SELECTBAG ONE (AX050G) SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; ACETIC ACID; DEXTROSE

Available from:

BAXTER CORPORATION

ATC code:

B05ZA

INN (International Name):

HEMODIALYTICS, CONCENTRATES

Dosage:

44.1G; 20.3G; 36G; 220G

Pharmaceutical form:

SOLUTION

Composition:

CALCIUM CHLORIDE 44.1G; MAGNESIUM CHLORIDE 20.3G; ACETIC ACID 36G; DEXTROSE 220G

Administration route:

HAEMODIALYSIS

Units in package:

1L

Prescription type:

Ethical

Therapeutic area:

HEMODIALYSIS SOLUTION

Product summary:

Active ingredient group (AIG) number: 0454850001; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-10-17

Summary of Product characteristics

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: 249586
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