Search Results (1,243)

Oral infections caused by antibiotic-resistant bacteria represent an emerging biomedical hazard and growing challenge for modern dentistry. To address this issue, Ag– and Cu–ZnO nanocomposites (NCs) were synthesized using ZnO carrier to combat the oral pathogens Streptococcus mutans and Streptococcus sobrinus. A comprehensive analysis of chemically synthesized metal oxide nanocomposites (MONCs) was performed, combining physicochemical characterization (TEM, XRD, ζ-potential, DLS, pH, and PFO/PSO kinetic models) with biological toxicity assessment (MIC, ATR–FTIR, SEM, and FAMEs) to better understand their antimicrobial mechanisms. The results confirmed that the synthesized nanoproducts fulfill the criteria for nanomaterials (NMs) (particle size < 100 nm). Among them, Ag–ZnO exhibited the highest antibacterial activity against both strains (MIC = 50 mg L⁻¹). Kinetic modeling revealed faster and more efficient Ag ion release from Ag–ZnO NCs compared to Cu from Cu–ZnO NCs. Molecular analyses indicated strong MONC–bacterial interactions at the cell surface, leading to changes in protein secondary structures, alterations in lipid composition, and disruption of Gram-positive bacterial membranes. Additionally, Ag–ZnO inhibited chain and cluster formation in both bacterial species, while Cu–ZnO affected only S. sobrinus. Overall, Ag– and Cu–ZnO NCs show strong potential as antimicrobial agents against oral pathogens. Full article

Background: Antimicrobial resistance (AMR) is a global health threat arising from inappropriate antibiotic use. Data on the prescription of antibiotics in emergency departments (EDs), critical care points for infection management, are limited. Objective: This study aimed to assess systemic antibiotic use in an Indonesian ED. Methods: This retrospective observational study was conducted in the Cilacap Teaching Hospital ED in 2022. Data, including patient demographics and systemic antibiotic prescription details (World Health Organization Anatomical Therapeutic Chemical (WHO ATC): J01) were extracted from electronic medical records. Antibiotic use was analyzed according to age groups (children [0–14 years], adults [15–64 years], and the elderly [≥65 years]), administration route, and the World Health Organization Access, Watch, and Reserve classification. Results: Among all ED visits during the study period, 52.1% (14,396/27,640) received systemic antibiotics, and adults comprised 68.5% (9861/14,396) of antibiotic-exposed cases. Cephalosporins were the most frequently prescribed antibiotics in all age groups (42.4–50.9%). Penicillins were more frequently prescribed in children (29.9%) than in adults (10.0%) and the elderly (6.6%), whereas fluoroquinolones were more commonly prescribed in the elderly (21.1%) than in adults (16.2%) and children (3.8%). Watch-class antibiotics, comprising 63.9% of all prescriptions, were commonly prescribed in the elderly (71.9%). Oral route was the predominant form (65.8%), particularly in children (76.5%). The most frequently prescribed antibiotics differed across age groups, with amoxicillin followed by cefixime in children, and cefixime followed by ceftriaxone in both adults and the elderly. Conclusions: This study showed high antibiotic exposure and identified age-related differences in antibiotic prescribing, and patterns that warrant further evaluation within antimicrobial stewardship frameworks, to optimize antibiotic use and mitigate AMR. Full article

Periodontitis is a highly prevalent chronic inflammatory disease with significant oral and systemic consequences, including associations with cardiovascular disease, diabetes, and adverse pregnancy outcomes. Although mechanical debridement remains the cornerstone of therapy, adjunctive antibiotic use is increasingly limited by antimicrobial resistance, biofilm-associated tolerance, pharmacokinetic constraints, and disruption of the commensal microbiome, leading to inconsistent outcomes and disease recurrence. This review highlights the mechanistic limitations of conventional antibiotic therapies in periodontitis and critically examines emerging next-generation therapeutic strategies aimed at overcoming these challenges. Specifically, it explores antimicrobial peptides, quorum sensing inhibitors, nanotechnology-based drug delivery systems, host modulation approaches, and microbiome-targeted therapies, with emphasis on their molecular mechanisms, clinical relevance, and translational potential. By integrating microbial, host, and pharmacological perspectives, this review provides a comprehensive framework for advancing precision-guided periodontal therapy and supports the shift toward targeted, sustainable, and personalized treatment strategies. Full article

Multidrug-resistant (MDR) Salmonella enteritidis infections cause high mortality and devastating economic losses in poultry, pose severe threats to animal health and food safety, and create an urgent demand for effective antibiotic alternatives. Herein, we developed a cationic liposome-encapsulated bacteriophage endolysin Lys40 (designated Lys40-Lip), and systematically evaluated its therapeutic efficacy in a chick model challenged with Salmonella enteritidis strain S4. Recombinant Lys40 was encapsulated into cationic liposomes with an encapsulation efficiency (EE) of 34.83%. The resulting Lys40-Lip nanoparticles had a hydrodynamic diameter of 137.3 ± 4.1 nm, a high positive zeta potential of +42.5 ± 0.3 mV, and excellent stability, retaining 78.52% of its initial bactericidal activity after 56 days of storage at 4 °C. Following a three-day oral treatment in Salmonella enteritidis S4-infected chicks, Lys40-Lip significantly increased survival rates in a dose-dependent manner (72.22% to 88.89% for low-to-high dose vs. 44.44% in infected controls, p < 0.05) and reduced ileal Salmonella enteritidis S4 colonization by 28.8% compared to free Lys40. Histopathology revealed Lys40-Lip restored duodenal villus integrity and reduced jejunal and ileal inflammation. Serum cytokine analysis confirmed that Lys40-Lip effectively regulated the host inflammatory response, significantly downregulating the pro-inflammatory cytokines IL-1β and IL-6, and upregulating the anti-inflammatory cytokine IL-10. Crucially, liposomal encapsulation overcame the outer membrane barrier of Gram-negative bacteria via charge-driven fusion mediated by its high positive surface potential (+42.5 ± 0.3 mV), enabling targeted delivery of Lys40 without the need for EDTA or other outer membrane permeabilizers. Lys40-Lip significantly improved the therapeutic outcomes of avian salmonellosis via synergistic direct bactericidal activity, intestinal barrier protection and inflammatory response regulation, offering a promising nanotherapeutic strategy for the control of this disease in veterinary practice. Full article

Necrotizing enteritis (NE) is an important intestinal disease threatening the poultry farming industry, and the ban on antibiotic growth promoters has created an urgent demand for safe and effective NE vaccines. Recombinant attenuated Salmonella vectors (RASVs) administered orally can induce mucosal immune responses against delivered antigens, thus showing great potential to elicit protective immunity against NE. The EntB protein is a newly discovered putative enterotoxin of Clostridium perfringens (C. perfringens). Bioinformatic predictions in this study revealed that EntB contains nineteen potential antigenic epitopes, two functional domains (NlpC and YgiM), and interacts with ten proteins, supporting its potential as a target antigen for NE vaccines. To optimize the immunogenicity of EntB-based vaccines, we constructed a novel recombinant attenuated Salmonella Enteritidis (S. Enteritidis) vector rSC0169 harboring a rhamnose-regulated delayed attenuation system, which was then used to deliver EntB to generate the recombinant strain rSC0169(pS-EntB). This system enhanced the immunogenicity of the Salmonella vector rSC0169 and further elicited robust mucosal immune responses against EntB, as well as humoral and cellular immune responses. Compared with the control strain rSC0169(pS0018), rSC0169(pS-EntB) candidate vaccine strain significantly alleviated NE symptoms, increased the intestinal villus height/crypt depth (VH/CD) ratio, upregulated tight junction protein expression, and reduced excessive pro-inflammatory cytokine production. In conclusion, this study provides a promising NE candidate vaccine and offers a valuable strategy for developing vaccines against other intestinal bacterial diseases. Full article

The global restriction of antimicrobial growth promoters has intensified the search for alternative strategies to sustain poultry health and productivity. One proposed mechanism underlying the historical efficacy of antibiotic performance enhancers is the modulation of intestinal inflammation. In this context, meloxicam (MLX), a preferential COX-2 inhibitor and non-steroidal anti-inflammatory drug, has emerged as a potential candidate for investigation. However, pharmacokinetic data in broiler chickens remain limited, particularly for practical oral formulations intended for production systems. This study aimed to characterize the pharmacokinetic profile of a novel granulated MLX formulation in male Cobb 500 broiler chickens following single-dose administration. Seventy-two 21-day-old broilers received MLX granulate (19.24% m/m) via oral gavage at 3.6 mg/kg body weight. Plasma samples were collected over 48 h post administration. MLX concentrations were quantified using validated high-performance liquid chromatography, and pharmacokinetic parameters were estimated using nonlinear mixed-effects modelling (NLME). Mean pharmacokinetic parameters included AUC_0–∞ of 79.97 μg·h/mL, C_max of 14.43 μg/mL, and T_max of 1 h, indicating rapid absorption and substantial systemic exposure. These findings provide novel insights into MLX disposition from the granulated formulation in broilers and provide pharmacokinetic information to support future investigations evaluating its potential biological effects in poultry production systems. Full article

Lactiplantibacillus plantarum LP28 (LP28), isolated from traditional Taiwanese dried tofu, has been demonstrated to have substantial probiotic potential because it increases the production of short-chain fatty acids (SCFAs) and strengthens anti-inflammatory responses. In this study, the safety of LP28 was assessed using both in vitro and in vivo approaches, including whole-genome sequence analysis, the Ames bacterial reverse mutation assay, a chromosomal aberration test, a rodent peripheral blood micronucleus test, a 28-day subacute oral toxicity assay, and an assessment of hemolytic activity. In vitro phenotypic evaluation revealed that LP28 exhibited no hemolytic activity and was susceptible to all the tested antibiotics except kanamycin. In vivo assessments revealed no significant alterations in reticulocyte counts or micronuclei incidence in ICR mice, and SD rats exhibited no subacute toxicity at an oral LP28 dosage of 2000 mg/kg body weight/day for 28 days. Moreover, a whole-genome sequence analysis of LP28 revealed the absence of antimicrobial resistance genes, harmful virulence factors, and genes associated with biogenic amine synthesis. Additionally, the presence of genes involved in stress responses (e.g., acid, bile salt, heat, osmotic, and oxidative stresses) and adhesion-related genes was confirmed. Furthermore, LP28 contains six genes (plnA, plnE, plnF, plnJ, plnK, and plnN) that encode bacteriocin precursor peptides, suggesting the potential for enhanced probiotic effects through the production of antimicrobial plantaricins. These findings highlight the potential of LP28 as a safe and effective probiotic for human consumption. Full article

Background: Conventional therapies for moderate-to-severe inflammatory acne include topical agents, systemic antibiotics, hormonal treatments, and oral isotretinoin. However, increasing resistance of Cutibacterium acnes to antibiotics and the potential adverse effects of systemic agents have prompted growing interest in non-pharmacological alternatives such as fractional microneedling radiofrequency (RF-MN), recently introduced in the clinical practice. Objective: This report of five cases aims to document the clinical benefits and safety of RF-MN using the Focus Dual^® device in the treatment of moderate-to-severe inflammatory acne vulgaris. Methods: Five patients (2 male, 3 female; aged 19–28 years; Fitzpatrick skin types II–III) with moderate-to-severe acne were treated with two RF-MN sessions at 4-week intervals using the Focus Dual^® device (Med & Tech, Occhiobello (RO), Italy). Acne severity was assessed using the Face Global Acne Grading System (F-GAGS) and the 5-point Global Improvement Score (GIS), with evaluations performed by two independent blinded raters (G.P and O.R). Standardized photographic documentation and lesion counting were conducted at baseline (T0) and 4 weeks after the second session (T2). All individual F-GAGS scores for each of the five patients showed a reduction from baseline to T2, as consistently assessed by both evaluators. Two patients improved from moderate to mild acne, one improved from severe to moderate, and one remained mild. GISs indicated clinical improvement ranging from Grade 1 to Grade 2 in all cases, with individual improvements between 8.33% and 37.93%. No adverse events were reported during treatment or follow-up. Conclusions: RF-MN appears to be a promising therapeutic option for moderate-to-severe inflammatory acne, providing clinical improvement and reduction in acne severity without adverse effects. Prospective studies with a larger sample are needed to confirm these preliminary results and support the potential role of RF-MN as an adjunctive or standalone treatment in patients with limited tolerance or response to conventional therapies. Full article

Background: Systemic lupus erythematosus (SLE) may present with heterogeneous clinical manifestations in pediatric patients. Although infections are a major cause of morbidity and mortality in SLE, severe bacterial infections rarely represent the presenting clinical event leading to diagnosis. Case description: We report the case of a 13-year-old boy diagnosed with SLE with Sjögren’s syndrome overlap who presented with pneumococcal sepsis. The patient was admitted with high-grade fever and facial swelling, and blood cultures grew Streptococcus pneumoniae. Although an initial clinical response to antibiotic therapy was observed, fever subsequently recurred, accompanied by persistent systemic symptoms and progressive laboratory abnormalities. Further investigations revealed hematologic abnormalities, serosal involvement, renal disease, and a characteristic autoantibody profile. The patient fulfilled the 2019 ACR/EULAR classification criteria for SLE after comprehensive autoimmune evaluation. The overlap with Sjögren’s syndrome was supported by the autoantibody profile and imaging findings involving the parotid glands. Following treatment with intravenous methylprednisolone pulses, oral prednisone, hydroxychloroquine, and mycophenolate mofetil, the patient showed rapid clinical improvement and sustained remission. Conclusions: This case highlights that severe invasive bacterial infection may occasionally be the clinical circumstance that leads to the diagnosis of pediatric systemic lupus erythematosus. Persistent systemic inflammation or evolving multisystem involvement despite appropriate antimicrobial therapy should prompt consideration of an underlying autoimmune disease, even in patients without a prior history of immune dysfunction. Full article

Background: Secondary pseudohypoaldosteronism (PHA) is a rare, transient condition caused by renal tubular resistance to aldosterone, most commonly associated with urinary tract infection (UTI) and/or congenital anomalies of the kidney and urinary tract (CAKUT). It mimics primary adrenal disorders, presenting with life-threatening electrolyte disturbances in early infancy. Case Presentation: We report a male infant admitted twice within the first four months of life with severe dehydration, hyponatremia, hyperkalemia, metabolic acidosis, and acute kidney injury (AKI). Urine cultures grew Klebsiella pneumoniae and later Escherichia coli. Imaging studies demonstrated obstructive CAKUT, including posterior urethral valves, bilateral megaureters, hydronephrosis, and bladder diverticulosis. Congenital adrenal hyperplasia was excluded. Further evaluation showed markedly elevated plasma renin and aldosterone levels, confirming secondary PHA. The patient was successfully treated with intravenous fluids, electrolyte correction, and antibiotic therapy. Subsequently, oral sodium chloride and bicarbonate supplementation were added. Stepwise surgical correction of the urinary tract anomalies was initiated. Conclusions: Secondary PHA should be considered in infants presenting with failure to thrive, dehydration, hyponatremia, and hyperkalemia, particularly in the presence of UTI or CAKUT. Early recognition and differentiation from primary adrenal disorders are essential to prevent life-threatening complications. Prompt correction of electrolyte imbalance and management of the underlying urinary tract pathology are crucial for favorable outcomes. Full article

Paediatric osteoarticular infections (OAIs) encompass a heterogeneous group of musculoskeletal infections associated with acute septic complications, prolonged morbidity and potentially long-term sequelae. Over the past two decades, advances in microbiological diagnostics—particularly nucleic acid amplification assays—have refined the aetiological understanding of OAIs and started a new therapeutic debate regarding the most appropriate routes of antibiotic administration. Clinicians now evaluate which children can be treated safely using oral antibiotics from the outset (oral-first), which require an initial intravenous (IV) phase before a step-down to oral therapy, and which will need IV therapy all along their care pathway. Treatment debates are particularly relevant in contexts involving constrained healthcare resources and limited hospital bed availability. This narrative review summarises the essential prerequisites for prescribing oral antibiotic therapy for paediatric OAIs and proposes a pharmacokinetic/pharmacodynamic (PK/PD) framework for guiding clinical decision-making. Key considerations include: pathogen identification and resistance profiling; contemporary bacteriological epidemiology; the comparative effectiveness of IV versus oral therapy; the availability of active oral antibiotics and their penetration into bone and joint compartments; achieving adequate systemic exposure and hitting PK/PD targets after oral administration; and the clinical limitations of oral antibiotic therapy, including patient selection criteria. We argue that oral-first and early-switch strategies are best framed as structured selection processes that integrate clinical severity and source control, pathogen/minimal inhibitory concentration constraints, the feasibility of attaining PK/PD targets orally and the reliability of follow-up. No single strategy should be seen as a universal default strategy. Full article

Background and Clinical Significance: Acetazolamide is routinely used post-cataract surgery to prevent intraocular pressure (IOP) spikes. Rare non-cardiogenic pulmonary edema (NCPE) cases highlight its risks in elderly comorbid patients. This report details acetazolamide-induced NCPE and provides a review of current evidence from the literature. Case Presentation: A 74-year-old male with chronic kidney disease, atrial fibrillation, and aortic aneurysm repair received 250 mg oral acetazolamide post-cataract extraction. Clinical, imaging, and lab data were documented during Intensive Care Unit (ICU) stay. PubMed/Google Scholar review identified similar cases. Within 30 min, severe hypoxemia with SpO₂ (peripheral oxygen saturation) of 77%, accompanied by tachypnea and hypertension, necessitated endotracheal intubation. Echocardiography showed preserved left ventricular (LV) function; computed tomography (CT) confirmed bilateral alveolar opacities without cardiomegaly or embolism, indicating permeability-mediated NCPE. Lung-protective mechanical ventilation and vasopressor therapy resulted in hemodynamic and respiratory stabilization. On day 4, ventilator-associated pneumonia (VAP) due to Acinetobacter baumannii resolved with targeted antibiotic therapy. The patient made a full recovery following ICU discharge. To date, nine prior cases have been reported, alongside 31 entries in EudraVigilance reflecting a 19.4% mortality rate. Conclusions: Rapid-onset NCPE from acetazolamide involves endothelial injury, distinct from cardiogenic pulmonary edema. Early recognition, drug cessation, and admission to the intensive care unit (ICU) are vital components of therapeutic intervention. Risk stratification and pharmacovigilance are recommended for perioperative safety. Full article

Background/Objectives: Spotty liver disease (SLD), caused by Campylobacter hepaticus, is an emerging disease that leads to substantial production losses in the egg industry. The shift toward antibiotic-free and cage-free production systems has further intensified the impact of SLD. The current control measures largely rely on autogenous killed vaccines; however, their use is constrained by the slow and fastidious growth of C. hepaticus and inconsistent efficacy. To overcome these limitations, this study aimed to identify immunogenic mimotopes as vaccine candidates and express them on the surface of an avian pathogenic Escherichia coli (APEC) vector. Methods: To identify immunogenic mimotopes, Ph.D.-12 phage display peptide library was screened using the hyperimmune serum raised against killed whole-cell C. hepaticus in specific pathogen-free chickens. Subsequently, the outer membrane protein C (OmpC) of E. coli was used as a scaffold for constructing a surface display library. A single restriction site, PstI, located in the seventh external loop of OmpC, was strategically utilized to insert each 12-amino-acid mimotope with a six-histidine (6xHis) tag sequence at its N-terminus, generating ompC + mimotope fusion constructs. These constructs were cloned into the inducible expression vector pTrc and electroporated into an E. coli DH5α ∆ompC strain, which lacked ompC. The surface expression of the mimotopes was confirmed in vitro. The verified ompC + mimotope constructs were subsequently subcloned into the pYA3422 constitutive expression vector and electroporated into the APEC PSUO78 ∆aroA ∆asd vaccine vector strain. A chicken vaccination–challenge trial was conducted using nine groups of chickens, including an unvaccinated challenged control and an unvaccinated–unchallenged negative control. Each experimental group received a mixture of two recombinant E. coli strains carrying different mimotopes at a dose of 1 × 10⁹ CFU, which were administered orally twice at 16 and 18 weeks of age. Results: Fourteen immunogenic mimotopes corresponding to 13 different C. hepaticus proteins were identified as potential vaccine candidates. The expression of these mimotopes on the surface of the E. coli was successfully demonstrated using the OmpC-mediated surface display system. Of the 14 mimotopes tested, two flagellar-related peptides and one major outer membrane protein (MOMP)-derived peptide elicited significant immune responses and conferred protection against the C. hepaticus challenge. Conclusions: We successfully developed a functional E. coli surface display system that was capable of expressing 12-amino-acid mimotopes of C. hepaticus, providing a robust platform for evaluating vaccine candidates against SLD. Immunogenicity and efficacy studies in chickens demonstrated that three identified mimotopes conferred protection against C. hepaticus colonization of the bile and liver. Future in vivo investigations are necessary to develop and evaluate the immunogenicity and protective efficacy of a multivalent mimotope vaccine consisting of three identified mimotopes against both C. hepaticus and APEC, utilizing the ΔaroA Δasd APEC PSU078 strain as the vaccine vector. Full article

Background: Pediatric adenotonsillectomy is commonly performed for infectious and obstructive indications, but postoperative hemorrhage remains a concern. This study describes outcomes from a high-volume territorial network in southern Modena province, Italy. Methods: Retrospective observational study of 10,753 pediatric patients (aged 3–18 years) undergoing adenotonsillectomy at Sassuolo Hospital and affiliates (Vignola, Pavullo) from 2005 to 2024. Indications included recurrent tonsillitis (Paradise criteria), obstructive sleep apnea (OSA) (polysomnography-confirmed or clinical), and recurrent otitis media or otitis media with effusion (OME). Surgical techniques included curettage adenoidectomy and Colorado microdissection needle tonsillectomy. Our institutional postoperative care protocol included analgesics, oral hydration, soft diet, antibiotics (amoxicillin) and scheduled follow-up; however, no analysis regarding this protocol was intended to demonstrate correlations with study outcomes. Primary outcomes were postoperative hemorrhage (overall and requiring revision), stratified by indication, age, and technique, and contextualized against ranges reported in large published cohorts (qualitative, exploratory comparison). Secondary outcomes included pain (VAS scores), infection rates, and tissue regrowth. Data completeness was verified via electronic records (95.6%). Statistical analyses used descriptive statistics with 95% confidence intervals (95% CI) and inferential tests for within-cohort comparisons (χ² tests, Fisher’s exact test, and t-tests where appropriate). Results: A total of 10,753 procedures were analyzed (4325 tonsillectomies, 3942 adenotonsillectomies, 2486 adenoidectomies). Postoperative hemorrhage occurred in 202 patients (1.88%; 95% CI 1.64–2.15%); surgical revision was required in 75 (0.70%; 95% CI 0.56–0.87%), with multifactorial stratification showing higher risk for infectious indications (OR 1.41 vs. OSA), younger age < 5 years (OR 2.1), and tonsillectomy origin (OR 8.25 vs. adenoidectomy); all rates are at the lower end of literature ranges (2–5% and 0.9–2.5%, respectively), in line with large published cohorts, although these comparisons are qualitative and exploratory. Mean VAS pain scores decreased from 3.2 (day 1) to 1.1 (day 7). No significant infections occurred; tissue regrowth rates aligned with the literature (adenoidal 6–26%, tonsillar 5–10%). Conclusions: Sassuolo Hospital’s experience highlights favorable postoperative outcomes and low complication rates in adenotonsillar surgery. Limitations include the retrospective design, potential selection bias and long period evaluation. Prospective studies are needed to confirm these findings. Full article

Background: Fixed-dose combination drugs (FDCs) are combinations of two or more active ingredients in a single dosage form. These formulations have proven effective in combating the development of resistance in diseases such as tuberculosis and malaria. Despite the benefits observed in the aforementioned cases, fixed-dose antibiotics combinations (FDACs) are increasingly raising questions about their rationality. This is the case for several FDACs listed in the AWaRe classification as not recommended, which unfortunately remain available on the pharmaceutical market, particularly in low- and middle-income countries like the Democratic Republic of Congo (DRC). Objectives: To identify the essential medicines available in pharmacies open to the public in the city of Kinshasa and to assess their inclusion in the DRC’s National List of Essential Medicines (NLEM) and in the World Health Organization’s (WHO) List of Essential Medicines (LEM). The rationality of the FDACs circulating in the city of Kinshasa were also evaluated based on the 2023 AWaRe classification. Methods: A cross-sectional and descriptive study was conducted between February and October 2025 in Kinshasa. For this purpose, fifty registered pharmacies open to the public were selected by systematic random sampling as the research sample. Data collection consisted of completing a data collection form after we had provided the pharmacies’ owners with the necessary explanations regarding the importance of the study and guaranteed their anonymity. Results: The controlled FDACs encountered comprised 27 specialties across 15 different formulations. Out of 15 formulations, 12 (80%) were included on the WHO list of non-recommended antibiotics and were not included in the DRC’s NLEM nor in the WHO’s LEM. Some had been withdrawn from the market in their countries of manufacture. Of the 15 FDACs evaluated for their rationality and compliance, the injectable FDACs presented problems related to the relevance and completeness of information contained on their packaging. On their primary packaging, there was a significant difference in the expiration dates of the powder and sterile water for injection contained in the combination pack, ranging from 6 to 36 months. Furthermore, the secondary packaging lacked data related to the sterile water for injection contained in the combination pack. In addition, several medications contained the same therapeutic combination. For injectable FDAC, for example, the combination Ceftriaxone-Sulbactam was represented by eight medications. For oral FDACs, the combination Sulfamethoxazole-Trimethoprim was represented by seven medications. Globally, 100% of these drug combinations originated from India. Conclusions: Fifteen varieties of FDACs were available in Kinshasa, most of which (80%) were unsuitable. It is important that public health authorities address this situation and develop stricter guidelines for granting marketing authorizations, particularly for FDACs. Full article