FLEBOGAMMA DIF SOLUTION FOR INFUSION 5%

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:

50 mg/ml

Pharmaceutical form:

INFUSION, SOLUTION

Composition:

HUMAN NORMAL IMMUNOGLOBULIN 50 mg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

INSTITUTO GRIFOLS, S.A.

Authorization status:

ACTIVE

Authorization date:

2011-05-20

Patient Information leaflet

Human normal immunoglobulin (IVIg)
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 50 mg of human normal immunoglobulin (IVIg) of which at least 97% is IgG.
The  percentage  of  IgG  subclasses  is  approximately  66.6%  IgG
1
,  28.5%  IgG
2
,  2.7%  IgG
3
  and 
2.2% IgG
4
. It contains trace amounts of IgA (lower than 0.05 mg/ml).
Excipient:
One ml contains 50 mg of D-sorbitol.
For a 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.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Flebogamma
®
 5% DIF is indicated for:
Replacement therapy in:
Primary immunodeficiency syndromes such as:
-  congenital agammaglobulinaemia and hypogammaglobulinaemia
-  common variable immunodeficiency
-  severe combined immunodeficiency
-  Wiskott Aldrich syndrome
Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and 
recurrent infections.
Children with congenital AIDS and recurrent infections.
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
Posology
The dose and dosage regimen is dependent on the indication.
In replacement therapy the dosage may need to be individualised for each patient dependent 
on  the  pharmacokinetic  and  clinical  response.  The  following  dosage  regimens  are  given  as  a 
guideline.
Replacement therapy in primary immunodeficiency syndromes
The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of 
at least 4 - 6 g/l. Three to 

Summary of Product characteristics

Human normal immunoglobulin (IVIg)
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 50 mg of human normal immunoglobulin (IVIg) of which
at least 97% is IgG.
The percentage of IgG subclasses is approximately 66.6% IgG
1
, 28.5% IgG
2
, 2.7% IgG
3
and
2.2% IgG
4
. It contains trace amounts of IgA (lower than 0.05 mg/ml).
Excipient
:
One ml contains 50 mg of D-sorbitol.
For a 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.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Flebogamma
®
5% DIF is indicated for:
Replacement therapy in:
Primary immunodeficiency syndromes such as:
-
congenital agammaglobulinaemia and hypogammaglobulinaemia
-
common variable immunodeficiency
-
severe combined immunodeficiency
-
Wiskott Aldrich syndrome
Myeloma or chronic lymphocytic leukaemia with severe secondary
hypogammaglobulinaemia and
recurrent infections.
Children with congenital AIDS and recurrent infections.
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
Posology
The dose and dosage regimen is dependent on the indication.
In replacement therapy the dosage may need to be individualised for
each patient dependent
on the pharmacokinetic and clinical response. The following dosage
regimens are given as a
guideline.
Replacement therapy in primary immunodeficiency syndromes
The dosage regimen should achieve a trough level of IgG (measured
before the next infusion) of
at least 4 - 6 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
three weeks.
The dose required to achieve a trough level of 6 g/l is of the order
of 0.2 - 0.8 g/kg/month. The
dosag