RATIO-ACYCLOVIR TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ACYCLOVIR

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

J05AB01

DCI (Dénomination commune internationale):

ACYCLOVIR

Dosage:

200MG

forme pharmaceutique:

TABLET

Composition:

ACYCLOVIR 200MG

Mode d'administration:

ORAL

Unités en paquet:

100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

NUCLEOSIDES AND NUCLEOTIDES

Descriptif du produit:

Active ingredient group (AIG) number: 0115506002; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2018-05-18

Résumé des caractéristiques du produit

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_Product Monograph _RATIO-ACYCLOVIR_ _
_Page 1 of 39_
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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
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_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
..........................................................................................