OCTAGAM 2.5G (50ML)

Land: Malaysia

Sprache: Englisch

Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Wirkstoff:

PLASMA PROTEIN (HUMAN) THEREOF IMMUNOGLOBULIN

Verfügbar ab:

Pharmaniaga Marketing Sdn Bhd

INN (Internationale Bezeichnung):

PLASMA PROTEIN (HUMAN) THEREOF IMMUNOGLOBULIN

Einheiten im Paket:

50ml mL

Hergestellt von:

OCTAPHARMA PHARMA PRODUKTIONSGES.M.B.H

Fachinformation

INSTRUCTIONS FOR USE
(Summary of Product Characteristics)1
NAME OF THE MEDICINAL PRODUCT
OCTAGAM
®
2
QU
ALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)* 50 mg/ml
* corresponding to the total protein content of which at least 95% is hu\
man Immunoglobulin G
Each infusion bottle of 20 ml contains 1g of human normal immunoglobulin\
.
Each infusion bottle of 50 ml contains 2.5g of human normal immunoglobul\
in.
Each infusion bottle of 100 ml contains 5g of human normal immunoglobuli\
n.
Each infusion bottle of 200 ml contains 10g of human normal immunoglobul\
in.
Distribution of IgG subclasses: IgG
1 ca. 60 %
IgG2 ca. 32 %
IgG3 ca. 7 %
IgG4 ca. 1 %
Maximum IgA content: 200 micrograms/ml
Produced from plasma of human donors.
For a full list of excipients, see section 6.1.
3
PHARMA CEUTICAL FORM
Solution for infusion
The liquid preparation is clear to slightly opalescent and colourless to \
slightly yellow. The pH of the liquid preparation is
5.1 – 6.0, the osmolality is ≥ 240 mosmol/kg.
4
CLINICAL P ARTICULARS
4.1
Ther apeutic Indications
Replacement therapy in adults, and children and adolescents (0-18 years) in:
•
Primary immunodeficiency syndromes with impaired antibody production (\
see Section 4.4).
•
Hypogammaglobulinaemia and recurrent bacterial infections in patients wi\
th chronic lymphocytic leukaemia, in whom
prophylactic antibiotics have failed.
•
Hypogammaglobulinaemia and recurrent bacterial infections in plateau pha\
se 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
•
Kaw
asaki disease
4.2
P
osology and method of administration
Replacemen