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GAMMAPLEX

Active substance(s): HUMAN NORMAL IMMUNOGLOBULIN

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Package leaflet: Information for the user
GAMMAPLEX® 2.5 G, 5 G, 10 G and 20 G
5% W/V SOLUTION FOR INFUSION
HUMAN NORMAL IMMUNOGLOBULIN

VSL9

Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
– K
 eep this leaflet. You may need to read it again.
– I f you have any further questions, ask your doctor,
pharmacist or nurse.
– T his medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
– If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
What is in this leaflet:
1. What Gammaplex® is and what it is used for
2. What you need to know before you use Gammaplex®
3. How to use Gammaplex®
4. Possible side effects
5. How to store Gammaplex®
6. Contents of the pack and other information
1. What Gammaplex® is and what it is used for
Gammaplex ® is a solution containing the active substance
called human normal immunoglobulin (a protein in the body
used to fight infections) which is obtained from blood plasma
from screened donors. These donors are selected from
carefully screened and healthy donors from the USA. The
product is given by injection into a vein (intravenous infusion).
It can be given in a hospital or for use at home and is only
available on a doctor’s prescription.
Gammaplex® is used to treat several illnesses. Your doctor
will advise you what you are receiving Gammaplex® for.
This medicine is used to replace antibodies which are missing
from your body in primary antibody deficiencies (lack of
certain proteins protective against infection that you may
either have been born with or may develop during life) such
as:
– agammaglobulinaemia (deficiency of gamma globulins in
the blood),
– hypogammaglobulinaemia (low levels of immunoglobulin
G (IgG), with or without low IgA and/or IgM),
– common variable immunodeficiency (failure of the immune
system to produce antibodies against infections),
– s evere combined immunodeficiency (a severe genetic
disorder of the immune system making you susceptible to
infections),
– Wiskott Aldrich syndrome (hereditary disorder with signs
of eczema, recurring infections, and a decrease in the
number of white blood cells).
Gammaplex® is also used to replace antibodies in secondary
antibody deficiencies caused by:
– chronic lymphocytic leukaemia (cancer of the blood where
too many white blood cells are produced),
– some other bone marrow cancers,
– A IDS in children born with the disease, when repeated
infections occur.
Gammaplex® is also used for the treatment of:
– Idiopathic thrombocytopenic purpura (ITP, a blood platelet
disorder),
– Kawasaki disease (disorder of the blood vessels and heart
in children),
– Guillain Barré syndrome (disorder of peripheral nerves),
– b one marrow transplant, as an immunoglobulin
supplement.
2. What you need to know before you use Gammaplex®
Do not use Gammaplex®
– if you suffer from hereditary fructose intolerance,
– for babies and young children who may have a fruit sugar
intolerance,
– if you are allergic to human normal immunoglobulin or any
of the other ingredients of this medicine (listed in Section
6). If you do experience an allergic reaction, seek medical
attention immediately,
– if you have developed antibodies to IgA. Your doctor will
advise you if this affects you.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
Gammaplex® if any of the following conditions applies to you.
– fruit sugar intolerance,
– diabetes,
– obesity,
– k idney disorder,
– stroke (now or in the past),
– heart complaint (now or in the past),
– are elderly,
– taking other medicines,
– pregnant or breast-feeding.
You may need to be monitored closely during treatment and
the dose may have to be altered.

Immunoglobulin infusions may also interfere with
immunisation with certain virus vaccines such as measles,
rubella, mumps and varicella for a period of at least 6 weeks
and up to 3 months. In the case of measles, this impairment
may persist for up to a year.
If you need a blood test during this period, tell your doctor
when you last had an injection of Gammaplex ®, as false
positive results may occur with certain tests. This medicine
will raise the level of various antibodies in your blood for
several weeks or longer.
Other medicines and Gammaplex®
Tell your doctor or pharmacist if you are using, have recently
used or might use any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor for advice before
taking this medicine.
Driving and using machines
Some side effects of Gammaplex® may affect your ability to
drive or operate machinery. Wait for side effects to resolve
before you drive or operate machines.
Gammaplex® contains D-sorbitol, sodium chloride, glycine,
sodium acetate and polysorbate 80.
If you know you are unable to digest fructose (a certain type
of sugar, sometimes called fruit sugar) then do not use
Gammaplex®. Also, this medicine should not be used in babies
or very young children until they are known to be able to digest
fructose. Sucrose (table sugar) contains fructose.
Please note:
When medicines are made from human blood or plasma,
certain measures are put in place to prevent infections being
passed on to patients. These include:
– careful selection of blood and plasma donors to make sure
those at risk of carrying infections are excluded,
– the testing of each donation and pools of plasma for signs
of virus/infections,
– the inclusion of steps in the processing of the blood or
plasma that can inactivate or remove viruses.
Despite these measures, when medicines prepared from
human blood or plasma are administered, the possibility of
passing on infection cannot be totally excluded. This also
applies to any unknown or emerging viruses or other types
of infections.
The measures taken are considered effective for enveloped
viruses such as human immunodeficiency virus (HIV),
hepatitis B virus and hepatitis C virus, and for the nonenveloped hepatitis A and parvovirus B19 viruses.
Immunoglobulins have not been associated with hepatitis A
or parvovirus B19 infections possibly because the antibodies
against these infections, which are contained in the product,
are protective.
It is strongly recommended that every time you receive a dose
of Gammaplex® the name and batch number of the medicine
are recorded in order to maintain a record of the batches used.
3. How to use Gammaplex®
Always use this medicine exactly as your doctor has told you.
Check with your doctor if you are not sure.
DO NOT EXCEED THE RECOMMENDED DOSE. See below for
full dosage recommendations. Your doctor will decide the
appropriate dose. DO NOT ADD any other medicines or fluids
to Gammaplex®.
The medicine is given by intravenous injection (infusion)
using a giving set which your doctor or nurse will provide.
The maximum safe rate of infusion is determined by your
body weight. An infusion rate of 0.01 - 0.02 mL/kg/minute is
recommended for the first 15 minutes, gradually increasing
it to 0.08 mL/kg/minute.
To reduce the risk of side effects, the infusion rate in the first
15 minutes must be low (0.01 - 0.02 mL/kg/minute). Some
severe side effects may be caused by injecting the product
too quickly.
The recommended infusion rate must be checked closely and
you must be carefully observed for any symptoms throughout
this period. If you feel unwell, tell your doctor and the infusion
will either be slowed or stopped until you feel better.
You should remain with another person for at least 20 minutes
after the infusion is complete or for an hour if it is the first
time you have had this product.

14610 Gammaplex PIL VSL9.indd 1

BPL 14610

21.01.15

Proof FOUR

21/01/2015 11:50

260 x 150mm

Colours: Pantone Process Black C Pan 361 Pan 274 Pan 430

BPL PO No. P8948

Dosage recommendations:
– antibody deficiency disease: the dosage is at first 0.4 - 0.8
g/kg body weight, then 0.2 - 0.8 g/kg body weight every
3 to 4 weeks, depending on your clinical response and
measurements of immunoglobulins in the bloodstream.
– bone marrow cancers (including leukaemia) and children
born with AIDS resulting in antibody deficiencies: 0.2 - 0.4
g/kg body weight every 3 to 4 weeks.
– Idiopathic thrombocytopenic purpura (ITP): 0.8 - 1 g/kg
body weight as a single dose, sometimes repeated within
3 days. A dose of 0.4 g/kg may be administered daily for
2 - 5 days.
– Guillain Barré syndrome: 0.4 g/kg/day for 5 days.
– Kawasaki disease: 1.6 to 2 g/kg body weight split into
several doses over 2 - 5 days or 2 g/kg body weight as a
single dose. Aspirin should usually be given as well. Your
doctor will decide the appropriate dose and whether you
should take aspirin.
– after bone marrow transplant: 0.2 - 0.4 g/kg body weight
every 3 to 4 weeks.
Bring the medicine to room temperature for at least 2 hours
before infusion. Do not use if there are any particles in the
medicine or it is discoloured. Contact your doctor if you are
not sure if your medicine is fit for use.
The product does not contain any additives to prevent the
growth of germs once it has been opened. Therefore the
infusion should begin immediately after piercing the cap.
This product is for single injection only. Safely throw away
any used materials or unused solution. To help you, your
doctor will provide instructions and a box.
If you use more Gammaplex® than you should
If you use more Gammaplex ® than you should there is no
cause for alarm. However, if you feel unwell afterwards or
have any discomfort, tell your doctor.
If you forget to use Gammaplex®
Do not take a double dose to make up for a forgotten dose.
If you stop using Gammaplex®
You should consult your doctor if you begin to feel unwell.
If you have any further questions on the use of this medicine,
ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. If you feel unwell, you
must tell your doctor immediately.
The risk of side effects can be minimised by making
sure that the infusion rate in the first 15 minutes is low
(0.01 - 0.02 mL/kg/minute) (see Section 3 “How to use
Gammaplex®”).
The following side effects have been reported to occur:
Very common side effects (affecting more than 1 in 10 people)
– headache
– high temperature
Common side effects (affecting less than 1 in 10 and more
than 1 in 100 people
– vomiting or feeling sick
– tiredness or weakness
– dizziness or vertigo
– body pain, back pain or neck pain
– muscle pain or spasms
– joint pain
– r aised blood pressure
– palpitations
– diarrhoea
– stomach pain or acidity
– nose congestion
– chills
– skin rash or itching
– chest discomfort
– pain or inflammation at infusion site
– f luid retention
– pins & needles or numbness
– blood test (Coombs’) positive
– insomnia
– dehydration
Uncommon side effects (affecting less than 1 in 100 and more
than 1 in 1,000 people
– blood clots
– wheeze
– migraine
– muscle or joint stiffness
– decreased appetite
– r inging in ears
– hot flushes
– sore throat
– mouth ulcers
– nose bleeds
– bloating
– constipation






r aised pulse rate
increased white blood cell count (shown by blood test)
antibody against red blood cells (shown by blood test)
p ositive urine test for haemosiderin, an iron storage
compound (related to anaemia)
– anaemia
– iron deficiency
Rare side effects (affecting less than 1 in 1,000 and more
than 1 in 10,000 people
– sudden fall in blood pressure which could be serious
– s evere allergic reaction that may cause difficulty in
breathing or swallowing
– k idney failure
If you are using this medicine at home and you feel unwell
during the infusion, stop the infusion and contact your doctor
immediately. If you feel unwell during an infusion in hospital
tell the doctor or nurse immediately. The rate of infusion will
probably then be slowed until you feel better. The rate of
infusion may then be slowly increased to half that achieved
when you started to feel unwell. If you still feel unwell, the
infusion should be stopped, but may be resumed after about
an hour when you are feeling better.
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet.
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 medicine.
5. How to store Gammaplex®
Keep this medicine out of the sight and reach of children.
The medicine should be stored in its carton, between
2°C and 25°C.
DO NOT FREEZE.
Do not use this medicine if you notice the solution is cloudy
or has deposits.
Do not use this medicine after the expiry date which is stated
on the label. The expiry date refers to the last day of that
month.
Disposal
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away any medicines
you no longer use. These measures will help protect the
environment.
6. Contents of the pack and other information
What Gammaplex® contains
The active substance is human normal immunoglobulin,
mainly immunoglobulin G (IgG) and is obtained from blood
plasma from screened donors. These donors are selected
from the USA.
The other ingredients are D-sorbitol, glycine, sodium chloride,
sodium acetate and polysorbate 80 (see also Section 2
“Gammaplex® contains D-sorbitol, sodium chloride, glycine,
sodium acetate and polysorbate 80”).
Gammaplex ® is slightly acidic, but this will not have any
unpleasant effects as your blood will neutralise it rapidly.
The maximum amount of sodium is 50 mmol/L.
The IgA content of Gammaplex® is less than 10 micrograms/mL
(typically about 4 micrograms/mL).
Gammaplex® has a composition of the different types of IgG
immunoglobulins similar to that in blood.
What Gammaplex® looks like and contents of the pack
Gammaplex® is a sterile, colourless liquid.
This product comes in 2.5 g, 5 g, 10 g and 20 g dose sizes,
with a sling to hold the bottle during infusion.
Marketing Authorisation Holder and Manufacturer
Bio Products Laboratory Limited,
Dagger Lane,
Elstree,
Hertfordshire,
WD6 3BX,
United Kingdom.
Tel: +44 (0)20 8957 2200
Marketing Authorisation Number
PL 08801/0053
This leaflet was revised in
01/2015
VSL9
Other sources of information
For further information or if you have any questions about
the use of this product, please contact BPL via the
Marketing Department at the address above or through
medinfo@bpl.co.uk.

14610 Gammaplex PIL VSL9.indd 2

BPL 14610

21.01.15

Proof FOUR

21/01/2015 11:50

260 x 150mm

Colours: Pantone Process Black C Pan 361 Pan 274 Pan 430

BPL PO No. P8948

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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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