FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment should be stopped or the dose reduced in patients who experience certain side effects or who have liver problems.
Danish: Behandlingen skal standses eller dosis reduceres hos patienter, der får visse bivirkninger, eller som har leverproblemer.
English: This reduces the rate at which the active substance is broken down, allowing it to circulate in the blood for longer.
Danish: Derved reduceres den hastighed, med hvilken det aktive stof nedbrydes, og det gør det muligt for stoffet at cirkulere i blodet i længere tid.
English: The most common side effect seen in all types of cancer (in more than 1 patient in 10) is nausea (feeling sick).
Danish: Den hyppigste bivirkning, der er set i alle kræfttyper (hos flere end 1 ud af 10 patienter), er kvalme.
English: • metastatic breast cancer in patients at risk of heart problems.
Danish: • Metastatisk brystkræft hos patienter med risiko for hjerteproblemer.
English: It cannot be interchanged with other medicines containing doxorubicin hydrochloride.
Danish: Det kan ikke skiftes ud med andre lægemidler, som indeholder doxorubicinhydrochlorid.
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 Caelyx.
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 anvendelsesbetingelserne for Caelyx.
English: It contains the active substance doxorubicin hydrochloride (2 mg/ml).
Danish: Det indeholder det aktive stof doxorubicinhydrochlorid (2 mg/ml).
English: Caelyx doxorubicin hydrochloride
Danish: Caelyx doxorubicinhydrochlorid
English: For more information about treatment with Caelyx, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Caelyx, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Doxorubicin hydrochloride has been available since the 1960s.
Danish: Doxorubicinhydrochlorid har været på markedet siden 1960'erne.
English: Caelyx is used in combination with bortezomib (another anticancer medicine).
Danish: Caelyx anvendes i kombination med bortezomib (et andet lægemiddel mod kræft).
English: Other information about Caelyx
Danish: Andre oplysninger om Caelyx
English: The additional studies showed that Caelyx was also more effective than the comparator combinations.
Danish: De andre undersøgelser viste, at Caelyx også havde en større virkning end de kombinationer, det blev sammenlignet med.
English: The main measure of effectiveness was time until the disease got worse or, for Kaposi's sarcoma, the number of patients who responded to treatment.
Danish: Det primære mål for virkning var tiden til sygdomsforværring eller, for så vidt angår Kaposis sarkom, antallet af patienter, der opnåede positiv respons på behandlingen.
English: For Kaposi's sarcoma, around 70% of the patients had a complete or partial response to treatment, with similar results in the study of patients who had been treated before.
Danish: I undersøgelsen af patienter med Kaposis sarkom havde cirka 70 % af patienterne en komplet eller delvis respons på behandlingen, og resultaterne fra undersøgelsen af patienter, der tidligere var blevet behandlet, var magen til.
English: Caelyx is used to treat the following types of cancer in adults:
Danish: Caelyx anvendes til behandling af følgende kræftformer hos voksne:
English: Caelyx is not recommended for patients whose spleen has been removed.
Danish: Caelyx anbefales ikke til patienter, der har fået fjernet milten.
English: However, patients receiving Caelyx were less likely to experience heart problems.
Danish: Dog havde patienter, der blev behandlet med Caelyx, en lavere risiko for at få hjerteproblemer.
English: For Kaposi's sarcoma, the dose is 20 mg/m2 every two to three weeks for two to three months, and for multiple myeloma, it is 30 mg/m2 on day four of each three-week cycle of bortezomib treatment, for as long as the patient continues to benefit from the treatment and can tolerate it.
Danish: Dosis ved behandling af Kaposis sarkom er 20 mg/m2 hver anden til tredje uge i en periode på to til tre måneder, og ved behandling af multipelt myelom er dosis 30 mg/m2 på den fjerde dag i hver tre ugers-periode med bortezomib-behandling, i så lang tid som patienten fortsat har gavn af behandlingen og kan tåle den.
English: • multiple myeloma (a cancer of the cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already undergone or are unsuitable for a bone marrow transplant.
Danish: • Multipelt myelom, der er en form for kræft i cellerne i knoglemarven, hos patienter med fremadskridende sygdom, som tidligere har fået mindst én anden behandling, og som allerede har fået eller ikke er egnede til en knoglemarvstransplantation.
English: Caelyx must not be used to treat Kaposi's sarcoma that could be treated effectively with ‘local' treatments that only affect the site of the tumour or with whole-body alfa interferon treatment.
Danish: Caelyx må ikke anvendes til behandling af Kaposis sarkom, der kan behandles effektivt med lokal behandling, der kun virker på tumorstedet, eller med alfa-interferonbehandling af hele kroppen.
English: The side effects with Caelyx depend on the type of cancer being treated.
Danish: Bivirkningerne ved Caelyx afhænger af den type kræft, der behandles for.
English: The CHMP decided that Caelyx's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Caelyx opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Caelyx.
English: Caelyx has been studied in a total of 2,512 patients in seven main studies.
Danish: Caelyx er blevet undersøgt i syv hovedundersøgelser af i alt 2 512 patienter.
English: The recommended starting dose of Caelyx for breast or ovarian cancer is 50 mg per square metre body surface area (calculated using the patient's height and weight) every four weeks for as long as the disease does not get worse and the patient can tolerate the treatment.
Danish: Den anbefalede startdosis af Caelyx til behandling af bryst- og æggestokkræft er 50 mg pr. kvadratmeter legemsoverfladeareal (beregnet ud fra patientens højde og vægt) én gang hver fjerde uge, i så lang tid som sygdommen ikke forværres, og så lang tid som patienten kan tåle behandlingen.
English: The marketing authorisation holder is Janssen-Cilag International NV.
Danish: Indehaveren af markedsføringstilladelsen er Janssen-Cilag International NV. Markedsføringstilladelsen er gyldig på ubegrænset tid.
English: Other very common side effects include palmar-plantar erythrodysaesthesia syndrome (redness and pain on the hands and feet), vomiting, stomatitis (inflammation of the lining of the mouth), rash, asthenia (weakness), low blood cell counts, loss of appetite, alopecia (hair loss), fatigue (tiredness), diarrhoea, constipation and mucositis (inflammation of the mouth and throat).
Danish: Andre hyppige bivirkninger omfatter smertefuld rødme på hænder og fødder, opkast, betændelse i mundslimhinden, udslæt, svaghed, for lavt antal blodlegemer, appetitløshed, hårtab, træthed, diarré, forstoppelse samt betændelse i munden og halsen.
English: For metastatic breast cancer, Caelyx has been compared with standard doxorubicin in one main study involving 509 women.
Danish: For så vidt angår metastatisk brystkræft, blev Caelyx sammenlignet med standard-doxorubicin i én hovedundersøgelse af 509 kvinder.
English: • advanced ovarian cancer (cancer of the ovary) in women whose previous treatment including a platinum-based anticancer medicine has stopped working;
Danish: • Fremskreden kræft i æggestokkene hos kvinder, hvor den tidligere behandling, herunder et platinbaseret lægemiddel mod kræft, ikke længere har nogen virkning.
English: • Kaposi's sarcoma (a cancer of the blood vessels) in patients with acquired immune deficiency syndrome (AIDS) who have very damaged immune systems and extensive sarcoma on the skin, the moist body surfaces or the internal organs;
Danish: • Kaposis sarkom, der er en form for kræft i blodkarrene, hos patienter med erhvervet immundefektsyndrom (aids), som har et svært skadet immunsystem og omfattende sarkom i huden, slimhinderne eller de indre organer.
English: For AIDS-related Kaposi's sarcoma, the effectiveness of Caelyx was studied in two main studies involving 384 patients, including 77 who had received treatment before.
Danish: For så vidt angår aids-relateret Kaposis sarkom, blev virkningen af Caelyx undersøgt i to hovedundersøgelser af 384 patienter, herunder 77, der tidligere var blevet behandlet.
English: Further studies compared Caelyx with the combination of doxorubicin, bleomycin and vincristine (other anticancer medicines) in 258 patients and with the combination of bleomycin and vincristine in 241 patients.
Danish: I andre undersøgelser blev Caelyx sammenlignet med en kombination af doxorubicin, bleomycin og vinkristin, der også er lægemidler mod kræft, hos 258 patienter og med en kombination af bleomycin og vinkristin hos 241 patienter.
English: It also reduces its effects on non-cancer tissues and cells, so it is less likely to cause some side effects.
Danish: Det mindsker også det aktive stofs virkning på andet væv og andre celler og nedsætter derigennem risikoen for visse bivirkninger.
English: The active substance in Caelyx, doxorubicin hydrochloride, is a cytotoxic medicine that belongs to the group ‘anthracyclines'.
Danish: Det aktive stof i Caelyx, doxorubicinhydrochlorid, er en cellegift, der tilhører gruppen af antracykliner.
English: For multiple myeloma, the effectiveness of the combination of Caelyx and bortezomib was compared with that of bortezomib alone in 646 patients.
Danish: For så vidt angår multipelt myelom, blev virkningen af kombinationen af Caelyx og bortezomib sammenlignet med virkningen af bortezomib alene i en undersøgelse af 646 patienter.
English: In the treatment of breast cancer, Caelyx was as effective as standard doxorubicin: the time until the disease got worse was around 7.5 months in both groups.
Danish: Caelyx var lige så effektivt som standard-doxorubicin til behandling af brystkræft: Tiden til sygdomsforværring var cirka 7,5 måneder i begge grupper.
English: Caelyx accumulates in areas in the body where the blood vessels have an abnormal shape, such as within tumours, where its action is concentrated.
Danish: Caelyx samles i områder af kroppen, hvor blodkarrene har en anomal form, f.eks. i tumorer, hvor virkningen af lægemidlet koncentreres.
English: For multiple myeloma, adding Caelyx to bortezomib increased the time until the disease got worse from 6.5 to 9.3 months.
Danish: For så vidt angår multipelt myelom, betød tilføjelsen af Caelyx til bortezomib-behandlingen, at tiden til sygdomsforværring øgedes fra 6,5 måneder til 9,3.
English: Caelyx should be given under the supervision of a doctor who is qualified in the use of cytotoxic (cellkilling) medicines.
Danish: Caelyx skal gives under nøje overvågning af en læge, der er specialiseret i anvendelsen af cellegifte.
English: For ovarian cancer, Caelyx was as effective as topotecan in extending time until the disease got worse.
Danish: Med hensyn til æggestokkræft havde Caelyx en lige så stor virkning som topotecan, for så vidt angår forlængelse af tiden til sygdomsforværring.
English: What is the risk associated with Caelyx?
Danish: Hvilken risiko er der forbundet med Caelyx?
English: Why has Caelyx been approved?
Danish: Hvorfor blev Caelyx godkendt?
English: For the full list of all side effects reported with Caelyx, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Caelyx fremgår af indlægssedlen.
English: For advanced ovarian cancer, Caelyx has been compared with topotecan (another anticancer medicine) in one study involving 474 women who had received platinum-based chemotherapy in the past.
Danish: For så vidt angår fremskreden æggestokkræft, blev Caelyx sammenlignet med topotecan, der også er et lægemiddel mod kræft, i én undersøgelse af 474 kvinder, der tidligere havde fået platinbaseret kemoterapi.
English: Caelyx is concentrate to be made up into a solution for infusion (drip into a vein).
Danish: Caelyx er et koncentrat, der anvendes til at lave en opløsning, som bruges til infusion (drop i en blodåre).
English: Caelyx is used on its own for this disease;
Danish: Til denne sygdom anvendes Caelyx alene.
English: What is Caelyx?
Danish: Hvad er Caelyx?
English: In Caelyx, it is contained in ‘pegylated liposomes' (tiny fatty spheres that are coated with a chemical called polyethylene glycol).
Danish: Det aktive stof i Caelyx er indkapslet i pegylerede liposomer, som er bittesmå fedtkugler belagt med et kemisk stof, der hedder polyethylenglykol.
English: How has Caelyx been studied?
Danish: Hvordan blev Caelyx undersøgt?
English: What is Caelyx used for?
Danish: Hvad anvendes Caelyx til?
English: What benefit has Caelyx shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Caelyx?
English: How is Caelyx used?
Danish: Hvordan anvendes Caelyx?
English: How does Caelyx work?
Danish: Hvordan virker Caelyx?
English: Caelyx should not be used in people who may be hypersensitive (allergic) to doxorubicin hydrochloride or any of the other ingredients.
Danish: Patienter, der kan være overfølsomme over for doxorubicinhydrochlorid eller andre af indholdsstofferne, bør ikke anvende Caelyx.
English: The improvement was maintained over a follow-up period of up to 60 months.
Danish: Bedringen blev fastholdt i en opfølgningsperiode på op til 60 måneder.
English: Kineret received a marketing authorisation valid throughout the European Union on 8 March 2002.
Danish: Kineret fik en markedsføringstilladelse med gyldighed i hele EU den 8. marts 2002.
English: Further information on Kineret can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Kineret findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Kineret
Danish: Andre oplysninger om Kineret
English: What is Kineret and what is it used for?
Danish: Hvad er Kineret, og hvad anvendes det til?
English: As for all medicines, data on the use of Kineret are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Kineret løbende overvåget.
English: An overview of Kineret and why it is authorised in the EU
Danish: En oversigt over Kineret og hvorfor det er godkendt i EU
English: For Still's disease, three small studies have been carried out.
Danish: Ved Stills sygdom er der udført tre små undersøgelser.
English: The Agency recommended that Kineret be given marketing authorisation.
Danish: Agenturet anbefalede udstedelse af markedsføringstilladelse for Kineret.
English: In addition levels of amyloid A, a marker of inflammation were also reduced.
Danish: Derudover reduceredes også indholdet af amyloid A, der er en markør for betændelse.
English: The injection site should be varied with each dose to avoid discomfort.
Danish: Der bør anvendes forskellige injektionssteder for hver dosis for at undgå ubehag.
English: Side effects reported with Kineret are carefully evaluated and any necessary action is taken to protect patients.
Danish: Bivirkninger rapporteret for Kineret vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Why is Kineret authorised in the EU?
Danish: Hvorfor blev Kineret godkendt i EU?
English: For more information about using Kineret, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Kineret, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Results showed a significant and rapid improvement in symptoms, with a fall in average symptom score from 4.5 to 0.8 within 3 days of starting treatment.
Danish: Resultaterne viste en betydelig og hurtig bedring i symptomerne, idet den gennemsnitlige symptomscore faldt fra 4,5 til 0,8 i løbet af de første tre dage efter behandlingens start.
English: Patients were given Kineret at a starting dose of 1 to 2 mg per kg body-weight daily, increased after a month if necessary.
Danish: Patienterne fik Kineret i en startdosis på 1-2 mg pr. kg legemsvægt dagligt, der blev øget efter en måned, hvis det var nødvendigt.
English: Severe disabilities such as deafness and loss of vision may also occur;
Danish: Svær invaliditet såsom døvhed og synstab kan også forekomme
English: What measures are being taken to ensure the safe use of Kineret?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Kineret?
English: Kineret is a medicine that is used to treat:
Danish: Kineret er et lægemiddel, der anvendes til behandling af:
English: In the other two studies, Kineret was used as an add-on to existing treatment including methotrexate: one study, which involved 419 patients, used a range of doses of Kineret that depended on the patient's weight, and the other study, which involved 501 patients, used Kineret at a fixed dose of 100 mg once a day.
Danish: I de to andre undersøgelser blev Kineret anvendt i tillæg til eksisterende behandling, herunder methotrexat: i den ene undersøgelse med 419 patienter blev der anvendt forskellige doser af Kineret afhængigt af patientens vægt, og i den anden undersøgelse med 501 patienter blev Kineret anvendt i en fast dosis på 100 mg én gang dagligt.
English: What are the risks associated with Kineret?
Danish: Hvilke risici er der forbundet med Kineret?
English: Results showed that Kineret was more effective than placebo when used as an add-on to methotrexate.
Danish: Resultaterne viste, at Kineret var mere effektivt end placebo som tillæg til methotrexat.
English: Given the beneficial effect and the fact that there were no new safety concerns, the Agency also considered that the benefits outweighed the risks in patients with CAPS and Still's disease.
Danish: På grund af den gavnlige virkning og da der ingen nye sikkerhedsmæssige betænkeligheder forelå, vurderede udvalget, at fordelene opvejede risiciene hos patienter med CAPS og Stills sygdom.
English: In patients with severely reduced kidney function the doctor should consider giving Kineret every other day
Danish: Ved svært nedsat nyrefunktion bør lægen overveje at give Kineret hver anden dag
English: Results showed that certain doses of Kineret were more effective than placebo in reducing the symptoms of the disease, measured by the doctor and the patient using the ‘American College of Rheumatology' score, which includes measurements of the number of painful or tender joints, disease activity, pain, disability and levels of C reactive protein in the blood (a marker of inflammation).
Danish: Resultaterne viste, at visse doser af Kineret var mere effektive end placebo til at reducere symptomerne på sygdommen, målt af lægen og patienten med "American College of Rheumatology"-scoresystemet, som omfatter målinger af antallet af smertende eller ømme led, sygdomsaktivitet, smerter, invaliditet og indhold af C-reaktivt protein i blodet (en markør for betændelse).
English: The active substance in Kineret, anakinra, is a copy of a natural human protein called ‘human interleukin 1 receptor antagonist'.
Danish: Det aktive stof i Kineret, anakinra, er en kopi af det naturlige menneskelige protein "human interleukin-1-receptorantagonist".
English: Although patients with Still's disease had a higher risk of liver problems, this risk was considered to be outweighed by the medicine's benefits.
Danish: Patienter med Stills sygdom havde større risiko for leverproblemer, men denne risiko ansås for at opvejes af lægemidlets fordele.
English: For CAPS, Kineret has been studied in one main study involving 43 patients with neonatal-onset multisystem inflammatory disease (NOMID/CINCA syndrome, the most severe form of CAPS).
Danish: Til CAPS blev Kineret undersøgt i én hovedundersøgelse med 43 patienter, der havde multisystemisk inflammatorisk sygdom med neonatal debut (NOMID/CINCA-syndrom, den sværeste form for CAPS).
English: This leads to inflammation in many parts of the body, with symptoms such as fever, rash, joint pain and tiredness.
Danish: Dette fører til betændelse i mange dele af kroppen med symptomer såsom feber, udslæt, ledsmerter og træthed.
English: Kineret has been studied in three main studies involving a total of 1,388 patients with rheumatoid arthritis.
Danish: Kineret blev undersøgt i tre hovedundersøgelser med i alt 1 388 patienter med leddegigt.
English: The recommended dose of Kineret for rheumatoid arthritis is 100 mg once a day, given at around the same time each day.
Danish: Den anbefalede dosis Kineret til behandling af leddegigt er 100 mg én gang dagligt, givet på cirka samme tidspunkt hver dag.
English: It is used in combination with methotrexate (a medicine used to reduce inflammation) in patients who have not responded adequately to methotrexate alone;
Danish: Kineret anvendes sammen med methotrexat (et lægemiddel til at reducere betændelse) hos patienter, der ikke har reageret tilstrækkeligt på behandling med methotrexat alene
English: After one month of treatment, more patients on Kineret (6 out of 12 patients) achieved remission compared with treatment with DMARD (3 out of 10 patients).
Danish: Efter en måneds behandling opnåede flere patienter, der fik Kineret (6 ud af 12 patienter), bedring end de, der fik DMARD (3 ud af 10 patienter).
English: The active substance in Kineret, anakinra, is an immunosuppressive medicine (a medicine that reduces the activity of the immune system).
Danish: Det aktive stof i Kineret, anakinra, er et immunsuppressivt lægemiddel (et lægemiddel, som undertrykker immunforsvarets aktivitet).
English: It blocks the receptors for a chemical messenger in the body called interleukin 1.
Danish: Det blokerer receptorerne for kroppens kemiske signalstof interleukin-1.
English: The most common side effects with Kineret (which may affect more than 1 patient in 10) are headache, injection site reactions (redness, bruising, pain and inflammation), and increase in blood cholesterol.
Danish: De hyppigste bivirkninger med Kineret (som kan forekomme hos flere end 1 ud af 10 patienter) er hovedpine, reaktioner på injektionsstedet (rødme, blå mærker, smerter og betændelse) og stigning i blodets indhold af kolesterol.
English: Kineret should be used with caution in patients who have severely reduced liver function or moderately reduced kidney function.
Danish: Kineret bør anvendes med forsigtighed ved svært nedsat leverfunktion eller moderat nedsat nyrefunktion.
English: Kineret can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of rheumatoid arthritis, CAPS or Still's disease as appropriate.
Danish: Kineret udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af leddegigt, CAPS eller Stills sygdom, efter hvad der er relevant.
English: All three studies compared the effectiveness of Kineret with that of placebo (a dummy treatment).
Danish: I alle tre undersøgelser blev virkningen af Kineret sammenlignet med virkningen af uvirksom behandling (placebo).
English: How is Kineret used?
Danish: Hvordan anvendes Kineret?
English: The European Medicines Agency decided that Kineret's benefits are greater than its risks for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone.
Danish: Det Europæiske Lægemiddelagentur afgjorde, at fordelene ved Kineret opvejer risiciene til behandling af tegn og symptomer på leddegigt i kombination med methotrexat hos patienter, der ikke reagerer tilstrækkeligt på behandling med methotrexat alene.