Maa: Kanada
Kieli: englanti
Lähde: Health Canada
ABACAVIR (ABACAVIR SULFATE); LAMIVUDINE
APOTEX INC
J05AR02
LAMIVUDINE AND ABACAVIR
600MG; 300MG
TABLET
ABACAVIR (ABACAVIR SULFATE) 600MG; LAMIVUDINE 300MG
ORAL
30/90
Prescription
NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS
Active ingredient group (AIG) number: 0251241001; AHFS:
APPROVED
2020-11-02
_APO-ABACAVIR-LAMIVUDINE (abacavir and lamivudine tablets) _ _Page 1 of 50 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-ABACAVIR-LAMIVUDINE Abacavir and Lamivudine Tablets Tablets, 600 mg abacavir (as abacavir sulfate) and 300 mg lamivudine, Oral USP Antiretroviral Agent APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization: MAR 14, 2016 Date of Revision: OCT 25, 2023 Submission Control Number: 277806 _APO-ABACAVIR-LAMIVUDINE (abacavir and lamivudine tablets) _ _Page 2 of 50 _ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 03/2023 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 03/2023 7 WARNINGS AND PRECAUTIONS, Clinical Management of Abacavir HSRs 03/2023 7 WARNINGS AND PRECAUTIONS, Immune 03/2023 7 WARNINGS AND PRECAUTIONS, General, Renal Insufficiency 03/2023 7 WARNINGS AND PRECAUTIONS, General 10/2023 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 (< 18 Years Of Age) ............................................................................. 4 1.2 Geriatrics (≥ 65 years of age) .............................................................................. 4 2 CONTRAINDICATIONS ............................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................ 5 4 DOSAGE AND ADMINISTRATION ............................................................................. 5 4.1 Dos Lue koko asiakirja