VAMIN 14 ELECTROLYTE - FREE SOLUTION FOR INFUSION,

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ALANINE ARGININE ASPARTIC ACID CYSTEINE L-GLUTAMIC ACID AMINOACETIC ACID HISTIDINE ISOLEUCINE LEUCINE L-LYSINE L-METHIONINE PHENYLALANINE PROLINE SERINE THREONINE TRYPTOPHAN, L- TYROSINE VALINE ACETIC ACID WATER FOR INJECTIONS LYSINE ACETATE

Available from:

Fresenius Kabi Limited

Dosage:

1000ml Millilitre

Pharmaceutical form:

Solution for Infusion

Authorization date:

1999-06-21

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)
PA0566/023/002
Case No: 2054727
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
FRESENIUS KABI LIMITED
CESTRIAN COURT, EASTGATE WAY, MANOR PARK, RUNCORN, CHESHIRE WA7 1NT, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
VAMIN 14 ELECTROLYTE - FREE SOLUTION FOR INFUSION,1000 ML.
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 10/03/2009 until 20/06/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/03/2009_
_CRN 2054727_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vamin 14 Electrolyte-Free Solution for Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1000 ml contains:
_Product Particulars_
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
A clear, colourless to slightly yellow solution of amino acids.
Alanine
12.0
g
Arginine
8.4
g
Aspartic Acid
2.5
g
Cysteine/Cystine
420.0
mg
Glutamic Acid
4.2
g
Glycine
5.9
g
Histidine
5.1
g
Isoleucine
4.2
g
Leucine
5.9
g
Lysine
6.8
g
Methionine
4.2
g
Phenylalanine
5.9
g
Proline
5.1
g
Serine
3.4
g
Threonine
4.2
g
Trytophan
1.4
mg
Tyrosine
170.0
mg
Valine
5.5
g
Nitrogen content
13