RAN-IRBESARTAN HCTZ TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
07-12-2018
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Aktiva substanser:
IRBESARTAN; HYDROCHLOROTHIAZIDE
Tillgänglig från:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC-kod:
C09DA04
INN (International namn):
IRBESARTAN AND DIURETICS
Dos:
150MG; 12.5MG
Läkemedelsform:
TABLET
Sammansättning:
IRBESARTAN 150MG; HYDROCHLOROTHIAZIDE 12.5MG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
Prescription
Terapiområde:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0240086001; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2022-07-12
Produktens egenskaper
_ _
_RAN-Irbesartan HCTZ _
_Page 1 of 40_
PRODUCT MONOGRAPH
PR
RAN™-IRBESARTAN HCTZ
IRBESARTAN/HYDROCHLOROTHIAZIDE
TABLETS, 150/12.5 MG, 300/12.5 MG AND 300/25 MG
HOUSE STANDARD
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER / DIURETIC
Ranbaxy Pharmaceuticals Canada Inc.
Date of Revision:
126 East Drive December 7, 2018
Brampton, Ontario
L6T 1C1
SUBMISSION CONTROL NO.: 222307
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_RAN-Irbesartan HCTZ _
_Page 2 of 40_
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...........................................................................................................
13
DOSAGE AND ADMINISTRATION
......................................................................................
18
OVERDOSAGE
.........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
20
STORAGE AND STABILITY
..................................................................................................
23
DOSAGE FORMS, COMPOSITION AND
PACKAGING...................................................... 23
PART II: SCIENTIFIC
INFORMATION.................................................................................
24
PHARMACEUTICAL INFORMATION
.............................................................
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