Epaxal vaccine emulsion for injection 0.5ml pre-filled syringes

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Hepatitis A virus inactivated

Dostupno od:

Janssen-Cilag Ltd

ATC koda:

J07BC02

INN (International ime):

Hepatitis A virus inactivated

Farmaceutski oblik:

Emulsion for injection

Administracija rute:

Subcutaneous; Intramuscular

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 14040000; GTIN: 5018741000857 5018741000864

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
EPAXAL, SUSPENSION FOR INJECTION IN A PREFILLED SYRINGE
HEPATITIS A VACCINE (INACTIVATED, VIROSOME)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this package insert:
1. What Epaxal is and what it is used for
2. Before you use Epaxal
3. How to use Epaxal
4. Possible side effects
5. How to store Epaxal
6. Further information
_1. WHAT EPAXAL IS AND WHAT IT IS USED FOR _
EPAXAL IS A SUSPENSION FOR INJECTION PRESENTED IN PREFILLED SYRINGE
Epaxal is used to vaccinate against hepatitis A (infectious jaundice)
for adults and children
from 1 year of age. The immune system is activated by means of killed
hepatitis A virus,
bound to virosomes (vaccine particles) consisting of fats (lipids) and
proteins. Protection
against hepatitis A infection is achieved in 80-97% of vaccinated
individuals after 14 days, in
92-100% after 28 days and in 78-100% after 1 year.
_2. BEFORE YOU USE EPAXAL _
DO NOT USE EPAXAL
-
If you are hypersensitive to any of the vaccine components
-
If you are hypersensitive to eggs, chicken protein, or formaldehyde
If you have an acute infection with a fever, your vaccination should
be postponed. Please tell
your doctor if you think you have a fever.
TAKE SPECIAL CARE WITH EPAXAL
Before vaccination with Epaxal, please tell your doctor if you have
any problems with your
immune system, as this may affect the way the vaccine works. If you
have had your spleen
removed (splenectomy) or your immune system does not work properly
(immunodeficiency),
you should be given a second dose of vaccine, not earlier than 1 month
after the first dose.
Your doctor

Svojstava lijeka

OBJECT 1
EPAXAL
Summary of Product Characteristics Updated 06-Jun-2016 | Janssen-Cilag
Ltd
1. Name of the medicinal product
Epaxal suspension for injection in a prefilled syringe
Hepatitis A vaccine (inactivated, virosome).
2. Qualitative and quantitative composition
1 vaccine dose (0.5 ml) contains at least 24 IU of inactivated
hepatitis A virus (strain RG-SB), propagated
in human diploid (MRC-5) cells.
The virus particles are adsorbed on virosomes as the adjuvant system,
composed of highly purified
influenza virus surface antigens (10 micrograms haemagglutinin) of the
A/Singapore/6/86 (H1N1) strain
and the phospholipids lecithin (80 micrograms) and cephalin (20
micrograms).
For more information on the adjuvant, see section 5.1.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Suspension for injection in a prefilled syringe. Clear, colourless
liquid.
4. Clinical particulars
4.1 Therapeutic indications
Active immunisation against hepatitis A of children from 1 year of age
and adults.
4.2 Posology and method of administration
One dose of 0.5 ml is injected intramuscularly. To ensure optimal
immune response, the vaccine should
be injected into the deltoid muscle. In patients with coagulation
disorders, the vaccine may be
administered subcutaneously in the upper arm.
In order to provide long-term protection, a second (booster) dose of
0.5 ml should be administered. This
is preferably given between 6-12 months after the first dose but may
be given up to 10 years later based
on limited experience in healthy adult travellers (see section 5.1).
Epaxal can be used interchangeably with other inactivated hepatitis A
vaccines for the first and second
(booster) dose.
_Simultaneous active and passive immunisation_
If immediate protection against hepatitis A is necessary, Epaxal can
be administered concomitantly with
human gamma globulin at separate injection sites.
_Post-exposure vaccination_
Post-exposure vaccination should be given according to official
recommendations.
4.3 Contraindications
Hypersensi