FLEBOGAMMA DIF SOLUTION FOR INFUSION 10%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Human Normal Immunoglobulin

Available from:

GRIFOLS ASIA PACIFIC PTE. LTD.

ATC code:

J06BA02

Dosage:

100mg/ml

Pharmaceutical form:

INFUSION, SOLUTION

Composition:

Human Normal Immunoglobulin 100mg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

INSTITUTO GRIFOLS, S.A.

Authorization status:

ACTIVE

Authorization date:

2012-06-14

Patient Information leaflet

QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)
One ml contains:
Human normal immunoglobulin  100 mg
(purity of at least 97% IgG)
One vial of 50 ml contains: 5 g of human normal immunoglobulin
One vial of 100 ml contains: 10 g of human normal immunoglobulin
One vial of 200 ml contains: 20 g of human normal immunoglobulin
Distribution of the IgG subclasses (approx. values):
IgG
1
 66.6%
IgG
2
 27.9%
IgG
3
 3.0%
IgG
4
 2.5%
The maximum IgA content is 100 micrograms/ml.
Produced from the plasma of human donors.
_Excipients with known effect:_
One ml contains 50 mg of D-Sorbitol.
For the full list of excipients, see section “List of excipients”.
PHARMACEUTICAL FORM
Solution for infusion
The solution is clear or slightly opalescent and colourless or pale
yellow.
Flebogamma
®
 10% DIF is isotonic, with an osmolality from 240 to 370 mOsm/kg. 
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Replacement therapy in adults, children and adolescents (2-18 years)
in:
-  Primary immunodeficiency syndromes with impaired antibody
production.
- Hypogammaglobulinaemia and recurrent bacterial infections in
patients with 
chronic lymphocytic leukaemia, in whom prophylactic antibiotics have
failed.
-  Hypogammaglobulinaemia and recurrent bacterial infections in
plateau phase 
multiple myeloma patients who failed to respond to pneumococcal
immunisation.
-  Hypogammaglobulinaemia in patients after allogenic
haematopoietic stem cell 
transplantation (HSCT).
Replacement therapy in children and adolescents (2-18 years) in:
-  Congenital AIDS with recurrent bacterial infections.
Immunomodulation in adults, children and adolescents (2-18 years) in:
-  Idiopathic Thrombocytopenic Purpura (ITP), in patients at high
risk of bleeding or 
prior to surgery to correct the platelet count.
-  Guillain Barré syndrome.
-  Kawasaki disease.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose and posology is dependent on the indication.
In replacement therapy the dose may need to
be 

Summary of Product characteristics

QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)
One ml contains:
Human normal immunoglobulin
100 mg
(purity of at least 97% IgG)
One vial of 50 ml contains: 5 g of human normal immunoglobulin
One vial of 100 ml contains: 10 g of human normal immunoglobulin
One vial of 200 ml contains: 20 g of human normal immunoglobulin
Distribution of the IgG subclasses (approx. values):
IgG
1
66.6%
IgG
2
27.9%
IgG
3
3.0%
IgG
4
2.5%
The maximum IgA content is 100 micrograms/ml.
Produced from the plasma of human donors.
_Excipients with known effect:_
One ml contains 50 mg of D-Sorbitol.
For the full list of excipients, see section “List of excipients”.
PHARMACEUTICAL FORM
Solution for infusion
The solution is clear or slightly opalescent and colourless or pale
yellow.
Flebogamma
®
10% DIF is isotonic, with an osmolality from 240 to 370 mOsm/kg.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Replacement therapy in adults, children and adolescents (2-18 years)
in:
-
Primary immunodeficiency syndromes with impaired antibody production.
-
Hypogammaglobulinaemia
and
recurrent
bacterial
infections
in
patients
with
chronic lymphocytic leukaemia, in whom prophylactic antibiotics have
failed.
-
Hypogammaglobulinaemia and recurrent bacterial infections in plateau
phase
multiple myeloma patients who failed to respond to pneumococcal
immunisation.
-
Hypogammaglobulinaemia in patients after allogenic haematopoietic stem
cell
transplantation (HSCT).
Replacement therapy in children and adolescents (2-18 years) in:
-
Congenital AIDS with recurrent bacterial infections.
Immunomodulation in adults, children and adolescents (2-18 years) in:
-
Idiopathic Thrombocytopenic Purpura (ITP), in patients at high risk of
bleeding or
prior to surgery to correct the platelet count.
-
Guillain Barré syndrome.
-
Kawasaki disease.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose and posology is dependent on the indication.
In replacement therapy the dose may need to be individualised for each
patient
dependent on the pharm