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Intrathecal Gadolinium-Enhanced MR Cisternography in the Evaluation Of
Intrathecal Gadolinium-Enhanced MR ORIGINAL RESEARCH Cisternography in the Evaluation of CSF Leakage H. Selcuk BACKROUND AND PURPOSE: Radiologic identification of the location of the CSF leakage is important S. Albayram for proper surgical planning and increases the chance of dural repair. This article describes our experience in analyzing clinically suspected cranial CSF fistulas by using MR imaging combined with H. Ozer the intrathecal administration of a gadolinium-based contrast agent. S. Ulus MATERIALS AND METHODS: A total of 85 consecutive patients with suspected CSF fistulas who G.Z. Sanus presented with persistent or intermittent rhinorrhea or otorrhea lasting for more than 1 month between M.Y. Kaynar 2003 and 2007 were included in this study. N. Kocer RESULTS: We observed objective CSF leakage in 64 of 85 patients (75%). The CSF leak was located C. Islak in the ethmoidal region in 37 patients (58%), in the superior wall of the sphenoid sinus in 8 patients (13%), in the posterior wall of the frontal sinus in 10 patients (15%), in the superior wall of the mastoid air cells in 6 patients (9%), and from the skull base into the infratemporal fossa in 1 patient (2%). Two patients (3%) showed leakage into Ͼ1 paranasal sinus. CONCLUSIONS: MR cisternography after the intrathecal administration of gadopentate dimeglumine represents an effective and minimally invasive method for evaluating suspected CSF fistulas along the skull base. It provides multiplanar capabilities without risk of radiation exposure and is an excellent approach to depict the anatomy of CSF spaces and CSF fistulas. SF leakage implies abnormal communication between the using this technique.19,20 In addition, the combination of CT Csubarachnoid space and the nasal or middle ear cavity. -
201277Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 201277Orig1s000 OTHER REVIEW(S) PMR/PMC Development Template This template should be completed by the PMR/PMC Development Coordinator and included for each PMR/PMC in the Action Package. PMR/PMC Description: DARRTS Set #1743-1 A study that will examine the safety of Gadavist in new born and neonates animals, following a single dose and limited repeated dose administrations. The study will provide safety data assessing mortality, toxicities, and potential reversibility of observed clinical and histopathological findings. The study will also examine the pharmacokinetics of Gadavist including tissue deposition of Gadolinium. PMR/PMC Schedule Milestones: Final Protocol Submission: May, 2011 Study/Trial Completion: January, 2012 Final Report Submission: June, 2012 Other: 1. During application review, explain why this issue is appropriate for a PMR/PMC instead of a pre-approval requirement. Check type below and describe. Unmet need Life-threatening condition Long-term data needed Only feasible to conduct post-approval (I removed this check on the nonclinical form) Prior clinical experience indicates safety Small subpopulation affected (I removed this check on the nonclinical form) Theoretical concern Other Proposed nonclinical study will evaluate the safety of Gadavist in a non clinical animal model prior to clinical exposure in view of known risk of NSF in adults especially those with renal impairment. 2. Describe the particular review issue and the goal of the study/clinical trial. If the study/clinical trial is a FDAAA PMR, describe the risk. If the FDAAA PMR is created post-approval, describe the “new safety information.” ReferencePMR/PMC ID: 2918081Development Template Last Updated 3/14/2011 Page 1 of 4 To evaluate the safety of Gadavist in newborn and neonate animals. -
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. -
Pharmacy Reengineering (PRE) V.0.5 Pre-Release Implementation
PHARMACY REENGINEERING (PRE) Version 0.5 Pre-Release Implementation Guide PSS*1*129 & PSS*1*147 February 2010 Department of Veterans Affairs Office of Enterprise Development Revision History Date Revised Patch Description Pages Number 02/2010 All PSS*1*147 Added Revision History page. Updated patch references to include PSS*1*147. Described files, fields, options and routines added/modified as part of this patch. Added Chapter 5, Additive Frequency for IV Additives, to describe the steps needed to ensure correct data is in the new IV Additive REDACTED 01/2009 All PSS*1*129 Original version REDACTED February 2010 Pharmacy Reengineering (PRE) V. 0.5 Pre-Release i Implementation Guide PSS*1*129 & PSS*1*147 Revision History (This page included for two-sided copying.) ii Pharmacy Reengineering (PRE) V. 0.5 Pre-Release February 2010 Implementation Guide PSS*1*129 & PSS*1*147 Table of Contents Introduction ................................................................................................................................. 1 Purpose ....................................................................................................................................1 Project Description ....................................................................................................................1 Scope ........................................................................................................................................3 Menu Changes ..........................................................................................................................4 -
MDCT and Contrast Media: What Are the Risks?
071_078_00_Thomsen:Thomsen 13-02-2008 9:32 Pagina 71 MDCT and Contrast Media: What are the Risks? Henrik S. Thomsen Department of Diagnostic Radiology, Copenhagen University Hospital Herlev, Herlev Department of Diagnostic Sciences, Faculty of Health Sciences, University of Copenhagen, Denmark Introduction Renal Adverse Reactions With the advent of multi-detector computed to- Contrast-material-induced kidney damage is imme- mography (MDCT) technology, the number of pa- diate, starting as soon as the first CM molecule reach- tients undergoing contrast-enhanced CT (CECT) es the kidney; however, it takes several hours or days studies has steadily grown in the last 6 years. In for a deterioration of renal function to be detected. 2005, approximately 22 million CECT examinations Despite more than 30 years of research, the patho- were carried out in the European Union, and 32 mil- physiology of CM-induced nephropathy (CIN) is lion in the United States (The Imaging Market Guide poorly elucidated. Nonetheless, several risk factors 2005. Arlington Medical Resources, Inc., Philadel- are well-known and can be divided into CM- and pa- phia, PA). Unfortunately, post-contrast-material-re- tient-related factors. lated adverse events, i.e., all those unintended and unfavorable signs, symptoms, or diseases temporally associated with the use of an iodinated contrast ma- Contrast-Medium-Related Factors terial (CM), are a common occurrence in radiology departments. Most adverse events occur within the More than 25 years ago, Barrett and Carlisle [1] first 60 min following CM administration (“imme- showed that the incidence of CIN is significantly diate” or “acute” adverse events), with the greatest higher after the administration of high-osmolarity risk in the first 20 min. -
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. -
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 -
)&F1y3x PHARMACEUTICAL APPENDIX to THE
)&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE -
Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017
Q UO N T FA R U T A F E BERMUDA PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 BR 111 / 2017 The Minister responsible for health, in exercise of the power conferred by section 48A(1) of the Pharmacy and Poisons Act 1979, makes the following Order: Citation 1 This Order may be cited as the Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017. Repeals and replaces the Third and Fourth Schedule of the Pharmacy and Poisons Act 1979 2 The Third and Fourth Schedules to the Pharmacy and Poisons Act 1979 are repealed and replaced with— “THIRD SCHEDULE (Sections 25(6); 27(1))) DRUGS OBTAINABLE ONLY ON PRESCRIPTION EXCEPT WHERE SPECIFIED IN THE FOURTH SCHEDULE (PART I AND PART II) Note: The following annotations used in this Schedule have the following meanings: md (maximum dose) i.e. the maximum quantity of the substance contained in the amount of a medicinal product which is recommended to be taken or administered at any one time. 1 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 mdd (maximum daily dose) i.e. the maximum quantity of the substance that is contained in the amount of a medicinal product which is recommended to be taken or administered in any period of 24 hours. mg milligram ms (maximum strength) i.e. either or, if so specified, both of the following: (a) the maximum quantity of the substance by weight or volume that is contained in the dosage unit of a medicinal product; or (b) the maximum percentage of the substance contained in a medicinal product calculated in terms of w/w, w/v, v/w, or v/v, as appropriate. -
Pharmacologyonline 2: 727-753 (2010) Ewsletter Bradu and Rossini
Pharmacologyonline 2: 727-753 (2010) ewsletter Bradu and Rossini COTRAST AGETS - IODIATED PRODUCTS. SECOD WHO-ITA / ITA-OMS 2010 COTRIBUTIO O AGGREGATE WHO SYSTEM-ORGA CLASS DISORDERS AD/OR CLUSTERIG BASED O REPORTED ADVERSE REACTIOS/EVETS Dan Bradu and Luigi Rossini* Servizio Nazionale Collaborativo WHO-ITA / ITA-OMS, Università Politecnica delle Marche e Progetto di Farmacotossicovigilanza, Azienda Ospedaliera Universitaria Ospedali Riuniti di Ancona, Regione Marche, Italia Summary From the 2010 total basic adverse reactions and events collected as ADRs preferred names in the WHO-Uppsala Drug Monitoring Programme, subdivided in its first two twenty years periods as for the first seven iodinated products diagnostic contrast agents amidotrizoate, iodamide, iotalamate, iodoxamate, ioxaglate, iohexsol and iopamidol, their 30 WHO-system organ class disorders (SOCDs) aggregates had been compared. Their common maximum 97% levels identified six SOCDs only, apt to evaluate the most frequent single ADRs for each class, and their percentual normalization profiles for each product. The WILKS's chi square statistics for the related contingency tables, and Gabriel’s STP procedure applied to the extracted double data sets then produced profile binary clustering, as well as Euclidean confirmatory plots. They finally showed similar objectively evaluated autoclassificative trends of these products, which do not completely correspond to their actual ATC V08A A, B and C subdivision: while amidotrizoate and iotalamate, and respectively iohesol and iopamidol are confirmed to belong to the A and B subgroups, ioxaglate behaves fluctuating within A, B and C, but iodamide looks surprizingly, constantly positioned together with iodoxamate as binary/ternary C associated. In view of the recent work of Campillos et al (Science, 2008) which throws light on the subject, the above discrepancies do not appear anymore unexpected or alarming. -
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. -
NON-HAZARDOUS CHEMICALS May Be Disposed of Via Sanitary Sewer Or Solid Waste
NON-HAZARDOUS CHEMICALS May Be Disposed Of Via Sanitary Sewer or Solid Waste (+)-A-TOCOPHEROL ACID SUCCINATE (+,-)-VERAPAMIL, HYDROCHLORIDE 1-AMINOANTHRAQUINONE 1-AMINO-1-CYCLOHEXANECARBOXYLIC ACID 1-BROMOOCTADECANE 1-CARBOXYNAPHTHALENE 1-DECENE 1-HYDROXYANTHRAQUINONE 1-METHYL-4-PHENYL-1,2,5,6-TETRAHYDROPYRIDINE HYDROCHLORIDE 1-NONENE 1-TETRADECENE 1-THIO-B-D-GLUCOSE 1-TRIDECENE 1-UNDECENE 2-ACETAMIDO-1-AZIDO-1,2-DIDEOXY-B-D-GLYCOPYRANOSE 2-ACETAMIDOACRYLIC ACID 2-AMINO-4-CHLOROBENZOTHIAZOLE 2-AMINO-2-(HYDROXY METHYL)-1,3-PROPONEDIOL 2-AMINOBENZOTHIAZOLE 2-AMINOIMIDAZOLE 2-AMINO-5-METHYLBENZENESULFONIC ACID 2-AMINOPURINE 2-ANILINOETHANOL 2-BUTENE-1,4-DIOL 2-CHLOROBENZYLALCOHOL 2-DEOXYCYTIDINE 5-MONOPHOSPHATE 2-DEOXY-D-GLUCOSE 2-DEOXY-D-RIBOSE 2'-DEOXYURIDINE 2'-DEOXYURIDINE 5'-MONOPHOSPHATE 2-HYDROETHYL ACETATE 2-HYDROXY-4-(METHYLTHIO)BUTYRIC ACID 2-METHYLFLUORENE 2-METHYL-2-THIOPSEUDOUREA SULFATE 2-MORPHOLINOETHANESULFONIC ACID 2-NAPHTHOIC ACID 2-OXYGLUTARIC ACID 2-PHENYLPROPIONIC ACID 2-PYRIDINEALDOXIME METHIODIDE 2-STEP CHEMISTRY STEP 1 PART D 2-STEP CHEMISTRY STEP 2 PART A 2-THIOLHISTIDINE 2-THIOPHENECARBOXYLIC ACID 2-THIOPHENECARBOXYLIC HYDRAZIDE 3-ACETYLINDOLE 3-AMINO-1,2,4-TRIAZINE 3-AMINO-L-TYROSINE DIHYDROCHLORIDE MONOHYDRATE 3-CARBETHOXY-2-PIPERIDONE 3-CHLOROCYCLOBUTANONE SOLUTION 3-CHLORO-2-NITROBENZOIC ACID 3-(DIETHYLAMINO)-7-[[P-(DIMETHYLAMINO)PHENYL]AZO]-5-PHENAZINIUM CHLORIDE 3-HYDROXYTROSINE 1 9/26/2005 NON-HAZARDOUS CHEMICALS May Be Disposed Of Via Sanitary Sewer or Solid Waste 3-HYDROXYTYRAMINE HYDROCHLORIDE 3-METHYL-1-PHENYL-2-PYRAZOLIN-5-ONE