STREPTOKINASE KARMA

Posology Paediatric population The safety and efficacy of Streptokinase Karma in children, infants and neonates have not been established. 4). Method of Administration The administration of streptokinase may be intravenous or intracoronary.

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. 6. Upon reconstitution with physiological saline a clear solution, colourless to yellowish, is obtained.

8). Adjuvant treatment Treatment 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.

The following adverse reactions are based on clinical trial and post-marketing experience.

The following standard categories are used:

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 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. , 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.

g. g. 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. g. dizziness, confusion, paralysis, hemiparesis, agitation, convulsion) in the context of cerebral haemorrhages or cardiovascular disorders with hypoperfusion of the brain Eye disorders 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.

g. g. g. g. open tuberculosis or severe bronchitis - mitral valve defects or atrial fibrilation - aortic dissection - diabetic retinopathy increase risk of local bleeding Antistreptokinase Repeat 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 prophylaxis At 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 derivatives If 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. 3 before starting the streptokinase infusion. Simultaneous treatment with acetylsalicylic acid Recent 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.

2. Streptokinase is not indicated for restoration of patency of intravenous catheters.

1. 3) - severe liver or kidney damage - endocarditis or pericarditis. g. recent organ biopsy, long-term (traumatic) closed chest cardiac massage