Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
LEUCINE PHENYLALANINE L-METHIONINE L-LYSINE ISOLEUCINE VALINE HISTIDINE THREONINE TRYPTOPHAN, L- ALANINE ARGININE AMINOACETIC ACID PROLINE SERINE TYROSINE SODIUM ACETATE TRIHYDRATE POTASSIUM PHOSPHATE DIBASIC SODIUM CHLORIDE MAGNESIUM CHLORIDE HEXAHYDRATE GLUCOSE CALCIUM CHLORIDE DIHYDRATE
Baxter Healthcare Limited
5.5/15 %v/v
Solution for Infusion
1996-04-30
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0167/098/001 Case No: 2063572 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 CLINIMIX N9G15E, 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 19/05/2009 until 11/12/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/05/2009_ _CRN 2063572_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CLINIMIX ® N9G15E, solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CLINIMIX ® N9G15E is packaged in a dual compartment plastic bag containing respectively an amino acid solution with electrolytes and a glucose solution with calcium. The injectable amino acid solution contains 15 L-amino acids (8 essential amino acids) needed for the protein synthesis. The amino acid profile is the following: o Essential amino acids/Total amino acids = 41.3 % o Essential amino acids/Total nitrogen =2.83 o Branched chain amino acids/Total amino acids = 19 % The quantitative composition of CLINI Soma hati kamili