Flebogamma DIF (previously Flebogammadif)

Nchi: Umoja wa Ulaya

Lugha: Kiingereza

Chanzo: EMA (European Medicines Agency)

Viambatanisho vya kazi:

Human normal immunoglobulin

Inapatikana kutoka:

Instituto Grifols S.A.

ATC kanuni:

J06BA02

INN (Jina la Kimataifa):

human normal immunoglobulin

Kundi la matibabu:

Immune sera and immunoglobulins,

Eneo la matibabu:

Mucocutaneous Lymph Node Syndrome; Guillain-Barre Syndrome; Bone Marrow Transplantation; Purpura, Thrombocytopenic, Idiopathic; Immunologic Deficiency Syndromes

Matibabu dalili:

Replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, 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);, congenital AIDS with recurrent bacterial infections. , Immunomodulation in adults, 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.

Bidhaa muhtasari:

Revision: 19

Idhini hali ya:

Authorised

Idhini ya tarehe:

2007-07-23

Taarifa za kipeperushi

- 49 -
B. PACKAGE LEAFLET
- 50 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLEBOGAMMA DIF 50 MG/ML SOLUTION FOR INFUSION
Human normal immunoglobulin (IVIg)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Flebogamma DIF is and what it is used for
2.
What you need to know before you use Flebogamma DIF
3.
How to use Flebogamma DIF
4.
Possible side effects
5.
How to store Flebogamma DIF
6.
Contents of the pack and other information
1.
WHAT FLEBOGAMMA DIF IS AND WHAT IT IS USED FOR
WHAT FLEBOGAMMA DIF IS
Flebogamma DIF contains human normal immunoglobulin, highly purified
protein extracted from
human plasma (part of the blood of donors). This medicine belongs to
the group of medicines called
intravenous immunoglobulins. These are used to treat conditions where
the body’s defence system
against disease is not working properly.
WHAT FLEBOGAMMA DIF IS USED FOR
Treatment of adults, children and adolescents (2 - 18 years) who do
not have sufficient antibodies
(Flebogamma DIF is used as replacement therapy). There are two groups:
•
Patients with Primary Immunodeficiency Syndromes (PID), an inborn lack
of antibodies
(group 1)
•
Patients with Secondary Immunodeficiency Syndromes (SID) with severe
or recurrent
infections, ineffective antimicrobial treatment and either PROVEN
SPECIFIC ANTIBODY FAILURE
(PSAF)* or serum IgG level of <4 g/l (group 2)
*PSAF= failure to mount at least a 2-fold rise in IgG antibody titre
to pneumococcal polysaccharide
and polypeptide antigen vaccines.
Treatment o

Tabia za bidhaa

- 1 -
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
- 2 -
1.
NAME OF THE MEDICINAL PRODUCT
Flebogamma DIF 50 mg/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)
One ml contains:
Human normal immunoglobulin ……….. 50 mg
(purity of at least 97% of IgG)
Each vial of 10 ml contains: 0.5 g of human normal immunoglobulin
Each vial of 50 ml contains: 2.5 g of human normal immunoglobulin
Each vial of 100 ml contains: 5 g of human normal immunoglobulin
Each vial of 200 ml contains: 10 g of human normal immunoglobulin
Each vial of 400 ml contains: 20 g of human normal immunoglobulin
Distribution of the IgG subclasses (approx. values):
IgG
1
66.6%
IgG
2
28.5%
IgG
3
2.7%
IgG
4
2.2%
Minimum level anti-measles IgG is 4.5 IU/ml.
The maximum IgA content is 50 micrograms/ml.
Produced from the plasma of human donors.
Excipient with known effect:
One ml contains 50 mg of D-sorbitol.
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 or pale
yellow.
Flebogamma DIF is isotonic, with an osmolality from 240 to 370
mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Replacement therapy in adults, children and adolescents (2 - 18 years)
in:
-
Primary immunodeficiency syndromes (PID) with impaired antibody
production
-
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
- 3 -
*PSAF= failure to mount at least a 2-fold rise in IgG antibody titre
to pneumococcal polysaccharide
and polypeptide antigen vaccines
Measles pre-/post exposure prophylaxis for susceptible adults,
children and adolescents (2 - 18 years)
in whom active immunisation is contraindicated or not advised.
Consideration should also be given to official recommendations on
intravenous human
immunoglobulin use in measles pre-/post exposure prophylaxis an