Syner-KINASE® (urokinase)
Abbreviated Prescribing Information. Please refer to Summary of Product Characteristics (SPC) before prescribing. Active ingredient: Each vial contains 10,000, 25,000, 100,000 IU of human urokinase. Indication: Lysis of blood clots in: thrombosed intravascular catheters and cannulae; extensive acute proximal deep vein thrombosis (DVT); acute massive pulmonary embolism (PE); acute occlusive peripheral arterial disease with limb threatening ischemia (PAD). Dosage and administration: Thrombosed intravascular catheters and cannulae: Instil 5,000 to 25,000 IU dissolved in saline into catheter or cannula and lock for 20-60 mins. Aspirate and repeat if necessary. Alternatively, infuse up to 250,000 IU over 90-180 mins. DVT: Infuse 4,400 IU/kg in 15 ml saline over 10 mins followed by 4,400 IU/kg/hr for 12-24 hrs. PE: Infuse 4,400 IU/kg in 15ml saline over 10 mins followed by 4,400 IU/kg/hr for 12hrs. Alternatively, inject 15,000 IU/Kg into the pulmonary artery repeated up to two times at 24hr intervals with dosage adjusted according to fibrinogen level. PAD: Infuse 500,000 IU in 250 ml saline into the clot with angiographic monitoring and advancement of catheter every 2hrs, repeated up to 4 times if flow has not been achieved. Elderly: As for adults but adjust dosing depending on response. Renal or hepatic impairment: Dose reduction may be required. Paediatrics: For thrombosed catheters use the same lock procedures as in adults. Do not use in thromboembolic disease. See SPC for full details. Contraindications: Hypersensitivity, active bleeding, recent severe gastrointestinal bleeding, recent major surgery, recent cerebrovascular accident, recent trauma including cardiopulmonary resuscitation or thoracic or neurosurgery, severe hypertension, severe hepatic or; renal insufficiency unless receiving renal replacement therapy, blood coagulation defects and severe thrombocytopenia, aneurysm and arteriovenous malformation, intracranial neoplasm or other neoplasm with risk of haemorrhage, acute pancreatitis or pericarditis or bacterial endocarditis or sepsis, recent obstetric delivery. Warnings and precautions: Balance risk of haemorrhage against risk of stopping treatment in patients with: recent surgery, severe cerebrovascular disease, moderate coagulation defects, high likelihood of left heart thrombus, cavernous pulmonary diseases, genitourinary tract diseases, known septic thrombotic disease, elderly patients especially over 75 years of age. Bleeding may occur from sites of needle puncture, catheter insertion or cuts in patients receiving urokinase. Intramuscular injections and unnecessary handling of the patient should be avoided due to risk of bruising or haematoma formation. Arterial invasive procedures must be avoided before and during urokinase treatment to minimise bleeding. Stop infusion immediately if severe bleeding occurs. Concomitant administration with thrombolytics, anticoagulants or anti-platelet agents may increase the risk of bleeding. Concomitant administration with angiotensin converting enzyme (ACE) inhibitors may increase risk of angioedema. Urokinase is obtained from human urine and risk of transmission of infectious agents cannot be completely eliminated. Therapeutic monitoring is required, see SPC for details. Pregnancy and lactation: Should not be given during pregnancy or immediate post-partum period unless necessary. Avoid breastfeeding. Undesirable effects: Very common: Haemorrhage, epistaxis, gingival bleeding, thromboembolism, embolism, haematuria (microscopic), decrease in haematocrit without clinically detectable haemorrhage, transient increase in transaminases. Common: Stroke, gastrointestinal haemorrhage, intracranial haemorrhage, retroperitoneal haemorrhage, urogenital haemorrhage, muscle haemorrhage, artery dissection, cholesterol embolism, fever, chills. Uncommon: Intrahepatic haemorrhage, renal failure. Rare: Hypersensitivity reactions, vascular pseudoaneurysm, haematuria (macroscopic). Very rare: Anaphylaxis. Legal category: POM. MA number and NHS list price per vial: 10,000 IU: PL 20675/0006 £35.95. 25,000 IU: PL 20675/0001 £45.95. 100,000 IU: PL 20675/0002 £112.95. MA holder: Syner-Medica Ltd, (Distributed by Syner-Med PP Ltd) Castle Court, 41 London Road, Reigate. Surrey, RH2 9RJ, UK. Date of last revision: May 2025
Adverse events should be reported.
Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Syner-Med (PP) Ltd. Tel: +44 (0)208 655 6380
Date of Preparation: May 2025 Approval Code:268