FrancophonIA/ELRC3.0 huggingface dataset:
English: This is followed by a dose of 420 mg every three weeks, with each dose given over half an hour to one hour.
Danish: Dette efterfølges af en dosis på 420 mg hver tredje uge, idet hver enkelt dosis gives over en halv til en hel time.
English: What is Perjeta and what is it used for?
Danish: Hvad er Perjeta, og hvad anvendes det til?
English: Perjeta contains the active substance pertuzumab.
Danish: Perjeta indeholder det aktive stof pertuzumab.
English: The most common severe side effect (affecting more than 1 in 10 people) is neutropenia, with or without fever.
Danish: Den hyppigste bivirkning (som optræder hos mere end 1 ud af 10 patienter) er neutropeni, med eller uden feber.
English: Why is Perjeta authorised in the EU?
Danish: Hvorfor er Perjeta tilladt i EU?
English: What are the risks associated with Perjeta?
Danish: Hvilke risici er der forbundet med Perjeta?
English: Side effects reported with Perjeta are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Perjeta vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: HER2-positive breast cancer is an aggressive form of breast cancer which occurs in around one in five cases.
Danish: HER2-positiv brystkræft er en aggressiv form for brystkræft, som forekommer i omkring ét ud af fem tilfælde.
English: For more information about using Perjeta, see the package leaflet or contact a doctor or pharmacist.
Danish: For mere information om brug af Perjeta se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: The studies looked at how many patients responded to treatment (i.e. patients who had no cancer cells in the breast after surgery).
Danish: I undersøgelserne blev det registreret, hvor mange patienter, der responderede på behandlingen (dvs. hvor mange patienter, der ikke havde kræftceller i brystet efter operationen).
English: Patients treated with Perjeta lived for 18.5 months without their disease getting worse, compared with 12.4 months for patients given placebo.
Danish: De patienter, der blev behandlet med Perjeta, levede gennemsnitligt i 18,5 måneder uden forværring af sygdommen sammenholdt med 12,4 måneder for dem, der fik placebo.
English: Perjeta is given by infusion (drip) into a vein.
Danish: Perjeta indgives med drop (infusion) i en vene.
English: In these studies, Perjeta was given with trastuzumab or chemotherapy or both.
Danish: I disse undersøgelser blev Perjeta anvendt sammen med trastuzumab eller kemoterapi eller begge dele.
English: Patients were treated until their disease got worse or the side effects of treatment became unmanageable.
Danish: Patienterne blev behandlet indtil sygdommen blev værre, eller indtil der opstod bivirkninger, som ikke kunne behandles.
English: The European Medicines Agency considered that Perjeta has been shown to benefit patients with metastatic cancer by extending the amount of time patients lived without their disease getting worse as well as how long they lived.
Danish: Det Europæiske Lægemiddelagentur vurderede, at det er påvist, at Perjeta er til fordel for patienter med metastatisk kræft ved at forlænge den tid, patienterne levede uden at deres sygdom forværredes, foruden hvor længe de overlevede.
English: The most common side effects (affecting more than 3 in 10 people) with Perjeta when given with trastuzumab and chemotherapy are neutropenia (low levels of neutrophils, a type of white blood cell important for fighting infections), diarrhoea, nausea (feeling sick), vomiting, hair loss and tiredness.
Danish: De hyppigste bivirkninger (som optræder hos mere end 3 ud af 10 patienter) ved Perjeta, når det kombineres med trastuzumab og kemoterapi, er neutropeni (lavt antal neutrofiler, som er en type hvide blodlegemer, der er vigtige til at bekæmpe infektion), diarré, kvalme, opkastning, hårtab og træthed.
English: Response to treatment in the second study ranged from 57% to 66% where Perjeta was given with trastuzumab and chemotherapy medicines.
Danish: Responsen på behandlingen i den anden undersøgelse var på mellem 57 % og 66 %, hvor Perjeta blev anvendt sammen med trastuzumab og kemoterapilægemidler.
English: Perjeta can only be obtained with a prescription and treatment should be started under the supervision of a doctor who is experienced in using cancer medicines and in a hospital setting where resuscitation equipment is available.
Danish: Perjeta udleveres kun efter recept, og behandlingen bør indledes under opsyn af en læge med erfaring i brug af kræftlægemidler og bør finde sted i hospitalsomgivelser, hvor der forefindes genoplivningsudstyr.
English: A fourth ongoing study compared Perjeta with placebo (both given with trastuzumab and chemotherapy) in 4,805 women with early breast cancer who had had surgery to remove the cancer.
Danish: En fjerde igangværende undersøgelse sammenlignede Perjeta med placebo (begge anvendt sammen med trastuzumab og kemoterapi) hos 4.805 kvinder med tidlig brystkræft, som var blevet opereret for at fjerne kræften.
English: In the first study, 46% of the patients treated with Perjeta plus trastuzumab and docetaxel responded to treatment, compared with 29% of patients who received trastuzumab and docetaxel alone.
Danish: I den første undersøgelse responderede 46 % af de patienter, der var behandlet med Perjeta plus trastuzumab og docetaxel, på behandlingen sammenholdt med 29 % af dem, der fik trastuzumab og docetaxel alene.
English: It considered that this would provide an additional benefit when added to other medicines for HER2-positive cancer, notably trastuzumab.
Danish: Agenturet fandt, at dette ville være en ekstra fordel, når det blev anvendt som supplement til andre lægemidler mod HER2-positiv kræft, navnlig trastuzumab.
English: Perjeta has also been shown to improve the outcome of patients with earlier stages of breast cancer, when used with trastuzumab and chemotherapy.
Danish: Perjeta er desuden påvist at forbedre udfaldet hos patienter med tidlige stadier af brystkræft, når det anvendes sammen med trastuzumab og kemoterapi.
English: The Agency considered that, despite the side effects of Perjeta, the overall safety profile was acceptable.
Danish: Agenturet fandt, at den overordnede sikkerhedsprofil var acceptabel trods de bivirkninger, der er beskrevet med Perjeta.
English: • treatment of metastatic breast cancer (cancer that has spread to other parts of the body) that has not already been treated with chemotherapy medicines or medicines designed to target HER2, or for breast cancer that has come back locally after treatment and cannot be removed by surgery.
Danish: • Behandling af metastatisk brystkræft (kræft, som har bredt sig til andre dele af kroppen), der ikke allerede er behandlet med kemoterapi eller med lægemidler, som er udviklet til at binde sig til HER2, eller til brystkræft, der er vendt tilbage lokalt efter behandling og ikke kan fjernes ved operation.
English: Perjeta is a cancer medicine for treating adults with ‘HER2-positive' breast cancer (where a protein called HER2 is found on the cancer cells).
Danish: Perjeta er et kræftlægemiddel til behandling af voksne med "HER2-positiv" brystkræft (hvor proteinet HER2 findes på kræftcellerne).
English: The company that markets Perjeta will carry out a study to assess the effects of using Perjeta and trastuzumab together with a type of cancer medicines called taxanes, in previously untreated patients with HER2-positive metastatic or locally advanced breast cancer.
Danish: Virksomheden, der markedsfører Perjeta, skal gennemføre en undersøgelse til vurdering af virkningerne af at anvende Perjeta og trastuzumab sammen med kræftlægemidler af typen taxaner hos tidligere ubehandlede patienter med HER2-positiv metastatisk eller lokalt fremskreden brystkræft.
English: In these cases, Perjeta is used with trastuzumab and docetaxel (other cancer medicines);
Danish: Perjeta anvendes i disse tilfælde sammen med trastuzumab og docetaxel (andre lægemidler mod kræft).
English: Perjeta has also been studied in two main studies involving a total of 642 patients with earlier stages of breast cancer who were to undergo surgery.
Danish: Perjeta er også blevet undersøgt i to hovedundersøgelser, hvori der deltog i alt 642 patienter med tidlige stadier af brystkræft, som skulle opereres.
English: For the full list of all side effects and restrictions with Perjeta, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Perjeta fremgår af indlægssedlen.
English: Perjeta has been studied in one main study involving 808 adults with previously untreated HER2positive metastatic breast cancer.
Danish: Perjeta er blevet undersøgt i én hovedundersøgelse med deltagelse af 808 voksne patienter med tidligere ubehandlet HER2-postiv metastatisk brystkræft.
English: The active substance in Perjeta, pertuzumab, is a monoclonal antibody, a type of protein that has been designed to attach to HER2, a protein found on HER2-positive cancer cells.
Danish: Det aktive stof i Perjeta, pertuzumab, er et monoklonalt antistof, som er en type protein, der er fremstillet således, at det bindes til proteinet HER2, som findes på HER2-positive kræftceller.
English: How is Perjeta used?
Danish: Hvordan anvendes Perjeta?
English: The effects of Perjeta were compared with placebo (a dummy treatment) when given together with other cancer medicines (trastuzumab and docetaxel).
Danish: Virkningerne af Perjeta blev sammenlignet med en uvirksom behandling (placebo), begge i kombination med andre kræftlægemidler (trastuzumab og docetaxel).
English: What benefits of Perjeta have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Perjeta?
English: pertuzumab stops HER2 producing signals that cause the cancer cells to grow.
Danish: Når pertuzumab binder sig til HER2, får det HER2 til at holde op med at afgive de signaler, der får kræftcellerne til at vokse.
English: The main measure of effectiveness was progression-free survival (how long the patients lived without their disease getting worse).
Danish: Virkningen blev hovedsagelig bedømt på, hvor længe patienterne levede uden forværring af sygdommen (progressionsfri overlevelse).
English: • treatment of early breast cancer at high risk of coming back, in combination with trastuzumab and chemotherapy, after the patient has had surgery.
Danish: • Behandling af tidlige stadier af brystkræft med høj risiko for at ville vende tilbage, i kombination med trastuzumab og kemoterapi, efter patienten er blevet opereret.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Perjeta 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 Perjeta.
English: • treatment of locally advanced, inflammatory or early-stage breast cancer at high risk of coming back, in combination with trastuzumab and chemotherapy, before the patient undergoes surgery;
Danish: • Behandling af lokalt fremskreden brystkræft, inflammatorisk brystkræft eller tidlige stadier af brystkræft med høj risiko for at ville vende tilbage, i kombination med trastuzumab og kemoterapi, før patienten opereres.
English: Perjeta was shown to be of benefit in patients whose cancer was at a high risk of coming back: after 4 years, the disease had not spread in 90% of patients with ‘node-positive' cancer treated with Perjeta compared with 87% of those receiving placebo; for those with ‘hormone-receptor negative' cancer, this figure was 91% of patients treated with Perjeta, and 89% of patients given placebo.
Danish: For patienter med "hormonreceptor-negativ" kræft var dette tal 91 % af de patienter, der blev behandlet med Perjeta, og 89 % af patienter de, der fik placebo.
English: How does Perjeta work?
Danish: Hvordan virker Perjeta?
English: Blister (PVC/aluminium) 70x1 tablets
Danish: 70x1 tabletter
English: EU number administration
Danish: EU-nummer
English: Side effects are mostly mild or moderate.
Danish: Bivirkningerne er hovedsagelig lette eller moderate.
English: The lowest dose that works well for the patient should be maintained.
Danish: Der bør bibeholdes den laveste dosis, der virker godt for patienten.
English: This is a summary of the European public assessment report (EPAR) for Reagila.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Reagila.
English: The full EPAR for Reagila can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Reagila findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Reagila cariprazine
Danish: Reagila cariprazin
English: Most of the side effects are as expected with antipsychotic medicines and many can be treated.
Danish: Størstedelen af bivirkningerne er som forventet for antipsykotiske lægemidler, og mange af dem kan behandles.
English: Reagila contains the active substance cariprazine.
Danish: Reagila indeholder det aktive stof cariprazin.
English: Reagila must not be taken at the same time as certain other medicines called strong or moderate CYP3A4 inhibitors or inducers.
Danish: Reagila må ikke tages samtidig med visse andre lægemidler, der er stærke eller moderate CYP3A4hæmmere eller -induktorer.
English: The PANSS score, which ranges from a minimum of 30 (no symptoms) to a maximum of 210 (severest symptoms), was around 96 at the start of treatment.
Danish: Scoren på PANSS-skalaen, der går fra et minimum på 30 (ingen symptomer) til et maksimum på 210 (sværeste symptomer), var ca. 96 ved behandlingens begyndelse.
English: Other information about Reagila
Danish: Andre oplysninger om Reagila
English: Reagila is an antipsychotic medicine used to treat schizophrenia in adults.
Danish: Reagila er et antipsykotisk lægemiddel, der anvendes til behandling af skizofreni hos voksne.
English: Reagila is available as capsules (1.5, 3, 4.5 and 6 mg) to be taken by mouth.
Danish: Reagila fås som kapsler (1,5; 3; 4,5 og 6 mg), der tages gennem munden.
English: This reduces symptoms of schizophrenia and prevents them from returning.
Danish: Dette mindsker symptomerne på skizofreni og forebygger, at de vender tilbage.
English: The dose can be increased by 1.5 mg at a time up to a maximum of 6 mg per day.
Danish: Dosis kan forhøjes med 1,5 mg ad gangen til højst 6 mg dagligt.
English: What measures are being taken to ensure the safe and effective use of Reagila?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Reagila?
English: The recommended starting dose is 1.5 mg once a day.
Danish: Startdosis er normalt 1,5 mg én gang dagligt.
English: Schizophrenia is a mental illness with symptoms such as delusions, disorganised thinking and speech, suspiciousness and hallucinations (hearing or seeing things that are not there).
Danish: Skizofreni er en psykisk sygdom med symptomer som vrangforestillinger, desorganiseret tankegang og tale, mistænksomhed og hallucinationer (dvs. at høre eller se ting, der ikke er der).
English: What is Reagila and what is it used for?
Danish: Hvad er Reagila, og hvad anvendes det til?
English: As well as studies showing that Reagila improves the positive symptoms of schizophrenia both in the short and longer term, one study also showed that the medicine improved the negative symptoms of the disease which have a large impact on patients' quality of life.
Danish: Foruden de undersøgelser, der viser, at Reagila bevirker bedring i de positive symptomer på skizofreni både på kort og længere sigt, viste én undersøgelse også, at lægemidlet bevirkede bedring i sygdommens negative symptomer, som stærkt påvirker patienternes livskvalitet.
English: Therefore, the European Medicines Agency decided that Reagila's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur afgjorde derfor, at fordelene ved Reagila overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse til anvendelse i EU.
English: Because the medicine's effects may take time to show, patients should be monitored for several weeks after starting treatment or changing the dose.
Danish: Patienten bør derfor overvåges i flere uger, efter at behandlingen er påbegyndt, eller dosis ændret.
English: Why is Reagila approved?
Danish: Hvorfor blev Reagila godkendt?
English: Finally, a fifth main study in 200 patients showed that Reagila was more effective than placebo at preventing symptoms from coming back after initial treatment.
Danish: Endelig viste en femte hovedundersøgelse med 200 patienter, at Reagila var mere effektivt end placebo til at forebygge, at symptomerne vendte tilbage efter den indledende behandling.
English: Reagila can only be obtained with a prescription.
Danish: Lægemidlet Reagila udleveres kun efter recept.
English: The active substance in Reagila, cariprazine, attaches to receptors (targets) in the brain for two neurotransmitters called dopamine and serotonin, which nerve cells use to communicate with neighbouring cells.
Danish: Det aktive stof i Reagila, cariprazin, bindes til receptorerne (målene) i hjernen for neurotransmitterne dopamin og serotonin, som nervecellerne anvender i deres kommunikation med nabocellerne.
English: Over a 72 week period, symptoms returned in a quarter of patients taking Reagila compared with around half of those taking placebo.
Danish: I løbet af 72 uger vendte symptomerne tilbage hos en fjerdedel af de patienter, der fik Reagila, sammenholdt med omkring halvdelen af dem, der fik placebo.
English: It is not intended to provide practical advice on how to use Reagila.
Danish: Det er ikke en praktisk vejledning i, hvordan Reagila bør anvendes.
English: After 6 weeks, depending on the study, the PANSS score fell by 17 to 23 points with Reagila compared with 9 to 14 points with placebo.
Danish: Efter 6 uger faldt scoren på PANSS-skalaen - alt efter undersøgelsen - med 17-23 point med Reagila, sammenholdt med 9-14 point med placebo.
English: For more information about treatment with Reagila, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Reagila, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The most common side effects with Reagila are akathisia (a constant urge to move) and parkinsonism (effects similar to Parkinson's disease such as shaking, muscle stiffness and slow movement).
Danish: De hyppigste bivirkninger med Reagila er konstant trang til at bevæge sig (akatisi) og parkinsonisme (virkninger som ved Parkinsons sygdom, såsom rystelser, muskelstivhed og langsomme bevægelser).
English: For the full list of all side effects and restrictions with Reagila, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Reagila fremgår af indlægssedlen.
English: Since dopamine and serotonin play a role in schizophrenia, by attaching to their receptors, cariprazine helps normalise the activity of the brain.
Danish: Da dopamin og serotonin har en medvirkende rolle ved skizofreni, kan cariprazin normalisere hjernens aktivitet ved at bindes til deres receptorer i hjernen.
English: In three main studies in a total of 1,795 adults, Reagila was more effective than placebo (a dummy treatment) at reducing symptoms on a standard rating scale called PANSS (positive and negative syndrome scale).
Danish: I tre hovedundersøgelser med i alt 1 795 voksne var Reagila mere effektivt end virkningsløs behandling (placebo) til at mindske symptomer på standardskalaen PANSS ("positive and negative syndrome scale").
English: What are the risks associated with Reagila?
Danish: Hvilke risici er der forbundet med Reagila?
English: For practical information about using Reagila, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Reagila, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Studies showed that Reagila improves symptoms of schizophrenia and prevents symptoms from returning.
Danish: Undersøgelserne har vist, at Reagila giver bedring i symptomerne ved skizofreni og forebygger, at de vender tilbage.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Reagila have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er anført anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Reagila.
English: What benefits of Reagila have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Reagila?
English: How is Reagila used?
Danish: Hvordan anvendes Reagila?
English: A fourth main study in 461 patients who mostly had ‘negative' symptoms (such as lack of drive, social withdrawal, and problems with attention and memory) and only few ‘positive' symptoms (such as delusions and hallucinations) showed that Reagila was effective at treating negative symptoms: after 26 weeks of treatment Reagila lowered the PANSS score for negative symptoms by around 9 points compared with around 7 points with another medicine, risperidone.
Danish: En fjerde hovedundersøgelse omfattede 461 patienter, der hovedsagelig havde "negative" symptomer (manglende energi, social isolation og koncentrations- og hukommelsesbesvær) og kun få "positive" symptomer (vrangforestillinger og hallucinationer).
English: How does Reagila work?
Danish: Hvordan virker Reagila?
English: There is a sun (for the morning) and a moon (for the evening).
Danish: Der er en sol (for morgen) og en måne (for aften).
English: This can be very dangerous because:
Danish: Dette kan være meget farligt, fordi:
English: Date of first authorisation: 03 December 2010 Date of latest renewal: 17 July 2015
Danish: Dato for første markedsføringstilladelse: 3. december 2010 Dato for seneste fornyelse: 17. juli 2015
English: In absolute terms, this risk was higher than in the overall PLATO population.
Danish: I absolutte termer var risikoen højere end i den samlede PLATO-population.
English: • a heart attack, over a year ago.
Danish: • et hjerteanfald for mere end et år siden.
English: • Stir and drink immediately.
Danish: • Rør rund og drik det straks
English: This dose will usually be given to you in the hospital.
Danish: Du vil sædvanligvis få denne dosis på hospitalet.
English: Nominal significance value; all others are formally statistically significant by pre-defined hierarchical testing.
Danish: Nominel signifikansværdi; alle andre er formelt statistisk signifikante ifølge prædefinerede hierarkiske tests.
English: You have been given this medicine because you have had:
Danish: Du har fået denne medicin, fordi du har haft:
English: About 30% of episodes resolved within 7 days.
Danish: Omkring 30 % af episoderne gik over af sig selv inden for 7 dage.
English: Children and adolescents Brilique is not recommended for children and adolescents under 18 years.
Danish: Børn og unge Brilique anbefales ikke til børn og teenagere under 18 år.
English: • Take this medicine around the same time every day (for example, one tablet in the morning and one in the evening).
Danish: • Tag dette lægemiddel på omtrent samme tidspunkt hver dag (f.eks. én tablet morgen og aften).
English: Creatinine increases of >50% from baseline.)
Danish: Kreatininstigninger på >50 % fra baseline.)
English: KM percentage calculated at 36 months.
Danish: KM-procentdel beregnet efter 36 måneder.
English: • You are bleeding now.
Danish: • hvis du bløder nu.
English: Excluding silent MI.
Danish: Tavst MI undtaget.
English: It can then be swallowed with or without water (see section 5.2).
Danish: Den kan derefter synkes med eller uden vand (se afsnit 5.2).
English: Brilique can be administered with or without food.
Danish: Brilique kan administreres med eller uden mad.