국가: 캐나다
언어: 프랑스어
출처: Health Canada
Candésartan cilexétil; Hydrochlorothiazide
AURO PHARMA INC
C09DA06
CANDERSARTAN AND DIURETICS
32MG; 12.5MG
Comprimé
Candésartan cilexétil 32MG; Hydrochlorothiazide 12.5MG
Orale
30/100/500
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Numéro de groupe d'ingrédients actifs (GIA) :0244181002; AHFS:
APPROUVÉ
2014-06-09
Page 1 of 46 PRODUCT MONOGRAPH PR AURO-CANDESARTAN HCT candesartan cilexetil/hydrochlorothiazide tablets 16 mg / 12.5 mg, 32 mg / 12.5 mg and 32 mg / 25 mg Professed Standard Angiotensin II AT 1 Receptor Blocker + Diuretic AURO PHARMA INC. Date of Revision: 3700 Steeles Avenue West, Suite # 402 August 26, 2019. Woodbridge, Ontario, L4L 8K8 CANADA Submission Control No: 230895 Page 2 of 46 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.......................................…………............. 9 DRUG INTERACTIONS…............................……………................ 14 DOSAGE AND ADMINISTRATION…............…............................ 20 OVERDOSAGE.........................................…………......................... 22 ACTION AND CLINICAL PHARMACOLOGY….......................... 22 STORAGE AND STABILITY…......................................…….......... 26 DOSAGE FORMS, COMPOSITION AND PACKAGING………..... 26 PART II: SCIENTIFIC INFORMATION............................…………….…....... 27 PHARMACEUTICAL INFORMATION...........................…............. 27 CLINICAL TRIALS.................................................……………....... 28 DETAILED PHARMACOLOGY.................................………….….. 32 TOXICOLOGY……………………………………………………….. 33 REFERENCES…....................................…………………………...... 37 PART III: CONSUMER INFORMATION.....................……………………....... 38 Page 3 of 46 PR AURO-CANDESARTAN HCT candesartan cilexetil/hydrochlorothiazide tablets 16 mg / 12.5 mg, 32 mg / 12.5 mg and 32 mg / 25 mg Pro 전체 문서 읽기