HBVaxPro
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
16-08-2022
Charakterystyka produktu
(SPC)
16-08-2022
Sprawozdanie z oceny publicznego
(PAR)
25-07-2011
Składnik aktywny:
hepatitis B, recombinant surface antigen
Dostępny od:
Merck Sharp & Dohme B.V.
Kod ATC:
J07BC01
INN (International Nazwa):
hepatitis B vaccine (recombinant DNA)
Grupa terapeutyczna:
Vaccines
Dziedzina terapeutyczna:
Hepatitis B; Immunization
Wskazania:
5 micrograms HBVaxPro is indicated for active immunisation against hepatitis-B-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-B virus. The specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis-B infection. 10 micrograms HBVaxPro is indicated for active immunisation against hepatitis-B-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-B virus. The specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis-B infection. 40 micrograms HBVaxPro is indicated for the active immunisation against hepatitis-B-virus infection caused by all known subtypes in predialysis and dialysis adult patients. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.,
Podsumowanie produktu:
Revision: 32
Status autoryzacji:
Authorised
Data autoryzacji:
2001-04-27
Ulotka dla pacjenta
70
PACKAGE LEAFLET: I
NFORMATION FOR THE USER
HBVAXPRO 5
MICROGRAMS,
SUSPENSION FOR INJECTION IN PRE
-FILLED SYRINGE
Hepatitis B vaccine (
r
ecombinant
DNA)
READ ALL OF
THIS LEAFLET CAREFULLY BEF
ORE YOU OR
YOUR CHILD IS VACCINATED
BECAUSE IT CONTAINS IMPORTANT
INFORMATION.
-
Keep this leaflet. You may need
to read it again.
-
If you have any further questions,
ask your doctor
,
pharmacist
or nurse.
-
If you or your child get
any side effects, talk
to your doctor
, pharmacist or nurse
. This includes any
possible side effe
cts not listed in this leaflet.
See section 4.
WHAT IS I
N THIS LEAFLET
:
1.
What HBVAXPRO 5
micro
grams is and what it is used for
2.
What you need
to know before
you or your child
receive
HBVAXPRO 5
micrograms
3.
How HBVAXPRO 5
micrograms
is given
4.
Possible side e
ffects
5.
How to store HBVAXPRO 5
micrograms
6.
Content of the p
ack and other information
1.
WHAT HB
VAXPRO 5
MICROGRAMS
IS AND WHAT IT IS USED FOR
This vaccine i
s indicated for active imm
unisation against hepatitis B virus infection caused by all known
subtypes in
individuals from birth through 15
years of age
consi
dered at risk of exposure to hepatitis
B
virus.
It can be expected that hepatitis D
will also be pr
evented by immunisation wi
th HBVAXPRO as hepatitis
D does not occur in the absence of hepatitis B
infection.
The vaccine will not prevent
infection caused
by other agents such as hepatitis A, h
epatitis C and hepatitis
E and other pathogens
known to infect the liver.
2.
WHAT YOU
NEED TO KNOW BEFORE YOU OR YOUR CHILD RECEIVE
HBVAXPRO
5
MICROGRAMS
DO
NOT USE HBVAXPRO 5
MICROGRAMS
-
if you or your child is allergic to hepatitis B surface antigen or to
any of the other
ingredients
of
HBVAXPRO
(see section 6)
-
if you or
your child ha
s a severe
illness with fever
WARNINGS AND PRECAUTIONS
The container of
this vaccine
contains latex rubber.
Latex rubber may caus
e severe allergic reactions.
Talk to your doctor,
pharmacist
or nurse
before you or y
our child recei
ve HBVAXPRO 5
micrograms.
OTHER VACCINES
AND HBVAXPRO 5
MIC
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
HBVAXPRO 5
micrograms
,
suspension for injection
Hepatitis B vaccine (
r
ecombinant
DNA)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5
mL) contains:
H
epatitis B virus surface antigen, recombinant (HBsAg) *
................... 5
micrograms
Adsorbed on amorphous aluminium hydroxyphosphate sulfate
(0.25 milligram Al
+
)
* produced in
Saccharomyces cerevisiae
(strain 2150-2-
3) yeast by recombinant DNA technology
.
This vaccine may contain traces of
formaldehyde
and
potassium
thiocyanate,
which are used during the
manufacturing process. See sections
4.3, 4.4 and 4.8.
Excipient(s)
with known effect:
Sodium less than 1
mmol (23
mg) per dose.
For the
full list of exc
ipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection
Slightly opaque white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HBVAXPRO
is indicated for active immunisation against hepatitis B virus
infection caused
by all known
subtypes in
individuals from birth through 15 years of age
considered at risk of exposure to hepatitis B
virus.
THE SPECIFIC AT RISK CATEGORIES TO BE IMMUNISED ARE TO BE DETERMINED
ON THE BASIS OF THE OFFICIAL
RECOMMENDATIONS.
It can be exp
ected
that hepatit
is
D will also be prevented by immunisation with HBVAXPRO as
hepatitis
D (caused by the delta agent) does not occur in the absence of
hepatitis B infection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Individuals from birth thro
ugh 15 years of age: 1 dose (0.5 mL)
at each injection
:
Primary vaccination
:
A course of vaccination should include at least three injections.
3
Two primary immunisation schedules can be recommended:
0, 1, 6 MONTHS:
two injections with an interval of one
month; a third injection 6
months after the first
administration.
0, 1, 2, 12 MONTHS
:
three injections with an interval of one month; a fourth dose should
be administered at
12 months.
It is recommended that the vaccine be administered in the schedule
s indicated. Infan
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