DOCSLIB.ORG

Harmonised Bds Suppl 20070

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

ABCDEF 1 EU Harmonised Birth Dates and related Data Lock Points, Supplementary list, 7 February 2007 Innovator brand name First DLP after Proposed Active substance name (INN) (for fixed combination 30 October Firm's Name Comments EU HBD products only) 2005 2 3 Aceclofenac 19900319 20080331 Almirall / UCB 4 Aciclovir 19810610 20060630 GSK 5 Adrafinil 19810710 20060131 Cephalon 6 Aldesleukine 19890703 20051231 Novartis NL=RMS Pfizer/Schwarz 7 Alprostadil (erectile dysfunction) 19840128 20080131 Pharma UK=RMS Alprostadil (peripheral arterial 19810723 20060731 Pfizer product differs from Schwarz Pharma 8 occlusive diseases) product Alprostadil (peripheral arterial 19841128 20051128 Schwarz Pharma product differs from Pfizer product 9 occlusive diseases) 10 Atenolol + chlorthalidone Tenoretic 19970909 20080908 AstraZeneca Azelaic acid 19881027 20060102 Schering AG / Pfizer AT = RMS 11 12 Aztreonam 19840804 20060803 BMS 13 Benazepril 19891128 20071130 Novartis Benazepril + hydrochlorothiazide Cibadrex 19920519 20070531 Novartis 14 15 Bisoprolol 19860128 20070930 Merck AG Bisoprolol + hydrochlorothiazide many product names 19920130 20061103 Merck AG 16 17 Botulinum Toxin A 19960906 20061030 Allergan currently 6-monthly PSURs 18 Brimonidine 19960906 20080930 Allergan UK=RMS 19 Brimonidine + timolol Combigan 19960906 20080930 Allergan UK=RMS 20 Bromperidol 20061115 J&J 21 Brotizolam 19830515 20071231 Boehringer Ingelheim 22 Budesonide 19920430 20070430 AstraZeneca 23 Budesonide + formoterol Symbicort 20000825 20070825 AstraZeneca 24 Buflomedil 19790523 20080522 Abbott 25 Buprenorphine 19820330 20080730 Schering Plough 26 Calcitonin/calcitonin salmon 19761206 20060630 Sanofi Aventis IE = RMS (art. 30 Referral) ABCDEF Innovator brand name First DLP after Proposed Active substance name (INN) (for fixed combination 30 October Firm's Name Comments EU HBD products only) 2005 2 Calcitriol 19780101 20060117 Roche Abbott will submit interim PSUR < 30/10/2008 and thereafter a PSUR with DLP 27 200901 Takeda / 28 Candesartan 19970429 20060428 AstraZeneca 29 Captopril 19800415 20070414 BMS Captopril + hyrochlorothiazide Captea 19800415 20070414 BMS / Sanofi Aventis 30 31 Carbomer (artificial tears) 19850101 20080131 Novartis 32 Carboplatine 19860123 20070122 BMS 33 Cefixime 19870630 20060630 Astellas 34 Ceftazidime 19831017 20061017 GSK 35 Ceftizoxime 19811207 20061004 Astellas 36 Cefuroxime 19860110 20060110 Eli Lilly following DLP 200904 37 Cefuroxime axetil (oral) 19870818 20060818 GSK following DLP 200904 38 Cefuroxime sodium (injection) 19780407 20060407 GSK following DLP 200904 39 Cetirizine 19861106 20061105 UCB Ciclesonide 20040224 200611 Altana UK = RMS, periodicity of PSURs is still 6 40 month 41 Cicletanine 19860728 20060131 Ipsen 42 Cilazapril 19900221 20051231 Roche Cilazapril + hydrochlorothiazide Vascase Plus 19911228 20051231 Pfizer 43 Will maintain the current PSUR periodicity up to the renewal (March Ciprofloxacine + fluocinolone 2007). Will follow HBD of ciprofloxacin 44 acetonide Cetraxal Plus 200203 200601 SALVAT thereafter. 45 Cisplatin 19781219 20061218 BMS 46 Clenbuterol 19801212 20070917 Boehringer Ingelheim 47 Clodronate 19870529 20060228 Roche / Schering 48 Dexrazoxane 19920217 20060228 Novartis FR=RMS 49 Diclofenac sodium/misoprostol Arthrotec 19910718 20060930 Pfizer UK = RMS ABCDEF Innovator brand name First DLP after Proposed Active substance name (INN) (for fixed combination 30 October Firm's Name Comments EU HBD products only) 2005 2 50 Diltiazem 19790502 20060531 Sanofi Aventis 51 Dipivefrin 19780919 20070930 Allergan 52 Dronabinol 19850531 20060531 Solvay Ebastine 19960101 20070531 Almirall 53 54 Eberconazole 200403 200601 SALVAT 55 Econazole 20061115 J&J Econazole combinations Pevisone / Econacort 20061115 J&J / BMS 56 Cream 57 Eprosartan 19970430 20060406 Solvay 58 Eprosartan + hydrochlorothiazide Teveten Plus 19970430 20060406 Solvay Ethinyl estradiol (EE) 20 mcg/ Lorette/Lowette/ 19970327 20060326 Wyeth FI=RMS 59 levonorgestrel (LNG) 100 mcg eios/Alesse 60 Etoposide 19760217 20070216 BMS 61 Famotidine 19840921 20080920 MSD Ferumoxsil (siloxane coated superparamagnetic 62 ironoxide)(infusion) 19940823 20080831 Guerbet Endorem. Fr=RMS Ferumoxsil (siloxane coated superparamagnetic 63 ironoxide)(oral and rectal) 19930122 20070531 Guerbet Lumirem 64 Finasteride 19980417 20070818 MSD SE = RMS 65 Flecainide 19820625 20060624 3M 66 Fluconazole 19880303 20080331 Pfizer 67 Flurbiprofen 19790901 20071109 Abbott 68 Fluvoxamine 19830713 20060712 Solvay 69 Gadobenate dimeglumine 19970722 20061130 Bracco UK=RMS 70 Gadobutrol 19980820 200602 Schering AG / Pfizer 71 Gadoteric acid (intraarticular) 20020131 20070731 Guerbet Artirem. NL=RMS ABCDEF Innovator brand name First DLP after Proposed Active substance name (INN) (for fixed combination 30 October Firm's Name Comments EU HBD products only) 2005 2 Gadoteric acid (IV and 72 intravascular) 19890308 20070930 Guerbet Dotarem. NL=RMS 73 Gadoteridol 19921029 20070228 Bracco 74 Galactose (contrast medium) 19901107 20070630 Schering AG 75 Galactose + palmitic acid Levovist 19950621 20070630 Schering AG 76 Iobitridol 19940824 20070430 Guerbet 77 Ioxaglic acid 197908 20070228 Guerbet 78 Ketorolac 19890720 20060731 Roche 79 Labetalol 19770304 20070228 GSK 80 Lanreotide 19940516 20051130 Ipsen 81 Levobunolol 19890608 20080630 Allergan 82 Lomefloxacin 19890602 20070630 Pfizer Lomefloxacin (ophtalmic 19941005 20071031 Novartis 83 preparations) 84 Mangafodipir 19970601 20060531 GE Healthcare 85 Mesalazine Salofalk 19840220 200702 Dr. Falk Pharma 86 Methylprednisolone aceponate 19901117 20051106 Schering AG 87 Metolazone 19910101 20071201 UCB 88 Miglitol 19960801 20060801 Bayer 89 Modafinil 19940901 20090831 Cephalon DLP second PSUR after 30 October 2005 90 Molsidomin 19770906 20060906 Sanofi Aventis 91 Monoxidine 19910123 20060122 Solvay 92 Nabumetone 19840315 20060315 GSK 93 Naloxone 19750414 20070413 BMS 94 Nicardipine 19810531 20060531 Astellas 95 Nilvadipine 19890101 20061231 Astellas Nimesulide 19970811 20061214 Helsinn 6 monthly PSUR, following DLP 20070615 96 97 Nimodipine 19871101 20061101 Bayer 98 Ofloxacin 19850416 20060416 Sanofi Aventis ABCDEF Innovator brand name First DLP after Proposed Active substance name (INN) (for fixed combination 30 October Firm's Name Comments EU HBD products only) 2005 2 Ofloxacin (ophtalmic 19890502 20060416 Allergan 99 preparations) 100 Olsalazine 19860601 20060531 UCB 101 Oxitropium 19820504 20071004 Boehringer Ingelheim 102 Oxybutynin 19840717 20060717 Sanofi Aventis 103 Pantoprazole 19940823 20060823 Altana Pantoprazole + Amoxicilline + ZacPac 19940823 20060823 Altana 104 clarithromycine 105 Phloroglucinol 19920218 20060918 Cephalon Phloroglucinol, Spasfon 19920218 20060918 Cephalon 106 Trimethylphloroglucinol 107 Piracetam 19881209 20071231 Pfizer 108 Pirenzepine 19790213 20070316 Boehringer Ingelheim 109 Pyrazinamide 19820215 20070215 Sanofi Aventis 110 Ramipril + felodipine Tazko 19890110 20060110 Sanofi Aventis Ramipril + furosemide Lasitace / Ramipril- 19860416 20080416 Sanofi Aventis 111 Furosemid Aventis 112 Ramipril + hydrochlorothiazide Cotriatec 19890110 20060110 Sanofi Aventis Ramipril + piretanide Trialix/Prilace/Aretensin 19930812 20080812 Sanofi Aventis 113 /Arelix 114 Rocuronium 19940317 20080228 Organon Simvastatin 19880406 20080405 MSD Simvastatin, 10 mg, pharmacy status, only 115 in UK, has different BD and DLP 116 Somatostatin 19791203 20060630 Sanofi Aventis 117 Somatropin 19910611 20080331 Ferring Zomacton; FR=RMS 118 Somatropin 19870308 20080331 Eli Lilly Humatrope; NL=RMS 119 Somatropin 19880329 20080331 Sanofi Aventis Maxomat; national MA in FR 120 Somatropin 19870127 20080331 Pfizer Genotropin; DK=RMS 121 Somatropin 19990301 20080331 Novonordisk Norditropin; DK=RMS 122 Somatropin 19880725 20080331 Merck Serono Saizen; IT=RMS 123 Terbinafine 19901003 20060930 Novartis ABCDEF Innovator brand name First DLP after Proposed Active substance name (INN) (for fixed combination 30 October Firm's Name Comments EU HBD products only) 2005 2 Thyrotropine releasing hormone 19790501 20070228 UCB 124 (synthetic) 125 Tiotropium 20011009 20081009 Boehringer Ingelheim NL=RMS 126 Tobramycin (for inhalation) 19991210 20051231 Novartis UK=RMS 127 Trandolapril + verapamil Tarka 19950316 20070315 Abbott NL=RMS 128 Trazodone 19770606 20080605 BMS 129 Urapidil 19800731 20060721 Altana 130 Ursodeoxycholic acid 19791127 20081104 Dr. Falk Pharma.
Recommended publications
  • The Study Programme for the Quality Management of Essential Medicines - Good Manufacturing Practical (GMP) and Inspection

    The Study Programme for the Quality Management of Essential Medicines - Good Manufacturing Practical (GMP) and Inspection

    The Study Programme for the Quality Management of Essential Medicines - Good Manufacturing Practical (GMP) and Inspection - Country Reports Japan International Corporation of Welfare Services (JICWELS) Contents 1. Cambodia 1 2. Indonesia 70 3. Malaysia 91 4. Philippines 116 5. Sri Lanka 141 6. Thailand 161 The Study Programme for the Quality Management of Essential Medicines - Good Manufacturing Practical (GMP) and Inspection - Cambodia -1- KINGDOM OF CAMBODIA Nation Religion King Ministry of Health Department of Drugs and Food Country Report The Study Program on Quality Management of Essential Medicines Good Manufacturing Practice (GMP) and Inspection November 4, 2012 – November 30, 2012 Sponsored by : The Government of Japan Japan International Cooperation Agency (JICA) Department of Drugs and Food Ministry of Health, Cambodia. -2- I- COUNTRY PROFILE -3- A-Geography Cambodia is an agricultural country located in South East Asia which bordering the Gulf of Thailand, between Thailand, Vietnam, and Laos. Its approximate geographical coordinates are 13°N 105°E. Its 2,572 km border is split among Vietnam (1,228 km), Thailand (803 km) and Laos (541 km), as well as 443 km of coastline. Cambodia covers 181,035 square kilometers in the southwestern part of the Indochina, Cambodia lies completely within the tropics; its southernmost points are only slightly more than 10° above the equator. The country is bounded on the north by Thailand and by Laos, on the east and southeast by Vietnam, and on the west by the Gulf of Thailand and by Thailand. It consists of the Tonle Sap Basin and the Mekong Lowlands. To the southeast of this great basin is the Mekong Delta, which extends through Vietnam to the South China Sea.
  • Xx250 Spc 2015 Uk

    Xx250 Spc 2015 Uk

    SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT XENETIX 250 (250 mgI/ml) Solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION per ml 50 ml 100 ml 200 ml 500 ml Iobitridol (INN) 548.4 mg 27.42 g 54.84 g 109.68 g 274.2 g Iodine corresponding to 250 mg 12.5 g 25 g 50 g 125 g Excipient with known effect : Sodium (up to 3.5 mg per 100 mL). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless to pale yellow solution 4. CLINICAL PARTICULARS 4.1. Therapeutic indications For adults and children undergoing: . whole-body CT . venography . intra-arterial digital subtraction angiography . ERP/ERCP This medicinal product is for diagnostic use only. 4.2. Posology and method of administration The dosage may vary depending on the type of examination, the age, weight, cardiac output and general condition of the patient and the technique used. Usually the same iodine concentration and volume are used as with other iodinated X-ray contrast in current use. As with all contrast media, the lowest dose necessary to obtain adequate visualisation should be used. Adequate hydration should be assured before and after administration as for other contrast media. As a guideline, the recommended dosages are as follows: Indications Recommended dosage Whole-body CT The doses of contrast medium and the rates of administration depend on the organs under investigation, the diagnostic problem and, in particular, the different scan and image-reconstruction times of the scanners in use.
  • List of Union Reference Dates A

    List of Union Reference Dates A

    Active substance name (INN) EU DLP BfArM / BAH DLP yearly PSUR 6-month-PSUR yearly PSUR bis DLP (List of Union PSUR Submission Reference Dates and Frequency (List of Union Frequency of Reference Dates and submission of Periodic Frequency of submission of Safety Update Reports, Periodic Safety Update 30 Nov. 2012) Reports, 30 Nov.
  • 01012100 Pure-Bred Horses 0 0 0 0 0 01012900 Lives Horses, Except

    01012100 Pure-Bred Horses 0 0 0 0 0 01012900 Lives Horses, Except

    AR BR UY Mercosu PY applied NCM Description applied applied applied r Final Comments tariff tariff tariff tariff Offer 01012100 Pure-bred horses 0 0 0 0 0 01012900 Lives horses, except pure-bred breeding 2 2 2 2 0 01013000 Asses, pure-bred breeding 4 4 4 4 4 01019000 Asses, except pure-bred breeding 4 4 4 4 4 01022110 Purebred breeding cattle, pregnant or lactating 0 0 0 0 0 01022190 Other pure-bred cattle, for breeding 0 0 0 0 0 Other bovine animals for breeding,pregnant or 01022911 lactating 2 2 2 2 0 01022919 Other bovine animals for breeding 2 2 2 2 4 01022990 Other live catlle 2 2 2 2 0 01023110 Pure-bred breeding buffalo, pregnant or lactating 0 0 0 0 0 01023190 Other pure-bred breeding buffalo 0 0 0 0 0 Other buffalo for breeding, ex. pure-bred or 01023911 pregnant 2 2 2 2 0 Other buffalo for breeding, except pure-bred 01023919 breeding 2 2 2 2 4 01023990 Other buffalos 2 2 2 2 0 01029000 Other live animals of bovine species 0 0 0 0 0 01031000 Pure-bred breedig swines 0 0 0 0 0 01039100 Other live swine, weighing less than 50 kg 2 2 2 2 0 01039200 Other live swine, weighing 50 kg or more 2 2 2 2 0 01041011 Pure-bred breeding, pregnant or lactating, sheep 0 0 0 0 0 01041019 Other pure-bred breeding sheep 0 0 0 0 0 01041090 Others live sheep 2 2 2 2 0 01042010 Pure-bred breeding goats 0 0 0 0 0 01042090 Other live goats 2 2 2 2 0 Fowls spec.gallus domestic.w<=185g pure-bred 01051110 breeding 0 0 0 0 0 Oth.live fowls spec.gall.domest.weig.not more than 01051190 185g 2 2 2 2 0 01051200 Live turkeys, weighing not more than 185g 2 2
  • Theranostics and Contrast Agents for Magnetic Resonance Imaging Yohan Jeong, Hee Sook Hwang and Kun Na*

    Theranostics and Contrast Agents for Magnetic Resonance Imaging Yohan Jeong, Hee Sook Hwang and Kun Na*

    Jeong et al. Biomaterials Research (2018) 22:20 https://doi.org/10.1186/s40824-018-0130-1 REVIEW Open Access Theranostics and contrast agents for magnetic resonance imaging Yohan Jeong, Hee Sook Hwang and Kun Na* Abstract Background: Magnetic resonance imaging is one of the diagnostic tools that uses magnetic particles as contrast agents. It is noninvasive methodology which provides excellent spatial resolution. Although magnetic resonance imaging offers great temporal and spatial resolution and rapid in vivo images acquisition, it is less sensitive than other methodologies for small tissue lesions, molecular activity or cellular activities. Thus, there is a desire to develop contrast agents with higher efficiency. Contrast agents are known to shorten both T1 and T2. Gadolinium based contrast agents are examples of T1 agents and iron oxide contrast agents are examples of T2 agents. In order to develop high relaxivity agents, gadolinium or iron oxide-based contrast agents can be synthesized via conjugation with targeting ligands or functional moiety for specific interaction and achieve accumulation of contrast agents at disease sites. Main body: This review discusses the principles of magnetic resonance imaging and recent efforts focused on specificity of contrast agents on specific organs such as liver, blood, lymph nodes, atherosclerotic plaque, and tumor. Furthermore, we will discuss the combination of theranostic such as contrast agent and drug, contrast agent and thermal therapy, contrast agent and photodynamic therapy, and neutron capture therapy, which can provide for cancer diagnosis and therapeutics. Conclusion: These applications of magnetic resonance contrast agents demonstrate the usefulness of theranostic agents for diagnosis and treatment.
  • Guideline on Core Smpc and Package Leaflet for Gadoteric Acid EMA/CHMP/337820/2016 Page 2/23

    Guideline on Core Smpc and Package Leaflet for Gadoteric Acid EMA/CHMP/337820/2016 Page 2/23

    1 26 May 2016 2 EMA/CHMP/337820/2016 3 Committee for Medicinal Products for Human Use (CHMP) 4 Guideline on core SmPC and Package Leaflet for gadoteric 5 acid 6 Draft Draft agreed by Radiopharmaceutical Drafting Group April 2016 Adopted by CHMP for release for consultation 26 May 2016 Start of public consultation 1 June 2016 End of consultation (deadline for comments) 30 September 2016 7 Comments should be provided using this template. The completed comments form should be sent to [email protected]. 8 Keywords Magnetic resonance, contrast media, gadolinium compounds, core SmPC, core Package Leaflet, gadoteric acid 9 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 10 Guideline on core SmPC and Package Leaflet for gadoteric 11 acid 12 Table of contents 13 Executive summary ..................................................................................... 3 14 1. Introduction (background) ...................................................................... 3 15 2. Scope....................................................................................................... 3 16 3. Legal basis .............................................................................................. 3 17 4. Core SmPC and Package Leaflet for gadoteric acid .................................
  • Drug-Induced Anaphylaxis in China: a 10 Year Retrospective Analysis of The

    Drug-Induced Anaphylaxis in China: a 10 Year Retrospective Analysis of The

    Int J Clin Pharm DOI 10.1007/s11096-017-0535-2 RESEARCH ARTICLE Drug‑induced anaphylaxis in China: a 10 year retrospective analysis of the Beijing Pharmacovigilance Database Ying Zhao1,2,3 · Shusen Sun4 · Xiaotong Li1,3 · Xiang Ma1 · Huilin Tang5 · Lulu Sun2 · Suodi Zhai1 · Tiansheng Wang1,3,6 Received: 9 May 2017 / Accepted: 19 September 2017 © The Author(s) 2017. This article is an open access publication Abstract Background Few studies on the causes of (50.1%), mucocutaneous (47.4%), and gastrointestinal symp- drug-induced anaphylaxis (DIA) in the hospital setting are toms (31.3%). A total of 249 diferent drugs were involved. available. Objective We aimed to use the Beijing Pharma- DIAs were mainly caused by antibiotics (39.3%), traditional covigilance Database (BPD) to identify the causes of DIA Chinese medicines (TCM) (11.9%), radiocontrast agents in Beijing, China. Setting Anaphylactic case reports from (11.9%), and antineoplastic agents (10.3%). Cephalospor- the BPD provided by the Beijing Center for Adverse Drug ins accounted for majority (34.5%) of antibiotic-induced Reaction Monitoring. Method DIA cases collected by the anaphylaxis, followed by fuoroquinolones (29.6%), beta- BPD from January 2004 to December 2014 were adjudi- lactam/beta-lactamase inhibitors (15.4%) and penicillins cated. Cases were analyzed for demographics, causative (7.9%). Blood products and biological agents (3.1%), and drugs and route of administration, and clinical signs and plasma substitutes (2.1%) were also important contributors outcomes. Main outcome measure Drugs implicated in DIAs to DIAs. Conclusion A variety of drug classes were impli- were identifed and the signs and symptoms of the DIA cases cated in DIAs.
  • Page 1 Note: Within Nine Months from the Publication of the Mention

    Page 1 Note: Within Nine Months from the Publication of the Mention

    Europäisches Patentamt (19) European Patent Office & Office européen des brevets (11) EP 1 411 992 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 49/04 (2006.01) A61K 49/18 (2006.01) 13.12.2006 Bulletin 2006/50 (86) International application number: (21) Application number: 02758379.8 PCT/EP2002/008183 (22) Date of filing: 23.07.2002 (87) International publication number: WO 2003/013616 (20.02.2003 Gazette 2003/08) (54) IONIC AND NON-IONIC RADIOGRAPHIC CONTRAST AGENTS FOR USE IN COMBINED X-RAY AND NUCLEAR MAGNETIC RESONANCE DIAGNOSTICS IONISCHES UND NICHT-IONISCHES RADIOGRAPHISCHES KONTRASTMITTEL ZUR VERWENDUNG IN DER KOMBINIERTEN ROENTGEN- UND KERNSPINTOMOGRAPHIEDIAGNOSTIK SUBSTANCES IONIQUES ET NON-IONIQUES DE CONTRASTE RADIOGRAPHIQUE UTILISEES POUR ETABLIR DES DIAGNOSTICS FAISANT APPEL AUX RAYONS X ET A L’IMAGERIE PAR RESONANCE MAGNETIQUE (84) Designated Contracting States: (74) Representative: Minoja, Fabrizio AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Bianchetti Bracco Minoja S.r.l. IE IT LI LU MC NL PT SE SK TR Via Plinio, 63 20129 Milano (IT) (30) Priority: 03.08.2001 IT MI20011706 (56) References cited: (43) Date of publication of application: EP-A- 0 759 785 WO-A-00/75141 28.04.2004 Bulletin 2004/18 US-A- 5 648 536 (73) Proprietor: BRACCO IMAGING S.p.A. • K HERGAN, W. DORINGER, M. LÄNGLE W.OSER: 20134 Milano (IT) "Effects of iodinated contrast agents in MR imaging" EUROPEAN JOURNAL OF (72) Inventors: RADIOLOGY, vol. 21, 1995, pages 11-17, • AIME, Silvio XP002227102 20134 Milano (IT) • K.M.
  • A General MRI-CEST Ratiometric Approach for Ph Imaging: Demonstration of in Vivo Ph Mapping with Iobitridol

    A General MRI-CEST Ratiometric Approach for Ph Imaging: Demonstration of in Vivo Ph Mapping with Iobitridol

    A General MRI-CEST Ratiometric Approach for pH Imaging: Demonstration of in Vivo pH Mapping with Iobitridol The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters Citation Longo, Dario L., Phillip Zhe Sun, Lorena Consolino, Filippo C. Michelotti, Fulvio Uggeri, and Silvio Aime. 2014. “A General MRI- CEST Ratiometric Approach for pH Imaging: Demonstration of in Vivo pH Mapping with Iobitridol.” Journal of the American Chemical Society 136 (41): 14333-14336. doi:10.1021/ja5059313. http:// dx.doi.org/10.1021/ja5059313. Published Version doi:10.1021/ja5059313 Citable link http://nrs.harvard.edu/urn-3:HUL.InstRepos:22856989 Terms of Use This article was downloaded from Harvard University’s DASH repository, and is made available under the terms and conditions applicable to Other Posted Material, as set forth at http:// nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of- use#LAA Communication pubs.acs.org/JACS Terms of Use A General MRI-CEST Ratiometric Approach for pH Imaging: Demonstration of in Vivo pH Mapping with Iobitridol † # ‡ # § § ⊥ ∥ Dario L. Longo, , Phillip Zhe Sun, , Lorena Consolino, Filippo C. Michelotti, , Fulvio Uggeri, § and Silvio Aime*, † § Institute of Biostructures and Bioimages (CNR) c/o Molecular Biotechnology Center and Department of Molecular Biotechnology and Health Sciences, Molecular Imaging Center, University of Torino, Torino 10126, Italy ‡ Athinoula A. Martinos Center for Biomedical Imaging, MGH and Harvard Medical School, Charlestown, Massachusetts 02129, United States ∥ Bracco Research Center, Bracco Imaging SpA, Colleretto Giacosa, Torino 10010, Italy *S Supporting Information facilitating in vivo imaging. This has been achieved by ratiometric ABSTRACT: Chemical exchange saturation transfer CEST MRI of agents with multiple magnetically non-equivalent (CEST) is a novel contrast mechanism for magnetic protons, whose CEST effects, upon ratioing, constitute the resonance imaging (MRI).
  • ACR Manual on Contrast Media

    ACR Manual on Contrast Media

    ACR Manual On Contrast Media 2021 ACR Committee on Drugs and Contrast Media Preface 2 ACR Manual on Contrast Media 2021 ACR Committee on Drugs and Contrast Media © Copyright 2021 American College of Radiology ISBN: 978-1-55903-012-0 TABLE OF CONTENTS Topic Page 1. Preface 1 2. Version History 2 3. Introduction 4 4. Patient Selection and Preparation Strategies Before Contrast 5 Medium Administration 5. Fasting Prior to Intravascular Contrast Media Administration 14 6. Safe Injection of Contrast Media 15 7. Extravasation of Contrast Media 18 8. Allergic-Like And Physiologic Reactions to Intravascular 22 Iodinated Contrast Media 9. Contrast Media Warming 29 10. Contrast-Associated Acute Kidney Injury and Contrast 33 Induced Acute Kidney Injury in Adults 11. Metformin 45 12. Contrast Media in Children 48 13. Gastrointestinal (GI) Contrast Media in Adults: Indications and 57 Guidelines 14. ACR–ASNR Position Statement On the Use of Gadolinium 78 Contrast Agents 15. Adverse Reactions To Gadolinium-Based Contrast Media 79 16. Nephrogenic Systemic Fibrosis (NSF) 83 17. Ultrasound Contrast Media 92 18. Treatment of Contrast Reactions 95 19. Administration of Contrast Media to Pregnant or Potentially 97 Pregnant Patients 20. Administration of Contrast Media to Women Who are Breast- 101 Feeding Table 1 – Categories Of Acute Reactions 103 Table 2 – Treatment Of Acute Reactions To Contrast Media In 105 Children Table 3 – Management Of Acute Reactions To Contrast Media In 114 Adults Table 4 – Equipment For Contrast Reaction Kits In Radiology 122 Appendix A – Contrast Media Specifications 124 PREFACE This edition of the ACR Manual on Contrast Media replaces all earlier editions.
  • ACR Manual on Contrast Media – Version 9, 2013 Table of Contents / I

    ACR Manual on Contrast Media – Version 9, 2013 Table of Contents / I

    ACR Manual on Contrast Media Version 9 2013 ACR Committee on Drugs and Contrast Media ACR Manual on Contrast Media – Version 9, 2013 Table of Contents / i ACR Manual on Contrast Media Version 9 2013 ACR Committee on Drugs and Contrast Media © Copyright 2013 American College of Radiology ISBN: 978-1-55903-012-0 Table of Contents Topic Last Updated Page 1. Preface. V9 – 2013 . 3 2. Introduction . V7 – 2010 . 4 3. Patient Selection And Preparation Strategies . V7 – 2010 . 5 4. Injection of Contrast Media . V7 – 2010 . 13 5. Extravasation Of Contrast Media . V7 – 2010 . 17 6. Allergic-Like And Physiologic Reactions To Intravascular Iodinated Contrast Media . V9 – 2013 . 21 7. Contrast Media Warming . V8 – 2012 . 29 8. Contrast-Induced Nephrotoxicity . V8 – 2012 . 33 9. Metformin . V7 – 2010 . 43 10. Contrast Media In Children . V7 – 2010 . 47 11. Gastrointestinal (GI) Contrast Media In Adults: Indications And Guidelines V9 – 2013 . 55 12. Adverse Reactions To Gadolinium-Based Contrast Media . V7 – 2010 . 77 13. Nephrogenic Systemic Fibrosis . V8 – 2012 . 81 14. Treatment Of Contrast Reactions . V9 – 2013 . 91 15. Administration Of Contrast Media To Pregnant Or Potentially Pregnant Patients . V9 – 2013 . 93 16. Administration Of Contrast Media To Women Who Are Breast-Feeding . V9 – 2013 . 97 Table 1 – Indications for Use of Iodinated Contrast Media . V9 – 2013 . 99 Table 2 – Organ and System-Specific Adverse Effects from the Administration of Iodine-Based or Gadolinium-Based Contrast Agents. V9 – 2013 . 100 Table 3 – Categories of Acute Reactions . V9 – 2013 . 101 Table 4 – Treatment of Acute Reactions to Contrast Media in Children . V9 – 2013 .
  • Advisory Committee Briefing Document Medical Imaging Drugs Advisory Committee (MIDAC) September 8, 2017

    Advisory Committee Briefing Document Medical Imaging Drugs Advisory Committee (MIDAC) September 8, 2017

    Dotarem® (gadoterate meglumine) Injection – NDA# 204781 Advisory Committee Optimark® (gadoversetamide) Injection - NDAs# 020937, 020975 & 020976 Briefing Document Advisory Committee Briefing Document Medical Imaging Drugs Advisory Committee (MIDAC) September 8, 2017 DOTAREM® (gadoterate meglumine) Injection NDA 204781 Guerbet LLC, 821 Alexander Rd, Princeton, NJ 08540 OPTIMARK® (gadoversetamide) Injection NDAs 020937, 020975 & 020976 Liebel-Flarsheim Company LLC, 1034 Brentwood Blvd., Richmond Heights, MO 63117 ADVISORY COMMITTEE BRIEFING MATERIALS AVAILABLE FOR PUBLIC RELEASE Information provided within this briefing document is based upon medical and scientific information available to date. ADVISORY COMMITTEE BRIEFING MATERIALS AVAILABLE FOR PUBLIC RELEASE Page 1 / 168 Dotarem® (gadoterate meglumine) Injection – NDA# 204781 Advisory Committee Optimark® (gadoversetamide) Injection - NDAs# 020937, 020975 & 020976 Briefing Document EXECUTIVE SUMMARY Gadolinium-based contrast agents (GdCAs) are essential for use in magnetic resonance imaging (MRI). Although non-contrast-enhanced MRI may be sufficient for use in some clinical conditions, contrast-enhanced MRI (CE-MRI) using GdCA provides additional vital diagnostic information in a number of diseases. It is widely recognized that CE-MRI increases diagnostic accuracy and confidence, and thus can impact the medical and/or surgical management of patients. Based on the chemical structure of the complexing ligand, GdCA are classified as linear (L-GdCA) or macrocyclic (M-GdCA) and can be ionic or nonionic and those characteristics have a dramatic influence on the stability of the GdCA. Dotarem®, a M-GdCA, was first approved in France in 1989. US-FDA approval was obtained in March 2013 for “intravenous use with MRI of the brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity”, at the dose of 0.1 mmol/kg BW.