BICALUTAMIDE TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

BICALUTAMIDE

Saadav alates:

SANIS HEALTH INC

ATC kood:

L02BB03

INN (Rahvusvaheline Nimetus):

BICALUTAMIDE

Annus:

50MG

Ravimvorm:

TABLET

Koostis:

BICALUTAMIDE 50MG

Manustamisviis:

ORAL

Ühikuid pakis:

15G/50G

Retsepti tüüp:

Prescription

Terapeutiline ala:

ANTINEOPLASTIC AGENTS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2021-08-18

Toote omadused

Page 1 of 33
P R O D U C T M O N O G R A P H
Pr
BICALUTAMIDE
Bicalutamide Tablets USP
50 mg
Non-Steroidal Antiandrogen
Sanis Health Inc.
1 President’s Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision: August 12, 2021
Submission Control No.: 252880
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
.......................................................................
16
PHARMACEUTICAL INFORMATION
.................................................................. 16
CLINICAL TRIALS
....................................................................................................
16
DETAILED PHARMACOLOGY
..............................................................................
19
TOXICOLOGY
......................................................................