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Norcuron News

Bridion Approved to Reverse Effects of Surgical Drugs

Posted 16 Dec 2015 by Drugs.com

TUESDAY, Dec. 15, 2015 – Bridion (sugammadex) has been approved by the U.S. Food and Drug Administration to reverse the effects of medications that are used to paralyze the vocal chords during certain surgical procedures. Rocuronium bromide and vecuronium bromide are prescribed when surgeons use an artificial airway or breathing tube, a process called tracheal intubation, the FDA said Tuesday in a news release. These so-called "neuromuscular blocking drugs" also may be used to prevent a person receiving general anesthesia from moving during surgery, or to prevent a person from breathing automatically while on a ventilator, the FDA added. In clinical studies involving more than 450 people, Bridion was evaluated in reversing the effects of these drugs. Most people who received Bridion recovered within 5 minutes of its use, the FDA said. However, the agency warned of the possibility of ... Read more

Related support groups: Reversal of Nondepolarizing Muscle Relaxants, Rocuronium, Reversal of Neuromuscular Blockade, Bridion, Norcuron, Vecuronium, Sugammadex, Zemuron

FDA Medwatch Alert: Vecuronium Bromide For Injection by Sagent Pharmaceuticals, Inc.: Recall - Elevated Impurity Result Detected

Posted 11 Jun 2013 by Drugs.com

ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of three lots of Vecuronium Bromide for Injection 10mg (NDC number 25021-657-10) manufactured by Mustafa Nevzat Ilac Sanayii A.S. (MN Pharmaceuticals) and distributed by Sagent.  Sagent has initiated this voluntary recall of Vecuronium Bromide for Injection to the user level due to the  discovery of an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval. The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill patients with renal failure.  BACKGROUND: Vecuronium Bromide for Injection is a neuromuscular blocking agent indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation and is supplied i ... Read more

Related support groups: Anesthesia, Anesthetic Adjunct, Norcuron, Vecuronium

FDA Medwatch Alert: Vecuronium Bromide For Injection Preservative Free (Bedford Laboratories): Recall - Particulate Matter

Posted 4 Jul 2012 by Drugs.com

  [Posted 06/29/2012] ISSUE: Bedford Laboratories issued recall of Vecuronium Bromide For Injection, 20 mg vial – NDC #55390-039-10, Lot 2067134, Exp. Date 5/31/2013 - due to the discovery of particulate matter in a small number of vials. This recall is for lot 2067134 only. Particulate matter has been recognized as a potential health hazard. Adverse reactions may include vein irritation and phlebitis, clinically occult pulmonary granulomas detected at routine autopsy examination, local tissue infarction, severe pulmonary dysfunction, occlusion of capillaries and arteries, anaphylactic shock and death. To date, there have been no reports of any adverse events for the lot being recalled. BACKGROUND: Vecuronium Bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. ... Read more

Related support groups: Anesthesia, Norcuron, Vecuronium

FDA Medwatch Alert: Bedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall - Glass Particles

Posted 13 Jan 2012 by Drugs.com

ISSUE: Bedford Laboratories issued guidance on the nationwide voluntary product recalls originally issued on August 2, 2011. The recalls were initiated after the discovery of a visible glass particle in a limited number of vials within the lots listed below to the user level. Polymyxin B for Injection USP, 500,000 Units per vial – NDC #55390-139-10 Lot 1942980 – Exp. Date August 2013 and Lot 1895027 – Exp. Date June 2013 Vecuronium Bromide for Injection, 10 mg per vial – NDC #55390-037-10 Lot 1865067 – Exp. Date May 2012 Vecuronium Bromide for Injection, 20 mg per vial – NDC #55390-039-10 Lot 1865069 – Exp. Date February 2012 Particulate matter in injections can be harmful when introduced into the bloodstream. Potential adverse events after intravenous administration may include vein irritation and phlebitis, pulmonary dysfunction and granulomas, local tissue infarction, occlusion of c ... Read more

Related support groups: Polymyxin B, Norcuron, Vecuronium

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