INTRATECT 50 G/L SOLUTION FOR INFUSION

Active substance: HUMAN NORMAL IMMUNOGLOBULIN

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50 g/l solution for infusion
Human normal immunoglobulin (IVIg)
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 INTRATECT is and what it is used for
2. Before you use INTRATECT
3. How to use INTRATECT
4. Possible side effects
5. How to store INTRATECT
6. Further information

185807 003

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”).
INTRATECT is 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 syn dromes) such as:
- hypogammaglobulinemia and repeated bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed.
- Hypogammaglobulinaemia and repeated bacterial infections in plateau phase multiple myeloma patients who have failed to respond to
pneumococcal immunisation.
- Hypogammaglobulinaemia in patients after allogeneic haematopoi etic 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 the nerves in the whole body)
- 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. BEFORE YOU USE INTRATECT
You should not be given INTRATECT if you
- are allergic (hypersensitive) to human immunoglobulin or any of the other ingredients of INTRATECT (see list of ingredients in Section 6). An allergic reaction
may include rash, itching, difficulty breathing or swelling of the face, lips, throat
or tongue.
- have an immunoglobulin A deficiency, especially if you have antibodies against
immunoglobulin A in your blood
Take special care with INTRATECT (and talk to your doctor) if you
- suffer from a condition with low antibody levels in your blood (hypo- or agam maglobulinemia)
- 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 al lergic 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.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines
including medicines obtained without a prescription.

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.

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 is dependent on the reason you are being given
INTRATECT.
Use in children
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.
For replacement therapy in patients with a weak immune system (immunodeficiency) and for patients with congenital AIDS, the infusion is given every 2 or 34 weeks.
To treat inflammatory disorders (immunomodulation) the infusion may be given
as followed:
Idiopathic Thrombocytopenic Purpura: 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.
Guillain Barré syndrome: the infusion is given for 5 days.
Kawasaki disease: the infusion should be administered over 2 to 5 days or as a single dose.

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.

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.

Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Your doctor will decide if INTRATECT may be used during pregnancy and breastfeeding.

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.



PACKAGE LEAFLET: INFORMATION FOR THE USER

THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR 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 immu noglobulin
- 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.
Instructions for handling and disposal
Do not use INTRATECT after the expiry date which is stated on the label and outer
carton. The expiry date refers to the last day of that month.
The product must be brought to room or body temperature before use.
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 re peated if relapse occurs.
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.

Indications

Dose

Replacement therapy in
primary immunodeficiency

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

Frequency of infusions

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

Immunomodulation
Primary immune
thrombocytopenia

0.8 – 1 g/kg

Guillain Barré syndrome

0.4 g/kg/d

Kawasaki disease

1.6 – 2 g/kg

or
0.4 g/kg/d

or
2 g/kg

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

on day 1; possibly repeated once
within 3 days
for 2 – 5 days
for 5 days
in divided doses over 2-5 days in
association with acetylsalicylic
acid
in one dose in association with
acetylsalicylic acid

Paediatric population
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.



The dosage recommendations are summarised in the following table:

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 product, ask your doctor or
nurse.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, INTRATECT can cause side-effects, although not everybody gets
them.
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, fast pulse
This can be an allergic or a serious allergic reaction (anaphylactic shock) or a hypersensitivity reaction.
Tell your doctor straight away if you notice any of the following very rare effects:
- severe chest pain or chest pressure (heart attack, cardiac infarct)
- weakness, paralysis or numbness on one side of the body, loss of vision in one or
both eyes, speech difficulties (stroke)
- cough, chest pain, rapid breathing, rapid heart rate (pulmonary embolism)
- swelling, pain, redness of the leg (deep vein thrombosis)
Occasionally, the following may occur:
- chills
- headache
- dizziness
- fever
- vomiting
- feeling sick (nausea)
- joint pain
- low blood pressure
- moderate low back pain

Rarely, the following may occur:
- a sudden fall in blood pressure
- temporary meningitis (inflammation of the brain lining)
- decrease in the number of red blood cells due to a breakdown of these cells in
the blood vessels (haemolytic anaemia)
- eczema-like symptoms (temporary skin reactions)
- an increase in the serum creatinine (a waste product) and/or sudden kidney
failure
Other reported side effects:
- severe chest pain or chest pressure (angina pectoris) (very rare)
- shivering or trembling (rigors) (very rare)
- decreased blood pressure (very rare)
- back pain (very rare)
- difficulty in breathing (dyspnoea) (very rare)
If a side effect occurs, the infusion rate will be decreased or stopped.
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.
5. HOW TO STORE INTRATECT
Keep out of the reach and sight 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. FURTHER INFORMATION
What INTRATECT contains
- The active substance of INTRATECT is human immunoglobulin for intravenous
administration.
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
2000 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.

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
Marketing Authorisation Holder and Manufacturer
Biotest Pharma GmbH
Landsteinerstrasse 5
63303 Dreieich
Germany
Tel.: + 49 6103 801-0
Fax: + 49 6103 801-150
mail@biotest.de
PL 04500/0005
This leaflet was last approved in 02/2012.

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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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