METOPROLOL TARTRATE INJECTION, USP SOLUTION

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

METOPROLOL TARTRATE

มีจำหน่ายจาก:

STRIDES PHARMA CANADA INC

รหัส ATC:

C07AB02

INN (ชื่อสากล):

METOPROLOL

ปริมาณ:

1MG

แบบฟอร์มเภสัชกรรม:

SOLUTION

องค์ประกอบ:

METOPROLOL TARTRATE 1MG

เส้นทางการบริหาร:

INTRAVENOUS

หน่วยในแพ็คเกจ:

100

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

BETA-ADRENERGIC BLOCKING AGENTS

สรุปสินค้า:

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

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2020-08-13

สรุปลักษณะสินค้า

_Page 1 of 37 _
PRODUCT MONOGRAPH
PR
METOPROLOL TARTRATE INJECTION, USP
1 mg/mL – 5 mL vial
STERILE SOLUTION FOR INTRAVENOUS INJECTION
ß-Adrenergic Receptor Blocking Agent
Strides Pharma Canada Inc.
1565, Boul. Lionel-Boulet
Varennes, Quebec
Canada, J3X 1P7
Date of Revision:
August 12, 2020
Submission Control No.: 241321
_Page 2 of 37 _
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
....................................................................................................
9
DRUG INTERACTIONS
..................................................................................................
11
DOSAGE AND ADMINISTRATION
..............................................................................
17
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 20
STORAGE AND STABILITY
..........................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
..........................................................................
25
DETAILED PHARMACOLOGY
....................