Rx Item-Retavase Half 10 Unit Kit By Chiesi USA

RETAVASE- reteplase
EKR Therapeutics, Inc.

DESCRIPTION

Retavase� (Reteplase) is a non-glycosylated deletion mutein of tissue plasminogen activator (tPA), containing the kringle 2 and the protease domains of human tPA. Retavase� contains 355 of the 527 amino acids of native tPA (amino acids 1-3 and 176-527). Retavase� is produced by recombinant DNA technology in E. coli. The protein is isolated as inactive inclusion bodies from E. coli, converted into its active form by an in vitro folding process and purified by chromatographic separation. The molecular weight of Reteplase is 39,571 daltons.



Potency is expressed in units (U) using a reference standard which is specific for Retavase� and is not comparable with units used for other thrombolytic agents.

Retavase� is a sterile, white, lyophilized powder for intravenous bolus injection after reconstitution with Sterile Water for Injection, USP (without preservatives). Following reconstitution, the pH is 6.0 � 0.3. Retavase� is supplied as a 10.4 unit vial to ensure sufficient drug for administration of each 10 unit injection. Each single-use vial contains:

Reteplase 18.1 mg

Tranexamic Acid 8.32 mg

Dipotassium Hydrogen Phosphate 136.24 mg

Phosphoric Acid 51.27 mg

Sucrose 364.0 mg

Polysorbate 80 5.20 mg

CLINICAL PHARMACOLOGY

General: Retavase� is a recombinant plasminogen activator which catalyzes the cleavage of endogenous plasminogen to generate plasmin. Plasmin in turn degrades the fibrin matrix of the thrombus, thereby exerting its thrombolytic action.1,2 In a controlled trial, 36 of 56 patients treated for an acute myocardial infarction (AMI) had a decrease in fibrinogen levels to below 100 mg/dL by 2 hours following the administration of Retavase� as a double-bolus intravenous injection (10 + 10 unit) in which 10 units (17.4 mg) was followed 30 minutes later by a second bolus of 10 units (17.4 mg).3 The mean fibrinogen level returned to the baseline value by 48 hours.

Pharmacokinetics: Based on the measurement of thrombolytic activity, Retavase� is cleared from plasma at a rate of 250-450 mL/min, with an effective half-life of 13-16 minutes. Retavase� is cleared primarily by the liver and kidney. INDICATIONS AND USAGE

Retavase� (Reteplase) is indicated for use in the management of acute myocardial infarction (AMI) in adults for the improvement of ventricular function following AMI, the reduction of the incidence of congestive heart failure and the reduction of mortality associated with AMI. Treatment should be initiated as soon as possible after the onset of AMI symptoms

RX ITEM-Retavase Half 10 Unit Kit By Chi
NDC 24477-0040-01 UPC/GTIN No.3-24477-04001-8 Mfg.Part No.4001

Retavase Half 10 Unit Kit By Chiesi USA
BRAND: RETAVASE NDC: 24477-0040-01,24477004001 UPC: 3-24477-04001-8,324477040018 Chiesi USA Inc

RETEPLASE INTRAVEN KIT 10
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