INTRAGAM 10 normal immunoglobulin (human) 10g/100mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

normal immunoglobulin, Quantity: 10 g

Available from:

CSL Behring Australia Pty Ltd

INN (International Name):

normal immunoglobulin

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; glycine

Administration route:

Intravenous

Units in package:

100mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Intragam? 10 is indicated for replacement IgG therapy in: ?Primary Immunodeficiency Diseases (PID) ?Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. Intragam? 10 is indicated for immunomodulatory therapy in: ?Idiopathic Thrombocytopenic Purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count ?Kawasaki disease ?Guillain-Barre Syndrome (GBS) ?Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) ?Multifocal Motor Neuropathy (MMN) ?Myasthenia Gravis (MG) in acute exacerbation (myasthenic crisis) or prior to surgery and/or thymectomy; as maintenance therapy for moderate to severe MG when other treatments have been ineffective or caused intolerable side effects ?Short-term therapy for severely affected nonparaneoplastic Lambert-Eaton Myasthenic Syndrome (LEMS) patients ?Treatment of significant functional impairment in patients who have a verified diagnosis of stiff person syndrome.

Product summary:

Visual Identification: Clear or slightly opalescent, colourless to pale yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-04-01

Patient Information leaflet

Intragam 10 AU CMI 12.00
Page 1 of 5
INTRAGAM
® 10
Human Normal Immunoglobulin 10% (10 g/100 mL), solution for
intravenous infusion.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Intragam
®
10. It does not take
the place of talking to your
doctor. It does not contain all
the available information about
Intragam
®
10.
All medicines have risks and
benefits. Your doctor has
weighed the benefits of you
receiving Intragam
®
10 against
the possible risks.
IF YOU HAVE ANY CONCERNS
ABOUT RECEIVING THIS MEDICINE,_ _
ASK YOUR DOCTOR. FOLLOW YOUR
DOCTOR’S ADVICE EVEN IF IT IS
DIFFERENT FROM WHAT THIS LEAFLET
SAYS.
PLEASE READ THIS LEAFLET
CAREFULLY AND KEEP IT AS YOU
MAY NEED TO READ IT AGAIN.
The information in this leaflet is
subject to change. Please check
with your doctor whether there
is any new information about
this medicine that you should
know since you were last
treated.
WHAT INTRAGAM
® 10 IS
USED FOR
Your medicine is Intragam
®
10,
a solution for intravenous
infusion. Intragam
®
10 contains
human immunoglobulins and is
manufactured from human
plasma (the liquid component of
blood) collected by Australian
Red Cross Lifeblood.
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
Intragam
®
10 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 antibodies
(referred to as
immunomodulation).
Your doctor may have
prescribed Intragam
®
10 for
another reason. Ask your doctor
if you have any questions about
why Intragam
®
10 has been
prescribed for you.
BEFORE YOU ARE GIVEN
INTRAGAM
® 10
MAKE SURE YOU TELL YOUR
DOCTOR OF ANY REASONS YOU
KNOW OF WHY

Summary of Product characteristics

Intragam 10 AU PI 12.00
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
INTRAGAM
® 10
(HUMAN NORMAL IMMUNOGLOBULIN)
1
NAME OF THE MEDICINE
Human Normal Immunoglobulin
2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Intragam
®
10 is a sterile, preservative free, clear or slightly opalescent and
colourless or pale
yellow solution for intravenous infusion. Intragam
®
10 contains 10% (10 g/100 mL) of
human plasma protein with a purity of at least 98% immunoglobulin G
(IgG). At least 90% of
the IgG consists of monomers and dimers (typically >96%). Aggregates
are <3%. The
distribution of the IgG subclasses closely resembles that found in
normal human plasma
(approximate mean ranges: 47.6–56.2% IgG
1
, 41.5–49.5% IgG
2
, 1.3–1.6% IgG
3
, 0.9–
1.3% IgG
4
).
Intragam
®
10 has a nominal osmolality of 350 mOsmol/kg and is approximately
isotonic. The
pH value of the ready-to-use solution is 4.25 (4.05–4.45). Intragam
®
10 contains 2.25 g of
glycine in each 100 mL as a stabiliser which is a physiological
non-essential amino acid.
Intragam
®
10 does not contain a carbohydrate stabiliser (e.g. sucrose, maltose)
and contains
no preservative. Intragam
®
10 contains only trace amounts of IgA, typically <0.025 mg/mL.
The maximum prekallikrein activator (PKA) levels are less than 28.6
IU/mL
(typically ≤1.2 IU/mL).
Intragam
®
10 is manufactured from human plasma collected by Australian Red Cross
Lifeblood.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Intragam
®
10 is indicated for replacement IgG therapy in:
•
Primary Immunodeficiency Diseases (PID)
•
Symptomatic hypogammaglobulinaemia secondary to underlying disease or
treatment.
Intragam 10 AU PI 12.00
Page 2 of 17
Intragam
®
10 is indicated for immunomodulatory therapy in:
•
Idiopathic Thrombocytopenic Purpura (ITP), in adults or children at
high risk of bleeding
or prior to surgery to correct the platelet count
•
Kawasaki disease
•
Guillain-Barré Syndrome (GBS)
•
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP