JAMP LAMIVUDINE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

LAMIVUDINE

Boleh didapati daripada:

JAMP PHARMA CORPORATION

Kod ATC:

J05AF05

INN (Nama Antarabangsa):

LAMIVUDINE

Dos:

300MG

Borang farmaseutikal:

TABLET

Komposisi:

LAMIVUDINE 300MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Prescription

Kawasan terapeutik:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0128157005; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2020-10-27

Ciri produk

_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
...................................................................................