Sleep Safe Balance 2.3% glucose, 1.25mmol/L Ca

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Calcium chloride dihydrate 0.1838 g/L; Glucose monohydrate 25 g/L equivalent to 22.73 g/L glucose anhydrous;  ; Magnesium chloride hexahydrate 0.1017 g/L; Sodium chloride 5.64 g/L;  ;  ;  ; Sodium lactate 3.925 g/L;  

Available from:

Fresenius Medical Care Australia Pty Ltd (NZ)

INN (International Name):

Calcium chloride dihydrate 0.1838 g/L

Pharmaceutical form:

Dialysis solution

Composition:

Active: Calcium chloride dihydrate 0.1838 g/L Glucose monohydrate 25 g/L equivalent to 22.73 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

Units in package:

Bag, plastic, Dual chamber 2x5L, 2 dose units

Class:

General sale

Prescription type:

General sale

Manufactured by:

Chemische Fabrik Lehrte

Product summary:

Package - Contents - Shelf Life: Bag, plastic, Bag, non-PVC plastic Dual chamber 2x5L - 2 dose units - 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 - 3 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 4x3L - 4 dose units - 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 - 5 L - 2 years from date of manufacture stored at or below 25°C 24 hours reconstituted stored at or below 25°C

Authorization date:

2002-03-19

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1
SLEEP SAFE BALANCE, DIALYSIS SOLUTION
_sleep•safe balance _1.5% glucose 1.25 mmol/L calcium peritoneal
dialysis solution
_sleep•safe balance _2.3% glucose 1.25 mmol/L calcium peritoneal
dialysis solution
_sleep•safe balance _4.25% glucose 1.25 mmol/L calcium peritoneal
dialysis solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_SLEEP•SAFE BALANCE _ready-to-use solution is available in a number
of different strengths in various
calcium ranges. _SLEEP•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:
_sleep•safe balance_
1.5% glucose,
1.25 mmol/L calcium
_sleep•safe balance_
2.3% glucose,
1.25 mmol/L calcium
_sleep•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:
_sleep•safe balance_
1.5% glucose,
1.25 mmol/L calcium
_sleep•safe balance_
2.3% glucose,
1.25 mmol/L calcium
_sleep•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
2
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
+
134 mmol/L
134