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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ____________________CONTRAINDICATIONS____________________ CLINOLIPID injection safely and effectively. See full prescribing • Known hypersensitivity to egg and soybean proteins, the lipid emulsion information for CLINOLIPID injection. and/or excipients. (4) • Severe hyperlipidemia or severe disorders of lipid metabolism. (4) CLINOLIPID (Lipid Injectable Emulsion) for intravenous use Initial U.S. Approval: 1975 ________________WARNINGS AND PRECAUTIONS_______________ • Preterm infants have poor clearance of intravenous lipid emulsion. (5.1) WARNING: DEATH IN PRETERM INFANTS • Monitor for signs or symptoms of hypersensitivity reactions. (5.2) See full prescribing information for complete boxed warning • Monitor for signs and symptoms of infection, fat overload, and refeeding • Deaths in preterm infants have been reported in literature. (5.1, complications. (5.3, 5.4, 5.5) 8.4) • Frequent clinical and laboratory determinations are necessary. (5.6) • Autopsy findings included intravascular fat accumulation in the lungs. (5.1, 8.4) __________________ADVERSE REACTIONS__________________ • Preterm and low birth weight infants have poor clearance of The most common (5%) adverse drug reactions from clinical trials were intravenous lipid emulsion and increased free fatty acid plasma nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and levels following lipid emulsion infusion. (5.1, 8.4) abnormal liver function tests. (6.1) __________________INDICATIONS AND USAGE___________________ To report SUSPECTED ADVERSE REACTIONS, contact Baxter CLINOLIPID injection is a lipid emulsion indicated in adults for parenteral Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or nutrition providing a source of calories and essential fatty acids when oral or www.fda.gov/medwatch enteral nutrition is not possible, insufficient, or contraindicated. -
Liposomes to Augment Dialysis in Preclinical Models: a Structured Review
pharmaceutics Review Liposomes to Augment Dialysis in Preclinical Models: A Structured Review Kevin Hart 1,*, Martyn Harvey 2, Mingtan Tang 3 , Zimei Wu 3 and Grant Cave 1 1 Intensive Care Unit, Hawkes Bay District Health Board, Hastings 9014, New Zealand; [email protected] 2 Waikato Hospital Emergency Department, Waikato District Health Board, Hamilton 3240, New Zealand; [email protected] 3 Faculty of Medicine and Health Sciences, School of Pharmacy, University of Auckland, Auckland 1023, New Zealand; [email protected] (M.T.); [email protected] (Z.W.) * Correspondence: [email protected] Abstract: In recent years, a number of groups have been investigating the use of “empty” liposomes with no drug loaded as scavengers both for exogenous intoxicants and endogenous toxic molecules. Preclinical trials have demonstrated that repurposing liposomes to sequester such compounds may prove clinically useful. The use of such “empty” liposomes in the dialysate during dialysis avoids recognition by complement surveillance, allowing high doses of liposomes to be used. The “reach” of dialysis may also be increased to molecules that are not traditionally dialysable. We aim to review the current literature in this area with the aims of increasing awareness and informing further research. A structured literature search identified thirteen papers which met the inclusion criteria. Augmenting the extraction of ammonia in hepatic failure with pH-gradient liposomes with acidic centres in peritoneal dialysis is the most studied area, with work progressing toward phase one trials. Liposomes used to augment the removal of exogenous intoxicants and protein- Citation: Hart, K.; Harvey, M.; Tang, bound uraemic and hepatic toxins that accumulate in these organ failures and liposome-supported M.; Wu, Z.; Cave, G. -
6 Literaturverzeichnis
6 Literaturverzeichnis 6 Literaturverzeichnis Adam, A., Lederer, E., Muramyl peptides: Immunomodulators, sleep factors and vitamins. Med. Res. Rev. 4, 111-153, 1984. Akao, T., Correlation between physicochemical characteristics of synthetic cationic am- phiphiles and their DNA transfection ability. Bull. Chem. Soc. Jpn. 64, 3677-3681, 1991. Allison, A.C., Byars, N.E., Immunological adjuvants: desirable properties and side-effects. Mol. Immunol. 28, 279-284, 1991. Alving, C.R., Verma, J.N., Rao, U., Krzych, U., Amselem, S. Green, S.M., Wassef, N.M., Liposomes containing lipid A as potent non-toxic adjuvant. Res. Immunol. 143, 197-198, 1992. Alving, C.R., Lipopolysaccharide, lipid A and liposomes containing lipid A as immuno- logic adjuvants. Immunobiology 187, 430-446, 1993. Anderson, W.F., Human gene therapy. Nature 392, 25-30, 1998. Aprile, M.A., Wardlaw, A.C.,Aluminum compounds as adjuvants for vaccines and toxoids in man: a review. Can. J. Publ. Hlth 57, 343-354, 1966. Avrameas, S., Guilbert, B., Dosage enzymoimmunologique de protéine à l'aide d'immu- noadsorbants et d'antigènes marqués aux enzymes. C. R. Acad. Sci.(Paris) 273, 2705-2707, 1971. Bally, M.B., Harvie, P., Wong, F.M.P., Kong, S., Wasan, E.K., Reimer, D.L., Biological barriers to cellular delivery of lipid-based DNA carriers. Adv. Drug Deliv. Rev. 38, 291- 315, 1999. Behr, J.P., Gene transfer with synthetic cationic amphiphiles: Prospects for Gene Therapy. Bioconj. Chem. 5, 382-389, 1994. Binnig, G., Quate, C.F., Gerber, C., Atomic force microscopy. Phys. Rev. Lett. 56, 930- 933, 1986. Biocompare.com, Auflistung kommerzieller liposomaler Transfektiosagenzien unter http://biocompare.com Birchall, J.C., Kellaway, I.W., Mills, S.N., Physico-chemical characterisation and trans- fection efficiency of lipid-based gene delivery complexes. -
Infektionskongress 11. Österreichischer
11. ÖSTERREICHISCHER INFEKTIONSKONGRESS WAS SIE IMMER SCHON WISSEN WOLLTEN Diagnostik – Therapie – Prophylaxe 29. März bis 1. April 2017 Hotel Gut Brandlhof, Saalfelden Information & Anmeldung: www.oegit.eu PROGRAMM PROGRAMM PROGRAMM VORWORT Unser ganz besonderer Dank gilt natürlich auch heuer wieder unseren Spon soren, die uns trotz schwieriger Zeiten im Gesundheitswesen die Treue halten. Ohne deren nachhaltiges Engagement wäre dieser Kongress in der gewohnten Form nicht realisierbar. Heuer haben wir auch eine kleine technische Neuigkeit für Sie vorbereitet: Sie werden während der Vorträge im Plenarsaal über Ihr Mobiltelefon anonym Fragen an die Referenten stellen können. Näheres werden Sie vor Ort am Brandlhof erfahren. Unten finden Sie den dafür nötigen QRCode bzw. Link. Sehr geehrte Kollegin, sehr geehrter Kollege, Wir hoffen, Ihnen mit dem vorliegenden Programm spannende Tage im Brandl wir freuen uns, Sie im Namen des Vorstandes der Österreichischen Gesellschaft für hof bieten zu können, und freuen uns schon auf das persönliche Gespräch mit Infektionskrankheiten und Tropenmedizin am 11. Österreichischen Infektions Ihnen in den Pausen. kongress in Saalfelden begrüßen zu dürfen. Das heurige Kongressthema „Was Sie immer schon wissen wollten: Diagnostik – Therapie – Prophylaxe“ steht für die Diskussion offener infektiologischer Frage stellungen und lädt zu interessanten Vorträgen ein. Das infektiologische Potpourri ist breit und behandelt den sinnvollen Einsatz von Kombinations Mit kollegialen Grüßen Xcom.events/oeginfekt therapien, ungewöhnliche Erkrankungen bei Asylsuchenden & Migranten sowie Impfungen – um nur ein paar Highlights des Kongresses zu nennen. Es ist uns auch heuer wieder gelungen, namhafte ReferentInnen zu wichtigen Themen zu gewinnen. Herr Professor Lemmen aus Aachen wird den Eröffnungs Univ.Prof. Dr. Cornelia LassFlörl Univ.Prof. -
Molecular Basis of Ligand Recognition and Activation of Human V2 Vasopressin Receptor
bioRxiv preprint doi: https://doi.org/10.1101/2021.01.18.427077; this version posted January 18, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. Molecular basis of ligand recognition and activation of human V2 vasopressin receptor Fulai Zhou1, 12, Chenyu Ye2, 12, Xiaomin Ma3, 12, Wanchao Yin1, Qingtong Zhou4, Xinheng He1, 5, Xiaokang Zhang6, 7, Tristan I. Croll8, Dehua Yang1, 5, 9, Peiyi Wang3, 10, H. Eric Xu1, 5, 11, Ming-Wei Wang1, 2, 4, 5, 9, 11, Yi Jiang1, 5, 1. The CAS Key Laboratory of Receptor Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China 2. School of Pharmacy, Fudan University, Shanghai 201203, China 3. Cryo-EM Centre, Southern University of Science and Technology, Shenzhen 515055, China 4. School of Basic Medical Sciences, Fudan University, Shanghai 200032, China 5. University of Chinese Academy of Sciences, 100049 Beijing, China 6. Interdisciplinary Center for Brain Information, The Brain Cognition and Brain Disease Institute, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences; 7. Shenzhen-Hong Kong Institute of Brain Science-Shenzhen Fundamental Research Institutions, Shenzhen, China 8. Cambridge Institute for Medical Research, Department of Haematology, University of Cambridge, Cambridge, UK 9. The National Center for Drug Screening, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, 201203 Shanghai, China 10. Department of Biology, Southern University of Science and Technology, Shenzhen 515055, China 11. School of Life Science and Technology, ShanghaiTech University, Shanghai 201210, China 12. These authors contributed equally: Fulai Zhou, Chenyu Ye, and Xiaomin Ma. -
Tractocile, Atosiban
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Tractocile 6.75 mg/0.9 ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless solution without particles. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Tractocile is indicated to delay imminent pre-term birth in pregnant adult women with: regular uterine contractions of at least 30 seconds duration at a rate of 4 per 30 minutes a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of 50% a gestational age from 24 until 33 completed weeks a normal foetal heart rate 4.2 Posology and method of administration Posology Treatment with Tractocile should be initiated and maintained by a physician experienced in the treatment of pre-term labour. Tractocile is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with Tractocile 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of Tractocile 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of Tractocile 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours. The duration of the treatment should not exceed 48 hours. The total dose given during a full course of Tractocile therapy should preferably not exceed 330.75 mg of atosiban. -
Treatment for Calcium Channel Blocker Poisoning: a Systematic Review
Clinical Toxicology (2014), 52, 926–944 Copyright © 2014 Informa Healthcare USA, Inc. ISSN: 1556-3650 print / 1556-9519 online DOI: 10.3109/15563650.2014.965827 REVIEW ARTICLE Treatment for calcium channel blocker poisoning: A systematic review M. ST-ONGE , 1,2,3 P.-A. DUB É , 4,5,6 S. GOSSELIN ,7,8,9 C. GUIMONT , 10 J. GODWIN , 1,3 P. M. ARCHAMBAULT , 11,12,13,14 J.-M. CHAUNY , 15,16 A. J. FRENETTE , 15,17 M. DARVEAU , 18 N. LE SAGE , 10,14 J. POITRAS , 11,12 J. PROVENCHER , 19 D. N. JUURLINK , 1,20,21 and R. BLAIS 7 1 Ontario and Manitoba Poison Centre, Toronto, ON, Canada 2 Institute of Medical Science, University of Toronto, Toronto, ON, Canada 3 Department of Clinical Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada 4 Direction of Environmental Health and Toxicology, Institut national de sant é publique du Qu é bec, Qu é bec, QC, Canada 5 Centre Hospitalier Universitaire de Qu é bec, Qu é bec, QC, Canada 6 Faculty of Pharmacy, Université Laval, Qu é bec, QC, Canada 7 Centre antipoison du Qu é bec, Qu é bec, QC, Canada 8 Department of Medicine, McGill University, Montr é al, QC, Canada 9 Toxicology Consulting Service, McGill University Health Centre, Montr é al, QC, Canada 10 Centre Hospitalier Universitaire de Qu é bec, Qu é bec, QC, Canada 11 Centre de sant é et services sociaux Alphonse-Desjardins (CHAU de Lévis), L é vis, QC, Canada 12 Department of Family Medicine and Emergency Medicine, Universit é Laval, Québec, QC, Canada 13 Division de soins intensifs, Universit é Laval, Qu é bec, QC, Canada 14 Populations -
Role of IV Lipid Emulsion Antidote
Vet Times The website for the veterinary profession https://www.vettimes.co.uk Role of IV lipid emulsion antidote Author : Lotfi El Bahri Categories : General, Vets Date : March 28, 2016 The first animal reports suggesting an increased rate of recovery from barbiturate-induced CNS depression with lipid infusion were published in 19621. Encouraging results of animal studies, and successful use in human case reports, have demonstrated lipid emulsion has a potential role in the treatment of lipophilic molecules intoxications2. Background Image: Fotolia/Sherry Young. Lipid emulsion – also referred to as intravenous lipid emulsion (ILE), lipid resuscitation therapy, intravenous lipid emulsion rescue and intravenous fat emulsion – is known as a component of parenteral nutrition (ILE 30 per cent). It is also used as a carrier for lipid soluble drugs, such as propofol, etomidate and diazepam3,4. ILE is an injectable oil in water emulsion mixing long-chain and medium-chain triglycerides, or a combination of both, purified egg phospholipids as emulsifiers, anhydrous glycerol for the adjustment of tonicity, water for injection (with a pH of six to nine) and contains no preservatives3,4. ILE is available in concentrations ranging from 10 per cent to 30 per cent. Although purified 1 / 6 soybean oil is most commonly used as the major source of triglycerides, other sources are also used (such as olive oil and fish oil)3,4. The United States Pharmacopeia and the European Pharmacopoeia standards have established a globule size distribution limit for all lipid emulsions where the mean droplet size must be lower than 500 nanometres, and the percentage of fat larger than 5µm must be lower than 0.05 per cent5. -
Largescale Synthesis of Peptides
Lars Andersson1 Lennart Blomberg1 Large-Scale Synthesis of Martin Flegel2 Ludek Lepsa2 Peptides Bo Nilsson1 Michael Verlander3 1 PolyPeptide Laboratories (Sweden) AB, Malmo, Sweden 2 PolyPeptide Laboratories SpoL, Prague, Czech Republic 3 PolyPeptide Laboratories, Inc., Torrance, CA, 90503 USA Abstract: Recent advances in the areas of formulation and delivery have rekindled the interest of the pharmaceutical community in peptides as drug candidates, which, in turn, has provided a challenge to the peptide industry to develop efficient methods for the manufacture of relatively complex peptides on scales of up to metric tons per year. This article focuses on chemical synthesis approaches for peptides, and presents an overview of the methods available and in use currently, together with a discussion of scale-up strategies. Examples of the different methods are discussed, together with solutions to some specific problems encountered during scale-up development. Finally, an overview is presented of issues common to all manufacturing methods, i.e., methods used for the large-scale purification and isolation of final bulk products and regulatory considerations to be addressed during scale-up of processes to commercial levels. © 2000 John Wiley & Sons, Inc. Biopoly 55: 227–250, 2000 Keywords: peptide synthesis; peptides as drug candidates; manufacturing; scale-up strategies INTRODUCTION and plants,5 have all combined to increase the avail- ability and lower the cost of producing peptides. For For almost half a century, since du Vigneaud first many years, however, the major obstacle to the suc- presented his pioneering synthesis of oxytocin to the cess of peptides as pharmaceuticals was their lack of world in 1953,1 the pharmaceutical community has oral bioavailability and, therefore, relatively few pep- been excited about the potential of peptides as “Na- tides reached the marketplace as approved drugs. -
Nanoparticle System Based on Amino-Dextran As a Drug Delivery Vehicle: Immune-Stimulatory Cpg-Oligonucleotide Loading and Delivery
pharmaceutics Article Nanoparticle System Based on Amino-Dextran as a Drug Delivery Vehicle: Immune-Stimulatory CpG-Oligonucleotide Loading and Delivery Hien V. Nguyen 1,2, Katrin Campbell 2 , Gavin F. Painter 3, Sarah L. Young 4 and Greg F. Walker 1,* 1 School of Pharmacy, University of Otago, Dunedin 9016, New Zealand; [email protected] 2 Department of Pathology, University of Otago, Dunedin 9016, New Zealand; [email protected] 3 The Ferrier Research Institute, Victoria University of Wellington, Wellington 5040, New Zealand; [email protected] 4 School of Medical Sciences, Faculty of Medicine and Health, University of Sydney, Sydney 2006, NSW, Australia; [email protected] * Correspondence: [email protected]; Tel.: +64-3-479-7133 Received: 11 November 2020; Accepted: 25 November 2020; Published: 27 November 2020 Abstract: The aim of this study is to prepare and characterize an amino-dextran nanoparticle (aDNP) platform and investigate two loading strategies for unmethylated cytosine-phosphate-guanine (CpG) oligonucleotide. aDNP was prepared by desolvation of amino-dextran followed by the chemical crosslinking of amino groups. Size, surface charge, and surface morphology of aDNP was determined by dynamic light scattering and transmission electron microscopy. CpG was either loaded onto aDNP by adsorption (CpG-adsorbed-aDNP) or conjugated to aDNP (CpG-conjugated-aDNP). In vitro cytokine production by bone marrow-derived dendritic cells (BMDCs) was measured by flow cytometry. aDNPs size and zeta potential could be controlled to produce uniform particles in the size range of 50 to 300 nm, surface charge of 16.5 to +14 mV, and were spherical in shape. -
Hemmo Pharmaceuticals Private Limited
Global Supplier of Quality Peptide Products Hemmo Pharmaceuticals Private Limited Corporate Presentation Privileged & Confidential Privileged & Confidential Corporate Overview Privileged & Confidential 2 Company at a glance • Commenced operations in 1966 as a Key Highlights trading house, focusing on Oxytocin amongst other products Amongst the largest Indian peptide manufacturing company • In 1979, ventured into manufacturing of Oxytocin Competent team of 154 people including 6 PhDs, 60+ chemistry graduates/post graduates and 3 engineers • Privately held family owned company Portfolio – Generic APIs, Custom Peptides for Research and Clinical Development and Peptide • Infrastructure Fragments − State of art manufacturing facility in Developed 21 generic products in-house. Navi Mumbai, 5 more in progress − R&D facilities at Thane and Spain − Corporate office at Worli First and the only independent Indian company to have a US FDA approved peptide manufacturing site Privileged & Confidential 3 Transition from a trading house to a research based manufacturing facility Commenced Commenced Investment in State of the Art Opened R& D Expanded operations manufacturing greenfield project facility at Navi Centre in manufacturing as a trading of peptides intended for Mumbai Girona,Spain capacity House regulated markets commissioned R&D center set up in Infrastructure Mumbai 1966 1979 2005 2007 2008 2010 2011 2012 2014 2015 Oxytocin Oxytocin Desmopressin Buserelin Triptorelin Goserelin Linaclotide Glatiramer amongst Gonadorelin Decapeptide Cetrorelix -
Oxytocin Receptor OXTR
Oxytocin Receptor OXTR The oxytocin receptor belongs to the G-protein-coupled seven-transmembrane receptor superfamily. Its main physiological role is regulating the contraction of uterine smooth muscle at parturition and the ejection of milk from the lactating breast. The oxytocin receptors are activated in response to binding oxytocin and a similar nonapeptide, vasopressin. Oxytocin receptor triggers Gi or Gq protein-mediated signaling cascades leading to the regulation of a variety of neuroendocrine and cognitive functions. Oxytocin is a nonapeptide of the neurohypophyseal protein family that binds specifically to the oxytocin receptor to produce a multitude of central and peripheral physiological responses. In vivo, oxytocin acts as a paracrine and/or autocrine mediator of multiple biological effects. These effects are exerted primarily through interactions with G-protein-coupled oxytocin/vasopressin receptors, which, via Gq and Gi, stimulate phospholipase C-mediated hydrolysis of phosphoinositides. www.MedChemExpress.com 1 Oxytocin Receptor Agonists & Antagonists Atosiban Atosiban acetate (RW22164; RWJ22164) Cat. No.: HY-17572 (RW22164 acetate; RWJ22164 acetate) Cat. No.: HY-17572A Atosiban (RW22164; RWJ22164) is a nonapeptide Atosiban acetate (RW22164 acetate;RWJ22164 competitive vasopressin/oxytocin receptor acetate) is a nonapeptide competitive antagonist, and is a desamino-oxytocin analogue. vasopressin/oxytocin receptor antagonist, and is a Atosiban is the main tocolytic agent and has the desamino-oxytocin analogue. Atosiban is the main potential for spontaneous preterm labor research. tocolytic agent and has the potential for spontaneous preterm labor research. Purity: 99.09% Purity: 99.92% Clinical Data: Launched Clinical Data: Launched Size: 10 mM × 1 mL, 5 mg, 10 mg, 50 mg Size: 10 mM × 1 mL, 5 mg, 10 mg, 50 mg Carbetocin Epelsiban Cat.