SODIUM CHLORIDE 0.9% INJ 9MG/ML USP LIQUID
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-08-2020
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Active ingredient:
SODIUM CHLORIDE
Available from:
MCGAW INC.
ATC code:
B05XA03
INN (International Name):
SODIUM CHLORIDE
Dosage:
9MG
Pharmaceutical form:
LIQUID
Composition:
SODIUM CHLORIDE 9MG
Administration route:
INTRAVENOUS
Units in package:
500 ML
Prescription type:
Ethical
Therapeutic area:
REPLACEMENT PREPARATIONS
Product summary:
Active ingredient group (AIG) number: 0100053002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
1998-04-08
Summary of Product characteristics
_0.9% Sodium Chloride Injection USP Prescribing Information _
_Page 1 of 10_
PRESCRIBING INFORMATION
0.9% SODIUM CHLORIDE INJECTION USP
Solution, Intravenous
IV Fluid and Electrolyte Replenisher
B. BRAUN MEDICAL INC. Date of Preparation:
824 Twelfth Avenue
August 24, 2020
Bethlehem, PA 18018-3524 USA
Distributed by:
B. BRAUN OF CANADA, LTD.
2000 Ellesmere Road, Unit 16
Scarborough, Ontario M1H 2W4
Submission Control No: 235120
_ _
_0.9% Sodium Chloride Injection USP Prescribing Information _
_Page 2 of 10_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3
1
INDICATIONS ...............................................................................................................
3
1.1
PEDIATRICS ............................................................................................................
3
1.2
GERIATRICS ............................................................................................................
3
2
CONTRAINDICATIONS ..............................................................................................
3
3
DOSAGE AND ADMINISTRATION ...........................................................................
3
3.1
DOSING CONSIDERATIONS ....................................................................................
3
3.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT ........................................... 4
3.3
ADMINISTRATION ...................................................................................................
4
4
OVERDOSAGE ............................................................................................................
5
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............... 5
6
WARNINGS AND PRECAUTIONS ............................................................................
6
6.1
SPECIAL POPULATIONS ..........................................................................................
7
6.1.1
PREGNANT WOMEN .....................................................
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