SYNTHAMIN 14 8.5 %w/w Solution for Infusion

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

LEUCINE ISOLEUCINE LYSINE HYDROCHLORIDE VALINE PHENYLALANINE HISTIDINE THREONINE DL-METHIONINE TRYPTOPHAN, L- ALANINE ARGININE AMINOACETIC ACID PROLINE SERINE TYROSINE SODIUM ACETATE POTASSIUM PHOSPHATE DIBASIC SODIUM CHLORIDE MAGNESIUM CHLORIDE HEXAHYDRATE

제공처:

Baxter Healthcare Limited

INN (국제 이름):

LEUCINE ISOLEUCINE LYSINE HYDROCHLORIDE VALINE PHENYLALANINE HISTIDINE THREONINE DL-METHIONINE TRYPTOPHAN, L- ALANINE

복용량:

8.5 %w/w

약제 형태:

Solution for Infusion

처방전 유형:

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

승인 상태:

Authorised

승인 날짜:

0000-00-00

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)
PA0167/091/004
Case No: 2036975
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
SYNTHAMIN 14, 8.5% W/V AMINO ACID INTRAVENOUS INFUSION, 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 03/12/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 03/12/2008_
_CRN 2036975_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Synthamin 14, 8.5% w/v Amino Acid Intravenous Infusion, Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Infusion
The product is a clear or slightly coloured sterile aqueous solution.
pH 5-7 Tonicity mOsm/l 1160
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Synthamin 14, 8.5% Amino Acid Intravenous Infusion is indicated for the correction of protein depletion and the
maintenance of adequate nitrogen and electrolyte balance.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The