IV Administer as single IV bolus over 5-10 sec & as early as possible & no later than 4.5 hr after last known well & after exclusion of intracranial haemorrhage. Max single dose: 5,000 u (25 mg). Patient weighing ≥90 kg 5,000 u (25 mg), ≥80 to <90 kg 4,500 u (22.5 mg), ≥70 to <80 kg 4,000 u (20 mg), ≥60 to <70 kg 3,500 u (17.5 mg), <60 kg 3,000 u (15 mg).
Hypersensitivity to tenecteplase or gentamicin. Situations associated w/ risk of bleeding eg, significant bleeding disorder at present or w/in past 6 mth, known haemorrhagic diathesis; history of CNS damage (ie, neoplasm, aneurysm, intracranial or spinal surgery); severe uncontrolled arterial HTN; prolonged or traumatic CPR (>2 min) w/in past 2 wk; active peptic ulceration; arterial aneurysm & known arterial/venous malformation; neoplasm w/ increased bleeding risk; acute pericarditis &/or subacute bacterial endocarditis; acute pancreatitis; acute ischaemic stroke w/o disabling neurological deficit; history or evidence or suspicion of intracranial haemorrhage including subarachnoid haemorrhage; patients w/ effective anticoagulation (eg, INR >1.7). Severe hepatic dysfunction including hepatic failure, cirrhosis, portal HTN (oesophageal varices) & active hepatitis.
Immune-mediated hypersensitivity reactions. Immediately terminate concomitant heparin administration if serious bleeding, particularly cerebral haemorrhage occurs. Not to initiate treatment later than 4.5 hr after last known well. Avoid use of rigid catheters, IM inj & non-essential handling of patient during treatment; bleeding from recent puncture sites may occur. Increased risk of intracranial haemorrhage in AIS patients; intracerebral haemorrhage in patients pre-treated w/ ASA & delayed treatment. Late time-to-treatment onset. Enhanced risk of angioedema AIS &/or by concomitant treatment w/ ACE inhibitors. Monitor for angioedema during & for up to 24 hr after administration. Reperfusion of the ischaemic area may induce cerebral oedema in infarcted zone. Patients w/ low body wt (<60 kg); receiving oral anticoagulants; recent IM inj or small recent traumas eg, biopsies, puncture of major vessels, cardiac massage for resuscitation; who had prior stroke or in whom uncontrolled diabetes exists. AIS patients w/ rapidly improving symptoms; extensive infarctions (eg, NIHSS >25); seizure at stroke onset; recent history of previous stroke or serious head or spinal trauma or major surgery (eg, cardiac, thoracic, abdominal, or orthopaedic); elevated aPTT at presentation; platelet count <100,000/mm³; HTN refractory to aggressive hyperacute antihypertensive treatment such that target BP <180/105 mmHg cannot be achieved or maintained; blood glucose <2.7 mmol/L or >22.2 mmol/L. Rapidly & aggressively treat systolic BP >180 mmHg or diastolic BP >105 mmHg, or uncontrolled arterial HTN in order to minimise delays to initiate thrombolysis. Monitor BP up to 24 hr after treatment. IV antihypertensive therapy if systolic BP >180 mmHg or diastolic BP >105 mmHg. Concomitant use of other active substances affecting coagulation or platelet function (eg, heparin) may contribute to bleeding. Consider administration of protamine if heparin has been given w/in 4 hr before onset of bleeding; transfusion of cryoprecipitate, fresh frozen plasma & platelets w/ clinical & lab reassessment after each administration in patients who fail to respond to conservative measures; antifibrinolytic agents. Pregnancy. Consider discontinuation of breastfeeding for the 1st 24 hr after administration of treatment. Not recommended in childn <18 yr. Advanced age >80 yr (increased risk of intracerebral haemorrhage when thrombolysed).
Increased risk of bleeding w/ medicinal products that affect coagulation or alter platelet function. Enhanced risk of hypersensitivity reaction w/ ACE inhibitors.
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