FrancophonIA/ELRC3.0 huggingface dataset:
English: Inflectra is also used in patients aged between six and 17 years with severe, active Crohn's disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Danish: • psoriasis (en sygdom, der giver røde, skællende hudområder) Inflectra anvendes desuden hos patienter mellem 6 og 17 år med svær aktiv Crohns sygdom eller svær aktiv ulcerøs kolitis, når andre lægemidler eller behandlinger ikke virker eller ikke kan anvendes.
English: • Crohn's disease (a disease causing inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of fistulae, abnormal passageways between the gut and other organs);
Danish: • Crohns sygdom (en sygdom, der medfører inflammation af fordøjelseskanalen), når sygdommen er moderat til svær eller har medført dannelse af fistler (abnorme passager mellem tarmen og andre organer)
English: Infliximab has been designed to attach to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Danish: Infliximab er opbygget, så det bindes til et af kroppens kemiske signalstoffer, der kaldes tumornekrosefaktor-alfa (TNF-alfa).
English: Therefore, the CHMP's view was that, as for Remicade, the benefit outweighs the identified risks.
Danish: CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Remicade.
English: The Committee recommended that Inflectra be approved for use in the EU.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse i EU for Inflectra.
English: For the full list of all side effects reported with Inflectra, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Inflectra fremgår af indlægssedlen.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Inflectra, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Inflectra er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: For practical information about using Inflectra, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Inflectra, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Inflectra have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Inflectra?
English: Inflectra was studied to show that it is comparable to the reference medicine, Remicade.
Danish: Undersøgelser viser, at Inflectra er sammenligneligt med referencelægemidlet Remicade.
English: The infliximab is made by cells that have received a gene (DNA), which makes them able to produce it.
Danish: Inflectra fremstilles ved en metode kaldet “rekombinant DNA-teknologi”: Det produceres af celler, der har fået indsat et gen (DNA), som gør dem i stand til at producere det.
English: Inflectra is used with methotrexate (a medicine that acts on the immune system);
Danish: Inflectra anvendes sammen med methotrexat (et lægemiddel,
English: Inflectra is available as a powder to be made up into a solution for infusion (drip) into a vein.
Danish: Inflectra leveres som et pulver, der anvendes til at fremstille en injektionsvæske, der gives ved infusion (med drop i en vene).
English: • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);
Danish: • ankyloserende spondylitis (en sygdom, der medfører inflammation og smerter i leddene i rygsøjlen)
English: • rheumatoid arthritis (an immune-system disease causing inflammation of the joints).
Danish: • reumatoid arthritis (leddegigt, en sygdom i immunsystemet, der medfører inflammation
English: See the summary of product characteristics (also part of the EPAR) for full details.
Danish: Fuldstændige oplysninger herom fremgår af produktresuméet, der ligeledes er en del af EPAR.
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
Danish: • ulcerøs kolitis (en sygdom, der medfører inflammation og sår i tarmslimhinden)
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
Danish: • psoriasisgigt (en sygdom, der giver røde, skællende hudområder og inflammation af leddene)
English: How does Inflectra work?
Danish: Hvordan virker Inflectra?
English: At any time:
Danish: På ethvert tidspunkt:
English: * Not statistically significant.
Danish: *Ikke statistisk signifikant
English: Swallow the capsule whole with a glass of water.
Danish: Slug kapslen hel med et glas vand.
English: Urgent treatment may be necessary.
Danish: Akut behandling er muligvis nødvendig.
English: Your doctor will tell you how many capsules of IBRANCE to take.
Danish: Din læge vil fortælle dig, hvor mange kapsler IBRANCE du skal tage.
English: Patients should be encouraged to take their dose at approximately the same time each day.
Danish: Patienterne skal opfordres til at tage dosis på omtrent samme tidspunkt hver dag.
English: Do not stop taking IBRANCE unless your doctor tells you to.
Danish: Du må ikke stoppe med at tage IBRANCE, medmindre din læge fortæller dig det.
English: Do not open the capsules.
Danish: Lad være med at åbne kapslerne.
English: Date of first authorisation: 09 November 2016
Danish: Dato for første markedsføringstilladelse: 9. november 2016
English: Approximately 20% of patients were pre/perimenopausal.
Danish: Omkring 20 % af patienterne var præ-/perimenopausale.
English: The next prescribed dose should be taken at the usual time.
Danish: Den næste dosis skal tages på det sædvanlige tidspunkt.
English: Tiredness is a very common side effect.
Danish: Træthed er en meget almindelig bivirkning.
English: IBRANCE is for oral use.
Danish: IBRANCE er til oral anvendelse.
English: Do not take a double dose to make up for the forgotten capsules.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte kapsel.
English: Discuss contraception with your doctor if there is any possibility that you or your partner may become pregnant.
Danish: Tal med din læge om prævention, hvis der er mulighed for, at du eller din partner kan blive gravid.
English: If you feel unusually tired, take special care when driving or using machines.
Danish: Hvis du føler dig usædvanligt træt, skal du være særligt forsigtig, når du kører bil eller betjener maskiner.
English: It may therefore have risk of foetal harm if used during pregnancy.
Danish: Der kan derfor være risiko for fosterskader ved anvendelse under graviditet.
English: Age, gender, and body weight
Danish: Alder, køn og kropsvægt
English: You will have regular blood tests during treatment to check whether IBRANCE affects your blood cells (white blood cells, red blood cells, and platelets).
Danish: Du vil få taget regelmæssige blodprøver under behandlingen for at kontrollere, om IBRANCE påvirker dine blodceller (hvide blodlegemer, røde blodlegemer og blodplader).
English: IBRANCE may affect the way some other medicines work.
Danish: IBRANCE kan påvirke den måde, andre lægemidler virker på.
English: Day 15 of first 2 cycles:
Danish: Dag 15 i de første 2 forløb:
English: • Grade ≤2 (if not considered a safety risk for the patient) Resume at the next lower dose.
Danish: • Grad ≤ 2 (hvis det ikke er betragtet som en sikkerhedsrisiko for patienten) Genoptag behandlingen med næste lavere dosis.
English: Steady state was achieved within 8 days following repeated once daily dosing.
Danish: Steady state blev nået inden for 8 dage ved gentagen dosering en gang daglig.
English: If the patient vomits or misses a dose, an additional dose should not be taken that day.
Danish: Hvis en patient kaster op eller glemmer en dosis, må der ikke tages en ekstra dosis samme dag.
English: Blocking these proteins can slow down growth of cancer cells and delay the progression of your cancer.
Danish: Når disse proteiner blokeres, kan det bremse kræftcellernes vækst og forsinke udviklingen af kræften.
English: Avoid grapefruit and grapefruit juice while you are taking IBRANCE as it may increase the side effects of IBRANCE.
Danish: Undgå grapefrugt og grapefrugtjuice, mens du tager IBRANCE, da det kan øge bivirkninger af IBRANCE.
English: The relevant Kaplan-Meier plots are shown in Figures 2 and 3, respectively.
Danish: De relevante Kaplan-Meier-kurver vises i henholdsvis figur 2 og 3.
English: The median age of patients enrolled in this study was 57 years (range 29, 88).
Danish: Den mediane alder for patienter inkluderet i studiet var 57 år (29-88 år).
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: However, this finding was not reproduced consistently in subsequent studies in Japanese or Asian breast cancer patients after multiple dosing.
Danish: Dette fund blev dog ikke konsistent reproduceret i efterfølgende studier med japanske eller asiatiske brystkræftpatienter efter multipel dosering.
English: Take the carton and this leaflet, so that the doctor knows what you have been taking.
Danish: Tag æsken og denne indlægsseddel med dig, så lægen ved, hvad du har taget.
English: Withhold until symptoms resolve to:
Danish: Udsæt indtil bedring af symptomer til:
English: After a median follow-up time of 45 months, the final OS analysis was performed based on 310 events (60% of randomised patients).
Danish: Efter en median opfølgningstid på 45 måneder blev en endelig OS-analyse udført baseret på 310 hændelser (60 % af randomiserede patienter).
English: PVC/PCTFE/PVC/Al blister strip containing 7 hard capsules (one capsule per cell).
Danish: PVC/PCTFE/PVC/Al blisterkort indeholdende 7 hårde kapsler (1 kapsel per bobbel).
English: IBRANCE with food and drink
Danish: Brug af IBRANCE sammen med mad og drikke
English: At the data cutoff date of 26-February-2016, the study met its primary objective of improving PFS.
Danish: Ved skæringsdatoen for data 26. februar 2016 nåede studiet det primære mål, forbedret PFS.
English: Supportive PFS analyses were based on an Independent Central Radiology Review.
Danish: Understøttende PFS-analyser var baseret på en central, uafhængig radiologisk gennemgang.
English: In vitro studies with transporters
Danish: In vitro-studie med transportproteiner
English: IBRANCE is not to be used in children or adolescents (under 18 years of age).
Danish: IBRANCE må ikke anvendes til børn eller unge (under 18 år).
English: There are no or limited amount of data from the use of palbociclib in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af palbociclib til gravide kvinder.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendix V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Treatment with IBRANCE should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Danish: Behandlingen med IBRANCE skal initieres og superviseres af en læge med erfaring i administration af lægemidler mod kræft.
English: IBRANCE may reduce the number of your white blood cells and weaken your immune system.
Danish: IBRANCE kan nedsætte antallet af hvide blodlegemer og svække dit immunforsvar.
English: Note: Laboratory results are graded according to the NCI CTCAE version 4.0 severity grade.
Danish: Bemærk: Laboratorieresultater graderes i forhold til sværhedsgraden af NCI CTCAE version 4.0.
English: Each carton contains 21 hard capsules (3 blister strips per pack) or 63 hard capsules (9 blister strips per pack).
Danish: Hver karton indeholder 21 hårde kapsler (3 blisterkort per æske) eller 63 hårde kapsler (9 blisterkort per æske).
English: If you experience certain side effects while you are taking IBRANCE (see section 4 “Possible side effects”), your doctor may lower your dose or stop treatment, either temporarily or permanently.
Danish: Hvis du oplever visse bivirkninger, mens du tager IBRANCE (se afsnit 4), vil din læge muligvis nedsætte din dosis eller stoppe behandlingen, enten midlertidigt eller permanent.
English: Crossover between treatment arms was not allowed.
Danish: Overkrydsning mellem de to behandlingsarme var ikke tilladt.
English: If you have taken too much IBRANCE, see a doctor or go to a hospital immediately.
Danish: Hvis du har taget for mange IBRANCE-kapsler, skal du straks kontakte en læge eller tage på hospitalet.
English: No studies have been conducted in humans or animals to assess the effect of palbociclib on milk production, its presence in breast milk, or its effects on the breast-fed child.
Danish: Der er ikke udført studier med mennesker eller dyr med henblik på at vurdere palbociclibs indvirkning på mælkeproduktion, dets tilstedeværelse i human mælk eller virkning på det ammede barn.
English: • Grade ≤1;
Danish: • Grad ≤ 1,
English: Dose modification of IBRANCE is recommended based on individual safety and tolerability.
Danish: Dosisjustering Det anbefales at justere dosis af IBRANCE på basis af individuel sikkerhed og tolerabilitet.
English: IBRANCE capsules should be swallowed whole (should not be chewed, crushed, or opened prior to swallowing).
Danish: IBRANCE-kapslerne skal synkes hele (må ikke tygges, knuses eller åbnes inden synkning).
English: The treatment with IBRANCE should be continued as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs.
Danish: Behandlingen med IBRANCE bør fortsætte, så længe patienten har klinisk gavn af behandlingen, eller indtil uacceptabel toksicitet.
English: Therefore, you may be at greater risk of getting an infection while you are taking IBRANCE.
Danish: Du har derfor en større risiko for at få en infektion, mens du tager IBRANCE.
English: Cardiac electrophysiology
Danish: Kardial elektrofysiologi
English: It is given together with aromatase inhibitors or fulvestrant, which are used as hormonal anticancer therapies.
Danish: Det gives sammen med aromatasehæmmere eller fulvestrant, der anvendes som hormonbehandlinger af kræft.
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: Kravene for fremsendelse af PSUR'er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Based on an analysis of the cumulative pharmacokinetic, safety, and efficacy data across Asian and non-Asian populations, no dose adjustment based on Asian race is considered necessary.
Danish: Baseret på en analyse af den kumulative farmakokinetik, sikkerheds- og effektivitetsdata på tværs af asiatiske og ikke-asiatiske populationer betragtes dosisjustering på basis af asiatisk race som unødvendig.
English: The safety and efficacy of IBRANCE in children and adolescents <18 years of age have not been established.
Danish: IBRANCEs sikkerhed og virkning hos børn og unge under < 18 år er ikke fastlagt.
English: Physicians should inform patients to promptly report any episodes of fever.
Danish: Lægen skal informere patienten om straks at indberette enhver feberepisode.
English: An updated analysis of the primary and secondary endpoints was performed after an additional 15 months of follow up (data cutoff date: 31-May-2017).
Danish: Der blev udført en opdateret analyse af det primære og sekundære endepunkt efter yderligere 15 måneders opfølgning (skæringsdato for data: 31. maj 2017).
English: Palbociclib absorption and exposure were very low in approximately 13% of the population under the fasted condition.
Danish: Palbociclibs absorption og eksponering var meget lav hos ca. 13 % af populationen ved den fastende tilstand.
English: Grade ≥3 non-haematological toxicity (if persisting despite medical treatment)
Danish: Grad ≥ 3 ikke-hæmatologisk toksicitet (hvis vedvarende trods behandling)
English: Frequency categories are defined as: very common (≥1/10), common (≥1/100 to <1/10), and uncommon (≥1/1,000 to
Danish: Hyppigheden er inddelt i følgende grupperinger: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥ 1/1.000 til < 1/100).
English: • Rifampin used to treat tuberculosis (TB).
Danish: • Rifampin, som anvendes til behandling af tuberkulose (TB).
English: a Preferred Terms (PTs) are listed according to MedDRA 17.1. b Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Danish: a. Foretrukne termer er angivet i henhold til MedDRA 17.1. b. Infektioner omfatter alle foretrukne termer, der er en del af systemorganklassen Infektioner og infestationer.
English: Ibrance plus Letrozole or Fulvestrant
Danish: Ibrance plus letrozol eller fulvestrant
English: IBRANCE hard capsules come in different strengths.
Danish: IBRANCE hårde kapsler fås i forskellige styrker.
English: Pre/perimenopausal women
Danish: Præ-/perimenopausale kvinder
English: The adverse reactions are listed by system organ class and frequency category.
Danish: Bivirkningerne er opstillet efter systemorganklasse og hyppighed.
English: Do not use this medicine after the expiry date which is stated on the bottle or blister and carton after “EXP”.
Danish: Brug ikke IBRANCE efter den udløbsdato, der står på beholderen, blisterkortet og æsken efter "EXP".
English: Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Danish: Tag ikke lægemidlet, hvis du bemærker, at pakningen er beskadiget, eller hvis der er tegn på, at pakningen har været åbnet.
English: Since IBRANCE has myelosuppressive properties, it may predispose patients to infections.
Danish: Eftersom IBRANCE har knoglemarvssupprimerende egenskaber, kan det prædisponere patienter for infektioner.
English: Table 6 shows the efficacy results based on the primary and the updated analyses from the PALOMA-2 study, as assessed by the investigator and by the independent review.
Danish: Skema 6 viser effektresultaterne baseret på den primære og den opdaterede analyse fra PALOMA-2 studiet ud fra investigators vurdering og den uafhængige gennemgang.
English: The mean Cmax of palbociclib is generally observed between 6 to 12 hours following oral administration.
Danish: Palbociclibs gennemsnitlige Cmax observeres normalt mellem 6 til 12 timer efter oral administration.
English: The majority of patients (97.4%) had metastatic disease at baseline, 23.6% of patients had bone-only disease, and 49.2% of patients had visceral disease.
Danish: Størstedelen af patienterne (97,4 %) havde metastatisk sygdom ved baseline, 23,6 % af patienterne havde kun knoglesygdom og 49,2 % af patienterne havde visceral sygdom.
English: These systemic toxicities were generally observed at clinically relevant exposures based on AUC.
Danish: Denne systemiske toksicitet blev normalt observeret ved klinisk relevante eksponeringer baseret på AUC.
English: Do not chew or crush the capsules.
Danish: Undgå at tygge eller knuse kapslerne.
English: Tell your doctor, pharmacist or nurse if you experience signs or symptoms of an infection, such as chills or fever.
Danish: Fortæl lægen, apotekspersonalet eller sundhedspersonalet, hvis du oplever tegn eller symptomer på en infektion, såsom kulderystelser og feber.
English: PALOMA-2 (intent-to-treat population) - Efficacy results based on primary and updated cutoff dates
Danish: PALOMA-2 (intent-to-treat population) - Effektresultater baseret på den primære og den opdaterede skæringsdato
English: IBRANCE has minor influence on the ability to drive and use machines.
Danish: IBRANCE påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Binding of palbociclib to human plasma proteins in vitro was ~85%, with no concentration dependence.
Danish: Bindingen af palbociclib til humane plasmaproteiner in vitro var ~85 % uafhængigt af koncentrationen.
English: Palbociclib is not a substrate of OATP1B1 or OATP1B3.
Danish: Palbociclib er ikke substrat for OATP1B1 eller OATP1B3.
English: These methods should be used during therapy and for at least 3 weeks after completing therapy for females and for at least 14 weeks for males.
Danish: Præventionen skal bruges under behandlingen og i mindst 3 uger efter afsluttet behandling for kvinder og mindst 14 uger for mænd.
English: Secondary efficacy endpoints included objective response (OR), clinical benefit response (CBR), safety, and change in quality of life (QoL).
Danish: Sekundære effektendepunkter omfattede objektiv respons (OR), positiv klinisk respons (clinical benefit response - CBR), sikkerhed og ændring i livskvalitet (QoL).
English: Actual foetal exposure and cross-placenta transfer have not been examined.
Danish: Faktisk føtal eksponering og placentapassage er ikke blevet undersøgt.
English: The median duration of palbociclib treatment across the pooled dataset at the time of the final overall survival (OS) analysis was 14.8 months.
Danish: Den mediane behandlingsvarighed af palbociclib i alle puljede datasæt på tidspunktet for den endelige analyse af samlet overlevelse (OS) var 14,8 måneder.
English: You should not use IBRANCE if you are pregnant.
Danish: Du må ikke tage IBRANCE hvis du er gravid.
English: Talk to your doctor, pharmacist or nurse before taking IBRANCE.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager IBRANCE.
English: Patients continued to receive assigned treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
Danish: Patienterne fortsatte med at få den tildelte behandling indtil objektiv sygdomsprogression, symptomatisk forværring, uacceptabel toksicitet, død eller tilbagetrækning af samtykke, uanset hvad der indtraf først.
English: Time-to-Deterioration was prespecified as time between baseline and first occurrence of ≥10 points increase from baseline in pain symptom scores.
Danish: Tid til forværring var specificeret som tiden mellem baseline og første forekomst af en ≥ 10 point stigning fra baseline i score for smertesymptomer.
English: A series of prespecified subgroup PFS analyses was performed based on prognostic factors and baseline characteristics to investigate the internal consistency of treatment effect.
Danish: Der blev udført en række præspecificerede PFS-analyser i undergrupper baseret på prognostiske faktorer og baseline-egenskaber for at undersøge den interne overensstemmelse af behandlingseffekten.
English: More than half (62%) had an ECOG PS of 0, 60% had visceral metastases, and 60% had received more than 1 prior hormonal regimen for their primary diagnosis.
Danish: Mere end halvdelen (62 %) havde ECOG-performancestatus 0, 60 % havde viscerale metastaser, og 60 % havde fået mere end en forudgående hormonbehandling for deres primære diagnose.
English: IBRANCE may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death.
Danish: IBRANCE kan forårsage alvorlig eller livstruende lungebetændelse under behandlingen, som kan være dødelig.
English: In the cell lines tested, the loss of retinoblastoma (Rb) was associated with loss of palbociclib activity.
Danish: I de testede cellelinjer var tabet af retinoblastom (Rb) associeret med nedsat aktivitet af palbociclib.