Embotape is a ready to use oral wormer for horses and other equines. A pale or buff coloured paste. Each syringe mark for 100kg weight, contains 1.9g Pyrantel embonate.
for the treatment and control of adult infections of large and small Redworms, Ascarids, and pinworms found in gastr-intestinal tract of horses and other equines. embotape also treats and controls tapeworm infection.
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Embotape Oral Paste 400 mg/g
Each syringe contains:
Active substance |
Per 28.5 g Syringe |
Per 57 g Syringe |
Pyrantel embonate Excipients |
11.4 g |
22.8 g |
Butylated Hydroxytoluene (E321) |
0.0057 g |
0.0114 g |
For a full list of excipients see section 6.1.
Oral paste.
A pale coloured to buff coloured paste.
4.1 Target Species
Horses and ponies.
For the control and treatment of adult infections of large and small Strongyles, Oxyuris, Parascaris and Anoplocephala perfoliata.
4.3 Contraindications
Do not use in severely debilitated animals.
Only intended for direct oral administration.
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.
As with other anthelmintics, veterinary advice should be sought on appropriate dosing programmes and stock management to achieve adequate parasite control and reduce the likelihood of anthelmintic resistance developing.
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 under-estimation of the bodyweight, mis-administration of the product or lack of calibration of the dosing device (if any).
Special precaution(s) for use in animals
None.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid contact with the skin. Wash hands and any other parts of the body which come into contact with the product after use.
4.6 Adverse reactions (frequency and seriousness)
Occasional skin sensitisation may occur.
The product may be used on pregnant and lactating mares.
4.8 Interaction with other medicinal products and other forms of interaction Combined administration of pyrantel and levamisole or piperazine is not recommended
For direct oral administration only.
Control and treatment of Strongyles, Oxyuris and Parascaris:
Embotape should be used at a dose rate of 19 mg pyrantel embonate per kg bodyweight. Suggested dosing programmes are as follows:
The appropriate amount of the product is deposited on the tongue of the animal and the animal allowed to swallow. The complete content 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 600 kg bodyweight. Each graduation of the syringe is sufficient for the treatment of 100 kg bodyweight.
The appropriate amount of the product is deposited on the tongue of the animal and the animal allowed to swallow. The complete content of one syringe contains 22.8g pyrantel embonate (12 graduated doses of 1.9g marked in 100 kg intervals from 0 to 1200 kg) in a 57g paste and one syringe is sufficient for the treatment of 1200 kg bodyweight. Each graduation of the syringe is sufficient for the treatment of 100 kg bodyweight.
Control and treatment of anoplocephala (tapeworm):
Embotape should be used at a dose rate of 38 mg pyrantel embonate per kg bodyweight (i.e. twice the dose used for strongyles). Two syringes are sufficient for the treatment of 600 kg bodyweight. The need for re-treatment may vary, but if considerded necessary, should be carried out after an interval of 6 weeks.
Embotape should be used at a dose rate of 38 mg pyrantel embonate per kg bodyweight (i.e. twice the dose used for strongyles). One syringe is sufficient for the treatment of 600 kg bodyweight. The need for re-treatment may vary, but if considerded necessary, should be carried out after an interval of 6 weeks.
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, serum cholinesterase and glutamic oxaloacetic transaminase levels.
4.11 Withdrawal Period(s)
Horses may be slaughtered for human consumption only after 7 days from the last treatment.
ATC Vet Code: QP52AF02
Pharmacotherapeutic Group: Anthelmintics, Pyrantel
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 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. Pyrantel embonate has a broad spectrum of activity, including activity against:
Large strongyles: Strongylus 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
Butylated Hydroxytoluene (E321)
Polysorbate 80
Colloidal Anhydrous Silica Maize Oil Refined
6.2 Incompatibilities
Not applicable
Shelf life of the veterinary medicinal product as packaged for sale: 2 years. This is a single dose product. Discard after use.
6.4 Special precautions for storage
Protect from direct sunlight.
White, high 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 (28.5 syringe) or 1 to 12 doses (57 g syringe) of the product.
28.5g syringe: Each box contains 20 × 28.5 g syringes
57g syringe: Each box contains 20 × 57g syringes
Any unused veterinaty medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Cross Vetpharm Group Limited
Broomhill Road
Tallaght
Dublin 24
VPA 10960/025/001
8th January 2008
18th June 2010