AURO-VALGANCICLOVIR POWDER FOR SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE)

Disponibbli minn:

AURO PHARMA INC

Kodiċi ATC:

J05AB14

INN (Isem Internazzjonali):

VALGANCICLOVIR

Dożaġġ:

50MG

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) 50MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Prescription

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0147203002; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2023-02-16

Karatteristiċi tal-prodott

_AURO-VALGANCICLOVIR PRODUCT MONOGRAPH _ Page 1 of 52
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-VALGANCICLOVIR
Valganciclovir Powder for Oral Solution
Powder for solution, 50 mg/mL when reconstituted valganciclovir (as
valganciclovir
hydrochloride), Oral
Antiviral Agent
AURO PHARMA INC.,
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Submission Control Number: 255848
Date of Initial Authorization:
February 14, 2023
_AURO-VALGANCICLOVIR PRODUCT MONOGRAPH _ Page 2 of 52
RECENT MAJOR LABEL CHANGES
N/A
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
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4
2
CONTRAINDICATIONS............................................................................................................
4
4 DOSAGE AND ADMINISTRATION
...........................................................................................
5
4.1 Dosing Considerations
.............................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
.......................................................... 6
4.3 Reconstitution Oral
Solutions:..................................................................................
8
4.4 Administra