IG Vena 50g/l Solution for Infusion (50ml vial)

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

HUMAN NORMAL, IMMUNOGLOBULIN

Verfügbar ab:

Kedrion S.p.A Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga - Lucca, Italy

ATC-Code:

J06BA02

INN (Internationale Bezeichnung):

HUMAN NORMAL IMMUNOGLOBULIN 50 g/l

Darreichungsform:

SOLUTION FOR INFUSION

Zusammensetzung:

HUMAN NORMAL IMMUNOGLOBULIN 50 g/l

Verschreibungstyp:

POM

Therapiebereich:

IMMUNE SERA AND IMMUNOGLOBULINS

Produktbesonderheiten:

Licence number in the source country: NOT APPLICAPABLE

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2005-10-27

Gebrauchsinformation

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_IgVena-PIL-50-100-200 ml-MT-K22 _
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PACKAGE LEAFLET: INFORMATION FOR THE USER
IG VENA 50 G/L SOLUTION FOR INFUSION
HUMAN NORMAL IMMUNOGLOBULIN (IVIG) FOR INTRAVENOUS USE
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 nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What IG Vena is and what it is used for
2. What you need to know before you use IG Vena
3. How to use IG Vena
4. Possible side effects
5. How to store IG Vena
6. Contents of the pack and other information
1.
WHAT IG VENA IS AND WHAT IT IS USED FOR
IG Vena is a solution of human normal immunoglobulin for intravenous
use. Immunoglobulins are
human antibodies present also in the blood.
IG Vena is used for:
TREATMENT OF ADULTS, AND CHILDREN AND ADOLESCENTS (0-18 YEARS) WHO DO
NOT HAVE SUFFICIENT
ANTIBODIES (REPLACEMENT THERAPY) IN THE FOLLOWING CASES:
1.
Patients with inborn deficiency of antibodies production (primary
immunodeficiency syndromes)
2.
Patients with acquired deficiency of antibody production (secondary
immunodeficiencies) who
suffer from severe or recurrent infections due to different medical
conditions (e.g. oncological
or autoimmune diseases or due to the consequent treatment of those
diseases). Those patients
demonstrated ineffective treatment with antibiotics and either did not
have sufficiently positive
increment
of
IgG
titer
of
antibody
after
vaccination
(pneumococcal
polysaccharide
and
polypeptide antigen vaccines) or had a level of Ig G in their blood <4
g/l.
TREATMENT OF ADULTS, AND CHILDREN AND ADOLESCENTS (0-18 YEARS) WITH
CERTAIN INFLAMMATORY
DISORDERS (IMMUNOMODULATION) IN THE FOLLOWING SITUATIONS:
1.
Patients who do not have enough blood platelets (Primary Immune
Thrombocytopenia, ITP),
and

Fachinformation

_Ig Vena-SPC-MT-K22 _
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
IG Vena 50 g/l Solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg).
One ml of solution contains:
Human normal immunoglobulin 50 mg
(purity of at least 95% IgG)
Each vial of 20 ml contains: 1 g of human normal immunoglobulin
Each vial of 50 ml contains: 2.5 g of human normal immunoglobulin
Each vial of 100 ml contains: 5 g of human normal immunoglobulin
Each vial of 200 ml contains:10 g of human normal immunoglobulin
Distribution of the IgG subclasses (approx. values):
IgG
1
62,1 %
IgG
2
34,8 %
IgG
3
2,5 %
IgG
4
0,6 %
The maximum IgA content is 50 micrograms/ml.
Produced from the plasma of human donors.
Excipients with known effect:
The product contains 100 mg of maltose per ml.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion.
The solution should be clear or slightly opalescent, colourless or
pale yellow.
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
•
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
_Ig Vena-SPC-MT-K22 _
* PSAF = failure to mount at least a 2-fold rise in IgG antibody titre
to pneumococcal polysaccharide
and polypeptide antigen vaccines
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 (in conjunction with acetylsalicylic acid; see 4.2)
•
Chronic inflammatory demyelinating poliradiculoneuropathy (CIDP)
•
Multifocal motor neuropathy (MMN)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Replacement th