Embotape Oral Paste 40% w/w

Composition

Each gram contains:

Active substance:

Pyrantel embonate 400 mg

Excipients:

Pale yellow to buff coloured paste.

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Pharmacological properties

4.1 ATCvet code: QP52AF02

4.2 Pharmacodynamics

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 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.

Pyrantel embonate is poorly absorbed from the gastrointestinal 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.

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Target species

Horses and ponies.

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Indications

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.

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Dosage

Oral use.

Control and treatment of Strongyles, Oxyuris and Parascaris:

The veterinary medicinal product should be used at a dose rate of 19 mg pyrantel embonate per kg bodyweight.

The prescribed amount of the veterinary medicinal product is deposited on the tongue of the animal and the animal allowed to swallow. The complete content of one syringe contains 11.4 g pyrantel embonate (6 graduated doses of 1.9 g) in 28.5 g paste and is sufficient for the treatment of 600 kg bodyweight. Each graduation of the syringe is sufficient for the treatment of 100 kg bodyweight.

Control and treatment of Anoplocephala (Tapeworm):

The veterinary medicinal product should be used at a dose rate of 38 mg pyrantel embonate per kg bodyweight (i.e. twice the dose used for stronglyes). To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked. Inappropriate use of anthelmintics may increase resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on professional advice and take into account current best practice recommendations for parasite control.

Practical dosage Recommendations:

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Contraindications

Not for use in foals less than 4 weeks of age.

Contraindicated in known sensitivity to pyrantel and in severely debilitated animals.

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Adverse reactions

1Of the small intestine, in foals infected with high numbers of Parascaris equorum. Symptoms (colic) may be seen as soon as 30 minutes after treatment.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

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 veterinary medicinal product after use.

People with known hypersensitivity to pyrantel embonate should avoid contact with the veterinary medicinal product.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

The veterinary medicinal product is safe to give to pregnant and lactating mares provided the recommendations on current best practice for parasite control are followed.

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Interactions

Combined administration of pyrantel and levamisole or piperazine is not recommended.

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Overdose

Pyrantel embonate is of low acute oral toxicity. Oral doses of up to 2000 mg/kg bodyweight in mice and rats and 1000 mg/kg in dogs have produced no evidence of toxicity.

Pyrantel embonate, at dosages of up to 60 mg/kg bodyweight, as base, (some 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.

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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:

• 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, misadministration of this veterinary medicinal 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 pyrantel has been reported in cyathostomes in horses (also widespread in the USA and Canada). Therefore, the use of this veterinary medicinal 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.

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Withdrawal period

Not authorised for use 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.

Not authorised for use in mares producing milk for human consumption.

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Incompatibilities

None known.

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Immediate packaging

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 veterinary medicinal product. Graduations on the syringe at 100 kg bodyweight intervals.

Pack sizes:

Carton box containing 1 × 28.5 g syringe.

Carton box containing 20 × 28.5 g syringes.

Not all pack sizes may be marketed.

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Storage

Do not store above 25 °C.

Protect from direct sunlight.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 50146/4014

8 DATE OF FIRST AUTHORISATION

12 May 2004

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

July 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

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Registration holder

Bimeda Animal Health Limited

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