Havrix Junior Monodose Vaccine, Hepatitis A Vaccine(Inactivated Absorbed) Susp for Inj 720ELU/0.5ml

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

HEPATITIS A, VIRUS, INACTIVATED, ELISA

Предлага се от:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

АТС код:

J07BC02

INN (Международно Name):

HEPATITIS A VIRUS (INACTIVATED) 720 ELISA unit/dose

Лекарствена форма:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Композиция:

HEPATITIS A VIRUS (INACTIVATED) 720 ELISA unit/dose

Вид предписание :

POM

Терапевтична област:

VACCINES

Статус Оторизация:

Authorised

Дата Оторизация:

2006-11-22

Листовка

- 1
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
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 additional dose
of Havrix.
•
Having this vaccine will only protect against

Данни за продукта

1
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
Excipients 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.
2
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 dose
should be given at any
time between 6 months and 5 years, but preferably