Avaxim Injektionsvätska, suspension, förfylld spruta

Quốc gia: Thụy Điển

Ngôn ngữ: Tiếng Thụy Điển

Nguồn: Läkemedelsverket (Medical Products Agency)

Thành phần hoạt chất:

hepatit A-virus, inaktiverat antigen

Sẵn có từ:

Pharmachim AB

Mã ATC:

J07BC02

INN (Tên quốc tế):

hepatitis A virus, inactivated antigen

Dạng dược phẩm:

Injektionsvätska, suspension, förfylld spruta

Thành phần:

hepatit A-virus, inaktiverat antigen 160 E Aktiv substans; aluminiumoxid, hydratiserad Adjuvans; formaldehyd Hjälpämne

Loại thuốc theo toa:

Receptbelagt

Khu trị liệu:

inaktiverat helvirusvaccin

Tình trạng ủy quyền:

Avregistrerad

Ngày ủy quyền:

2013-04-10

Tờ rơi thông tin

Page 1 of 6
PACKAGE LEAFLET
Page 2 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
AVAXIM, SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE
Hepatitis A vaccine (inactivated, adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE 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 pharmacist, or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or 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 is and what it is used for
2.
What you need to know before you use Avaxim
3.
How to use Avaxim
4.
Possible side effects
5.
How to store Avaxim
6.
Contents of the pack and other information
1.
WHAT AVAXIM IS AND WHAT IT IS USED FOR
Avaxim is a vaccine. Vaccines are used to protect you against
infectious diseases. This vaccine helps
to protect against hepatitis A infection in people 16 years of age and
older.
Hepatitis A infection is due to a virus that attacks the liver. It may
be caught from food or drink that
contains the virus. Symptoms include yellowing of the skin (jaundice)
and feeling generally unwell.
When you are given an injection of Avaxim, your body’s natural
defenses will produce protection
against hepatitis A infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AVAXIM
DO NOT USE AVAXIM :
-
if you are allergic to:
•
the active ingredient or any ingredients of Avaxim (listed in section
6), or
•
neomycin, an antibiotic used during vaccine production, which may be
present in the
vaccine in small amounts, or
•
Avaxim,
-
if you are ill with a high temperature, the vaccination will be
delayed until you have recovered.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Avaxim, if you have:
•
liver disease.
•
a

Đặc tính sản phẩm

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Avaxim, suspension for injection in a 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
……160 EU
3
1
produced in human diploid (MRC-5) cells
2
adsorbed on aluminium hydroxide, hydrated (0.3 milligrams Al
3+
)
3
ELISA Unit.
In the absence of an international standardised reference, the antigen
content is
expressed using an in- house reference
Excipient(s) with known effect:
Ethanol anhydrous…………2.5 microlitres
Phenylalanine………………10 micrograms
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in a pre-filled syringe.
Hepatitis A vaccine (inactivated, adsorbed) is a cloudy and white
suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Avaxim is indicated for active immunisation against infection caused
by hepatitis A virus in
susceptible adults and adolescents of 16 years of age and above.
The use of Avaxim should be based on official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage for subjects of at least 16 years of age is 0.5
millilitres for each injection.
Initial protection is achieved with one single dose of vaccine.
Protective levels of antibody may not be
reached until 14 days after administration of the vaccine.
In order to provide long-term protection, a second dose (booster) of
an inactivated hepatitis A vaccine
should be given. The second dose is preferably given between 6 and 12
months but may be
administered up to 36 months after the first dose (see section 5.1).
It is predicted that HAV antibodies
persist for many years (beyond 10 years) after the second dose.
The vaccine may be used to provide the second dose (booster) in
subjects from 16 years of age who
received another inactivated hepatitis A vaccine (monovale