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VIGAM LIQUID

Active substance(s): IMMUNOGLOBULIN G HUMAN NORMAL

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VIGAM® LIQUID 2.5 G, 5 G and 10 G
5% W/V SOLUTION FOR INFUSION
HUMAN NORMAL IMMUNOGLOBULIN

VLL12

14988 VL UK PIL VLL12.indd 1

11/09/2014 12:41

Colours: Pantone Process Black C Pan 570 Pan 273 Pan 430
Size: 260 x 150mm
Proof No: SIX
Date: 11.09.14

Immunoglobulin infusions may also interfere with
immunisation with certain virus vaccines such as measles,
rubella, mumps, varicella and yellow fever, 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 Vigam Liquid, 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 Vigam Liquid
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 and 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 Vigam Liquid may affect your ability to
drive or operate machinery. Wait for side effects to resolve
before you drive or operate machines.
Vigam Liquid contains sucrose and sodium
If you have been told that you have an intolerance to some
sugars or are on a sodium-controlled diet, tell the doctor
before he/she gives you the infusion.
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. The measures taken
may be of limited value against non-enveloped viruses such
as hepatitis A virus and parvovirus B19.
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 Vigam Liquid the name and batch number of the medicine
are recorded in order to maintain a record of the batches used.
3. How to use Vigam Liquid
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 Vigam Liquid.
Dosage recommendations:
• antibody deficiency disease: the dosage is initially 0.4 - 0.8
g/kg body weight, then at least 0.2 g/kg body weight every
2 - 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 3 days
later. A dose of 0.4 g/kg may be administered for 2 - 5 days.
• Guillain Barré syndrome: 0.4 g/kg/day for 3 - 7 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.
• Before and after bone marrow transplant: as required,
initially 0.5 g/kg body weight/week. If antibody levels
remain low this dose may be given monthly until no longer
required.

Job No:  14988

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor,
pharmacist or nurse.
• This 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 Vigam Liquid is and what it is used for
2. What you need to know before you use Vigam Liquid
3. How to use Vigam Liquid
4. Possible side effects
5. How to store Vigam Liquid
6. Content of pack and other information
1. What Vigam Liquid is and what it is used for
Vigam Liquid 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 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.
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), IgA and/or IgM),
• common variable immunodeficiency (failure of the immune
system to produce antibodies against infections),
• severe 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).
Vigam Liquid is also used to replace antibodies in secondary
antibody deficiencies caused by:
• lymphocytic leukaemia (cancer of the blood where too
many white blood cells are produced),
• other bone marrow cancers,
• AIDS in children born with the disease, when repeated
infections occur.
Vigam Liquid 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),
• bone marrow transplant, as an immunoglobulin supplement.
2. What you need to know before you use Vigam Liquid
Do not use Vigam Liquid:
• 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 lack IgA or 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 Vigam Liquid if any of the following
conditions apply to you;
• diabetes
• obesity
• kidney disorder
• stroke (now or in the past)
• heart complaint (now or in the past)
• are older
• taking other medicines
• pregnant or breast-feeding.
You may need to be monitored closely during treatment and
the dose may have to be altered.

BPL PO No: 268657

Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.

14988 VL UK PIL VLL12.indd 2

11/09/2014 12:41

BPL PO No: 268657
Colours: Pantone Process Black C Pan 570 Pan 273 Pan 430
Size: 260 x 150mm

6. Contents of pack and other information
What Vigam Liquid 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 human albumin, sucrose, glycine,
sodium acetate and sodium-n-octanoate added as stabilisers
(see also end of Section 2 “Vigam Liquid contains sucrose
and sodium”).
Vigam Liquid is slightly acidic, but this will not have any
unpleasant effects as your blood will neutralise it rapidly.
The maximum amount of sodium is 160 mmol/L.
The IgA content of Vigam Liquid is not greater than 0.02% of
the total protein content.
Vigam Liquid has a composition of the different types of
immunoglobulins similar to that in blood.
What Vigam Liquid looks like and contents of the pack
Vigam Liquid is a sterile, colourless to pale amber or pale
green liquid.
This product comes in 2.5 g, 5 g and 10 g dose sizes, with a
sling to hold the bottle during infusion.
Marketing Authorisation Holder and Manufacturer
BPL, Bio Products Laboratory Limited
Dagger Lane
Elstree
Hertfordshire
WD6 3BX
United Kingdom.
Tel: +44 (0)20 8957 2200
Marketing Authorisation Number
PL 08801/0040
This leaflet was revised in
September 2014
VLL12
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.

Proof No: SIX

If you stop using Vigam Liquid
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 30 minutes is low (0.01 - 0.02
mL/kg/minute) (see Section 3 “How to use Vigam Liquid”).
Some side effects may persist for several hours to a few days
after receiving the infusion. These include:
• severe headache
• dislike of bright light
• vomiting
• fever
• stiff neck
• chills
• backache
• shortness of breath
• skin and other allergic reactions
If you have a history of migraine and/or receiving large doses
you may be more likely to develop these symptoms. You
should tell your doctor if you suffer from migraines. No
longterm damage is known to occur.
The following side effects have also been reported to occur:
Very common side effects (affecting more than 1 in 10 people)
• fever
Common side effects (affecting less than 1 in 10 people)
• headache
• sore throat
• joint pain
• feeling sick
• being sick

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via The Yellow Card
System. Website: 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 Vigam Liquid
Keep this medicine out of the sight and reach of children.
The medicine should be stored in the dark in its carton,
between 2°C and 8°C. DO NOT FREEZE. Storage for a short
period of up to 3 months at 25°C is possible within the storage
date printed on the label.
Do not use Vigam Liquid 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 medicines
you no longer use. These measures will help protect the
environment.

Date: 11.09.14

If you forget to use Vigam Liquid
Do not take a double dose to make up for a forgotten dose.

• feeling drowsy
• spotty rash
• itchy reddened skin
• tiredness
• scaly inflammation of the skin
• pain and inflammation at the injection site
• high or low blood pressure
Rare side effects (occurring in less than 1 in 1,000 and more
than 1 in 10,000 people):
• sudden fall in blood pressure, which could lead to shock;
• some red blood cells may be destroyed;
• kidney function may be reduced.
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet.

Job No:  14988

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 medicine is given by intravenous injection (infusion)
using a recommended 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 30 minutes, gradually
increasing it to 0.04 mL/kg/minute up to a maximum of 3 mL/
minute.
To reduce the risk of side effects, the infusion rate in the first
30 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.
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, tell the doctor or nurse.
The rate of infusion will probably then be slowed until you
feel better. The rate of infusion may then be cautiously
increased. If you feel particularly unwell during an infusion,
the infusion may be stopped, but it may be resumed when
you are feeling better.
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 or
within 2 hours.
This product is for single injection only. Safely throw away
any used materials or unused solution. Your doctor will do
this.
If you use more Vigam Liquid than you should
If you use more Vigam Liquid than you should there is no
cause for alarm. However, if you feel unwell afterwards or
have any discomfort, tell your doctor.

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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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