PRISM0CAL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MAGNESIUM CHLORIDE; SODIUM CHLORIDE; LACTIC ACID; SODIUM BICARBONATE

Available from:

BAXTER CORPORATION

ATC code:

B05ZA

INN (International Name):

HEMODIALYTICS, CONCENTRATES

Dosage:

0.108G; 6.449G; 0.284G; 58.8G

Pharmaceutical form:

SOLUTION

Composition:

MAGNESIUM CHLORIDE 0.108G; SODIUM CHLORIDE 6.449G; LACTIC ACID 0.284G; SODIUM BICARBONATE 58.8G

Administration route:

INTRAVENOUS

Units in package:

5000ML

Prescription type:

Ethical

Therapeutic area:

HEMODIALYSIS SOLUTION

Product summary:

Active ingredient group (AIG) number: 0451567002; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-12-31

Summary of Product characteristics

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PRESCRIBING INFORMATION
PRISM0CAL
Lactic acid 0.284 g/L, Magnesium chloride hexahydrate 0.108 g/L,
Sodium bicarbonate 58.8 g/L,
and Sodium chloride 6.449 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:
December 24, 2005
Date of Revision:
March 20, 2019
Submission Control No: 218872
Baxter and Prism0CAL are trademarks of Baxter International Inc., or
its subsidiaries.
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_Prism0CAL _
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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
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
.