TEVA-ACYCLOVIR TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ACYCLOVIR

Pieejams no:

TEVA CANADA LIMITED

ATĶ kods:

J05AB01

SNN (starptautisko nepatentēto nosaukumu):

ACYCLOVIR

Deva:

200MG

Zāļu forma:

TABLET

Kompozīcija:

ACYCLOVIR 200MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

NUCLEOSIDES AND NUCLEOTIDES

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2011-01-06

Produkta apraksts

Teva-Acyclovir
Page 1 of 40
_ _
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PRODUCT MONOGRAPH
PR
TEVA-ACYCLOVIR
Acyclovir Tablets, USP
200 mg, 400 mg and 800 mg
(Acyclovir, as Acyclovir Hydrate)
ANTIVIRAL AGENT
Teva Canada Limited
30 Novopharm Court
Toronto, Canada
Ontario M1B 2K9
Date of Revision:
April 28, 2015
Submission Control No: 183526
Teva-Acyclovir
Page 2 of 40
_ _
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
...............................................................................
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
.................