Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
IMMUNOGLOBULIN HUMAN NORMAL
DEXA MEDICA - Indonesia
IMMUNOGLOBULIN HUMAN NORMAL
10%
INFUS
DUS, 1 VIAL @ 50 ML
CSL BEHRING AG - Switzerland
2018-08-27
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 Baca dokumen lengkapnya