FLEBOGAMMA 10% DIF normal immunoglobulin (Human) intravenous use injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

normal immunoglobulin, Quantity: 5 g

Available from:

Grifols Australia Pty Ltd

INN (International Name):

normal immunoglobulin

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous

Units in package:

5 g/50 mL - single vial pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Replacement therapy indications: - Primary Immunodeficiency (PI) Diseases - Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,Immunomodulation indications: - Idiopathic Thrombocytopaenic Purpura (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count. - Guillain Barr? syndrome - Kawasaki disease.

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:

2013-02-12

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 10% DIF is and what it is used for
2. Before you use Flebogamma 10% DIF
3. How to use Flebogamma 10% DIF
4. Possible side effects
5. How to store Flebogamma 10% DIF
6. Further information
1. WHAT FLEBOGAMMA 10% DIF IS AND WHAT IT IS USED FOR
WHAT FLEBOGAMMA 10% DIF IS
Flebogamma 10% DIF is a solution for intravenous infusion containing
100 g/l human normal
immunoglobulin.
Flebogamma 10% DIF is one of 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 10% DIF IS USED FOR
Treatment of patients who do not have sufficient antibodies
(replacement therapy):
•
Primary Immunodeficiency (PI) Diseases
•
Symptomatic hypogammaglobulinaemia secondary to underlying disease or
treatment.
Treatment of patients with certain inflammatory disorders
(immunomodulation):
•
Idiopathic Thrombocytopaenic Purpura (ITP), in children or adults at
high risk of
bleeding or prior to surgery to correct the platelet count.
•
Guillain Barré syndrome.
•
It is used to treat Kawasaki disease, an illness in children where the
blood vessels
(arteries) in the body become enlarged.
If you have any question about use of Flebogamma 10% DIF please ask
your doctor.
2
2. BEFORE YOU USE FLEBOGAMMA 10% DIF
DO NOT USE FLEBOGAMMA 10% DIF
-
If you are allergic (hypersensitive) to human normal immunoglobulin or
any of the other
ingredients of Flebogamma 10% DIF (see special warnin

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
FLEBOGAMMA 10% DIF (HUMAN NORMAL IMMUNOGLOBULIN (IVIG)
100 MG/ML) SOLUTION FOR INFUSION
1
NAME OF THE MEDICINE
Human normal immunoglobulin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Flebogamma 10% 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 10% 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
, 27.9%, IgG
3
, 3.0%, and IgG
4
, 2.5%.
Flebogamma 10% DIF contains only trace amounts of IgA (lower than 100
micrograms/ml).
In the final formulation, Flebogamma 10% DIF contains 10 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 10% 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
Replacement therapy indications:
•
Primary Immunodeficiency (PI) Diseases
•
Symptomatic hypogammaglobulinaemia secondary to underlying disease or
treatment.
2
Immunomodulation indications:
•
Idiopathic Thrombocytopaenic Purpura (ITP), in patients at high risk
of bleeding or prior to
surgery to correct the platelet count.
•
Guillain Barré syndrome.
•
Kawasaki disease.
4.2
D
OSE AND