TORPHASOL INJ 20ML

Target species Horses. Indications for use, specifying the target species For short term relief of pain associated with colic of gastrointestinal tract origin. For information on the onset and duration of analgesia that can be expected following treatment, see pharmacodynamic properties. For sedation in combination with certain α2-adrenoceptor agonists. Contraindications Butorphanol – as a sole agent and in any combination: Do not use in horses with a history of liver or kidney disease. Do not use in case of known hypersensitivity to the active substance or to any of the excipients. Do not use in cases of cerebral injury or organic brain lesions (e.g. lesions following cranial trauma) and in animals with obstructive respiratory diseases, heart dysfunction or spastic convulsions. Butorphanol / detomidine hydrochloride combination: The combination should not be used in pregnant animals. Do not use the combination in horses with a pre-existing cardiac dysrhythmia or bradycardia. Do not use in horses with emphysema due to a possible depressive effect in the respiratory system. Butorphanol / romifidine combination: Do not use during the last month of pregnancy. Butorphanol / xylazine combination: The combination should not be used in pregnant animals. Any reduction in gastrointestinal motility caused by butorphanol (see adverse reactions) may be enhanced by the concomitant use of α2-adrenoceptor agonists. Consequently, such combinations should not be used in cases of colic associated with impaction. Special warnings for each target species None. Special precautions for use Special precautions for use in animals Safety and efficacy of butorphanol in foals have not been established. In foals use the product only according to the benefit/risk assessment by the responsible veterinarian. Due to its antitussive properties, butorphanol may lead to an accumulation of mucous in the respiratory tract. Therefore, in animals with respiratory diseases associated with increased mucous production or in animals that are being treated with expectorants, butorphanol should only be used on the basis of a risk-benefit analysis by the responsible veterinarian. The use of the product at the recommended dose may lead to transient ataxia and/or excitement. Therefore, to prevent injuries in patient and people, the location for the treatment should be chosen carefully. Butorphanol / detomidine hydrochloride combination: Routine cardiac auscultation should be performed prior to use in combination with detomidine. Special precautions to be taken by the person administering the veterinary medicinal product to animals Direct contact with skin or eye of the user should be avoided since the product might induce irritation and sensitization. Accidental spillage on the skin should be washed immediately with soap and water. When the product comes into contact with the eyes, rinse immediately with plenty of water. Care should be taken when handling the product to avoid self-injection. In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician, and DO NOT DRIVE, since drowsiness, nausea and dizziness may occur. Effects can be reversed by the administration of an opioid antagonist. Adverse reactions Butorphanol may cause the following side-effects: - Excitatory locomotor effects (pacing) - Mild sedation (may occur following the administration of butorphanol as a sole agent) - Ataxia - Reduction in gastrointestinal motility - Depression of cardiovascular system Use during pregnancy, lactation or lay The safety of this product has not been investigated in the target species during pregnancy and lactation. The use of butorphanol during pregnancy and lactation is not recommended. For information on use in combination with α2-adrenoceptor agonists, see contraindications Interaction with other medicinal products and other forms of interaction See special precautions for use. Butorphanol may be used in combination with other sedatives such as α2-adrenoceptor agonists (e.g. romifidine, detomidine, xylazine) where synergistic effects can be expected. Therefore, an appropriate reduction in dose is necessary when used concomitantly with such agents. Because of its antagonist properties at the opiate mu receptor, butorphanol may inhibit the analgesic effect in animals, which have already received pure opioid mu agonists (morphine/oxymorphine). Because of the antitussive properties of butorphanol, it should not be used in combination with an expectorant, as this may lead to an accumulation of mucous in the airways. The combination of butorphanol and α2-adrenoceptor agonists should be used with caution in animals with cardiovascular disease. The concurrent use of anticholinergic drugs, e.g. atropine should be considered.
Vat Rate: 20%