FrancophonIA/ELRC3.0 huggingface dataset:
English: An additional study looked at the effectiveness of Tygacil in patients who had caught pneumonia in hospital.
Danish: En anden undersøgelse så på virkningen af Tygacil hos patienter, som havde fået lungebetændelse på hospitalet.
English: This is expected to help in the treatment of community-acquired pneumonia.
Danish: Dette forventes at være til hjælp ved behandlingen af ikke-hospitalserhvervet lungebetændelse.
English: Tygacil was also expected to be used to treat adults with community-acquired pneumonia.
Danish: Tygacil forventedes anvendt til behandling af voksne med ikke-hospitalserhvervet lungebetændelse.
English: More information can be found here.
Danish: Yderligere information kan findes her.
English: Procoralan received a marketing authorisation valid throughout the EU on 25 October 2005.
Danish: Procoralan fik en markedsføringstilladelse med gyldighed i hele EU den 25. oktober 2005.
English: Procoralan must not be taken with a number of other medicines.
Danish: Procoralan må ikke tages sammen med en række andre lægemidler.
English: Further information on Procoralan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Procoralan.
Danish: Yderligere information om Procoralan findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Procoralan.
English: Procoralan (ivabradine)
Danish: Procoralan (ivabradin)
English: The main measure of effectiveness was how long patients could exercise on a bicycle or a treadmill, which was measured at the start and the end of each study.
Danish: Det vigtigste mål for virkningen var, hvor længe patienterne kunne motionere på en cykel eller trædemølle, målt ved begyndelsen og slutningen af hvert studie.
English: Procoralan therefore reduces or prevents the symptoms of angina.
Danish: Procoralan reducerer eller forbygger således symptomerne på angina.
English: Other information about Procoralan
Danish: Andre oplysninger om Procoralan
English: For more information about using Procoralan, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Procoralan, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Procoralan contains the active substance ivabradine.
Danish: Procoralan indeholder det aktive stof ivabradin.
English: Procoralan is available as tablets (5 and 7.5 mg) and it can only be obtained with a prescription.
Danish: Procoralan fås som tabletter (5 og 7,5 mg) og udleveres kun efter recept.
English: As for all medicines, data on the use of Procoralan are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Procoralan løbende overvåget.
English: However, a fifth study in 728 patients showed that adding Procoralan to amlodipine did not provide an additional benefit.
Danish: Et femte studie hos 728 patienter viste imidlertid ingen ekstra fordel af at tilføje Procoralan til amlodipin.
English: What measures are being taken to ensure the safe and effective use of Procoralan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Procoralan?
English: Side effects reported with Procoralan are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Procoralan vurderes omhyggeligt, og der træffes de nødvendige forholdsregler til at beskytte patienterne.
English: In a fourth study in 889 patients, Procoralan was more effective than placebo, when both were added to atenolol.
Danish: I et fjerde studie med 889 patienter var Procoralan mere effektivt end placebo, når de begge blev tilføjet til atenolol.
English: The Agency decided that Procoralan's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede, at fordelene ved Procoralan opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: An overview of Procoralan and why it is authorised in the EU
Danish: En oversigt over Procoralan og hvorfor det er godkendt i EU
English: The most common side effect with Procoralan (which may affect more than 1 in 10 people) is luminous phenomena or ‘phosphenes' (a temporary brightness in the field of vision).
Danish: Den hyppigste bivirkning med Procoralan (som kan forekomme hos mere end 1 ud af 10 patienter), er forbigående lysfornemmelser eller "fosfener" (forbigående oplysthed i synsfeltet).
English: The European Medicines Agency concluded that Procoralan was shown to be effective in long-term angina with an acceptable safety profile for it to provide an alternative treatment for patients who cannot take beta blockers or whose disease is not controlled with them.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at Procoralan var påvist at være effektivt ved kronisk angina og at have en acceptabel sikkerhedsprofil, som gør det anvendeligt som alternativ behandling af patienter, der ikke kan tage betablokkere, eller hvis sygdom ikke kan kontrolleres med disse.
English: Results showed that Procoralan was more effective than placebo at preventing death due to disease of the heart or blood vessels or hospitalisation due to worsening heart failure: 24.5% (793 out of 3,241) of patients treated with Procoralan died or were hospitalised due to worsening heart failure, compared with 28.7% (937 out of 3,264) of patients receiving placebo.
Danish: Resultaterne viste, at Procoralan var mere effektivt end placebo til at forebygge dødsfald som følge af sygdom i hjerte eller blodkar, eller indlæggelse pga. forværret hjertesvigt: 24,5 % (793 ud af 3.241) af de patienter, der blev behandlet med Procoralan, døde eller blev indlagt som følge af forværret hjertesvigt sammenholdt med 28,7 % (937 ud af 3.264) af dem, der fik placebo.
English: By lowering the heart rate, Procoralan reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Danish: Ved at nedsætte hjertefrekvensen mindsker Procoralan belastningen af hjertet og bremser på den måde udviklingen af hjerteinsufficiens og giver bedring i symptomerne.
English: Why is Procoralan authorised in the EU?
Danish: Hvorfor blev Procoralan godkendt i EU?
English: The symptoms of heart failure are caused by the heart not pumping enough blood around the body.
Danish: Symptomerne på hjertesvigt skyldes, at hjertet ikke pumper tilstrækkeligt blod rundt i kroppen.
English: What is Procoralan and what is it used for?
Danish: Hvad er Procoralan, og hvad anvendes det til?
English: For the treatment of angina, Procoralan was originally authorised for patients whose heart rate is at least 60 beats per minute.
Danish: Til behandling af angina blev Procoralan oprindeligt godkendt til patienter med en puls på mindst 60 slag pr. minut.
English: The active substance in Procoralan, ivabradine, works by blocking the ‘If currents' in the sinus node, the ‘pacemaker' for the heart that controls the heart's contractions and regulates the heart rate.
Danish: Det aktive stof i Procoralan, ivabradin, virker ved at blokere "If -strømmene" i sinusknuden - hjertets "pacemaker", som styrer hjertets sammentrækninger og regulerer hjertefrekvensen.
English: Procoralan must not be used in patients who have a resting heart rate below 70 beats per minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver problems.
Danish: Procoralan må ikke anvendes hos patienter med en hvilende hjertefrekvens på under 70 pr. minut, meget lavt blodtryk, forskellige hjertesygdomme (herunder kardiogent shock, rytmeforstyrrelser, hjerteanfald, ustabilt eller akut (pludseligt) hjertesvigt og ustabil angina) eller svære leverproblemer.
English: In this study, a specific subgroup of patients who had symptomatic angina had a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Procoralan compared with placebo (3.4% vs 2.9% yearly incidence rates).
Danish: I dette studie havde en særlig undergruppe af patienter med anginasymptomer en lille, men statistisk sikker stigning i den kombinerede risiko for hjerte-kar-dødelighed og ikke-dødeligt hjerteanfald, når de fik Procoralan i forhold til placebo (3,4 % mod 2,9 % i årlig forekomst).
English: A sixth study compared Procoralan with placebo in 19,102 patients with coronary artery disease and without clinical heart failure.
Danish: I et sjette studie sammenlignedes Procoralan med placebo hos 19.102 patienter med koronararteriesygdom og uden klinisk hjertesvigt.
English: Procoralan was compared with placebo (a dummy treatment) and other treatments in five main studies involving over 4,000 adults with long-term stable angina.
Danish: Procoralan er blevet sammenlignet med virkningsløs behandling (placebo) og andre behandlinger i fem hovedstudier hos over 4.000 voksne med langvarig stabil angina.
English: Also, the doctor should consider stopping treatment if the medicine has only a limited effect on reducing angina symptoms or reducing the heart rate within 3 months.
Danish: Lægen bør desuden overveje at stoppe behandlingen, hvis lægemidlet efter 3 måneder kun har begrænset virkning til reduktion af anginasymptomer eller nedsættelse af pulsen.
English: It also concluded that Procoralan was effective in long-term heart failure with an acceptable safety profile.
Danish: Udvalget konkluderede også, at Procoralan var effektivt til behandling af kronisk hjerteinsufficiens og havde en acceptabel sikkerhedsprofil.
English: The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient's heart rate and symptoms.
Danish: Dette kan af lægen sættes op til 7,5 mg to gange dagligt eller sættes ned til 2,5 mg (en halv 5 mg tablet) to gange dagligt afhængigt af patientens hjertefrekvens og symptomer.
English: What are the risks associated with Procoralan?
Danish: Hvilke risici er der forbundet med Procoralan?
English: Procoralan is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) who have a normal heart rhythm and whose heart rate is at least 75 beats per minute.
Danish: Procoralan anvendes desuden hos patienter, hos hvem hjertet til stadighed ikke kan pumpe tilstrækkeligt med blod til resten af kroppen (kronisk hjertesvigt), og som har normal hjerterytme og en puls på mindst 75 slag pr. minut.
English: Procoralan was compared with placebo in one main study involving over 6,500 patients with long-term moderate to severe heart failure.
Danish: Procoralan blev sammenlignet med placebo i et hovedstudie, som omfattede 6.500 patienter med kronisk moderat til svær hjertesvigt.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Procoralan have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Procoralan.
English: How is Procoralan used?
Danish: Hvordan anvendes Procoralan?
English: For the full list of all side effects reported with Procoralan, see the package leaflet.
Danish: Den fuldstændige liste over alle indberettede bivirkninger med Procoralan fremgår af indlægssedlen.
English: The symptoms of angina are caused by the heart not receiving enough oxygenated blood.
Danish: Anginasymptomer skyldes, at hjertet ikke får tilstrækkeligt med iltet blod.
English: For the full list of restrictions with Procoralan, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger ved Procoralan fremgår af indlægssedlen.
English: What benefits of Procoralan have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Procoralan?
English: Procoralan is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle).The medicine is used in patients who have a normal heart rhythm, and whose heart rate is at least 70 beats per minute.
Danish: Procoralan anvendes til behandling af symptomer på kronisk stabil angina (smerter i brystet, kæben og ryggen som følge af fysisk anstrengelse) hos voksne med koronararteriesygdom (hjertesygdom, som skyldes tillukning af de blodkar, der forsyner hjertemuskulaturen).
English: How does Procoralan work?
Danish: Hvordan virker Procoralan?
English: What is Zubsolv and what is it used for?
Danish: Hvad er Zubsolv, og hvad anvendes det til?
English: The tablets are taken once a day by placing them under the tongue and allowing them to dissolve for up to 10 minutes.
Danish: Tabletterne tages én gang dagligt ved at placere dem under tungen og lade dem opløses i op til 10 minutter.
English: The full EPAR for Zubsolv can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zubsolv findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Zubsolv.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zubsolv.
English: Zubsolv buprenorphine / naloxone
Danish: Zubsolv buprenorphin/naloxon
English: Zubsolv is a ‘hybrid medicine'.
Danish: Zubsolv er et "hybridt lægemiddel".
English: Once the patient has been stabilised, the maintenance dose may be reduced gradually if the patients agrees, and eventually treatment may be stopped.
Danish: Når patienten først er stabiliseret, kan vedligeholdelsesdosen reduceres gradvist, hvis patienten er villig til dette, hvorefter behandlingen med tiden kan ophøre.
English: The study also showed that Zubsolv tablets dissolved faster and had a better taste than the reference medicine.
Danish: Undersøgelsen viste også, at Zubsolv-tabletter opløses hurtigere og har en bedre smag end referencelægemidlet.
English: Zubsolv is available as tablets of various strengths (0.7 mg/0.18 mg, 1.4 mg/0.36 mg, 2.9 mg/0.71 mg, 5.7 mg/1.4 mg, 8.6 mg/2.1 mg, 11.4 mg/2.9 mg).
Danish: Zubsolv fås som tabletter i forskellige styrker (0,7 mg/0,18 mg, 1,4 mg/0,36 mg, 2,9 mg/0,71 mg, 5,7 mg/1,4 mg, 8,6 mg/2,1 mg og 11,4 mg/2,9 mg).
English: What measures are being taken to ensure the safe and effective use of Zubsolv?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zubsolv?
English: It is not intended to provide practical advice on how to use Zubsolv.
Danish: Det er ikke en praktisk vejledning i, hvordan Zubsolv bør anvendes.
English: The addition of naloxone helps prevent the misuse of the medicine.
Danish: Tilføjelsen af naloxon medvirker til at forebygge misbrug af lægemidlet.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Zubsolv contains these at different strengths.
Danish: Det betyder, at det svarer til et "referencelægemiddel", der indeholder de samme aktive stoffer, men Zubsolv indeholder en anden styrke af disse stoffer.
English: Sublingual tablets containing buprenorphine alone have been available in the EU since the mid-1990s for the treatment of opioid addiction.
Danish: Sublinguale tabletter, som indeholder buprenorphin alene, har kunnet fås i EU siden midten af 1990'erne til behandling af opioidafhængighed.
English: What are the risks associated with Zubsolv?
Danish: Hvilke risici er der forbundet med Zubsolv?
English: Why is Zubsolv approved?
Danish: Hvorfor blev Zubsolv godkendt?
English: Zubsolv is used in individuals who are also receiving medical, social and psychological support and who have agreed to be treated for their addiction.
Danish: Zubsolv anvendes hos patienter, der også får lægehjælp samt social og psykologisk støtte, og som har indvilget i at blive behandlet for deres afhængighed.
English: The reference medicine for Zubsolv is Suboxone.
Danish: Referencelægemidlet for Zubsolv er Suboxone.
English: A study involving 125 healthy volunteers showed that some strengths of the Zubsolv tablets produced a lower level of the active substances in the body than the reference product and therefore the two medicines cannot be used interchangeably.
Danish: En undersøgelse af 125 raske frivillige forsøgspersoner viste, at nogle styrker af Zubsolv-tabletter medførte et lavere niveau af stofferne i kroppen end referencelægemidlet, og derfor kan de to lægemidler ikke erstatte hinanden.
English: The company provided data from studies with the reference medicine Suboxone and from the published literature showing the benefits of buprenorphine and naloxone in the treatment of opioid dependence.
Danish: Virksomheden fremlagde data fra undersøgelser med referencelægemidlet Suboxone og fra publiceret litteratur, der viser fordelene ved buprenorphin og naloxon til behandling af opioidafhængighed.
English: As for Suboxone, the European Medicines Agency decided that Zubsolv's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Som for Suboxone konkluderede Det Europæiske Lægemiddelagentur, at fordelene ved Zubsolv opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Zubsolv is a medicine used in adults and adolescents aged over 15 years to treat dependence on opioid (narcotic) drugs such as heroin or morphine.
Danish: Zubsolv er et lægemiddel, der anvendes til behandling af voksne og unge over 15 år, som er afhængige af opioider (narkotika), som f.eks. heroin eller morfin.
English: Since Zubsolv does not produce the same amounts of buprenorphine and naloxone in the blood as the reference medicine, the medicines cannot be used interchangeably.
Danish: Da Zubsolv ikke giver den samme mængde buprenorphin og naloxon i blodet som referencelægemidlet, kan lægemidlerne ikke erstatte hinanden.
English: However, buprenorphine tablets have been misused by drug addicts who dissolve the tablets and inject themselves with the resulting solution.
Danish: Buprenorphin-tabletterne er imidlertid blevet misbrugt af stofmisbrugere, som opløser tabletterne og derefter indsprøjter denne opløsning.
English: It contains the active substances buprenorphine and naloxone.
Danish: Det indeholder de aktive stoffer buprenorphin og naloxon.
English: Other information about Zubsolv
Danish: Andre oplysninger om Zubsolv
English: Because Zubsolv can be misused or cause addiction, it can only be obtained by ‘special' prescription and must be used under the supervision of a doctor who has experience in the management of opioid addiction.
Danish: Da Zubsolv kan misbruges eller skabe afhængighed, udleveres det kun efter særlig recept og skal anvendes under overvågning af en læge med erfaring i behandling af opioidafhængighed.
English: Zubsolv contains two active substances: buprenorphine, a partial opioid agonist (it acts like an opioid drug but less powerfully), and naloxone, an opioid antagonist (it counteracts the effects of opioid drugs).
Danish: Zubsolv indeholder de to aktive stoffer buprenorphin, der er en partiel opioid-agonist (virker som et opioidt lægemiddel), og naloxon, en opioid-antagonist (modvirker effekten af opioide lægemidler).
English: For more information about treatment with Zubsolv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zubsolv, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Combining buprenorphine and naloxone is an established strategy for managing opioid dependence which prevents misuse of the medicine.
Danish: Kombination af buprenorphin og naloxon er en velkendt strategi til behandling af opioidafhængighed, som forebygger misbrug af lægemidlet.
English: This is because, when injected, naloxone counteracts the effects of opioids, causing the patient to experience acute withdrawal symptoms.
Danish: Dette skyldes, at naloxon modvirker effekten af opioider, når det indsprøjtes, hvilket giver patienten akutte abstinenssymptomer.
English: It must also not be used with the medicines naltrexone and nalmefene, other opioid antagonists used for the treatment of alcohol or opioid dependence.
Danish: Det må ikke bruges sammen med lægemidlerne naltrexon og nalmefen, som er andre opioidantagonister til behandling af alkohol- eller opioidafhængighed.
English: Zubsolv must not be used in patients with severe respiratory insufficiency (inability to breathe properly), severe liver problems, acute alcoholism (excessive alcohol consumption) or delirium tremens (a condition caused by alcohol withdrawal).
Danish: Zubsolv må ikke anvendes hos patienter med svært nedsat vejrtrækningsfunktion, alvorlige leverproblemer, akut alkoholisme (umådeholdent forbrug af alkohol) eller delirium tremens (en tilstand, der skyldes alkoholabstinenser).
English: The most common side effects with Zubsolv (which may affect more than 1 in 10 people) are constipation and symptoms of drug withdrawal such as insomnia (difficulty sleeping), headache, nausea (feeling sick), hyperhidrosis (excessive sweating) and pain.
Danish: De hyppigste bivirkninger ved Zubsolv (som optræder hos mere end 1 ud af 10 patienter) er forstoppelse og abstinenssymptomer, herunder søvnløshed, hovedpine, kvalme, kraftig svedtendens og smerter.
English: Serious side effects include seizures (fits), vomiting, diarrhoea and abnormal results of blood tests for liver function.
Danish: Alvorlige bivirkninger omfatter krampeanfald, opkastning, diarré og unormale værdier i leverfunktionstest.
English: For practical information about using Zubsolv, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Zubsolv, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How does Zubsolv work?
Danish: Hvordan virker Zubsolv?
English: What benefits of Zubsolv have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zubsolv?
English: On the first day of treatment, the recommended daily dose is one or two tablets of Zubsolv 1.4 mg/0.36 mg or 2.9 mg/0.71 mg. During the next days, the doctor may increase the dose depending on the patient's response, but the daily dose should not be higher than 17.2 mg buprenorphine.
Danish: Den anbefalede daglige dosis for den første behandlingsdag er 1-2 tabletter Zubsolv 1,4 mg/0,36 mg eller 2,9 mg/0,71 mg.
English: For the full list of side effects reported with Zubsolv, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Zubsolv fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zubsolv have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Zubsolv.
English: How is Zubsolv used?
Danish: Hvordan anvendes Zubsolv?
English: Annex A_en
Danish: Annex A_da
English: 90 capsules blister (PVC/Aclar/alu)
Danish: Oral anvendelse Blisterpakning (PVC/Aclar/alu)
English: 17 February 2011 EMA/121971/2011 EMEA/H/C/002091
Danish: 17. februar 2011 EMA/121971/2011 EMEA/H/C/002091
English: When the enzyme is blocked, the DNA strands break.
Danish: Når enzymet blokeres, går DNA-strengene i stykker.
English: The company provided data from the published literature on topotecan.
Danish: Virksomheden fremlagde data fra den publicerede litteratur om topotecan.
English: This prevents the cancer cells from dividing and they eventually die.
Danish: Det forhindrer kræftcellerne i at dele sig, og de dør efterhånden.