Domosedan 10 mg/ml Solution for Injection 20ml

Target Species Horses. 4.2 Indications for Use, Specifying the Target Species A sedative with analgesic properties used to facilitate handling of horses for examination, minor surgical interventions and other manipulations. It can be used with or without butorphanol. The product is also indicated for use with ketamine for short duration general anaesthesia to carry out surgical procedures such as castration. 4.3 Contraindications 1. Do not use in conjunction with sympathomimetic amines or with intravenous potentiated sulphonamides. 2. Do not administer simultaneously with ketamine in the same syringe (see sections 4.8 and 4.9). 3. Do not use the butorphanol combination in horses suffering from colic. 4. Do not use in seriously ill animals with heart failure or impaired liver or kidney function. 5. Do not use in case of hypersensitivity to the active substance or to any of the excipients. 6. Do not administer to horses in the last month of pregnancy 4.4 Special warnings for each target species None 4.5 Special precautions for use i. Special precautions for use in animals The product should not be used in horses with pre-existing AV blocks, with severe cardiac insufficiency, respiratory disease or chronic renal failure. Careful consideration should be given prior to administration to animals in shock and to animals with liver or kidney disease. Intravenous administration should be slow. It is recommended that feed should be withheld for at least 12 hours prior to anaesthesia. The horse should not be given water or feed before the drug effect has passed. Routine safety measures should be employed to protect practitioners and handlers. ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals In the case of accidental oral intake or self-injection, seek medical advice immediately and show the package leaflet to the doctor but DO NOT DRIVE as sedation and changes in blood pressure may occur. Avoid skin, eye or mucosal contact. Immediately after exposure, wash the exposed skin with large amounts of fresh water. Remove contaminated clothes that are in direct contact with skin. In the case of accidental contact of the product with eyes, rinse with large amounts of fresh water. If symptoms occur, seek the advice of a doctor. If pregnant women handle the product, special caution should be observed not to self inject as uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure. Advice to the Doctor: Detomidine hydrochloride is an alpha-2 adrenoreceptor agonist. Symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia. Ventricular arrhythmias have also been reported. Respiratory and haemodynamic symptoms should be treated symptomatically. 4.6 Adverse reactions (frequency and seriousness) Adverse reactions are very rare All alpha-2 adrenoceptor agonists, including detomidine, may cause decreased heart rate, changes in the conductivity of cardiac muscle (as evidenced by partial atrioventricular and sinoatrial blocks), changes in the respiratory rate, incoordination/ataxia and sweating. A diuretic effect is usually observed within 45 to 60 minutes after treatment. The potential for isolated cases of hypersensitivity exists, including paradoxical response (excitation). Partial, transient penis prolapse may occur in male horses. In rare cases, horses may show signs of mild colic following administration of alpha-2 adrenoceptor agonists because substances of this class inhibit intestinal motility. Occasional reports of urticaria have been received. Mild adverse reactions have reportedly resolved without treatment. Severe reactions should be treated symptomatically. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports)’ 4.7 Use during pregnancy, lactation or lay Not to be used in mares in the last month of pregnancy. No studies have been conducted in mares; however trace amounts of detomidine have been detected in the milk of cows treated with the product. . The safety of the product has not been investigated in breeding horses; use only according to benefit/risk assessment during the other months of pregnancy 4.8 Interaction with other medicinal products and other forms of interaction Use with care with other sedatives and anaesthetics because of an additive/synergistic effect. Where appropriate the product may be used in conjunction with local anaesthetic agents. Induction of anaesthesia with detomidine and ketamine has been used prior to maintenance with halothane. Because of the nature of the induction agents, the effects of halothane may be delayed and special care must be taken to avoid over-dosage. When detomidine is used as a premedication prior to general anaesthesia, the product may delay onset of induction. Use in conjunction with sympathomimetic amines and intravenous potentiated sulphonamides is contra-indicated.