STAY SAFE BALANCE 1.5% glucose 1.25mmol/L calcium peritoneal dialysis solution bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium (S)-lactate, Quantity: 7.85 g/L

Available from:

Fresenius Medical Care Australia Pty Ltd

INN (International Name):

calcium chloride dihydrate,glucose monohydrate,hydrochloric acid,magnesium chloride hexahydrate,sodium bicarbonate,sodium (S)-la

Pharmaceutical form:

Solution, irrigation

Composition:

Excipient Ingredients: water for injections; sodium bicarbonate

Administration route:

Intraperitoneal

Units in package:

2500mL x 4 bags, 2000mL x 4 bags

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

For use as a peritoneal dialysis solution in the management of end stage renal disease and acute renal failure.

Product summary:

Visual Identification: Clear solution; Container Type: Bag; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2003-06-20

Patient Information leaflet

stay•safe balance CMI
v3.0 (June 2022)
1
stay•safe balance
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1. Why am I using stay•safe balance?
stay•safe balance contains the active ingredients glucose
monohydrate, calcium chloride dihydrate, sodium chloride, sodium S-
lactate and magnesium chloride hexahydrate. stay•safe balance is
used to treat acute and end-stage chronic kidney failure. It
helps with the removal of waste products and excess fluid from your
blood when your kidneys do not work properly.
For more information, see Section 1. Why am I using stay•safe
balance? in the full CMI.
2. What should I know before I use stay•safe balance?
Do not use if you have ever had an allergic reaction to stay•safe
balance or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
stay•safe balance? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with stay•safe balance and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4. How do I use stay•safe balance?
•
Follow all directions given to you by your doctor or pharmacist
carefully.
•
Qualified nurses will train you in the use of stay•safe balance at
the hospital or the dialysis clinic. Your doctor will make
certain that you can carry out peritoneal dialysis correctly before
you are discharged from the hospital or dialysis clinic, and
before you do it at home.
•
You must follow the procedures and instructions given by your nurse
every time you do peritoneal dialysis. Contact your
doctor if you are having problems or are unsure about any of the
techniques
More instructions can be found in Section 4.

Summary of Product characteristics

_AUSTRALIAN _
_PRODUCT _
_INFORMATION _
_– _
_STAY•SAFE _
_BALANCE _
_(GLUCOSE _
_MONOHYDRATE, CALCIUM CHLORIDE DIHYDRATE, SODIUM CHLORIDE, SODIUM
(S)-LACTATE _
_AND MAGNESIUM CHLORIDE HEXAHYDRATE) PERITONEAL DIALYSIS SOLUTIONS_
_STAY•SAFE _
_BALANCE _
1.5%
GLUCOSE
1.75
MMOL/L
CALCIUM
PERITONEAL
DIALYSIS
SOLUTION
_STAY•SAFE _
_BALANCE _
2.3%
GLUCOSE
1.75
MMOL/L
CALCIUM
PERITONEAL
DIALYSIS
SOLUTION
_STAY•SAFE _
_BALANCE _
4.25%
GLUCOSE
1.75
MMOL/L
CALCIUM
PERITONEAL
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
1
NAME OF THE MEDICINE
Sodium
(S)-lactate,
calcium
chloride
dihydrate, glucose
monohydrate,
magnesium
chloride
hexahydrate, sodium chloride.
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,
1.25/1.75 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
:
Table 1: 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
_STAY•SAFE_
_BALANCE _
1.5% glucose
1.75 mmol/L
calcium
_STAY•SAFE_
_BALANCE _
2.3% glucose
1.75 mmol/L
calcium
_STAY•SAFE _
_BALANCE _
4.25% glucose
1.75 mmol/L
calcium
Calcium
chloride
dihydrate
0.3675 g
0.3675 g
0.3675 g
0.5145 g
0.5145 g
0.5145 g
Sodium
chloride
11.279 g
11.279 g
11.279 g
11.279 g
11.279 g
11.279 g
Magnesium
chloride
hex