Reseptregisteret 2012–2016 the Norwegian Prescription Database 2012–2016
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1 Annex I Annex I Summary of Product Characteristics
ANNEX I ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT VENVIA 1 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains rosiglitazone maleate corresponding to 1 mg rosiglitazone. For excipients see 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets Yellow film-coated tablets marked "SB" on one side and "1" on the other. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Rosiglitazone is indicated only in oral combination treatment of type 2 diabetes mellitus in patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or a sulphonylurea: − in combination with metformin only in obese patients. − in combination with a sulphonylurea only in patients who show intolerance to metformin or for whom metformin is contraindicated. 4.2 Posology and method of administration Treatment should only be initiated by a physician experienced in the treatment of type 2 diabetes. Experience from clinical trials with rosiglitazone is currently limited to 2 years. The long-term benefits of therapy with rosiglitazone have not been demonstrated (see section 5.1). Rosiglitazone therapy is usually initiated at 4 mg/day. Combination with Metformin This dose can be increased to 8 mg/day after 8 weeks if greater glycaemic control is required. Combination with sulphonylurea There is currently no experience with doses of rosiglitazone above 4 mg/day in combination with sulphonylureas. Rosiglitazone may be given once or twice a day. Rosiglitazone may be taken with or without food. Elderly No dose adjustment is required in the elderly. 2 Patients with renal impairment No dose adjustment is required in patients with mild and moderate renal insufficiency. -
Analysis of Mutations Leading to Para-Aminosalicylic Acid Resistance in Mycobacterium Tuberculosis
www.nature.com/scientificreports OPEN Analysis of mutations leading to para-aminosalicylic acid resistance in Mycobacterium tuberculosis Received: 9 April 2019 Bharati Pandey1, Sonam Grover2, Jagdeep Kaur1 & Abhinav Grover3 Accepted: 31 July 2019 Thymidylate synthase A (ThyA) is the key enzyme involved in the folate pathway in Mycobacterium Published: xx xx xxxx tuberculosis. Mutation of key residues of ThyA enzyme which are involved in interaction with substrate 2′-deoxyuridine-5′-monophosphate (dUMP), cofactor 5,10-methylenetetrahydrofolate (MTHF), and catalytic site have caused para-aminosalicylic acid (PAS) resistance in TB patients. Focusing on R127L, L143P, C146R, L172P, A182P, and V261G mutations, including wild-type, we performed long molecular dynamics (MD) simulations in explicit solvent to investigate the molecular principles underlying PAS resistance due to missense mutations. We found that these mutations lead to (i) extensive changes in the dUMP and MTHF binding sites, (ii) weak interaction of ThyA enzyme with dUMP and MTHF by inducing conformational changes in the structure, (iii) loss of the hydrogen bond and other atomic interactions and (iv) enhanced movement of protein atoms indicated by principal component analysis (PCA). In this study, MD simulations framework has provided considerable insight into mutation induced conformational changes in the ThyA enzyme of Mycobacterium. Antimicrobial resistance (AMR) threatens the efective treatment of tuberculosis (TB) caused by the bacteria Mycobacterium tuberculosis (Mtb) and has become a serious threat to global public health1. In 2017, there were reports of 5,58000 new TB cases with resistance to rifampicin (frst line drug), of which 82% have developed multidrug-resistant tuberculosis (MDR-TB)2. AMR has been reported to be one of the top health threats globally, so there is an urgent need to proactively address the problem by identifying new drug targets and understanding the drug resistance mechanism3,4. -
Journal of Diabetes and Obesity
Journal of Diabetes and Obesity Research Article Open Access The Different Association between Metformin and Sulfony- lurea Derivatives and the Risk of Cancer May be Confounded by Body Mass Index Catherine E. de Keyser1,2, Loes E. Visser1, Albert Hofman1, Bruno H. Stricker1,2*, Rikje Ruiter1# 1 Department of Epidemiology, Erasmus Medical Center, Rotterdam, the Netherlands 2 The Health Care Inspectorate, The Hague, the Netherlands *Corresponding author: Bruno H. Stricker, Department of Epidemiology, Erasmus MC, P.O. Box 2040, 3000CA Rotterdam, the Netherlands, Tel: +31-10-7044958; Fax: +31-10-7044657; E-mail: [email protected] #Submitting author: Rikje Ruiter, Department of Epidemiology, Erasmus MC, P.O. Box 2040, 3000CA Rotterdam, the Nether- lands, Tel: +31-10-7044958; Fax: +31-10-7044657; E-mail: [email protected] Abstract Received date: July 09, 2016 Aim: Several studies in large databases suggest that in comparison to glucose-low- Accepted date: : September 05, 2016 ering sulfonylurea derivatives, metformin is associated with a reduced risk of cancer Publication date: September 12, 2016 in patients with diabetes. As many databases miss relevant confounder data, our objective was to investigate whether the determinants age, body mass index (BMI), alcohol consumption, and renal function were associated with dispensing of either Citation: Stricker, B.H., et al. The Dif- metformin or sulfonylurea derivatives as first drug therapy for type 2 diabetes mel- ferent Association between Metformin and litus while taking into account calendar time. Sulfonylurea Derivatives and the Risk of Methods: We identified 639 incident metformin users and 934 incident sulfonylurea Cancer May be Confounded by Body Mass derivatives users in the Rotterdam Study, a prospective population-based cohort Index. -
Are Metformin, Statin and Aspirin Use Still Associated with Overall Mortality Among Colorectal Cancer Patients with Diabetes If Adjusted for One Another? Zanders, M
Tilburg University Are metformin, statin and aspirin use still associated with overall mortality among colorectal cancer patients with diabetes if adjusted for one another? Zanders, M. M. J.; van Herk-Sukel, M. P. P.; Vissers, P. A. J.; Herings, R. M. C.; Haak, H. R.; van de Poll-Franse, L. V. Published in: The British Journal of Cancer DOI: 10.1038/bjc.2015.259 Publication date: 2015 Document Version Publisher's PDF, also known as Version of record Link to publication in Tilburg University Research Portal Citation for published version (APA): Zanders, M. M. J., van Herk-Sukel, M. P. P., Vissers, P. A. J., Herings, R. M. C., Haak, H. R., & van de Poll- Franse, L. V. (2015). Are metformin, statin and aspirin use still associated with overall mortality among colorectal cancer patients with diabetes if adjusted for one another? The British Journal of Cancer, 113(3), 403-410. https://doi.org/10.1038/bjc.2015.259 General rights Copyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights. • Users may download and print one copy of any publication from the public portal for the purpose of private study or research. • You may not further distribute the material or use it for any profit-making activity or commercial gain • You may freely distribute the URL identifying the publication in the public portal Take down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. -
Actos II-10-11
ANNEX I ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Actos 15 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg of pioglitazone as hydrochloride. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Tablet. The tablets are white to off-white, round, convex and marked ‘15’ on one face. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Pioglitazone is indicated as oral monotherapy in type 2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. Pioglitazone is also indicated for oral combination treatment in type 2 diabetes mellitus patients with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy with either metformin or sulphonylurea: - in combination with metformin particularly in overweight patients - in combination with a sulphonylurea only in patients who show intolerance to metformin or for whom metformin is contraindicated 4.2 Posology and method of administration The long-term benefits of therapy with pioglitazone have not been demonstrated (see section 5.1). Pioglitazone tablets are taken orally once daily with or without food. Dosage in adults: Pioglitazone may be initiated at 15mg or 30mg once daily. The dose may be increased in increments up to 45mg once daily. In combination with metformin, the current metformin dose can be continued upon initiation of pioglitazone therapy. In combination with sulphonylurea, the current sulphonylurea dose can be continued upon initiation of pioglitazone therapy. If patients report hypoglycaemia, the dose of sulphonylurea should be decreased. 2 Elderly: No dosage adjustment is necessary for elderly patients (see section 5.2). -
Pharmaceutical Services Division and the Clinical Research Centre Ministry of Health Malaysia
A publication of the PHARMACEUTICAL SERVICES DIVISION AND THE CLINICAL RESEARCH CENTRE MINISTRY OF HEALTH MALAYSIA MALAYSIAN STATISTICS ON MEDICINES 2008 Edited by: Lian L.M., Kamarudin A., Siti Fauziah A., Nik Nor Aklima N.O., Norazida A.R. With contributions from: Hafizh A.A., Lim J.Y., Hoo L.P., Faridah Aryani M.Y., Sheamini S., Rosliza L., Fatimah A.R., Nour Hanah O., Rosaida M.S., Muhammad Radzi A.H., Raman M., Tee H.P., Ooi B.P., Shamsiah S., Tan H.P.M., Jayaram M., Masni M., Sri Wahyu T., Muhammad Yazid J., Norafidah I., Nurkhodrulnada M.L., Letchumanan G.R.R., Mastura I., Yong S.L., Mohamed Noor R., Daphne G., Kamarudin A., Chang K.M., Goh A.S., Sinari S., Bee P.C., Lim Y.S., Wong S.P., Chang K.M., Goh A.S., Sinari S., Bee P.C., Lim Y.S., Wong S.P., Omar I., Zoriah A., Fong Y.Y.A., Nusaibah A.R., Feisul Idzwan M., Ghazali A.K., Hooi L.S., Khoo E.M., Sunita B., Nurul Suhaida B.,Wan Azman W.A., Liew H.B., Kong S.H., Haarathi C., Nirmala J., Sim K.H., Azura M.A., Asmah J., Chan L.C., Choon S.E., Chang S.Y., Roshidah B., Ravindran J., Nik Mohd Nasri N.I., Ghazali I., Wan Abu Bakar Y., Wan Hamilton W.H., Ravichandran J., Zaridah S., Wan Zahanim W.Y., Kannappan P., Intan Shafina S., Tan A.L., Rohan Malek J., Selvalingam S., Lei C.M.C., Ching S.L., Zanariah H., Lim P.C., Hong Y.H.J., Tan T.B.A., Sim L.H.B, Long K.N., Sameerah S.A.R., Lai M.L.J., Rahela A.K., Azura D., Ibtisam M.N., Voon F.K., Nor Saleha I.T., Tajunisah M.E., Wan Nazuha W.R., Wong H.S., Rosnawati Y., Ong S.G., Syazzana D., Puteri Juanita Z., Mohd. -
Estonian Statistics on Medicines 2016 1/41
Estonian Statistics on Medicines 2016 ATC code ATC group / Active substance (rout of admin.) Quantity sold Unit DDD Unit DDD/1000/ day A ALIMENTARY TRACT AND METABOLISM 167,8985 A01 STOMATOLOGICAL PREPARATIONS 0,0738 A01A STOMATOLOGICAL PREPARATIONS 0,0738 A01AB Antiinfectives and antiseptics for local oral treatment 0,0738 A01AB09 Miconazole (O) 7088 g 0,2 g 0,0738 A01AB12 Hexetidine (O) 1951200 ml A01AB81 Neomycin+ Benzocaine (dental) 30200 pieces A01AB82 Demeclocycline+ Triamcinolone (dental) 680 g A01AC Corticosteroids for local oral treatment A01AC81 Dexamethasone+ Thymol (dental) 3094 ml A01AD Other agents for local oral treatment A01AD80 Lidocaine+ Cetylpyridinium chloride (gingival) 227150 g A01AD81 Lidocaine+ Cetrimide (O) 30900 g A01AD82 Choline salicylate (O) 864720 pieces A01AD83 Lidocaine+ Chamomille extract (O) 370080 g A01AD90 Lidocaine+ Paraformaldehyde (dental) 405 g A02 DRUGS FOR ACID RELATED DISORDERS 47,1312 A02A ANTACIDS 1,0133 Combinations and complexes of aluminium, calcium and A02AD 1,0133 magnesium compounds A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 811120 pieces 10 pieces 0,1689 A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 3101974 ml 50 ml 0,1292 A02AD83 Calcium carbonate+ Magnesium carbonate (O) 3434232 pieces 10 pieces 0,7152 DRUGS FOR PEPTIC ULCER AND GASTRO- A02B 46,1179 OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 2,3855 A02BA02 Ranitidine (O) 340327,5 g 0,3 g 2,3624 A02BA02 Ranitidine (P) 3318,25 g 0,3 g 0,0230 A02BC Proton pump inhibitors 43,7324 A02BC01 Omeprazole -
Pharmacoepidemiological Study Report Synopsis ER-9489 A
DAHLIA Report synopsis ER-9489 Version 1.0 14 November 2017 Pharmacoepidemiological study report synopsis ER-9489 A retrospective nationwide cohort study to investigate the treatment of type 2 diAbetic pAtients in Finland - DAHLIA Authors: Solomon Christopher, Anna Lundin, Minna Vehkala, Fabian Hoti Study ID: ER-9489 Sponsor: AstraZeneca Nordic Baltic Report version: 1.0 Report date: 14 November 2017 EPID ReseArch CONFIDENTIAL DAHLIA Report synopsis ER-9489 Version 1.0 14 November 2017 Study Information Title A retrospective nationwide cohort study to investigate the treatment of type 2 diabetic patients in Finland – DAHLIA Study ID ER-9489 Report synopsis version 1.0 Report synopsis date 14 November 2017 EU PAS register number ENCEPP/SDPP/8202 Sponsor AstraZeneca Nordic Baltic SE-151 85 Södertälje, Sweden Sponsor contact person Susanna Jerström, Medical Evidence Manager Medical Nordic-Baltic SE-151 85 Södertälje, Sweden Active substance ATC codes A10 (Drugs used in diabetes) Medicinal product The folloWing AstraZeneca products are available on the Finnish market: Bydureon (exenatide A10BX04), Byetta (exenatide A10BX04), Forxiga (dapagliflozin A10BX09), Komboglyze (metformine and saxagliptin A10BD10), Onglyza (saxagliptin A10BH03), Xigduo (dapagliflozin and metformin A10BD15) Country of study Finland Authors of the report Solomon Christopher, Anna Lundin, Minna Vehkala, Fabian Hoti synopsis EPID ReseArch Page 2 of 43 DAHLIA Report synopsis ER-9489 Version 1.0 14 November 2017 Table of contents 1 Study report summary (Abstract) ........................................................................................... -
Preliminary Results of Bedaquiline As Salvage Therapy for Patients with Nontuberculous Mycobacterial Lung Disease
[ Original Research Chest Infections ] Preliminary Results of Bedaquiline as Salvage Th erapy for Patients With Nontuberculous Mycobacterial Lung Disease Julie V. Philley , MD ; Richard J. Wallace Jr , MD , FCCP ; Jeana L. Benwill , MD ; Varsha Taskar , MD ; Barbara A. Brown-Elliott , MS , MT(ASCP)SM ; Foram Thakkar , MBBS ; Timothy R. Aksamit , MD , FCCP ; and David E. Griffi th , MD , FCCP BACKGROUND: Bedaquiline is an oral antimycobacterial agent belonging to a new class of drugs called diarylquinolines. It has low equivalent minimal inhibitory concentration s for Mycobacterium tuberculosis and nontuberculous mycobacterial (NTM) lung disease , especially Mycobacterium avium complex (MAC) and Mycobacterium abscessus (Mab). Bedaquiline appears to be eff ective for the treatment of multidrug-resistant TB but has not been tested clinically for NTM disease. METHODS: We describe a case series of off -label use of bedaquiline for treatment failure lung disease caused by MAC or Mab. Only patients whose insurance would pay for the drug were included. Fift een adult patients were selected, but only 10 (six MAC, four Mab) could obtain bedaquiline. Th e 10 patients had been treated for 1 to 8 years, and all were on treatment at the start of bedaquiline therapy. Eighty percent had macrolide-resistant isolates (eight of 10). Th e patients were treated with the same bedaquiline dosage as that used in TB trials and received the best available companion drugs (mean, 5.0 drugs). All patients completed 6 months of therapy and remain on bedaquiline. RESULTS: Common side eff ects included nausea (60%), arthralgias (40%), and anorexia and subjective fever (30%). No abnormal ECG fi ndings were observed with a mean corrected QT interval lengthening of 2.4 milliseconds at 6 months. -
BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available
BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] BMJ Open Pediatric drug utilization in the Western Pacific region: Australia, Japan, South Korea, Hong Kong and Taiwan Journal: BMJ Open ManuscriptFor ID peerbmjopen-2019-032426 review only Article Type: Research Date Submitted by the 27-Jun-2019 Author: Complete List of Authors: Brauer, Ruth; University College London, Research Department of Practice and Policy, School of Pharmacy Wong, Ian; University College London, Research Department of Practice and Policy, School of Pharmacy; University of Hong Kong, Centre for Safe Medication Practice and Research, Department -
Appendices: V Ervolgonderzoek Medicatieveiligheid
APPENDICES: V ERVOLGONDERZOEK MEDICATIEVEILIGHEID Dit is een bijlage bij het rapport Vervolgonderzoek Medicatieveiligheid en is opgesteld voor het Ministerie van VWS vanuit een samenwerkingsverband tussen het Erasmus MC (Rotterdam), NIVEL (Utrecht), Radboud UMC (Nijmegen) en PHARMO (Utrecht) Januari 2017 Versie 1.0 1 Appendices Hoofstuk 2: Onderzoek naar de mate van opvolging van HARM-Wrestling aanbevelingen (2009-2014) 2 Appendix 1 Appendix 1: Technische omzetting van HARM-Wrestling aanbevelingen naar indicatoren Algemene specificaties Tabel A1a. Bepaling van medicatiegebruik. Geneesmiddel of ATC-code geneesmiddelen groep Antidepressiva N06A Laag gedoseerd ASA B01AC06, B01AC08, B01AC30, N02BA15 (dosering 100mg) of N02BA01 (dosering 80mg) Benzodiazepinen N05CF, N05CD, N05BA of N05CC Beta-blokkers C07 Bisfosfonaten M05BA, M05BB, of M05XX Calcineurine remmers L04AA05 of L04AD01 Carbamazepine N03AF01 Corticosteroiden H02AB Co-trimoxazol J01EE01 Coxibs M01AH Diabetesmedicatie A10 Digoxine C01AA05 Glibenclamide A10BB01 of A10BD02 of A10BD04 H2RA A02BA Itraconazol J02AC02 Kaliumsparende diuretica C03DA, C03DB, of C03EA Kaliumverliezende diuretica C03A, C03B, C03E, C07B, C07CB03, C09BA, C09DA, C09XA52, C03C of C09DX01 Ketoconazol J02AB02 Niet-selectieve NSAID’s N02BA01, N02BA15, N02BA11, N02BA51, N02BA65 of M01A met uitzondering van M01AH, M01AX05, M01AX12, M01AX21, M01AX24, M01AX25 en M01AX26 Laxantia A06A, A02AA02, A02AA03, A02AA04, A06AC, A06AA, of A06AG Lisdiuretica C03C Macroliden J01FA of A02BD04 VKA B01AA Opioïden N02AA met uitzondering van N02AA55, N02AA59 en N02AA79, N02AB, N02AC, N02AD, N02AG, N02AE of N07BC01 Pentamidine P01CX01 PPI’s A02BC of M01AE52 RAS-remmers C09 Sotalol C07AA07 Spironolacton C03DA01 SSRI's N06AB, N06AX21 of N06AX16 Sulonylureumderivaten A10BB, A10BD02 of A10BD04 Thiazidediuretica C03A, C03B, C03EA, C07B, C09BA, C09DA, C09XA52, C09DX01 of C07CB03 TAR B01AC04, B01AC06, B01AC08, B01AC22, B01AC30, N02BA15 (dosering 100mg) of N02BA01 (dosering 80mg) Thienopyridine derivaten B01AC04, B01AC22 of B01AC30 3 Appendix 1 Tabel A1b. -
Treatment of Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis in Children: the Role of Bedaquiline and Delamanid
microorganisms Review Treatment of Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis in Children: The Role of Bedaquiline and Delamanid Francesco Pecora, Giulia Dal Canto, Piero Veronese and Susanna Esposito * Pediatric Clinic, Department of Medicine and Surgery, Pietro Barille Children’s Hospital, University Hospital of Parma, 43126 Parma, Italy; [email protected] (F.P.); [email protected] (G.D.C.); [email protected] (P.V.) * Correspondence: [email protected] Abstract: Multidrug-resistant (MDR) tuberculosis (TB) has been emerging at an alarming rate over the last few years. It has been estimated that about 3% of all pediatric TB is MDR, meaning about 30,000 cases each year. Although most children with MDR-TB can be successfully treated, up to five years ago effective treatment was associated with a high incidence of severe adverse effects and patients with extensively drug-resistant (XDR) TB had limited treatment options and no standard regimen. The main objective of this manuscript is to discuss our present knowledge of the management of MDR- and XDR-TB in children, focusing on the characteristics and available evidence on the use of two promising new drugs: bedaquiline and delamanid. PubMed was used to search for all of the studies published up to November 2020 using key words such as “bedaquiline” and “delamanid” and “children” and “multidrug-resistant tuberculosis” and “extensively drug-resistant tuberculosis”. The search was limited to articles published in English and providing evidence-based Citation: Pecora, F.; Dal Canto, G.; data. Although data on pediatric population are limited and more studies are needed to confirm Veronese, P.; Esposito, S.