Target Species
Horses, ponies, donkeys and foals over four weeks of age.
Indications for Use, Specifying the Target Species
A broad spectrum anthelmintic for use in horses and donkeys for the control and treatment of adult infections of large and small strongyles, Oxyuris, Parascaris and Anoplocephala perfoliata.
Effective against benzimidazole resistant strains of small strongyles.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
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.
•Underdosing, 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 anthelmintics 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 US and Canada). Therefore the use of this product should be based on a 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
Special precautions for use in target species:
The same oral doser 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
Avoid contact with skin. Wash hands and any other parts of the body which come into contact with the product.
Special precautions for the protection of the environment:
Not applicable.
Adverse reactions (frequency and seriousness)
Horses, ponies, donkeys, foals:
Very rare (<1 animal/10,000 animals treated, including isolated reports): | Colic1, Intestinal impaction2 |
1May be seen within 30 minutes of treatment.2May occur in foals infected with high numbers of Parascaris equorum.
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 the national competent authority via the national reporting system. See the label for respective contact details.
Use during pregnancy, lactation or lay
The veterinary medicinal product is specifically recommended for use in mares which may be pregnant and/or lactating.
Interaction with other medicinal products and other forms of interaction
Combined administration of pyrantel and levamisole or piperazine is not recommended.
Amounts to be administered and administration route
Oral use.
Administration:
The veterinary medicinal product is recommended for direct oral administration in horses, ponies, donkeys and foals over four weeks of age. It is not necessary to withhold any feed prior to administration. The following method of administration is recommended:
1. Position the locking ring over the appropriate mark on the plunger.
2. Remove the cap from the nozzle.
3. The paste is best deposited on the upper surface of the tongue. Introduce the nozzle end of the oral doser at the corner of the mouth. Direct the oral doser backwards and depress the plunger to deposit the paste onto tongue. Providing the paste is given in this way it is unlikely that any rejection will occur. Raising the head by a hand under the chin sometimes helps with swallowing.
Dosage:
For the control and treatment of strongyles Oxyuris and Parascaris but excluding Anoplocephala (tapeworm). The veterinary medicinal product should be used at a dose rate of 19 mg pyrantel embonate per kg bodyweight.
Bodyweight range | Dose – contents of | Dose of pyrantel embonate |
Up to 150kg | ¼ oral doser | 2.85g |
151 – 300kg | ½ oral doser | 5.70g |
301 – 450kg | ¾ oral doser | 8.55g |
451 – 600kg | Full oral doser | 11.40g |
Note: Position locking ring over appropriate mark on plunger.
Dosage: For the control and treatment of tapeworms: The veterinary medicinal product should be used at a dose rate of 38 mg pyrantel embonate per kg bodyweight, that is twice the dose rate for strongyles.
To ensure administration of a correct dose, body weight 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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
The veterinary medicinal product has an extremely wide safety margin and overdosage should not produce any adverse reactions.
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.
Withdrawal Period(s)
Meat and offal: zero days.