FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in ellaOne, ulipristal acetate, acts as a progesterone receptor modulator.
Danish: Det aktive stof i ellaOne, ulipristalacetat, virker som en progesteron-receptormodulator.
English: What is the risk associated with ellaOne?
Danish: Hvilken risiko er der forbundet med ellaOne?
English: This number was then compared with the number of women who would have been expected to become pregnant if they had not taken a contraceptive.
Danish: Dette blev derefter sammenlignet med antallet af kvinder, som kunne være blevet gravide, hvis de ikke havde taget et svangerskabsforebyggende middel.
English: Through its actions on the progesterone receptors, ellaOne prevents pregnancies mainly by preventing or delaying ovulation.
Danish: I kraft af dets virkninger på progesteron-receptorerne forebygger ellaOne graviditeter ved primært at forhindre eller udsætte ægløsningen.
English: The most common side effects with ellaOne are headache, nausea (feeling sick), abdominal pain (stomach ache) and dysmenorrhea (period pains).
Danish: De hyppigste bivirkninger ved ellaOne er hovedpine, kvalme, mavesmerter og menstruationssmerter (dysmenoré).
English: EllaOne was effective as an emergency contraceptive, reducing the number of unintended pregnancies.
Danish: EllaOne var effektivt som lægemiddel til akut svangerskabsforebyggelse, da det reducerede antallet af utilsigtede svangerskaber.
English: An additional study compared ellaOne with levonorgestrel (another medicine used in emergency contraception).
Danish: I en yderligere undersøgelse blev ellaOne sammenlignet med levonorgestrel (et andet lægemiddel til akut svangerskabsforebyggelse).
English: If a woman's menstrual period is late or in case of symptoms of pregnancy, pregnancy should be excluded before ellaOne is taken.
Danish: I tilfælde af forsinket menstruation eller svangerskabssymptomer, skal graviditet udelukkes inden indtagelsen af ellaOne.
English: The sex hormone progesterone plays a role in the timing of ovulation and in preparing the lining of womb to receive the fertilised egg.
Danish: Kønshormonet progesteron spiller en rolle i forbindelse med tidspunktet for ægløsningen og med at gøre livmodervæggen klar til at modtage det befrugtede æg.
English: In this study, ellaOne was as effective as levonorgestrel at preventing pregnancies.
Danish: I denne undersøgelse var ellaOne lige så effektivt som levonorgestrel til svangerskabsforebyggelse.
English: For pregnancy to occur there has to be ovulation (release of eggs) followed by the fertilisation of the egg (fusion with a sperm) and implantation in the womb.
Danish: For at der opstår en graviditet, skal der ske ægløsning, og ægget skal befrugtes (sammensmelte med en sædcelle) og implanteres i livmoderen.
English: Why has ellaOne been approved?
Danish: Hvorfor blev ellaOne godkendt?
English: What is ellaOne?
Danish: Hvad er ellaOne?
English: This study included women who took the medicine within two days of unprotected sex or contraceptive failure.
Danish: Denne undersøgelse omfattede kvinder, som tog lægemidlet inden for to dage efter ubeskyttet samleje eller efter svigt af en svangerskabsforebyggende metode.
English: The additional study, which included women who took the medicine within two days of unprotected sex or contraceptive failure, supported the effectiveness of ellaOne.
Danish: I den yderligere undersøgelse af kvinder, der tog lægemidlet inden for to dage efter ubeskyttet samleje eller efter svigt af svangerskabsforebyggende metode, blev ellaOnes virkning påvist.
English: EllaOne is taken as one tablet by mouth as soon as possible, but no later than 120 hours, after unprotected sex or contraceptive failure.
Danish: EllaOne tages oralt som én tablet hurtigst muligt og senest fem dage efter det ubeskyttede samleje eller efter svigt af den svangerskabsforebyggende metode.
English: What is ellaOne used for?
Danish: Hvad anvendes ellaOne til?
English: EllaOne is a female emergency contraceptive to be taken within 120 hours (five days) of unprotected sex or contraceptive failure (such as a tear in a condom during sex).
Danish: Det skal tages inden for 120 timer (fem dage) efter ubeskyttet samleje eller efter svigt af svangerskabsforebyggende metode (såsom et kondom, der går i stykker under samleje).
English: What benefit has ellaOne shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved ellaOne?
English: How has ellaOne been studied?
Danish: Hvordan blev ellaOne undersøgt?
English: How is ellaOne used?
Danish: Hvordan anvendes ellaOne?
English: How does ellaOne work?
Danish: Hvordan virker ellaOne?
English: • At the request of the European Medicines Agency;
Danish: • på anmodning fra det Europæiske Lægemiddelagentur.
English: (% of recommended starting dose)
Danish: (% af anbefalet startdosis)
English: This “treatment cycle” will be repeated every 4 weeks.
Danish: Denne ”behandlingscyklus” vil blive gentaget hver 4. uge.
English: You may feel tired and pale.
Danish: Du kan føle dig træt og bleg.
English: From a microbiological point of view, the reconstituted product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør det rekonstituerede produkt anvendes øjeblikkeligt.
English: The primary endpoint of the study was overall survival.
Danish: Studiets primære endepunkt var Overall Survival.
English: You are also more likely to get infections.
Danish: Du har også større risiko for at få infektioner.
English: They are also responsible for preparing and disposing of any unused Vidaza correctly.
Danish: De er også ansvarlige for at forberede og bortskaffe al ubrugt Vidaza på korrekt vis.
English: After reconstitution:
Danish: Efter rekonstitution:
English: Other side effects include:
Danish: Andre bivirkninger omfatter:
English: • Vidaza is given every day for one week, followed by a rest period of 3 weeks.
Danish: • Vidaza gives hver dag i en uge, efterfulgt af en hvileperiode på 3 uger.
English: Your doctor will check your progress and may change your dose if necessary.
Danish: Din læge vil kontrollere dine fremskridt og kan ændre dosen, hvis det er nødvendigt.
English: Your doctor will decide your dose of this medicine, depending on your general condition, height and weight.
Danish: Din læge vil bestemme din dosis af dette lægemiddel ud fra din almene tilstand, din højde og vægt.
English: Response was assessed by the investigator or by the Independent Review Committee (IRC).
Danish: Responsen blev vurderet af investigatoren eller af den uafhængige evalueringskomité (Independent Review Committee, IRC).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/488/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/488/001
English: Patients with secondary MDS were excluded from the study.
Danish: Patienter med sekundær MDS blev ekskluderet fra studiet.
English: Package leaflet: Information for the user
Danish: Indlægsseddel: Information til brugeren
English: Treatment should be continued as long as the patient continues to benefit or until disease progression.
Danish: Behandling bør fortsætte, så længe patienten drager fordel deraf, eller indtil sygdomsprogression.
English: • Loss of appetite.
Danish: • Tab af appetit.
English: Tell your doctor straight away if you become pregnant during treatment.
Danish: Fortæl det straks til din læge, hvis du bliver gravid under behandlingen.
English: There are also links to other websites about rare diseases and treatments.
Danish: Der er også links til andre websteder om sjældne sygdomme og om, hvordan de behandles.
English: Tell your doctor straight away if you notice any of the following side effects:
Danish: Fortæl det straks til lægen, hvis du bemærker en eller flere af følgende bivirkninger:
English: Time (months) from Randomization
Danish: Tid (måneder) fra randomisering
English: The advantages of treatment should be weighed against the possible risk for the foetus in every individual case.
Danish: Fordelene ved behandling bør opvejes i forhold til den mulige risiko for fostret i hvert enkelt tilfælde.
English: HRQoL data could be analysed for a subset of the full trial population.
Danish: HRQoL-data kunne analyseres for en undergruppe af hele studiepopulationen.
English: Myelosuppression may lead to neutropenia and an increased risk of infection.
Danish: Myelosuppression kan føre til neutropeni og øget infektionsrisiko.
English: Cardiopulmonary assessment before and during the treatment should be considered.
Danish: Kardiopulmonal vurdering før og under behandling bør overvejes.
English: Procedures for proper handling and disposal of anticancer medicinal products should be applied.
Danish: Der skal anvendes procedurer for korrekt håndtering og destruktion af anticancer-lægemidler.
English: • High or low blood pressure (hypertension or hypotension).
Danish: • Højt eller lavt blodtryk (hypertension eller hypotension).
English: These patients should be monitored closely and appropriate precautions taken.
Danish: Disse patienter skal monitoreres nøje, og der skal tages passende forholdsregler.
English: Summary of the safety profile
Danish: Resumé af sikkerhedsprofil
English: The individual baseline parameters were comparable between the Vidaza and CCR groups.
Danish: De individuelle baseline-parametre var sammenlignelige mellem grupperne med Vidaza og CCR.
English: It is recommended that patients be treated for a minimum of 6 cycles.
Danish: Det anbefales, at patienterne behandles i mindst 6 cyklusser.
English: The safety and efficacy of Vidaza in children aged 0-17 years have not yet been established.
Danish: Vidazas sikkerhed og virkning hos børn i alderen 0-17 år er endnu ikke klarlagt.
English: Total volume of reconstituted suspension required
Danish: Samlet påkrævet volumen af rekonstitueret suspension
English: The differences between the IRC and investigator assessments of response were a consequence of the International Working Group (IWG) criteria requiring improvement in peripheral blood counts and maintenance of these improvements for a minimum of 56 days.
Danish: Forskellene mellem IRC'er og investigatorens vurderinger af respons var en konsekvens af kriterierne i den internationale arbejdsgruppe (International Working Group, IWG), som kræver forbedring i perifere blodtællinger og opretholdelse af disse forbedringer i mindst 56 dage.
English: Shake the suspension vigorously before administration.
Danish: Ryst suspensionen kraftigt inden administration.
English: LIST OF EXCIPIENTS Also contains mannitol.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også mannitol.
English: While there are limitations in the analysis, the available data suggest that patients do not experience meaningful deterioration in quality of life during treatment with Vidaza.
Danish: Selvom der er begrænsninger i analysen, tyder de tilgængelige data på, at patienterne ikke oplever betydelige forringelser i livskvalitet under behandling med Vidaza.
English: Doses greater than 4 mL should be injected into two separate sites.
Danish: Doser på over 4 ml bør injiceres på to separate steder.
English: Do not use Vidaza
Danish: Brug ikke Vidaza
English: The following table is provided only as an example of how to calculate individual azacitidine doses based on an average BSA value of 1.8 m2.
Danish: Følgende tabel er kun et eksempel på, hvordan individuelle azacitidindoser beregnes baseret på en gennemsnitlig BSA-værdi på 1,8 m2.
English: On analyses of age subgroups, an increase in median overall survival was observed for all groups (< 65 years, ≥ 65 years and ≥ 75 years).
Danish: Ved analyser af aldersundergrupper blev der observeret en stigning i den mediane samlede overlevelse for alle grupper (< 65 år, ≥ 65 år og ≥ 75 år).
English: This medicine will be given to you as an injection under the skin (subcutaneously) by a doctor or nurse.
Danish: Du vil få dette lægemiddel som en indsprøjtning under huden (subkutant) af en læge eller en sygeplejerske.
English: The potential carcinogenicity of azacitidine was evaluated in mice and rats.
Danish: Azacitidins potentielle carcinogenicitet blev evalueret hos mus og rotter.
English: Adverse reactions considered to be possibly or probably related to the administration of Vidaza have occurred in 97 % of patients.
Danish: Bivirkninger, der muligvis eller sandsynligvis kan relateres til administrationen af Vidaza, forekom hos 97 % af patienterne.
English: Children and adolescents Vidaza is not recommended for use in children and adolescents below the age of 18.
Danish: Børn og unge Vidaza bør ikke anvendes til børn og unge under 18 år.
English: Once the suspension has been prepared it should be administered within 45 minutes.
Danish: Når suspensionen er blevet forberedt, bør den administreres i løbet af 45 minutter.
English: This is to check that you have enough blood cells and that your liver and kidneys are working properly.
Danish: Dette sker for at kontrollere, at du har nok blodlegemer, og at din lever og dine nyrer fungerer korrekt.
English: Recommendations for safe handling
Danish: Anbefalinger for sikker håndtering
English: Vidaza works by preventing cancer cells from growing.
Danish: Vidaza virker ved at forhindre kræftcellernes vækst.
English: You should not use Vidaza during pregnancy as it may be harmful to the baby.
Danish: Du bør ikke bruge Vidaza under graviditet, da det kan være skadeligt for fosteret.
English: Non-proliferating cells are relatively insensitive to azacitidine.
Danish: Non-prolifererende celler er relativt ufølsomme over for azacitidin.
English: Cardiac events
Danish: Kardiale hændelser
English: Vidaza treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic agents.
Danish: Behandling med Vidaza bør initieres og monitoreres under supervision af en læge, der har erfaring i anvendelsen af kemoterapeutika.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: This is because Vidaza may affect the way some other medicines work.
Danish: Det skyldes, at Vidaza kan påvirke den måde, hvorpå anden medicin virker.
English: # at risk months months
Danish: Andel, der overlevede antal med risiko måneder måneder
English: The product should be discarded if it contains large particles or agglomerates.
Danish: Suspensionen skal bortskaffes, hvis den indeholder store partikler eller agglomerater.
English: Adverse reactions are presented in the table below according to the highest frequency observed in any of the main clinical studies.
Danish: Bivirkningerne er opstillet i tabellen nedenunder i henhold til den højeste observerede hyppighed i alle de primære kliniske studier.
English: The following information is intended for healthcare professionals only:
Danish: Nedenstående oplysninger er til læger og sundhedspersonale:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 December 2008
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 17. december 2008 Dato for seneste fornyelse: 13. november 2013
English: Your doctor, pharmacist or nurse are responsible for storing Vidaza.
Danish: Din læge, apoteket eller sundhedspersonalet er ansvarlig for opbevaringen af Vidaza.
English: • Changes to your skin at the injection site.
Danish: • Ændringer i huden ved indsprøjtningsstedet.
English: Necrotising fasciitis
Danish: Nekrotiserende fasciitis
English: • Tumour lysis syndrome - Metabolic complications that can occur during treatment of cancer and sometimes even without treatment.
Danish: • Tumorlysesyndrom - metaboliske komplikationer, der kan forekomme under cancerbehandling og nogle gange endda uden behandling.
English: For immediate use
Danish: Til umiddelbar anvendelse
English: Details on storage of the reconstituted product are provided below.
Danish: Detaljer om opbevaring af det rekonstituerede præparat gives nedenunder.
English: Patients should be advised to promptly report febrile episodes.
Danish: Patienter skal opfordres til straks at indberette feberepisoder.
English: Following intravenous administration, the mean volume of distribution was 76 ± 26 L, and systemic clearance was 147 ± 47 L/h.
Danish: Efter intravenøs administration var det gennemsnitlige fordelingsvolumen 76 ± 26 l og systemisk clearance var 147 ± 47 l/t.
English: Laboratory tests
Danish: Laboratorieprøver
English: Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.
Danish: Da ældre patienter har større sandsynlighed for at have nedsat nyrefunktion, kan det være nyttigt at monitorere nyrefunktionen hos disse patienter.
English: The contents of the dosing syringe must be re-suspended immediately prior to administration.
Danish: Indholdet af doseringssprøjten skal resuspenderes umiddelbart inden administration.
English: You will usually receive at least 6 treatment cycles.
Danish: Du skal normalt gennemgå mindst 6 behandlingscyklusser.
English: • Red or purple spots under your skin.
Danish: • Røde eller lilla pletter under huden.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: Hyppighederne defineres som: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Driving and using machines Do not drive or use any tools or machines if you experience side effects, such as tiredness.
Danish: Du må ikke føre motorkøretøj eller betjene værktøj eller maskiner, hvis du oplever bivirkninger, såsom træthed.
English: • A fall in blood pressure when standing (orthostatic hypotension) leading to dizziness when moving to a standing or sitting position.
Danish: • Et fald i blodtrykket, når du står op (ortostatisk hypotension), der fører til svimmelhed, når der skiftes til stående eller siddende stilling.
English: Calculation of an individual dose The total dose, according to the body surface area (BSA) can be calculated as follows:
Danish: Den samlede dosis i forhold til legemsoverfladeareal (Body Surface Area, BSA) kan beregnes som følger:
English: Vidaza plus BSC (n=241) was compared to CCR.
Danish: Vidaza plus BSC (n=241) blev sammenlignet med CCR.
English: If large particles are present in the suspension it should be discarded.
Danish: Hvis der er store partikler i suspensionen, skal den bortskaffes.
English: Vidaza treatment was also associated with a reduction in cytopenias, and their related symptoms.
Danish: Behandling med Vidaza var ligeledes associeret med en reduktion i cytopenier og deres relaterede symptomer.
English: Urinary excretion is the primary route of elimination of azacitidine and/or its metabolites.
Danish: Urinudskillelse er den primære elimineringsvej for azacitidin og/eller dets metabolitter.
English: Very common Common
Danish: Meget almindelig
English: This may be due to an allergic (hypersensitivity) reaction.
Danish: Det kan skyldes en allergisk reaktion (overfølsomhedsreaktion).
English: RAEB-T patients (21-30 % blasts) are now considered to be AML patients under the current WHO classification system.
Danish: RAEB-T-patienter (21-30 % blaster) anses nu for at være AML-patienter i henhold til den gældende WHO-klassifikation.
English: Haematologic and cytogenetic responses were assessed by the investigator and by the IRC with similar results.
Danish: Hæmatologisk og cytogenetisk respons blev vurderet af investigatoren og af IRC med sammenlignelige resultater.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic EXPIRY DATE
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytotoksisk UDLØBSDATO
English: Cumulatively, the safety database includes 51 cases with 56 events of pericarditis, myocarditis, and/or endocarditis reported with the use of Vidaza.
Danish: Kumulativt indeholder sikkerhedsdatabasen 51 tilfælde med 56 hændelser med perikarditis, myokarditis og/eller endokarditis rapporteret med anvendelse af Vidaza.
English: This medicinal product must not be mixed with other medicinal products except those mentioned below (see “Reconstitution Procedure”).
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført herunder (se ”Rekonstitutionsprocedure”).
English: • if you have advanced liver cancer.
Danish: • hvis du har fremskreden leverkræft.
English: • AML with >30% marrow blasts according to the WHO classification.
Danish: • AML med > 30 % knoglemarvsblaster i henhold til klassifikationen fra WHO.
English: There are no adequate data from the use of azacitidine in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af azacitidin til gravide kvinder.
English: It is unknown whether azacitidine/metabolites are excreted in human milk.
Danish: Det er ukendt, om azacitidin/metabolitter udskilles i human mælk.
English: New injections should be given at least 2.5 cm from the previous site and never into areas where the site is tender, bruised, red, or hardened.
Danish: Nye injektioner bør indgives mindst 2,5 cm fra det forrige sted og aldrig i områder, hvor stedet er ømt, blodunderløbent, rødt eller hårdt.
English: Patients and physicians are also advised to be observant for signs and symptoms of bleeding.
Danish: Både patienter og læger opfordres ligeledes til at være opmærksomme på objektive tegn og symptomer på blødning.
English: Therefore, caution is recommended when driving or operating machines.
Danish: Der skal derfor rådes til forsigtighed, når der føres motorkøretøj eller betjenes maskiner.
English: Following dose modifications, the cycle duration should return to 28 days.
Danish: Efter dosisjusteringerne bør cyklusvarigheden atter være 28 dage.
English: When more than 1 vial is needed all the above steps for preparation of the suspension should be repeated.
Danish: Når mere end 1 hætteglas er nødvendigt, gentages alle overstående trin til klargøring af suspensionen.
English: It is therefore advised to exercise caution when prescribing azacitidine to these patients.
Danish: Der bør derfor udvises forsigtighed, når azacitidin ordineres til disse patienter.
English: Although there are some confounding factors, e.g. underlying cancerous conditions of the patients and the presence of other risk factors such as infection and history of cardiac disorders, there are other factors that strengthen this signal, including positive re-challenge, and imbalance in the pooled clinical trials between active and control arms.
Danish: Selvom der er nogle forstyrrende faktorer, f.eks. underliggende cancertilfælde hos patienterne og tilstedeværelse af andre risikofaktorer, såsom infektion og hjertesygdomme i anamnesen, er der andre faktorer, som forstærker dette signal, herunder positiv re-challenge og ubalance i de samlede kliniske studier mellem den aktive arm og kontrolarmen.
English: Vidaza is a cytotoxic medicinal product and, as with other potentially toxic compounds, caution should be exercised when handling and preparing azacitidine suspensions.
Danish: Vidaza er et cytotoksisk lægemiddel, og som det er tilfældet med andre potentielt toksiske stoffer, bør der udvises forsigtighed ved håndtering og klargøring af azacitidinsuspensioner.
English: • The other ingredient is mannitol (E421).
Danish: • Øvrige indholdsstoffer: mannitol (E421).
English: • if you are allergic to azacitidine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for azacitidin eller et af de øvrige indholdsstoffer i Vidaza (angivet i punkt 6).
English: EXP Read the leaflet for the shelf life of the reconstituted medicine.
Danish: EXP Læs indlægssedlen for opbevaringstiden for det rekonstituerede lægemiddel.