BICALUTAMIDE TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
12-08-2021
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
BICALUTAMIDE
Inapatikana kutoka:
SANIS HEALTH INC
ATC kanuni:
L02BB03
INN (Jina la Kimataifa):
BICALUTAMIDE
Kipimo:
50MG
Dawa fomu:
TABLET
Tungo:
BICALUTAMIDE 50MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
15G/50G
Dawa ya aina:
Prescription
Eneo la matibabu:
ANTINEOPLASTIC AGENTS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0127996001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2021-08-18
Tabia za bidhaa
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
......................................................................
Soma hati kamili
