Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PENTAMIDINE ISETHIONATE
Sanofi-Aventis Ireland Limited
300 MG/5ml
Nebuliser Solution
2001-10-14
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0540/120/001 Case No: 2083927 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANOFI-AVENTIS IRELAND LIMITED CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product PENTACARINAT READY-TO-USE 300MG/5ML NEBULISER SOLUTION 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 23/08/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/08/2010_ _CRN 2083927_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pentacarinat Ready-To-Use 300mg/5ml Nebuliser Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml bottle contains 300mg Pentamidine Isethionate (60mg/ml), equivalent to 172.4 mg pentamidine base per 5ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nebuliser solution. A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pentacarinat Ready-to-Use Solution is indicated in the treatment of Pneumocystis carinii pneumonia (PCP). Pentacarinat Ready-to-Use Solution is also indicated in the prevention of Pneumocystis carinii pneumonia (PCP) in patients infected by the human immunod Read the complete document