MYLAN-TERAZOSIN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

TERAZOSIN HYDROCHLORIDE

זמין מ:

MYLAN PHARMACEUTICALS ULC

קוד ATC:

G04CA03

INN (שם בינלאומי):

TERAZOSIN

כמות:

5MG

טופס פרצבטיות:

TABLET

הרכב:

TERAZOSIN HYDROCHLORIDE 5MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

ALPHA-ADRENERGIC BLOCKING AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0121210001; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2016-06-28

מאפייני מוצר

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_Page 1 of 39_
PRODUCT MONOGRAPH
PR
MYLAN-TERAZOSIN
Terazosin Hydrochloride Tablets
1 mg, 2 mg 5 mg and 10 mg
Antihypertensive Agent
Symptomatic Treatment of Benign Prostatic Hyperplasia (BPH)
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
November 17, 2014
Submission Control No: 179465
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_Page 2 of 39_
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
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND STABILITY
.........................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 19
PART II: SCIENTIFIC INFORMATION
...............................................................................
20
PHARMACEUTICAL INFORMATION
.........................................................................
20
CLINICAL TRIALS
.........................................................................................................
21
DETAILED PHARMACOLOGY
.