METOPROLOL TARTRATE INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

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Active ingredient:

METOPROLOL TARTRATE

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

C07AB02

INN (International Name):

METOPROLOL

Dosage:

1MG

Pharmaceutical form:

SOLUTION

Composition:

METOPROLOL TARTRATE 1MG

Administration route:

INTRAVENOUS

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0111923004; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-09-02

Summary of Product characteristics

                                _Metoprolol Tartrate Injection USP _
_ _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING CONSUMER INFORMATION
PR
METOPROLOL TARTRATE INJECTION USP
(metoprolol tartrate)
5 mL vials (1 mg/mL)
β-Adrenergic Receptor Blocking Agent
Sandoz Canada Inc.
Date of Revision: August 10, 2020
110 Rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Submission Control No: 240543
_Metoprolol Tartrate Injection USP _
_ _
_Page 2 of 39_
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
.........................................................................................................
10
DOSAGE AND ADMINISTRATION
.....................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
21
STORAGE AND STABILITY
.................................................................................................
25
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
25
DOSAGE FORMS, COMPOSITION AND
PACKAGING..................................................... 25
PART II: SCIENTIFIC INFORMATION
...............................................................................
26
PHARMACEUTICAL INFORMATION
.................................................................................
26
DETAILED PHARMACOLOGY
............................................................................................
27
TOXICOLOGY...........
                                
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