DOM-BICALUTAMIDE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

BICALUTAMIDE

Διαθέσιμο από:

DOMINION PHARMACAL

Φαρμακολογική κατηγορία (ATC):

L02BB03

INN (Διεθνής Όνομα):

BICALUTAMIDE

Δοσολογία:

50MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

BICALUTAMIDE 50MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0127996001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2006-06-16

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
DOM-BICALUTAMIDE
Bicalutamide Tablets, House Standard
50 mg
NON-STEROIDAL ANTIANDROGEN
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Revision:
March 15, 2017
Submission Control No.: 202528
_ _
_Dom-BICALUTAMIDE Product Monograph _
_ _
_Page 2 of 30 _
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
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..........................................................................................................16
DETAILED PHARMACOLOGY
.............................................