Product News

Published Online: Saturday, November 1, 2008

Ultrasite Ag Luer Access Device

B. Braun Medical Inc (Bethlehem, PA) recently received 510(k) clearance from the FDA for its Ultrasite Ag Luer Access Device (LAD) designed to reduce potential catheterrelated bloodstream infections. The device uses a controlledrelease silver ion technology that effectively achieves 4-log reductions in bacteria Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter aerogenes, and 3-log reductions in bacteria Staphylococcus aureus, methicillinresistant Staphylococcus aureus, and methicillin-resistant Staphylococcus epidermidis through 96-hour simulated use in clinical tests. Because all fluid path and external surfaces in the device are impregnated with silver, Ultrasite Ag LAD is designed to offer more protection against bacteria. For more information, visit www.bbraunusa.com, or call 800-854-6851.


Adenosine Injection USP

Teva Pharmaceuticals (North Wales, PA) recently introduced Adenosine Injection USP in a new prefilled syringe. The product is indicated for the conversion to sinus rhythm of paroxysmal supraventricular tachycardia, including that associated with accessory bypass tracts (Wolff-Parkinson- White syndrome). When clinically advisable, appropriate vagal maneuvers (eg, Valsalva maneuver) should be attempted prior to Adenosine Injection USP administration. Adenosine Injection USP is AP-rated to Adenocard IV Injection (King Pharmaceuticals Research and Development Inc). The product should be given as a rapid bolus by the peripheral intravenous (IV) route. To be certain the solution reaches the systemic circulation, it should be administered either directly into a vein or, if given into an IV line, it should be given as close to the patient as possible and followed by a rapid saline flush. Adenosine Injection USP is available in a 2-mL, 3-mg/mL prefilled syringe and in 3-mg/mL, 2-mL, and 4-mL injectable single-dose vials. For more 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) clearance from the FDA for expanded labeling for the first antimicrobial needleless intravenous (IV) connector.VLink Luer-activated Device (LAD) with VitalShield protective coating. The FDA cleared expanded labeling based on the product's ability to combat 3 additional pathogens: vancomycin-resistant Enterococcus faecalis, Escherichia coli, and Staphylococcus epidermidis. These 3 pathogens improve upon the previously cleared labeling, which included methicillin-resistant Staphylococcus aureus, Pseudomonas aeruginosa, and Enterobacter cloacae. V-Link LAD with VitalShield, a needleless IV connector used with the catheter or IV tubing, helps to prevent contamination and growth of specific pathogens within the device at the point of entry to the patient's bloodstream. Silver is a well-known antimicrobial agent, and the device is coated on both inner and outer surfaces with a specially designed formulation, VitalShield, which has been shown to be effective against a broad spectrum of microorganisms. The silver antimicrobial agent helps prevent the contamination and growth of these pathogens within the V-Link device. For more information, visit www.baxter.com.


Ketamine Hydrochloride Injection USP

Bioniche Pharma (Lake Forest, IL) recently received FDA approval for its 10-mg/mL Ketamine Hydrochloride Injection USP. The product is the generic equivalent of JHP Pharmaceuticals' Ketalar CIII. Ketamine Hydrochloride Injection USP is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. The product is best suited for short procedures, but it can be used, with additional doses, for longer procedures. Ketamine Hydrochloride Injection USP also is indicated for the induction of anesthesia prior to the administration of other general anesthetic agents. The product is indicated to supplement lowpotency agents, such as nitrous oxide. In addition to the 10-mg/mL strength, Ketamine Hydrochloride Injection USP is available in 50- and 100-mg/mL strengths. For more information, visit www.bionichepharma.com, or call 888-258-4199.

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