מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
SILDENAFIL (SILDENAFIL CITRATE)
NORA PHARMA INC
G04BE03
SILDENAFIL
25MG
TABLET
SILDENAFIL (SILDENAFIL CITRATE) 25MG
ORAL
4/8
Prescription
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Active ingredient group (AIG) number: 0136261001; AHFS:
CANCELLED PRE MARKET
2022-07-29
PRODUCT MONOGRAPH PR PRIVA-SILDENAFIL Sildenafil Citrate Tablets 25 mg, 50 mg, and 100 mg , cGMP-Specific Phosphodiesterase Type 5 Inhibitor Treatment of Erectile Dysfunction NORA PHARMA INC. 1565, Lionel-Boulet Boul. Varennes, Quebec J3X 1P7 Control #: 264224 Date of Preparation: June 10, 2022 _Priva-SILDENAFIL_ Page 2 of 55 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......................................................................... 20 PHARMACEUTICAL INFORMATION........................................................................... 20 CLINICAL TRIALS........................................................................................................... 21 DETAILED PHARMACOLOGY................................. קרא את המסמך השלם