FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with moderate renal impairment (CLcr of 30-59 mL/min), frequencies of some adverse reactions increased: Grade 3 or 4 anaemia (31%), Grade 3 or 4 thrombocytopenia (12%), and Grade 3 fatigue/asthenia (15%) were higher than in patients with mild renal impairment (CLcr > 59-80 mL/min) or normal renal function (CLcr > 80 mL/min) (21%, 5%, and 8%).
Danish: Hos patienter med moderat nedsat nyrefunktion (CLCR 30-59 ml/min) steg hyppigheden af nogle bivirkninger: Klasse 3 eller 4 anæmi (31 %), grad 3 eller 4 trombocytopeni (12 %) og grad 3 træthed/asteni (15 %) var højere end hos patienter med let nedsat nyrefunktion (CLCR >59-80 ml/min) eller normal nyrefunktion (CLCR >80 ml/min) (21 %, 5 % og 8 %).
English: Interrupt rucaparib until values return to Grade ≤ 2; then resume rucaparib with a dose reduction and monitor LFTs weekly for 3 weeks
Danish: Rucaparib genoptages derefter med en nedsat dosis, og LFT monitoreres ugentligt i 3 uger
English: In order to further confirm the safety and efficacy of rucaparib in the treatment of platinum sensitive, relapsed or progressive, BRCA mutated (germline and/ or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, the MAH should submit the results of study CO-338-043 (ARIEL4), a phase 3, multicentre, open-label, randomised study evaluating the efficacy and safety of rucaparib versus chemotherapy for treatment of relapsed ovarian cancer.
Danish: For yderligere at bekræfte sikkerheden og effekten af rucaparib ved behandling af platinfølsom, recidiveret eller progressiv BRCA-muteret (kimcelle og/eller somatisk), high grade epitelial kræft i æggestokkene, æggelederne eller primær peritoneal kræft, skal indehaveren af markedsføringstilladelsen indsende resultaterne af forsøg CO-338-043 (ARIEL4), et fase 3, multicenter, ikke-blindet, randomiseret forsøg til evaluering af effektiviteten og sikkerheden af rucaparib versus kemoterapi til behandling af recidiveret kræft i æggestokkene.
English: If you take more tablets than you should, tell your doctor, pharmacist or nurse straight away.
Danish: Hvis du har taget for mange tabletter, skal du fortælle det til lægen, apotekspersonalet eller sundhedspersonalet med det samme.
English: Rucaparib showed no effect on Cmax of digoxin while marginally increasing AUC0-72h by 1.20 fold (90% CI: 1.12 to 1.29).
Danish: Rucaparib havde ingen virkning på Cmax af digoxin, mens det marginalt øgede AUC0-72h med 1,20 gange (90 % CI: 1,12 til 1,29).
English: Rucaparib is a weak inhibitor of CYP2C8, CYP2D6, and UGT1A1.
Danish: Rucaparib er en svag hæmmer af CYP2C8, CYP2D6 og UGT1A1.
English: 60 film-coated tablets.
Danish: 60 filmovertrukket tablet.
English: Efficacy of Rubraca as treatment for relapsed or progressive EOC, FTC, or PPC has not been investigated in patients who have received prior treatment with a PARP inhibitor.
Danish: Effekten af Rubraca som behandling for recidiverende eller progressiv epitelial ovariecancer, tubacancer eller primær peritonealcancer er ikke blevet undersøgt hos patienter, der tidligere er blevet behandlet med en PARP-hæmmer.
English: Tabulated list of adverse reactions by MedDRA system organ class Adverse reactions
Danish: Tabel over bivirkninger efter MedDRA systemorganklasse Bivirkninger
English: Data suggest that rucaparib is a moderate inhibitor of CYP1A2, and a mild inhibitor of CYP2C9, CYP2C19, and CYP3A.
Danish: Data antyder, at rucaparib er en moderat hæmmer af CYP1A2, og en mild hæmmer af CYP2C9, CYP2C19 og CYP3A.
English: Other medicines and Rubraca
Danish: Brug af anden medicin sammen med Rubraca
English: Effect of P-gp and BCRP inhibitors on rucaparib PK cannot be ruled out.
Danish: Virkning af P-gp og BCRP-hæmmere på rucaparib PK kan ikke udelukkes.
English: In vitro, rucaparib reversibly inhibited CYP1A2, CYP2C19, CYP2C9, and CYP3A, and to a lesser extent CYP2C8, CYP2D6, and UGT1A1.
Danish: In vitro hæmmede rucaparib reversibelt CYP1A2, CYP2C19, CYP2C9 og CYP3A, og i mindre grad CYP2C8, CYP2D6 og UGT1A1.
English: The primary tumour in most patients was ovarian (84%); most patients (95%) had serous histology and 4% of patients reported endometrioid histology.
Danish: De fleste patienter (95 %) havde tumorer med serøs histologi og 4 % af patienterne indberettede endometrioid histologi.
English: HR (95% CI) p-valueb nonBRCA LOH+ Group
Danish: HR (95 % CI) p-værdib nonBRCA LOH+ gruppe
English: Check with your doctor, pharmacist, or nurse if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er noget, du er i tvivl om.
English: Grade 3 without other signs of liver dysfunction Monitor LFTs weekly until resolution to Grade ≤ 2
Danish: Leverfunktionstest monitoreres ugentligt, indtil der ses resolution til klasse ≤2
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines.
Danish: Fortæl altid lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: A population PK analysis was performed to evaluate the effect of renal impairment on the clearance of rucaparib in patients receiving rucaparib 600 mg twice daily.
Danish: En populations-PK-analyse blev foretaget for at evaluere effekten af nedsat nyrefunktion på clearance for rucaparib hos patienter, der modtager rucaparib 600 mg to gange dagligt.
English: Thrombocytopeniab, Neutropeniab, Febrile neutropenia, Leukopeniab
Danish: Trombocytopenib, neutropenib, febril neutropeni, leukopenib
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en særlig recept (se Bilag I: Produktresumé, pkt.
English: • red blood-cells, white blood-cells, or platelets.
Danish: Det skyldes at Rubraca kan forårsage lave blodtællinger af: røde blodceller, hvide blodceller eller blodplader.
English: Rucaparib induced CYP1A2, and down regulated CYP2B6 and CYP3A4 in human hepatocytes at clinically relevant exposures.
Danish: Rucaparib inducerede CYP1A2 og nedregulerede CYP2B6 og CYP3A4 i humane hepatocytter ved klinisk relevante eksponeringer.
English: CI: Confidence interval
Danish: CI: Konfidensinterval
English: CYP1A2 substrates
Danish: CYP1A2-substrater
English: Interrupt treatment if AST/ALT levels do not decline within 2 weeks until Grade ≤ 2, then resume rucaparib at the same or at a reduced dose
Danish: Behandling afbrydes, hvis ASAT/ALATniveauer ikke falder til klasse ≤ 2 inden for 2 uger.
English: Although no cardiac effects were observed following oral dosing, based on the findings in the intravenous studies and safety margins, cardiac effects in patients cannot be excluded when rucaparib is given orally.
Danish: Selvom der ikke blev set hjertepåvirkning efter oral dosering, kan hjertepåvirkning hos patienter ikke udelukkes ved oral administration af rucaparib baseret på fundene i de intravenøse forsøg og sikkerhedsmargener.
English: during treatment with Rubraca and for 6 months after taking the last dose of Rubraca.
Danish: - i 6 måneder efter at have taget sidste dosis Rubraca.
English: Moreover, according to its mechanism of action, rucaparib may impact human fertility.
Danish: Baseret på virkningsmekanismen er det muligt, at rucaparib kan påvirke human fertilitet.
English: Talk to your doctor, pharmacist or nurse before or during taking Rubraca.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Rubraca.
English: Patients should avoid spending time in direct sunlight because they may burn more easily during rucaparib treatment; when outdoors, patients should wear a hat and protective clothing, and use sunscreen and lip balm with sun protection factor (SPF) of 50 or greater.
Danish: Under ophold udendørs bør patienterne bruge en hat og beskyttende beklædning samt bruge solcreme og læbepomade med solbeskyttelsesfaktor (SPF) 50 eller derover.
English: There is no requirement for BRCA testing prior to using Rubraca for the maintenance treatment of adult patients with relapsed high-grade epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) who are in a complete or partial response to platinum-based chemotherapy.
Danish: Der er intet krav om BRCA-testning, før Rubraca anvendes som vedligeholdelsesbehandling af voksne patienter med recidiverende high-grade epitelial ovariecancer, tubacancer eller primær peritonealcancer, der udviser fuldstændig eller delvis respons på platinbaseret kemoterapi.
English: In an animal reproduction study, administration of rucaparib to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 600 mg twice daily (see section 5.3).
Danish: Et dyreforsøg vedrørende reproduktionstoksicitet, viste embryo-fatal toksicitet ved administrering af rucaparib til drægtige rotter i doser under niveau af den anbefalede dosis til mennesker på 600 mg to gange dagligt (se pkt.
English: No interaction with MRP2 or MRP3 was observed in vitro at the clinical exposure of rucaparib, however, mild bi-phasic activation and inhibition of MRP2 and concentration dependent inhibition of MRP3 were observed at concentrations higher than the observed plasma Cmax of rucaparib.
Danish: Der blev imidlertid observeret mild bifasisk aktivering og hæmning af MRP2, og koncentrationsafhængig hæmning af MRP3 blev observeret ved koncentrationer større end den observerede plasma Cmax rucaparib.
English: • Tablet content: Microcrystalline cellulose, sodium starch glycolate (Type A), colloidal anhydrous silica and magnesium stearate.
Danish: Øvrige indholdsstoffer: - Tabletindhold: Mikrokrystallin, cellulose, natriumstivelsesglycolat (type A), kolloid vandfri silica og magnesiumstearat
English: Myelodysplastic syndrome / Acute myeloid leukaemiaa
Danish: Myelodysplastisk syndrom/akut myeloid leukæmia
English: PAES: In order to further investigate the efficacy of rucaparib maintenance treatment in patients with relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy, the MAH should submit the final analysis of OS and updated analyses of PFS2, chemotherapy-free interval and time to start of subsequent anti-cancer treatment of the phase 3, randomised, double-blind study CO-338-014
Danish: Virkningsundersøgelse efter tilladelse til markedsføring (PAES): For yderligere at undersøge effekten af vedligeholdelsesbehandling med rucaparib til patienter med recidiverende high grade epitelial ovariecancer, tubacancer eller primær peritonealcancer, der udviser respons (komplet eller delvis) på platinbaseret kemoterapi, skal indehaveren af markedsføringstilladelsen indsende den endelige analyse af OS og opdaterede analyser af PFS2, det kemoterapifrie interval og tid til første efterfølgende kræfthæmmende behandling fra det randomiserede, dobbeltblindede fase 3-studie CO-338-014.
English: Before taking Rubraca as treatment for relapsed or progressive EOC, FTC, or PPC, patients must have confirmation of deleterious germline or somatic mutations in the breast cancer 1 (BRCA1) or breast cancer 2 (BRCA2) gene using a validated test.
Danish: Inden patienten påbegynder behandling med Rubraca som behandling for recidiverende eller progressiv epitelial ovariecancer, tubacancer eller primær peritonealcancer, skal vedkommende have bekræftet mutation, enten skadelige kimcelle eller somatiske mutationer, i brystcancergen 1 (BRCA1) eller brystcancergen 2 (BRCA2) ved hjælp af en valideret test.
English: Median duration of responsea - days (95% CI)
Danish: Gennemsnitlig responsvarigheda - dage (95 % CI)
English: In vitro, rucaparib is metabolised primarily by CYP2D6, and to a lesser extent by CYP1A2, and CYP3A4.
Danish: In vitro metaboliseres rucaparib primært af CYP2D6 og i mindre grad af CYP1A2, og CYP3A4.
English: Median progression-free survival - days (95% CI)
Danish: Gennemsnitlig progressionsfri overlevelse dage (95 % CI)
English: No starting dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Danish: Der er ikke behov for dosisjustering hos patienter med mild eller moderat nedsat nyrefunktion (se pkt.
English: Always take this medicine exactly as your doctor, pharmacist or nurse has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens, apotekspersonalets eller sundhedspersonalets anvisning.
English: Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube,
Danish: Rubraca er indiceret som monoterapibehandling af voksne patienter med platinfølsom, recidiverende eller progressiv BRCA-muteret (kimcelle og/eller somatisk), high grade epitelial ovariecancer,
English: In addition, according to its mechanism of action rucaparib may have the potential to impair fertility in humans.
Danish: Baseret på virkningsmekanismen kan rucaparib endvidere muligvis svække fertilitet hos mennesker.
English: Study 10 population characteristics in 42 patients were: median age 57 years (range 42 to 84), white (83%), ECOG performance status 0 (62%) or 1 (38%), high grade ovarian cancer (100%), 3 or more prior lines of chemotherapy (36%), median time since ovarian cancer diagnosis 43 months [range: 6178], median progression-free interval from the last platinum treatment 8.0 months [range: 6.0
Danish: Forsøg 10 populationskarakteristika hos 42 patienter var: Gennemsnitsalder 57 år (fra 42 til 84), hvid (83 %), ECOG performance status 0 (62 %) eller 1 (38 %), kræft i æggestokkene - high grade (100 %), 3 eller flere tidligere behandlingsformer med kemoterapi (36 %), gennemsnitlig tid fra diagnosen kræft i æggestokkene 43 måneder [fra 6 til 178], gennemsnitligt progressionsfrit tidsinterval fra sidste platin-behandling 8,0 måneder [fra: 6,0 til 116,4].
English: ARIEL2 population characteristics in 64 patients were: median age 60 years (range 33 to 80), white(75%), ECOG performance status 0 (61%) or 1 (39%), high grade ovarian cancer (100%), 3 or more prior lines of chemotherapy (78%), median time since ovarian cancer diagnosis 53 months [range: 22-197], median progression-free interval from the last platinum treatment 7.6 months [range:
Danish: ARIEL2 populationskarakteristika hos 64 patienter var: Gennemsnitsalder 60 år (fra 33 til 80), hvid (75 %), ECOG performance status 0 (61 %) eller 1 (39%), kræft i æggestokkene - high grade (100 %), 3 eller flere tidligere behandlingsformer med kemoterapi (78 %), gennemsnitlig tid fra diagnosen kræft i æggestokkene 53 måneder [fra 22 til 197], gennemsnitlig progressionsfrit tidsinterval fra de sidste platin-behandling 7,6 måneder [fra 0 ,7 26,5].
English: Oxidation, N-demethylation, N-methylation, glucuronidation, and N-formylation were the major metabolic pathways for rucaparib.
Danish: Rucaparibs vigtigste metaboliske veje var oxidering, N-demetylering, N-metylering, glucuronidering og N-formylering.
English: How to take Rubraca
Danish: Sådan skal du tage Rubraca
English: Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinumsensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Danish: Rubraca er indiceret som monoterapi til vedligeholdelsesbehandling af voksne patienter med platinsensitiv, recidiverende high-grade epitelial ovariecancer, tubacancer eller primær peritonealcancer, der udviser respons (komplet eller delvis) på platinbaseret kemoterapi.
English: HR (95% CI) p-valueb nonBRCA LOH- Group
Danish: HR (95 % CI) p-værdib nonBRCA LOH- gruppe
English: Lymphopeniab
Danish: Lymfopenib
English: • The active substance is rucaparib.
Danish: - Aktivt stof: rucaparib
English: Blood samples for 94% (186/196) of the tBRCA patients were evaluated using a central blood germline BRCA (gBRCA) test. Based on these results, 70% (130/186) of the tBRCA patients had a gBRCA mutation and 30% (56/186) had a somatic BRCA mutation.
Danish: Baseret på disse resultater havde 70 % (130/186) af tBRCA-patienterne en gBRCA-mutation, og 30 % (56/186) havde en somatisk BRCA-mutation.
English: No formal studies of rucaparib in patients with renal impairment have been conducted.
Danish: Ingen formelle undersøgelser for rucaparib hos patienter med nedsat nyrefunktion er blevet udført.
English: Rucaparib is a potent inhibitor of MATE1 and MATE2-K, a moderate inhibitor of OCT1, and a weak inhibitor of OCT2.
Danish: Rucaparib er en potent hæmmer af MATE1 og MATE2-K, en moderat hæmmer af OCT1 og en svag hæmmer af OCT2.
English: Nausea, Vomiting, Diarrhoea, Dyspepsia, Abdominal pain
Danish: Kvalme, opkastning, diarré, dyspepsi, mavesmerter
English: In vitro, rucaparib is a potent inhibitor of MATE1 and MATE2-K, a moderate inhibitor of OCT1, and a weak inhibitor of OCT2.
Danish: In vitro er rucaparib en potent hæmmer af MATE1 og MATE2-K, en moderat hæmmer af OCT1 og en svag hæmmer af OCT2.
English: Rucaparib induced structural chromosomal aberrations in the in vitro human lymphocyte chromosomal aberration assay.
Danish: Rucaparib inducerede strukturelle kromosomafvigelser i in vitro lymfocyt-proliferationsanalysen.
English: Gastrointestinal toxicities (nausea and vomiting) are frequently reported with rucaparib, are generally low grade (CTCAE Grade 1 or 2), and may be managed with dose reduction (refer to Table 1) or interruption.
Danish: Generelt af lav grad (CTCAE klasse 1 eller 2) og kan styres ved dosisreduktion (se tabel 1) eller afbrydelse.
English: HR (95% CI) p-valueb tBRCA Groupd
Danish: HR (95 % CI) p-værdib tBRCA grupped
English: Interactions between rucaparib and oral contraceptives have not been studied.
Danish: Lægemiddelinteraktion mellem rucaparib og p-piller er ikke blevet undersøgt.
English: The ≥ Grade 3 adverse reactions occurring in > 5% of patients were anaemia (23%), ALT elevations (10%), fatigue/asthenia (10%), neutropenia (8%), thrombocytopenia (6%), and nausea (5%).
Danish: Bivirkninger ≥ grad 3, som forekommer hos > 5 % af patienter, var anæmi (23 %), ALAT-stigning (10 %), træthed/asteni (10 %) neutropeni (8 %), trombocytopeni (6 %) og kvalme (5 %).Den eneste alvorlige bivirkning hos > 2 % af patienterne var anæmi (5 %).
English: Rucaparib increased S-warfarin Cmax by 1.05 fold (90% CI: 0.99 to 1.12) and AUC0-96h by 1.49 fold (90% CI: 1.40 to 1.58), respectively.
Danish: Rucaparib øgede S-warfarin henholdsvis Cmax med 1,05 gange (90 % CI: 0,99 til 1,12) og AUC0-96h med 1,49 gange (90 % CI: 1,40 til 1,58).
English: • being short of breath, feeling tired, having pale skin, or fast heart beat - these may be signs of a low red blood cell count (anaemia)
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer): - åndenød, træthedsfølelse, at have bleg hud eller hurtig hjerterytme - dette kan være tegn på et lavt antal røde blodlegemer (blodmangel) - blødning eller blå mærker i længere tid end sædvanlig, hvis du slår dig - dette kan være tegn på et lavt antal blodplader (trombocytopeni) - feber eller infektion - dette kan være tegn på et lavt antal hvide blodlegemer (neutropeni)
English: Rubraca should be interrupted or dose reduced according to Table 1 (see section 4.2) and blood counts monitored weekly until recovery.
Danish: 4.2) og blodtællinger bør overvåges ugentligt indtil bedring.
English: Tablet core
Danish: - Tabletovertræk:
English: What you need to know before you take Rubraca Do not take Rubraca:
Danish: Det skal du vide, før du begynder at tage Rubraca Sådan skal du tage Rubraca Bivirkninger
English: Rubraca 200 mg film-coated tablets Rubraca 250 mg film-coated tablets Rubraca 300 mg film-coated tablets
Danish: Rubraca 200 mg filmovertrukket tablet Rubraca 250 mg filmovertrukket tablet Rubraca 300 mg filmovertrukket tablet
English: The pharmacokinetic characteristics of rucaparib in patients with CLcr less than 30 mL/min or patients on dialysis are unknown (see section 4.2).
Danish: De farmakokinetiske egenskaber for rucaparib hos patienter med CLCR mindre end 30 ml/min.
English: CYP2C19 substrates
Danish: CYP2C19-substrater
English: Rash maculo-papular, Palmarplantar erythrodysaesthesia syndrome, Erythema
Danish: Makulo-papuløst udslæt, palmoplantar erytrodysæstesisyndrom, erytem
English: Patients with mild renal impairment (N=149; CLcr between 60 and 89 mL/min, as estimated by the Cockcroft-Gault method) and those with moderate renal impairment (N=76; CLcr between 30 and 59 mL/min) showed approximately 15% and 33% higher steady-state AUC, respectively, compared to patients with normal renal function (N=147; CLcr greater than or equal to 90 mL/min).
Danish: Patienter med mild nedsat nyrefunktion (N = 149, CLCR mellem 60 og 89 ml/min, som estimeret efter Cockcroft-Gault-metoden) og patienter med moderat nedsat nyrefunktion (N=76, CLCR mellem 30 og 59 ml/min.)
English: Talc (E553b)
Danish: Macrogol 4000 (E1521) Talkum (E553b)
English: Randomisation was stratified by best response to last platinum therapy (complete or partial), time to progression following the penultimate platinum therapy (6 to ≤ 12 months and > 12
Danish: Randomisering blev stratificeret efter bedste respons på sidste platinbehandling (komplet eller delvis), tid til progression efter den næstsidste platinbehandling (6 til ≤ 12 måneder og > 12 måneder) og tumorbiomarkørstatus (tBRCA, non-BRCA homolog rekombination-defekt [nbHRD] og negativ biomarkør).
English: Yellow, 8 x 16 mm, oval film-coated tablet, debossed with “C3”.
Danish: Rubraca 300 mg filmovertrukket tablet Gul, 8 x 16 mm, oval filmovertrukket tablet, præget med “C3” .
English: Rucaparib increased omeprazole Cmax by 1.09 fold (90% CI: 0.93 to 1.27) and AUCinf by 1.55 fold (90% CI: 1.32 to 1.83).
Danish: Rucaparib øgede omeprazol Cmax med 1,09 gange (90 % CI: 0,93 til 1,27) og AUCinf med 1,55 gange (90 % CI: 1,32 til 1,83).
English: Rucaparib increased midazolam Cmax by 1.13 fold (90% CI: 0.95 to 1.36) and AUCinf by 1.38 fold (90% CI: 1.13 to 1.69).
Danish: Rucaparib øgede midazolam Cmax med 1,13 gange (90 % CI: 0,95 til 1,36) og AUCinf med 1,38 gange (90 % CI: 1,13 til 1,69).
English: • Rubraca 300 mg film-coated tablets are yellow, oval, film-coated tablets with “C3” marked on one side.
Danish: Rubraca 300 mg filmovertrukket tablet er gule, ovale, filmovertrukket tablet med “C3” markeret på den ene side.
English: • before treatment with Rubraca
Danish: - under behandling med Rubraca og
English: Anaemiab, Thrombocytopeniab, Neutropeniab
Danish: Anæmib, trombocytopenib, neutropenib,
English: Nausea, Vomiting, Diarrhoea, Abdominal pain
Danish: Kvalme, opkastning, diarré, mavesmerter
English: • Rubraca 250 mg film-coated tablets are white, diamond-shaped, film-coated tablets with “C25” marked on one side.
Danish: Rubraca 250 mg filmovertrukket tablet er hvide, diamantformede, filmovertrukket tablet med “C25” markeret på den ene side.
English: Your doctor or nurse will perform blood tests to check your blood cell-counts:
Danish: Din læge eller sundhedspersonalet vil tage blodprøver for at kontrollere din blodcelletælling: før behandling med Rubraca hver måned under behandling med Rubraca
English: • Rubraca 200 mg film-coated tablets are blue, round, film-coated tablets with “C2” marked on one side.
Danish: Rubraca 200 mg filmovertrukket tablet er blå, runde, filmovertrukket tablet med “C2” markeret på den ene side.
English: No starting dose adjustment is required in patients with mild hepatic impairment (see section 5.2).
Danish: Der er ikke behov for dosisjustering hos patienter med let nedsat leverfunktion (se pkt.
English: Children unde 18 years of age should not be given Rubraca, This medicine has not beem studied in this age group.
Danish: Børn under 18 år må ikke få Rubraca.
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem Meget almindelig