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Package leaflet: Information forthe user

Intratect® 100 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.

What is in this leaflet:

1.    What Intratect 100 g/l is and what it is used for

2.    What you need to know before you use Intratect 100 g/l

3.    Howto use Intratect 100 g/l

4.    Possible side effects

5.    Howto store Intratect 100 g/l

6.    Contents of the pack and other information

1. What Intratect 100 g/l is and what it is used for

Intratect 100 g/l 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 100 g/l 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 100 g/l can restore normal values when blood levels of Immunoglobulin G are low.

Intratect 100 g/l 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)

-    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 100 g/l 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. What you need to know before you use Intratect 100 g/l Do not use Intratect 100 g/l:

-    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.

Warning and precautions

Talktoyourdoctor, pharmacist or nurse before using Intratect 100 g/l 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 100 g/l recently (you will need to be observed during the infusion and for at least 20 minutes afteryour infusion)

-    have had a reaction toother 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 100 g/l)

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 100 g/l to make sure that you do not suffer a reaction. Your doctor will make sure that the rate at which Intratect 100 g/l is infused is suitable foryou.

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 100 g/l, tel I your doctor immediately The rate of infusion can be slowed or the infusion can be stopped altogether.

Information on transmission of infectious agents

IntratectlOO g/l is madefrom 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 100 g/l

Tell your doctor if you are using, have recently used or might use any other medicines.

Intratect 100 g/l 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 100 g/l can affect blood tests. If you have a blood test after receiving Intratect 100 g/l, please inform the person taking your blood or your doctor that you have received Intratect 100 g/l.

Pregnancyand breast-feeding

If you are pregnant or breast-feeding, thin kyou may be pregnant or are planning to have a baby, askyour doctor for advice before taking this medicine.

Your doctor will decide if Intratect 100 g/l may be used during pregnancy and breast-feeding.

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 100 g/l

Intratect 100 g/l 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 100 g/l 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 100 g/l.

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.

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.

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 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.

¥ The following information is intended for healthcare professionals only:

Method of administration

Intratect 100 g/l 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.

Replacement Therapy:

In patients who have tolerated the infusion rate of 1.9 ml/kg/h well, the rate may be gradually increased to 6 ml/kg/h and if still tolerated well, it may be further increased gradually to a maximum of 8 ml/kg/h.

In general, dosage and infusion rates have to be individually tailored according to the patient's needs.

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 100 g/l 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 100 g/l 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 4 - 8 ml (0.4 - 0.8 g)/kg body weight (b.w.) given once, followed by at least 2 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 2 - 8 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 2 - 4 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 2-4 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:

-    8 -10 ml (0.8 -1 g)/kg b.w. on day one, this dose may be repeated once within 3 days,

-    4 ml (0.4 g)/kg b.w. given daily for two to five days.The treatment can be repeated if relapse occurs.

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.

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 100 g/l 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 100 g/l 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 100 g/l, 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.

Tell your doctor straight away if you notice any of the following very rare effects:

-    severe chest pain or chest pressure (heart attack, cardiac infarction)

-    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)

The following side effects have been reported during clinical trials with Intratect 100 g/l:

Common: may occur with up to 1 in 10 infusions

-    palpitations

-    discomfort

-    infusion related reaction

-    headache

-    joint pain

-    back pain

-    bone pain

Uncommon: may occur with up to 1 in 100 infusions

-    hypersensitivity

-    fatigue

-    chills

-    hypothermia

-    sensory disturbance

-    muscle pain

-    pain of skin

-    rash

-    exaggerated blood flow in organs or tissues

-    high blood pressure

-    diarrhoea

-    abdominal pain

Human immunoglobulin preparations in general may cause the following additional side effects:

-    a sudden fall in blood pressure (rare: may affect up to 1 in 1,000 people)

-    temporary meningitis (inflammation of the brain lining) (rare)

-    eczema-like symptoms (temporary skin reactions) (rare)

-    an increase in the serum creatinine (a waste product) and/or sudden kidney failure (rare)

-    severe chest pain or chest pressure (angina pectoris) (very rare: may affect up to 1 in 10,000 people)

-    shivering or trembling (rigors) (very rare)

-    difficulty in breathing (dyspnoea) (very rare)

-    dizziness

-    fever

-    vomiting

-    feeling sick (nausea)

-    low blood pressure

-    decrease in the number of red blood cells due to a breakdown of these cells in the blood vessels (haemolytic anaemia)

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 side effects not listed in this leaflet.

5.    How to store Intratect 100 g/l

Keep this medicine out of the sight and reach of children.

Your pharmacist or doctor knows how to store Intratect 100 g/l.

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 100 g/l contains

-    The active substance of Intratect 100 g/l is human immunoglobulin for intravenous administration.

Intratect 100 g/l contains 100 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 1800 micrograms/ml.

-    The other ingredients are: glycine and water for injections.

What Intratect 100 g/l looks like and the contents of the pack

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Biotest Pharma GmbH Landsteinerstrasse 5 63303 Dreieich Germany

Tel.: + 49 6103 801-0 Fax: + 49 6103 801-150

This leaflet was last revised in June 2013.