MINT-ACYCLOVIR TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
21-01-2022
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Active ingredient:
ACYCLOVIR
Available from:
MINT PHARMACEUTICALS INC
ATC code:
J05AB01
INN (International Name):
ACYCLOVIR
Dosage:
200MG
Pharmaceutical form:
TABLET
Composition:
ACYCLOVIR 200MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0115506002; AHFS:
Authorization status:
APPROVED
Authorization date:
2022-01-25
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
MINT-ACYCLOVIR
ACYCLOVIR TABLETS USP
200 MG, 400 MG AND 800 MG
ANTIVIRAL AGENT
MINT PHARMACEUTICALS INC.
DATE OF PREPARATION:
6575 DAVAND DRIVE
JANUARY 21, 2022
MISSISSAUGA, ONTARIO
L5T 2M3
Control No. 239932
_MINT-ACYCLOVIR Product Monograph_
_ _
_Page 2 of 37 _
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
..............................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
.............................................................12
STORAGE AND STABILITY
.........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................14
PART II: SCIENTIFIC
INFORMATION.......................................................................
15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
........................................................................................................15
DETAILED PHARMACOLOGY
....................................................................................16
VIR
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