50 g / l infusion solution
Human normal immunoglobulin (IVIg)
1. What Intratect is and what it is used for
Intratect is an extract of human blood that contains antibodies (the body’s defenses) against diseases, available as an infusion solution. The solution is ready to be administered via a vein (a drip).
Intratect contains human immunoglobulin ( antibodies ) from blood donated by a wide range of the population and which is likely to contain antibodies against the most common infectious diseases. Appropriate doses of Intratect can restore normal levels of low levels of immunoglobulin G in the blood.
Intratect is used in adults and children and adolescents (0-18 years) who do not have enough antibodies (replacement therapy) for:
- Congenital deficiency of antibodies (primary immunodeficiency syndrome)
- severe or recurrent infection and ineffective antimicrobial treatment
- and lack of antibodies (secondary immune deficiencies). *
* patients with documented specific antibody deficiency or IgG level <4 g / l
Intratect is also used in adults and children and adolescents (0-18 years) for the treatment of inflammatory diseases (immune modulation) eg:
- primary immunothrombocytopenia (ITP, the patient has a low platelet count ) when the patient is to undergo surgery in the near future or is at risk of bleeding
- Guillain-Barré syndrome (a disease that damages the nerves and can lead to general paralysis)
- Kawasaki disease (a disease of children that cause inflammation in several organs of the body and means artery are in the heart is enlarged) together with acetylsalicylic acid
- chronic inflammatory demyelinating polyneuropathy (CIDP). This is a chronic disease characterized by inflammation of the peripheral nerves and which causes muscle weakness and / or numbness mainly in the legs and arms.
- multifocal motor neuropathy (MMN). This is a rare condition characterized by slow progressive asymmetric weakness in the arms and legs without loss of sensation.
Human normal immunoglobulin (IVIg) contained in Intratect may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Intratect
Do not use Intratect
- if you are allergic to human immunoglobulin or any of the other ingredients of this medicine (listed in section 6).
- if you have immunoglobulin A deficiency, especially if you have antibodies to immunoglobulin A in your blood, as it may lead to anaphylaxis .
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Intratect if you
- have not received this medicine before or it has been a long time (eg several weeks) since you last received it (you must be closely monitored during the infusion one and for one hour after the end of the infusion )
- have recently received Intratect (you must be monitored during infusion one and at least 20 minutes after infusion one)
- have an untreated infection or an 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 disease
- have been given medicines that can damage your kidneys (if your kidney function deteriorates, treatment with Intratect may need to be stopped).
Your doctor should take extra care if you are overweight, elderly, diabetic, or have high blood pressure, if you have low blood volume ( hypovolemia ) or if your blood is thicker than normal (high blood viscosity) if you have been bedridden or immobile (immobile). for a long time or if you have problems with the blood vessels (vascular diseases) or if you have another risk factor for thrombotic events (blood clots).
Note – reactions
You will be closely monitored during the infusion period with Intratect to check that you are not getting a reaction (eg anaphylaxis ). Your doctor will check that the infusion rate of Intratect is right for you.
If you notice any of the following signs of a reaction, ie. headache, flushing, chills, muscle aches, tingling, rapid heartbeat, low back pain, nausea, low blood pressure during infusion with Intratect, tell your doctor immediately. The infusion rate can be reduced or the infusion can be stopped completely.
After infusion one of Intratect, you may have a low concentration of white blood cells ( neutropenia ) which disappears spontaneously within 7 to 14 days. If you have any further questions on the use of this product, ask your doctor.
In very rare cases, transfusion-related acute lung injury (TRALI) may occur after receiving immunoglobulins. This leads to non-cardiac accumulation of fluid in the airways of the lungs (non-cardiogenic pulmonary edema ) which causes severe difficulty breathing ( respiratory stress), rapid breathing ( tachypnea ), abnormally low levels of oxygen in the blood ( hypoxia ), and increased body temperature (fever). . The symptoms usually appear within 1 to 6 hours after you receive treatment. Contact a doctor immediately if you notice such reactions during infusion one of Intratect. The doctor will immediately discontinue the infusion.
Information on the transmission of infectious agents
Intratect is made from human plasma (the part of the blood that is made up of fluid). When drugs are made from human blood or human plasma, it is important to prevent the transmission of infection 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, the risk of transmitting infection cannot be completely ruled out when administering medicinal products derived from human blood or human plasma.
The measures taken are considered to be effective for enveloped viruses e.g. human immunodeficiency virus ( HIV ), hepatitis B virus, and hepatitis C virus.
Measures taken may be of limited value against uncovered viruses, e.g. hepatitis A virus and parvovirus B19.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly due to the protective effect of the antibodies against these infections present in the product.
Other medicines and Intratect
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Intratect may reduce the effectiveness of certain vaccines, eg:
- measles
- rubella
- mumps
- chicken-pox
You may have to wait up to 3 months before you can get certain vaccines and up to a year before you can get the measles vaccine.
Do not use loop diuretics with Intratect.
Effects on blood tests
Intratect may affect blood test results. If you have taken a blood sample after receiving Intratect, inform the person taking the blood sample or your doctor that you have received Intratect.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Your doctor will decide if you can use Intratect during pregnancy and breastfeeding.
Driving and using machines
Intratect has little effect on the ability to drive and use machines. Patients who have experienced side effects during treatment should wait until they subside before driving or using machines. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use Intratect
Intratect is for intravenous administration ( infusion into a vein). It is given by a doctor or nurse. Dose one depends on your condition and your body weight. Your doctor knows which is the right amount for you.
At the beginning of infusion one, you will receive Intratect at a low rate. Your doctor may then gradually increase the infusion rate.
The infusion rate and dosing frequency depend on the reason why you are receiving Intratect.
Use for children and adolescents
Dosage one for children and adolescents (0–18 years) is no different than for adults, as dosage one for each indication is given by body weight and adjusted according to the clinical outcome of the above conditions.
As replacement therapy for patients with a weakened immune system (primary or secondary immunodeficiency) every three to four weeks.
To treat inflammatory diseases (immune modulation), an infusion can be given as follows.
- primary immunothrombocytopenia: for the treatment of an acute episode, an infusion is given on day 1. This dose can be repeated once within 3 days. Alternatively, a lower dose is given daily for 2 to 5 days.
- Guillain-Barré syndrome: infusion is given for 5 days.
- Kawasaki disease: an infusion should be given as a single dose together with acetylsalicylic acid .
- chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy: treatment efficacy should be evaluated after each treatment cycle.
If an infusion fails
Intratect is given in a hospital by a doctor or nurse, so it is unlikely that an infusion would be forgotten. However, tell your doctor if you think an infusion has failed.
If you take more Intratect than you should
An overdose can lead to fluid overload and thickening 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 if your infusion should be stopped and alternative treatment given.
If you have any further questions on the use of this product, ask your doctor or nurse.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
The frequency groups listed below have generally been calculated based on the number of patients treated unless otherwise indicated, e.g. according to the number of infusions .
If you notice any of the following side effects , tell your doctor immediately:
- rash
- itching
- rosslingar
- breathing difficulties
- swelling of eyelids, face, lips, throat or tongue
- extremely low blood pressure with symptoms such as dizziness, confusion, fainting, fast pulse .
This can be an allergic or a severe allergic reaction (anaphylactic shock ) or a hypersensitivity reaction .
The following adverse reactions have been reported during clinical trials with Intratect 50 g / l:
Common: may occur with up to 1 in 10 infusions:
- headache
- fever
Uncommon : may occur in up to 1 in 100 infusions
- slight increase in the breakdown of red blood cells in the blood vessels ( hemolysis )
- taste disorders
- high blood pressure
- inflammation in a superficial friend
- nausea (nausea)
- vomiting
- abdominal pain
- rash with raised dots
- overindulge
- feeling of warmth
- elevated body temperature
- positive blood test for antibodies against red blood cells
The following side effects have been reported spontaneously with Intratect:
No known frequency (can not be calculated from the available data)
- severe chest pain or pressure over the chest ( angina pectoris )
- chills or tremors
- (anaphylactic) shock , allergic reaction
- difficulty breathing (shortness of breath)
- low blood pressure
- back pain
- decreased white blood cell count ( leukopenia )
Preparations with human immunoglobulin generally cause the following side effects (in decreasing frequency):
- chills, headache, dizziness, fever, vomiting, allergic reactions, nausea,joint pain, low blood pressure , moderate low back pain
- decreased number of red blood cells due to their degradation in the blood vessels ([reversible] haemolytic reactions) and (rare) haemolytic anemia requiring blood transfusion
- (in rare cases) a sudden drop in blood pressure and, in rare cases, anaphylactic shock
- (in rare cases) transient skin reactions (including cutaneous lupus erythematosus – no known frequency)
- (in very rare cases) thromboembolic reactions such as myocardial infarction ( myocardial infarction ), stroke , blood clots in the blood vessels of the lungs ( pulmonary embolism ), blood clots in a vein (deep vein thrombosis )
- case of transient acute inflammation of the protective membrane surrounding the brain and spinal cord ( meningitis )
- blood test results indicating renal impairment and / or sudden renal failure
- cases of transfusion-related acute lung injury (TRALI), see also section “Warnings and precautions”
If a side effect occurs, the infusion rate is reduced or the infusion is stopped .
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Intratect
Keep this medicine out of the sight and reach of children.
The pharmacy staff or the doctor knows how to store Intratect.
Keep the vial in the outer carton. Sensitive to light.
Do not store above 25 ° C. Do not freeze.
6. Contents of the packaging and other information
Content declaration
The active substance in Intratect is human immunoglobulin for intravenous administration .
Intratect contains 50 g / l human plasma proteins , of which at least 96% are immunoglobulin G (IgG). The distribution of IgG subclasses is approximately 57% IgG1, 37% IgG2, 3% IgG3 and 3% IgG4. Maximum immunoglobulin A ( IgA ) content is 900 micrograms / ml.
The other ingredients are: glycine and water for injections.
What the medicine looks like and contents of the pack
Intratect is a solution for infusion . The solution is clear or slightly opalescent (milky, opalescent) and colorless to pale yellow.
20 ml, 50 ml, 100 ml or 200 ml solution in a vial (type II glass) with a stopper (bromobutyl) and a cap (aluminum).
Pack size: 1 vial with 20 ml, 50 ml, 100 ml or 200 ml solution.
Pack size: 3 vials with 200 ml solution.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Biotest Pharma GmbH
Landsteinerstrasse 5
63303 Three
Germany
Tel: + 49 6103 801-0
Fax: + 49 6103 801-150