APO-CLONIDINE TAB 0.1MG TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
20-05-2020
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Aktívna zložka:
CLONIDINE HYDROCHLORIDE
Dostupné z:
APOTEX 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:
100/500
Typ predpisu:
Prescription
Terapeutické oblasti:
CENTRAL ALPHA-AGONISTS
Prehľad produktov:
Active ingredient group (AIG) number: 0108891001; AHFS:
Stav Autorizácia:
MARKETED
Dátum Autorizácia:
1990-12-31
Súhrn charakteristických
Page 1 of 26
PRODUCT MONOGRAPH
PR
APO-CLONIDINE
CLONIDINE HYDROCHLORIDE TABLETS USP
0.1 MG AND 0.2 MG
ANTIHYPERTENSIVE
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
DATE OF REVISION:
M9L 1T9
May 20, 2020
Control Number 237322
Page 2 of 26
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 3
SUMMARY PRODUCT INFORMATION
.................................................................................
3
INDICATIONS AND CLINICAL USE
.......................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
3
ADVERSE
REACTIONS.........................................................................................................
6
DRUG INTERACTIONS
.........................................................................................................
8
DOSAGE AND ADMINISTRATION
.......................................................................................10
OVERDOSAGE
.....................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
........................................................................12
STORAGE AND STABILITY
..................................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................13
PART II: SCIENTIFIC INFORMATION
.....................................................................................14
PHARMACEUTICAL INFORMATION
....................................................................................14
CLINICAL STUDIES
..............................................................................................................15
DETAILED
PHARMACOL
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