NAT-AZACITIDINE POWDER FOR SUSPENSION
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
16-01-2023
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:
AZACITIDINE
Inapatikana kutoka:
NATCO PHARMA (CANADA) INC
ATC kanuni:
L01BC07
INN (Jina la Kimataifa):
AZACITIDINE
Kipimo:
100MG
Dawa fomu:
POWDER FOR SUSPENSION
Tungo:
AZACITIDINE 100MG
Njia ya uendeshaji:
SUBCUTANEOUS
Vitengo katika mfuko:
100MG
Dawa ya aina:
Prescription
Eneo la matibabu:
ANTINEOPLASTIC AGENTS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0152665001; AHFS:
Idhini hali ya:
CANCELLED PRE MARKET
Idhini ya tarehe:
2023-05-11
Tabia za bidhaa
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NAT-AZACITIDINE
Azacitidine for Injection
Powder, 100 mg azacitidine per vial, for subcutaneous use
Antineoplastic Agent
Pyrimidine Analogue
Natco Pharma (Canada) Inc.
2000 Argentia Road
Plaza 1, Suite 200
Mississauga, ON
L5N 1P7
Date of Initial Authorization:
August 16, 2018
Date of Revision:
January 16, 2023
Submission Control Number: 267064
_NAT-AZACITIDINE, Azacitidine for injection _
_Page 2 of 39_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS
01/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
01/2023
7 WARNINGS AND PRECAUTIONS
01/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND
ADMINISTRATION.................................................................................
4
4.1
Dosing Considerations
.......................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.3
Reconstit
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