Country: Canada
Language: English
Source: Health Canada
LAMIVUDINE
JAMP PHARMA CORPORATION
J05AF05
LAMIVUDINE
300MG
TABLET
LAMIVUDINE 300MG
ORAL
15G/50G
Prescription
NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS
Active ingredient group (AIG) number: 0128157005; AHFS:
APPROVED
2020-10-27
_JAMP Lamivudine_ _ _ _Page 1 of 46 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr JAMP LAMIVUDINE Lamivudine Tablets Tablets, 150 mg and 300 mg, oral USP Antiretroviral Agent JAMP Pharma Corporation 1310 rue Nobel Boucherville, Quebec J4B 5H3, Canada Date of Initial Authorization: October 27, 2020 Date of Revision: February 13, 2024 Submission Control Number: 278588 _JAMP Lamivudine_ _ _ _Page 2 of 46 _ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, 1.1_PEDIATRICS 02/2024 4 DOSAGE AND ADMINISTRATION, 4.2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT 11/2022 7 WARNINGS AND PRECAUTIONS, GENERAL 11/2022 TABLE OF CONTENTS 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 .................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 4 4 DOSAGE AND ADMINISTRATION.................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment ........................................................ 5 4.5 Missed Dose ............................................................................................................ 6 5 OVERDOSAGE ................................................................................... Read the complete document