Mirel

Mirel

reteplase

Manufacturer:

Reliance

Distributor:

Ambica

Marketer:

Ambica
Concise Prescribing Info
Contents
Reteplase
Indications/Uses
Thromboembolic disorders eg, acute MI.
Dosage/Direction for Use
IV 2 bolus inj of 10 u each (each bolus is administered over 2 min). 2nd bolus is given 30 min after initial bolus inj.
Contraindications
Hypersensitivity to reteplase & polysorbate 80. Active internal bleeding; history of CVA; recent intracranial or intraspinal surgery or trauma; intracranial neoplasm, arteriovenous malformation or aneurysm; known bleeding diathesis; severe uncontrolled HTN.
Special Precautions
Bleeding (intracranial, retroperitoneal, GI, genitourinary or resp) & superficial bleeding sites. Monitor all potential bleeding sites (including catheter insertion sites, arterial & venous puncture sites, cutdown sites & needle puncture sites). Recent major surgery eg, CABG, obstetrical delivery, organ biopsy; previous puncture of noncompressible vessels; cerebrovascular disease; recent GI or genitourinary bleeding; HTN (systolic BP ≥180 mmHg &/or diastolic BP ≥110 mm Hg); subacute bacterial endocarditis; hemostatic defects including those secondary to severe hepatic or renal disease; severe hepatic or renal dysfunction; diabetic hemorrhage retinopathy or other hemorrhagic ophth conditions; septic thrombophlebitis or occluded AV cannula at seriously infected site; any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location. Arrhythmias; cholesterol embolism. Concomitant use w/ heparin & other oral anticoagulants (eg, warfarin Na). Pregnancy & lactation. Elderly >75 yr.
Adverse Reactions
Hemorrhage; intracranial bleeding (those w/ systolic BP >160 mmHg are at greater risk). Cardiac complications eg, hypotension, HTN, pericarditis, bradycardia & thrombosis.
Drug Interactions
Increased risk of bleeding w/ heparin, vit K antagonists & drugs that alter platelet function (eg, acetylsalicylic acid, dipyridamole, abciximab).
ATC Classification
B01AD07 - reteplase ; Belongs to the class of enzymes. Used in the treatment of thrombosis.
Presentation/Packing
Form
Mirel lyophilized powd for inj 10 u
Packing/Price
20 mL x 1's (P20,000/vial)
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