Țară: Canada
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Sursă: Health Canada
ALFUZOSIN HYDROCHLORIDE
SANOFI-AVENTIS CANADA INC
G04CA01
ALFUZOSIN
10MG
TABLET (EXTENDED-RELEASE)
ALFUZOSIN HYDROCHLORIDE 10MG
ORAL
100
Prescription
Selective Alfa-1-Adrenergic Blocking Agents
Active ingredient group (AIG) number: 0146806001; AHFS:
APPROVED
2006-03-20
_ _ _ _ _Page 1 of 44 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr XATRAL ® Alfuzosin Hydrochloride Prolonged-Release Tablets 10 mg Pharmaceutical standard: Professed SYMPTOMATIC TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) ADJUNCTIVE THERAPY IN ACUTE URINARY RETENTION (AUR) ATC Code: G04CA01 sanofi-aventis Canada Inc. 2905 Place Louis-R.-Renaud Laval, Quebec H7V 0A3 Date of Revision: January 2, 2019 Submission Control No.: 221120 _ _ _ _ _Page 2 of 44 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................... 3 SUMMARY PRODUCT INFORMATION .............................................................................. 3 INDICATIONS AND CLINICAL USE .................................................................................... 3 CONTRAINDICATIONS ......................................................................................................... 4 WARNINGS AND PRECAUTIONS ........................................................................................ 4 ADVERSE REACTIONS ......................................................................................................... 6 DRUG INTERACTIONS ........................................................................................................ 11 DOSAGE AND ADMINISTRATION .................................................................................... 14 OVERDOSAGE ...................................................................................................................... 15 ACTION AND CLINICAL PHARMACOLOGY .................................................................. 16 STORAGE AND STABILITY ................................................................................................ 23 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................... 23 PART II: SCIENTIFIC INFORMATION ........................................ Citiți documentul complet