FrancophonIA/ELRC3.0 huggingface dataset:
English: By blocking these processes, Firmagon reduces the amount of testosterone in the body and slows down the growth of the cancer cells.
Danish: Ved at hæmme disse processer, reducerer Firmagon mængden af testosteron i kroppen og bremser væksten af kræftceller.
English: The main measure of effectiveness was the number of patients whose testosterone levels were below those seen in men whose testes were producing no testosterone, over the first year of treatment.
Danish: Det primære effektmål var antallet af patienter, hvis testosteronkoncentrationer var under dem, der sås hos mænd, hvis testikler ikke producerede testosteron, i løbet af det første år af behandlingen.
English: ‘Advanced' means that the cancer has spread beyond the gland to some lymph nodes, but not to other organs.
Danish: "Fremskreden" betyder, at kræften har bredt sig ud over kirtlen og til nogle lymfekirtler, men ikke til andre organer.
English: However, because the main study looked at the medicine's effects on testosterone levels rather than the cancer or the patient's outcome directly, and because leuprorelin is only used for prostate cancer that is advanced, the Committee decided to restrict the use of Firmagon to advanced prostate cancer.
Danish: Men eftersom hovedundersøgelsen havde til formål at undersøge lægemidlets virkninger på testosteronkoncentrationer, frem for direkte på kræften eller behandlingsresultatet for patienten, og da leuprorelin kun anvendes til fremskreden prostatakræft, besluttede udvalget at begrænse brugen af Firmagon til fremskreden prostatakræft.
English: Similar results were seen in patients receiving Firmagon at the higher dose of 160 mg once a month.
Danish: Der blev observeret lignende resultater hos patienter, som fik behandling med Firmagon ved den høje dosis på 160 mg én gang om måneden.
English: The materials will include information on Firmagon's safety and remind doctors how to administer the medicine.
Danish: Materialet vil omfatte information om sikkerheden ved Firmagon og påmindelser til lægerne om, hvordan lægemidlet skal indgives.
English: During the first year, 97% of the patients receiving Firmagon at the approved dose of 80 mg once a month dose had testosterone levels below the required level.
Danish: I løbet af det første år havde 97% af de patienter, som fik behandling med Firmagon ved den godkendte dosis på 80 mg én gang om måneden, testosteronkoncentrationer under det krævede niveau.
English: Which measures are being taken to ensure the safe use of Firmagon?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Firmagon?
English: Firmagon is a powder and solvent that are made up into a solution for injection.
Danish: Firmagon er et pulver og en solvens, der skal forberedes til en opløsning til injektion.
English: Firmagon can be used if the cancer is ‘hormone-dependent', which means that it responds to treatments that reduce the levels of the hormone testosterone.
Danish: Firmagon kan anvendes, hvis kræften er "hormonafhængig", hvilket vil sige, at den responderer på behandlinger, som reducerer koncentrationerne af hormonet testosteron.
English: GnRH normally stimulates the pituitary gland at the base of the brain to produce two hormones which cause the testes to produce testosterone.
Danish: GnRH stimulerer normalt hypofysen ved hjernestammen til at producere to hormoner, som får testiklerne til at producere testosteron.
English: Testosterone can make prostate cancer cells grow.
Danish: Testosteron kan få prostatakræftcellerne til at brede sig.
English: The active substance in Firmagon, degarelix, is a gonadotrophin-releasing hormone antagonist, which means that it blocks the effects of a natural hormone called gonadotrophin-releasing hormone (GnRH).
Danish: Det aktive stof i Firmagon, degarelix, er en antagonist til det gonadotrophinfrigørende hormon, hvilket betyder, at det hæmmer virkningen af et naturligt hormon kaldet gonadotrophinfrigørende hormon (GnRH).
English: Firmagon should not be used in people who may be hypersensitive (allergic) to degarelix or any of the other ingredients.
Danish: Firmagon bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for degarelix eller andre af indholdsstofferne.
English: The Committee also noted that treatment with Firmagon does not trigger the temporary sharp rise in testosterone levels seen with ‘GnRH agonists' (other medicines for prostate cancer that stimulate the production of GnRH).
Danish: Udvalget noterede sig også, at behandling med Firmagon ikke udløser den midlertidige bratte stigning i testosteronkoncentrationerne, som man ser med "GnRH-agonister" (andre lægemidler mod prostatakræft, som stimulerer produktionen af GnRH).
English: Firmagon should be used with caution in patients who have severe kidney or liver problems.
Danish: Firmagon skal anvendes med forsigtighed til patienter med alvorlige nyre- eller leverproblemer.
English: What is the risk associated with Firmagon?
Danish: Hvilken risiko er forbundet med Firmagon?
English: Therefore, the CHMP decided that Firmagon's benefits are greater than its risks for the treatment of adult male patients with advanced hormone-dependent prostate cancer.
Danish: CHMP konkluderede derfor, fordelene ved Firmagon er større end risiciene ved behandling af voksne mandlige patienter med fremskreden hormonafhængig prostatakræft.
English: For the full list of all side effects reported with Firmagon, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Firmagon fremgår af indlægssedlen.
English: Firmagon was as effective as leuprorelin at reducing testosterone levels.
Danish: Firmagon var lige så effektivt som leuprorelin til at reducere koncentrationerne af testosteron.
English: Firmagon is used to treat patients with advanced prostate cancer.
Danish: Firmagon anvendes til behandling af patienter med fremskreden prostatakræft.
English: This was compared with 96% of patients receiving leuprorelin.
Danish: Hos de patienter, som fik behandling med leuprorelin, var den tilsvarende andel 96%.
English: Firmagon is injected under the skin of the abdomen.
Danish: Firmagon injiceres under huden i maveregionen.
English: Why has Firmagon been approved?
Danish: Hvorfor blev Firmagon godkendt?
English: Doctors should monitor the effectiveness of Firmagon treatment by looking at blood levels of testosterone and prostate-specific antigen (PSA).
Danish: Virkningen af Firmagon-behandling skal overvåges af en læge, som skal se på koncentrationerne af testosteron og prostataspecifikt antigen (PSA) i blodet.
English: PSA is a protein that is produced by the prostate gland and is often found at high levels in men with prostate cancer.
Danish: PSA er et protein, som produceres af prostatakirtlen og forekommer i høje koncentrationer hos mænd med prostatakræft.
English: This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in the semen.
Danish: Det er en kræftform, der påvirker prostatakirtlen, den kirtel, der sidder under blæren hos mænd, og som producerer sædvæske.
English: What is Firmagon?
Danish: Hvad er Firmagon?
English: What benefit has Firmagon shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Firmagon?
English: How has Firmagon been studied?
Danish: Hvordan blev Firmagon undersøgt?
English: What is Firmagon used for?
Danish: Hvad anvendes Firmagon til?
English: How is Firmagon used?
Danish: Hvordan anvendes Firmagon?
English: How does Firmagon work?
Danish: Hvordan virker Firmagon?
English: Prevention of rejection
Danish: Forebyggelse af afstødning
English: Treatment of S-LAM
Danish: Behandling af S-LAM
English: Rapamune received a marketing authorisation valid throughout the EU on 14 March 2001.
Danish: Rapamune fik en markedsføringstilladelse med gyldighed i hele EU den 14. marts 2001.
English: Further information on Rapamune can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Rapamune findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most common side effects with Rapamune (which may affect more than 1 in 10 people) are infections, fever, slow wound healing, low counts of various blood cells, blood tests showing altered levels of various substances (including low potassium and phosphate; raised fats, cholesterol, glucose and markers for tissue breakdown and for liver and kidney function), diabetes, lymphocele (collection of lymph fluid usually in the lower belly), pain in various parts of the body, rapid heartbeat, raised blood pressure, problems affecting the gut, proteinuria (protein in the urine), menstrual disorders, oedema (swelling because of fluid build-up), rash and acne.
Danish: De hyppigste bivirkninger ved Rapamune (som kan forekomme hos flere end 1 ud af 10 patienter) er infektioner, feber, langsom sårheling, lavt antal af forskellige blodlegemer, blodprøver, der viser ændrede niveauer af forskellige bestanddele (herunder lavt niveau af kalium og fosfat, forhøjet niveau af fedtstoffer, kolesterol, glukose og markører for nedbrydning af væv og for lever- og nyrefunktion), diabetes, ophobning af lymfevæske (typisk i den nederste del af maven), smerter i forskellige dele af kroppen, hurtig hjerterytme, forhøjet blodtryk, tarmproblemer, proteinuri (protein i urinen), menstruationsforstyrrelser, ødem, udslæt og akne.
English: Other information about Rapamune
Danish: Andre oplysninger om Rapamune
English: The main measure of effectiveness was the number of treatment failures (rejection or loss of the new kidney, or death) after 6 months.
Danish: Det primære mål for virkningen var antallet af mislykkede behandlinger (afstødning eller tab af den nye nyre eller dødsfald) efter 6 måneder.
English: As for all medicines, data on the use of Rapamune are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Rapamune løbende overvåget.
English: Rapamune contains the active substance sirolimus.
Danish: Rapamune indeholder det aktive stof sirolimus.
English: Two additional studies looked at Rapamune as continuing treatment for up to 5 years in 765 patients who were able to stop ciclosporin after 2 to 3 months.
Danish: To yderligere studier undersøgte Rapamune som fortsat behandling i op til 5 år hos 765 patienter, der var i stand til at stoppe ciclosporin efter 2-3 måneder.
English: For more information about using Rapamune, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Rapamune, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Rapamune is available as an oral solution (1 mg/ml) and tablets (0.5, 1 and 2 mg).
Danish: Rapamune fås som en oral opløsning (1 mg/ml) og tabletter (0,5 mg, 1 mg og 2 mg).
English: The doctor will adjust the dose to achieve appropriate levels of sirolimus in the patient's blood.
Danish: Lægen vil justere dosen for at opnå et tilstrækkeligt niveau af sirolimus i patientens blod.
English: What measures are being taken to ensure the safe and effective use of Rapamune?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rapamune?
English: Side effects reported with Rapamune are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Rapamune vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: This complex then blocks another protein called ‘mammalian target of rapamycin' (mTOR).
Danish: Komplekset blokerer et andet protein, der kaldes det mammale mål for rapamycin (mTOR).
English: It is recommended that Rapamune is used with ciclosporin and corticosteroids (other medicines to prevent organ rejection) for two to three months.
Danish: Det anbefales, at Rapamune anvendes sammen med ciclosporin og kortikosteroider (andre lægemidler til forebyggelse af organafstødning) i to til tre måneder.
English: All patients were also treated with ciclosporin and corticosteroids and were at low to moderate risk of rejection.
Danish: Alle patienter blev også behandlet med ciclosporin og kortikosteroider og havde en lav til moderat risiko for afstødning.
English: The main measure of effectiveness was a change of FEV1 (the maximum volume of air a person can breathe out in 1 second).
Danish: Det primære mål for virkningen var ændringen i forceret ekspirationsvolumen (FEV1, den maksimale luftmængde, en person kan udånde på et sekund).
English: An overview of Rapamune and why it is authorised in the EU
Danish: En oversigt over Rapamune, og hvorfor det er godkendt i EU
English: Rapamune can then be used for continuing treatment with corticosteroids, but only if ciclosporin treatment can be stopped.
Danish: Behandlingen med Rapamune kan derefter fortsættes sammen med kortikosteroider, men kun hvis ciclosporinbehandlingen kan stoppes.
English: What is Rapamune and what is it used for?
Danish: Hvad er Rapamune, og hvad anvendes det til?
English: To prevent organ rejection, the first dose is usually 6 mg given soon after the transplantation followed by 2 mg once a day.
Danish: Ved forebyggelse af organafstødning er den første dosis typisk 6 mg, der gives straks efter transplantationen, efterfulgt af 2 mg én gang dagligt.
English: Why is Rapamune authorised in the EU?
Danish: Hvorfor blev Rapamune godkendt i EU?
English: Rapamune treatment should be started by and remain under the guidance of a doctor who is a qualified specialist in transplantation.
Danish: Behandlingen med Rapamune bør indledes og gennemføres under vejledning af en læge, som er uddannet specialist i transplantationer.
English: The Agency decided that Rapamune's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede, at fordelene ved Rapamune opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: It is used in adults who are at a low to moderate risk of rejection.
Danish: Det anvendes hos voksne, som har en lav til moderat risiko for organafstødning.
English: By blocking mTOR, Rapamune reduces the multiplication of these cells.
Danish: Ved at blokere mTOR reducerer Rapamune formeringen af disse celler.
English: FEV1 improved by an average of 1 ml per month in patients treated with Rapamune compared with a worsening by 12 ml per month in patients receiving placebo.
Danish: FEV1 blev forbedret med gennemsnitligt 1 ml pr. måned hos patienter, der blev behandlet med Rapamune, sammenholdt med en forværring på 12 ml pr. måned hos patienter, der fik placebo.
English: The Agency noted that no medicinal product has been approved for the treatment of S-LAM and Rapamune's effect on lung function is considered important.
Danish: Agenturet bemærkede, at der ikke findes noget godkendt lægemiddel til behandling af S-LAM, og Rapamunes virkning på lungefunktionen anses for vigtig.
English: Patients allergic to peanut or soya must not take Rapamune oral solution because the solution contains soya oil.
Danish: Patienter, der er allergiske over for jordnødder eller soja, må ikke tage Rapamune som oral opløsning, da den indeholder sojaolie.
English: The active substance in Rapamune, sirolimus, is an immunosuppressant (a medicine that reduces the activity of the immune system).
Danish: Det aktive stof i Rapamune, sirolimus, er et immunundertrykkende stof (et lægemiddel, som undertrykker immunforsvarets aktivitet).
English: S-LAM is a rare lung disease that causes worsening symptoms such as shortage of breath and occurs mainly in women who are at an age when they can have children.
Danish: S-LAM er en sjælden lungesygdom, der medfører forværring af symptomer som f.eks. åndenød, og den opstår hovedsagelig hos kvinder i den fødedygtige alder.
English: To treat patients with S-LAM, the dose of Rapamune is 2 mg daily and after 10 to 20 days the doctor will adjust the dose to achieve appropriate levels of sirolimus in the patient's blood.
Danish: Ved behandling af S-LAM er dosen af Rapamune 2 mg dagligt, og efter 10-20 dage justerer lægen dosen for at opnå et tilstrækkeligt niveau af sirolimus i patientens blod.
English: In S-LAM, mTOR is overactive, causing excessive multiplication of cells that cause the disease.
Danish: Ved S-LAM er mTOR overaktiv, hvilket medfører kraftig formering af de celler, der forårsager sygdommen.
English: The European Medicines Agency considered that Rapamune is effective for the prevention of rejection of a transplanted kidney in patients at low to moderate risk of rejection.
Danish: Det Europæiske Lægemiddelagentur fandt, at Rapamune er effektivt til forebyggelse af afstødning af en transplanteret nyre hos patienter med lav til moderat risiko for afstødning.
English: Rapamune is also used for treating patients with sporadic lymphangioleiomyomatosis (S-LAM) with moderate lung disease or worsening lung function.
Danish: Rapamune anvendes også til behandling af patienter med sporadisk lymphangioleiomyomatosis (SLAM) med moderat lungesygdom eller forværring af lungefunktionen.
English: In the body, sirolimus attaches to a protein inside cells to make a ‘complex'.
Danish: Sirolimus binder til et protein i kroppens celler og danner et "kompleks".
English: Rapamune was more effective than placebo (a dummy treatment) or azathioprine (another immunosuppressive medicine) in two main studies involving a total of 1,295 patients who were having a kidney transplant.
Danish: Rapamune var mere effektivt end placebo (ikke-aktivt stof) eller azathioprin (et andet immunundertrykkende lægemiddel) i to hovedstudier med i alt 1.295 patienter, der fik en nyretransplantation.
English: What are the risks associated with Rapamune?
Danish: Hvilke risici er der forbundet med Rapamune?
English: Rapamune was more effective than placebo in improving lung function in a study involving 81 patients with S-LAM.
Danish: Rapamune var mere effektivt end placebo til at forbedre lungefunktionen i et studie med 81 patienter med S-LAM.
English: Rapamune is a medicine used to prevent the body from rejecting a newly transplanted kidney.
Danish: Rapamune er et lægemiddel, der anvendes til at forebygge, at kroppen afstøder en nytransplanteret nyre.
English: Rapamune was effective in helping the new kidney to survive, with an improvement in how well it worked and an improvement in blood pressure when ciclosporin treatment was stopped.
Danish: Rapamune havde en positiv virkning på den nye nyres overlevelse, og behandlingen forbedrede den nye nyres funktion og blodtrykket, når ciclosporinbehandlingen blev stoppet.
English: In the first study, treatment failed in 19% (53 out of 284) of the patients adding Rapamune after 6 months, compared with 32% (52 out of 161) of those adding azathioprine.
Danish: I det første studie mislykkedes behandlingen hos 19 % (53 ud af 284) af de patienter, der fik tilføjet Rapamune efter 6 måneder, sammenholdt med 32 % (52 ud af 161) af de patienter, der fik tilføjet azathioprin.
English: In the second study, treatment failed in 30% (68 out of 277) of the patients adding Rapamune, compared with 48% (62 out of 130) of those adding placebo.
Danish: I det andet studie mislykkedes behandlingen hos 30 % (68 ud af 277) af de patienter, der fik tilføjet Rapamune, sammenholdt med 48 % (62 ud af 130) af de patienter, der fik tilføjet placebo.
English: For the full list of side effects and restrictions of Rapamune, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Rapamune fremgår af indlægssedlen.
English: How is Rapamune used?
Danish: Hvordan anvendes Rapamune?
English: What benefits of Rapamune have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Rapamune?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rapamune 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 Rapamune.
English: How does Rapamune work?
Danish: Hvordan virker Rapamune?
English: Since mTOR is involved in the multiplication of activated T-lymphocytes (white blood cells that are responsible for attacking the transplanted organ), Rapamune reduces the number of these cells, reducing the risk of organ rejection.
Danish: mTOR medvirker til formeringen af aktiverede T-lymfocytter (hvide blodlegemer, der angriber det transplanterede organ).
English: Tibolona Aristo
Danish: Tibolona Aristo 2,5 mg
English: Tibolon Aristo
Danish: Tibolon Aristo 2,5 mg
English: This authorisation was based on the authorisation granted to Januvia in 2007 (‘informed consent').
Danish: Denne tilladelse byggede på den tilladelse, som blev udstedt for Januvia i 2007 ("informeret samtykke").
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tesavel on 10 January 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tesavel den 10. januar 2008.
English: The full EPAR for Tesavel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Tesavel findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Tesavel.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tesavel.
English: Other information about Tesavel
Danish: Andre oplysninger om Tesavel
English: Tesavel is taken at a dose of 100 mg once a day.
Danish: Tesavel tages i en dosis a 100 mg én gang dagligt.
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 Tesavel.
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 Tesavel.
English: Tesavel was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines.
Danish: Tesavel havde større effekt end placebo, når det blev taget alene eller i kombination med andre lægemidler mod diabetes.
English: For more information about treatment with Tesavel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Tesavel, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In patients with moderately or severely reduced kidney function the dose of Tesavel should be reduced.
Danish: Hos patienter med moderat eller svært nedsat nyrefunktion skal dosis af Tesavel nedsættes.
English: The CHMP decided that Tesavel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Tesavel opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Tesavel is a medicine that contains the active substance sitagliptin.
Danish: Tesavel er et lægemiddel, der indeholder det aktive stof sitagliptin.
English: • four of the studies compared Tesavel with placebo (a dummy treatment).
Danish: • I fire af undersøgelserne sammenlignedes Tesavel med placebo (en virkningsløs behandling).
English: The active substance in Tesavel, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Danish: Det aktive stof i Tesavel, sitagliptin, er en dipeptidylpeptidase-4 (DPP-4)-hæmmer.
English: • two studies compared Tesavel with other antidiabetes medicines.
Danish: • I to undersøgelser sammenlignedes Tesavel med andre lægemidler mod diabetes.