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(Tea Tree) Oil and Dimethyl Sulfoxide (DMSO) Against Trophozoites and Cysts of Acanthamoeba Strains
pathogens Article In Vitro Evaluation of the Combination of Melaleuca alternifolia (Tea Tree) Oil and Dimethyl Sulfoxide (DMSO) against Trophozoites and Cysts of Acanthamoeba Strains. Oxygen Consumption Rate (OCR) Assay as a Method for Drug Screening Tania Martín-Pérez *, Irene Heredero-Bermejo , Cristina Verdú-Expósito and Jorge Pérez-Serrano Department of Biomedicine and Biotechnology, Faculty of Pharmacy, University of Alcalá, Alcalá de Henares, 28805 Madrid, Spain; [email protected] (I.H.-B.); [email protected] (C.V.-E.); [email protected] (J.P.-S.) * Correspondence: [email protected] Abstract: Ameobae belonging to the genus Acanthamoeba are responsible for the human diseases Acanthamoeba keratitis (AK) and granulomatous amoebic encephalitis (GAE). The treatment of these illnesses is hampered by the existence of a resistance stage (cysts). In an attempt to add new agents that are effective against trophozoites and cysts, tea tree oil (TTO) and dimethyl sulfoxide (DMSO), separately and in combination, were tested In Vitro against two Acanthamoeba isolates, Citation: Martín-Pérez, T.; T3 and T4 genotypes. The oxygen consumption rate (OCR) assay was used as a drug screening Heredero-Bermejo, I.; Verdú-Expósito, method, which is to some extent useful in amoebicide drug screening; however, evaluation of lethal C.; Pérez-Serrano, J. In Vitro effects may be misleading when testing products that promote encystment. Trophozoite viability Evaluation of the Combination of analysis showed that the effectiveness of the combination of both compounds is higher than when Melaleuca alternifolia (Tea Tree) Oil either compound is used alone. Therefore, the TTO alone or TTO + DMSO in combination were and Dimethyl Sulfoxide (DMSO) against Trophozoites and Cysts of an amoebicide, but most of the amoebicidal activity in the combination’s treatments seemed to be Acanthamoeba Strains. -
Characterising the Risk of Major Bleeding in Patients With
EU PE&PV Research Network under the Framework Service Contract (nr. EMA/2015/27/PH) Study Protocol Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU Version 3.0 1 June 2018 EU PAS Register No: 16014 EMA/2015/27/PH EUPAS16014 Version 3.0 1 June 2018 1 TABLE OF CONTENTS 1 Title ........................................................................................................................................... 5 2 Marketing authorization holder ................................................................................................. 5 3 Responsible parties ................................................................................................................... 5 4 Abstract ..................................................................................................................................... 6 5 Amendments and updates ......................................................................................................... 7 6 Milestones ................................................................................................................................. 8 7 Rationale and background ......................................................................................................... 9 8 Research question and objectives .............................................................................................. 9 9 Research methods .................................................................................................................... -
NARMS – EB 2000 Veterinary Isolates Fig. 18. Resistance Among Salmonella Serotypes for Isolates from Cattle*
NARMS – EB 2000 Veterinary Isolates Fig. 18. Resistance Among Salmonella Serotypes for Isolates from Cattle* S. typhimurium (n=332)** S. montevideo (n=330) Amikacin 0.00% Amikacin 0.00% Amox-Clav 14.46% Amox-Clav 0.61% Ampicillin 66.87% Ampicillin 0.61% Apramycin 1.20% Apramycin 0.00% Cefoxitin 10.54% Cefoxitin 0.61% Ceftiofur 12.65% Ceftiofur 0.61% Ceftriaxone 0.00% Ceftriaxone 0.00% Cephalothin 13.25% Cephalothin 0.61% Chloramphenicol 39.46% Chloramphenicol 0.91% Ciprofloxacin 0.00% Ciprofloxacin 0.00% Gentamicin 3.31% Gentamicin 0.30% Kanamycin 38.86% Kanamycin 0.00% Nalidixic Acid 0.00% Nalidixic Acid 0.00% Streptomycin 66.57% Streptomycin 1.52% Sulfamethoxazole 66.87% Sulfamethoxazole 1.21% Tetracycline 66.57% Tetracycline 2.12% Trimeth-Sulfa 5.42% Trimeth-Sulfa 0.30% 0% 10% 20% 30% 40% 50% 60% 70% 80% 0% 1% 1% 2% 2% 3% **including copenhagen S. anatum (n=292) S. newport (n=185) Amikacin 0.00% Amikacin 0.00% Amox-Clav 1.71% Amox-Clav 80.00% Ampicillin 2.40% Ampicillin 80.54% Apramycin 0.00% Apramycin 0.00% Cefoxitin 1.37% Cefoxitin 77.84% Ceftiofur 1.37% Ceftiofur 80.00% Ceftriaxone 0.00% Ceftriaxone 2.16% Cephalothin 2.05% Cephalothin 77.84% Chloramphenicol 1.71% Chloramphenicol 81.62% Ciprofloxacin 0.00% Ciprofloxacin 0.00% Gentamicin 0.68% Gentamicin 7.57% Kanamycin 1.71% Kanamycin 7.57% Nalidixic Acid 0.34% Nalidixic Acid 0.00% Streptomycin 2.05% Streptomycin 82.70% Sulfamethoxazole 2.05% Sulfamethoxazole 74.05% Tetracycline 35.96% Tetracycline 83.24% Trimeth-Sulfa 0.34% Trimeth-Sulfa 25.41% 0% 5% 10% 15% 20% 25% 30% 35% 40% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% *all sources NARMS – EB 2000 Veterinary Isolates Fig. -
2012 Case Definitions Infectious Disease
Arizona Department of Health Services Case Definitions for Reportable Communicable Morbidities 2012 TABLE OF CONTENTS Definition of Terms Used in Case Classification .......................................................................................................... 6 Definition of Bi-national Case ............................................................................................................................................. 7 ------------------------------------------------------------------------------------------------------- ............................................... 7 AMEBIASIS ............................................................................................................................................................................. 8 ANTHRAX (β) ......................................................................................................................................................................... 9 ASEPTIC MENINGITIS (viral) ......................................................................................................................................... 11 BASIDIOBOLOMYCOSIS ................................................................................................................................................. 12 BOTULISM, FOODBORNE (β) ....................................................................................................................................... 13 BOTULISM, INFANT (β) ................................................................................................................................................... -
Health Reports for Mutual Recognition of Medical Prescriptions: State of Play
The information and views set out in this report are those of the author(s) and do not necessarily reflect the official opinion of the European Union. Neither the European Union institutions and bodies nor any person acting on their behalf may be held responsible for the use which may be made of the information contained therein. Executive Agency for Health and Consumers Health Reports for Mutual Recognition of Medical Prescriptions: State of Play 24 January 2012 Final Report Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Acknowledgements Matrix Insight Ltd would like to thank everyone who has contributed to this research. We are especially grateful to the following institutions for their support throughout the study: the Pharmaceutical Group of the European Union (PGEU) including their national member associations in Denmark, France, Germany, Greece, the Netherlands, Poland and the United Kingdom; the European Medical Association (EMANET); the Observatoire Social Européen (OSE); and The Netherlands Institute for Health Service Research (NIVEL). For questions about the report, please contact Dr Gabriele Birnberg ([email protected] ). Matrix Insight | 24 January 2012 2 Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Executive Summary This study has been carried out in the context of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross- border healthcare (CBHC). The CBHC Directive stipulates that the European Commission shall adopt measures to facilitate the recognition of prescriptions issued in another Member State (Article 11). At the time of submission of this report, the European Commission was preparing an impact assessment with regards to these measures, designed to help implement Article 11. -
Regulation of Glucose Metabolism in Muscles from Dexamethasone Treated Rats
Regulation of Glucose Metabolism in Muscles from Dexamethasone Treated Rats Effect of insulin, adrenaline and contraction Anders Rasmushaugen Master thesis in pharmacology for the degree Master of Pharmacy Department of Pharmaceutical Biosciences, School of Pharmacy, Faculty of Mathematics and Natural Sciences UNIVERSITY OF OSLO Spring 2009 2 Regulation of Glucose Metabolism in Muscles from Dexamethasone Treated Rats Effect of insulin, adrenaline and contraction Anders Rasmushaugen The thesis was conducted between July 2008 and May 2009 at the Department for Work-related Muscoskeletal Complaints, National Institiute of Occupational Health (STAMI) Master thesis in pharmacology for the degree Master of Pharmacy Departement of Pharmaceutical Biosciences, School of Pharmacy, Faculty of Mathematics and Natural Sciences UNIVERSITY OF OSLO Advisors Senior scientist Dr. scient Jørgen Jensen Professor Arild C Rustan 3 Preface This thesis has been my biggest challenge in my years at the Institute of Pharmacy, and I want to thank those who have supported me during it. My advisor, Jørgen Jensen, has directed me through the work of this thesis and I greatly appreciate his efforts. Jørgen is a man that involves himself in his work, I hope this eagerness carries on. Special thanks are directed to the ones of you helping me with the practical work involved in the various analyses. Ada Ingvaldsen, Astrid Bolling and Jorid Thrane Stuenæs have always been accessible for questions as well as discussions. I will also thank STAMI in general for making this thesis possible. The student environment on the 5th floor has been comforting and a source of great fun as well as discussions related the studies. -
Statistical Analysis Plan (SAP)
Statistical Analysis Plan (SAP) Protocol Title: A Phase IIa, two-part, randomised, multi-centre, multinational, double-blind, placebo-controlled, parallel group study to compare the efficacy and safety of BCT197 when added on to standard of care for the treatment of acute respiratory exacerbations of chronic obstructive pulmonary disease (COPD) requiring hospitalisation in adults Protocol Number: MBCT206 Protocol Version, Date Final V1.0, 05 November 2015 Final V2.0 (Amendment 1), 23 December 2015 Final V3.0 (Amendment 2), 10 March 2016 Final V4.0 (Amendment 3), 26 May 2016 Final V5.0 (Amendment 4), 08 November 2016 ICON ID: 3082/0004 Document Version, Date: FINAL 1.0, 07 September 2017 FINAL 2.0, 16 November 2017 Prepared by: ICON Clinical Research Services On behalf of: Mereo BioPharma 1 Ltd Statistical Analysis Plan Version: FINAL 2.0, Date:16 November 2017 Protocol Number: MBCT206 Page 1 of 112 Statistical Analysis Plan (SAP) Confidentiality statement: The information provided in this document is strictly confidential. The recipients of the SAP must not disclose the confidential information . contained within this document or any related information to other persons without the permission of the sponsor. In addition, the recipients of the SAP must keep this confidential document in a . controlled environment which prevents unauthorized access to the document. Statistical Analysis Plan Version: FINAL 2.0, Date:16 November 2017 Protocol Number: MBCT206 Page 2 of 112 Statistical Analysis Plan (SAP) SIGNATURE PAGE Prepared at ICON Clinical Research by: Date (DD Mmm YYYY) Reviewed at ICON Clinical Research by: Date (DD Mmm YYYY) Approved at Mereo BioPharma 1 Ltd by: Date (DD Mmm YYYY) Statistical Analysis Plan Version: FINAL 2.0, Date:16 November 2017 Protocol Number: MBCT206 Page 3 of 112 Statistical Analysis Plan (SAP) REVISION HISTORY Version/Date Version name Section Changes implemented Version 1.0/ Initial approved N/A N/A 07-Sep-2017 version 7.1.4.13 Clinical treatment failure Medical review clarification added. -
Annex I Summary of Product Characteristics
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT NutropinAq 10 mg/2 ml (30 IU) solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One cartridge contains 10 mg (30 IU) of somatropin* * human growth hormone produced in Escherichia coli cells by recombinant DNA technology. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. NutropinAq is a solution for subcutaneous use. The clear, colourless, sterile solution for multidose use is contained in a glass cartridge, closed with a rubber stopper and a rubber seal. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications - Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. - Long-term treatment of growth failure associated with Turner syndrome. - Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. - Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment (see section 4.4). 4.2 Posology and method of administration Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with the therapeutic indication of use. The NutropinAq dosage and administration schedule should be individualised for each patient. Dosage Growth failure in children due to inadequate growth hormone secretion: 0.025 - 0.035 mg/kg bodyweight given as a daily subcutaneous injection. Somatropin therapy should be continued in children and adolescents until their epiphysis are closed. -
Customs Tariff - Schedule
CUSTOMS TARIFF - SCHEDULE 99 - i Chapter 99 SPECIAL CLASSIFICATION PROVISIONS - COMMERCIAL Notes. 1. The provisions of this Chapter are not subject to the rule of specificity in General Interpretative Rule 3 (a). 2. Goods which may be classified under the provisions of Chapter 99, if also eligible for classification under the provisions of Chapter 98, shall be classified in Chapter 98. 3. Goods may be classified under a tariff item in this Chapter and be entitled to the Most-Favoured-Nation Tariff or a preferential tariff rate of customs duty under this Chapter that applies to those goods according to the tariff treatment applicable to their country of origin only after classification under a tariff item in Chapters 1 to 97 has been determined and the conditions of any Chapter 99 provision and any applicable regulations or orders in relation thereto have been met. 4. The words and expressions used in this Chapter have the same meaning as in Chapters 1 to 97. Issued January 1, 2020 99 - 1 CUSTOMS TARIFF - SCHEDULE Tariff Unit of MFN Applicable SS Description of Goods Item Meas. Tariff Preferential Tariffs 9901.00.00 Articles and materials for use in the manufacture or repair of the Free CCCT, LDCT, GPT, UST, following to be employed in commercial fishing or the commercial MT, MUST, CIAT, CT, harvesting of marine plants: CRT, IT, NT, SLT, PT, COLT, JT, PAT, HNT, Artificial bait; KRT, CEUT, UAT, CPTPT: Free Carapace measures; Cordage, fishing lines (including marlines), rope and twine, of a circumference not exceeding 38 mm; Devices for keeping nets open; Fish hooks; Fishing nets and netting; Jiggers; Line floats; Lobster traps; Lures; Marker buoys of any material excluding wood; Net floats; Scallop drag nets; Spat collectors and collector holders; Swivels. -
A Sensitive Method for Direct Analysis of Impurities in Apramycin and Other Aminoglycoside Antibiotics Using Charged Aerosol
- SO4 A Sensitive Method for Direct Analysis of Impurities in Apramycin and Other Aminoglycoside Antibiotics Using Charged Aerosol Detection Zhen Long1, Qi Zhang2, Yan Jin1, Lina Liang1, Bruce Bailey2, Ian Acworth2, Deepali Mohindra3 1 2 3 Thermo Fisher Scientific, Shanghai, China, Thermo Fisher Scientific, Chelmsford, MA, USA and Thermo Fisher Scientific, Sunnyvale, CA, USA Comparison of CAD and ELSD Detection Analysis of Other Aminoglycoside Antibiotics Overview Results Purpose: To develop a sensitive non-derivatization method for impurity assessment of Sample pre-treatment with SPE This method has also been applied to impurity analysis of an additional eleven apramycin sulfate and other aminoglycoside antibiotics. Sample pre-treatment with SPE SPE Column: Dionex OnGuard II A CAD and ELSD are both nebulization-based universal detection technologies. aminoglycoside antibiotics, including neomycin, gentamicin, kanamycin, streptomycin, Comparison between CAD and ELSD under the same chromatographic conditions tobramycin, amikacin, etimicin, netilmicin, sisomicin, ribostamycin and paromomycin. Methods: A 30min gradient method using hydrophilic interaction liquid chromatography Sample solvent: 80% 5mM ammonium formate, 20% acetonitrile Sulfate is a major interference for apramycin impurity assessment with a HILIC method. demonstrated that CAD is much more sensitive than ELSD. As shown in the Figure 5 shows impurity analysis of kenamycin, etimicin, ribostamycin and paromomycin with charged aerosol detection (HILIC-CAD) was developed for direct analysis of Sample: 220.6 mg/mL in 2 mL sample solvent Without sample cleanup, some early eluting impurities were found to be masked under chromatograms in Figure 4 and data summarized in Table 1, 16 impurities (S/N >3) were using the HILIC-CAD method. -
Journal of Pharmaceutical and Biomedical Analysis Stability Of
Journal of Pharmaceutical and Biomedical Analysis 49 (2009) 519–524 Contents lists available at ScienceDirect Journal of Pharmaceutical and Biomedical Analysis journal homepage: www.elsevier.com/locate/jpba Short communication Stability of selected chlorinated thiazide diuretics K. Deventer a,∗, G. Baele b, P. Van Eenoo a, O.J. Pozo a, F.T. Delbeke a a DoCoLab, UGent, Department of Clinical Chemistry, Microbiology and Immunology, Technologiepark 30, B-9052 Zwijnaarde, Belgium b Department of Applied Mathematics and Computer Science, Krijgslaan 281, S9, B-9000 Gent, Belgium article info abstract Article history: In sports, diuretics are used for two main reasons: to flush previously taken prohibited substances with Received 6 August 2008 forced diuresis and in sports where weight classes are involved to achieve acute weight loss. A com- Received in revised form 5 November 2008 mon property observed for thiazides is hydrolysis in aqueous media resulting in the formation of the Accepted 6 November 2008 degradation product aminobenzenedisulphonamide. This degradation product can be observed for sev- Available online 13 November 2008 eral thiazides. Because there is limited information regarding the effect of pH, temperature and light on the stability of thiazides, these parameters were investigated for chlorothiaizide, hydrochlorothiazide Keywords: and altizide. For all three compounds the degradation product could be detected after incubation at pH Doping ◦ Urine 9.5 for 48 h at 60 C. At lower pH and temperature the degradation product could not be detected for all Diuretics compounds. When samples were exposed to UV-light altizide and hydrochlorothiazide were photode- Thiazides graded to chlorothiazide. When the degradation rate between the different compounds was compared Sports for a given temperature and pH, altizide is the most unstable compound. -
PHARMACEUTICAL APPENDIX to the TARIFF SCHEDULE 2 Table 1
Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names INN which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service CAS registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known.