FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of a prolonged release formulation may be preferable to other treatment formulations in order to avoid high peak plasma concentrations.
Danish: For at undgå høje maksimalkoncentrationer (peaks) kan anvendelse af en depotformulering være at foretrække frem for andre formuleringer.
English: In women planning to become pregnant all efforts should be made to switch to appropriate alternative treatment prior to conception, if possible (see section 4.6).
Danish: Hos kvinder, der planlægger at blive gravide, bør det tilstræbes at skifte til alternativ behandling forud for undfangelse, hvis det er muligt (se pkt.
English: <Invented name> should not be used in female children, in female adolescents, in women of childbearing potential and in pregnant women unless other treatments are ineffective or not tolerated.
Danish: [Dette afsnit skal ændres for at inkludere følgende ordlyd] <Særnavn> bør ikke anvendes af piger, både børn og unge, kvinder i den fødedygtige alder og gravide kvinder, medmindre andre behandlinger er ineffektive eller ikke tolereres.
English: In women planning to become pregnant all efforts should be made to switch to appropriate alternative treatment prior to conception, if possible.
Danish: Hos kvinder, der planlægger at blive gravide, bør skift til alternativ behandling tilstræbes forud for undfangelsen, hvis det er muligt.
English: Section 4.3 Contraindications [The text below is only to be implemented where the marketing authorisation currently includes the indication prophylaxis of migraine attacks]
Danish: 4.3 Kontraindikationer [Afsnittet nedenfor skal indsættes, når markedsføringstilladelsen omfatter indikationen "migræneprofylakse"].
English: <Invented name> treatment must be started and supervised by a doctor specialised in the treatment of <epilepsy> <or> <bipolar disorders>.
Danish: Behandling med <Særnavn> skal startes og overvåges af en læge med speciale i behandling af<epilepsi> <eller> <bipolær lidelse>.
English: • In women planning to become pregnant or who are pregnant, valproate therapy should be reassessed [The sentence below should be inserted where the marketing authorisation currently includes the indication prophylaxis of migraine attacks]
Danish: • Valproatbehandling skal revurderes hos kvinder, der planlægger at blive gravide, eller som er gravide [Sætningen nedenfor skal indsættes, når markedsføringstilladelsen omfatter indikationen "migræneprofylakse"].
English: • If you have any further questions, ask your doctor or pharmacist.
Danish: • Spørg lægen eller apoteketspersonalet, hvis der er mere, du vil vide.
English: <Invented name> treatment must be started and supervised by a doctor specialised in the treatment of migraine.
Danish: Behandling med <Særnavn> skal startes og overvåges af en læge med speciale i behandling af migræne.
English: Your doctor will discuss this with you but you should also follow the advice in section 2 of this leaflet.
Danish: Du skal også følge vejledningen i afsnit 2 i denne indlægsseddel - din læge vil diskutere dette med dig.
English: Treatment should only be initiated if other treatments are ineffective or not tolerated (see section 4.3, 4.4 and 4.6) and the benefit and risk should be carefully reconsidered at regular treatment reviews.
Danish: 4.3, 4.4 og 4.6), og fordele og risici skal revurderes nøje ved regelmæssige vurderinger af behandlingen.
English: <Invented name> should be initiated and supervised by a specialist experienced in the management of <epilepsy> <or> <bipolar disorder>.
Danish: Behandling med <Særnavn> skal initieres og superviseres af en specialist med erfaring i behandling af <epilepsi> <eller> <bipolar lidelse>.
English: Possible side effects [This section should be amended to include the below wording in all indications]
Danish: Bivirkninger [Dette afsnit skal ændres for at indeholde nedenstående]
English: [This sentence below should be adapted to National requirements] Make sure you read the patient booklet and sign the Acknowledgement of Risk form which should be given to you and discussed with you by your doctor or pharmacist.
Danish: Du skal sørge for at læse patientinformationen og underskrive Kvittering for information om risiko, som du har fået udleveret af din læge eller apotekspersonalet, og som de har informeret dig om.
English: Both valproate monotherapy and valproate polytherapy are associated with abnormal pregnancy outcomes.
Danish: Eksponeringsrisiko relateret til valproat under graviditet Både valproat-monoterapi og valproat-polyterapi er forbundet med risiko for medfødte misdannelser.
English: <Invented name> is contraindicated for prophylaxis of migraine attacks in pregnancy and women of childbearing potential who are not using effective methods of contraception during treatment with valproate (see sections 4.4 and 4.6 above).
Danish: <Særnavn> er kontraindiceret til migræneprofylakse under graviditet og til kvinder i den fødedygtige alder, som ikke anvender effektiv prævention under behandlingen med valproat (se pkt.
English: <Invented name> should only be initiated and supervised by a specialist experienced in the management of migraine.
Danish: Behandling med <Særnavn> skal initieres og superviseres af en specialist med erfaring i behandling af migræne.
English: Treatment should only be initiated if other treatments are ineffective or not tolerated (see section 4.4 and 4.6) and the benefit and risk should be carefully reconsidered at regular treatment reviews.
Danish: 4.4 og 4.6), og fordele og risici skal revurderes nøje ved regelmæssige vurderinger af behandlingen.
English: Tell your doctor at once if you become pregnant or think you might be pregnant.
Danish: Fortæl det øjeblikkeligt til din læge, hvis du bliver gravid, eller hvis du har mistanke om, at du er gravid.
English: UNPLANNED PREGNANCY WHILST CONTINUING TREATMENT [The paragraph below should be inserted only where the marketing authorisation currently includes the indication “prophylaxis of migraine attacks”].
Danish: UPLANLAGT GRAVIDITET OG FORSAT BEHANDLING [Afsnittet nedenfor skal indsættes, når markedsføringstilladelsen omfatter indikationen "migræneprofylakse"].
English: • Tell your doctor at once if you are pregnant or think you might be pregnant.
Danish: • Fortæl øjeblikkeligt din læge, hvis du er gravid, eller har mistanke om, at du er gravid.
English: [The paragraph below should be inserted only where the marketing authorisation currently includes the indication “prophylaxis of migraine attacks”].
Danish: [Afsnittet nedenfor skal indsættes, når markedsføringstilladelsen omfatter indikationen "migræneprofylakse"].
English: • Tell your doctor at once if you know you are pregnant or think you might be pregnant.
Danish: • Fortæl øjeblikkeligt din læge, hvis du er gravid eller har mistanke om, at du er gravid.
English: CONTINUING TREATMENT AND CONSIDERING TRYING FOR A BABY [The paragraph below should be inserted only where the marketing authorisation currently includes the indication “prophylaxis of migraine attacks”].
Danish: FORTSAT BEHANDLING, HVIS DU PLANLÆGGER AT BLIVE GRAVID [Afsnittet nedenfor skal indsættes, når markedsføringstilladelsen omfatter indikationen "migræneprofylakse"].
English: If you are taking valproate and you think you are pregnant or might be pregnant contact your doctor at once.
Danish: Kontakt din læge, hvis du tager valproat, og du har mistanke om, at du er gravid eller kan være gravid.
English: [The following sentence should be inserted only where the marketing authorisation currently includes the indication prophylaxis of migraine attacks]
Danish: [Følgende sætning skal indsættes, når markedsføringstilladelsen omfatter indikationen "migræneprofylakse"].
English: If you are trying for a baby you should not use valproate.
Danish: Du må ikke tage valproat, hvis du forsøger at blive gravid.
English: [All text below should be inserted only where the marketing authorisation currently includes the indications for epilepsy and/or bipolar disorder].
Danish: [Al tekst nedenfor skal indsættes, når markedsføringstilladelsen omfatter indikationerne epilepsi og/eller bipolær lidelse]
English: [The text below should be inserted only where the marketing authorisation currently includes indications for the epilepsy and/or bipolar disorder].
Danish: [Teksten nedenfor skal indsættes, når markedsføringstilladelsen omfatter indikationerne epilepsi og/eller bipolær lidelse].
English: [The sentence below should be inserted only where the marketing authorisation currently includes the epilepsy and/or bipolar disorders indications]
Danish: [Sætningen nedenfor skal indsættes, når markedsføringstilladelsen omfatter indikationerne epilepsi og/eller bipolær lidelse]
English: Bavencio received a conditional marketing authorisation valid throughout the European Union on 18 September 2017.
Danish: Bavencio fik en markedsføringstilladelse med gyldighed i hele Den Europæiske Union den 18. september 2017.
English: Further information on Bavencio can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/bavencio.
Danish: Yderligere information om Bavencio findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/bavencio.
English: If no reactions have occurred by the fourth infusion, the treating doctor may decide to stop giving these medicines before subsequent infusions.
Danish: Hvis der ikke er nogen reaktioner ved den fjerde infusion, kan den behandlende læge beslutte at ophøre med at give disse lægemidler før de efterfølgende infusioner.
English: The side effects of the combination were consistent with what was expected, and were considered acceptable given the nature of the condition being treated.
Danish: Bivirkningerne ved kombinationen var i overensstemmelse med det forventede og blev anset for at være acceptable i betragtning af arten af den sygdom, der blev behandlet.
English: As for all medicines, data on the use of Bavencio are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Bavencio løbende overvåget.
English: Patients with MCC that has spread and come back after initial treatment with chemotherapy have very limited treatment options.
Danish: Patienter med MCC, som har spredt sig og er vendt tilbage efter første behandling med kemoterapi, har meget begrænsede behandlingsmuligheder.
English: Other information about Bavencio
Danish: Andre oplysninger om Bavencio
English: Treatment should continue as long as the patient benefits from it or side effects become unacceptable.
Danish: Behandlingen bør fortsættes, så længe patienten har fordel af den, eller indtil patienten får bivirkninger, som ikke kan tolereres.
English: Bavencio contains the active substance avelumab.
Danish: Bavencio indeholder det aktive stof avelumab.
English: The European Medicines Agency decided that Bavencio's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Bavencio opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Longer follow-up was needed to draw a reliable conclusion on how well patients given Bavencio and axitinib survive overall.
Danish: Der var behov for en længere opfølgning for at drage en pålidelig konklusion om, hvor længe de patienter, der fik Bavencio og axitinib, overlevede generelt.
English: What measures are being taken to ensure the safe and effective use of Bavencio?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Bavencio?
English: An overview of Bavencio and why it is authorised in the EU
Danish: En oversigt over Bavencio, og hvorfor det er godkendt i EU
English: Although the dose of Bavencio in these studies was based on the patients' body weight, the company also supplied supporting data to show that Bavencio could be given in a standard dose, regardless of weight.
Danish: Selv om dosen af Bavencio i disse studier var baseret på patientens kropsvægt, fremlagde virksomheden også data til påvisning af, at Bavencio kunne gives i en standarddosis uanset vægt.
English: For more information about using Bavencio, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Bavencio, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Why is Bavencio authorised in the EU?
Danish: Hvorfor er Bavencio godkendt i EU?
English: Although the response rates to Bavencio are not outstanding, the duration of the response (at least 6 months) is important for these patients, since the responses seen with chemotherapy medicines are of shorter duration.
Danish: Selv om responsraterne for Bavencio ikke er enestående, er varigheden af virkningen (mindst 6 måneder) af stor betydning for disse patienter, da den virkning, der ses i forbindelse med kemoterapilægemidler, er af kortere varighed.
English: Bavencio can only be obtained with a prescription, and treatment should be started and monitored by a doctor experienced in the treatment of cancer.
Danish: Bavencio fås kun på recept, og behandlingen skal påbegyndes og overvåges af en læge med erfaring i kræftbehandling.
English: The safety of Bavencio for this use is considered acceptable and side effects manageable with the additional measures put in place.
Danish: Sikkerheden ved Bavencio for denne anvendelse anses for at være acceptabel, og bivirkningerne kan håndteres ved hjælp af de supplerende foranstaltninger, der er indført.
English: Side effects reported with Bavencio are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Bavencio vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: The company that markets Bavencio will issue educational materials for patients containing important information about possible side effects of Bavencio, particularly immune-related reactions, and how to manage them.
Danish: Virksomheden, der markedsfører Bavencio, vil udarbejde informationsmateriale til patienter, der indeholder vigtige oplysninger om de mulige bivirkninger ved Bavencio, især immunrelaterede reaktioner, og hvordan de skal håndteres.
English: The active substance in Bavencio, avelumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called ‘programmed death-ligand-1' (PD-L1), which is present on the surface of many cancer cells.
Danish: Det aktive stof i Bavencio, avelumab, er et monoklonalt antistof, en type protein, der er designet til at genkende og binde sig til et protein, der kaldes "programmeret død-ligand 1" (PD-L1), og som findes på overfladen af mange kræftceller.
English: What is Bavencio and what is it used for?
Danish: Hvad er Bavencio, og hvad anvendes det til?
English: Since Bavencio has been granted a conditional approval for MCC, the company that markets the medicine will provide further data from the ongoing study of patients who did not receive chemotherapy before starting treatment with Bavencio.
Danish: Da Bavencio har fået en betinget godkendelse til MCC, vil den virksomhed, der markedsfører lægemidlet, fremlægge yderligere oplysninger fra det igangværende studie af patienter, som ikke fik kemoterapi før påbegyndelse af behandling med Bavencio.
English: Bavencio is a cancer medicine used to treat adults with Merkel cell carcinoma (MCC), a type of skin cancer, when the cancer has spread to other parts of the body.
Danish: Bavencio er et kræftlægemiddel, der anvendes til behandling af voksne med Merkel-cellekarcinom (MCC), en type hudkræft, hvor kræften har bredt sig til andre dele af kroppen.
English: For MCC, Bavencio has been given ‘conditional approval'.
Danish: Bavencio til MCC har fået en betinget godkendelse.
English: For the full list of side effects and restrictions of Bavencio, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Bavencio fremgår af indlægssedlen.
English: Merkel cell carcinoma
Danish: Merkel-cellekarcinom
English: What information is still awaited for Bavencio?
Danish: Hvilke oplysninger afventes der stadig for Bavencio?
English: The average time patients lived without their disease getting worse was around 13 months in those given Bavencio and axitinib versus 8 months in those given sunitinib.
Danish: Den gennemsnitlige tid, patienterne levede, uden at sygdommen forværredes, var ca. 13 måneder hos dem, der fik Bavencio og axitinib, sammenlignet med 8 måneder hos dem, der fik sunitinib.
English: PD-L1 usually attaches to cells of the immune (defence) system called T cells, preventing the T cells from attacking the cancer cells.
Danish: PD-L1 knytter sig normalt til celler i immunsystemet (kroppens forsvarssystem), der kaldes T-celler, og forhindrer T-celler i at angribe kræftcellerne.
English: By attaching to PD-L1, Bavencio prevents the cancer cells from switching off the T cells, thereby increasing the ability of the T cells to kill the cancer cells.
Danish: Ved at binde sig til PD-L1 forhindrer Bavencio kræftcellerne i at slukke for T-cellerne, og derved forstærkes immunsystemets evne til at dræbe kræftcellerne.
English: In addition, early data from an ongoing study indicate that the majority of patients who have not had previous chemotherapy also respond to treatment with Bavencio, with a similar duration of response.
Danish: Desuden viser tidlige data fra et igangværende studie, at størstedelen af de patienter, der ikke tidligere har fået kemoterapi, også reagerer på behandling med Bavencio med en tilsvarende responsvarighed.
English: In patients with advanced RCC, Bavencio plus axitinib has been shown to improve the length of time patients survive without their disease getting worse, when compared with sunitinib, though how long patients survive overall remains to be shown.
Danish: Hos patienter med fremskredent RCC har Bavencio plus axitinib vist sig at forbedre den tid, patienterne overlever, uden at sygdommen bliver værre, sammenlignet med sunitinib, selv om det fortsat ikke er påvist, hvor længe patienterne overlever generelt.
English: What are the risks associated with Bavencio?
Danish: Hvilke risici er der forbundet med Bavencio?
English: In a main study involving 886 patients with advanced RCC, who had not been previously treated, Bavencio infusion in combination with axitinib by mouth was compared with standard treatment using another cancer medicine, sunitinib.
Danish: I et hovedstudie, hvori der indgik 886 patienter med fremskredent RCC, som ikke tidligere var blevet behandlet, blev Bavencio givet som infusion i kombination med axitinib indtaget gennem munden sammenlignet med standardbehandling med et andet kræftlægemiddel, sunitinib.
English: Treatment may need to be delayed or stopped if certain side effects occur.
Danish: Hvis der optræder visse bivirkninger, kan det være nødvendigt at udsætte eller afbryde behandlingen.
English: Early results from an ongoing study looking at the effects of Bavencio in patients with metastatic MCC who had not received previous chemotherapy showed that the overall response rate at the time of analysis was 62% (18 out of 29 patients).
Danish: Tidlige resultater fra en igangværende undersøgelse af virkningerne af Bavencio hos patienter med metastatisk MCC, som ikke tidligere havde fået kemoterapi, viste, at den samlede responsrate på analysetidspunktet var 62 % (18 ud af 29 patienter).
English: Bavencio is also used in combination with another cancer medicine, axitinib, for the initial treatment of patients with advanced renal cell carcinoma (RCC, a cancer of the kidney).
Danish: Bavencio anvendes også i kombination med et andet kræftlægemiddel, axitinib, til den første behandling af patienter med fremskredent nyrecellekarcinom (RCC, kræft i nyrerne).
English: Bavencio has been shown to be of benefit in one main study that showed the cancer shrank in patients with MCC and one that showed patients with RCC could live longer without their disease getting worse.
Danish: Bavencios gavnlige virkning er blevet påvist i et hovedstudie, der viste, at kræften blev mindre hos patienter med MCC, og et hovedstudie, der viste, at patienter med RCC kunne leve længere, uden at deres sygdom forværredes.
English: Serious side effects include immune-related and infusion-related reactions, anaemia (low red blood cell counts), difficulty breathing and abdominal pain.
Danish: Alvorlige bivirkninger omfatter immunrelaterede reaktioner og infusionsrelaterede reaktioner, anæmi (lavt antal røde blodlegemer), vejrtrækningsbesvær og mavesmerter.
English: In both its uses, Bavencio is given in a dose of 800 mg once every 2 weeks as an infusion (drip) into a vein that lasts around 1 hour..
Danish: I begge tilfælde gives Bavencio i en dosis på 800 mg én gang hver 2. uge.
English: Before the first 4 infusions of Bavencio, the patient receives an antihistamine and paracetamol to help prevent infusion-related reactions, such as reddening of the skin, chills, fever, back or abdominal (belly) pain, allergic reactions and difficulty breathing.
Danish: Før de første 4 infusioner af Bavencio får patienten antihistamin og paracetamol for at forebygge infusionsrelaterede reaktioner, såsom rødme, kulderystelser, feber, rygsmerter eller mavesmerter, allergiske reaktioner og vejrtrækningsbesvær.
English: When Bavencio is used with axitinib the most common side effects of the combination, which may affect more than 1 in 5 people, are diarrhoea, high blood pressure, tiredness, nausea, dysphonia (hoarseness), decreased appetite, hypothyroidism (reduced thyroid function), cough, headache, breathing difficulties and arthralgia (joint pain).
Danish: Når Bavencio anvendes sammen med axitinib, er de mest almindelige bivirkninger ved denne kombination, som kan forekomme hos mere end 1 ud af 5 personer, diarré, højt blodtryk, træthed, kvalme, dysfoni (hæshed), nedsat appetit, hypothyreoidisme (reduceret skjoldbruskkirtel-funktion), hoste, hovedpine, åndedrætsbesvær og ledsmerter.
English: In a main study involving 88 patients with metastatic MCC who had received previous treatment with chemotherapy (cancer medicines), around 33% of patients (29 out of 88) were considered to have had a reduction in tumour size or no sign of it after treatment with the medicine; in most of these patients, the response lasted for at least 6 months.
Danish: I et hovedstudie, hvori der indgik 88 patienter med metastatisk MCC, som tidligere havde fået behandling med kemoterapi (kræftlægemidler), blev det hos ca. 33 % af patienterne (29 ud af 88) vurderet at tumoren var blevet mindre, eller var forsvundet efter behandling med lægemidlet.
English: How does Bavencio work?
Danish: Hvordan fungerer Bavencio?
English: How is Bavencio used?
Danish: Hvordan anvendes Bavencio?
English: The most common side effects with Bavencio used alone (which may affect more than 1 in 10 people) include tiredness, nausea (feeling sick), diarrhoea, decreased appetite, constipation, infusion-related reactions, weight loss and vomiting.
Danish: De hyppigste bivirkninger ved Bavencio (som kan forekomme hos mere end 1 ud af 10 personer) er træthed, kvalme, diarré, nedsat appetit, forstoppelse, infusionsrelaterede reaktioner, vægttab og opkastning.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bavencio have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Bavencio.
English: What benefits of Bavencio have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Bavencio?
English: Renal cell carcinoma
Danish: Nyrecellekarcinom
English: Each cycle was 28 days.
Danish: Hver cyklus var 28 dage.
English: For the first 4 weeks you will get a new pack each week.
Danish: I de første 4 uger vil du få en ny pakning hver uge.
English: This may affect your ability to father a child.
Danish: Det kan påvirke din evne til at blive far til et barn.
English: NE=not evaluable.
Danish: NE=ikke evaluerbar.
English: Drink plenty of water
Danish: Drik masser af vand