MYLAN-TERAZOSIN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

TERAZOSIN HYDROCHLORIDE

Boleh didapati daripada:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

G04CA03

INN (Nama Antarabangsa):

TERAZOSIN

Dos:

10MG

Borang farmaseutikal:

TABLET

Komposisi:

TERAZOSIN HYDROCHLORIDE 10MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ALPHA-ADRENERGIC BLOCKING AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0121210004; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2016-06-28

Ciri produk

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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
.