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Article ; Online: A narrative review of nontuberculous mycobacterial pulmonary disease: microbiology, epidemiology, diagnosis, and management challenges.

Hamed, Kamal A / Tillotson, Glenn

2023 Volume 17, Issue 11, Page(s) 973–988

Abstract: Introduction: Nontuberculous mycobacteria (NTM) are a diverse group of mycobacterial species that are ubiquitous in the environment. They are opportunistic pathogens that can cause a range of diseases, especially in individuals with underlying ... ...

Abstract	Introduction: Nontuberculous mycobacteria (NTM) are a diverse group of mycobacterial species that are ubiquitous in the environment. They are opportunistic pathogens that can cause a range of diseases, especially in individuals with underlying structural lung disease or compromised immune systems. Areas covered: This paper provides an in-depth analysis of NTM infections, including microbiology, environmental sources and transmission pathways, risk factors for disease, epidemiology, clinical manifestations and diagnostic approaches, guideline-based treatment recommendations, drugs under development, and management challenges. Expert opinion: Future approaches to the management of NTM pulmonary disease will require therapies that are well tolerated, can be taken for a shorter time period and perhaps less frequently, have few drug-drug interactions, and are active against the various strains of pathogens. As the numbers of infections increase, such therapies will be welcomed by clinicians and patients.
MeSH term(s)	Humans ; Mycobacterium Infections, Nontuberculous/diagnosis ; Mycobacterium Infections, Nontuberculous/drug therapy ; Mycobacterium Infections, Nontuberculous/epidemiology ; Nontuberculous Mycobacteria ; Lung/microbiology ; Lung Diseases/diagnosis ; Lung Diseases/epidemiology ; Lung Diseases/therapy ; Risk Factors
Language	English
Publishing date	2023-12-26
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2479146-5
ISSN	1747-6356 ; 1747-6348
ISSN (online)	1747-6356
ISSN	1747-6348
DOI	10.1080/17476348.2023.2283135
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Article ; Online: Safety and pharmacokinetics of SPR206 in subjects with varying degrees of renal impairment.

Bruss, Jon B / Bader, Justin / Hamed, Kamal A

Antimicrobial agents and chemotherapy

2023 Volume 67, Issue 11, Page(s) e0050523

Abstract: SPR206 is a novel polymyxin derivative with ... ...

Abstract	SPR206 is a novel polymyxin derivative with potent
MeSH term(s)	Humans ; Kidney Failure, Chronic/drug therapy ; Renal Dialysis ; Renal Insufficiency ; Administration, Intravenous ; Metabolic Clearance Rate ; Area Under Curve
Language	English
Publishing date	2023-10-12
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	217602-6
ISSN	1098-6596 ; 0066-4804
ISSN (online)	1098-6596
ISSN	0066-4804
DOI	10.1128/aac.00505-23
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Article ; Online: Nontuberculous mycobacterial pulmonary disease and the potential role of SPR720.

Winthrop, Kevin L / Flume, Patrick / Hamed, Kamal A

Expert review of anti-infective therapy

2023 Volume 21, Issue 11, Page(s) 1177–1187

Abstract: Introduction: Nontuberculous mycobacteria infect patients who have structural lung disease or those who are immunocompromised. Nontuberculous mycobacterial pulmonary disease (NTM-PD) is increasing in prevalence. Treatment guidelines for : Areas ... ...

Abstract	Introduction: Nontuberculous mycobacteria infect patients who have structural lung disease or those who are immunocompromised. Nontuberculous mycobacterial pulmonary disease (NTM-PD) is increasing in prevalence. Treatment guidelines for Areas covered: SPR720 is a novel therapeutic agent that has demonstrated activity against a range of NTM species, including MAC and MAB. Encouraging Expert opinion: Management of NTM-PD is challenging for many reasons including length of therapy, poor efficacy, drug intolerance, recurrence, and resistance development. The current antimicrobial management options for NTM-PD are limited in number and there exists a large unmet need for new treatments. SPR720 has encouraging data that warrant further study in the context of a multidrug regimen.
MeSH term(s)	Humans ; Mycobacterium Infections, Nontuberculous/drug therapy ; Mycobacterium Infections, Nontuberculous/epidemiology ; Mycobacterium Infections, Nontuberculous/microbiology ; Nontuberculous Mycobacteria ; Mycobacterium avium Complex ; Lung Diseases/drug therapy ; Lung Diseases/microbiology ; Anti-Bacterial Agents/adverse effects
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2023-11-08
Publishing country	England
Document type	Journal Article
ZDB-ID	2181279-2
ISSN	1744-8336 ; 1478-7210
ISSN (online)	1744-8336
ISSN	1478-7210
DOI	10.1080/14787210.2023.2270158
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Article ; Online: Efficacy of SPR720 in murine models of non-tuberculous mycobacterial pulmonary infection.

Cotroneo, Nicole / Stokes, Suzanne S / Pucci, Michael J / Rubio, Aileen / Hamed, Kamal A / Critchley, Ian A

The Journal of antimicrobial chemotherapy

2024 Volume 79, Issue 4, Page(s) 875–882

Abstract: Background: Non-tuberculous mycobacterial pulmonary disease (NTM-PD) is increasing worldwide, with Mycobacterium avium complex (MAC) and Mycobacterium abscessus as the predominant pathogens. Current treatments are poorly tolerated and modestly effective, ...

Abstract	Background: Non-tuberculous mycobacterial pulmonary disease (NTM-PD) is increasing worldwide, with Mycobacterium avium complex (MAC) and Mycobacterium abscessus as the predominant pathogens. Current treatments are poorly tolerated and modestly effective, highlighting the need for new treatments. SPR719, the active moiety of the benzimidazole prodrug SPR720, inhibits the ATPase subunits of DNA gyrase B, a target not exploited by current antibiotics, and therefore, no cross-resistance is expected with standard-of-care (SOC) agents. Objectives: To evaluate the in vitro activity of SPR719 against MAC and M. abscessus clinical isolates, including those resistant to SOC agents, and in vivo efficacy of SPR720 in murine non-tuberculous mycobacteria (NTM) pulmonary infection models. Methods: NTM isolates were tested for susceptibility to SPR719. Chronic C3HeB/FeJ and severe combined immunodeficient murine models of pulmonary infection were used to assess efficacy of SPR720 against MAC and M. abscessus, respectively. Results: SPR719 was active against MAC (MIC90, 2 mg/L) and M. abscessus (MIC90, 4 mg/L) clinical isolates. Efficacy of SPR720 was demonstrated against MAC pulmonary infection, both as a monotherapy and in combination with SOC agents. SPR720 monotherapy exhibited dose-dependent reduction in bacterial burden, with the largest reduction observed when combined with clarithromycin and ethambutol. Efficacy of SPR720 was also demonstrated against M. abscessus pulmonary infection where monotherapy exhibited a dose-dependent reduction in bacterial burden with further reductions detected when combined with SOC agents. Conclusions: In vitro activity of SPR720 against common NTM pathogens and efficacy in murine infections warrant the continued clinical evaluation of SPR720 as a new oral option for the treatment of NTM-PD.
MeSH term(s)	Humans ; Animals ; Mice ; Nontuberculous Mycobacteria ; Mycobacterium Infections, Nontuberculous/drug therapy ; Mycobacterium Infections, Nontuberculous/microbiology ; Disease Models, Animal ; Mycobacterium avium Complex ; Anti-Bacterial Agents/pharmacology ; Anti-Bacterial Agents/therapeutic use ; Lung Diseases/drug therapy ; Pneumonia/drug therapy
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2024-02-23
Publishing country	England
Document type	Journal Article
ZDB-ID	191709-2
ISSN	1460-2091 ; 0305-7453
ISSN (online)	1460-2091
ISSN	0305-7453
DOI	10.1093/jac/dkae046
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Zs.A 1197: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Pharmacokinetics of SPR206 in Plasma, Pulmonary Epithelial Lining Fluid, and Alveolar Macrophages following Intravenous Administration to Healthy Adult Subjects.

Rodvold, Keith A / Bader, Justin / Bruss, Jon B / Hamed, Kamal

Antimicrobial agents and chemotherapy

2023 Volume 67, Issue 7, Page(s) e0042623

Abstract: SPR206 is a next-generation polymyxin being developed for the treatment of multidrug-resistant (MDR) Gram-negative infections. This Phase 1 bronchoalveolar lavage (BAL) study was conducted to evaluate SPR206's safety and pharmacokinetics in plasma, ... ...

Abstract	SPR206 is a next-generation polymyxin being developed for the treatment of multidrug-resistant (MDR) Gram-negative infections. This Phase 1 bronchoalveolar lavage (BAL) study was conducted to evaluate SPR206's safety and pharmacokinetics in plasma, pulmonary epithelial lining fluid (ELF), and alveolar macrophages (AM) in healthy volunteers. Subjects received a 100 mg intravenous (IV) dose of SPR206 infused over 1 h every 8 h for 3 consecutive doses. Each subject underwent 1 bronchoscopy with BAL at 2, 3, 4, 6, or 8 h after the start of the third IV infusion. SPR206 concentrations in plasma, BAL, and cell pellet were measured with a validated LC-MS/MS assay. Thirty-four subjects completed the study and 30 completed bronchoscopies. Mean SPR206 peak concentrations (
MeSH term(s)	Humans ; Adult ; Macrophages, Alveolar ; Anti-Bacterial Agents ; Healthy Volunteers ; Chromatography, Liquid ; Bronchoalveolar Lavage Fluid ; Tandem Mass Spectrometry ; Lung ; Administration, Intravenous
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2023-06-20
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, Non-U.S. Gov't
ZDB-ID	217602-6
ISSN	1098-6596 ; 0066-4804
ISSN (online)	1098-6596
ISSN	0066-4804
DOI	10.1128/aac.00426-23
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Article ; Online: Post-hoc analysis of the safety and efficacy of isavuconazole in older patients with invasive fungal disease from the VITAL and SECURE studies.

Hamed, Kamal / Engelhardt, Marc / Kovanda, Laura L / Huang, Jin Ju / Yan, Jean / Aram, Jalal A

Scientific reports

2023 Volume 13, Issue 1, Page(s) 6730

Abstract: Isavuconazole is a triazole with broad-spectrum antifungal activity. In this post-hoc analysis of two prospective clinical trials (VITAL and SECURE), the safety and efficacy of isavuconazole in patients aged ≥ 65 years with invasive fungal diseases were ... ...

Abstract	Isavuconazole is a triazole with broad-spectrum antifungal activity. In this post-hoc analysis of two prospective clinical trials (VITAL and SECURE), the safety and efficacy of isavuconazole in patients aged ≥ 65 years with invasive fungal diseases were evaluated. Patients were divided into two subgroups (≥ 65 and < 65 years). Adverse events (AEs); all-cause mortality; and overall, clinical, mycological, and radiological response were assessed. A total of 155 patients ≥ 65 years were enrolled in both trials. Most patients reported AEs. In the isavuconazole arm of both studies, serious AEs (SAEs) were greater in patients ≥ 65 versus < 65 years: 76.7% versus 56.9% (VITAL); 61.9% versus 49.0% (SECURE). In SECURE, SAE rates were similar in the ≥ 65 years subgroup of both treatment arms (61.9% vs 58.1%), while in the < 65 years subgroup the SAE rate was lower in the isavuconazole arm (49.0% vs 57.4%). In VITAL, all-cause mortality through day 42 (30.0% vs 13.8%) was higher, and overall response at end of treatment (27.6% vs 46.8%) was lower in patients ≥ 65 years versus < 65 years. In SECURE, all-cause mortality was similar between both subgroups, and isavuconazole (20.6% vs 17.9%) and voriconazole (22.6% vs 19.4%) treatment arms. The overall response was lower in the ≥ 65 years than the < 65 years subgroup in the isavuconazole (23.7% vs 39.0%) and voriconazole (32.0% vs 37.5%) arms. The safety and efficacy of isavuconazole were better in patients < 65 versus ≥ 65 years, and the safety profile was more favorable than that of voriconazole in both subgroups.Clinicaltrials.gov identifier NCT00634049 and NCT00412893.
MeSH term(s)	Aged ; Humans ; Antifungal Agents/adverse effects ; Aspergillosis/drug therapy ; Invasive Fungal Infections/drug therapy ; Invasive Fungal Infections/microbiology ; Nitriles/adverse effects ; Prospective Studies ; Triazoles/adverse effects ; Voriconazole/adverse effects
Chemical Substances	Antifungal Agents ; isavuconazole (60UTO373KE) ; Nitriles ; Triazoles ; Voriconazole (JFU09I87TR)
Language	English
Publishing date	2023-04-25
Publishing country	England
Document type	Evaluation Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-31788-1
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Article: No Evidence for Ceftobiprole-Induced Immune Hemolytic Anemia in Three Phase 3 Clinical Trials.

Hamed, Kamal / Wiktorowicz, Tatiana / Assadi Gehr, Maziar

Infection and drug resistance

2020 Volume 13, Page(s) 3209–3215

Abstract: Purpose: Drug-induced immune hemolytic anemia (DIIHA) is a rare but serious adverse event associated with a number of drugs, including second- and third-generation cephalosporins. A positive direct antiglobulin test (DAT) is a reliable finding in DIIHA, ...

Abstract	Purpose: Drug-induced immune hemolytic anemia (DIIHA) is a rare but serious adverse event associated with a number of drugs, including second- and third-generation cephalosporins. A positive direct antiglobulin test (DAT) is a reliable finding in DIIHA, but positive results without evidence of hemolysis can occur, particularly in hospitalized patients. There have been no reports of hemolytic anemia in four previous Phase 3 trials or from post-marketing surveillance of the advanced-generation, broad-spectrum cephalosporin, ceftobiprole. The aim of this analysis was to review the incidence of positive DAT results and any evidence of hemolytic anemia from three recent Phase 3 trials of ceftobiprole. Patients and methods: Patients were enrolled in three Phase 3 randomized controlled trials: 94 pediatric patients with pneumonia received ceftobiprole in the BPR-PIP-002 trial; 335 adults with acute bacterial skin and skin structure infections received ceftobiprole in the TARGET trial; and 201 adults with Results: In the BPR-PIP-002 trial, five patients (all ceftobiprole treated) had a documented negative DAT result at baseline followed by a positive result at the TOC visit. One patient in the ongoing, blinded ERADICATE trial had a positive DAT result at both baseline and EOT. Results from other laboratory investigations showed no evidence of hemolytic anemia in these patients. No positive DAT results were reported in the TARGET trial. Conclusion: No evidence of hemolytic anemia associated with ceftobiprole was observed in either adults or children across several indications in this analysis of three large Phase 3 trials.
Language	English
Publishing date	2020-09-16
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2494856-1
ISSN	1178-6973
ISSN	1178-6973
DOI	10.2147/IDR.S268269
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Article ; Online: A

Huang, Haihui / Gao, Lei / Engelhardt, Marc / Saulay, Mikael / Hamed, Kamal

Future microbiology

2021 Volume 16, Page(s) 783–796

Abstract: Aim: ...

Abstract	Aim:
MeSH term(s)	Cephalosporins/adverse effects ; Cephalosporins/therapeutic use ; Community-Acquired Infections/drug therapy ; Community-Acquired Infections/microbiology ; Cross Infection/drug therapy ; Cross Infection/microbiology ; Far East ; Humans ; Pneumonia, Bacterial/drug therapy
Chemical Substances	Cephalosporins ; ceftobiprole (5T97333YZK)
Language	English
Publishing date	2021-06-22
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial
ZDB-ID	2254620-0
ISSN	1746-0921 ; 1746-0913
ISSN (online)	1746-0921
ISSN	1746-0913
DOI	10.2217/fmb-2021-0121
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Article ; Online: Tobramycin inhalation powder for the treatment of pulmonary Pseudomonas aeruginosa infection in patients with cystic fibrosis: a review based on clinical evidence.

Hamed, Kamal / Debonnett, Laurie

Therapeutic advances in respiratory disease

2017 Volume 11, Issue 5, Page(s) 193–209

Abstract: Chronic airway infection with Pseudomonas aeruginosa is a major cause of increased morbidity and mortality in patients with cystic fibrosis (CF). The development and widespread use of nebulized antibacterial therapies, including tobramycin inhalation ... ...

Abstract	Chronic airway infection with Pseudomonas aeruginosa is a major cause of increased morbidity and mortality in patients with cystic fibrosis (CF). The development and widespread use of nebulized antibacterial therapies, including tobramycin inhalation solution (TIS), has led to improvements in lung function and quality of life. However, the use of nebulizers is associated with various challenges, including extended administration times and the need for frequent device cleaning and disinfection. Multiple therapies are required for patients with CF, which poses a considerable burden to patients, and adherence to the recommended treatments remains a challenge. Tobramycin inhalation powder (TIP), delivered via the T-326 Inhaler, has been shown to have similar clinical efficacy and safety as compared to TIS, with improved patient convenience, satisfaction, and treatment adherence. Long-term safety studies have shown that TIP was well tolerated with no unexpected adverse events in patients with CF. This review of the TIP pivotal and postmarketing studies reinforces the well-established efficacy and safety profile of TIP and its ease of use.
Language	English
Publishing date	2017-05
Publishing country	England
Document type	Journal Article
ZDB-ID	2476459-0
ISSN	1753-4666 ; 1753-4658
ISSN (online)	1753-4666
ISSN	1753-4658
DOI	10.1177/1753465817691239
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Zs.A 6753: Show issues

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Article ; Online: Mucormycosis in South America: A review of 143 reported cases.

Nucci, Marcio / Engelhardt, Marc / Hamed, Kamal

Mycoses

2019 Volume 62, Issue 9, Page(s) 730–738

Abstract: Mucormycosis is a rare but important invasive fungal disease that most often affects immunocompromised hosts. The incidence of mucormycosis appears to be increasing worldwide, as risk factors such as the use of immunosuppressive therapies become more ... ...

Abstract	Mucormycosis is a rare but important invasive fungal disease that most often affects immunocompromised hosts. The incidence of mucormycosis appears to be increasing worldwide, as risk factors such as the use of immunosuppressive therapies become more common. We report the results of a literature review of 143 mucormycosis cases reported in South America between 1960 and 2018. The number of reported cases has increased by decade, from 6 in the 1960s to 51 in the 2010s. The most common underlying conditions associated with mucormycosis in South America were diabetes mellitus (42.0%) and penetrating trauma/burns (20.0%). Underlying conditions involving immunosuppression, including treatment of haematologic malignancy, solid organ transplant, and corticosteroid use, also accounted for a large proportion of cases (45.5%). Between 1960 and 2018, cases of mucormycosis associated with conditions involving immunosuppression accounted for the highest mortality rate (58.5%), followed by diabetes mellitus (45.0%), and penetrating trauma/burns (37.9%). Overall mortality decreased from 100% to 39.4% during this period, mainly driven by the increasing availability and use of antifungal therapies and surgical intervention. However, these treatments are not yet universally utilised across the region in the treatment of mucormycosis; efforts to improve availability of effective treatments would be likely to improve outcomes.
MeSH term(s)	Antifungal Agents/therapeutic use ; Diabetes Complications ; Hematologic Neoplasms/complications ; Humans ; Immunocompromised Host ; Immunosuppression/adverse effects ; Invasive Fungal Infections/drug therapy ; Invasive Fungal Infections/epidemiology ; Mucormycosis/blood ; Mucormycosis/drug therapy ; Mucormycosis/epidemiology ; Organ Transplantation/adverse effects ; South America/epidemiology
Chemical Substances	Antifungal Agents
Language	English
Publishing date	2019-07-11
Publishing country	Germany
Document type	Journal Article ; Review
ZDB-ID	392487-7
ISSN	1439-0507 ; 0933-7407
ISSN (online)	1439-0507
ISSN	0933-7407
DOI	10.1111/myc.12958
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