JAMP LAMIVUDINE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

LAMIVUDINE

제공처:

JAMP PHARMA CORPORATION

ATC 코드:

J05AF05

INN (International Name):

LAMIVUDINE

복용량:

300MG

약제 형태:

TABLET

구성:

LAMIVUDINE 300MG

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2020-10-27

제품 특성 요약

_JAMP Lamivudine_
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_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
...................................................................................