MINT-CANDESARTAN TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Preparatomtale Preparatomtale (SPC)
29-11-2022

Aktiv ingrediens:

CANDESARTAN CILEXETIL

Tilgjengelig fra:

MINT PHARMACEUTICALS INC

ATC-kode:

C09CA06

INN (International Name):

CANDESARTAN

Dosering :

16MG

Legemiddelform:

TABLET

Sammensetning:

CANDESARTAN CILEXETIL 16MG

Administreringsrute:

ORAL

Enheter i pakken:

30/100/1000

Resept typen:

Prescription

Terapeutisk område:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0135220003; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2018-06-05

Preparatomtale

                                MINT-CANDESARTAN Product Monograph
Page 1 of 34
PRODUCT MONOGRAPH
PR
MINT-CANDESARTAN
Candesartan Cilexetil Tablets
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
Mint Pharmaceuticals Inc., DATE OF REVISION:
6575 Davand Drive
November 29, 2022
Mississauga, Ontario
L5T 2M3
Submission
Control No: 265629
MINT-CANDESARTAN Product Monograph
Page 2 of 34
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
....................................................................................................
8
DRUG
INTERACTIONS....................................................................................................13
DOSAGE AND
ADMINISTRATION.................................................................................14
OVERDOSAGE
.................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
................................................................17
STORAGE AND
STABILITY............................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................20
PART II: SCIENTIFIC
INFORMATION................................................................................21
PHARMACEUTICAL
INFORMATION.............................................................................21
CLINICAL TRIALS
..........................................................................................
                                
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