PRIVIGEN

Land: Indonesië

Taal: Indonesisch

Bron: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Werkstoffen:

IMMUNOGLOBULIN HUMAN NORMAL

Beschikbaar vanaf:

DEXA MEDICA - Indonesia

INN (Algemene Internationale Benaming):

IMMUNOGLOBULIN HUMAN NORMAL

Dosering:

10%

farmaceutische vorm:

INFUS

Eenheden in pakket:

DUS, 1 VIAL @ 25 ML

Geproduceerd door:

CSL BEHRING AG - Switzerland

Autorisatie datum:

2018-08-27

Productkenmerken

Oil., Baring, ('NE ASEAN
MI
Privigen,
HUMAN
Normal 1mmunoglobulin
Version IA) Revision Date II-16-2015
CSL BEHRING
Name of the product
Privigen FM
Human normal immunoglobulin
Solution for infusion (10%)
For intravenous use only
Composition
_a. _
_Active substance _
Human immunoglobulin for intravenous use (IVIg)*.
Human plasma protein containing at least 98% immunoglobulin G (IgG).
Distribution of the IgG subclasses (approx. values): IgGi 67.8%, IgG2
28.7%, IgG3 2.3%,
IgG4 1.2%.
The maximum IgA content is 25 micrograms
*Produced from the plasma of human donors.
_b. _
_Excipients _
L-proline, water for injection.
Privigen contains trace amounts of sodium (< 1 mmo1/1).
Privigen contains no preservatives.
Privigen contains no carbohydrate stabiliser (e.g. sucrose, maltose).
(en)
Privigen, CSL Behring AG
CSL Baring, L NE ASEAN
RPI
Pris igen, Duman Normal Immunoglobulin
Version 1.0 Revision Date 11-16-2015
_har111C1COtherapeutic _
_group _
Immune sera and immunoglobulins: immunoglobulins, normal human, for
intravascular
administration.
ATC code:
JO6BA02
PHARMACEUTICAL FORM AND ACTIVE SUBSTANCE CONTENT PER UNIT
Solution for intravenous infusion.
1 ml of 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. Privigen is isotonic,
with an osmolality of 320 mOsmol/kg.
The pH value of' the ready-to-use solution is 4.6 to 5.0 [4.8].
THERAPEUTIC INDICATIONS
Replacement therapy in
_• _
_Primary imrmmodeliciency syndromes (PID) _
such as:
congenital agammaglobulinaemia and hypoga
mia
-
common variable immunodeficiency
severe combined immunodeficiency
-
Wiskott-Aldrich syndrome
_• _
_Myeloma _
or
_chronic lymphocytic leukaemia with severe secondary _
_hypogammaglohulinaemia and recurrent infections _
_• _
_Children with congenital AIDS and recurrent infections _
Privigen, CSL Behring AG
a
Behring, ()NE ASEAN RPI
Privigen, Human Norma I IMMUNOGLOBULIN
Version 1.0 Revision Date 11-16-2015
_• _
_Hypogamma