PRISMASOL 4 SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE ANHYDROUS; L-LACTIC ACID; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE

Available from:

BAXTER CORPORATION

ATC code:

B05ZA

INN (International Name):

HEMODIALYTICS, CONCENTRATES

Dosage:

5.145G; 2.033G; 22.00G; 5.400G; 6.450G; 3.090G; 0.314G

Pharmaceutical form:

SOLUTION

Composition:

CALCIUM CHLORIDE 5.145G; MAGNESIUM CHLORIDE 2.033G; DEXTROSE ANHYDROUS 22.00G; L-LACTIC ACID 5.400G; SODIUM CHLORIDE 6.450G; SODIUM BICARBONATE 3.090G; POTASSIUM CHLORIDE 0.314G

Administration route:

INTRAVENOUS

Units in package:

250+4750ML CHAMBER BAG

Prescription type:

Ethical

Therapeutic area:

HEMODIALYSIS SOLUTION

Product summary:

Active ingredient group (AIG) number: 0752650002; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-12-31

Summary of Product characteristics

_ _
_PrismaSOL 4 mmol/l Potassium _
_Page 1 of 22_
PRESCRIBING INFORMATION
PRISMASOL 4
Calcium chloride dihydrate 5.145 g/L, Glucose anhydrous 22.0 g/L,
Lactic acid 5.4g/L,
Magnesium chloride hexahydrate 2.033 g/L, Potassium chloride 0.314
g/L, Sodium bicarbonate
3.090 g/L, and Sodium chloride 6.45 g/L solution
Sterile solution for hemofiltration and hemodialysis
Hemodialytics, concentrates, ATC code: B05Z A
BAXTER CORPORATION
MISSISSAUGA, ON
CANADA, L5N 0C2
Date of Initial Approval:
February 21, 2006
Date of Preparation:
February 26, 2019
Submission Control No: 218874
Baxter and PrismaSOL are trademarks of Baxter International Inc., or
its subsidiaries.
_ _
_PrismaSOL 4 _
_Page 2 of 22_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................11
SPECIAL HANDLING INSTRUCTIONS
.......................................................................12
DOSAGE