Privigen

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

human normal immunoglobulin (IVIg)

Available from:

CSL Behring GmbH

ATC code:

J06BA02

INN (International Name):

human normal immunoglobulin (IVIg)

Therapeutic group:

Immune sera and immunoglobulins,

Therapeutic area:

Purpura, Thrombocytopenic, Idiopathic; Bone Marrow Transplantation; Immunologic Deficiency Syndromes; Guillain-Barre Syndrome; Mucocutaneous Lymph Node Syndrome

Therapeutic indications:

Replacement therapy in adults, and children and adolescents (0-18 years) in:primary immunodeficiency (PID) syndromes with impaired antibody production;hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed;hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who have failed to respond to pneumococcal immunisation;hypogammaglobulinaemia in patients after allogeneic haematopoietic-stem-cell transplantation (HSCT);congenital AIDS with recurrent bacterial infections.Immunomodulation in adults, and children and adolescents (0-18 years) in:primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count;Guillain-Barré syndrome;Kawasaki disease;chronic inflammatory demyelinating polyneuropathy (CIDP). Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.

Product summary:

Revision: 31

Authorization status:

Authorised

Authorization date:

2008-04-24

Patient Information leaflet

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRIVIGEN 100 MG/ML (10%) SOLUTION FOR INFUSION
human normal immunoglobulin (IVIg)
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 healthcare
professional.
-
If you get any side effects, talk to your doctor or healthcare
professional. This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Privigen is and what it is used for
2.
What you need to know before you are given Privigen
3.
How to use Privigen
4.
Possible side effects
5.
How to store Privigen
6.
Contents of the pack and other information
1.
WHAT PRIVIGEN IS AND WHAT IT IS USED FOR
WHAT PRIVIGEN IS
Privigen belongs to the class of medicines called human normal
immunoglobulins. Immunoglobulins
are also known as antibodies and are blood proteins that help your
body to fight infections.
HOW PRIVIGEN WORKS
Privigen contains immunoglobulins that have been prepared from the
blood of healthy people. The
medicine works in exactly the same way as the immunoglobulins
naturally present in human blood of
healthy people.
WHAT PRIVIGEN IS USED FOR
Privigen is used for the treatment of adults and children (0-18 years)
in the following situations:
A)
To increase abnormally low immunoglobulin levels in your blood to
normal levels
(replacement therapy):
1.
Patients who are born with a reduced ability or inability to produce
immunoglobulins
(primary immunodeficiencies (PID)).
2.
Patients with an acquired immunodeficiency (SID) who suffer from
severe or recurrent
infections, ineffective antimicrobial treatment and either proven
specific antibody failure
or serum IgG level of <4 g/l.
B)
To treat certain inflammatory disorders (immunomodulation). There are
5 groups:
1.
Patients who do not have enough blood platelets (primary immune
thrombocytopenia
(ITP) and who are at high risk of bleedin

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Privigen 100 mg/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)*
One ml contains:
Human normal immunoglobulin
100 mg
(purity of at least 98% IgG)
Each vial of 25 ml solution contains: 2.5 g human normal
immunoglobulin
Each vial of 50 ml solution contains: 5 g human normal immunoglobulin
Each vial of 100 ml solution contains: 10 g human normal
immunoglobulin
Each vial of 200 ml solution contains: 20 g human normal
immunoglobulin
Each vial of 400 ml solution contains: 40 g human normal
immunoglobulin
Distribution of the IgG subclasses (approx. values):
IgG
1
.......................69 %
IgG
2
.......................26 %
IgG
3
........................ 3 %
IgG
4
........................ 2 %
The maximum IgA content is 25 micrograms/ml.
*Produced from the plasma of human donors.
Excipients with known effects:
Privigen contains approximately 250 mmol/L (range: 210 to 290) of
L-proline.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear or slightly opalescent and colourless to pale
yellow.
Privigen is isotonic, with an approximate osmolality of 320 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Replacement therapy in adults, and children and adolescents (0-18
years) in:
– Primary immunodeficiency syndromes (PID) with impaired antibody
production (see
section 4.4).
– Secondary immunodeficiencies (SID) in patients who suffer from
severe or recurrent infections,
ineffective antimicrobial treatment and either proven specific
antibody failure (PSAF)* or
serum IgG level of <4 g/l.
* PSAF = failure to mount at least a 2-fold rise in IgG antibody titre
to pneumococcal polysaccharide
and polypeptide antigen vaccines.
3
Immunomodulation in adults, and children and adolescents (0-18 years)
in:
– Primary immune thrombocytopenia (ITP), in patients at high risk of
bleeding or prior to surgery
to correct the platele