FrancophonIA/ELRC3.0 huggingface dataset:
English: What are sweet fennel fruit medicines used for?
Danish: Na co se léčivé přípravky z plodu fenyklu obecného sladkého používají?
English: How are sweet fennel fruit medicines used?
Danish: Jak se léčivé přípravky z plodu fenyklu obecného sladkého používají?
English: The active substance of Myoson is tolperisone hydrochloride, which is a centrally acting muscle relaxant indicated for the symptomatic treatment of post-stroke spasticity in adults.
Danish: Det aktive stof i Myoson er tolperisonhydrochlorid, som er et muskelafslappende middel, der er indiceret til symptomatisk behandling af postapoplektisk spasticitet hos voksne.
English: The marketing authorisation application (MAA) for Myoson was submitted under Article 10(1) of Directive 2001/83/EC (i.e. a generic application), vis-à-vis the reference medicinal product Mydeton (Gedeon Richter Plc).
Danish: Ansøgningen om markedsføringstilladelse for Myoson blev indgivet i henhold til artikel 10, stk. 1, i direktiv 2001/83/EF (dvs. en generisk ansøgning) med Mydeton (Gedeon Richter Plc) som referencelægemiddel.
English: • The Committee reviewed the responses submitted by the applicant to address the issues raised with regard to the bioequivalence of Myoson with respect to the reference medicinal product;
Danish: • udvalget gennemgik ansøgerens besvarelse af de rejste spørgsmål om bioækvivalensen af Myoson med referencelægemidlet,
English: The CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group, for Myoson and associated names (see Annex I).
Danish: anbefalede CHMP udstedelse af markedsføringstilladelsen, for hvilken produktresuméet, etiketteringen og indlægssedlen er uændrede svarende til den endelige version, der er fastlagt ved behandlingen i koordinationsgruppen for Myoson og relaterede navne (se bilag I).
English: • Therefore, the Committee concluded by majority that the bioequivalence studies conducted in the fasting state give sufficient evidence to conclude on the bioequivalence also in the fed state since Myoson contains a highly soluble and highly permeable active substance, and pharmacokinetic principles and convincing experimental evidence suggest that the food effect of this active substance is formulation independent.
Danish: • udvalget konkluderede derfor ved en flertalsafgørelse, at de udførte fastende bioækvivalensundersøgelser giver tilstrækkelig evidens til at drage konklusioner om bioækvivalens også i postprandial tilstand, eftersom Myoson indeholder et højopløseligt og højpermeabelt aktivt stof, og eftersom farmakokinetiske principper og overbevisende eksperimentel evidens viser, at effekten af fødeindtagelse for tolperison er uafhængig af formuleringen,
English: Since the summary of product characteristics (SmPC) of the reference medicinal product did not make any recommendations regarding food and did not mention a food effect, the MAA that was submitted for Myoson included two bioequivalence studies with 50 and 150 mg tolperisone film-coated tablets conducted under fasting conditions with 52 volunteers each.
Danish: Da produktresuméet for referencelægemidlet ikke indeholdt anbefalinger om fødeindtagelse og ikke omtalte en effekt af fødeindtagelse, indeholdt ansøgningen om markedsføringstilladelse for Myoson to bioækvivalensundersøgelser, der blev udført med filmovertrukne tabletter med tolperison, 50 og 150 mg, begge med 52 forsøgspersoner under fastende betingelser.
English: Therefore based on the results of the submitted bioequivalence studies, the CHMP members agreed that Myoson 50 and 150 mg tablets are bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets (Gedeon Richter Plc) under fasting conditions.
Danish: På grundlag af de forelagte bioækvivalensundersøgelse fandt CHMP's medlemmer derfor, at tabletterne med tolperison, 50 og 150 mg ved fastende indtagelse er bioækvivalente med referencelægemidlet Mydeton, tabletter, 50 og 150 mg (Gedeon Richter Plc).
English: • The Committee was of the view that results of the submitted bioequivalence studies showed that Myoson 50 and 150 mg tablets was bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets under fasting conditions;
Danish: • udvalget fandt, at de forelagte bioækvivalensundersøgelse viste, at Myoson, tabletter, 50 og 150 mg, under fastende betingelser var bioækvivalente med referencelægemidlet Mydeton, tabletter, 50 og 150 mg,
English: You may need medical treatment.
Danish: Du kan have brug for medicinsk behandling.
English: Often these are colds, but there have been cases of more severe infections.
Danish: Det vil ofte være forkølelse, men der er set tilfælde af mere alvorlige infektioner.
English: 82377 Penzberg GERMANY
Danish: 82377 Penzberg Tyskland
English: The following side effects have been reported with this medicine:
Danish: Følgende bivirkninger har været rapporteret med dette lægemiddel:
English: · Risk Management Plan (RMP)
Danish: Risikostyringsplan (RMP)
English: This is because for this medicine to be as effective as possible, it is important to follow the dosing schedule.
Danish: For at dette lægemiddel er så effektiv som muligt, er det meget vigtigt at følge behandlingsplanen.
English: However, no notable differences in quality of life during follow up have been identified to date.
Danish: Der er dog til dato ikke observeret tydelige forskelle i livskvalitet i opfølgningsperioden.
English: Poloxamer 188
Danish: Poloxamerer 188
English: Based on your disease status after the initial treatment cycles your doctor will decide whether you will receive treatment in the maintenance phase.
Danish: Baseret på din sygdomsstatus efter de initielle behandlingsserier vil din læge beslutte, om du vil modtage behandling i vedligeholdelsesfasen.
English: Due to the open label design the patient reported outcomes should be interpreted with caution.
Danish: På grund af det open-label design bør de patient-rapporterede resultater fortolkes med forsigtighed.
English: Obinutuzumab is administered intravenously, therefore absorption is not applicable.
Danish: Obinutuzumab administreres intravenøst og derfor er absorptionen ikke relevant.
English: A risk for interactions with other concomitantly used medicinal products cannot be excluded.
Danish: En risiko for interaktioner med andre samtidigt anvendte lægemidler kan ikke udelukkes.
English: From a microbiological point of view, the prepared infusion solution should be used immediately.
Danish: Af mikrobiologiske årsager bør den tilberedte infusionsopløsning anvendes straks.
English: Each cycle lasts 28 days.
Danish: Hver serie varer 28 dage.
English: The diluted solution should not be shaken or frozen.
Danish: Den fortyndede opløsning må ikke rystes eller fryses.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/937/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/937/001
English: Bendamustine N=166
Danish: Bendamustin N=166
English: Standard dosing of CHOP and CVP was given.
Danish: Standard dosering af CHOP og CVP blev givet.
English: Stage 1a
Danish: Stadie 1a
English: If treatment is necessary it should be administered in accordance with local guidelines and the administration of granulocyte-colony stimulating factors (G-CSF) should be considered.
Danish: Hvis behandling er nødvendig, skal den administreres i overensstemmelse med lokale retningslinjer og administration af granulocytkolonistimulerende faktorer (G-CSF) bør overvejes.
English: The affected “B-lymphocytes” multiply too quickly and live too long.
Danish: De påvirkede B-lymfocytter deler sig for hurtigt og lever for længe.
English: The median age was 73 years, with 44% being 75 years or older.
Danish: Medianalder var 73 år; 44% var 75 år eller ældre.
English: Gazyvaro should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Danish: Gazyvaro bør ikke administreres til gravide kvinder med mindre den potentielle fordel opvejer den potentielle risiko.
English: While the clinical significance of HAHA is not known, a potential correlation between HAHA and clinical course cannot be ruled out.
Danish: Mens den kliniske betydning af HAHA ikke er kendt, kan en potentiel sammenhæng mellem HAHA og klinisk forløb ikke udelukkes.
English: These reactions led to unscheduled termination of 6/36 animals treated with obinutuzumab during dosing and recovery phases; these changes were partially reversible.
Danish: Disse reaktioner medførte uplanlagt afslutning af 6/36 dyrs behandling med obinutuzumab under behandlings- og remissionsfaser; disse forandringer var delvist reversible.
English: Any additional guidelines according to standard practice should be followed.
Danish: Enhver yderligere vejledning i henhold til standard praksis bør følges.
English: There are no data from the use of obinutuzumab in pregnant women.
Danish: Der er ingen data vedrørende brug af obinutuzumab til gravide kvinder.
English: The median OS was not yet reached for either arm.
Danish: Den mediane samlede overlevelse var endnu ikke nået i nogen af armene.
English: Pay attention to the following side effects
Danish: Vær særlig opmærksom på følgende bivirkninger
English: This decreasing trend continued during maintenance therapy with Gazyvaro alone.
Danish: Denne faldende tendens fortsatte under vedligeholdelsesbehandlingen med Gazyvaro alene.
English: Fatal infections have been reported.
Danish: Der har været rapporter om dødelige infektioner.
English: The majority of patients were Caucasian (95%) and male (61%).
Danish: De fleste patienter var kaukasere (95%) og mænd (61%).
English: Infusion related reactions can happen during the infusion or up to 24 hours after the infusion.
Danish: De infusionsrelaterede reaktioner kan opstå under infusionen eller op til 24 timer efter infusionen.
English: The demographics data and baseline characteristics were well balanced between the treatment arms.
Danish: Demografiske data og baseline-karakteristika var ligeligt fordelt mellem behandlingsarmene.
English: These can be complemented with other appropriate markers as per local guidelines.
Danish: Disse kan, i overensstemmelse med lokale retningslinjer, suppleres med andre relevante markører.
English: The incidence and intensity of adverse reactions reported in these studies did not appear to be dose dependent.
Danish: Incidens og intensitet af bivirkninger indberettet i disse studier syntes ikke at være dosisafhængige.
English: When these symptoms go away, or improve, the infusion can be continued.
Danish: Når symptomerne forsvinder, eller bedres, kan infusionen fortsætte.
English: Hypersensitivity symptoms can occur after previous exposure and very rarely with the first infusion.
Danish: Overfølsomhedsreaktioner kan forekomme efter tidligere eksponering og meget sjældent ved første infusion.
English: No meaningful differences were seen between the arms in HRQOL or health status measures.
Danish: Ingen betydningsfulde forskelle blev set mellem armene i HRQOL eller målt sundhedsstatus.
English: In the follicular lymphoma studies, a high incidence of infections was observed in all phases of the studies, including follow-up, with the highest incidence seen in the maintenance phase.
Danish: I follikulært lymfom studier blev en høj forekomst af infektioner observeret i alle faser af studierne, herunder opfølgning; med den højeste forekomst af infektioner i vedligeholdelsesfasen.
English: At baseline, 22% of patients had Binet Stage A, 42% had Binet Stage B and 36% had Binet Stage C.
Danish: Ved baseline havde 22% af patienterne Binet stadie A, 42% havde Binet stadie B og 36% havde Binet stadie C.
English: Therefore, no pharmacokinetic interaction is expected with medicinal products known to be metabolised by these enzyme systems.
Danish: Der forventes derfor ingen farmakokinetisk interaktion med lægemidler, der vides at metaboliseres gennem disse enzymsystemer.
English: Antibodies are mostly cleared by catabolism.
Danish: Antistoffer udskilles primært ved katabolisme.
English: #with a higher incidence (difference of ≥ 2% between the treatment arms).
Danish: # Med en højere incidens (en forskel på ≥ 2% mellem behandlingsarmene).
English: Premedication for subsequent infusions and other premedication should be administered as described below.
Danish: Præmedicinering ved efterfølgende infusioner og anden præmedicinering skal administreres som beskrevet nedenfor.
English: Additional safety information from clinical studies experience
Danish: Yderligere erfaringer vedrørende sikkerhed fra kliniske studier
English: · you are allergic to obinutuzumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • du er allergisk over for obinutuzumab eller et af de øvrige indholdsstoffer i lægemidlet (angivet i afsnit 6).
English: Antibodies work by attaching themselves to specific targets in your body.
Danish: Antistofferne virker ved at sætte sig fast bestemte steder i kroppen.
English: Consideration should be given to the need for regular monitoring of blood cell count and for increased risk of infections while patients are B-cell depleted.
Danish: Der bør overvejes om der er behov for jævnlig monitorering af blodværdier og for øget infektionsrisiko mens patienter er B-celle-depleterede.
English: In such instances, all subsequent visits and the start of Cycle 2 will be shifted to accommodate for the delay in Cycle 1.
Danish: I sådanne tilfælde vil alle efterfølgende besøg og begyndelsen af 2. behandlingsserie blive rykket for at tilpasses forsinkelsen i 1. behandlingsserie.
English: In addition these patients should be hydrated with caution in order to prevent a potential fluid overload.
Danish: Derudover bør disse patienter hydreres med forsigtighed for at undgå væskeoverskud.
English: Exposure in utero to obinutuzumab and vaccination of infants with live virus vaccines
Danish: Obinutuzumab-eksponering in utero og vaccination af spædbørn med levende vacciner
English: A post hoc analysis was performed 8 months after the primary analysis data cut.
Danish: En post-hoc analyse blev udført 8 måneder efter skæringsdato for den primære dataanalyses.
English: Gazyvaro will be stored by the healthcare professionals at the hospital or clinic.
Danish: Gazyvaro opbevares af sundhedspersonalet på hospitalet eller klinikken.
English: These reactions are more likely to happen with the first infusion.
Danish: Det er mest sandsynligt, at reaktionerne opstår under den første infusion.
English: This is indicative of target mediated drug disposition (TMDD), where the initial abundance of CD20 cells causes a rapid removal of obinutuzumab from the circulation.
Danish: Dette indikerer target-medieretlægemiddel-disposition (TMDD), hvor den initiale overflod af CD20-celler forårsager hurtig fjernelse af obinutuzumab fra cirkulationen.
English: For subgroups, reduction of the risk of disease progression or death ranged from 92% to 58% for GClb versus Clb and 72% to 29% for GClb versus RClb.
Danish: I subgrupperne spændte reduktionen af risiko for sygdomsprogression eller død fra 92% til 58% for GClb versus Clb og fra 72% til 29% for GClb versus RClb
English: The incidence of prolonged neutropenia and late onset neutropenia was 3% and 7%, respectively.
Danish: Incidensen af forlænget neutropeni og sent opstået neutropeni var hhv. 3 % og 7 %.
English: Gazyvaro was administered prior to chemotherapy.
Danish: Gazyvaro blev administreret før kemoterapi.
English: Fifty-seven percent received bendamustine, 33% received CHOP, and 10% received CVP chemotherapy.
Danish: 57 % fik bendamustin, 33 % fik CHOP, og 10 % fik CVP kemoterapi.
English: Patients should continue to receive repeated prophylaxis prior to each subsequent infusion, if deemed appropriate.
Danish: Patienten bør fortsætte med at få profylaktisk behandling inden hver efterfølgende infusion, hvis det skønnes nødvendigt.
English: In the QLQC30 and QLQ-CLL-16 questionnaires conducted during the treatment period, no substantial difference in any of the subscales was observed.
Danish: I QLQC30- og QLQ-CLL-16-spørgeskemaerne, der blev udfyldt i behandlingsperioden, sås ingen betydelige forskelle i nogen af underkategorierne.
English: Gazyvaro can cause some serious side effects that you need to tell your doctor or nurse about straight away.
Danish: Gazyvaro kan give alvorlige bivirkninger, som du straks skal informere lægen eller sundhedspersonalet om.
English: Day 2 (or Day 1 continued)
Danish: 2. dag (eller 1. dag fortsat)
English: This is because there is no information about its use in these age groups.
Danish: Der er ingen information om brug af denne medicin i denne aldersgruppe.
English: Worsening of pre-existing cardiac conditions
Danish: Forværring af eksisterende hjertesygdom
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: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af PSUR'er for dette lægemiddel er på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevar hætteglasset i køleskab Må ikke fryses
English: Based on the FACT-Lym questionnaire and EQ-5D index scale collected during the treatment and during follow-up periods, health-related quality of life was generally maintained in the pivotal study with no meaningful difference between the arms.
Danish: Baseret på FACT-Lym spørgeskemaet samt EQ-5D indeks-skalaen, der blev indsamlet under behandlingen og i opfølgningsperioderne, blev helbredsrelateret livskvalitet generelt opretholdt i det pivotale studie uden betydningsfuld forskel mellem behandlingsarmene.
English: Patients with active hepatitis B disease should not be treated with Gazyvaro.
Danish: Patienter med aktiv hepatitis B bør ikke behandles med Gazyvaro.
English: At a minimum this should include hepatitis B surface antigen (HBsAg) status and hepatitis B core antibody (HBcAb) status.
Danish: Dette bør som minimum omfatte hepatitis B-overfladeantigen (HBsAg)-status og hepatitis B-kerneantistof (HBcAb)-status.
English: Gazyvaro can be used in adults to treat two different types of cancer
Danish: Gazyvaro kan bruges til at behandle to forskellige former for kræft hos voksne
English: A therapy choice for these patients should carefully consider the overall safety profile of Gazyvaro plus chemotherapy and the patient-specific situation.
Danish: Valg af behandling for disse patienter skal grundig overvejes med hensyntagen til den samlede sikkerhedsprofil for Gazyvaro plus kemoterapi samt den enkelte patients specifikke situation.
English: Do not increase the infusion rate.
Danish: Infusionshastigheden må ikke øges.
English: Induction phase
Danish: Induktionsfase
English: Dose delays should be considered in case of severe or life-threatening neutropenia.
Danish: Dosisforsinkelse bør overvejes i tilfælde af svær eller livstruende neutropeni.
English: For these reasons, comparison of incidence of antibodies to Gazyvaro with the incidence of antibodies to other products may be misleading.
Danish: Sammenligning af forekomst af antistoffer mod Gazyvaro med forekomst af antistoffer mod andre lægemidler kan derfor være vildledende.
English: If toxicity occurs before Cycle 1 Day 8 or Cycle 1 Day 15, requiring delay of treatment, these doses should be given after resolution of toxicity.
Danish: Hvis der forekommer toksicitet før 1. behandlingsserie 8. dag eller 1. behandlingsserie 15. dag, og som kræver forsinkelse af behandling, bør disse doser gives efter toksiciteten er forsvundet.
English: Median was not reached at time of analysis # not adjusted for multiplicity **Assessed as per modified Cheson 2007 criteria ‡ End of Induction = end of induction phase, does not include monotherapy maintenance
Danish: Median var ikke nået ved tidspunktet af analyse # ikke justeret for multipel testing ** Vurderet per modificerede Cheson 2007 kriterier ‡ Endt induktionsbehandling = endt induktionsfase, inkluderer ikke monoterapi vedligeholdelsesbehandling
English: The safety and efficacy of Gazyvaro in children and adolescents aged below 18 years has not been established.
Danish: Sikkerhed og virkning af Gazyvaro hos børn og unge under 18 år gamle er ikke klarlagt.
English: No significant difference was observed in the pharmacokinetics of obinutuzumab among patients < 65 years (n=375), patients between 65-75 years (n=265) and patients > 75 years (n=171).
Danish: Der sås ingen signifikant forskel i obinutuzumabs farmakokinetik blandt patienter <65 år (n=375), patienter mellem 65 og 75 år (n=265) og patienter >75 år (n=171).
English: The B-cell counts returned to normal levels, and immunologic function was restored within 6 months post-partum.
Danish: B-celleværdier steg til normale niveauer og den immunologiske funktion reetableredes inden for 6 måneder postpartum.
English: Recovery of B-cells was observed within 12-18 months of follow up in 35% (14 out of 40) of patients without progressive disease and 13% (5 out of 40) with progressive disease.
Danish: Genopretning af B-celle værdier sås inden for 12-18 måneders opfølgning hos 35% (14 ud af 40) af patienterne uden progressiv sygdom og 13% (5 ud af 40) af patienterne med progressiv sygdom.
English: You must not be given Gazyvaro if:
Danish: Du får ikke Gazyvaro, hvis:
English: During maintenance, maintain the original dosing schedule for subsequent doses.
Danish: Under vedligeholdelsesbehandling skal det oprindelige doseringsskema for efterfølgende doser følges.
English: During the initial treatment, the non-linear time-varying clearance pathway is dominant and is consequently the major clearance pathway.
Danish: Under den initiale behandling, er den non-lineære, tidsvarierende clearance dominerende og dermed den primære clearancevej.
English: Obinutuzumab elimination comprises two parallel pathways which describe clearance, a linear clearance pathway and a non-linear clearance pathway which changes as a function of time.
Danish: Elimination af obinutuzumab omfatter 2 parallelle metaboliseringsveje, der beskriver clearance, en lineær clearancevej og en non-lineær clearancevej, der ændrer sig som funktion aftiden.
English: For instructions on dilution of Gazyvaro before administration, see below.
Danish: For instruksioner vedrørende fortynding af Gazyvaro før administration, se forneden.
English: No specific dose recommendations can be made.
Danish: Der findes ingen specifikke dosisanbefalinger.
English: Late onset neutropenia (occurring >28 days after the end of treatment) or prolonged neutropenia (lasting more than 28 days after treatment has been completed/stopped) may occur.
Danish: Sent indsættende neutropeni (28 dage efter endt behandling) eller forlænget neutropeni (varende mere end 28 dage efter behandlingen er gennemført/afbrudt)kan også forekomme.
English: Day 15
Danish: 15. dag
English: It is strongly recommended that patients with severe neutropenia lasting more than 1 week receive antimicrobial prophylaxis throughout the treatment period until resolution to Grade 1 or 2.
Danish: Det anbefales kraftigt, at patienter med svær neutropeni, der varer længere end 1 uge, får antimikrobiel profylakse gennem hele behandlingsperioden, indtil sværhedsgraden er nede på grad 1 eller 2.
English: Discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy should also be considered.
Danish: Seponering eller reduktion af samtidig kemoterapi eller immunsuppressiv behandling bør overvejes.
English: Instructions on the rate of infusion are shown in Tables 4 and 5.
Danish: Instruksioner vedrørende infusionshastigheden er vist i tabel 4 og 5.
English: No experience with overdose is available from human clinical studies.
Danish: Der er ingen erfaring med overdosis fra kliniske studier i mennesker.