PRISMASOL 0 SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; LACTIC ACID; SODIUM CHLORIDE; SODIUM BICARBONATE

Available from:

BAXTER CORPORATION

ATC code:

B05ZA

INN (International Name):

HEMODIALYTICS, CONCENTRATES

Dosage:

5.145G; 2.033G; 5.4G; 6.45G; 3.09G

Pharmaceutical form:

SOLUTION

Composition:

CALCIUM CHLORIDE 5.145G; MAGNESIUM CHLORIDE 2.033G; LACTIC ACID 5.4G; SODIUM CHLORIDE 6.45G; SODIUM BICARBONATE 3.09G

Administration route:

INTRAVENOUS

Units in package:

4750/5000 ML

Prescription type:

Ethical

Therapeutic area:

HEMODIALYSIS SOLUTION

Product summary:

Active ingredient group (AIG) number: 0552651001; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-07-23

Summary of Product characteristics

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_PrismaSOL 0 _
_Page 1 of 20_
PRESCRIBING INFORMATION
PRISMASOL 0
Calcium chloride dihydrate 5.145 g/L, Lactic acid 5.4 g/L, Magnesium
chloride hexahydrate
2.033 g/L, Sodium bicarbonate 3.09 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:
January 1, 2001
Date of Revision:
February 27, 2019
Submission Control No: 218869
Baxter and PrismaSOL are trademarks of Baxter International Inc., or
its subsidiaries.
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_PrismaSOL 0 _
_Page 2 of 20_
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
................................................................................8
OVERDOSAGE
..................................................................................................................9
ACTION AND CLINICAL PHARMACOLOGY
..............................................................9
STORAGE AND STABILITY
..........................................................................................10
SPECIAL HANDLING INSTRUCTIONS
.......................................................................11
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................