FrancophonIA/ELRC3.0 huggingface dataset:
English: Keep the vial of powder in the outer carton in order to protect from light After reconstitution, use immediately or within 8 hours if stored in a refrigerator
Danish: Efter rekonstitution skal vaccinen anvendes straks eller inden for 8 timer, hvis den opbevares i køleskab.
English: Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) + 1 needle.
Danish: 1 enkeltdosishætteglas (pulver) + 1 fyldt sprøjte (solvens) + 1 kanyle.
English: not less than 1x10
Danish: ikke under 1x10 3 CCID50*
English: Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) without needle.
Danish: 1 enkeltdosishætteglas (pulver) + 1 fyldt sprøjte (solvens) uden kanyle.
English: Persons who are breast-feeding or intend to breast-feed should tell the doctor.
Danish: Fortæl det til Deres læge, hvis De ammer eller har til hensigt at amme.
English: • Deafness.
Danish: • Døvhed.
English: Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) with needle.
Danish: 1 enkeltdosishætteglas (pulver) + 1 fyldt sprøjte (solvens) med kanyle.
English: Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) + 2 needles.
Danish: 1 enkeltdosishætteglas (pulver) + 1 fyldt sprøjte (solvens) + 2 kanyler.
English: Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00 msdromania@merck.com
Danish: Tel: + 4021 529 29 00 msdromania@merck.com
English: M-M-RVAXPRO - Powder in vial and solvent in prefilled syringe with attached needle - Pack of
Danish: M-M-RVAXPRO - Pulver i hætteglas og solvens i fyldt sprøjte med påsat kanyle Pakning a 1, 10 stk
English: This is expected and may last for a few months.
Danish: Dette forventes og kan vare i et par måneder.
English: Age ≥ 65 years
Danish: Alder ≥ 65 år
English: Then take your next dose as usual.
Danish: Tag dernæst din næste dosis som sædvanligt.
English: This generally does not mean that your blood cancer is getting worse.
Danish: Det betyder sædvanligvis ikke, at din blodkræft er blevet værre.
English: This list is not exhaustive and is intended to serve as guidance only.
Danish: Denne liste er ikke udtømmende, og den er kun beregnet til at være vejledende.
English: The median duration of response (DOR) has not been reached.
Danish: Medianen for varighed af responset (DOR) er ikke nået.
English: Date of first authorisation: 18 September 2014 Date of latest renewal: 30 April 2019
Danish: Dato for første markedsføringstilladelse: 18. september 2014 Dato for seneste fornyelse: 30. april 2019
English: Talk to your doctor about what your test results mean.
Danish: Tal med lægen om, hvad dine testresultater betyder.
English: Progression free survival (%)
Danish: Progressionsfri overlevelse (%)
English: Do not give this medicine to children and adolescents under 18 years of age because it has not been studied in this age group.
Danish: Giv ikke dette lægemiddel til børn og unge under 18 år, da det ikke er undersøgt til denne aldersgruppe.
English: N at risk (Events)
Danish: N med risiko (hændelser)
English: This is to check that you do not have an infection, that your liver is working properly, and that your blood counts are normal.
Danish: Dette er for at kontrollere, at du ikke har en infektion, at din lever fungerer korrekt, og at dine blodtal er normale.
English: STOP taking Zydelig and seek medical help immediately if you experience any of the following:
Danish: HOLD OP med at tage Zydelig og søg straks lægehjælp, hvis du oplever noget af følgende:
English: It is very important that you read the package leaflets that are provided with these medicines too.
Danish: Det er meget vigtigt, at du også læser indlægssedlerne, der leveres med disse lægemidler.
English: Your doctor will monitor you for evidence of infection.
Danish: Din læge vil monitorere dig for tegn på infektion.
English: There is no information about the safety of this medicine in pregnant women.
Danish: Der er ingen information om sikkerheden af dette lægemiddel til gravide kvinder.
English: In vitro interaction data
Danish: In vitro interaktionsdata
English: Alternative medicinal products, such as olanzapine, may be considered.
Danish: Andre lægemidler, som f.eks. olanzapin, kan overvejes.
English: • Zydelig should not be used during pregnancy.
Danish: • Zydelig må ikke anvendes under graviditet.
English: • if you have any other medical conditions or illness (especially an infection or fever)
Danish: • hvis du har andre medicinske sygdomme (især en infektion eller feber)
English: • changes in the number of white blood cells
Danish: • ændringer i antallet af hvide blodlegemer
English: Zydelig should not be used with any other medicines unless your doctor has told you it is safe to do so.
Danish: Zydelig bør ikke anvendes sammen med andre lægemidler, medmindre lægen har fortalt dig, at det er sikkert at gøre det.
English: Tell your doctor right away at the first sign of diarrhoea.
Danish: Fortæl det straks til lægen ved det første tegn på diarré.
English: Zydelig can be taken with or without food.
Danish: Zydelig kan tages med eller uden mad.
English: < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from available data).
Danish: < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If necessary, your doctor may decide to stop treatment for a while, before starting treatment again at the same or a lower dose.
Danish: Hvis det er nødvendigt, kan din læge beslutte sig for at stoppe behandlingen i et stykke tid, før behandlingen startes igen med den samme eller en lavere dosis.
English: INFORMATION IN BRAILLE 17.
Danish: INFORMATION I BRAILLESKRIFT 17.
English: The analysis of PFS was based on evaluation by an IRC.
Danish: Analysen af PFS var baseret på evaluering af en IRC.
English: Zydelig is for oral use.
Danish: Zydelig er til oral anvendelse.
English: Keep the bottle and this leaflet with you so that you can easily describe what you have taken.
Danish: Tag tabletbeholderen og denne indlægsseddel med dig, så du let kan beskrive, hvad du har taget.
English: For pulmonary arterial hypertension:
Danish: For pulmonal arteriel hypertension:
English: → Talk to your doctor if this applies to you.
Danish: → Kontakt lægen, hvis dette gælder dig.
English: DOR was a secondary endpoint and was defined as the time from the first documented response (CR, PR, or MR) to the first documentation of disease progression or death from any cause.
Danish: DOR var et sekundært endepunkt, og det blev defineret som tiden fra det første dokumenterede respons (CR, PR eller MR) til den første dokumentation af sygdomsprogression eller død af enhver årsag.
English: However, your doctor may reduce this dose to 100 mg twice a day if you experience particular side effects.
Danish: Din læge kan imidlertid reducere denne dosis til 100 mg to gange dagligt, hvis du oplever særlige bivirkninger.
English: The median time since diagnosis was 7.7 years.
Danish: Mediantiden fra diagnosticering var 7,7 år.
English: Adverse reactions are listed by system organ class and frequency.
Danish: Bivirkningerne er opstillet efter systemorganklasse og hyppighed.
English: The median time from diagnosis of CLL to randomisation was 8.5 years.
Danish: Mediantiden fra diagnose af CLL til randomisering var 8,5 år.
English: The median number of prior therapies was 3.0.
Danish: Medianen for antal tidligere behandlinger var 3,0.
English: Effects on embryo-foetal development were not investigated in a second species.
Danish: Virkningerne på embryoføtal udvikling blev ikke undersøgt i en anden dyreart.
English: Any grade
Danish: Alle grader
English: Tell your doctor:
Danish: Fortæl det til lægen:
English: Because this enzyme is overactivated in certain cancerous white blood cells, by blocking it, Zydelig will kill and reduce the number of cancer cells.
Danish: Da dette enzym er overaktiveret i visse kræftagtige hvide blodlegemer, vil Zydelig ved at blokere det dræbe og reducere antallet af kræftceller.
English: Grade ≥ 3
Danish: Grad ≥ 3
English: Taking Zydelig with certain medicines may stop them working properly, or may make side effects worse.
Danish: Hvis du tager Zydelig sammen med visse lægemidler, kan det stoppe dem fra at virke korrekt, eller det kan gøre bivirkninger værre.
English: Malformations were observed at exposures from 12 times the human exposure based on AUC.
Danish: Der blev observeret misdannelser ved eksponeringer fra 12 gange den humane eksponering baseret på AUC.
English: Your doctor may also decide to permanently stop treatment with Zydelig.
Danish: Din læge kan også beslutte sig for at stoppe behandlingen med Zydelig permanent.
English: Serious and fatal infections have occurred in patients taking Zydelig.
Danish: Der er forekommet alvorlige og dødelig infektioner hos patienter, som tager Zydelig.
English: Contact your doctor or nearest emergency department immediately for advice.
Danish: Kontakt øjeblikkeligt lægen eller den nærmeste skadestude for rådgivning.
English: Peeling away of the skin may lead to serious infection.
Danish: Afskalning af huden kan føre til alvorlig infektion.
English: In general, B-lymphocyte dependent areas were more affected than T-lymphocyte dependent areas.
Danish: Generelt var B-lymfocytafhængige områder mere påvirkede end T-lymfocytafhængige områder.
English: Investigations Increased triglycerides
Danish: Undersøgelser Forhøjede triglycerider
English: Treatment should be continued until disease progression or unacceptable toxicity.
Danish: Behandlingen bør fortsættes indtil sygdomsprogression eller uacceptabel toksicitet.
English: Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioural signs or symptoms.
Danish: Læger bør overveje PML i differentialdiagnosen hos patienter med nye eller forværrende neurologiske, kognitive eller adfærdsmæssige tegn eller symptomer.
English: For erectile dysfunction:
Danish: Til erektil dysfunktion:
English: Patients should be advised to report new respiratory symptoms promptly.
Danish: Patienterne skal informeres om straks at rapportere nye respiratoriske symptomer.
English: Monitor ANC at least weekly.
Danish: Monitorér ANC mindst én gang ugentligt.
English: The primary endpoint was PFS. Efficacy results are summarised in Tables 5 and 6.
Danish: Det primære endepunkt var PFS. Virkningsresultaterne er opsummeret i tabel 5 og 6.
English: Idelalisib is 93% to 94% bound to human plasma proteins at concentrations observed clinically.
Danish: Idelalisib er 93 - 94 % bundet til humane plasmaproteiner ved koncentrationer der observeres klinisk.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: UNIK IDENTIFIKATOR - MENNESKELIGT LÆSBAR DATA
English: You will need regular blood tests before and during treatment with Zydelig.
Danish: Du vil have behov for at få taget regelmæssige blodprøver før og under behandlingen med Zydelig.
English: Ask your doctor if you have any questions about any of your medicines.
Danish: Spørg lægen, hvis du har spørgsmål om nogle af dine lægemidler.
English: Tell your doctor right away if you become ill (especially with a fever, cough or breathing difficulties) while you are taking Zydelig.
Danish: Kontakt straks din læge, hvis du bliver syg (især med feber, hoste eller vejrtrækningsbesvær), mens du tager Zydelig.
English: SJS or TEN occurred within one month of the medicinal combination and fatal outcomes have resulted.
Danish: SJS eller TEN forekom inden for en måned efter administration af lægemiddelkombinationen, og er resulteret i dødelig udgang.
English: Assessment of adverse reactions is based on two Phase 3 studies (study 312-0116 and study 312-0119) and six Phase 1 and 2 studies.
Danish: Vurderingen af bivirkninger er baseret på to fase 3-studier (studie 312-0116 og studie 312-0119) og seks fase 1- og fase 2-studier.
English: This is extremely important, as using more than one medicine at the same time can strengthen or weaken their effect.
Danish: Dette er yderst vigtigt, da lægemidlernes virkning kan forstærkes eller svækkes, hvis der bruges mere end ét lægemiddel på samme tid.
English: One hundred and twelve (89.6%) subjects were refractory to their last regimen prior to study entry.
Danish: Et hundrede og tolv (89,6 %) patienter var refraktære til deres sidste behandlingsprogram, før de indgik i studiet.
English: ALPHA-1 ADRENORECEPTOR ANTAGONISTS
Danish: ALFA 1-ADRENORECEPTORANTAGONISTER
English: Tell your doctor immediately if you notice or someone notices in you: memory loss, trouble thinking, difficulty walking or sight loss - these may be due to a very rare but serious brain infection which can be fatal (progressive multifocal leukoencephalopathy or PML).
Danish: Fortæl straks lægen, hvis du eller andre bemærker, at du har: hukommelsestab, problemer med at tænke, gangbesvær eller synstab - dette kan skyldes en meget sjælden men alvorlig hjerneinfektion, der kan være dødelig (progressiv multifocal leukoencephalopati eller PML).
English: Laboratory tests may show an increase in white blood cells (called “lymphocytes”) in your blood in the first few weeks of treatment.
Danish: Laboratorieundersøgelser vil muligvis vise en stigning i antallet af hvide blodlegemer (“kaldet lymfocytter”) i dit blod i de første par uger med behandling.
English: The apparent volume of distribution for idelalisib (mean) was approximately 96 L.
Danish: Det tilsyneladende fordelingsvolumen for idelalisib (gennemsnit) var ca. 96 l.
English: The primary endpoint was progression free survival (PFS).
Danish: Det primære endepunkt var progressionsfri overlevelse (PFS, progression free survival).
English: Tell your doctor if you have problems swallowing tablets.
Danish: Fortæl det til lægen, hvis du har problemer med at sluge tabletter.
English: Patients should be monitored for respiratory signs and symptoms throughout treatment.
Danish: Patienterne skal monitoreres for respiratoriske tegn og symptomer under hele behandlingsforløbet.
English: Treatment of overdose with Zydelig consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Danish: Behandling af en overdosis med Zydelig består af generel støttende behandling, herunder overvågning af vitale tegn og observation af patientens kliniske tilstand.
English: Idelalisib induced inflammatory changes in both rats and dogs.
Danish: Idelalisib inducerede inflammatoriske ændringer hos både rotter og hunde.
English: You should take additional medicine provided by your doctor while you are taking Zydelig to prevent one type of infection.
Danish: Du skal tage ekstra medicin, som din læge vil ordinere, mens du tager Zydelig, for at forebygge en type infektion.
English: The mean blood-to-plasma concentration ratio was approximately 0.5.
Danish: Det gennemsnitlige koncentrationsforhold mellem blod og plasma var ca. 0,5.
English: For patients with CrCl < 60 mL/min, alternative antibacterials should be considered.
Danish: For patienter med CrCl < 60 ml/min bør alternative antibakterielle midler overvejes.
English: Zydelig may be used for the treatment of two different cancers in adults:
Danish: Zydelig kan anvendes til behandling af to forskellige kræftsygdomme hos voksne:
English: In many instances the pathogen was not identified; however, both conventional and opportunistic pathogens, including PJP and CMV, were among those identified.
Danish: I mange tilfælde blev patogenet ikke identificeret, dog var konventionelle og opportunistiske patogener, herunder PJP og CMV, blandt de identificerede.
English: Idelalisib is not considered to have broad immunosuppressive activity.
Danish: Idelalisib anses ikke for at have en bred immunosuppressiv aktivitet.
English: Zydelig is a cancer medicine that contains the active substance idelalisib.
Danish: Zydelig er et lægemiddel mod kræft, som indeholder det aktive stof idelalisib.
English: • midazolam, triazolam, when taken by mouth to help you sleep and/or relieve anxiety
Danish: • midazolam, triazolam, når det tages gennem munden, til at hjælpe dig med at sove og/eller lindre angst
English: Patients should be instructed to swallow the tablet whole.
Danish: Patienterne skal instrueres i at sluge tabletten hel.
English: Subjects had a median Cumulative Illness Rating Scale (CIRS) score of 8.
Danish: Patienterne havde en median Cumulative Illness Rating Scale (CIRS) score på 8.
English: If you are currently breast-feeding, talk to your doctor before starting treatment.
Danish: Hvis du i øjeblikket ammer, skal du kontakte lægen, før du starter behandlingen.
English: Talk to your doctor before taking Zydelig.
Danish: Kontakt lægen, før du tager Zydelig.
English: If you accidentally take more than the recommended dose of Zydelig, you may be at increased risk of side effects with this medicine (see section 4, Possible side effects).
Danish: Hvis du ved et uheld tager mere end den anbefalede dosis Zydelig, kan du have en øget risiko for bivirkninger med dette lægemiddel (se punkt 4, Bivirkninger).
English: ENDOTHELIN RECEPTOR ANTAGONISTS
Danish: ENDOTELIN-RECEPTORANTAGONISTER
English: Other side effects Very common side effects
Danish: Andre bivirkninger Meget almindelige bivirkninger
English: In particular, tell your doctor if you are taking any of the following:
Danish: Du skal især fortælle det til lægen, hvis du tager nogle af de følgende lægemidler:
English: In this disease, the lymphocytes multiply too quickly and live for too long, so that there are too many of them circulating in the blood.
Danish: Ved denne sygdom deler lymfocytterne sig for hurtigt og lever for længe, så der cirkulerer for mange af dem i blodet.
English: The carcinogenicity potential of idelalisib was evaluated in a 26-week transgenic RasH2 mouse study and a 2-year rat study.
Danish: Idelalisibs potentielle karcinogenicitet blev evalueret i et 26-ugers transgent RasH2 musestudie og et 2-årigt rottestudie.
English: INHALED BETA AGONIST
Danish: INHALERET BETA-AGONIST
English: Treatment with Zydelig should be conducted by a physician experienced in the use of anti-cancer therapies.
Danish: Behandling med Zydelig bør udføres af en læge med erfaring i anvendelsen af anticancerbehandling.
English: Nearly all (95.9%) subjects had received prior anti-CD20 monoclonal antibodies.
Danish: Næsten alle (95,9 %) patienter havde tidligere fået anti-CD20 monoklonale antistoffer.
English: Female fertility was not affected in rats.
Danish: Fertiliteten hos hunner blev ikke påvirker hos rotter.
English: The median OS, including long-term follow-up for all 125 subjects, was 48.6 months.
Danish: Medianen for OS, herunder langvarig opfølgning for alle 125 patienter, var 48,6 måneder.
English: It works by blocking the effects of an enzyme involved in multiplication and survival of certain white blood cells called lymphocytes.
Danish: Det virker ved at blokere virkningerne af et enzym, som er involveret i multiplikationen og overlevelsen af visse hvide blodlegemer, som kaldes lymfocytter.
English: The safety and efficacy of Zydelig in children under the age of 18 years have not been established.
Danish: Pædiatrisk population Zydeligs sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: In vitro, the CYP3A4 inhibition was irreversible, and return to normal enzyme activity is therefore expected to take several days after stopping idelalisib administration.
Danish: In vitro var CYP3A4-hæmningen irreversibel, og det forventes derfor at tage flere dage at vende tilbage til normal enzymaktivitet efter administrationen af idelalisib stoppes.
English: It is not known whether the active substance in Zydelig passes into human milk.
Danish: Det er ukendt, om det aktive stof i Zydelig udskilles i human mælk.
English: It is currently unknown whether idelalisib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method as a second form of contraception.
Danish: Det er aktuelt ukendt, om idelalisib kan reducere effektiviteten af hormonel kontraception, og derfor skal kvinder, der bruger hormonel kontraception, tilføje en barrieremetode, som ekstra kontraception.
English: Clinical monitoring is recommended and a lower starting dose of atorvastatin may be considered.
Danish: Klinisk overvågning anbefales, og en lavere startdosis af atorvastatin kan overvejes.
English: Clinical monitoring is recommended for increased signs/symptoms of corticosteroid effects.
Danish: Klinisk overvågning anbefales for øgede tegn/symptomer på kortikosteroidvirkninger.
English: ↑ serum concentrations Dose reductions of colchicine may be required.
Danish: ↑ serumkoncentrationer Dosisreduktion af colchicin kan være nødvendig.
English: Further investigation of this topic in current B-cell malignancy studies is not planned.
Danish: Der er ikke planlagt yderligere undersøgelser af dette emne i de igangværende studier af B-celle-malignitet.
English: Efficacy results are summarised in Tables 3 and 4.
Danish: Virkningsresultaterne er opsummeret i tabel 3 og 4.
English: Unchanged idelalisib accounted for 23% of total radioactivity recovered in urine over 48 hours and 12% of total radioactivity recovered in faeces over 144 hours.
Danish: Uændret idelalisib udgjorde 23 % af den totale radioaktivitet, der blev genfundet i urinen i løbet af 48 timer, og 12 % af den totale radioaktivitet, der blev genfundet i fæces i løbet af 144 timer.
English: Based on findings in animals, idelalisib may cause foetal harm.
Danish: Baseret på fund hos dyr kan idelalisib forårsage fosterskade.
English: Subjects had a median CIRS score of 4.
Danish: Patienterne havde en median CIRS-score på 4.
English: Tell your doctor right away:
Danish: Fortæl det straks til lægen:
English: Efficacy results are summarised in Table 7.
Danish: Virkningsresultater er opsummeret i tabel 7.
English: FL subset (N=72) n (%)
Danish: FL undergruppe (N = 72) n (%)
English: Concentration monitoring of sedatives/hypnotics is recommended and dose reduction may be considered.
Danish: Monitorering af koncentrationen af sedativa/hypnotika anbefales, og dosisreduktion kan overvejes.
English: Your doctor will check your blood counts before or during treatment with Zydelig and in rare cases they may need to give you another medicine.
Danish: Din læge vil kontrollere dine blodtal før eller under behandling med Zydelig og i sjældne tilfælde vil lægen give dig et andet lægemiddel.
English: Degeneration of the seminiferous tubules in the testes was observed in 2- to 13-week repeated dose studies in dogs and rats, but not in studies of 26 weeks and longer duration.
Danish: Degeneration af de seminiferuse tubuli i testiklerne blev observeret i 2 til 13 ugers studier med gentagne doser hos hunde og rotter, men ikke i studier, der varede 26 uger eller længere.
English: This observed lymphocytosis is a pharmacodynamic effect and should not be considered progressive disease in the absence of other clinical findings.
Danish: Denne observerede lymfocytose er en farmakodynamisk virkning og skal ikke betragtes som progressiv sygdom ved fravær af andre kliniske fund.
English: Zydelig can cause severe diarrhoea.
Danish: Zydelig kan forårsage svær diarré.
English: Table 7: Summary of efficacy in Study 101-09 (IRC assessment) Characteristic
Danish: Tabel 7: Oversigt over virkning i studie 101-09 (IRC-vurdering) Karakteristik
English: In CLL Zydelig treatment is used in combination with another medicine (rituximab) in patients who have certain high-risk factors or in patients whose cancer has come back after at least one previous treatment.
Danish: Ved CLL anvendes Zydelig sammen med et andet lægemiddel (rituximab) hos patienter med visse højrisiko-faktorer og hos patienter, hvor kræften er vendt tilbage efter mindst én tidligere behandling.
English: Nearly all PJP infections, including fatal cases, occurred in the absence of PJP prophylaxis.
Danish: Næsten alle PJP-infektioner, herunder tilfælde med dødelig udgang, opstod uden PJP-profylakse.