PRIVIGEN SOLUTION FOR INFUSION 100gL

البلد: سنغافورة

اللغة: الإنجليزية

المصدر: HSA (Health Sciences Authority)

العنصر النشط:

Human Immunoglobulin

متاح من:

CSL BEHRING PTE. LTD.

ATC رمز:

J06BA02

الشكل الصيدلاني:

INFUSION, SOLUTION

تركيب:

Human Immunoglobulin 100g/L

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

Prescription Only

المصنعة من قبل:

CSL Behring AG

الوضع إذن:

ACTIVE

تاريخ الترخيص:

2018-11-07

خصائص المنتج

SG Privigen package insert (date of last revision Aug-2022)
1
1.
NAME OF THE MEDICINAL PRODUCT
Privigen Solution for infusion 100g/L
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 g human normal
immunoglobulin
Each vial of 50 ml solution contains: 5 g human normal immunoglobulin
Each vial of 100 ml solution contains: 10 g human normal
immunoglobulin
Each vial of 200 ml solution contains: 20 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 the full 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 adults, and children and adolescents (0-18
years) in:
–
Primary immunodeficiency (PID) syndromes with impaired antibody
production (see section
4.4).
–
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.
* PSAF = failure to mount at least a 2-fold rise in IgG antibody titre
to pneumococcal polysaccharide
and polypeptide antigen vaccines.
–
SG Privigen package insert (date of last revision Aug-2022)
2
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 acetylsalicyli