ENGERIX B 10 MCG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

PURIFIED HEPATITIS B ANTIGEN

Tilgjengelig fra:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-kode:

J07BC01

Legemiddelform:

SUSPENSION FOR INJECTION

Sammensetning:

PURIFIED HEPATITIS B ANTIGEN 10 MCG / 0.5 ML

Administreringsrute:

I.M

Resept typen:

Required

Produsert av:

GLAXO SMITH KLINE BIOLOGICALS S.A

Terapeutisk gruppe:

HEPATITIS B, PURIFIED ANTIGEN

Terapeutisk område:

HEPATITIS B, PURIFIED ANTIGEN

Indikasjoner:

Engerix B is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes in non immune subjects . The 20 µg dose vaccine in 1.0 ml suspension is intended for use in subjects 16 years of age and above. The 10 µg dose vaccine in 0.5 ml suspension is intended for use in subjects up to and including 15 years of age, including neonates. The categories within the population to be immunised are determined on the basis of official recommendations.It can be expected that hepatitis D will also be prevented by immunisation with Engerix B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

Autorisasjon dato:

2021-12-31

Informasjon til brukeren

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
Engerix B 20 mcg
Suspension for injection
Each dose (1 mL) contains: Purified hepatitis B antigen 20 mcg
Engerix B 10 mcg
Suspension for injection
Each dose (0.5 mL) contains: Purified hepatitis B antigen 10 mcg
For the list of the inactive and allergenic ingredients in the
medicine, see
section 2 – "Important information about some of the ingredients in
the
medicine" and section 6 – "Additional information".
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions, refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Engerix B is an active vaccine used against liver infection (jaundice)
caused
by the hepatitis B virus.
Engerix B 20 mcg
The vaccine is intended for adults and adolescents from 16 years of
age and
above.
Engerix B 10 mcg
The vaccine is intended for neonates, children and adolescents up to
15 years
of age (including age 15 years).
Hepatitis B is an infectious illness of the liver caused by a virus.
Some people
have the virus that causes hepatitis B in their body but cannot get
rid of it.
They can still infect other people and are known as carriers. The
disease is
spread by the virus which enters the body following contact with body
fluids,
most often, blood from an infected person.
If the mother is a carrier of the virus, she can pass the virus to her
baby at
birth. It is also possible to catch the virus from a carrier through,
for example,
unprotected sex, sharing of injection needles or treatment with
medical
equipment, which has not been properly sterilised.
The main symptoms of the illness include headache, fever, sickness and
jaundice (yellowing of t

Preparatomtale

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1
NAME OF THE MEDICINAL PRODUCT
Engerix B10MCG
Engerix B 20MCG
Suspension for injection
Hepatitis B (rDNA) vaccine (adsorbed) (HBV)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ENGERIX B 10MCG vaccine –
1 dose (0.5 ml) contains:
Purified hepatitis B antigen
1,2
10 micrograms
1
Adsorbed
on aluminium hydroxide, hydrated
Total: 0.25 milligrams Al
3+
2
Produced
in yeast cells (
_Saccharomyces cerevisiae_
) by recombinant DNA
technology
ENGERIX B 20MCG vaccine –
1 dose (1 ml) contai
ns :
Purified hepatitis B antigen
1,2
20 micrograms
1
Adsorbed on aluminium hydroxide, hydrated
Total: 0.50 milligrams Al
3+
2
Produced in yeast cells (
_Saccharomyces cerevisiae_
) by recombinant DNA
technology
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Suspension for injection.
The suspension is turbid white.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Engerix B is indicated for active immunisation against hepatitis B
virus
infection (HBV) caused by all known subtypes in non immune subjects .
The
20 µg dose vaccine in 1.0 ml suspension is intended for use in
subjects 16
years of age and above. The 10 µg dose vaccine in 0.5 ml suspension
is
intended for use in subjects up to and including 15 years of age,
including
neonates. The categories within the population to be immunised are
determined on the basis of official recommendations.
Page
2
of
18
It can be expected that hepatitis D will also be prevented by
immunisation
with Engerix B 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 _
_Dosage _
The 20 µg dose vaccine
in 1.0 ml suspension is intended for use in subjects 16
years of age and above.
The 10 µg dose vaccine
in 0.5 ml suspension is intended
for use in subjects up to and including 15 years of age, including
neonates.
However, the 20 µg vaccine can also be used in subjects from 11 years
up to
and including 15 years of age as a 2-dose schedule in situations when
there is a
low r