Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
LISINOPRIL (LISINOPRIL DIHYDRATE)
MINT PHARMACEUTICALS INC
C09AA03
LISINOPRIL
20MG
TABLET
LISINOPRIL (LISINOPRIL DIHYDRATE) 20MG
ORAL
100/500
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0121550002; AHFS:
CANCELLED POST MARKET
2012-08-02
_ _ _Page 1 of 41_ PRODUCT MONOGRAPH PR MINT-LISINOPRIL lisinopril tablets 5 mg, 10 mg and 20 mg of lisinopril as lisinopril dihydrate USP Angiotensin Converting Enzyme Inhibitor Manufactured for: Mint Pharmaceuticals Canada Inc., 1 First Canadian Place, Suite 5600 100 King Street West Toronto, Ontario M5X 1E2 Date of Preparation: September 29, 2008 Submission Control No: 124991 _ _ _ _ _Page 2 of 41_ 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................................................................................................. 10 DRUG INTERACTIONS ................................................................................................. 16 DOSAGE AND ADMINISTRATION............................................................................. 18 OVERDOSAGE ............................................................................................................... 21 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 21 STORAGE AND STABILITY......................................................................................... 24 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 24 PART II: SCIENTIFIC INFORMATION .............................................................................. 25 PHARMACEUTICAL INFORMATION......................................................................... 25 CLINICAL TRIALS........................................................................................... Baca dokumen lengkap