Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
ISOFLURANE
Baxter Healthcare Limited
100 %v/v
Inhalation Vapour Liquid
1999-12-02
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0167/106/001 Case No: 2084267 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BAXTER HEALTHCARE LIMITED CAXTON WAY, THETFORD, NORFOLK IP24 3SE, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product AERRANE (ISOFLURANE), 100% V/V INHALATION VAPOUR, LIQUID the particulars of which are set out in the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 16/08/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/08/2010_ _CRN 2084267_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT AErrane (isoflurane), 100% v/v inhalation vapour, liquid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Isoflurane 100% v/v. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation vapour, liquid Clear, colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Induction and maintenance of general anaesthesia in adults and children. Use of isoflurane in dental anaesthesia should be restricted to hospitals or day care units only (see Contraindications, Section 4.3). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION In order to be able to accurately control the precise concentration of isoflurane, v Đọc toàn bộ tài liệu