APO-VALACYCLOVIR TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE)

Available from:

APOTEX INC

ATC code:

J05AB11

INN (International Name):

VALACICLOVIR

Dosage:

1000MG

Pharmaceutical form:

TABLET

Composition:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) 1000MG

Administration route:

ORAL

Units in package:

21

Prescription type:

Prescription

Therapeutic area:

NUCLEOSIDES AND NUCLEOTIDES

Product summary:

Active ingredient group (AIG) number: 0128626003; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-07-16

Summary of Product characteristics

_APO-VALACYCLOVIR (valacyclovir tablets) Product Monograph _
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-VALACYCLOVIR
Valacyclovir Tablets
Tablets, 500 mg and 1000 mg valacyclovir (as valacyclovir
hydrochloride monohydrate), Oral
USP
Antiviral Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAY 23, 2008
Date of Revision:
JUN 13, 2023
Submission Control Number: 270920
_APO-VALACYCLOVIR (valacyclovir tablets) Product Monograph _
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS - Driving and Operating Machinery
06/2023
7 WARNINGS AND PRECAUTIONS - Immune
06/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED_. _
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
.....................................................................................................................
4
1.2
Geriatrics
.....................................................................................................................
4
2
CONTRAINDICATIONS
....................................................................................................
4
4
DOSAGE AND ADMINISTRATION
....................................................................................
4
4.1
Dosing Considerations
................................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................... 5
4.5
Missed Dose
........................