FrancophonIA/ELRC3.0 huggingface dataset:
English: Cometriq was given once a day in an initial dose of 140 mg (reduced if necessary due to side effects) and compared with placebo (a dummy treatment).
Danish: Cometriq blev givet én gang dagligt med en begyndelsesdosis på 140 mg (som om nødvendigt kunne nedsættes ved bivirkninger) og sammenlignet med placebo (en virkningsløs behandling).
English: Other information about Cometriq
Danish: Andre oplysninger om Cometriq
English: It is used to treat adults with medullary thyroid cancer, a type of cancer originating in the cells in the thyroid gland that produce the hormone calcitonin.
Danish: Det anvendes til behandling af voksne med medullær thyroideacancer, en kræfttype, som udgår fra de celler i skjoldbruskkirtlen, der producerer hormonet calcitonin.
English: Cometriq is a cancer medicine that contains the active substance cabozantinib.
Danish: Cometriq er et kræftlægemiddel, der indeholder det aktive stof cabozantinib.
English: The full EPAR and risk management plan summary for Cometriq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Cometriq findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Cometriq can only be obtained with a prescription and treatment should only be started by a doctor who has experience in using cancer medicines.
Danish: Cometriq udleveres kun efter recept, og behandlingen bør kun iværksættes af en læge med erfaring i brug af kræftmedicin.
English: Since Cometriq has been granted a conditional approval, the company that markets Cometriq will provide information from a study comparing the safety and effectiveness of different doses of Cometriq, and its benefit in patients lacking the RET gene mutation or whose cancer has changes in another family of genes called RAS.
Danish: Da Cometriq har fået en betinget godkendelse, skal den virksomhed, der markedsfører Cometriq, fremlægge oplysninger fra en undersøgelse, der sammenligner sikkerheden og virkningen af forskellige doser af Cometriq og fordele heraf hos patienter, der ikke har RET-genmutationen, eller hos hvem kræftcellerne har forandringer i en anden familie af gener (RAS).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cometriq, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Cometriq, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: What measures are being taken to ensure the safe and effective use of Cometriq?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cometriq?
English: The active substance in Cometriq, cabozantinib, is a tyrosine kinase inhibitor.
Danish: Det aktive stof i Cometriq, cabozantinib, er en tyrosinkinasehæmmer.
English: Cometriq is used when the cancer cannot be removed by surgery and has progressed or spread to other parts of the body.
Danish: Cometriq anvendes, når kræften ikke kan fjernes ved operation og er fremskreden eller har bredt sig til andre dele af kroppen.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Cometriq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Cometriq findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: For more information about treatment with Cometriq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cometriq, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Cometriq has been shown to be effective in one main study involving 330 adults with medullary thyroid cancer that could not be treated with surgery and was extensive or had spread to other parts of the body.
Danish: Cometriq er påvist at være effektivt i én hovedundersøgelse med 330 voksne med medullær thyroideacancer, der ikke kunne behandles med operation og var omfattende eller havde bredt sig til andre dele af kroppen.
English: What is Cometriq and what is it used for?
Danish: Hvad er Cometriq, og hvad anvendes det til?
English: Why is Cometriq approved?
Danish: Hvorfor blev Cometriq godkendt?
English: Cometriq should be used with care in patients taking certain other medicines that affect the way it is broken down in the body.
Danish: Cometriq bør anvendes med forsigtighed hos patienter, der får andre lægemidler, som påvirker dets nedbrydning i kroppen.
English: It is not intended to provide practical advice on how to use Cometriq.
Danish: Det er ikke en praktisk vejledning i, hvordan Cometriq bør anvendes.
English: For the full list of all side effects and restrictions with Cometriq, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger ved Cometriq fremgår af indlægssedlen.
English: What information is still awaited for Cometriq?
Danish: Hvilke oplysninger afventes der stadig for Cometriq?
English: What are the risks associated with Cometriq?
Danish: Hvilke risici er der forbundet med Cometriq?
English: By blocking the activity of these receptors in cancer cells, the medicine reduces the growth and spread of the cancer.
Danish: Ved at blokere virkningen af disse enzymer i kræftcellerne medvirker Cometriq til at begrænse kræftens vækst og spredning.
English: Cometriq had shown a benefit in patients with advanced medullary thyroid cancer unsuitable for surgery, who have few other treatment options.
Danish: Cometriq havde vist gavnlig virkning hos patienter med fremskreden, ikke-operationsegnet medullær thyroideacancer, for hvem der kun er få andre behandlingsmuligheder.
English: The benefits of Cometriq may be smaller for patients whose cancer does not have a mutation in a gene called the ‘re-arranged during transfection' (RET) gene, and this should be taken into account when deciding whether to start treatment.
Danish: Fordelene ved Cometriq er muligvis mindre for patienter, hvis kræftceller ikke har en mutation i genet RET ("re-arranged during transfection").
English: The most common abnormal results in laboratory blood tests were increased liver enzymes such as aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP), low white cell counts (lymphopenia or neutropenia), thrombocytopenia (low blood-platelet counts), hypocalcaemia (low blood calcium levels), hypophosphataemia (low blood levels of phosphates), hypomagnesaemia (low blood magnesium levels), hypokalaemia (low blood potassium levels) and hyperbilirubinaemia (increased amounts of bilirubin, a breakdown product of red blood cells).
Danish: De hyppigste abnorme blodprøver var forhøjede leverenzymer, såsom aspartataminotransferase (AST), alaninaminotransferase (ALT) og alkalisk fosfatase (ALP), lavt antal hvide blodlegemer (lymfopeni eller neutropeni), lavt antal blodplader (trombocytopeni), lavt calciumindhold i blodet (hypocalcæmi), lavt fosfatindhold i blodet (hypofosfatæmi), lavt magnesiumniveau i blodet (hypomagnesiæmi), lavt kaliumindhold i blodet (hypokaliæmi) og forhøjet indhold af bilirubin, et nedbrydningsprodukt af røde blodlegemer (hyperbilirubinæmi).
English: The most common side effects with Cometriq (which may affect more than 2 in 10 people) are diarrhoea, palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome, which involves rash and numbness on the palms and soles), loss of weight, loss of appetite, nausea (feeling sick), tiredness, taste disturbances, changes in hair colour, hypertension (high blood pressure), inflammation of the mucosa (moist tissue that lines certain body cavities) including stomatitis (inflammation of the lining of the mouth), constipation, vomiting, weakness, and changes in the sound of the voice.
Danish: De hyppigste bivirkninger ved Cometriq (som optræder hos mere end 2 ud af 10 patienter) er diarré, hånd-fod-syndrom med udslæt og følelsesløshed af håndflader og fodsåler (palmart-plantart erytrodysæstesisyndrom), vægttab, nedsat appetit, kvalme, træthed, smagsforstyrrelser, ændret hårfarve, for højt blodtryk (hypertension), inflammation af slimhinderne, herunder mundslimhinden (stomatitis), forstoppelse, opkastning, svaghed og ændret stemme.
English: For practical information about using Cometriq, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Cometriq, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The dose may need to be reduced or stopped temporarily
Danish: Det kan være nødvendigt at nedsætte dosis eller midlertidigt standse behandlingen på grund af bivirkninger, navnlig i de første otte uger af
English: The most common serious side effects are pneumonia, inflammation of the mucosa, hypocalcaemia (low calcium levels in the blood), dysphagia (difficulty swallowing), dehydration, pulmonary embolism (blood clots in the vessels supplying the lungs), and hypertension.
Danish: De alvorligste bivirkninger er lungebetændelse, inflammation af slimhinder, for lavt calciumindhold i blodet (hypokalcæmi), synkebesvær (dysfagi), væsketab (dehydrering), blodpropper i karrene til lungerne (lungeemboli) og for højt blodtryk (hypertension).
English: The main measure of effectiveness was progression-free survival (how long the patients lived before their disease got worse): in patients given Cometriq this was 11.2 months, compared with 4.0 months in those given placebo.
Danish: Hos de patienter, der fik Cometriq, var dette 11,2 måneder, sammenlignet med 4,0 måneder hos dem, der fik placebo.
English: How is Cometriq used?
Danish: Hvordan anvendes Cometriq?
English: These enzymes can be found in certain receptors (such as VEGF, MET and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels to supply the cancer.
Danish: Disse enzymer findes i visse receptorer (såsom VEGF-, MET- og RETreceptorer) i kræftceller.
English: How does Cometriq work?
Danish: Hvordan virker Cometriq?
English: What benefits of Cometriq have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Cometriq?
English: Member State EU/EEA
Danish: Medlemsland EU/EØS
English: Other beneficial effects on patients with regards to other system organ classes have not convincingly been shown.
Danish: Andre gavnlige virkninger på patienter med hensyn til andre systemorganklasser er ikke blevet påvist på en overbevisende måde.
English: In the EU sibutramine was first authorised in January 1999.
Danish: Sibutramin blev tilladt i EU første gang i januar 1999.
English: These non-fatal events are considered serious and life-threatening and may be associated with considerable morbidity.
Danish: Disse ikke-dødelige hændelser anses for at være alvorlige og livstruende og kan knyttes sammen med en betydelig morbiditet.
English: In addition, the maintenance of weight loss after cessation of treatment is questionable.
Danish: Desuden er vedligeholdelsen af vægttabet efter behandlingens ophør tvivlsom.
English: ANNEX III CONDITIONS FOR LIFTING THE SUSPENSION
Danish: BILAG III BETINGELSER FOR OPHÆVELSE AF SUSPENDERINGEN
English: For the suspension to be lifted the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following:
Danish: Hvis suspenderingen skal ophæves, skal indehaverne af markedsføringstilladelserne forelægge følgende for de kompetente nationale myndigheder:
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SIBUTRAMINECONTAINING MEDICINAL PRODUCTS (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LÆGEMIDLER INDEHOLDENDE SIBUTRAMIN (SE BILAG I)
English: The CHMP also requested a Scientific Advisory Group (SAG) Diabetes/Endocrinology meeting to be held in January to provide additional expert input.
Danish: CHMP anmodede ligeledes om, at der blev afholdt et møde i den videnskabelige rådgivende gruppe (SAG) om diabetes/endokrinologi i januar for at skaffe yderligere input fra sagkyndige.
English: 04010 Campoverde di Aprilia Italy
Danish: 04010 Campoverde di Aprilia Italien
English: In conclusion, the CHMP was of the opinion that the results of the SCOUT study are of concern.
Danish: Afslutningsvis mente CHMP, at resultaterne af SCOUT-undersøgelsen giver anledning til bekymring.
English: 1074 Budapest Hungary
Danish: 1074 Budapest Ungarn
English: Plaza CEIN 5, Nave B-14Noain (Navarra) Spain
Danish: Plaza CEIN 5, Nave B-14Noain (Navarra) Spanien
English: Even in this “best case scenario” approximately 1400 patients would need to be treated with sibutramine to prevent one CV event.
Danish: Selv i dette "best case-scenarie" skal omkring 1.400 patienter behandles med sibutramin for at forebygge en enkelt kardiovaskulær hændelse.
English: The SCOUT data shows a lower benefit compared to previous trials and to the meta-analysis by Rucker et al. (2007).
Danish: Dataene fra SCOUT-undersøgelsen viser en mindre fordel sammenlignet med tidligere undersøgelser og med metaanalysen foretaget af Rucker et al. (2007).
English: An Article 31 referral was triggered in March 2002 due to safety concerns based on fatal adverse reactions.
Danish: Der blev foretaget en indbringelse i henhold til artikel 31 i marts 2002 på grund af betænkeligheder vedrørende sikkerheden på grund af bivirkninger med dødelig udgang.
English: DK-1100 København K Denmark
Danish: DK-1100 København K Danmark
English: Rowex Ltd Bantry Co.Cork Ireland
Danish: Rowex Ltd Bantry Co.Cork Irland
English: Belgium Teva pharma belgium Laarstraat 16
Danish: Teva pharma belgium Laarstraat 16
English: 2132 WT, Hoofddorp Netherlands
Danish: 2132 WT, Hoofddorp Holland
English: The CHMP considered that the currently approved indication and contraindications already provide substantial restrictions and that additional restrictions would not be practical.
Danish: CHMP fandt, at den indikation og de kontraindikationer, der er godkendt i øjeblikket, allerede indebærer væsentlige begrænsninger, og at yderligere begrænsninger ikke ville være praktiske.
English: The CHMP also recommended that temporary measures are needed and therefore recommends to the European Commission that the marketing and use of sibutramine-containing medicinal products be suspended forthwith in all concerned EU Member States awaiting the adoption of the final measures.
Danish: CHMP anbefalede ligeledes, at der gennemføres midlertidige foranstaltninger, og anbefaler derfor Europa-Kommissionen, at markedsføringen og anvendelsen af lægemidler indeholdende sibutramin fremover suspenderes i alle de berørte EU-medlemsstater, mens vedtagelsen af de endelige foranstaltninger afventes.
English: Eastbourne, East Sussex BN22 9AG United Kingdom
Danish: Eastbourne, East Sussex BN22 9AG Storbritannien
English: 94528 RUNGIS CEDEX FRANCE
Danish: 94528 RUNGIS CEDEX FRANKRIG
English: 2031 GA, Haarlem Netherlands
Danish: 2031 GA, Haarlem Holland
English: 83602 Holzkirchen Germany
Danish: 83602 Holzkirchen Tyskland
English: The CHMP also suggested that the influence of gender within this subgroup (61% females compared with 32-37% in the CV Only group and 36% in the CV + DM group) warrants consideration, as the Cox regression analysis suggests that females have a 40% lower risk of primary outcome than males.
Danish: CHMP foreslog også, at betydningen af køn i denne undergruppe (61 % kvinder sammenlignet med 32-37 % i gruppen "kun CV" og 36 % i gruppen "CV + DM") bør overvejes, da Cox-regressionsanalyser tyder på, at kvinder har en 40 % lavere risiko for primære hændelser end mænd.
English: After 12 months of treatment no additional mean weight loss was achieved with sibutramine.
Danish: Efter 12 måneders behandling blev der ikke opnået noget yderligere gennemsnitligt vægttab med sibutramin.
English: Veluwezoom 22 1327 AH, Almere Netherlands
Danish: Veluwezoom 22 1327 AH, Almere Holland
English: However, although there was no evidence of increased risk of POE or mortality within the DM Only group, the evidence of benefit was considered to be weak.
Danish: Selv om der ikke forelå nogen tegn på en øget risiko for primære hændelser eller dødelighed i gruppen "kun DM", blev beviserne for en fordel anset for at være svage.
English: The Sibutramine Cardiovascular OUTcomes (SCOUT) study was initiated in January
Danish: SCOUT-undersøgelsen (Sibutramine Cardiovascular OUTcomes) blev indledt i januar 2003.
English: Comparing sibutramine-treated responders and placebo-treated non-responders (although this comparison may be influenced by behavioural differences including compliance to diet and exercise and is not a logical or scientific comparison to make) provides the most favourable benefit/risk for sibutramine.
Danish: En sammenligning af sibutraminbehandlede respondenter og placebobehandlede ikke-respondenter (selv om denne sammenligning kan være påvirket af adfærdsmæssige forskelle, herunder overholdelse af diæt og motion og ikke er en logisk eller videnskabelig sammenligning) resulterer i det mest gunstige benefit/risk-forhold for sibutramin.
English: The current use of sibutramine is already substantially restricted by the SPC and no further useful or practical restrictions were identified.
Danish: Den nuværende anvendelse af sibutramin er allerede væsentligt begrænset af produktresuméet, og ingen yderligere nyttige eller praktiske begrænsninger blev påvist.
English: S.C. TERAPIA S.A. Str. Fabricii, nr. 124, Cluj-Napoca, Romania
Danish: S.C. TERAPIA S.A. Str. Fabricii, nr. 124, Cluj-Napoca, Rumænien
English: With sibutramine treatment, only 30.4% of the patients were responders (defined as patients who lost at least 5% body weight within 3 months), compared with 19.5% of patients treated with placebo.
Danish: Med sibutraminbehandling var kun 30,4 % af patienterne respondenter (defineret som patienter, som tabte mindst 5 % af deres kropsvægt inden for 3 måneder) sammenlignet med 19,5 % af patienterne behandlet med placebo.
English: 1A Farma A/S Herstedøstervej 27-29 DK-2620 Albertslund Denmark
Danish: 1A Farma A/S Herstedøstervej 27-29 DK-2620 Albertslund Danmark
English: The Kaplan-Meier curve shows an early increased risk of POE and an even earlier increase for non-fatal POE.
Danish: Kaplan-Meier-kurven viser en tidlig øget risiko for primære hændelser og en endnu tidligere stigning i ikke-dødelig primære hændelser.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE SUSPENSION OF THE MARKETING AUTHORISATIONS
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR SUSPENDERING AF MARKEDSFØRINGSTILLADELSERNE
English: ANNEX I LIST OF THE INVENTED NAME, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA)
Danish: BILAG I LISTE OVER SÆRNAVNE, LÆGEMIDDELFORM, STYRKER AF LÆGEMIDMLET, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSLANDENE (EU/EØS)
English: Belgium Sandoz NV Telecom Gardens Medialaan 40
Danish: Sandoz NV Telecom Gardens Medialaan 40
English: Sibutramine should be used in conjunction with a reduced calorie diet and increased physical activity in - Patients with nutritional obesity and a body mass index (BMI) of 30 kg/m2 or higher.
Danish: Sibutramin bør anvendes sammen med en kaloriefattig kost og øget fysisk aktivitet hos - patienter med ernæringsbetinget fedme og et kropsmasseindeks (BMI) på 30 kg/m2 eller derover.
English: In addition, it was not possible, based on the SCOUT data and other published or unpublished studies, to identify patient groups that may derive benefit from sibutramine use without an increased cardiovascular risk.
Danish: Derudover var det ikke muligt på grundlag af SCOUT-dataene og andre offentliggjorte eller ikke offentliggjorte undersøgelser at identificere patientgrupper, der kan have fordel af sibutramin uden en øget kardiovaskulær risiko.
English: GROUNDS FOR THE SUSPENSION OF THE MARKETING AUTHORISATIONS
Danish: BEGRUNDELSER FOR SUSPENDERING AF MARKEDSFØRINGSTILLADELSERNE
English: A revision of the packaging to limit availability to a 1-month supply was not considered to reduce the increased cardiovascular risk associated with sibutramine and restriction to a one month prescription may not be appropriate for a primary care prescribed product for an increasingly prevalent condition.
Danish: En revision af pakken for at begrænse tilgængeligheden til en måneds forsyning blev ikke anset for at nedbringe den øgede kardiovaskulære risiko forbundet med sibutramin, og begrænsningen til en recept på en måneds forbrug er måske ikke velegnet til et produkt, der ordineres til primær behandling for en stadig mere udbredt lidelse.
English: Furthermore, given the clear divergence of risks between sibutramine and placebo treated patients early on in therapy, the CHMP did not agree that the data supports a treatment duration of one year.
Danish: På grund af den klare forskel i risiciene mellem patienter behandlet med sibutramin og patienter behandlet med placebo tidligt i behandlingsforløbet var CHMP desuden ikke enig i, at dataene støtter en behandlingsvarighed på et år.
English: Abbot Laboratories Ireland Ltd 4051 Kingswood Drive Citywest Business Campus Dublin 24
Danish: Abbott Laboratories Ireland Ltd 4051 Kingswood Drive Citywest Business Campus Dublin 24
English: Sibutramine-treated patients in SCOUT had a statistically significantly higher incidence of primary outcome events compared with placebo treatment (hazard ratio HR 1.161, p=0.016), driven by non-fatal MI (HR 1.275, p=0.022) and non-fatal stroke (HR 1.354, 0.026).
Danish: Patienter, der blev behandlet med sibutramin i SCOUT-undersøgelsen, havde en statistisk signifikant højere forekomst af primære effektmål sammenlignet med patienter i placebobehandling (risikoforhold (HR) 1,161, p=0,016) foranlediget af ikke-dødeligt myokardieinfarkt (HR 1,275, p = 0,022) og ikke-dødeligt slagtilfælde (HR 1,354, 0,026).
English: A procedure under Article 107 of Directive 2001/83/EC was triggered in November 2009 based on preliminary results from SCOUT that suggested an increased cardiovascular risk with sibutramine treatment compared with placebo.
Danish: En procedure i henhold til artikel 107 i direktiv 2001/83/EF blev indledt i november 2009 baseret på de foreløbige resultater af SCOUT-undersøgelsen, der tydede på en øget kardiovaskulær risiko ved sibutraminbehandling sammenlignet med placebobehandling.
English: No firm conclusion was reached with regards to these reactions and on the basis of the available data on sibutramine, the CHMP therefore considered the benefit-risk balance to be favourable and adopted an Opinion recommending the maintenance of the Marketing Authorisations.
Danish: Man nåede ikke frem til nogen klar konklusion med hensyn til disse reaktioner, og på grundlag af de tilgængelige data om sibutramin anså CHMP derfor benefit/risk-forholdet for at være gunstigt og vedtog en udtalelse, hvori det anbefaledes at opretholde markedsføringstilladelserne.
English: Consequently the CHMP expressed concern that the increase in rates of POEs in the sibutramine arm compared with placebo was in fact sufficient to be statistically significant.
Danish: CHMP gav derfor udtryk for bekymring over, at stigningen i antallet af primære hændelser i sibutramin-armen sammenlignet med placebo rent faktisk var tilstrækkelig til at være statistisk signifikant.
English: In addition, an increase in duration of use tended to increase the risk of non-fatal POE in this subgroup and the point estimate for non-fatal POE tended towards harm at the three year time point.
Danish: Desuden havde en øget varighed af anvendelsen tendens til at øge risikoen for ikke-dødelige primære hændelser i denne undergruppe, og punktestimatet for ikke-dødelige primære hændelser gik i retning af skader efter tre år.