País: Canadá
Língua: inglês
Origem: Health Canada
CANDESARTAN CILEXETIL
ALEMBIC PHARMACEUTICALS LIMITED
C09CA06
CANDESARTAN
16MG
TABLET
CANDESARTAN CILEXETIL 16MG
ORAL
30/100/1000
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0135220003; AHFS:
APPROVED
2014-04-25
______________________________________________________________________________ _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 ....................................... Leia o documento completo