JAMP LAMIVUDINE TABLET

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

LAMIVUDINE

Доступно од:

JAMP PHARMA CORPORATION

АТЦ код:

J05AF05

INN (Међународно име):

LAMIVUDINE

Дозирање:

300MG

Фармацеутски облик:

TABLET

Састав:

LAMIVUDINE 300MG

Пут администрације:

ORAL

Јединице у пакету:

15G/50G

Тип рецептора:

Prescription

Терапеутска област:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2020-10-27

Карактеристике производа

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