Intratect Special Precautions

Talk to the doctor, pharmacist or nurse before using Intratect if the patient: Suffers from a condition with low antibody levels in the blood (hypo- or agammaglobulinemia).
Has not received this medicine before or if there has been a long interval (e.g. several weeks) since last receipt (the patient will need to be closely monitored during infusion and for an hour after infusion has stopped).
Has been given Intratect recently (the patient will need to be observed during the infusion and for at least 20 minutes after infusion).
Has had a reaction to other antibodies (in rare cases the patient may be at risk of allergic reactions).
Has or has had a kidney disorder.
Has received medicines that may harm the kidneys (if kidney function worsens, stop treatment with Intratect).
The doctor will take special care if the patient is overweight, elderly, diabetic, or if suffering from high blood pressure, low blood volume (hypovolaemia), if blood is thicker than normal (high blood viscosity), if patient has been bed-ridden or immobile for some time (immobilisation) or if with problems with the blood vessels (vascular diseases) or other risks for thrombotic events (blood clots).
Please note - reactions: The patient will be carefully observed during the infusion period with Intratect to make sure that the patient does not suffer a reaction. The doctor will make sure that the rate at which Intratect is infused is suitable.
For 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 the whole body) during the infusion of Intratect, tell the 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.
Effects on blood tests: Intratect can affect blood tests. If the patient has a blood test after receiving Intratect, please inform the person taking the blood or the doctor that the patient received Intratect.
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.
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.
Thrombosis: Care should be used when normal immunoglobulin products are given to individuals determined to be at increased risk of thrombosis.
Patients at increased risk of thrombosis include those with acquired or hereditary hypercoagulable states, prolonged immobilization, in-dwelling vascular catheters, advanced age, estrogen use, a history of venous or arterial thrombosis, cardiovascular risk factor (including history of atherosclerosis and/or impaired cardiac output), and hyperviscosity (including cryoglobulins, fasting chylomicronemia and/or high triglyceride levels, and monoclonal gammopathies).
Patients at risk for thrombosis should receive normal immunoglobulin products at the slowest infusion rate practicable, and these individuals should be monitored for thrombotic complications.
Consideration should also be given to measurement of baseline blood viscosity in individuals at risk of hyperviscosity.
Hemolysis: Heightened awareness of the potential for hemolysis is recommended in individuals receiving normal immunoglobulin products, particularly those who are determined to be at increased risk.
Patients at increased risk for hemolysis following treatment with normal immunoglobulin include those with non-O blood group types, those who have underlying associated inflammatory conditions, and those receiving high cumulative doses of normal immunoglobulin over the course of several days.
Patients receiving normal immunoglobulin products should be monitored for hemolysis, particularly those at increased risk.
Clinical symptoms and signs of hemolysis include fever, chills and dark urine. If these occur, appropriate laboratory testing should be obtained.