País: Canadá
Língua: inglês
Origem: Health Canada
CANDESARTAN CILEXETIL
ZINDA PHARMA LIMITED
C09CA06
CANDESARTAN
16MG
TABLET
CANDESARTAN CILEXETIL 16MG
ORAL
30/100/1000
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0135220003; AHFS:
CANCELLED PRE MARKET
2021-10-04
_ZINDA-CANDESARTAN – Product Monograph _ _ Page 1 of 30_ PRODUCT MONOGRAPH Pr ZINDA-CANDESARTAN candesartan cilexetil tablets 16 mg and 32 mg Angiotensin II AT 1 Receptor Blocker Zinda Pharma Limited 8250 Décarie - suite 110 Montreal, Quebec H4P 2P5 Date of Preparation: May 2, 2014 SUBMISSION CONTROL NO: 157357 _ _ _ZINDA-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 ...................................................................................................3 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 ............................................ Leia o documento completo