JAMP LAMIVUDINE TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

LAMIVUDINE

متاح من:

JAMP PHARMA CORPORATION

ATC رمز:

J05AF05

INN (الاسم الدولي):

LAMIVUDINE

جرعة:

300MG

الشكل الصيدلاني:

TABLET

تركيب:

LAMIVUDINE 300MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2020-10-27

خصائص المنتج

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