Country: Kesatuan Eropah
Bahasa: Inggeris
Sumber: EMA (European Medicines Agency)
sevoflurane
Chanelle Pharmaceuticals Manufacturing Limited
QN01AB08
sevoflurane
Dogs; Cats
Anesthetics, general
For the induction and maintenance of anaesthesia.
Revision: 5
Authorised
2016-06-21
18 B. PACKAGE LEAFLET 19 PACKAGE LEAFLET: SEVOHALE INHALATION VAPOUR, LIQUID FOR DOGS AND CATS, 100% V/V SEVOFLURANE 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, IRELAND 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Sevohale 100% v/v Inhalation vapour, liquid for dogs and cats. sevoflurane 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 100% v/v sevoflurane. 4. INDICATION(S) For the induction and maintenance of anaesthesia. 5. CONTRAINDICATIONS Do not use in animals with known hypersensitivity to sevoflurane or other halogenated anaesthetic agents. Do not use in animals with a known or suspected genetic susceptibility to malignant hyperthermia. 6. ADVERSE REACTIONS Hypotension, tachypnoea, muscle tenseness, excitation, apnoea, muscle fasciculations and emesis have been reported very commonly, based on post-authorisation spontaneous reporting experience. Dose-dependent respiratory depression is commonly observed while using sevoflurane, therefore respiration should be closely monitored during sevoflurane anaesthesia and the inspired concentration of sevoflurane adjusted accordingly. Anaesthetic-induced bradycardia is commonly observed during sevoflurane anaesthesia. It may be reversed by administration of anticholinergics. Paddling, retching, salivation, cyanosis, premature ventricular contractions and excessive cardiopulmonary depression have been reported very rarely, based on post-authorisation spontaneous reporting experience. In dogs, transient elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), bilirubin and white blood cell counts may occur with sevoflurane, as 20 with the use of other halogenated anaesthetic agents. In cats, transient increases in AST and ALT may occur with sevoflurane, howev Baca dokumen lengkap
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Sevohale 100% v/v Inhalation vapour, liquid for dogs and cats. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Sevoflurane 100% v/v. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation vapour, liquid. Clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the induction and maintenance of anaesthesia. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to sevoflurane or other halogenated anaesthetic agents. Do not use in animals with a known or suspected genetic susceptibility to malignant hyperthermia. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Halogenated volatile anaesthetics can react with dry carbon dioxide (CO 2 ) absorbents to produce carbon monoxide (CO) that may result in elevated levels of carboxyhaemoglobin in some dogs. In order to minimise this reaction in rebreathing anaesthetic circuits, Sevohale should not be passed through soda lime or barium hydroxide that has been allowed to dry out. The exothermic reaction that occurs between inhalation agents (including sevoflurane) and CO 2 absorbents is increased when the CO 2 absorbent becomes desiccated, such as after an extended period of dry gas flow through the CO 2 absorbent canisters. Rare cases of excessive heat production, smoke and/or fire in the anaesthetic machine have been reported during the use of a desiccated CO 2 absorbent and sevoflurane. An unusual decrease in the expected depth of anaesthesia compared to the vaporiser setting may indicate excessive heating of the CO 2 absorbent canister. If it is suspected that the CO 2 absorbent may be desiccated, it must be replaced. The colour indicator of most CO 2 absorbents does not necessarily change as a result of desiccation. Therefore, the lack of 3 significant colour change shou Baca dokumen lengkap