Страна: Армения
Език: английски
Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
halothane
Piramal Enterprises Limited
N01AB01
halothane
100%
liquid for inhalation
250ml glass bottle
Prescription
Registered
2017-06-22
IN/PI/0039/19/00 PROFESSIONAL USER LEAFLET HALOTHANE 100% INHALATION VAPOUR, LIQUID NAME OF MEDICINAL PRODUCT Halothane ACTIVE INGREDIENT Halothane 100% v/v. PHARMACEUTICAL FORM CONTENTS BY WEIGHT, VOLUME OR DOSAGE UNIT Halothane is supplied in 250 ml amber glass bottles. PHARMACOTHERAPEUTIC GROUP General anaesthetic. INDICATIONS Induction and maintenance of general anaesthesia in adults and children. Use of halothane in paediatric dental anaesthesia should be restricted to hospitals only. CONTRAINDICATIONS History of unexplained jaundice or pyrexia after a previous exposure to halothane is an absolute contra-indication to its future use in that patient. Halothane is contraindicated in patients with known, or suspected, genetic predisposition to malignant hyperpyrexia. Children under 18 years undergoing dental procedures outside hospital. 100% Inhalation Vapour, Liquid Inhalation Vapour, Liquid. PRECAUTIONS FOR USE Halothane can induce liver damage. Minor changes in serum amino-transferase activity have been reported to occur in up to 30% of patients. The incidence of severe liver damage (jaundice, which may lead to hepatic failure as a consequence of massive hepatic cell necrosis) is much rarer but cases requiring liver transplants and fatalities have been reported. The risk of developing hepatic failure appears to be greatly increased by repeated exposure to halothane. Although short intervals of time between exposures are likely to increase the risk of hepatotoxicity, even long intervals between exposure may not reduce the risks, since some patients have developed severe reactions to halothane given many years after the previous exposure. _Other _ risk factors for hepatotoxicity include female gender, obesity, middle age and a history of drug allergy. On present available information, the following precautions should be taken: 1. A careful anaesthetic history is to be taken from patients due to undergo anaesthesia in order to determine whether exposure to halothane took place and the nature of any adverse reac Прочетете целия документ