GAMUNEX normal immunoglobulin (Human) 1g/10mL intravenous solution vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

normal immunoglobulin, Quantity: 10 mg/mL

Available from:

Grifols Australia Pty Ltd

INN (International Name):

normal immunoglobulin

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients: glycine; water for injections

Administration route:

Intravenous, Subcutaneous

Units in package:

1 X 10mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Replacement therapy in: - Primary Immunodeficiency (PI) Diseases; - Symptomatic Hypogammaglobulinaemia secondary to underlying disease or treatment. Immunomodulation in: - Idiopathic Thrombocytopaenic Purpura (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - Guillain Barr? Syndrome (GBS); - Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); - Kawasaki disease.

Product summary:

Visual Identification: Clear liquid, colourless to pale yellow.; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2006-05-05

Patient Information leaflet

GAMUNEX
®
1
CONSUMER MEDICINE INFORMATION
GAMUNEX
®
Normal Immunoglobulin (Human), 10% for Intravenous or Subcutaneous
Administration
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about GAMUNEX
®
. It does not contain all the
available information. 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 you receiving
GAMUNEX
®
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT RECEIVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT GAMUNEX
®
IS USED FOR
GAMUNEX
®
is used to replace antibodies (used to fight infections) in people
with
conditions that impair the body’s ability to make antibodies. These
conditions include:

Primary Immunodeficiency Diseases.

Symptomatic Hypogammaglobulinaemia secondary to underlying disease or
treatment.
GAMUNEX
®
is also used to modulate the immune system in people whose immune
systems
are not working well. These conditions include

Idiopathic Thrombocytopaenic Purpura (ITP), in patients at high risk
of bleeding or
prior to surgery to correct the platelet count.
People with ITP have antibodies that do not work properly and may need
treatment
with GAMUNEX
®
to raise
blood platelet counts to prevent bleeding or prior to
undergoing surgery.

Guillain Barré Syndrome (GBS).

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

Kawasaki disease.
This medicine belongs to a group of medicines called immunoglobulins.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it for another reason.
GAMUNEX
®
2
BEFORE YOU RECEIVE GAMUNEX
®
_WHEN YOU MUST NOT RECEIVE IT_
YOU SHOULD NOT RECEIVE GAMUNEX
®
IF:

you have an allergy to immunoglobulin or any of the ingredients listed
at the end of this
leaflet.

you have severe immunoglobulin A (IgA) deficiency (which may also
cause a severe
a

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
GAMUNEX
®
(NORMAL IMMUNOGLOBULIN (HUMAN), 10%, INTRAVENOUS
SOLUTION VIAL)
1
NAME OF THE MEDICINE
Normal immunoglobulin (Human), 10%, for Intravenous or Subcutaneous
Administration
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
GAMUNEX
®
Normal immunoglobulin (Human), 10%, Solution for Intravenous or
Subcutaneous
Administration.
One mL contains:
Normal immunoglobulin (Human)
...............................................................................100
mg
(purity of at least 98% IgG)
Each vial of 10 mL contains: 1 g of human normal immunoglobulin
Each vial of 25 mL contains: 2.5 g of human normal immunoglobulin
Each vial of 50 mL contains: 5 g of human normal immunoglobulin
Each vial of 100 mL contains: 10 g of human normal immunoglobulin
Each vial of 200 mL contains: 20 g of human normal immunoglobulin
Each vial of 400 mL contains: 40 g of human normal immunoglobulin
Distribution of the IgG subclasses (average values):
IgG
1
.................... 62.8%
IgG
2
.................... 29.7%
IgG
3
...................... 4.8%
IgG
4
...................... 2.7%
The maximum IgA content is 84 micrograms/mL.
Produced from plasma of human donors.
For a full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Dosage form: Injection
The solution is clear to opalescent, colourless to pale yellow.
2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
REPLACEMENT THERAPY IN:
- Primary Immunodeficiency (PI) Diseases.
- Symptomatic Hypogammaglobulinaemia secondary to underlying disease
or treatment.
IMMUNOMODULATION IN:
- Idiopathic Thrombocytopaenic Purpura (ITP), in patients at high risk
of bleeding or prior to
surgery to correct the platelet count.
- Guillain Barré Syndrome (GBS).
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
- Kawasaki disease.
4.2
D
OSE AND METHOD OF ADMINISTRATION
GAMUNEX
®
is recommended for administration by intravenous infusion for all
indications.
GAMUNEX
®
can also be administered by subcutaneous infusion for replacement
therapy i