Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
CANDESARTAN CILEXETIL
RANBAXY PHARMACEUTICALS CANADA INC.
C09CA06
CANDESARTAN
4MG
TABLET
CANDESARTAN CILEXETIL 4MG
ORAL
100
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0135220001; AHFS:
APPROVED
2013-08-21
_ _ _CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_ _ _ _Page 1 of 28_ PRODUCT MONOGRAPH PR CANDESARTAN candesartan cilexetil tablets 4 mg, 8 mg, 16 mg, and 32 mg Angiotensin II AT 1 Receptor Blocker Ranbaxy Pharmaceuticals Canada Inc., 2680 Matheson Blvd. E., Suite 200 Mississauga, Ontario L4W 0A5 Submission Control No: 166986 DATE OF PREPARATION: August 15, 2013 _ _ _CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_ _ _ _Page 2 of 28_ 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 ....................................................................................................6 DRUG INTERACTIONS ..................................................................................................10 DOSAGE AND ADMINISTRATION ..............................................................................13 OVERDOSAGE ................................................................................................................14 ACTION AND CLINICAL PHARMACOLOGY ............................................................14 STORAGE AND STABILITY ..........................................................................................16 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................17 PART II: SCIENTIFIC INFORMATION ...............................................................................18 PHARMACEUTICAL INFORMATION ..........................................................................18 CLINICAL TRIALS ..................................................... Baca dokumen lengkapnya