ACYCLOVIR TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-03-2015
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Active ingredient:
ACYCLOVIR
Available from:
SANIS HEALTH INC
ATC code:
J05AB01
INN (International Name):
ACYCLOVIR
Dosage:
400MG
Pharmaceutical form:
TABLET
Composition:
ACYCLOVIR 400MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
NUCLEOSIDES AND NUCLEOTIDES
Product summary:
Active ingredient group (AIG) number: 0115506004; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-07-31
Summary of Product characteristics
_ _
_Product Monograph –Acyclovir _
_Page 1 _
PRODUCT MONOGRAPH
PR
ACYCLOVIR
Acyclovir, USP
400 mg Tablets
Manufacturer Standard
ANTIVIRAL AGENT
Sanis Health Inc.
333 Champlain Street, Suite 102
Dieppe, New Brunswick
EIA IP2
Control No.: 182995
DATE OF REVISION:
March 27, 2015
_ _
_Product Monograph –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
...............................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................................
15
CLINICAL TRIALS
.....................................................
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