PMS-VALACYCLOVIR TABLET

Country: Kanada

Tungumál: enska

Heimild: Health Canada

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Vara einkenni Vara einkenni (SPC)
10-05-2023

Virkt innihaldsefni:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE)

Fáanlegur frá:

PHARMASCIENCE INC

ATC númer:

J05AB11

INN (Alþjóðlegt nafn):

VALACICLOVIR

Skammtar:

500MG

Lyfjaform:

TABLET

Samsetning:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) 500MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

NUCLEOSIDES AND NUCLEOTIDES

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2008-05-15

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                                _pms-VALACYCLOVIR (Valacyclovir Tablets) page 1 of 39 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-VALACYCLOVIR
Valacyclovir tablets
Tablets, 500 mg and 1000 mg (as valacyclovir hydrochloride), oral
House Standard
Antiviral Agent
PHARMASCIENCE INC.
Date of Initial Authorization:
6111 Royalmount Ave., Suite 100
MAY 15, 2008
Montréal, Québec
H4P 2T4
Date of Revision:
MAY 10, 2023
www.pharmascience.com
Submission Control Number: 270106
_pms-VALACYCLOVIR (Valacyclovir Tablets) page 2 of 39 _
RECENT MAJOR LABEL CHANGES
Not applicable.
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
.................................................................
                                
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