MONOSOL Per Cent Solution for Haemofiltration

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

GLUCOSE MONOHYDRATE SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE SODIUM LACTATE

제공처:

Baxter Healthcare Limited

INN (국제 이름):

GLUCOSE MONOHYDRATE SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE SODIUM LACTATE

복용량:

Per Cent

약제 형태:

Solution for Haemofiltration

처방전 유형:

Product subject to prescription which may not be renewed (A)

승인 상태:

Withdrawn

승인 날짜:

2012-03-13

제품 특성 요약

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0167/103/001
Case No: 2044285
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
MONOSOL. SOLUTION FOR HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION
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 08/06/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 21/03/2010_
_CRN 2044285_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Monosol
Solution for haemodialysis, haemodiafiltration and haemofiltration
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for haemodialysis, haemodiafiltration and haemofiltration
Monosol is a sterile, non-pyrogenic, clear solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As substitution solution in continuous hemofiltration and hemodiafiltration and as dialysis solution in continuous
hemodialysis and hemodiafiltration for acute renal failure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Substitution fluid�