Maa: Kanada
Kieli: englanti
Lähde: Health Canada
ALFUZOSIN HYDROCHLORIDE
AURO PHARMA INC
G04CA01
ALFUZOSIN
10MG
TABLET (EXTENDED-RELEASE)
ALFUZOSIN HYDROCHLORIDE 10MG
ORAL
15G/50G
Prescription
Selective Alfa-1-Adrenergic Blocking Agents
Active ingredient group (AIG) number: 0146806001; AHFS:
APPROVED
2015-07-02
Page 1 of 42 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR AURO-ALFUZOSIN Alfuzosin Hydrochloride Prolonged-Release Tablets 10 mg House Standard SYMPTOMATIC TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) ADJUNCTIVE THERAPY IN ACUTE URINARY RETENTION (AUR) AURO PHARMA INC. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8, CANADA Date of Revision: April 5, 2019 Submission Control No.: 225758 Page 2 of 42 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 ......................................…………......................... 14 ACTION AND CLINICAL PHARMACOLOGY…......................... 14 STORAGE AND STABILITY ........................................…….......... 20 SPECIAL HANDLING INSTRUCTION………………………….. 21 DOSAGE FORMS, COMPOSITION AND PACKAGING……..... 21 PART II: SCIENTIFIC INFORMATION .........................…………….…....... 22 PHARMACEUTICAL INFORMATION ........................…............. 22 CLINICAL TRIALS ...............................................……………...... 23 DETAILED PHARMACOLOGY ..............................…………….. 28 TOXICOLOGY ...........................…………………………............ 31 BIBLIOGRAPHY.................................…………………………..... 36 PART III: PATIENT MEDICATION INFORMATION.....................……… 40 Page 3 of 42 PR AURO-ALFUZOSIN Alfuzosin Hydrochloride Prolonged-Rel Lue koko asiakirja