FrancophonIA/ELRC3.0 huggingface dataset:
English: If the levels have not recovered to CTCAE Grade 1 or better after 4 weeks, the patient should be referred to a haematologist for further investigations.
Danish: Hvis niveauerne ikke er restitueret til CTCAE klasse 1 eller bedre efter 4 uger, bør patienten henvises til en hæmatolog med henblik på yderligere undersøgelser.
English: They may stop treatment with Rubraca until your blood cell counts improve.
Danish: De kan stoppe behandlingen med Rubraca, indtil antallet af blodceller forbedres.
English: It is important to proactively manage these events to avoid prolonged or more severe events of nausea/vomiting which have the potential to lead to complications such as dehydration or hospitalisation.
Danish: Det er vigtigt at håndtere disse episoder proaktivt for at undgå langvarige eller mere alvorlige episoder med kvalme/opkastning, der potentielt kan føre til komplikationer såsom dehydrering eller indlæggelse.
English: Four (0.4%) patients reported a CTCAE Grade 3 reaction.
Danish: Fire (0,4 %) patienter indberettede en CTCAE Klasse 3 reaktion.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Danish: BILAG II A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE OMSTÆNDIGHEDER
English: Four (5.1%) of 79 platinum sensitive patients overall had progressive disease as best response.
Danish: I alt fire (5,1 %) af 79 platinfølsomme patienter havde progressiv sygdom som bedste respons.
English: HDPE bottle, with a polypropylene (PP) induction seal closure, containing 60 tablets.
Danish: HDPE-flaske med en polypropylen (PP) induktionsforseglingslukning, der indeholder 60 tabletter.
English: Patients who had been hospitalised for bowel obstruction in the last 3 months were excluded.
Danish: Patienter, som var blevet hospitalsindlagt for tarmslyng i løbet af de sidste 3 måneder blev ekskluderet.
English: BRCA status based on a local test was known for some patients at the time of enrollment.
Danish: BRCA-status baseret på en lokal test var kendt for nogle patienter ved indrulleringstidspunktet.
English: This is because Rubraca can affect the way some other medicines work.
Danish: Dette skyldes, at Rubraca kan påvirke, hvordan nogle andre lægemidler virker.
English: • if you are allergic to rucaparib or any of the other ingredients of this medicine (listed in section 6).
Danish: hvis du er allergisk over for rucaparib eller et af de øvrige indholdsstoffer i lægemidlet (angivet i punkt 6).
English: There are no or limited data from the use of rucaparib in pregnant women.
Danish: Der er ingen eller begrænsede data fra anvendelse af rucaparib til gravide kvinder.
English: Treatment with rucaparib should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Danish: Behandling med rucaparib skal påbegyndes og overvåges af en læge med erfaring i anvendelse af kræfthæmmende lægemidler.
English: Rubraca can be administered with or without food.
Danish: Rubraca kan administreres med eller uden mad.
English: Rucaparib may only be used in patients with severe renal impairment if the potential benefit outweighs the risk.
Danish: Rucaparib kan kun anvendes til patienter med alvorligt nedsat nyrefunktion, hvis den potentielle fordel opvejer risikoen.
English: IRR- assessment for the ITT population supported the primary endpoint.
Danish: IRR-vurdering for ITT-populationen understøttede det primære effektmål.
English: Rubraca is for oral use and can be taken with or without food.
Danish: Rubraca er til oral anvendelse og kan tages med eller uden mad.
English: Supportive care and institutional guidelines should be implemented for the management of low blood counts for the treatment of anaemia and neutropenia.
Danish: Understøttende behandling og institutionelle retningslinjer bør implementeres til håndtering af lave blodtællinger, ved behandling af anæmi og neutropeni.
English: The signs and symptoms of low blood cell counts include fever, infection, bruising or bleeding.
Danish: Tegn og symptomer på et lavt antal hvide blodceller omfatter feber, infektion, blå mærker eller blødning.
English: Patients were randomised within 8 weeks of completion of platinum chemotherapy and no intervening maintenance treatment was permitted.
Danish: Patienterne blev randomiseret inden for 8 uger efter gennemførsel af platinkemoterapi, og der blev ikke tilladt intervenerende vedligeholdelsesbehandling.
English: Rubraca should not be used during pregnancy unless the clinical condition of the woman requires treatment with rucaparib.
Danish: Rubraca må ikke anvendes under graviditet, medmindre kvindens kliniske tilstand nødvendiggør behandling med rucaparib.
English: It is used after the cancer has responded to previous chemotherapy treatments.
Danish: Det bruges, når kræften har reageret på tidligere behandlinger med kemoterapi.
English: This is because rucaparib may affect the unborn baby.
Danish: Det skyldes at rucaparib kan påvirke det ufødte barn.
English: These events occurred within the first few weeks of treatment with rucaparib, were reversible, and were rarely associated with increases in bilirubin.
Danish: Disse bivirkninger opstod inden for de første få uger af behandling med rucaparib, var reversible, og blev sjældent associeret med stigninger i bilirubin.
English: All patients had potential contributing factors for the development of MDS/AML; in all cases, patients had received previous platinumcontaining chemotherapy regimens and/or other DNA damaging agents.
Danish: Alle patienterne havde potentielle bidragende faktorer for udvikling af MDS/AML; i alle tilfældene havde patienterne fået tidligere platinholdige kemoterapiregimer og/eller andre DNA-beskadigende midler.
English: Central BRCA testing was performed retrospectively after patients were enrolled.
Danish: Der blev gennemført central BRCA-testning med tilbagevirkende kraft, efter at patienterne var indrulleret.
English: Based on population PK analysis, no clinically significant relationships were identified between predicted steady-state exposure and patient's age, race, and body weight.
Danish: Baseret på populations PK-analyse blev der ikke identificeret klinisk signifikante forhold mellem forventet steady-state eksponering og patientens alder, race og kropsvægt.
English: These findings occurred at exposures below those observed in patients treated at the recommended dose, and were largely reversible within 4 weeks of cessation of dosing.
Danish: Disse fund viste sig ved eksponeringer under det, der blev fundet hos patienter, der blev behandlet med den anbefalede dosis, og var generelt reversible inden for 4 uger efter endt dosering.
English: Dose adjustments may be considered, if clinically indicated based on observed adverse reactions.
Danish: Dosisjusteringer kan overvejes, hvis klinisk indiceret baseret på observerede bivirkninger.
English: Complete blood count testing prior to starting treatment with Rubraca, and monthly thereafter, is advised.
Danish: Komplet blodtællingstest før starten af behandling med Rubraca, og derefter hver måned, tilrådes.
English: Rucaparib preferentially distributed to red blood cells with a blood-to-plasma concentration ratio of 1.83.
Danish: Rucaparib distribueres fortrinsvis til røde blodlegemer med et blod-plasma koncentrationsforhold på 1,83.
English: Interaction of rucaparib with other enzymes and transporter was evaluated in vitro.
Danish: Interaktion mellem rucaparib og andre enzymer og transporter blev evalueret in vitro.
English: The recommended dose is 600 mg rucaparib taken twice daily, equivalent to a total daily dose of 1,200 mg, until disease progression or unacceptable toxicity.
Danish: Den anbefalede dosis er 600 mg rucaparib to gange dagligt, svarende til en samlet daglig dosis på 1.200 mg, indtil sygdomsprogression eller uacceptabel toksicitet.
English: Each bottle contains 60 film-coated tablets.
Danish: Hver flaske indeholder 60 filmovertrukne tablet.
English: The duration of therapy with rucaparib in patients who developed MDS/AML varied from less than 1 month to approximately 28 months.
Danish: Varigheden af behandlingen med rucaparib hos patienter, der udviklede MDS/AML, varierede fra under 1 måned til ca. 28 måneder.
English: Other minor metabolites accounted for 13.8% of the radioactivity in plasma.
Danish: Andre mindre væsentlige metabolitter tegnede sig for 13,8 % af radioaktiviteten i plasma.
English: Ninety percent of the observed faecal recovery was achieved within 168 hours postdose.
Danish: 90 % af den observerede udskillelse i fæces blev opnået inden for 168 timer efter dosis.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX55
Danish: Farmakoterapeutisk klassifikation: andre antineoplastiske midler, ATC-kode: L01XX55
English: The in vitro protein binding of rucaparib is 70.2% in human plasma at therapeutic concentration levels.
Danish: In vitro proteinbindingen for rucaparib er 70,2 % i humant plasma ved terapeutiske koncentrationsniveauer.
English: Talk to your doctor if you feel sick (nauseous), have been sick (vomiting) or you have had diarrhoea.
Danish: Tal med din læge, hvis du har kvalme, har kastet op eller du har haft diarré.
English: • Talk to your doctor or pharmacist about the most effective methods of contraception.
Danish: - Tal med din læge eller apotekspersonalet om de mest effektive præventionsmetoder.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse 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, sundhedspersonalet eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Rubraca blocks an enzyme that repairs damaged DNA in the cancer cells, resulting in their death.
Danish: Rubraca blokerer et enzym, der reparerer beskadiget DNA i kræftcellerne og dræber dem således.
English: Pharmacokinetics in specific populations
Danish: Farmakokinetik hos særlige populationer
English: Rubraca can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings from animal studies.
Danish: Rubraca kan forårsage fosterskader, når det administreres til gravide kvinder baseret på virkningsmekanismen og fund i dyreforsøg.
English: If MDS/AML is suspected, the patient should be referred to a haematologist for further investigations, including bone marrow analysis and blood sampling for cytogenetics.
Danish: Hvis der er mistanke om MDS/AML, bør patienten henvises til en hæmatolog med henblik på yderligere undersøgelser, herunder knoglemarvsanalyse og blodprøvetagning for cytogenetik.
English: Pyrexia a MDS/AML rate is based on overall total patient population of 1321 who have received one dose of oral rucaparib.
Danish: Pyreksi a MDS/AML-rate er baseret på den samlede patientpopulation på 1321, der har modtaget en dosis oral rucaparib.
English: Demographics, baseline disease characteristics, and prior treatment history were generally well balanced between the rucaparib and placebo arms.
Danish: Demografi, baseline sygdomskarakteristika og tidligere behandlingshistorik var generelt godt afbalanceret mellem rucaparib- og placeboarmene.
English: The primary efficacy outcome measure of both studies was objective response rate (ORR) as assessed by the investigator according to RECIST version 1.1.
Danish: Den primære effektresultatmåling fra begge forsøg var objektiv responsrate (ORR) som vurderet af investigator ifølge RECIST version 1.1.
English: The majority of adverse reactions were mild to moderate (Grade 1 or 2).
Danish: Størstedelen af bivirkningerne var milde til moderate (klasse 1 eller 2).
English: The time of onset for adverse reactions of myelosuppression Grade 3 or higher was generally later in treatment (after 2 or more months).
Danish: Starttidspunktet for bivirkninger med myelosuppression klasse 3 eller højere lå generelt senere i behandlingen (efter 2 måneder eller mere).
English: In repeat-dose toxicity studies of up to 3 months duration in rats and dogs, the target organs were the gastrointestinal, haematopoietic, and lymphopoietic systems.
Danish: I toksicitetsforsøg med gentagen dosis af op til 3 måneders varighed hos rotter og hunde var målorganerne de gastrointestinale, hæmatopoietiske, og lymfopoietiske systemer.
English: The primary efficacy outcome was investigator-assessed progression-free survival (invPFS) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (v1.1).
Danish: De primære effektmål var investigator-vurderet progressionsfri overlevelse (invPFS) i henhold til RECIST (Response Evaluation Criteria in Solid Tumors), version 1.1.
English: Frequency of all CTCAE grades Frequency of CTCAE grade 3 and above
Danish: Hyppighed af CTCAE klasse 3 og derover
English: You may get sunburn more easily during treatment with Rubraca.
Danish: Du kan nemmere blive solskoldet under behandling med Rubraca.
English: It is unknown whether rucaparib/or its metabolites are excreted in human milk.
Danish: Det vides ikke, om rucaparib/eller dets metabolitter udskilles i human mælk.
English: Rubraca is an anti-cancer medicine, also known as a ‘PARP (poly adenosine diphosphate-ribose polymerase) inhibitor'.
Danish: Rubraca er et lægemiddel mod kræft, også kendt som en ‘PARP (poly adenosin diphosphat-ribose polymerase) hæmmer'.
English: Name and address of the manufacturer(s) responsible for batch release Almac Pharma Services Ltd
Danish: Navn og adresse på fremstilleren (fremstillerne) ansvarlig(e) for batchfrigivelse Almac Pharma Services Ltd
English: Following repeated twice daily dosing, the accumulation based on AUC ranged from 3.5 to 6.2 fold.
Danish: Efter gentagen dosering to gange dagligt varierede ophobning baseret på AUC fra 3,5 til 6,2 gange.
English: The overall safety profile of rucaparib is based on data from 937 patients in clinical trials in ovarian cancer treated with rucaparib monotherapy.
Danish: Rucaparibs samlede sikkerhedsprofil er baseret på data fra 937 patienter i kliniske forsøg med ovariecancer, der blev behandlet med rucaparib monoterapi.
English: • Do not take a double dose to make up for a forgotten dose.
Danish: - Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Frequencies of occurrence of adverse reactions are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare
Danish: Hyppigheden af forekomst af bivirkninger er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Do not use this medicine after the expiry date which is stated on the bottle and the carton after EXP.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på flasken og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Rubraca may affect your ability to drive or use tools or machines.
Danish: Rubraca kan påvirke din evne til at føre motorkøretøj eller betjene værktøj eller maskiner.
English: Antiemetics, such as 5-HT3 antagonists, dexamethasone, aprepitant and fosaprepitant, can be used as treatment for nausea/vomiting and may also be considered for prophylactic (i.e., preventative) use prior to starting Rubraca.
Danish: Antiemetika, som f.eks. 5-HT3-antagonister, dexamethason, aprepitant og fosaprepitant, kan bruges som behandling for kvalme/opkastning og kan også overvejes som profylaktisk (dvs. forebyggende) brug inden påbegyndelse af Rubraca.
English: Continue rucaparib provided bilirubin is < ULN and alkaline phosphatase is < 3 x ULN
Danish: Fortsæt med rucaparib såfremt bilirubin er < ULN og alkalisk phosphatase (ALP) er < 3 x ULN
English: Thus, the risk for clinically significant QTcF increase from baseline (i.e. > 20 msec) is low.
Danish: Risikoen for en klinisk signifikant stigning af QTcF (dvs. > 20 msek) fra baseline er derfor lav.
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving rucaparib.
Danish: Kvinder i den fødedygtige alder bør rådes til at undgå at blive gravide, mens de får rucaparib.
English: All patients had achieved a response (complete or partial) to their most recent platinum-based chemotherapy and their cancer antigen 125 (CA-125) was below the upper limit of normal (ULN).
Danish: Alle patienter havde opnået respons (komplet eller delvis) på deres seneste platinbaserede kemoterapi, og deres cancerantigen 125 (CA-125) lå under den øvre grænse for normal (ULN).
English: Based on its mechanism of action and preclinical data, rucaparib may cause fetal harm when administered to a pregnant woman.
Danish: Baseret på dets virkningsmekanisme og prækliniske data kan rucaparib forårsage fosterskader, når det gives til en gravid kvinde.
English: ARIEL3 demonstrated a statistically significant improvement in PFS for patients randomised to rucaparib as compared with placebo in the ITT population and in the HRD and tBRCA subgroups.
Danish: ARIEL3 viste en statistisk signifikant forbedring i PFS for patienter randomiseret til rucaparib sammenlignet med placebo hos ITT-populationen og i HRD- og tBRCA-undergrupper.
English: • a low blood-cell count may be a sign of a serious bone marrow problem - such as ‘myelodysplastic syndrome' (MDS) or ‘acute myeloid leukaemia' (AML).
Danish: En lav blodcelletælling kan være et tegn på et alvorligt knoglemarvsproblem - som f.eks. ‘myelodysplastisk syndrom' (MDS) eller ‘akut myeloid leukæmi' (AML).
English: Other moderate to severe non-haematological adverse reactions such as nausea and vomiting, can be managed through dose interruption and/or reductions, if not adequately controlled by appropriate symptomatic management.
Danish: Andre moderate til svære ikke-hæmatologiske bivirkninger som f.eks. kvalme og opkastning kan håndteres ved dosisafbrydelse og/eller -reduktioner, hvis de ikke kontrolleres tilstrækkeligt af passende symptomatisk behandling.
English: Decreased appetite, Increased blood creatinineb
Danish: Nedsat appetit, øget blodkreatininb
English: The mean half-life (t1/2) of rucaparib was 25.9 hours.
Danish: Rucaparibs gennemsnitlige halveringstid (t1/2) var 25,9 timer.
English: Liver transaminase elevations (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) occur early in treatment and are generally transient.
Danish: Forhøjede lever-transaminaser (aspartat aminotransferase (ASAT)) og/eller alanin aminotransferase (ALAT) forekommer tidligt i behandlingen og er som regel forbigående.
English: In vitro, M324 was at least 30 fold less potent than rucaparib against PARP-1, PARP-2, and PARP-3.
Danish: In vitro var M324 mindst 30 gange mindre potent end rucaparib mod PARP-1, PARP-2 og PARP-3.
English: Population PK analysis suggested that concomitant use of PPIs is unlikely to have clinically meaningful impact on rucaparib PK. A firm conclusion cannot be made regarding the effect of co-administration of rucaparib and PPIs because dose level and time of administration have not been documented in detail for the PPIs.
Danish: Populations PK-analyse antydede, at det er usandsynligt, at samtidig brug af PPI'er, har en klinisk meningsfuld effekt på rucaparib PK. Der kan ikke drages nogen konkret konklusion vedrørende effekten af samtidig administration af rucaparib og PPI'er, da dosisniveau og administrationstidspunkt ikke er blevet dokumenteret detaljeret for PPI'erne.
English: Also some other medicines can affect the way Rubraca works.
Danish: Andre lægemidler kan også påvirke den måde, Rubraca fungerer på.
English: Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in patients who received rucaparib.
Danish: Myelodysplastisk syndrom/akut myeloid leukæmi (MDS/AML), herunder tilfælde med letalt udfald, er rapporteret hos patienter, der fik rucaparib.
English: • For women who are able to become pregnant, a pregnancy test is recommended before starting treatment with Rubraca
Danish: - For kvinder, som kan blive gravide, anbefales en graviditetstest før behandling med Rubraca påbegyndes.
English: No significant P-gp inhibition was observed in vivo (section 4.5).
Danish: Ingen signifikant P-gp hæmning blev observeret in vivo (pkt.
English: Thrombocytopenia and anaemia led to discontinuation in 1.8% and 2.1% of patients.
Danish: Trombocytopeni og anæmi førte til ophør hos 1,8 % og 2,1 % af patienterne.
English: Greater sensitivity of some elderly patients (≥ 65 years of age) to adverse events cannot be ruled out.
Danish: Større følsomhed overfor bivirkninger hos ældre patienter (≥ 65 år) kan ikke udelukkes.
English: Rucaparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, including PARP-1, PARP-2, and PARP-3, which play a role in DNA repair.
Danish: Rucaparib er en hæmmer af poly (ADP-ribose) polymerase (PARP) enzymer, herunder PARP-1, PARP-2, og PARP-3, som spiller en rolle i reparationen af DNA.
English: Increases in serum creatinine, predominantly mild to moderate (CTCAE Grade 1 or 2), were observed in 20% of patients within the first few weeks of treatment with rucaparib.
Danish: Stigninger i serumkreatinin, overvejende milde til moderate (CTCAE klasse 1 eller 2), blev observeret hos 20 % af patienterne inden for de første få ugers behandling med rucaparib.
English: The mean absolute oral bioavailability following a single oral dose of 12 to 120 mg rucaparib was 36%.
Danish: Den gennemsnitlige orale biotilgængelighed efter en enkelt oral dosis på 12 til 120 mg rucaparib var 36 %.
English: Cardiac electrophysiology
Danish: Kardiologisk elektrofysiologi
English: This medicine has been given ‘conditional approval'.
Danish: Dette lægemiddel er godkendt under “betingede omstændigheder”.
English: All 106 patients received rucaparib 600 mg twice daily.
Danish: Alle 106 patienter modtog rucaparib 600 mg to gange dagligt.
English: PFS events, n (%) PFS, median in months (95% CI)
Danish: PFS-hændelser, n (%) PFS, median i måneder (95 % CI)
English: Caution should be exercised and additional International Normalised Ratio (INR) monitoring with co-administration of warfarin and therapeutic drug level monitoring of phenytoin should be considered, if used concomitantly with rucaparib.
Danish: Der skal udvises forsigtighed og overvejes yderligere international normaliset ratio (INR) overvågning ved samtidig administration af warfarin og overvågning af det terapeutiske lægemiddelniveau af phenytoin, hvis anvendt samtidigt med rucaparib.
English: Effects of rucaparib on other medicinal products
Danish: Virkninger af rucaparib på andre lægemidler
English: Rubraca has minor influence on the ability to drive and use machines.
Danish: Rubraca påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: There are no data on the effect of rucaparib on human fertility.
Danish: Der er ingen data om virkningen af rucaparib på human fertilitet.
English: As inhibition of these transporters could increase metformin renal elimination and decrease liver uptake of metformin, caution is advised when metformin is co-administered with rucaparib.
Danish: Da hæmning af disse transportere kan øge ekskretion af metformin i nyrerne og reducere leveroptagelse af metformin, tilrådes forsigtighed, når metformin gives samtidig med rucaparib.
English: MedDRA system organ class
Danish: Systemorganklasser i henhold til MedDRA