JAMP ENTECAVIR TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ENTECAVIR (ENTECAVIR MONOHYDRATE)

제공처:

JAMP PHARMA CORPORATION

ATC 코드:

J05AF10

INN (International Name):

ENTECAVIR

복용량:

0.5MG

약제 형태:

TABLET

구성:

ENTECAVIR (ENTECAVIR MONOHYDRATE) 0.5MG

관리 경로:

ORAL

패키지 단위:

30

처방전 유형:

Prescription

치료 영역:

NUCLEOSIDES AND NUCLEOTIDES

제품 요약:

Active ingredient group (AIG) number: 0151648001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2017-08-17

제품 특성 요약

1
PRODUCT MONOGRAPH
PR
JAMP ENTECAVIR
Entecavir
Tablets, House Standard
0.5 mg entecavir (as entecavir monohydrate)
Antiviral
Date of Preparation:
February 20, 2019
JAMP Pharma Corporation
1310 Nobel Street,
Boucherville, Québec,
J4B 5H3
Control No. 215406
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY PRODUCT INFORMATION
..................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................
3
CONTRAINDICATIONS
..............................................................................................................
3
WARNINGS AND PRECAUTIONS
............................................................................................
4
ADVERSE REACTIONS
..............................................................................................................
8
DRUG
INTERACTIONS..........................................................................................................
11
DOSAGE AND ADMINISTRATION
........................................................................................
13
OVERDOSAGE
...........................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
14
STORAGE AND STABILITY
....................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 24
PART II: SCIENTIFIC INFORMATION
..................................................................................
25
PHARMACEUTICAL INFORMATION
....................................................................................
25
CLINICAL TRIALS
.........................................................................................