MYLAN-TERAZOSIN TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

TERAZOSIN HYDROCHLORIDE

Dostępny od:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

G04CA03

INN (International Nazwa):

TERAZOSIN

Dawkowanie:

5MG

Forma farmaceutyczna:

TABLET

Skład:

TERAZOSIN HYDROCHLORIDE 5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ALPHA-ADRENERGIC BLOCKING AGENTS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2016-06-28

Charakterystyka produktu

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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
.