Țară: Canada
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Sursă: Health Canada
FEBUXOSTAT
JAMP PHARMA CORPORATION
M04AA03
FEBUXOSTAT
80MG
TABLET
FEBUXOSTAT 80MG
ORAL
15G/50G
Prescription
ANTIGOUT AGENTS
Active ingredient group (AIG) number: 0152809001; AHFS:
APPROVED
2019-07-25
_JAMP FEBUXOSTAT Product Monograph_ _Page 1 of 30_ PRODUCT MONOGRAPH PR JAMP FEBUXOSTAT Febuxostat Tablets, 80 mg Preparations Inhibiting Uric Acid Production JAMP Pharma Corporation 1310 rue Nobel Boucherville, Québec, J4B 5H3, Canada Date of Revision: March 24, 2020 Submission Control No: 235670 _JAMP FEBUXOSTAT Product Monograph_ _Page 2 of 30_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............................................................. 3 SUMMARY PRODUCT INFORMATION ............................................................................ 3 INDICATIONS AND CLINICAL USE ............................................................................... 3 CONTRAINDICATIONS ........................................................................................................ 3 WARNINGS AND PRECAUTIONS ..................................................................................... 3 ADVERSE REACTIONS ........................................................................................................ 6 DRUG INTERACTIONS .................................................................................................. 10 DOSAGE AND ADMINISTRATION .................................................................................. 12 OVERDOSAGE ..................................................................................................................... 13 ACTION AND CLINICAL PHARMACOLOGY ................................................................ 13 STORAGE AND STABILITY .............................................................................................. 15 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................ 15 PART II: SCIENTIFIC INFORMATION .................................................................................... 16 PHARMACEUTICAL INFORMATION ............................................................................. 16 CLINICAL TRIALS ......................................................................... Citiți documentul complet