natgillin/translations-raw huggingface dataset:
Insulin Human Winthrop-serien består af hurtigtvirkende insulinopløsninger (Insulin Human Winthrop Rapid og Insulin Human Winthrop Infusat), der indeholder opløseligt insulin, en middellangt virkende insulinsuspension (Insulin Human Winthrop Basal), der indeholder isophaninsulin, og kombinationer af hurtigt- og middelangtvirkende insulin i forskellige blandingsforhold (Insulin Human Winthrop Comb):
The Insulin Human Winthrop range is comprised of fast-acting insulin solutions (Insulin Human Winthrop Rapid and Insulin Human Winthrop Infusat) that contain soluble insulin, an intermediate-acting insulin suspension (Insulin Human Winthrop Basal) that contains isophane insulin, and combinations of fast- and intermediateacting in various proportions (Insulin Human Winthrop Comb):
Insulin Human Winthrop er et erstatningsinsulin, der er identisk med det insulin, der produceres af kroppen.
Insulin Human Winthrop is a replacement insulin that is identical to the insulin made by the body.
Den fuldstændige EPAR for Insulin Human Winthrop findes her.
The full EPAR for Insulin Human Winthrop is available here.
Andre oplysninger om Insulin Human Winthrop:
Other information about Insulin Human Winthrop:
Insulin Human Winthrop er en række forskellige opløsninger og suspensioner af insulin til injektion.
Insulin Human Winthrop is a range of insulin solutions and suspensions for injection.
Insulin Human Winthrop Infusat er specielt fremstillet til anvendelse i infusionspumper.
Insulin Human Winthrop Infusat is specially prepared ready to be used in infusion pumps.
Den fuldstændige liste over de indberettede bivirkninger ved Insulin Human Winthrop fremgår af indlægssedlen.
For the full list of all side effects reported with Insulin Human Winthrop, see the Package Leaflet.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Insulin Human Winthrop.
The Committee recommended that Insulin Human Winthrop be given marketing authorisation.
Hvorfor blev Insulin Human Winthrop godkendt?
Why has Insulin Human Winthrop been approved?
Hvilken risiko er der forbundet med Insulin Human Winthrop?
What is the risk associated with Insulin Human Winthrop?
Hvad er Insulin Human Winthrop?
What is Insulin Human Winthrop?
Hvordan blev Insulin Human Winthrop undersøgt?
How has Insulin Human Winthrop been studied?
Insulin Human Winthrop skal indgives før et måltid (nøjagtige tidsangivelser findes i indlægssedlen).
Insulin Human Winthrop should be given before meals.
Hvad anvendes Insulin Human Winthrop til?
What is Insulin Human Winthrop used for?
Hvordan anvendes Insulin Human Winthrop?
How is Insulin Human Winthrop used?
Hvordan virker Insulin Human Winthrop?
How does Insulin Human Winthrop work?
Hvilken fordel viser undersøgelserne, at der er ved Insulin Human Winthrop?
What benefit has Insulin Human Winthrop shown during the studies?
Lægemidlets sikkerhedsprofil anses for at være acceptabel.
The safety profile of the medicine is considered acceptable.
Xeloda fik en markedsføringstilladelse med gyldighed i hele EU den 2. februar 2001.
Xeloda received a marketing authorisation valid throughout the EU on 2 February 2001.
Xeloda må desuden ikke anvendes til følgende grupper:
Xeloda must also not be used in the following groups:
Tabletterne gives to gange dagligt i 14 dage, efterfulgt af en 7-dages pause inden næste behandlingsserie.
The tablets are given twice daily for 14 days followed by a 7-day gap before the next course.
Yderligere information om Xeloda findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Xeloda.
Further information on Xeloda can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Xeloda.
Xeloda (capecitabin)
Xeloda (capecitabine)
Det leveres som tabletter (150 og 500 mg).
Xeloda is available as tablets (150 and 500 mg).
Dosis afhænger af patientens højde og vægt og den behandlede kræfttype.
The dose depends on the patient's height and weight and the type of cancer being treated.
Behandlingen fortsættes i seks måneder efter tyktarmsoperationen.
Treatment is continued for 6 months after colon surgery.
Andre oplysninger om Xeloda
Other information about Xeloda
Som for alle lægemidler er data vedrørende brug af Xeloda løbende overvåget.
As for all medicines, data on the use of Xeloda are continuously monitored.
Xeloda-tabletter tages med vand inden for 30 minutter efter et måltid.
Xeloda tablets should be taken within 30 minutes after a meal.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xeloda?
What measures are being taken to ensure the safe and effective use of Xeloda?
• gravide eller ammende kvinder
• pregnant or breastfeeding women;
For mere information om brug af Xeloda, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using Xeloda, see the package leaflet or contact your doctor or pharmacist.
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Xeloda opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency therefore decided that Xeloda's benefits are greater than its risks and it can be authorised for use in the EU.
De hyppigste bivirkninger ved Xeloda er diarré, kvalme, opkastning, mavesmerter, stomatitis (sår i munden), palmar-plantar erythrodysæstesi (hånd-fodsyndrom, hudreaktion med udslæt og smerte på hænder og fødder), træthed, svaghed, appetitløshed, problemer som følge af dannelse af blodpropper i blodkarrene, hjerteproblemer og nyreproblemer hos patienter, der allerede har nedsat nyrefunktion.
The most common side effects with Xeloda are diarrhoea, nausea (feeling sick), vomiting, abdominal (belly) pain, stomatitis (sores in the mouth), palmar-plantar erythrodysaesthesia (hand-foot syndrome, a skin reaction with rash and pain on the hands and feet), tiredness, weakness, loss of appetite, problems due to formation of blood clots in the blood vessels, heart problems and kidney problems in patients who already have reduced kidney function.
Xeloda indeholder det aktive stof capecitabin.
Xeloda contains the active substance capecitabine.
Derved hæmmes væksten af kræftcellerne, der til sidst dør.
As a result, it prevents the growth of tumour cells and eventually kills them.
Bivirkninger rapporteret for Xeloda vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Xeloda are carefully evaluated and any necessary action taken to protect patients.
Fluorouracil ligner i høj grad pyrimidin.
Fluorouracil is very similar to pyrimidine.
Sygdommen udviste respons på behandlingen hos 19 til 25 % af de patienter, der blev behandlet med Xeloda, sammenlignet med 12 til 15 % hos dem, der fik sammenligningskombinationen.
The disease responded in 19 to 25% of patients treated with Xeloda, compared with 12 to 15% with the comparator combination.
For de andre kræftformers vedkommende afbrydes behandlingen, hvis sygdommen forværres, eller bivirkningerne ikke kan tolereres.
For other types of cancer, treatment is stopped if the disease gets worse or the side effects are unacceptable.
Xeloda bør kun ordineres af en læge med erfaring i brug af kræftlægemidler.
Xeloda should only be prescribed by a doctor who is experienced in the use of cancer medicines.
Xeloda tages som tabletter, mens fluorouracil sædvanligvis må gives ved indsprøjtning.
Xeloda is taken as tablets, while fluorouracil normally needs to be injected.
• patienter, der tager brivudin (et antiviralt lægemiddel til behandling af helvedesild eller skoldkopper), eller som har taget det inden for de sidste 4 uger.
• patients taking brivudine (an antiviral medicine for treating shingles or chickenpox) or who have taken it in the last 4 weeks.
En oversigt over Xeloda, og hvorfor det er godkendt i EU
An overview of Xeloda and why it is authorised in the EU
Ca. to tredjedele af de patienter, der fik Xeloda eller kombinationen, var fortsat sygdomsfri i de 3,8 år, som studiet varede.
About two-thirds of the patients taking Xeloda or the combination remained disease-free throughout the 3.8 years of the study.
Hvad er Xeloda, og hvad anvendes det til?
What is Xeloda and what is it used for?
• patienter, som har haft svære, uventede reaktioner mod behandling med fluoropyrimidin
• patients who have had severe and unexpected reactions to fluoropyrimidine therapy;
• patienter med svær leukopeni, neutropeni eller trombocytopeni (for lavt antal hvide blodlegemer eller blodplader i blodet)
• patients with severe leucopenia, neutropenia, or thrombocytopenia (low levels of white cells or platelets in the blood);
Hvorfor blev Xeloda godkendt i EU?
Why is Xeloda authorised in the EU?
I kroppen indtager fluorouracil pyrimidinets plads og forstyrrer virkningen af de enzymer, der medvirker ved dannelse af ny dna.
In the body, fluorouracil takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Capecitabin er et "prodrug" (et forstadium), der i kroppen omdannes til fluoruracil, men omdannelsen sker i højere grad i svulstcellerne end i normalt væv.
Capecitabine is a ‘prodrug' that is converted to the medicine fluorouracil in the body, but more is converted in tumour cells than in normal tissues.
Hos patienter, der fik Xeloda med docetaxel, varede det længere tid, inden sygdommen blev forværret sammenlignet med patienter, der fik docetaxel, anvendt alene, (186 dage i forhold til 128 dage).
Patients taking Xeloda with docetaxel had a longer time before the disease got worse compared with patients taking docetaxel on its own (186 days compared with 128 days).
Hvilke risici er der forbundet med Xeloda?
What are the risks associated with Xeloda?
• metastatisk kolorektal cancer (kræft i tyktarmen, der har bredt sig til andre dele af kroppen).
• metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body).
To mindre studier (238 patienter) viste, at Xeloda var effektivt efter behandling med taxaner, og at antracycliner ikke virkede.
Two smaller studies (238 patients) showed that Xeloda was effective after treatment with taxanes and anthracyclines did not work.
Xeloda anvendes alene eller sammen med andre kræftlægemidler
Xeloda is used on its own or with other cancer medicines;
Resultaterne viste, at når enten Xeloda eller fluorouracil og folinsyre blev givet sammen med oxaliplatin, varede det gennemsnitligt otte måneder, før sygdommen forværredes hos ikke tidligere behandlede patienter, og fem måneder hos patienter, hvis tidligere behandling ikke var lykkedes.
Results showed that when either Xeloda or fluorouracil and folinic acid were used with oxaliplatin, it took an average of 8 months for the disease to get worse in patients who had not been treated before, and 5 months in patients whose previous treatment had not worked.
Xeloda må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for capecitabin, andre af indholdsstofferne eller over for fluoruracil.
Xeloda must not be used in people who may be hypersensitive (allergic) to capecitabine, to any of the other ingredients, or to fluorouracil.
Det aktive stof i Xeloda, capecitabin, er et cytotoksisk lægemiddel (dvs. det dræber celler, der deler sig, f.eks. kræftceller) og tilhører gruppen af antimetabolitter (stofskiftehæmmere).
The active substance in Xeloda, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Xeloda anvendes alene eller sammen med andre kræftlægemidler til patienter, der er opereret for tyktarmskræft i stadium III eller Dukes' stadium C
Xeloda is used on its own or with other cancer medicines in patients who have had surgery for stage III or Dukes' stage C colon cancer;
Xeloda anvendes sammen med andre kræftlægemidler, herunder et platinholdigt kræftlægemiddel såsom cisplatin
Xeloda is used with other cancer medicines, including a platinum-containing cancer medicine such as cisplatin;
Det kan desuden bruges alene, når antracycliner og taxaner (en anden type kræftlægemidler) ikke virker, eller når yderligere behandling med antracycliner ikke er hensigtsmæssigt.
It can also be used on its own when treatment with both anthracyclines and taxanes (another type of cancer medicine) has failed or when further treatment with anthracyclines is not suitable for the patient.
Desuden viste resultaterne fra et offentliggjort studie, der omfattede 1.002 patienter, at patienter, der fik kombinationsbehandling med Xeloda, overlevede i en lige så lang periode som dem, der fik kombinationsbehandling med fluorouracil.
Also, the results of a published study involving 1,002 patients showed that patients taking combinations of medicines that included Xeloda survived for a similar period as those taking combinations that included fluorouracil.
Xeloda er et lægemiddel, der anvendes til behandling af:
Xeloda is a cancer medicine that is used to treat:
• patienter med svær lever- eller nyresygdom
• patients with severe liver or kidney disease;
Med hensyn til lokalt fremskreden eller metastatisk brystkræft var Xeloda, anvendt med docetaxel, mere effektivt end docetaxel, anvendt alene, i et studie, der omfattede 511 kvinder.
In locally advanced or metastatic breast cancer, Xeloda with docetaxel was more effective than docetaxel on its own in a study involving 511 women.
Xeloda har vist sig effektivt til at behandle patienter med tyktarmskræft, enedetarmskræft, mavekræft og brystkræft.
Xeloda has been shown to be effective in treating colon, colorectal, gastric and breast cancer.
• patienter med for lavt indhold i blodet af enzymet dihydropyrimidin dehydrogenase
• patients with complete absence of activity of the dihydropyrimidine dehydrogenase enzyme;
Xeloda anvendes sammen med docetaxel (et andet kræftlægemiddel), hvis behandling med antracykliner (en anden type kræftlægemidler) ikke har virket.
Xeloda is used with docetaxel (another cancer medicine) after treatment with anthracyclines (another type of cancer medicine) has failed.
Den fuldstændige liste over indberettede bivirkninger ved Xeloda fremgår af indlægssedlen.
For the full list of side effects reported with Xeloda, see the package leaflet.
Hvordan anvendes Xeloda?
How is Xeloda used?
Ved fremskreden mavekræft var Xeloda med cisplatin lige så effektivt som en kombination af fluoruracil og cisplatin til at forhale sygdommen i et studie, hvori der indgik 316 patienter.
In advanced gastric cancer, Xeloda with cisplatin was as effective as a combination of fluorouracil and cisplatin in slowing down the disease in a study involving 316 patients.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Xeloda.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xeloda have been included in the summary of product characteristics and the package leaflet.
Hvilke fordele viser studierne, at der er ved Xeloda?
What benefits of Xeloda have been shown in studies?
Til behandling af metastatisk tyktarmskræft var Xeloda, anvendt alene, lige så effektivt som kombinationen af fluorouracil og folinsyre i to studier, der omfattede 1.207 patienter.
In metastatic colorectal cancer, Xeloda taken on its own was as effective as the combination of fluorouracil and folinic acid in 2 studies involving 1,207 patients.
Hvordan virker Xeloda?
How does Xeloda work?
Hos de patienter, der fik Xeloda og cisplatin, gik der 5,6 måneder, uden at sygdommen skred frem, mens der gik 5,0 måneder hos dem, der fik fluorouracil og cisplatin.
It took 5.6 months for the disease to get worse in patients taking Xeloda and cisplatin, and 5.0 months in patients receiving fluorouracil and cisplatin.
Det første omfattede 2.035 patienter, der ikke tidligere havde været behandlet, og det andet omfattede 627 patienter, hos hvem tidligere behandling med irinotecan og et fluoropyrimidin (en gruppe kræftlægemidler, der omfatter fluorouracil)ikke havde virket.
Xeloda has also been compared with the combination of fluorouracil and folinic acid, both used in combination with oxaliplatin, in 2 studies: the first involved 2,035 patients who had not been treated before, and the second involved 627 patients in whom previous treatment with irinotecan and a fluoropyrimidine (a group of cancer medicines that includes fluorouracil) had not worked.
Med hensyn til tyktarmskræft har Xeloda, anvendt alene, vist sig at være lige så effektivt som en kombination af fluorouracil og folinsyre (et lægemiddel, der øger virkningen af fluorouracil) i et hovedstudie, der omfattede 1.987 kræftopererede patienter.
In colon cancer, Xeloda on its own has been shown to be as effective as the combination of fluorouracil and folinic acid (a medicine that enhances the effects of fluorouracil) in a main study involving 1,987 patients who had had surgery for their cancer.
I et andet studie, der omfattede 1.886 opererede patienter, var Xeloda sammen med oxaliplatin (et andet kræftlægemiddel) mere effektivt end kombinationen af fluoruracil og folinsyre.
Another study involving 1,886 patients who had had surgery showed that Xeloda together with oxaliplatin (another cancer medicine) was more effective than the combination of fluorouracil and folinic acid: patients taking Xeloda and oxaliplatin had 20% lower risk of getting cancer again or death compared with patients taking fluorouracil and folinic acid.
Mavekræft
Gastric cancer
EMEA/599/113/2008
Ref. EMEA/551181/2008
London, den 23. oktober 2008 Ref. dok.
London, 23 October 2008 Doc.
Hvilken dokumentation blev der fremlagt for at underbygge denne ansøgning?
What documentation was presented to support this application?
• tilfælde af alvorlig depression
• episodes of major depression;
De kan anmode om en revurdering af udtalelsen senest 15 dage efter modtagelse af meddelelsen om denne negative udtalelse.
They may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Det blev målt ved hjælp af standardskalaer og spørgeskemaer.
These were measured using standard scales and questionnaires.
Årsagen til fibromyalgi kendes ikke.
The cause of fibromyalgia is not known.
Det anvendes til behandling af voksne med:
It is used for the treatment of adults with the following diseases:
I alle undersøgelserne var de primære effektmål baseret på ændringer i patienternes symptomer, særlig smerteniveauet, og deres generelle helbredstilstand.
In all of the studies, the main measures of effectiveness were based on changes in the patients' symptoms, particularly pain levels, and their overall state of health.
Internationalt fællesnavn (INN): duloxetin
International non-proprietary name (INN): duloxetine
Hvad sker der med duloxetin til behandling af andre sygdomme?
What is happening for duloxetine used for the treatment of other diseases?
Resultatet af fem undersøgelser af i alt 1 718 voksne med fibromyalgi blev forelagt CHMP for at underbygge ansøgningen.
The results of five studies involving a total of 1,718 adults with fibromyalgia were presented to the CHMP to support the application.
• generaliseret angst (vedvarende angst eller nervøsitet over dagligdags ting).
• generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Det leveres som gastroresistente kapsler.
It is available as gastroresistant capsules.
Ansøgningen om ændring vedrørte en udvidelse af indikationen til også at omfatte behandling af fibromyalgi.
The change concerned an extension of indication to add the treatment of fibromyalgia.
Fibromyalgi kan også give andre symptomer som ømhed, stivhed, træthed, angst og ændringer i patientens søvn, følelser og tanker.
Fibromyalgia can also cause other symptoms such as tenderness, stiffness, tiredness, anxiety and changes in how the patient sleeps, feels and thinks.
Cymbalta/Xeristar har været godkendt siden december 2004.
Cymbalta/Xeristar has been authorised since December 2004.
"Gastroresistent" betyder, at kapslernes indhold passerer gennem maven og først bliver nedbrudt, når det når ned i tarmene.
‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Den 23. oktober 2008 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, hvori udvalget anbefaler afslag på ansøgning om ændring af markedsføringstilladelsen for lægemidlet Cymbalta/Xeristar 30 mg og 60 mg gastroresistente kapsler.
On 23 October 2008, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Cymbalta/Xeristar 30 mg and 60 mg gastroresistant capsules.
Spørgsmål og svar vedrørende anbefalingen af afslag på ansøgningen om ændring af markedsføringstilladelsen for Cymbalta/Xeristar
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Cymbalta/Xeristar
Det virker ved at forhindre neurotransmitterne 5-hydroxytrypamin (også kaldet serotonin) og noradrenalin i at blive genoptaget i nerveceller i hjernen og rygmarven.
It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Da disse neurotransmittere også menes at være en medvirkende faktor ved fibromyalgi, forventes blokering af genoptagelsen af disse i nervecellerne at forbedre symptomerne på sygdommen.
Since these neurotransmitters are thought to be involved in fibromyalgia, blocking their re-uptake into nerve cells is expected to improve the symptoms of the disease.
Den femte undersøgelse var langvarig, og heri sammenlignedes virkningen af to doser Cymbalta/Xeristar i løbet af et år hos 307 patienter.
The fifth, a long-term study, compared the effects of two doses of Cymbalta/Xeristar over a year in 307 patients.
Der er ingen konsekvenser for anvendelsen af Cymbalta/Xeristar, Ariclaim eller Yentreve til de for disse lægemidler allerede godkendte indikationer, hvor benefit/risk-forholdet forbliver uændret.
There are no consequences on the use of Cymbalta/Xeristar, Ariclaim or Yentreve in their authorised indications, for which the balance of benefits and risks remains unchanged.
Cymbalta/Xeristar er et lægemiddel, som indeholder det aktive stof duloxetin.
Cymbalta/Xeristar is a medicine containing the active substance duloxetine.
Duloxetin er under navnene Ariclaim og Yentreve også godkendt til anvendelse ved stressinkontinens.
Duloxetine, under the names Ariclaim and Yentreve, is also authorised for use in stress urinary incontinence.
Man havde forventet, at Cymbalta/Xeristar også skulle anvendes til behandling af voksne med fibromyalgi, en sygdom, som giver vedvarende, udbredte smerter og smertereaktioner ved berøring.
Cymbalta/Xeristar was also expected to be used to treat adults with fibromyalgia, a disease causing long-lasting, widespread pain and painful responses to touch.
Hvilke konsekvenser har afslaget for patienter, som deltager i kliniske undersøgelser med Cymbalta/Xeristar?
What are the consequences of the refusal for patients in clinical trials with Cymbalta/Xeristar?
CHMP konkluderede også, at den langvarige undersøgelse var utilstrækkelig til at påvise effekten af lægemidlet, og at der var behov for en langvarig undersøgelse, som sammenlignede Cymbalta/Xeristar med placebo.
The CHMP also concluded that the long-term study was insufficient to show the effectiveness of the medicine and that a long-term study comparing Cymbalta/Xeristar with placebo would be needed.
Det var forventet, at Cymbalta/Xeristar skulle anvendes til patienter med fibromyalgi med eller uden depression.
Cymbalta/Xeristar was expected to be used in fibromyalgia patients with or without depression.
Virksomhederne informerede CHMP om, at der i øjeblikket ikke foregår kliniske undersøgelser med Cymbalta/Xeristar hos fibromyalgipatienter i Europa.
The companies informed the CHMP that there are currently no ongoing clinical trials with Cymbalta/Xeristar in fibromyalgia patients in Europe.