Item Number: ROMPUN
Presentation A water soluble crystalline white powder and solvent for solution for injection. Each vial contains 583 mg xylazine hydrochloride. Each pack contains 1 vial of 50 ml of solvent which contains 0.70 mg/ml methyl hydroxybenzoate (Ph Eur) and 0.30 mg/ml propyl hydroxybenzoate (Ph Eur) as preservatives. Uses For use in horses and zoo animals where sedation is required, including— 1) Handling fractious animals, e.g. for transportation 2) Medical examinations, e.g. x-ray examination, removal of bandages, examination of teats, penis and oral cavity. 3) Premedication for minor superficial operations, painful manipulative procedures and local or regional anaesthesia. Contra-indications, warnings, etc Not for use in zoo animals intended for human consumption. Caution is required when pulmonary disease is present or suspected. In recumbent ruminants tympany should be prevented by maintaining sternal recumbency. For operations on ruminants in lateral or dorsal recumbency it is advisable to lower the head and neck in order to avoid inhalation of saliva or ruminal fluids. It must be noted that the swallowing reflex is reduced during the period when the action of the drug is at its peak. When high doses are to be employed the animal should be fasted for some hours beforehand. After high doses animals are likely to remain drowsy for several hours and should be kept in the shade. In case of accidental overdosage leading to respiratory failure cold water douches and artificial respiration are indicated. In the event of respiratory failure manual compression of the thorax is usually sufficient to restore normal respiration. Following intravenous injection in horses there is a transient rise followed by a fall in blood pressure. With horses and zoo animals the usual precautions required for handling should always be observed even when a high dose of Rompun has been given. Transient hyperglycaemia is a common finding after Rompun sedation. Operator Warnings Xylazine is an alpha adrenoceptor agonist acting primarily on alpha-2 receptors. Care should be taken to avoid accidental self-administration (see above). It is recommended that once the required dose has been withdrawn from the vial, the needle should be kept guarded until the product is administered. Alternatively, it should be removed from the syringe and immediately inserted into the injection site and the syringe should then be connected to it. Wash splashes from skin and eyes immediately. In the event of accidental self-administration, seek medical advice and show the label and other product literature to medical staff. DO NOT DRIVE as changes in blood pressure may occur. Information for Doctors 1.Human sedative dose: 0.3-0.6 mg/kg (1-2 ml Rompun 2%; 0.25-0.5 ml Rompun Dry Substance 10% solution). 2.Xylazine is an alpha adrenoceptor agonist whose toxicity may cause clinical effects including sedation, respiratory depression and coma, bradycardia, hypotension and hyperglycaemia. Ventricular arrhythmias have also been reported. 3.Treatment should be supportive with appropriate intensive therapy. Withdrawal Periods Horse Meat: Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation. Zoo Animals: Contra-indicated for animals intended for human consumption. Pharmaceutical precautions Do not store above 25°C Store in a dry place. Reconstitute the solution immediately before use. Discard any unused solution. Use solvent within 28 days of first broaching vial. Do not use solvent if it becomes visibly contaminated. Any unused product and containers should be disposed of in accordance with national requirements. Further information Xylazine, 5, 6-dihydro-2-(2, 6-xylidino)-4H-1, 3-thiazine, is a thiazine derivative with sedative, hypnotic, local anaesthetic and hypotensive properties. It also has muscle relaxant and analgesic effects; the degree of relaxation/analgesia depends upon the animal species. Xylazine is an agonist of the alpha-2 adrenergic receptors. It acts on pre-synaptic and post-synaptic receptors of the central and peripheral nervous system. Both the sedation and the analgesia are due to stimulation of central alpha-2 adrenergic receptors. Xylazine is absorbed extremely rapidly and distributed widely throughout tissues. After intramuscular injection maximum plasma concentrations are achieved within 12-14 minutes in all species. Bioavailability varies after intramuscular injection; in the dog it is between 52 and 90%, in the sheep. 17-73% and in the horse 40-48%. Metabolism is extremely rapid. The molecule is broken down into several metabolites. Elimination after intramuscular and intravenous application takes place with a half-life of between 23 and 60 minutes depending on species. The half-life for total elimination, which is dependent on the route of administration and dosage, is 2-3 hours. Analeptics will shorten the period or reduce the depth of sedation. Alpha-2 blockers such as atipamazole are effective in reversing the sedation and other physiological effects of the drug. Legal category POM-V (previously POM) Packaging Quantities Carton containing 5 bottles of 500 mg Xylazine and one 50 ml bottle of solvent each with a pierceable rubber stopper.
ROMPUN: Data Sheet
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