Summary of Product Characteristics Updated 13-Aug-2015 | Beacon Pharmaceuticals
Paediatric populationThe safety and efficacy of Biofactor Streptokinase have not been sufficiently established in children. Due to low levels of plasminogen in newborns and in children with acquired plasminogen deficiency and due to the potential of streptokinase for allergic/anaphylactic reactions, it is not recommended in neonates, infants and children.
AdultsSystemic administration: A single dose of 1.5 million IU streptokinase should be infused intravenously over one hour.Local intracoronary administration: A bolus of 20,000 IU streptokinase should be followed by a maintenance infusion of 2,000 IU to 4,000 IU per minute over 30 to 90 minutes depending on the achievement of coronary artery patency.
Method of AdministrationThe administration of streptokinase may be intravenous or intracoronary.For instructions on reconstitution of the medicinal product before administration, see section 6.6.Upon reconstitution with physiological saline a clear solution, colourless to yellowish, is obtained.Note: When thrombolytic therapy is necessary and a high antibody concentration against streptokinase is present or when recent streptokinase therapy has been given (more than 5 days and less than one year previously), homologous fibrinolytics should be used (see sections 4.4 and 4.8).
Adjuvant treatmentTreatment with aspirin (150 mg daily) for at least 4 weeks is recommended for prophylaxis after streptokinase therapy for acute myocardial infarction. The first dose should be given as soon as possible after the myocardial infarction.
AntistreptokinaseRepeat treatment with streptokinase administered more than 5 days and less than 12 months after initial treatment may not be effective. This is because of the increased likelihood of resistance due to antistreptokinase antibodies.Also, the therapeutic effect may be reduced in patients with recent streptococcal infections such as streptococcal pharyngitis, acute rheumatic fever and acute glomerulonephritis.
Infusion rate and corticosteroid prophylaxisAt the beginning of therapy, a fall in blood pressure, tachycardia or bradycardia (in individual cases going as far a shock) are commonly observed. Therefore, at the beginning of therapy the infusion should be performed slowly. Corticosteroids can be administered prophylactically to reduce the likelihood of infusion-related allergic reactions.
Pre-treatment with heparin or coumarin derivativesIf the patient is under active heparinization, it should be neutralised by administering protamine sulphate before the start of the thrombolytic therapy. The thrombin time should not be more than twice the normal control value before thrombolytic therapy is started. In patients previously treated with coumarin derivatives, the INR (International Normalized Ratio) must be less than 1.3 before starting the streptokinase infusion.
Simultaneous treatment with acetylsalicylic acidRecent evidence indicates that controlled-dose adjuvant acetylsalicyclic therapy in combination with streptokinase is capable of improving the response in the management of acute myocardial infarction. See also section 4.2.Streptokinase is not indicated for restoration of patency of intravenous catheters.
|Very common||more than1/10|
|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 disordersCommon: haemorrhage at the injection site, ecchymoses, gastrointestinal bleeding, genitourinary bleeding, epistaxisUncommon: 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 infarctionIn 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 disordersVery Common: development of antistreptokinase antibodies (see also 4.4)Common: allergic anaphylactic reactions, e.g. rash, flushing, itching, urticaria, angioneurotic oedema, dyspnoea, bronchospasm, hypotensionVery Rare: delayed allergic reactions, e.g. serum sickness, arthritis, vasculitis, nephritis, neuroallergic symptoms (polyneuropathy, e.g. Guillain Barré syndrome), severe allergic reactions up to shock including respiratory arrest. Allergic reactions can largely be avoided by giving the infusion slowly. 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 disordersRare: neurologic symptoms (e.g. dizziness, confusion, paralysis, hemiparesis, agitation, convulsion) in the context of cerebral haemorrhages or cardiovascular disorders with hypoperfusion of the brain
Eye disordersVery rare: iritis/uveitis/iridocyclitis
Cardiac and vascular disordersCommon: at the start of therapy, hypotension, tachycardia, bradycardiaVery rare: crystal cholesterol embolismDuring 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 pectorisCommon: recurrent ischaemia, heart failure, reinfarction, cardiogenic shock, pericarditis, pulmonary oedemaUncommon: cardiac arrest (leading to respiratory arrest), mitral insufficiency, pericardial effusion, cardiac tamponade, myocardial rupture, pulmonary or peripheral embolismThese cardiovascular complications can be life-threatening and may lead to death. During local lysis of peripheral arteries, distal embolization cannot be excluded.
Respiratory DisordersVery rare: non-cardiogenic pulmonary oedema after intracoronary thrombolytic therapy in patients with extensive myocardial infarction
Gastrointestinal disordersCommon: nausea, diarrhoea, epigastric pain, vomiting
General disorders and administration site conditionsCommon: headache, back pain, musculoskeletal pain, chills, fever, asthenia, malaise
TestingCommon: Transient elevations of serum transaminases and bilirubin
Reporting of suspected adverse reactionsReporting 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 via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
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