Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
HUMAN ALBUMIN
Octapharma Limited
40 Mg/Ml
Solution for Infusion
2000-06-14
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0521/008/002 Case No: 2065438 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to OCTAPHARMA LIMITED THE ZENITH BUILDING, 26 SPRING GARDENS, MANCHESTER, M2 1AB, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ALBUMINATIV 40 MG/ML, SOLUTION FOR INFUSION 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 08/05/2009 until 09/10/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/05/2009_ _CRN 2065438_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Albuminativ 40 mg/ml, solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human albumin Solution containing 4% of protein of which at least 96% is human albumin. Each 100ml contains at least 3.84g of human albumin. The product is iso-oncotic. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate. The choice of albumin rather than artificial colloid will depend Read the complete document