HIZENTRA AU Human Normal Immunoglobulin 20% Solution for Subcutaneous Injection 20 mL vial

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

normal immunoglobulin, Quantity: 4 g

Disponible desde:

CSL Behring Australia Pty Ltd

formulario farmacéutico:

Injection, solution

Composición:

Excipient Ingredients: polysorbate 80; proline; water for injections

Vía de administración:

Subcutaneous

Unidades en paquete:

20 mL

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Replacement therapy in adults and children in: - Primary Immunodeficiency Disease (PID) and - Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. Immunomodulatory therapy in: - Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as maintenance therapy after stabilisation with IVIg.

Resumen del producto:

Visual Identification: Clear and pale-yellow or light-brown solution; during storage it may show formation of slight turbidity or a small amount of particulate matter; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

2020-07-07

Información para el usuario

Hizentra AU CMI 2.00
Page 1 of 6
HIZENTRA
® AU
Human Normal Immunoglobulin 20% (20 g per 100 mL), solution for
subcutaneous
administration.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
Hizentra
®
AU.
It does not contain all the available information. If you
require further information about this medicine or your
treatment, have any questions, or are not sure about
something in this leaflet, consult your doctor or
pharmacist.
All medicines have benefits and risks. Your doctor has
weighed the benefits that Hizentra
®
AU will have for you
against the possible risks.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR. FOLLOW YOUR DOCTOR’S ADVICE EVEN IF IT
IS DIFFERENT FROM WHAT THIS LEAFLET SAYS.
KEEP THIS LEAFLET WITH THE MEDICINE.
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 HIZENTRA
® AU IS USED FOR
Your medicine is Hizentra
®
AU, a solution for
subcutaneous infusion. Hizentra
®
AU 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 Hizentra
®
AU 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).
Your doctor may have prescribed Hizentra
®
AU for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT
HAS BEEN PRESCRIBED FOR YOU.
BEFORE

Ficha técnica

Hizentra AU PI 3.00
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
HIZENTRA
® AU
(NORMAL IMMUNOGLOBULIN (HUMAN))
1
NAME OF THE MEDICINE
Normal immunoglobulin (Human) 20% (20 g/100 mL), subcutaneous
injection.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hizentra
®
AU is a 20% solution containing 20 g/100 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%). 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
).
The maximum IgA content is 0.05 mg/mL (normally below 0.005 mg/mL).
Hizentra
®
AU is manufactured from human plasma collected in Australia by
Australian Red
Cross Lifeblood. Hizentra
®
is manufactured from human plasma collected outside Australia
by CSL Plasma.
The product contains 250 mmol/L of proline as a stabiliser which is a
physiological
non-essential amino acid. The product also contains trace amounts of
Polysorbate 80 and
sodium. Hizentra
®
AU contains no carbohydrate stabiliser (e.g. sucrose, maltose) and no
preservative.
3
PHARMACEUTICAL FORM
Hizentra
®
AU is a sterile, clear and colourless or pale-yellow or light-brown
solution of
human normal immunoglobulin for subcutaneous injection.
Hizentra
®
AU has a nominal osmolality of 380 mOsm/kg and is approximately
isotonic. The
pH value of the ready-to-use solution is 4.8.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
REPLACEMENT THERAPY IN ADULTS AND CHILDREN IN:
•
Primary Immunodeficiency Disease (PID) and
•
Symptomatic hypogammaglobulinaemia secondary to underlying disease or
treatment.
Hizentra AU PI 3.00
Page 2 of 20
IMMUNOMODULATORY THERAPY IN:
•
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as
maintenance therapy
after stabilisation with IVIg.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Hizentra
®
AU should only be administered
SUBCUTANEOUSLY
.
DOSAGE
The dose and dose regimen are dependent on the i