ZOVIRAX SUSPENSION
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
31-05-2016
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有効成分:
ACYCLOVIR
から入手可能:
GLAXOSMITHKLINE INC
ATCコード:
J05AB01
INN（国際名）:
ACYCLOVIR
投薬量:
200MG
医薬品形態:
SUSPENSION
構図:
ACYCLOVIR 200MG
投与経路:
ORAL
パッケージ内のユニット:
125ML
処方タイプ:
Prescription
治療領域:
NUCLEOSIDES AND NUCLEOTIDES
製品概要:
Active ingredient group (AIG) number: 0115506003; AHFS:
認証ステータス:
APPROVED
承認日:
2001-08-07
製品の特徴
_Page 1 of 39_
PRODUCT MONOGRAPH
PR
ZOVIRAX
®
Acyclovir Oral Suspension USP, 200 mg /5 mL
Antiviral Agent
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
May 30, 2016
Submission Control No: 191703
_©_
_2016 GlaxoSmithKline Inc. All Rights Reserved _
_ZOVIRAX is a registered trademark of GlaxoSmithKline Inc. _
_Page 2 of 39_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..........................................................................................................15
DETALIL
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