Intratect 50 g/l, solution for infusion

• 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.

1. What Intratect is and what it is used for
2. What you need to know before you use Intratect
3. How to use Intratect
4. Possible side effects
5. How to store Intratect
6. Contents of the pack and other information

• Patients who are born with a lack of antibodies (primary immunodeficiency syndromes, PID)
• Acquired lack of antibodies (secondary immunodeficiency syndrome, SID) in patients who suffer from severe or recurrent infections and ineffective antimicrobial treatment with either proven specific antibody failure or low IgG level (< 4 g/l)

• 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) together with acetylsalicylic acid
• Chronic inflammatory demyelinating polyneuropathy (CIDP). This is a chronic disease that is characterised by inflammation of the peripheral nerves that causes muscle weakness and/or numbness mainly in the legs and upper limbs.
• Multifocal motor neuropathy (MMN). This is a rare condition characterized by slow progressive asymmetrical weakness of limbs without sensory loss.

• if you are allergic to human immunoglobulin or any of the other ingredients of this medicine (listed in section 6).
• if you have an immunoglobulin A deficiency, especially if you have antibodies against immunoglobulin A in your blood, because this might lead to anaphylaxis.

Talk to your doctor, pharmacist or nurse before using Intratect if you

• 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 an active infection or underlying chronic inflammation
• 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).

You will be carefully observed during the infusion period with Intratect to make sure that you do not suffer a reaction (e.g. anaphylaxis). 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. headache, flushing, chills, muscle pain, wheezing, rapid heartbeat, lower back pain, nausea, low blood pressure during the infusion of Intratect, tell your doctor immediately. The rate of infusion can be slowed or the infusion can be stopped altogether.

After the Intratect infusion you might have a low concentration of white blood cells (neutropenia) which resolves spontaneously within 7 to 14 days. If you are not sure about symptoms, please contact your doctor.

In very rare cases transfusion-related acute lung injury (TRALI) can occur after receiving immunoglobulins. This will lead to non-heart related accumulation of fluid in the air spaces of the lungs (non-cardiogenic pulmonary oedema). You will experience severe difficulty in breathing (respiratory distress), rapid breathing (tachypnoe), abnormally low level of oxygen in the blood (hypoxia), and increased body temperature (fever). Symptoms typically appear within 1 to 6 hours after receiving treatment. Tell your doctor immediately if you notice such reactions during the infusion of Intratect, he will stop the infusion immediately.

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.

It is strongly recommended that every time you are given a dose of Intratect your doctor records the name and batch number of the product. The batch number provides information about the particular starting materials of your medicine. If necessary, a connection between you and the starting material used can thereby be made.

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.

Please avoid the concomitant use of loop diuretics together with Intratect.

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.

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 breast-feeding.

Intratect has a minor influence on the ability to drive and use machines. Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines

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 (primary or secondary immunodeficiency) the infusion is given every 3 to 4 weeks.

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

• 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.
• Guillain Barré syndrome: the infusion is given for 5 days.
• Kawasaki disease: the infusion should be administered as a single dose together with acetylsalicylic acid.
• Chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy: the treatment effect should be evaluated after each cycle of administration.

An overdose can lead to fluid overload and increased thickness of the blood, especially in children, elderly patients or patients with impaired heart or kidney function. Make sure that you drink adequate fluids so you are not dehydrated and tell your doctor about any medical problems. 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.

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.

• 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.

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

• 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

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 (dyspnoea)
• low blood pressure
• back pain
• decrease in number of white blood cells (leukopenia)

• chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, joint pain, low blood pressure and moderate low back pain
• decrease in the number of red blood cells due to a breakdown of these cells in the blood vessels ((reversible) haemolytic reactions) and (rarely) haemolytic anaemia requiring transfusion
• (rarely) a sudden fall in blood pressure and, in isolated cases, anaphylactic shock
• (rarely) transient cutaneous reactions (including cutaneous lupus erythematosus - frequency unknown)
• (very rarely) thromboembolic reactions such as heart attack (myocardial infarction), stroke, blood clots in blood vessels in the lung (pulmonary embolism), blood clots in a vein (deep vein thromboses)
• cases of temporary acute inflammation of the protective membranes covering the brain and spinal cord (reversible aseptic meningitis)
• cases of blood test results which indicate that the renal function is impaired and/or sudden kidney failure
• cases of Transfusion Related Acute Lung Injury (TRALI) see also section “Warnings and precautions”

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

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance of Intratect is human immunoglobulin for intravenous administration.
  Intratect contains 50 g/l human normal immunoglobulin 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.

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

20 ml, 50 ml, 100 ml or 200 ml of solution in a vial (Type II glass) with a stopper (bromobutyl) and a cap (aluminium).

Pack with 1 vial with 20 ml, 50 ml, 100 ml or 200 ml solution.

Pack with 3 vials with 200 ml solution.

Not all pack sizes may be marketed.