4.1 Target species Horses, cattle, dogs and cats. 4.2 Indications for use, specifying the target species Used in all cases where sedation is required. The main indications for use include the following: - General handling and transport of nervous or fractious animals. - Medical examinations and treatment such as X-rays, oral, genital and rectal examination. - Premedication for minor surgical interventions and for anaesthesia in combination with other analgesics, narcotics and inhalant anaesthetics. 4.3 Contra-indications Not for use in the latter stages of pregnancy except at parturition. Because of the emetic effect which is sometimes produced, the product should not be used in cats and dogs with mechanical complications of the alimentary tract such as obstruction of the oesophagus, gastric torsion, or hernia. 4.4 Special warnings for each target species Horse Following intravenous injection there is a transient rise followed by a fall of blood pressure. The usual precautions required for handling should always be observed even when a high dose of xylazine is given. Cattle In recumbent cattle tympany should be prevented by maintaining sternal recumbency. For operations in lateral or dorsal recumbency it is advisable to lower the head and neck in order to avoid inhalation of saliva or rumenal fluids. When high doses are to be employed the animal should be fasted for some hours beforehand. After dose level 3 & 4, cattle are likely to remain drowsy for several hours and should be kept in the shade. 4.5 Special precautions for use i. Special precautions for use in animals As safety of xylazine use during organogenesis has not been proven by current methods, care should be taken during the first month of pregnancy. Care should be taken with aged animals or those with comprised lung function or suspected pulmonary disease since xylazine will depress respiration. In the event of respiratory failure, manual compression of the thorax is usually sufficient to restore normal respiration. Calm, old, sick animals react more distinctly to the product. Sedated animals should be kept under supervision until normal, and they should be segregated to avoid bullying by others. ii. Special precautions to be taken by the person administering the veterinary 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 needle 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 mucosal contact. 3. Immediately after exposure, wash the exposed skin with large amounts of fresh water. 4. Remove contaminated clothes that are in direct contact with skin. 5. 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. 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 alpha2-adrenoceptor 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) Transient hyperglycaemia is a common finding after administration Horses Following intravenous injection there is a transient rise followed by a fall of blood pressure. Cattle The swallowing reflex is reduced during the period when the action of the drug is at its peak. 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 6-24 hours before administration.. 4.7 Use during pregnancy, lactation or lay The product is contraindicated for use at the latter stages of pregnancy except at parturition. 4.8 Interaction with other medicinal products and other forms of interaction Analeptics (stimulants) will shorten the period or reduce the depth of sedation. In horses and dogs a deeper sedation with less side effects is achieved when Xylazine is combined with strong analgesics. Horses The concurrent intravenous use of potentiated sulphonamides with alpha-2 agonists has been reported to cause cardiac arrhythmia which may be fatal. It is recommended that intravenous administration of trimethoprim/sulphonamide containing products should not be undertaken when horses have been sedated with the product. Limited information available indicates that alpha-2 blockers such as atipamazole may be effective in reversing the sedation and other physiological effects of the drug.
Vat Rate: 20%