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SUBCUVIA 160 G/L SOLUTION FOR INJECTION

Active substance(s): IMMUNOGLOBULIN NORMAL

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0728889
Human Normal Immunoglobulin

160 g/l Solution for Injection
Active substance: Human Normal Immunoglobulin

Read all of this leaflet carefully before you
start using this medicine.
– Keep this leaflet. You may need to read it
again.
– If you have further questions, please ask your
doctor or your pharmacist.
– This medicine has been prescribed for you
personally and you should not pass it on
to others. It may harm them, even if their
symptoms are the same as yours.
– If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
p­ lease tell your doctor or pharmacist.
In this leaflet:
1. What SUBCUVIA is and what it is used for
2. Before you use SUBCUVIA
3. How to use SUBCUVIA
4. Possible side effects
5. Storing SUBCUVIA
6. Further information
1. WHAT SUBCUVIA IS AND WHAT IT IS USED FOR
SUBCUVIA belongs to a class of medicines called
immuno­globulins. These medicines contain anti­
bodies which are normally found in your blood.
Antibodies are proteins that help you to fight
infection by neutralizing bacteria, viruses, and
other foreign bodies. SUBCUVIA is used in the
treat­ment of ­certain diseases that are caused by
a lack of anti­bodies in your blood. These types of
diseases are called antibody deficiency syndromes.
If you do not have enough antibodies, you become
vulnerable to frequent infections. Regular and
sufficient doses of SUBCUVIA can correct this lack
of antibodies.
Adults and children can be prescribed SUBCUVIA
as antibody replacement therapy. The most
common reasons for people being prescribed
antibody replacement therapy are:
• People who are born with an inability to make their
own antibodies (congenital agammaglobulin-
aemia),
• People who cannot make enough own immune
anti­bodies (hypogammaglobulinaemia),
• People who have a mixed group of reasons for
not making enough own immune antibodies
­(common variable immunodeficiency),
• People whose blood and other body systems
are ­unable to make sufficient antibodies (severe
­combined immunodeficiency),
• People who cannot make a particular class
of antibody (IgG subclass deficiencies) with
recurrent infections
In addition, SUBCUVIA is used for antibody
replacement therapy with certain severe blood
diseases, such as ­cancers of the bone marrow:
• myeloma
• chronic lymphatic leukaemia
These cancers can lead to severe secondary
(acquired) antibody deficiencies and recurrent
infections.

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2. BEFORE YOU USE SUBCUVIA
Do NOT use SUBCUVIA
You MUST NOT use SUBCUVIA
• If you are allergic (hypersensitive) to
immunoglobulins or any of the other ingredients
of SUBCUVIA (see Section 6 – “What SUB­
CUVIA contains”)
• You must not inject SUBCUVIA into a blood
vessel (intravascularly)
• You must not inject SUBCUVIA into a muscle
(intramuscularly) if you have severe platelet
­deficiency (low platelets) or other blood clotting
disorders.
Take special care with SUBCUVIA
The following is very important and should be
con­sidered before you receive or use SUBCUVIA:
• Infusion speed: the correct infusion speed is
­important (see Section 3, HOW TO USE SUB­
CUVIA). You are more likely to get side effects if
the infusion is too fast.
• Side effects are more frequent if you
– are using SUBCUVIA for the first time
– have received another immunoglobulin and
have been switched to SUBCUVIA
– have not used SUBCUVIA treatment for more
than 8 weeks.
• Immunoglobulin A (IgA) deficiency: if you suffer
from a deficiency with anti-IgA antibodies. There
is an in­creased­ risk of allergic reactions.
• Severe allergic reactions (anaphylaxis). You may
experience severe allergic reactions with a fall
in blood pressure. These reactions are rare but
they can occur even if you have not previously
had problems with similar treatments.
• Please tell your doctor that you have been using
SUBCUVIA before you have a blood test. This
is because SUBCUVIA may affect the results of
the test.
• SUBCUVIA contains 1.2 mg sodium per ml. This
should be taken into account if you are on a low
sodium diet.
Home treatment
Before you start home treatment you should assign
a guardian person. This guardian should help you
keep an eye on potential side effects. During the
infusion you must look out for first signs of side
effects (for further details see section 3. “HOW TO
USE SUBCUVIA”). If you ­experience any, you or
your guardian must stop the infu­sion immediately
and contact a doctor. If you experience a severe
side effect, you must seek emergency treatment
immediately.
Viral Safety
When medicines are made from human blood
or plasma, certain measures are put in place to
prevent the spread of infection. These measures
include careful selection of blood and plasma
donors to make sure that people who are at risk
of carrying infections are not donors. Donated
blood and plasma is tested for viruses and other
infec­tions. The blood and plasma is also treated to
inactivate or remove viruses. However, it cannot be
guaranteed that infection will not be transmitted.
This also applies to any unknown or emerging
viruses or other types of infections. The measures
taken are considered effective for some viruses

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728889

PACKAGE LEAFLET: INFORMATION FOR THE USER

such as human immunodeficiency virus (HIV),
hepatitis B virus and hepatitis C virus. However,
they may not be effective against other viruses
such as hepatitis A virus and parvovirus B19.
Parvovirus B19 infection can be serious for
pregnant women because of its potential
effect on the unborn child and for individuals
with immunodeficiency or increased red blood
cell turnover (e.g., haemolytic anaemia).
Immunoglobulins have not been associated with
infections from hepatitis A and parvovirus B19.
It is strongly recommended that you keep a record
of the batch number and expiry date every time you
receive a dose of SUBCUVIA.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines.
This includes medicines obtained without a
prescription, or if you have received a vaccination
in the last 6 weeks.
• SUBCUVIA may reduce the effect of some live
virus vaccines such as measles, rubella, mumps
and ­chicken pox. Therefore, after receiving
SUBCUVIA, you may have to wait for up to
3 months before receiving certain vaccines. You
may have to wait for up 1 year after receiving
SUBCUVIA before you can receive a measles
vaccine.
• Do not mix SUBCUVIA with other medicinal
products.
Pregnancy and breast-feeding
Please tell your doctor, if you are pregnant
or breast-­feeding. Your doctor will decide if
SUBCUVIA may be used during pregnancy or
breast-feeding.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
No effects on ability to drive and use machines
have been observed.
3. HOW TO USE SUBCUVIA
Starting of treatment
Your treatment will be started by your doctor. At
first, SUBCUVIA will be injected slowly. You will
then be ­watched carefully for at least 20 minutes
to see if you have any side effects. Once the doctor
has found the right dose for you, you may be
allowed to give the treatment to yourself at home.
Home treatment
Your doctor will show you how to use the syringe
driver, and the infusion techniques. Your doctor will
also teach you how to recognize severe adverse
effects and what to do if these occur. You will also
be shown how to keep the treatment diary. You will
be allowed to start home treat­ment as soon as you
show that you can give yourself the treatment. You
may start home treatment as long as you do not
have any severe side effects.
Preparations
• Always use SUBCUVIA exactly as your doctor
has instructed you. You should check with your
doctor if you are unsure.
• Assign a guardian person who can watch you
for potential side effects during the infusion
and for at least 20 minutes after you received
SUBCUVIA. These side effects could be a
low blood pressure or allergic reaction. Your
doctor will give you and your guardian detailed
instructions. These include information to
­recognize an allergic reaction as soon as
possible. Early symptoms of an allergic reaction
include:
– fall in blood pressure (hypotension)
– increased pulse rate
– vomiting (being sick)

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cold sweat
chills
sensation of heat
hives
itching
difficulty in breathing.

During the infusion you must look out for first signs
of allergic reactions. If you experience any of the
above symptoms you or your guardian must stop
the infusion immediately and contact a doctor.
If you have severe symptoms, you must seek
emergency treatment immediately.
• You should bring the solution to room
temperature (25°C) or body temperature (37°C)
before use.
• Do not use heating devices to warm up the
medicine.
• Do not use solutions that are more than just
slightly cloudy. The solution will be clear and
pale yellow to light brown. During storage it
may show formation of slight turbidity or a small
amount of particulate matter.
• Do not reuse a vial once the stopper has been
punc­tured.
Infusion
1. Infusion sites are the abdomen, the thighs or the
buttocks. You should position the needle at an
angle of 45 to 90 degrees.
2. Infuse SUBCUVIA subcutaneously (under the
skin). You must make sure that SUBCUVIA is
not infused into a blood vessel because this can
lead to a shock (See Section 2 – Take special
care with SUBCUVIA).
3. Please keep strictly to the dosage and infusion
speed your doctor instructed you to use. The
usual starting speed is 10 ml/h/pump. The
infusion speed can be increased by 1 ml/h/pump
after each new i­nfusion up to a maximum of
20 ml/h/pump. You can use more than one pump
at the same time.
4. Change the infusion site every 5 – 15 ml.
5. Use each syringe only once.
6. Sometimes it is not possible to give SUBCUVIA
sub­cutaneously (under the skin). When this
happens, SUBCUVIA may be given to you
intramuscularly (into a muscle). Intramuscular
administration must be given by your doctor or
nurse.
7. Keep a full record of SUBCUVIA dosing by
attaching the self-adhesive label into your
dosing diary.
Disposal
Dispose of any unused product or waste material as
instructed by your doctor or pharmacist. Do not put
the cover back on used needles. Put used needles,
syringes and vials into the puncture-proof container
and keep it out of the reach and sight of children.
Dispose of the full puncture-proof container as
instructed by your doctor. Never put the unused
needles and syringes into your household waste
bin.
If you use more SUBCUVIA than you should
You should strictly keep to the dosage and infusion
speed your doctor instructed you to use. Please
tell your doctor if you accidentally used more
SUBCUVIA than instructed.
There are no known symptoms of an overdose.
If you forget to use SUBCUVIA
Do not infuse a double dose to make up for a
forgotten dose. Just infuse your next dose as usual
and make a note in your diary that you missed a
dose.
If you stop using SUBCUVIA
Tell your doctor if you decide to stop treatment and
the reasons why.

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4. POSSIBLE SIDE EFFECTS
Like all medicines, SUBCUVIA can cause side
effects although not everybody gets them.
If you notice one of the following side effects,
contact your doctor immediately:
• a sudden fall in blood pressure. This side effect
occurs rarely or in 1 to 10 out of 10,000 treated
patients.
• laboured breathing (dyspnoea), chest tightness,
flushing of the face and skin, feeling of heat,
and skin rash (urticaria). These could be signs
of a severe allergic reaction (anaphylactic shock
and anaphylactoid reaction) and can occur even
if the patient has shown no hypersensitivity
to previous administration. These side effects
occur very rarely or in less than 1 out of 10,000
treated patients.
The following side effects may also occur during
the use of SUBCUVIA:
Common side effects, occurring in
100 treated patients:
• bleeding at the injection site
haemorrhage)
• injection site pain
• bruising at the injection site
haematoma)
• redness at the injection site
erythema)
• chills

1 to 10 out of
(injection site
(injection site
(injection site

Uncommon side effects, occurring in 1 to 10 out
of 1,000 treated patients:
• dizziness
• headache
• nausea
• itching at the injection site or generally (pruritus)
• redness of the skin (erythema)
• injection site swelling
• pain
• tiredness (fatigue)
• feeling hot
Rare side effects, occurring in 1 to 10 out of
10,000 treated patients:
• tremor
• increased heart rate (tachycardia)
• coldness in the extremities such as the hands or
feet (peripheral coldness)
• pain in the stomach area (abdominal pain)
• pain in one or more joints (arthralgia)
• stiffness in the muscles and joints (musculo­
skeletal stiffness)
• pain in one or more muscles (myalgia)
• injection site rash
• increased levels of alanine aminotransferase
Side effects with unknown frequencies/OR: Very
rare side effects, occurring in less than 1 out of
10,000 treated patients:
• allergic reactions (hypersensitivity reactions)
• sensation of prickling, tingling or creeping on the
skin (paraesthesia)
• abnormally low blood presure (hypotension)
• abnormally high blood pressure (hypertension)
• flushing
• pallor
• vomiting
• swelling of the face
• skin rash (urticaria)
• rash with red spots covered with bumps (rash
maculopapular)
• inflammation of the skin due to an allergy
(dematitis allergic)

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excessive sweating (hyperhidrosis)
back pain
chest discomfort
fever (pyrexia)
feeling poorly (malaise)
injection site reaction
injection site urticaria
hardening of the injection site (injection site
induration)
• injection site warmth

Perforation

If you have any more questions on the use of this
product, ask your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE SUBCUVIA
• Keep out of the reach and sight of children.
• Do not use SUBCUVIA after the expiry date
which is stated on the label and carton after
EXP. The expiry date refers to the last day of
that month.
• Store at 2°C – 8°C (in a refrigerator).
• Do not store above 25°C.
• Do not freeze.
• SUBCUVIA may be stored at room temperature
(not more than 25°C) for up to 3 months. Record
the date of transfer to room temperature and
the end of the 3 month period on the outer
carton. Once SUBCUVIA has been stored at
room ­temperature, it must not be returned to the
refrigerator. It must be discarded if not used by
the end of the 3 month period.
• Keep the vial in the outer carton to protect it from
light.
• Do not use SUBCUVIA if the solution appears
foggy or milky. It should be clear or slightly
cloudy.
• Once a vial has been opened, the product must
be used immediately.
• Medicines should not be disposed of via waste­
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.
6. FURTHER INFORMATION
What SUBCUVIA contains
The active substance is human normal immuno-
globulin.
It contains 16% (160 g/l) of human protein of which
at least 90% is immunoglobulin G (IgG). The IgG
sub­­class contents are:
• IgG1 45 – 75%
• IgG2 20 – 45%
• IgG3   3 – 10%
• IgG4   2 –   8%
Maximum IgA content 4.8 g/l
The other ingredients are Glycine, Sodium chloride
and Water for injections.
What SUBCUVIA looks like and contents of the
pack
SUBCUVIA is a solution for injection in a vial
(0.8  g/5  ml or 1.6 g/10 ml; pack sizes of 1 vial
or 20  vials). The liquid preparation is clear and
pale yellow to light brown. Slight cloudiness or a
small number of visible ­particles may form during
storage. Do not use if the solu­tion is more than just
slightly cloudy.

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Perforation

Marketing Authorisation Holder
Baxalta Innovations GmbH
Industriestrasse 67
A-1221 Vienna
Austria
Tel. 01635 798 777

0728889_GB_V2.indd 4

Manufacturer
Baxter AG
Industriestrasse 67
A-1220 Vienna, Austria
This leaflet was last revised in May 2015

23.03.15 11:07

The following information is intended for
medical or healthcare professionals only:

The product should be brought to room or body
temperature before use.
Do not use heating devices.

Posology and method of administration

Subcutaneous infusion
for home treatment should be initiated by a
physician experienced in the guidance of patients
for home treatment. The patient must be instructed­
in the use of a syringe driver, infusion techniques,
the keeping of treatment diary, recognition of and
measures to be taken in case of severe adverse
events. It is recommended to use an initial
administration speed of 10 ml/h/pump.
The infusion speed can be enhanced for
1 ml/h/pump every subsequent infusion. The
recommended maximum speed is 20 ml/h/pump.
More than one pump can be used simultaneously.
The infusion site should be changed ­every
5 – 15 ml.
Potential complications can often be avoided by
ensuring that:
• patients are not sensitive to human normal
immuno­globulin by first injecting the product
slowly.
• patients are carefully monitored for any
symptoms throughout the infusion period. In
particular, patients naive to human normal
immunoglobulin, patients ­switched from an
alternative product or when there has been a
long interval since the previous infusion should
be monitored during the first infusion and for
the first hour after the first infusion, in order to
detect potential adverse signs. All other patients
should be observed for at least 20 minutes after
administration.

Posology
Treatment should be initiated and monitored under
the supervision of a physician experienced in the
treatment of immunodeficiency.
The dosage may need to be individualised for each
patient dependent on the pharmacokinetic and
clinical response. The following dosage regimens
are given as a guideline.
The dosage should be adjusted to maintain a
trough level of at least 4 – 6 g/L of circulating IgG.
The dosage regimen using the subcutaneous route
should achieve a sustained level of IgG (measured
before the next in­fusion). A loading dose of at least
0.2 – 0.5 g/kg given during the course of one week
(0.1 – 0.15 g/kg bodyweight at any given day) may
be required. After steady state IgG levels have been
attained, maintenance doses are administered at
repeated intervals to reach a cumulative monthly
dose of the order of 0.4 – 0.8 g/kg. Trough levels
should be measured in order to adjust the dose and
dosage interval.
The subcutaneous route is the method of choice for
the SUBCUVIA administration.
SUBCUVIA may also be injected by the intra­
muscular route. In such cases, the cumulative
monthly dose should be divided up into weekly, or
bi-weekly applications, in order to keep the injected
volume low. To further minimize the discomfort for
the patient, each single dosage may need to be
injected at different anatomic sites.
Method of administration
Human normal immunoglobulin is administered via
the subcutaneous or intramuscular route.
SUBCUVIA should be administered via the sub-
cutaneous route. In exceptional cases, where
the subcutaneous administration is not possible,
SUBCUVIA can be given intramuscularly.

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Intramuscular injection must be given by a
­physician or nurse.
Incompatibilities
This medicinal product must not be mixed with
other medicinal products.
Subcuvia is a trademark of Baxalta Incorporated
Baxter is a registered trademark of Baxter International
Inc.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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