INTRATECT 50 g/l solution for infusion
Human normal immunoglobulin for intravenous administration
Read all of this leaflet carefully before you start using this medicine
- Keep this leaflet. You may want 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
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 patients who do not have sufficient antibodies (replacement therapy) in cases of:
- Patients born with lack of antibodies (primary immunodeficiency syndromes) such as:
- congenital agammaglobulinemia or hypogammaglobulinemia
- common variable immunodeficiency
- severe combined immunodeficiencies
- Wiskott Aldrich syndrome
- Patients with blood diseases that cause recurrent infections and a lack of antibody production such as:
- myeloma
- chronic lymphocytic leukaemia with severe secondary hypogammaglobulinemia
- children born with AIDS and frequent infections
INTRATECT is also used to treat inflammatory disorders (immunomodulation) such as:
- 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)
- Idiopathic thrombocytopenic purpura (ITP, where a patient has reduced blood platelets) when the patient will have surgery in the near future or is at risk of bleeding
INTRATECT is also used against infection after bone marrow transplantation.
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 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.
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.
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
Ask your doctor for advice before taking any medicine.
Your doctor will decide if INTRATECT may be used during pregnancy and breast-feeding.
Driving and using machines
INTRATECT has no known effects on your ability to drive or use machines.
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 dependant on the reason you are being given INTRATECT.
For replacement therapy in patients with a weak immune system (immunodeficiency) and for children with 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, which 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 3 to 7 days.
Kawasaki disease: the infusion should be administered over 2 to 5 days or as a single dose.
For bone marrow transplantation to treat infection and prevent rejection, the infusion is given every week for up to 3 months. 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 reduced 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.
Possible Side-Effects
Like all medicines, INTRATECT can have 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
- fever
- vomiting
- feeling sick (nausea)
- joint pain
- low blood pressure
- mild lower 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 (dyspnoe) (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.
How To Store Intratect
Keep out of the reach and sight of children.
Your pharmacist or doctor knows how to store INTRATECT.
It should be kept in the outer carton to protect it from light.
Do not store above 25°C. Do not freeze.
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 2 mg/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 to 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:
PL 04500/0005
This leaflet was approved in October 2008
No comments:
Post a Comment