ACH-CANDESARTAN TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
12-04-2017
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Aktívna zložka:
CANDESARTAN CILEXETIL
Dostupné z:
ACCORD HEALTHCARE INC
ATC kód:
C09CA06
INN (Medzinárodný Name):
CANDESARTAN
Dávkovanie:
8MG
Forma lieku:
TABLET
Zloženie:
CANDESARTAN CILEXETIL 8MG
Spôsob podávania:
ORAL
Počet v balení:
30/100
Typ predpisu:
Prescription
Terapeutické oblasti:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Prehľad produktov:
Active ingredient group (AIG) number: 0135220002; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2012-02-02
Súhrn charakteristických
Page 1 of 38
PRODUCT MONOGRAPH
ACH-CANDESARTAN
Candesartan Cilexetil
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AIMIPENEM AND CILASTATIN FOR INJECTION T
1
Receptor Blocker
Accord Healthcare Inc.
3535 boul. St. Charles suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Revision:
March 30, 2017
Submission Control Number: 203995
Page 2 of 38
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
..........................................................................................................
8
DRUG INTERACTIONS
........................................................................................................
14
DOSAGE AND ADMINISTRATION
....................................................................................
17
OVERDOSAGE
.......................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 20
STORAGE AND STABILITY
................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 23
PART II: SCIENTIFIC INFORMATION
................................................................................
24
PHARMACEUTICAL INFORMATION
..............................................................................
24
CLINICAL TRIALS
.......................................................................
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