OCTAGAM normal immunoglobulin (human) 2.5g/50mL injection bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

human immunoglobulin G, Quantity: 50 mg/mL

Tilgjengelig fra:

Octapharma Australia Pty Ltd

INN (International Name):

human immunoglobulin G

Legemiddelform:

Injection

Sammensetning:

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

Administreringsrute:

Intravenous

Enheter i pakken:

50ml

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Replacement therapy: 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; Immunomodulatory effect: 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 Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2004-11-16

Informasjon til brukeren

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OCTAGAM
® 5%
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
®
5% ?
Octagam
®
5% is a solution for infusion into a vein. Octagam
®
5% contains the active
ingredient human normal immunoglobulin. Octagam
®
5% 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
® 5%? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE OCTAGAM
®
5%?
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
®
5%. See Section 2. What should I know before I use octagam
® 5%? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with octagam
®
5% 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
®
5%?
Your doctor will administer octagam
®
5% as a slow injection (infusion) into a vein.
For more
information, see Section 4. How do I use octagam
®
5%? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OCTAGAM
®
5%?
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
®
5%?
before starting any new medicines
For more information, see Section 5. What should I know while using
octagam® 5%? in the
full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
All medicines can h

Preparatomtale

_ _
_1/15 _
AUSTRALIAN PRODUCT INFORMATION – OCTAGAM
®
5% (HUMAN
NORMAL IMMUNOGLOBULIN, 50 MG/ML, SOLUTION FOR
INTRAVENOUS INFUSION)
1. NAME OF THE MEDICINE
Human Normal Immunoglobulin
2. QUALITATIVE AND QUANTITATIVE COMPOSTION
Octagam
®
5% contains 50mg/mL 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
65%
IgG
2
29%
IgG
3
4%
IgG
4
2%
Octagam
®
5% contains

3 % polymers. Monomer and dimer content is ≥ 90 %.
The
human
immunoglobulin
A
(IgA)
content
is

0.2mg/mL.
Octagam
5%
is
contraindicated in patients with IgA deficiency (for further details,
refer to section 4.3
Contraindications),
Octagam
®
5% contains all the IgG activities, which are present in the normal
population. It is prepared from pooled plasma from more than 3500
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

Primary immunodeficiency syndromes:
- congenital agammaglobulinaemia and hypogammaglobulinaemia
- common variable immunodeficiency
_ _
_2/15 _
- 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.
Immunomodulatory effect

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 to be individualise