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,reparati ns Bonjigar (EoH)l)KHrap); Entoban (3Hro6aH); Pilex (ITaiilleKc); solutions have a blue or bluish-purple colour. Store in P ?. Ukr.: Bonjigar (EoH,ll)KHrap); Entoban (3HT06aH). airtight containers at a temperature of 2 5 degrees, Proprietary Preparations (details are given in Volume B) excursions permitted between 15 degrees and 30 degrees. Single-ingredient Preparations. Austria: Elaprase; Belg.: Ela­ Protect from light. prase; Canad.: Elaprase; Cz.: Elaprase; Denm.: Elaprase; Fr.: Indian Gooseberry Elaprase; Ger.: Elaprase; Gr.: Elaprase; Hong Kong: Elaprase; Uses and Administration Hung.: Elaprase; Irl. : Elaprase; Israel: Elaprase; Jpn: Elaprase; Malaysia: Elaprase; Neth.: Elaprase; Norw.: Elaprase; NZ: Ela­ On intravenous injection indigo carmine is rapidly excreted, prase; Pol.: Elaprase; Port.: Elaprase; Spain: Elaprase; Swed. : mainly by the kidneys. It has been used in a test of renal Elaprase; Switz.: Elaprase; UK: Elaprase; USA: Elaprase. function, but has largely been replaced by agents that give more precise results. It is used as a marker dye, particularly in urological procedures, when it is given in a usual dose of 40 mg, preferably by intravenous injection but sometimes Ignatia NOTE. The common name myrobalan or myrobalans refers to several unrelated fruit-bearing plant species from the intramuscularly. It has also been used as a marker dye in Eeve de Bean; Song genera Emblica (Emblica officinalis, Emblic Myrobalan or amniocentesis. St :iaint-l'i)nace; ignatia ar:rara; Ignatius Lv Guq; ignqtius' �an. Indian Gooseberry, above), Prunus (P. cerasife ra, Myrobalan Indigo carmine has been used as a blue dye in medicinal preparations but it is relatively unstable. It has also been A TC Herb· ,-- HA09WAS023 Plum), and Terminalia (T. arjuna, Arjun Myrobalan - see investigated as a dye-spray in the detection of colorectal LIN/1 -.o- iNM3M2481K Arjuna, p. 2447.2; T. bellirica - see Beleric Myrobalan, p. 2453.2; and T. chebula see Chebulic Myrobalan, adenomas. It is used as a food colour. - Profile p. 2474.3). Care should be taken to distinguish between them. Adverse Effects and Precautions Ignatia consists of the dried ripe seeds of Strychnos ignatii (S. The name Terminalia has been applied to all the Indigo carmine may cause nausea, vomiting, hypertension, tieute; I. amara) (Loganiaceae). Ignatia contains strychnine myrobalans mentioned above from the Terminalia genus i and bradycardia, and occasionally, hypersensitivity reac­ (p. 2623.2) in higher concentrations than those found in and, again, care should be taken to avoid confusion. Nux Vomica (p. 2573.3), plus similar concentrations of tions such as rashes, pruritus, and bronchoconstriction. Skin Br. includes Phyllanthus Emblica Peri­ brucine, and has been used in herbal tonic preparations and Pharmacopoeias. discoloration may occur after large parenteral doses, carp. as a bitter. particularly in children and underweight patients. BP 2014: (Phyllanthus Emblica Pericarp). The pericarp of Hornoeopathy dried mature fruits of Phyllanthus emblica (E. officina/is). It Hypersensitivity. Cardiac arrest after a dose of indigo car­ Ignatia has been used in homoeopathic medicines under contains not less than 6.0% tannins, expressed as mine 80 mg intravenously resulted in the deaths of 2 the following names: Iamara; Ignatia amara; Ign.; Strychnos pyrogallol, calculated with reference to the dried drug. elderly patients .' Both had a history of asthmatic bronch­ ignatii. itis. A life-threatening anaphylactoid reaction associated with indigo carmine use has also been reported, although the authors commented that such events are rare.2 Proprietary Preparations (details are given in Volume B) The fruits of the Indian Gooseberry, Phyllanthus emblica I. Voiry et al. Deux accidents mortels Jars d'une injection per­ AM, (Emblica officinalis, Mirobalanus embilica) (Euphorbiaceae), operatoire de carmin d'indigo. Ann Med Nancy 1976; 15: 413-19. Multi-ingredient Preparations. Austral.: Nervatona Calm; Nerva­ have traditionally been used in Ayurvedic medicine and are 2. Gousse AE, etal. Life-threatening anaphylactoid reaction associated with indigo carmine intravenous injection. Urology 2000; 56: 508. tona Focus. included in herbal preparations. Homoeopathic Preparations. Austral.: Childrens Sleep; Nervato­ The traditional Ayurvedic medicine triphala is a na Calm; Nervatona Focus; Smoke Eze; Austria: Berberis Cos­ combination of Indian gooseberry, beleric myrobalan Preparations moplext; Ignatia-Homaccord; Klimaktoplant; Mandragora Med (p. 2453.2), and chebulic myrobalan (p. 2474.3). The fruits Pharmacopoeial Preparations Complex; Mastodynon; Nervoheel; Pascofemin; Pasconal; are reputed to contain large amounts of vitamin C, and are USP 36: Indigotindisulfonate Sodium Injection. Relax; Vomitusheel; Canad.: Fibromyalgie; Hylands Gas; also used as a foodstuff. Hylands Insomnia; Kids Calm; Nixotinex; Sedilort; Stress L72t; Stress; Chile: Bioactiv 0; Cz. : Hormeel S; Mastodynon; Vita C­ Rl5 fortet; Vita C-RISt: Ypsiloheel; Fr. : Abbe Chaupitre no 7; lndocyanine Green Anxietum; Boripharm No 3; Dolirelaxt; Dolisedalt; Dolitravelt; Proprietary Preparations (details are given in Volume B) L 72; Lobelia Complexe No 74t; Neurocynesinet; Passiflora Single-ingredient Preparations. Hung.: Vita Jam; Thai.: Com­ Compose; Soludor; Staphysagria Complexe No 92t; Stressdor­ pound Makham Porn. on; Tabacum Compose; Tarentula Complexe No 71; Vinicardt; Zenalia; Ger.: Ambrax; Antimast TNt; Calm valera; Cefaneuro; Multi�ingredient Preparations. Arg.: Recover Whitening; Aus­ Corselect N; Cranio-cyl He-Len-Complex; Gastroplant; Gold­ tral. : Ultra Calm; Fr.: Triphala; Hung.: Herbadict; Munipyrin; tropfen S; Hyperforat Nerve; Klimaktoplant N; Mastodynon; India: Anti Dysp; Flexi-muvt; Malaysia: Bonnisan; Philipp.: Myonasan; Nervoject F; Nervoregin camp; Pascofemin; Pascoli­ Cogent db+; Rus.: Doktor Mom Herbal Cough Lozenges (,[(OK­ brin; Pasconal Nerventropfen; Psychoneuroticum (Rowo-578)t; TOP MoM PacTIITeJlhHhle IIacTHJJKH OT KarnJN); Fitovit (<llHTOBHT); Psychoneuroticum N; Rowo Rytesthin Ro-Plex (Rowo-318); Pilex (ITaiineKc); Travisil (TpasHCHJI); Singapore: Hemoglo; Imu­ Rytesthin; Sedaphint; Sedaselect; Sedativa-Injektopas; Sepia nomet; Septilin; Septilin; Thai.: Couffee Mixture; lyara Ma­ USP 36: (Indocyanine Green). An olive-brown, dark green, camp; Ypsiloheel N; Zincum Revert N; Zincum valerianicum Weang; Ukr.: Alfagin (AJI<j>arHH); Bon-Apetit (ooH-AnnemT); blue-green, dark blue, or black powder. Is odourless or has a camp; Zincum valerianicum-Hevert Nt; Hung.: Hormeel S; Kli­ Bronchomed (EpoHxoMe,IJ;); Doktor Mom Herbal Cough slight odour. It contains not more than 5.0% of sodium Lozenges (,ll;oKTop MoM PacTHTeJihHhie IIacTHJIKH Or KaiiiiDI); Eve makt-Heel; Nervoheel; PSY-Stabil; Neth.: Cerebrum camp; iodide, calculated on the dried basis. Soluble in water and in Care Kep)t; Fitovit (<I>HTOBHT); Imunin (HMM)'HHH)t; lntel­ Echilite; Emvita 11; Hyperilite; Klimaktolan; Mastodynont; methyl alcohol; practically insoluble in most other organic lan (liHTeJIJiaH);(liB Septilin (CeiiTif.TIHH); Travisil (TpasHcJIJI); Trypsi­ Nervival; Nervofleur; Nervoheel; Neurocynesinet; PSY-stabil; solvents. Its solutions are deep emerald-green in colour. pH Rus.: Crataegus-Plus (Kpareryc-Ilmoc); Hormeel SN (fopMenh dan (TpHTICH�an)t. of a 0.5% solution in water is about 6. Its aqueous solutions CH); Klimaktoplan (KnHMaKTOIIJia.H); Mastodynon (Macro.n;�-moH); are stable for about 8 hours. Store at a temperature of 25 Uspokoi (YcrroKoii); Valeriana-Plus (BarrepmlHa-Ilmoc); Switz.: Ignatia-Homaccord; Menosant; Nervoheel; Vomitusheel; Thai.: degrees, excursions permitted between 15 degrees and 30 Mastodynont; Ukr. : Aurocard (AypoKapJJ;); Homvio-Nervin degrees. (XoMBHo-HepBHH); Klimaktoplan N (KnHMaiiTormaH H); Mastody­ non (MacTO.UHHOH); USA: Preferred Remedies Fatigue; Preferred Uses and Administration Remedies Sleep. Indocyanine green is an indicator dye used for assessing cardiac output and liver function, and for examining the choroidal vasculature in ophthalmic angiography. It is also used to assess blood flow and haemodynamics in various organs including the liver. The usual dose for cardiac assessment is 5 mg injected rapidly via a cardiac catheter. A suggested dose for children is 2.5 mg, and for infants 1.25 mg. Several doses need to be BP 2014: (Berberis Aristata). The dried cut stem of Berberis given obtain a number of dilution curves. However, the to aristata. It contains not less than 1.4% of berberine total dose should not exceed 2 mg/kg. calculated with reference to the dried material. The usual dose of indocyanine green for testing liver Protect from moisture. function is 500 micrograms/kg given intravenously. NOTE. The name Cerulein has been applied to Ceruletide Doses of indocyanine green Profile (p. 2473.3). Administration in children. for cardiac assessment in infants and children are given Although the name FD & C Blue No.2 is widely used to The stem and root bark of the Indian barberry (Berberis under Uses and Administration, above. denote indigo carmine it is actually defined as being mainly aristata (Berberidaceae)) is used orally in herbal medicine indigo carmine with smaller amounts of the disodium salt of mainly for fevers, and in hepatic and gastrointestinal Diagnostic use. Indocyanine green has been used to assess 2-(I,3 -dihydro-3 -oxo-7 -sulfa-2H-indo!- 2 -ylidene)- 2, 3- disorders and topically for skin lesions. The fruit and other blood flow to various organs and in other haemodynamic
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    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.
  • WO 2017/011544 Al 19 January 2017 (19.01.2017) P O PCT

    WO 2017/011544 Al 19 January 2017 (19.01.2017) P O PCT

    (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 2017/011544 Al 19 January 2017 (19.01.2017) P O PCT (51) International Patent Classification: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, A61K 38/16 (2006.01) A61K 39/395 (2006.01) DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, A61K 39/00 (2006.01) HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, (21) International Application Number: MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PCT/US20 16/042074 PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, (22) International Filing Date: SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 13 July 2016 (13.07.2016) TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, 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, ST, SZ, (30) Priority Data: TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, 62/192,269 14 July 2015 (14.07.2015) US TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, 62/197,966 28 July 2015 (28.07.2015) US DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, 62/277,201 11 January 2016 ( 11.01.2016) u s LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, (71) Applicant: IMMUNEXT, INC.