MINT-CLONIDINE TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

CLONIDINE HYDROCHLORIDE

Verfügbar ab:

MINT PHARMACEUTICALS INC

ATC-Code:

C02AC01

INN (Internationale Bezeichnung):

CLONIDINE

Dosierung:

0.2MG

Darreichungsform:

TABLET

Zusammensetzung:

CLONIDINE HYDROCHLORIDE 0.2MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

CENTRAL ALPHA-AGONISTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0108891002; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2017-03-15

Fachinformation

_Page 1 of 29_
PRODUCT
MONOGRAPH
PR
MINT-CLONIDINE
Clonidine Hydrochloride Tablets, USP
0.1 mg and 0.2 mg
Antihypertensive
Mint Pharmaceuticals Inc.
1093 Meyerside Drive, Unit #1
Mississauga, Ontario
L5T 1J6
Date of Preparation:
MARCH 8, 2017
Submission Control No: 184607
_Page 2 of 29_
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
...............................................................................................................
7
DRUG INTERACTIONS
...............................................................................................................
9
DOSAGE AND ADMINISTRATION
.........................................................................................
11
OVERDOSAGE
...........................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
13
STORAGE AND STABILITY
.....................................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 15
PART II: SCIENTIFIC INFORMATION
..................................................................................
16
PHARMACEUTICAL INFORMATION
.....................................................................................
16
CLINICAL TRIALS
..............................................