FrancophonIA/ELRC3.0 huggingface dataset:
English: Tesavel must not be used in people who are hypersensitive (allergic) to sitagliptin or any of the other ingredients.
Danish: Tesavel må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for sitagliptin eller andre af indholdsstofferne.
English: What is the risk associated with Tesavel?
Danish: Hvilken risiko er der forbundet med Tesavel?
English: Tesavel was studied in nine studies involving almost 6,000 patients with type 2 diabetes whose blood glucose levels were not adequately controlled:
Danish: Tesavel blev undersøgt i ni undersøgelser, som omfattede næsten 6 000 patienter med type 2diabetes, hvis blodglukoseniveauer ikke var tilstrækkeligt reguleret:
English: Serious side effects reported with Tesavel include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions).
Danish: Alvorlige indberettede bivirkninger ved Tesavel omfatter pankreatitis (betændelse i bugspytkirtlen) og overfølsomhed (allergiske reaktioner).
English: If Tesavel is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
Danish: Hvis Tesavel tages sammen med et sulfonylurinstof eller insulin, er det muligvis nødvendigt at nedsætte dosis af sulfonylurinstoffet for at mindske risikoen for hypoglykæmi (lave blodsukkerniveauer).
English: When taken on their own, Tesavel and metformin produced similar reductions in HbA1c levels, but the effectiveness of Tesavel seemed to be slightly lower than that of metformin.
Danish: Når de blev taget hver for sig, bevirkede Tesavel og metformin tilsvarende fald i HbA1c-niveauer, men effekten af Tesavel var tilsyneladende en anelse lavere end effekten af metformin.
English: In the studies comparing Tesavel with other medicines, the effectiveness of adding Tesavel to metformin was similar to that of adding glipizide.
Danish: I de undersøgelser, hvor Tesavel blev sammenlignet med andre lægemidler, svarede effekten af at tilføje Tesavel til metformin til effekten af at tilføje glipizid.
English: Tesavel or placebo were used on their own in two studies involving 1,262 patients, as an add-on to metformin in one study involving 701 patients, and as an add-on to pioglitazone (a PPAR-gamma agonist) in one study involving 353 patients;
Danish: Tesavel eller placebo blev anvendt hver for sig i to undersøgelser, der omfattede 1 262 patienter, som en tillægsbehandling til metformin i en undersøgelse, der omfattede 701 patienter, og som tillægsbehandling til pioglitazon (en PPAR-gammaagonist) i en undersøgelse, der omfattede 353 patienter.
English: What is Tesavel?
Danish: Hvad er Tesavel?
English: Tesavel is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels.
Danish: Tesavel anvendes til patienter med type 2-diabetes til at forbedre reguleringen af blodglukoseniveauerne (sukker).
English: • three additional studies compared Tesavel with placebo when they were added to other antidiabetes medicines: glimepiride (another sulphonylurea), with or without metformin, in 441 patients; the combination of metformin and rosiglitazone (a PPAR-gamma agonist) in 278 patients; and a stable dose of insulin, with or without metformin, in 641 patients.
Danish: • I tre yderligere undersøgelser blev Tesavel sammenlignet med placebo, når disse blev anvendt som tillægsbehandling til andre lægemidler mod diabetes: glimepirid (et andet sulfonylurinstof), med eller uden metformin, hos 441 patienter, en kombination af metformin og rosiglitazon (en PPAR-gamma-agonist) hos 278 patienter og en stabil dosis insulin, med eller uden metformin, hos 641 patienter.
English: Why has Tesavel been approved?
Danish: Hvorfor blev Tesavel godkendt?
English: In patients taking Tesavel on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% after 24 weeks.
Danish: Hos patienter, som fik Tesavel alene, faldt HbA1c-niveauerne fra ca. 8,0 % i starten af undersøgelserne med 0,48 % efter 18 uger og med 0,61 % efter 24 uger.
English: For the full list of all side effects reported with Tesavel, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Tesavel fremgår af indlægssedlen.
English: One study compared Tesavel with glipizide (a sulphonylurea), when they were used as an add-on to metformin in 1,172 patients.
Danish: I en undersøgelse sammenlignedes Tesavel med glipizid (et sulfonylurinstof), hvor de blev anvendt som en tillægsbehandling til metformin hos 1 172 patienter.
English: The other study compared Tesavel with metformin, used on their own, in 1,058 patients;
Danish: I den anden undersøgelse sammenlignedes Tesavel med metformin anvendt hver for sig hos 1 058 patienter.
English: Finally, they were reduced by 0.59% in patients adding Tesavel to insulin (with or without metformin), compared with a fall of 0.03% in those adding placebo.
Danish: Niveauerne blev endelig reduceret med 0,59 % hos patienter, som fik tilføjet Tesavel til insulin (med eller uden metformin), sammenlignet med et fald på 0,03 % hos dem, der fik tilføjet placebo.
English: Hypoglycaemia has been reported in combination with a sulphonylurea in 4.7-13.8% of patients and with insulin in 9.6% of patients.
Danish: Hypoglykæmi blev indberettet hos 4,7 til 13,8 % af patienterne, der fik Tesavel i kombination med et sulfonylurinstof, og hos 9,6 % af patienterne, som fik Tesavel med insulin.
English: • in combination with both metformin and a sulphonylurea or a PPAR-gamma agonist, in patients who are not satisfactorily controlled on the two medicines;
Danish: • i kombination med både metformin og et sulfonylurinstof eller en PPAR-gammaagonist hos patienter, som ikke reguleres tilfredsstillende med de to lægemidler
English: HbA1c levels were reduced by 1.03% after 18 weeks in patients adding Tesavel to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo.
Danish: HbA1c-niveauerne blev reduceret med 1,03 % efter 18 uger hos patienter, som fik tilføjet Tesavel til metformin og rosiglitazon sammenlignet med et fald på 0,31 % hos dem, som fik tilføjet placebo.
English: What is Tesavel used for?
Danish: Hvad anvendes Tesavel til?
English: What benefit has Tesavel shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Tesavel?
English: In the additional studies, adding Tesavel to glimepiride (with and without metformin) led to a reduction in HbA1c levels of 0.45% after 24 weeks, compared with an increase of 0.28% in the patients adding placebo.
Danish: I de yderligere undersøgelser bevirkede tilføjelsen af Tesavel til glimepirid (med og uden metformin) et fald i HbA1c-niveauerne på 0,45 % efter 24 uger sammenlignet med en stigning på 0,28 % hos patienter, som fik tilføjet placebo.
English: How has Tesavel been studied?
Danish: Hvordan blev Tesavel undersøgt?
English: Adding Tesavel to metformin reduced HbA1c levels by 0.67% after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Danish: Ved at tilføje Tesavel til metformin reduceredes HbA1c-niveauerne med 0,67 % efter 24 uger sammenlignet med et fald på 0,02 % hos patienter, som fik tilføjet placebo.
English: How is Tesavel used?
Danish: Hvordan anvendes Tesavel?
English: When added to pioglitazone, Tesavel reduced HbA1c levels by 0.85% after 24 weeks, compared with a fall of 0.15% in the patients adding placebo.
Danish: Ved at tilføje Tesavel til pioglitazon reduceredes HbA1cniveauerne med 0,85 % efter 24 uger sammenlignet med et fald på 0,15 % hos patienter, som fik tilføjet placebo.
English: How does Tesavel work?
Danish: Hvordan virker Tesavel?
English: This overview was last updated in 09-2018.
Danish: Denne oversigt er sidst opdateret i 09-2018.
English: 1 See outcome of safety review carried out in 2018 here.
Danish: 1 Se resultatet af sikkerhedsgennemgangen i 2018 her.
English: Xofigo received a marketing authorisation valid throughout the EU on 13 November 2013.
Danish: Xofigo fik en markedsføringstilladelse med gyldighed i hele EU den 13. november 2013.
English: This may limit the damage to nearby healthy tissues.
Danish: Dette kan begrænse skaden på det omkringliggende sunde væv.
English: Further information on Xofigo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Xofigo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It should be used only for patients who have had at least two previous treatments for prostate cancer or who cannot receive other treatments.
Danish: Det bør kun anvendes hos patienter, der har fået mindst to tidligere behandlinger for prostatakræft, eller som ikke kan få andre behandlinger.
English: Patients were given up to 6 injections at 1-month intervals and were followed up for 3 years from the first injection.
Danish: Patienterne fik op til 6 injektioner med 1 måneds mellemrum og blev fulgt i 3 år efter den første injektion.
English: Injections are repeated every 4 weeks for a total of 6 injections.
Danish: Behandlingen gentages hver 4. uge, indtil der er indgivet i alt 6 injektioner.
English: As for all medicines, data on the use of Xofigo are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Xofigo løbende overvåget.
English: Other information about Xofigo
Danish: Andre oplysninger om Xofigo
English: The bones in the body take up radium in the same way as calcium.
Danish: Kroppens knogler optager radium på samme måde som kalcium.
English: What measures are being taken to ensure the safe and effective use of Xofigo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xofigo?
English: Patients given Xofigo lived on average for 14.9 months, compared with 11.3 months for those given placebo.
Danish: De patienter, der fik Xofigo, overlevede gennemsnitligt i 14,9 måneder, sammenholdt med 11,3 måneder for de patienter, der fik placebo (ikke-aktivt stof).
English: Xofigo must not be used with the medicine abiraterone acetate and the corticosteroids prednisone or prednisolone.
Danish: Xofigo må ikke anvendes sammen med lægemidlet abirateronacetat eller kortikosteroiderne prednison og prednisolon.
English: For more information about using Xofigo, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Xofigo, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Xofigo are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Xofigo vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Xofigo can increase the risk of having fractures.
Danish: Xofigo kan øge risikoen for at få knoglebrud.
English: The most serious side effects were thrombocytopenia and neutropenia (low levels of neutrophils, a type of white blood cell that fights infection).
Danish: De alvorligste bivirkninger var trombocytopeni og neutropeni (lavt antal neutrofiler (en type hvide blodlegemer, der bekæmper infektion)).
English: The European Medicines Agency decided that Xofigo's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Xofigo opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: An overview of Xofigo and why it is authorised in the EU
Danish: En oversigt over Xofigo, og hvorfor det er godkendt i EU
English: The radioactive radium builds up in bone tissues where the cancer has spread, and the alpha particles destroy surrounding cancer cells and help to control the associated symptoms.
Danish: Det radioaktive radium ophobes i knoglevæv, som kræften har spredt sig til, og alfapartiklerne ødelægger de omgivende kræftceller og hjælper med at kontrollere de tilknyttede symptomer.
English: Why is Xofigo authorised in the EU?
Danish: Hvorfor blev Xofigo godkendt i EU?
English: The dose of Xofigo is calculated to provide a specific dose of radioactivity based on the patient's body weight.
Danish: Xofigo-dosen beregnes, så der opnås en specifik dosis radioaktivitet ud fra patientens legemsvægt.
English: What is Xofigo and what is it used for?
Danish: Hvad er Xofigo, og hvad anvendes det til?
English: Xofigo has been shown to prolong life and delaying signs and symptoms of progressive disease.
Danish: Det er påvist, at Xofigo forlænger overlevelsen og forsinker tegn og symptomer på sygdomsforværring.
English: Xofigo (radium-223 dichloride)
Danish: Xofigo (radium-223 dichlorid)
English: The company that markets Xofigo will have to conduct studies to further characterise the safety profile of the medicine, in particular with regard to the risk of fractures and the risk of new metastases that do not affect the bone in patients treated with Xofigo.
Danish: Den virksomhed, der markedsfører Xofigo, skal gennemføre studier til nærmere beskrivelse af lægemidlets sikkerhedsprofil, navnlig hvad angår risikoen for knoglebrud og risikoen for nye metastaser i andre væv end knoglevævet hos patienter, der behandles med Xofigo.
English: Xofigo is used on its own or in combination with a medicine known as an ‘LHRH analogue'.
Danish: Xofigo anvendes alene eller i kombination med en såkaldt GnRH-analog.
English: The most common side effects with Xofigo (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), vomiting, thrombocytopenia (low blood-platelet counts) and bone fractures.
Danish: De hyppigste bivirkninger ved Xofigo (der kan forekomme hos mere end 1 ud af 10 patienter) er diarré, kvalme, opkastning, trombocytopeni (lavt antal blodplader) og knoglebrud.
English: Xofigo is used when castration (to stop the production of male hormones) by surgery or with medicines does not work, and when the cancer has spread to the bones (bone metastases) and is causing symptoms such as pain, but has not spread to other internal organs.
Danish: Xofigo anvendes, når kastration (standsning af produktionen af mandlige kønshormoner) ved medicinering eller kirurgi ikke har nogen effekt, og når kræften har spredt sig til knoglerne (knoglemetastaser) og giver symptomer som f.eks. smerter, men ikke har spredt sig til andre indre organer.
English: What are the risks associated with Xofigo?
Danish: Hvilke risici er der forbundet med Xofigo?
English: Xofigo was compared with placebo (a dummy treatment) as an addition to standard care in a main study involving 921 men with cancer of the prostate that had spread to the bones and for which suppression of male hormones using medicines or surgery did not work.
Danish: Xofigo blev sammenlignet med placebo (et ikke-aktivt stof) som tillæg til standardbehandling i et hovedstudie med 921 mænd med prostatakræft, der havde spredt sig til knoglerne, og hvor undertrykkelse af de mandlige kønshormoner ved medicinering eller kirurgi ikke havde nogen effekt.
English: Xofigo can only be obtained with a prescription and should only be handled and given by someone who is authorised to use radioactive medicines and after evaluation of the patient by a qualified doctor.
Danish: Xofigo udleveres kun efter recept og må kun håndteres og indgives af en autoriseret sundhedsperson med erfaring i anvendelse af radioaktive lægemidler.
English: Xofigo contains the active substance radium-223 dichloride.
Danish: Xofigo indeholder det aktive stof radium-223 dichlorid.
English: The active substance in Xofigo, radium-223, emits short-range radiation known as alpha particles.
Danish: Det aktive stof i Xofigo, radium-223, udsender kortrækkende stråling i form af såkaldte alfapartikler.
English: The medicine is slowly injected into a vein usually for up to one minute.
Danish: Det tager typisk op til et minut.
English: For the full list of side effects of Xofigo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Xofigo fremgår af indlægssedlen.
English: The signs and symptoms of progressive disease such as bone pain also took longer to develop in patients given Xofigo.
Danish: Det tog også længere tid, før der sås tegn og symptomer på sygdomsforværring, f.eks. knoglesmerter, hos de patienter, der fik Xofigo.
English: Xofigo is a radiopharmaceutical (a medicine containing a radioactive substance) that is used to treat adults with cancer of the prostate (a gland of the male reproductive system).
Danish: Xofigo er et radioaktivt lægemiddel, der anvendes til behandling af voksne mænd med prostatakræft (kræft i blærehalskirtlen).
English: How is Xofigo used?
Danish: Hvordan anvendes Xofigo?
English: What benefits of Xofigo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Xofigo?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xofigo have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Xofigo.
English: How does Xofigo work?
Danish: Hvordan virker Xofigo?
English: Regarding its safety, several measures have been put in place to minimise the risks of the medicine such as bone fractures1 The radiation emitted by Xofigo has a shorter range than the radiation of currently available radiopharmaceuticals.
Danish: Hvad angår sikkerheden, er der truffet en række foranstaltninger for at minimere lægemidlets bivirkninger, f.eks. knoglebrud1.
English: Take your dose once a day.
Danish: Tag din dosis én gang om dagen.
English: You have been prescribed CRESTOR because:
Danish: Du har fået ordineret Crestor fordi:
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende efter behov blive opdateret af den relevante myndighed i medlemsstaten i samarbejde med referencemedlemsstaten i overensstemmelse med de procedurer, der er fastlagt i kapitel 4 af titel III af direktiv 2001/83/EC.
English: These changes were each in the direction of improved lipid responses and were sustained over 2 years.
Danish: Disse ændringer var alle i retning af forbedret lipidrespons og blev fastholdt over 2 år.
English: This trial (n=176) was not suited for comparison of rare adverse drug events.
Danish: Dette studie (n=176) egnede sig ikke til sammenligning af sjældne uønskede hændelser.
English: Children younger than 6 years
Danish: Børn under 6 år
English: • You have other factors that increase your risk of having a heart attack, stroke or related health problems.
Danish: • Du har andre faktorer, der øger din risiko for at få en blodprop i hjertet, et slagtilfælde eller helbredsproblemer relateret hertil.
English: Rosuvastatin exposure was predictable with respect to dose and time over a 2-year period.
Danish: Rosuvastatineksponeringen var forudsigelig med hensyn til dosis og tid over en 2-årig periode.
English: Treatment of hypercholesterolaemia
Danish: Behandling af hyperkolesterolæmi
English: Use in children and adolescents aged 6-17 years
Danish: Brug til børn og teenagere i alderen 6- 17 år
English: The starting dose for all patients was 5 mg rosuvastatin once daily.
Danish: Startdosis til alle patienter var 5 mg rosuvastatin én gang dagligt.
English: Paediatric population Paediatric use should only be carried out by specialists.
Danish: Pædiatrisk population Den pædiatriske population bør kun behandles af specialister.
English: [The wording of the indication for treatment of hypercholesterolaemia should be replaced with the following:]
Danish: [Ordlyden vedrørende indikationen for behandling af hyperkolesterolæmi skal ersattes af følgende:]
English: What CRESTOR is and what it is used for [Existing wording of this section should be replaced with the following:] CRESTOR belongs to a group of medicines called statins.
Danish: Virkning og anvendelse [Eksisterende ordlyd i dette afsnit skal erstattes af følgende:] Crestor tilhører en gruppe af lægemidler, der kaldes statiner.
English: • If the patient is under 6 years old: CRESTOR should not be given to children younger than 6 years.
Danish: • hvis patienten er under 6 år: Crestor bør ikke gives til børn under 6 år.
English: Crestor is used in adults, adolescents and children 6 years or older to treat high cholesterol.
Danish: Crestor anvendes hos voksne, unge og børn på 6 år og derover til behandling af forhøjet kolesterol.
English: You should continue with your cholesterol-lowering diet and exercise while you are taking CRESTOR.
Danish: Du skal fortsætte med din kolesterolfattige kost og med at motionere, mens du tager Crestor.
English: The 40 mg tablet is not suitable for use in paediatric patients.
Danish: 40 mg-tabletten er ikke egnet til pædiatriske patienter.
English: Therefore, Crestor is not recommended for use in children younger than 6 years.
Danish: Derfor anbefales Crestor ikke til børn under 6 år.
English: Experience in children with homozygous familial hypercholesterolaemia is limited to a small number of children aged between 8 and 17 years.
Danish: Erfaringen hos børn med homozygot familiær hyperkolesterolæmi er begrænset til et lille antal børn i alderen 8 til 17 år.
English: Your doctor may increase your dose to find the right amount of CRESTOR for you.
Danish: Den sædvanlige startdosis er 5 mg. Din læge kan øge din dosis for at finde den mængde Crestor, der passer til dig.
English: CRESTOR 40 mg tablet should not be used by children.
Danish: Crestor 40 mg må ikke anvendes til børn.
English: At study entry, approximately 30% of the patients were 10-13 years and approximately 17%, 18%, 40%, and 25% were Tanner stage II, III, IV, and V, respectively.
Danish: Ved inklusionen i forsøget var ca. 30 % af patienterne 10-13 år og ca. 17 %, 18 %, 40 % og 25 % var henholdsvis på Tanner Stage II, III, IV og V.
English: Titration should be conducted according to the individual response and tolerability in paediatric patients, as recommended by the paediatric treatment recommendations (see Section 4.4).
Danish: Titrering skal ske i henhold til pædiatriske patienters individuelle reaktion og tolerabilitet i henhold til anbefalingerne for behandling af børn (se pkt.
English: The maximum daily dose of CRESTOR is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years.
Danish: Den maksimale daglige Crestor-dosis er 10 mg til børn i alderen 6 til 9 år og 20 mg til børn i alderen 10 til 17 år.
English: Rosuvastatin 5 mg, 10 mg, and 20 mg also achieved statistically significant mean changes from baseline for the following secondary lipid and lipoprotein variables: HDL-C, TC, non-HDL-C,LDL-C/HDLC, TC/HDL-C, TG/HDL-C, non HDL C/HDL-C, ApoB, ApoB/ApoA-1.
Danish: Rosuvastatin 5 mg, 10 mg og 20 mg medførte også statistisk signifikante gennemsnitlige ændringer i forhold til baseline hvad angik følgende sekundære lipid- og lipoproteinvariable: HDL-C, TC, non-HDL-C, LDL-C/HDL-C, TC/HDL-C, TG/HDL-C, non-HDL-C/HDL-C, ApoB, ApoB/ApoA-1.
English: LDL-C was reduced 38.3%, 44.6%, and 50.0% by rosuvastatin 5, 10 and 20 mg, respectively, compared to 0.7% for placebo.
Danish: LDL-C var reduceret med 38,3 %, 44,6 % og 50,0 % ved henholdsvis rosuvastatin 5, 10 og 20 mg sammenlignet med 0,7 % ved placebo.
English: Safety and efficacy of doses greater than 20 mg have not been studied in this population.
Danish: Sikkerheden og virkningen af doser over 20 mg er ikke undersøgt i denne population.
English: Safety and efficacy of doses greater than 10 mg have not been studied in this population.
Danish: Sikkerheden og virkningen af doser over 10 mg er ikke undersøgt i denne population.
English: The safety and efficacy of use in children younger than 6 years has not been studied.
Danish: Sikkerheden og virkningen hos børn under 6 år er ikke klarlagt.