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INTRATECT 50 G/L SOLUTION FOR INFUSION

Active substance(s): HUMAN NORMAL IMMUNOGLOBULIN / HUMAN NORMAL IMMUNOGLOBULIN / HUMAN NORMAL IMMUNOGLOBULIN

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Intratect

®

50 g/l solution for infusion
Human normal immunoglobulin (IVIg)
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or
nurse.
• 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.
2.
3.
4.
5.
6.

What Intratect is and what it is used for
What you need to know before you use Intratect
How to use Intratect
Possible side effects
How to store Intratect
Contents of the pack and other information

1. What Intratect is and what it is used for
Intratect is an extract of human blood which contains antibodies (the
body’s own defensive substances) to diseases, available in the form of an
infusion solution. The solution is ready for infusion into a vein (a “drip”).

185807 005

Intratect contains human normal immunoglobulin (antibodies) from blood
donated by a broad spectrum of the population and is likely to contain
antibodies to most common infectious diseases. Adequate doses of
Intratect can restore normal values when blood levels of Immunoglobulin
G are low.
Intratect is used in adults, and children and adolescents (0-18 years) who
do not have sufficient antibodies (replacement therapy) in cases of:
• Patients born with lack of antibodies (primary immunodeficiency
syndromes)
• Hypogammaglobulinemia and repeated bacterial infections in patients
with chronic lymphocytic leukaemia, in whom prophylactic antibiotics
have failed

185.807.005.s.1_12.indd 1

• Hypogammaglobulinaemia and repeated bacterial infections in plateau
phase multiple myeloma patients who have failed to respond to pneumococcal
immunisation
• Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem
cell transplantation (HSCT)
• Congenital AIDS with recurrent bacterial infections
Intratect is also used in adults, and children and adolescents (0-18 years) to treat
inflammatory disorders (immunomodulation) such as:
• Primary immune thrombocytopenia (ITP, where a patient has reduced blood
platelets) when the patient will have surgery in the near future or is at risk of
bleeding
• Guillain-Barré syndrome (a disease that damages nerves and may lead to
generalised palsy)
• Kawasaki disease (a disease in children which causes inflammations of several
organs of the body and where the arteries in the heart become enlarged)
2. What you need to know before you use Intratect
Do not use Intratect
• If you are allergic to human immunoglobulin or any of the other ingredients of
this medicine (listed in section 6). An allergic reaction may include rash, itching,
difficulty breathing or swelling of the face, lips, throat or tongue.
• If you have an immunoglobulin A deficiency, especially if you have antibodies
against immunoglobulin A in your blood.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Intratect if you
• suffer from a condition with low antibody levels in your blood (hypo- or
agammaglobulinemia)
• have not received this medicine before or if there has been a long interval (e.g.
several weeks) since you last received it (you will need to be closely monitored
during your infusion and for an hour after your infusion has stopped)
• have been given Intratect recently (you will need to be observed during the
infusion and for at least 20 minutes after your infusion)
• have had a reaction to other antibodies (in rare cases you may be at risk of
allergic reactions)
• have or have had a kidney disorder
• have received medicines that may harm your kidneys (if your kidney function
worsens, you may need to stop treatment with Intratect)
Your doctor will take special care if you are overweight, elderly, diabetic, or if you
suffer from high blood pressure, low blood volume (hypovolaemia), if your blood

is thicker than normal (high blood viscosity), if you have been bed-ridden or
immobile for some time (immobilisation) or if you have problems with your blood
vessels (vascular diseases) or other risks for thrombotic events (blood clots).
Please note - reactions
You will be carefully observed during the infusion period with Intratect to make
sure that you do not suffer a reaction. Your doctor will make sure that the rate at
which Intratect is infused is suitable for you.
If you notice any of the following signs of a reaction, i.e. sudden wheeziness,
difficulty in breathing, fast pulse, swelling of the eyelids, face, lips, throat or
tongue, rash or itching (especially affecting your whole body) during the infusion
of Intratect, tell your doctor immediately. The rate of infusion can be slowed or the
infusion can be stopped altogether.
Information on transmission of infectious agents
Intratect is made from human plasma (the liquid part of blood). When medicines
are made from human blood or plasma, it is important to prevent infections
being passed on to patients. Blood donors are tested for viruses and infections.
Manufacturers of these products also process the blood or plasma to inactivate or
remove viruses. Despite these measures, when medicines prepared from human
blood or plasma are given, the possibility of passing on infection cannot be totally
excluded.
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.
Other medicines and Intratect
Tell your doctor if you are using, have recently used or might use any other
medicines.
Intratect can reduce the effectiveness of some vaccines such as:
• measles
• rubella
• mumps
• chicken pox
You may have to wait up to 3 months before you can have some vaccines and up
to a year before you can have a measles vaccine.

Effects on blood tests

Intratect can affect blood tests. If you have a blood test after receiving Intratect,
please inform the person taking your blood or your doctor that you have received
Intratect.
Pregnancy and breast-feeding

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.
Your doctor will decide if Intratect may be used during pregnancy and breastfeeding.
Driving and using machines

The ability to drive and operate machines may be impaired by some adverse
reactions associated with Intratect. Patients who experience adverse reactions
during treatment should wait for these to resolve before driving or operating
machines
3. How to use Intratect
Intratect is intended for intravenous administration (infusion into a vein). It is
given to you by a doctor or nurse. The dose will depend on your condition and your
body weight. Your doctor will know the right amount to give you.
At the beginning of your infusion you will receive Intratect at a slow rate. Your
doctor may then gradually increase the infusion rate.
The infusion rate and its frequency are dependent on the reason you are being
given Intratect.
Use in children and adolescents

The posology in children and adolescents (0-18 years) is not different to that of
adults as the posology for each indication is given by body weight and adjusted to
the clinical outcome of the above mentioned conditions.



PACKAGE LEAFLET: INFORMATION FOR THE USER

The following information is intended for healthcare professionals only:
Method of administration

Intratect is intended for intravenous infusion. During the infusion, an initial rate
of no more than 1.4 ml/kg/h for 30 minutes must not be exceeded. If well
tolerated, the rate of administration may gradually be increased to a maximum of
1.9 ml/kg/h for the remainder of the infusion.
Special Precautions

Certain severe adverse drug reactions may be related to the rate of infusion. The
recommended infusion rate given under "Method of administration" must be
closely followed. Patients must be closely monitored and carefully observed for
any symptoms throughout the infusion period.
Any infusion-related adverse events should be treated by lowering the infusion
rate or by stopping the infusion.
In all patients, intravenous immunoglobulin administration requires:
adequate hydration prior to the initiation of the infusion of intravenous
immunoglobulin
monitoring of urine output
monitoring of serum creatinine levels
avoidance of concomitant use of loop diuretics
It is strongly recommended that every time Intratect is administered to a patient,
the name and batch number of the product is recorded.
In case of shock, standard medical treatment for shock should be implemented.
Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed
with other medicinal products.

For replacement therapy in patients with a weak immune system
(immunodeficiency) and for patients with congenital AIDS, the infusion is given
every 3 to 4 weeks.

Instructions for handling and disposal

To treat inflammatory disorders (immunomodulation) the infusion may be given
as followed:

The product must be brought to room or body temperature before use.

Primary immune thrombocytopenia: for the treatment of an acute episode an
infusion is given on day 1, this dose may be repeated once in 3 days. Alternatively a
lower dosage may be given daily for 2 to 5 days.

Do not use Intratect after the expiry date which is stated on the label and outer
carton.

The solution should be clear or slightly opalescent and colourless or pale yellow.
Solutions that are cloudy or have deposits should not be used.
The product once opened should be used immediately.

Any unused product or waste material should be disposed of in accordance with
local requirements.
Dosage

The dose and dosage regimen is dependant on the indication. In replacement
therapy the dose may need to be individualised for each patient dependent on the
pharmacokinetic and clinical response. The following dose regimens are given as
a guideline:
Replacement therapy in primary immunodeficiency syndromes:

The dose regimen should achieve a trough level of IgG (measured before the next
infusion) of at least 5 - 6 g/l. Three to six months are required after the initiation
of therapy for equilibration to occur.
The recommended starting dose is 8 - 16 ml (0.4 - 0.8 g)/kg body weight (b.w.)
given once, followed by at least 4 ml (0.2 g)/kg b.w. every three to four weeks.
The dose required to achieve a trough level of 5-6 g/l is of the order of 4 - 16 ml
(0.2 - 0.8 g)/kg b.w./month. The dosage interval when steady state has been
reached varies from 3 - 4 weeks.
Trough levels should be measured in order to adjust the dose and dosage interval.
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; congenital AIDS with recurrent bacterial infections:

The recommended dose is 4 - 8 ml (0.2 - 0.4 g)/kg b.w. every three to four weeks.
Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell
transplantation
The recommended dose is 4-8 ml (0.2-0.4 g)/kg every three to four weeks. The
trough levels should be maintained above 5 g/l.
Primary immune thrombocytopenia:

There are two alternative treatment schedules:
16 - 20 ml (0.8 - 1 g)/kg b.w. on day one, this dose may be repeated once within
3 days,
8 ml (0.4 g)/kg b.w. given daily for two to five days.
The treatment can be repeated if relapse occurs.
09.02.16 13:46

Guillain Barré syndrome:

8 ml (0.4 g)/kg b.w./day over 5 days.
Kawasaki disease:

32 - 40 ml (1.6 - 2.0 g)/kg b.w. should be administered in divided doses over
two to five days or 40 ml (2.0 g)/kg b.w. as a single dose. Patients should receive
concomitant treatment with acetylsalicylic acid.



The following information is intended for healthcare professionals only:
The dosage recommendations are summarised in the following table:
Indications

Dose

Frequency of infusions

Replacement therapy in
primary immunodeficiency

starting dose:
0.4-0.8 g/kg
thereafter:
0.2-0.8 g/kg every 3-4 weeks to obtain IgG
trough level of at least 5-6 g/l

Replacement therapy in
secondary immunodeficiency

0.2-0.4 g/kg

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

Congenital AIDS

0.2-0.4 g/kg

every 3-4 weeks

Hypogammaglobulinaemia
(< 4 g/l) in patients after
allogeneic haematopoietic
stem cell transplantation

0.2-0.4 g/kg

every 3-4 weeks to obtain IgG
trough level above 5 g/l

Immunomodulation
Primary immune
thrombocytopenia

0.8-1 g/kg
or
0.4 g/kg/d

on day 1; possibly repeated
once within 3 days
for 2-5 days

Guillain Barré syndrome

0.4 g/kg/d

for 5 days

Kawasaki disease

1.6–2 g/kg

in divided doses over 2-5 days in
association with acetylsalicylic
acid

or
2 g/kg

Paediatric population

in one dose in association with
acetylsalicylic acid

The posology in children and adolescents (0-18 years) is not different to that of
adults as the posology for each indication is given by body weight and adjusted to
the clinical outcome of the above mentioned conditions.

Guillain Barré syndrome: the infusion is given for 5 days.

The following side effects have been reported during clinical trials with Intratect:

Kawasaki disease: the infusion should be administered over 2 to 5 days or as a
single dose.

Common: may occur with up to 1 in 10 infusions:

For hypogammaglobulinaemia in patients after allogeneic haematopoietic stem
cell transplantation to treat infection and prevent rejection, the infusion is given
every 3 to 4 weeks. Where there is lack of antibody production, the infusion is
given every month until there are normal levels of antibodies.
If you miss an infusion

Intratect will be given to you in hospital by a doctor or nurse so you are unlikely
to miss an infusion. However, tell your doctor if you think you have missed an
infusion.
If you receive more Intratect than you should

An overdose can lead to fluid overload and increased thickness of the blood,
especially in elderly patients or patients with impaired heart or kidney function. If
you think you have been given too much Intratect, tell your doctor, who will decide
if the infusion should be stopped and an alternative treatment given.
If you have any further questions on the use of this medicine, ask your doctor or
nurse.
4. Possible side effects
Like all medicines, this medicine can cause side-effects, although not everybody
gets them.
Frequencies outlined below have been generally calculated based on number of
patients treated if not otherwise specified, e.g. by number of infusions.
If you notice any of the following effects, tell your doctor immediately:







rash,
itching,
wheezing,
difficulty in breathing,
swelling of the eyelids, face, lips, throat or tongue,
extremely low blood pressure with symptoms like dizziness, confusion,
fainting, fast pulse

This can be an allergic or a serious allergic reaction (anaphylactic shock) or a
hypersensitivity reaction.

185.807.005.s.1_12.indd 2

• headache
• fever

Uncommon: may occur with up to 1 in 100 infusions














mildly increased breakdown of red blood cells in the blood vessels (haemolysis)
disturbed sense of taste
high blood pressure
inflammation of a superficial vein
feeling sick (nausea)
vomiting
abdominal pain
rash with raised spots
chills
feeling hot
increased body temperature
positive blood test for antibodies against red blood cells

The following side effects have been reported spontaneously with Intratect:
Not known (frequency cannot be estimated from the available data)









severe chest pain or chest pressure (angina pectoris)
shivering or trembling (rigors)
(anaphylactic) shock, allergic reaction
difficulty in breathing (dyspnoe)
low blood pressure
back pain
decrease in number of white blood cells (leukopenia)

Human immunoglobulin preparations in general may cause the following
additional side effects:
uncommon (may affect up to 1 in 100 patients):







headache, dizziness
nausea, vomiting
joint pain, moderate low back pain
low blood pressure
chills, fever
allergic reactions

Rare (may affect up to 1 in 1,000 patients)
• a sudden fall in blood pressure in isolated cases an anaphylactic shock
• temporary skin reactions
Very rare (may affect up to 1 in 10,000 patients)
• thromboembolic reactions such as
- heart attack (cardial infarction),
- stroke,
- blood clots in blood vessels in the lung (pulmonary embolism),
- blood clots in a vein (deep vein thromboses)

Intratect contains 50 g/l human plasma proteins of which at least 96% is
immunoglobulin G (IgG). The IgG subclass distribution is approx. 57% IgG1, 37%
IgG2, 3% IgG3 and 3% IgG4. The maximum immunoglobulin A (IgA) content is
900 micrograms/ml.
The other ingredients are: glycine and water for injections.
What Intratect looks like and the contents of the pack

Intratect is a solution for infusion. The solution is clear or faintly opalescent (milky
colours like an opal) and colourless to pale yellow.

Not known (frequency cannot be estimated from the available data)
• temporary acute inflammation of the protective membranes covering the brain
and spinal cord (meningitis)
• results of blood tests which indicate that the renal function is impaired and/or
sudden kidney failure
• decrease in the number of red blood cells due to a breakdown of these cells in
the blood vessels ((reversible) haemolytic reactions)

Pack containing 1 vial with 1 g in 20 ml of solution
Pack containing 1 vial with 2.5 g in 50 ml of solution
Pack containing 1 vial with 5 g in 100 ml of solution
Pack containing 1 vial with 10 g in 200 ml of solution

If a side effect occurs, the infusion rate will be decreased or stopped.

Biotest Pharma GmbH
Landsteinerstrasse 5
63303 Dreieich
Germany
Tel.: + 49 6103 801-0
Fax: + 49 6103 801-150
mail@biotest.de

Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This includes
any side effects not listed in this leaflet. You can also report side effects directly via
Yellow Card Scheme
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 Intratect

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

PL 04500/0005
This leaflet was last revised in 02/2016.

Keep this medicine out of the sight and reach of children.
Your pharmacist or doctor knows how to store Intratect.
Keep the vial in the outer carton in order to protect from light.
Do not store above 25°C. Do not freeze.
6. Contents of the pack and other information
What Intratect contains
The active substance of Intratect is human immunoglobulin for intravenous
administration.
09.02.16 13:46

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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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