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ARAGAM 50 MG/ML SOLUTION FOR INFUSION

Active substance(s): HUMAN NORMAL IMMUNOGLOBULIN

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Aragam
PACKAGE LEAFLET: INFORMATION FOR THE USER

Aragam 50 mg/ml solution for infusion
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 any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you. Do 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, please tell your doctor
or pharmacist.
In this leaflet:
1. What Aragam is and what it is used for
2. Before you use Aragam
3. How to use Aragam
4. Possible side effects
5. How to store Aragam
6. Further information
1. WHAT ARAGAM IS AND WHAT IT IS USED FOR
Aragam is a solution for infusion which contains the human
protein immunoglobulin. Immunoglobulins are antibodies
and normal constituents of human blood and they protect you
from infections. Aragam is used to raise antibody levels in
your blood when the antibody level is too low or if you need
additional antibodies in certain diseases. The administration
of antibodies can also have an effect in case of a disrupted
immune system.
Aragam is used for:
Replacement therapy (treatment of patients who do not
have sufficient antibodies) in adults, and children and
adolescents (0-18 years) in:
• Primary immunodeficiency syndromes (diseases which are
caused by a hereditary disorder of the immune system) with
impaired antibody production.
- Hypogammaglobulinemia (complete or partial lack of the
immune response caused by a complete or partial deficit
of antibodies) and recurrent bacterial infections in
patients with chronic lymphocytic leukaemia (malignant
bleeding disorder), in whom prophylactic antibiotics have
failed.
- Hypogammaglobulinemia and recurrent bacterial
infections in plateau phase multiple myeloma (malignant
bone marrow tumour) patients who have failed to respond
to pneumococcal immunisation.
- Hypogammaglobulinemia in patients after allogenic
haematopoietic stem cell transplantation (HSCT).
- Congenital AIDS with recurrent bacterial infections.
Immunomodulation (influencing a disrupted immune
system) in adults, and children and adolescents (0-18 years)
in:
• Primary immune thrombocytopenia (ITP, a bleeding
disorder caused by a reduced number of platelets), in
patients at risk of bleeding or prior to surgery to correct the
platelet count.
• Guillain Barré syndrome (this is a syndrome of unknown
cause at which muscle paralysis occur).
• Kawasaki disease (a very rare disease in children with
defects of the skin, mucous membrane, blood vessels of the
brain and coronary arteries).
2. BEFORE YOU USE ARAGAM
Do not use Aragam
• if you are allergic (hypersensitive) to immunoglobulins or
any of the other ingredients of Aragam.
• if you have immunoglobulin A (IgA) deficiency with
antibodies against IgA. Aragam contains a small amount of
IgA which might cause an allergic reaction.
If an allergic reaction occurs, administration of Aragam
should be discontinued immediately.
Take special care with Aragam
You will be observed carefully during the infusion period to
detect potential adverse reactions (unwanted side effects).
Certain adverse reactions may be related to the rate of
infusion, therefore your doctor makes sure that the infusion
rate is suitable for you. If you experience a reaction during
infusion, tell your doctor immediately. The doctor will decide
if the infusion will be discontinued.
Certain adverse reactions may occur more frequently:
• in case of high rate of infusion.
• if you have hypo- or agammaglobulinemia (a complete or
partial lack of antibodies) with or without IgA deficiency.
• if you receive Aragam for the first time.
• in rare cases, when the human normal immunoglobulin
product is replaced by another product or there has been a
long interval since the previous infusion.
Risk factors during treatment with Aragam
Please tell your doctor if any of the following factors
concerns you, since these might be risk factors during the
treatment with Aragam. In particular, tell your doctor if you
have:
• renal insufficiency (when your kidneys are not working
well).
• nephrotoxic (toxic for the kidney) medication.

• diabetes (abnormally high glucose levels in the blood)
• history of vascular (blood vessel) diseases or thrombosis
(formation of a clot inside a blood vessel).
• hypertension.
• overweight.
• diseases which increase blood viscosity (thickness of the
blood).
• hypovolemia (a decrease in circulating blood volume).
• advanced age (over 65).
While using Aragam the following should be taken into
account
• adequate hydration before infusion of Aragam.
• follow-up of urine output.
• follow-up of serum creatinine levels (a substance which is
an indicator of the activity of the kidneys).
• avoiding concomitant use of certain diuretics (so called
loop diuretics).
Effects on blood tests
If you will have blood tests taken, please tell your doctor that
you are using Aragam, since Aragam contains antibodies and
this may result in misleading positive results in antibody
tests.
Using other medicines
 Do not mix Aragam with other medicinal products.
 Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including medicines
obtained without a prescription.
Vaccination
Tell your doctor if you have planned to take a vaccination.
Aragam may impair the efficacy of vaccines such as measles,
rubella, mumps and varicella. After using Aragam, an
interval of three months should elapse before vaccination
with these vaccines. In case of measles, this impairment may
persist for up to one year.
Using Aragam with food and drink
While using Aragam adequate hydration before infusion
should be taken into account.
Fertility, pregnancy and breast-feeding
 Clinical experience with immunoglobulins suggests that no
harmful effects on fertility are to be expected.
 In pregnant women the safety of this medicine has not been
investigated. Therefore caution should be taken with pregnant
women and women who are breast-feeding. Clinical
experience with immunoglobulins indicate that these are not
expected to have a harmful effect on the course of a
pregnancy nor on the foetus (unborn child) or the newborn.
 Immunoglobulins are excreted in breast-milk and can
contribute to the transfer of protective antibodies to the
newborn.
 Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
The ability to drive and operate machines may be impaired
by some adverse reactions associated with Aragam. Patients
who experience adverse reactions during treatment should
wait for these to resolve before driving or operating
machines.
Important information about some of the ingredients of
Aragam
Aragam contains glucose 50 mg/ml (5 %). Please note this
may increase your blood glucose levels. If you are a diabetic,
your doctor will decide if there is a need to monitor your
blood glucose levels and a need for insulin, especially if high
doses of Aragam are given.
Special warnings and special precautions for use
 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, and the testing of each
donation and pools of plasma for signs of virus/infections.
Manufacturers of these products also include 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 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.
Batch number control:
It is strongly recommended that every time you receive a
dose of Aragam the name and batch number of the

product are recorded in order to maintain a record of the
batches used.
3. HOW TO USE ARAGAM
 Aragam is given to you by your doctor or nurse. Aragam
may be self administered if it is an approved practice in your
country and when you have been trained sufficiently. Always
use Aragam exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
 Bring Aragam to room or body temperature before use.
Start the intravenous infusion of Aragam as soon as possible
after puncturing the stopper.
 The solution should be clear or slightly opalescent. Do not
use solutions that are cloudy or have deposits. Discard any
unused solution.
Dosage and route of administration
Aragam is intended for infusion into a vein. Dosage will vary
depending on your condition and weight. If you administer
Aragam yourself your doctor will tell you the dose and
infusion rate.
If you use more Aragam than you should
Overdose may lead to fluid overload and hyperviscosity (an
increased thickness of the blood). Tell your doctor
immediately.
If you forget to use Aragam
Tell your doctor immediately and follow his/her instructions.
Do not take a double dose to make up for a forgotten dose.
If you stop using Aragam
If you have any further questions on the use of this product,
ask your doctor
4. POSSIBLE SIDE EFFECTS
Like all medicines, Aragam can cause side effects, although
not everybody gets them.
Occasional side effects
- chills,
- headache,
- dizziness,
- fever,
- vomiting,
- allergic reactions,
- nausea,
- arthralgia (joint pain),
- low blood pressure,
- moderate low back pain.
Rare side effects
- a sudden fall in blood pressure and in isolated cases,
anaphylactic shock, even if you have not experienced
hypersensitive reactions during previous administrations.
- reversible aseptic meningitis (meningitis without
infection).
- reversible haemolytic anemia/haemolysis (disruption of
red cells).
- temporary skin reactions.
- increase in serum creatinine level and/or acute renal failure.
Very rare side effects
- thromboembolic reactions such as myocardial infarction,
stroke, pulmonary embolism and deep vein thromboses
(obstruction of veins).
5. HOW TO STORE ARAGAM
 Keep Aragam out of the reach and sight of children.
 Store Aragam in a refrigerator (2°C – 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from
light.
 Aragam can be stored at or below 25°C up to six months,
for example while travelling, without impairing its efficacy.
The date when taken to room temperature should be marked
on the package. If not used during six months storage at room
temperature the product must be discarded.
 Do not use Aragam after the expiry date which is stated on
the label and the carton after EXP.
6. FURTHER INFORMATION
What Aragam contains
 The active substance is human normal immunoglobulin for
intravenous administration. One ml contains 50 mg
immunoglobulin, of which at least 95% is immunoglobulin G
(IgG).
 The other ingredients are glucose and water for injections.
What Aragam looks like and contents of the pack
 Aragam is a solution for infusion. The solution is a clear or
slightly opalescent, colourless or pale yellow.
 Aragam is supplied in five pack sizes 20 ml, 50 ml, 100 ml,
200 ml and 400 ml, containing 1 g, 2.5 g, 5 g, 10 g and 20 g
of immunoglobulin, respectively. Not all sizes may be
marketed.
Marketing Authorisation Holder
Oxbridge Pharma Ltd, 15 Fitzroy House, Lynwood Drive
Worcester Park, Surrey, KT4 7AT, United Kingdom
Telephone: +44 208 335 4110
Manufacturer
Stichting Sanquin Bloedvoorziening, Plesmanlaan 125
1066 CX Amsterdam, The Netherlands
This leaflet was last approved in September 2012.
The following information is intended for medicinal or
healthcare professionals only:
Posology and method of administration

 Aragam must only be administered intravenously.
 Start the intravenous infusion of Aragam as soon as
possible after puncturing the stopper. If not used
immediately, in-use storage times and conditions prior to use
are the responsibility of the user. The in-use storage times
would normally not be longer than 24 hours at 2°C – 8°C,
unless puncturing has taken place in controlled and validated
aseptic conditions.
 If you need large quantities of Aragam, it is also possible to
transfer the contents of several vials to an Ethyl Vinyl
Acetate container (Clintec EVA-parenteral nutrition
container, Baxter, CE0123). A maximum amount of 800 ml
of Aragam can be transferred to such a container using an
aseptic technique. For microbiological reasons, start the
infusion as soon as possible after transfer of Aragam into the
EVA-container, but not later than three hours after the
transfer.
 The dose and dosage depend on the indication. Aragam is
given as an intravenous infusion under controlled
circumstances at an initial rate of 0.5 ml/kg/hr for 20 minutes.
If well tolerated, the rate of administration may gradually be
increased to 1.0 ml/kg/hr for 20 minutes and thereafter
increased to a maximum of 3.0 ml/kg/hr for the first time
user. In adult patients who receive Aragam on a regular basis
with good tolerance, the infusion rate may be increased to a
maximum of 7.0 ml/kg/hr.
 The dose and dosage regimen is dependent on the
indication.
 In replacement therapy the dosage may need to be
individualized for each patient dependent on the
pharmacokinetic and clinical response. The following dosage
regimens are given as a guideline.
The dosage recommendations are summarised in the
following table:
Frequency of
Indication
Dose
injections
Replacement Therapy
Primary
immunodeficiency
syndromes with impaired
antibody production

Hypogammaglobulinaemia
and recurrent bacterial
infections in patients with
chronic lymphocytic
leukaemia, in whom
prophylactic antibiotics
have failed
Hypogammaglobulinaemia
and recurrent bacterial
infections in plateau phase
multiple myeloma patients
who have failed to respond
to pneumococcal
immunisation
Hypogammaglobulinaemia
in patients after allogenic
haematopoietic stem cell
transplantation
Congenital AIDS with
recurrent bacterial
infections
Immunomodulation
Primary Immune
thrombocytopenia (ITP),
in patients at high risk of
bleeding or prior to
surgery to correct the
platelet count.
Guillain Barré syndrome
Kawasaki disease

starting
dose: 0.4 0.8 g/kg
thereafter:
0.2 0.8 g/kg
0.2 0.4 g/kg

every 3-4 weeks to
obtain IgG trough
level of at least 5-6
g/l
every 3-4 weeks to
obtain IgG trough
level of at least 5-6
g/l

0.2 0.4 g/kg

every 3-4 weeks to
obtain IgG trough
level of at least 5-6
g/l

0.2 0.4 g/kg

every 3-4 weeks to
obtain IgG trough
level of at least
5g/l
every 3-4 weeks

0.2 0.4 g/kg
0.8 1.0 g/kg

on day 1, possibly
repeated once
within 3 days

or
0.4 g/kg/d
0.4 g/kg/d
1.6 – 2
g/kg
or
2 g/kg

for 2-5 days
for 5 days
in several doses for
2 – 5 days in
association with
acetylsalicylic acid
in one dose in
association with
acetylsalicylic acid

Special precautions
It is strongly recommended that every time you receive a
dose of Aragam the name and batch number of the product
are recorded in order to maintain a record of the batches used.
Incompatibilities
Aragam should not be mixed with other medicines.
Instructions for handling and disposal
Bring Aragam to room or body temperature before use. The
solution should be clear or slightly opalescent. Do not use
solutions that are cloudy or have deposits. Discard any
unused solution.

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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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