Maa: Kanada
Kieli: englanti
Lähde: Health Canada
SILDENAFIL (SILDENAFIL CITRATE)
ANGITA PHARMA INC.
G04BE03
SILDENAFIL
25MG
TABLET
SILDENAFIL (SILDENAFIL CITRATE) 25MG
ORAL
4
Prescription
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Active ingredient group (AIG) number: 0136261001; AHFS:
CANCELLED POST MARKET
2022-11-15
_Pr_ _AG-SILDENAFIL_ _Page 1 of 43_ PRODUCT MONOGRAPH PR AG-SILDENAFIL sildenafil (as sildenafil citrate) tablets 25 mg, 50 mg and 100 mg cGMP-Specific Phosphodiesterase Type 5 Inhibitor Treatment of Erectile Dysfunction Date of Revision: August 28, 2018 Angita Pharma Inc. 1310 Nobel Street Boucherville, Quebec J4B 5H3 SUBMISSION CONTROL NO.: 214622 _Pr_ _AG-SILDENAFIL_ _Page 2 of 43_ 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 DOSAGEAND 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...................................................... Lue koko asiakirja