JAMP LAMIVUDINE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

LAMIVUDINE

Disponible depuis:

JAMP PHARMA CORPORATION

Code ATC:

J05AF05

DCI (Dénomination commune internationale):

LAMIVUDINE

Dosage:

300MG

forme pharmaceutique:

TABLET

Composition:

LAMIVUDINE 300MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2020-10-27

Résumé des caractéristiques du produit

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