FrancophonIA/ELRC3.0 huggingface dataset:
English: The medicine packs containing Imnovid capsules will carry a warning on the risk of severe birth defects.
Danish: De lægemiddelpakninger, der indeholder Imnovid-kapsler, skal påføres en advarsel om risikoen for alvorlige fosterskader.
English: Why is Imnovid authorised in the EU?
Danish: Hvorfor blev Imnovid godkendt i EU?
English: Imnovid contains the active substance pomalidomide.
Danish: Imnovid indeholder det aktive stof pomalidomid.
English: What are the risks associated with Imnovid?
Danish: Hvilke risici er der forbundet med Imnovid?
English: Multiple myeloma is rare, and Imnovid was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 October 2009.
Danish: Multipel myeloma er sjælden, og Imnovid blev udpeget som (lægemiddel til sjældne sygdomme) den 8. oktober 2009.
English: The company will also set up a registry of patients treated with Imnovid to monitor the side effects reported and whether the medicine is used for its approved indication and in compliance with the pregnancy-prevention programme.
Danish: Virksomheden vil desuden oprette et register over patienter, der behandles med Imnovid, for at overvåge de indberettede bivirkninger, og om lægemidlet anvendes til den godkendte indikation og i overensstemmelse med det graviditetsforebyggende program.
English: The Agency also noted that Imnovid's side effects were acceptable for these patients, with side effects similar to those of other medicines of this type.
Danish: Agenturet bemærkede også, at bivirkningerne ved Imnovid kunne tolereres for disse patienter, idet de svarer til bivirkningerne ved andre lægemidler af denne type.
English: Each Member State will also ensure that educational materials and patient cards are provided to prescribers and patients.
Danish: Hver medlemsstat skal desuden sikre, at der udleveres informationsmateriale og patientkort til de ordinerende læger og patienterne.
English: Imnovid plus low-dose dexamethasone was more effective than high-dose dexamethasone alone at delaying the worsening of multiple myeloma.
Danish: Imnovid plus lav dosis-dexamethason var mere effektivt end dexamethason i høj dosis, anvendt alene, til at forhale forværringen af multipel myeloma.
English: The active substance in Imnovid, pomalidomide, is an immunomodulating agent.
Danish: Det aktive stof i Imnovid, pomalidomid, er et immunmodulerende middel.
English: The Agency concluded that Imnovid is effective at delaying the progression of multiple myeloma in patients whose disease has not got better or has come back after previous treatment, who have very limited treatment options.
Danish: Agenturet konkluderede, at Imnovid er effektivt til at forhale udviklingen af multipel myeloma hos patienter, hvis sygdom ikke er blevet bedre, eller hvis sygdom er vendt tilbage efter tidligere behandling, og som har meget begrænsede behandlingsmuligheder.
English: A further study included 559 patients with multiple myeloma who had received at least one treatment including lenalidomide, and whose disease got worse during or after their last treatment.
Danish: Et yderligere studie omfattede 559 patienter med multipel myeloma, som havde modtaget mindst én behandling, herunder lenalidomid, og hvis sygdom blev forværret under eller efter deres seneste behandling.
English: The disease worsened after 16 weeks on average in patients taking Imnovid plus low-dose dexamethasone, compared with 8 weeks in those taking high-dose dexamethasone.
Danish: Sygdommen forværredes efter 16 uger i gennemsnit hos patienter, der tog Imnovid og lav dosis-dexamethason, sammenlignet med 8 uger hos dem, der fik dexamethason i høj dosis.
English: It is taken in the first 2 weeks of 3-week treatment cycles, when given in combination with bortezomib and dexamethasone, and in the first 3 weeks of 4-week treatment cycles when given in combination with dexamethasone only.
Danish: Det tages i de første 2 uger af 3 uger lange behandlingsforløb, når det gives i kombination med bortezomib og dexamethason, og i de første 3 uger af 4 uger lange behandlingsforløb, når det gives i kombination kun med dexamethason.
English: Pomalidomide works in a number of ways in multiple myeloma, similarly to other immunomodulating medicines such as lenalidomide and thalidomide: it blocks the development of tumour cells, prevents the growth of blood vessels within tumours and also stimulates some specialised cells of the immune system to attack the tumour cells.
Danish: Pomalidomid virker på forskellige måder ved multipel myeloma ligesom andre immunomodulerende lægemidler såsom lenalidomid og thalidomid: Det blokerer for udviklingen af tumorceller, forhindrer væksten af blodkar i tumorer og stimulerer desuden specialiserede celler i immunsystemet til at angribe tumorcellerne.
English: Patients treated with Imnovid, bortezomib and low-dose dexamethasone lived on average 11.2 months before their disease got worse, compared with 7.1 months for patients treated with bortezomib and low dose dexamethasone.
Danish: De patienter, der blev behandlet med Imnovid, bortezomib og lav dosis-dexamethason, levede i gennemsnit 11,2 måneder, før deres sygdom blev forværret, sammenlignet med 7,1 måneder for de patienter, der blev behandlet med bortezomib og lav dosis-dexamethason.
English: It is also used in combination with dexamethasone in adults who have received at least two prior therapies, including both lenalidomide and bortezomib, and whose disease has worsened.
Danish: Det anvendes også i kombination med dexamethason til voksne, der har modtaget mindst to forudgående behandlinger, herunder både med lenalidomid og bortezomib, og hvis sygdom er blevet forværret.
English: For the full list of side effects and restrictions with Imnovid, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Imnovid fremgår af indlægssedlen.
English: Imnovid is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow).
Danish: Imnovid er et kræftlægemiddel, der anvendes til at behandle multipel myeloma (knoglemarvskræft).
English: The company will also provide final results from a study with Imnovid in combination with bortezomib and dexamethasone in patients with multiple myeloma who had received at least one treatment including lenalidomide, to confirm the medicine's effect on overall survival.
Danish: Virksomheden skal desuden fremlægge de endelige resultater af et studie med Imnovid i kombination med bortezomib og dexamethason hos patienter med multipel myeloma, der har modtaget mindst én behandling, som omfatter lenalidomid, for at bekræfte lægemidlets virkning på den samlede overlevelse.
English: It is used in combination with bortezomib (another cancer medicine) and dexamethasone (an anti-inflammatory medicine) in adults who have received at least one treatment including lenalidomide (another cancer medicine).
Danish: Det anvendes sammen med bortezomib (et andet lægemiddel mod kræft) og dexamethason (et antiinflammatorisk lægemiddel) til voksne, der har modtaget mindst én behandling, som omfatter lenalidomid (et andet lægemiddel mod kræft).
English: The most common side effects with Imnovid (which affect more than 1 in 10 patients), some of which can be serious, include anaemia (low red blood cell counts), neutropenia (low white blood cell count), tiredness, thrombocytopenia (low platelet counts), fever, peripheral oedema (swelling of the limbs due to fluid retention), peripheral neuropathy (nerve damage causing tingling, pain and numbness in the hands and feet) and infections including pneumonia (infection of the lungs).
Danish: De hyppigste bivirkninger ved Imnovid (som påvirker mere end 1 ud af 10 patienter), hvoraf nogle kan være alvorlige, omfatter anæmi (lavt antal røde blodlegemer), neutropeni (lavt antal hvide blodlegemer), træthed, trombocytopeni (lavt antal blodplader), feber, perifert ødem (hævelse af lemmerne på grund af væskeophobning), perifer neuropati (nerveskader, der medfører en prikkende fornemmelse , smerte og følelsesløshed i hænder og fødder) og infektioner, herunder lungebetændelse (infektion i lungerne).
English: Imnovid has been studied in one main study involving 455 adults with multiple myeloma whose disease did not get better or came back after previous treatments.
Danish: Imnovid er blevet undersøgt i et hovedstudie, der omfattede 455 voksne med multipel myeloma, hvis sygdom ikke havde vist tegn på bedring, eller hvis sygdom ikke var vendt tilbage efter tidligere behandlinger.
English: Treatment with Imnovid must be started and supervised by a doctor experienced in treating multiple myeloma.
Danish: Behandling med Imnovid skal indledes og overvåges af en læge med erfaring i behandling af kræft.
English: Serious side effects, which affect up to 1 in 10 patients, include blood disorders (such as neutropenia, anaemia and thrombocytopenia), lower respiratory tract infection (such as bronchitis or pneumonia), pulmonary embolism (clot in a blood vessel in the lungs), flu, and acute kidney injury.
Danish: Alvorlige bivirkninger, som påvirker op til 1 ud af 10 patienter, omfatter blodsygdomme (f.eks. neutropeni, anæmi og trombocytopeni), infektioner i de nedre luftveje (f.eks. bronkitis eller lungebetændelse), lungeemboli (blodpropper i kar i lungerne), influenza og akut nyreskade.
English: How is Imnovid used?
Danish: Hvordan anvendes Imnovid?
English: What benefits of Imnovid have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Imnovid?
English: Treatment with Imnovid may need to be interrupted or stopped, or the dose reduced, if the disease gets worse or certain side effects occur.
Danish: Hvis sygdommen bliver værre, og patienten mærker visse bivirkninger, kan det være nødvendigt at afbryde eller standse behandlingen med Imnovid eller nedsætte dosis.
English: How does Imnovid work?
Danish: Hvordan virker Imnovid?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imnovid have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Imnovid.
English: It will provide a letter and educational kits for healthcare workers, and brochures for patients, explaining that the medicine is expected to be harmful to the unborn child and detailing the steps needed to use the medicine safely.
Danish: Heri skal det forklares, at lægemidlet forventes at være skadeligt for det ufødte barn, og der skal redegøres nærmere for de forholdsregler, der er nødvendige at følge, for at lægemidlet kan anvendes på sikker vis.
English: These measures will help protect the environment.
Danish: Disse foranstaltninger er med til at beskytte miljøet.
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør produktet anvendes straks.
English: Date of first authorisation: 15 October 2015.
Danish: Dato for første markedsføringstilladelse: 15 oktober 2015
English: This is because it is not known if it may affect or harm your unborn baby.
Danish: Det skyldes, at man ikke ved, om det kan påvirke eller skade det ufødte barn.
English: (Mechanism unknown)
Danish: (mekanisme ukendt)
English: It must be further diluted prior to administration.
Danish: Det skal fortyndes yderligere inden administration.
English: 48 months
Danish: 48 måneder
English: Median treatment duration was 45 days.
Danish: Den gennemsnitlige behandlingsvarighed var 45 dage.
English: The protocol-defined maximum treatment duration was 84 days.
Danish: Den protokoldefinerede maksimale behandlingsvarighed var 84 dage.
English: Usual dose after the first two days
Danish: Den sædvanlige dosis efter de første to dage
English: Susceptibility data were available in only a small subset of cases.
Danish: Følsomhedsdata var kun tilgængelige for en lille undergruppe af tilfælde.
English: A risk to newborns and infants cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes.
English: Capsules length: 24.2 mm.
Danish: Kapsellængde: 24,2 mm.
English: Environmental risk assessment has shown that Cresemba may pose a risk for the aquatic environment.
Danish: Miljørisikovurdering har vist, at CRESEMBA kan udgøre en risiko for vandmiljøet.
English: Other statins were not studied.
Danish: Andre statiner er ikke undersøgt.
English: Effect of food on absorption
Danish: Fødevarers virkning på absorptionen
English: No carcinogenicity studies have been performed.
Danish: Der er ikke udført studier af karcinogeniciteten.
English: The clinical experience in other species is very limited (Lichtheimia spp.
Danish: Den kliniske erfaring med andre arter er meget begrænset (Lichtheimia spp.
English: A stable response was observed in an additional 10/35 patients (28.6%).
Danish: Der blev observeret en stabil respons hos yderligere 10/35 patienter (28,6%).
English: ^ Indicates that grouping of appropriate preferred terms into a single medical concept occurred.
Danish: ^ Viser, at de relevante foretrukne termer er grupperet i et enkelt medicinsk koncept.
English: CRESEMBA is indicated in adults for the treatment of
Danish: CRESEMBA er indiceret hos voksne til behandling af
English: Unnecessary vibration or vigorous shaking of the solution should be avoided.
Danish: Unødvendige vibrationer eller kraftig omrystning af opløsningen skal undgås.
English: This is to make sure that the fungal infection has gone.
Danish: Det er for at sikre, at svampeinfektionen er væk.
English: These patients should be carefully monitored for potential drug toxicity.
Danish: Disse patienter bør monitoreres nøje for potentiel lægemiddeltoksicitet.
English: This is started 12 to 24 hours after your last starting dose.
Danish: Denne dosis startes 12 til 24 timer efter din sidste startdosis.
English: MMF: monitoring for MPArelated toxicities is advised.
Danish: MMF: monitorering for MPArelaterede toksicitet tilrådes.
English: The duration of treatment with Cresemba may be longer than 6 months if your doctor considers this necessary.
Danish: Behandlingen med Cresemba kan vare mere end 6 måneder, hvis lægen anser det for at være nødvendigt.
English: Your doctor may carry out blood tests while you are taking this medicine.
Danish: Lægen vil muligvis tage nogle blodprøver, mens du får dette lægemiddel.
English: There are no data from the use of CRESEMBA in pregnant women.
Danish: Der er ingen data fra anvendelse af CRESEMBA til gravide kvinder.
English: Cresemba should not be used in children or adolescents younger than 18 years because there is no information on use in this age group.
Danish: Cresemba bør ikke anvendes til børn og unge under 18 år, da der ikke findes nogen informationer om anvendelse til denne aldersgruppe.
English: In the event of an overdose, supportive treatment should be instituted.
Danish: I tilfælde af overdosering skal supportiv behandling iværksættes.
English: As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Danish: Da du vil få dette lægemiddel under nøje opsyn, er det usandsynligt, at en dosis bliver glemt.
English: The pharmacokinetics in paediatric patients (< 18 years) have not yet been evaluated.
Danish: Farmakokinetikken hos pædiatriske patienter (< 18 år) er endnu ikke undersøgt.
English: It can also make you pass out.
Danish: Du kan også besvime.
English: Table 1 Interactions
Danish: Tabel 1 Interaktioner
English: EUCAST MIC breakpoints are defined for the following species (susceptible S; resistant R):
Danish: EUCASTs MIC-breakpoints er defineret for følgende arter (følsom S; resistent R):
English: Take the medicine pack with you so the doctor knows what you have taken.
Danish: Tag lægemiddelpakningen med, så lægen kan se, hvad du har taget.
English: CRESEMBA must only be given as an intravenous infusion.
Danish: CRESEMBA må kun gives som en intravenøs infusion.
English: Following single doses of [cyano
Danish: Efter enkelte doser [cyano
English: Delirium includes reactions of confusional state.
Danish: Delirium inkluderer reaktioner med konfusion.
English: Cresemba can sometimes affect your liver function.
Danish: Cresemba kan sommetider påvirke leverfunktionen.
English: Treatment of mucormycosis
Danish: Behandling af mucormycose
English: Intravenous administration of
Danish: Intravenøs administration af
English: Consideration should be given to official guidance on the appropriate use of antifungal agents.
Danish: Man bør være opmærksom på de officielle retningslinier vedrørende korrekt brug af antisvampe midler.
English: Unless otherwise stated, studies detailed in Table 1 have been performed with the recommended dose of CRESEMBA.
Danish: Medmindre andet er oplyst, er studierne i Tabel 1 gennemført med den anbefalede dosis af CRESEMBA.
English: The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); and uncommon (≥1/1,000 to <1/100).
Danish: Bivirkningernes hyppighed defineres således: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10) og ikke almindelig (≥1/1.000 til <1/100).
English: There are currently insufficient data to set clinical breakpoints for other Aspergillus species.
Danish: Der er aktuelt ikke tilstrækkelige data til at fastlægge de kliniske breakpoints for andre Aspergillusarter.
English: Based on these findings, intravenous and oral dosing can be used interchangeably.
Danish: Baseret på disse resultater kan intravenøs og oral dosering anvendes indbyrdes udskifteligt.
English: Potential for CRESEMBA to affect exposures of other medicines
Danish: CRESEMBAs potentiale for at påvirke andre lægemidlers eksponering
English: Reconstituted concentrate should be clear and free of visible particulate.
Danish: Det rekonstituerede koncentrat skal være klart og fri for synlige partikler.
English: The diluted solution should be mixed gently, or the bag should be rolled to minimise the formation of particulates.
Danish: Den fortyndede opløsning skal blandes forsigtigt, eller posen skal rulles for at minimere dannelsen af partikler.
English: % decrease of the mean trough level values b)
Danish: % fald i gennemsnitlige laveste værdier b)
English: Some medicines may affect the way Cresemba works or Cresemba may affect the way they work, if they are taken at the same time.
Danish: Nogle lægemidler kan påvirke den måde, Cresemba virker på, eller Cresemba kan påvirke den måde, lægemidlerne virke på, hvis de tages samtidigt.
English: Except for the active moiety isavuconazole, no individual metabolite was observed with an AUC > 10% of total radio-labelled material.
Danish: Bortset fra den aktive del, isavuconazol, blev der ikke observeret nogen individuelle metabolitter med et AUC på > 10% af det samlede radioaktivt mærkede materiale.
English: Medicinal products renally excreted via transport proteins
Danish: Lægemidler, der udskilles renalt via transportproteiner
English: Switch to intravenous infusion
Danish: Skift til intravenøs infusion
English: Co-administration should be avoided unless the potential benefit is considered to outweigh the risk.
Danish: Samtidig administration bør undgås, medmindre den potentielle fordel anses for at opveje risikoen.
English: Concomitant use with other medicinal products
Danish: Samtidig anvendelse med andre lægemidler
English: There are no data on the effect of isavuconazole on human fertility.
Danish: Der foreligger ingen data vedrørende effekten af isavuconazol på human fertilitet.
English: The safety and efficacy of CRESEMBA in children aged below 18 years has not yet been established.
Danish: CRESEMBAs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Metformin: dose reduction may be required.
Danish: Metformin: Reduktion af dosis kan være nødvendig.
English: The frequency of adverse reactions shown in Table 2 is based on data from 403 patients with invasive fungal infections treated with CRESEMBA in phase 3 studies.
Danish: Hyppigheden af bivirkninger, der vises i Tabel 2, er baseret på data fra 403 patienter med invasive svampeinfektioner, der blev behandlet med CRESEMBA i fase 3-studier.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler, bortset fra dem, der er nævnt i pkt.
English: Oral administration of CRESEMBA equivalent to 400 mg isavuconazole with a high-fat meal reduced isavuconazole Cmax by 9% and increased AUC by 9%.
Danish: Oral administration af CRESEMBA svarende til 400 mg isavuconazol med et fedtholdigt måltid reducerede isavuconazols Cmax med 9% og forhøjede AUC med 9%.
English: If this happens, do not drive or use machines.
Danish: Lad være med at køre bil eller betjene maskiner, hvis det sker.
English: See the end of section 4 for how to report side effects.
Danish: Se sidst i afsnit punkt 4, hvordan du indberetter bivirkninger.
English: Monitoring of adverse reactions typical of statins is advised.
Danish: Monitorering af bivirkninger, der er typiske for statiner, tilrådes.
English: C] isavuconazonium and [pyridinylmethyl
Danish: C] -isavuconazonium og [pyridinylmethyl
English: There is no specific antidote for isavuconazole.
Danish: Der findes ingen specifik antidot mod isavuconazol.
English: The DRC-assessed overall success rate at EOT was 11/35 (31.4%), with 5 patients considered completely cured and 6 patients partially cured.
Danish: Den af DRC-vurderede overordnede succesrate ved behandlingens afslutning (EOT) var 11/35 (31,4%), hvor 5 patienter blev anset for at være helt helbredt og 6 patienter delvis helbredt.
English: This results in an accumulation of methylated sterol precursors and a depletion of ergosterol within the cell membrane, thus weakening the structure and function of the fungal cell membrane.
Danish: Dette medfører akkumulering af methylerede sterolforstadier og depletering af ergosterol inde i svampecellemembranen, så cellemembranens struktur og funktion svækkes.
English: Isavuconazole has a moderate potential to influence the ability to drive and use machines.
Danish: Isavuconazol har moderat potentiale til at påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: If this is not possible, the infusion solution should be immediately refrigerated after dilution, and infusion should be completed within 24 hours.
Danish: Hvis det ikke er muligt, skal infusionsvæsken sættes i køleskab straks efter fortynding, og infusionen skal gennemføres inden for 24 timer.
English: However, tell your doctor or nurse if you think that a dose has been forgotten.
Danish: Du skal dog fortælle det til lægen eller sundhedspersonalet, hvis du mener, at en dosis er blevet glemt.
English: No clear correlation between in vitro MIC and clinical response for the different species (Aspergillus and Mucorales) could be established.
Danish: Der kunne ikke fastlægges nogen tydelig sammenhæng mellem MIC in vitro og den kliniske respons for de forskellige arter (Aspergillus og Mucorales).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er opbevaringstider og -betingelser efter åbning brugerens eget ansvar og bør ikke være mere end 24 timer ved 2 °C til 8 °C, medmindre rekonstitution og fortynding er sket under kontrollerede og validerede aseptiske betingelser.
English: Median treatment duration was 84 days for the overall mucormycosis patient population, and 102 days for the 21 patients not previously treated for mucormycosis.
Danish: Den gennemsnitlige behandlingsvarighed var 84 dage for den samlede population med mucormycosepatienter og 102 dage for de 21 patienter, der ikke tidligere var behandlet for mucormycose.