TEVA-ACYCLOVIR TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
05-05-2015
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Active ingredient:
ACYCLOVIR
Available from:
TEVA CANADA LIMITED
ATC code:
J05AB01
INN (International Name):
ACYCLOVIR
Dosage:
800MG
Pharmaceutical form:
TABLET
Composition:
ACYCLOVIR 800MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
NUCLEOSIDES AND NUCLEOTIDES
Product summary:
Active ingredient group (AIG) number: 0115506005; AHFS:
Authorization status:
APPROVED
Authorization date:
2011-01-06
Summary of Product characteristics
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
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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
...................................................................................................
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
.................
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