FrancophonIA/ELRC3.0 huggingface dataset:
English: In schizophrenia, a mental illness with symptoms such as delusions, disorganised speech, and hallucinations (hearing or seeing things that are not there), Abilify is used to treat patients from the age of 15 years.
Danish: Ved skizofreni, der er en psykisk sygdom med symptomer som vrangforestillinger, taleforstyrrelser og hallucinationer (at høre eller se ting, som ikke er der), anvendes Abilify til at behandle patienter på 15 år og derover.
English: For more information about treatment with Abilify, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Abilify, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For information on the dose and dose adjustments, see the package leaflet.
Danish: Oplysninger om dosis og dosisjustering fremgår af indlægssedlen.
English: It is also available as a solution for injection into the shoulder or buttock muscle.
Danish: Det fås også som en opløsning til indsprøjtning i skulder- eller sædemusklen.
English: In another adult study, Abilify was as effective as haloperidol, another antipsychotic medicine, in preventing symptoms from returning over 1 year.
Danish: I en anden undersøgelse hos voksne var Abilify lige så effektivt som haloperidol, et andet antipsykotisk lægemiddel, til at forhindre symptomerne i at vende tilbage inden for et år.
English: Abilify has also been studied in 302 adolescents aged between 13 and 17, with results showing Abilify to be more effective than placebo.
Danish: Abilify er også blevet undersøgt hos 302 unge på mellem 13 og 17 år, hvor Abilify viste sig at være mere effektivt end placebo.
English: Studies showed that Abilify is effective at treating symptoms of schizophrenia using standard rating scales (such as the Positive and Negative Syndrome Scale, PANSS).
Danish: Undersøgelserne viste, at Abilify var effektivt til behandling af symptomer på skizofreni ved hjælp af standardscoreskalaer (såsom "Positive and Negative Syndrome Scale" (PANSS)).
English: Studies comparing Abilify to placebo or other medicines (such as haloperidol and lithium) show that Abilify is effective at reducing symptoms of schizophrenia and at treating and preventing high moods in patients with bipolar I disorder.
Danish: Undersøgelser, hvori Abilify sammenlignes med placebo eller andre lægemidler (såsom haloperidol og litium), viser, at Abilify er effektivt til at reducere symptomer på skizofreni og behandle og forebygge højt humør hos patienter med bipolar lidelse type 1.
English: Abilify is an antipsychotic medicine for patients with schizophrenia and bipolar I disorder.
Danish: Abilify er et antipsykotisk lægemiddel til patienter med skizofreni og bipolar lidelse type 1.
English: For practical information about using Abilify, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Abilify, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In studies of 1,203 adults, Abilify was more effective than placebo (a dummy treatment) at reducing symptoms.
Danish: I undersøgelser med 1 203 voksne var Abilify mere effektivt end placebo (en virkningsløs behandling) til at reducere symptomer.
English: Bipolar I disorder
Danish: Bipolar lidelse type 1
English: A study in 296 children and adolescents showed that Abilify was more effective than placebo at reducing the manic symptoms in patients aged 13 years and older.
Danish: En undersøgelse med 296 børn og unge viste, at Abilify var mere effektivt end placebo til at reducere de maniske symptomer hos patienter på 13 år og derover.
English: In 4 out of 5 studies in 1,900 adults, Abilify was more effective than placebo at reducing manic symptoms, with two of these studies showing that Abilify has a similar effect to haloperidol and to lithium.
Danish: I fire ud af fem undersøgelser hos 1 900 voksne var Abilify mere effektivt end placebo til at reducere maniske symptomer, og to af undersøgelserne viste, at virkningen af Abilify var tilsvarende haloperidol og litium.
English: In addition, the injection has been shown to be effective at quickly controlling agitation or disturbing behaviour in patients with schizophrenia or bipolar I disorder.
Danish: Desuden har indsprøjtningen vist sig at være effektiv til hurtigt at kontrollere uro eller forstyrret adfærd hos patienter med skizofreni eller bipolar lidelse type 1.
English: Finally, a study in 291 patients treated by injection for agitation and disturbed behaviour showed that improvement with Abilify was greater after 2 hours than with placebo and similar to that with lorazepam (another medicine for treating agitation).
Danish: Endelig viste en undersøgelse med 291 patienter, som blev behandlet med indsprøjtning for uro og forstyrret adfærd, at forbedringen med Abilify var større efter to timer end med placebo og var tilsvarende den forbedring, der sås med lorazepam (et andet lægemiddel mod uro).
English: Studies in bipolar I disorder showed that Abilify is effective at treating manic episodes using standard measurements such as the Young-Mania Rating Scale (YMRS) scale.
Danish: Undersøgelserne af bipolar lidelse type 1 viste, at Abilify var effektivt til behandling af maniske episoder ved brug af standardskalaer, såsom "Young-Mania Rating Scale" (YMRS).
English: A study in 544 patients treated by injection for agitation and disturbed behaviour showed that improvement with Abilify over 24 hours was greater than with placebo and similar to that with haloperidol.
Danish: En undersøgelse med 544 patienter, som blev behandlet med indsprøjtning for uro og forstyrret adfærd, viste, at forbedringen med Abilify i løbet af 24 timer var større end med placebo og var tilsvarende den forbedring, der sås med haloperidol.
English: In bipolar I disorder, Abilify is used in adults to treat manic episodes (periods of abnormally high mood) and to prevent new ones in those who have responded to the medicine in the past.
Danish: Ved bipolar lidelse type 1 anvendes Abilify hos voksne til behandling af maniske episoder (perioder med abnormt højt humør) og forebyggelse af nye maniske episoder hos voksne, hos hvem lægemidlet tidligere har virket.
English: The injection is used only for quickly controlling agitation or disturbed behaviour in patients with schizophrenia or bipolar I disorder.
Danish: Indsprøjtningen bruges udelukkende til hurtigt at kontrollere uro eller forstyrret adfærd hos patienter med skizofreni eller bipolar lidelse type 1.
English: Abilify contains the active substance aripiprazole.
Danish: Det indeholder det aktive stof aripiprazol.
English: How is Abilify used?
Danish: Hvordan anvendes Abilify?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abilify 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 Abilify.
English: What benefits of Abilify have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Abilify?
English: How does Abilify work?
Danish: Hvordan virker Abilify?
English: This summary was last updated in 10-2017.
Danish: Dette sammendrag blev sidst ajourført i 05-2012.
English: The European Commission granted a marketing authorisation valid throughout the EU for Helixate NexGen on 4 August 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Helixate NexGen den 4. august 2000.
English: The full EPAR for Helixate NexGen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Helixate NexGen findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness in the studies was the number of treatments required to stop each new bleed.
Danish: De primære effektmål i undersøgelserne var antallet af behandlinger, som var nødvendigt for at standse hver ny blødning.
English: The main measure of effectiveness was the doctor's assessment of how well bleeding was stopped.
Danish: Det primære effektmål var lægens vurdering af, hvor godt blødningen var standset.
English: This is a summary of the European public assessment report (EPAR) for Helixate NexGen.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Helixate NexGen.
English: Because of this, Helixate NexGen has been compared with Helixate to show that the two medicines are equivalent.
Danish: Derfor er Helixate NexGen blevet sammenlignet med Helixate for at vise, at de to lægemidler svarer til hinanden.
English: Stopping bleeding was assessed as ‘excellent' in all 15 patients.
Danish: Når det blev givet som en kontinuerlig infusion, vurderedes standsningen af blødningen som ”særdeles god” hos alle 15 patienter.
English: For more information about treatment with Helixate NexGen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Helixate NexGen, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In the previously untreated patients, about 90% of bleeding episodes responded to treatment with one or two injections into a vein.
Danish: Hos de ikke tidligere behandlede patienter reagerede cirka 90 % af blødningsepisoderne på behandling med en eller to injektioner i en vene.
English: Helixate NexGen is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Danish: Helixate NexGen anvendes til at korrigere manglen på faktor VIII ved at erstatte den manglende faktor VIII, hvorved der opnås midlertidig kontrol med blødningsforstyrrelser.
English: Some patients may develop factor VIII inhibitors, which are antibodies (proteins) that the body's immune system produces against factor VIII and which can cause the medicine to stop working resulting in a loss of bleeding control.
Danish: Nogle patienter kan udvikle faktor VIII-inhibitorer, dvs. antistoffer (proteiner), som kroppens immunsystem producerer mod faktor VIII, og som kan være årsag til, at lægemidlet holder op med at virke, hvilket medfører manglende kontrol med blødninger.
English: Helixate NexGen is intended for either short-term or long-term use.
Danish: Helixate NexGen er beregnet enten til kortvarig eller langvarig behandling.
English: Helixate NexGen given at high dose has been studied to see whether it is effective in clearing antibodies against factor VIII from the blood (a process known as immune tolerance induction) so that treatment with factor VIII remains effective.
Danish: Helixate NexGen givet ved høj dosis er blevet undersøgt for at se, om det er effektivt til at nedbryde antistoffer mod faktor VIII fra blodet (en proces, der kaldes immuntoleransinduktion), så behandlingen med faktor VIII forbliver effektiv.
English: The Agency decided that Helixate NexGen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Helixate NexGen opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Helixate NexGen.
English: Helixate NexGen is similar to another medicine that was previously authorised in the EU called Helixate, but it is prepared differently so that there are no human-derived proteins in the medicine.
Danish: Helixate NexGen ligner et andet lægemiddel, som tidligere er godkendt i Den Europæiske Union (EU), kaldet Helixate, men fremstilles på en anden måde, så lægemidlet ikke indeholder humant afledte proteiner.
English: Patients with haemophilia A lack factor VIII, and this causes blood clotting problems such as bleeding in the joints, muscles and internal organs.
Danish: Patienter med hæmofili A mangler faktor VIII, hvilket medfører blodstørkningsproblemer såsom blødninger i led, muskler eller indre organer.
English: Helixate NexGen given as an injection into a vein has been studied in 66 patients who had previously been treated with recombinant human coagulation factor VIII and 61 children who had not.
Danish: Helixate NexGen givet som en injektion i en vene blev undersøgt hos 66 patienter, som tidligere er blevet behandlet med rekombinant human koagulationsfaktor VIII, og hos 61 børn, som ikke har modtaget denne behandling.
English: Other information about Helixate NexGen
Danish: Andre oplysninger om Helixate NexGen:
English: In the previously treated patients, overall, 95% of bleeds responded to one or two injections of Helixate NexGen into a vein.
Danish: Som helhed reagerede 95 % af blødningerne hos de tidligere behandlede patienter på en eller to injektioner af Helixate NexGen i en vene.
English: The active substance in Helixate NexGen, octocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Danish: Det aktive stof i Helixate NexGen, human koagulationsfaktor VIII, er et stof, der hjælper blodet med at størkne.
English: The data provided on immune tolerance induction in patients with inhibitors showed, that some patients benefit from the high dosage and the inhibitor could be eliminated, nevertheless the data were not considered sufficient to specifically approve the medicine for this use.
Danish: De data, der blev fremlagt om immuntoleransinduktion hos patienter med inhibitorer, viste, at den høje dosering gavner nogle patienter, og at inhibitoren kan elimineres.
English: Why is Helixate NexGen approved?
Danish: Hvorfor blev Helixate NexGen godkendt?
English: Helixate NexGen as a continuous infusion has also been studied in 15 patients with haemophilia A undergoing major surgery.
Danish: Helixate NexGen givet som en kontinuerlig infusion blev også undersøgt hos 15 patienter med hæmofili A, der gennemgik større kirurgiske indgreb.
English: Helixate NexGen must not be used in people who are known to be hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein or to any of the other ingredients.
Danish: Helixate NexGen må ikke anvendes til personer, som er overfølsomme (allergiske) over for human koagulationsfaktor VIII eller andre af indholdsstofferne.
English: For the full list of all side effects reported with Kogenate Bayer, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Helixate NexGen fremgår af indlægssedlen.
English: Helixate NexGen can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia.
Danish: Behandling med Helixate NexGen bør indledes af en læge med erfaring i behandling af hæmofili.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Helixate NexGen.
English: What are the risks associated with Helixate NexGen?
Danish: Hvilken risiko er der forbundet med Helixate NexGen?
English: EPAR summary for the public octocog alfa
Danish: EPAR - sammendrag for offentligheden human koagulationsfaktor VIII (octocog alfa)
English: Helixate NexGen is available as a powder and solvent that are mixed together to make a solution for injection or infusion (drip) into a vein.
Danish: Helixate NexGen består af et pulver og en solvens, som blandes til en injektionsvæske, opløsning.
English: Helixate NexGen is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Danish: Helixate NexGen anvendes til behandling og forebyggelse af blødning hos patienter med hæmofili A (medfødte blødningsforstyrrelser).
English: It contains the active substance octocog alfa (human coagulation factor VIII).
Danish: Helixate NexGen indeholder det aktive stof human koagulationsfaktor VIII (octocog alfa).
English: The dose and duration of treatment depend on whether Helixate NexGen is used to treat or prevent bleeding or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Danish: Dosis og injektionshyppighed afhænger af, om Helixate NexGen anvendes til behandling eller forebyggelse af blødning eller til at mindske blødning under et kirurgisk indgreb.
English: How is Helixate NexGen used?
Danish: Hvordan anvendes Helixate NexGen?
English: What benefits of Helixate NexGen have been shown in studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Helixate NexGen?
English: How does Helixate NexGen work?
Danish: Hvordan virker Helixate NexGen?
English: Octocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.
Danish: Det fremstilles af en celle, som har modtaget et gen (dna), der sætter det i stand til at producere human koagulationsfaktor VIII.
English: Skin- associated hypersensitivity reactions (itching, hives and rash) may occur commonly (in between 1 and 10 patients in 100) but a severe allergic reaction is rare (between 1 and 10 in 10,000 patients).
Danish: De hyppigste bivirkninger ved Helixate NexGen (som optræder hos mellem 1 og 10 patienter ud af 100) er udvikling af antistoffer mod faktor VIII, hovedsageligt hos patienter, der ikke før er blevet behandlet med faktor VIII, reaktioner på infusionsstedet og allergiske hudreaktioner (overfølsomhed) (kløe, nældefeber og udslæt).
English: The dose may need to be adjusted if Helixate NexGen is to be given continuously as an infusion into a vein.
Danish: Helixate NexGen gives ved injektion i en vene over flere minutter.
English: What is Helixate NexGen and what is it used for?
Danish: Hvad anvendes Helixate NexGen til?
English: Oral suspension Oral use bottle (glass)
Danish: Oral suspension Peroral anvendelse
English: EU/1/13/813/001 Perjeta
Danish: EU/1/13/813/001
English: 420 mg Concentrate for solution for infusion
Danish: 420 mg Koncentrat til infusionsvæske, opløsning
English: Intravenous use Vial (glass) 30 mg/ml
Danish: 30 mg/ml
English: Packaging Content (concentration)
Danish: Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: Pre-filled syringe (glass) 3 ml (1 mg/ml) 4 pre-filled syringes
Danish: Fyldt injektionssprøjte (glas) 3 ml (1 mg/ml) 4 fyldt injektions-sprøjter
English: Pre-filled syringe (glass) 3 ml (1 mg/ml) 1 pre-filled syringe
Danish: Fyldt injektionssprøjte (glas) 3 ml (1 mg/ml) 1 fyldt injektions-sprøjte
English: Doc.
Danish: dok.
English: Ref.: EMEA/464033/2009 EMEA/H/C/546/II/24
Danish: : EMEA/464033/2009 EMEA/H/C/546/II/24
English: The study lasted for six months.
Danish: Undersøgelsen varede seks måneder.
English: Lyrica has been authorised since July 2004.
Danish: Lyrica har været godkendt siden juli 2004.
English: London, 23 July 2009
Danish: London, 23. juli 2009 Ref.
English: It is available as capsules.
Danish: Det fås som kapsler.
English: In this study, the main measure of effectiveness was how long it took until the patient's pain came back.
Danish: I denne undersøgelse var det primære effektmål, hvor længe det varede, før patientens smerter vendte tilbage.
English: Most of the patients included in the studies came from outside the European Union (EU).
Danish: De fleste af de patienter, der deltog i undersøgelserne, kom fra lande uden for EU.
English: The company that applied for authorisation is Pfizer Limited.
Danish: Virksomheden, som ansøgte om tilladelse, er Pfizer Limited.
English: • epilepsy in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
Danish: • epilepsi hos patienter med partielle anfald (epileptiske anfald, der begynder i en bestemt del af hjernen), som ikke kan kontrolleres med deres aktuelle behandling
English: The main measure of effectiveness was the change in pain levels over eight to 14 weeks of treatment.
Danish: Det primære effektmål var ændringen i smerteniveauer efter 8-14 ugers behandling.
English: What is Lyrica?
Danish: Hvad er Lyrica?
English: It is used to treat adults with the following conditions:
Danish: Det anvendes til behandling af følgende infektioner hos voksne:
English: This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters.
Danish: Dette nedsætter aktiviteten i nogle af nervecellerne i hjernen og rygmarven, hvilket nedbringer frigivelsen af andre neurotransmittere.
English: The company presented the results of five main studies involving over 3,000 adults with fibromyalgia.
Danish: Virksomheden fremlagde resultaterne af fem hovedundersøgelser med over 3.000 voksne med fibromyalgi.
English: The change concerned an extension of indication to add the treatment of fibromyalgia.
Danish: Ændringen omhandlede en udvidelse af indikationen til også at omfatte behandling af fibromyalgi.
English: Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica pregabalin
Danish: Spørgsmål og svar vedrørende anbefalingen af afslag på ansøgningen om ændring af markedsføringstilladelsen for Lyrica pregabalin
English: This is expected to reduce the symptoms of fibromyalgia, such as pain.
Danish: Dette forventes at reducere symptomerne på fibromyalgi, såsom smerte.
English: The active substance in Lyrica, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma-amino butyric acid (GABA), but has very different biological effects.
Danish: Det aktive stof i Lyrica, pregabalin, har en struktur, der ligner kroppens egen "neurotransmitter", gammaaminobutansyre (GABA), men har meget anderledes biologiske virkninger.
English: The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Danish: Det vides ikke helt, præcis, hvordan pregabalin virker, men man mener, at det påvirker den måde, hvorpå calcium trænger ind i nervecellerne.
English: There are no consequences on the use of Lyrica in the authorised indications, for which the balance of benefits and risks remains unchanged.
Danish: Det får ingen konsekvenser for anvendelsen af Lyrica til den godkendte indikation, for hvilken benefit/risk-forholdet forbliver uændret.
English: The Committee was also concerned that the safety and effectiveness of Lyrica had not been shown in patients from the EU.
Danish: Udvalget var også betænkelig ved, at sikkerheden og effektiviteten af Lyrica ikke var blevet påvist hos patienter fra EU.
English: Lyrica is a medicine that contains the active substance pregabalin.
Danish: Lyrica er et lægemiddel, der indeholder det aktive stof pregabalin.
English: There were no consistent or relevant reductions in pain or other symptoms in the short-term studies, and the maintenance of Lyrica's effect was not shown in the longer study.
Danish: Der var ikke nogen vedvarende eller relevante reduktioner af smerter eller andre symptomer i de kortvarige undersøgelser, og det blev ikke påvist i den længerevarende undersøgelse, at Lyricas virkning blev opretholdt.
English: What was Lyrica expected to be used for?
Danish: Hvad forventedes Lyrica anvendt til?
English: Four of the studies compared the short-term effects of Lyrica at doses between 150 and 600 mg per day with those of placebo (a dummy treatment) in a total of 2,757 patients.
Danish: I fire af undersøgelserne sammenlignede man de kortsigtede virkninger af Lyrica ved doser på mellem 150 og 600 mg om dagen med virkningerne af placebo (en virkningsløs behandling) hos i alt 2.757 patienter.