TEVA-VALACYCLOVIR TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE)

Available from:

TEVA CANADA LIMITED

ATC code:

J05AB11

INN (International Name):

VALACICLOVIR

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) 500MG

Administration route:

ORAL

Units in package:

42

Prescription type:

Prescription

Therapeutic area:

NUCLEOSIDES AND NUCLEOTIDES

Product summary:

Active ingredient group (AIG) number: 0128626001; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-11-01

Summary of Product characteristics

_TEVA-VALACYCLOVIR (valacyclovir) _
_ _
_Page 1 of 42 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-VALACYCLOVIR
Valacyclovir Tablets
Tablets, 500 mg valacyclovir (as valacyclovir hydrochloride), Oral
BP
Antiviral Agent
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
www.tevacanada.com
Submission Control No: 271297
Date of Initial Authorization:
October 01, 2010
Date of Revision:
June 29, 2023
_TEVA-VALACYCLOVIR (valacyclovir) _
_ _
_Page 2 of 42 _
_ _
RECENT MAJOR LABEL CHANGES
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
..........................................................................................
7
5
OVERDOSAGE
.....................................................................................................
7
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
................