ALBUMINATIV 200 Mg/Ml Solution for Infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
HUMAN ALBUMIN
Available from:
Octapharma Limited
INN (International Name):
HUMAN ALBUMIN
Dosage:
200 Mg/Ml
Pharmaceutical form:
Solution for Infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2011-03-31
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0521/008/001
Case No: 2063102
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 200 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 2063102_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Albuminativ 200mg/ml, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human albumin
Solution containing 20% of protein of which at least 96% is human albumin.
Each 100ml contains at least 19.2g of human albumin.
The product is mildly hyperoncotic.
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 wil
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