RATIO-ACYCLOVIR TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

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Hent Produktets egenskaber (SPC)
07-08-2013

Aktiv bestanddel:

ACYCLOVIR

Tilgængelig fra:

TEVA CANADA LIMITED

ATC-kode:

J05AB01

INN (International Name):

ACYCLOVIR

Dosering:

400MG

Lægemiddelform:

TABLET

Sammensætning:

ACYCLOVIR 400MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

NUCLEOSIDES AND NUCLEOTIDES

Produkt oversigt:

Active ingredient group (AIG) number: 0115506004; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2018-05-18

Produktets egenskaber

                                _ _
_Product Monograph _RATIO-ACYCLOVIR_ _
_Page 1 of 39_
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_ _
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PRODUCT MONOGRAPH
PR
RATIO-ACYCLOVIR
acyclovir
Tablets USP, 200 mg, 400 mg and 800 mg
Antiviral Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Preparation :
July 24, 2013
Submission Control No: 166251
_ _
_Product Monograph _RATIO-ACYCLOVIR_ _
_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
................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 12
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 14
PART II: SCIENTIFIC
INFORMATION...............................................................................
16
PHARMACEUTICAL INFORMATION
.........................................................................
16
CLINICAL TRIALS
..........................................................................................
                                
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