FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequent side effects with MabCampath are: infusion reactions (fever, chills, low blood pressure, itching, feeling sick, hives, increased heart rate, breathlessness), low counts of blood cells (white blood cells, platelets and red blood cells), infections (signs of cytomegalovirus in the blood, cytomegalovirus infection or other infections), gastrointestinal symptoms (feeling sick, vomiting, abdominal pain) and neurological symptoms (insomnia, anxiety).
Danish: De hyppigste bivirkninger ved MabCampath er: infusionsreaktioner (feber, kulderystelser, lav blodtryk, kløe, kvalme, nældefeber, forøget hjertefrekvens , åndenød), lavt antal røde blodlegemer)(hvide blodlegemer, -plader og røde blodlegemer), infektioner (symptomer på cytomegalovirus i blodet, cytomegalovirus-infektion eller andre infektioner), gastrointestinale symptomer (kvalme opkastning, mavesmerter) og neurologiske symptomer(søvnløshed, angst).
English: It compared a 12-week course of MabCampath with a year-long course of chlorambucil (another anticancer medicine).
Danish: Den sammenlignede virkningen af et 12 uger langt behandlingsforløb med MabCampath med et et årligt behandlingsforløb med chlorambucil (et andet lægemiddel mod kræft).
English: The other three studies looked at a total of 149 patients who had already received other treatments.
Danish: Der blev foretaget tre andre undersøgelser af i alt 149 patienter, som allerede havde modtaget anden behandling.
English: The active substance in MabCampath, alemtuzumab, is a monoclonal antibody.
Danish: Alemtuzumab, det aktive stof i MabCampath, er et monoklonalt antistof.
English: MabCampath should not be used in people who may be hypersensitive (allergic) to alemtuzumab, mouse proteins, or any of the other ingredients.
Danish: MabCampath bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for alemtuzumab, museproteiner eller andre af indholdsstofferne.
English: Alemtuzumab has been designed to attach to a glycoprotein (a protein that is coated with sugar molecules) called CD52 that is found on the surface of lymphocytes.
Danish: Alemtuzumab er udformet, så det bindes til et glykoprotein (et protein, der er overtrukket med sukkermolekyler), der kaldes CD52, som findes på lymfocytternes overflade.
English: MabCampath is a concentrate that is made up into a solution for infusion (drip into a vein).
Danish: MabCampath er et koncentrat, der blandes til en opløsning til infusion (drop i en vene).
English: The CHMP noted that the effectiveness of MabCampath had been demonstrated, but that there is no information from studies directly comparing MabCampath with treatment combinations including fludarabine, which are widely used to treat patients with CLL.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konstaterede, at virkningen af MabCampath er blevet påvist, men der er ingen oplysninger om undersøgelser, der direkte sammenligner MabCampath med behandlingskombinationer, der omfatter fludarabin, som har udbredt anvendelse til behandling af patienter med CLL.
English: What measures are being taken to ensure the safe use of MabCampath?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af
English: As a result, the lymphocytes die, and this helps to control the CLL.
Danish: Når denne binding dannes, dør lymfocytterne, hvorved CLL bedre kan kontrolleres.
English: One of these studies included 93 patients in whom previous treatment with fludarabine had stopped working.
Danish: En af disse undersøgelser omfattede 93 patienter, hos hvem tidligere behandling med fludarabin var holdt op med at virke Det primære effektmål var patientens almene bedring.
English: The company that makes MabCampath will provide a brochure containing information on the medicine's safety to all doctors in all Member States who prescribe the medicine.
Danish: Virksomheden, som fremstiller MabCampath, skal sørge for, at alle læger i alle medlemsstater, som ordinerer lægemidlet, får udleveret en folder med oplysninger om lægemidlets sikkerhed.
English: For more information about treatment with MabCampath, read the package leaflet (also part of the EPAR) or contact your doctor or
Danish: Hvis du ønsker yderligere oplysninger om behandling med MabCampath, kan du læse indlægssedlen (også en del af denne EPAR)
English: See the summary of product characteristics (also part of the EPAR) for full details.
Danish: De nærmere oplysninger fremgår af produktresuméet (også en del af EPAR).
English: For the full list of all side effects reported with MabCampath,
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved MabCampath fremgår af indlægssedlen.
English: Therefore, the Committee concluded that MabCampath's benefits are greater than its risks for the treatment of patients with B-CLL for whom fludarabine combination chemotherapy is not appropriate.
Danish: Udvalget konkluderede derfor at fordelene ved MabCampath opvejer risiciene til behandling af patienter med B-celle CLL, hos hvem kemoterapi kombineret med fludarabin ikke er hensigtsmæssig Udvalget anbefalede udstedelse af markedsføringstilladelse for MabCampath.
English: What benefit has MabCampath shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved MabCampath?
English: MabCampath is used to treat patients with B-cell chronic lymphocytic leukaemia (B-CLL), a cancer of a type of white blood cell called B lymphocytes.
Danish: MabCampath anvendes til behandling af patienter med B-celle kronisk lymfatisk leukæmi (B-CLL), som er kræftform i en type hvide blodlegemer kaldet B-lymfocytter.. MabCampath anvendes til patienter, hos hvem kombinationsbehandlinger, der omfatter fludarabin (et andet lægemiddel, der bruges mod
English: Patients should be monitored during treatment to see how they respond, but also to check their blood levels of platelets (components that help the blood to clot) and neutrophils (a type of white blood cell that fights infection): if these are too low the treatment should be interrupted or stopped.
Danish: Dels overvåges det, at lægemidlet virker, dels overvåges blodets indhold af blodplader (de blodlegemer, der medvirker ved blodets størkning) og af neutrofiler (de hvide blodlegemer, der bekæmper infektioner).
English: The medicine can only be obtained with a prescription.
Danish: Under behandlingen skal patienten overvåges.
English: 90 (3 x 30) capsules
Danish: 90 (3 x 30) kapsler
English: Strength Pharmaceutical Form
Danish: Lægemiddelform Administration E Emballage
English: Treatment should continue for as long as the patient benefits from it or for up to 1 year.
Danish: Behandlingen bør fortsættes, så længe patienten har gavn af den, eller i op til 1 år.
English: The dose is calculated based on the patient's body weight.
Danish: Dosen beregnes ud fra patientens legemsvægt.
English: Further information on Imfinzi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Imfinzi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Treatment may be paused or stopped permanently if the patient experiences severe side effects.
Danish: Behandlingen kan pauseres eller stoppes permanent, hvis patienten får svære bivirkninger.
English: As for all medicines, data on the use of Imfinzi are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Imfinzi løbende overvåget.
English: Other information about Imfinzi
Danish: Andre oplysninger om Imfinzi
English: Imfinzi contains the active substance durvalumab.
Danish: Imfinzi indeholder det aktive stof durvalumab.
English: Imfinzi is given as an infusion (drip) into a vein every 2 weeks.
Danish: Imfinzi gives som infusion (drop) i en vene hver anden uge.
English: What measures are being taken to ensure the safe and effective use of Imfinzi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Imfinzi?
English: For more information about using Imfinzi, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Imfinzi, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: An overview of Imfinzi and why it is authorised in the EU
Danish: En oversigt over Imfinzi, og hvorfor det er godkendt i EU
English: The European Medicines Agency therefore decided that Imfinzi'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 Imfinzi opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The most common serious side effect (which may affect up to 1 in 10 people) is pneumonia (infection of the lungs).
Danish: Den hyppigste alvorlige bivirkning (der kan forekomme hos op til 1 ud af 10 patienter) er lungebetændelse.
English: What is Imfinzi and what is it used for?
Danish: Hvad er Imfinzi, og hvad anvendes det til?
English: Side effects reported with Imfinzi are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Imfinzi vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Imfinzi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cancer.
Danish: Imfinzi udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kræft.
English: The use of Imfinzi is restricted to patients whose tumours produce PD-L1, since a clear benefit was only shown in this group of patients.
Danish: Anvendelse af Imfinzi er begrænset til patienter, hvis tumorer producerer PDL1, da der kun er påvist tydelig gavnlig effekt hos denne gruppe patienter.
English: In one main study of 713 patients, patients given Imfinzi lived on average for around 17 months without their disease getting worse, compared with 6 months for those given placebo.
Danish: I et hovedstudie med 713 patienter levede de patienter, der fik Imfinzi, i gennemsnit ca. 17 måneder uden sygdomsforværring, sammenholdt med 6 måneder for de patienter, der fik placebo.
English: Why is Imfinzi authorised in the EU?
Danish: Hvorfor blev Imfinzi godkendt i EU?
English: Preliminary results also indicated that patients given Imfinzi lived longer overall, compared with patients on placebo, though longer monitoring would be needed to confirm the extent of the benefit.
Danish: Foreløbige resultater har også vist, at patienter, der fik Imfinzi, overlevede i længere tid generelt, sammenholdt med patienter, der fik placebo, idet der dog er brug for længere tids overvågning for at bekræfte fordelens omfang.
English: The active substance in Imfinzi, durvalumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called ‘programmed death-ligand 1' (PD-L1), which is present on the surface of many cancer cells.
Danish: Det aktive stof i Imfinzi, durvalumab, er et monoklonalt antistof (en type protein, der er designet til at genkende og binde til et protein, der kaldes "programmeret død-ligand 1" (PD-L1), og som sidder på overfladen af mange kræftceller.
English: PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells.
Danish: PD-L1 slukker immunceller, der ellers ville gå til angreb på kræftcellerne.
English: Side effects with Imfinzi were considered manageable, and its safety profile acceptable and in line with that of similar medicines.
Danish: Bivirkningerne ved Imfinzi vurderes at være håndterbare, og sikkerhedsprofilen vurderes at være acceptabel og at svare til sikkerhedsprofilen ved lignende lægemidler.
English: Imfinzi is a medicine used to treat a type of lung cancer called non-small cell lung cancer (NSCLC).
Danish: Imfinzi er et lægemiddel til behandling af såkaldt ikke-småcellet lungekræft (NSCLC).
English: Imfinzi is used specifically when the tumour produces a protein known as PD-L1.
Danish: Imfinzi anvendes specifikt, når tumoren producerer proteinet PD-L1.
English: By attaching to PDL1 and blocking its effects, Imfinzi increases the ability of the immune system to attack the cancer cells and thereby slow down the progression of the disease.
Danish: Ved at binde til PD-L1proteinet og blokere dets effekt øger Imfinzi immunsystemets evne til at angribe kræftcellerne og bremser dermed udviklingen af sygdommen.
English: What are the risks associated with Imfinzi?
Danish: Hvilke risici er der forbundet med Imfinzi?
English: Imfinzi is used in adult patients with advanced cancer that cannot be removed by surgery but is not getting worse after treatment with radiation and platinum-based chemotherapy (medicines to treat cancer).
Danish: Imfinzi anvendes hos voksne patienter med fremskreden kræft, der ikke kan fjernes ved operation, men som ikke er blevet værre efter strålebehandling og platin-baseret kemoterapi.
English: The most common side effects with Imfinzi (which may affect more than 1 in 5 people) are cough, nose and throat infections, and rash.
Danish: De hyppigste bivirkninger ved Imfinzi (der kan forekomme hos mere end 1 ud af 5 patienter) er hoste, infektioner i svælget og udslæt.
English: For the full list of side effects and restrictions of Imfinzi, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Imfinzi fremgår af indlægssedlen.
English: Imfinzi has been shown to be more effective than placebo (a dummy treatment) at prolonging the time patients with advanced non-small cell lung cancer lived without their disease getting worse.
Danish: Det er påvist, at Imfinzi er mere effektivt end placebo (et ikke-aktivt stof) til at forlænge den tid, patienter med fremskreden ikke-småcellet lungekræft lever uden sygdomsforværring.
English: Imfinzi was shown to improve the length of time patients with advanced NSCLC lived without their disease getting worse, and this was considered important for these patients, who have few treatment options.
Danish: Det er påvist, at Imfinzi forlænger den tid, patienter med fremskreden ikke-småcellet lungekræft lever uden sygdomsforværring, og det vurderes at være vigtigt for disse patienter, der kun har få behandlingsmuligheder.
English: What benefits of Imfinzi have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Imfinzi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imfinzi 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 Imfinzi.
English: How is Imfinzi used?
Danish: Hvordan anvendes Imfinzi?
English: How does Imfinzi work?
Danish: Hvordan virker Imfinzi?
English: This overview was last updated in 09-2019.
Danish: Denne oversigt blev sidst ajourført i 08-2019.
English: The safety of the medicine is in line with other similar medicines.
Danish: Sikkerheden ved lægemidlet er den samme som for andre tilsvarende lægemidler.
English: As for all medicines, data on the use of Inbrija are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Inbrija løbende overvåget.
English: Further information on Inbrija can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Inbrija.
Danish: Yderligere information om Inbrija findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Inbrija.
English: Other information about Inbrija
Danish: Andre oplysninger om Inbrija
English: Inbrija contains the active substance levodopa.
Danish: Inbrija indeholder det aktive stof levodopa.
English: What measures are being taken to ensure the safe and effective use of Inbrija?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Inbrija?
English: The European Medicines Agency therefore decided that Inbrija'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 Inbrija opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The recommended dose is 2 capsules in each ‘off' period up to a maximum of 10 capsules per day.
Danish: Den anbefalede dosis er 2 kapsler pr. "off-periode" og højst 10 kapsler pr. dag.
English: What is Inbrija and what is it used for?
Danish: Hvad er Inbrija, og hvad anvendes det til?
English: For more information about using Inbrija, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Inbrija, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: An overview of Inbrija and why it is authorised in the EU
Danish: En oversigt over Inbrija, og hvorfor det er godkendt i EU
English: Why is Inbrija authorised in the EU?
Danish: Hvorfor er Inbrija godkendt i EU?
English: Side effects reported with Inbrija are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Inbrija vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: What are the risks associated with Inbrija?
Danish: Hvilke risici er der forbundet med Inbrija?
English: Of patients treated with Inbrija, 71% reported that their symptoms were improved, compared with 46% of patients on placebo.
Danish: Af de patienter, der blev behandlet med Inbrija, rapporterede 71 %, at deres symptomer blev bedre, sammenholdt med 46 % af dem, der fik placebo.
English: The most common side effect with Inbrija is cough (which may affect more than 1 in 10 people).
Danish: Den hyppigste bivirkning ved Inbrija (som kan forekomme hos mere end 1 ud af 10 personer) er hoste.
English: The first study involved 226 patients who had 12 weeks of standard treatment with levodopa and a dopa-decarboxylase inhibitor.
Danish: Det første studie omfattede 226 patienter, som fik 12 ugers standardbehandling med levodopa og en dopa-decarboxylasehæmmer.
English: Allergic oedema (swelling) and gastrointestinal haemorrhage (bleeding in the gut) have been reported for other medicines containing levodopa.
Danish: Allergisk ødem (hævelse) og gastrointestinal blødning (blødning i tarmen) er indberettet for andre lægemidler, der indeholder levodopa.
English: Two main studies have shown that Inbrija is effective at improving patients' symptoms during ‘off' periods.
Danish: To hovedstudier har vist, at Inbrija er effektivt til at forbedre patienternes symptomer i "offperioderne".
English: Other common side effects, which may affect up to 1 in 10 people, are falls, upper respiratory tract infection (nose and throat infection), dyskinesia (difficulty controlling movement) and discoloured sputum (phlegm).
Danish: Andre almindelige bivirkninger, som kan forekomme hos op til 1 ud af 10 personer, er fald, infektioner i de øvre luftveje (næse og hals), problemer med at kontrollere bevægelserne (dyskinesi) og misfarvning af spyttet.
English: Because it is inhaled, Inbrija provides rapid relief of symptoms, which improves patients' quality of life.
Danish: Fordi Inbrija inhaleres, giver det en hurtig symptomlindring, hvilket forbedrer patienternes livskvalitet.
English: In patients with Parkinson's disease, the cells in the brain that produce dopamine, a neurotransmitter important for controlling movement, begin to die and the amount of dopamine in the brain decreases.
Danish: Hos patienter med Parkinsons sygdom begynder de celler i hjernen, der producerer dopamin (en neurotransmitter, der er vigtig for at kontrollere bevægelserne), at dø, og dopaminindholdet i hjernen falder.
English: In the second study involving 77 patients who had 4 weeks of standard treatment, patients who took Inbrija during ‘off' periods had an average improvement of 10 points on the scale 10 to 60 minutes later, compared with 3 points for patients taking placebo.
Danish: I det andet studie med 77 patienter, som fik 4 ugers standardbehandling, opnåede de patienter, der fik Inbrija i "off-perioder", en gennemsnitlig forbedring på 10 point på skalaen 10-60 minutter senere sammenlignet med 3 point for patienter, der fik placebo.
English: Effects were measured using a standard symptom scale known as the unified Parkinson's disease rating scale, UPDRS, part III.
Danish: Virkningerne blev målt ved hjælp af en standardskala for symptomer på Parkinsons sygdom (UPDRS, Part III).
English: Inbrija is available as capsules containing a powder for inhalation and can only be obtained with a prescription.
Danish: Inbrija fås som kapsler med et pulver til inhalation, og fås kun på recept.
English: Because Inbrija is inhaled, it can supply extra levodopa (and hence dopamine) quickly when needed during an ‘off' period.
Danish: Da Inbrija inhaleres, kan det hurtigt forsyne hjernen med mere levodopa (og dermed dopamin), når det er nødvendigt i en "off-periode".
English: Inbrija should be inhaled using the Inbrija inhaler device when the patient recognises the symptoms of an ‘off' period.
Danish: Inbrija bør indhaleres ved hjælp af Inbrija-inhalatoren, når patienten får symptomerne på en "offperiode".
English: In this study, patients who took Inbrija during their ‘off' periods had an average improvement of 10 points on the scale 30 minutes later, compared with 6 points for patients taking placebo (a dummy treatment).
Danish: I dette studie opnåede de patienter, der fik Inbrija i deres "off-perioder", en gennemsnitlig forbedring på 10 point på skalaen 30 minutter senere sammenlignet med 6 point for patienter, der fik placebo (en uvirksom behandling).
English: How is Inbrija used?
Danish: Hvordan anvendes Inbrija?
English: It must also not be used in patients taking medicines known as non-selective monoamine oxidase (MAO) inhibitors or in patients with a history of neuroleptic malignant syndrome or rhabdomyolysis.
Danish: Det må heller ikke anvendes hos patienter, der får lægemidler af typen ikke-selektive MAO-hæmmere (monoaminoxidasehæmmere) eller hos patienter, der tidligere har haft malignt neuroleptikasyndrom eller rhabdomyolyse.
English: Medicines containing levodopa and a dopa-decarboxylase inhibitor have shown side effects of symptoms like neuroleptic malignant syndrome (a nervous disorder) and rhabdomyolysis (breakdown of muscle fibres).
Danish: Lægemidler, der indeholder levodopa og en dopadecarboxylasehæmmer, har givet bivirkninger som malignt neuroleptikasyndrom (en nervesygdom) og rhabdomyolyse (nedbrydning af muskelfibre).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Inbrija 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 Inbrija.
English: Inbrija is a medicine used to treat adults with Parkinson's disease (a progressive brain disease that causes shaking and muscle stiffness and slows movement).
Danish: Inbrija er et lægemiddel til behandling af voksne med Parkinsons sygdom, som er en fremadskridende hjernesygdom, der medfører rysten, muskelstivhed og langsomme bevægelser.
English: Studies show that Inbrija is effective at reducing symptoms during ‘off' periods in patients with Parkinson's disease on levodopa/dopa-decarboxylase-inhibitor treatment.
Danish: Studier viser, at Inbrija er effektivt til at reducere symptomerne i "off-perioder" hos patienter med Parkinsons sygdom, som behandles med levodopa og en dopa-decarboxylasehæmmer.
English: Inbrija is used to treat symptoms during ‘off' periods (times when the patient has more difficulty moving about) that occur while the patient is taking their usual treatment of a combination of levodopa and an inhibitor of dopa-decarboxylase.
Danish: Inbrija anvendes til behandling af symptomer i "off-perioder" (tidspunkter, hvor patienten har sværere ved at bevæge sig), som forekommer i løbet af den normale behandling med en kombination af levodopa og en dopa-decarboxylasehæmmer.