Remifentanil Hydrochloride for Injection CII Now Available from Fresenius Kabi

LAKE ZURICH, Ill., January 26, 2018 – Fresenius Kabi announced today the immediate availability in the United States of Remifentanil Hydrochloride for Injection. Fresenius Kabi Remifentanil for Injection is available as a lyophilized powder in three presentations: 1mg in a 3mL vial; 2 mg in a 5 mL vial and 5mg in a 10 mL vial.

Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.

“Fresenius Kabi has been investing significantly in product development over the last several years, and plans to launch multiple generic injectable products in the U.S. this year,” said John Ducker, president and CEO of Fresenius Kabi USA. “We are pleased to announce the introduction of Remifentanil, a first – and lower cost – alternative for anesthesia clinicians.”

Fresenius Kabi offers a broad portfolio of anesthesia and analgesia medicines for injection.

About Remifentanil Hydrochloride for Injection

Remifentanil HCl for Injection is indicated for IV administration as an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures; for continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting and as an analgesic component of monitored anesthesia care in adult patients.

Important Safety Information

WARNING: ADDICTION, ABUSE, and MISUSE

Remifentanil HCl for Injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death.

Remifentanil HCl for Injection is contraindicated for epidural or intrathecal administration due to the presence of glycine in the formulation and in patients with hypersensitivity to remifentanil (e.g., anaphylaxis).

Respiratory Depression in Spontaneously Breathing Patients: Monitor closely, particularly during initiation and titration.

Risks from Use as Postoperative Analgesia with Concomitant Benzodiazepines or other CNS Depressants: Hypotension, profound sedation, respiratory depression, coma, and death may result from the concomitant use with benzodiazepines or other CNS depressants.

Serotonin Syndrome: Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue Remifentanil HCl for Injection if serotonin syndrome is suspected.

Administration: Continuous infusions should be administered only by an infusion device. Skeletal Muscle Rigidity: is related to the dose and speed of administration and should be managed in the context of the patient’s clinical condition.

Potential Inactivation by Nonspecific Esterases in Blood Products: Remifentanil HCl for Injection should not be administered into the same IV tubing with blood due to potential inactivation by nonspecific esterases in blood products.

Bradycardia: Monitor heart rate during dosage initiation and titration. It is responsive to ephedrine or anticholinergic drugs.

Hypotension: Monitor blood pressure during dosage initiation and titration. It is responsive to decreases in the administration of Remifentanil HCl for Injection or to IV fluids or catecholamine administration.

Intraoperative Awareness: has been reported in patients under 55 years of age when Remifentanil HCl for Injection has been administered with propofol infusion rates of ≤75 mcg/kg/min.

Risks of Use in Spontaneously Breathing Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression.

Risks of Use in Patients with Biliary Tract Disease, including acute pancreatitis: Monitor patients for worsening symptoms.

Increased Risk of Seizures in Patients with Seizure Disorders: Monitor patients for worsened seizure control.

Rapid Offset of Action: Standard monitoring should be maintained in the postoperative period to ensure adequate recovery without stimulation.

Most common adverse reactions (incidence ≥1%) were respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity.

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

Overdosage: Acute overdose with Remifentanil HCl for Injection can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death.

This Important Safety Information does not include all the information needed to use Remifentanil HCl for Injection safely and effectively. Please click on the following link https://tinyurl.com/y7sq8oga for the full prescribing information for Remifentanil HCl for Injection, including Boxed Warning or visit www.fresenius-kabi.com/us.

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