Država: Kanada
Jezik: angleščina
Source: Health Canada
FOSINOPRIL SODIUM
RANBAXY PHARMACEUTICALS CANADA INC.
C09AA09
FOSINOPRIL
20MG
TABLET
FOSINOPRIL SODIUM 20MG
ORAL
90/1000
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0122777002; AHFS:
APPROVED
2009-08-24
_ _ _Page 1 of 34_ PRODUCT MONOGRAPH Pr FOSINOPRIL Tablets Fosinopril sodium Tablets USP 10 mg and 20 mg Angiotensin Converting Enzyme Inhibitor Ranbaxy Pharmaceuticals Canada Inc. 2680 Matheson Blvd. East, Suite 200 Mississauga, ON L4W 0A5 Canada Date of Preparation: August 20, 2009 Submission Control No: 132105 _ _ _ _ _Page 2 of 34_ 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................................................................................................... 8 DRUG INTERACTIONS ................................................................................................. 13 DOSAGE AND ADMINISTRATION............................................................................. 14 OVERDOSAGE ............................................................................................................... 16 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 17 STORAGE AND STABILITY......................................................................................... 20 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 20 PART II: SCIENTIFIC INFORMATION .............................................................................. 21 PHARMACEUTICAL INFORMATION......................................................................... 21 CLINICAL TRIALS......................................................................................................... 21 DETAILED PHARMACOLOGY........................... Preberite celoten dokument