MED-BICALUTAMIDE TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
17-10-2017
Nogle dokumenter til dette produkt er ikke tilgængelige i øjeblikket, du kan sende en anmodning til vores kundeservice, og vi vil underrette dig, så snart vi er i stand til at få dem.
Send anmodning.
Send anmodning.
Aktiv bestanddel:
BICALUTAMIDE
Tilgængelig fra:
GENERIC MEDICAL PARTNERS INC
ATC-kode:
L02BB03
INN (International Name):
BICALUTAMIDE
Dosering:
50MG
Lægemiddelform:
TABLET
Sammensætning:
BICALUTAMIDE 50MG
Indgivelsesvej:
ORAL
Enheder i pakken:
30/100
Recept type:
Prescription
Terapeutisk område:
ANTINEOPLASTIC AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0127996001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2013-06-04
Produktets egenskaber
Page 1 of 33
PRODUCT MONOGRAPH
PR
MED-BICALUTAMIDE
bicalutamide
ta
blets
50 mg
Ta
blets
Manufacturer
Sta
ndard
Non-Steroidal Antiandrogen
Generic Medical Partners Inc.
DATE OF REVISION:
251 Consumers Road, Suite 1200
October 17, 2017
Toronto, Ontario
M2J 4R3
CONTROL NO: 209486
Page 2 of 33
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
...............................................................................
13
OVERDOSAGE
.............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 14
STORAGE AND STABILITY
..........................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 15
PART II: SCIENTIFIC INFORMATION
.........................................................................
15
PHARMACEUTICAL INFORMATION
...........................................................................
15
CLINICAL TRIALS
.........................................................................................................
16
DETAILED PHARMACOLOGY
...........................................................
Læs hele dokumentet
