November Product News

Ultrasite Ag Luer Access Device

B. Braun MedicalInc (Bethlehem, PA)recently received510(k) clearancefrom the FDA forits Ultrasite Ag LuerAccess Device (LAD)designed to reducepotential catheterrelatedbloodstreaminfections. The deviceuses a controlledreleasesilver ion technologythat effectivelyachieves 4-log reductionsin bacteriaPseudomonas aeruginosa, Klebsiellapneumoniae, Enterobacter aerogenes,and 3-log reductions in bacteriaStaphylococcus aureus, methicillinresistantStaphylococcus aureus, andmethicillin-resistant Staphylococcusepidermidis through 96-hour simulateduse in clinical tests. Because allfluid path and external surfaces in thedevice are impregnated with silver,Ultrasite Ag LAD is designed to offermore protection against bacteria. Formore information, visit www.bbraunusa.com, or call 800-854-6851.

Adenosine Injection USP

Teva Pharmaceuticals (North Wales,PA) recently introduced AdenosineInjection USP in a new prefilled syringe.The product is indicated for theconversion to sinus rhythm of paroxysmalsupraventricular tachycardia,including that associated with accessorybypass tracts (Wolff-Parkinson-White syndrome). When clinicallyadvisable, appropriate vagal maneuvers(eg, Valsalva maneuver) should beattempted prior to Adenosine InjectionUSP administration. Adenosine InjectionUSP is AP-rated to AdenocardIV Injection (King PharmaceuticalsResearch and Development Inc). Theproduct should be given as a rapidbolus by the peripheral intravenous(IV) route. To be certain the solutionreaches the systemic circulation, itshould be administered either directlyinto a vein or, if given into an IV line, itshould be given as close to the patientas possible and followed by a rapidsaline flush. Adenosine Injection USPis available in a 2-mL, 3-mg/mL prefilledsyringe and in 3-mg/mL, 2-mL, and4-mL injectable single-dose vials. Formore information, visit www.tevausa.com, or call 888-TEVA USA (888-838-2872).

V-Link Luer-Activated Device

Baxter Healthcare Corp (Deerfield,IL) recently received 510(k) clearancefrom the FDA for expanded labelingfor the first antimicrobial needlelessintravenous (IV) connector.VLinkLuer-activatedDevice (LAD) withVitalShield protectivecoating. The FDAcleared expandedlabeling based onthe product's abilityto combat 3 additionalpathogens:vancomycin-resistantEnterococcus faecalis,Escherichia coli,and Staphylococcusepidermidis. These3 pathogens improveupon the previouslycleared labeling, which includedmethicillin-resistant Staphylococcusaureus, Pseudomonas aeruginosa,and Enterobacter cloacae. V-Link LADwith VitalShield, a needleless IV connectorused with the catheter or IVtubing, helps to prevent contaminationand growth of specific pathogenswithin the device at the point of entryto the patient's bloodstream. Silver isa well-known antimicrobial agent, andthe device is coated on both innerand outer surfaces with a speciallydesigned formulation, VitalShield,which has been shown to be effectiveagainst a broad spectrum of microorganisms.The silver antimicrobial agenthelps prevent the contamination andgrowth of these pathogens within theV-Link device. For more information,visit www.baxter.com.

Ketamine Hydrochloride Injection USP

Bioniche Pharma (Lake Forest, IL)recently received FDA approval forits 10-mg/mL Ketamine HydrochlorideInjection USP. The product is the genericequivalent of JHP Pharmaceuticals'Ketalar CIII. Ketamine HydrochlorideInjection USP is indicated as the soleanesthetic agent for diagnostic andsurgical proceduresthat donot require skeletalmuscle relaxation.Theproduct is bestsuited for shortprocedures, butit can be used,with additionaldoses, for longerprocedures.Ketamine HydrochlorideInjectionUSPalso is indicatedfor the induction of anesthesiaprior to the administration of othergeneral anesthetic agents. The productis indicated to supplement lowpotencyagents, such as nitrous oxide.In addition to the 10-mg/mL strength,Ketamine Hydrochloride InjectionUSP is available in 50- and 100-mg/mLstrengths. For more information, visitwww.bionichepharma.com, or call 888-258-4199.