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Legal category
POM-VPS (previously PML)
Pharmaceutical precautions
This veterinary medicinal product does not require any special storage condition. Do not use after the expiry date stated on the box. Once opened, use the product within 12 months.

Keep out of the reach and sight of children.

Presentation
White, circular, biconcave tablet with brown spots. Each chewable tablet of 3300mg contains 20mg ivermectin.

 

Dosage and administration

Single oral administration.200 µg of ivermectin per kg of bodyweight corresponding to 1 tablet per 100 kg bodyweight. To ensure a correct dosage, bodyweight should be determined as accurately as possible. Once the correct dose has been determined, it should be administered in the following way : Present the tablet in the palm of your hand. Presenting one tablet at a time makes it easier for the horse to accept it, however the administration of multiple tablets at once is also possible. Repeat this gesture until the complete dose has been administered. During the initial administration, the tablet can be combined with a small amount of food or a treat to increase the acceptance by the horse. In the event that the required dose is not ingested an alternative treatment should be administered. Seek the advice of your SQP.

The SQP should give advice regarding appropriate dosing programmes and stock management to achieve adequate parasite control for both roundworm and bot infestations.

 


 

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ERAQUELL TABLETS
Contra-indications, warnings, etc

Do not use in foals under 2 weeks of age. Do not use in horses known to be hypersensitive to the active ingredient or any of the other ingredients.Colic, diarrhoea and anorexia have been reported in very rare occasions post treatment, in particular when there is heavy worm burden. In very rare occasions, allergic reactions such as hypersalivation, lingual oedema, urticaria, tachycardia, congested mucus membranes, and subcutaneous oedema have been reported following treatment with the product.
Special precautions for use in animals

Avermectins may not be well tolerated in non target species. Cases of intolerance are reported in dogs, especially Collies, Old English Sheepdogs and related breeds or crosses, and also in turtles and tortoises.
Dogs and cats should not be allowed to ingest spilled tablet or have access to used packaging due to the potential for adverse effects related to ivermectin toxicity.
Young foals, miniature horses and toy breeds weighing less than 50 kg may be unable to ingest tablets. Seek the advice of your
SQP

Uses

For the treatment of nematode and arthropod infestations, due to adult and immature roundworms and bots in horses:
Nematodes

Large-strongyles
:
Strongylus vulgaris
(adult and arterial larvae)
Strongylus edentatus
(adult and L4 tissue larval stages)
Strongylus equinus
(adult and L4 larval stage)
Triodontophorus
spp. (adult)
Small-strongyles
:
Cyathostomum (adult and non-encysted mucosal larvae)
: Cylicocyclus spp., Cylicostephanus spp., Gyalocephalus spp.
Parascaris
: Parascaris equorum (adult and larvae).
Oxyuris
: Oxyuris equi (adult and larvae).
Trichostrongylus
: Trichostrongylus axei (adult).

Dipteran insects
Gasterophilus
spp. (larvae).

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Wash hands after use. Avoid contact with the eyes. In case of eye irritation, seek medical attention. Do not eat, drink or smoke while handling this product. In the event of accidental ingestion, seek medical advice and show the leaflet to the physician so that he knows what you have taken.

Special warnings for 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 anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

Resistance to ivermectin has been reported in Parascaris equorum in horses. 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 resistance to anthelmintics.

The product is safe for use in stallions.

Overdose

A tolerance study performed with the product in adult horses with doses up to 5 times the recommended dosage did not show any adverse reactions.

Safety studies were conducted with a veterinary medicinal product containing praziquantel and the same dose of ivermectin (EQUIMAX oral gel), in mares, stallions and foals.

Administration to mares at 3 times the recommended dosage at 14-day intervals during the whole gestation and lactation periods did not result in any abortion, nor any adverse effect during gestation, at parturition or on the mares general health, nor any abnormality in the foals.

Administration to stallions at 3 times the recommended dosage did not show any adverse effect in particular on the reproductive performances.

Administration to foals with doses up to 5 times the recommended dosage did not show any adverse reaction.

Withdrawal period: Horses may be slaughtered for human consumption only after 35 days from the last treatment. Not to be used in horse producing milk for human consumption

Container disposal: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with the product or used container.

18/02/2010

 


 

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