Land: Canada
Sprog: engelsk
Kilde: Health Canada
SODIUM CHLORIDE
B. BRAUN MEDICAL INC
B05XA03
SODIUM CHLORIDE
4.5MG
SOLUTION
SODIUM CHLORIDE 4.5MG
INTRAVENOUS
500ML/1000ML
Ethical
REPLACEMENT PREPARATIONS
Active ingredient group (AIG) number: 0100053005; AHFS:
APPROVED
1998-04-29
_0.45% Sodium Chloride Injection USP Prescribing Information _ _Page 1 of 10_ PRESCRIBING INFORMATION 0.45 % 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 _ _ _0.45% 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 ................................................................................. 7 6.1.2 BREAST-FEEDING ............................... Læs hele dokumentet