RIVA-DUTASTERIDE CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DUTASTERIDE

Διαθέσιμο από:

LABORATOIRE RIVA INC.

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:

2014-09-17

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
RIVA-DUTASTERIDE
Dutasteride Capsules
Capsules, 0.5 mg
Professed Standard
Type I and II 5 Alpha-reductase Inhibitor
Laboratoire Riva Inc.,
DATE OF PREPARATION:
660 Boul. Industriel,
July 30, 2014
Blainville, Québec,
J7C 3V4
SUBMISSION CONTROL NO: 175813
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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
...................................................................................................
7
DRUG INTERACTIONS
..................................................................................................
12
DOSAGE AND ADMINISTRATION
..............................................................................
14
OVERDOSAGE
................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 15
STORAGE AND STABILITY
...........................................................................................
17
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 18
PART II: SCIENTIFIC INFORMATION
................................................................................
19
PHARMACEUTICAL INFORMATION
..........................................................................
19
CLINICAL TRIALS
................................................................................