West (Lionville, PA) recently received510(k) clearance from the FDA to marketthe Vial2Bag device, a needle-free transfersystem developed by its Medimopsubsidiary that provides a safe and convenientmethod for adding drugs toany intravenous (IV) bag from a vial orsyringe. The Vial2Bag device helps nursesand other health care practitionersavoid needle-stick injuries and increasespatient safety by helping to ensure theappropriate reconstitution of drugs priorto IV delivery. The device and systemcan be used for complete needle-freereconstitution of powdered or lyophilizeddrugs directly into all manufacturers' IVbags, guaranteeing optimal use of a drugproduct. The Vial2Bag device reducesthe need for drug overfill and helpsensure that a patient receives the appropriatedosage. The product is availableas part of a kit or with an appropriatevial adapter. For more information, visitwww.westreconstitution.com.
Epoprostenol Sodium forInjection
Teva Pharmaceuticals (North Wales,PA) recently received FDA approval forits abbreviated new drug applicationto market Epoprostenol Sodium forInjection—the first generic version ofGlaxoSmithKline's Flolan for Injection.The company's approval is for the 0.5-mgbase/vial and 1.5-mg/base/vial strengthsas well as the sterile diluent. The product,which is AP-rated, is indicated forthe long-term intravenous treatment ofprimary pulmonary hypertension andpulmonary hypertension associated withthe scleroderma spectrum of disease inNYHA Class III and Class IV patients whodo not respond adequately to conventionaltherapy. For more information,visit www.tevausa.com.
CADD-Solis AmbulatoryInfusion System
Smiths Medical (St. Paul, MN) recentlyreceived 510(k) clearance from the FDAfor its CADD-Solis Ambulatory InfusionSystem—a clinically and technologicallyadvanced next generation ambulatoryinfusion system that enhancespatient safety and personalized care forpain management patients. Ambulatorysystems administer pain managementmedications, including narcotics, via avariety of delivery routes including intravenous(IV) and epidural. It is importantfor these devices to have safeguards,such as safety software andintuitive programming options to helpclinicians care for their pain managementpatients. CADD-Solis AmbulatoryInfusion System includes the CADDSolisAmbulatory Infusion Pump, CADDSolisMedication Safety Software, andCADD Medication Cassette Reservoirsand Administration Sets. The CADD-SolisAmbulatory Infusion Pump is small andlightweight to promote patient mobilityand clinician convenience. The versatilepump can be used for a variety of painmanagement therapies and patients. Itslarge color graphic display screen helpsclinicians view and verify pump programs,identify and respond to alarms,and interpret delivery trends and patientactivity. CADD-Solis Medication SafetySoftware is an innovative, therapy-basedmedication safety system designed todeploy the client?s current best practicemanagement protocols to help reducethe risk of adverse events and promoteclinician confidence. CADD MedicationCassette Reservoirs provide a compact,durable, self-contained medication reservoirto promote patient mobility anddrug security. The CADD AdministrationSets also are available for medicationdelivery from an IV bag. For more information,visit www.smiths-medical.com.
Oxacillin Sodium Injection
Sandoz (Princeton, NJ) recentlyannounced the reintroduction ofOxacillin Sodium Injection. The productis the generic equivalent of Bactocill(GlaxoSmithKline) in ADD-Vantage vials(Hospira) in the United States. The companyis marketing Oxacillin SodiumInjection in ADD-Vantage vials of 1-g and2-g base strengths. The product is alsoavailable in a 10-g pharmacy bulk package.The ADD-Vantage design keeps thedrug and diluent separate until the systemis activated just prior to administration.Oxacillin Sodium Injection is indicatedin the treatment of infections causedby penicillinase-producing staphylococciwhich have demonstrated susceptibilityto the drugs. For more information, visitwww.us.sandoz.com.
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