ALFUZOSIN TABLET (EXTENDED-RELEASE)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ALFUZOSIN HYDROCHLORIDE

Saatavilla:

SANIS HEALTH INC

ATC-koodi:

G04CA01

INN (Kansainvälinen yleisnimi):

ALFUZOSIN

Annos:

10MG

Lääkemuoto:

TABLET (EXTENDED-RELEASE)

Koostumus:

ALFUZOSIN HYDROCHLORIDE 10MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

Selective Alfa-1-Adrenergic Blocking Agents

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0146806001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2021-09-02

Valmisteyhteenveto

Page 1 of 42
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ALFUZOSIN
Alfuzosin Hydrochloride
Prolonged-Release Tablets
10 mg
House Standard
SYMPTOMATIC TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)
ADJUNCTIVE THERAPY IN ACUTE URINARY RETENTION (AUR)
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Preparation:
August 31, 2021
Submission Control No.: 254250
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
ALFUZOSIN
Alfuzosin Hydrochloride
Prolonged-Release Tablets
10 mg
House