HAVRIX 1440 SUSPENSION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

HEPATITIS A VIRUS, INACTIVATED

Disponível em:

GLAXOSMITHKLINE INC

Código ATC:

J07BC02

DCI (Denominação Comum Internacional):

HEPATITIS A, INACTIVATED, WHOLE VIRUS

Dosagem:

1440UNIT

Forma farmacêutica:

SUSPENSION

Composição:

HEPATITIS A VIRUS, INACTIVATED 1440UNIT

Via de administração:

INTRAMUSCULAR

Unidades em pacote:

15G/50G

Tipo de prescrição:

Schedule D

Área terapêutica:

VACCINES

Resumo do produto:

Active ingredient group (AIG) number: 0165325001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2001-06-12

Características técnicas

_HAVRIX (hepatitis A vaccine, inactivated) _
_Page 1 of 20_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
HAVRIX
Hepatitis A vaccine, inactivated
720 ELISA units per 0.5 mL of formaldehyde-inactivated hepatitis A
virus (HM175 hepatitis A virus
strain) or 1440 ELISA units per 1 mL of formaldehyde-inactivated
hepatitis A virus (HM175 hepatitis A
virus strain)
Suspension for injection, Intramuscular
Active immunizing agent against infection by hepatitis A virus
ATC Code: J07BC02
GlaxoSmithKline Inc.
100 Milverton Drive, Suite 800
Mississauga, Ontario
L5R 4H1
Date of Initial Authorization:
December 31, 1996
Date of Revision:
November 9, 2023
Submission Control Number: 276326
_©_
_2023 GSK group of companies or its licensor _
_Trademarks are owned by or licensed to the GSK group of companies _
_HAVRIX (hepatitis A vaccine, inactivated) _
_Page 2 of 20_
RECENT MAJOR LABEL CHANGES
SECTION
DATE
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
APR 2023
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
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.2
Recommended Dose and Dosage Adjustment
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