Gas Gangrene

SHIRLEY, N.Y., Oct. 29, 2024 /PRNewswire/ -- American Regent announces the launch of 30 mL Epinephrine Injection, USP.1 Epinephrine Injection, USP is indicated for emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Continue Reading Epinephrine Injection, USP is supplied as a 30 mg/30 mL (1 mg/mL) multiple-dose vial in a shelf pack of one. "With the approval of Epinephrine Injection, USP we continue to show our commitment to ensuring both patients and providers have access to high-quality treatment options," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc. Product is available for immediate shipment. Customers can order Epinephrine Injection, USP through their wholesaler/distributor or by contacting our Customer Support Group at 1-800-645-1706. Epinephrine Injection, USP is supplied as follows: Please see the accompanying Important Safety Information in addition to the Full Prescribing Information. For additional information, please visit americanregent.com. REFERENCE: 1. Epinephrine Injection, USP. Package insert. American Regent, Inc. © 2024 American Regent, Inc. All rights reserved. PP-EP-US-0024 5 Ramsey Road, Shirley, NY 11747 \\ 1.800.645.1706 F 631.924.1731 \\ A Daiichi Sankyo Group Company Epinephrine Injection, USP 30 mL For intramuscular, subcutaneous, and intravenous use. INDICATIONS AND USAGE Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Hypotension associated with Septic Shock To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS Incorrect Locations of Injection for Anaphylaxis: Injection into the anterolateral aspect of the thigh (vastus lateralis muscle) is the most appropriate location for administration because of its location, size, and available blood flow. Injection into (or near) smaller muscles, such as in the deltoid, is not recommended. Do not administer repeated injections of epinephrine at the same site, as the resulting vasoconstriction may cause tissue necrosis. Do not inject into buttock, digits, hands, or feet. Serious Infections at the Injection Site: Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported. Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation into tissues, which can cause local necrosis. When epinephrine is administered intravenously, check the infusion site frequently. Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension. Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia, especially in patients suffering from coronary artery disease or cardiomyopathy. May aggravate angina pectoris or produce ventricular arrhythmias. Allergic Reactions Associated with Sulfite: The Epinephrine 30 mL multiple-dose vial contains sodium metabisulfite, which may cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes in susceptible individuals. ADVERSE REACTIONS Common adverse reactions to systemically administered epinephrine include, but are not limited to, anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism. The true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below by body system: Cardiovascular: Angina, arrhythmias, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy, and stress cardiomyopathy. Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Neurological: Disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling. Psychiatric: Anxiety, apprehensiveness, restlessness. Other: Patients with Parkinson's disease may experience psychomotor agitation or a temporary worsening of symptoms. Diabetic patients may experience transient increases in blood sugar. Injection into the buttock has resulted in cases of gas gangrene. Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh. USE IN SPECIFIC POPULATIONS Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. Pregnancy May cause fetal harm. Labor or Delivery: There are risks to the mother and fetus associated with epinephrine use during labor or delivery. Epinephrine usually inhibits spontaneous or oxytocin-induced contractions of the pregnant human uterus and may delay the second stage of labor. Avoid epinephrine during the second stage of labor. Although epinephrine may improve maternal hypotension associated with septic shock and anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. Lactation There is no information regarding the presence of epinephrine in human milk or the effects of epinephrine on the breastfed infant or on milk production. Pediatric Use Reported clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Safety and effectiveness of epinephrine in pediatric patients with septic shock have not been established. Geriatric Use In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. OVERDOSAGE Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema, transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Myocardial ischemia and infarction, cardiomyopathy, extreme pallor and coldness of the skin, metabolic acidosis due to elevated blood lactic acid levels, and renal insufficiency have also been reported. For additional Safety Information, please see the Full Prescribing Information. REF-2454 4/2023 You are encouraged to report adverse drug events (ADEs) to American Regent®: T 1.800.734.9236; E [email protected]; F 1.610.650.0170 ADEs may also be reported to the FDA: 1.800.FDA.1088 or Medical information: T 1.888.354.4855 (9:00 am–5:00 pm Eastern Time, Monday–Friday) medical information outside of normal business hours that cannot wait until the next business day, please call 1.877.845.6371 About American Regent For more than 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables. For more than 20 years, we have been a leader in IV iron therapy. We are committed to setting a higher standard for responsiveness and reliability as a US-based manufacturer. To ensure that we deliver on our mission to improve human and animal health, we continue to make investments in expanding and modernizing our manufacturing facilities in Ohio and New York and have expanded our footprint into California. This growth will increase our capacity, create redundancies across our manufacturing sites, and strengthen our expertise in the development of complex drug products and delivery systems. What that means for you is a partner committed to delivering essential medications now and in the future. For more information, please visit . About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical needs. For more information, please visit . SOURCE American Regent, Inc. 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WEDNESDAY, June 19, 2024 -- A deadly bacterial infection known as streptococcal toxic shock syndrome (STSS) is spreading across Japan, officials in that country report. In March, Japan's National Institute of Infectious Diseases issued its first warning that STSS cases were on the rise. As of June 2, Japan's health ministry has reported 977 cases for 2024 -- a count that already surpasses last year's total of 941 cases. That's also nearly two and a half times the number of cases reported in the United States so far this year: 395 cases have been reported, not far off from the 390 seen at this time last year. The disease is nothing to trifle with: STSS can "develop very quickly into a life-threatening emergency," according to the U.S. Centers for Disease Control and Prevention. First symptoms of STSS often include fever, chills, muscle aches, nausea and vomiting, according to the CDC . After 24 to 48 hours, low blood pressure typically develops and can cause more serious issues, including organ failure, increased heart rate and rapid breathing. "Even with treatment, STSS can be deadly. Out of 10 people with STSS, as many as 3 people will die from the infection," the CDC stated. STSS is caused by toxins released by Streptococcus pyogenes, also known as Group A Streptococcus (GAS), which commonly cause sore throat and skin infections, said Dr. Céline Gounder , an infectious diseases expert and CBS News medical contributor. "Less commonly, GAS causes infection in the blood, lungs, as well as 'flesh-eating' infections," Gounder told CBS News . It is not yet understood why these severe infections are becoming more common, but there are ways to help prevent getting sick in the first place, experts said. "Because chickenpox and influenza are risk factors for severe GAS infection, vaccination against varicella zoster virus and influenza can reduce the risk of severe GAS infection," Gounder noted. "People who have been in close contact with someone with severe GAS infection and who are immunocompromised, pregnant or have open wounds should be given antibiotics to prevent infection." Certain risk factors can increase your risk, the CDC said, including: Since late 2022 , multiple countries have seen spikes in GAS cases, including the United Kingdom, Ireland, France, the Netherlands and Sweden, according to the World Health Organization . "Outbreaks like these speak to the need for ongoing infectious disease surveillance and control, not only in the United States, but around the world," Gounder said. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

A panel of female medical professionals will discuss the clinical evidence of Kerecis’ products in surgical and outpatient settings ORLANDO, Fla.--(BUSINESS WIRE)-- Kerecis, the pioneer in the use of fish skin and fatty acids for tissue regeneration and protection, will unveil its latest scientific and clinical updates, including trial results, at the upcoming Symposium on Advanced Wound Care (SAWC) Spring. The company will offer educational symposiums, a hands-on skills lab, an interactive poster session, a cultural event, and a panel discussion of female medical professionals. Kerecis will exhibit at booth 419 at SAWC, which will take place from May 14 to 18 in Orlando, Florida. This press release features multimedia. View the full release here: Kerecis' ongoing research and data underscore significantly improved healing times, reduced complications, and enhanced patient outcomes for the company's medical fish skin across different clinical settings. (Photo: Business Wire) “The recent abstracts and case studies provide compelling evidence of the efficacy of our products in wound management and add to our growing body of clinical evidence,” said Fertram Sigurjonsson, founder and CEO of Kerecis. “Our ongoing research and data underscore significantly improved healing times, reduced complications, and enhanced patient outcomes across different clinical settings. These findings reaffirm our leadership in regenerative medicine and highlight our commitment to scientific excellence and the tangible benefits our technology brings patients,” he added. Symposium on Fish-Skin Graft Applications A symposium entitled “Diving into the Diverse Applications of Fish-Skin Grafts: Head to Toe” will be led by Dr. John Lantis and Dr. Simon Simmon, a specialist in pressure injuries. The session will explore the use of Kerecis products across various medical specialties including Mohs surgery, pressure injuries, and venous leg ulcers. The symposium will take place Thursday, May 16, from 10:30 a.m. to 11:30 a.m. in Magnolia 10-12. Symposium on Clinical Evidence A 30-minute symposium entitled “Clinical Evidence of Fish-Skin-Graft Applications” will feature an all-female panel including Thea Price, MD; Lizzy Faust, FNP, WOCN; and Roxana Reyna, NP. This session will occur on Wednesday, May 15, from 11:45 a.m. to 12:15 p.m. in the Canary 4 Foyer. Innovative Research and Techniques During a hands-on skills lab, Kerecis medical affairs program managers will demonstrate Kerecis products, highlighting advanced applications in real-world clinical settings. The skills lab will take place Friday, May 17, from 2:15 p.m. to 4:25 p.m. in Crystal Ballroom G1. Cultural Connection Through a Taste of Iceland The “Taste of Iceland” event will allow participants to explore Icelandic culture and its connection to Kerecis innovations. This popular event will take place Thursday, May 16, from 5 p.m. to 7:15 p.m. in Magnolia 19-21. Poster Presentations Additionally, 24 posters will detail advancements and case studies involving Kerecis products. The following abstracts will be presented on Thursday, May 16, from 7:30 p.m. to 8:30 p.m. at Sabal. CS-022: Vitaliya Boyar, MD, Healing Complex Neonatal Dehisced Surgical Wounds with Fish Skin Graft CS-025: Richard Bruno, DPM, Utility of Fish Xenograft in Diabetic Plantar Foot Ulcerations CS-026: Richard Bruno, DPM, Fish Skin Xenografts Facilitating the Healing of Complex Achilles Tendon Wounds CS-027: Richard Bruno, DPM, Fish Skin Xenografts in the Management of Gas Gangrene Foot Infections CS-028: Richard Bruno, DPM, Association of Hemoglobin A1c and Wound Healing with Application of Omega-3 Fatty Acid Fish Skin CS-072: Ronald Guberman, DPM, Case Series of Complex Diabetic Ulcers Healed With Fish Skin Grafts CS-076: Mary Hanley, MD, Healing a Large Moh’s Surgical Wound Due to Squamous Cell Skin Cancer with Icelandic Cod Fish Skin CS-083: Kevin Hopkins, MD, Successful Use of Decellularized Piscine Graft in a Pediatric Extensive Wound Reconstruction CS-097: Patrick McEneaney, DPM, Open Midfoot Fracture/Dislocation Wound Healed with a Fish Skin Graft CS-107: Luis Navazo, MD, Application of Intact Fish Skin Graft to Support Healing of a Chronic Sacral Ulceration CS-108: Luis Navazo, MD, The Use of Intact Fish Skin Xenograft to Support Healing in a Nonhealing Ulceration in Quadriplegic Patient CS-109: Luis Navazo, MD, Application of Fish Skin Grafts on Persistent Lower Extremity Ulceration CS-110: Luis Navazo, MD, The Use of Intact Fish Skin Graft in the Treatment of a Third-Degree Burn Injury CS-113: Nikul Panchal, DPM, Fragmented Fish Skin Graft to Heal Wounds Due to “Tranq” Injections CS-114: Nikul Panchal, DPM, Fragmented Fish Skin Graft to Treat Large Soft Tissue Defects Due to Gas Gangrene CS-116: Dhiren Patel, MD, Use of Fish Skin Xenograft in a Patient with Bullous Pemphigoid CS-119: Thea Price, MD, When Granulation Really Matters: Codfish Skin Graft (CFSG) Rapidly Fills Soft Tissue Defects CS-126: Roxana Reyna, NP, Successful Use of Fish Skin Graft in Neonatal and Pediatric Wounds CS-144: Karl Stark, MD, Application of Fish Skin Graft to Salvage a Complex Foot Wound with Loss of the Majority of the Dorsum and Heel of the Foot Resulting from Necrotizing Fasciitis CS-148: Mark Suski, MD, Successful Staged Reconstruction of a Large Scalp Defect with Exposed Cranium Secondary to a Rare Cutaneous Metastasis from Urothelial Bladder Carcinoma Utilizing Fish Skin Xenografts CS-149: Mark Suski, MD, Fish Skin Graft for the Treatment of Bilateral Burns in an Aging Patient CS-152: Roland Tolliver, DPM, Management of an Intractable Ulcer of the Achilles Tendon with Fish Skin Grafting: a Case Report CS-161: Christopher Winters, DPM, Application of Novel Fish Skin Graft in the Foot & Ankle: A Retrospective Case Series CS-164: Marcus Yarbrough, MD, Outpatient Reconstruction of Traumatic Dog Bite Avulsion Injuries of the Lower Extremity with Kerecis Acellular Fish Graft and Negative Pressure Wound Therapy in a Two-stage Procedure About Kerecis Kerecis develops products from fish skin and fatty acids for cellular therapy, tissue regeneration, and protection. When grafted onto damaged human tissue or implanted, the patented material supports the body’s own processes to heal and regenerate. Because no disease-transfer risk exists between cold-water fish and humans, the Kerecis fish skin is only gently processed and retains its similarity to human tissue. The gentle processing preserves the skin’s original three-dimensional structure, maintaining its inherent natural strength, complexity, and molecules (such as fatty acids). Clinical studies have found that the Kerecis products heal wounds faster than competing products and are cost effective. Kerecis is the only approved manufacturer of medical devices containing intact fish skin in the world. Kerecis is the fastest-growing and one of the top five companies in the U.S. biologics-skin and dermal-substitute market, according to SmartTRAK Business Intelligence. Kerecis’ expanding product portfolio includes SurgiBind®/SurgiClose®, which are used for reconstructive surgery in hospital operating rooms; GraftGuide®, which is mostly sold to burn centers; and MariGen® and Shield™, which are sold to healthcare facilities to treat chronic wounds such as diabetic wounds, as well as post-Moh's surgery wounds. Kerecis is committed to the United Nations Sustainable Development Goals. The fish skin used in Kerecis’ products derives from wild and sustainable fish stock caught in pristine Icelandic waters and processed with 100% renewable energy in the town of Isafjordur, close to the Arctic Circle. Kerecis is part of Coloplast, the leading global supplier of intimate healthcare products. For more information, visit . Trademarks and registered trademarks are the property of their respective owners. View source version on businesswire.com: Contacts Kay Paumier Communications Plus kay@communicationsplus.net 408-370-1243 (office) 408-806-1177 (mobile) Source: Kerecis Smart Multimedia Gallery Photo Kerecis' ongoing research and data underscore significantly improved healing times, reduced complications, and enhanced patient outcomes for the company's medical fish skin across different clinical settings. (Photo: Business Wire) Logo View this news release and multimedia online at: