AVAXIM Junior Injektionsvätska, suspension, förfylld spruta

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

hepatit A-virus, inaktiverat antigen

Tillgänglig från:

Sanofi Pasteur Europe

ATC-kod:

J07BC02

INN (International namn):

hepatitis A virus, inactivated antigen

Läkemedelsform:

Injektionsvätska, suspension, förfylld spruta

Sammansättning:

formaldehyd Hjälpämne; aluminiumoxid, hydratiserad Adjuvans; hepatit A-virus, inaktiverat antigen 80 E Aktiv substans; etanol, vattenfri Hjälpämne

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Förfylld spruta, 10 st (utan nålar); Förfylld spruta, 1 st (utan nålar); Förfylld spruta med fastsatt nål, 10 st; Förfylld spruta med fastsatt nål, 1 st; Förfylld spruta, 1 st ( med två nålar); Förfylld spruta, 10 st ( med 20 st nålar)

Bemyndigande status:

Godkänd

Tillstånd datum:

2021-01-26

Bipacksedel

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
AVAXIM JUNIOR, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Hepatitis A vaccine (inactivated, adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD IS
VACCINATED 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, pharmacist or
nurse.
•
This medicine has been prescribed for you or your child only. Do not
pass it on to others. It may
harm them.
•
If you or your child gets any side effects, talk to your doctor,
pharmacist, or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What AVAXIM Junior is and what it is used for
2.
What you need to know before you use AVAXIM Junior
3.
How to use AVAXIM Junior
4.
Possible side effects
5.
How to store AVAXIM Junior
6.
Contents of the pack and other information
1.
WHAT AVAXIM JUNIOR IS AND WHAT IT IS USED FOR
WHAT AVAXIM JUNIOR IS
Avaxim Junior is a vaccine. Vaccines are used to protect against
infectious diseases.
WHAT AVAXIM JUNIOR IS USED FOR
This vaccine helps to protect against hepatitis A infection.
•
It is used in children aged from 1 year up and including 15 years of
age.
Hepatitis A infection is caused by a virus that attacks the liver.
•
It may be caught from food or drink that contains the virus.
•
Symptoms include yellowing of the skin and eyes (jaundice) and feeling
generally unwell.
HOW AVAXIM JUNIOR WORKS
•
When an injection of Avaxim Junior is given, the body’s natural
defenses produce protection
(antibodies) against hepatitis A infection.
•
This vaccine protects against hepatitis A - but it cannot cause a
hepatitis A infection.
•
This vaccine will not protect against other viruses that attack the
liver (such as hepatitis B,
hepatitis C or hepatitis E viruses).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AVAXIM JUNIOR
DO NOT USE AVAXIM JUNIOR IF YOU OR YOUR CHILD HAVE:
•
an allergy to the activ

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
AVAXIM Junior, suspension for injection in pre-filled syringe.
Hepatitis A vaccine (inactivated, adsorbed).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 0.5 millilitre dose contains:
Hepatitis A virus, GBM strain (inactivated)
1, 2
……80EU
3
1
produced in human diploid (MRC-5) cells
2
adsorbed on aluminium hydroxide, hydrated (0.15 milligrams Al
3+
)
3
ELISA Unit.
In the absence of an international standardised reference, the antigen
content is
expressed using an in- house reference
Residues of clinical relevance
The vaccine may contain traces of neomycin, which is used during the
manufacturing process (see
section 4.3).
Excipient(s) with known effect (see Section 4.4):
Phenylalanine………………10 micrograms
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
Hepatitis A vaccine (inactivated, adsorbed) is a cloudy and whitish
suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Active immunisation against infection caused by hepatitis A virus in
children from 1 year up and
including 15 years of age.
The use of Avaxim Junior should be based on official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The primary vaccination consists of one 0.5 ml dose of vaccine.
Initial protection starts within 2 weeks
after administration.
In order to provide a long-term protection, a second dose (booster) of
vaccine is recommended. This
booster dose should be given between 6 months to 10 years after the
first dose (see section 5.1).In line
with WHO recommendation, in a setting transitioning from high to
intermediate endemicity, in
childhood immunization programmes either a single-dose or two-dose
schedule (primary vaccination
and booster) can be used.
3
This vaccine can be used as a booster in subjects previously
vaccinated with another inactivated
hepatitis A vaccine.
Method of administration
Avaxim Junior should