PRIVIGEN normal immunoglobulin (human) 40g (100g/L, 10%) solution for intravenous infusion
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
07-07-2021
Summary of Product characteristics
(SPC)
07-07-2021
Public Assessment Report
(PAR)
18-10-2017
Active ingredient:
normal immunoglobulin, Quantity: 40 g
Available from:
CSL Behring Australia Pty Ltd
INN (International Name):
normal immunoglobulin
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: water for injections; proline
Administration route:
Intravenous
Units in package:
40 g: 400 mL solution in a 400 mL bottle
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Replacement therapy for Primary immunodeficiency diseases (PID), Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. Immunomodulatory therapy for Idiopathic thrombocytopenic purpura (ITP) in patients at high risk of bleeding or prior to surgery to correct the platelet count, Guillain-Barr Syndrome (GBS), Kawasaki disease, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Multifocal Motor Neuropathy (MMN), Myasthenia Gravis (MG) exacerbations, Lambert-Eaton Myasthenic Syndrome (LEMS), Stiff Person Syndrome (SPS).
Product summary:
Visual Identification: Clear or slightly opalescent and colourless or pale yellow solution; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-06-17
Patient Information leaflet
Privigen AU CMI 12.00
Page 1 of 5
PRIVIGEN
®
Normal immunoglobulin (Human) 10% (100 g/L), intravenous infusion.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet contains answers to
some common questions about
Privigen
®
. It does not contain all
the available information about
Privigen
®
. It does not take the
place of talking to your doctor
or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of giving you
Privigen
®
against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,_ _ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may want to read it again.
WHAT PRIVIGEN
® IS
USED FOR
Your medicine is Privigen
®
.
Privigen
®
is a ready-to-use
solution for intravenous
infusion. Privigen
®
contains
human immunoglobulins.
Immunoglobulins are also called
antibodies and are a type of
protein found in the blood.
Immunoglobulins are produced
by your body’s immune system
to fight infections caused by
bacteria and viruses. If you do
not have enough antibodies you
may not be able to fight off
diseases.
Your doctor may give you
Privigen
®
either for:
•
the replacement of
antibodies because your
antibody levels are low
(referred to as
immunodeficiency), or
•
a condition where there is
an imbalance in your
immune system requiring
treatment with
immunoglobulins (referred
to as immunomodulation).
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
This medicine is available only
with a doctor’s prescription.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
PRIVIGEN
®
MAKE SURE YOU TELL YOUR
DOCTOR OF ANY REASONS YOU
KNOW OF WHY YOU SHOULD NOT
BE GIVEN THIS MEDICINE.
INFORM YOUR DOCTOR OF YOUR
BLOOD GROUP, IF KNOWN.
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE:
•
a history of allergy to
human immunoglobulin
products (allergic reactions
may include skin rash, face
swelling, wheezing or
breathing difficulties) or
previously been told you
react to any of the
ingre
Read the complete document
Summary of Product characteristics
Privigen AU PI 23.00
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
PRIVIGEN
®
(HUMAN NORMAL IMMUNOGLOBULIN) – SOLUTION FOR INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Human Normal Immunoglobulin
2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Privigen
®
is a sterile, clear or slightly opalescent, colourless or pale yellow
solution of human
normal immunoglobulin for intravenous infusion.
Privigen
®
is a 10% solution containing 100 mg/mL of total human plasma protein
with a
purity of at least 98% immunoglobulin G (IgG). More than 90% of the
IgG consists of
monomers and dimers, aggregates (≤2%–typically below 0.1%) and
albumin (≤3%). The
distribution of the IgG subclasses is similar to that of normal human
plasma (approximate
values: 69% IgG
1
, 26% IgG
2
, 3% IgG
3
, 2% IgG
4
).
Privigen
®
has a nominal osmolality of 320 mOsm/kg and is approximately isotonic.
The pH
value of the ready-to-use solution is 4.6–5.0. The product contains
250 mmol/L of L-proline
as a stabiliser which is a physiological non-essential amino acid.
Privigen
®
contains no
carbohydrate stabiliser (e.g. sucrose, maltose) and no preservative,
and it has a low sodium
content of ≤1 mmol/L.
The maximum IgA content is 0.025 mg/mL. Prekallikrein activator (PKA)
levels are less than
10 IU/mL.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
REPLACEMENT THERAPY
•
Primary Immunodeficiency Diseases (PID).
•
Myeloma or chronic lymphocytic leukaemia with severe secondary
hypogammaglobulinaemia and recurrent infections.
•
Symptomatic hypogammaglobulinaemia secondary to underlying disease or
treatment.
Privigen AU PI 23.00
Page 2 of 20
IMMUNOMODULATORY THERAPY
•
Idiopathic Thrombocytopenic Purpura (ITP) in patients at high risk of
bleeding or prior to
surgery to correct the platelet count.
•
Guillain-Barré Syndrome (GBS).
•
Kawasaki disease.
•
Chronic Inflammatory
Demyelinating Polyneuropathy (CIDP).
•
Multifocal Motor Neuropathy (MMN).
•
Myasthenia Gravis (MG) exacerbations.
•
Lambert-Eaton Mya
Read the complete document
