GAMBROSOL TRIO 40
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
GLUCOSE ANHYDROUS SODIUM CHLORIDE SODIUM LACTATE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE
Available from:
Fresenius Medical Care Deutschland GmbH
Pharmaceutical form:
Solution for Dialysis
Authorization date:
2011-07-22
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gambrosol trio 40, solution for peritoneal dialysis.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Gambrosol trio 40 is filled in a three-compartment bag.
Two smaller compartments (A and B) each contain 50% glucose solution and sodium chloride (NaCl) and a larger third
compartment (C) the electrolyte solution. After breaking the frangible pin between compartments A and C and
thoroughly mixing the two fluids a PD solution containing 1.5% glucose will be produced. Similarly mixing the
contents of compartments B and C will produce a PD solution containing 2.5% glucose. Finally by breaking both
frangible pins and mixing the contents of all three compartments will produce a solution containing 3.9% glucose.
_BEFORE RECONSTITUTION_
_EACH 1000 ML CONTAINS:_
GLUCOSE COMPARTMENTS A AND B
ELECTROLYTE COMPARTMENT C
_AFTER RECONSTITUTION_
The glucose compartments A or/and B are mixed with the electrolyte compartment C to give the following
reconstituted solutions:
_ELECTROLYTE CONTENT PER EACH 1000 ML OF RECONSTITUTED SOLUTION:_
ACTIVE INGREDIENTS:
Glucose anhydrous
500.0 g
_(as glucose monohydrate_
_550.0 g)_
Sodium chloride
5.38 g
ACTIVE INGREDIENTS:
Sodium chloride
5.38 g
Sodium lactate S-(+) anhydrous
4.72 g
_(as 60% m/m solution)_
_(7.87 g)_
Calcium chloride dihydrate
0.209 g
Magnesium chloride hexahydrate
0.054 g
Mix compartments A and C
Reconstituted solution 40L (Light)
Mix compartments B and C
Reconstituted solution 40M (Medium)
Mix compartments A, B and C
Reconstituted solution 40H (High)
RECONSTITUTED SOLUTION MMOL/L
L
M
H
Sodium Na
+
133
132
131 mmol/l
Calcium Ca
++
1.38
1.35
1.31 mmol/l
Magnesium Mg
++
0.26
0.25
0.24 mmol/l
Chloride Cl
-
95.4
95.2
95.2 mmol/l
Lactate
41
40
39 mmol/l
IRISH MEDICINES BOARD
_______________________________________________
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