AG-CANDESARTAN TABLETS

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Preparatomtale Preparatomtale (SPC)
19-06-2020

Aktiv ingrediens:

CANDESARTAN CILEXETIL

Tilgjengelig fra:

ANGITA PHARMA INC.

ATC-kode:

C09CA06

INN (International Name):

CANDESARTAN

Dosering :

16MG

Legemiddelform:

TABLET

Sammensetning:

CANDESARTAN CILEXETIL 16MG

Administreringsrute:

ORAL

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2020-06-22

Preparatomtale

                                1
PRODUCT MONOGRAPH
Pr
AG-Candesartan Tablets
Candesartan Cilexetil Tablets
8 mg, 16 mg and 32 mg
Angiotensin II
AT
1
Receptor Blocker
Date of Revision:
June 19, 2020
Submission
Control
No.:
239327
J4B 5H3
Boucherville
,
Québec
1310
rue
Nobel
Angita Pharma Inc.
2
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 RE ACT IONS
..................................................................................................
8
DRUG INTERACTIONS
........................................................................................................
14
DOS AGE AND AD MINISTRAT IO
N.........................................................................
18
O V E RD O SA GE
..........................................................................................
21
ACTION AND CLINICAL PHARMAC OLOGY
................................................... 21
STORAGE AND STABILITY
................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 23
PART II: SCIENTIFIC INFORMATION
.................................................................................25
PHARMACEUTICAL INFORMATION
25
CLINICAL TRIALS
..........................................................................................................
26
DET AIL ED PHARMACO LOG Y
.................................................................................
30
TO XI COL O G Y
................................
                                
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Preparatomtale Preparatomtale fransk 19-06-2020

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