Twinrix Paediatric

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

hepatitis A virus (inactivated), hepatitis B surface antigen

MAH:

GlaxoSmithKline Biologicals S.A.

ATC_code:

J07BC20

INN:

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

therapeutic_group:

Vaccines

therapeutic_area:

Immunization; Hepatitis B; Hepatitis A

therapeutic_indication:

Twinrix Paediatric is indicated for use in non-immune infants, children and adolescents from one year up to and including 15 years who are at risk of both hepatitis-A and hepatitis-B infection.

leaflet_short:

Revision: 23

authorization_status:

Authorised

authorization_date:

1997-02-10

PIL

18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE USER
TWINRIX PAEDIATRIC, 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 START/ 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 or your pharmacist.
-
This vaccine has been prescribed for you/ your child only. Do not pass
it on to others.
-
If you get / your child gets any side effects, talk to your doctor 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 Twinrix Paediatric is and what it is used for
2.
What you need to know before you receive Twinrix Paediatric
3.
How Twinrix Paediatric is given
4.
Possible side effects
5.
How to store Twinrix Paediatric
6.
Contents of the pack and other information
1.
WHAT TWINRIX PAEDIATRIC IS AND WHAT IT IS USED FOR
Twinrix Paediatric is a vaccine used in infants, children and
adolescents from 1 year up to and
including 15 years to prevent two diseases: hepatitis A and hepatitis
B. The vaccine works by causing
the body to produce its own protection (antibodies) against these
diseases.
•
HEPATITIS A:
Hepatitis A is an infectious disease, which can affect the liver. This
disease is
caused by the hepatitis A virus. The hepatitis A virus can be passed
from person to person in
food and drink, or by swimming in water contaminated by sewage.
Symptoms of hepatitis A
begin 3 to 6 weeks after coming into contact with the virus. These
consist of nausea (feeling
sick), fever and aches and pains. After a few days the whites of eyes
and skin may become
yellowish (jaundice). The severity and type of symptoms can va

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Twinrix Paediatric, suspension for injection in pre-filled syringe
_ _
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine
(adsorbed).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Hepatitis A virus (inactivated)
1,2
360 ELISA Units
Hepatitis B surface antigen
3,4
10 micrograms
1
Produced on human diploid (MRC-5) cells
2
Adsorbed on aluminium hydroxide, hydrated
0.025 milligrams Al
3+
3
Produced in yeast cells (
_Saccharomyces_
_cerevisiae_
) by recombinant DNA technology
4
Adsorbed on aluminium phosphate
0.2 milligrams Al
3+
The vaccine may contain traces of neomycin which is used during the
manufacturing process (see
section 4.3).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Turbid white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Twinrix Paediatric is indicated for use in non immune infants,
children and adolescents from 1 year up
to and including 15 years who are at risk of both hepatitis A and
hepatitis B infection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
- Dosage
The dose of 0.5 ml (360 ELISA Units HA/10 µg HBsAg) is recommended
for infants, children and
adolescents from 1 year up to and including 15 years of age.
- Primary vaccination schedule
The standard primary course of vaccination with Twinrix Paediatric
consists of three doses, the first
administered at the elected date, the second one month later and the
third six months after the first
dose. 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 Twinrix
Paediatric administered as a booster
3
dose following a three-dose primary course have not been evaluated.
Long-term antibody persistence data f