Stay Safe Balance 4.25% glucose, 1.25mmol/L Ca

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Calcium chloride dihydrate 0.1838 g/L; Glucose monohydrate 46.75 g/L equivalent to 42.5 g/L glucose anhydrous;  ; Magnesium chloride hexahydrate 0.1017 g/L; Sodium chloride 5.64 g/L;  ;  ;  ; Sodium lactate 3.925 g/L;  

Verfügbar ab:

Fresenius Medical Care Australia Pty Ltd (NZ)

INN (Internationale Bezeichnung):

Calcium chloride dihydrate 0.1838 g/L

Darreichungsform:

Dialysis solution

Zusammensetzung:

Active: Calcium chloride dihydrate 0.1838 g/L Glucose monohydrate 46.75 g/L equivalent to 42.5 g/L glucose anhydrous   Magnesium chloride hexahydrate 0.1017 g/L Sodium chloride 5.64 g/L       Sodium lactate 3.925 g/L   Excipient: Hydrochloric acid Sodium bicarbonate Sodium hydroxide Water for injection

Einheiten im Paket:

Bag, plastic, Dual disc & drain, 1.5 L

Klasse:

General sale

Verschreibungstyp:

General sale

Hergestellt von:

Chemische Fabrik Lehrte

Produktbesonderheiten:

Package - Contents - Shelf Life: Bag, plastic, Bag, non-PVC plastic Dual chamber with disc & drainage bag 6X1.5L - 1.5 L - 2 years from date of manufacture stored at or below 25°C 24 hours reconstituted stored at or below 25°C - Bag, plastic, Bag, non-PVC plastic Dual chamber with disc & drainage bag 4X2L - 2 L - 2 years from date of manufacture stored at or below 25°C 24 hours reconstituted stored at or below 25°C - Bag, plastic, Bag, non-PVC plastic Dual chamber with disc & drainage bag 4X2.5L - 2.5 L - 2 years from date of manufacture stored at or below 25°C 24 hours reconstituted stored at or below 25°C - Bag, plastic, Bag, non-PVC plastic Dual chamber with disc & drainage bag 4X3L - 3 L - 2 years from date of manufacture stored at or below 25°C 24 hours reconstituted stored at or below 25°C

Berechtigungsdatum:

2002-03-19

Fachinformation

Version 2.0
NEW ZEALAND DATA SHEET
1.
STAY SAFE BALANCE, DIALYSIS SOLUTION
_stay•safe balance _1.5% glucose 1.25 mmol/L calcium peritoneal
dialysis solution
_stay•safe balance _2.3% glucose 1.25 mmol/L calcium peritoneal
dialysis solution
_stay•safe balance _4.25% glucose 1.25 mmol/L calcium peritoneal
dialysis solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_STAY•SAFE BALANCE _ready-to-use solution is available in a number
of different strengths in various
calcium ranges. _STAY•SAFE BALANCE_ 1.5%/2.3%/4.25% glucose, 1.25
mmol/L calcium is delivered
in a double chamber bag. One chamber contains the alkaline lactate
solution, the other chamber
contains the acidic glucose-based electrolyte solution. Mixing of both
solutions by opening the
middle seam between the two chambers results in the neutral
ready-to-use solution.
BEFORE RECONSTITUTION
1 litre of acidic glucose based electrolyte solution contains:
_stay•safe balance_
1.5% glucose,
1.25 mmol/L calcium
_stay •safe balance_
2.3% glucose,
1.25 mmol/L calcium
_stay •safe balance_
4.25% glucose,
1.25 mmol/L calcium
Calcium chloride
dihydrate
0.3675 g
0.3675 g
0.3675 g
Sodium chloride
11.279 g
11.279 g
11.279 g
Magnesium chloride
hexahydrate
0.2033 g
0.2033 g
0.2033 g
Glucose monohydrate
(anhydrous glucose)
33.0 g
(30.0 g)
50.0 g
(45.46 g)
93.5 g
(85.0 g)
1 litre of alkaline lactate solution contains:
Sodium (S)-lactate solution 15.69 g
(sodium (S)-lactate 7.85 g)
AFTER RECONSTITUTION
1 litre of the neutral ready-to-use solution contains:
_stay•safe balance_
1.5% glucose,
1.25 mmol/L calcium
_stay•safe balance_
2.3% glucose,
1.25 mmol/L calcium
_stay•safe balance _
4.25% glucose,
1.25 mmol/L calcium
Calcium chloride
dihydrate
0.1838 g
0.1838 g
0.1838 g
Sodium chloride
5.640 g
5.640 g
5.640 g
Sodium (S)-lactate
3.925 g
3.925 g
3.925 g
Magnesium chloride
hexahydrate
0.1017 g
0.1017 g
0.1017 g
Version 2.0
Glucose monohydrate
(anhydrous glucose)
16.5 g
(15.0 g)
25.0 g
(22.73 g)
46.75 g
(42.5 g)
Ca
2+
1.25 mmol/L
1.25 mmol/L
1.25 mmol/L
Na
+
13