FLEBOGAMMA 5% DIF Human normal immunoglobulin 0.5g/10mL intravenous use injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

normal immunoglobulin, Quantity: 50 mg/mL

Available from:

Grifols Australia Pty Ltd

INN (International Name):

normal immunoglobulin

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: human immunoglobulin A; water for injections; sorbitol

Administration route:

Intravenous

Units in package:

1 X 10mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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; and children with congenital AIDS and recurrent infections. Immunomodulation: Idiopathic thrombocytopenia purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count, Guillian Barre syndrome. Allogenic bone marrow transplantation.

Product summary:

Visual Identification: Clear or slightly opalescent, colourless or pale yellow solution; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-12-23

Patient Information leaflet

1
CONSUMER MEDICINE INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1. What Flebogamma 5% DIF is and what it is used for
2. Before you use Flebogamma 5% DIF
3. How to use Flebogamma 5% DIF
4. Possible side effects
5. How to store Flebogamma 5% DIF
6. Further information
1. WHAT FLEBOGAMMA 5% DIF IS AND WHAT IT IS USED FOR
Flebogamma 5% DIF is a solution for intravenous infusion containing 50
g/l human normal
immunoglobulin.
This medicine belongs to the pharmacotherapeutic group called immune
sera and
immunoglobulins.
Flebogamma 5% DIF is used for:
Treatment of patients who do not have sufficient antibodies
(replacement therapy):
•
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.
Treatment of patients with certain inflammatory disorders
(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.
Treatment or prevention of infections after a bone marrow
transplantation (allogeneic bone
marrow transplantation).
2
If you have any question about use of Flebogamma 5% DIF please ask
your doctor.
2. BEFORE YOU USE FLEBOGAMMA 5% DIF DO NOT USE FLEBOGAMMA 5% DIF
-
if you are allergic (hypersensitive) to human n

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
FLEBOGAMMA 5% DIF (HUMAN NORMAL IMMUNOGLOBULIN (IVIG)
50 MG/ML) SOLUTION FOR INFUSION
1
NAME OF THE MEDICINE
Human normal immunoglobulin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Flebogamma 5% DIF (dual
_ _
inactivation plus nanofiltration) (IVIg) is a sterile, liquid ready to
use,
preparation of
highly
purified
immunoglobulin
(IgG)
obtained
from
human
plasma
pools.
The
purification
process
includes
cold
alcohol
fractionation,
polyethylene
glycol
precipitation,
ion
exchange chromatography, low pH treatment, pasteurisation, solvent
detergent treatment and two
sequential nanofiltrations through 35 nm and 20 nm pore size
nanofilters connected in series.
Flebogamma 5% DIF is a highly purified (≥ 97% IgG), unmodified,
human IgG that contains the
antibody specificities found in the donor population. IgG subclasses
are fully represented with the
following approximate percents of total IgG: IgG
1
is 66.6%, IgG
2
, 28.5%, IgG
3
, 2.7%, and IgG
4
, 2.2%.
Flebogamma 5% DIF contains only trace amounts of IgA (lower than 0.05
mg/ml).
In the final formulation, Flebogamma 5% DIF contains 5 g human normal
immunoglobulin and 5 g
sorbitol (as stabiliser) in 100 ml of water for injections. There is
no preservative in the formulation.
The Fc and Fab functions are maintained in Flebogamma 5% DIF.
3
PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear or slightly opalescent and colourless or pale
yellow.
The pH of the solution ranges from 5 to 6 and the osmolality from 250
to 350 mOsm/kg, which is
within the normal physiologic range.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
2
Myeloma or chronic lymphocytic leukaemia with severe secondary
hypogammaglobulinaemia and
recurrent infections.
Children with congenital AIDS and r