LAKE ZURICH, Ill., January 6, 2015 – Fresenius Kabi announced today it has received approval from the U.S. Food and Drug Administration to market Naropin® (ropivacaine HCL Injection, USP) 0.2% 100mL and 200mL premix bags in the company’s proprietary Freeflex® delivery system. These new presentations are available now for U.S. customers.
Fresenius Kabi is a global health care company that specializes in life-saving medicines and technologies for infusion, transfusion and clinical nutrition.
“We introduced Naropin in Freeflex containers to give clinicians more choices and greater convenience in treating patients requiring continuous epidural infusions or local infiltration,” said John Ducker, president and CEO of Fresenius Kabi USA.
Fresenius Kabi offers the broadest ropivacaine portfolio, providing the most options for patient care in surgical anesthesia, labor and delivery, and acute pain management. In addition to the new 0.2% Freeflex bag, Naropin is available in multiple presentations including single-dose vials, plastic ampule sterile-paks, and infusion bottles in four different strengths – 0.2%, 0.5%, 0.75% and 1%.
Freeflex® is an innovative bag designed for infusion solutions that has been marketed globally since 2005 and in the U.S. since 2008. Freeflex’s multilayer polyolefin film is non-PVC and non-DEHP that is designed for easy handling with enhanced safety and environmental performance in mind.
NAROPIN® is indicated for the production of local or regional anesthesia for surgery and for acute pain management.
NAROPIN is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type.
Important Safety Information
Using NAROPIN beyond recommended doses to increase motor block or duration of sensory block may negate its favorable cardiovascular advantages, in the event that an inadvertent intravascular injection occurs. NAROPIN may be associated with adverse reactions which are characteristic of those associated with other amide-type local anesthetics. In clinical trials, side effects were mild and transient and may reflect the procedures, patient health status, and/or other medications used. Adverse events reported at a rate of ≥5%: hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain.
There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. NAROPIN is not approved for this use.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC, Vigilance & Medical Affairs at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional information about NAROPIN, please visit www.NAROPIN-US.com.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.us) is a global health care company that specializes in lifesaving medicines and medical devices for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. For more information about Fresenius Kabi worldwide, please visit www.fresenius-kabi.com.