Land: Kanada
Sprache: Englisch
Quelle: Health Canada
SILDENAFIL (SILDENAFIL CITRATE)
LABORATOIRE RIVA INC.
G04BE03
SILDENAFIL
100MG
TABLET
SILDENAFIL (SILDENAFIL CITRATE) 100MG
ORAL
4/8/30
Prescription
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Active ingredient group (AIG) number: 0136261003; AHFS:
APPROVED
2023-07-20
_RIVA-SILDENAFIL - Product Monograph _ _Page 1 of 54_ PRODUCT MONOGRAPH PR RIVA-SILDENAFIL Sildenafil Citrate Tablets Tablets, 25 mg, 50 mg and 100 mg Sildenafil (as Sildenafil citrate) cGMP-Specific Phosphodiesterase Type 5 Inhibitor Treatment of Erectile Dysfunction LABORATOIRE RIVA INC. 660 Boul. Industriel Blainville, Quebec J7C 3V4 www.labriva.com Submission Control No.: 276533 DATE OF INITIAL APPROVAL: April 22, 2016 DATE OF REVISION: July 20, 2023 _RIVA-SILDENAFIL - Product Monograph _ _Page 2 of 54_ 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 ................................................................................................... 8 DRUG INTERACTIONS ................................................................................................. 12 DOSAGE AND ADMINISTRATION ............................................................................. 16 OVERDOSAGE ............................................................................................................... 17 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 18 STORAGE AND STABILITY ......................................................................................... 21 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 21 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 21 PART II: SCIENTIFIC INFORMATION ....................................................................... Lesen Sie das vollständige Dokument