AURO-VALGANCICLOVIR POWDER FOR SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE)

可用日期:

AURO PHARMA INC

ATC代码:

J05AB14

INN（国际名称）:

VALGANCICLOVIR

剂量:

50MG

药物剂型:

POWDER FOR SOLUTION

组成:

VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) 50MG

给药途径:

ORAL

每包单位数:

15G/50G

处方类型:

Prescription

產品總結:

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

授权状态:

APPROVED

授权日期:

2023-02-16

产品特点

_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
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS............................................................................................................
4
4 DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
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5
4.2 Recommended Dose and Dosage Adjustment
.......................................................... 6
4.3 Reconstitution Oral
Solutions:..................................................................................
8
4.4 Administra