PMS-ENTECAVIR TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
22-03-2022
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유효 성분:
ENTECAVIR
제공처:
PHARMASCIENCE INC
ATC 코드:
J05AF10
INN (국제 이름):
ENTECAVIR
복용량:
1MG
약제 형태:
TABLET
구성:
ENTECAVIR 1MG
관리 경로:
ORAL
패키지 단위:
30
처방전 유형:
Prescription
치료 영역:
NUCLEOSIDES AND NUCLEOTIDES
제품 요약:
Active ingredient group (AIG) number: 0151648003; AHFS:
승인 상태:
APPROVED
승인 날짜:
2014-08-26
제품 특성 요약
PRODUCT MONOGRAPH
Pr
PMS-ENTECAVIR
Entecavir Tablets, USP
0.5 mg and 1 mg
ANTIVIRAL
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Revision:
March 22, 2022
Submission
Control No: 256242
_pms-ENTECAVIR Product Monograph _
_Page 2 of 47_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
....................................................................3
INDICATIONS AND CLINICAL USE
.........................................................................3
CONTRAINDICATIONS
.............................................................................................3
WARNINGS AND PRECAUTIONS
.............................................................................3
ADVERSE
REACTIONS..............................................................................................7
DRUG INTERACTIONS
............................................................................................
11
DOSAGE AND ADMINISTRATION
.........................................................................
12
OVERDOSAGE
.........................................................................................................
13
ACTION AND CLINICAL
PHARMACOLOGY.........................................................
13
STORAGE AND STABILITY
....................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 20
PART II: SCIENTIFIC INFORMATION
..........................................................................
22
PHARMACEUTICAL INFORMATION
.....................................................................
22
CLINICAL TRIALS
...................................................................................................
23
DETAILED
PHARMACOLOGY................................................................................
32
TOXICOLOGY
..................................
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