Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
SITAXSENTAN SODIUM
PFIZER CANADA ULC
C02KX03
SITAXENTAN
100MG
TABLET
SITAXSENTAN SODIUM 100MG
ORAL
28
Prescription
MISCELLANEOUS VASODILATATING AGENTS
Active ingredient group (AIG) number: 0152215001; AHFS:
CANCELLED POST MARKET
2011-04-30
_ _ _ _ _PR_ _THELIN_ _® _ _(sitaxsentan sodium tablets) Product Monograph _ _Page 1 of 28_ PRODUCT MONOGRAPH PR THELIN ® (sitaxsentan sodium tablets) 100 mg Endothelin receptor antagonist ® Registered trademark of Encysive Pharmaceuticals Inc. Pfizer Canada Inc. 17 300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 Date of preparation: April 26, 2010 Submission Control Number: 134705 _ _ _ _ _PR_ _THELIN_ _® _ _(sitaxsentan sodium tablets) Product Monograph _ _Page 2 of 28_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION................................................... 3 SUMMARY OF PRODUCT INFORMATION ............................................................. 3 INDICATIONS AND CLINICAL USE......................................................................... 3 CONTRAINDICATIONS .............................................................................................. 3 DOSAGE AND ADMINISTRATION......................................................................... 13 OVERDOSAGE: .......................................................................................................... 14 ACTION AND CLINICAL PHARMACOLOGY ....................................................... 15 STORAGE AND STABILITY..................................................................................... 16 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................ 16 PART II: SCIENTIFIC INFORMATION........................................................................ 18 PHARMACEUTICAL INFORMATION..................................................................... 18 CLINICAL TRIALS..................................................................................................... 19 DETAILED PHARMACOLOGY................................................................................ 21 TOXICOLOGY ............................................................................................................ 24 REFERENCES ................................................................. Đọc toàn bộ tài liệu