FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xeplion on 4 March 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xeplion den 4. marts 2011.
English: The monthly maintenance dose is 75 mg.
Danish: Den månedlige vedligeholdelsesdosis er 75 mg.
English: This is a summary of the European public assessment report (EPAR) for Xeplion.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Xeplion.
English: The full EPAR for Xeplion can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Xeplion findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The dose may be adjusted depending on the medicine's benefit to the patient and how the patient tolerates the treatment.
Danish: Dosis kan justeres afhængigt af lægemidlets gavnlige virkning for patienten, og hvordan patienten tolererer behandlingen.
English: It is available as a prolongedrelease suspension for injection in pre-filled syringes (25, 50, 75, 100 and 150 mg).
Danish: Det fås som en depotinjektionsvæske, suspension, i fyldte injektionssprøjter (25, 50, 75, 100 og 150 mg).
English: The most frequently reported side effects are insomnia (difficulty sleeping), headache, anxiety, upper respiratory tract infection (colds), reactions at the site of injection, parkinsonism (neurological symptoms including tremor and impaired muscular control), increased weight, akathisia (restlessness), agitation, somnolence (sleepiness), nausea, constipation, dizziness, muscle and bone pain, tachycardia (rapid heartbeat), tremor (shaking), abdominal pain (stomach ache), vomiting diarrhoea, fatigue (tiredness) and dystonia (involuntary muscle contractions).
Danish: De hyppigst indberettede bivirkninger er insomni (søvnløshed), hovedpine, angst, infektioner i de øvre luftveje (forkølelser), reaktioner på injektionsstedet, parkinsonisme (neurologiske symptomer, herunder rysten og nedsat muskelkontrol), vægtstigning, akatisi (rastløshed), ophidselse, somnolens (søvnighed), kvalme, forstoppelse, svimmelhed, muskel- og knoglesmerter, takykardi (hurtig hjerterytme), tremor (rysten), mavesmerter, opkastning, diarré, træthed og dystoni (ufrivillige muskelsammentrækninger).
English: In the brain, it attaches to several different receptors on the surface of nerve cells.
Danish: Det sætter sig på flere forskellige receptorer på overfladen af nervecellerne i hjernen.
English: The main measure of effectiveness in the studies was the change in the patients' symptoms after nine or 13 weeks assessed using a standard scale for schizophrenia.
Danish: Det primære effektmål i undersøgelserne var en ændring i patienternes symptomer efter 9 eller 13 uger vurderet ved hjælp af en standardskala for skizofreni.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xeplion.
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 Xeplion.
English: By blocking these receptors, paliperidone helps to normalise the activity of the brain and reduce symptoms of the disease.
Danish: Ved at blokere disse receptorer medvirker paliperidon til at normalisere hjerneaktiviteten og derved mindske symptomerne på sygdommen.
English: This study looked at how well Xeplion prevented the relapse of severe symptoms.
Danish: I denne undersøgelse blev det undersøgt, hvor godt Xeplion forhindrede tilbagefald til svære symptomer.
English: This allows for the injection to have a long duration of action.
Danish: Det bevirker, at injektionen kan virke over lang tid.
English: Other information about Xeplion
Danish: Andre oplysninger om Xeplion:
English: Six short-term studies were carried out with Xeplion.
Danish: Der er udført seks korttidsundersøgelser med Xeplion.
English: The injections on days 1 and 8 are into the upper part of the shoulder (deltoid muscle), while the maintenance doses can be given in the buttocks or the deltoid muscle.
Danish: Injektionen på dag 1 og 8 sker i den øvre del af skulderen (deltoideusmusklen), mens vedligeholdelsesdosen kan gives i balderne eller deltoideusmusklen.
English: In two other studies (one long- and one short-term), Xeplion was not proven to be as effective as risperidone.
Danish: I to andre undersøgelser (en langtids- og en korttidsundersøgelse) viste Xeplion sig ikke at være lige så effektivt som risperidon.
English: The CHMP noted that the studies comparing Xeplion with placebo and risperidone showed that the medicine is beneficial to patients with schizophrenia.
Danish: CHMP bemærkede, at de undersøgelser, hvori Xeplion blev sammenlignet med placebo og risperidon, viste, at lægemidlet er gavnligt for patienter med skizofreni.
English: Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Danish: Skizofreni er en psykisk sygdom med symptomer, der blandt andet består i desorganiseret tankegang og tale, hallucinationer (hører eller ser ting, som ikke er der), mistænksomhed og vrangforestillinger (forestillinger, der er ude af trit med virkeligheden).
English: Paliperidone acts mainly by blocking receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin), which are involved in schizophrenia.
Danish: Paliperidon virker hovedsagelig ved at blokere receptorerne for neurotransmitterne dopamin og 5-hydroxytryptamin (også kaldet serotonin), som er aktive ved skizofreni.
English: Prolonged-release means that the active substance is released slowly over a few weeks after being injected.
Danish: Depotinjektion betyder, at det aktive stof frigives langsomt i løbet af nogle få uger efter injektionen.
English: Because paliperidone has already been authorised in the EU as Invega, the company used some of the data from Invega to support the use of Xeplion.
Danish: Paliperidon er allerede godkendt i EU under navnet Invega, og virksomheden har derfor brugt nogle af dataene for Invega til at understøtte brugen af Xeplion.
English: Xeplion is used for the maintenance treatment of schizophrenia in adults whose disease has already been stabilised on treatment with paliperidone or risperidone.
Danish: Xeplion anvendes til vedligeholdelsesbehandling af skizofreni hos voksne, hvor sygdommen allerede er stabiliseret med behandling med paliperidon eller risperidon.
English: Because the medicine is a prolonged release suspension, it also has the advantage of being given at monthly intervals.
Danish: Da lægemidlet er en depotinjektionsvæske, suspension, har det den yderligere fordel, at det kan gives med en måneds mellemrum.
English: The Committee decided that Xeplion's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget konkluderede derfor, at fordelene ved Xeplion er større end risiciene, og udvalget anbefalede udstedelse af markedsføringstilladelse for Xeplion.
English: What is the risk associated with Xeplion?
Danish: Hvilken risiko er der forbundet med Xeplion?
English: Xeplion must not be given to people who are hypersensitive (allergic) to paliperidone or any of the other ingredients, or to risperidone.
Danish: Xeplion må ikke gives til personer, som er overfølsomme (allergiske) over for paliperidon eller et eller flere af de øvrige indholdsstoffer eller over for risperidon.
English: Some patients whose symptoms have not yet been stabilised may still be given Xeplion if they have responded well to oral paliperidone or risperidone in the past, their symptoms are mild to moderate and a long-acting injectable treatment is needed.
Danish: Nogle patienter, hvis symptomer endnu ikke er stabiliseret, kan alligevel få Xeplion, hvis de tidligere har reageret godt på oral paliperidon eller risperidon, hvis symptomerne er milde til moderate, og hvis der er behov for langtidsvirkende behandling med et injicerbart lægemiddel.
English: Xeplion was more effective than placebo in reducing schizophrenia symptoms in the short-term.
Danish: Xeplion var mere effektivt end placebo til at reducere skizofrenisymptomerne på kort sigt.
English: The active substance in Xeplion, paliperidone, is an antipsychotic medicine.
Danish: Det aktive stof i Xeplion, paliperidon, er et antipsykotisk lægemiddel.
English: In Xeplion, paliperidone has been attached to a fatty acid that allows it to be released slowly after being injected.
Danish: I Xeplion er paliperidon bundet til en fedtsyre, således at det kan frigives langsomt, når det er injiceret.
English: Two long-term studies lasting about a year were carried out with Xeplion.
Danish: Der er udført to langtidsundersøgelser med Xeplion af ca. et års varighed.
English: Xeplion is a medicine that contains the active substance paliperidone.
Danish: Xeplion er et lægemiddel, der indeholder det aktive stof paliperidon.
English: Paliperidone is an active breakdown product (metabolite) of risperidone, another antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s.
Danish: Paliperidon er et aktivt nedbrydningsprodukt (metabolit) af risperidon, som er et andet antipsykotisk lægemiddel, der har været anvendt til behandling af skizofreni siden 1990'erne.
English: For more information on the use of Xeplion including how to adjust the doses, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om anvendelsen af Xeplion, herunder hvordan doserne justeres, fremgår af produktresuméet (der ligeledes er en del af denne EPAR).
English: In four short-term studies the reductions in symptom scores were greater for patients receiving Xeplion than for those receiving placebo.
Danish: I fire korttidsundersøgelser var reduktionen i symptomscoren større for patienter, som fik Xeplion, end for patienter, som fik placebo.
English: Paliperidone has been authorised in the European Union as Invega since 2007 as an oral treatment for schizophrenia.
Danish: Paliperion har siden 2007 været godkendt i Den Europæiske Union (EU) som oral behandling af skizofreni under navnet Invega.
English: Xeplion was also shown to be effective in preventing relapses in the longterm, with fewer patients in the Xeplion group having a relapse compared with the placebo group.
Danish: Det blev også vist, at Xeplion var effektivt til at forhindre tilbagefald på langt sigt, idet færre patienter i Xeplion-gruppen fik tilbagefald i forhold til placebogruppen.
English: For the full list of all side effects reported with Xeplion, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Xeplion fremgår af indlægssedlen.
English: Xeplion treatment starts with two injections, one week apart, to bring the blood levels of paliperidone up, followed by monthly maintenance injections.
Danish: Behandlingen med Xeplion starter med to injektioner med en uges mellemrum for at øge koncentrationen af paliperidon i blodet, og derefter vedligeholdes behandlingen med en injektion én gang om måneden.
English: The two initial injections are 150 mg on the first day
Danish: De to første injektioner er 150 mg på den første dag (dag 1) og 100 mg på dag 8.
English: The second study, involving 749 adults, compared Xeplion with risperidone long-acting injection (taken with oral risperidone supplements) and looked at the change in the patients' symptoms.
Danish: I den anden undersøgelse, der omfattede 749 voksne, blev Xeplion sammenlignet med langtidsvirkende risperidoninjektion (kombineret med orale risperidontilskud), og den havde til formål at undersøge ændringen i patienternes symptomer.
English: One of the studies, involving 410 adults, compared Xeplion with placebo.
Danish: I en af undersøgelserne, der omfattede 410 voksne, blev Xeplion sammenlignet med placebo.
English: Why has Xeplion been approved?
Danish: Hvorfor blev Xeplion godkendt?
English: For more information about treatment with Xeplion, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: De nærmere oplysninger om behandling med Xeplion fremgår af indlægssedlen (også en del af EPAR) eller kan fås hos lægen eller på apoteket.
English: What is Xeplion?
Danish: Hvad er Xeplion?
English: Four of the studies, involving 1,774 adults with schizophrenia, compared Xeplion with placebo (a dummy treatment).
Danish: I fire af undersøgelserne, der omfattede 1 774 voksne med skizofreni, blev Xeplion sammenlignet med placebo (en virkningsløs behandling).
English: Two studies, involving 1,178 patients, compared Xeplion with risperidone long-acting injection (taken with oral risperidone supplements).
Danish: I to undersøgelser, der omfattede 1 178 patienter, blev Xeplion sammenlignet med langtidsvirkende risperidoninjektion (kombineret med orale risperidontilskud).
English: Of these, akathisia and somnolence appear to be related to the dose.
Danish: Af disse er akatisi og somnolens dosisrelaterede.
English: How has Xeplion been studied?
Danish: Hvordan blev Xeplion undersøgt?
English: What benefit has Xeplion shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Xeplion?
English: What is Xeplion used for?
Danish: Hvad anvendes Xeplion til?
English: Xeplion was shown to be as effective as risperidone long-acting injection in reducing schizophrenia in one of the short-term studies.
Danish: Det blev i en af de tre korttidsundersøgelser vist, at Xeplion var lige så effektivt som langtidsvirkende risperidoninjektion til at reducere skizofreni.
English: How is Xeplion used?
Danish: Hvordan anvendes Xeplion?
English: How does Xeplion work?
Danish: Hvordan virker Xeplion?
English: Transmission to National Competent Authorities of the translations of the annexes to the agreement:
Danish: Fremsendelse til de nationale kompetente myndigheder af oversættelserne af aftalens bilag:
English: Implementation of the agreement by the Member States (submission of the variation type IB by the Marketing Authorisation Holder):
Danish: Gennemførelse af aftalen i medlemsstaterne (type IB-ændringsansøgningen indsendes af indehaveren af markedsføringstilladelsen):
English: 16 October 2015
Danish: 16. oktober 2015
English: 17 June 2015
Danish: 17. juni 2015
English: Adoption of CMDh agreement:
Danish: Vedtagelse af CMDh-aftalen:
English: May 2015 CMDh meeting
Danish: CMDh's møde i maj 2015
English: It is used in the following ways:
Danish: Det anvendes på følgende måder:
English: It is available as tablets (50 mg/850 mg and 50 mg/1,000 mg).
Danish: Det fås som tabletter (50 mg/ 850 mg og 50 mg/1000 mg).
English: The European Commission granted a marketing authorisation valid throughout the EU for Eucreas on 14 November 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Eucreas den 14. november 2007.
English: The full EPAR for Eucreas can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Eucreas findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Vildagliptin on its own was approved by the European Union (EU) in September 2007 under the name Galvus, and metformin has been available in the EU since 1959.
Danish: Vildagliptin alene blev godkendt af Den Europæiske Union (EU) i september 2007 under navnet Galvus, og metformin har været på markedet i EU siden 1959.
English: This is a summary of the European public assessment report (EPAR) for Eucreas.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Eucreas.
English: Doses of vildagliptin above 100 mg are not recommended.
Danish: Det anbefales ikke at anvende doser af vildagliptin over 100 mg.
English: The recommended dose of Eucreas is one tablet twice a day, with one tablet taken in the morning and one in the evening.
Danish: Den anbefalede dosis Eucreas er en tablet to gange dagligt, hvor den ene tablet tages om morgenen og den anden om aftenen.
English: Other information about Eucreas
Danish: Andre oplysninger om Eucreas
English: Vildagliptin / metformin hydrochloride
Danish: Eucreas vildagliptin/metforminhydrochlorid
English: For more information about treatment with Eucreas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Eucreas, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The applicant also presented the results of two studies showing that the active substances in the two strengths of Eucreas were absorbed in the body in the same way as when they were taken as separate tablets.
Danish: Ansøgeren fremlagde også resultaterne af to undersøgelser, der viser, at de aktive stoffer i de to styrker af Eucreas blev optaget i kroppen på samme måde, som når de blev taget hver for sig i to tabletter.
English: Eucreas is used to treat adults with type 2 diabetes.
Danish: Eucreas anvendes til behandling af voksne med type 2 diabetes.
English: Eucreas contains two active substances, which each have a different mode of action.
Danish: Eucreas indeholder to aktive stoffer, som hver især virker forskelligt.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Eucreas.
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 Eucreas.
English: Therefore, the Committee decided that the benefits of Eucreas are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget var derfor af den opfattelse, at fordelene ved Eucreas opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Vildagliptin, which is a dipeptidyl peptidase 4 (DPP-4) inhibitor, works by blocking the breakdown of ‘incretin' hormones in the body.
Danish: Vildagliptin, som er en dipeptidyl peptidase- 4 (DPP-4)-hæmmer, virker ved at blokere nedbrydningen af ‘inkretin'-hormoner i kroppen.
English: Elderly patients taking Eucreas should have their kidney function monitored regularly.
Danish: Ældre patienter, som behandles med Eucreas, skal have deres nyrefunktion kontrolleret regelmæssigt.
English: It should also not be used in patients who have diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic pre-coma, problems with their kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Danish: Det må heller ikke anvendes til patienter, som har diabetisk ketoacidose (høje koncentrationer af ketoner og syrer i blodet), diabetisk prækoma, nyreeller leverproblemer, sygdomme, som kan påvirke nyrerne, eller en sygdom, som forårsager reduceret iltforsyning til vævene såsom hjerte- eller lungeinsufficiens eller et nyligt hjerteanfald.
English: Taking Eucreas with or just after food may reduce any stomach problems caused by metformin.
Danish: Hvis Eucreas tages sammen med eller lige efter et måltid, kan eventuelle maveproblemer forårsaget af metformin begrænses.
English: The choice of tablet strength to start with depends on the patient's current treatment and the expected effects of Eucreas, but it is recommended to provide a dose of metformin similar to the dose already being taken.
Danish: Valget af tabletstyrke i begyndelsen afhænger af patientens nuværende behandling og de forventede virkninger af Eucreas, men det anbefales, at den dosis metformin, der gives, svarer til den dosis, der allerede tages.
English: Patients already taking vildagliptin and metformin should switch to Eucreas containing the same amounts of each active substance.
Danish: Patienter, som allerede tager vildagliptin og metformin, bør skifte til Eucreas, der indeholder de samme mængder af hvert af de aktive stoffer.
English: • in patients who are already taking the combination of vildagliptin and metformin as separate tablets;
Danish: • til patienter, som allerede tager kombinationen af vildagliptin og metformin som særskilte tabletter
English: Eucreas is a medicine that contains the active substances vildagliptin and metformin hydrochloride.
Danish: Eucreas er et lægemiddel, der indeholder de to aktive stoffer vildagliptin og metforminhydrochlorid.
English: Patients adding vildagliptin had falls in HbA1c levels of 0.88 percentage points after 24 weeks from a starting level of 8.38%.
Danish: Patienter, som fik suppleret med vildagliptin, havde et fald i HbA1c-niveauerne på 0,88 procent efter 24 uger fra et udgangsniveau på 8,38 %.
English: Eucreas should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients.
Danish: Eucreas bør ikke anvendes til personer, som kan være overfølsomme (allergiske) over for vildagliptin, metformin eller et af de øvrige indholdsstoffer.
English: The CHMP concluded that vildagliptin taken with metformin reduces blood glucose levels and the combination of the two active substances in one tablet may help patients to stick to their treatment.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at vildagliptin taget med metformin nedsætter blodglukoseniveauerne, og at kombinationen af de to aktive stoffer i en tablet kan medvirke til, at patienterne overholder deres behandling.
English: The most common side effects with Eucreas (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
Danish: De hyppigste bivirkninger ved Eucreas (som ses hos flere end 1 ud af 10 patienter) er kvalme, opkastning og diarré, mavesmerter og appetitløshed.
English: It should also not be used in patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, or during breastfeeding.
Danish: Det må heller ikke gives til patienter med alkoholforgiftning (overdrevet alkoholforbrug) eller alkoholisme eller til ammende kvinder.
English: Vildagliptin can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Danish: Vildagliptin kan anvendes med metformin til type 2-diabetespatienter, som ikke er tilfredsstillende reguleret med metformin alene.
English: • in patients whose disease is insufficiently controlled with the maximum tolerated dose of metformin taken alone;
Danish: • til patienter, hvis sygdom ikke er under tilstrækkelig kontrol med den maksimalt tolererede dosis af metformin alene,
English: The studies compared Galvus with placebo and measured the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Danish: I undersøgelserne blev der foretaget en sammenligning af Galvus med placebo og en måling af niveauerne i blodet af et stof kaldet glykosyleret hæmoglobin (HbA1c), som viser, hvor godt blodglukosen er reguleret.
English: The studies with Galvus as an add-on to metformin, metformin and a sulphonylurea, or metformin and insulin have been used to support the use of Eucreas in the same indications.
Danish: Undersøgelserne af Galvus som tillægsbehandling til metformin, metformin og et sulfonylurinstof eller metformin og insulin blev anvendt til at underbygge brugen af Eucreas til samme indikationer.
English: What is the risk associated with Eucreas?
Danish: Hvilken risiko er der forbundet med Eucreas?