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DEERFIELD, Ill.--( BUSINESS WIRE )--Baxter International Inc. (NYSE:BAX), a global leader in injectables, anesthesia and drug compounding, today announced five new injectable pharmaceutical product launches in the U.S., joining the previous five launches announced in April of this year and marking a total of 10 U.S. injectable product launches in 2024. “ Our Pharmaceuticals teams are relentlessly focused on bringing differentiated products to market that support our customers in helping to address vital patient needs,” said Alok Sonig, executive vice president and group president, Pharmaceuticals, at Baxter. “ We look forward to further accelerating our impact with a robust innovation pipeline across our key therapeutic areas, including critical care, anti-infectives, pain and oncology.” The five recent product launches within Baxter’s Pharmaceuticals portfolio in the U.S. include the following. For all products, please see full Indications, including Limitations of Use, Important Risk Information and links to full Prescribing Information below. Micafungin in 0.9% Sodium Chloride Injection single-dose container is indicated for use in adult and pediatric patients to treat Candida infections and for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation for whom appropriate dosing with this formulation can be achieved. Micafungin uses Baxter’s proprietary container technology. Baxter offers Micafungin in 50 mg/50 mL, 100 mg/100 mL and 150 mg/150 mL strengths. Cyclophosphamide Injection is an alkylating drug indicated for treatment of adults and pediatric patients with various malignant diseases and is frequently used in combination with other oncology medications. This liquid cyclophosphamide product requires further dilution before use. Baxter offers Cyclophosphamide Injection in 500 mg/2.5 mL and 1000 mg/5 mL strengths in Multiple-Dose Vials. Pantoprazole Sodium in 0.9% Sodium Chloride Injection is a proton pump inhibitor indicated in adults for the short-term treatment (seven to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE) and pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. Pantoprazole uses Baxter’s proprietary container technology. Baxter offers Pantoprazole in 40 mg/50 mL, 40 mg/100 mL and 80 mg/100 mL strengths. Cefazolin in Dextrose Injection, USP now available in a new 3 g/150 mL strength, is a single-dose, first generation cephalosporin antibacterial indicated for adults and pediatric patients to treat various infections caused by susceptible organisms and for perioperative prophylaxis. Cefazolin uses Baxter’s proprietary container technology. Baxter offers Cefazolin in 1 g/50 mL, 2 g/100 mL and 3 g/150 mL strengths. Levetiracetam in Sodium Chloride Injection is an anti-epileptic drug indicated for adjunct therapy in adult patients for partial onset seizures, myoclonic seizures, and tonic-clonic seizures. Levetiracetam uses Baxter’s proprietary container technology and is now offered in 500 mg/100 mL, 1000 mg/100 mL and 1500 mg/100 mL strengths. Ready-to-use formats of standard concentrations of commonly prescribed drugs may offer operational efficiencies for healthcare providers. Compounding a drug for patient use is a multi-step, manual process that requires oversight by pharmacy staff. A ready-to-use product can simplify the preparation process and support patient safety by reducing the chance of contamination 2 and avoiding potential errors that may occur when medications are compounded. 3 These five newly launched products are now available for use in the U.S. About Baxter Pharmaceuticals Baxter is a global leader in specialty injectables, drug compounding and anesthesia that addresses unmet patient needs in the therapeutic areas of pain, critical care, anti-infectives and oncology. Baxter’s comprehensive pharmaceuticals portfolio contains injectables (including ready-to-use products), inhaled gases and compounded medications, and is designed to expand access to products that simplify medication preparation and support patient safety. Pharmaceuticals employees across the globe are focused on driving customer-centered innovation, bringing new and differentiated products and delivery platforms to market, and helping patients receive the medications they need. About Baxter Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on X , LinkedIn and Facebook . Micafungin in 0.9% Sodium Chloride Injection Indications Micafungin in Sodium Chloride Injection is an echinocandin indicated in adult and pediatric patients for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved. Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age for whom appropriate dosing with this formulation can be achieved. Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved. Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT) for whom appropriate dosing with this formulation can be achieved. Limitations of Use: The safety and effectiveness of Micafungin in Sodium Chloride Injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed. Micafungin in Sodium Chloride Injection has not been adequately studied in patients with endocarditis, osteomyelitis or meningoencephalitis due to Candida. The efficacy of Micafungin in Sodium Chloride Injection against infections caused by fungi other than Candida has not been established. Important Risk Information Contraindications: Micafungin in Sodium Chloride Injection is contraindicated in persons with known hypersensitivity to micafungin sodium, any component of Micafungin in Sodium Chloride Injection, or other echinocandins. Hypersensitivity Reactions: Anaphylaxis and anaphylactoid reactions (including shock) have been observed. Discontinue Micafungin in Sodium Chloride Injection and administer appropriate treatment. Hematological Effects: Acute intravascular hemolysis and hemoglobinuria was seen in a healthy volunteer during infusion of Micafungin for Injection (200 mg) and oral prednisolone (20 mg). Cases of significant hemolysis and hemolytic anemia have also been reported in patients treated with Micafungin for Injection. Patients who develop clinical or laboratory evidence of hemolysis or hemolytic anemia during therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing therapy. Hepatic Effects: Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with Micafungin. In some patients with serious underlying conditions who were receiving Micafungin along with multiple concomitant medications, clinical hepatic abnormalities have occurred, and isolated cases of significant hepatic impairment, hepatitis, and hepatic failure have been reported. Monitor hepatic function. Discontinue if severe dysfunction occurs. Renal Effects: Elevations in BUN and creatinine; isolated cases of renal impairment or acute renal failure have been reported. Monitor renal function. Infusion and Injection Site Reactions: Possible histamine-mediated symptoms have been reported with Micafungin for Injection, including rash, pruritus, facial swelling, and vasodilatation. Slow the infusion rate if infusion reaction occurs. Injection site reactions, including phlebitis and thrombophlebitis have been reported, at Micafungin for Injection doses of 50 to 150 mg/day. These reactions tended to occur more often in patients receiving Micafungin for Injection via peripheral intravenous administration. High Sodium Load: Each 50, 100, and 150 mL Galaxy container contains 200, 400, and 600 mg of sodium, respectively. Avoid use in patients with congestive heart failure, elderly patients, and patients requiring restricted sodium intake. Adverse Reactions: Most common adverse reactions across adult and pediatric clinical trials for all indications include diarrhea, nausea, vomiting, abdominal pain, pyrexia, thrombocytopenia, neutropenia, and headache. In pediatric patients younger than 4 months of age, the following additional common adverse reactions were reported at an incidence rate of ≥15%: hypokalemia, acidosis, sepsis, anemia, and oxygen saturation decreased. Drug Interactions: Monitor for sirolimus, itraconazole or nifedipine toxicity, and dosage of sirolimus, itraconazole or nifedipine should be reduced, if necessary. Pregnancy: Based on animal data, Micafungin in Sodium Chloride Injection may cause fetal harm. Advise pregnant women of the risk to the fetus. Please see accompanying full Prescribing Information for Micafungin in 0.9% Sodium Chloride Injection . Cyclophosphamide Injection Indications Cyclophosphamide Injection is an alkylating drug indicated for treatment of adult and pediatric patients with: Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. Important Risk Information Contraindications Hypersensitivity: Cyclophosphamide is contraindicated in patients who have a history of severe hypersensitivity reactions to it, any of its metabolites, or to other components of the product. Anaphylactic reactions including death have been reported. Possible cross-sensitivity with other alkylating agents can occur. Urinary outflow obstruction Myelosuppression, Immunosuppression, Bone Marrow Failure and Infections: Cyclophosphamide can cause myelosuppression, bone marrow failure, and severe immunosuppression which may lead to serious and sometimes fatal infections, including sepsis and septic shock. Latent infections can be reactivated. Monitoring of complete blood counts is essential during cyclophosphamide treatment so that the dose can be adjusted, if needed. Urinary Tract and Renal Toxicity: Hemorrhagic cystitis, pyelitis, ureteritis, and hematuria have been reported with cyclophosphamide. Discontinue cyclophosphamide therapy in case of severe hemorrhagic cystitis. Urotoxicity may require interruption of cyclophosphamide treatment or cystectomy. Urotoxicity can be fatal. Before starting treatment, exclude or correct any urinary tract obstructions. Urinary sediment should be checked regularly for the presence of erythrocytes and other signs of urotoxicity and/or nephrotoxicity. Cyclophosphamide Injection should be used with caution, if at all, in patients with active urinary tract infections. Aggressive hydration with forced diuresis and frequent bladder emptying can reduce the frequency and severity of bladder toxicity. Mesna has been used to prevent severe bladder toxicity. Cardiotoxicity: Myocarditis, myopericarditis, pericardial effusion including cardiac tamponade, and congestive heart failure, which may be fatal, have been reported with cyclophosphamide therapy. Supraventricular arrhythmias and ventricular arrhythmias have been reported after treatment with regimens that included cyclophosphamide. The risk of cardiotoxicity may be increased with high doses of cyclophosphamide, in patients with advanced age, and in patients with previous radiation treatment to the cardiac region and/or previous or concomitant treatment with other cardiotoxic agents. Monitor patients, especially those with risk factors for cardio toxicity or pre-existing cardiac disease. Pulmonary Toxicity: Pneumonitis, pulmonary fibrosis, pulmonary veno-occlusive disease and other forms of pulmonary toxicity leading to respiratory failure have been reported during and following treatment with cyclophosphamide. Late onset pneumonitis appears to be associated with increased mortality. Monitor patients for signs and symptoms of pulmonary toxicity. Secondary Malignancies: Cyclophosphamide is genotoxic. Secondary malignancies have been reported in patients treated with cyclophosphamide-containing regimens. The risk of bladder cancer may be reduced by prevention of hemorrhagic cystitis. Veno-occlusive Liver Disease (VOD): VOD including fatal outcome has been reported in patients receiving cyclophosphamide-containing regimens. A cytoreductive regimen in preparation for bone marrow transplantation that consists of cyclophosphamide in combination with whole-body irradiation, busulfan, or other agents has been identified as a major risk factor. VOD has also been reported to develop gradually in patients receiving long-term low-dose immunosuppressive doses of cyclophosphamide. Alcohol Content: The alcohol content in a dose of Cyclophosphamide Injection may affect the central nervous system. Consideration should be given to the alcohol content on the ability to drive or use machines immediately after the infusion. Embryo-Fetal Toxicity: Cyclophosphamide Injection can cause fetal harm when administered to a pregnant woman. Exposure to cyclophosphamide during pregnancy may cause birth defects, miscarriage, fetal growth retardation, and fetotoxic effects in the newborn. Advise females of reproductive potential to use effective contraception during treatment and for up to 1 year after completion of therapy. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after completion of therapy. Infertility: Male and female reproductive function and fertility may be impaired in patients being treated with Cyclophosphamide Injection. Cyclophosphamide interferes with oogenesis and spermatogenesis. It may cause sterility in both sexes. Cyclophosphamide-induced sterility may be irreversible in some patients. Adverse Reactions: Most common adverse reactions reported are neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, and diarrhea. Lactation: Advise not to breastfeed. Renal Patients: Monitor for toxicity in patients with moderate and severe renal impairment. Please see accompanying full Prescribing Information for Cyclophosphamide Injection . Pantoprazole Sodium in 0.9% Sodium Chloride Injection Indications Pantoprazole Sodium in 0.9% Sodium Chloride Injection is a proton pump inhibitor (PPI) indicated in adults for the following: Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE). Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. Important Risk Information Contraindications Patients with a known hypersensitivity to any component of the formulation or to substituted benzimidazoles. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria. Patients receiving rilpivirine-containing products. Presence of Gastric Malignancy: In adults, symptomatic response to therapy does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy. Injection Site Reactions: Thrombophlebitis was reported in association with the administration of another intravenous pantoprazole sodium product. Potential for Exacerbation of Zinc Deficiency: Pantoprazole Sodium in 0.9% Sodium Chloride Injection contains edetate disodium (the salt form of EDTA), a chelator of metal ions including zinc. Therefore, zinc supplementation should be considered in patients who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously. Acute Tubulointerstitial Nephritis (TIN): Has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function. Discontinue Pantoprazole Sodium in 0.9% Sodium Chloride Injection and evaluate patients with suspected acute TIN. Clostridioides difficile -associated diarrhea: Published observational studies suggest that PPI therapy may be associated with an increased risk of Clostridioides difficile -associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Bone Fracture: Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines. Severe Cutaneous Adverse Reactions: Including erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs. Discontinue Pantoprazole Sodium in 0.9% Sodium Chloride Injection at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE): Have been reported in patients taking PPIs, including pantoprazole sodium. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematous cases were CLE. Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Hepatic Effects: Mild, transient transaminase elevations have been observed in clinical studies with another intravenous pantoprazole sodium product. The clinical significance of this finding in a large population of subjects is unknown. Hypomagnesemia and Mineral Metabolism: Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, and in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. Fundic Gland Polyps: PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic. Use the shortest duration of PPI therapy appropriate to the condition being treated. Adverse Reactions: Most common adverse reactions (incidence > 2%) are headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. Drug Interactions: See the full prescribing information for a list of clinically important drug interactions. Pregnancy: Based on animal data, may cause fetal harm. Please see accompanying full Prescribing Information for Pantoprazole Sodium in 0.9% Sodium Chloride Injection . Cefazolin in Dextrose Injection, USP Indications Cefazolin in Dextrose Injection is a cephalosporin antibacterial indicated for: Treatment of respiratory tract infections in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved. Limitations of Use : Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: Urinary tract infections; Skin and skin structure infections; Biliary tract infections; Bone and joint infections; Genital infections; Septicemia; Endocarditis. Perioperative prophylaxis in adults and pediatric patients aged 10 – 17 years old for whom appropriate dosing with this formulation can be achieved. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin in Dextrose Injection and other antibacterial drugs, Cefazolin in Dextrose Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Important Risk Information Contraindications: Hypersensitivity to Cefazolin or other cephalosporin class antibacterial drugs, penicillins, or other beta-lactams. Hypersensitivity Reactions to Cefazolin, Cephalosporins, Penicillins, or Other Beta-lactams: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with Cefazolin in Dextrose Injection, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to cefazolin, cephalosporins, penicillins, or carbapenems. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among betalactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue the drug. Seizures in Patients with Renal Impairment: Seizures may occur particularly in patients with renal impairment when the dosage is not reduced appropriately. Discontinue Cefazolin in Dextrose Injection if seizures occur or make appropriate dosage adjustments in patients with renal impairment. Anticonvulsant therapy should be continued in patients with known seizure disorders Clostridioides difficile -associated Diarrhea (CDAD): May range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. Prothrombin Activity: Cefazolin in Dextrose Injection may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated. Adverse Reactions: Adult and Pediatric Patients : Most common adverse reactions: gastrointestinal (nausea, vomiting, diarrhea), and allergic reactions (anaphylaxis, urticaria, skin rash). Pediatric Patients with Perioperative Prophylaxis : The most frequently reported adverse reactions (incidence ≥ 5%) were nausea, infusion site pain, and headache. Drug Interactions: Probenecid: The renal excretion of cefazolin is inhibited by probenecid. Co-administration of probenecid with Cefazolin in Dextrose Injection is not recommended. Please see accompanying full Prescribing Information for Cefazolin in Dextrose Injection, USP . Levetiracetam in Sodium Chloride Injection Indications Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible: Partial-onset seizures Myoclonic seizures in patients with juvenile myoclonic epilepsy Primary generalized tonic-clonic seizures Important Risk Information Contraindications: Levetiracetam in Sodium Chloride Injection is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema. Psychiatric Reactions: Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed. Monitor patients for psychiatric signs and symptoms. Somnolence and Fatigue: Monitor patients for these symptoms and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam. Anaphylaxis and Angioedema: Levetiracetam can cause anaphylaxis or angioedema. In some reported cases, reactions were life-threatening and required emergency treatment. If a patient develops signs or symptoms of anaphylaxis or angioedema, levetiracetam should be discontinued and the patient should seek immediate medical attention. Serious Dermatological Reactions: Serious reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with levetiracetam. Recurrence of the serious skin reactions following rechallenge has also been reported. Levetiracetam should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed, and alternative therapy should be considered. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: This has been reported in patients taking antiepileptic drugs, including levetiracetam. These events can be fatal or life-threatening, particularly if diagnosis and treatment do not occur as early as possible. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, sometimes resembling an acute viral infection. If such signs or symptoms are present, the patient should be evaluated immediately. Levetiracetam should be discontinued if an alternative etiology for the signs or symptoms cannot be established. Coordination Difficulties: Monitor for ataxia, abnormal gait, and incoordination. Patients should be monitored for these signs and symptoms and advised not to drive or operate machinery until they have gained sufficient experience on levetiracetam. Withdrawal Seizures: Levetiracetam must be gradually withdrawn. But if withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered. Hematologic Abnormalities: Hematologic abnormalities occurred in clinical trials and included decreases in white blood cell, neutrophil, and red blood cells counts; decreases in hemoglobin and hematocrit; and increases in eosinophil counts. Cases of agranulocytosis, pancytopenia, and thrombocytopenia have been reported in the post-marketing setting. A complete blood count is recommended in patients experiencing significant weakness, pyrexia, recurrent infections, or coagulation disorders. Adverse Reactions: Most common adverse reactions (incidence in levetiracetam-treated patients is ≥5% more than in placebo-treated patients) include: somnolence, asthenia, infection, and dizziness. Pregnancy: Plasma levels of levetiracetam may be decreased; monitor closely during pregnancy. Based on animal data, may cause fetal harm. Encourage women who are taking levetiracetam injection during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry. Renal Impairment: Dosage adjustment is recommended for patients with impaired renal function and supplemental doses should be given to patients after dialysis. Please see accompanying full Prescribing Information for Levetiracetam in Sodium Chloride Injection . This release includes forward-looking statements concerning Micafungin in 0.9% Sodium Chloride Injection, Cyclophosphamide Injection, Pantoprazole Sodium in 0.9% Sodium Chloride Injection, Cefazolin in Dextrose Injection, USP and Levetiracetam in Sodium Chloride Injection, including potential benefits associated with the use of these products. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: demand for and market acceptance for new and existing products; product development risks; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and Form 10-Q and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements. Baxter is a registered trademark of Baxter International Inc. 1 Includes line extensions. 2 Mercaldi CJ, Lanes S, Bradt J. Comparative risk of bloodstream infection in hospitalized patients receiving intravenous medication by open, point-of-care, or closed delivery systems. Am J Health-Syst Pharm. 2013;70:957-965. 3 Billstein-Leber M, Carrillo CJD, Cassano AT, Moline K, Robertson JJ. ASHP Guidelines on Preventing Medication Errors in Hospitals. Am J Health Syst Pharm. 2018;75(19):1493-1517. US-PH121-240011 (v3.0) 12/2024

SHIRLEY, N.Y., July 2, 2024 /PRNewswire/ -- American Regent announces the launch and availability of Sodium Phosphates Injection, USP, which is FDA-approved and therapeutically equivalent to Sodium Phosphates .1 Sodium Phosphates Injection, USP 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Continue Reading Sodium Phosphates Injection, USP is available in three presentations The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions. Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia. "An important part of our company's mission is to assist in mitigating shortages and ensuring supply of critical medications whenever possible. To that end, we are pleased to add Sodium Phosphates Injection, USP to our robust line of products that are formulated, filled, and finished at our US-based manufacturing facilities," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc. This product is available for immediate shipment. Customers can order Sodium Phosphates Injection, USP through their wholesaler/distributor, or by contacting our Customer Support Group at 1-800-645-1706. Sodium Phosphates Injection, USP is supplied as follows: See the following Important Safety Information, in addition to the product's Full Prescribing Information. For additional information, please visit FOR ADDITIVE USE ONLY AFTER DILUTION IN I.V. FLUIDS INDICATIONS AND USAGE Sodium Phosphates Injection, USP 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia. WARNINGS Sodium Phosphates Injection, USP 3 mM P/mL must be diluted and thoroughly mixed before use. To avoid phosphorus intoxication, infuse solutions containing sodium phosphate slowly. Infusing high concentrations of phosphorus may result in a reduction of serum calcium and symptoms of hypocalcemic tetany. Calcium levels should be monitored. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. PRECAUTIONS Do not administer unless solution is clear and seal is intact. Discard unused portion. Phosphorus replacement therapy with sodium phosphate should be guided primarily by the serum phosphorus level and the limits imposed by the accompanying sodium (Na+) ion. Use with caution in patients with renal impairment, cirrhosis, cardiac failure, and other edematous or sodium-retaining states. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin. Pregnancy: Animal reproduction studies have not been conducted with sodium phosphate. It is also not known whether sodium phosphate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium phosphate should be given to a pregnant woman only if clearly needed. Pediatric Use: The safety and effectiveness of sodium phosphate has been established in pediatric patients (neonates, infants, children, and adolescents). Geriatric Use: An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Sodium ions and phosphorus are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. ADVERSE REACTIONS Adverse reactions involve the possibility of phosphorus intoxication. Phosphorus intoxication results in a reduction of serum calcium and the symptoms are those of hypocalcemic tetany. OVERDOSAGE In the event of overdosage, discontinue infusions containing sodium phosphate immediately and institute corrective therapy to restore depressed serum calcium and to reduce elevated serum sodium levels. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS. For additional safety information, please see Full Prescribing Information . You are encouraged to report Adverse Drug Events to American Regent Inc. at 1-800-734-9236, or to the FDA by visiting or by calling 1-800-FDA-1088. 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 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 American Regent, Inc.®, a Daiichi Sankyo Group company, is an industry-leading injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables for healthcare providers. For more than 20 years, we have been a leader in IV iron therapy. American Regent is committed to US-based manufacturing. To that end, over the last several years we have made significant investments in expanding and modernizing our manufacturing facilities in Ohio and New York. This expansion will nearly double our capacity and allow us to better serve our customers now and in the future. Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need. For more information, please visit . About Daiichi Sankyo Group Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose "to contribute to the enrichment of quality of life around the world." In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. 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Researchers have developed a robotic feeding system that uses computer vision, machine learning and multimodal sensing to safely feed people with severe mobility limitations, including those with spinal cord injuries, cerebral palsy and multiple sclerosis. Cornell researchers have developed a robotic feeding system that uses computer vision, machine learning and multimodal sensing to safely feed people with severe mobility limitations, including those with spinal cord injuries, cerebral palsy and multiple sclerosis. "Feeding individuals with severe mobility limitations with a robot is difficult, as many cannot lean forward and require food to be placed directly inside their mouths," said Tapomayukh "Tapo" Bhattacharjee, assistant professor of computer science in the Cornell Ann S. Bowers College of Computing and Information Science and senior developer behind the system. "The challenge intensifies when feeding individuals with additional complex medical conditions." A paper on the system, "Feel the Bite: Robot-Assisted Inside-Mouth Bite Transfer using Robust Mouth Perception and Physical Interaction-Aware Control," was presented at the Human Robot Interaction conference, held March 11-14, in Boulder, Colorado. It received a Best Paper Honorable Mention recognition, while a demo of the research team's broader robotic feeding system received a Best Demo Award. A leader in assistive robotics, Bhattacharjee and his EmPRISE Lab have spent years teaching machines the complex process by which we humans feed ourselves. It's a complicated challenge to teach a machine -- everything from identifying food items on a plate, picking them up and then transferring it inside the mouth of a care recipient. "This last 5 centimeters, from the utensil to inside the mouth, is extremely challenging," Bhattacharjee said. Some care recipients may have very limited mouth openings, measuring less than 2 centimeters, while others experience involuntary muscle spasms that can occur unexpectedly, even when the utensil is inside their mouth, Bhattacharjee said. Further, some can only bite food at specific locations inside their mouth, which they indicate by pushing the utensil using their tongue, he said. "Current technology only looks at a person's face once and assumes they will remain still, which is often not the case and can be very limiting for care recipients," said Rajat Kumar Jenamani, the paper's lead author and a doctoral student in the field of computer science. To address these challenges, researchers developed and outfitted their robot with two essential features: real-time mouth tracking that adjusts to users' movements, and a dynamic response mechanism that enables the robot to detect the nature of physical interactions as they occur, and react appropriately. This enables the system to distinguish between sudden spasms, intentional bites and user attempts to manipulate the utensil inside their mouth, researchers said. The robotic system successfully fed 13 individuals with diverse medical conditions in a user study spanning three locations: the EmPRISE Lab on the Cornell Ithaca campus, a medical center in New York City, and a care recipient's home in Connecticut. Users of the robot found it to be safe and comfortable, researchers said. "This is one of the most extensive real-world evaluations of any autonomous robot-assisted feeding system with end-users," Bhattacharjee said. The team's robot is a multi-jointed arm that holds a custom-built utensil at the end that can sense the forces being applied on it. The mouth tracking method -- trained on thousands of images featuring various participants' head poses and facial expressions -- combines data from two cameras positioned above and below the utensil. This allows for precise detection of the mouth and overcomes any visual obstructions caused by the utensil itself, researchers said. This physical interaction-aware response mechanism uses both visual and force sensing to perceive how users are interacting with the robot, Jenamani said. "We're empowering individuals to control a 20-pound robot with just their tongue," he said. He cited the user studies as the most gratifying aspect of the project, noting the significant emotional impact of the robot on the care recipients and their caregivers. During one session, the parents of a daughter with schizencephaly quadriplegia, a rare birth defect, witnessed her successfully feed herself using the system. "It was a moment of real emotion; her father raised his cap in celebration, and her mother was almost in tears," Jenamani said. While further work is needed to explore the system's long-term usability, its promising results highlight the potential to improve care recipients' level of independence and quality of life, researchers said. "It's amazing," Bhattacharjee said, "and very, very fulfilling." Paper co-authors are: Daniel Stabile, M.S. '23; Ziang Liu, a doctoral student in the field of computer science; Abrar Anwar of the University of South California, and Katherine Dimitropoulou of Columbia University. This research was funded primarily by the National Science Foundation.