The following adverse reactions are based on clinical trial and post-marketing experience. The following standard categories are used: Very common more than 1/10. Common more than 1/100; less than 1/10. Uncommon more than 1/1000; less than 1/100. Rare more than 1/10,000; less than 1/1000. Very Rare less than 1/10,000 (including Isolated cases).
Blood and lymphatic system disorders:
Common: haemorrhage at the injection site, ecchymoses, gastrointestinal bleeding, genitourinary bleeding, epistaxis. Uncommon: cerebral haemorrhages with their complications and possible fatal outcome, retinal haemorrhages, severe haemorrhages (also with fatal outcome), liver haemorrhages, retroperitoneal bleeding, bleeding into joints, splenic rupture. Blood transfusions are rarely required. Very rare: haemorrhage into the pericardium including myocardial rupture during thrombolytic treatment of acute myocardial infarction.
In serious haemorrhagic complications, streptokinase therapy should be discontinued and a proteinase inhibitor, e.g., aprotinin, should be given as follows. Initially 500 000 KIU (Kallikrein Inactivator Unit) up to one million KIU by slow intravenous injection or infusion. If necessary this should be followed by 200,000 KIU every four hours by intravenous drip until the bleeding stops. In addition, combination with synthetic antifibrinolytics, is recommended. If necessary, clotting factors can be substituted. Additional administration of synthetic antifibrinolytics has been reported to be efficient in single cases of bleeding episodes.
Immune system disorders:
Very Common: development of antistreptokinase antibodies (see Precautions). Common: allergic anaphylactic reactions, e.g. rash, flushing, itching, urticaria, angioneurotic oedema. dyspnoea, bronchospasm, hypotension. Very Rare: delayed allergic reactions, e.g. serum sickness, arthritis, vasculitis, nephritis, neuroallergic symptoms (polyneuropathy, e.g. Guillain Barre syndrome), severe allergic reactions up to shock including respiratory arrest.
Moderate or mild allergic reactions can be managed with concomitant antihistamine and/or corticosteroid therapy. If a severe allergic reaction occurs the infusion of streptokinase should be discontinued immediately and the patient given the appropriate treatment. The current medical standards for shock treatment should be observed. Lysis therapy should be continued with homologous fibrinolytics, such as Urokinase or tPA.
Nervous system disorders:
Rare: neurologic symptoms (e.g. dizziness, confusion, paralysis, hemiparesis, agitation, convulsion) in the context of cerebral haemorrhages or cardiovascular disorders with hypoperfusion of the brain
Very rare: iritis/uveitis/iridocyclitis.
Cardiac and vascular disorders:
Common: at the start of therapy, hypotension, tachycardia, bradycardia. Very rare: crystal cholesterol embolism.
During fibrinolytic therapy with streptokinase in patients with myocardial infarction, the following events have been reported as complications of myocardial infarction and/or symptoms of reperfusion: Very common: hypotension, heart rate and rhythm disorders, angina pectoris. Common: recurrent ischaemia, heart failure, reinfarction, cardiogenic shock, pericarditis, pulmonary oedema. Uncommon: cardiac arrest (leading to respiratory arrest), mitral insufficiency, pericardial effusion, cardiac tamponade, myocardial rupture, pulmonary or peripheral embolism.
These cardiovascular complications can be life-threatening and may lead to death.
During local lysis of peripheral arteries, distal embolization cannot be excluded.
Very rare: non-cardiogenic pulmonary oedema after intracoronary thrombolytic therapy in patients with extensive myocardial infarction.
Common: nausea, diarrhoea, epigastric pain, vomiting.
General disorders and administration site conditions:
Common: headache, back pain, musculoskeletal pain, chills, fever, asthenia, malaise.
Common: Transient elevations of serum transaminases and bilirubin.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.