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Sandoglobulin NF Liquid_AU_CMI_3.00
Page 1 of 5
Consumer Medicine Information
SANDOGLOBULIN
®
NF LIQUID
NORMAL IMMUNOGLOBULIN (HUMAN) 12 % (120 G/L) - INTRAVENOUS
INJECTION
WHAT IS IN THIS LEAFLET
This leaflet contains answers to some common questions about
Sandoglobulin
®
NF Liquid. It
does not contain all the available information about Sandoglobulin
®
NF Liquid. 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 taking
Sandoglobulin
®
NF Liquid against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE,_ _ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET. You may need to read it again.
WHAT SANDOGLOBULIN
®
NF LIQUID IS USED FOR
Your medicine is Sandoglobulin
®
NF Liquid. Sandoglobulin
®
NF Liquid contains human
‘immunoglobulins’ which are also called antibodies, 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 Sandoglobulin
®
NF Liquid either for the replacement of antibodies
because your antibody levels are low (referred to as immunodeficiency)
or for a condition
where there is an imbalance in your immune system requiring
treatment with antibodies
(referred to as immunomodulation).
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED
FOR YOU.
This medicine is available only with a doctor’s prescription.
This medicine is not addictive.
This medicine is not expected to affect your ability to drive a car or
operate machinery.
BEFORE YOU ARE GIVEN SANDOGLOBULIN
®
NF LIQUID
MAKE SURE YOU TELL YOUR DOCTOR OF ANY REASONS YOU KNOW OF WHY YOU
SHOULD NOT BE GIVEN
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製品の特徴
Sandoglobulin NF Liquid_AU_PI_2.00
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Product Information
SANDOGLOBULIN
®
NF LIQUID
AUSTRALIA
NAME OF THE MEDICINE
Normal immunoglobulin (Human) 12 % (120 g/L) – intravenous
injection
DESCRIPTION
Sandoglobulin
®
NF Liquid is a sterile, clear or slightly opalescent, colourless or
pale yellow
solution of unmodified human immunoglobulin for intravenous
injection.
Sandoglobulin
®
NF Liquid has a nominal osmolality of 360 mOsmol/kg and is
approximately
isotonic. The pH value of the ready-to-use solution is 5.3 and the
solution contains no buffer
substances. Sandoglobulin
®
NF Liquid is supplied as a 50 mL or 100 mL solution containing 6 g
or 12 g of human immunoglobulin respectively.
The concentration of the active ingredient (unmodified immunoglobulin
G (IgG) of human
origin) is 12 % (120 g/L). At least 96 % (typically 99 %) of the
total protein is IgG (at least 90 %
of it exists as monomers and dimers). The product contains further
small amounts of IgG
fragments (≤ 10 %), aggregates (≤ 2 % - typically 0.5 %),
albumin (≤ 3 %) and traces of
Immunoglobulin A (IgA) and Immunoglobulin M (IgM). The level of IgA in
the product is
normally below 15 mg/L. The distribution of the IgG subclasses
present in Sandoglobulin
®
NF
Liquid closely resembles that in normal human plasma. The
distribution of IgG subclasses
present in Sandoglobulin
®
NF Liquid is, on the average, 64.5 % IgG
1
, 32.4 % IgG
2
, 2.3 % IgG
3
and 0.8 % IgG
4
. Prekallikrein activator (PKA) levels are less than 10 IU/mL.
Sandoglobulin
®
NF Liquid contains the following stabilisers: proline, isoleucine
and
nicotinamide.
The stabilisers, in particular nicotinamide, minimise the formation
of IgG dimers, which is
important for the tolerability of the product. The preparation
contains traces of sodium chloride
(≤ 10 mmol/L). Sandoglobulin
®
NF Liquid contains no carbohydrates (for example sucrose or
maltose) or antimi
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