METOPROLOL TARTRATE INJECTION USP SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-11-2020
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Active ingredient:
METOPROLOL TARTRATE
Available from:
STERIMAX INC
ATC code:
C07AB02
INN (International Name):
METOPROLOL
Dosage:
1MG
Pharmaceutical form:
SOLUTION
Composition:
METOPROLOL TARTRATE 1MG
Administration route:
INTRAVENOUS
Units in package:
10 X 5 ML
Prescription type:
Prescription
Therapeutic area:
BETA-ADRENERGIC BLOCKING AGENTS
Product summary:
Active ingredient group (AIG) number: 0111923004; AHFS:
Authorization status:
APPROVED
Authorization date:
2016-06-15
Summary of Product characteristics
_ Metoprolol Tartrate Injection USP _
_Page 1 of 45_
PRODUCT MONOGRAPH
Pr
METOPROLOL TARTRATE INJECTION USP
5 mg / 5 mL (1 mg / mL) Solution
ß-Adrenergic Receptor Blocking Agent
SteriMax Inc.
2770 Portland Drive
Oakville, ON
Canada L6H 6R4
Date of Revision:
November 23, 2020
Submission Control No: 244731
_Metoprolol Tartrate Injection USP _
_Page 2 of 45_
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
.............................................................................................................
12
DRUG INTERACTIONS
.............................................................................................................
15
DOSAGE AND ADMINISTRATION
.........................................................................................
21
OVERDOSAGE
...........................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
24
STORAGE AND
STABILITY………………………………………………………………….
27
SPECIAL HANDLING INSTRUCTIONS
..................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 29
PART II: SCIENTIFIC INFORMATION
...........................................................................................
30
PH
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