Metalyse

Metalyse

tenecteplase

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Tenecteplase
Indications/Uses
Thrombolytic treatment of suspected MI in adults w/ persistent ST elevation or recent left bundle branch block w/in 6 hr after onset of acute MI (AMI) symptoms.
Dosage/Direction for Use
IV Administer on the basis of body wt. Max: 10,000 u (50 mg).
Contraindications
Hypersensitivity to tenecteplase, to any of the excipients (L-arginine, phosphoric acid, polysorbate 20), or to gentamicin. Significant bleeding disorder either at present or w/in the past 6 mth; patients receiving effective oral anticoagulant treatment eg, warfarin Na (INR >1.3); any history of CNS damage (ie, neoplasm, aneurysm, intracranial or spinal surgery); known haemorrhagic diathesis; severe uncontrolled HTN; major surgery, biopsy of a parenchymal organ, or significant trauma w/in the past 2 mth (including any trauma associated w/ current AMI); recent trauma to the head or cranium; prolonged CPR (>2 min) w/in the past 2 wk; acute pericarditis &/or subacute bacterial endocarditis; acute pancreatitis; severe hepatic dysfunction, including hepatic failure, cirrhosis, portal HTN (oesophageal varices) & active hepatitis; active peptic ulceration; arterial aneurysm & known arterial/venous malformation; neoplasm w/ increased bleeding risk; any known history of haemorrhagic stroke or stroke of unknown origin; known history of ischaemic stroke or transient ischaemic attack in the preceding 6 mth; dementia.
Special Precautions
Immediately discontinue inj if an anaphylactoid reaction occurs. Should not be given if primary percutaneous coronary intervention is scheduled. Most common complication encountered during therapy is bleeding; concomitant use of heparin anticoagulation may contribute to bleeding. Coronary thrombolysis may result in arrhythmias associated w/ reperfusion. Concomitant use w/ GPIIb/IIIa antagonists. Pregnancy & lactation. Not recommended for use in childn <18 yr. Caution in the elderly ≥75 yr due to higher bleeding risk.
Adverse Reactions
Haemorrhage. Epistaxis; GI haemorrhage; ecchymosis; urogenital haemorrhage; inj site haemorrhage, puncture site haemorrhage.
Drug Interactions
Medicinal products that affect coagulation or those that alter platelet function (eg, ticlopidine, clopidogrel, LMWH) may increase risk of bleeding prior to, during, or after tenecteplase therapy. Increased bleeding risk w/ GPIIb/IIIa antagonists.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AD11 - tenecteplase ; Belongs to the class of enzymes. Used in the treatment of thrombosis.
Presentation/Packing
Form
Metalyse powd for inj 10,000 u
Packing/Price
1's
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