Riik: Kanada
keel: inglise
Allikas: Health Canada
TADALAFIL
RANBAXY PHARMACEUTICALS CANADA INC.
G04BE08
TADALAFIL
2.5MG
TABLET
TADALAFIL 2.5MG
ORAL
4/28/30/56/100/500
Prescription
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Active ingredient group (AIG) number: 0149485003; AHFS:
APPROVED
2016-07-12
Page 1 of 48 PRODUCT MONOGRAPH PR RAN™-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) Ranbaxy Pharmaceuticals Canada Inc. DATE OF REVISION: 126 East Drive July 17, 2017 Brampton, Ontario L6T 1C1 Control# 207323 RAN trademark owned by Sun Pharmaceutical Industries Ltd. 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........................................................................................................................ 11 DOSAGE AND ADMINISTRATION ................................................................................................... 14 OVERDOSAGE ...................................................................................................................................... 15 ACTION AND CLINICAL PHARMACOLOGY .................................................................................. 16 STORAGE AND STABILITY ............................................................................................................... 21 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................................... 21 PAR Lugege kogu dokumenti