Noropraz Oral Paste Horses 7.49G

Target species Horses Indicationsfor use, specifying the target species For the treatment of mixed cestode and nematode or arthropod infestations, due to adult and immature roundworms, lungworms, bots and tapeworms in horses: Nematodes: Large strongyle: Strongylus vulgaris (adult and arterial larvae), Strongylus edentatus (adult and L4 tissue larval stages), Strongylus equinus (adult), Tridontophorus spp. (adult) Small strongyle: Cyathostomum: Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Gyalocephalus spp. (adult and non-inhibited mucosal larvae) Parascaris: Parascaris equorum (adult and larvae) Oxyuris: Oxyuris equi (larvae) Trichostrongylus: Trichostrongylus axei (adult) Strongyloides: Strongyloides westeri (adult) Habronema: Habronema spp. (adult) Onchocerca: Onchocerca spp. microfilariae i.e. cutaneous onchocerciasis Lungworm: Dictyocaulus arnfieldi (adult and larvae) Cestodes (Tapeworm): Anoplocephala perfoliata (adult), Anoplocephala magna (adult), Paranoplocephala mamillana (adult) Dipteran insects: Gasterophilus spp. (larvae) Contraindications Do not use in foals under 2 weeks of age. Do not use in case of hypersensitivity to the active substances or to any of the excipients. 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 body weight, misadministration of the product, or lack of calibration of the dosing device. 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 (an avermectin) has been reported in Parascaris equorum in horses in a number of countries including in the EU. 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. As tapeworm infestation is unlikely to occur in horses before two months of age, treatment of foals below this age is not considered necessary. Special precautions for use Special precautions for use in animals Avermectins may not be well tolerated in all non target animals. Cases of intolerance are reported in dogs, especially Collies, Old English Sheepdogs and related breeds or crosses, and also in turtle and tortoises. Dogs and cats should not be allowed to ingest spilled paste or access to used syringes due to the potential for adverse effects related to ivermectin toxicity. Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after use. Do not eat, drink or smoke while handling this product. Avoid contact with the eyes as the product may cause eye irritation. In case of accidental eye contact, rinse immediately with plenty of water. In case of accidental ingestion or eye irritation, seek medical advice and show the package leaflet or label to the physician. Adverse reactions (frequency and seriousness) Horses carrying heavy infection of Onchocerca microfilariae have experienced such reactions as swelling and itching after treatment. It is assumed that these reactions are the result of the destruction of large numbers of microfilariae. In case of very high levels of infestation, destruction of the parasites may cause a mild transient colic and loose faeces in the treated horse. Colic, diarrhea 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 and urticaria, tachycardia, congested mucus membranes, and subcutaneous oedema have been reported following treatment with the product. A veterinarian should be consulted if these signs persist. Use during pregnancy, lactation or lay Can be used during pregnancy and lactation. Interaction with other medicinal products and other forms of interaction None known.