ImmunoGam

Țară: Uniunea Europeană

Limbă: engleză

Sursă: EMA (European Medicines Agency)

Ingredient activ:

human hepatitis B immunoglobulin

Disponibil de la:

Cangene Europe Limited

Codul ATC:

J06BB04

INN (nume internaţional):

human hepatitis B immunoglobulin

Grupul Terapeutică:

Specific immunoglobulins

Zonă Terapeutică:

Immunization, Passive; Hepatitis B

Indicații terapeutice:

Immunoprophylaxis of Hepatitis B - In case of accidental exposure in non-immunised subjects (including persons whose vaccination isincomplete or status unknown).- In haemodialysed patients, until vaccination has become effective.- In the newborn of a hepatitis B virus carrier-mother.- In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.Consideration should also be given to other official guidance on the appropriate use of human hepatitis B immunoglobulin for intramuscular use.

Statutul autorizaţiei:

Withdrawn

Data de autorizare:

2010-03-16

Prospect

Medicinal product no longer authorised
16
B. PACKAGE LEAFLET
Medicinal product no longer authorised
17
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMMUNOGAM 312 IU/ML SOLUTION FOR INJECTION
Human Hepatitis B Immunoglobulin
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 any further questions, ask your doctor.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
IN THIS LEAFLET:
1.
What ImmunoGam is and what it is used for
2.
Before you receive ImmunoGam
3.
How ImmunoGam is administered
4.
Possible side effects
5.
How to store ImmunoGam
6.
Further information
1.
WHAT IMMUNOGAM IS AND WHAT IT IS USED FOR
WHAT IMMUNOGAM IS
ImmunoGam belongs to a group of medicines containing immunoglobulins
(antibodies which can protect against
certain infections), which are present in your blood. ImmunoGam
contains increased levels of human hepatitis B
immunoglobulins mainly immunoglobulin G (IgG) and is obtained from
blood plasma of screened donors from
the USA.
WHAT IMMUNOGAM IS USED FOR
ImmunoGam provides protection against hepatitis B virus for a short
period of time and it is used to treat the
following:
-
Accidental exposure in non-immunised subjects (including persons whose
vaccination is incomplete or
status unknown).
-
Haemodialysed patients, until vaccination has become effective.
-
Newborn of a hepatitis B virus carrier-mother.
-
Subjects who did not show an immune response (no measurable hepatitis
B antibodies) after vaccination
and for whom a continuous prevention is necessary due to the
continuous risk of being infected with
hepatitis B.
2.
BEFORE YOU RECEIVE IMMUNOGAM
YOU SHOULD NOT BE GIVEN IMMUNOGAM
-
if you have previously developed an allergic reaction to human
immunoglobulins, to other blood products
or to any of the other ingredients of ImmunoGam.
-
if you have an IgA deficiency such that you have developed an allergic
reaction to IgA containing
pr

Caracteristicilor produsului

Medicinal product no longer authorised
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_ _
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
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1.
NAME OF THE MEDICINAL PRODUCT
ImmunoGam 312 IU/ml solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 312 IU Human hepatitis B immunoglobulin,
corresponding to a protein content
of 30-70 mg/ml of which 96% is Immunoglobulin G (IgG).
One vial contains 312 IU of anti-HBs in 1 ml
One vial contains 1560 IU of anti-HBs in 5 ml
The immunoglobulin IgG subclasses are:
IgG1:
64-67%
IgG2:
25-27%
IgG3:
7-9%
IgG4:
0.1-0.3%
IgA content is less than 40 micrograms/ml.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
ImmunoGam is a clear to slightly opalescent and colourless or pale
yellow liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Immunoprophylaxis of Hepatitis B
-
In case of accidental exposure in non-immunised subjects (including
persons whose vaccination is
incomplete or status unknown).
-
In haemodialysed patients, until vaccination has become effective.
-
In the newborn of a hepatitis B virus carrier-mother.
-
In subjects who did not show an immune response (no measurable
hepatitis B antibodies) after
vaccination and for whom a continuous prevention is necessary due to
the continuous risk of being
infected with hepatitis B.
Consideration should also be given to other official guidance on the
appropriate use of human hepatitis B
immunoglobulin for imtramuscular use.
Medicinal product no longer authorised
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
-
Prevention of hepatitis B in case of accidental exposure in
non-immunised subjects:
At least 500 IU, depending on the intensity of exposure, as soon as
possible after exposure, and preferably
within 24 - 72 hours.
-
Immunoprophylaxis of hepatitis B in haemodialysed patients:
8-12 IU/kg with a maximum of 500 IU, every 2 months until
seroconversion following vaccination.
-
Prevention of hepatitis B in the newborn, of a hepatitis B virus
carrier