SELECTBAG ONE (AX125G) SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; ACETIC ACID; DEXTROSE

Tillgänglig från:

BAXTER CORPORATION

ATC-kod:

B05ZA

INN (International namn):

HEMODIALYTICS, CONCENTRATES

Dos:

14.9G; 36.8G; 20.3G; 36.0G; 220.0G

Läkemedelsform:

SOLUTION

Sammansättning:

POTASSIUM CHLORIDE 14.9G; CALCIUM CHLORIDE 36.8G; MAGNESIUM CHLORIDE 20.3G; ACETIC ACID 36.0G; DEXTROSE 220.0G

Administreringssätt:

HAEMODIALYSIS

Enheter i paketet:

1L

Receptbelagda typ:

Ethical

Terapiområde:

HEMODIALYSIS SOLUTION

Produktsammanfattning:

Active ingredient group (AIG) number: 0554851001; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2013-10-17

Produktens egenskaper

Page 1 of 10
Prescribing Information
SelectBag One
PRESCRIBING INFORMATION
SELECTBAG ONE
Solution for Dialysis
Baxter Corporation
Mississauga, Ontario L5N 0C2
Canada
Date of Revision:
June 10, 2021
Submission Control No: 247855
Baxter, Gambro, BiCart Select and SelectBag are trademarks of Baxter
International
Inc., or its subsidiaries.
Page 2 of 10
Prescribing Information
SelectBag One
SELECTBAG ONE
DESCRIPTION
The SelectBag One product is a low-density polyethylene (LDPE)
container containing a highly concentrated dialysis
concentrate of the minor electrolytes (e.g. KCI, CaCl
2
, MgCl
2
) and acid needed in a bicarbonate- based dialysis fluid.
When the product is attached to the specially designed container
holder and the spike is inserted into the container,
the concentrate is drawn out by the dialysis machine.
The dialysis machine mixes the acidic concentrate with the sodium
chloride concentrate and the sodium bicarbonate
concentrate to produce a bicarbonate-based dialysis fluid.
Free from bacterial endotoxins.
INDICATIONS
To be used in a bicarbonate dialysis treatment for patients suffering
from acute renal failure, chronic renal failure or
acute intoxication with dialysable substances.
INTENDED USE
The SelectBag One product is intended to be used as an acetic acid
based concentrate together with the BiCart
Select
combi-pak for on-line preparation of haemodialysis, haemodiafiltration
or haemofiltration
fluids on compatible
Gambro dialysis systems.
SPECIFICATIONS
CONTENTS
1000 mL dialysis concentrate
Please refer to the product label for the exact composition.
CAPACITY
Diluted 1:200, 200 litres of dialysis fluid can be produced.
REQUIREMENTS FOR MIXING
The dialysis concentrate must be mixed with a pure sodium chloride
concentrate and a pure sodium bicarbonate
concentrate, on a specially adapted dialysis machine to obtain the
final dialysis fluid composition. Please refer to
page 6.
Page 3 of 10
Prescribing Information
SelectBag One
As an example, when the SelectBag One AX 250 G concentrate is mixed
with a dilu