APO-ZIDOVUDINE CAPSULE

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ZIDOVUDINE

Pieejams no:

APOTEX INC

ATĶ kods:

J05AF01

SNN (starptautisko nepatentēto nosaukumu):

ZIDOVUDINE

Deva:

100MG

Zāļu forma:

CAPSULE

Kompozīcija:

ZIDOVUDINE 100MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100/500

Receptes veids:

Prescription

Ārstniecības joma:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Produktu pārskats:

Active ingredient group (AIG) number: 0122716002; AHFS:

Autorizācija statuss:

MARKETED

Autorizācija datums:

1992-12-31

Produkta apraksts

_APO-ZIDOVUDINE (Zidovudine Capsules) _
_ _
_Page 1 of 52 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-ZIDOVUDINE
Zidovudine Capsules
Capsules, 100 mg, Oral
USP
Antiretroviral Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAY 25, 1992
Date of Revision:
NOV 23, 2023
Submission Control Number: 278652
_APO-ZIDOVUDINE (Zidovudine Capsules) _
_ _
_Page 2 of 52 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.2 Geriatrics
06/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
06/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
06/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose
and Dosage Adjustment
06/2023
7 WARNINGS AND PRECAUTIONS, General
06/2023
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
06/2023
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
.......................................................................
5
1
INDICATIONS
....................................................................................................................
5
1.1
Pediatrics
........................................................................................................................
5
1.2
Geriatrics
.........................................................................................................................
5
2
CONTRAINDICATIONS
.......................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.................................................................. 6
4
DOSAGE AND ADMINISTRATION
......................................................................................
6
4.1
Dosing Consid