DOCSLIB.ORG

Dicycloverine Hydrochloride Preparations O (BANM, Rinnm) Proprietary Preparations (Details Are Given in Part 3) NOTE

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Dicycloverine Hydrochloride Preparations O (BANM, Rinnm) Proprietary Preparations (Details Are Given in Part 3) NOTE 1722 Gastrointestinal Drugs Clebopride (BAN, USAN, rINN) Pharmacopoeias. In US. ical evidence had increased and dantron was now established as USP 31 (Clidinium Bromide). A white or nearly white, practical- a potential human carcinogen.5 Cleboprida; Clébopride; Clebopridum; LAS-9273. 4-Amino-N- ly odourless, crystalline powder. Soluble in water and in alcohol; 1. Tolman KG, et al. Possible hepatotoxicity of Doxidan. Ann In- (1-benzyl-4-piperidyl)-5-chloro-o-anisamide. slightly soluble in ether and in benzene. Store in airtight contain- tern Med 1976; 84: 290–2. Клебоприд ers. Protect from light. 2. Darke CS, Cooper RG. Unusual case of skin discoloration. BMJ 1978; 1: 1188–9. C20H24ClN3O2 = 373.9. Profile 3. Greer IA. Orange periods. BMJ 1984; 289: 323. CAS — 55905-53-8. Clidinium bromide is a quaternary ammonium antimuscarinic 4. Patel PM, et al. Anthraquinone laxatives and human cancer: an association in one case. Postgrad Med J 1989; 65: 216–17. ATC — A03FA06. with peripheral effects similar to those of atropine (p.1219). It 5. Committee on Safety of Medicines/Medicine Control Agency. ATC Vet — QA03FA06. has been used alone or more often with chlordiazepoxide in the Danthron restricted to constipation in the terminally ill. Current symptomatic treatment of peptic ulcer disease and other gas- Problems 2000; 26: 4. Also available at: http:// trointestinal disorders. www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE& dDocName=CON007462&RevisionSelectionMethod= Cl Preparations LatestReleased (accessed 08/11/06) USP 31: Chlordiazepoxide Hydrochloride and Clidinium Bromide Cap- 1 H2N Breast feeding. The American Academy of Pediatrics state sules. that, although usually compatible with breast feeding, use of dan- H Proprietary Preparations (details are given in Part 3) tron by breast-feeding mothers has been reported to cause in- N Multi-ingredient: Arg.: Libraxin; Canad.: Apo-Chlorax; Librax; Chile: creased bowel activity in the infant. Gastrolen; Lerogin; Libraxin; Lironex†; Sedogastrol†; Tensoliv; Fin.: Librax; 1. American Academy of Pediatrics. The transfer of drugs and oth- Fr.: Librax; Gr.: Distedon; Librax; Hong Kong: Bralix; Librax; Medocalum†; er chemicals into human milk. Pediatrics 2001; 108: 776–89. O O N India: Equirex; Normaxin; Spasrax; Indon.: Braxidin; Cliad; Klidibrax; Li- H C Correction. ibid.; 1029. Also available at: 3 brax; Melidox; Renagas; Israel: Nirvaxal; Ital.: Librax; Malaysia: Apo- http://aappolicy.aappublications.org/cgi/content/full/ Chlorax†; Liblan; Port.: Librax; S.Afr.: Librax; Singapore: Apo-Chlorax; pediatrics%3b108/3/776 (accessed 08/11/06) Chlobax; Librax; Medocalum; Switz.: Librax; Librocol; Thai.: Kenspa; Li- brax; Pobrax†; Tumax; Zepobrax†; Turk.: Klipaks; Librax; USA: Clindex; Pharmacokinetics Clebopride Malate (BANM, rINNM) Librax; Venez.: Librax. Dantron is metabolised by bacteria in the colon. Dantron or its Clébopride, malate de; Clebopridi malas; Kleboprid malát; Kle- metabolites are absorbed from the gastrointestinal tract, as indi- bopridimalaatti; Klebopridmalat; Kleboprid-malát; Kleboprido cated by discoloration of urine in some patients. Dantron or its malatas; Malato de cleboprida. metabolites are excreted in the faeces and the urine, and also in Colocynth other secretions including breast milk. Клебоприда Малат Bitter Apple; Bitter Cucumber; Colocinto; Colocynth Pulp; Colo- Uses and Administration C20H24ClN3O2,C4H6O5 = 508.0. cynthis; Coloquinte; Coloquintidas; Koloquinthen. Dantron is an anthraquinone stimulant laxative but, unlike senna CAS — 57645-91-7. Колоцинт (p.1769), it is not a glycoside. It is given orally to treat constipa- ATC — A03FA06. tion (p.1693) and is effective within 6 to 12 hours. However, be- ATC Vet — QA03FA06. NOTE. The synonym Bitter Apple has also been applied to the cause of concern over rodent carcinogenicity it has been with- fruits of Solanum incanum. Pharmacopoeias. In Eur. (see p.vii). drawn in some countries, and its use restricted in others. In the Ph. Eur. 6.2 (Clebopride Malate). A white or almost white, crys- Profile UK, it may be used only in terminally ill patients. talline powder. Sparingly soluble in water and in methyl alcohol; Colocynth is the dried pulp of the fruit of Citrullus colocynthis Dantron is given in doses of 25 to 75 mg when given with (Cucurbitaceae). It has a drastic purgative and irritant action and slightly soluble in dehydrated alcohol; practically insoluble in poloxamer 188 (p.1918) as co-danthramer, and in doses of 50 to has been superseded by less toxic laxatives. dichloromethane. The pH of a 1% solution in water is 3.8 to 4.2. 150 mg when given with docusate sodium (p.1725) as co-dan- Protect from light. Homoeopathy. Colocynth has been used in homoeopathic thrusate. Doses are usually given at bedtime. For doses in chil- medicines under the following names: Colocynthis; Coloc. dren, see below. Profile Administration in children. Children under 12 years have Clebopride is a substituted benzamide similar to metoclopramide been given dantron 12.5 to 25 mg orally as co-danthramer or (p.1747), that is used for its antiemetic and prokinetic actions in 50 mg as co-danthrusate. Doses are usually given at bedtime. nausea and vomiting (p.1700) and various other gastrointestinal Dantron (BAN, rINN) Children aged 12 years and over may be treated with the adult disorders. It is given as the malate but doses are expressed in Antrapurol; Chrysazin; Danthron; Dantrón; Dantrone; Dantroni; dose (see Uses and Administration, above). terms of the base. Clebopride malate 679 micrograms is equiva- lent to about 500 micrograms of clebopride. Dantronum; Dianthon; Dioxyanthrachinonum. 1,8-Dihydroxyan- The BNFC recommends similar doses to these, but restricts the thraquinone. use of co-danthramer to children aged 2 years and over, and the Clebopride malate is given in a usual oral dose equivalent to use of co-danthrusate to those aged 6 years and over. clebopride 0.5 mg three times daily before meals or 0.5 to 1 mg Дантрон C H O = 240.2. Dantron should not be used in infants wearing nappies (diapers) by intramuscular or intravenous injection for acute symptoms. 14 8 4 as it may cause discoloration and superficial sloughing of the For dosage in children see below. CAS — 117-10-2. skin. ATC — A06AB03. Administration in children. Adolescents aged 12 to 20 years ATC Vet — QA06AB03. Preparations may be given clebopride malate orally in a dose equivalent to BP 2008: Co-danthrusate Capsules. clebopride 250 micrograms three times daily. An oral dose of 15 (details are given in Part 3) to 20 micrograms/kg daily in 3 divided doses may be used for Proprietary Preparations OH OHO children under 12; the following doses have been recommended: Multi-ingredient: Braz.: Fenogar†; Chile: Modane; Irl.: Ailax; Codalax; Cotron; Mex.: Modaton; NZ: Codalax†; Conthram†; UK: Ailax†; Capsu- • 1 to 4 years: 50 micrograms 3 times daily vac; Codalax; Danlax; Normax. • 4 to 8 years: 100 micrograms 3 times daily • 8 to 10 years: 150 micrograms 3 times daily • 10 to 12 years: 200 micrograms 3 times daily Dicycloverine Hydrochloride Preparations O (BANM, rINNM) Proprietary Preparations (details are given in Part 3) NOTE. Compounded preparations of dantron may be represented Cloridrato de Dicicloverina; Dicikloverin-hidroklorid; Dicikloveri- Arg.: Gastridin; Indon.: Clast; Ital.: Motilex; Port.: Clebofex; Clebutec; by the following names: no hidrochloridas; Dicyclomine Hydrochloride; Dicyclovérine, Spain: Cleboril. chlorhydrate de; Dicycloverini hydrochloridum; Dicykloverin-hy- • Co-danthramer x/y (BAN)—where x and y are the strengths in Multi-ingredient: Arg.: Eudon; Gastridin-E; Somasedan; Spain: Clanzo- drochlorid; Dicykloverinhydroklorid; Disykloveriinihydrokloridi; flat; Flatoril. milligrams of dantron and poloxamer respectively Hidrocloruro de dicicloverina. 2-Diethylaminoethyl bicyclohexyl- • Co-danthrusate (BAN)—dantron 5 parts and docusate sodium 1-carboxylate hydrochloride. 6 parts (w/w). Дицикловерина Гидрохлорид Pharmacopoeias. In Br. Clidinium Bromide (BAN, USAN, rINN) C19H35NO2,HCl = 345.9. BP 2008 (Dantron). An orange, odourless or almost odourless, Bromuro de clidinio; Clidinii Bromidum; Clidinium, Bromure de; CAS — 77-19-0 (dicycloverine); 67-92-5 (dicycloverine hy- crystalline powder. Practically insoluble in water; very slightly drochloride). Klidiniumbromid; Klidiniumbromidi; Klidinyum Bromür; Ro-2- soluble in alcohol; soluble in chloroform; slightly soluble in ATC — A03AA07. 3773. 3-Benziloyloxy-1-methylquinuclidinium bromide. ether; dissolves in solutions of alkali hydroxides. ATC Vet — QA03AA07. Клидиния Бромид Adverse Effects and Precautions C22H26BrNO3 = 432.4. As for Senna, p.1769. Dantron may colour the urine pink or red. CAS — 7020-55-5 (clidinium); 3485-62-9 (clidinium bro- Discoloration and superficial sloughing of perianal skin can oc- CH3 mide). cur after prolonged contact, therefore dantron should not be used O in infants wearing nappies (diapers) and should be used with cau- tion in incontinent patients. The mucosa of the large intestine N CH3 O CH3 may be discoloured with prolonged use or high dosage. + In rodents, dantron has been associated with the development of N intestinal and liver tumours. Consequently, its use has been re- O stricted, see Uses and Administration, below. − (dicycloverine) Br ◊ References to adverse effects occurring with dantron-contain- O ing laxatives include individual cases of leucopenia with liver 1 2 Pharmacopoeias. In Eur. (see p.vii) and US. OH damage, greyish-blue skin discoloration, and orange vaginal
Load more

Recommended publications
  • Appendix A: Potentially Inappropriate Prescriptions (Pips) for Older People (Modified from ‘STOPP/START 2’ O’Mahony Et Al 2014)
    Appendix A: Potentially Inappropriate Prescriptions (PIPs) for older people (modified from ‘STOPP/START 2’ O’Mahony et al 2014) Consider holding (or deprescribing - consult with patient): 1. Any drug prescribed without an evidence-based clinical indication 2. Any drug prescribed beyond the recommended duration, where well-defined 3. Any duplicate drug class (optimise monotherapy) Avoid hazardous combinations e.g.: 1. The Triple Whammy: NSAID + ACE/ARB + diuretic in all ≥ 65 year olds (NHS Scotland 2015) 2. Sick Day Rules drugs: Metformin or ACEi/ARB or a diuretic or NSAID in ≥ 65 year olds presenting with dehydration and/or acute kidney injury (AKI) (NHS Scotland 2015) 3. Anticholinergic Burden (ACB): Any additional medicine with anticholinergic properties when already on an Anticholinergic/antimuscarinic (listed overleaf) in > 65 year olds (risk of falls, increased anticholinergic toxicity: confusion, agitation, acute glaucoma, urinary retention, constipation). The following are known to contribute to the ACB: Amantadine Antidepressants, tricyclic: Amitriptyline, Clomipramine, Dosulepin, Doxepin, Imipramine, Nortriptyline, Trimipramine and SSRIs: Fluoxetine, Paroxetine Antihistamines, first generation (sedating): Clemastine, Chlorphenamine, Cyproheptadine, Diphenhydramine/-hydrinate, Hydroxyzine, Promethazine; also Cetirizine, Loratidine Antipsychotics: especially Clozapine, Fluphenazine, Haloperidol, Olanzepine, and phenothiazines e.g. Prochlorperazine, Trifluoperazine Baclofen Carbamazepine Disopyramide Loperamide Oxcarbazepine Pethidine
    [Show full text]
  • Pain Management 101
    PAIN MANAGEMENT 101 By: Vicki McCulloch RN, NP & DeAnna Looper RN, CHPN, CHPCA Expect more from us. We do. Objectives • Identify a step-wise approach to pain management. • Identify the WHO Pain Ladder. • Identify non-pharmacological pain control measures. • Identify adjuvant treatment measures. • Identify common myths and truths • Identify common side effects and treatment options. Expect more from us. We do. Pain Management Principles • Use Multi-Treatment and Multi-Discipline Approach • Combine opioids with non-opioid medications • Non-pharmaceutical approaches • Include family and caregiver in planning • Include the patient! • Coordinate with facility • Coordinate with all providers- • Primary Care Provider • Nursing Home Physician • Hospice IDG Members Expect more from us. We do. Utilize the WHO Ladder World Health Organization • (WHO) “analgesic ladder” • Follow the steps as indicated. • Determine if adjuvants are necessary. Expect more from us. We do. WHO Pain Ladder STEP 3 “Strong” opioid for severe pain +/- non-opioid +/- adjuvant STEP 2 “Mild” opioid for mild- moderate pain +/- non- opioid +/- adjuvant STEP 1 Non-opioid + / - adjuvant Expect more from us. We do. Step 1-Mild Pain NON-OPIOID MEDICATION OPTIONS • Acetaminophen (Tylenol)-(Paracetamol)-(Panadol) • Non-steroidal anti-inflammatory drugs (NSAIDs) Traditional NSAIDS Ibuprofen-(Motrin) Aspirin-(Bayer) Naproxen- (Aleve) Nabumetone-(Relafen) Cox-2 Inhibitors Celecoxib-(Celebrex) Rofecoxib-(Vioxx) Valdecoxib-(Bextra) Expect more from us. We do. Adjuvants • Antidepressants
    [Show full text]
  • Wo 2010/075090 A2
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 1 July 2010 (01.07.2010) WO 2010/075090 A2 (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every C07D 409/14 (2006.01) A61K 31/7028 (2006.01) kind of national protection available): AE, AG, AL, AM, C07D 409/12 (2006.01) A61P 11/06 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, (21) International Application Number: DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/US2009/068073 HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (22) International Filing Date: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, 15 December 2009 (15.12.2009) ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, (25) Filing Language: English SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, (26) Publication Language: English TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 61/122,478 15 December 2008 (15.12.2008) US kind of regional protection available): ARIPO (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, (71) Applicant (for all designated States except US): AUS- ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, PEX PHARMACEUTICALS, INC.
    [Show full text]
  • Department of Health
    DEPARTMENT OF HEALTH National Drug Policy - Pharmaceutical Management Unit 50 National Formulary Committee Philippine National Drug Formulary EssentialEssential MedicinesMedicines ListList Volume I, 7th Edition ( 2008 ) Published by: The National Formulary Committee National Drug Policy ‐ Pharmaceutical Management Unit 50 DEPARTMENT OF HEALTH Manila, Philippines All rights reserved 2008 The National Formulary Committee National Drug Policy‐Pharmaceutical Management Unit 50 (NDP‐PMU 50) Department of Health San Lazaro Cmpd., Rizal Ave., Sta. Cruz, Manila, Philippines 1003 ISBN 978‐971‐91620‐7‐0 Any part or the whole book may be reproduced or transmitted without any alteration, in any form or by any means, with permission from DOH provided it is not sold commercially. ii PHILIPPINE NATIONAL DRUG FORMULARY Volume I, 7th Edition 2 0 0 8 Francisco T. Duque III, MD, MSc Secretary of Health Alexander A. Padilla Undersecretary of Health, Office for External Affairs Robert Louie P. So, MD Program Manager, NDP-PMU 50 Dennis S. Quiambao, MD Proj. Mgmt. Operating Officer & Coordinator (PMOOC) NDP-PMU 50 NATIONAL FORMULARY COMMITTEE Estrella B. Paje-Villar, MD, DTM & H Chairperson Jose M. Acuin, MD, MSc Alma L. Jimenez, MD Alejandro C. Baroque II, MD Marieta B. de Luna, MD Bu C. Castro, MD Nelia P. Cortes-Maramba, MD Dina V. Diaz, MD Yolanda R. Robles, PhD Pharm Mario R. Festin, MD, MS, MHPEd Isidro C. Sia, MD BFAD Representative SECRETARIAT Luzviminda O. Marquez, RPh, RMT Mary Love C. Victoria, RPh Michael D. Junsay, RPh Ermalyn M. Magturo iii Republic of the Philippines DEPARTMENT OF HEALTH OFFICE OF THE SECRETARY 2/F Bldg. 1, San Lazaro Cmpd., Rizal Avenue, Sta.
    [Show full text]
  • Pcf5 Palliative Care Formulary
    PCF5 PALLIATIVE CARE FORMULARY Published by palliativedrugs.com Ltd. Palliativedrugs.com Ltd Hayward House Study Centre Nottingham University Hospitals NHS Trust, City Campus Nottingham NG5 1PB United Kingdom www.palliativedrugs.com # palliativedrugs.com Ltd 2014 The moral rights of the editors have been asserted. PCF4þ ePDF 2013 PCF4þ ePDF 2012 PCF4 2011, reprinted 2012 (twice), 2013 PCF3 2007, reprinted 2008, 2009 PCF2 2002, reprinted 2003 PCF1 1998 All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise without the prior permission in writing of palliativedrugs.com Ltd or as expressly permitted by law, or under terms agreed with the appropriate reprographics rights organization. Enquiries concerning reproduction outside the scope of the above should be sent to [email protected] or by ordinary mail to the above address. British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library. ISBN 978-0-9552547-9-6 Typeset by OKS Prepress Services Private Ltd, Chennai, India Printed by Halstan Printing Group, Amersham, UK DISCLAIMER Every effort has been made to ensure the accuracy of this text, and that the best information available has been used. However, palliativedrugs.com Ltd neither represents nor guarantees that the practices described herein will, if followed, ensure safe and effective patient care. The recommendations contained in this book reflect the editors’ judgement regarding the state of general knowledge and practice in the field as of the date of publication. Information in a book of this type can never be all-inclusive, and therefore will not cover every eventuality.
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2006/0024365A1 Vaya Et Al
    US 2006.0024.365A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0024365A1 Vaya et al. (43) Pub. Date: Feb. 2, 2006 (54) NOVEL DOSAGE FORM (30) Foreign Application Priority Data (76) Inventors: Navin Vaya, Gujarat (IN); Rajesh Aug. 5, 2002 (IN)................................. 699/MUM/2002 Singh Karan, Gujarat (IN); Sunil Aug. 5, 2002 (IN). ... 697/MUM/2002 Sadanand, Gujarat (IN); Vinod Kumar Jan. 22, 2003 (IN)................................... 80/MUM/2003 Gupta, Gujarat (IN) Jan. 22, 2003 (IN)................................... 82/MUM/2003 Correspondence Address: Publication Classification HEDMAN & COSTIGAN P.C. (51) Int. Cl. 1185 AVENUE OF THE AMERICAS A6IK 9/22 (2006.01) NEW YORK, NY 10036 (US) (52) U.S. Cl. .............................................................. 424/468 (22) Filed: May 19, 2005 A dosage form comprising of a high dose, high Solubility active ingredient as modified release and a low dose active ingredient as immediate release where the weight ratio of Related U.S. Application Data immediate release active ingredient and modified release active ingredient is from 1:10 to 1:15000 and the weight of (63) Continuation-in-part of application No. 10/630,446, modified release active ingredient per unit is from 500 mg to filed on Jul. 29, 2003. 1500 mg, a process for preparing the dosage form. Patent Application Publication Feb. 2, 2006 Sheet 1 of 10 US 2006/0024.365A1 FIGURE 1 FIGURE 2 FIGURE 3 Patent Application Publication Feb. 2, 2006 Sheet 2 of 10 US 2006/0024.365A1 FIGURE 4 (a) 7 FIGURE 4 (b) Patent Application Publication Feb. 2, 2006 Sheet 3 of 10 US 2006/0024.365 A1 FIGURE 5 100 ov -- 60 40 20 C 2 4.
    [Show full text]
  • Composition Colicon ® Tablet: Each Tablet Contains Dicycloverine Hydrochloride BP 10 Mg
    Composition Colicon ® Tablet: Each tablet contains Dicycloverine Hydrochloride BP 10 mg. Colicon ® Syrup: Each 5 ml syrup contains Dicycloverine Hydrochloride BP 10 mg. Colicon ® Injection: Each 2 ml ampoule contains Dicycloverine Hydrochloride BP 20 mg. Description Colicon ® (Dicycloverine Hydrochloride) is an antispasmodic and anticholinergic (antimuscarinic) agent. Colicon ® relieves smooth muscle spasm of the gastrointestinal tract, urinary bladder & ureter. It works at specific receptors, called cholinergic (or muscarinic) receptors, located on the involuntary muscle in the walls of the gut. As antispasmodic drug Colicon ® causes the gut muscle to relax, relieving the pain of colic produced by gut muscle contraction and spasm. Also it has direct musculotropic action. Indication and usage Irritable bowel syndrome (Diarrhea Predominant) Infantile colic GIT spasm Diverticulitis Abdominal colic Diarrhea Dysentery Dosage and administration Adults : 10 to 20 mg three to four times a day. Maximum recommended oral dose is 160 mg daily in divided dose. Children : Children over 6 months of age- 5 to 10 mg three times a day. IM injection: Usual recommended injectable dose is 80 mg daily by IM route in 4 divided dose. Side-Effects Insomnia, headache, weakness, confusion, increased ocular tension, urinary hesitancy, palpitations etc. Precaution Use with caution in patients with autonomic neuropathy, hepatic or renal disease, ulcerative colitis, coronary heart disease, congestive heart failure, cardiac tachyarrhythmia, known or suspected prostatic hypertrophy. Contraindication Obstructive uropathy Obstruction disorder in GIT Severe ulcerative colitis Unstable cardiovascular status in acute hemorrhage Glucoma Myasthenia gravis Patients with hypersensitivity to dicycloverine hydrochloride Infants less than 6 months of age Use in Pregnancy and Lactation Pregnancy Category B.
    [Show full text]
  • Partial Agreement in the Social and Public Health Field
    COUNCIL OF EUROPE COMMITTEE OF MINISTERS (PARTIAL AGREEMENT IN THE SOCIAL AND PUBLIC HEALTH FIELD) RESOLUTION AP (88) 2 ON THE CLASSIFICATION OF MEDICINES WHICH ARE OBTAINABLE ONLY ON MEDICAL PRESCRIPTION (Adopted by the Committee of Ministers on 22 September 1988 at the 419th meeting of the Ministers' Deputies, and superseding Resolution AP (82) 2) AND APPENDIX I Alphabetical list of medicines adopted by the Public Health Committee (Partial Agreement) updated to 1 July 1988 APPENDIX II Pharmaco-therapeutic classification of medicines appearing in the alphabetical list in Appendix I updated to 1 July 1988 RESOLUTION AP (88) 2 ON THE CLASSIFICATION OF MEDICINES WHICH ARE OBTAINABLE ONLY ON MEDICAL PRESCRIPTION (superseding Resolution AP (82) 2) (Adopted by the Committee of Ministers on 22 September 1988 at the 419th meeting of the Ministers' Deputies) The Representatives on the Committee of Ministers of Belgium, France, the Federal Republic of Germany, Italy, Luxembourg, the Netherlands and the United Kingdom of Great Britain and Northern Ireland, these states being parties to the Partial Agreement in the social and public health field, and the Representatives of Austria, Denmark, Ireland, Spain and Switzerland, states which have participated in the public health activities carried out within the above-mentioned Partial Agreement since 1 October 1974, 2 April 1968, 23 September 1969, 21 April 1988 and 5 May 1964, respectively, Considering that the aim of the Council of Europe is to achieve greater unity between its members and that this
    [Show full text]
  • Quality Issues in Caring for Older People
    Doctoral Thesis - Tesis Doctoral Quality issues in caring for older people: • Appropriateness of transition from long-term care facilities to acute hospital care • Potentially inappropriate medication: development of a European list Anna Renom Guiteras Prof. Gabriele Meyer Prof. Ramón Miralles Basseda Martin Luther University Halle-Wittenberg Universitat Autònoma de Barcelona Halle (Saale) & Barcelona, Catalonia University of Witten/Herdecke Spain Witten Germany Programa de doctorat en Medicina Departament de Medicina, Facultat de Medicina Universitat Autònoma de Barcelona Barcelona, 2015 13 Contents 15 1. Introduction • Research context • Background of the research topics • Pesetaio of the ailes 23 2. Summary and discussion of the results 31 3. Conclusions 37 4. References 47 5. Articles • Article 1: Renom-Guiteras A, Uhrenfeldt L, Meyer G, Mann E. Assessment tools for determining appropriateness of admission to acute care of persons transferred from long-term care facilities: a systematic review. BMC Geriatr. 2014;14:80 • Article 2: Renom-Guiteras A, Meyer G, Thürmann PA. The EU(7)-PIM list: a list of potentially inappropriate medications for older people consented by experts from seven European countries. Eur J Clin Pharmacol. 2015;71(7):861-75 77 6. Annexes • Annex 1.1 (article 1) - Additional file 1: Studies dealing with assessment tools for determining appropriateness of hospital admissions among residents of LTC facilities. • Annex 1.2 (article 1) - Additional file 2: Characteristics of the assessment tools for determining appropriateness of hospital admissions among residents of LTC facilities. • Annex 2.1 (article 2) - Appendix 1: Complete EU(7)-PIM list • Annex 2.2 (article 2) - Appendix 2: Questionable Potentially Inappropriate Medications (Questionable PIM): results of the Delphi survey.
    [Show full text]
  • NVA237 / Glycopyrronium Bromide Multinational, Multi-Database Drug
    Quantitative Safety & Epidemiology NVA237 / Glycopyrronium bromide Non-interventional Final Study Report NVA237A2401T Multinational, multi-database drug utilization study of inhaled NVA237 in Europe Author Document Status Final Date of final version 28 April 2016 of the study report EU PAS register ENCEPP/SDPP/4845 number Property of Novartis Confidential May not be used, divulged, published or otherwise disclosed without the consent of Novartis NIS Report Template Version 2.0 August-13-2014 Novartis Confidential Page 2 Non-interventional study report NVA237A/Seebri® Breezhaler®/CNVA237A2401T PASS information Title Multinational, multi-database drug utilization study of inhaled NVA237 in Europe –Final Study Report Version identifier of the Version 1.0 final study report Date of last version of 28 April 2016 the final study report EU PAS register number ENCEPP/SDPP/4845 Active substance Glycopyrronium bromide (R03BB06) Medicinal product Seebri®Breezhaler® / Tovanor®Breezhaler® / Enurev®Breezhaler® Product reference NVA237 Procedure number SeebriBreezhaler: EMEA/H/C/0002430 TovanorBreezhaler: EMEA/H/C/0002690 EnurevBreezhaler: EMEA/H/C0002691 Marketing authorization Novartis Europharm Ltd holder Frimley Business Park Camberley GU16 7SR United Kingdom Joint PASS No Research question and In the context of the NVA237 marketing authorization objectives application, the Committee for Medicinal Products for Human Use (CHMP) recommended conditions for marketing authorization and product information and suggested to conduct a post-authorization
    [Show full text]
  • The Use of Stems in the Selection of International Nonproprietary Names (INN) for Pharmaceutical Substances
    WHO/PSM/QSM/2006.3 The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances 2006 Programme on International Nonproprietary Names (INN) Quality Assurance and Safety: Medicines Medicines Policy and Standards The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 © World Health Organization 2006 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
    [Show full text]
  • 1. What Panadol Night Does 2. Check Before You Take Panadol Night
    GSK LOCisresponsibletoapprovethechangedocumentation, artworkbrief and finalartwork,ensuringthatitisaccurate,consistent complete. GSK MarketisresponsibletoadviseSDCwhenchanges GSK SDCisresponsibleforsitetechnicalrequirements Storage conditions andShelfLife Formulation, Tablet embossing, Formulation, Tablet IMPORTANT required impactthefollowing: and pre-presssuitability. Local approversmustensurethattrademarkand NOTE TO MARKET NOTE TO copyright statementsincludedinthebrief comply withguidanceprovidedby Legal: Global Trade Marks. Legal: GlobalTrade PATIENT INFORMATION LEAFLET 2. Check before you take Panadol Night Do not take Panadol Night: • if you have ever had an allergic reaction to paracetamol, diphenhydramine hydrochloride or to any of the other ingredients (listed in Section 6) • if you have porphyria (too much of the pigment called porphyrin which may discolour the urine) • if you have taken another medicine containing paracetamol in the last 4 hours. Contains paracetamol. Do not take with any other antihistamine-containing products, including those used Night on your skin or in cough and cold medicines. Paracetamol + Diphenhydramine Ask your doctor before you take this medicine: Please read right through this leaflet before you start using this medicine. • if you have liver or kidney problems, including alcoholic liver disease, are This medicine is available without prescription, but you still need to use underweight or malnourished or regularly drink alcohol. You may need to avoid Panadol Night carefully to get the best results from them. using this product altogether or limit the amount of paracetamol that you take. • Keep this leaflet you may need to read it again. • if you have epilepsy, or seizure disorders • If you have any questions, or if there is anything you do not understand, • if you have an obstruction in your stomach or gut (for example, because of an ulcer) ask your pharmacist.
    [Show full text]