Rompun 2%

4.1 Target species Cattle, horses, dogs and cats. 4.2 Indications for use, specifying the target species Sedative with some analgesic and muscle relaxant properties for use in cattle, horses, dogs and cats. All cases where sedation is required including: i) Handling fractious animals (e.g. for transportation). ii) Medical examination e.g. X-ray examination, removal of bandages, examination of teats, penis and oral cavity. iii) Pre-medication for minor superficial operations, painful manipulative procedures and local or regional anaesthesia. 4.3 Contra-indications Do not use in the latter stages of pregnancy except at parturition. As the safety of xylazine use during organogenesis has not been fully demonstrated by current methods it should be used with caution during the first month of pregnancy. In the cat and dog, because of the emetic effect which is sometimes produced, do not use xylazine in mechanical complications of the alimentary tract e.g. obstruction of the oesophagus, gastric torsion or hernia. 4.4 Special warnings for each target species Applicable to all species Use with care in elderly or debilitated patients which may be adversely affected by profound cardiovascular changes. Cattle Tympany should be prevented in recumbent cattle by sternal recumbency. For operations in lateral or dorsal recumbency, lower head and neck to prevent inhalation of ruminal contents. Maintain recumbent and drowsy animals in the shade. In case of accidental overdosage leading to respiratory failure, cold water douches and artificial respiration are indicated. After dose levels 3 and 4 cattle are likely to remain drowsy for several hours and should be kept in the shade. Horses Following intravenous injection in horses a transient rise and fall of blood pressure may be seen. With horses the usual precautions required in handling should always be observed even when a high dose of xylazine has been given. Dogs and cats In cats and dogs if the stomach is full, vomiting occurs before sedation is complete. This is an advantage if general anaesthesia is to follow. The emetic effect is reduced by fasting for 6 to 24 hours. Pre-medication with atropine in cats and dogs may reduce salivation and bradycardia effects. 4.5 Special precautions for use i. Special precautions for use in animals Caution is required when pulmonary disease is present. When high doses are to be employed the animal should be fasted for some hours beforehand. It must be noted that the swallowing reflex is reduced during the period when the action of the drug is at its peak. Sedated animals should remain under observation until normal. Segregate sedated animals. In the event of respiratory failure manual compression of the thorax is usually sufficient to restore normal respiration. Observe aseptic precautions. ii. Special precautions to be taken by the person administering the medicinal product to animals Care should be taken to avoid accidental self-injection. To avoid accidental self-injection, one of the following procedures should be adopted. Either use two sterile needles, one to fill syringe from bottle and one to inject patient, or once the required dose has been withdrawn from the vial, immediately remove the needle from the syringe, insert the needles into the injection site, and then connect the syringe to it. Used needles should be safely deposited in a closed container. 1. 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. 2. Avoid skin, eye or mucoal contact. 3. Immediately after exposure, wash the exposed sking with large amounts of fresh water. 4. Remove contaminated clothes that are in direct contacat with skin. 5. In 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. 6. 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. 7. Advice to doctors: Xylazine is an aplha2-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) Not applicable. 4.7 Use during pregnancy, lactation or lay Do not use in the latter stages of pregnancy except at parturition. As the safety of xylazine use during organogenesis has not been fully demonstrated by current methods it should be used with caution during the first month of pregnancy. 4.8 Interaction with other medicinal products and other forms of interaction Concurrent administration of adrenoceptor stimulants is not recommended. The concurrent intravenous use of potentiated sulphonamides with alpha-2 agonists has been reported to cause cardiac arrhythmias which may be fatal. Whilst no such effects have been reported with Rompun, it is recommended that intravenous administration of Trimethoprim/Sulphonamide containing products should not be undertaken when horses have been sedated with xylazine.
Vat Rate: 20%