FrancophonIA/ELRC3.0 huggingface dataset:
English: It must not be used in patients who have or have had a severe infection within the past two weeks or in patients with a neutrophil count of less than 1,500 per mm for the first administration or less than 1,000/mm3 for subsequent administrations or a platelet count less than 100,000 per mm3.
Danish: Det må ikke anvendes til patienter, som har eller inden for de seneste to uger har haft en alvorlig infektion, eller til patienter med et neutrofiltal på under 1 500 per mm3 ved den første indgivelse eller på under 1 000/mm3 ved efterfølgende indgivelser eller et blodpladetal på under 100 000 per mm3.
English: The dose of Javlor to be given is based on the patient's body surface area (calculated using height and weight).
Danish: Doseringen af Javlor beregnes ud fra patientens kropsoverflade (beregnes ud fra højde og vægt).
English: During the study all patients received best supportive care (any medicines or techniques to help patients, but not other anticancer medicines).
Danish: Alle patienterne i undersøgelsen modtog den bedste understøttende behandling (dvs. alle typer lægemidler eller teknikker, der kan hjælpe patienterne, men ikke andre lægemidler mod kræft).
English: It attaches to a protein in cells called ‘tubulin', which is important in the formation of the internal ‘skeleton' that cells need to assemble when they divide.
Danish: Det binder sig til et protein i cellerne kaldet "tubulin", som er vigtigt for dannelsen af det indre "skelet", som cellerne opbygger, når de deler sig.
English: The study also looked separately at the results in eligible patients who fulfilled strict criteria such as having had a worsening of the disease after treatment with a platinum-containing medicine.
Danish: Der blev i undersøgelsen endvidere foretaget en særskilt undersøgelse hos egnede patienter, som opfyldte strenge kriterier, såsom at have oplevet en forværring af sygdommen efter at være blevet behandlet med et platinholdigt lægemiddel.
English: Javlor is a concentrate for solution for infusion (drip into a vein).
Danish: Javlor er et koncentrat til infusionsopløsning (drop i en vene).
English: All the patients had previously received treatment with a platinum-containing medicine which failed.
Danish: Alle patienterne var tidligere blevet behandlet med platinholdige lægemidler, som havde slået fejl.
English: For more information about treatment with Javlor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Javlor, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The most common side effects with Javlor (seen in more than 1 patient in 10) are neutropenia, leucopenia (low white blood cell counts), anaemia (low red blood cell counts), thrombocytopenia (low platelet count), loss of appetite, constipation, abdominal (stomach) pain, vomiting, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), diarrhoea, alopecia (hair loss), myalgia (muscle pain), asthenia (weakness) or fatigue (tiredness), injection site reaction, fever and weight loss.
Danish: De hyppigste bivirkninger ved Javlor (som optræder hos flere end 1 ud af 10 patienter) er neutropeni, leukopeni (lavt antal hvide blodlegemer), anæmi (lavt antal røde blodlegemer), trombocytopeni (lavt antal blodplader), appetitløshed, forstoppelse, mavesmerter, opkastning, kvalme, stomatitis (betændelse i mundslimhinden), diarré, alopeci (hårtab), myalgi (muskelsmerter), asteni (svaghed) eller træthed, reaktioner på injektionsstedet, feber og vægttab.
English: What is the risk associated with Javlor?
Danish: Hvilken risiko er der forbundet med Javlor?
English: This is because low levels of haemoglobin (a protein found in red blood cells that carries oxygen around the body) and blood cells (white blood cells and platelets) are frequent side effect of the medicine.
Danish: Dette skyldes, at et lavt indhold af hæmoglobin (et protein i de røde blodlegemer, der transporterer ilt rundt i kroppen) og blodlegemer (hvide blodceller og -plader) er hyppige bivirkninger ved lægemidlet.
English: The active substance in Javlor, vinflunine, belongs to the group of anticancer medicines known as the vinca alkaloids.
Danish: Det aktive stof i Javlor, vinflunin, tilhører en gruppe af lægemidler mod kræft, der kaldes vinkaalkaloider.
English: The doctor may need to adjust the dose by taking into account the patient's age, liver or kidney function and certain side effects that the patient may be experiencing.
Danish: Det kan være nødvendigt for lægen at justere doseringen i betragtning af patientens alder, lever- og nyrefunktion og visse bivirkninger, som patienten kan få.
English: By attaching to tubulin in cancer cells, vinflunine stops the formation of the skeleton, preventing the division and spread of the cancer cells.
Danish: Ved at binde sig til tubulinen i kræftcellerne standser vinflunin skeletdannelsen, og derved forhindres det, at kræftcellerne deler sig og breder sig.
English: Treatment with Javlor should be started under the supervision of a doctor qualified to use anticancer medicines and is only given in specialised hospital units.
Danish: Behandling med Javlor bør indledes under overvågning af en læge med erfaring i behandling med lægemidler mod kræft og gives kun ved specialiserede hospitalsenheder.
English: The doctor may also delay or stop doses if the patient experiences certain side effects, including low levels of platelets and neutrophils (a type of white blood cell), and certain side effects affecting the heart, liver or lungs.
Danish: Lægen kan også udsætte eller afbryde dosisindgivelsen, hvis patienten oplever visse bivirkninger, herunder lavt indhold af plader og neutrofiler (en type hvide blodlegemer), samt visse bivirkninger, der påvirker hjerte, lever eller lunger.
English: For the full list of all side effects reported with Javlor, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Javlor fremgår af indlægssedlen.
English: Javlor must not be used in people who are hypersensitive (allergic) to vinflunine or other vinca alkaloids.
Danish: Javlor bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for vinflunin eller andre vinkaalkaloider.
English: Before administering Javlor, patients should have a blood test to check their blood cell and haemoglobin levels.
Danish: Inden Javlor indgives, skal patienter have taget en blodprøve for at kontrollere mængden af blodlegemer og hæmoglobin.
English: In one main study of 370 adults with advanced or metastatic transitional cell carcinoma of the urothelial tract, patients who were given Javlor treatment were compared with patients who were not given any anticancer medicine.
Danish: I en hovedundersøgelse af 370 voksne patienter med fremskredent eller metastatisk transitionalcellekarcinom i urinvejene sammenlignede man patienter, som fik behandling med Javlor, med patienter, som ikke blev behandlet med lægemidler mod kræft.
English: Javlor is used when previous treatment with a platinum-containing anticancer medicine has failed.
Danish: Javlor anvendes, når tidligere behandling med platinholdige lægemidler mod kræft har slået fejl.
English: Javlor with best supportive care was more effective than best supportive care alone in prolonging the lives of patients with advanced or metastatic transitional cell carcinoma of the urothelial tract.
Danish: Javlor anvendt sammen med den bedste understøttende behandling var mere effektivt end den bedste understøttende behandling alene til at forlænge levetiden for patienter med fremskredent eller metastatisk transitionalcellekarcinom i urinvejene.
English: Why has Javlor been approved?
Danish: Hvorfor blev Javlor godkendt?
English: Javlor is used for the treatment of adults with advanced or metastatic ‘transitional cell carcinoma of the urothelial tract' (a cancer that affects the lining of the bladder and the rest of the urinary tract).
Danish: Javlor anvendes til behandling af voksne med fremskredent eller metastatisk "transitionalcellekarcinom i urinvejene" (en kræfttype, som påvirker blærens slimhinde og de øvrige dele af urinvejene).
English: However, there was a difference among patients who fulfilled the strict criteria entry requirements for the study.
Danish: Der kunne imidlertid påvises en forskel blandt den gruppe patienter, der deltog i undersøgelsen med de strenge kriterier.
English: For more information, see the summary of product characteristics (also part of the EPAR).
Danish: De nærmere oplysninger fremgår af produktresuméet (også en del af denne EPAR).
English: Among all patients in the study, there was no clear evidence of a difference in survival between patients who received Javlor and those who did not.
Danish: Der blev i undersøgelsen ikke påvist nogen klar forskel i patientoverlevelsen hos de patienter, som blev behandlet med Javlor, i forhold til dem, der ikke gjorde.
English: What is Javlor used for?
Danish: Hvad anvendes Javlor til?
English: What benefit has Javlor shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Javlor?
English: How has Javlor been studied?
Danish: Hvordan blev Javlor undersøgt?
English: How is Javlor used?
Danish: Hvordan anvendes Javlor?
English: How does Javlor work?
Danish: Hvordan virker Javlor?
English: Invented name
Danish: Navn Styrke
English: The patients were treated for up to 23 months.
Danish: Patienterne blev behandlet i op til 23 måneder.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Forsteo on 10 June 2003.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Forsteo den 10. juni 2003.
English: Forsteo teriparatide
Danish: Forsteo teriparatid
English: This is a summary of the European public assessment report (EPAR) for Forsteo.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Forsteo.
English: The full EPAR for Forsteo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Forsteo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It also increases the absorption of calcium from food and prevents too much calcium being lost in the urine.
Danish: Det øger også optagelsen af calcium fra fødevarer og forebygger, at der går for meget calcium tabt i urinen.
English: What measures are being taken to ensure the safe and effective use of Forsteo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Forsteo?
English: Forsteo has been studied in three main studies.
Danish: Forsteo blev undersøgt i tre hovedundersøgelser.
English: The main measure of effectiveness was the number of new vertebral fractures at the end of the study, although the study also looked at non-vertebral fractures.
Danish: Den vigtigste målestok for virkningen var antallet af nye vertebrale frakturer ved undersøgelsens afslutning, selvom undersøgelsen også omfattede ikkevertebrale brud.
English: • men who are at an increased risk of fractures;
Danish: • mænd med forhøjet risiko for brud
English: Patients may inject themselves once they have been trained.
Danish: Patienterne kan give sig selv indsprøjtningen, når de har lært teknikken.
English: Other information about Forsteo
Danish: Andre oplysninger om Forsteo
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 Forsteo.
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, hvordan Forsteo skal anvendes.
English: For more information about treatment with Forsteo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Forsteo, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Forsteo is a medicine that contains the active substance teriparatide.
Danish: Forsteo er et lægemiddel, der indeholder det aktive stof teriparatid.
English: It also reduced the risk of non-vertebral fractures by 62%, but did not reduce the risk of hip fractures.
Danish: Det mindskede også risikoen for ikkevertebrale brud med 62 %, dog ikke hoftebrud.
English: • men and women who are at an increased risk of fractures due to long-term treatment with glucocorticoids (a type of steroid).
Danish: • mænd og kvinder med forhøjet risiko for brud som følge af langvarig glukokortikoidbehandling (en type steroid).
English: The recommended dose is 20 micrograms of Forsteo given once a day as an injection under the skin of the thigh or abdomen (tummy).
Danish: Den anbefalede dosis er 20 mikrogram Forsteo givet en gang dagligt som en indsprøjtning under huden i låret eller abdomen (maven).
English: The study included 429 women and men who had osteoporosis and had been taking glucocorticoids for at least three months.
Danish: Undersøgelsen omfattede 429 kvinder og mænd, som havde osteoporose og havde taget glukokortikoider i mindst tre måneder.
English: Forsteo must not be used in patients who have other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease.
Danish: Forsteo må ikke anvendes til patienter, som har haft andre knoglesygdomme, som f.eks. Pagets sygdom, knoglekræft eller knoglemetastaser (kræft, der har bredt sig til knoglerne), patienter, som har fået stråleterapi på knoglerne, eller patienter, som har haft hypercalcæmi (højt calciumindhold i blodet), som har haft forhøjet alkalisk phosphatase (et enzym) af ukendte årsager eller svær nyresygdom.
English: Forsteo must not be used in children or in young adults whose bones are not yet fully mature, or during pregnancy or breastfeeding.
Danish: Forsteo må ikke gives til børn eller unge, hvis knoglesystem ikke er færdigudviklet, eller anvendes under graviditet eller amning.
English: The most common side effect with Forsteo (seen in more than 1 patient in 10) is pain in the arms or legs.
Danish: Den mest almindelige bivirkning ved Forsteo (som optræder hos flere end 1 ud af 10 patienter) er smerter i arme og ben.
English: The active substance in Forsteo, teriparatide, is identical to part of the human parathyroid hormone.
Danish: Det aktive stof i Forsteo, teriparatid, er identisk med en del af det humane parathyroidhormon.
English: It is available as a solution for injection in prefilled pens (one 2.4 ml prefilled pen contains 600 micrograms of teriparatide).
Danish: Det fås som injektionsvæske, opløsning i fyldte penne (en fyldt pen på 2,4 ml indeholder 600 mikrogram teriparatid).
English: In the study in men, Forsteo increased bone density in the spine by about 6% after an average of almost 12 months.
Danish: I undersøgelsen hos mænd øgede Forsteo knogletætheden i rygsøjlen med cirka 6 % efter næsten 12 måneder i gennemsnit.
English: Forsteo is used for the treatment of osteoporosis (a disease that makes bones fragile) in the following groups:
Danish: Forsteo anvendes til behandling af osteoporose (en sygdom, der gør knoglerne skøre) i følgende grupper:
English: A user manual is available for the pen.
Danish: Der medfølger en brugsanvisning til pennen.
English: What is the risk associated with Forsteo?
Danish: Hvilken risiko er der forbundet med Forsteo?
English: Osteoporosis can also occur in both sexes as a side effect of glucocorticoid treatment.
Danish: Osteoporose kan forekomme hos både mænd og kvinder som en bivirkning af glukokortikoidbehandling.
English: The CHMP concluded that Forsteo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Forsteo opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Forsteo.
English: It acts like the hormone to stimulate bone formation by acting on osteoblasts (bone-forming cells).
Danish: Det virker ligesom hormonet og stimulerer knogledannelsen ved at indvirke på osteoblasterne (knogledannende celler).
English: The first study involved 1,637 women with osteoporosis who had been through the menopause (average age: 69.5 years), in which Forsteo was compared with placebo (a dummy treatment) for an average of 19 months.
Danish: I den første undersøgelse deltog 1 637 kvinder med osteoporose, som havde været gennem overgangsalderen (gennemsnitsalder: 69,5 år), hvor Forsteo blev sammenlignet med placebo (en uvirksom behandling) over en periode på gennemsnitligt 19 måneder.
English: The studies also showed that the benefits of Forsteo treatment continued to increase for up to two years, with further increases in bone density.
Danish: Undersøgelserne viste også, at fordelene ved behandlingen med Forsteo fortsatte med at forøges i op til to år, og at knogletætheden blev yderligere forøget.
English: Patients should receive calcium and vitamin D supplements if they do not get enough from their diet. Forsteo can be used for up to two years.
Danish: Patienterne bør tage calcium- og D-vitamintilskud, hvis de ikke får tilstrækkeligt gennem deres kost.
English: Why has Forsteo been approved?
Danish: Hvorfor blev Forsteo godkendt?
English: An additional study looked at the effects of Forsteo on bone density over two years in 234 women who had been through the menopause.
Danish: En yderligere undersøgelse omhandlede virkningerne af Forsteo på knogletætheden i en periode på to år hos 234 kvinder, som havde været gennem overgangsalderen.
English: What is Forsteo?
Danish: Hvad er Forsteo?
English: • women who have been through the menopause.
Danish: • kvinder efter overgangsalderen.
English: Forsteo reduced the risk of developing a new vertebral fracture over 19 months by 65% compared with placebo.
Danish: Forsteo mindskede risikoen for at udvikle en ny vertebral fraktur i de 19 måneder, undersøgelsen varede, med 65 % sammenlignet med placebo.
English: The second study looked at the use of Forsteo in 437 men with osteoporosis, comparing its effect on the density of bones in the spine with that of placebo.
Danish: Den anden undersøgelse omhandlede anvendelsen af Forsteo hos 437 mænd med osteoporose, hvor Forsteos indvirkning på knogletætheden i rygsøjlen blev sammenlignet med placeboens indvirkning.
English: In these patients, Forsteo has been shown to significantly reduce vertebral (spine) and non-vertebral fractures (broken bones), but not those of the hip;
Danish: Det er påvist, at Forsteo hos disse patienter i væsentlig grad begrænser forekomsten af vertebrale brud (i rygsøjlen) og ikkevertebrale brud (knoglebrud), men ikke forekomsten af hoftebrud
English: Only one two-year course of Forsteo should be given to a patient in their lifetime.
Danish: Patienterne bør kun én gang i deres liv få en toårig behandling med Forsteo.
English: The third study compared the effects of Forsteo and alendronate (another medicine used to treat osteoporosis) on spine bone density over three years.
Danish: I den tredje undersøgelse sammenlignede man over tre år virkningen af Forsteo og alendronat (et andet lægemiddel til behandling af osteoporose) på knogletætheden i rygsøjlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Forsteo have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Forsteo.
English: How has Forsteo been studied?
Danish: Hvordan blev Forsteo undersøgt?
English: What benefit has Forsteo shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Forsteo?
English: For the full list of all side effects reported with Forsteo, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Forsteo fremgår af indlægssedlen.
English: What is Forsteo used for?
Danish: Hvad anvendes Forsteo til?
English: In the study of patients taking glucocorticoids, Forsteo was more effective than alendronate: after 18 months, patients receiving Forsteo had a 7% increase in bone density in the spine, compared with 3% in those receiving alendronate.
Danish: Efter 18 måneder var knogletætheden i rygsøjlen hos patienter, der fik Forsteo, øget med 7 %, sammenlignet med 3 % hos dem, der fik alendronat.
English: Forsteo was more effective than placebo in reducing vertebral fractures: 5% of the women who received Forsteo had a new fracture during the study, compared with 14% in the group who received placebo.
Danish: 5 % af de kvinder, der blev behandlet med Forsteo, fik en ny fraktur i løbet af undersøgelsen, sammenholdt med 14 % i placebogruppen.
English: How is Forsteo used?
Danish: Hvordan anvendes Forsteo?
English: How does Forsteo work?
Danish: Hvordan virker Forsteo?
English: It can be very serious.
Danish: Dette kan være meget alvorligt.
English: This could be dangerous to yourself or others.
Danish: Det kan være farligt for dig selv eller andre.
English: Turn until it is on tight.
Danish: Drej, indtil den sidder godt fast.
English: You may then hear or feel a click.
Danish: Du kan nu måske høre eller mærke et klik.
English: ATC code: A10AE06.
Danish: ATC-kode: A10AE06.
English: Component of a multipack, cannot be sold separately
Danish: Del af en multipakning, kan ikke sælges separat
English: • the local reactions spread to other parts of your body
Danish: • de lokale reaktioner spreder sig til resten af din krop
English: 4 Episodes from week 16 in each treatment period
Danish: 4 Episoder fra uge 16 i hver behandlingsperiode
English: If you have poor eyesight, please see section 3.
Danish: Hvis du har nedsat syn, se venligst punkt 3.
English: This can be short or long-lasting.
Danish: Det kan vare kort eller lang tid.
English: • how much Tresiba you will need each day
Danish: • hvor meget Tresiba du har behov for hver dag
English: • turn you on your side
Danish: • vende dig om på siden
English: The reactions usually disappear after a few days.
Danish: Reaktionerne forsvinder normalt efter nogle dage.
English: This is normal and does not affect your dose.
Danish: Det er normalt og påvirker ikke din dosis.
English: All cause death
Danish: Alle dødsårsager
English: CI: 95% confidence interval.
Danish: CI: 95% konfidensinterval.
English: These reactions are usually mild and transitory and they normally disappear during continued treatment.
Danish: Sædvanligvis er disse reaktioner milde og forbigående, og de forsvinder normalt af sig selv under fortsat behandling.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Danish: Dette kan udgøre en risiko i situationer, hvor disse evner er af speciel vigtighed (f.eks. ved bilkørsel eller brug af maskiner).
English: This medicinal product must not be mixed with any other medicinal products.
Danish: Dette lægemiddel må ikke blandes med nogen andre lægemidler.
English: Further important information
Danish: Yderligere vigtig information
English: 6 seconds
Danish: 6 sekunder
English: Table 8 Results from DEVOTE
Danish: Tabel 8 Resultater fra DEVOTE
English: Tresiba which has been frozen must not be used.
Danish: Tresiba, som har været frosset, må ikke anvendes.
English: The signs of a serious allergic reaction are:
Danish: Tegn på alvorlig allergisk reaktion er:
English: A specific overdose for insulin cannot be defined.
Danish: En specifik overdosis af insulin kan ikke defineres.
English: • Test your urine or blood for ketones.
Danish: • Test din urin eller dit blod for ketoner.