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

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

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

Доступно од:

Fresenius Medical Care Australia Pty Ltd

INN (Међународно име):

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

Фармацеутски облик:

Solution, irrigation

Састав:

Excipient Ingredients: water for injections; sodium bicarbonate

Пут администрације:

Intraperitoneal

Јединице у пакету:

5000mL x2 bags

Тип рецептора:

Not scheduled. Not considered by committee

Терапеутске индикације:

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

Резиме производа:

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

Статус ауторизације:

Registered

Датум одобрења:

2003-06-20

Информативни летак

Page 1 of 4
CMI FOR
_SLEEP•SAFE BALANCE_
Revised June 2020
_SLEEP_

_SAFE _BALANCE
_solution for peritoneal dialysis _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
_sleep_

_safe balance _peritoneal
dialysis solutions and how they
are used.
It does not contain all available
information. It does not take the
place of talking to your doctor or
nurse.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using
this medicine against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING _SLEEP_

_SAFE _
_BALANCE_, ASK YOUR DOCTOR OR
NURSE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT _SLEEP_

_SAFE _
_BALANCE _IS USED FOR
_sleep_

_safe balance _is a clear
sterile solution for peritoneal
dialysis containing electrolytes
and glucose with a neutral pH,
supplied in double chamber
flexible plastic bags. The double
chamber solution bag comes
with a tubing system in a clear
protective overwrap.
The _sleep_

_safe balance _
solutions can only be used with
the _sleep_

_safe _cycler.
_sleep_

_safe balance _is used to
treat acute and chronic kidney
failure. It helps with the removal
of waste products and excess
fluid from your blood when your
kidneys do not work properly.
BEFORE YOU USE
_SLEEP_

_SAFE BALANCE _
_ _
_WHEN YOU MUST NOT USE IT _
_SLEEP_

_SAFE BALANCE _MUST NOT
BE USED FOR INTRAVENOUS
INFUSION
DO NOT USE _SLEEP_

_SAFE _
_BALANCE_:

if the expiry date on the pack
has passed

if the packaging shows signs
of being damaged or
tampered with, or if you think
it may be damaged

if the solution in the bag looks
cloudy or has small specks in
it

if you have low potassium
levels (hypokalaemia)
DO NOT USE _SLEEP_

_SAFE BALANCE _
SOLUTIONS CONTAINING 1.75
MMOL CALCIUM:

if you have high calcium
levels (hypercalcaemia)
DO NOT USE _SLEEP_

_SAFE BALANCE _
SOLUTIONS CONTAINING 1.25 MMOL
CALCIUM:

if you have low calcium levels

Карактеристике производа

_AUSTRALIAN _
_PRODUCT _
_INFORMATION _
_– _
_SLEEP•SAFE _
_BALANCE _
_(GLUCOSE _
_MONOHYDRATE, CALCIUM CHLORIDE DIHYDRATE, SODIUM CHLORIDE, SODIUM (S)-
_
_LACTATE _
_AND _
_MAGNESIUM _
_CHLORIDE _
_HEXAHYDRATE) _
_PERITONEAL _
_DIALYSIS _
_SOLUTIONS_
_SLEEP•SAFE _
_BALANCE _
1.5%
GLUCOSE
1.75
MMOL/L
CALCIUM
PERITONEAL
DIALYSIS
SOLUTION
_SLEEP•SAFE _
_BALANCE _
2.3%
GLUCOSE
1.75
MMOL/L
CALCIUM
PERITONEAL
DIALYSIS
SOLUTION
_SLEEP•SAFE _
_BALANCE _
4.25%
GLUCOSE
1.75
MMOL/L
CALCIUM
PERITONEAL
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
1 NAME OF THE MEDICINE
Sodium
(S)-lactate,
calcium
chloride
dihydrate,
glucose
monohydrate,
magnesium
chloride
hexahydrate, sodium chloride.
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,
1.25/1.75 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 solutions
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
_SLEEP•SAFE _
_BALANCE _
1.5% glucose
1.75 mmol/L
calcium
_SLEEP•SAFE _
_BALANCE _
2.3% glucose
1.75 mmol/L
calcium
_SLEEP•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