The investigators hypothesized that the empirical use of fluoroquinolones together with beta-lactam antibiotics will change their therapeutic success in patients with acute exacerbations of COPD compared to that in patients in whom a single beta-lactam treatment was used. The main goal of this study was to compare the clinical and bacterial success from the use of a combination of beta-lactam and fluoroquinolone antibiotics with that of a single beta-lactam treatment, in adult patients with COPD exacerbations.

开始日期2020-01-01

申办/合作机构

Hai phong University Of Medicine and Pharmacy

NCT01963442

/ Unknown status临床2期IIT

A Non-Inferiority, Multicentered, Controlled, Randomized, Double Blinded Study Investigating the Antibiotic Treatment Duration (3-day Versus 8-day) for Subjects Admitted to Emergency Services With Acute Non-severe Community Acquired Pneumonia (CAP)

To investigate the non inferiority of a short lasting antibiotic treatment (3 days) when compared to a long lasting antibiotic treatment (8 days), at Day 15 after the beginning of treatment in terms of clinical efficacy, in adults admitted to emergency services for a non severe Community Acquired Pneumonia (PAC), who responded well to 3 days of beta-lactamin treatment (3GC or A/AC).

开始日期2013-11-01

申办/合作机构

Centre Hospitalier de Versailles

NCT02158442

/ Completed临床2期

Randomized Study Comparing Clinical and Microbiological Efficacy of Timentin Delivered Via Percutaneous Isolated Limb Perfusion (PILP) or Intravenous Infusion in Diabetic Subjects With Moderate to Severe Lower Limb Infection

The use of the Percutaneous Isolated Limb Procedure (PILP) which enables the use of existing antibiotic therapies in a more targeted and concentrated fashion in patients with diabetes who have a significant lower limb infection and it is deemed that IV antibiotics are needed in order to salvage the limb or life.

开始日期2013-10-01

申办/合作机构

Osprey Medical, Inc.

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项与替卡西林钠克拉维酸钾相关的文献（医药）

2024-07-01·Plant Disease

First Report of Strawberry Root Rot Caused by Fusarium falciforme in China

Article

作者: Wu, Bin ; Xin, Xiangqi ; Xin, Zhimei ; Sun, Xiaohui

Root rot caused by Fusarium spp. is a destructive disease affecting agricultural regions worldwide. Strawberries (Fragaria × ananassa Duch.) are an economically important crop in China. In March 2023, root rot was observed in strawberries grown in Jinan, Shandong Province, China. Symptoms included leaf wilt, necrotic roots, and plant death (Figure 1). Four strawberry samples (two symptomatic and two asymptomatic) were collected from ~2-acre fields where the disease incidence rate ranged from 2 to 3%. Tissue pieces (5 mm × 5 mm × 5 mm) from two healthy and two diseased strawberry root tissues were surface-disinfected with 75% ethanol for 3 min, treated with 10% sodium hypochlorite for 5 min, and washed three times with sterile water. These pieces were cultured for 5 days at 28°C on potato dextrose agar (PDA) containing 200 mg/L timentin. Typical Fusarium spp. like growth was observed on plates with the two symptomatic samples. Two representative fungal isolates (CM1 and CM2) with similar morphological characteristics were purified using the single-spore method (Figure 1). CM1 showed an average growth rate of 5 mm/d in PDA and comprised of several white-to-cream aerial mycelia after 5 d. After cultivation in carnation leaf agar medium for 7 d, falciform macroconidia, with blunt apical cells and slightly hooked basal cells comprising 3 to 4 septa of varying sizes (20 to 39)×(3.6 to 6.7 μm) were observed (n=50) (Figure 1). The chlamydospores were spherical, terminal or intercalary, solitary or chain-forming, and 3.1-10.5 μm in diameter (Figure 1). The microconidia on PDA were (5.8 to 13.6)× (2.5 to 3.3) μm in size (n=50). These morphological characteristics are consistent with previous descriptions of the Fusarium solani species complex (FSSC). DNA was extracted using the CTAB method (Stenglein and Balatti 2006). The internal transcribed spacer (ITS), translation elongation factor 1-α gene (tef1), RNA polymerase II largest subunit (rpb1), and RNA polymerase II second largest subunit (rpb2) were amplified and sequenced using specific primers (O'Donnell et al. 2010). The ITS (OR526528, OR526529), tef1 (OR536947, OR536948), rpb1 (OR536949, OR536950), and rpb2 (OR536951, OR536952) sequences of the CM1 and CM2 isolates were uploaded to the NCBI database. BLASTn analysis revealed that the ITS, tef1, rpb1, and rpb2 sequences were 99.1-100% identical to those of the Fusarium falciforme reference strains NRRL 54989 and NRRL 54978. A phylogenetic tree based on the ITS, tef1, rpb1, and rpb2 sequences was generated using MEGA v.11 via the maximum-likelihood method (Tamura et al. 2021). CM1 clustered with the Fusarium falciforme reference strains NRRL 54989 and NRRL 54978 and belonged to the FSSC based on its morphological and molecular characteristics (Figure 2). To test for pathogenicity, the roots of nine 3-month-old healthy strawberry (cv. Akihime) plants were exposed to conidial suspensions (1×10⁸ spores/mL) of the CM1 isolate. Another nine root samples were treated with sterile water and used as controls. All strawberry plants were maintained in a growth chamber under a 12/12 h light/dark cycle at 28°C and 90% relative humidity and the experiment was repeated three times. After one month, the inoculated plants had withered and died, and the pith became dark red (similar to field plants) (Figure 1). The fungi isolated from the experimental plants were confirmed as F. falciforme using morphological and sequence analyses. F. falciforme causes root rot in several species including Nicotiana tabacum (Qiu et al. 2023) and Weigela florida (Shen et al. 2020); however, this study is the first to report root rot caused by F. falciforme in strawberries in China. Overall, F. falciforme infection poses a threat to strawberry production and breeding.

2024-03-01·Plant Disease

First Report of Fruit Rot Caused by Fusarium luffae in Cherry Tomato in China

Article

作者: Jiang, Shanshan ; Hong, Hao ; Zhang, Mei ; Xin, Zhimei ; Wu, Bin ; Xin, Xiangqi ; Sun, Xiaohui

Tomato (Solanum lycopersicum L.) is a fruit of great economic value that is grown worldwide. In November 2022, fruit rot symptoms were observed in cherry tomatoes (cv. Qianxi) in Jinan City of Shandong Province, China. Six cherry tomato samples (four symptomatic and two asymptomatic) were collected from commercial fields (approximately 1.2 ha) where the incidence of the disease ranged from 5 to 10%. The core and surface of the infected fruit were colonized and covered with white mycelia. Tissue pieces (5 mm × 5 mm) from the junction of healthy and diseased samples were surface-disinfected with 75% ethanol for 3 min, followed by 10% sodium hypochlorite for 5 min, and washed three times with sterile water. Tissue pieces were cultured on potato dextrose agar (PDA containing 200 mg/L timentin) at 28°C for five days. Four fungal isolates with similar morphological characteristics were obtained from each sample. Two representative isolates were collected and purified using the single-spore method. After five days on PDA at 28°C, FL1 and FL2 colonies showed abundant white to cream colored aerial mycelia with an average growth rate of 5 mm/day. On carnation leaf agar, FL1 was characterized by falcate macroconidia with pronounced dorsiventral curvature containing three to eight tapered apical cells and foot-shaped basal cells ranging in size from 25 to 74 μm × 3.6 to 6.8 μm (n=50). Microconidia and chlamydospores were not observed. These morphological characteristics were consistent with the description of F. luffae (Wang et al. 2019). DNA was extracted using the CTAB method. The nucleotide sequences of the translation elongation factor 1-α gene (TEF1) and the second largest RNA polymerase II subunit (RPB2) were amplified using specific primers EF1/EF2 and RPB2F/R, respectively (O'Donnell et al. 1998, 2010). FL1 and FL2 sequences were deposited in GenBank (TEF1: OQ427345 and OQ427346, RPB2: OQ427347 and OQ427348). Polyphasic identification indicated 100% similarity of FL1 and FL2 to F. luffae. A combined dataset of TEF1 and RPB2 was aligned using MAFFT v.7, and phylogenetic analysis was performed in MEGA v.7.0 using the maximum likelihood method. The cherry tomato isolates (FL1 and FL2) clustered together with the F. luffae reference strain NRRL31167 (100% bootstrap) and were identified on a morphological and molecular basis as F. luffae belonging to the Fusarium incarnatum-equiseti species complex. F. luffae was the only pathogen recovered from the infected fruit. To test for pathogenicity, healthy cherry tomato fruit were inoculated in a greenhouse (28°C, 12/12 h light/dark cycle, 90% relative humidity), six by wounded inoculation and six by nonwounded inoculation) with 10 μL conidial suspensions of isolate FL1 at 1 × 106 conidia/mL. Six wounded-treated cherry tomato fruit were used for the control. All cherry tomatoes were kept in a growth chamber at 28℃ with 90% relative humidity. After seven days, the inside of the wound inoculated fruit began to rot, expanding toward the surface and producing white mycelia. Two diseased cherry tomatoes were randomly selected for tissue isolation and F. luffae was re-isolated showing the same morphology as the FL1 isolate, thus fulfilling Koch's postulates. The nonwounded inoculated fruits and control cherry tomatoes remained asymptomatic with no pathogens recovered. This indicates that the wound is an important way for F. luffae to invade tomato, and fruit rot is caused by F. luffae's infection of tomato. To the best of our knowledge, F. luffae has caused fruit rot in muskmelon (Zhang et al. 2022), but this is the first report of fruit rot disease in cherry tomatoes caused by F. luffae in China. Since cherry tomatoes are an important commercial crop in China, F. luffae infection has the potential to pose a threat to the industry.

2023-01-01·Frontiers in plant science

Ticarcillin degradation product thiophene acetic acid is a novel auxin analog that promotes organogenesis in tomato.

Article

作者: Sudalaimuthuasari, Naganeeswaran ; Mishra, Ajay Kumar ; Aldarmaki, Maitha ; George, Suja ; Nath, Vishnu Sukumari ; Rafi, Mohammed ; Amiri, Khaled M A ; Nuaimi, Mariam Al ; Shah, Iltaf ; Hazzouri, Khaled Michel ; ElSiddig, Mohamed

Efficient regeneration of transgenic plants from explants after transformation is one of the crucial steps in developing genetically modified plants with desirable traits. Identification of novel plant growth regulators and developmental regulators will assist to enhance organogenesis in culture. In this study, we observed enhanced shoot regeneration from tomato cotyledon explants in culture media containing timentin, an antibiotic frequently used to prevent Agrobacterium overgrowth after transformation. Comparative transcriptome analysis of explants grown in the presence and absence of timentin revealed several genes previously reported to play important roles in plant growth and development, including Auxin Response Factors (ARFs), GRF Interacting Factors (GIFs), Flowering Locus T (SP5G), Small auxin up-regulated RNAs (SAUR) etc. Some of the differentially expressed genes were validated by quantitative real-time PCR. We showed that ticarcillin, the main component of timentin, degrades into thiophene acetic acid (TAA) over time. TAA was detected in plant tissue grown in media containing timentin. Our results showed that TAA is indeed a plant growth regulator that promotes root organogenesis from tomato cotyledons in a manner similar to the well-known auxins, indole-3-acetic acid (IAA) and indole-3-butyric acid (IBA). In combination with the cytokinin 6-benzylaminopurine (BAP), TAA was shown to promote shoot organogenesis from tomato cotyledon in a concentration-dependent manner. To the best of our knowledge, the present study reports for the first time demonstrating the function of TAA as a growth regulator in a plant species. Our work will pave the way for future studies involving different combinations of TAA with other plant hormones which may play an important role in in vitro organogenesis of recalcitrant species. Moreover, the differentially expressed genes and long noncoding RNAs identified in our transcriptome studies may serve as contender genes for studying molecular mechanisms of shoot organogenesis.

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2024-12-11

·Business Wire

Baxter Announces Continued Growth of Pharmaceuticals Portfolio With Five Injectable Product Launches in the U.S.

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

上市批准临床结果

2024-12-03

·PRNewswire

InsightRX to Present Latest Research and Platform Enhancements at ASHP 2024 Midyear

SAN FRANCISCO, Dec. 3, 2024 /PRNewswire/ -- InsightRX – the leader in Bayesian model-informed precision dosing (MIPD) software – today announced it will attend the ASHP 2024 Midyear Clinical Meeting & Exhibition as both an exhibitor and presenter. The meeting is scheduled for Dec. 8-12 at the Ernest N. Morial Convention Center in New Orleans. ASHP 2024 is organized by the American Society of Health-System Pharmacists and will include vendor exhibits, educational sessions, poster presentations, and networking opportunities for pharmacy professionals. Representatives from the InsightRX team will be at booth 1340 in the exhibition hall (available on Monday Dec 9 and Tuesday Dec 10 from 11am - 3pm, and Wed Dec 11 from 11am - 2pm) to meet with visitors and discuss product updates, new features, and benefits of Bayesian MIPD adoption. Additionally, InsightRX Senior Director of Product & Customer Experience Jonathan Faldasz, PharmD, BCPS, will present a poster from the InsightRX team on Monday, Dec. 9, from 2-3:30 p.m. The title of the poster is Proposed Update to the Cockcroft-Gault Equation for Patients with Low Serum Creatinine: Results from a Massive Multi-Site Dataset. This study evaluated the accuracy of the Cockcroft-Gault equation–long regarded as the gold standard for estimating renal function–in patients with serum creatinine levels below 1 mg/dL. By analyzing data from nearly 100,000 patients, the InsightRX team identified significant inaccuracies in the equation's predictions for this population. In response, they developed a modified equation incorporating adjusted serum creatinine, which demonstrated greatly improved accuracy. The poster will detail these findings and their implications for clinical practice. Front and center will be demonstrations of a new feature to the Nova platform, InsightRX Gemini, designed to eliminate complexities of manual PK model selection. InsightRX Gemini automatically chooses the best-performing PK model for the patient, based on four common covariates, and was built analyzing approximately 400,000 vancomycin treatment courses contained in the Nova data lake. When compared to commonly available PK models (seen in "freeware" and various other applications), InsightRX Gemini: increases dosing accuracy for individual patients up to 47.2% increases precision by up to 25% decreases bias by up to 93% Overall, MIPD dosing activities have increased for a variety of therapeutic areas and hold promise for enhancing workflows and producing more accurate dosing and improved outcomes. In addition to vancomycin, InsightRX offers numerous other Drug Modules, which the team will also present at the exhibition. Several of these were highlighted in recent studies, thought leadership articles, and blog posts by the InsightRX team over the past year, including: Antifungals – Posaconazole is a pharmacotherapeutic pillar for prophylaxis and treatment of invasive fungal diseases. Dose individualization is critical to achieving adequate antifungal exposure associated with improved outcome. InsightRX validated an MIPD strategy for posaconazole for its fit-for-purpose, an important first step toward dosage optimization with the goal to improve antifungal treatment in clinical practice. Beta-lactams – Therapeutic drug monitoring (TDM) can improve PK/PD target attainment of beta-lactam levels and optimize dosing in vulnerable populations. There are still several barriers to widespread adoption of TDM of beta-lactams into routine clinical practice, however, beta-lactam TDM has great potential to improve patient care by optimizing antibiotic dosing, especially in high-risk populations. Solid organ transplant – Therapeutic drug monitoring is essential with tacrolimus, one of the key immunosuppressive agents used after solid organ transplant. Although most transplant centers rely on trough concentrations drawn immediately before the dose, evidence shows a poor correlation between tacrolimus trough concentrations and outcomes. A 2019 tacrolimus guidance document concludes that Bayesian estimation may be a better way to improve future tacrolimus TDM. Bone marrow transplant – Dose personalization improves patient outcomes for many drugs with a narrow therapeutic index and high inter-individuality variability, including busulfan. In a simulated study, InsightRX demonstrated that while area under the curve (AUC) estimates between the two methods showed good correlation, the maximum a posteriori Bayesian (MAP) approach led to higher target attainment for busulfan dosing. Anticoagulants – Heparin is a lifesaving mainstay of anticoagulation in patients at high risk of coagulation-related morbidity and mortality. Yet most hospitals struggle to keep their patients at a target heparin exposure, which can result in increased morbidity and mortality from both clotting and bleeding events. Several exciting advances in the use of MIPD for heparin would allow clinicians to better individualize therapy for each treatment course. Inflammatory bowel disease – Efficacy of infliximab in children with inflammatory bowel disease can be enhanced when serum concentrations are measured and further dosing is adjusted to achieve and maintain a target concentration. A recent collaborative study showed that a population pharmacokinetic model may help to predict an individual's infliximab dose requirement. "InsightRX has enjoyed a year of real growth and accomplishment and we're excited to meet with our colleagues at ASHP in New Orleans to discuss what we've learned and how we plan to continue improving dosing safety and accuracy," said Sirj Goswami, PhD, CEO and cofounder of InsightRX. "Model-informed precision dosing holds great promise for contributing to better clinical outcomes and operational efficiency." About InsightRX InsightRX is a healthcare technology company providing a cloud-based clinical decision support platform that applies quantitative pharmacology and AI to enhance therapeutic decision-making from phase I drug development to point of care. The company's platform provides an individualized, predictive understanding of a patient's response to treatment which enables an enhanced understanding of dose-effect response and toxicity for clinicians to improve medication effectiveness. Media Contact Michelle Noteboom Amendola Communications for InsightRX [email protected] SOURCE InsightRX WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-10-17

·shionogi.com

IDWeek 2024: Shionogi Presents Largest Global Real-World Evidence Study of Cefiderocol Demonstrating Strong Clinical Response Rates Across Seriously Ill Patients

Additional presentations show potent in vitro* activity for cefiderocol against emerging pathogens with limited treatment options, including those that are resistant to newer agents OSAKA, Japan, October 16, 2024 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President & CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announces new data at IDWeek 2024 from PROVE (Retrospective Cefiderocol Chart Review), the largest global real-world evidence study of Fetroja®/Fetcroja® (cefiderocol), an innovative siderophore cephalosporin, for the treatment of seriously ill adult patients with certain Gram-negative (GN) bacterial infections, the majority of which were carbapenem-resistant (CR). Please see below under About Cefiderocol the Full indications, and Important Safety Information of Fetroja in the U.S. PROVE is an international, multicenter, retrospective medical chart review study designed to describe the patient characteristics and clinical outcomes in patients treated with cefiderocol for GN bacterial infections in real-world settings between 2020 and 2024.1 Of the patients included in the analysis, 75.1% had a favorable clinical response to cefiderocol at the end of treatment (defined as resolution or improvement of signs and symptoms as judged by the physician, excluding deaths while on therapy).1 “Seriously ill patients with resistant Gram-negative bacterial infections are often difficult to treat. Although antibiotics are usually approved based on data from randomized controlled clinical trials, clinicians often rely on real-world evidence data to understand how antibiotics may perform in clinical settings,” said Cornelius (Neil) Clancy, MD, Professor of Medicine, University of Pittsburgh. “This real-world evidence from PROVE, the largest to date for cefiderocol, further support its use and importance as a treatment option for appropriate patients with carbapenem-resistant Gram-negative infections in clinical settings.” This analysis included 1,075 hospitalized patients, the majority (56.6%) of whom were in the intensive care unit and had a median age of 60 (range from 46-69 years).1 The majority (53.1%) of patients had respiratory tract infections (RTIs), 10.6% of patients had urinary tract infections (UTIs), and 10% of patients had bloodstream infections.1 Additionally, 74.6% of infections were resistant to carbapenems, antibiotic agents commonly used for treatment of severe bacterial infections.1,2 Of monomicrobial infections, the predominant pathogen was Pseudomonas aeruginosa (35.9%) followed by Acinetobacter baumannii (18.1%), and Enterobacterales (13.1%).1 Also a quarter of patients (25.2%) had polymicrobial infections, where an infection involved multiple concurrent Gram-negative pathogens.1 Clinical response rates were 71.6% in patients with RTI, 74.1% in patients with bloodstream infections and 91.2% in patients with UTIs.1 Overall, the rate of 30-day all-cause mortality (ACM) was 23.3%.1 There were 29 adverse drug reactions (ADRs) across 25 patients, including three serious ADRs.1 Of the 1,075 patients, 13 patients discontinued treatment with cefiderocol due to adverse drug reactions.1 Additional Studies Presented at IDWeek High Rates of Cross-Resistance Were Observed Among Beta-lactam/Beta-lactamase Inhibitors, But Not with Cefiderocol Data from two studies demonstrated the in vitro* activity of cefiderocol against multidrug-resistant Pseudomonas aeruginosa and Enterobacterales isolates that were non-susceptible to several contemporary beta-lactam/beta-lactamase inhibitor (BL/BLI) combinations.3,4 Cross-resistance, where bacteria are resistant to multiple distinct antibiotics within the same class, was observed at high rates between BL/BLI combinations, but not with cefiderocol.3,4,5 Cefiderocol Maintained Activity Against Highly Resistant Metallo-beta-lactamase Producing Bacteria Also at IDWeek, data will be presented from two studies that demonstrated the in vitro* activity of cefiderocol against bacteria that produce metallo-beta-lactamases (MBL), enzymes that can inactivate a majority of antibiotics.6,7 MBL-producing bacteria are difficult-to-treat and are becoming increasingly prevalent around the world, with almost no treatment options.8,9 These studies showed that cefiderocol was active against clinical isolates of Pseudomonas aeruginosa and Enterobacterales carrying MBL genes, including those that were nonsusceptible to carbapenems and BL/BLI combinations.6,7 “The findings of these studies provide insights on the dynamics where cross-resistance was observed among the beta-lactams and beta-lactamase inhibitor combinations where notably, cefiderocol demonstrated potent activity against isolates resistant to these inhibitor combinations. Additionally, cefiderocol showed activity against carbapenemase-producing Enterobacterales, especially isolates carrying metallo-beta-lactamases,” said Jose Alexander, MD, Director of Microbiology, Virology and Immunology at AdventHealth. “This information can lead us to more rational antimicrobial susceptibility testing and enhance rapid therapy decisions based on resistance markers and specific carbapenemase detection.” *In vitro activity does not necessarily correlate with clinical efficacy. About Shionogi in Infectious Disease Since 1953, Shionogi has been a leader in infectious disease discovery and commercialization. Our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Today, our global pipeline includes investigational agents developed to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus. As part of our commitment to addressing unmet medical needs, Shionogi is partnering with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi has a landmark license and technology transfer agreement for cefiderocol with Global Antibiotic Research and Development Partnership (GARDP) and a collaboration agreement with the Clinton Health Access Initiative (CHAI) to transform the landscape of access to antibiotics in many low-income countries, most lower-middle and upper middle-income countries, and select high-income countries. About Shionogi & Co. Ltd. Shionogi & Co., Ltd. is a leading global research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of "supplying the best possible medicine to protect the health and well-being of the patients we serve." Shionogi has discovered and developed novel antibiotics and medicines for HIV and influenza and currently markets medicines for infectious diseases and central nervous system disorders. Shionogi’s global pipeline includes research programs in infectious diseases, pain/CNS, metabolic disorders, rare diseases, oncology and stroke. For more information, visit https://www.shionogi.com/global/en/. Antimicrobial Resistance AMR is a major health burden that urgently needs to be addressed.10 Globally, in 2019, there were 1.27 million deaths attributable to bacterial AMR.10 Infections caused by carbapenem-resistant Gram-negative bacteria are often associated with a high mortality rate.11 If no action is taken, drug-resistant pathogens could cause more than 39 million deaths over the next 25 years.12 Shionogi’s Commitment to Fighting Antimicrobial Resistance Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years. Shionogi is proud to be one of the few large pharmaceutical companies that continues to focus on research and development in anti-infectives. For more information, please refer to: https://www.shionogi.com/global/en/sustainability/amr.html. About Cefiderocol In Europe, cefiderocol is commercially available under the brand name Fetcroja® for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.13 In the U.S., cefiderocol is available under the brand name Fetroja® and is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTIs) caused by certain susceptible Gram-negative microorganisms.14 In Japan, cefiderocol is commercially available under the brand name Fetroja® and received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for various infections caused by strains resistant to carbapenem antibiotics among sensitive strains of Escherichia coli, Citrobacter species, Klebsiella pneumoniae, Enterobacter species, Serratia marcescens, Proteus species, Morganella morganii, Pseudomonas aeruginosa, Burkholderia species, Stenotrophomonas maltophilia, and Acinetobacter species. U.S. INDICATIONS Fetroja® (cefiderocol) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. Fetroja is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens. USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Fetroja is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of Fetroja. WARNINGS AND PRECAUTIONS Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections An increase in 28-day all-cause mortality was observed in Fetroja-treated nosocomial pneumonia, bloodstream infections, or sepsis patients compared to those treated with best available therapy (BAT) in a clinical study (NCT02714595). Most BAT regimens contained colistin. All-cause mortality remained higher in patients treated with Fetroja than in patients treated with BAT through Day 49. Generally, deaths were in patients with infections caused by Gram-negative organisms, including non-fermenters such as Acinetobacter baumannii complex, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa, and were the result of worsening or complications of infection, or underlying comorbidities. The cause of the increase in mortality has not been established. Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP. Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Hypersensitivity was observed with Fetroja. Before Fetroja is instituted, inquire about previous hypersensitivity to cephalosporins, penicillins, or other beta-lactam drugs. If an allergic reaction occurs, discontinue Fetroja. Clostridioides difficile-associated Diarrhea (CDAD) CDAD has been reported with nearly all systemic antibacterial agents, including Fetroja. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued. Seizures and Other Central Nervous System (CNS) Adverse Reactions Cephalosporins, including Fetroja, have been implicated in triggering CNS adverse reactions such as seizures. Encephalopathy, coma, asterixis, and neuromuscular excitability have been reported with cephalosporins, particularly in patients with a history of epilepsy and/or when recommended dosages of cephalosporins were exceeded due to renal impairment. Adjust Fetroja dosing based on creatinine clearance. If focal tremors or seizures occur, evaluate patients to determine whether Fetroja should be discontinued. Development of Drug-Resistant Bacteria Prescribing Fetroja in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONS The most common adverse reactions occurring in ≥2% of patients receiving Fetroja in the cUTI trial were: diarrhea (4%), infusion site reactions (4%), constipation (3%), rash (3%), candidiasis (2%), cough (2%), elevations in liver tests (2%), headache (2%), hypokalemia (2%), nausea (2%), and vomiting (2%). The most common adverse reactions occurring in ≥4% of patients receiving Fetroja in the HABP/VABP trial were: elevations in liver tests (16%), hypokalemia (11%), diarrhea (9%), hypomagnesemia (5%), and atrial fibrillation (5%). Please click here for Full U.S. Prescribing Information for Fetroja® (cefiderocol). Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html U.S. Media: ShionogiCommunications@shionogi.com References: 1. Clancy C, et al. Real-World Effectiveness and Safety of Cefiderocol in the Treatment of Patients with Serious Gram-negative Bacterial Infections: Results of the PROVE Chart Review Study. Poster presented at IDWeek 2024. 2. Papp-Wallace KM, et al. Carbapenems: past, present, and future. Antimicrob Agents Chemother. 2011 Nov;55(11):4943-60. doi: 10.1128/AAC.00296-11. Epub 2011 Aug 22. PMID: 21859938; PMCID: PMC3195018. 3. Nguyen S, et al. Evaluation of Phenotypic Cross-Resistance between Cefiderocol and β-lactam/β-lactamase inhibitor combinations against Pseudomonas aeruginosa isolates from US Medical Centers. Poster presented at IDWeek 2024. 4. DeJonge B, et al. Cefiderocol retains in vitro activity against Enterobacterales non-susceptible to β-lactam-β-lactamase inhibitor combinations. Poster presented at IDWeek 2024. 5. Colclough A, et al. Patterns of cross-resistance and collateral sensitivity between clinical antibiotics and natural antimicrobials. Evol Appl. 2019 Jan 28;12(5):878-887. doi: 10.1111/eva.12762. PMID: 31080502; PMCID: PMC6503891. 6. Mendes RE, et al. Cefiderocol Activity against Pseudomonas aeruginosa Clinical Isolates Carrying Metallo-β-lactamase Genes in United States and European Hospitals (2020–2023). Poster presented at IDWeek 2024. 7. Mendes RE, et al. Cefiderocol Activity against Clinical Enterobacterales Isolates Carrying Metallo-β-lactamase Genes in United States and European Hospitals (2020–2023). Poster presented at IDWeek 2024. 8. Gharavi MJ, et al. Comprehensive study of antimicrobial susceptibility pattern and extended spectrum beta-lactamase (ESBL) prevalence in bacteria isolated from urine samples. Sci Rep 11, 578 (2021). https://doi-org.libproxy1.nus.edu.sg/10.1038/s41598-020-79791-0 9. Boyd SE, et al. Metallo-β-Lactamases: Structure, Function, Epidemiology, Treatment Options, and the Development Pipeline. Antimicrob Agents Chemother. 2020 Sep 21;64(10):e00397-20. doi: 10.1128/AAC.00397-20. PMID: 32690645; PMCID: PMC7508574. 10. Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet 2022; 399: 629–55. 11. Perez F, et al. ‘Carbapenem-Resistant Enterobacteriaceae: A Menace to our Most Vulnerable Patients’. Cleve Clin J Med. Apr 2013; 80(4): 225–33. 12. GBD 2021 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance 1990-2021: a systematic analysis with forecasts to 2050. Lancet. 2024 Sep 28;404(10459):1199-1226. doi: 10.1016/S0140-6736(24)01867-1. Epub 2024 Sep 16. PMID: 39299261. 13. Fetcroja® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/fetcroja-epar-product-information_en.pdf. Accessed September 10, 2024. 14. Fetroja® Prescribing information. Available at: https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf. Accessed September 10, 2024.

引进/卖出临床结果上市批准

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-	替卡西林钠克拉维酸钾	J01CR03	-

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细菌感染	中国	Smithkline Beecham Pharmaceuticals (India) Ltd.	2000-05-16

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02158442 (CTgov)	临床2期	糖尿病 \| 感染	15	Percutaneous Isolated Limb Perfusion (PILP) delivery+Timentin (Treatment Group)	鏇網膚積選遞積糧廠齋(夢構簾築蓋衊齋鑰觸製) = 餘選鬱構鑰鏇範醖鏇糧鑰餘獵餘憲窪淵遞衊願 (夢顧願範壓餘鏇選網餘, 鹹憲遞繭蓋選窪蓋願簾 ~ 淵衊築遞淵憲醖遞艱顧) 更多	-	2016-08-03
				Timentin (Control Group)	鏇網膚積選遞積糧廠齋(夢構簾築蓋衊齋鑰觸製) = 壓選鬱糧艱壓鏇網網構鑰餘獵餘憲窪淵遞衊願 (夢顧願範壓餘鏇選網餘, 積網築觸觸網蓋範遞衊 ~ 顧遞衊糧選觸鹹構淵憲) 更多