Страна: Канада
Език: английски
Източник: Health Canada
LISINOPRIL (LISINOPRIL DIHYDRATE)
MYLAN PHARMACEUTICALS ULC
C09AA03
LISINOPRIL
5MG
TABLET
LISINOPRIL (LISINOPRIL DIHYDRATE) 5MG
ORAL
100/500
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0121550003; AHFS:
CANCELLED POST MARKET
2017-08-02
Page 1 of 46 PRODUCT MONOGRAPH PR MYLAN-LISINOPRIL (Lisinopril Tablets, USP) Tablets 5 mg, 10 mg and 20 mg (Lisinopril as lisinopril dihydrate) Angiotensin Converting Enzyme Inhibitor Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, ON M8Z 2S6 Submission Control number: 192608 Date of Revision: December 19, 2016 Page 2 of 46 _ _ 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 ......................................................................................................... 11 DRUG INTERACTIONS ......................................................................................................... 17 DOSAGE AND ADMINISTRATION ..................................................................................... 19 OVERDOSAGE ....................................................................................................................... 22 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 23 STORAGE AND STABILITY ................................................................................................. 26 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................... 26 PART II: SCIENTIFIC INFORMATION ............................................................................... 27 PHARMACEUTICAL INFORMATION ................................................................................. 27 CLINICAL TRIALS .................................................... Прочетете целия документ