APO-ACYCLOVIR TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
31-08-2021
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Active ingredient:
ACYCLOVIR
Available from:
APOTEX INC
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:
1997-08-21
Summary of Product characteristics
_____________________________________________________________________________________
_APO-ACYCLOVIR Product Monograph _
_ _
_Page 1 of 39_
PRODUCT MONOGRAPH
PR
APO-ACYCLOVIR
ACYCLOVIR TABLETS
APOTEX STANDARD
200 MG, 400 MG AND 800 MG
ANTIVIRAL AGENT
APOTEX INC. DATE OF PREPARATION:
150 SIGNET DRIVE
April 10, 1997
TORONTO, ONTARIO
DATE OF REVISION:
M9L 1T9
August 31, 2021
Control No. 255331
_____________________________________________________________________________________
_APO-ACYCLOVIR Tablets Product Monograph _
_Page 2 of 39_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
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3
SUMMARY PRODUCT INFORMATION
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3
INDICATIONS AND CLINICAL USE
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3
CONTRAINDICATIONS
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4
WARNINGS AND PRECAUTIONS
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4
ADVERSE REACTIONS
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6
DRUG INTERACTIONS
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9
DOSAGE AND ADMINISTRATION
......................................................................................................................
9
OVERDOSAGE
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11
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................................
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