NTP-ACYCLOVIR TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
03-07-2013
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Aktiv bestanddel:
ACYCLOVIR
Tilgængelig fra:
TEVA CANADA LIMITED
ATC-kode:
J05AB01
INN (International Name):
ACYCLOVIR
Dosering:
200MG
Lægemiddelform:
TABLET
Sammensætning:
ACYCLOVIR 200MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
NUCLEOSIDES AND NUCLEOTIDES
Produkt oversigt:
Active ingredient group (AIG) number: 0115506002; AHFS:
Autorisation status:
CANCELLED PRE MARKET
Autorisation dato:
2015-08-06
Produktets egenskaber
_ _
_ _
PRODUCT MONOGRAPH
PR
NTP-ACYCLOVIR
Acyclovir Tablets, USP
200 mg, 400 mg and 800 mg
(Acyclovir, as Acyclovir Hydrate)
ANTIVIRAL AGENT
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Date of Preparation:
June 20, 2013
Submission Control No: 165696
_ _
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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
...................................................................................................
8
DOSAGE AND ADMINISTRATION
...............................................................................
9
OVERDOSAGE
...............................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 11
STORAGE AND STABILITY
.........................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 13
PART II: SCIENTIFIC INFORMATION
..............................................................................
14
PHARMACEUTICAL INFORMATION
.........................................................................
14
CLINICAL TRIALS
.........................................................................................................
15
DETAILED PHARMACOLOGY
...................................................................
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