Country: Armenja
Lingwa: Ingliż
Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
halothane
Piramal Pharma Limited
N01AB01
halothane
100%
liquid for inhalation
250ml glass bottle
Prescription
Registered
2021-06-29
IN/PI/0039/19/01 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 Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Halothane 100% Inhalation Vapour, Liquid 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Halothane 100% v/v active. 3. PHARMACEUTICAL FORM Inhalation Vapour, Liquid. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Induction and maintenance of general anaesthesia in adults and children. Use of halothane in paediatric dental anaesthesia should be restricted to hospitals only. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Adults Induction: Anaesthesia may be induced with 2 to 4% v/v of halothane in oxygen or mixtures of nitrous oxide and oxygen. Induction may also be started at a concentration of 0.5% v/v and increased gradually to the required level. Maintenance: Anaesthesia is maintained with concentrations of 0.5 Lo 2% depending on the tlow rate used; the lower concentration is usually suitable for the elderly. Children: For induction in children a concentration of 1.5 to 2% v/v has been used. Elderly: Elderly patients tend to require less halothane than adults but the actual dose is dependent on the patient's physical state 4.3. 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 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Halothane can induce liver damage. Minor changes in serum amino-transferascactivity have been reported to occur in up to 30% of patients. The incidence ofsevere liver damage Uaundice, which may lead to hepatic failure as a consequenceof massive hepatic cell necrosis) is much rarer but cases requiring liver transplantsand fatalities have been reported. The risk of developing hepatic failure appears tobe greatly increased by repeated exposure to halothane. Although short intervals of time between exposures are likely to increase th Aqra d-dokument sħiħ