Страна: Канада
Язык: английский
Источник: Health Canada
CANDESARTAN CILEXETIL
SEPTA PHARMACEUTICALS INC
C09CA06
CANDESARTAN
16MG
TABLET
CANDESARTAN CILEXETIL 16MG
ORAL
100
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0135220003; AHFS:
APPROVED
2015-10-20
_SEPTA-CANDESARTAN – Product Monograph _ _ Page 1 of 30_ PRODUCT MONOGRAPH Pr SEPTA-CANDESARTAN candesartan cilexetil tablets 16 mg and 32 mg Angiotensin II AT 1 Receptor Blocker Septa Pharmaceuticals Inc. 7490 Pacific Circle, Unit # 1 Mississauga, ON L5T 2A3 Canada Date of Preparation: October 16, 2015 SUBMISSION CONTROL NO: 187806 _ _ _SEPTA-CANDESARTAN – Product Monograph Page 2 of 30 _ 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 ....................................................................................................7 DRUG INTERACTIONS ..................................................................................................12 DOSAGE AND ADMINISTRATION ..............................................................................14 OVERDOSAGE…………………………………………………………………………16 ACTION AND CLINICAL PHARMACOLOGY ............................................................17 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................19 PART II: SCIENTIFIC INFORMATION ...............................................................................20 PHARMACEUTICAL INFORMATION ..........................................................................20 CLINICAL TRIALS ..........................................................................................................21 DETAILED PHARMACOLOGY .....................................................................................23 TOXICOLOGY ...................... Прочитать полный документ