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PACKAGE LEAFLET: INFORMATION FORTHE USER

Intratect® 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.    Howto use INTRATECT

4.    Possible side effects

5.    Howto store INTRATECT

6.    Further 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”).

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 (0-18years) who do not have sufficient antibodies (replacement therapy) in cases of:

-    Patients born with lack of antibodies (primary immunodeficiency syndromes) 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 haematopoietic stem cell transplantation (HSCT).

-    Congenital AIDS with recurrent bacterial infections.

INTRATECT is also used in adults, and children and adolescents (0-18years) 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-Barre 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 ofthe 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 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 duringyour infusion and for an hour afteryour infusion has stopped)

-    have been given INTRATECT recently (you will need to be observed during the infusion and for at least 20 minutes afteryour 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 sufferfrom 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 dots).

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 ofthe following signs of a reaction, i.e. sudden wheeziness, difficulty in breathing, fast pulse, swelling ofthe eyelids, face, lips, throat or tongue, rash or itching (especially affectingyour 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 somevaccines 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. Ifyou 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

Ask your doctor for advice before taking any 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. HOWTO 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 3-4 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 Barre 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.

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.

| 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 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.

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 repeated if relapse occurs.

Guillain Barre syndrome:

8 ml (0.4g)/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 acetylsa licylic acid.