BENAZEPRIL TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
02-12-2019
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Viambatanisho vya kazi:
BENAZEPRIL HYDROCHLORIDE
Inapatikana kutoka:
AA PHARMA INC
ATC kanuni:
C09AA07
INN (Jina la Kimataifa):
BENAZEPRIL
Kipimo:
5MG
Dawa fomu:
TABLET
Tungo:
BENAZEPRIL HYDROCHLORIDE 5MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
100
Dawa ya aina:
Prescription
Eneo la matibabu:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0122438001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2007-01-02
Tabia za bidhaa
Page 1 of 35
PRODUCT MONOGRAPH
PR
BENAZEPRIL
BENAZEPRIL HYDROCHLORIDE
TABLETS 5 MG, 10 MG AND 20 MG
ANGIOTENSIN CONVERTING ENZYME INHIBITOR
AA PHARMA INC.
DATE OF REVISION:
1165 CREDITSTONE ROAD, UNIT #1
DECEMBER 2, 2019
VAUGHAN, ONTARIO
L4K 4N7
SUBMISSION CONTROL NUMBER: 233587
Page 2 of 35
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
................................................................................................
12
DOSAGE AND ADMINISTRATION
............................................................................
16
OVERDOSAGE
..............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 17
STORAGE AND STABILITY
........................................................................................
19
SPECIAL HANDLING INSTRUCTIONS
.....................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 19
PART II: SCIENTIFIC INFORMATION
..............................................................................
21
PHARMACEUTICAL INFORMATION
........................................................................
21
CLINICAL TRIALS
.......................................................................................................
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