Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
ZIDOVUDINE
VIIV HEALTHCARE ULC
J05AF01
ZIDOVUDINE
100MG
CAPSULE
ZIDOVUDINE 100MG
ORAL
100
Prescription
NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS
Active ingredient group (AIG) number: 0122716002; AHFS:
CANCELLED POST MARKET
2021-06-28
_RETROVIR (AZT) (Zidovudine Capsules, Syrup and Solution for Infusion) _ _Page 1 of 58_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr RETROVIR (AZT) Zidovudine Capsules USP, 100 mg Zidovudine Syrup, 50 mg/5mL Zidovudine Solution for Infusion, 10 mg/mL Antiretroviral Agent ViiV Healthcare ULC 245, boulevard Armand-Frappier Laval, Quebec H7V 4A7 Date of Initial Authorization: January 12, 1995 Date of Revision: June 9, 2021 Submission Control Number: 249459 _©_ _2021 ViiV Healthcare group of companies or its licensor _ _Trademarks are owned by or licensed to the ViiV Healthcare group of companies _ _RETROVIR (AZT) (Zidovudine Capsules, Syrup and Solution for Infusion) _ _Page 2 of 58_ 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 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 ............................................................................................................5 1.2 Geriatrics.............................................................................................................5 2 CONTRAINDICATIONS ............................................................... Přečtěte si celý dokument