Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
SILDENAFIL (SILDENAFIL CITRATE)
DOMINION PHARMACAL
G04BE03
SILDENAFIL
50MG
TABLET
SILDENAFIL (SILDENAFIL CITRATE) 50MG
ORAL
4/8/30
Prescription
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Active ingredient group (AIG) number: 0136261002; AHFS:
APPROVED
2013-06-26
PRODUCT MONOGRAPH PR DOM-SILDENAFIL Sildenafil Citrate Tablets 25 mg, 50 mg and 100 mg sildenafil (as sildenafil citrate) cGMP-Specific Phosphodiesterase Type 5 Inhibitor Treatment of Erectile Dysfunction DOMINION PHARMACAL DATE OF PREPARATION: 6111 Royalmount Ave., Suite 100 June 5, 2013 Montreal, Quebec H4P 2T4 SUBMISSION CONTROL NO: 164964 _ _ _Dom-SILDENAFIL Product Monograph _ _Page 2 of 46 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL 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 SPECIAL HANDLING INSTRUCTIONS .......................................................................... 19 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................ 19 PART II: SCIENTIFIC INFORMATION ..................................................................................... 20 PHARMACEUTICAL INFORMATION ............................................................................. 20 CLINICAL TRIALS ........................ Izlasiet visu dokumentu