If the patient experience reactions, especially which are not mentioned, inform the physician or pharmacist.
The following adverse reactions based on experience from clinical trials and on post-marketing experience. The following standard categories of frequency are used: Very common: >1/10; common: >1/100 and <1/10; uncommon: >1/1,000 and <1/100; rare: >1/10,000 and <1/1,000; very rare: <1/10,000 (including reported single cases).
Common: Haemorrhages at the injection site and ecchymoses (small-area skin bleedings). Gastrointestinal or urogenital bleedings, epistaxis (nosebleeding). Uncommon: Cerebral haemorrhages with their complications and possible fatal outcome, retinal haemorrhages, severe haemorrhages (also with fatal outcome), including liver haemorrhages, retroperitoneal (in the back of the abdomen) bleedings, splenic rupture. Blood transfusions are rarely required. Very Rare: Haemorrhages into the pericardium (heart sac), including myocardial rupture (tearing of the heart muscle) during the thrombolytic (clot dissolving) treatment of acute myocardial infarction.
In severe haemorrhagic complications, the Streptase therapy is discontinued and a proteinase inhibitor eg, aprotinin, administered in the following dosage: Initially, 500,000 KIU (Kallikrein inactivator unit), if necessary up to 1 million KIU, followed by 50,000 KIU/hr by IV drip until the bleeding stops. In addition, combination with synthetic antifibrinolytics is recommended. If necessary, coagulation factors can be administered. Additional administration of synthetic antifibrinolytics was 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 with rash, flushing (skin reddening with heat sensation), itching, urticaria, angioneurotic edema, dyspnoea, bronchospasm (constriction of airways) or fall in blood pressure. Very Rare: Delayed allergic reactions eg, serum sickness, arthritis (inflammation of the joints with pain, swelling and loss of motion), vasculitis (inflammation of a vessel wall), nephritis (inflammation of the kidney) and neuroallergic (concerning the nerves) symptoms [polyneuropathy (disease concerning several nerves) eg, Guillain Barre syndrome], severe allergic reactions up to shock including respiratory arrest.
Mild or moderate allergic reactions may be managed with concomitant antihistamine and/or corticosteroid therapy. If a severe allergic/anaphylactic reaction occurs, the administration of Streptase has to be discontinued immediately and an appropriate treatment should be initiated. The current medical standards for shock treatment should be observed. Lysis therapy should be continued with homologous fibrinolytics.
Nervous System Disorders:
Rare: Neurologic symptoms eg, dizziness, confusion, paralysis, hemiparesis (paralysis of the left or right part of the body), restlessness or convulsions (cramps) in the context of cerebral haemorrhages or cardiovascular (relating to the heart and circulation) disorders with hypoperfusion (reduced blood flow) of the brain.
Cardiac Complications and Vascular Disorders:
Common: At the beginning of therapy, fall in blood pressure, tachycardia or bradycardia (see Precautions: Infusion Rate and Corticosteroid Prophylaxis). Very Rare: Crystal cholesterol embolism.
In the setting of fibrinolytic (clot dissolving) therapy with Streptase in patients with myocardial infarction the following events have been reported as complications of myocardial infarction and/or symptoms of reperfusion (re-opening of occluded blood vessels): Very Common: Fall in blood pressure, heart rate and rhythm disorders, angina pectoris. Common: Recurrent ischaemia (depletion of blood), heart failure, reinfarction (repeated infarction), cardiogenic (triggered by heart failure) shock, pericarditis, pulmonary oedema. Uncommon: Cardiac arrest (leading to respiratory arrest), mitral (heart valve) insufficiency, pericardial effusion (seropurulent liquid accumulation in the heart sac), cardiac tamponade (liquid load in the heart sac), 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 (away from the heart) embolization cannot be excluded.
Very Rare: Noncardiogenic (not triggered by heart failure) pulmonary edema after intracoronary thrombolytic therapy in patients with extensive myocardial infarction.
Common: Nausea, diarrhoea, epigastric (upper abdomen) pain and vomiting.
Common: Headache and back pain, muscle pain, chills and/or rise in temperature, as well as faintness/weariness.
Common: Transient elevations of serum transaminases (liver function parameters), as well as of bilirubin.