Privigen solution for infusion

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

human normal immunoglobulin

Disponible depuis:

CSL Behring AG

Code ATC:

J06BA02

DCI (Dénomination commune internationale):

human normal immunoglobulin

Dosage:

100mg/ml

forme pharmaceutique:

solution for infusion

Unités en paquet:

100ml glass vial

Type d'ordonnance:

Prescription

Statut de autorisation:

Registered

Date de l'autorisation:

2016-11-10

Notice patient

1.
PRIVIGEN
®
2.
_COMPOSITION_
a)
_Active substance_
Human normal immunoglobulin for intravenous administration (IVIg).
Human plasma
protein with a minimum of ≥98 % Immunoglobulin G (IgG).
IgG subclass distribution (approximate values): IgG
1
69 %, IgG
2
26 %, IgG
3
3 % IgG
4
2 %.
The maximum IgA content is 25 micrograms/mL.
The isoagglutinin titre is 1:8 for anti-A antibodies and 1:4 for
anti-B antibodies (median
measured
by
the
direct
agglutination
test
according
to
European
Pharmacopoeia
(Ph.Eur.)).
b)
_Excipients_
L-proline, sodium hydroxide (corresponds to maximum 1 mmol/L sodium),
hydrochloric
acid, water for injection.
3.
PHARMACEUTICAL FORM AND AMOUNT OF ACTIVE SUBSTANCE PER UNIT
Solution for infusion for intravenous use.
1 mL solution contains: 100 mg human plasma protein with an IgG
content of at least 98
% (10 % solution).
The solution is clear to slightly opalescent and colourless to pale
yellow. Osmolarity is
320 mOsmol/kg and is thus isotonic.
4.
INDICATIONS/POSSIBILITIES FOR USE
Replacementtherapyin

_Primary immunodeficiency syndromes (PID) _such as:
-
congenital agammaglobulinaemia and hypogammaglobulinaemia
-
common variable immunodeficiency syndrome
-
severe combined immunodeficiency syndrome
-
Wiskott-Aldrich syndrome

_Secondary immune defects (SID) _ in patients with severe or recurring
infections,
ineffective
antimicrobial
treatment
and
either
confirmed
insufficient
increase
of
antibodies from vaccinations (PSAF*) or IgG serum levels of < 4 g/L.
*PSAF
=
Absence
of a
minimum
two-fold
increase
of
the
IgG
antibody
concentration
against
pneumococci-polysaccharides and polypeptide antigen vaccine (PSAF =
proven specific antibody
failure).
Immunomodulation

_Primary immune thrombocytopenia (ITP) in children or adults at high
risk of _
_bleeding or prior to surgery to correct platelet count_

_Guillain-Barré syndrome_

_Kawasaki’s disease_

_Chronic inflammatory demyelinating polyneuropathy (CIDP)_
5.
POSOLOGY/ADMINISTRATION
_POSOLOGY_
The dosage and intervals between infus

Résumé des caractéristiques du produit

1
1.
NAME OF THE MEDICINAL PRODUCT
Privigen100 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 ghuman normal immunoglobulin
Each vial of 50 ml solution contains: 5 ghuman normal immunoglobulin
Each vial of 100 ml solution contains: 10 ghuman 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 thefull 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:

Primary immunodeficiency syndromes (PID) with impaired antibody
production such us
(see section 4.4):
–
congenital agammaglobulinaemia and hypogammaglobulinaemia
–
common variable immunodeficiency syndrome
–
severe combined immunodeficiency syndrome
–
Wiskott-Aldrich syndrome
2

Secondary immunodeficiencies (SID) in patients who suffer from severe
or recurrent
infections, ineffective antimicrobial treatment and either proven
specific antibody failure
(PSAF)* or serumIgG 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.
Immunomodulationin adults, and children and adolescents (0-18 years)
in:
–
Primary immune thrombocyt