SANDOZ ALFUZOSIN TABLET (EXTENDED-RELEASE)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ALFUZOSIN HYDROCHLORIDE

Mevcut itibaren:

SANDOZ CANADA INCORPORATED

ATC kodu:

G04CA01

INN (International Adı):

ALFUZOSIN

Doz:

10MG

Farmasötik formu:

TABLET (EXTENDED-RELEASE)

Kompozisyon:

ALFUZOSIN HYDROCHLORIDE 10MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

Selective Alfa-1-Adrenergic Blocking Agents

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2008-07-08

Ürün özellikleri

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_Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr SANDOZ ALFUZOSIN
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
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Revision:
April 3, 2019
Submission Control No.: 225472
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_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
........................................................................................................
12
DOSAGE AND ADMINISTRATION
....................................................................................
15
OVERDOSAGE
......................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 16
STORAGE AND
STABILITY................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
.............................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 22
PART II: SCIENTIFIC INFORMATION
...............................................