GLAMIN 250 Millilitre Solution for Infusion

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

ALANINE ARGININE ASPARTIC ACID GLUTAMIC ACID GLYCYL - GLUTAMINE MONOHYDRATE GLYCYL -TYROSINE DIHYDRATE HISTIDINE ISOLEUCINE LEUCINE LYSINE ACETATE METHIONINE PHENYLALANINE PROLINE SERINE THREONINE TRYPTOPHAN, L- VALINE

זמין מ:

Fresenius Kabi Limited

INN (שם בינלאומי):

ALANINE ARGININE ASPARTIC ACID GLUTAMIC ACID GLYCYL - GLUTAMINE MONOHYDRATE GLYCYL -TYROSINE DIHYDRATE HISTIDINE ISOLEUCI

כמות:

250 Millilitre

טופס פרצבטיות:

Solution for Infusion

סוג מרשם:

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

מצב אישור:

Withdrawn

תאריך אישור:

0000-00-00

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glamin, solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless to slightly yellow solution.
Theoretical osmolarity
1040 mosm/l
Theoretical osmolality
1140 mosm/kg
Titration acidity to pH 7.4
approx. 60 mmol/l
pH
approx. 5.8
1000 ml of the infusion solution contains:
Active ingredients
Quantity
Alanine
16.00
g
Arginine
11.30
g
Aspartic acid
3.40
g
Glutamic acid
5.60
g
Glycyl-Glutamine H2O
30.27
g
(corresp.to Glycine 10.27 g
corresp.to Glutamine 20.0 g)
Glycyl-Tyrosine 2 H2O
3.45
g
(corresp.to Glycine 0.94 g
corresp.to Tyrosine 2.28 g)
Histidine
6.80
g
Isoleucine
5.60
g
Leucine
7.90
g
Lysine-Acetate
12.70
g
(corresp.to Lysine 9.0 g)
Methionine
5.60
g
Phenylalanine
5.85
g
Proline
6.80
g
Serine
4.50
g
Threonine
5.60
g
Tryptophan
1.90
g
Valine
7.30
g
_For a full list of excipients, see section 6.1._
Amino acids/dipeptides
134.00
g/l
Total nitrogen
22.40
g/l
Energy content
2300.00 kJ
(540 kcal)/l
Density
1.0414
g/cm
3
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/09/2011_
_CRN 2100428_
_page number: 1_
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Glamin provides amino acids as part of parenteral nutrition therapy, when oral or enteral nutrition is impossible,
insufficient or contraindicated, especially in patients with a moderate to severe catabolic status.
In parenteral nutrition regimens amino acid solutions should always be administered in combination with appropriate
energy-supplying infusion solutions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage depends on the amino acid requirements.
Generally, 1-2 g amino acids/dipeptides (corresp. to 0.17-0.34 g N) per kg body weight per day are recommended. This