SANDOZ METOPROLOL (TYPE L) TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

METOPROLOL TARTRATE

متاح من:

SANDOZ CANADA INCORPORATED

ATC رمز:

C07AB02

INN (الاسم الدولي):

METOPROLOL

جرعة:

50MG

الشكل الصيدلاني:

TABLET

تركيب:

METOPROLOL TARTRATE 50MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

BETA-ADRENERGIC BLOCKING AGENTS

ملخص المنتج:

Active ingredient group (AIG) number: 0111923002; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2018-08-01

خصائص المنتج

_Sandoz Metoprolol (Type L) and Sandoz Metoprolol SR _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ METOPROLOL (TYPE L)
PR
SANDOZ METOPROLOL SR
Metoprolol tartrate
50 and 100 mg tablets
100 mg and 200 mg slow-release tablets
β-Adrenergic Receptor Blocking Agent
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Date of Revision:
November 20, 2020
Submission Control No: 240568
_Sandoz Metoprolol (Type L) and Sandoz Metoprolol SR _
_Page 2 of 38_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
DETAILED PHARMACOLOGY
....................................................................................
26
TOXI