CANDESARTAN CILEXETIL TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
18-03-2022
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Tuma ombi.
Viambatanisho vya kazi:
CANDESARTAN CILEXETIL
Inapatikana kutoka:
ALEMBIC PHARMACEUTICALS LIMITED
ATC kanuni:
C09CA06
INN (Jina la Kimataifa):
CANDESARTAN
Kipimo:
16MG
Dawa fomu:
TABLET
Tungo:
CANDESARTAN CILEXETIL 16MG
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: 0135220003; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2014-04-25
Tabia za bidhaa
______________________________________________________________________________
_Candesartan Cilexetil Product Monograph_
_ Page 1 of 39_
PRODUCT MONOGRAPH
PR
CANDESARTAN CILEXETIL
Candesartan Cilexetil Tablets
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
MANUFACTURED BY:
Alembic Pharmaceuticals Limited, DATE OF PREPARATION:
Alembic Road, Vadodara 390003,
March 18, 2022
Gujarat, India.
IMPORTED AND DISTRIBUTED BY:
Alembic Pharmaceuticals Canada Ltd.
225 Gibraltar Road, Unit 5
Vaughan, Ontario
L4H 4P9, Canada
Submission
Control Numbers: 257724
______________________________________________________________________________
_Candesartan Cilexetil Product Monograph_
_ Page 2 of 39_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................3
SUMMARY PRODUCT
INFORMATION...........................................................................3
INDICATIONS AND CLINICAL
USE.................................................................................3
CONTRAINDICATIONS......................................................................................................4
WARNINGS AND PRECAUTIONS
....................................................................................5
ADVERSE
REACTIONS.......................................................................................................9
DRUG
INTERACTIONS.....................................................................................................15
DOSAGE AND ADMINISTRATION
................................................................................19
OVERDOSAGE...................................................................................................................22
ACTION AND CLINICAL
PHARMACOLOGY...............................................................22
STORAGE AND
STABILITY.............................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................
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