MINT-CLONIDINE TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
16-03-2017
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Aktívna zložka:
CLONIDINE HYDROCHLORIDE
Dostupné z:
MINT PHARMACEUTICALS INC
ATC kód:
C02AC01
INN (Medzinárodný Name):
CLONIDINE
Dávkovanie:
0.1MG
Forma lieku:
TABLET
Zloženie:
CLONIDINE HYDROCHLORIDE 0.1MG
Spôsob podávania:
ORAL
Počet v balení:
100
Typ predpisu:
Prescription
Terapeutické oblasti:
CENTRAL ALPHA-AGONISTS
Prehľad produktov:
Active ingredient group (AIG) number: 0108891001; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2017-03-15
Súhrn charakteristických
_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
..............................................
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