Land: Kanada
Sprache: Englisch
Quelle: Health Canada
TADALAFIL
LABORATOIRE RIVA INC.
G04BE08
TADALAFIL
5MG
TABLET
TADALAFIL 5MG
ORAL
15G/50G
Prescription
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Active ingredient group (AIG) number: 0149485004; AHFS:
APPROVED
2016-07-12
_RIVA-TADALAFIL - Product Monograph _ _Page 1 of 48_ PRODUCT MONOGRAPH PR RIVA-TADALAFIL Tadalafil Tablets, USP 2.5 mg, 5 mg tablets (for _Once-a-Day_ use) 10 mg, 20 mg tablets (for _“On-Demand”_ dosing) cGMP-Specific Phosphodiesterase Type 5 Inhibitor TREATMENT OF ERECTILE DYSFUNCTION (ED) LABORATOIRE RIVA INC. 660 Boul. Industriel Blainville, Quebec J7C 3V4 www.labriva.com Submission Control No.: 269361 DATE OF INITIAL APPROVAL: JUL 12, 2016 DATE OF REVISION: NOV 23, 2022 _RIVA-TADALAFIL - Product Monograph _ _Page 2 of 48_ 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 ................................................................................................. 10 DOSAGE AND ADMINISTRATION ............................................................................. 13 OVERDOSAGE ............................................................................................................... 14 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 15 STORAGE AND STABILITY ......................................................................................... 20 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 20 PART II: SCIENTIFIC INFORMATION ............................................................................... 22 PHARMACEUTICAL INFORMATION .......................................... Lesen Sie das vollständige Dokument