国: カナダ
言語: 英語
ソース: Health Canada
VARDENAFIL (VARDENAFIL HYDROCHLORIDE TRIHYDRATE)
MYLAN PHARMACEUTICALS ULC
G04BE09
VARDENAFIL
10MG
TABLET
VARDENAFIL (VARDENAFIL HYDROCHLORIDE TRIHYDRATE) 10MG
ORAL
4/30
Prescription
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Active ingredient group (AIG) number: 0150003002; AHFS:
APPROVED
2018-11-01
_ _ _ _ _Page 1 of 58_ PRODUCT MONOGRAPH PR MYLAN-VARDENAFIL Vardenafil tablets 5 mg, 10 mg, 20 mg of vardenafil, as vardenafil hydrochloride trihydrate cyclic GMP-Specific Phosphodiesterase Type 5 Inhibitor Treatment of Erectile Dysfunction Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, ON M8Z 2S6 Date of Revision June 22, 2020 Submission Control No: 240066 _ _ _ _ _Page 2 of 58_ 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 ................................................................................................... 9 DRUG INTERACTIONS ................................................................................................. 12 DOSAGE AND ADMINISTRATION ............................................................................. 16 OVERDOSAGE ............................................................................................................... 17 TREATMENT OF PRIAPISM…………………………………………………...…….. 16 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 18 STORAGE AND STABILITY ......................................................................................... 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 23 PART II: SCIENTIFIC INFORMATION .............................................................................. 25 PHARMACEUTICAL INFORMATION ......................................................................... 25 CLINICAL TRIALS… 完全なドキュメントを読む