MINT-VALGANCICLOVIR TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE)

Saadav alates:

MINT PHARMACEUTICALS INC

ATC kood:

J05AB14

INN (Rahvusvaheline Nimetus):

VALGANCICLOVIR

Annus:

450MG

Ravimvorm:

TABLET

Koostis:

VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) 450MG

Manustamisviis:

ORAL

Ühikuid pakis:

60TAB

Retsepti tüüp:

Prescription

Terapeutiline ala:

NUCLEOSIDES AND NUCLEOTIDES

Toote kokkuvõte:

Active ingredient group (AIG) number: 0147203001; AHFS:

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2020-01-06

Toote omadused

PRODUCT MONOGRAPH
Pr
MINT-VALGANCICLOVIR
Valganciclovir Tablets
450 mg (as valganciclovir hydrochloride)
Manufacturer’s Standard
Antiviral Agent
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Approval:
January 2, 2020
Submission Control No: 226331
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
....................................................................................3
INDICATIONS AND CLINICAL USE
..........................................................................................3
CONTRAINDICATIONS
...............................................................................................................4
WARNINGS AND PRECAUTIONS
..............................................................................................4
ADVERSE REACTIONS
................................................................................................................8
DRUG INTERACTIONS
..............................................................................................................20
DOSAGE AND ADMINISTRATION
..........................................................................................24
OVERDOSAGE
............................................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
........................................................................28
STORAGE AND STABILITY
......................................................................................................30
SPECIAL HANDLING INSTRUCTIONS
...................................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................31
PART II: SCIENTIFIC INFORMATION
................................................................................32
PHARMACEUTICAL INFORMATION
...........................