RETROVIR (AZT) SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

ZIDOVUDINE

זמין מ:

VIIV HEALTHCARE ULC

קוד ATC:

J05AF01

INN (שם בינלאומי):

ZIDOVUDINE

כמות:

10MG

טופס פרצבטיות:

SOLUTION

הרכב:

ZIDOVUDINE 10MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

20ML DOSE X 10

סוג מרשם:

Prescription

איזור תרפויטי:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0122716001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2009-12-08

מאפייני מוצר

_RETROVIR (AZT) (Zidovudine Syrup and Solution for Infusion) _
_Page 1 of 55_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
RETROVIR (AZT)
Zidovudine Syrup, 50 mg/5mL
Zidovudine Solution for Infusion, USP, 10 mg/mL
Antiretroviral Agent
ViiV Healthcare ULC
75 Queen Street, Suite 1400
Montreal, Quebec H3C 2N6
Date of Initial Authorization:
January 12, 1995
Date of Revision:
June 16, 2023
Submission Control Number: 271660
_©_
_2023 ViiV Healthcare group of companies or its licensor _
_Trademarks are owned by or licensed to the ViiV Healthcare group of
companies _
_RETROVIR (AZT) (Zidovudine Syrup and Solution for Infusion) _
_Page 2 of 55_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 PEDIATRICS
06/2021
1 INDICATIONS, 1.2 GERIATRICS
06/2021
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
06/2021
4 DOSAGE AND ADMINISTRATION, 4.1 DOSING CONSIDERATIONS
06/2021
4 DOSAGE AND ADMINISTRATION, 4.2 RECOMMENDED DOSE AND
DOSAGE ADJUSTMENT
06/2021
7 WARNINGS AND PRECAUTIONS, GENERAL
06/2021
7 WARNINGS AND PRECAUTIONS, HEPATIC/BILIARY/PANCREATIC
06/2021
7 WARNINGS AND PRECAUTIONS, GENERAL
[Removed] 06/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
5
2
CONTRAINDICATIONS
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