MYLAN-ACYCLOVIR TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

ACYCLOVIR

Verfügbar ab:

MYLAN PHARMACEUTICALS ULC

ATC-Code:

J05AB01

INN (Internationale Bezeichnung):

ACYCLOVIR

Dosierung:

400MG

Darreichungsform:

TABLET

Zusammensetzung:

ACYCLOVIR 400MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

NUCLEOSIDES AND NUCLEOTIDES

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2009-07-03

Fachinformation

_ _
_Product Monograph –Mylan_-_Acyclovir _
_Page 1 _
PRODUCT MONOGRAPH
PR
MYLAN-ACYCLOVIR
Acyclovir, USP
200, 400 and 800 mg Tablets
Manufacturer Standard
ANTIVIRAL AGENT
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
Canada
M8Z 2S6
Control No.: 181160
DATE OF REVISION:
January 15, 2015
_ _
_Product Monograph –Mylan_-_Acyclovir _
_Page 2_
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
...............................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 12
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
AVAILABILITY OF DOSAGE FORMS
........................................................................
14
PART II: SCIENTIFIC INFORMATION
...............................................................................
16
PHARMACEUTICAL INFORMATION
.........................................................................
16
CLINICAL TRIALS
.........................