Twinrix Adult

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

hepatitis A virus (inactivated), hepatitis B surface antigen

Διαθέσιμο από:

GlaxoSmithKline Biologicals S.A.

Φαρμακολογική κατηγορία (ATC):

J07BC20

INN (Διεθνής Όνομα):

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

Θεραπευτική ομάδα:

Vaccines

Θεραπευτική περιοχή:

Hepatitis B; Hepatitis A; Immunization

Θεραπευτικές ενδείξεις:

Twinrix Adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.

Περίληψη προϊόντος:

Revision: 23

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

1996-09-19

Φύλλο οδηγιών χρήσης

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
TWINRIX ADULT, 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 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 only. Do not pass it on to
others.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Twinrix Adult is and what it is used for
2.
What you need to know before you receive Twinrix Adult
3.
How Twinrix Adult is given
4.
Possible side effects
5.
How to store Twinrix Adult
6.
Contents of the pack and other information
1.
WHAT TWINRIX ADULT IS AND WHAT IT IS USED FOR
Twinrix Adult is a vaccine used in adults and adolescents 16 years of
age and above 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 vary. Young children may not
develop jaundice. Most
people recover completely but the illness is usually severe enough to
keep people ill for about a
month.
•
HEPATITIS B:
Hepatitis B is caused by the hepatitis B virus. It causes the liver to
become swollen
(inflamed). The virus is fou

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Twinrix Adult, 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+
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 Adult is indicated for use in non immune adults and
adolescents 16 years of age and above
who are at risk of both hepatitis A and hepatitis B infection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
- Dosage
A dose of 1.0 ml is recommended for adults and adolescents 16 years of
age and above.
_ _
- Primary vaccination schedule
The standard primary course of vaccination with Twinrix Adult 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.
In exceptional circumstances in adults, when travel is anticipated
within one month or more after
initiating the vaccination course, but where insufficient time is
available to allow the standard 0, 1, 6
month schedule to be completed, a schedule of three intramuscular
injections given at 0, 7 and 21 days
may be used. When this schedule is applied, a fourth dose is
recommended 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
Long-term an