Ambirix

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

hepatitis A virus (inactivated), hepatitis B surface antigen

Available from:

GlaxoSmithKline Biologicals S.A.

ATC code:

J07BC20

INN (International Name):

hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)

Therapeutic group:

Vaccines

Therapeutic area:

Hepatitis B; Hepatitis A; Immunization

Therapeutic indications:

Ambirix is for use in non-immune persons from one year up to and including 15 years of age for protection against hepatitis-A and hepatitis-B infection.Protection against hepatitis-B infections may not be obtained until after the second dose.Therefore:Ambirix should be used only when there is a relatively low risk of hepatitis-B infection during the vaccination course;it is recommended that Ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.

Product summary:

Revision: 17

Authorization status:

Authorised

Authorization date:

2002-08-30

Patient Information leaflet

21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMBIRIX, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine
(adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU/YOUR CHILD STARTS
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 you/your child only. Do not pass
it on to others.
•
If you/your child gets any side effects, talk to your doctor, nurse or
pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
This leaflet has been written assuming the person receiving the
vaccine is reading it, but it can be
given to adolescents and children so you may be reading it for your
child.
WHAT IS IN THIS LEAFLET
1.
What Ambirix is and what it is used for
2.
What you need to know before you receive Ambirix
3.
How Ambirix is given
4.
Possible side effects
5.
How to store Ambirix
6.
Contents of the pack and other information
1.
WHAT AMBIRIX IS AND WHAT IT IS USED FOR
Ambirix is a vaccine used in infants, children and young people from 1
year up to and including 15
years. It is used to prevent two diseases: hepatitis A and hepatitis
B.
•
HEPATITIS A:
Infection with the hepatitis A virus may cause the liver to become
swollen (inflamed).
The virus is usually caught from food or drink that contains the
virus. However, it is sometimes
caught in other ways, such as by swimming in water that has sewage in
it or from another infected
person. The virus is found in body fluids such as faeces, serum or
saliva.
Symptoms begin 3 to 6 weeks after infection. Some people can feel
sick, have a fever and aches
and pains. After a few days they may be very tired, and have dark
urine, pale faeces, yellowish skin
or eyes (jaundice). The severity and type of symptoms can vary. Young
children may not get all
symptoms. Most children reco

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ambirix, suspension for injection in pre-filled syringe
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine
(adsorbed).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (1 ml) contains:
Hepatitis A virus (inactivated)
1,2
720 ELISA Units
Hepatitis B surface antigen
3,4
20 micrograms
1
Produced on human diploid (MRC-5) cells
2
Adsorbed on aluminium hydroxide, hydrated
0.05 milligrams Al
3+
3
Produced in yeast cells (
_Saccharomyces_
_cerevisiae_
) by recombinant DNA technology
4
Adsorbed on aluminium phosphate
0.4 milligrams Al
3+
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for
injection.
Ambirix is a turbid white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ambirix is indicated in non-immune children and adolescents from 1
year up to and including 15 years
of age for protection against hepatitis A and hepatitis B infection.
Protection against hepatitis B infections may not be obtained until
after the second dose (see section
5.1).
Therefore:
-
Ambirix should be used only when there is a relatively low risk of
hepatitis B infection during
the vaccination course.
-
It is recommended that Ambirix should be administered in settings
where completion of the
two-dose vaccination course can be assured.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
- Dosage
A dose of 1.0 ml is recommended for subjects from 1 year up to and
including 15 years of age.
- Primary vaccination schedule
The standard primary course of vaccination consists of two doses, the
first administered at the elected
date and the second between 6 and 12 months after the first dose.
3
The recommended schedule should be adhered to. Once initiated, the
primary course of vaccination
should be completed with the same vaccine.
- Booster dose
In situations where a booster dose of hepatitis A and/or hepatitis B
is desired, a monovalent or
combined vaccine can be given. The safety and immunogenicity of
Ambirix a