Vial2Bag
West (Lionville, PA) recently received
510(k) clearance from the FDA to market
the Vial2Bag device, a needle-free transfer
system developed by its Medimop
subsidiary that provides a safe and convenient
method for adding drugs to
any intravenous (IV) bag from a vial or
syringe. The Vial2Bag device helps nurses
and other health care practitioners
avoid needle-stick injuries and increases
patient safety by helping to ensure the
appropriate reconstitution of drugs prior
to IV delivery. The device and system
can be used for complete needle-free
reconstitution of powdered or lyophilized
drugs directly into all manufacturers' IV
bags, guaranteeing optimal use of a drug
product. The Vial2Bag device reduces
the need for drug overfill and helps
ensure that a patient receives the appropriate
dosage. The product is available
as part of a kit or with an appropriate
vial adapter. For more information, visit
www.westreconstitution.com.
Epoprostenol Sodium for
Injection
Teva Pharmaceuticals (North Wales,
PA) recently received FDA approval for
its abbreviated new drug application
to market Epoprostenol Sodium for
Injection—the first generic version of
GlaxoSmithKline's Flolan for Injection.
The company's approval is for the 0.5-mg
base/vial and 1.5-mg/base/vial strengths
as well as the sterile diluent. The product,
which is AP-rated, is indicated for
the long-term intravenous treatment of
primary pulmonary hypertension and
pulmonary hypertension associated with
the scleroderma spectrum of disease in
NYHA Class III and Class IV patients who
do not respond adequately to conventional
therapy. For more information,
visit www.tevausa.com.
CADD-Solis Ambulatory
Infusion System
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Smiths Medical (St. Paul, MN) recently
received 510(k) clearance from the FDA
for its CADD-Solis Ambulatory Infusion
System—a clinically and technologically
advanced next generation ambulatory
infusion system that enhances
patient safety and personalized care for
pain management patients. Ambulatory
systems administer pain management
medications, including narcotics, via a
variety of delivery routes including intravenous
(IV) and epidural. It is important
for these devices to have safeguards,
such as safety software and
intuitive programming options to help
clinicians care for their pain management
patients. CADD-Solis Ambulatory
Infusion System includes the CADDSolis
Ambulatory Infusion Pump, CADDSolis
Medication Safety Software, and
CADD Medication Cassette Reservoirs
and Administration Sets. The CADD-Solis
Ambulatory Infusion Pump is small and
lightweight to promote patient mobility
and clinician convenience. The versatile
pump can be used for a variety of pain
management therapies and patients. Its
large color graphic display screen helps
clinicians view and verify pump programs,
identify and respond to alarms,
and interpret delivery trends and patient
activity. CADD-Solis Medication Safety
Software is an innovative, therapy-based
medication safety system designed to
deploy the client’s current best practice
management protocols to help reduce
the risk of adverse events and promote
clinician confidence. CADD Medication
Cassette Reservoirs provide a compact,
durable, self-contained medication reservoir
to promote patient mobility and
drug security. The CADD Administration
Sets also are available for medication
delivery from an IV bag. For more information,
visit www.smiths-medical.com.
Oxacillin Sodium Injection
Sandoz (Princeton, NJ) recently
announced the reintroduction of
Oxacillin Sodium Injection. The product
is the generic equivalent of Bactocill
(GlaxoSmithKline) in ADD-Vantage vials
(Hospira) in the United States. The company
is marketing Oxacillin Sodium
Injection in ADD-Vantage vials of 1-g and
2-g base strengths. The product is also
available in a 10-g pharmacy bulk package.
The ADD-Vantage design keeps the
drug and diluent separate until the system
is activated just prior to administration.
Oxacillin Sodium Injection is indicated
in the treatment of infections caused
by penicillinase-producing staphylococci
which have demonstrated susceptibility
to the drugs. For more information, visit
www.us.sandoz.com.
