Havrix Junior Monodose Vaccine. Hepatitis A Vaccine (Inactivated, Adsorbed). 720 ELISA units/ 0.5ml Suspension for injection in a pre-filled syringe

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Aluminium; Hepatitis A antigen

Saatavilla:

GlaxoSmithKline (Ireland) Limited

ATC-koodi:

J07BC; J07BC02

INN (Kansainvälinen yleisnimi):

Aluminium; Hepatitis A antigen

Annos:

720 enzyme-linked immunosorbent assay unit

Lääkemuoto:

Suspension for injection in pre-filled syringe

Prescription tyyppi:

Product subject to prescription which may not be renewed (A)

Terapeuttinen alue:

Hepatitis vaccines; hepatitis A, inactivated, whole virus

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1998-10-02

Pakkausseloste

- 1 -
GSK (LOGO)
PACKAGE LEAFLET: INFORMATION FOR THE
USER
HAVRIX JUNIOR
MONODOSE VACCINE
Hepatitis A Vaccine (Inactivated, adsorbed). 720 ELISA Units/ 0.5 ml
Suspension for Injection in a pre-filled syringe
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS
VACCINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, nurse or
pharmacist.
•
This vaccine has been prescribed for your child only. Do not pass it
on to others. It may
harm them.
•
If you get any side-effects, talk to your doctor or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
What Havrix Junior Monodose is and what it is used for
2
What you need to know before your child receives Havrix Junior
Monodose
3
How Havrix Junior Monodose is given
4
Possible side effects
5
How to store Havrix Junior Monodose
6
Contents of the pack and other information
1
WHAT HAVRIX JUNIOR MONODOSE IS AND WHAT IT IS USED FOR
Havrix Junior Monodose is a vaccine containing the inactivated
hepatitis A virus. It is used to
boost the body’s immune system to stop infection from hepatitis A in
children and
adolescents from 1 year up to and including 15 years of age.
HOW HAVRIX JUNIOR MONODOSE WORKS
•
The virus is not alive so this vaccine cannot cause hepatitis A
infection.
•
When your child is given Havrix Junior Monodose their body will make
antibodies (the
body’s natural defence system) against the hepatitis A virus.
•
After 2 to 4 weeks, these antibodies will have been produced and will
protect your child
against hepatitis A infection.
•
To ensure long term protection from hepatitis A of up to 40 years,
your child should
receive a second (booster) vaccination 6 to 12 months after their
first dose. As long as
the booster is given within 5 years, they should still be fully
protected. Once the booster
vaccination is given, they are not expected to need an additi

Valmisteyhteenveto

Health Products Regulatory Authority
11 May 2023
CRN00DKK3
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Havrix Junior Monodose Vaccine. Hepatitis A Vaccine (Inactivated,
Adsorbed). 720 ELISA units/ 0.5ml Suspension for injection in
a pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hepatitis A virus antigen (HM175 strain)*
​720 ELISA units/0.5 ml
​
adsorbed on aluminium hydroxide (adjuvant)
​Total: 0.25 mg Al
3+
* Produced on MRC-5 human diploid cells
Excipient(s) with known effect:
This vaccine contains phenylalanine 83 micrograms per dose (see
section 4.4).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection.
Slightly opaque white suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Havrix Junior Monodose vaccine is indicated for active immunisation
against HAV infection in children and adolescents from 1
year up to and including 15 years of age. The vaccine is particularly
indicated for those at increased risk of infection or
transmission.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Children/adolescents (1-15 years) _
_Primary immunisation_
Primary immunisation consists of a single dose of Havrix Junior
Monodose vaccine (720 ELISA units/0.5 ml) given
intramuscularly.
Havrix Junior Monodose confers protection against hepatitis A within
two to three weeks (See Section 5.1, _Pharmacodynamic _
_Effects_).
If exposure to a high risk of contracting hepatitis A is expected
within two weeks of the primary immunisation dose, human
normal immunoglobulin may be given simultaneously with Havrix Junior
Monodose at different injection sites.
Serological data indicate that there should be continuing protection
against Hepatitis A for up to 5 years after the first dose of
Havrix Junior Vaccine in subjects who responded to the initial
vaccination.
_Booster Vaccination_
After primary vaccination with Havrix Junior Monodose Vaccine, a
booster dose is recommended in order to ensure long term
protection. This booster