País: Canadá
Idioma: inglés
Fuente: Health Canada
BOSENTAN (BOSENTAN MONOHYDRATE)
MYLAN PHARMACEUTICALS ULC
C02KX01
BOSENTAN
125MG
TABLET
BOSENTAN (BOSENTAN MONOHYDRATE) 125MG
ORAL
56/100
Prescription
VASODILATING AGENTS
Active ingredient group (AIG) number: 0145922002; AHFS:
CANCELLED POST MARKET
2018-07-12
1 PRODUCT MONOGRAPH Pr MYLAN-BOSENTAN Bosentan monohydrate (film coated) tablet Bosentan 62.5 mg and 125 mg Endothelin Receptor Antagonist Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, ON M8Z 2S6 Submission Control No.: 218925 Date of Revision: August 28, 2018 2 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 ................................................................................... 15 DOSAGE AND ADMINISTRATION .............................................................. 18 OVERDOSAGE .................................................................................................. 19 ACTION AND CLINICAL PHARMACOLOGY ............................................ 19 STORAGE AND STABILITY........................................................................... 21 SPECIAL HANDLING INSTRUCTIONS ....................................................... 21 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................ 22 PART II: SCIENTIFIC INFORMATION ................................................................... 23 PHARMACEUTICAL INFORMATION.......................................................... 23 CLINICAL TRIALS ........................................................................................... 24 DETAILED PHARMACOLOGY...................................................................... 31 MICROBIOLOGY .............................................................................................. 32 TOXICOLOGY ................. Leer el documento completo