FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Deltyba are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Deltyba vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Deltyba must not be used in patients who have low levels of albumin (a blood protein).
Danish: Deltyba må ikke anvendes hos patienter, der har lav koncentration af albumin (et protein) i blodet.
English: Other information about Deltyba
Danish: Andre oplysninger om Deltyba
English: The European Medicines Agency decided that Deltyba'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 Deltyba opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: It should be used according to official guidelines on treating multi-drug resistant tuberculosis.
Danish: Det bør anvendes i henhold til de officielle retningslinjer for behandling af multiresistent tuberkulose.
English: It must also not be used in patients who are taking certain other medicines that affect the way Deltyba is broken down in the body.
Danish: Det må heller ikke anvendes hos patienter, der får visse andre lægemidler, som påvirker nedbrydningen af Deltyba i kroppen.
English: Why is Deltyba authorised in the EU?
Danish: Hvorfor blev Deltyba godkendt i EU?
English: What is Deltyba and what is it used for?
Danish: Hvad er Deltyba, og hvad anvendes det til?
English: The Agency noted that an on-going clinical study will provide confirmation on the long-term effectiveness.
Danish: Agenturet bemærkede, at et igangværende studie undersøger virkningen på lang sigt.
English: An overview of Deltyba and why it is authorised in the EU
Danish: En oversigt over Deltyba, og hvorfor det er godkendt i EU
English: The most common side effects with Deltyba (which may affect more than 1 patient in 10) are nausea, vomiting, headache, insomnia (sleeping problems), dizziness, tinnitus (ringing or buzzing in the ears), blood tests showing low potassium levels in the blood, gastritis (inflammation of the stomach lining), decreased appetite and weakness.
Danish: De hyppigste bivirkninger ved Deltyba (som kan forekomme hos mere end 1 ud af 10 patienter) er kvalme, opkastning, hovedpine, søvnløshed, svimmelhed, tinnitus, blodprøver, der viser lav koncentration af kalium i blodet, betændelse i bughinden, nedsat appetit og svaghed.
English: Deltyba contains the active substance delamanid.
Danish: Deltyba indeholder det aktive stof delamanid.
English: The effects of Deltyba have been looked at in one main study involving 481 adults with tuberculosis resistant to standard treatments.
Danish: Virkningen af Deltyba er undersøgt i et hovedstudie med deltagelse af 481 patienter med tuberkulose, der er resistent over for standardbehandlingerne.
English: Deltyba can only be obtained with a prescription and treatment should be started and monitored by a doctor who is experienced in the treatment of multi-drug resistant tuberculosis.
Danish: Deltyba udleveres kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af multiresistent tuberkulose.
English: The main measure of effectiveness was the proportion of patients who no longer had the bacteria in their sputum (phlegm).
Danish: Det primære mål for virkning var andelen af patienter, som ikke længere havde bakterien i deres sputum (slim).
English: The active substance in Deltyba, delamanid, is an antibiotic active against M. tuberculosis.
Danish: Det aktive stof i Deltyba, delamanid, er et antibiotikum, der virker mod M. tuberculosis.
English: Since Deltyba has been given conditional authorisation, the company that markets Deltyba will carry out further studies to confirm the long-term effectiveness and safety of Deltyba.
Danish: Eftersom Deltyba har fået en "betinget godkendelse", skal den virksomhed, der markedsfører Deltyba, udføre en række studier for at undersøge den langsigtede virkning og sikkerhed af Deltyba.
English: Deltyba is a medicine that is used in adults with tuberculosis affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, the two standard tuberculosis medicines).
Danish: Deltyba er et lægemiddel til behandling af voksne med tuberkulose, der sætter sig i lungerne, og som er multiresistent (resistens over for som minimum isoniazid og rifampicin, der er de to standardmidler mod tuberkulose).
English: Although the way it works is unclear, delamanid is known to block the production of methoxy-mycolic and ketomycolic acids, two essential components of the cell walls of M. tuberculosis, which will cause the bacteria to die.
Danish: Det vides ikke præcist, hvordan det virker, men delamanid vides at blokere dannelsen af methoxy-mycol- og ketomycolsyrer, der er to vigtige komponenter i cellevæggen på M. tuberculosis, og det får cellerne til at dø.
English: For more information about using Deltyba, see the package leaflet or contact a doctor or pharmacist.
Danish: Hvis du ønsker ydrligere oplysninger om anvendelsen af af Deltyba, kan du læse indlægssedlen eller kontakte lægen eller apoteket.
English: Patients in the study were given Deltyba or placebo (a dummy treatment) for 2 months in addition to their other treatments.
Danish: Patienterne i studiet fik Deltyba eller placebo (et ikke-aktivt stof) i 2 måneder i tillæg til deres andre behandlinger.
English: After 2 months of treatment more than 40% of the patients who were taking Deltyba no longer had the bacteria in their sputum compared with 30% of the patients who were taking placebo.
Danish: Efter 2 måneders behandling havde mere end 40 % af de patienter, der fik Deltyba, ikke længere bakterien i deres sputum sammenholdt med 30 % af de patienter, der fik placebo.
English: After the main study had finished, patients had the option to receive treatment with Deltyba for 6 months in an extension study.
Danish: Efter afslutningen af hovedstudiet fik patienterne mulighed for at få behandling med Deltyba i yderligere 6 måneder i et forlængelsesstudie.
English: The company that markets Deltyba will provide educational material for healthcare professionals, explaining how to use the medicine safely to avoid problems such as the development of resistance and side effects on the heart, as well as the risks in pregnancy or women who are breast-feeding.
Danish: Den virksomhed, der markedsfører Deltyba, skal udarbejde informationsmateriale til sundhedspersoner med oplysninger om sikker brug af lægemidlet (med henblik på at undgå problemer som f.eks. udvikling af resistens), hjerterelaterede bivirkninger og risiciene ved graviditet eller amning.
English: What are the risks associated with Deltyba?
Danish: Hvilke risici er der forbundet med Deltyba?
English: Furthermore the medical need for new agents to treat multi-drug resistant tuberculosis was highlighted.
Danish: Desuden blev det medicinske behov for nye stoffer mod multiresistent tuberkulose fremhævet.
English: What information is still awaited for Deltyba?
Danish: Hvilke oplysninger afventes der stadig for Deltyba?
English: Looking at the results of these follow-up studies together, 2 years after starting treatment 75% of patients who received Deltyba for 6 months or more had no bacteria in their sputum compared with 55% of patients who received Deltyba for 2 months or less.
Danish: Når man ser på disse opfølgningsstudier, havde 75 % af de patienter, der fik Deltyba i 6 måneder eller mere, ikke længere bakterien i deres sputum 2 år efter behandlingsstart sammenholdt med 55 % af de patienter, der fik Deltyba i 2 måneder eller derunder.
English: The Agency considered that the benefits of Deltyba had been shown for patients with multi-drug resistant tuberculosis affecting the lung.
Danish: Agenturet fandt, at fordelene for patienter med multiresistent tuberkulose, der rammer lungerne, var påvist.
English: For the full list of side effects of Deltyba, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Deltyba fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Deltyba 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 Deltyba.
English: How is Deltyba used?
Danish: Hvordan anvendes Deltyba?
English: What benefits of Deltyba have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Deltyba?
English: How does Deltyba work?
Danish: Hvordan virker Deltyba?
English: Sixmo (buprenorphine)
Danish: Sixmo (buprenorphin)
English: Further information on Sixmo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/sixmo.
Danish: Yderligere information om Sixmo findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/sixmo.
English: Other information about Sixmo
Danish: Andre oplysninger om Sixmo
English: The company will also provide an alert card which patients should carry at all times and show to other healthcare professionals before receiving any medical treatment.
Danish: Virksomheden skal også udlevere et patientkort, som patienterne til enhver tid skal have på sig og vise andet sundhedspersonale, før de modtager nogen form for lægebehandling.
English: It contains the active substance buprenorphine.
Danish: Det indeholder det aktive stof buprenorphin.
English: As for all medicines, data on the use of Sixmo are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Sixmo løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Sixmo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Sixmo?
English: The European Medicines Agency therefore decided that Sixmo's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Sixmo opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The most common side effects with Sixmo (which may affect up to 1 in 10 people) include headache, constipation and difficulty sleeping.
Danish: De hyppigste bivirkninger ved Sixmo (som kan forekomme hos op til 1 ud af 10 personer) er hovedpine, forstoppelse og søvnløshed.
English: Sixmo is used in adults who are already stable while taking buprenorphine under the tongue (no more than 8 mg/day), and who are also receiving medical, social and psychological support.
Danish: Sixmo anvendes til voksne, som allerede er stabile, når de tager buprenorphin under tungen (højst 8 mg pr. dag), og som også får medicinsk, social og psykologisk støtte.
English: The active substance in Sixmo, buprenorphine, is a partial opioid agonist (which means that it acts like an opioid but less powerfully).
Danish: Det aktive stof i Sixmo, buprenorphin, er en partiel opioid-agonist (dvs., at det virker som et opioid, men mindre kraftfuldt).
English: An overview of Sixmo and why it is authorised in the EU
Danish: En oversigt over Sixmo, og hvorfor det er godkendt i EU
English: The patient receives four implants, which are inserted under local anaesthesia in the inner side of the upper arm and kept in place for 6 months.
Danish: Patienten får fire implantater, der indsættes under lokalanæstesi i indersiden af overarmen og beholdes i 6 måneder.
English: Sixmo is an implant used to treat dependence on opioid drugs such as heroin or morphine.
Danish: Sixmo er et implantat, som anvendes til at behandle afhængighed af opioider som f.eks. heroin eller morfin.
English: What is Sixmo and what is it used for?
Danish: Hvad er Sixmo, og hvad anvendes det til?
English: The medicine can therefore be used in a controlled way to help prevent withdrawal symptoms and reduce the urge to misuse other opioids.
Danish: Lægemidlet kan derfor anvendes på en kontrolleret måde for at medvirke til at forebygge abstinenssymptomer og reducere trangen til at misbruge andre opioider.
English: Sixmo must not be used together with medicines known as ‘opioid antagonists' (naltrexone and nalmefene).
Danish: Sixmo må ikke anvendes sammen med lægemidler, der kaldes "opioidantagonister" (naltrexon og nalmelfen).
English: The most common side effects related to the insertion and removal of the implant are pain, itching, bruising, bleeding, reddening of the skin and rash at the site of the implant.
Danish: De hyppigste bivirkninger ved indsættelse og fjernelse af implantatet er smerter, kløe, blå mærker, blødning, rødmen af huden og udslæt på implantationsområdet.
English: Side effects reported with Sixmo are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Sixmo vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Why is Sixmo authorised in the EU?
Danish: Hvorfor er Sixmo godkendt i EU?
English: Three studies involving a total of 627 patients with opioid dependence showed that Sixmo is effective at reducing patients' intake of opioids.
Danish: Tre studier, der omfattede i alt 627 patienter med opioidafhængighed, viste, at Sixmo er effektivt til at reducere patienternes indtagelse af opioider.
English: In addition, the company will conduct a study to investigate breakages and other complications during the insertion and removal of the implants in clinical practice.
Danish: Virksomheden vil desuden gennemføre en undersøgelse for at undersøge implantatbrud og andre komplikationer i forbindelse med indsættelse og fjernelse af implantater i klinisk praksis.
English: The insertion and removal of the implant must be performed by a doctor who is experienced in minor surgery and has been trained to carry out the insertion and removal procedures.
Danish: Indsættelse og fjernelse af implantatet skal foretages af en læge, der har erfaring i mindre kirurgiske indgreb, og som er uddannet til at gennemføre procedurerne for indsættelse og fjernelse.
English: For more information about using Sixmo, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Sixmo, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: What are the risks associated with Sixmo?
Danish: Hvilke risici er der forbundet med Sixmo?
English: The main studies showed that Sixmo was more effective than placebo and at least as effective as sublingual buprenorphine at treating opioid dependence.
Danish: Hovedstudierne viste, at Sixmo var mere effektivt end placebo og mindst lige så effektivt som buprenorphin i sublingual form til behandling af opioidafhængighed.
English: Sixmo can only be obtained by ‘special' prescription.
Danish: Lægemidlet fås kun på "særlig" recept.
English: It must also not be used by patients who cannot have an MRI scan and by patients who have had an excessive formation of scar tissue, as this would make locating and removing the implants more difficult.
Danish: Det må heller ikke anvendes af patienter, der ikke kan få en MR-scanning, og af patienter, der har haft en unormal kraftig dannelse af arvæv, da dette ville vanskeliggøre lokalisering og fjernelse af implantater.
English: Treatment with Sixmo must be under the supervision of a healthcare professional experienced in the management of opioid dependence.
Danish: Behandling med Sixmo skal ske under tilsyn af en sundhedsperson med erfaring i håndtering af opioidafhængighed.
English: The company that markets Sixmo will set up an educational programme for doctors who are expected to prescribe Sixmo to provide detailed information about the surgical procedure for the insertion and removal of the implant.
Danish: Den virksomhed, der markedsfører Sixmo, skal udarbejde et oplysningsprogram til læger, der forventes at ordinere Sixmo, med detaljerede oplysninger om den kirurgiske procedure for indsættelse og fjernelse af implantatet.
English: This means that because the medicine can be misused or cause addiction, it is used under stricter conditions than normal.
Danish: Det betyder, at lægemidlet anvendes under strengere betingelser end normalt, fordi det kan misbruges og medføre afhængighed.
English: In both of these studies, the number of urine tests that were negative for opioid use decreased towards the end of the treatment period, indicating a reduction of the effect of Sixmo over time.
Danish: I begge studier faldt antallet af urintest, som var negative for opioidbrug, hen imod slutningen af behandlingsperioden, hvilket tyder på, at virkningen af Sixmo var aftagende med tiden.
English: Sixmo must not be used by patients with severe respiratory insufficiency (inability to breathe properly), patients with severe liver problems, and patients who are intoxicated with alcohol or are experiencing alcohol withdrawal symptoms.
Danish: Sixmo må ikke anvendes hos patienter med svært nedsat vejrtrækningsfunktion, alvorlige leverproblemer, eller hos patienter, der er forgiftet med alkohol, eller som har symptomer på alkoholabstinenser.
English: During the first 4 months of treatment, the percentage of negative urine tests for opioids was around 40% for patients treated with Sixmo, compared with around 28% for those treated with placebo.
Danish: I de første 4 måneder af behandlingen var procentdelen af negative urintest for opioider på ca. 40 % for patienter, der blev behandlet med Sixmo, sammenlignet med ca. 28 % for dem, der blev behandlet med placebo.
English: During the 6 months of treatment, the percentage of negative urine tests for opioids was around 31% for Sixmo, 13% for placebo and 33% for sublingual buprenorphine.
Danish: I de 6 måneder behandlingen varede, var procentdelen af negative urintest for opioider på ca. 31 % for Sixmo, 13 % for placebo og 33 % for buprenorphin i sublingual form.
English: The side effects of Sixmo are those expected for a buprenorphine medicine and side effects linked to the implant itself are considered manageable.
Danish: Sixmos bivirkninger er dem, der forventes for et lægemiddel med buprenorphin, og de bivirkninger, der er knyttet til implantatet, anses for at kunne håndteres.
English: The first study compared Sixmo with placebo (dummy) implants in 163 patients who had not received buprenorphine before.
Danish: I det første studie blev Sixmo sammenlignet med placebo (en virkningsløs behandling) hos 163 patienter, som ikke tidligere havde modtaget buprenorphin.
English: The second study in 287 patients who had not received buprenorphine before compared Sixmo with placebo implants and with sublingual buprenorphine (given under the tongue).
Danish: I det andet studie, hvori der indgik 287 patienter, som ikke tidligere havde fået buprenorphin, blev Sixmo sammenlignet med placeboimplantater og buprenorphin i sublingual form (givet under tungen).
English: While the effect of the implants tended to wear off with time in patients not previously treated with buprenorphine, it was maintained in patients who were already stable on low doses of buprenorphine and the use of Sixmo is therefore reserved for these patients.
Danish: Virkningen af implantaterne havde tendens til at aftage hos patienter, der ikke tidligere var blevet behandlet med buprenorphin, hvorimod den blev bibeholdt hos patienter, som allerede var stabile med lave doser buprenorphin.
English: For the full list of side effects of Sixmo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Sixmo fremgår af indlægssedlen.
English: How is Sixmo used?
Danish: Hvordan anvendes Sixmo?
English: How does Sixmo work?
Danish: Hvordan virker Sixmo?
English: What benefits of Sixmo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Sixmo?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sixmo 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 Sixmo.
English: Sixmo is available as an implant to be inserted under the skin, which continuously releases buprenorphine into the body.
Danish: Sixmo fås som et implantat, der indsættes under huden.
English: The third study compared Sixmo with sublingual buprenorphine in 177 patients whose opioid dependence was already being managed with sublingual buprenorphine at a daily dose of up to 8 mg. After 6 months of treatment, around 96% of patients who received Sixmo responded to treatment (i.e. there was no evidence of opioid use in at least 4 out of 6 months) compared with around 88% in patients on sublingual buprenorphine.
Danish: Efter 6 måneders behandling responderede ca. 96 % af de patienter, der fik Sixmo, på behandlingen (dvs. at der ingen evidens var for anvendelse af opioider i mindst 4 ud af 6 måneder) sammenlignet med ca. 88 % hos patienter, der fik buprenorphin i sublingual form.
English: NeoRecormon is available in various strengths from 500 to 50,000 international units (IU).
Danish: NeoRecormon fås i forskellige styrker fra 500 til 50 000 internationale enheder (IE).
English: The European Commission granted a marketing authorisation valid throughout the European Union for NeoRecormon on 17 July 1997.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for NeoRecormon den 17. juli 1997.
English: This is a summary of the European public assessment report (EPAR) for NeoRecormon.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for NeoRecormon.
English: The full EPAR for NeoRecormon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for NeoRecormon findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: NeoRecormon is used in the following situations:
Danish: NeoRecormon anvendes i følgende situationer:
English: The multidose formulation of NeoRecormon contains benzyl alcohol and must not be given to children below three years of age.
Danish: Flerdosis formulering af NeoRecormon indeholder benzylalkohol og må ikke gives til børn under tre år.
English: • to prevent anaemia in premature babies;
Danish: • til forebyggelse af anæmi hos for tidligt fødte spædbørn
English: A risk management plan has been developed to ensure that NeoRecormon is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at NeoRecormon anvendes så sikkert som muligt.
English: It contains the active substance epoetin beta.
Danish: Det indeholder det aktive stof epoetin beta.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for NeoRecormon.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan NeoRecormon skal anvendes.
English: For more information about treatment with NeoRecormon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med NeoRecormon, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Other information about NeoRecormon
Danish: Andre oplysninger om NeoRecormon
English: The most common side effects (seen in between 1 and 10 patients in 100) are hypertension (high blood pressure), headache and thromboembolic events (formation of blood clots in the blood vessels).
Danish: De mest almindelige bivirkninger (set hos mellem 1 og 10 patienter ud af 100) er hypertension (for højt blodtryk), hovedpine, tromboemboliske hændelser (dannelse af blodpropper i blodkarrene).