CITRASATE C0125 SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SODIUM ACETATE; SODIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE; CITRIC ACID

Available from:

CHIEF MEDICAL SUPPLIES LTD

ATC code:

B05ZA

INN (International Name):

HEMODIALYTICS, CONCENTRATES

Dosage:

1.11G; 263G; 6.24G; 2.14G; 49.50G; 6.91G

Pharmaceutical form:

SOLUTION

Composition:

SODIUM ACETATE 1.11G; SODIUM CHLORIDE 263G; CALCIUM CHLORIDE 6.24G; MAGNESIUM CHLORIDE 2.14G; DEXTROSE 49.50G; CITRIC ACID 6.91G

Administration route:

HAEMODIALYSIS

Units in package:

4.5L

Prescription type:

Ethical

Therapeutic area:

HEMODIALYSIS SOLUTION

Product summary:

Active ingredient group (AIG) number: 0652910001; AHFS:

Authorization status:

MARKETED

Authorization date:

2013-03-04

Summary of Product characteristics

Page 1 of 7
PRODUCT MONOGRAPH
CITRASATE
® C0125
Haemodialysis Solution, BP
Sodium Chloride
263 g / L
Potassium Chloride
0 g / L
Calcium Chloride
6.24 g / L
Magnesium Chloride
2.14 g / L
Citric Acid
6.91 g / L
Sodium Acetate
1.11 g / L
Glucose Monohydrate
49.5 g / L
CHIEF MEDICAL SUPPLIES LTD.
DATE OF REVISION:
411-19
th
Street S.E.
January 14, 2021
Calgary Alberta T2E 6J7
CONTROL NO.: 242788
Page 2 of 7
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION………………………...
3
SUMMARY PRODUCT
INFORMATION……………………………………...
3
INDICATIONS AND CLINICAL
USE…………………………………………
3
CONTRAINDICATIONS……………………………………………………….
3
WARNINGS AND
PRECAUTIONS……………………………………………
4
ADVERSE
REACTIONS………………………………………………………..
4
DRUG
INTERACTIONS………………………………………………………...
4
DOSAGE AND
ADMINISTRATION…………………………………………..
4
OVERDOSAGE………………………………………………………………….
5
ACTIONS AND CLINCAL PHARMACOLOGY………………………………
6
STORAGE AND
STABILITY…………………………………………………...
6
DOSAGE FORMS, COMPOSITION AND PACKAGING……………………..
6
REFERENCES……………………………………………………………………
6
MORE
INFORMATION…………………………………………………………
6
Page 3 of 7
CITRASATE
® C0125
Haemodialysis Solution, BP
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF ADMINISTRATION
DOSAGE FORM / STRENGTH
CLINICALLY RELEVANT NON-
MEDICINAL INGREDIENTS
Hemodialysis
Concentrated solution
Sodium Chloride 263 g / L
Potassium Chloride
0 g / L
Calcium Chloride 6.24 g / L
Magnesium Chloride 2.14 g / L
Citric Acid 6.91 g / L
Sodium Acetate 1.11 g / L
Glucose Monohydrate 49.5 g / L
None
INDICATIONS AND CLINICAL USE
Citrasate C0125 i