CAPD/DPCA 19 stay safe peritoneal dialysis solution bag

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

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

Tilgængelig fra:

Fresenius Medical Care Australia Pty Ltd

Lægemiddelform:

Solution, irrigation

Sammensætning:

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

Indgivelsesvej:

Intraperitoneal

Enheder i pakken:

4 x 3000mL

Recept type:

Not scheduled. Not considered by committee

Terapeutiske indikationer:

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

Produkt oversigt:

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

Autorisation status:

Licence status A

Autorisation dato:

1998-03-05

Indlægsseddel

CMI FOR
_CAPD/DPCA STAY_
•
_SAFE _
Revised August 2015
_CAPD/DPCA STAY_
•
_SAFE_
_solution for peritoneal dialysis _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
_CAPD/DPCA stay_
•
_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 _
_STAY_
•
_SAFE_, ASK YOUR DOCTOR OR
NURSE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT _CAPD/DPCA _
_STAY_
•
_SAFE _IS USED FOR
_CAPD/DPCA stay_
•
_safe _is a clear
sterile solution for peritoneal
dialysis containing electrolytes
and glucose with a neutral pH,
supplied in double chamber
flexible plastic bags. The
solution bag comes with a
system disc connector, a
rotating switch and a drainage
bag in a clear protective
overwrap.
_CAPD/DPCA stay_
•
_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 _
_STAY_
•
_SAFE _
_WHEN YOU MUST NOT USE IT _
_CAPD/DPCA STAY_
•
_SAFE _MUST
NOT BE USED FOR INTRAVENOUS
INFUSION
DO NOT USE _CAPD/DPCA _
_STAY_
•
_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)
DO NOT USE _CAPD/DPCA 17, 18, _
_19 STAY_
•
_SAFE _SOLUTIONS:
•
if you have low calcium levels
(hypocalcaemia)
DO NOT USE _CAPD/DPCA 18, 19 _
_STAY_
•
_SAFE _SOLUTIONS:
•
if you have low blood
pressure or are dehydrated
•
if you have suffered acute
blood loss or have muscle
wastage
_BEFORE YOU

Produktets egenskaber

1
AUSTRALIAN PRODUCT INFORMATION – CAPD/DPCA STAY•SAFE RANGE OF
STERILE PERITONEAL DIALYSIS SOLUTIONS:
CAPD/DPCA 17 STAY•SAFE
CAPD/DPCA 18 STAY•SAFE
CAPD/DPCA 19 STAY•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 stay•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 stay•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
Stay•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 usual ad