OCTAGAM normal immunoglobulin (human) 10g/100mL solution for intravenous infusion

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

human immunoglobulin G, Quantity: 100 mg/mL

Tilgjengelig fra:

Octapharma Australia Pty Ltd

INN (International Name):

human immunoglobulin G

Legemiddelform:

Injection

Sammensetning:

Excipient Ingredients: maltose; octoxinol 10; tributyl phosphate; water for injections; human immunoglobulin A

Administreringsrute:

Intravenous

Enheter i pakken:

100 mL in 100mL bottle

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Replacement therapy in: Primary immunodeficiency syndromes: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiencies; Wiskott Aldrich syndrome; Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. Children with congenital Acquired Immune Deficiency Syndrome (AIDS) who have repeated bacterial infections; Immunomodulation: Idiopathic thrombocytopenic purpura, in adults or children with a high risk of bleeding or prior to surgery to correct platelet count. Guillain Barre syndrome. Kawasaki disease. Allogeneic bone marrow transplantation.

Produkt oppsummering:

Visual Identification: Clear or slightly opalescent solution.; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Restricted flow insert

Autorisasjon status:

Licence status A

Autorisasjon dato:

2009-11-30

Informasjon til brukeren

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OCTAGAM
®
10%
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine,
speak to your doctor or pharmacist.
1.
WHY AM I USING OCTAGAM
®
10%?
Octagam
®
10% contains the active ingredient human normal immunoglobulin.
Octagam
®
10%
is used in patients who do not have enough antibodies (proteins that
help the body fight
infection) in their blood.
For more information, see section 1. Why am I using octagam
®
10%? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE OCTAGAM
®
10%?
Do not use if you have ever had an allergic reaction to any human
normal immunoglobulin or
to any ingredients listed at the end of the CMI.
Do not use if you have antibodies to human immunoglobulin A in your
blood – this may occur
if you have human immunoglobulin A deficiency.
There are a number of circumstance in which people may need to use
caution when using
this medicine. It is important to understand if these apply to you
before taking octagam
®
10%
(see Section 2. What should I know before I use octagam
®
10%? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with OCTAGAM
®
10% and effect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE OCTAGAM® 10%?
Your doctor will administer octagam
®
10% as a slow injection (infusion) into a vein.
For more information, see Section 4. How do I use octagam
®
10%? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OCTAGAM® 10%?
THINGS YOU
SHOULD DO

Tell your doctor if you become pregnant

Tell your doctor if you are to have any blood glucose tests

Tell your doctor if you are to receive a vaccine

Remind your doctor/pharmacist that you are on octagam
®
10%? before
starting any new medicines
For more information, see Section 5. What should I know while using
octagam® 10%? in the
full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
All medicines can have side effects allthough not everybo

Preparatomtale

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AUSTRALIAN PRODUCT INFORMATION - OCTAGAM
® 10% (HUMAN
NORMAL IMMUNOGLOBULIN, 100 MG/ML, SOLUTION FOR
INTRAVENOUS INFUSION)
1.
NAME OF THE MEDICINE
Human Normal Immunoglobulin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Octagam
®
10% contains 100 mg/mL of human normal immunoglobulin with a purity
of at least 95% immunoglobulin G (IgG), and a broad spectrum of
antibodies against
infectious agents. It is composed of the following distribution of IgG
subclasses
(approx. values):
IgG
1
60%
IgG
2
32%
IgG
3
7%
IgG
4
1%
Octagam
®
10% contains ≤ 3% polymers. Monomer and dimer content is ≥ 90%.
The human immunoglobulin A (IgA) content is
≤
0.4 mg/mL. Octagam 10% is
contraindicated in patients with IgA deficiency (for further details,
refer to section 4.3
Contraindications).
Octagam
®
10% contains all the IgG activities, which are present in the normal
population. It is prepared from pooled plasma from more than 3,500
donors.
For a full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Solution for intravenous infusion.
The solution is clear or slightly opalescent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Replacement therapy in:
•
Primary immunodeficiency syndromes:
−
congenital agammaglobulinaemia and hypogammaglobulinaemia
−
common variable immunodeficiency
−
severe combined immunodeficiencies
−
Wiskott Aldrich syndrome
•
Myeloma
or
chronic
lymphocytic
leukaemia
with
severe
secondary
hypogammaglobulinaemia and recurrent infections.
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•
Children with congenital Acquired Immune Deficiency Syndrome (AIDS)
who
have repeated bacterial infections.
Immunomodulation
•
Idiopathic thrombocytopenic purpura, in adults or children with a high
risk of
bleeding or prior to surgery to correct the platelet count.
•
Guillain Barré syndrome
•
Kawasaki disease
Allogeneic bone marrow transplantation
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
The dose and dosage regimen is dependent on the indication. In
replacement
therapy the dosage may need