OCTAGAM SOLUTION FOR INFUSION 50 mgml

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

IMMUNOGLOBULIN (HUMAN) (NORMAL)

Disponibil de la:

WELLCHEM PHARMACEUTICALS PTE LTD

Codul ATC:

J06BA02

Dozare:

50 mg/ml

Forma farmaceutică:

INJECTION

Compoziție:

IMMUNOGLOBULIN (HUMAN) (NORMAL) 50 mg/ml

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

Prescription Only

Produs de:

OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES MBH

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

1999-04-06

Prospect

INSTRUCTIONS FOR USE
(Summary of Product Characteristics)
1     NAME OF THE MEDICINAL PRODUCT
OCTAGAM® 
2    QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1   ACTIVE INGREDIENTS
Human normal immunoglobulin (IVIg)
2.2   QUANTITATIVE COMPOSITION:
1 ml solution contains:
Protein 50 
mg
of which ≥ 95% is human Immunoglobulin G
IgA 
≤ 0.2 mg
Distribution of IgG subclasses:
IgG
1

ca. 60 %
IgG
2

ca. 32 %
IgG
3

ca.   7 %
IgG
4

ca.   1 %
For a full list of excipients, see section 6.1.
3  PHARMACEUTICAL 
FORM
Solution for infusion
4  CLINICAL 
PARTICULARS
4.1   THERAPEUTIC INDICATIONS
_4.1.1  Replacement therapy in:_
•  Primary immunodefi ciency syndromes such as:

- congenital agammaglobulinaemia and hypogammaglobulinaemia

- common variable immunodefi ciency

- severe combined immunodefi ciency

- Wiskott Aldrich syndrome
•  Myeloma or chronic lymphatic leukaemia with severe secondary
hypogammaglobulinaemia and recurrent infections
•  Children with congenital AIDS and recurrent infections.
_4.1.2 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
_4.1.3  Allogeneic bone marrow transplantation_
4.2   POSOLOGY AND METHOD OF ADMINISTRATION
_4.2.1 Posology_
The dose and dosage regimen is dependant on the indication.
In replacement therapy the dosage may need to be individualised for
each patient dependant on the pharmacokinetic and 
clinical response.
The following dosage regimens are given as a guideline:
Replacement therapy in primary immunodefi ciency syndromes:
•  The dosage regimen should achieve a trough level of IgG
(measured before the next infusion) of at least 4.0 – 6.0 g/l. 
Three to six months are required after the initiation of therapy for
equilibration to occur. The recommended starting dose 
    is 0.4 - 0.8 g/kg, followed by at least 0.2 g/kg every

Caracteristicilor produsului

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INSTRUCTIONS FOR USE
(Summary of Product Characteristics)
1
NAME OF THE MEDICINAL PRODUCT
OCTAGAM®
50 mg/ml solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)
One ml contains:
Human normal immunoglobulin* 50 mg
*
corresponding
to
the
total
protein
content
of
which
at
least
95%
is
human
Immunoglobulin G
Distribution of IgG subclasses:
IgG
1
ca. 60 %
IgG
2
ca. 32 %
IgG
3
ca. 7 %
IgG
4
ca. 1 %
Maximum IgA content: 200 micrograms/ml
Each vial of 20 ml contains 1g of human normal immunoglobulin.
Each bottle of 50 ml contains 2.5g of human normal immunoglobulin.
Each bottle of 100 ml contains 5g of human normal immunoglobulin.
Each bottle of 200 ml contains 10g of human normal immunoglobulin.
Produced from plasma of human donors.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL 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 PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_4.1.1_
_ _
_Replacement therapy in: _
•
Primary immunodeficiency syndromes such as:
- congenital agammaglobulinaemia and hypogammaglobulinaemia
- common variable immunodeficiency
- severe combined immunodeficiency
- Wiskott Aldrich syndrome
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_ _
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_ _
•
Myeloma or chronic lymphatic leukaemia with severe secondary
hypogammaglobulinaemia and recurrent infections
•
Children with congenital AIDS and recurrent infections.
_4.1.2_
_ _
_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
_4.1.3_
_ _
_Allogeneic bone marrow transplantation _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_4.2.1_
_ _
_Posology _
The dose and dosage regimen is dependant on the indication.
In
replacement
therapy
the
do