Intratect Adverse Reactions

Like all medicines, this medicine can cause side-effects, although not everybody gets them.
Frequencies outlined as follows have been generally calculated based on number of patients treated if not otherwise specified, e.g. by number of infusions.
For any of the following effects, tell the 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.
The following side effects 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 with up to 1 in 100 infusions: mildly increased breakdown of red blood cells in the blood vessels (haemolysis), disturbed sense of taste, high blood pressure, inflammation of a superficial vein, feeling sick (nausea), vomiting, abdominal pain, rash with raised spots, chills, feeling hot, increased body temperature, positive blood test for antibodies against red blood cells.
The following side effects have been reported spontaneously with Intratect: Not known (frequency cannot be estimated from the available data): severe chest pain or chest pressure (angina pectoris); shivering or trembling (rigors); (anaphylactic) shock, allergic reaction; difficulty in breathing (dyspnoea); low blood pressure; back pain; decrease in number of white blood cells (leukopenia).
Human immunoglobulin preparations in general may cause the following additional side effects: Uncommon (may affect up to 1 in 100 patients): headache, dizziness; nausea, vomiting; joint pain, moderate low back pain; low blood pressure; chills, fever; allergic reactions.
Rare (may affect up to 1 in 1,000 patients): a sudden fall in blood pressure and in isolated cases an anaphylactic shock, temporary skin reactions.
Very rare (may affect up to 1 in 10,000 patients): thromboembolic reactions such as: heart attack (cardial infarction), stroke, blood clots in blood vessels in the lung (pulmonary embolism), blood clots in a vein (deep vein thromboses).
Not known (frequency cannot be estimated from the available data): temporary acute inflammation of the protective membranes covering the brain and spinal cord (meningitis), results of blood tests which indicate that the renal function is impaired and/or sudden kidney failure, decrease in the number of red blood cells due to a breakdown of these cells in the blood vessels ((reversible) haemolytic reactions).
If a side effect occurs, the infusion rate will be decreased or stopped.
Reporting of side effects: If any side effects occur, talk to the doctor, pharmacist or nurse. This includes any side effects not listed.