APO-VALACYCLOVIR TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE)

Dostopno od:

APOTEX INC

Koda artikla:

J05AB11

INN (mednarodno ime):

VALACICLOVIR

Odmerek:

1000MG

Farmacevtska oblika:

TABLET

Sestava:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) 1000MG

Pot uporabe:

ORAL

Enote v paketu:

21

Tip zastaranja:

Prescription

Terapevtsko območje:

NUCLEOSIDES AND NUCLEOTIDES

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2010-07-16

Lastnosti izdelka

_APO-VALACYCLOVIR (valacyclovir tablets) Product Monograph _
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-VALACYCLOVIR
Valacyclovir Tablets
Tablets, 500 mg and 1000 mg valacyclovir (as valacyclovir
hydrochloride monohydrate), Oral
USP
Antiviral Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAY 23, 2008
Date of Revision:
JUN 13, 2023
Submission Control Number: 270920
_APO-VALACYCLOVIR (valacyclovir tablets) Product Monograph _
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS - Driving and Operating Machinery
06/2023
7 WARNINGS AND PRECAUTIONS - Immune
06/2023
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
........................................................... 5
4.5
Missed Dose
........................