JAMP-IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
02-01-2014
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Aktiv bestanddel:
IRBESARTAN; HYDROCHLOROTHIAZIDE
Tilgængelig fra:
JAMP PHARMA CORPORATION
ATC-kode:
C09DA04
INN (International Name):
IRBESARTAN AND DIURETICS
Dosering:
150MG; 12.5MG
Lægemiddelform:
TABLET
Sammensætning:
IRBESARTAN 150MG; HYDROCHLOROTHIAZIDE 12.5MG
Indgivelsesvej:
ORAL
Enheder i pakken:
28/100
Recept type:
Prescription
Terapeutisk område:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Produkt oversigt:
Active ingredient group (AIG) number: 0240086001; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2022-09-06
Produktets egenskaber
_Jamp-Irbesartan and Hydrochlorothiazide _
_Page 1 of 40_
PRODUCT MONOGRAPH
PR
JAMP-IRBESARTAN AND HYDROCHLOROTHIAZIDE
IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS
(House Standard)
150/12.5 mg, 300/12.5 mg and 300/25 mg
Angiotensin II AT
1
Receptor Blocker / Diuretic
JAMP PHARMA CORPORATION
DATE OF PREPARATION:
1380-203 NEWTON,
BOUCHERVILLE, QUÉBEC, J4B 5H2
December 11, 2013
SUBMISSION CONTROL NO.: 170093
_Jamp-Irbesartan and Hydrochlorothiazide _
_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
..............................................................................................................
9
DRUG INTERACTIONS
............................................................................................................
13
DOSAGE AND ADMINISTRATION
........................................................................................
16
OVERDOSAGE
...........................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
19
STORAGE AND STABILITY
....................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 22
PART II: SCIENTIFIC INFORMATION
.......................................................................................
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