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Metalyse 40 mg

Metalyse 40 mg

tenecteplase

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Tenecteplase
Indications/Uses
Dosage/Direction for Use
IV Administer as single IV bolus over 5-10 sec & as early as possible after symptom onset. Max dose: 10,000 u (50 mg). Patient weighing ≥90 kg 10,000 u (50 mg), ≥80 to <90 kg 9,000 u (45 mg), ≥70 to <80 kg 8,000 u (40 mg), ≥60 to <70 kg 7,000 u (35 mg), <60 kg 6,000 u (30 mg).
Contraindications
Hypersensitivity to tenecteplase or gentamicin. Significant bleeding disorder (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; major surgery, parenchymal organ biopsy or significant trauma w/in past 2 mth, recent head or cranial trauma; 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; haemorrhagic stroke or stroke of unknown origin at any time; ischaemic stroke or transient ischaemic attack in the preceding 6 mth. Concomitant treatment w/ oral anticoagulant eg, warfarin Na (INR >1.3). Severe hepatic dysfunction including hepatic failure, cirrhosis, portal HTN (oesophageal varices) & active hepatitis.
Special Precautions
Discontinue use if anaphylactoid reaction occurs. Terminate concomitant heparin administration if serious bleeding particularly cerebral haemorrhage occurs. Not to be given if primary percutaneous coronary intervention (PCI) is scheduled according to current relevant treatment guidelines as administered in the ASSENT-4 PCI study. Avoid use of rigid catheters, IM inj & non-essential handling of patient during treatment. Bleeding; reperfusion arrhythmias. Systolic BP >160 mmHg; recent GI or genitourinary bleeding w/in the past 10 days; recent IM inj w/in the past 2 days; low body wt (<60 kg); cerebrovascular disease. Increased risk of thromboembolic events in patients w/ left heart thrombus eg, mitral stenosis or atrial fibrillation. Consider protamine administration if heparin has been administered w/in 4 hr before onset of bleeding; transfusion of cryoprecipitate, fresh frozen plasma, & platelet after each administration; antifibrinolytics. Transfer patients on primary coronary recanalization treatment to coronary intervention capable facility w/o delay for angiography & timely coronary intervention w/in 6-24 hr or earlier. Increased risk of bleeding w/ concomitant use of GPIIb/IIIa antagonists. Concomitant use w/ oral anticoagulants. Pregnancy. Consider discontinuation of breastfeeding for the 1st 24 hr after administration of treatment. Elderly >75 yr.
Adverse Reactions
Haemorrhage (superficial & internal bleeding) at any site or body cavity. Anaphylactoid reactions including rash, urticaria, bronchospasm, laryngeal oedema; intracranial haemorrhage eg, cerebral & subarachnoid haemorrhage, cerebral & intracranial haematoma, haemorrhagic & haemorrhagic transformation stroke; eye haemorrhage; reperfusion arrhythmias (eg, asystole, accelerated idioventricular arrhythmia, arrhythmia, extrasystoles, atrial fibrillation, 1st degree AV block, bradycardia, tachycardia, ventricular arrhythmia, fibrillation & tachycardia), pericardial haemorrhage; embolism; epistaxis, pulmonary haemorrhage; GI haemorrhage (eg, gastric, gastric ulcer, rectal & mouth haemorrhage, haematemesis, malaena), nausea, vomiting, retroperitoneal haemorrhage eg, retroperitoneal haematoma; ecchymosis; urogenital haemorrhage eg, haematuria, haemorrhage urinary tract; inj & puncture site haemorrhage; decreased BP, increased body temp; fat embolism; transfusion.
Drug Interactions
Increased risk of bleeding w/ medicinal products that affect coagulation or alter platelet function.
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 40 mg powd for inj 8000 U
Packing/Price
1's
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/thailand/image/info/metalyse-40-mg-powd-for-inj-8000-u/8000-u?id=76831461-99d9-4d90-b32f-ae29010c1a47
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