FrancophonIA/ELRC3.0 huggingface dataset:
English: Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules indacaterol/glycopyrronium
Danish: Ultibro Breezhaler 85 mikrogram/43 mikrogram inhalationspulver, hårde kapsler indacaterol/glycopyrronium
English: Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 110 micrograms of indacaterol maleate equivalent to 85 micrograms of indacaterol and 54 micrograms of glycopyrronium bromide equivalent to 43 micrograms of glycopyrronium.
Danish: Hver leveret dosis (den dosis, der afgives fra mundstykket af inhalatoren) indeholder 110 mikrogram indacaterolmaleat svarende til 85 mikrogram indacaterol og 54 mikrogram glycopyrroniumbromid svarende til 43 mikrogram glycopyrronium.
English: - you have difficulty passing urine.
Danish: - hvis du har vandladningsbesvær.
English: • itching or rash.
Danish: • kløe eller udslæt.
English: 90 capsules + 1 inhaler
Danish: 90 kapsler + 1 inhalator
English: Heart rate effects in healthy volunteers were investigated after a single dose of 4 times the recommended therapeutic dose of Ultibro Breezhaler administered in four dose steps each separated by one hour and compared to the effects of placebo, indacaterol, glycopyrronium and salmeterol.
Danish: Den blev indgivet i 4 dosistrin med en times mellemrum mellem hver dosis og sammenlignet med virkningen af placebo, indacaterol, glycopyrronium og salmeterol.
English: 10 x 1 capsules + 1 inhaler.
Danish: 10 x 1 kapsler + 1 inhalator.
English: Studies in subjects with severe hepatic impairment were not performed.
Danish: Der blev ikke udført forsøg med personer med svært nedsat leverfunktion.
English: The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 85 micrograms of indacaterol (equivalent to 110 micrograms of indacaterol maleate) and 43 micrograms of glycopyrronium (equivalent to 54 micrograms of glycopyrronium bromide).
Danish: Leveret dosis (den dosis, som afgives fra mundstykket af inhalatoren) svarer til 85 mikrogram indacaterol (svarende til 110 mikrogram indacaterolmaleat) og 43 mikrogram glycopyrronium (svarende til 54 mikrogram glycopyrroniumbromid).
English: Ultibro Breezhaler showed similar adverse reactions to the individual components.
Danish: De samme bivirkninger blev observeret for Ultibro Breezhaler, som for de individuelle komponenter.
English: What Ultibro Breezhaler is and what it is used for What you need to know before you use Ultibro Breezhaler How to use Ultibro Breezhaler Possible side effects
Danish: Det skal du vide, før du begynder at tage Ultibro Breezhaler Sådan skal du tage Ultibro Breezhaler Bivirkninger
English: How much Ultibro Breezhaler to use
Danish: Så meget Ultibro Breezhaler skal du tage
English: The inhaler in each pack should be disposed of after all capsules in that pack have been used.
Danish: Inhalatoren i hver pakning skal smides ud efter alle kapsler i pakningen er brugt.
English: Excipients
Danish: Paræstesi
English: - Dispose of the inhaler in each pack after all capsules in that pack have been used.
Danish: - Smid inhalatoren i hver pakning ud efter alle kapsler i pakningen er brugt.
English: (such as propranolol), or for an eye problem called glaucoma (such as timolol).
Danish: medicin, som kaldes betablokkere, som kan bruges mod for højt blodtryk eller andre hjerteproblemer (fx propranolol), eller mod øjensygdommen kaldet grøn stær (glaukom) (fx timolol).
English: 30 capsules + 1 inhaler
Danish: 30 kapsler + 1 inhalator
English: How long to continue your treatment with Ultibro Breezhaler Keep using Ultibro Breezhaler for as long as your doctor tells you.
Danish: Hvor længe skal du fortsætte med Ultibro Breezhaler-behandling
English: • cough.
Danish: • hoste.
English: Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl metacrylate acrylonitrile butadiene styrene.
Danish: Trykknapperne er fremstillet af methylmethacrylat-acrylonitrilbutadienstyren.
English: 6 capsules + 1 inhaler
Danish: 6 kapsler + 1 inhalator
English: 12 capsules + 1 inhaler
Danish: 12 kapsler + 1 inhalator
English: How to store Ultibro Breezhaler
Danish: Sådan skal du tage Ultibro Breezhaler
English: 10 capsules + 1 inhaler
Danish: 10 kapsler + 1 inhalator
English: • muscle spasm.
Danish: • muskelkrampe.
English: - Do not swallow the capsules.
Danish: - Kapslerne må ikke synkes.
English: Mouthpiece
Danish: Mundtørhed
English: (same class) to those in Ultibro Breezhaler (see section “Other medicines and Ultibro
Danish: - hvis du tager medicin mod din lungesygdom, som indeholder lignende aktive stoffer (samme klasse) som dem i Ultibro Breezhaler (se under ”Brug af anden medicin sammen med Ultibro
English: Do not swallow the capsule.
Danish: Kapslen må ikke synkes.
English: Dental caries
Danish: Øjne Glaukom
English: Inhale deeply
Danish: Inhalato r
English: • Do not swallow the capsule.
Danish: • Kapslerne må ikke synkes.
English: Inhaler base
Danish: Inhalatorund erdel
English: Posology
Danish: Mundstykke
English: It could take approximately 45 seconds.
Danish: Det kan tage ca. 45 sekunder.
English: This can lead to death.
Danish: Dette kan medføre døden.
English: These effects were partially reversible after 8 weeks.
Danish: Disse virkninger var delvist reversible efter 8 uger.
English: None were considered related by the investigator.
Danish: Ingen af tilfældene blev anset som relateret af investigatoren.
English: • you have ever had any allergies.
Danish: • du nogensinde har haft allergier.
English: • You will usually have an infusion once every 3 weeks.
Danish: • Du vil sædvanligvis få en infusion hver 3. uge.
English: Other appropriate symptomatic measures should be taken.
Danish: Der bør tages andre hensigtsmæssige symptomatiske foranstaltninger.
English: Tell your doctor immediately if:
Danish: Fortæl straks din læge hvis:
English: After opening
Danish: Efter åbning
English: • you have fever.
Danish: • du har feber.
English: Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.
Danish: Døde eller inaktiverede vacciner kan administreres; dog kan respons på disse vacciner være formindsket.
English: Use a condom during sex if your partner is or could become pregnant.
Danish: Brug kondom, når du dyrker sex, hvis din partner er eller kan blive gravid.
English: 7/ 21 weeks
Danish: 7 / 21 uger
English: See a doctor immediately if you notice any of the following side effects:
Danish: Søg straks læge, hvis du bemærker nogen af følgende bivirkninger:
English: It is normal for foam to persist after this time period.
Danish: Det er helt almindeligt, at der stadig er skum efter dette tidsrum.
English: Early use of supportive care measures may help improve the condition.
Danish: Tidlig understøttende behandling kan hjælpe til med at forbedre tilstanden.
English: Treatment should be delayed until improvement of symptoms.
Danish: Behandling bør udskydes, indtil symptomerne bedres.
English: 6/ 18 weeks
Danish: 6 / 18 uger
English: If any of the above applies to you, tell your doctor immediately.
Danish: Hvis en af ovenstående gælder for dig, skal du straks underrette din læge.
English: Let this solution stand for approximately 5 minutes and check then that the solution is homogeneous and clear.
Danish: Lad denne opløsning stå i ca. 5 minutter og kontrollér derpå, at opløsningen er klar og homogen.
English: • The usual dose depends on your body surface area.
Danish: • Den normale dosis afhænger af din krops overfladeareal.
English: Your doctor will monitor your blood and general condition for signs of infections.
Danish: Din læge vil holde øje med dit blod og din generelle tilstand for tegn på infektioner.
English: • fever (high temperature).
Danish: • feber (høj temperatur).
English: Appropriate measures should be taken to identify the cause and intensively treat the patients if this occurs.
Danish: Der bør træffes passende foranstaltninger for at identificere årsagen og behandle patienterne intensivt, hvis dette forekommer.
English: • you have blood in your urine.
Danish: • du har blod i din urin.
English: PSA secondary endpoints were positive in the JEVTANA arm.
Danish: PSA sekundære endepunkter var positive i JEVTANA-armen.
English: You may feel tired or dizzy when having this medicine.
Danish: Du kan føle dig træt eller svimmel, når du tager denne medicin.
English: The earliest sign of infection may be fever, so if you experience fever, tell your doctor right away.
Danish: Det tidligste tegn på infektion kan være feber, så hvis du får feber, skal du straks fortælle det til din læge.
English: Pregnant staff should not handle it.
Danish: Gravide medarbejdere må ikke håndtere det.
English: Physicians should assess for the presence or worsening of neuropathy before each treatment.
Danish: Læger skal vurdere tilstedeværelse eller forværring af neuropati før hver behandling.
English: It belongs to a group of medicines called “taxanes” used to treat cancers.
Danish: Det tilhører en gruppe lægemidler, der betegnes "taxaner” og anvendes til at behandle cancer.
English: Patients should be observed closely for hypersensitivity reactions especially during the first and second infusions.
Danish: Patienter skal observeres nøje for overfølsomhedsreaktioner, især under første og anden infusion.
English: • trouble with balance
Danish: • problemer med balancen
English: Ask your doctor to give you information about this other medicine.
Danish: Bed din læge om at fortælle dig mere om denne medicin.
English: • short term hair loss (in most cases normal hair growth should return)
Danish: • hårtab på kort sigt (i det fleste tilfælde vender almindelig hårvækst tilbage)
English: JEVTANA requires TWO dilutions prior to administration.
Danish: JEVTANA kræver TO fortyndinger inden administration.
English: Dehydration is more common in patients aged 65 or older.
Danish: Dehydrering er mere almindelig hos patienter i alderen 65 år og derover.
English: If this happens, do not drive or use any tools or machines until you feel better.
Danish: Hvis det sker, må du ikke køre bil eller andet motorkøretøj eller betjene værktøjer eller maskiner, før du har det bedre.
English: Median number of cycles/ median duration of treatment
Danish: Mediant antal serier / median behandlingsvarighed
English: • you have recently received or are about to receive a vaccine against yellow fever.
Danish: • du for nyligt er blevet vaccineret eller snart skal vaccineres mod gul feber.
English: People with low blood counts can develop life-threatening infections.
Danish: Personer med et lavt antal blodlegemer kan udvikle livstruende infektioner.
English: The patient should be advised to report any significant change in daily urinary volume immediately.
Danish: Patienten skal anmodes om straks at rapportere signifikante ændringer i den daglige vandladningsmængde.
English: Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose.
Danish: Patienter skal modtage terapeutisk G-CSF hurtigst muligt, efter at overdosen opdages.
English: Your doctor will calculate your body surface area in square meters (m²) and will decide the dose you should have.
Danish: Din læge vil beregne din krops overfladeareal i kvadratmeter (m²) og vil beslutte, hvilken dosis du skal have.
English: • JEVTANA will be given by a drip (infusion) into one of your veins (intravenous use) in hospital for about an hour.
Danish: • JEVTANA gives med drop (infusion) ind i en af dine vener (intravenøs brug) på hospitalet i ca. en time.
English: Renal failure including cases with fatal outcome has been observed.
Danish: Nyresvigt, inklusiv tilfælde med dødeligt udfald, er blevet observeret.
English: Read this ENTIRE section carefully before mixing and diluting.
Danish: Læs HELE dette afsnit grundigt inden blanding og fortynding.
English: There is no relevant use of JEVTANA in the paediatric population.
Danish: Der er ingen relevant anvendelse af JEVTANA i den pædiatriske population.
English: Demographics, including age, race, and ECOG performance status (0 to 2), were balanced between the treatment arms.
Danish: Demografi, inklusiv alder, race og ECOG-performancestatus (0 til 2) var afbalanceret mellem behandlingsarmene.
English: Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed.
Danish: Antiemetisk profylakse anbefales og kan gives oralt eller intravenøst efter behov.
English: Figure 1: Kaplan Meier overall survival curves (EFC6193)
Danish: Figur 1: Kaplan Meier-kurver for samlet overlevelse (EFC6193)
English: Overall survival (OS) was the primary efficacy end-point.
Danish: Samlet overlevelse (OS) var det primære endepunkt.
English: • lack of white blood cells associated with fever and infection
Danish: • mangel på hvide blodlegemer forbundet med feber og infektion
English: • decrease or increase in blood pressure
Danish: • fald eller stigning i blodtryk
English: This leads to the stabilisation of microtubules, which results in the inhibition of mitotic and interphase cellular functions.
Danish: Dette fører til stabilisering af mikrotubuli, hvilket resulterer i hæmning af mitotiske og interfase cellulære funktioner.
English: • JEVTANA must be prepared (diluted) before it is given.
Danish: • JEVTANA skal klargøres (fortyndes), inden det kan indgives.
English: The second dilution should be done immediately (within 1 hour) as detailed in Step 2.
Danish: Den skal straks fortyndes (inden for 1 time) som beskrevet i Trin 2.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83 EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Overall survival (OS) was the primary efficacy endpoint of the study.
Danish: Samlet overlevelse (OS) var studiets primære effektendepunkt.
English: The name of your medicine is JEVTANA.
Danish: Navnet på din medicin er JEVTANA.
English: Prolonged grade ≥3 neutropenia (longer than 1 week) despite appropriate treatment including G-CSF
Danish: Langvarig grad ≥ 3 neutropeni (længere end 1 uge) på trods af passende behandling, inklusive G-CSF
English: In this case, the solution must not be used and should be discarded.
Danish: I dette tilfælde må opløsningen ikke anvendes, men skal kasseres.
English: Nevertheless, considering the pharmacological activity of taxanes, their genotoxic potential and effect of several compounds of this class on fertility in animal studies, effect on male fertility could not be excluded in human.
Danish: I betragtning af taxanernes farmakologiske aktivitet, deres genotoksiske potentiale og indvirkningen af flere forbindelser i denne klasse på fertiliteten i dyrestudier, kunne indvirkning på fertiliteten hos mænd dog ikke udelukkes.
English: If the bleeding or pain is severe, your doctor will stop your treatment with JEVTANA.
Danish: Hvis blødningen eller smerten er alvorlig, vil lægen stoppe behandlingen med JEVTANA.
English: You should not be given JEVTANA if any of the above apply to you.
Danish: Du må ikke få JEVTANA, hvis nogen af ovenstående gælder for dig.
English: • infections or risk of infections
Danish: • infektioner eller risiko for infektioner
English: Serious allergic reactions can occur during treatment with JEVTANA.
Danish: Der kan opstå alvorlige allergiske reaktioner under behandling med JEVTANA.
English: Adverse reactions are listed in table 2 according to MedDRA system organ class and frequency categories.
Danish: Bivirkninger er angivet i tabel 2 i henhold til MedDRA-systemorganklasse og hyppighedskategorier.
English: JEVTANA contains ethanol (alcohol)
Danish: JEVTANA indeholder ethanol (alkohol)
English: A risk to the suckling child cannot be excluded.
Danish: Det kan ikke udelukkes, at det ammende barn vil være udsat for risiko.
English: • liver problems occur during the treatment.
Danish: • der opstår problemer med leveren under behandlingen.
English: Appropriate measures should be taken to rehydrate patients and to monitor and correct serum electrolyte levels, particularly potassium.
Danish: Der bør træffes passende foranstaltninger for at rehydrere patienterne og monitorere og korrigere elektrolytniveauerne i serum, særligt kalium.
English: This is because some medicines can affect the way JEVTANA works or JEVTANA can affect how other medicines work.
Danish: Det skyldes, at visse lægemidler kan påvirke den måde, JEVTANA virker på, eller JEVTANA kan påvirke, hvordan andre lægemidler virker.
English: • you experience any significant increase or decrease in daily urinary volume.
Danish: • hvis du oplever et betydeligt fald eller en betydelig stigning i din daglige mængde urin.
English: Frequencies are based on all grades and 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: Hyppigheder er baseret på alle grader og defineres som: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10); ualmindelig (≥1/1,000 til <1/100); sjælden (≥1/10,000 til <1/1,000); meget sjælden (<1/10,000); ukendt (kan ikke estimeres ud fra de tilgængelige data).
English: JEVTANA is administered as a 1 hour infusion.
Danish: JEVTANA indgives som en 1-times infusion.
English: The solvent is a clear and colourless solution.
Danish: Solvensen er en klar og farveløs opløsning.
English: • severe loss of body fluids (dehydration).
Danish: • stort tab af kropsvæsker (dehydrering).
English: Monitoring of complete blood counts is essential on a weekly basis during cycle 1 and before each treatment cycle thereafter so that the dose can be adjusted, if needed.
Danish: Det er essentielt at monitorere det fulde blodbillede ugentligt i serie 1 og inden hver enkelt efterfølgende behandlingsserie, så dosis kan justeres om nødvendigt.
English: • decrease in the number of platelets (which results in increased risk of bleeding)
Danish: • fald i antal blodplader, (der resulterer i en øget blødningsrisiko)
English: This information supplements sections 3 and 5 for the user.
Danish: 3 og 5 for brugeren.
English: From a microbiological point of view, the two-step dilution process must take place in controlled and aseptic conditions (see below “Preparation and administration precautions”).
Danish: Fra et mikrobiologisk synspunkt skal totrins-fortyndingsprocessen finde sted under kontrollerede og aseptiske forhold (se nedenfor under "Forholdsregler under klargøring og administration").
English: However, limited efficacy data are available at this dose.
Danish: Der findes dog kun begrænsede data om effekten ved denne dosis.
English: • inflammation of the bladder, which can occur when your bladder has been previously exposed to radiation therapy (cystitis due to radiation recall phenomenon).
Danish: • Blærebetændelse, som kan forekomme, når din blære tidligere har været udsat for strålebehandling (cystitis, som skyldes radiation recall fænomen).
English: It is important that you read the entire content of this procedure prior to the preparation of the infusion solution.
Danish: Det er vigtigt, at du læser hele indholdet af denne procedure, inden du klargør infusionsvæsken.
English: Pharmacotherapeutic group: Antineoplastic agents, taxanes, ATC code: L01CD04
Danish: Farmakoterapeutisk gruppe: Antineoplastiske midler, taxaner, ATC-kode: L01CD04
English: If new or worsening pulmonary symptoms develop, patients should be closely monitored, promptly investigated, and appropriately treated.
Danish: Hvis nye eller forværrede lungesymptomer opstår, skal patienter overvåges nøje, undersøges straks, og behandles på passende vis.
English: Neutropenia, and associated clinical events
Danish: Neutropeni og tilknyttede kliniske hændelser
English: In case of overdose, the patient should be kept in a specialised unit and closely monitored.
Danish: I tilfælde af overdosis skal patienten anbringes på særlig afdeling og monitoreres nøje.
English: There was no statistically difference with regards to the other secondary endpoints (PFS, tumour and pain response, tumour and pain progression, and four subcategories of FACT-P).
Danish: Der var ingen statistisk forskel med hensyn til de andre sekundære endepunkter (PFS, tumor og smerterespons, tumor og smerteprogression og fire underkategorier af FACT-P).
English: The median number of cycles was 6 in the JEVTANA group and 4 in the mitoxantrone group.
Danish: Antallet af serier var mediant 6 i JEVTANA-gruppen og 4 i mitoxantron-gruppen.
English: Your doctor may reduce the dose of JEVTANA or stop the treatment.
Danish: Din læge vil muligvis reducere din JEVTANA-dosis eller indstille behandlingen.
English: • the number of your white blood cells is too low (neutrophil counts less than or equal to
Danish: • antallet af hvide blodlegemer er for lavt (neutrofiltal på eller mindre end eller lig med
English: Anti-allergic medicines will be given to you before you have JEVTANA to reduce the risk of allergic reactions.
Danish: Du vil få anti-allergisk medicin, inden du får JEVTANA, for at mindske risikoen for allergiske reaktioner.
English: Date of latest renewal: 19 November 2015
Danish: Dato for første markedsføringstilladelse: 17. marts 2011 Dato for seneste fornyelse: 19. november 2015
English: This medicine may be harmful for those suffering from alcoholism.
Danish: Denne medicin kan være skadelig for alkoholikere.
English: • decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection)
Danish: • fald i antallet af røde (anæmi) eller hvide blodlegemer (der er vigtige ved bekæmpelse af infektion)
English: Frequency not known (cannot be estimated from the available data): • interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing).
Danish: Frekvens ikke kendt (kan ikke vurderes ud fra tilgængelige data): • interstitiel lungesygdom (betændelse i lungerne der forårsager hoste og åndedrætsbesvær).
English: • JEVTANA will be given to you by a doctor or a nurse.
Danish: • Du vil få JEVTANA af en læge eller sygeplejerske.
English: • Neutrophil counts less than 1,500/mm3.
Danish: • Neutrofiltal på under 1.500/mm3.
English: • H2 antagonist (ranitidine or equivalent) (see section 4.4).
Danish: • H2-antagonist (ranitidin eller tilsvarende) (se pkt.
English: • you have any bleeding problems from the gut or have changes in the colour of your stool or stomach pain.
Danish: • du har blødningsproblemer fra tarmen eller har ændringer i farven på din afføring eller har mavesmerter.
English: Colitis, enterocolitis, gastritis, neutropenic enterocolitis have been observed.
Danish: Colitis, enterocolitis, gastritis og neutropenisk enterocolitis er blevet observeret.
English: Ethanol 96% Water for injections
Danish: 96 % ethanol Vand til injektionsvæsker
English: It works by stopping cells from growing and multiplying.
Danish: Det virker ved at forhindre celler i at vokse og formere sig.
English: It was not clastogenic in an in vitro test in human lymphocytes (no induction of structural chromosomal aberration but it increased number of polyploid cells) and induced an increase of micronuclei in the in vivo test in rats.
Danish: Det var ikke klastogent i en in vitro test med humane lymfocytter (ingen induktion af strukturel kromosomaberration, men øgede antallet af polyploide celler) og inducerede en stigning i antallet af mikronuklei i in vivo test hos rotter.
English: For intravenous use (infusion) AFTER final dilution.
Danish: Til intravenøs anvendelse (infusion) EFTER endelig fortynding.
English: Conjunctivitis Lacrimation increased
Danish: Conjunctivitis Øget tåreflod