natgillin/translations-raw huggingface dataset:
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Deltyba?
What measures are being taken to ensure the safe and effective use of Deltyba?
Det anvendes sammen med andre lægemidler mod tuberkulose og kun, når andre standardlægemidler ikke kan anvendes, enten fordi sygdommen er resistent over for dem, eller fordi patienten ikke kan tåle bivirkningerne ved dem.
It is used together with other tuberculosis medicines and only when other standard medicine cannot be used either because the disease is resistant to them or because of their side effects.
Yderligere information vedrørende Deltyba findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Further information on Deltyba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Tuberkulose er en sjælden sygdom i EU, og Deltyba blev udpeget som "lægemiddel til sjældne sygdomme" den 1. februar 2008.
Tuberculosis is rare in the EU, and Deltyba was designated an ‘orphan medicine' (a medicine used in rare diseases) on 1 February 2008.
Selvom hovedstudiet var af kort varighed og opfølgningsstudierne havde en række mangler, vurderede agenturet, at den virkning, der er påvist efter 2 måneders behandling, sandsynligvis vil vare ved i hele behandlingsforløbet.
Although the main study was of short duration and the follow-up studies had shortcomings, the Agency considered that the effects shown after the initial 2 months of treatment are likely to be sustained for the full treatment duration.
Bivirkninger rapporteret for Deltyba vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Deltyba are carefully evaluated and any necessary action taken to protect patients.
Deltyba må ikke anvendes hos patienter, der har lav koncentration af albumin (et protein) i blodet.
Deltyba must not be used in patients who have low levels of albumin (a blood protein).
Andre oplysninger om Deltyba
Other information about Deltyba
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Deltyba opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that Deltyba's benefits are greater than its risks and it can be authorised for use in the EU.
Det bør anvendes i henhold til de officielle retningslinjer for behandling af multiresistent tuberkulose.
It should be used according to official guidelines on treating multi-drug resistant tuberculosis.
Det må heller ikke anvendes hos patienter, der får visse andre lægemidler, som påvirker nedbrydningen af Deltyba i kroppen.
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.
Hvorfor blev Deltyba godkendt i EU?
Why is Deltyba authorised in the EU?
Hvad er Deltyba, og hvad anvendes det til?
What is Deltyba and what is it used for?
Agenturet bemærkede, at et igangværende studie undersøger virkningen på lang sigt.
The Agency noted that an on-going clinical study will provide confirmation on the long-term effectiveness.
En oversigt over Deltyba, og hvorfor det er godkendt i EU
An overview of Deltyba and why it is authorised in the EU
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.
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.
Deltyba indeholder det aktive stof delamanid.
Deltyba contains the active substance delamanid.
Virkningen af Deltyba er undersøgt i et hovedstudie med deltagelse af 481 patienter med tuberkulose, der er resistent over for standardbehandlingerne.
The effects of Deltyba have been looked at in one main study involving 481 adults with tuberculosis resistant to standard treatments.
Deltyba udleveres kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af multiresistent tuberkulose.
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.
Det primære mål for virkning var andelen af patienter, som ikke længere havde bakterien i deres sputum (slim).
The main measure of effectiveness was the proportion of patients who no longer had the bacteria in their sputum (phlegm).
Det aktive stof i Deltyba, delamanid, er et antibiotikum, der virker mod M. tuberculosis.
The active substance in Deltyba, delamanid, is an antibiotic active against M. tuberculosis.
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.
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.
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).
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).
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.
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.
Hvis du ønsker ydrligere oplysninger om anvendelsen af af Deltyba, kan du læse indlægssedlen eller kontakte lægen eller apoteket.
For more information about using Deltyba, see the package leaflet or contact a doctor or pharmacist.
Patienterne i studiet fik Deltyba eller placebo (et ikke-aktivt stof) i 2 måneder i tillæg til deres andre behandlinger.
Patients in the study were given Deltyba or placebo (a dummy treatment) for 2 months in addition to their other treatments.
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.
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.
Efter afslutningen af hovedstudiet fik patienterne mulighed for at få behandling med Deltyba i yderligere 6 måneder i et forlængelsesstudie.
After the main study had finished, patients had the option to receive treatment with Deltyba for 6 months in an extension study.
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.
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.
Hvilke risici er der forbundet med Deltyba?
What are the risks associated with Deltyba?
Desuden blev det medicinske behov for nye stoffer mod multiresistent tuberkulose fremhævet.
Furthermore the medical need for new agents to treat multi-drug resistant tuberculosis was highlighted.
Hvilke oplysninger afventes der stadig for Deltyba?
What information is still awaited for Deltyba?
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.
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.
Agenturet fandt, at fordelene for patienter med multiresistent tuberkulose, der rammer lungerne, var påvist.
The Agency considered that the benefits of Deltyba had been shown for patients with multi-drug resistant tuberculosis affecting the lung.
Den fuldstændige liste over bivirkninger ved Deltyba fremgår af indlægssedlen.
For the full list of side effects of Deltyba, see the package leaflet.
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.
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.
Hvordan anvendes Deltyba?
How is Deltyba used?
Hvilke fordele viser studierne, at der er ved Deltyba?
What benefits of Deltyba have been shown in studies?
Hvordan virker Deltyba?
How does Deltyba work?
Sixmo (buprenorphin)
Sixmo (buprenorphine)
Yderligere information om Sixmo findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/sixmo.
Further information on Sixmo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/sixmo.
Andre oplysninger om Sixmo
Other information about Sixmo
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.
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.
Det indeholder det aktive stof buprenorphin.
It contains the active substance buprenorphine.
Som for alle lægemidler bliver data vedrørende brug af Sixmo løbende overvåget.
As for all medicines, data on the use of Sixmo are continuously monitored.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Sixmo?
What measures are being taken to ensure the safe and effective use of Sixmo?
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Sixmo opvejer risiciene, og at det kan godkendes til anvendelse i EU.
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.
De hyppigste bivirkninger ved Sixmo (som kan forekomme hos op til 1 ud af 10 personer) er hovedpine, forstoppelse og søvnløshed.
The most common side effects with Sixmo (which may affect up to 1 in 10 people) include headache, constipation and difficulty sleeping.
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.
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.
Det aktive stof i Sixmo, buprenorphin, er en partiel opioid-agonist (dvs., at det virker som et opioid, men mindre kraftfuldt).
The active substance in Sixmo, buprenorphine, is a partial opioid agonist (which means that it acts like an opioid but less powerfully).
En oversigt over Sixmo, og hvorfor det er godkendt i EU
An overview of Sixmo and why it is authorised in the EU
Patienten får fire implantater, der indsættes under lokalanæstesi i indersiden af overarmen og beholdes i 6 måneder.
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.
Sixmo er et implantat, som anvendes til at behandle afhængighed af opioider som f.eks. heroin eller morfin.
Sixmo is an implant used to treat dependence on opioid drugs such as heroin or morphine.
Hvad er Sixmo, og hvad anvendes det til?
What is Sixmo and what is it used for?
Lægemidlet kan derfor anvendes på en kontrolleret måde for at medvirke til at forebygge abstinenssymptomer og reducere trangen til at misbruge andre opioider.
The medicine can therefore be used in a controlled way to help prevent withdrawal symptoms and reduce the urge to misuse other opioids.
Sixmo må ikke anvendes sammen med lægemidler, der kaldes "opioidantagonister" (naltrexon og nalmelfen).
Sixmo must not be used together with medicines known as ‘opioid antagonists' (naltrexone and nalmefene).
De hyppigste bivirkninger ved indsættelse og fjernelse af implantatet er smerter, kløe, blå mærker, blødning, rødmen af huden og udslæt på implantationsområdet.
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.
De indberettede bivirkninger ved Sixmo vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Sixmo are carefully evaluated and any necessary action taken to protect patients.
Hvorfor er Sixmo godkendt i EU?
Why is Sixmo authorised in the EU?
Tre studier, der omfattede i alt 627 patienter med opioidafhængighed, viste, at Sixmo er effektivt til at reducere patienternes indtagelse af opioider.
Three studies involving a total of 627 patients with opioid dependence showed that Sixmo is effective at reducing patients' intake of opioids.
Virksomheden vil desuden gennemføre en undersøgelse for at undersøge implantatbrud og andre komplikationer i forbindelse med indsættelse og fjernelse af implantater i klinisk praksis.
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.
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.
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.
Hvis du ønsker mere information om anvendelsen af Sixmo, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
For more information about using Sixmo, see the package leaflet or contact your doctor or pharmacist.
Hvilke risici er der forbundet med Sixmo?
What are the risks associated with Sixmo?
Hovedstudierne viste, at Sixmo var mere effektivt end placebo og mindst lige så effektivt som buprenorphin i sublingual form til behandling af opioidafhængighed.
The main studies showed that Sixmo was more effective than placebo and at least as effective as sublingual buprenorphine at treating opioid dependence.
Lægemidlet fås kun på "særlig" recept.
Sixmo can only be obtained by ‘special' prescription.
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.
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.
Behandling med Sixmo skal ske under tilsyn af en sundhedsperson med erfaring i håndtering af opioidafhængighed.
Treatment with Sixmo must be under the supervision of a healthcare professional experienced in the management of opioid dependence.
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.
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.
Det betyder, at lægemidlet anvendes under strengere betingelser end normalt, fordi det kan misbruges og medføre afhængighed.
This means that because the medicine can be misused or cause addiction, it is used under stricter conditions than normal.
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.
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.
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.
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.
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.
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.
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.
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.
Sixmos bivirkninger er dem, der forventes for et lægemiddel med buprenorphin, og de bivirkninger, der er knyttet til implantatet, anses for at kunne håndteres.
The side effects of Sixmo are those expected for a buprenorphine medicine and side effects linked to the implant itself are considered manageable.
I det første studie blev Sixmo sammenlignet med placebo (en virkningsløs behandling) hos 163 patienter, som ikke tidligere havde modtaget buprenorphin.
The first study compared Sixmo with placebo (dummy) implants in 163 patients who had not received buprenorphine before.
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).
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).
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.
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.
Den fuldstændige liste over bivirkninger ved Sixmo fremgår af indlægssedlen.
For the full list of side effects of Sixmo, see the package leaflet.
Hvordan anvendes Sixmo?
How is Sixmo used?
Hvordan virker Sixmo?
How does Sixmo work?
Hvilke fordele viser studierne, at der er ved Sixmo?
What benefits of Sixmo have been shown in studies?
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.
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.
Sixmo fås som et implantat, der indsættes under huden.
Sixmo is available as an implant to be inserted under the skin, which continuously releases buprenorphine into the body.
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.
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.
NeoRecormon fås i forskellige styrker fra 500 til 50 000 internationale enheder (IE).
NeoRecormon is available in various strengths from 500 to 50,000 international units (IU).
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for NeoRecormon den 17. juli 1997.
The European Commission granted a marketing authorisation valid throughout the European Union for NeoRecormon on 17 July 1997.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for NeoRecormon.
This is a summary of the European public assessment report (EPAR) for NeoRecormon.
Den fuldstændige EPAR for NeoRecormon findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for NeoRecormon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
NeoRecormon anvendes i følgende situationer:
NeoRecormon is used in the following situations:
Flerdosis formulering af NeoRecormon indeholder benzylalkohol og må ikke gives til børn under tre år.
The multidose formulation of NeoRecormon contains benzyl alcohol and must not be given to children below three years of age.
• til forebyggelse af anæmi hos for tidligt fødte spædbørn
• to prevent anaemia in premature babies;
Der er udarbejdet en risikostyringsplan for at sikre, at NeoRecormon anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that NeoRecormon is used as safely as possible.
Det indeholder det aktive stof epoetin beta.
It contains the active substance epoetin beta.
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.
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.
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.
For more information about treatment with NeoRecormon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Andre oplysninger om NeoRecormon
Other information about NeoRecormon