SELECTBAG ONE (AX200G) SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

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

Saatavilla:

BAXTER CORPORATION

ATC-koodi:

B05ZA

INN (Kansainvälinen yleisnimi):

HEMODIALYTICS, CONCENTRATES

Annos:

29.4G; 29.8G; 20.3G; 36G; 220G

Lääkemuoto:

SOLUTION

Koostumus:

CALCIUM CHLORIDE 29.4G; POTASSIUM CHLORIDE 29.8G; MAGNESIUM CHLORIDE 20.3G; ACETIC ACID 36G; DEXTROSE 220G

Antoreitti:

HAEMODIALYSIS

Kpl paketissa:

1L

Prescription tyyppi:

Ethical

Terapeuttinen alue:

HEMODIALYSIS SOLUTION

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0554851003; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2013-10-17

Valmisteyhteenveto

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