VALACYCLOVIR TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE)

Pieejams no:

SANIS HEALTH INC

ATĶ kods:

J05AB11

SNN (starptautisko nepatentēto nosaukumu):

VALACICLOVIR

Deva:

1000MG

Zāļu forma:

TABLET

Kompozīcija:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) 1000MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Ārstniecības joma:

NUCLEOSIDES AND NUCLEOTIDES

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2021-08-27

Produkta apraksts

_VALACYCLOVIR (Valacyclovir Tablets) page 1 of 39 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VALACYCLOVIR
Valacyclovir Tablets
Tablets, 500 mg and 1000 mg (as valacyclovir hydrochloride), oral
House Standard
Antiviral Agent
Sanis Health Inc.
1 President’s Choice Circle
Brampton, Ontario
L6Y 5S5
Submission
Control
Number:
276375
Date
of
Initial
Authorization:
MAY
06, 2016
Date
of
Revision:
JUL 06, 2023
_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
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2
TABLE OF CONTENTS
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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
..........................