FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the Committee considered that the data could be important for healthcare professionals and recommended their inclusion in Abilify's product information.
Danish: Kommittén ansåg emellertid att dessa data kunde vara viktiga för hälso- och sjukvårdspersonal och rekommenderade att de skulle inkluderas i produktinformationen för Abilify.
English: What was the conclusion of the CHMP?
Danish: Vad har CHMP kommit fram till?
English: The active substance in Abilify, aripiprazole, is an antipsychotic medicine.
Danish: Den aktiva substansen i Abilify, aripiprazol, är ett antipsykotiskt läkemedel.
English: What is Abilify?
Danish: Vad är Abilify?
English: There are no consequences of the outcome of this application on patients currently in or who may be joining clinical trials with Abilify.
Danish: Resultatet av denna ansökan får inga följder för patienter som för närvarande deltar i eller som kommer att delta i kliniska prövningar med Abilify.
English: However, the CHMP noted that schizophrenia is rare in younger patients and that including the data in Abilify's product information could help the healthcare professionals who manage them.
Danish: CHMP konstaterade emellertid att schizofreni är sällsynt hos yngre patienter och att införandet av dessa data i produktinformationen för Abilify skulle kunna hjälpa hälso- och sjukvårdspersonalen som behandlar dem.
English: On 15 September 2016, the Committee for Medicinal Products for Human Use (CHMP) concluded the review of an application to extend the use of Abilify in schizophrenia to adolescents aged 13 and 14 years.
Danish: Den 15 september 2016 avslutade kommittén för humanläkemedel (CHMP) granskningen av en ansökan om att utvidga användningen av Abilify vid schizofreni till ungdomar i åldern 13 och 14 år.
English: What was Abilify expected to be used for?
Danish: Vad skulle Abilify användas för?
English: Abilify is a medicine for treating schizophrenia and bipolar disorder.
Danish: Abilify är ett läkemedel för behandling av schizofreni och bipolär sjukdom.
English: The CHMP therefore concluded that Abilify could not be approved for schizophrenia in 13 and 14 year olds on the basis of these data.
Danish: Därför kom CHMP fram till att Abilify inte kunde godkännas för schizofreni hos 13- och 14-åringar på basis av dessa data.
English: There are no consequences on the use of Abilify in bipolar disorder or its currently approved use in patients with schizophrenia aged 15 years and over.
Danish: Det blir inga följder för användningen av Abilify vid bipolär sjukdom eller dess för närvarande godkända användning för patienter med schizofreni som är 15 år och äldre.
English: Abilify contains the active substance aripiprazole.
Danish: Det innehåller den aktiva substansen aripiprazol.
English: Application to extend use of Abilify in schizophrenia to 13 and 14 year olds
Danish: Ansökan om att utvidga användningen av Abilify vid schizofreni till 13- och 14-åringar
English: The company that markets Abilify applied for it to be used to treat schizophrenia in patients aged 13 years and over.
Danish: Företaget som marknadsför Abilify ansökte om att det skulle användas för att behandla schizofreni hos patienter som är 13 år och äldre.
English: The company presented data from a main study in which 146 adolescents with schizophrenia whose symptoms were stable received either Abilify or placebo (a dummy treatment) for one year.
Danish: Företaget presenterade data från en huvudstudie som omfattade 146 ungdomar med stabila symtom på schizofreni.
English: How does Abilify work?
Danish: Hur verkar Abilify?
English: The recommended dose depends on the patient's body weight and is given once a week for the first 4 weeks and then every 2 weeks.
Danish: Den anbefalede dosis afhænger af patientens legemsvægt og gives én gang om ugen de første fire uger og derefter hver anden uge.
English: Effects are clinically relevant considering that patients have limited treatment options.
Danish: Virkningen er klinisk relevant i betragtning af, at patienterne har begrænsede behandlingsmuligheder.
English: As for all medicines, data on the use of Poteligeo are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Poteligeo løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Poteligeo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Poteligeo?
English: For more information about using Poteligeo, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Poteligeo, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency therefore decided that Poteligeo's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Poteligeo opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Other information about Poteligeo
Danish: Andre oplysninger om Poteligeo
English: The medicine is given as an infusion (drip) into a vein lasting at least 1 hour.
Danish: Lægemidlet gives som infusion (drop) i en blodåre over mindst 1 time.
English: Further information on Poteligeo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Poteligeo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Side effects reported with Poteligeo are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Poteligeo vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Patients should be monitored during and after the infusion for certain side effects related to the infusion.
Danish: Patienterne bør overvåges for visse infusionsrelaterede bivirkninger under og efter infusionen.
English: To reduce this risk, patients may be given other medicines such as an antipyretic (medicine that reduces fever) and an antihistamine (for treating allergic reactions) before or during treatment with Poteligeo.
Danish: For at minimere risikoen kan patienterne få andre lægemidler, som f.eks. et feberstillende lægemiddel og et antihistamin (mod allergiske reaktioner), før eller under behandlingen med Poteligeo.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
Danish: Yderligere oplysninger om lægemidler til sjældne sygdomme findes her: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: The most commonly reported serious reactions are pneumonia (infection of the lungs), fever, infusion-related reactions and cellulitis (inflammation of the deep skin tissue).
Danish: De hyppigst indberettede alvorlige bivirkninger er lungebetændelse, feber, infusionsrelaterede reaktioner og cellulitis (betændelse af det dybereliggende væv i huden).
English: An overview of Poteligeo and why it is authorised in the EU
Danish: En oversigt over Poteligeo, og hvorfor det er godkendt i EU
English: In this study, patients receiving Poteligeo lived for around 8 months without their disease getting worse compared with 3 months for patients on vorinostat.
Danish: De patienter, der fik Poteligeo, levede i gennemsnit otte måneder uden forværring af deres sygdom sammenholdt med tre måneder for de patienter, der fik vorinostat.
English: Poteligeo contains the active substance mogamulizumab.
Danish: Poteligeo indeholder det aktive stof mogamulizumab.
English: What are the risks associated with Poteligeo?
Danish: Hvilke risici er der forbundet med Poteligeo?
English: In all patients the cancer did not respond to a previous treatment or had come back.
Danish: Alle patienter var tidligere blevet behandlet uden at opleve respons, eller også var kræften vendt tilbage.
English: Poteligeo can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the treatment of cancer and in a place where equipment for resuscitation is available in case of rare and severe allergic reaction to the medicine.
Danish: Poteligeo udleveres kun efter recept, og behandlingen bør gives under overvågning af en læge med erfaring i behandling af kræft på et sted, hvor der er genoplivningsudstyr, der kan tages i anvendelse, hvis der opstår en sjælden alvorlig allergisk reaktion på lægemidlet.
English: The side effects seen with Poteligeo are considered manageable and most of them are mild or moderate.
Danish: Bivirkningerne ved Poteligeo anses for at være håndterbare, og de fleste af dem er af mild eller moderat sværhedsgrad.
English: The most common side effects with Poteligeo (seen in more than 1 patient in 10) are infusion-related reactions and rash.
Danish: De hyppigste bivirkninger ved Poteligeo (som optræder hos mere end 1 ud af 10 patienter) er infusionsrelaterede reaktioner og udslæt.
English: It is used in patients who have received previous treatment by mouth or injection.
Danish: Det anvendes hos patienter, der tidligere er blevet behandlet oralt (gennem munden) eller ved injektion.
English: By attaching to CCR4, mogamulizumab stimulates the body's immune system to attack the cancer cells, helping to control the disease.
Danish: Ved at binde til CCR4 stimulerer mogamulizumab kroppens immunsystem til at angribe kræftcellerne, hvorved sygdommen kan kontrolleres.
English: Poteligeo is effective at prolonging the time patients with mycosis fungoides or Sezary syndrome live without their disease getting worse.
Danish: Poteligeo er effektivt til at forlænge den tid, som patienter med mycosis fungoides eller Sezarys syndrom kan leve, uden at deres sygdom forværres.
English: Why is Poteligeo authorised in the EU?
Danish: Hvorfor blev Poteligeo godkendt i EU?
English: What is Poteligeo and what is it used for?
Danish: Hvad er Poteligeo, og hvad anvendes det til?
English: CCR4 is found on the surface of white blood cells, including the cancerous cells in mycosis fungoides or Sezary syndrome.
Danish: CCR4 findes på overfladen af de hvide blodlegemer, herunder kræftcellerne ved mycosis fungoides og Sezarys syndrom.
English: The active substance in Poteligeo, mogamulizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to a receptor (target) called CCR4.
Danish: Det aktive stof i Poteligeo, mogamulizumab, er et monoklonalt antistof (en type protein), der er designet til at binde til en receptor (et mål), der hedder CCR4.
English: For the full list of side effects and restrictions with Poteligeo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Poteligeo fremgår af indlægssedlen.
English: Both mycosis fungoides and Sezary syndrome belong to a group of rare cancers (cutaneous T-cell lymphomas), and Poteligeo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 October 2016.
Danish: Både mycosis fungoides og Sezarys syndrom tilhører en gruppe af sjældne kræftformer (kutane Tcellelymfomer), og Poteligeo blev udpeget som lægemiddel til sjældne sygdomme den 14. oktober 2016.
English: Poteligeo is a cancer medicine used to treat mycosis fungoides and Sezary syndrome - two cancers of blood cells that affect mainly the skin.
Danish: Poteligeo er et lægemiddel mod kræft, der anvendes til at behandle mycosis fungoides og Sezarys syndrom (to typer af kræft i blodlegemerne, der primært berører huden).
English: The doctor may interrupt or stop treatment, or reduce the dose, if the patient develops certain serious side effects.
Danish: Hvis patienten får visse alvorlige bivirkninger, kan lægen enten reducere dosen eller afbryde eller standse behandlingen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Poteligeo 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 Poteligeo.
English: How does Poteligeo work?
Danish: Hvordan virker Poteligeo?
English: What benefits of Poteligeo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Poteligeo?
English: How is Poteligeo used?
Danish: Hvordan anvendes Poteligeo?
English: Poteligeo was shown to be more effective than a comparator medicine, vorinostat, in a study of 372 adults with either mycosis fungoides or Sezary syndrome.
Danish: Det er i et studie af 372 voksne med enten mycosis fungoides eller Sezarys syndrom påvist, at Poteligeo er mere effektivt end et sammenligningslægemiddel.
English: This may take up to 5 weeks.
Danish: Dette kan tage op til fem uger.
English: This summary was last updated in 03-2017.
Danish: Dette sammendrag blev sidst ajourført i 03-2017.
English: This may help these women to become pregnant.
Danish: Dette kan øge kvindens mulighed for at blive gravid.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pergoveris on 25 June 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pergoveris den 25. juni 2007.
English: Pergoveris must not be used in women who have:
Danish: Pergoveris må ikke anvendes hos kvinder, som har:
English: The full EPAR for Pergoveris can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Pergoveris findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Mild or moderate OHSS is common, while severe OHSS is uncommon.
Danish: Mildt eller moderat OHSS er almindeligt, mens svært OHSS er usædvanligt.
English: Using less than the recommended starting dose may not be sufficient to stimulate development of a follicle.
Danish: Bruges der mindre end den anbefalede startdosis, kan det være for lidt til at stimulere dannelse af en follikel.
English: This is a summary of the European public assessment report (EPAR) for Pergoveris.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pergoveris.
English: The first injection must be given under direct supervision of a doctor who has experience in the treatment of fertility problems, but the patient can inject herself if she wants to, provided she has been properly trained and has access to expert advice.
Danish: Den første indsprøjtning skal gives under direkte overvågning af en læge med erfaring i behandling af fertilitetsproblemer, men patienten kan selv give indsprøjtningen, hvis hun ønsker det, forudsat at hun er blevet behørigt instrueret heri og har adgang til ekspertrådgivning.
English: Other information about Pergoveris
Danish: Andre oplysninger om Pergoveris
English: The company also carried out bioequivalence studies to establish whether the combined injection produced the same levels of the active substances in the body as the two medicines given separately.
Danish: Virksomheden gennemførte også bioækvivalensundersøgelser for at fastslå, hvorvidt den kombinerede indsprøjtning gav den samme mængde af de aktive stoffer i kroppen som de to lægemidler givet separat.
English: If necessary, the dose of follitropin alfa can be increased by adding it as a separate medicine, with 7 to 14 days between each dose increase.
Danish: Om nødvendigt kan dosis af follitropin alfa øges ved, at dette lægemiddel gives særskilt, idet dosis øges med 7 til 14 dages mellemrum.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Pergoveris's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Pergoveris opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The recommended starting dose is 150 International Units (IU) of follitropin alfa and 75 IU of lutropin alfa once a day, but this should be tailored to the patient's response.
Danish: Den anbefalede startdosis er 150 internationale enheder (IE) follitropin alfa og 75 IE lutropin alfa en gang dagligt, men bør tilpasses patientens respons.
English: What measures are being taken to ensure the safe and effective use of Pergoveris?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pergoveris?
English: It must also not be used in women who have malformations of the sexual organs or fibroid tumours of the womb that would stop them from becoming pregnant.
Danish: Det må heller ikke anvendes hos kvinder med misdannelser af kønsorganerne eller bindevævssvulster i livmoderen, som kan forhindre dem i at blive gravide.
English: • enlarged ovaries or a cyst on the ovary that is not due to polycystic ovarian disease and is of unknown origin,
Danish: • forstørrede æggestokke eller æggestokcyster, der ikke skyldes polycystisk æggestoksygdom og er af ukendt oprindelse
English: Why is Pergoveris approved?
Danish: Hvorfor blev Pergoveris godkendt?
English: Treatment can cause overstimulation of the ovaries (known as ovarian hyperstimulation syndrome, OHSS), which can lead to serious medical problems.
Danish: Behandling kan medføre overstimulering af æggestokkene (kendt som ovarielt hyperstimulationssyndrom, OHSS), der kan føre til alvorlige helbredsproblemer.
English: • bleeding from the genital region whose cause is unknown,
Danish: • blødning fra underlivet af ukendt årsag
English: The most common side effects reported with Pergoveris (seen in more than 1 patient in 10) are headache, ovarian cysts and injection site reactions (e.g. pain, itching, redness, bruising, swelling or irritation at the site of injection).
Danish: De hyppigste bivirkninger ved Pergoveris (som optræder hos mere end 1 ud af 10 patienter) er hovedpine, æggestokcyster og reaktioner på injektionsstedet (f.eks. smerte, kløe, rødme, blå mærker, hævelse eller irritation på injektionsstedet).
English: What is Pergoveris and what is it used for?
Danish: Hvad er Pergoveris, og hvad anvendes det til?
English: • cancer of the ovary, womb or breast.
Danish: • kræft i æggestokkene, livmoderen eller brysterne.
English: For more information about treatment with Pergoveris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pergoveris, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Pergoveris must not be used when a benefit cannot be obtained, such as in women with primary ovarian failure (when the ovaries stop working before the menopause).
Danish: Pergoveris må ikke anvendes, når det ikke er til nogen nytte, som hos kvinder med primær ovarieinsufficiens (når æggestokkene holder op med at virke forud for overgangsalderen).
English: It is not intended to provide practical advice on how to use Pergoveris.
Danish: Det er ikke en praktisk vejledning i, hvordan Pergoveris bør anvendes.
English: In the body, FSH stimulates the production of eggs, and LH stimulates their release.
Danish: I kroppen stimulerer FSH ægproduktionen, og LH fremkalder ægløsning.
English: What are the risks associated with Pergoveris?
Danish: Hvilke risici er der forbundet med Pergoveris?
English: EPAR summary for the public follitropin alfa / lutropin alfa
Danish: EPAR - sammendrag for offentligheden follitropin alfa/lutropin alfa
English: Pergoveris is a fertility medicine used in women to stimulate the development of follicles, the structures inside the ovaries that contain an egg.
Danish: Pergoveris er et fertilitetslægemiddel, som anvendes hos kvinder til at stimulere udviklingen af follikler, som er de strukturer i æggestokkene, der indeholder æg.
English: For the full list of all side effects and restrictions with Pergoveris, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Pergoveris fremgår af indlægssedlen.
English: The active substances in Pergoveris, follitropin alfa and lutropin alfa, are copies of the natural hormones FSH and LH.
Danish: De aktive stoffer i Pergoveris, follitropin alfa og lutropin alfa, er kopier af de naturlige hormoner FSH og LH.
English: These studies confirmed that Pergoveris produced similar blood levels of follitropin alfa and lutropin alfa as when the two medicines are given separately.
Danish: Disse undersøgelser bekræftede, at Pergoveris dannede samme mængde af follitropin alfa og lutropin alfa i blodet, som når de to lægemidler gives separat.
English: Pergoveris is for adult women who have low levels of two hormones that stimulate the ovariesfollicle-stimulating hormone (FSH) and luteinising hormone (LH).
Danish: Pergoveris er beregnet til voksne kvinder, som har lave niveauer af to hormoner, som stimulerer æggestokkene, nemlig follikelstimulerende hormon (FSH) og luteiniserende hormon (LH).
English: Thromboembolism (clots in the blood vessels) may occur very rarely, usually associated with severe OHSS.
Danish: Der kan i yderst sjældne tilfælde forekomme tromboemboli (blodpropper i blodkarrene), normalt i forbindelse med svært OHSS.
English: For practical information about using Pergoveris, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pergoveris, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Pergoveris is available as a solution for injection in a pre-filled pen or as a powder and solvent to be made up into a solution for injection.
Danish: Pergoveris fås som injektionsvæske, opløsning, i en fyldt pen og som et pulver og en solvens, der blandes til en injektionsvæske, opløsning.
English: The medicine contains the active substances follitropin alfa and lutropin alfa.
Danish: Lægemidlet indeholder de aktive stoffer follitropin alfa og lutropin alfa.
English: Therefore, the company presented information from studies carried out during the development of Luveris to support the use of Pergoveris.
Danish: Som dokumentation for anvendelsen af Pergoveris fremlagde virksomheden derfor oplysninger fra undersøgelser, der er udført under udviklingen af Luveris.
English: By replacing the missing hormones, Pergoveris allows women with FSH and LH deficiency to develop a follicle, which will release an egg after an injection of the hormone human chorionic gonadotrophin (hCG).
Danish: Pergoveris erstatter de manglende hormoner og giver derved kvinder med mangel på FSH og LH mulighed for at danne en follikel, der kan udløse et æg efter indsprøjtning af hormonet humant choriongonadotropin (hCG).
English: For further information see the package leaflet.
Danish: De nærmere oplysninger fremgår af indlægssedlen.
English: How is Pergoveris used?
Danish: Hvordan anvendes Pergoveris?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pergoveris 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 Pergoveris.
English: What benefits of Pergoveris have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Pergoveris?
English: • tumours of the hypothalamus or pituitary gland,
Danish: • svulster i hypotalamus eller hypofysen
English: In these studies, the combination of follitropin alfa and lutropin alfa at the same doses as in Pergoveris produced active follicles.
Danish: I disse undersøgelser blev der dannet aktive follikler ved behandling med en kombination af follitropin alfa og lutropin alfa i samme doser som Pergoveris.