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.
