FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall implement a controlled access program to ensure that HES solutions for infusion are only delivered to accredited hospitals / centres where healthcare professionals expected to prescribe / administer these medicinal products have been trained on their appropriate use.
Danish: Indehaveren af markedsføringstilladelse skal gennemføre et program til kontrolleret adgang for at sikre, at HES-infusionsvæske, opløsning, kun leveres til akkrediterede hospitaler/centre, hvor det sundhedspersonale, der forventes at ordinere/administrere disse lægemidler, er oplært i at anvende dem korrekt.
English: - managing the accreditation system - ensuring HES solutions for infusion are only delivered to accredited hospital/centres, i.e where all relevant HCPs have been trained.
Danish: Oplæringen bør gentages regelmæssigt - at forvalte akkrediteringssystemet - at sikre, at HES-infusionsvæske, opløsning, kun leveres til hospitaler/centre, der er akkrediteret, dvs. hvor alle relevante sundhedspersoner har fået oplæring.
English: Each MAH of HES solutions for infusion shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures implemented as an outcome of this referral procedure.
Danish: Hver indehaver af markedsføringstilladelse for HES-infusionsvæske, opløsning, skal foretage et studie af lægemiddelanvendelse til vurdering af effektiviteten af de risikominimeringsforanstaltninger,
English: The MAH should submit and agree with the National Competent Authorities: - the details of the controlled access program and the modalities of its implementation - the final training materials, including communication media and distribution modalities.
Danish: • resultaterne af studierne af lægemiddelanvendelse Indehaveren af markedsføringstilladelse indsender og aftaler med de nationale kompetente myndigheder: - de nærmere enkeltheder i programmet for kontrolleret adgang, og hvordan dette gennemføres - det endelige oplysningsmateriale, herunder kommunikationsmedier og nærmere enkeltheder om distributionen Disse foranstaltninger indsendes med en risikostyringsplan: Programmet for kontrolleret adgang skal være faktisk implementeret senest:
English: As a consequence, the MAH shall be responsible of: - delivering the training to all relevant HCPs prescribing / administering HES solutions for infusion through agreed training material.
Danish: Indehaveren af markedsføringstilladelsen er som følge heraf ansvarlig for: - ved hjælp af godkendt oplysningsmateriale at oplære alle relevante sundhedspersoner, der ordinerer/administrerer HES-infusionsvæske, opløsning.
English: The benefit of treatment should be re-assessed at regular intervals.
Danish: Fordelen ved behandlingen bør tages op til revurdering med regelmæssige mellemrum.
English: It is available as blue (20 mg) and orange (40 mg) capsules.
Danish: Det fås som blå (20 mg) og orange (40 mg) kapsler.
English: Other information about Yentreve:
Danish: Andre oplysninger om Yentreve:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Yentreve to Eli Lilly Nederland B.V. on 11 August 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Yentreve til Eli Lilly Nederland B.V.
English: The recommended dose of Yentreve is 40 mg twice a day.
Danish: Den anbefalede dosis af Yentreve er 40 mg to gange dagligt.
English: The Committee recommended that Yentreve be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Yentreve.
English: Yentreve is a medicine containing the active substance duloxetine.
Danish: Yentreve er et lægemiddel, som indeholder det aktive stof duloxetin.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) YENTREVE EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) YENTREVE EPAR - sammendrag for offentligheden
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Danish: Neurotransmittere er kemiske stoffer, som nervecellerne anvender til deres indbyrdes kommunikation.
English: The full EPAR for Yentreve is available here.
Danish: Den fuldstændige EPAR om Yentreve findes her.
English: Yentreve has been studied in a total of 2,850 women with SUI.
Danish: Yentreve blev undersøgt hos i alt 2 850 kvinder med stressinkontinens.
English: Treatment with Yentreve should not be started in patients with uncontrolled high blood pressure, because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Danish: Behandling med Yentreve bør ikke påbegyndes hos patienter med ukontrolleret hypertension på grund af risikoen for hypertensive kriser (pludseligt, ekstremt højt blodtryk).
English: Some patients may benefit from starting treatment at a dose of 20 mg twice a day for two weeks before increasing to 40 mg twice a day, to reduce nausea (feeling sick) and dizziness.
Danish: For nogle patienter kan det være en fordel at begynde behandlingen med 20 mg to gange dagligt i to uger, før den sættes op til 40 mg to gange dagligt, da de derved får mindre kvalme og svimmelhed.
English: The most common side effects with Yentreve (seen in more than 1 patient in 10) are nausea, dry mouth, constipation and fatigue (tiredness).
Danish: De hyppigste bivirkninger ved Yentreve (som ses hos flere end 1 ud af 10 patienter) er kvalme, mundtørhed, forstoppelse og træthed.
English: What is the risk associated with Yentreve?
Danish: Hvilken risiko er der forbundet med Yentreve?
English: By closing the urethra more powerfully, Yentreve prevents the unwanted loss of urine during physical stress such as coughing or laughing.
Danish: Ved at styrke lukningen af urinrøret forhindrer Yentreve uønsket tab af urin under fysisk belastning såsom hoste eller latter.
English: It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Danish: Det virker ved at forhindre, at neurotransmitterne 5-hydroxytryptamin (også kaldet serotonin) og noradrenalin genoptages i nervecellerne i hjernen og rygmarven.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Yentreve's benefits are greater than its risks for the treatment of moderate to severe SUI.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Yentreve opvejede risiciene ved behandling af moderat til svær stressinkontinens.
English: The four main studies involved 1,913 women and lasted 12 weeks, comparing Yentreve (mostly as 40 mg twice daily) with placebo (a dummy treatment).
Danish: I de fire hovedundersøgelser, som omfattede 1 913 kvinder og varede i 12 uger, blev Yentreve (hovedsagelig i en dosis på 40 mg to gange dagligt) sammenlignet med placebo (en uvirksom behandling).
English: The IEF decreased by 52% in the Yentreve group, compared with a decrease of 33% in the placebo-treated group.
Danish: Hyppigheden af inkontinensepisoderne faldt med 52 % i Yentreve -gruppen, sammenholdt med et fald på 33 % i placebogruppen.
English: Yentreve should not be used with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Danish: Yentreve må ikke anvendes sammen med monoaminoxidasehæmmere (en gruppe lægemidler mod depression), fluvoxamin (et andet lægemiddel mod depression) eller ciprofloxacin eller enoxacin (antibiotika).
English: Why has Yentreve been approved?
Danish: Hvorfor blev Yentreve godkendt?
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Danish: Ved at blokere for genoptagelsen af neurotransmitterne øger duloxetin mængden af neurotransmittere i mellemrummene mellem disse nerveceller og forbedrer dermed kommunikationen mellem dem.
English: The I-QOL questionnaire scores were also improved in the Yentreve group compared with the placebo group.
Danish: Også den opnåede score i I-QOL-spørgeskemaerne var bedre i Yentreve-gruppen end i placebogruppen.
English: The main measures of effectiveness were incontinence episode frequency (IEF, the number of episodes of incontinence per week) recorded in patient diaries and the patients' scores on an incontinence-specific quality-of-life questionnaire (I-QOL).
Danish: Hovedmålene for lægemidlets virkning var dels hyppigheden af inkontinensepisoder (IEF dvs. det ugentlige antal inkontinensepisoder) angivet i dagskemaer, dels den opnåede scoreværdi i et spørgeskema om inkontinensrelateret livskvalitet (I-QOL).
English: What is Yentreve?
Danish: Hvad er Yentreve?
English: The active substance in Yentreve, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor (SNRI).
Danish: Det aktive stof i Yentreve er duloxetin, der hæmmer genoptagelsen af serotonin-noradrenalin (SNRI).
English: Yentreve should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Danish: Yentreve bør ikke anvendes hos patienter, som kan være overfølsomme (allergiske) over for duloxetin eller andre af indholdsstofferne.
English: For the full list of all side effects reported with Yentreve, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Yentreve fremgår af indlægssedlen.
English: In all four studies, the patients treated with Yentreve had fewer episodes of incontinence after 12 weeks, with about four or five fewer episodes of incontinence per week, in comparison with the number before the study.
Danish: I alle fire undersøgelser havde patienterne efter 12 ugers behandling med Yentreve ca. 4-5 færre ugentlige inkontinensepisoder end før undersøgelsen.
English: Yentreve was more effective than placebo only in patients who had more than 14 incontinence episodes per week (moderate to severe SUI) at the start of the study.
Danish: Yentreve virkede kun bedre end placebo hos de patienter, der inden undersøgelsen havde haft flere end 14 inkontinensepisoder om ugen (moderat til svær stressinkontinens).
English: What is Yentreve used for?
Danish: Hvad anvendes Yentreve til?
English: Yentreve should not be used in patients with certain types of liver disease or with severe kidney disease.
Danish: Yentreve bør ikke anvendes hos patienter, som lider af visse leversygdomme eller en svær nyresygdom.
English: SUI is accidental leaks of urine during physical exertion or when coughing, laughing, sneezing, lifting or exercising.
Danish: Stressinkontinens er utilsigtet tab af urin ved fysisk belastning eller i forbindelse med hoste, latter, nysen, løftning eller gymnastik.
English: How duloxetine works in SUI is not clear but it is thought that, by increasing the levels of 5-hydroxytryptamine and noradrenaline at the level of the nerves that control the muscle of the urethra (the tube that leads from the bladder to outside), duloxetine causes a stronger closure of the urethra during urine storage.
Danish: Det vides ikke med sikkerhed, hvordan denne mekanisme virker på stressinkontinens, men duloxetin menes at øge koncentrationen af 5-hydroxytryptamin og noradrenalin omkring de nerver, der kontrollerer urinrørets muskel, og derved forstærkes urinrørets lukning under opbevaring af urinen.
English: How has Yentreve been studied?
Danish: Hvordan blev Yentreve undersøgt?
English: What benefit has Yentreve shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Yentreve?
English: Yentreve is used to treat moderate to severe stress urinary incontinence (SUI) in women.
Danish: Yentreve anvendes til behandling af kvinder med moderat til svær stressinkontinens.
English: How is Yentreve used?
Danish: Hvordan anvendes Yentreve?
English: How does Yentreve work?
Danish: Hvordan virker Yentreve?
English: Combining Yentreve with pelvic floor muscle training may provide additional benefit.
Danish: Ekstra fordel af behandlingen med Yentreve kan fås ved at kombinere den med bækkenbundstræning.
English: This 4 week period is called a ‘cycle.'
Danish: Denne 4 ugers periode kaldes en ”cyklus”.
English: You start a new cycle every 4 weeks.
Danish: Du starter en ny cyklus hver 4. uge.
English: This is because it may not work or be safe.
Danish: Det skyldes, at det måske ikke virker eller ikke er sikkert.
English: • Your doctor will tell you how many tablets to take each time.
Danish: • Din læge vil fortælle dig, hvor mange tabletter du skal tage hver gang.
English: International normalised ratio increased
Danish: Forhøjet international normaliseret ratio
English: • It is used when other treatments have not worked - or when other treatments are not suitable for you.
Danish: • Det anvendes, når andre behandlinger ikke har virket - eller når andre behandlinger ikke er egnede til dig.
English: Do not take Lonsurf if the above applies to you.
Danish: Tag ikke Lonsurf, hvis ovenstående gælder for dig.
English: • Week 3 - No medicine
Danish: • Uge 3 - Ingen medicin
English: Therefore, caution is required when using medicinal products that interact with these transporters.
Danish: Derfor er forsigtighed påkrævet, når der anvendes lægemidler, der interagerer med disse transportører.
English: Dosing adjustments may be required based on individual safety and tolerability.
Danish: Dosisjustering kan være nødvendig, baseret på individuel sikkerhed og tolerabilitet.
English: • feeling of being cold
Danish: • følelse af at være kold
English: • Your doctor will decide the right dose for you - the dose depends on your weight and height.
Danish: • Din læge vil beregne den rigtige dosis til dig - dosis afhænger af din vægt og højde.
English: b. Fatal cases have been reported.
Danish: b. Der er rapporteret tilfælde med dødelig udgang.
English: You should also do this for 6 months after you stop taking the medicine.
Danish: Du skal også gøre det i 6 måneder, efter du er stoppet med at tage medicinen.
English: This medicine is not indicated for use in children and adolescents below the age of 18 years.
Danish: Dette lægemiddel er ikke beregnet til brug hos børn og unge under 18 år.
English: ANNEX IV CONCLUSIONS ON THE REQUEST FOR ONE-YEAR MARKETING PROTECTION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Danish: BILAG IV KONKLUSIONER VEDRØRENDE ANMODNING OM MARKEDSFØRINGSBESKYTTELSE I ET ÅR FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR
English: • It is used when the cancer has spread to other parts of the body.
Danish: • Det anvendes, når kræften har spredt sig til andre steder i kroppen.
English: • changes in the menstrual cycle
Danish: • ændringer i menstruationscyklus
English: All AUC groups performed better than placebo throughout the follow-up period.
Danish: Alle AUC-grupper klarede sig bedre end placebo i hele opfølgningsperioden.
English: • Take this medicine by mouth.
Danish: • Tag denne medicin gennem munden.
English: Lonsurf is for oral use.
Danish: Lonsurf er til oral anvendelse.
English: Therefore, Lonsurf should be treated as a potential carcinogen.
Danish: Derfor bør Lonsurf håndteres som potentielt karcinogent.
English: If you become pregnant, you and your doctor will have to decide if the benefits of Lonsurf are greater than the risk of harm to the baby.
Danish: Hvis du bliver gravid, vil du og din læge blive nødt til at beslutte, om fordelene ved Lonsurf er større end risikoen for skade på barnet.
English: • one-year marketing protection
Danish: • Markedsføringsbeskyttelse i et år
English: • problem with sleeping or falling asleep
Danish: • problemer med at sove eller falde i søvn
English: This is because it may harm your unborn baby.
Danish: Dette skyldes, at det kan skade dit ufødte barn.
English: Do not take Lonsurf :
Danish: Tag ikke Lonsurf:
English: Treatment may lead to the following side effects (see section 4):
Danish: Behandlingen kan medføre følgende bivirkninger (se punkt 4):
English: In vitro interaction studies
Danish: In vitro interaktionsstudier
English: Your doctor will do blood tests before each cycle of Lonsurf.
Danish: Din læge vil tage blodprøver før hver cyklus med Lonsurf.
English: Read all of this leaflet carefully before you start taking this medicine - because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: Some of these serious side effects may lead to death.
Danish: Nogle af disse alvorlige bivirkninger kan være dødelige.
English: • Trifluridine stops the growth of cancer cells.
Danish: • Trifluridin standser væksten af kræftcellerne.
English: General physical health deterioration
Danish: Generel forværring af fysisk sundhedstilstand
English: • Swallow the tablets whole with a glass of water.
Danish: • Synk tabletterne hele og drik samtidig et glas vand.
English: Lonsurf may harm your unborn baby.
Danish: Lonsurf kan skade dit ufødte barn.
English: Take your pack(s) of medicine with you.
Danish: Tag din pakning/dine pakninger med medicin med.
English: Tumor assessments, according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, were performed by the investigator/local radiologist every 8 weeks.
Danish: Tumorvurderingen, i henhold til Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, blev udført af investigator/lokal radiolog hver 8. uge.
English: 6.6 Special precautions for disposal and other handling Hands should be washed after handling the tablets.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Hænderne skal vaskes efter håndtering af tabletterne.
English: You and your partner should use effective methods of contraception while taking this medicine.
Danish: Du og din partner skal anvende effektive præventionsmetoder, mens du tager denne medicin.
English: • Wash your hands after handling this medicine.
Danish: • Vask hænder, efter du har taget medicinen.
English: Lonsurf should not be used during pregnancy unless the clinical condition of the woman requires treatment with Lonsurf.
Danish: Lonsurf bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver behandling med Lonsurf.
English: • Week 4 - No medicine You will then start again with another cycle of 4 weeks following the above pattern.
Danish: • Uge 4 - Ingen medicin Derefter skal du starte forfra med en ny cyklus på 4 uger efter ovenstående mønster.
English: Your doctor will be looking out for these side effects in your test results.
Danish: Din læge vil se efter disse bivirkninger i dine prøveresultater.
English: The tests are needed because Lonsurf can sometimes affect your blood cells.
Danish: Disse prøver er nødvendige, fordi Lonsurf sommetider kan påvirke dine blodlegemer.
English: Lonsurf comes in two strengths.
Danish: Lonsurf fås i to styrker.
English: There is limited data on Lonsurf in Black/African American patients but there is no biological rationale to expect any difference between this subgroup and the overall population.
Danish: Der er begrænsede data fra anvendelse af Lonsurf til sorte/afroamerikanske patienter, men der er ikke biologisk rationale for at forvente nogen forskel mellem denne undergruppe og den samlede population.
English: The dosage must not exceed 80 mg/dose.
Danish: Dosis må ikke overstige 80 mg.
English: If doses were missed or held, the patient must not make up for missed doses.
Danish: Hvis en dosis glemmes eller undlades, må patienten ikke tage den glemte dosis.
English: • low or high blood pressure
Danish: • lavt eller højt blodtryk
English: Therefore, women using hormonal contraceptive must also use a barrier contraceptive method.
Danish: Derfor skal kvinder, der anvender et hormonelt præventionsmiddel, også anvende en barriere-præventionsmetode.
English: Tell your doctor if you notice any of the following side effects.
Danish: Fortæl din læge, hvis du bemærker nogle af nedenstående bivirkninger.
English: Tell your doctor immediately if you notice any of the following serious side effects (many of the side effects are shown in laboratory tests - for example those affecting your blood cells):
Danish: Kontakt straks din læge, hvis du bemærker nogen af følgende alvorlige bivirkninger (mange af bivirkningerne ses i laboratorieanalyser - for eksempel dem, der påvirker dine blodlegemer):
English: • if you are allergic to trifluridine or tipiracil or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for trifluridin eller tipiracil eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet punkt 6).
English: There are no available data from the use of Lonsurf in pregnant women.
Danish: Der er ikke tilgængelige data fra anvendelse af Lonsurf til gravide kvinder.
English: The adverse drug reactions reported in association with overdoses were consistent with the established safety profile.
Danish: Bivirkningerne rapporteret i forbindelse med overdoser var i overensstemmelse med den etablerede sikkerhedsprofil.
English: • Anaemia (very common).
Danish: • Anæmi (meget almindelig).
English: This is because zidovudine may not work as well if you are taking Lonsurf.
Danish: Dette skyldes, at zidovudin måske ikke virker så godt, hvis du tager Lonsurf.
English: Patients with severe renal impairment were not enrolled in the study.
Danish: Patienter med svært nedsat nyrefunktion blev ikke inkluderet i studiet.
English: No. at Risk: Lonsurf
Danish: Antal i risiko: Lonsurf
English: System Organ Class (MedDRA)a
Danish: Systemorganklasse (MedDRA)
English: • changes in urine test, blood in urine
Danish: • ændringer i urinprøver, blod i urinen
English: Haematocrit decreased a. Different MedDRA preferred terms that were considered clinically similar have been grouped into a single term.
Danish: Nedsat hæmatokrit a. Forskellige foretrukne MedDRA-termer, som blev betragtet som værende klinisk ens, er grupperet i en enkelt term.
English: Many of the side effects are shown in laboratory tests - for example those affecting your blood cells.
Danish: Mange af bivirkningerne ses i laboratorieanalyser - for eksempel dem, der påvirker dine blodlegemer.
English: Efficacy and safety data in patients over 75 years old is limited.
Danish: Der er begrænsede effekt- og sikkerhedsdata fra patienter over 75 år.
English: Talk to your doctor about whether to switch to a different HIV medicine.
Danish: Tal med din læge, om du skal skifte til anden HIV-medicin.
English: They are classified according to System Organ Class (SOC) and the appropriate Medical Dictionary for Regulatory (MedDRA) term is used to describe a certain drug reaction and its synonyms and related conditions.
Danish: De er klassificeret i henhold til systemorganklasse (SOC) og den relaterede MedDRA- (Medical Dictionary for Regulatory) term, som anvendes til at beskrive en bestemt lægemiddelbivirkning og dens synonymer og relaterede tilstande.
English: Your doctor may prescribe both strengths for your prescribed dose.
Danish: Din læge kan ordinere begge styrker til din dosis.
English: 92284 Suresnes Cedex France
Danish: 92284 Suresnes Cedex
English: Frequency groups are defined by the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); and uncommon (≥1/1,000 to < 1/100).
Danish: Frekvensgrupperne er defineret ud fra følgende: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥1/1,000 til < 1/100).
English: • Tipiracil stops the trifluridine from being broken down by the body, helping trifluridine to work longer.
Danish: • Tipiracil hindrer, at trifluridin bliver nedbrudt i kroppen og hjælper derved trifluridin til at virke længere.
English: Lonsurf on overall survival was similar in patients <65 years and ≥65 years of age.
Danish: Effekten af Lonsurf på samlet overlevelse var ens hos patienter i alderen <65 år og ≥65 år.
English: • pain, including pain from the cancer
Danish: • smerter, herunder cancersmerter
English: See the end of Section 4 for how to report side effects.
Danish: Se sidst i punkt 4, hvordan du indberetter bivirkninger.
English: Effect of food
Danish: Effekt af føde
English: There is no known antidote for an overdose of Lonsurf.
Danish: Der er ingen kendt antidot mod overdosering af Lonsurf.