Country: Канада
Језик: Енглески
Извор: Health Canada
DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM); LAMIVUDINE
VIIV HEALTHCARE ULC
J05AR25
LAMIVUDINE AND DOLUTEGRAVIR
50MG; 300MG
TABLET
DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM) 50MG; LAMIVUDINE 300MG
ORAL
15G/50G
Prescription
HIV INTEGRASE INHIBITORS
Active ingredient group (AIG) number: 0261731001; AHFS:
APPROVED
2019-08-22
_ _ _ _ _DOVATO, dolutegravir sodium and lamivudine _ _ June 2023 _ _ _ _Page 1 of 46_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr DOVATO dolutegravir and lamivudine tablets 50 mg dolutegravir (as dolutegravir sodium) and 300 mg lamivudine, Oral Antiretroviral Agent ViiV Healthcare ULC 75 Queen Street, Suite 1400 Montreal, Quebec Canada H3C 2N6 Date of Initial Authorization: AUG 22, 2019 Date of Revision: JUN 27, 2023 Submission Control Number: 272489 _©_ _2023 ViiV Healthcare group of companies or its licensor _ _Trademarks are owned by or licensed to the ViiV Healthcare group of companies_ _ _ _ _ _DOVATO, dolutegravir sodium and lamivudine _ _February 2023 _ _ _ _Page 2 of 46_ RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 09/2021 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 09/2021 7 WARNINGS AND PRECAUTIONS, Renal 09/2021 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 09/2022 7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast Feeding 09/2022 7 WARNINGS AND PRECAUTIONS, General 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 ..................................................................... 4 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics ................................................................................................................... 4 1.2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................. Прочитајте комплетан документ