TEVA-DUTASTERIDE CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DUTASTERIDE

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

G04CB02

INN (Διεθνής Όνομα):

DUTASTERIDE

Δοσολογία:

0.5MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

DUTASTERIDE 0.5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

5 ALFA REDUCTASE INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0149361001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2014-07-16

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
TEVA-DUTASTERIDE
(Dutasteride)
0.5 mg Soft Gelatin Capsules
Teva Standard
Type I and II 5 Alpha-reductase Inhibitor
Teva Canada Limited
Date of Revision:
30 Novopharm Court
November 24, 2023
Toronto, Ontario
M1B 2K9
Submission Control No: 276215
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
....................................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................................
3
CONTRAINDICATIONS
...............................................................................................................
3
WARNINGS AND PRECAUTIONS
..............................................................................................
4
ADVERSE REACTIONS
................................................................................................................
8
DRUG INTERACTIONS
..............................................................................................................
12
DOSAGE AND ADMINISTRATION
..........................................................................................
14
OVERDOSAGE
............................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
15
STORAGE AND STABILITY
......................................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
...................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 17
PART II: SCIENTIFIC INFORMATION
................................................................................
18
PHARMACEUTICAL INFORMATION
...............................................