Review Article
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
SUMMARY of the PRODUCT CHARACTERISTICS 1. NAME of the MEDICINAL PRODUCT <Invented Name> 10 Mg/10 Mg Film-Coated Tablets
SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT <Invented name> 10 mg/10 mg film-coated tablets <Invented name> 20 mg/10 mg film-coated tablets <Invented name> 40 mg/10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION <Invented name> 10 mg/10 mg: Each film-coated tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. <Invented name> 20 mg/10 mg: Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. <Invented name> 40 mg/10 mg: Each film-coated tablet contains 40 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. Excipient with known effect: <Invented name> 10 mg/10 mg: Each film-coated tablet contains 111.2 mg of lactose (as lactose monohydrate). <Invented name> 20 mg/10 mg: Each film-coated tablet contains 168.6 mg of lactose (as lactose monohydrate). <Invented name> 40 mg/10 mg: Each film-coated tablet contains 286.0 mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) <Invented name> 10 mg/10 mg: white to off-white oblong film-coated tablets. <Invented name> 20 mg/10 mg: yellow to light yellow oblong film-coated tablets. <Invented name> 40 mg/10 mg: pink oblong film-coated tablets. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Primary Hypercholesterolaemia/Homozygous Familial Hypercholesterolaemia (HoFH) <Invented name> is indicated for substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products, as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia. -
Package Leaflet: Information for the Patient Nustendi 180 Mg/10 Mg Film-Coated Tablet Bempedoic Acid/Ezetimibe This Medicine Is
Package leaflet: Information for the patient Nustendi 180 mg/10 mg film-coated tablet bempedoic acid/ezetimibe This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Nustendi is and what it is used for 2. What you need to know before you take Nustendi 3. How to take Nustendi 4. Possible side effects 5. How to store Nustendi 6. Contents of the pack and other information 1. What Nustendi is and what it is used for What Nustendi is and how it works Nustendi is a medicine that lowers levels of ‘bad’ cholesterol (also called “LDL-cholesterol”), a type of fat, in the blood. Nustendi contains two active substances, which reduce your cholesterol in two ways: • bempedoic acid decreases the production of cholesterol in the liver and increases the removal of LDL-cholesterol from the blood; • ezetimibe works in your bowel by reducing the amount of cholesterol absorbed from food. -
Quasi-Experimental Health Policy Research: Evaluation of Universal Health Insurance and Methods for Comparative Effectiveness Research
Quasi-Experimental Health Policy Research: Evaluation of Universal Health Insurance and Methods for Comparative Effectiveness Research The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters Citation Garabedian, Laura Faden. 2013. Quasi-Experimental Health Policy Research: Evaluation of Universal Health Insurance and Methods for Comparative Effectiveness Research. Doctoral dissertation, Harvard University. Citable link http://nrs.harvard.edu/urn-3:HUL.InstRepos:11156786 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 Quasi-Experimental Health Policy Research: Evaluation of Universal Health Insurance and Methods for Comparative Effectiveness Research A dissertation presented by Laura Faden Garabedian to The Committee on Higher Degrees in Health Policy in partial fulfillment of the requirements for the degree of Doctor of Philosophy in the subject of Health Policy Harvard University Cambridge, Massachusetts March 2013 © 2013 – Laura Faden Garabedian All rights reserved. Professor Stephen Soumerai Laura Faden Garabedian Quasi-Experimental Health Policy Research: Evaluation of Universal Health Insurance and Methods for Comparative Effectiveness Research Abstract This dissertation consists of two empirical papers and one methods paper. The first two papers use quasi-experimental methods to evaluate the impact of universal health insurance reform in Massachusetts (MA) and Thailand and the third paper evaluates the validity of a quasi- experimental method used in comparative effectiveness research (CER). My first paper uses interrupted time series with data from IMS Health to evaluate the impact of Thailand’s universal health insurance and physician payment reform on utilization of medicines for three non-communicable diseases: cancer, cardiovascular disease and diabetes. -
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 -
Regulation of Pharmaceutical Prices: Evidence from a Reference Price Reform in Denmark
A Service of Leibniz-Informationszentrum econstor Wirtschaft Leibniz Information Centre Make Your Publications Visible. zbw for Economics Kaiser, Ulrich; Mendez, Susan J.; Rønde, Thomas Working Paper Regulation of pharmaceutical prices: Evidence from a reference price reform in Denmark ZEW Discussion Papers, No. 10-062 Provided in Cooperation with: ZEW - Leibniz Centre for European Economic Research Suggested Citation: Kaiser, Ulrich; Mendez, Susan J.; Rønde, Thomas (2010) : Regulation of pharmaceutical prices: Evidence from a reference price reform in Denmark, ZEW Discussion Papers, No. 10-062, Zentrum für Europäische Wirtschaftsforschung (ZEW), Mannheim This Version is available at: http://hdl.handle.net/10419/41440 Standard-Nutzungsbedingungen: Terms of use: Die Dokumente auf EconStor dürfen zu eigenen wissenschaftlichen Documents in EconStor may be saved and copied for your Zwecken und zum Privatgebrauch gespeichert und kopiert werden. personal and scholarly purposes. Sie dürfen die Dokumente nicht für öffentliche oder kommerzielle You are not to copy documents for public or commercial Zwecke vervielfältigen, öffentlich ausstellen, öffentlich zugänglich purposes, to exhibit the documents publicly, to make them machen, vertreiben oder anderweitig nutzen. publicly available on the internet, or to distribute or otherwise use the documents in public. Sofern die Verfasser die Dokumente unter Open-Content-Lizenzen (insbesondere CC-Lizenzen) zur Verfügung gestellt haben sollten, If the documents have been made available under an Open gelten abweichend von diesen Nutzungsbedingungen die in der dort Content Licence (especially Creative Commons Licences), you genannten Lizenz gewährten Nutzungsrechte. may exercise further usage rights as specified in the indicated licence. www.econstor.eu Dis cus si on Paper No. 10-062 Regulation of Pharmaceutical Prices: Evidence from a Reference Price Reform in Denmark Ulrich Kaiser, Susan J. -
Supplemental Material BMJ Open Doi: 10.1136/Bmjopen-2020-039104 :E039104. 10 2020; BMJ Open , Et Al. Randall SM
BMJ Publishing Group Limited (BMJ) disclaims all liability and responsibility arising from any reliance Supplemental material placed on this supplemental material which has been supplied by the author(s) BMJ Open Supplementary Table 1 – Injury categories Injury Category ICD Codes Fractures S02, S12, S22, S32, S42, S52, S62, S72, S82, S92, T02.1-5, T02.8-9, T08, T10, T12, T14.2, T90.2, T91.1-2 T92.1-2, T93.1-2 Open Wounds S01, S05.2, S05.3, S05.4, S05.5, S05.6, S05.7, S08.0, S09.2, S11, S21, S31.0-5, S31.7-8, S41, S51, S61, S71.0-8, S81, S91, T01.2-3, T01.9, T09.1, T11.1, T13.1, T14.1, T90.1, T92.0, T93.0, Contusions and superficial S00, S05.0-1, S10, S20, S30.0-2, S30.7-9, S40, S50, S60, S70, S80, S90, T00.2-3, T00.8- injuries 9, T09.0, T11.0, T13.0, T14.0, T90.0 Dislocations S03.0-3, S13.0-3, S23.0-3, S33.0-4, S43.0-3, S53.0-1, S63.0-2, S66, S73.0, S83, S86, S93.0-1, S93.3 Internal organ injuries S06, S14.0-2, S24.0-1, S26.0, S27.0-6, S27.8-9, S34.0-1, S34.3, S36, S37, S39.6-7, T06.5, T09.3, T90.5, T91.3-5 Foreign bodies T15-9 Amputations S08.1-9, S18, S28.1, S38.2-3, S48, S58, S68, S78, S88, S98, T05.0, T05.2-3, T05.5, T05.8-9, T09.6, T11.6, T13.6 Burns T20-T32 Randall SM, et al. -
Information for the Patient Questran Light™ 4 G/Sachet Powder for Oral Suspension Colestyramine
Package leaflet: Information for the patient Questran Light™ 4 g/sachet Powder for Oral Suspension Colestyramine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What QUESTRAN LIGHT is and what it is used for 2. What you need to know before you take QUESTRAN LIGHT 3. How to take QUESTRAN LIGHT 4. Possible side effects 5. How to store QUESTRAN LIGHT 6. Contents of the pack and other information 1. What QUESTRAN LIGHT is and what it is used for Questran Light contains the active substance colestyramine. Each sachet of Questran Light contains 4 g of colestyramine. Colestyramine belongs to a group of medicines called bile acid binding resins. Questran Light is used to lower your body’s level of cholesterol (a type of fat) which can cause heart disease. This medicine works in the digestive system and absorbs the cholesterol-containing bile acids, which then pass out through the body in the faeces. Questran Light may also be used to help stop some types of diarrhoea or itching. -
Name of Trust / Logo
Shortage of Bile Acid Sequestrants – Colestyramine Powder for Oral Suspension 4g (Questran) and Colestipol (Colestid) Updated: 1st October 2019 Description of product affected • Colestyramine is licensed for use in the following indications1,2: o Primary prevention of coronary heart disease in men between 35 and 59 years of age and with primary hypercholesterolaemia who have not responded to diet and other appropriate measures. o Reduction of plasma cholesterol in hypercholesterolaemia, particularly in those patients who have been diagnosed as Fredrickson's Type II (high plasma cholesterol with normal or slightly elevated triglycerides). o Relief of pruritus associated with partial biliary obstruction and primary biliary cirrhosis. o Relief of diarrhoea associated with ileal resection, Crohn's disease, vagotomy and diabetic vagal neuropathy. o Management of radiation-induced diarrhoea. • The dose used varies between 4g and 36g daily according to the indication.1,2 • For relief of diarrhoea, it is common practice to use colestyramine off-label to treat “bile acid diarrhoea” where considered clinically appropriate. In Cambridgeshire and Peterborough colestyramine is recommended first line for the management of bile acid malabsorption (unlicensed indication). • Colestyramine is also used to help reduce the volume of jejunal and ileostomy outputs as a consequence of bowel resection for any cause3 and in patients with myeloma treatment induced diarrhoea that is unresponsive to loperamide.4 • Colesevelam 625mg tablets5 has a much more restricted range of licensed indications limited to treatment of hypercholesterolaemia and is recommended in Cambridgeshire and Peterborough as second line therapy for bile acid malabsorption after colestyramine and where conventional anti-diarrhoea medication have failed.6 • Colestipol7,8 is restricted to treatment of hypercholesterolaemia and is NON- FORMULARY in Cambridgeshire and Peterborough. -
MPS 2742 To: All Community Pharmacists 15 December 2020 Dear Colleague
MPS 2742 Pharmaceutical Services, 2 Franklin Street, Belfast BT2 8DQ Telephone No. 028 95 36 0333 To: All Community Pharmacists 15th December 2020 Dear colleague Re: Bile acid sequestrants- colestyramine powder for oral suspension 4g (Questran and Questran Light), colesevelam (Cholestagel) and colestipol (Colestid) Description of product affected Colestyramine is licensed for use in the following indications1,2: Primary prevention of coronary heart disease in men between 35 and 59 years of age and with primary hypercholesterolaemia who have not responded to diet and other appropriate measures. Reduction of plasma cholesterol in hypercholesterolaemia, particularly in those patients who have been diagnosed as Fredrickson's Type II (high plasma cholesterol with normal or slightly elevated triglycerides). Relief of pruritus associated with partial biliary obstruction and primary biliary cirrhosis. Relief of diarrhoea associated with ileal resection, Crohn's disease, vagotomy and diabetic vagal neuropathy. Management of radiation-induced diarrhoea The dose used varies between 4g and 36g daily according to the indication.1,2 MPS 2742 Pharmaceutical Services, 2 Franklin Street, Belfast BT2 8DQ Telephone No. 028 95 36 0333 For relief of diarrhoea, it is common practice to use colestyramine off-label to treat “bile acid diarrhoea” where considered clinically appropriate. This condition may be diagnosed using a radionucleotide SeHCAT test.3 Colestyramine is also used to help reduce the volume of jejunal and ileostomy outputs as a consequence -
Pravafenix, INN-Pravastatin/Fenofibrate
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Pravafenix 40 mg/160 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate. Excipient: Each hard capsule contains 19 mg of lactose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Pravafenix is a hard capsule, with light green body and olive cap, containing a waxy white beige mass and a tablet. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Pravafenix is indicated for the treatment of high coronary heart disease (CHD) -risk adult patients with mixed dyslipidaemia characterised by high triglycerides and low HDL-cholesterol levels whose LDL- C levels are adequately controlled while on a treatment with pravastatin 40 mg monotherapy. 4.2 Posology and method of administration Prior to initiating Pravafenix, secondary causes of combined dyslipidaemia should be excluded and patients should be placed on a standard cholesterol and triglycerides-lowering diet which should be continued during treatment. Posology The recommended dose is one capsule per day. Dietary restrictions instituted before therapy should be continued. Response to therapy should be monitored by determination of serum lipid values. Rapid reduction of serum lipid levels usually follows Pravafenix treatment, but treatment should be discontinued if an adequate response has not been achieved within three months. Special populations Elderly patients (≥ 65 years old) Treatment initiation with Pravafenix should be decided after renal function has been evaluated (see section 4.4 Renal and urinary disorders). Limited safety data on Pravafenix is available in patients >75 years of age and care should be exercised. -
Proposed Package Leaflet Simvastatin 40 Mg , Film-Coated Tablets Simvastatin Read All of This Leaflet Carefully Before You Start
Proposed Package leaflet Simvastatin 40 mg , film-coated tablets Simvastatin Read all of this leaflet carefully before you start taking this medicine • Keep this leaflet. You may need to read it again • If you have any further questions, ask your doctor or pharmacist • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Simvastatin 40 mg is and what it is used for. 2. Before you take Simvastatin 40 mg. 3. How to take Simvastatin 40 mg. 4. Possible side effects. 5. How to store Simvastatin 40 mg. 6. Further information. 1. WHAT SIMVASTATIN 40 mg IS AND WHAT IT IS USED FOR Simvastatin belongs to a group of medicines known as statins. These work by reducing the amount of cholesterol and certain fatty substances called triglycerides in your blood. Simvastatin is used: - to lower cholesterol and triglycerides in the blood when a low fat diet and other measures (such as exercise, weight loss) have failed. - to lower inherited high levels of cholesterol in your blood (homozygous familial hypercholesterolemia), together with dieting and other treatments (e.g. LDL-apheresis), or when such treatments are not appropriate. - to reduce the risk of coronary heart disease if you have hardening of the arteries (arteriosclerosis) or diabetes, even if your cholesterol levels are normal, together with dieting and other treatments. -
Information for the User Ezetimibe/Simvastatin Clonmel 10 Mg/10 Mg Tablets Ezetimibe/Simvastatin Clonmel 10 Mg
Package leaflet: Information for the user Ezetimibe/Simvastatin Clonmel 10 mg/10 mg tablets Ezetimibe/Simvastatin Clonmel 10 mg/20 mg tablets Ezetimibe/Simvastatin Clonmel 10 mg/40 mg tablets Ezetimibe/Simvastatin Clonmel 10 mg/80 mg tablets Ezetimibe/simvastatin Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Ezetimibe/Simvastatin Clonmel is and what it is used for 2. What you need to know before you take Ezetimibe/Simvastatin Clonmel 3. How to take Ezetimibe/Simvastatin Clonmel 4. Possible side effects 5. How to store Ezetimibe/Simvastatin Clonmel 6. Contents of the pack and other information 1. What Ezetimibe/Simvastatin Clonmel is and what it is used for Ezetimibe/Simvastatin Clonmel is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Ezetimibe/Simvastatin Clonmel raises levels of “good” cholesterol (HDL cholesterol). Ezetimibe/Simvastatin Clonmel contains the active substances ezetimibe and simvastatin. Ezetimibe/Simvastatin Clonmel works to reduce your cholesterol in two ways.