Fresenius Kabi Introduces Low Concentration Heparin Sodium in Sodium Chloride Injection in Ready to Use Freeflex® Bags

"In line with our commitment to offering convenient, ready-to-administer products to help minimize drug errors and assure patient safety, we are pleased to introduce a low concentration option in our line of Heparin Sodium in Sodium Chloride," said John Ducker, president and CEO of Fresenius Kabi USA. "We remain focused on meeting clinicians' needs by expanding the variety of presentations of products we offer in Freeflex IV bags and Simplist prefilled syringes."

Available exclusively from Fresenius Kabi, Freeflex is a multilayer polyolefin film container designed to reduce end users' steps compared to using vials. From the leak-resistant technology to the easy-to-handle bag design, every element of the innovative and flexible container system is designed to enable safe and simple infusion therapy.

Fresenius Kabi introduced the Freeflex bag advanced IV-container technology in the U.S. in 2013, and has expanded its portfolio of convenient, ready-to-administer medicines to 23 presentations across seven molecules.

Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. To learn more about Fresenius Kabi, including its expanding U.S. centers for pharmaceutical research, manufacturing and distribution, please visit: www.fresenius-kabi.com/us.

About Heparin Sodium in Sodium Chloride Injection

INDICATIONS AND USAGE

Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency.

IMPORTANT SAFETY INFORMATION

Heparin Sodium in Sodium Chloride Injection is contraindicated in patients with the following conditions:

• Uncontrollable active bleeding state, except when this is due to disseminated intravascular coagulation
• History of heparin-induced thrombocytopenia (HIT) and heparin induced thrombocytopenia with thrombosis (HITT)
• Severe thrombocytopenia
• Known hypersensitivity to heparin or pork products

Hemorrhage: Fatal hemorrhages have occurred. Monitor for signs of bleeding and manage promptly.

HIT and HITT: Monitor for signs and symptoms and discontinue if indicative of HIT or HITT.

Thrombocytopenia: Monitor platelet count during therapy; discontinue heparin if HIT or HITT is suspected.

Heparin Resistance: Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients.

Hypersensitivity Reactions: Use in patients with prior reactions only in life threatening situations.

Increased Risk of Bleeding in Older patients, Especially Women: A higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age.

Laboratory Tests: Periodic platelet counts, hematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration.

Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT and HITT, hypersensitivity, and elevations of aminotransferase levels.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drugs that interfere with platelet aggregation or drugs that counteract coagulation may induce bleeding.

Geriatric Use: A higher incidence of bleeding has been reported in patients over 60 years of age, especially women.

This Important Safety Information does not include all the information needed to use Heparin Sodium in Sodium Chloride Injection 2 units/mL safely and effectively. Please see full prescribing information for Heparin Sodium in Sodium Chloride Injection 2 units/mL at www.fresenius-kabi.com/us.

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