FrancophonIA/ELRC3.0 huggingface dataset:
English: It is available as modified release tablets (containing 0.45 mg conjugated oestrogens and 20 mg bazedoxifene) which release bazedoxifene immediately and conjugated oestrogens over a longer period of time.
Danish: Det fås som tabletter med modificeret udløsning (med 0,45 mg konjugerede østrogener og 20 mg bazedoxifen).
English: In the study investigating the effects on hot flushes, treatment with Duavive (conjugated oestrogen 0.45 mg and bazedoxifene 20 mg) over 12 weeks reduced the average daily number of moderate and severe hot flushes by 7.6 compared with 4.9 for placebo.
Danish: I undersøgelsen af virkningerne på hedeture fik patienterne i 12 uger Duavive (konjugeret østrogen 0,45 mg og bazedoxifen 20 mg).
English: Because the observed treatment effects were smaller than what is seen with alternative treatments (progestogen-containing treatments) the CHMP therefore concluded that Duavive should be reserved for women who cannot take these alternative medicines.
Danish: De iagttagne virkninger af behandlingen var mindre end med andre behandlinger (gestagenholdige lægemidler).
English: Further information on NovoEight can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/novoeight.
Danish: Yderligere information om NovoEight findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/novoeight.
English: NovoEight received a marketing authorisation valid throughout the European Union on 13 November
Danish: NovoEight fik en markedsføringstilladelse med gyldighed i hele EU den 13. november 2013.
English: As for all medicines, data on the use of NovoEight are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af NovoEight løbende overvåget.
English: These inhibitors are antibodies that the immune system (the body's natural defences) produces against factor VIII.
Danish: Disse hæmmere er antistoffer, som immunsystemet (kroppens naturlige forsvar) producerer mod faktor VIII.
English: Other information about NovoEight
Danish: Andre oplysninger om NovoEight
English: An overview of NovoEight and why it is authorised in the EU
Danish: En oversigt over NovoEight, og hvorfor det er godkendt i EU
English: Hypersensitivity (allergic) reactions can occur rarely with NovoEight and may in some cases progress to severe allergic reactions.
Danish: Sjældne tilfælde af overfølsomhedsreaktioner (allergi) kan forekomme ved brug af NovoEight og kan i nogle tilfælde udvikle sig til alvorlige allergiske reaktioner.
English: What measures are being taken to ensure the safe and effective use of NovoEight?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af NovoEight?
English: The European Medicines Agency decided that NovoEight's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved NovoEight opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The medicine contains the active substance turoctocog alfa.
Danish: Lægemidlet indeholder det aktive stof turoctocog alfa.
English: The active substance in NovoEight, turoctocog alfa, works in the same way as natural factor VIII and helps the blood to clot.
Danish: Det aktive stof i NovoEight, turoctocog alfa, virker på samme måde som naturlig faktor VIII og hjælper blodet med at størkne.
English: The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as the seriousness of the haemophilia, the extent and location of the bleeding and the patient's age and condition.
Danish: Dosis og hyppighed af behandlingerne afhænger af, om lægemidlet skal anvendes til behandling eller forebyggelse af blødning såvel som af hæmofiliens sværhedsgrad, blødningens omfang og lokalisering og patientens alder og tilstand.
English: NovoEight can only be obtained with a prescription, and treatment should be started under the supervision of a doctor who has experience in the treatment of haemophilia.
Danish: NovoEight fås kun på recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af hæmofili.
English: Side effects reported with NovoEight are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved NovoEight vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: NovoEight must not be used in patients who are allergic to hamster protein.
Danish: NovoEight må ikke gives til patienter med allergi over for hamsterproteiner.
English: In the first study involving 150 patients aged 12 years and above, adolescents who used NovoEight to prevent bleeding had an average of 5.55 bleeding episodes per year and adults had an average of 6.68 bleeding episodes per year.
Danish: I det første studie, der omfattede 150 patienter i alderen 12 år og opefter, havde unge, som fik NovoEight til forebyggelse af blødning, i gennemsnit 5,55 blødningsepisoder om året, og voksne havde i gennemsnit 6,68 blødningsepisoder om året.
English: NovoEight was effective at preventing and treating bleeding episodes in two main studies involving a total of 213 patients with haemophilia A. Neither study compared NovoEight with any other medicines.
Danish: NovoEight var effektivt til forebyggelse og behandling af blødningsepisoder i to hovedstudier med i alt 213 patienter med hæmofili A. I ingen af studierne blev NovoEight sammenlignet med andre lægemidler.
English: In the second study involving 63 children less than 12 years of age, children treated with NovoEight had an average of 5.33 bleeding episodes per year.
Danish: I det andet studie, der omfattede 63 børn under 12 år, havde de børn, der fik NovoEight, i gennemsnit 5,33 blødningsepisoder om året.
English: NovoEight is available for injection into a vein.
Danish: NovoEight gives som injektion i en vene.
English: What is NovoEight and what is it used for?
Danish: Hvad er NovoEight, og hvad anvendes det til?
English: For more information about using NovoEight, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af NovoEight, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Patients or their carers may be able to inject NovoEight themselves once they have been trained.
Danish: Patienten selv eller dennes omsorgsperson kan injicere NovoEight derhjemme, når de er blevet instrueret i det.
English: The safety profile of NovoEight was also considered similar to other factor VIII products.
Danish: NovoEights sikkerhedsprofil vurderes også at svare til sikkerhedsprofilen ved andre faktor VIII-produkter.
English: In addition, 89.4% of the bleeding episodes resolved after 1 to 2 doses of NovoEight.
Danish: Endvidere fortog 89,4 % af blødningsepisoderne sig efter 1-2 doser NovoEight.
English: NovoEight is used to correct the factor VIII deficiency by replacing the missing factor VIII, thereby giving temporary control of the bleeding disorder.
Danish: NovoEight anvendes til at korrigere manglen på faktor VIII ved at erstatte den manglende faktor VIII, så der opnås midlertidig kontrol med blødersygdommen.
English: Why is NovoEight authorised?
Danish: Hvorfor er NovoEight godkendt?
English: The Agency concluded that NovoEight is effective for treating and preventing bleeding episodes, with effects similar to other factor VIII products.
Danish: Agenturet vurderede, at NovoEight er effektivt til behandling og forebyggelse af blødningsepisoder med en effekt svarende til andre faktor VIII-produkter.
English: In addition, 95.2% of the bleeding episodes resolved after 1 to 2 doses of NovoEight.
Danish: Endvidere fortog 95,2 % af blødningsepisoderne sig efter 1-2 doser NovoEight.
English: Patients with haemophilia A lack factor VIII, which prevents blood from clotting and can cause problems such as bleeding in the joints, muscles or internal organs.
Danish: Patienter med hæmofili A mangler faktor VIII, hvilket forhindrer blodet i at størkne og kan forårsage problemer som blødning i leddene, musklerne eller de indre organer.
English: What are the risks associated with NovoEight?
Danish: Hvilke risici er der forbundet med NovoEight?
English: NovoEight was rated as ‘excellent' or ‘good' at treating 116 of the 126 bleeding episodes.
Danish: NovoEight blev vurderet som "fremragende" eller "godt" til behandling af blødning (udviste gavnlig effekt ved 116 ud af 126 blødningsepisoder).
English: For continuing treatment, the doctor may adjust the dose and frequency of injection according to the blood levels of factor VIII.
Danish: Ved fortsat behandling kan lægen justere dosis og injektionshyppighed afhængigt af patientens faktor VIIIniveauer.
English: NovoEight is a medicine used to treat and prevent bleeding in patients with haemophilia A an inherited bleeding disorder caused by lack of factor VIII.
Danish: NovoEight er et lægemiddel til behandling og forebyggelse af blødning hos patienter med den arvelige blødningsforstyrrelse hæmofili A, som skyldes mangel på faktor VIII.
English: Some patients may develop factor VIII inhibitors, which can cause the medicine to stop working, resulting in a loss of bleeding control.
Danish: Nogle patienter kan udvikle faktor VIIIhæmmere, som kan forhindre lægemidlet i at virke, så blødningskontrollen svigter.
English: How is NovoEight used?
Danish: Hvordan anvendes NovoEight?
English: When used for the treatment of spontaneous bleeding, NovoEight was rated as ‘excellent' or ‘good' at treating 403 of 499 of the bleeding episodes.
Danish: NovoEight blev vurderet som "fremragende" eller "godt" til behandling af spontan blødning (udviste gavnlig effekt ved 403 ud af 499 blødningsepisoder.
English: What benefits of NovoEight have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved NovoEight?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of NovoEight have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af NovoEight.
English: How does NovoEight work?
Danish: Hvordan virker NovoEight?
English: 3.1 mg / 24 h Transdermal patch Transdermal use sachet (coated paper/alu/LLDPE)
Danish: Transdermal anvendelse brev (overtrukket papir/alu/LLDPE)
English: (Invented) name
Danish: Særnavn
English: 1 patch
Danish: 1 plaster
English: This makes it hard to breathe.
Danish: Det gør det svært at trække vejret.
English: Solvent: 3 years.
Danish: Solvens: 3 år.
English: Begin your treatment.
Danish: Begynd behandlingen.
English: You will need the following:
Danish: Du skal bruge følgende:
English: This pack is not to be sold separately.
Danish: Denne pakning sælges ikke separat.
English: Date of first authorisation: 21 September 2009 Date of latest renewal: 26 May 2016
Danish: Dato for første markedsføringstilladelse: 21 september 2009 Dato for seneste fornyelse: 26 maj 2016
English: This helps to ensure that you get the proper dose of medicine.
Danish: Dette er med til at sikre, at du får den korrekte dosis medicin.
English: This may be more common in children than in adults.
Danish: Dette kan være hyppigere hos børn end hos voksne.
English: Overall, 539 patients (78% adults) were treated in these studies.
Danish: I alt blev 539 patienter (78% voksne) behandlet i disse studier.
English: Avoid breathing through your nose.
Danish: Undgå at trække vejret gennem næsen.
English: You will hear one “beep” and the status light will turn green.
Danish: Du vil høre et "bip", og statuslyset lyser grønt.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Officielle retningslinjer om korrekt brug af antibakterielle stoffer skal tages i betragtning.
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1000 to < 1/100).
Danish: Hyppigheden defineres som følger: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥ 1/1.000 til < 1/100).
English: What if I need to stop my treatment before I've finished?
Danish: Hvad skal jeg gøre, hvis jeg har brug for at stoppe inhalationen, før jeg er færdig?
English: Pharmacokinetics in special populations
Danish: Farmakokinetik i særlige populationer
English: White to off-white powder.
Danish: Hvidt til offwhite pulver.
English: Tell your doctor if you have any of these effects.
Danish: Fortæl det til lægen, hvis du har nogen af disse bivirkninger.
English: Recovery data indicate that about 10% of the dose is excreted as this metabolite.
Danish: Genfindingsdata indikerer, at ca. 10% af dosis udskilles som denne metabolit.
English: Sit in a relaxed, upright position.
Danish: Sid i opret, afslappet stilling.
English: The four additional solvent ampoules are provided in case of spillage.
Danish: De fire ekstra ampuller med solvens medleveres til brug i tilfælde af spild.
English: Each treatment takes about 2 to 3 minutes to inhale.
Danish: Det tager cirka 2 til 3 minutter at inhalere hver behandling.
English: There are no data from the use of aztreonam in pregnant women.
Danish: Der er ingen data fra anvendelse af aztreonam til gravide kvinder.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: If a case of bronchospasm is suspected to be part of an allergic reaction appropriate measures should be taken (see “allergic reactions” paragraph above).
Danish: Hvis der er mistanke om, at et anfald med bronkospasme er en del af en allergisk reaktion, bør der træffes passende foranstaltninger (se afsnittet "Allergiske reaktioner" ovenfor).
English: For patients taking multiple inhaled therapies, the recommended order of administration is as follows:
Danish: For patienter, som tager flere inhalationsbehandlinger, er den anbefalede rækkefølge for administration følgende:
English: Doses should be taken at least 4 hours apart.
Danish: Dosis bør tages med mindst 4 timers mellemrum.
English: L-Lysine
Danish: L-lysin
English: All these may be signs of an allergic reaction.
Danish: Alt dette kan være tegn på en overfølsomhedsreaktion.
English: Adults and children 6 years and older
Danish: Voksne og børn i alderen 6 år og derover
English: However, due to the uncontrolled nature of the study and concomitant medications no conclusion can be drawn on the sustainability of the observed short term benefit over subsequent courses of treatment.
Danish: Men p.g.a. den ukontrollerede natur af studiet og samtidigt administreret medicin kan der ikke drages konklusioner med hensyn til, om de fordele, der observeredes på kort sigt, kan opretholdes i eventuelle efterfølgende behandlingsforløb.
English: Hold the handset level and place the mouthpiece in your mouth and close your lips around it (Figure 4).
Danish: Hold forstøveren vandret, placer mundstykket i munden og luk læberne omkring det (figur 4).
English: Efficacy has not been established in patients with FEV1 > 75% predicted.
Danish: Virkningen er ikke blevet klarlagt hos patienter med forventet FEV1 > 75%.
English: Use the prepared solution within 8 hours.
Danish: Brug den klargjorte opløsning inden for 8 timer.
English: The information that appears on the solvent ampoule is provided in English only (see section 6).
Danish: De oplysninger, der er anført på ampullen med solvens er kun på engelsk (se punkt 6).
English: Microbiology
Danish: Mikrobiologi
English: The survival rate during the lactation period was slightly reduced in the offspring of rats that received the highest dose.
Danish: Overlevelsesraten i dieperioden var let reduceret hos afkommet af de rotter, som havde fået den højeste dosis.
English: If you have ever coughed up blood you should only use Cayston if your doctor thinks the benefit of taking this medicine outweighs the risk of coughing up blood.
Danish: Hvis du nogensinde har hostet blod op, må du kun bruge Cayston, hvis din læge mener, at fordelen ved at tage denne medicin opvejer risikoen for at hoste blod op.
English: If you notice that the performance has changed before this time (for instance, if it takes longer to produce a mist, more than 5 minutes), please refer to the Altera Nebuliser instructions for use.
Danish: Hvis du bemærker, at apparatets virkning har ændret sig før dette tidspunkt (hvis det for eksempel tager længere tid at forstøve opløsningen, mere end 5 minutter), skal du se i Altera-forstøverens brugervejledning.
English: Use this medicine immediately after preparation.
Danish: Brug lægemidlet umiddelbart efter klargøring.
English: Cayston contains the active substance aztreonam.
Danish: Cayston indeholder det aktive stof aztreonam.
English: Carefully remove (but do not yet discard) the rubber stopper.
Danish: Fjern forsigtigt gummiproppen (men bortskaf den ikke endnu).
English: However, all mean sputum concentration values were associated with relatively large standard deviations.
Danish: Alle de gennemsnitlige værdier for koncentrationen i ekspektorat var imidlertid forbundet med relativt store standardafvigelser.
English: The information that appears on the ampoule is presented below:
Danish: De oplysninger, der er anført på ampullen er angivet nedenfor:
English: Do not completely tear through the metal seal.
Danish: Riv ikke helt igennem metalforseglingen.
English: If you miss a dose, you can still take all 3 daily doses as long as they are at least 4 hours apart.
Danish: Hvis du glemmer en dosis, kan du stadig inhalere alle 3 daglige doser, blot der er mindst 4 timer imellem.
English: Cayston is not for use in children under the age of 6 years.
Danish: Cayston må ikke anvendes til børn under 6 år.
English: The majority of the treatment-emergent isolations were intermittent.
Danish: Størstedelen af de isolater, som fremkom under behandlingen, var intermitterende.
English: Do not stop taking Cayston without first talking to your doctor.
Danish: Du må ikke holde op med at bruge Cayston uden først at tale med lægen.
English: Fifty-nine paediatric patients aged 6 to 17 years were included in the study.
Danish: 59 pædiatriske patienter i alderen 6 til 17 år blev inkluderet i studiet.
English: Cayston should not be used during pregnancy unless the clinical condition of the woman requires treatment with aztreonam.
Danish: Cayston bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med aztreonam.
English: Clinical studies of Cayston did not include Cayston-treated patients aged 65 years and older to determine whether they respond differently from younger patients.
Danish: De kliniske studier med Cayston omfattede ikke Cayston-behandlede patienter i alderen 65 år og ældre for at fastlægge, om de responderer anderledes på behandlingen end yngre patienter.
English: bronchodilator mucolytics and lastly, Cayston.
Danish: bronkodilatator mukolytika og til sidst Cayston.
English: There was no clinically relevant effect of age or sex on the pharmacokinetics of aztreonam.
Danish: Der var ingen klinisk relevant effekt af alder eller køn i farmakokinetikken for aztreonam.
English: If an allergic reaction to aztreonam does occur, stop administration of the medicinal product and initiate treatment as appropriate.
Danish: Hvis der opstår en allergisk reaktion over for aztreonam, skal administration af lægemidlet ophøre, og relevant behandling skal iværksættes.
English: Plasma concentrations
Danish: Plasmakoncentrationer
English: You may get a temporary lowering of lung function test result during treatment with Cayston, but this is typically not a lasting effect.
Danish: Du kan midlertidigt få lavere resultater af lungefunktionstest under behandlingen med Cayston, men normalt er dette ikke en varig virkning.
English: Patients continued on their baseline medications, including macrolide antibiotics.
Danish: Patienterne fortsatte med deres baseline-medicin, herunder makrolidantibiotika.
English: In-use storage times and conditions prior to use are the responsibility of the user.
Danish: Brugeren er ansvarlig for opbevaringstider og tilstanden før brug.
English: Patients were required to have been off antipseudomonal antibiotics for at least 28 days before treatment with study drug.
Danish: Patienterne måtte ikke have taget antipseudomonale antibiotika i mindst 28 dage før behandling med studiemedicinen.
English: Reconstitute before use.
Danish: Blandes før brug.
English: You can breast-feed during treatment with Cayston because the amount of Cayston likely to be passed to your child during breast-feeding will be extremely small.
Danish: Du kan godt amme under behandlingen med Cayston, fordi den mængde af Cayston, som muligvis bliver givet videre til dit barn via mælken, er meget lille.
English: Do not use this medicine after the expiry date which is stated on the vial label, solvent ampoule and the carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på hætteglassets etiket, ampullen med solvensen og æsken.
English: Following reconstitution, Cayston is a clear, colourless to slightly coloured solution.
Danish: Efter rekonstitution er Cayston en klar, farveløs eller let farvet opløsning.
English: The recommended dose for adults is 75 mg three times per 24 hours for 28 days.
Danish: Den anbefalede dosis for voksne er 75 mg tre gange i døgnet i 28 dage.
English: Aztreonam, a monobactam, is only weakly immunogenic.
Danish: Aztreonam, et monobactam, har kun en svag immunogen virkning.
English: The dosing in children aged 6 years and older is the same as for adults.
Danish: Doseringen for børn i alderen 6 år og derover er den samme som for voksne.
English: Press and hold the On/Off button on the Control Unit for a few seconds.
Danish: Tryk på knappen On/Off på styreenheden i få sekunder.
English: If for any reason you must stop the treatment before you have finished, press and hold the On/Off button for one full second.
Danish: Hvis du af en eller anden grund skal stoppe inhalationen, før du er færdig, skal du trykke på knappen On/Off i et helt sekund.
English: ESBLs from Class A, B and D beta-lactamases may have activity against aztreonam.
Danish: ESBL'er fra klasse A, B og D beta-laktamaser kan have aktivitet over for aztreonam.
English: If Cayston is to be prescribed to the elderly then the posology is the same as for adults.
Danish: Hvis Cayston skal ordineres til ældre, er dosis den samme som til andre voksne.
English: If you get a rash, tell your doctor immediately because this could mean that you have an allergic reaction to Cayston.
Danish: Fortæl det straks til lægen, hvis du får udslæt, fordi det kan betyde, at du har en allergisk reaktion over for Cayston.
English: Patients continued on their baseline medications and whenever indicated additional antibiotics were used in the majority of patients to treat exacerbations.
Danish: Patienterne fortsatte med deres baseline-medicin, og yderligere antibiotika blev anvendt hos størstedelen af patienterne, når det var påkrævet, til at behandle forværringer.
English: Systemically absorbed aztreonam is eliminated about equally by active tubular secretion and glomerular filtration.
Danish: Systemisk absorberet aztreonam elimineres nogenlunde ligeligt ved aktiv tubulær sekretion og glomerulær filtrering.
English: When all of the medicine has been delivered, you will hear a tone that means “treatment complete” (2 beeps).
Danish: Når al medicinen er inhaleret, hører du en lyd, som betyder, at "inhalationen er afsluttet" (2 bip).
English: Cayston is not expected to affect your ability to drive or use machines.
Danish: Cayston forventes ikke at påvirke din evne til at føre motorkøretøj eller bruge maskiner.
English: An association between persistent isolation of MRSA and more severe disease and increased mortality has been reported in the literature.
Danish: En forbindelse mellem vedvarende isolering af MRSA og mere alvorlig sygdom og forøget mortalitet er blevet rapporteret i litteraturen.