HIZENTRA human normal immunoglobulin 20% solution for subcutaneous injection 10 mL vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
03-06-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
normal immunoglobulin, Quantity: 2 g
Available from:
CSL Behring Australia Pty Ltd
INN (International Name):
normal immunoglobulin
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: polysorbate 80; proline; water for injections
Administration route:
Subcutaneous
Units in package:
10 mL
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
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.
Product summary:
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
Authorization status:
Licence status A
Authorization date:
2014-05-08
Patient Information leaflet
Hizentra AU CMI 7.00
Page 1 of 7
HIZENTRA
®
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
®
.
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
®
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
® IS USED FOR
Your medicine is Hizentra
®
, a solution for subcutaneous
infusion. Hizentra
®
contains human immunoglobulins.
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
®
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
®
for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU ARE GIVEN HIZENTRA
®
WHEN YOU MUST NOT HAVE IT
DO NOT HAVE HIZENTRA
®
_ _IF YOU HAVE:
•
a history of allergy to human immunoglob
Read the complete document
Summary of Product characteristics
Hizentra AU PI 12.00
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
HIZENTRA
®
(NORMAL IMMUNOGLOBULIN (HUMAN))
1
NAME OF THE MEDICINE
Normal immunoglobulin (Human) 20% (20 g/100 mL), subcutaneous
injection.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hizentra
®
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).
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
®
contains no carbohydrate stabiliser (e.g. sucrose, maltose) and no
preservative.
3
PHARMACEUTICAL FORM
Hizentra
®
is a sterile, clear and colourless or pale-yellow or light-brown
solution of human
normal immunoglobulin for subcutaneous injection.
Hizentra
®
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.
IMMUNOMODULATORY THERAPY IN:
•
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as
maintenance therapy
after stabilisation with IVIg.
Hizentra AU PI 12.00
Page 2 of 20
4.2
D
OSE AND METHOD OF ADMINISTRATION
Hizentra
®
should only be administered
SUBCUTANEOUSLY
.
DOSAGE
The dose and dose regimen are dependent on the indication.
_REPLACEMENT THERAPY (PID AND SYMPTOMATIC HYPOGAMMAGLOBULINAEMIA) _
The dose may need to be individualised for each patient dependent on
the clinical response
and serum IgG trough levels. The following
Read the complete document
