embonate is a broad spectrum anthelmintic with a depolarising neuromuscular blocking action which results in spastic paralysis of the worm, and their expulsion from the intestinal tract.
Pyrantel embonate also inhibits cholinesterases which contributes to its neuromuscular effects. Pyrantel embonate is poorly absorbed from the gastronintestinal tract, making it suitable for use as an intestinal anthelmintic. The small amount of pyrantel embonate which is absorbed is quickly metabolised with little being excreted intact.
Pharmaceutical particulars
List of Excipients
Butylated hydroxytoluene
Polysorbate 80
Silica Colloidal Anhydrous
Maize Oil
Major incompatibilities
None Known.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Special precautions for storage
Do not store above 25°C. Protect from direct sunlight.
Immediate packaging
28.5g white, low density polyethylene syringe with a low density polyethylene cap. The syringe is fitted with a screw ring on a graduated plunger allowing adjustment of 1 to 6 doses of the product. Graduations on the syringe at 100kg bodyweight intervals.
Disposal
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 50146/4014
Significant changes
12 May 2004
Date of revision of the text
October 2018
Any other information
From authorised packaging details (labelling)
Practical Dosage Recommendations
WEIGHT
TYPE
ROUTINE TREATMENT
UP TO 100 KG
MINIATURE PONIES
SYRINGE MARK 100KG
101-300 KG
DONKEY, SHETLAND & OTHER SMALL PONIES, FOALS
SYRINGE MARK 300KG (1/2 SYRINGE)
301-400 KG
DARTMOOR, NEW FOREST, WELSH
SYRINGE MARK 400KG
401-500 KG
LIGHT HUNTERS, ARABS, ETC
SYRINGE MARK 500KG
501-600 KG
THOROUGHBREDS
SYRINGE MARK 600KG (1 SYRINGE)
601 KG AND OVER
HEAVY HUNTERS, DRAUGHT HORSES
1 FULL SYRINGE PLUS ONE 100KG SYRINGE MARK FOR EACH ADDITIONAL 10KG BODYWEIGHT
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Embotape Paste 1's
GTIN:5391510230151