Kiovig Solution for Infusion 100mgml

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

Human normal immunoglobulin

Dostępny od:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Kod ATC:

J06BA02

Dawkowanie:

100mg/ml

Forma farmaceutyczna:

INFUSION, SOLUTION

Skład:

Human normal immunoglobulin 100mg/ml

Droga podania:

INTRAVENOUS

Typ recepty:

Prescription Only

Wyprodukowano przez:

Baxalta Belgium Manufacturing SA

Status autoryzacji:

ACTIVE

Data autoryzacji:

2010-05-21

Ulotka dla pacjenta

Page 1 of 15 

BAXTER

KIOVIG 
NAME OF THE MEDICINAL PRODUCT 
KIOVIG 100 mg/ml solution for infusion 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
1 ml contains: 
Human normal immunoglobulin
(IVIg)..............................................100 mg* 
*corresponding to human protein content, of which at least 98% is
IgG 
One vial of 10 ml contains: 1 g 
One vial of 25 ml contains: 2.5 g 
One vial of 50 ml contains: 5 g 
One vial of 100 ml contains: 10 g 
One vial of 200 ml contains: 20 g 
One vial of 300ml contains: 30g 

Distribution of IgG subclasses: 
IgG1 ≥ 56.9% 
IgG2 ≥ 26.6% 
IgG3 ≥ 3.4% 
IgG4 ≥ 1.7% 
Maximum immunoglobulin A (IgA) content: 0.14 milligram per ml. 

Excipient: Glycine 
For a full list of excipients, see ‘List of excipients’. 

PHARMACEUTICAL FORM 
Solution for infusion 
The solution is clear or slightly opalescent and colourless or pale
yellow. 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
Replacement therapy in 
Primary immunodeficiency syndromes such as: 
-  congenital agammaglobulinaemia and hypogamma-globulinaemia 
- common 
variable 
immunodeficiency 
-  severe combined immunodeficiency 
-  Wiskott Aldrich syndrome 

Myeloma or chronic lymphocytic leukaemia (CLL) with severe secondary
hypogamma-
globulinaemia and recurrent infections. 
Children with congenital AIDS and recurrent infections. 
Page 2 of 15 

Immunomodulation 
-  Idiopathic thrombocytopenic purpura (ITP), in children or adults
at high risk of bleeding or 
prior to surgery to correct the platelet count. 
-  Guillain Barré syndrome 
- Kawasaki 
disease 

Allogeneic bone marrow transplantation 

POSOLOGY AND METHOD OF ADMINISTRATION 
Replacement therapy should be initiated and monitored under a
physician experienced in the 
treatment of immunodeficiency. 

POSOLOGY 
The dose and dosage regimen are dependent on the indication. 
In replacement therapy the dosage may need to be individualised fo

Charakterystyka produktu

Page 1 of 15
BAXALTA
KIOVIG
NAME OF THE MEDICINAL PRODUCT
KIOVIG 100 mg/ml solution for infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
Human normal immunoglobulin
(IVIg)..............................................100 mg*
*corresponding to human protein content, of which at least 98
% is IgG
One vial of 10 ml contains: 1 g
One vial of 25 ml contains: 2.5 g
One vial of 50 ml contains: 5 g
One vial of 100 ml contains: 10 g
One vial of 200 ml contains: 20 g
One vial of 300ml contains: 30g
Distribution
of IgG subclasses:
IgG1 ≥ 56.9%
IgG2 ≥ 26.6%
IgG3 ≥ 3.4%
IgG4 ≥ 1.7%
Maximum immunoglobulin A (IgA) content: 0.14 milligram per ml.
Excipient: Glycine
For a full list of excipients, see ‘List of excipients’.
PHARMACEUTICAL FORM
Solution for infusion
The solution is clear or slightly opalescent and colourless or pale
yellow.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Replacement therapy in
Primary immunodeficiency syndromes such as:
-
congenital agammaglob
ulinaemia and hypogamma-globulinaemia
-
common
variable immunodeficiency
-
severe combined immunodeficienc
y
-
Wiskott Aldrich syndrome
Myeloma or chronic lymphocytic leukaemia (CLL) with severe secondary
hypogamma-
globulinaemia and recurrent infections.
Children with congenital AIDS and recurrent infections.
Page 2 of 15
Immunomodulation
-
Idiopathic thrombocytopenic purpura (ITP), in children or adults at
high risk of bleeding or
prior to surgery to correct the platelet count.
-
Guillain Barré syndrome
-
Kawasaki disease
-
Multifocal Motor Neuropathy (MMN)
Allogeneic bone marrow transplantation
POSOLOGY AND METHOD OF ADMINISTRATION
Replacement therapy should be initiated and monitored under a
physician experienced in the
treatment of immunodeficiency.
POSOLOGY
The dose and dosage regimen are dependent on the indication.
In replacement therapy the dosage may need to be individualised for
each patient depending on
the pharmacokinetic and clinical response. The following dosage
regimens are given as a
guideline.
Replacement therapy in