MINT-IRBESARTAN/HCTZ TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
26-08-2019
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Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
IRBESARTAN; HYDROCHLOROTHIAZIDE
Inapatikana kutoka:
MINT PHARMACEUTICALS INC
ATC kanuni:
C09DA04
INN (Jina la Kimataifa):
IRBESARTAN AND DIURETICS
Kipimo:
150MG; 12.5MG
Dawa fomu:
TABLET
Tungo:
IRBESARTAN 150MG; HYDROCHLOROTHIAZIDE 12.5MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
30/100/1000
Dawa ya aina:
Prescription
Eneo la matibabu:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0240086001; AHFS:
Idhini hali ya:
CANCELLED POST MARKET
Idhini ya tarehe:
2020-07-08
Tabia za bidhaa
PRODUCT MONOGRAPH
Pr
MINT-IRBESARTAN/HCTZ
(Irbesartan and hydrochlorothiazide Tablets)
150/12.5 mg, 300/12.5 mg and 300/25 mg Tablets
House Standard
Angiotensin II AT
1
Receptor Blocker / Diuretic
Mint Pharmaceuticals Inc.
Date of Revision:
1093 Meyerside Drive, Unit 1
August 26, 2019
Mississauga, Ontario
L5T 1J6
CONTROL NO.: 230635
_ _
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
................................................................................................................
9
DRUG INTERACTIONS
...............................................................................................................
14
DOSAGE AND ADMINISTRATION
...........................................................................................
20
OVERDOSAGE
.............................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
22
STORAGE AND STABILITY
......................................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 26
PART II: SCIENTIFIC INFORMATION
....................................................................................
27
PHARMACEUTICAL INFORMATION
...............................................................................
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