FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Bovilis Blue-8, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Bovilis Blue-8, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Bovilis Blue-8, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Bovilis Blue-8, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Other information about Bovilis Blue-8:
Danish: Andre oplysninger om Bovilis Blue-8
English: How is Bovilis Blue-8 used?
Danish: Hvordan anvendes Bovilis Blue-8?
English: How does Bovilis Blue-8 work?
Danish: Hvordan virker Bovilis Blue-8?
English: What benefits of Bovilis Blue-8 have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Bovilis Blue-8?
English: The recommended dose is one tablet taken once a day.
Danish: Den anbefalede dosis er en tablet én gang dagligt.
English: The tablets must always be taken after the patient has fasted overnight for at least six hours and at least 30 minutes before the first food or drink of the day.
Danish: Tabletterne skal altid tages om morgenen, efter at patienten har fastet i mindst seks timer om natten, og mindst 30 minutter inden dagens første indtagelse af mad eller drikke.
English: Medicines are bioequivalent when they produce the same levels of the active substance in the body.
Danish: To lægemidler er bioækvivalente, når de danner den samme mængde af det aktive stof i kroppen.
English: The full EPAR for Ibandronic Acid Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Ibandronsyre Sandoz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Ibandronic Acid Sandoz EMA/140299/2015
Danish: Ibandronsyre Sandoz EMA/140299/2015
English: Ibandronic Acid Sandoz must be taken with a full glass of plain water (but not mineral water) while standing or sitting up, and the tablets should not be chewed, sucked or crushed.
Danish: Ibandronsyre Sandoz skal indtages sammen med et helt glas almindeligt vand (ikke mineralvand), mens patienten står eller sidder op, og tabletterne må ikke tygges, suttes eller knuses.
English: Ibandronic Acid Sandoz is used to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).
Danish: Ibandronsyre Sandoz anvendes til forebyggelse af "knoglerelaterede hændelser" (frakturer (knoglebrud) eller knoglekomplikationer, der kræver behandling) hos patienter med brystkræft og knoglemetastaser (kræft, der har spredt sig til knoglerne).
English: The European Commission granted a marketing authorisation valid throughout the EU for Ibandronic Acid Sandoz on 26 July 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ibandronsyre Sandoz den 26. juli 2011.
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 Ibandronic Acid Sandoz.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Ibandronsyre Sandoz skal anvendes.
English: For more information about treatment with Ibandronic Acid Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ibandronsyre Sandoz, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This document is a summary of the European public assessment report (EPAR) for Ibandronic Acid Sandoz.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ibandronsyre Sandoz.
English: It stops the action of osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Danish: Det virker hæmmende på osteoklasterne, der er de celler i kroppen, som medvirker ved nedbrydningen af knoglevæv.
English: The CHMP concluded that, in accordance with EU requirements, Ibandronic Acid Sandoz has been shown to have comparable quality and to be bioequivalent to Bondronat.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Ibandronsyre Sandoz er af sammenlignelig kvalitet og er bioækvivalent med Bondronat.
English: A risk management plan has been developed to ensure that Ibandronic Acid Sandoz is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Ibandronsyre Sandoz anvendes så sikkert som muligt.
English: The patient must also not lie down for one hour after taking the tablets.
Danish: Efter at patienten har taget tabletten, må han/hun ikke ligge ned i en time.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ibandronic Acid Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Ibandronsyre Sandoz, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: This means that Ibandronic Acid Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU).
Danish: Det betyder, at Ibandronsyre Sandoz er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Bondronat.
English: The active substance in Ibandronic Acid Sandoz, ibandronic acid, is a bisphosphonate.
Danish: Det aktive stof i Ibandronsyre Sandoz, ibandronsyre, er et bisphosphonat.
English: Because Ibandronic Acid Sandoz is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine.
Danish: Da Ibandronsyre Sandoz er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet.
English: Because Ibandronic Acid Sandoz is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Ibandronsyre Sandoz er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Ibandronic Acid Sandoz is a medicine that contains the active substance ibandronic acid.
Danish: Ibandronsyre Sandoz er et lægemiddel, der indeholder det aktive stof ibandronsyre.
English: What measures are being taken to ensure the safe and effective use of Ibandronic Acid Sandoz?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ibandronsyre Sandoz?
English: Ibandronic Acid Sandoz is a ‘generic medicine'.
Danish: Ibandronsyre Sandoz er et "generisk lægemiddel".
English: The Committee recommended that Ibandronic Acid Sandoz be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Ibandronsyre Sandoz.
English: What are the benefits and risks of Ibandronic Acid Sandoz?
Danish: Hvilken fordel og risiko er der forbundet med Ibandronsyre Sandoz?
English: Ibandronic Acid Sandoz ibandronic acid
Danish: Ibandronsyre Sandoz ibandronsyre
English: Other information about Ibandronic Acid Sandoz:
Danish: Andre oplysninger om Ibandronsyre Sandoz
English: Why has Ibandronic Acid Sandoz been approved?
Danish: Hvorfor blev Ibandronsyre Sandoz godkendt?
English: How has Ibandronic Acid Sandoz been studied?
Danish: Hvordan blev Ibandronsyre Sandoz undersøgt?
English: What is Ibandronic Acid Sandoz?
Danish: Hvad er Ibandronsyre Sandoz?
English: What is Ibandronic Acid Sandoz used for?
Danish: Hvad anvendes Ibandronsyre Sandoz til?
English: How is Ibandronic Acid Sandoz used?
Danish: Hvordan anvendes Ibandronsyre Sandoz?
English: How does Ibandronic Acid Sandoz work?
Danish: Hvordan virker Ibandronsyre Sandoz?
English: What is Nenad?
Danish: Hvad er Nenad?
English: Idiopathic means that the disease has no obvious cause.
Danish: Idiopatisk betyder, at sygdommen ikke har nogen klar årsag.
English: The 210 patients who completed the first 12 weeks were also offered the opportunity to continue treatment in an extension study.
Danish: De 210 patienter, der gennemførte de første 12 uger, fik ligeledes mulighed for at fortsætte behandlingen i en forlænget undersøgelse.
English: The effects of Nenad were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Nenad blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The company had also provided results on studies involving patients with Parkinson's disease.
Danish: Virksomheden havde også fremlagt resultater om undersøgelser, der omfattede patienter med Parkinsons sygdom.
English: What was Nenad expected to be used for?
Danish: Hvad forventedes Nenad anvendt til?
English: The active substance in Nenad, lisuride, is a dopamine agonist.
Danish: Det aktive stof i Nenad, lisurid, er en dopaminagonist.
English: Restless legs syndrome is a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Danish: Restless legs-syndrom er en sygdom, hvor patienten har en ukontrollabel trang til at bevæge benene for at stoppe ubehagelige, smertefulde eller mærkelige fornemmelser i kroppen, som regel om natten.
English: Since restless legs syndrome is often a lifelong disease, long-term data were considered essential.
Danish: Eftersom restless legssyndrom ofte er en livsvarig sygdom, blev langtidsdata anset for at være nødvendige.
English: However, the syndrome is thought to be caused by problems in the way dopamine works in the brain, which was expected to be corrected by lisuride.
Danish: Syndromet antages dog at være forårsaget af problemer med den måde, som dopamin virker på i hjernen, hvilket forventedes at kunne korrigeres med lisurid.
English: On 30 November 2009, Axxonis Pharma AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Nenad, for the treatment of the signs and symptoms of moderate-to-severe idiopathic restless legs syndrome in adults.
Danish: Den 30. november 2009 meddelte Axxonis Pharma AG officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Nenad til behandling af tegn og symptomer på moderat til svært idiopatisk restless legssyndrom hos voksne.
English: There were also problems with the patches not sticking well enough to the skin.
Danish: Der var også problemer med, at plastrene ikke sad godt nok fast på huden.
English: How was Nenad expected to work?
Danish: Hvordan forventedes Nenad at virke?
English: The company presented results of one main study of 309 patients with moderate-to-severe restless legs syndrome.
Danish: Virksomheden fremlagde resultaterne af en hovedundersøgelse, der omfattede 309 patienter med moderat til svært idiopatisk restless legs-syndrom.
English: Nenad is a transdermal patch (patch that delivers a medicine across the skin) that contains the active substance lisuride.
Danish: Nenad er et depotplaster (et plaster, der afgiver et lægemiddel gennem huden), som indeholder det aktive stof lisurid.
English: However, during the CHMP evaluation, the company withdrew its application for Nenad to be used for this disease.
Danish: Under CHMP's vurdering trak virksomheden dog sin ansøgning tilbage for Nenad til denne sygdom.
English: The CHMP noted that, while the short-term effectiveness of Nenad for the treatment of restless legs syndrome had been shown, there was not enough evidence to demonstrate its long-term effectiveness.
Danish: CHMP bemærkede, at selv om korttidsvirkningen af Nenad til behandling af restless legs-syndrom er påvist, var der ikke tilstrækkelig dokumentation for dets langtidsvirkning.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Nenad in the treatment of restless legs syndrome did not outweigh its risks.
Danish: På daværende tidspunkt var CHMP derfor af den opfattelse, at fordelene ved Nenad til behandling af restless legs-syndrom ikke opvejer risiciene.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation for Nenad be refused.
Danish: På tidspunktet for tilbagetrækningen af ansøgningen havde CHMP på baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål afgivet en negativ udtalelse og anbefalede ikke udstedelse af markedsføringstilladelse for Nenad.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Nenad?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Nenad eller i programmer for anvendelse af Nenad med særlig udleveringstilladelse?
English: This means that it imitates the action of dopamine, a messenger substance in the parts of the brain that control movement and co ordination.
Danish: Det betyder, at stoffet efterligner virkningen af dopamin, som er et signalstof i de dele af hjernen, der styrer bevægelser og koordination.
English: Nenad was expected to be used in adults with moderate-to-severe idiopathic restless legs syndrome.
Danish: Nenad forventedes anvendt til voksne med moderat til svært idiopatisk restless legs-syndrom.
English: The Committee was also concerned that a large proportion of patients in the study stopped treatment with Nenad because of skin irritation, making the patch unsuitable for long-term use.
Danish: CHMP havde ligeledes betænkeligheder med hensyn til, at en stor andel af patienterne i undersøgelsen stoppede behandlingen med Nenad på grund af hudirritation, hvilket gjorde plastret uegnet til langtidsbrug.
English: patients' symptoms after 12 weeks using the International Restless Legs Syndrome rating scale (IRLS) score.
Danish: Det primære effektmål var forandringen i vurderingen af patientens symptomer efter 12 uger ved hjælp af IRLSscoren (International Restless Legs Syndrome Rating Scale).
English: The company informed the CHMP that there are no consequences for patients using Nenad in clinical trials or compassionate use programmes.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som for øjeblikket deltager i kliniske undersøgelser med Nenad eller i programmer for anvendelse af Nenad med særlig udleveringstilladelse.
English: The patients were given Nenad, ropinirole (another medicine for restless legs syndrome) or placebo (a dummy medicine).
Danish: lægemiddel mod restless legs-syndrom) eller placebo (en virkningsløs behandling).
English: EMA/830685/2009
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Nenad (lisurid) EMA/68455/2010
English: The way lisuride was expected to work in restless legs syndrome is not fully understood.
Danish: Det vides ikke med nøjagtighed, hvordan lisurid forventedes at virke mod restless legs-syndrom.
English: However, the magnitude of change is not clinically significant, so that Xiliarx can be given with or without food.
Danish: Men ændringens størrelse er ikke klinisk signifikant, så Xiliarx kan gives med eller uden mad.
English: Your doctor will tell you exactly how many tablets of Xiliarx to take.
Danish: Din læge vil fortælle dig helt nøjagtigt, hvor mange Xiliarx-tabletter du skal tage.
English: The elimination halflife after oral administration is approximately 3 hours.
Danish: Eliminationshalveringstiden efter oral administration er ca. 3 timer.
English: How to take Xiliarx • Swallow the tablets whole with some water.
Danish: Hvordan du skal tage Xiliarx • Synk tabletterne hele med lidt vand.
English: Some symptoms need immediate medical attention: You should stop taking Xiliarx and see your doctor immediately if you experience the following side effects:
Danish: Nogle symptomer kræver øjeblikkelig lægelig opmærksomhed: Du bør stoppe med at tage Xiliarx og straks kontakte din læge, hvis du oplever nogle af følgende bivirkninger:
English: The active substance of Xiliarx, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.
Danish: Det aktive stof i Xiliarx, vildagliptin, tilhører en gruppe af lægemidler, der hedder ”orale antidiabetika”.
English: • if you have moderate or severe kidney disease (you will need to take a lower dose of Xiliarx).
Danish: • hvis du har en moderat eller alvorlig nyresygdom (det er nødvendigt, at du tager en lavere dosis af Xiliarx).
English: Xiliarx is not a substitute for insulin in insulin-requiring patients.
Danish: Xiliarx kan ikke erstatte insulin hos insulinkrævende patienter.
English: • Take Xiliarx every day for as long as your doctor tells you.
Danish: • Tag Xiliarx hver dag, så længe din læge siger, at du skal gøre det.
English: EU/1/08/486/001 7 tablets EU/1/08/486/002 14 tablets EU/1/08/486/003 28 tablets EU/1/08/486/004 30 tablets EU/1/08/486/005 56 tablets EU/1/08/486/006 60 tablets EU/1/08/486/007 90 tablets EU/1/08/486/008 112 tablets EU/1/08/486/009 180 tablets EU/1/08/486/010 336 tablets
Danish: EU/1/08/486/001 7 tabletter EU/1/08/486/002 14 tabletter EU/1/08/486/003 28 tabletter EU/1/08/486/004 30 tabletter EU/1/08/486/005 56 tabletter EU/1/08/486/006 60 tabletter EU/1/08/486/007 90 tabletter EU/1/08/486/008 112 tabletter EU/1/08/486/009 180 tabletter EU/1/08/486/010 336 tabletter
English: Do not stop taking Xiliarx unless your doctor tells you to.
Danish: Hold ikke op med at tage Xiliarx, medmindre lægen siger det.
English: If you take too many Xiliarx tablets, or if someone else has taken your medicine, talk to your doctor straight away.
Danish: Hvis du tager for mange Xiliarx tabletter, eller hvis en anden har taget din medicin, skal du straks kontakte din læge.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: ENTYDIG IDENTIFIKATOR - 2D STREGKODE Der er anført 2D-stregkode, som indeholder en entydig identifikator.
English: Liver function tests should be performed prior to the initiation of treatment with Xiliarx in order to know the patient's baseline value.
Danish: Leverfunktionstest skal udføres før initiering af behandling med Xiliarx for at kende patientens baseline-værdi.
English: Your doctor may wish to alter your dose of Xiliarx if you are taking other medicines such as: - thiazides or other diuretics (also called water tablets) - corticosteroids(generally used to treat inflammation) - thyroid medicines - certain medicines affecting the nervous system.
Danish: Din læge vil muligvis ønske at ændre din Xiliarx-dosis, hvis du tager anden medicin såsom: - thiazider eller andre diuretika (også kaldet vanddrivende tabletter) - kortikosteroider (bruges normalt til at behandle betændelseslignende reaktioner) - medicin, der påvirker skjoldbruskkirtlen - visse typer medicin, der påvirker nervesystemet.
English: Talk to your doctor, pharmacist or nurse before taking Xiliarx
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Xiliarx
English: Your doctor will prescribe Xiliarx either alone or together with certain other antidiabetic medicines which you will already be taking, if these have not proved sufficiently effective to control diabetes.
Danish: Din læge kan ordinere Xiliarx enten alene eller sammen med visse andre typer medicin mod sukkersyge, som du allerede tager, hvis disse har vist sig ikke at være tilstrækkeligt effektive til at kontrollere sukkersygen.
English: Xiliarx should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Danish: Xiliarx bør ikke anvendes til patienter med type 1-diabetes eller til behandling af diabetisk ketoacidose.
English: Due to lack of human data, Xiliarx should not be used during pregnancy.
Danish: På grund af manglende data for mennesker bør Xiliarx ikke anvendes under graviditet.
English: Information on the likely symptoms of overdose was taken from a rising dose tolerability study in healthy subjects given Xiliarx for 10 days.
Danish: Oplysningerne om de sandsynlige symptomer på overdosering er taget fra et studie af tolerabilitet af stigende doser hos raske forsøgspersoner, som fik Xiliarx i 10 dage.
English: Oral use Xiliarx can be administered with or without a meal (see also section 5.2).
Danish: Oral anvendelse Xiliarx kan tages med eller uden mad (se også pkt.
English: • Do not use any Xiliarx pack that is damaged or shows signs of tampering.
Danish: • Brug ikke Xiliarx, hvis emballagen er beskadiget eller viser tegn på, at nogen har forsøgt at åbne den.
English: Liver function should be monitored during treatment with Xiliarx at three-month intervals during the first year and periodically thereafter.
Danish: Leverfunktionen skal monitoreres under behandling med Xiliarx med 3 måneders interval i det første år og derefter regelmæssigt.
English: It is not known if Xiliarx passes into breast milk.
Danish: Der er uvist om Xiliarx passerer ind i modermælken.
English: Do not take Xiliarx:
Danish: Tag ikke Xiliarx:
English: No studies on the effect on human fertility have been conducted for Xiliarx (see section 5.3).
Danish: Der er ikke udført studier vedrørende Xiliarxs virkning på human fertilitet (se pkt.
English: Xiliarx works by making the pancreas produce more insulin and less glucagon.
Danish: Xiliarx virker ved at få bugspytkirtlen til at producere mere insulin og mindre glucagon.
English: Driving and using machines If you feel dizzy while taking Xiliarx, do not drive or use machines.
Danish: Trafik- og arbejdssikkerhed Hvis du føler dig svimmel, når du tager Xiliarx, må du ikke køre bil eller betjene maskiner.
English: Following withdrawal of treatment with Xiliarx and LFT normalisation, treatment with Xiliarx should not be reinitiated.
Danish: Efter behandlingsophør med Xiliarx og normalisering af leverfunktion, bør behandling med Xiliarx ikke genoptages.
English: You are also advised to pay particular attention to new onset of blisters or ulcers while taking Xiliarx.
Danish: Du bør også være særlig opmærksom på nye vabler eller sår, som du får, mens du tager Xiliarx.
English: A clinical trial of vildagliptin in patients with New York Heart Association (NYHA) functional class I-III showed that treatment with vildagliptin was not associated with a change in left-ventricular function or worsening of pre-existing congestive heart failure (CHF) versus placebo.
Danish: Et klinisk studie med vildagliptin hos patienter med New York Heart Association (NYHA) funktionsklasse I-III-hjerteinsufficiens viste, at behandling med vildagliptin ikke var forbundet med en ændring i venstre ventrikels funktion eller forværring af allerede eksisterende kongestiv hjerteinsufficiens (CHF), sammenlignet med placebo.
English: Xiliarx is used to treat adult patients with type 2 diabetes.
Danish: Xiliarx bruges til at behandle voksne patienter med type 2-diabetes (sukkersyge).
English: The safety and efficacy of Xiliarx in children and adolescents (< 18 years) have not been established.
Danish: Xiliarx's sikkerhed og virkning hos børn og unge (< 18 år) er ikke klarlagt.