Introduction

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

Strongid Caramel is a pale yellow to buff paste, containing 43.72% w/w Pyrantel embonate in an inert carrier and presented in a disposable plastic oral doser.

Each oral doser contains 11.4g pyrantel embonate in 26g (22 ml) paste.

Uses

Strongid Caramel is a broad-spectrum anthelmintic, which is indicated for use in horses, ponies, foals over four weeks of age and donkeys for the control and treatment of adult infections of large and small strongyles, Oxyuris, Parascaris and Anoplocephala perfoliata.

Strongid Caramel is effective against benzimidazole resistant strains of small strongyles.

Dosage and administration

Administration

Strongid Caramel is recommended for direct oral administration in horses, ponies and foals of over four weeks of age and donkeys. 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 the tongue. Providing the paste is given in this way it is unlikely that any rejection will occur. Raising the horse's head by a hand under the chin sometimes assists in the swallowing process.

4. If only part of the paste has been used (see Contra-indications, warnings, etc.), replace the cap on the oral doser nozzle. Any part used oral doser should be stored below 25°C and used within two months.

Dosage

For the control and treatment of strongyles including benzimidazole resistant strains (redworm), Oxyuris (seatworm/pinworm) and Parascaris (roundworm).

Strongid Caramel should be used at a dose rate of 19mg pyrantel embonate per kg bodyweight

Bodyweight range	Dose-contents of	Dose of pyrantel embonate
Up to 150kg	¼ oral doser marked 150kg	2.85 g
151kg to 300kg	½ oral doser marked 300kg	5.7 g
301kg to 450kg	¾ oral doser marked 450kg	8.55 g
451 to 600kg	Full oral doser marked 600kg	11.4 g
Note: Position locking ring over appropriate mark on plunger

Dosing programme

Strongyles (including benzimidazole resistant strains), Oxyuris and Parascaris

Foals one to eight months of age:

Dose every four weeks.

Horses and donkeys over eight months of age:

Routinely dose every six to eight weeks, but during the summer and autumn when at grass every four to six weeks.

Always dose three to four days before turning out after in-wintering.

Suckler mares

It has been shown that reduction of strongyle challenge to the suckling foal at pasture can be achieved by using clean pasture (re-seeded or not grazed the previous year by horses), dosing the mare three to four days before turning out and then at intervals of two to four weeks until the end of autumn.

Ideally mares with foals should go out to 'clean'; pasture or, if this is not possible, delay turning them out until June.

Dosage

For the control and treatment of Anoplocephala perfoliata (Tapeworm).

Strongid Caramel should be used at a dose rate of 38mg pyrantel embonate per kg bodyweight, which is twice the dose rate for strongyles.

Dosing programme

Anoplocephala perfoliata

The need for retreatment may vary, but if considered necessary should be carried out after an interval of six weeks.

Contra-indications, warnings, etc

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.

Avoid contact with the skin. Wash hands and any other parts of the body which come into contact with the product.

Only for direct oral administration

For animal treatment only

Keep out of the reach of children

Withdrawal Period

Horse meat: zero days.

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 bodyweight, 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 in a number of countries, including the EU. 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.

Pharmaceutical precautions

Do not store above 25°C. Protect from direct sunlight.

If only part of the paste has been used, replace the cap on the syringe. Any part-used oral doser should be used within 2 months.

Legal category

POM-VPS

Packaging Quantities

Each oral doser contains 11.4g pyrantel embonate in 26g (22ml) paste.

Further information

Strongid Caramel, is well tolerated and is safe to give to horses and donkeys, including young foals of over four weeks of age, and pregnant mares and stallions, provided the recommendations are followed.

Pyrantel embonate is the recognised UK name for the active principle in Strongid Caramel and is synonymous with pyrantel pamoate.

Pyrantel embonate is also available as Strongid-P Granules which is recommended for feed or stomach-tube administration.

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Marketing authorisation number

Vm 00057/4181.