SITAVIG TABLET
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
27-03-2020
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有効成分:
ACYCLOVIR
から入手可能:
EPI HEALTH, LLC
ATCコード:
J05AB01
INN（国際名）:
ACYCLOVIR
投薬量:
50MG
医薬品形態:
TABLET
構図:
ACYCLOVIR 50MG
投与経路:
BUCCAL
パッケージ内のユニット:
2X1
処方タイプ:
Prescription
治療領域:
ANTIVIRALS
製品概要:
Active ingredient group (AIG) number: 0115506009; AHFS:
認証ステータス:
APPROVED
承認日:
2020-03-31
製品の特徴
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SITAVIG™
acyclovir mucoadhesive buccal tablets
Mucoadhesive Buccal Tablet 50 mg
Antiviral
_ _
Oakville, Ontario
3470 Superior Court
March
27, 2020
Date of
Revision:
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Submission Control
No:
235479
L6L 0C4
Innomar Strategies
Inc.
Canadian Importer/Distributor:
USA 29403
Charleston, South Carolina
134 Columbus Street
EPI
Health,
LLC
_SITAVIG™ (acyclovir mucoadhesive buccal tablets) _
_Page 2 of 20_
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
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................6
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
............................................................................................9
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................9
PART II: SCIENTIFIC INFORMATION
...............................................................................10
PHARMACEUTICAL INFOR
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