CAPD/DPCA 19 sleep safe peritoneal dialysis solution bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium chloride, Quantity: 5.786 g/L; chloride, Quantity: 102.5 mmol/L; calcium chloride dihydrate, Quantity: 0.1838 g/L; magnesium chloride hexahydrate, Quantity: 0.1017 g/L; magnesium, Quantity: 0.5 mmol/L; lactate, Quantity: 35 mmol/L; sodium lactate, Quantity: 3.925 g/L; glucose monohydrate, Quantity: 25 g/L; calcium, Quantity: 1.25 mmol/L; sodium, Quantity: 134 mmol/L

Available from:

Fresenius Medical Care Australia Pty Ltd

Pharmaceutical form:

Solution, irrigation

Composition:

Excipient Ingredients: water for injections; sodium hydroxide; hydrochloric acid

Administration route:

Intraperitoneal

Units in package:

2 x 6000mL, 2 x 5000mL, 4 x 3000mL

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: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1999-07-19

Patient Information leaflet

Page 1 of 4
CMI FOR _CAPD/DPCA_
_SLEEP•SAFE_
Revised June 2020
_CAPD/DPCA SLEEP_

_SAFE _
_solution for peritoneal dialysis _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
_CAPD/DPCA sleep_

_safe _
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 _CAPD/DPCA _
_SLEEP_

_SAFE_, ASK YOUR DOCTOR OR
NURSE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT _CAPD/DPCA _
_SLEEP_

_SAFE _IS USED FOR
_CAPD/DPCA sleep_

_safe _is a
clear sterile solution for
peritoneal dialysis containing
electrolytes and glucose with a
neutral pH, supplied in flexible
plastic bags. The solution bag
comes with a tubing system in a
clear protective overwrap
The _CAPD/DPCA sleep_

_safe _
solutions can only be used with
the _sleep_

_safe _cycler.
_CAPD/DPCA sleep_

_safe _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
_CAPD/DPCA _
_SLEEP_

_SAFE _
_ _
_WHEN YOU MUST NOT USE IT _
_CAPD/DPCA SLEEP_

_SAFE _MUST
NOT BE USED FOR INTRAVENOUS
INFUSION
DO NOT USE _CAPD/DPCA _
_SLEEP_

_SAFE: _

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)


if you have low calcium levels
(hypocalcaemia)

DO NOT USE _CAPD/DPCA 18, 19 _
_SLEEP_

_SAFE _SOLUTIONS:

if
you
have
low
blood
pressure or are dehydrated


if you have suffered acute
blood loss or have muscle
w

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – CAPD/DPCA SLEEP•SAFE RANGE OF
STERILE PERITONEAL DIALYSIS SOLUTIONS
CAPD/DPCA 17 SLEEP•SAFE
CAPD/DPCA 18 SLEEP •SAFE
CAPD/DPCA 19 SLEEP •SAFE
1
NAME OF THE MEDICINE
Calcium,
calcium
chloride
dihydrate,
chloride,
glucose
monohydrate,
lactate,
magnesium,
magnesium chloride hexahydrate, sodium, sodium chloride, sodium
lactate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CAPD/DPCA sleep•safe is available in a number of different strengths
in various calcium ranges.
The strengths have the following compositions:
SOLUTIONS CONTAINING 1.25 MMOL/L CALCIUM
CAPD/DPCA 17
CAPD/DPCA 18
CAPD/DPCA 19
Sodium chloride
Sodium lactate
Calcium chloride dihydrate
Magnesium chloride
hexahydrate
Glucose monohydrate
≈Glucose anhydrous
5.786 g/L
3.925 g/L
0.1838 g/L
0.1017 g/L
16.5 g/L
15.0 g/L
5.786 g/L
3.925 g/L
0.1838 g/L
0.1017 g/L
46.75 g/L
42.5 g/L
5.786 g/L
3.925 g/L
0.1838 g/L
0.1017 g/L
25.0 g/L
22.7 g/L
Na
+
Ca
++
Mg
++
Cl
-
Lactate
-
Glucose
134 mmol/L
1.25 mmol/L
0.5 mmol/L
102.5 mmol/L
35 mmol/L
83.2 mmol/L
134 mmol/L
1.25 mmol/L
0.5 mmol/L
102.5 mmol/L
35 mmol/L
235.8 mmol/L
134 mmol/L
1.25 mmol/L
0.5 mmol/L
102.5 mmol/L
35 mmol/L
126.1 mmol/L
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Irrigation solution.
CAPD/DPCA sleep•safe is a clear, sterile water-based solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
2
For use as a peritoneal dialysis solution in the management of
end-stage renal disease and acute
renal failure.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Sleep•safe solutions are for use in one patient on one occasion
only. They contain no antimicrobial
preservative. The solution should not be used if it is not clear, or
if leaks are detected in the bag.
The choice of peritoneal dialysate will depend on each individual
clinical situation and must be at
the discretion of the treating physician.
The number of bag exchanges and the volumes are dependant on body
weight, body size and
residual kidney function. The us