Alimentary Tract and Metabolism
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Classification of Medicinal Drugs and Driving: Co-Ordination and Synthesis Report
Project No. TREN-05-FP6TR-S07.61320-518404-DRUID DRUID Driving under the Influence of Drugs, Alcohol and Medicines Integrated Project 1.6. Sustainable Development, Global Change and Ecosystem 1.6.2: Sustainable Surface Transport 6th Framework Programme Deliverable 4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Due date of deliverable: 21.07.2011 Actual submission date: 21.07.2011 Revision date: 21.07.2011 Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UVA Revision 0.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public PP Restricted to other programme participants (including the Commission x Services) RE Restricted to a group specified by the consortium (including the Commission Services) CO Confidential, only for members of the consortium (including the Commission Services) DRUID 6th Framework Programme Deliverable D.4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Page 1 of 243 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Authors Trinidad Gómez-Talegón, Inmaculada Fierro, M. Carmen Del Río, F. Javier Álvarez (UVa, University of Valladolid, Spain) Partners - Silvia Ravera, Susana Monteiro, Han de Gier (RUGPha, University of Groningen, the Netherlands) - Gertrude Van der Linden, Sara-Ann Legrand, Kristof Pil, Alain Verstraete (UGent, Ghent University, Belgium) - Michel Mallaret, Charles Mercier-Guyon, Isabelle Mercier-Guyon (UGren, University of Grenoble, Centre Regional de Pharmacovigilance, France) - Katerina Touliou (CERT-HIT, Centre for Research and Technology Hellas, Greece) - Michael Hei βing (BASt, Bundesanstalt für Straßenwesen, Germany). -
Safety Data Sheet
SAFETY DATA SHEET 1. Identification Product identifier TWINRIX ADULT Other means of identification Synonyms TWINRIX ADULT INJECTION 720 EL U AND 20 MCG/ML * TWINRIX SUSPENSION FOR INJECTION * TWINRIX ADULT PRE-FILLED SYRINGE * TWINRIX ERWACHSENE AMPULLE MIT 1 ML SUSPENSION * TWINRIX ERWACHSENE FERTIGSPRITZE MIT 1 ML SUSPENSION * HAB ADULT (720/20) * COMBINED HEPATITIS A/HEPATITIS B VACCINE * TWINRIX VACUNA COMBINADA ANTIHEPATITIS A Y B * TWINRIX VACUNA CONTRA LA HEPATITIS A Y B * TWINRIX ADULTO * AMBIRIX * HEPATITIS A VIRUS ANTIGEN (HM175) AND r-DNA HEPATITIS B SURFACE ANTIGEN (HBsAg) COMBINED VACCINE Recommended use Medicinal Product This safety data sheet is written to provide health, safety and environmental information for people handling this formulated product in the workplace. It is not intended to provide information relevant to medicinal use of the product. In this instance patients should consult prescribing information/package insert/product label or consult their pharmacist or physician. For health and safety information for individual ingredients used during manufacturing, refer to the appropriate safety data sheet for each ingredient. Recommended restrictions No other uses are advised. Manufacturer/Importer/Supplier/Distributor information COMPANY NAME GlaxoSmithKline US Address: 5 Moore Drive Research Triangle Park, NC 27709 USA Telephone: +1-888-825-5249 (General Inquiries) Email: [email protected] Website: www.gsk.com EMERGENCY CONTACTS CHEMTREC EMERGENCY NUMBERS Telephone: +(1) 703 527 3887 (International) 24/7; multi-language response Contract Number: CCN9484 VERISK 3E GLOBAL INCIDENT RESPONSE Telephone: +(1) 760 476 3971 (In country) +(1) 760 476 3962 or +(1) 866 519 4752 (International) 24/7; multi-language response Contract Number: 334878 2. -
Aluminum Phosphates
Dr. Ralf Giskow, The Variety of Phosphates Jörg Lind, Erwin Schmidt Chemische Fabrik Budenheim KG, for Refractory and Technical D-55257 Buden- heim www.budenheim- Applications by the Example cfb.com of Aluminium Phosphates In 1669 the chemical element phos- Phase-I-content influences, for phorus was discovered by H. Brandt, example, the dissolution property of an alchemist. In 1694 Boyle made STPP in water. The choice of the the first phosphoric acid by dissolv- right phosphate can already be the ing phosphorus pentoxide (P2O5) in crucial point even with such a “sim- water. This was the start of the phos- ple“ phosphate like sodium tripoly- phorus chemistry. Since this time phosphate. phosphoric acid and its salts have a The next step into the direction firm place in chemistry and technical of complexity is a phosphate called applications. Phosphates are part of sodium hexametaphosphate (SHMP) our life and are used in a variety of in colloquial language. In fact, the ways also in industrial fields like chemical name is a mistake. The refractories, glass, ceramics, con- name sodium hexametaphosphate struction industry and for a lot of would stand for a sodium phosphate other technical purposes. with a ring structure (“meta”). But SHMP has a chaintype structure as can be proved. These melted glassy polyphosphates (SHMP) with pH-val- Fig. 1 Phosphates in Refractory phosphates are polyphosphates with ues between three and nine, most of FABUTIT 734, a modified STPP and Technical Industries different chain lengths. The average the products also in an instantised against a standard The most common and well known chain length and thus the properties quality (Fig. -
Sodium Aluminium Phosphate, Acidic
SODIUM ALUMINIUM PHOSPHATE, ACIDIC Prepared at the 61st JECFA (2003) and published in the Combined Compendium of Food Additive Specifications, FAO JECFA Monographs 1 (2005). A PTWI of 2 mg/kg bw for aluminium was established at the 74th JECFA (2011). SYNONYMS SALP; INS No. 541(i) Chemical names Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate; trisodium dialuminium pentadecahydrogen octaphosphate Chemical formula NaAl3H14(PO4)8 · 4H2O Na3Al2H15(PO4)8 Formula weight NaAl3H14(PO4)8 · 4H2O: 949.88 Na3Al2H15(PO4)8: 897.82 Assay Not less than 95% of NaAl3H14(PO4)8 · 4H2O or not less than 95% of Na3Al2H15(PO4)8 DESCRIPTION White, odourless powder FUNCTIONAL USES Raising agent CHARACTERISTICS IDENTIFICATION Solubility (Vol. 4) Insoluble in water; soluble in hydrochloric acid pH (Vol. 4) Acid to litmus Test for aluminium Passes test (Vol. 4) Test a 1 in 10 solution in dilute hydrochloric acid (1 in 2) Test for sodium (Vol. 4) Passes test Test a 1 in 10 solution in dilute hydrochloric acid (1 in 2) Test for phosphate Passes test (Vol. 4) Test a 1 in 10 solution in dilute hydrochloric acid (1 in 2) PURITY Loss on ignition (Vol. 4) NaAl3H14(PO4)8 · 4H2O: 19.5 - 21% (750-800°, 2 h) Na3Al2H15(PO4)8 : 15 - 16% (750-800°, 2 h) Fluoride (Vol. 4) Not more than 25 mg/kg (Method I) Arsenic (Vol. 4) Not more than 3 mg/kg (Method II) Lead (Vol. 4) Not more than 2 mg/kg Determine using an AAS/ICP-AES technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the methods described in Volume 4 (under “General Methods, Metallic Impurities”). -
Aluminium Distearate, Aluminium Hydroxide Acetate, Aluminium Phosphate and Aluminium Tristearate
The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/MRL/393/98-FINAL April 1998 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS ALUMINIUM DISTEARATE, ALUMINIUM HYDROXIDE ACETATE, ALUMINIUM PHOSPHATE AND ALUMINIUM TRISTEARATE SUMMARY REPORT 1. Aluminium is an ubiquitous element in the environment. It is present in varying concentrations in living organisms and in foods. Aluminium compounds are widely used in veterinary and human medicine. Other uses are as an analytical reagent, food additives (e.g. sodium aluminium phosphate as anticaking agent) and in cosmetic preparations (aluminium chloride). Aluminium distearate is used for thickening lubricating oils. Aluminium hydroxide acetate and phosphate are antacids with common indications in veterinary medicine: gastric hyperacidity, peptic ulcer, gastritis and reflux esophagitis. A major use of antacids in veterinary medicine is in treatment and prevention of ruminal acidosis from grain overload, adsorbent and antidiarrheal. The dosage of aluminium hydroxide is 30 g/animal in cattle and 2 g/animal in calves and foals. Gel preparations contain approximately 4% aluminium hydroxide. Aluminium potassium sulphate is used topically as a antiseptic, astringent (i.e. washes, powders, and ‘leg tighteners’ for horses (30 to 60 g/animal) and antimycotic (1% solution for dipping or spraying sheeps with dermatophilus mycotic dermatitis). In cattle it is occasionally used for stomatitis and vaginal and intrauterine therapy at doses of 30 to 500 g/animal. In human medicine, aluminium hydroxide-based preparations have a widespread use in gastroenterology as antacids (doses of about 1 g/person orally) and as phosphate binders (doses of about 0.8 g/person orally) in patients an impairment of renal function. -
Ep 3106176 B1
(19) TZZ¥_Z__T (11) EP 3 106 176 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 39/12 (2006.01) A61K 39/39 (2006.01) 11.10.2017 Bulletin 2017/41 (21) Application number: 16183076.5 (22) Date of filing: 06.12.2012 (54) ALUMINIUM COMPOUNDS FOR USE IN THERAPEUTICS AND VACCINES ALUMINIUMVERBINDUNGEN ZUR VERWENDUNG FÜR THERAPEUTIKA UND IMPFSTOFFE COMPOSÉS D’ALUMINIUM POUR UTILISATION DANS DES PRODUITS THÉRAPEUTIQUES ET VACCINS (84) Designated Contracting States: (56) References cited: AL AT BE BG CH CY CZ DE DK EE ES FI FR GB WO-A2-2009/158284 US-A1- 2005 158 334 GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR • SRIVASTAVA A K ET AL: "A purified inactivated Japaneseencephalitis virus vaccine made in vero (30) Priority: 06.12.2011 EP 11192230 cells", VACCINE, vol. 19, no. 31, 14 August 2001 13.03.2012 PCT/EP2012/054387 (2001-08-14), pages 4557-4565, XP027321987, ELSEVIER LTD, GB ISSN: 0264-410X [retrieved (43) Date of publication of application: on 2001-08-14] 21.12.2016 Bulletin 2016/51 • ANONYMOUS: "Rehydragel Adjuvants. Product profile", General Chemical , 2008, pages 1-2, (60) Divisional application: XP002684848, Retrieved from the Internet: 17185526.5 URL:http://www.generalchemical.com/assets/ pdf/Rehydragel_Adjuvants_Product_Profile.p df (62) Document number(s) of the earlier application(s) in [retrieved on 2012-10-08] accordance with Art. 76 EPC: • LINDBLAD, EB: "Special feature. Aluminium 12795830.4 / 2 788 023 compoundsfor usein vaccines", IMMUNOL. -
Ehealth DSI [Ehdsi V2.2.2-OR] Ehealth DSI – Master Value Set
MTC eHealth DSI [eHDSI v2.2.2-OR] eHealth DSI – Master Value Set Catalogue Responsible : eHDSI Solution Provider PublishDate : Wed Nov 08 16:16:10 CET 2017 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 1 of 490 MTC Table of Contents epSOSActiveIngredient 4 epSOSAdministrativeGender 148 epSOSAdverseEventType 149 epSOSAllergenNoDrugs 150 epSOSBloodGroup 155 epSOSBloodPressure 156 epSOSCodeNoMedication 157 epSOSCodeProb 158 epSOSConfidentiality 159 epSOSCountry 160 epSOSDisplayLabel 167 epSOSDocumentCode 170 epSOSDoseForm 171 epSOSHealthcareProfessionalRoles 184 epSOSIllnessesandDisorders 186 epSOSLanguage 448 epSOSMedicalDevices 458 epSOSNullFavor 461 epSOSPackage 462 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 2 of 490 MTC epSOSPersonalRelationship 464 epSOSPregnancyInformation 466 epSOSProcedures 467 epSOSReactionAllergy 470 epSOSResolutionOutcome 472 epSOSRoleClass 473 epSOSRouteofAdministration 474 epSOSSections 477 epSOSSeverity 478 epSOSSocialHistory 479 epSOSStatusCode 480 epSOSSubstitutionCode 481 epSOSTelecomAddress 482 epSOSTimingEvent 483 epSOSUnits 484 epSOSUnknownInformation 487 epSOSVaccine 488 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 3 of 490 MTC epSOSActiveIngredient epSOSActiveIngredient Value Set ID 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 TRANSLATIONS Code System ID Code System Version Concept Code Description (FSN) 2.16.840.1.113883.6.73 2017-01 A ALIMENTARY TRACT AND METABOLISM 2.16.840.1.113883.6.73 2017-01 -
Progress Report Antacids and Peptic Ulcer-A Reappraisal
Gut: first published as 10.1136/gut.20.6.538 on 1 June 1979. Downloaded from Gut, 1979, 20, 538-545 Progress report Antacids and peptic ulcer-a reappraisal There is a considerable difference of opinion between clinicians on opposite sides of the Atlantic about the role of antacid therapy in peptic ulcer. As a result of Doll's work1 most clinicians in the United Kingdom have considered antacids to be of symptomatic benefit only, but without effect on the natural history of disease. In the United States, however, antacids have remained the basic medical treatment for peptic ulcer and large quantities are prescribed in intensive regimens with the belief that they accelerate ulcer healing. Such a difference of opinion usually means that the treatment in question is without any dramatic effect and objective assessment is therefore different. It is in this field that randomised, controlled trials are most helpful, indeed vital2. Carbenoxolone3 and recently the H 2-receptor antagonists4'5 have been tested in this way and found to be effective in healing peptic ulcer. We feel a review of similar work on antacids is appropriate. The use of antacids is based on the premise that gastric acid plays some part in the causation of peptic ulcer and also on the observation that symptoms are often relieved by antacid preparations. Schwarz's dictum, 'no acid-no ulcer', is still valid, though the pattern of acid secretion is different in gastric and duodenal ulcer. Hypersecretion of acid is probably a more important http://gut.bmj.com/ factor in duodenal ulcer, though several aspects of the pathophysiology remain controversial6. -
(12) United States Patent (10) Patent No.: US 9,283,192 B2 Mullen Et Al
US009283192B2 (12) United States Patent (10) Patent No.: US 9,283,192 B2 Mullen et al. (45) Date of Patent: Mar. 15, 2016 (54) DELAYED PROLONGED DRUG DELIVERY 2009. O1553.58 A1 6/2009 Diaz et al. 2009,02976O1 A1 12/2009 Vergnault et al. 2010.0040557 A1 2/2010 Keet al. (75) Inventors: Alexander Mullen, Glasgow (GB); 2013, OO17262 A1 1/2013 Mullen et al. Howard Stevens, Glasgow (GB); Sarah 2013/0022676 A1 1/2013 Mullen et al. Eccleston, Scotstoun (GB) FOREIGN PATENT DOCUMENTS (73) Assignee: UNIVERSITY OF STRATHCLYDE, Glasgow (GB) EP O 546593 A1 6, 1993 EP 1064937 1, 2001 EP 1607 O92 A1 12/2005 (*) Notice: Subject to any disclaimer, the term of this EP 2098 250 A1 9, 2009 patent is extended or adjusted under 35 JP HO5-194188 A 8, 1993 U.S.C. 154(b) by 0 days. JP 2001-515854. A 9, 2001 JP 2001-322927 A 11, 2001 JP 2003-503340 A 1, 2003 (21) Appl. No.: 131582,926 JP 2004-300148 A 10, 2004 JP 2005-508326 A 3, 2005 (22) PCT Filed: Mar. 4, 2011 JP 2005-508327 A 3, 2005 JP 2005-508328 A 3, 2005 (86). PCT No.: PCT/GB2O11AOOO3O7 JP 2005-510477 A 4/2005 JP 2008-517970 A 5, 2008 JP 2009-514989 4/2009 S371 (c)(1), WO WO99,12524 A1 3, 1999 (2), (4) Date: Oct. 2, 2012 WO WOO1 OO181 A2 1, 2001 WO WOO3,O266.15 A2 4/2003 (87) PCT Pub. No.: WO2011/107750 WO WOO3,O26625 A1 4/2003 WO WO 03/026626 A2 4/2003 PCT Pub. -
Pharmaceutical Compositions Having Cytoprotective Properties
Europaisches Patentamt J European Patent Office Office europden des brevets @ Publication number: 0 220 849 B1 EUROPEAN PATENT SPECIFICATION (45) Date of publication of patent specification : © int CI.5 : A61K 33/08, //(A61K33/08, 27.02.91 Bulletin 91/09 33:00, 31:19) @ Application number : 86307619.6 (§) Date of filing : 02.10.86 (si) Pharmaceutical compositions having cytoprotective properties. The file contains technical information (73) Proprietor: AMERICAN HOME PRODUCTS submitted after the application was filed and CORPORATION not included in this specification 685, Third Avenue New York, New York 10017 (US) (§) Priority: 08.10.85 US 785417 20.02.86 US 831756 (72) Inventor : Borella, Luis Enrique 5 Jacob Drive Lawrenceville New Jersey (US) (43) Date of publication of application : Inventor : Dijoseph, John Francis 06.05.87 Bulletin 87/19 571 Linden Avenue Woodbridge New Jersey (US) Inventor : Mir, Ghulam Nabi (45) Publication of the grant of the patent : P.O. Box 392 27.02.91 Bulletin 91/09 Buckingham Pennsylvania 18912 (US) Inventor: Reuter, Gerald Louis 23 Crescent Drive (84) Designated Contracting States : Pittsburgh New York 12901 (US) AT BE CH DE FR GB IT LI LU NL SE (74) Representative : Porter, Graham Ronald et al @ References cited : C/O John Wyeth & Brother Limited FR-A- 2 103 569 Huntercombe Lane South Taplow CHEMICAL ABSTRACTS, vol. 80, no. 26, 1st Maidenhead Berkshire, SL6 0PH (GB) July 1974, pages 193-194, no. 149115a, Colum- bus, Ohio, US; & JP-A-74 13 319 CHEMICAL ABSTRACTS, vol. 98, no. 17, 25th April 1983, page 47, no. 137460L Columbus, Ohio, US; I. -
EUROPEAN PHARMACOPOEIA Free Access to Supportive Pharmacopoeial Texts in the Field of Vaccines for Human Use During the Coronavirus Disease (COVID-19) Pandemic
EUROPEAN PHARMACOPOEIA Free access to supportive pharmacopoeial texts in the field of vaccines for human use during the coronavirus disease (COVID-19) pandemic Updated package - October 2020 Published in accordance with the Convention on the Elaboration of a European Pharmacopoeia (European Treaty Series No. 50) European Directorate Direction européenne for the Quality de la qualité of Medicines du médicament & HealthCare & soins de santé Council of Europe Strasbourg Free access to supportive pharmacopoeial texts in the field of vaccines for human use during the coronavirus disease (COVID-19) pandemic Updated package The EDQM is committed to supporting users during the coronavirus disease (COVID-19) pandemic – as well as contributing to the wider global effort to combat the virus – by openly sharing knowledge and providing access to relevant guidance/standards. To support organisations involved in the development, manufacture or testing of COVID-19 vaccines worldwide, many of which are universities and small and medium-sized enterprises, the EDQM is offeringte mporary free access to texts of the European Pharmacopoeia (Ph. Eur.) in the field of vaccines. This package includes quality standards for vaccines which developers can take into account to help build appropriate analytical control strategies for their COVID-19 candidate vaccines and ensure the quality and safety of the final product. Application of such quality requirements may ultimately help to facilitate regulatory acceptance of a subsequent marketing authorisation application. For ease of reading, a summary table listing the pharmacopoeial texts, with information regarding the vaccine types or vaccine platforms concerned (e.g. live attenuated viral vaccine, recombinant viral-vectored vaccines) is provided. -
EUROPEAN PHARMACOPOEIA 10.0 Index 1. General Notices
EUROPEAN PHARMACOPOEIA 10.0 Index 1. General notices......................................................................... 3 2.2.66. Detection and measurement of radioactivity........... 119 2.1. Apparatus ............................................................................. 15 2.2.7. Optical rotation................................................................ 26 2.1.1. Droppers ........................................................................... 15 2.2.8. Viscosity ............................................................................ 27 2.1.2. Comparative table of porosity of sintered-glass filters.. 15 2.2.9. Capillary viscometer method ......................................... 27 2.1.3. Ultraviolet ray lamps for analytical purposes............... 15 2.3. Identification...................................................................... 129 2.1.4. Sieves ................................................................................. 16 2.3.1. Identification reactions of ions and functional 2.1.5. Tubes for comparative tests ............................................ 17 groups ...................................................................................... 129 2.1.6. Gas detector tubes............................................................ 17 2.3.2. Identification of fatty oils by thin-layer 2.2. Physical and physico-chemical methods.......................... 21 chromatography...................................................................... 132 2.2.1. Clarity and degree of opalescence of