Uses of Tenalase 50 IV Injection: - Heart attack Acute myocardial infarction Patients at risk of cerebral bleeding including severe hypertension, history of stroke, intracranial or intraspinal surgery or trauma within 2 mth, arteriovenous malformation or aneurysm, cerebral neoplasm. Haemorrhage or known bleeding diathesis.

How to use Tenecteplase: Your doctor or nurse will give you this medicine. Kindly do not self administer. Administration: IV Preparation Add 10 mL SWI to a 50 mg vial using TwinPak® device directing stream of diluent into powder. If foaming (usually slight) occurs, leave vial undisturbed for several minutes to allow dissipation of any large bubbles. Gently swirl (do not shake) until contents are completely dissolved. Adult Dose: Intravenous Acute myocardial infarction Adult: 30-50 mg as a single bolus dose over 5-10 sec as soon as possible after the onset of symptoms. The dose is based on body weight. Max: 50mg. Administer ASAP (within 30 minutes) after onset of acute MI 30-50 mg IV bolus over 5 sec once (based on weight) <60 kg: 30 mg 60-70 kg: 35 mg 70-80 kg: 40 mg 80-90 kg: 45 mg >90 kg: 50 mg

Increased risk of haemorrhage with heparin, oral anticoagulants, antiplatelet drugs and other drugs that can affect platelet function.

Patients at risk of cerebral bleeding including severe hypertension, history of stroke, intracranial or intraspinal surgery or trauma within 2 mth, arteriovenous malformation or aneurysm, cerebral neoplasm. Haemorrhage or known bleeding diathesis.

Common - Injection site bleeding - Nosebleeds - Blood in stool - Blood in urine - Gastrointestinal bleeding >10% Minor bleeding (22%) Frequency Not Defined Reperfusion arrhythmias MI Fever Nausea Vomiting Cholesterol embolization Allergic reaction

Precaution: Patients with increased risk of bleeding. Recent history of GI or genitourinary bleed, recent major surgery, previous puncture of noncompressible vessels, hypertension (>180/110 mm Hg), high risk of left heart thrombus, acute pericarditis, subacute bacterial endocarditis, coagulation defects, invasive procedures, haemorrhagic ophthalmic conditions. Elderly, pregnancy and lactation. Severe hepatic impairment. Lactation: not known whether drug crosses into breast milk, nursing not a priority in AMI

Store lyophilized Tenecteplase at controlled room temperature not to exceed 30°C or under refrigeration 2-8°C. Do not use beyond the expiration date stamped on the vial.

Fibrinolytics (Thrombolytics)

Tenecteplase is a biosynthetic form of the enzyme human tissue-type plasminogen activator (t-PA). It is a fibrin-specific thrombolytic, converts plasminogen to plasmin, a proteolytic enzyme that has fibrinolytic effects.

Pregnancy: Tenectaplase has been shown to elicit maternal and embryo toxicity in rabbits given multiple IV administrations. In rabbits administered 0.5, 1.5, and 5.0 mg/kg/day during organogenesis, vaginal hemorrhage resulted in maternal deaths. Subsequent embryonic deaths were secondary to maternal hemorrhage and no fetal anomalies were observed. Tenectaplase does not elicit maternal and embryo toxicity in rabbits following a single IV administration. Thus, in developmental toxicity studies conducted in rabbits, the no observable effect level (NOEL) of a single IV administration of Tenectaplase on maternal or developmental toxicity (5 mg/kg) was approximately 7 times human exposure (based on AUC) at the dose for AMI. There are no adequate and well controlled studies in pregnant women. Tenectaplase should be given to pregnant women only if the potential benefits justify the potential risk to the fetus.Nursing Mothers: It is not known if Tenectaplase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tenectaplase is administered to a nursing woman.