국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
ISOPROPANOL
Medlock Medical Ltd
Impregnated Dressing
2006-06-23
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1175/009/001 Case No: 2043167 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MEDLOCK MEDICAL LTD TUBITON HOUSE, MEDLOCK STREET, OLDHAM, OL1 3HS, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product STERETS PRE-INJECTION SWABS %V/V IMPREGNATED DRESSING The particulars of which are set out in Part I and Part II of 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 23/04/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/12/2008_ _CRN 2043167_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sterets Pre-Injection Swabs 70% v/v 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each swab is impregnated with an aqueous solution of Isopropyl Alcohol 70% v/v. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Impregnated dressing. Impregnated dressing in a colourless to pale straw solution presented in a disposable sachet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For pre-injection site cleansing. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical administration. To be used as directed by a physician. 4.3 CONTRAINDICATIONS Use in patients hypersensitive to the act 전체 문서 읽기