Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
SILDENAFIL (SILDENAFIL CITRATE)
JAMP PHARMA CORPORATION
G04BE03
SILDENAFIL
50MG
TABLET
SILDENAFIL (SILDENAFIL CITRATE) 50MG
ORAL
4
Prescription
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Active ingredient group (AIG) number: 0136261002; AHFS:
CANCELLED POST MARKET
2022-09-07
_Jamp-SILDENAFIL (Sildenafil Citrate Tablets) 25 mg, 50 mg, 100 mg _ _Page 1 of 44_ _ _ PRODUCT MONOGRAPH PR JAMP-SILDENAFIL sildenafil (as sildenafil citrate) tablets 25 mg, 50 mg and 100 mg cGMP-Specific Phosphodiesterase Type 5 Inhibitor Treatment of Erectile Dysfunction SPONSOR: Jamp Pharma Corporation DATE OF PREPARATION: 1380-203 Newton April 24, 2013 Boucherville, Québec J4B 5H2 SUBMISSION CONTROL NO: 163804 _Jamp-SILDENAFIL (Sildenafil Citrate Tablets) 25 mg, 50 mg, 100 mg _ _Page 2 of 44_ _ _ 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 ....................................................................................................10 DOSAGE AND ADMINISTRATION................................................................................13 OVERDOSAGE ..................................................................................................................14 ACTION AND CLINICAL PHARMACOLOGY ..............................................................15 STORAGE AND STABILITY............................................................................................18 SPECIAL HANDLING INSTRUCTIONS .........................................................................18 DOSAGE FORMS, COMPOSITION AND PACKAGING ...............................................18 PART II: SCIENTIFIC INFORMATION ..................................................................... Baca dokumen lengkap