FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 After reconstitution, each dose (2 ml) contains 1.4-2.5 x 106 chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells .
Danish: 1 Efter blanding indeholder hver dosis (2 ml) kondrogent inducerede equine allogene perifert blod-deriverede mesenkymale stamceller 1,4-2,5 x 106 celler.
English: Packaging Content
Danish: Indgivelsesvej Emballage Indhold Pakningss tørrelse
English: Suspension (plasma): vial (plastic).
Danish: Suspension (plasma): hætteglas (plastik).
English: Horses Intraarticular use Suspension (stem cells): vial (plastic).
Danish: Suspension (stamceller): hætteglas (plastik).
English: 1 vial of stem cell suspension + 1 vial of plasma suspension
Danish: Suspension (plasma): 1 ml hætteglas med stamcelles uspension hætteglas med plasmasus pension
English: Strength Pharmaceutical form
Danish: Særnavn Styrke Lægemiddelform Dyrear ter, som lægemi dlet er beregn et til
English: Target species
Danish: Heste Intraartikulær brug
English: Steady-state was achieved within 2 weeks.
Danish: Steady-state blev opnået inden for 2 uger.
English: No formal statistical comparisons were planned.
Danish: Der var ingen formel statistisk sammenligning planlagt.
English: Date of first authorisation: 03 August 2009 Date of latest renewal: 16 May 2014
Danish: Dato for første markedsføringstilladelse: 3. august 2009 Dato for seneste fornyelse: 16. maj 2014
English: Frequency based upon number of women from 10 to 55 years of age in the pooled data
Danish: Hyppighed baseret på antal kvinder fra 10 til 55 år i de puljede data
English: Plus exemestane b
Danish: Plus exemestan b
English: Includes different bleeding events from different sites not listed individually c
Danish: Inkluderer forskellige tilfælde af blødninger fra forskellige steder, som ikke er anført individuelt c
English: The increase in exemestane levels is unlikely to have an impact on efficacy or safety.
Danish: Det er usandsynligt, at stigningen i exemestan-niveau påvirker virkning eller sikkerhed.
English: Your doctor will tell you how many tablets of Afinitor to take.
Danish: Din læge vil fortælle dig, hvor mange Afinitor-tabletter du skal tage.
English: Reactivation of infection is an expected event during periods of immunosuppression.
Danish: Reaktivering af infektion er en forventet hændelse i perioder med immunsuppression.
English: Open the blister just before taking the tablets.
Danish: Åbn først blisteren lige inden, du tager tabletterne.
English: Your doctor will discuss with you whether you should take this medicine during your pregnancy.
Danish: Din læge vil drøfte med dig, om du skal tage denne medicin under din graviditet.
English: You will have regular blood tests during treatment.
Danish: Du vil regelmæssigt få taget blodprøver i løbet af behandlingen.
English: Single doses of up to 70 mg have been given with acceptable acute tolerability.
Danish: Enkeltdoser på op til 70 mg er blevet givet med acceptabel akut tolerabilitet.
English: The grades follow CTCAE Version 3.0 and 4.03.
Danish: Graderne følger CTCAE Version 3.0 og 4.03.
English: Take Afinitor once a day, at about the same time every day, consistently either with or without food.
Danish: Tag Afinitor en gang om dagen på omtrent samme tidspunkt hver dag og konsekvent altid enten sammen med eller uden mad.
English: Children and adolescents Afinitor is not to be used in children or adolescents (age below 18 years).
Danish: Børn og unge Afinitor må ikke bruges til børn eller unge (under 18 år gamle).
English: CgA: Chromogranin A
Danish: CgA: Kromogranin A
English: The Independent Data Monitoring Committee recommended termination of this trial at the time of the second interim analysis as the primary endpoint had been met.
Danish: Den uafhængige datamonitoreringskomite (The Independent Data Monitoring Committee) anbefalede afbrydelse af dette studie på tidspunktet for den anden interimanalyse, da det primære endepunkt var opfyldt.
English: Afinitor may also: weaken your immune system.
Danish: Afinitor kan også: svække dit immunforsvar.
English: Re-initiate treatment at same dose.
Danish: Genoptag behandlingen ved samme dosis.
English: Kaplan-Meier medians
Danish: Kaplan-Meier medianer
English: The immune response to vaccination may be affected and, therefore, vaccination may be less effective during treatment with Afinitor.
Danish: Immunresponset på vaccination kan påvirkes, og derfor kan vaccination være mindre effektiv under behandling med Afinitor.
English: Probability (%)
Danish: Sandsynlighed (%)
English: In favour of
Danish: Til fordel for
English: Male patients should not be prohibited from attempting to father children.
Danish: Mandlige patienter bør ikke forhindres i at prøve at få børn.
English: Supportive/sensitivity analyses All (local review by investigator)
Danish: Understøttende/sensitivitetsanalyser Alle (lokal gennemgang ved investigator)
English: These metabolites were also identified in animal species used in toxicity studies, and showed approximately 100 times less activity than everolimus itself.
Danish: Disse metabolitter blev også identificeret hos dyrearter, der blev anvendt i toksicitetsstudie, og udviste en ca. 100 gange lavere aktivitet end everolimus selv.
English: Following documented radiological progression, patients could be unblinded by the investigator.
Danish: Efter dokumenteret radiologisk progression kunne patienterne blive ublindede af investigator.
English: Some cases were severe and on rare occasions, a fatal outcome was observed.
Danish: Nogle tilfælde var alvorlige, og der har i sjældne tilfælde været letal udgang.
English: Investigator radiological review a
Danish: Investigators radiologiske vurdering a
English: Talk to your doctor before taking Afinitor: if you have any problems with your liver or if you have ever had any disease which may have affected your liver.
Danish: Kontakt lægen, før du tager Afinitor: hvis du har nogle problemer med din lever, eller hvis du nogensinde har haft en sygdom, som kan have påvirket din lever.
English: If you stop taking Afinitor Do not stop taking Afinitor unless your doctor tells you to.
Danish: Hvis du holder op med at tage Afinitor Hold ikke op med at tage Afinitor, medmindre lægen siger det.
English: There are no adequate data from the use of everolimus in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af everolimus til gravide kvinder.
English: Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Danish: Behandlingen skal fortsættes, så længe der observeres en klinisk gavnlig effekt, eller indtil der opstår uacceptabel toksicitet.
English: Aluminium/polyamide/aluminium/PVC blister containing 10 tablets.
Danish: Aluminium/polyamid/aluminium/PVC-blister indeholdende 10 tabletter.
English: The tablets should not be chewed or crushed.
Danish: Tabletterne må ikke tygges eller knuses.
English: You might need treatment with a mouthwash, gel or other products.
Danish: Du får muligvis behov for at behandle med mundskyllevæske, gel eller andre produkter.
English: Afinitor could harm your unborn baby and is not recommended during pregnancy.
Danish: Afinitor kan skade dit ufødte barn og frarådes under graviditet.
English: If you forget to take Afinitor
Danish: Hvis du har glemt at tage Afinitor
English: Therefore, the progression-free survival advantage primarily reflects the population with disease stabilisation (corresponding to 67% of the Afinitor treatment group).
Danish: Derfor afspejler fordelen med hensyn til progressionsfri overlevelse primært populationen med sygdomsstabilisering (svarende til 67% af Afinitor-behandlingsgruppen).
English: Afinitor will only be prescribed for you by a doctor with experience in cancer treatment.
Danish: Afinitor vil kun blive ordineret til dig af en læge med erfaring i kræftbehandling.
English: Stratified log-rank test
Danish: Stratificeret log-rank-test
English: Table 3 Adverse reactions reported in clinical studies
Danish: Tabel 3 Bivirkninger rapporteret i kliniske studier
English: Food, however, had no apparent effect on the post absorption phase concentration-time profile.
Danish: Mad havde imidlertid ingen synlig effekt på koncentrations-/tidsprofilen efter absorptionsfasen.
English: Treatment with somatostatin analogues was allowed as part of BSC.
Danish: Behandling med somatostatin-analoger var tilladt som en del af BSC.
English: Swallow the tablet(s) whole with a glass of water.
Danish: Synk tablet(ten)(terne) hele med et glas vand.
English: Afinitor with food and drink Avoid grapefruit and grapefruit juice while you are on Afinitor.
Danish: Brug af Afinitor sammen med mad og drikke Undgå grapefrugt og grapefrugtjuice, mens du tager Afinitor.
English: Due to between subject variability the recommended dose adjustments may not be optimal in all individuals, therefore close monitoring of side effects is recommended.
Danish: Pga. variabiliteten mellem personer er den anbefalede dosis ikke optimal for alle individer, og det anbefales derfor, at bivirkninger monitoreres omhyggeligt.
English: STOP taking Afinitor and seek medical help immediately if you experience any of the following signs of an allergic reaction:
Danish: STOP med at tage Afinitor og søg straks læge eller skadestue, hvis du oplever nogen af følgende tegn på en allergisk reaktion:
English: ULN: Upper limit of normal
Danish: ULN: Øvre normalværdi
English: Physicians and patients should be aware of the increased risk of infection with Afinitor.
Danish: Læger og patienter skal være opmærksomme på den øgede infektionsrisiko med Afinitor.
English: Afinitor tablets should be swallowed whole with a glass of water.
Danish: Afinitor tabletter skal synkes hele med et glas vand.
English: However, the corresponding oestradiol levels at steady state (4 weeks) were not different between the two treatment arms.
Danish: De tilsvarende estradiolniveauer ved steady-state (4 uger) adskilte sig dog ikke i de to behandlingsarme.
English: mTOR is a key serine-threonine kinase, the activity of which is known to be upregulated in a number of human cancers.
Danish: mTOR er en vigtig serin-threonin-kinase, hvis aktivitet er kendt for at være opreguleret i et antal humane cancersygdomme.
English: • Pink eye or red eye (conjunctivitis)
Danish: • Lyserødt eller rødt øje (konjunktivitis)
English: The following may reduce the effectiveness of Afinitor: rifampicin, used to treat tuberculosis (TB).
Danish: Følgende kan nedsætte virkningen af Afinitor: rifampicin, som bruges til behandling af tuberkulose (TB).
English: Poor risk a
Danish: Dårlig risiko a
English: There was a significant correlation between AUC0-τ and pre-dose trough concentration at steady-state.
Danish: Der var en signifikant korrelation mellem AUC0-τ og prædosis-dalkoncentrationen ved steady-state.
English: RADIANT-3 involved patients with well- and moderately-differentiated advanced pNET whose disease had progressed within the prior 12 months.
Danish: RADIANT-3 involverede patienter med højt og moderat differentieret progressiv pNET, hvis sygdom havde progredieret inden for de seneste 12 måneder.
English: If you feel unusually tired (fatigue is a very common side effect), take special care when driving or using machines.
Danish: Hvis du føler dig usædvanlig træt, (træthed er en meget almindelig bivirkning), skal du være ekstra forsigtig med at køre eller betjene maskiner.
English: • Menstruation disorders such as irregular periods
Danish: • Menstruationsforstyrrelser, såsom uregelmæssig menstruation
English: If a dose is missed, the patient should not take an additional dose, but take the next prescribed dose as usual.
Danish: Hvis en dosis glemmes, må patienten ikke tage en ekstra dosis, men skal tage den næste ordinerede dosis som sædvanligt.
English: If, despite these measures, you think you may have become pregnant, ask your doctor for advice before taking any more Afinitor.
Danish: Hvis du på trods af denne forholdsregel tror, du kan være blevet gravid, skal du spørge din læge til råds, før du tager mere Afinitor.
English: These will check the amount of blood cells (white blood cells, red blood cells and platelets) in your body to see if Afinitor is having an unwanted effect on these cells.
Danish: Det sker for at kontrollere antallet af blodlegemer (hvide blodlegemer, røde blodlegemer og blodplader) i din krop for at se, om Afinitor har en uønsket virkning på disse celler.
English: It is given if the tumours are inoperable and do not overproduce specific hormones or other related natural substances.
Danish: Det gives, hvis tumorerne ikke kan opereres og ikke producerer for meget af bestemte hormoner eller andre beslægtede stoffer.
English: Patients should be advised to be cautious when driving or using machines if they experience fatigue during treatment with Afinitor.
Danish: Patienter bør rådes til at være forsigtige ved kørsel eller betjening af maskiner, hvis de oplever træthed under behandlingen med Afinitor.
English: Efavirenz, nevirapine Not studied.
Danish: Efavirenz, nevirapin Ikke undersøgt.
English: NSE: Neuron specific enolase
Danish: NSE: Neuronspecifik enolase
English: Independent radiological review
Danish: Uafhængig radiologisk vurdering
English: More frequent monitoring is recommended when Afinitor is co-administered with other medicinal products that may induce hyperglycaemia.
Danish: Hyppigere monitorering anbefales, når Afinitor anvendes sammen med andre lægemidler, som kan inducere hyperglykæmi.
English: Primary analysis All (blinded independent central review)
Danish: Primær analyse Alle (blindet uafhængig central gennemgang)
English: Randomisation was stratified by documented sensitivity to prior hormonal therapy and by the presence of visceral metastasis.
Danish: Randomiseringen var stratificeret efter dokumenteret sensitivitet for tidligere hormonbehandling og efter tilstedeværelse af viscerale metastaser.
English: Caution should therefore be exercised with the use of Afinitor in the peri-surgical period.
Danish: Der skal derfor udvises forsigtighed med brugen af Afinitor i den perioperative periode.
English: Other possible side effects of Afinitor include:
Danish: Andre bivirkninger ved Afinitor kan omfatte:
English: The safety and efficacy of Afinitor in children aged 0 to 18 years have not been established.
Danish: Afinitors sikkerhed og virkning hos børn i alderen 0 til 18 år er ikke klarlagt.
English: Probability (%) of event
Danish: Sandsynlighed (%) for hændelse
English: Talk to your doctor if you wish to have children.
Danish: Tal med din læge, hvis du ønsker at få et barn.
English: Therefore, women taking everolimus should not breast-feed during treatment and for 2 weeks after the last dose.
Danish: Derfor må kvinder, der tager everolimus, ikke amme under behandlingen og i 2 uger efter sidste dosis.
English: Confirmed objective tumour responses were observed in 5 patients (2%) receiving Afinitor, while none were observed in patients receiving placebo.
Danish: Bekræftet objektiv tumorrespons blev observeret hos 5 af de patienter (2%), der fik Afinitor, mens der ikke sås nogen respons hos de patienter, der fik placebo.
English: If symptoms are moderate (Grade 2) or severe (Grade 3) the use of corticosteroids may be indicated until clinical symptoms resolve.
Danish: Hvis symptomerne er moderate (Grad 2) eller alvorlige (Grad 3), kan kortikosteroid være indiceret, indtil de kliniske symptomer forsvinder.
English: In the safety pooling, 37% of the Afinitor-treated patients were ≥65 years of age.
Danish: I de samlede sikkerhedsdata var 37 % af patienterne, som blev behandlet med Afinitor, ≥65 år.
English: Serious side effects of Afinitor include:
Danish: Alvorlige bivirkninger ved Afinitor kan omfatte:
English: If dose reduction is required, the recommended dose is 5 mg daily and must not be lower than 5 mg daily.
Danish: Hvis dosisreduktion er nødvendig, er den anbefalede dosis 5 mg daglig, og den må ikke være lavere end 5 mg daglig.
English: Administration of everolimus for up to 2 years did not indicate any oncogenic potential in mice and rats up to the highest doses, corresponding respectively to 3.9 and 0.2 times the estimated clinical exposure.
Danish: Administration af everolimus i op til 2 år viste intet onkogent potentiale hos mus og rotter op til højeste dosis, svarende til henholdsvis 3,9 og 0,2 gange den estimerede kliniske eksponering.
English: MSKCC prognostic score (blinded independent central review) Favourable risk
Danish: MSKCC-prognosescoring (blindet uafhængig central undersøgelse) Favorabel risiko
English: Not applicable e p value is obtained from the exact Cochran-Mantel-Haenszel test using a stratified version of the Cochran-Armitage permutation test.
Danish: P-værdien er indhentet fra den præcise Cochran-Mantel-Haenszel-test ved hjælp af en stratificeret version af Cochran-Armitage-permutationstesten.
English: These medicines should be avoided during your treatment with Afinitor.
Danish: Disse typer medicin skal undgås under din behandling med Afinitor.
English: Afinitor was superior to placebo for the primary endpoint of progression-free survival, with a statistically significant 67% reduction in the risk of progression or death (see Table 7 and Figure 6).
Danish: Afinitor var bedre end placebo, for så vidt angik det primære endepunkt for progressionsfri overlevelse, med en statistisk signifikant reduktion på 67% af risikoen for progression eller dødsfald (se tabel 7 og figur 6).
English: If you have liver problems, your doctor may start you on a lower dose of Afinitor (2.5, 5 or 7.5 mg per day).
Danish: Hvis du har leverproblemer, kan det være, at din læge vil give dig en lavere dosis Afinitor (2,5, 5, eller 7,5 mg daglig).
English: nefazodone, used to treat depression.
Danish: nefazodon, der bruges til behandling af depression.
English: No differences in the time to ≥5% deterioration in the global and functional domain scores of QLQ-C30 were observed in the two arms.
Danish: Der blev ikke observeret en forskel i tiden til ≥5% forværring i de globale og funktionelle domæneresultater af QLQ-C30 i de to behandlingsarme.
English: In this case, a dose of 2.5 mg daily must not be exceeded.
Danish: I denne situation må den daglige dose på 2,5 mg ikke overskrides.
English: leukopenia, lymphopenia and/or neutropenia)
Danish: leukopeni, lymfopeni og/eller neutropeni)
English: Renal function should be monitored particularly where patients have additional risk factors that may further impair renal function.
Danish: Nyrefunktion skal monitoreres, specielt hos patienter med risikofaktorer, der kan svække nyrefunktionen yderligere.
English: If you experience certain side effects while you are taking Afinitor (see section 4), your doctor may lower your dose or stop treatment, either for a short time or permanently.
Danish: Hvis du får visse bivirkninger, mens du tager Afinitor (se punkt 4), kan det være, at din læge vil nedsætte dosis eller stoppe behandlingen enten i en kort periode eller permanent.
English: Time (weeks) Everolimus/Exemestane Everolimus
Danish: Tid (uger) Everolimus/Exemestan Everolimus
English: Six-month PFS rates were 36% for Afinitor therapy compared with 9% for placebo.
Danish: PFS-raten ved seks måneder var 36% for Afinitor-behandling sammenlignet med 9% for placebo.
English: This dose of Afinitor is predicted to adjust the AUC to the range observed without inducers.
Danish: Dosis af Afinitor er tilpasset AUC til det interval, der er observeret uden induktorer.
English: You should not breast-feed during treatment and for 2 weeks after the last dose of Afinitor.
Danish: Du må ikke amme under behandlingen og i 2 uger efter den sidste dosis af Afinitor.
English: Objective response rate = proportion of patients with complete or partial response c
Danish: Objektiv responsrate = andel af patienter med fuldstændig eller delvis respons c
English: The number of patients with an adverse reaction leading to discontinuation of the medicinal product was higher in patients ≥65 years of age (20% vs. 13%).
Danish: Antallet af patienter med en bivirkning, som førte til seponering af lægemidlet, var højere for patienter ≥65 år (20 % vs. 13 %).
English: However, there are no clinical data with this dose adjustment.
Danish: Der foreligger dog ikke kliniske data med denne dosisjustering.
English: if you have previously had hepatitis B, because this may be reactivated during treatment with Afinitor (see section 4 ‘Possible side effects').
Danish: hvis du før har haft hepatitis B, da hepatitis B kan blive reaktiveret under behandling med Afinitor (se afsnit 4 ”Bivirkninger”).
English: It may be necessary to treat your infection before starting Afinitor.
Danish: Det kan være nødvendigt at behandle din infektion, før du begynder at tage Afinitor.
English: Therefore, the safety and efficacy of Afinitor in patients with functional carcinoid tumours have not been established.
Danish: Som følge heraf er sikkerheden og virkningen af Afinitor hos patienter med funktionelle karcinoide tumorer ikke klarlagt.
English: Prior therapy with bevacizumab and interferon-α was also permitted.
Danish: Tidligere behandling med bevacizumab og interferon-α var også tilladt.
English: The estimated PFS treatment effect was supported by planned subgroup analysis of PFS per investigator assessment.
Danish: Den estimerede behandlingsvirkning på PFS blev understøttet af en planlagt undergruppeanalyse af PFS efter investigators vurdering.
English: Based on analysis of population pharmacokinetics, CL/F is on average 20% higher in black transplant patients.
Danish: Baseret på en farmakokinetisk populationsanalyse er CL/F i gennemsnit 20% højere hos transplantationspatienter af negroid afstamning.
English: Do not use this medicine if any pack is damaged or shows signs of tampering.
Danish: Brug ikke lægemidlet, hvis emballagen er beskadiget eller viser tegn på at have været åbnet.
English: When possible optimal glycaemic control should be achieved before starting a patient on Afinitor.
Danish: Når det er muligt, skal optimal glykæmisk kontrol være opnået, før en patient sættes i behandling med Afinitor.
English: It is given together with a medicine called exemestane, a steroidal aromatase inhibitor, which is used for hormonal anticancer therapy.
Danish: Det gives sammen med et lægemiddel, som kaldes exemestan, en steroid aromatasehæmmer, som anvendes til hormonel kræftbehandling.
English: The preclinical safety profile of everolimus was assessed in mice, rats, minipigs, monkeys and rabbits.
Danish: Everolimus' prækliniske sikkerhedsprofil er vurderet hos mus, rotter, minigrise, aber og kaniner.
English: After documented radiological progression, patients could be unblinded by the investigator: those randomised to placebo were then able to receive open-label everolimus 10 mg/day.
Danish: Efter dokumenteret radiologisk progression kunne patienterne afblindes af investigator: de, der var randomiseret til placebo, kunne derefter modtage open-label everolimus 10 mg/dag.
English: The median PFS was 8.4 months (90% CI: 6.6, 9.7) and 6.8 months (90% CI: 5.5, 7.2), respectively.
Danish: Median PFS var henholdsvis 8,4 måneder (90 % CI: 6,6; 9,7) og 6,8 måneder (90 % CI: 5,5; 7,2).
English: Opportunistic infections such as pneumocystis jirovecii (carinii) pneumonia (PJP/PCP) should be ruled out in the differential diagnosis of non-infectious pneumonitis (see “Infections” below).
Danish: Opportunistiske infektioner som pneumocystis jirovecii (carinii) pneumoni (PJP/PCP) bør udelukkes i differentialdiagnosticeringen af non-infektiøs pneumonitis (se ”Infektioner” nedenfor).
English: Afinitor should be administered orally once daily at the same time every day, consistently either with or without food (see section 5.2).
Danish: Afinitor skal administreres oralt en gang daglig på samme tidspunkt hver dag, konsekvent enten med eller uden mad (se pkt.
English: S6K1is thought to phosphorylate the activation function domain 1 of the oestrogen receptor, which is responsible for ligand-independent receptor activation.
Danish: S6K1 menes at fosforylere aktiveringsfunktion domæne 1 på østrogenreceptoren, som er ansvarlig for den liganduafhængige receptoraktivering.