SITAVIG TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ACYCLOVIR

Commercializzato da:

EPI HEALTH, LLC

Codice ATC:

J05AB01

INN (Nome Internazionale):

ACYCLOVIR

Dosaggio:

50MG

Forma farmaceutica:

TABLET

Composizione:

ACYCLOVIR 50MG

Via di somministrazione:

BUCCAL

Confezione:

2X1

Tipo di ricetta:

Prescription

Area terapeutica:

ANTIVIRALS

Dettagli prodotto:

Active ingredient group (AIG) number: 0115506009; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2020-03-31

Scheda tecnica

_ _
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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_(acyclovir_
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_Page_
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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