Actilyse50mg

Alteplase is a medicine which dissolves the clots that have formed in blood vessels. It is used to treat stroke, heart attack and blood clots in the lungs (pulmonary embolism). It is known as a thrombolytic or “clot-busting” medicine. Alteplase is given directly into a vein by a doctor as soon as possible after the first signs of a heart attack, stroke or pulmonary embolism are noticed. Your breathing, blood pressure, oxygen levels and other vital signs will be watched closely. You may be given another medicine to prevent formation of new blood clots at the same time or after the treatment. Alteplase may cause confusion, nausea and vomiting. It has many serious side effects. The most common and serious side effect of this medicine is bleeding. Treatment with this drug can lead to bleeding in the brain (cerebral haemorrhage), extremely low blood pressure (shock) and cardiac arrest (where your heart stops beating). Your treatment may be stopped if any of these happen. Talk to your doctor about the risk of serious side effects before you are given this medicine. This medicine is not suitable for everyone. There is a long list of situations where you will not be given Alteplase including if you have had a head injury, surgery of your brain or spinal cord and any current bleeding anywhere in your body. Your healthcare team will need to know a lot about your medical history before giving you this medicine. Alteplase is a thrombolytic medication. It works by dissolving the harmful blood clots in the blood vessels. This restores the blood flow to the affected tissue, thereby preventing tissue death and improving outcomes.

• Heart attack • Ischemic stroke

Recombinant human tissue-type plasminogen activator (t-PA); produces local fibrinolysis Promotes thrombolysis by converting plasminogen to plasmin; plasmin degrades fibrin and fibrinogen

Adult Dose: Intravenous Acute Myocardial Infarction Administer as soon as possible after onset of symptoms Recommended total dose for AMI is based on patient weight, not to exceed 100 mg, regardless of the selected administration regimen (accelerated or 3 hr) Accelerated infusion (1-1/2 hr) 67 kg (100 mg total dose infused over 1.5 hr): 15 mg IVP bolus over 1-2 minutes, THEN 50 mg IV infusion over next 30 minutes, and THEN remaining 35 mg over next 60 minutes 3-hr infusion 65 kg: (100 mg total dose infused over 3 hr): 6-10 mg IVP bolus over 1-2 minutes, THEN 50-54 mg infused over the rest of the first hr (ie, 60 mg in 1st hr including 6-10 mg bolus), THEN 20 mg/hr for the next 2 hr Pulmonary Embolism 100 mg IV infused over 2 hr; institute parenteral anticoagulation near the end of or immediately following alteplase infusion when the PTT or thrombin time returns to <2x normal Acute Ischemic Stroke 0.9 mg/kg IV; not to exceed 90 mg total dose; administer 10% of the total dose as an initial IV bolus over 1 minute and the remainder infused over 60 minutes Injection Central Venous Catheter Occlusion 2 mg in 2 mL instilled into occluded catheter Assess catheter function after 30 minutes of dwell time by attempting to aspirate blood; if unable to aspirate after 120 minutes dwell time, a 2nd dose may be administered and the process repeated If catheter function restored, aspirate 4-5 mL blood to remove Cathflo Activase and residual clot Gently irrigate with 0.9% NaCl Child Dose: Central Venous Catheter Occlusion 30 kg 2 mg instilled into occluded catheter Assess catheter function after 30 minutes of dwell time by attempting to aspirate blood; if unable to aspirate after 120 minutes dwell time, a 2nd dose may be administered and the process repeated If catheter function restored, aspirate 4-5 mL blood in patients 10 kg or more (aspirate 3 mL if <10 kg) to remove injection solution and residual clot Gently irrigate with 0.9% NaCl

Your doctor or nurse will give you this medicine. Kindly do not self administer.

Common: • Decreased blood pressure • Nausea • Vomiting • Bleeding

[NOT RELEVANT] Not relevant, as Alteplase is intended for use in hospitalised patients. It should be given as soon as possible (within 12 hours) after the onset of a heart attack or within 4.5 hours of onset of stroke. Let your doctor know immediately if you develop any nosebleeds, gum bleeding, black or tarry stools, or bruising. Do not discontinue the medicines started after this injection as it may increase your chances of having another heart attack or stroke.

Known hyper-sensitivity to Alteplase or any component of the formulation. Acute Ischemic Stroke Do not administer to treat acute ischemic stroke in the following situations in which the risk of bleeding is greater than the potential benefit Current intracranial hemorrhage Subarachnoid hemorrhage Active internal bleeding Recent (within 3 months) intracranial or intraspinal surgery or serious head trauma Presence of intracranial conditions that may increase the risk of bleeding (eg, some neoplasms, arteriovenous malformations, aneurysms) Bleeding diathesis Current severe uncontrolled hypertension Acute myocardial infarction or pulmonary embolism Do not administer for treatment of AMI or PE in the following situations in which the risk of bleeding is greater than the potential benefit Active internal bleeding History of recent stroke Recent (within 3 months) intracranial or intraspinal surgery or serious head trauma Presence of intracranial conditions that may increase the risk of bleeding (eg, some neoplasms, arteriovenous malformations, aneurysms) Bleeding diathesis Current severe uncontrolled hypertension

The risk of haemorrhage is increased if coumarine derivatives, oral anticoagulants, platelet aggregation inhibitors, unfractionated heparin or LMWH or active substances which interfere with coagulation are administered (before, during or within the first 24 hours after treatment with Alteplase). Concomitant treatment with ACE inhibitors may enhance the risk of suffering an anaphylactoid reaction, as in the cases describing such reactions a relatively larger proportion of patients were receiving ACE inhibitors concomitantly. Concomitant use of GPIIb/IIIa antagonists increases the risk of bleeding.

[CONSULT YOUR DOCTOR] It is not known whether it is safe to consume alcohol with Alteplase. Please consult your doctor.

[CONSULT YOUR DOCTOR] Alteplase may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

[SAFE IF PRESCRIBED] Alteplase is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.

[SAFE IF PRESCRIBED] Alteplase is probably safe to use in patients with kidney disease. Limited data available suggests that dose adjustment of Alteplase may not be needed in these patients. Please consult your doctor. [CONSULT YOUR DOCTOR] There is limited information available on the use of Alteplase in patients with liver disease. Please consult your doctor.

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