Profile Profile Profile Uses and Administration Adverse Effects

Total Page:16

File Type:pdf, Size:1020Kb

Profile Profile Profile Uses and Administration Adverse Effects 1464 Cardiovascular Oxprenolol plasma concentrations in the newborn ranged injection of 4250, 6400, or 8500 units for a further 10 to 20 from 0 to 0.186 nanomoles/mL during the first 24 hours of days. life. The concentrations of oxprenolol in breast milk 3 to 6 References. days after delivery ranged from 0 to 1.342 nanomoles/mL, L Frampton JE, Faulds D. Parmparin: a review of its pharmacology, and and the milk to plasma concentration ratio was 0.45: I. clinical application in the prevention and treatment of thromboembolic Based on the highest milk concentration seen it was calcu­ and other vascular disorders, Drugs 1994; 47: 652-76. 2. McKeage K, Keating GM. Parnaparin: a review of its use in the lated that a breast-fed infant could receive, at a maximum, management of venous thromboembolism, chronic venous disease and a daily dose at least 60 times less than an average adult other vascular disorders. Drugs 2008; 68: 105-22. daily dose (240 mg daily) for hypertension. In another study2 in 12 women given oxprenolol, mean milk to Inflammatory bowel disease, Oral parnaparin, formu­ plasma concentration ratios were 0.21:1 to 0.43: I, depend­ lated for colonic release, has been investigatedL2 in the ing on dose. Pamiteplase is a thrombolytic related to alteplase (p. 1296.3) management of patients with mild to moderate ulcerative I. Sioufi A, et al. Oxprenolul placental transfer, plasma concentrations in that has been used in acute myocardial infarction. It has colitis (p. 1811.3). See also under Low-molecular-weight newborns and passage into breast milk. Br J Clin Pharmacal 1984; 18: been investigated in ischaemic stroke. Heparins, p. 1426.2. 453-6. I. Pastnrelli L, et al. Oral, colonic-release low-molecular-weight heparin: 2. Fidler J, et al. Excretion of oxprenolol and timolol in breast milk. Br 1 an initial of Parnaparin-MMX for the treatment of mild-to- Obstet Gynaecol 1983; 90: 961-5. P epa a ons 28: r r ti . .......................... ...... ... ......... ....................... moderate ulcerative colitis. Aliment Pharmacol Ther 2008; . .. 581-8. Proprietary Preparations (details are given in Volume B) r ti 2. Celasco G, et a!. Clinical trial: oral colon-rcle<Jse parnaparin sodium �r.�p? ? ".n.� tablets (CB-Ol-05 MMX) for active left-sided ulcerative colitis. Aliment Single-ingredient Prepara�ons. Jp n: Solinaset. Proprietary Preparations (details are given in Volume B) Pharmacal Ther 2010; 31: 375-86. Single-ingredient Preparations. Austral. : Corbeton; Canad.: Tra­ sicort; Fr.: Trasicort; Ger.: Trasicort; Gr. : Drisoftaline; Trasicor; ........... ............ .. ...... ...... ...................... Vrachor; Zetonium; Hong Kong: Corbetont; Neth.: Trasicort; Proprietary Preparations (details are given in Volume B) Spain: Trasicort; Switz.: Slow-Trasicort; Trasicort; Turk. : Trasi­ cort; UK: Slow-Trasicor; Trasicor. Single-ingredient Prepara�ons, China: Fluxum (10"#/l.Lf:); Cz.: Fluxum; Gr.: Thromboparin; Tromboparin; Hung.: Fluxum; Multi-ingredient Preparations. Fr.: Trasitensinet; Gr.: Trasiten­ India: Fluxum; Indon.: Fluxum; Ital.: Fluxum; Zoltar; Mex. : sin; Ital.: Trasitensin; Spain: Trasitensin; Switz.: Slow-Trasiten­ Fluxum; Pol. : Fluxumt; Port.: Fluxum; Tromboparin; Turk.: sine; UK: Trasidrext. Fluxum; Venez. : Tromboparin. Pharmacopoeial Preparations BP 2014: Oxprenolol Tablets; USP 36: Oxprenolol Hydrochloride Extended-release Tablets; Penbutolol Sulfate (BANM, USAN, r/NNMJ ® Oxprenolol Hydrochloride Tablets. NOTE. The names Dermorizin, Palfadin, Panholeata, Hoe·-39-.$93d; Panpyotin, Parutox, and Youtetine have been used as trade marks for pantethine. Hemisulfate: Oxyfedrine Hydrochloride IBANM r/NNMJ P�nbutolol, • sulfato de: Pe,nbutc:ioi Pharmacopoeias. In Jp n. sulfas; Penbt;t. oioho suifutas; PeQbvt(Jicl'isu'lta.otti; D-563; Hidrodoruro de oxifedrina; Oxifedrina, ni<:lrodoruro lolsulfat: . Penbutotol·szulfat;. Oxifedrini Ch,oridum; Oxyfedrim;, (hlorhydrate. d'; de; . ronbfla Cynb(j)at. Oxyfedr!ni f-lydro<;;hloridum; OKcwrpegpwHa lwgpOXJlop�A- Pantethine, a derivative of pantothenic acid (p. 2085.2), is a (5)-.1 -tert- Butylarnino-3· (2-cyc!Opentyi pbenoxy)propan-2�ot 3-(13-Hydroxy,a- methylphenethylamino •methoxypro­ l · )-3' component of coenzyme A. It is used as a lipid regulating piophenone hyqrochioride. drug in the treatment of hyperlipidaemias (p. 1248.1). The C ,QH,N03,HCI�349.9 - usual oral dose is 0.6 to 1.2 g daily in divided doses. C45 - - - 'i5687�4 l-"9 Pantethine is also used as a nutritional supplement. hydrochioride/, ATC� .. COlDX03. P epa a ons r r ti..... ........... ........... ATC Vet � !...ICO WXOJ . Proprietary Preparations (details are given in Volume B) UN!! ----- 63CF9XK7DA (see p. vii), Jpn, and US. Single-ingredient Preparations. Ital. : Pantetina; Jp n: Pantosin. Ph. Eur. 8: (Penbutolol Sulfate). A white or almost white, Profile crystalline powder. Slightly soluble in water; practically Oxyfedrine hydrochloride has vasodilator properties and Parnaparin Sodium (BAN, r/NNJ insoluble in cyclohexane; soluble in methyl alcohol. Protect has been used in angina pectoris, and myocardial infarction. from light. It is metabolised to phenylpropanolamine (p. 1674. 1). OP-2 1-23; ParnaparHniqat;lum; Parna!J'irin-Natr!Um; Parna­ USP 36: (Penbutolol Sulfate). A white to off-white, parin sodna sUI; · Parnaparin S<Jdyum; Parnaparina s6dica: crystalline powder. Soluble in water and in methyl alcohol. Preparations Parnapariqe . Sodiqui); Parnaparinnatrlum; . .. Parnaparin' Store in airtight containers. Protect from light. rlatrium:Pamaparinp natrio druska; Parni\parinum- natrlcum; Proprietary Preparations (details are given in Volume B) napHanapwl Ha Tpl!lii. Single-ingredient Preparations. India: lldamen; Philipp.: llda· Uses and Administration .CAS ·-- 904 /-08- 1. men; Port. : Ildamen. Penbutolol is a non-cardioselective beta blocker (p. 1316.3). ATC -� E!OIABO?. A7CVer -·-·Q80 7A807. It is reported to possess smne intrinsic sympathomimetic activity but lacks membrane-stabilising properties. Pamabrom (USANJ Pharmacopoeias. In Eur. (see p. vii) and Jp n. Penbutolol is used as the sulfate in the management of Ph. Eur. 8: (Parnaparin Sodium). It is prepared by hydrogen hypertension (p. 1251.1). It may also be used in cardiac peroxide and cupric salt depolymerisation of heparin disorders such as angina pectoris (p. 1254.3). obtained from the intestinal mucosa of pigs and cattle. The In hypertension penbutolol sulfate is given in an initial majority of the components have a 2-0-sulfo-a-L­ oral dose of 20 mg daily; the dose may be increased if idopyranosuronic acid structure at the non-reducing end necessary to 40 to 80mg daily. Maximum antihypertensive and a 2-N,6-0-disulfo-n-glucosamine structure at the efficacy is reported to occur within 2 weeks in patients given a dose of 20 mg daily but about 4 weeks may be required for Pharmacopoeias. In US. reducing end of their chain. The mass-average molecular mass ranges between 4000 and 6000, with a characteristic rnaximum effect in patients given lOmg daily. value of about 5000. The mass percentage of chains lower Penbutolol sulfate has also been used in similar doses in Profile than 3000 is not more than 30%. The degree of sulfation is cardiac disorders such as angina. Pamabrom is a weak diuretic that has been used, with 2.0 to 2.6 per disaccharide unit. Potency is not less than analgesics and antihistamines, for symptomatic relief of the 7 5 units and not more than II0 units of anti-factor Xa Adverse Effects, Treatment, and Precautions premenstrual syndrome. activity per mg with reference to the dried substance, and As for Beta Blockers, p. 1319.1. the ratio of anti-factor Xa activity to anti-factor ITa (antithrombin) activity is between 1.5 and 3.0. �r�p?r?ti()_n.� ..................................... Proprietary Preparations (details are given in Volume B) Profile The interactions associated with beta blockers are discussed Single-ingredient Preparations. Canad.: Diurex; USA: Maximum on p. 1321.2. Strength Aqua-Ban. Parnaparin sodium is a low-molecular-weight heparin (p. 142 6.1) with anticoagulant activity used in the Multi-ingredient Preparations. Arg.: Everfem; Canad.: Extra prevention of postoperative venous thromboembolism Pharmacokinetics Strength Multi-Symptom PMS Relief; Midol PMS; Multi-Symp­ (p. 1274. 1); it has also been used in other thromboembolic Penbutolol is readily absorbed from the gastrointestinal tract tom PMS Relief; Painaid PMF; Pamprin; Relievol PMS; Tylenol disorders. For general surgical procedures it is given by and peak plasma concentrations occur about I to 3 hours Menstrual; Chile: Dolo-Esan Periodo Menstrual; Kitadol Peri­ subcutaneous injection in a dose of 3200 units 2 hours after a dose. Penbutolol is 80 to 98% bound to plasma ado Menstrual; Minfaden; Panagesic Periodo Menstrual; Pre­ before the procedure, followed by 3200 units once daily for dual; Sentual Periodo; Tapsin Periodo Menstrual; Tapsin Peri­ proteins. It has a high lipid solubility. It is extensively 7 days or until the patient is fully ambulant. For higher risk ado Premenstrual; China: Ai Jia (_)t{i); Malaysia: Panadol metabolised in the liver by hydroxylation and glucuronida­ Menstn1al; Mex. : Femsedin Kutz; Rus.: Femizol (<l>eMJIJon); Sin­ or orthopaedic patients a dose of 42 50units is given 12 tion, the metabolites being excreted in the urine with only gapore: Panadol Menstrual; USA: Lurline PMS; Midol Pre-Men­ hours before the procedure, followed by 4250 units 12 small amounts of unchanged penbutolol. A plasma strual Syndrome; Midol Teen Formula; Painaid PMF Premen­ hours postoperatively and then once daily for 10 days. elimination half·life of about 20 hours has been reported. strual Formula; Pamprin; Premsyn PMS; Womens Tylenol For treatment of thromboembolism a dose of 6400 units Multi-Symptom Menstrual Relief. is given by subcutaneous injection twice daily for 7 to 10 Renal impairment. Glucuronidation was considered more days. This may be followed by a once-daily subcutaneous prominent than hydroxylation in the _metabolism of All cross-references refer to entries in Volume A .
Recommended publications
  • Protective Role of Parnaparin in Reducing Systemic Inflammation and Atherosclerotic Plaque Formation in Apoe-/- Mice
    INTERNATIONAL JOURNAL OF MoleCular MEDICine 27: 561-565, 2011 Protective role of parnaparin in reducing systemic inflammation and atherosclerotic plaque formation in ApoE-/- mice MARCO ArtiCO1, RACHELE RIGANÒ2, BRiGitta Buttari2, ELisabetta PROFUMO2, BRUNELLA Ionta1, sANDRO BOsCO3, MANUELA RASILE2, ENRiCA BiANCHi1, MOiRA BRUNO1 and LORENZO FUMAGALLI4 1Department of sensory Organs, University of Rome ‘sapienza’; 2Department of Infectious, Parasitic and Immuno-mediated Diseases of the superior Health institute of Rome; Departments of 3Experimental Medicine and 4Anatomical, Histological, Medico-legal and Locomotor system sciences, University of Rome ‘sapienza’, Rome, italy Received November 15, 2010; Accepted December 29, 2010 DOi: 10.3892/ijmm.2011.606 Abstract. Atherosclerosis is a degenerative disease whose Unstable atherosclerotic plaques are vulnerable to rupture, and role in the onset and development of cardiovascular patholo- usually contain an increased accumulation of inflammatory gies and complications is of importance. Due to its silent but cells, particularly macrophages and T-lymphocytes secreting progressive development, and considering the endothelial, growth factors (EGF and bFGF) and pro-inflammatory immunological and inflammatory processes that are involved cytokines (4-6). Rather than remaining localized within in its clinical course, this still relatively unknown pathological the ‘culprit’ plaque, the inflammatory components spread condition has been and continues to be a matter of investiga- throughout the peripheral blood. Several studies suggest an tion worldwide. Our experience with previous studies on association between pro-inflammatory cytokines (TNFα, IL-6, atherosclerosis led us to investigate the possible influence IL-1) in the peripheral blood of patients with atherosclerosis of a low molecular weight heparin (LMWH) – Parnaparin® and the clinical outcome or stage of atherosclerotic disease on the development and clinical course of atherosclerosis in (7-11).
    [Show full text]
  • 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
    [Show full text]
  • Patent Application Publication ( 10 ) Pub . No . : US 2019 / 0192440 A1
    US 20190192440A1 (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2019 /0192440 A1 LI (43 ) Pub . Date : Jun . 27 , 2019 ( 54 ) ORAL DRUG DOSAGE FORM COMPRISING Publication Classification DRUG IN THE FORM OF NANOPARTICLES (51 ) Int . CI. A61K 9 / 20 (2006 .01 ) ( 71 ) Applicant: Triastek , Inc. , Nanjing ( CN ) A61K 9 /00 ( 2006 . 01) A61K 31/ 192 ( 2006 .01 ) (72 ) Inventor : Xiaoling LI , Dublin , CA (US ) A61K 9 / 24 ( 2006 .01 ) ( 52 ) U . S . CI. ( 21 ) Appl. No. : 16 /289 ,499 CPC . .. .. A61K 9 /2031 (2013 . 01 ) ; A61K 9 /0065 ( 22 ) Filed : Feb . 28 , 2019 (2013 .01 ) ; A61K 9 / 209 ( 2013 .01 ) ; A61K 9 /2027 ( 2013 .01 ) ; A61K 31/ 192 ( 2013. 01 ) ; Related U . S . Application Data A61K 9 /2072 ( 2013 .01 ) (63 ) Continuation of application No. 16 /028 ,305 , filed on Jul. 5 , 2018 , now Pat . No . 10 , 258 ,575 , which is a (57 ) ABSTRACT continuation of application No . 15 / 173 ,596 , filed on The present disclosure provides a stable solid pharmaceuti Jun . 3 , 2016 . cal dosage form for oral administration . The dosage form (60 ) Provisional application No . 62 /313 ,092 , filed on Mar. includes a substrate that forms at least one compartment and 24 , 2016 , provisional application No . 62 / 296 , 087 , a drug content loaded into the compartment. The dosage filed on Feb . 17 , 2016 , provisional application No . form is so designed that the active pharmaceutical ingredient 62 / 170, 645 , filed on Jun . 3 , 2015 . of the drug content is released in a controlled manner. Patent Application Publication Jun . 27 , 2019 Sheet 1 of 20 US 2019 /0192440 A1 FIG .
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2010/0209499 A1 Cumming Et Al
    US 2010O209499A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/0209499 A1 Cumming et al. (43) Pub. Date: Aug. 19, 2010 (54) SOLID ORAL DOSAGE FORM CONTAINING A 6LX 3L/727 (2006.01) AN ENHANCER A638/24 (2006.01) A638/28 (2006.01) (76) Inventors: Kenneth I. Cumming, Dublin (IE): A638/08 (2006.01) Zebunnissa Ramtoola, Dublin (IE) A6II 3/66 (2006.01) A638/3 (2006.01) Correspondence Address: A6IR 9/22 (2006.01) MYERS BIGELSIBLEY & SAJOVEC A 6LX 9/52 (2006.01) POBOX37428 A6IP 43/00 (2006.01) RALEIGH, NC 27627 (US) (52) U.S. Cl. ............. 424/456; 514/784: 514/54: 514/12: (21) Appl. No.: 12/768,008 514/2: 514/56; 514/8: 514/3: 514/15: 514/108; 514/11; 424/468; 424/457 (22) Filed: Apr. 27, 2010 (57) ABSTRACT Related U.S. Application Data The invention relates to a solid oral dosage form comprising (63) Continuation of application No. 12/172,707, filed on a pharmaceutically active ingredient in combination with an Jul. 14, 2008. enhancer which enhances the bioavailability and/or the absorption of the active ingredient. Accordingly, a Solid oral Publication Classification dosage form comprises a drug and an enhancer wherein the (51) Int. C. enhancer is a medium chain fatty acid ester, ether or salt or a A6 IK 9/64 (2006.01) derivative of a medium chain fatty acid, which is, preferably, A6 IK 47/12 (2006.01) Solid at room temperature and which has a carbon chain A 6LX 3L/75 (2006.01) length of from 6 to 20 carbonatoms.
    [Show full text]
  • (12) Patent Application Publication (10) Pub
    US 2002006 1835A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2002/0061835A1 Kensey (43) Pub. Date: May 23, 2002 (54) IN VIVO DELIVERY METHODS AND which is a continuation-in-part of application No. COMPOSITIONS 08/919,906, filed on Aug. 28, 1997, now patented. (76) Inventor: Kenneth R. Kensey, Malvern, PA (US) Publication Classification Correspondence Address: (51) Int. Cl. ............................. A61K 31/00; A61 B 5/00 CAESAR, RIVISE, BERNSTEIN, (52) U.S. Cl. ................................................. 514/1; 600/309 COHEN & POKOTILOW, LTD. 12TH FLOOR, SEVEN PENN CENTER (57) ABSTRACT 1635 MARKET STREET Various methods are provided for determining and utilizing PHILADELPHIA, PA 19103-2212 (US) the Viscosity of the circulating blood of a living being over Appl. No.: 09/828,761 a range of Shear rates for diagnostics and treatment, Such as (21) detecting/reducing blood Viscosity, work of the heart, con (22) Filed: Apr. 9, 2001 tractility of the heart, for detecting/reducing the Surface tension of the blood, for detecting plasma Viscosity, for Related U.S. Application Data explaining/countering endothelial cell dysfunction, for pro Viding high and low blood vessel wall Shear StreSS data, red (63) Continuation-in-part of application No. 09/727,950, blood cell deformability data, lubricity of blood, and for filed on Dec. 1, 2000, which is a continuation-in-part treating different ailments Such as peripheral arterial disease of application No. 09/628,401, filed on Aug. 1, 2000, in combination with administering to a living being at least which is a continuation-in-part of application No. one pharmaceutically acceptable agent.
    [Show full text]
  • Application Note 747014H HPLC Ana Llys Is of Th E M Ol Ecul Ar M Ass of L Ow-Mlmolecul Ar-Mhmass Hepari Ns Using the Method Described in the European Pharmacopoeia
    Application Note 747014H HPLC ana llys is o f the Mo lecul ar M ass of L ow-MlMolecu lar-MHMass Hepar ins using the method described in the European Pharmacopoeia Introduction Heparins are a class of mucopolysaccharide obtained from the porcine small intestine and is widely used in the pharmaceutical field as an anticlotting drug for the treatment and prevention of thromboembolism, treatment of disseminated intravascular coagulation syndrome, and as an anti-blood clilotting agent when using extracorporeal bloo d ciliirculating apparatus such as bloo d dia lys isand artific ial heart/lung. Low-molecular-mass heparin is produced by enzymatic treatment and chemical manipulation of heparin and is used as an anticlotting drug similarly to heparin due to its more predictable pharmacokinetics. Low-molecular-mass heparin is classified as parnaparin, dalteparin, enoxaparin etc., by decomposition method and molecular weight distribution. In the European Pharmacopoeia 8th Edition (EP), the molecular weight measurement method is defined in the pharmaceutical products article of low-molecular-mass heparin, the average molecular weight and molecular weight distribution are also defined in the pharmaceutical article for low- molecular-mass heparin (sodium) and low-molecular-mass heparin (calcium) 1)-7). Size exclusion chromatography (SEC) combined with a UV-Visible and Refractive Index detection is defined as the measurement method. In the analytical method, a molecular weight calibration curve using low- molecular-mass heparin is created using low-molecular-mass heparin as the reference sample. In common molecular weight measurement methods using SEC, a calibration curve is created from the retention volume and molecular weight; this common method is used for oligomers and polymers where the molecular weight has already been determined and used as a standard sample.
    [Show full text]
  • WHO Drug Information Vol. 04, No. 4, 1990
    WHO DRUG INFORMATION VOLUME 4 • NUMBER 4 • 1990 PROPOSED INN LIST 64 INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES WORLD HEALTH ORGANIZATION • GENEVA WHO Drug Information WHO Drug Information provides an cerned with the rational use of overview of topics relating to drug drugs. In effect, the journal seeks development and regulation that to relate regulatory activity to are of current relevance and im­ therapeutic practice. It also aims to portance, and will include the lists provide an open forum for debate. of proposed and recommended In­ Invited contributions will portray a ternational Nonproprietary Names variety of viewpoints on matters of for Pharmaceutical Substances general policy with the aim of (INN). Its contents reflect, but do stimulating discussion not only in not present, WHO policies and ac­ these columns but wherever rel­ tivities and they embrace socio­ evant decisions on this subject economic as well as technical mat­ have to be taken. ters. WHO Drug Information is pub­ The objective is to bring issues that lished 4 times a year in English are of primary concern to drug and French. regulators and pharmaceutical manufacturers to the attention of a Annual subscription: Sw.fr. 50.— wide audience of health profes­ Airmail rate: Sw.fr. 60.— sionals and policy-makers con­ Price per copy: Sw.fr. 15.— © World Health Organization 1990 Authors alone are responsible for views expressed Publications of the World Health Organization in signed contributions. enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal The mention of specific companies or of certain Copyright Convention. For rights of reproduc­ manufacturers' products does not imply that they are tion or translation, in part or in toto, applica­ endorsed or recommended by the World Health tion should be made to: Chief, Office of Organization in preference to others of a similar na­ Publications, World Health Organization, ture which are not mentioned.
    [Show full text]
  • Stembook 2018.Pdf
    The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
    [Show full text]
  • A Abacavir Abacavirum Abakaviiri Abagovomab Abagovomabum
    A abacavir abacavirum abakaviiri abagovomab abagovomabum abagovomabi abamectin abamectinum abamektiini abametapir abametapirum abametapiiri abanoquil abanoquilum abanokiili abaperidone abaperidonum abaperidoni abarelix abarelixum abareliksi abatacept abataceptum abatasepti abciximab abciximabum absiksimabi abecarnil abecarnilum abekarniili abediterol abediterolum abediteroli abetimus abetimusum abetimuusi abexinostat abexinostatum abeksinostaatti abicipar pegol abiciparum pegolum abisipaaripegoli abiraterone abirateronum abirateroni abitesartan abitesartanum abitesartaani ablukast ablukastum ablukasti abrilumab abrilumabum abrilumabi abrineurin abrineurinum abrineuriini abunidazol abunidazolum abunidatsoli acadesine acadesinum akadesiini acamprosate acamprosatum akamprosaatti acarbose acarbosum akarboosi acebrochol acebrocholum asebrokoli aceburic acid acidum aceburicum asebuurihappo acebutolol acebutololum asebutololi acecainide acecainidum asekainidi acecarbromal acecarbromalum asekarbromaali aceclidine aceclidinum aseklidiini aceclofenac aceclofenacum aseklofenaakki acedapsone acedapsonum asedapsoni acediasulfone sodium acediasulfonum natricum asediasulfoninatrium acefluranol acefluranolum asefluranoli acefurtiamine acefurtiaminum asefurtiamiini acefylline clofibrol acefyllinum clofibrolum asefylliiniklofibroli acefylline piperazine acefyllinum piperazinum asefylliinipiperatsiini aceglatone aceglatonum aseglatoni aceglutamide aceglutamidum aseglutamidi acemannan acemannanum asemannaani acemetacin acemetacinum asemetasiini aceneuramic
    [Show full text]
  • WO 2014/031398 Al 27 February 2014 (27.02.2014) P O P C T
    (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 WO 2014/031398 Al 27 February 2014 (27.02.2014) P O P C T (51) International Patent Classification: DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, A61L 33/06 (2006.01) A61M 25/01 (2006.01) HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KN, KP, KR, A61L 27/14 (2006.01) A61F 2/82 (2006.01) KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (21) International Application Number: OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, PCT/US20 13/054841 SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, (22) International Filing Date: TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, 14 August 2013 (14.08.2013) ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (26) Publication Language: English GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, (30) Priority Data: UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, 61/684,947 20 August 2012 (20.08.2012) US TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, 61/787,237 15 March 2013 (15.03.2013) US EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, (71) Applicant: TICONA LLC [US/US]; 8040 Dixie High TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, way, Florence, KY 41042 (US).
    [Show full text]
  • International Nonproprietary Names (Inn) for Biological and Biotechnological Substances
    INN Working Document 05.179 Distr.: GENERAL ENGLISH ONLY 15/06/2006 INTERNATIONAL NONPROPRIETARY NAMES (INN) FOR BIOLOGICAL AND BIOTECHNOLOGICAL SUBSTANCES (A REVIEW) Programme on International Nonproprietary Names (INN) Quality Assurance and Safety: Medicines (QSM) Medicines Policy and Standards (PSM) Department CONTENTS 0. INTRODUCTION…………………………………….........................................................................................v 1. PHARMACOLOGICAL CLASSIFICATION OF BIOLOGICAL AND BIOTECHNOLOGICAL SUBSTANCES……………………………………................................1 2. CURRENT STATUS OF EXISTING STEMS OR SYSTEMS FOR BIOLOGICAL AND BIOTECHNOLOGICAL SUBSTANCES…………………….3 2.1 Groups with respective stems ……………………………………………………………………3 2.2 Groups with respective pre-stems………………………………………………………………4 2.3 Groups with INN schemes………………………………………………………………………….4 2.4 Groups without respective stems / pre-stems and without INN schemes…..4 3. GENERAL POLICIES FOR BIOLOGICAL AND BIOTECHNOLOGICAL SUBSTANCES……………………………………………………………………………………………………...5 3.1 General policies for blood products……………………………………………………………5 3.2 General policies for fusion proteins……………………………………………………………5 3.3 General policies for gene therapy products………………………………………………..5 3.4 General policies for glycosylated and non-glycosylated compounds………...6 3.5 General policies for immunoglobulins……………………………………………………….7 3.6 General polices for monoclonal antibodies………………………………………………..7 3.7 General polices for skin substitutes……………………………………………………………9 3.8 General policies for transgenic products……………………………………………………9
    [Show full text]
  • (INN) for Biological and Biotechnological Substances
    WHO/EMP/RHT/TSN/2019.1 International Nonproprietary Names (INN) for biological and biotechnological substances (a review) 2019 WHO/EMP/RHT/TSN/2019.1 International Nonproprietary Names (INN) for biological and biotechnological substances (a review) 2019 International Nonproprietary Names (INN) Programme Technologies Standards and Norms (TSN) Regulation of Medicines and other Health Technologies (RHT) Essential Medicines and Health Products (EMP) International Nonproprietary Names (INN) for biological and biotechnological substances (a review) FORMER DOCUMENT NUMBER: INN Working Document 05.179 © World Health Organization 2019 All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased 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 non-commercial distribution– should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html). 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 and dashed 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.
    [Show full text]