国家: 加拿大
语言: 英文
来源: Health Canada
SILDENAFIL (SILDENAFIL CITRATE)
TEVA CANADA LIMITED
G04BE03
SILDENAFIL
25MG
TABLET
SILDENAFIL (SILDENAFIL CITRATE) 25MG
ORAL
4/8/30/100
Prescription
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Active ingredient group (AIG) number: 0136261001; AHFS:
CANCELLED PRE MARKET
2015-11-25
_ _ _ratio-SILDENAFIL Tablets 25 mg, 50 mg and 100 mg _ _Page 1 of 49_ PRODUCT MONOGRAPH PR RATIO-SILDENAFIL Sildenafil Citrate 25 mg, 50 mg and 100 mg of sildenafil (as sildenafil citrate) Film Coated Tablets cGMP-Specific Phosphodiesterase Type 5 Inhibitor Treatment of Erectile Dysfunction ratiopharm inc. 30 Novopharm Court Toronto, Ontario Canada, M1B 2K9 www.tevacanada.com DATE OF PREPARATION: NOVEMBER 8, 2012 SUBMISSION CONTROL NO: 121353, 129879, 158416 _ _ _ratio-SILDENAFIL Tablets 25 mg, 50 mg and 100 mg _ _Page 2 of 49_ 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 ................................................................................................... 7 DRUG INTERACTIONS ................................................................................................. 11 DOSAGE AND ADMINISTRATION ............................................................................. 14 OVERDOSAGE ............................................................................................................... 15 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 16 STORAGE AND STABILITY ......................................................................................... 19 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 19 PART II: SCIENTIFIC INFORMATION .............................................................................. 21 PHARMACEUTICAL INFORMATION ............................................. 阅读完整的文件