FrancophonIA/ELRC3.0 huggingface dataset:
English: Film-coated tablets Multipack: 112 (2 packs of 56) film-coated tablets
Danish: Filmovertrukne tabletter Multipakning: 112 (2 pakninger a 56) filmovertrukne tabletter
English: For germline breast cancer susceptibility genes (gBRCA1/2) mutated human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, patients must have confirmation of a deleterious or suspected deleterious gBRCA1/2 mutation before Lynparza treatment is initiated.
Danish: For germline brystcancerdisponerede gener (gBRCA1/2)-muteret human epidermal vækstfaktorreceptor 2 (HER2)-negativ metastatisk brystcancer skal patienter have en bekræftet risikogivende eller en formodet risikogivende gBRCA1/2-mutation før behandling med Lynparza initieres.
English: Baseline testing, followed by monthly monitoring of complete blood counts is recommended for the first 12 months of treatment and periodically after this time to monitor for clinically significant changes in any parameter during treatment which may require dose interruption or reduction and/or further treatment (see sections 4.2 and 4.4).
Danish: Baseline-test efterfulgt af månedlig monitorering af komplette blodtal anbefales i de første 12 måneder af behandlingen og regelmæssigt efter dette tidspunkt for at monitorere for klinisk signifikante ændringer i et eller flere parametre under behandling, som kunne kræve afbrydelse af doseringen eller dosisreduktion og/eller yderligere behandling (se pkt.
English: No placebo-treated patients discontinued due to vomiting or dyspepsia.
Danish: Ingen placebobehandlede patienter seponerede behandlingen på grund af opkastning eller dyspepsi.
English: Patients whose disease had recurred >6 months after completion of penultimate platinum-based chemotherapy were enrolled.
Danish: Patienter, hvis sygdom var vendt tilbage > 6 måneder efter afslutning af deres næstsidste platinbaserede kemoterapi, blev inkluderet.
English: The most frequent adverse reactions leading to dose interruption or dose reduction were anaemia, nausea and vomiting.
Danish: De hyppigste bivirkninger, som førte til dosisafbrydelse eller dosisreduktion var anæmi, kvalme og opkastning.
English: PFS2 (65% maturity) - DCO 25 September 2017
Danish: PFS2 (65 % modenhed) - DCO 25. september 2017
English: Uncommon Dizziness, Headache
Danish: Ikke almindelig Svimmelhed, hovedpine
English: Figure 4 Study 19: Kaplan-Meier plot of PFS in the FAS (58% maturity - investigator assessment) DCO 30 June 2010
Danish: Study 19: Kaplan-Meier-plot af PFS i FAS (58 % modenhed - investigatorvurdering) DCO 30. juni 2010
English: Nonclinical studies in rats have shown that olaparib causes adverse effects on embryofoetal survival and induces major foetal malformations at exposures below those expected at the recommended human dose of 400 mg twice daily.
Danish: Prækliniske studier med rotter har vist, at olaparib har negativ indvirkning på embryoføtal overlevelse og giver omfattende føtale misdannelser ved eksponering under det, der forventes ved den anbefalede humane dosis på 400 mg to gange dagligt.
English: • ergot alkaloids - used to treat migraines and headaches
Danish: • sekalealkaloider - anvendes til behandling af migræne og hovedpine
English: It can be used after the cancer has responded to previous treatment with standard platinum-based chemotherapy.
Danish: Det kan anvendes efter kræften har reageret på tidligere behandling med standard kemoterapi baseret på platin.
English: Each hard capsule contains 50 mg of olaparib.
Danish: Hver hård kapsel indeholder 50 mg olaparib.
English: The investigator assessment of PFS was consistent with a blinded independent central radiological review of PFS. At the final analysis (DCO 9 May 2016), the time from randomisation to start of first subsequent therapy or death (TFST) was 9.4 months longer for olaparib-treated patients (HR 0.33; 95% CI 0.22-0.49; p<0.00001; median 15.6 months versus 6.2 months).
Danish: Investigators vurdering af PFS var i overensstemmelse med en blindet, uafhængig, central radiologisk vurdering af PFS. Ved den endelige analyse (DCO 9. maj 2016) var tiden fra randomisering til starten på første efterfølgende behandling eller død (TFST) 9,4 måneder længere for olaparibbehandlede patienter (HR 0,33; 95 % CI 0,22-0,49; p<0,00001; gennemsnitligt 15,6 måneder versus 6,2 måneder).
English: Response to prior platinum chemotherapy was complete in 45% and partial in 55% of the patients.
Danish: Respons på tidligere platinkemoterapi var fuldstændigt hos 45 % og delvist hos 55 % af patienterne.
English: For the secondary endpoint of OS, the HR for olaparib versus placebo was 0.62 (95% CI 0.42-0.93; p=0.02140; median 34.9 months versus 30.2 months) (Table 2).
Danish: For det sekundære endepunkt OS var HR for olaparib versus placebo 0,62 (95 % CI 0,42-0,93; p=0,02140; gennemsnitligt 34,9 måneder versus 30,2 måneder) (tabel 2).
English: The investigator assessment of PFS was supported with a blinded independent central radiological (BICR) review of PFS. At the time of PFS analysis, interim OS data were immature (21%), with HR 0.95 (95% CI 0.60, 1.53; p-value=0.9).
Danish: Investigatorvurderingen af PFS blev understøttet af en blindet, uafhængig central radiologisk (BICR) vurdering af PFS. På tidspunktet for PFS-analysen var de midlertidige OS-data umodne (21 %) med HR på 0,95 (95 % CI 0,60, 1,53; p-værdi=0,9).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Lynparza in all subsets of the paediatric population, in ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours) (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Lynparza i alle sub-grupper af den pædiatriske population ved ovariecarcinoma (eksklusive rhabdomyosarkom og kimcelletumorer) (se pkt.
English: Nonclinical studies in rats have shown that olaparib causes adverse effects on embryofoetal survival and induces major foetal malformations at exposures below those expected at the recommended human dose of 300 mg twice daily.
Danish: Prækliniske studier med rotter har vist, at olaparib har negativ indvirkning på embryoføtal overlevelse og giver omfattende føtale misdannelser ved eksponering under det, der forventes ved den anbefalede humane dosis på 300 mg to gange dagligt.
English: TNBC gBRCA mutation type (%) gBRCA1 gBRCA2 gBRCA1 and gBRCA2 ≥2 Metastatic sites (%) Location of the metastasis (%) Bone only
Danish: TNBC gBRCA-mutationstype (%) gBRCA1 gBRCA2
English: The time from randomisation to start of second subsequent therapy or death (TSST) was 6.1 months longer for olaparib-treated patients (HR 0.43; 95% CI 0.29-0.64; p=0.00003; median 21.4 months versus 15.3 months).
Danish: Tiden fra randomisering til starten på anden efterfølgende behandling eller død (TSST) var 6,1 måneder længere for olaparibbehandlede patienter (HR 0,43; 95 % CI 0,29-0,64; p=0,00003; gennemsnitligt 21,4 måneder versus 15,3 måneder).
English: Leukopenia Uncommon Lymphopenia
Danish: leukopeni Almindelig Lymfopeni
English: • rash or itchy rash on swollen, reddened skin (dermatitis)
Danish: • udslæt eller kløende udslæt på hævet, rød hud (dermatitis)
English: A clinical study to evaluate the impact of itraconazole, a known CYP3A inhibitor, has shown that coadministration with olaparib increased mean olaparib Cmax by 42% (90% CI: 33-52%) and mean AUC by 170% (90% CI: 144-197%).
Danish: Et klinisk studie, der evaluerede påvirkningen fra itraconazol, en kendt CYP3A-inhibitor, viste, at administration sammen med olaparib øgede den gennemsnitlige olaparib-Cmax med 42 % (90 % CI: 33-52 %) og det gennemsnitlige AUC med 170 % (90 % CI: 144-197 %).
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken samt blisterpakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: There are no data from the use of olaparib in pregnant women, however, based on the mode of action of olaparib, Lynparza should not be used during pregnancy and in women of childbearing potential not using reliable contraception during therapy and for 1 month after receiving the last dose of Lynparza.
Danish: Der findes ingen data fra anvendelse af olaparib til gravide kvinder, men baseret på virkningsmekanismen for olaparib, bør Lynparza ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker antikonception under behandlingen og i 1 måned efter at have fået den sidste dosis af Lynparza.
English: The most frequent adverse reactions leading to dose interruption or dose reduction were nausea, anaemia, vomiting, neutropenia and fatigue.
Danish: De hyppigste bivirkninger, som førte til dosisafbrydelse eller dosisreduktion var kvalme, anæmi, opkastning, neutropeni og træthed.
English: Ovarian cancer was the primary tumour in 85% of the patients.
Danish: Ovariecancer var den primære tumor hos 85 % af patienterne.
English: Patients can continue treatment until radiological disease progression, unacceptable toxicity or for up to 2 years if there is no radiological evidence of disease after 2 years of treatment.
Danish: Førstelinjevedligeholdelsesbehandling af BRCA-muteret fremskreden ovariecancer: Patienterne kan fortsætte behandlingen indtil radiologisk sygdomsprogression, uacceptabel toksicitet eller i op til 2 år, hvis der ikke er radiologisk påvist sygdom efter 2 års behandling.
English: OS (64% maturity) - DCO 25 September 2017
Danish: OS (64 % modenhed) - DCO 25. september 2017
English: A summary of the primary objective outcome for patients with gBRCA1/2m PSR ovarian cancer in SOLO2 is presented in Table 3 and Figure 3.
Danish: En sammenfatning af de primære, objektive resultater for patienter med gBRCA1/2 m PSR-ovariecancer i SOLO2 er præsenteret i Tabel 3 og Figur 3.
English: bd Twice daily; PFS Progression free survival
Danish: bd To gange dagligt; PFS Progressionsfri overlevelse
English: The key efficacy findings from Study 19 for BRCA-mutated patients are presented in Table 2, and Figures 1 and 2.
Danish: Nøgleresultaterne fra Study 19 for BRCA-muterede patienter kan ses i tabel 2 samt i figur 1 og 2.
English: Number of objective responders: Total number of patients with measurable disease (%)
Danish: Antallet objektive respondenter: Samlet antal patienter med målbar sygdom (%) 95% CI
English: bd Twice daily; PFS progression-free survival; DCO data cut off; CI confidence interval; NR not reached.
Danish: bd To gange dagligt; PFS Progressionsfri overlevelse; DCO Skæringsdato for data; CI Konfidensinterval; NR Ikke opnået.
English: In patients with moderate renal impairment (creatinine clearance 31 to 50 ml/min), AUC increased by 44% and Cmax by 26% compared with patients with normal renal function.
Danish: Hos patienter med moderat nedsat nyrefunktion (kreatininclearance 31 til 50 ml/min) steg AUC med 44 % og Cmax med 26 % i sammenligning med patienter med normal nyrefunktion.
English: Patients with PR at study entry had PFS HR 0.31 (95% CI 0.18, 0.52; median PFS 30.9 months on olaparib vs 8.4 months on placebo).
Danish: Patienterne med PR ved indtræden i studiet havde PFS HR på 0,31 (95 % CI 0,18, 0,52; median PFS 30,9 måneder på olaparib vs. 8,4 måneder på placebo).
English: Lynparza is not recommended for use in patients with severe renal impairment or end-stage renal disease (creatinine clearance ≤ 30 ml/min), as safety and pharmacokinetics have not been studied in these patients.
Danish: Lynparza frarådes til patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet (kreatininclearance ≤ 30 ml/min), da sikkerhed og farmakokinetik ikke er undersøgt hos disse patienter.
English: One pack contains 448 capsules (4 bottles of 112 capsules).
Danish: En pakning indeholder 448 kapsler (4 flasker a 112 kapsler).
English: Previous platinum-based therapy in (neo)adjuvant setting metastatic setting in (neo)adjuvant and metastatic setting 3 (1) Previous anthracycline treatment in (neo) adjuvant setting metastatic setting
Danish: Tidligere platinbaseret behandling (%) 60 (29) i (neo)adjuverende regi metastatisk regi i (neo)adjuverende og metastatisk regi Tidligere behandling med antracyklin i (neo)adjuverende regi metastatisk regi
English: Before Lynparza treatment is initiated for first-line maintenance treatment of high-grade epithelial ovarian cancer (EOC), fallopian tube cancer (FTC) or primary peritoneal cancer (PPC), patients must have confirmation of deleterious or suspected deleterious germline and/or somatic mutations in the breast cancer susceptibility genes (BRCA) 1 or 2 using a validated test.
Danish: Før behandling med Lynparza initieres til førstelinjevedligeholdelsesbehandling af high-grade epitelial ovariecancer (EOC), tubacancer (FTC) eller primær peritonealcancer (PPC), skal patienterne have bekræftet, at de har risikogivende eller formodet risikogivende germline- eller somatiske mutationer i de brystcancerdisponerede gener (BRCA) 1 eller 2 ved anvendelse af en valideret test.
English: PFS (77% maturity) - DCO 09 December 2016
Danish: PFS (77 % modenhed) - DCO 9. december 2016
English: Figure 5 Study 19: Kaplan Meier plot of OS in the FAS (79% maturity) DCO 09 May 2016
Danish: Study 19: Kaplan Meier-plot af OS i FAS (79 % modenhed) DCO 9. maj 2016
English: In patients with mild hepatic impairment (Child-Pugh classification A), AUC increased by 15% and Cmax by 13% and in patients with moderate hepatic impairment (Child-Pugh classification B), AUC increased by 8% and Cmax decreased by 13% compared with patients with normal hepatic function.
Danish: Hos patienter med let nedsat leverfunktion (Child-Pugh klassifikation A) steg AUC med 15 % og Cmax med 13 % og hos patienter med moderat nedsat leverfunktion (Child-Pugh klassifikation B) steg AUC med 8 % og Cmax faldt med 13 % i sammenligning med patienter med normal leverfunktion.
English: TSST- an approximation of PFS2 (DCO 09 May
Danish: TSST- en tilnærmelse af PFS2 (DCO 9. maj 2016)
English: In the event that a patient already receiving Lynparza requires treatment with a strong or moderate CYP3A inducer, the prescriber should be aware that the efficacy of Lynparza may be substantially reduced (see section 4.5).
Danish: Hvis en patient, som allerede får Lynparza, har behov for behandling med en stærk eller moderat CYP3A-induktor, skal den ordinerende læge være opmærksom på, at effekten af Lynparza kan være væsentligt nedsat (se pkt.
English: If you are having sex, you should use two effective methods of contraception while taking this medicine and for 1 month after taking the last dose of Lynparza.
Danish: Hvis du dyrker sex, skal du anvende to effektive former for beskyttelse mod graviditet, mens du tager denne medicin og i 1 måned efter du har taget den sidste dosis af Lynparza.
English: It is used after the cancer has responded to previous treatment with standard platinum-based chemotherapy.
Danish: Det anvendes efter kræften har reageret på tidligere behandling med standard kemoterapi baseret på platin.
English: • The usual recommended dose is 300 mg (2 x 150 mg tablets) twice a day - a total of 4 tablets each day.
Danish: • Den normale anbefalede dosis er 300 mg (2 x 150 mg tabletter) to gange dagligt - i alt 4 tabletter hver dag.
English: The median PFS improvement was 6.9 months over placebo for olaparib-treated patients (HR 0.18; 95% CI 0.10-0.31; p<0.00001; median 11.2 months versus 4.3 months).
Danish: Den gennemsnitlige PFS-forbedring var 6,9 måneder over placebo for olaparibbehandlede patienter (HR 0,18; 95 % CI 0,10-0,31; p<0,00001; gennemsnitligt 11,2 måneder versus 4,3 måneder).
English: bd Twice daily; PFS progression-free survival; CI confidence interval
Danish: bd To gange dagligt; PFS Progressionsfri overlevelse; CI Konfidensinterval
English: In replicating cells this also leads to the formation of DNA double-strand breaks (DSBs) when replication forks meet the PARP-DNA adducts.
Danish: I replikerende celler fører dette til DNA-dobbeltstrengsbrud (DSB), når replikationsgafler møder PARP-DNA-addukterne.
English: Figure 8 OlympiAD: Kaplan-Meier plot of OS in patients with gBRCA1/2-mutated HER2-negative metastatic breast cancer (64% maturity) DCO 25 September 2017
Danish: Figur 8 OlympiAD: Kaplan-Meier-plot af OS hos patienter med gBRCA1/2-muteret HER2-negativ metastatisk brystcancer (64 % modenhed) DCO 25. september 2017
English: • Printing ink: shellac, iron oxide black (E172).
Danish: • Trykfarve på kapslen: shellac, jernoxid, sort (E172).
English: Patients with germline or somatic BRCA1/2 mutations were identified prospectively either from germline testing in blood via a local test (n=208) or central test (n=181) or from testing a tumour sample using a local test (n=2).
Danish: Patienter med germline- eller somatisk BRCA1/2-mutationer blev identificeret prospektivt enten via germline-test i blod via en lokal test (n=208) eller central test (n=181) eller ved test af en tumorprøve i en lokal test (n=2).
English: (E172), iron oxide black (E172) (150 mg tablets only).
Danish: Jernoxid, sort (E172) (kun 150 mg tabletter)
English: Breast-feeding during treatment and for 1 month after the last dose (see section 4.6).
Danish: Amning under behandlingen og i 1 måned efter sidste dosis (se pkt.
English: Lynparza dose adjustment is recommended for patients with moderate renal impairment (see section 4.2).
Danish: Dosisjustering af Lynparza anbefales til patienter med moderat nedsat nyrefunktion (se pkt.
English: Pack of 448 capsules (4 bottles of 112 capsules).
Danish: Pakning med 448 kapsler (4 flasker a 112 kapsler).
English: The investigator assessment of PFS was supported with a blinded independent central radiological review of PFS (HR 0.25; 95% CI 0.18-0.35; p<0.0001; median 30.2 months for olaparib and 5.5 months placebo).
Danish: Investigatorvurderingen af PFS blev understøttet af en blindet, uafhængig, central radiologisk vurdering af PFS (HR 0,25; 95 % CI 0,18-0,35; p<0,0001; median 30,2 måneder for olaparib og 5,5 måneder for placebo).
English: Hard capsule 448 capsules (4 bottles of 112 capsules)
Danish: Hårde kapsler 448 kapsler (4 flasker a 112 kapsler)
English: Film-coated tablets 56 film-coated tablets
Danish: Filmovertrukne tabletter 56 filmovertrukne tabletter
English: The recommended dose reduction is to 250 mg (one 150 mg tablet and one 100 mg tablet) twice daily (equivalent to a total daily dose of 500 mg).
Danish: Den anbefalede dosisreduktion er til 250 mg (én 150 mg tablet og én 100 mg tablet) to gange dagligt (svarende til en samlet daglig dosis på 500 mg).
English: No Lynparza dose adjustment is required for patients with mild renal impairment.
Danish: Det er ikke nødvendigt med dosisjustering af Lynparza til patienter med let nedsat nyrefunktion.
English: Please note Lynparza is also available as a 100 mg and 150 mg tablet.
Danish: Bemærk, at Lynparza også findes som 100 mg og 150 mg tabletter.
English: Patients with BRCA1/2 mutations were identified either from germline testing in blood via a local test or by central testing at Myriad or from testing a tumour sample using a local test. Large rearrangements in the BRCA1/2 genes were detected in 4.7% (14/295) of the randomised patients.
Danish: Patienter med BRCA1/2-mutationer blev identificeret enten ved germline-test i blod via en lokal test eller central test hos Myriad eller ved at teste en tumorprøve ved en lokal test. Der blev opdaget større strukturelle ændringer i BRCA1/2 generne hos 4,7 % (14/295) af de randomiserede patienter.
English: Do not breast-feed if you are taking Lynparza and for 1 month after taking the last dose of Lynparza.
Danish: Du må ikke amme, hvis du tager Lynparza og indtil 1 måned efter du har taget din sidste dosis af Lynparza.
English: Lynparza 50 mg hard capsules
Danish: Lynparza 50 mg hårde kapsler
English: Olaparib 400 mg bd Placebo bd Twice daily; DCO Data cut-off; FAS Full analysis set; PFS progression-free survival
Danish: Placebo bd To gange dagligt; DCO Skæringsdato for data; FAS Fuldt analysesæt; PFS progressionsfri overlevelse
English: In patients with mild renal impairment (creatinine clearance 51 to 80 ml/min), AUC increased by 24% and Cmax by 15% compared with patients with normal renal function.
Danish: Hos patienter med let nedsat nyrefunktion (kreatininclearance 51 til 80 ml/min) steg AUC med 24 % og Cmax med 15 % i sammenligning med patienter med normal nyrefunktion.
English: OS - DCO 09 May 2016
Danish: OS - DCO 09 maj 2016
English: • maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
Danish: • vedligeholdelsesbehandling af voksne patienter med fremskreden (FIGO stadie III og IV) BRCA1/2-muteret (germline og/eller somatisk) high-grade epitelial ovarie-, tuba- eller primær peritonealcancer, som responderer (fuldstændigt eller delvist) efter afslutning af platinbaseret førstelinjekemoterapi
English: • Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow
Danish: • Tabletovertræk: hypromellose, macrogol 400, titandioxid (E171), jernoxid; gul (E172),
English: A total of 32 (23.5%) patients received treatment for ≥2 years in the olaparib group compared with 5 (3.9%) patients in the placebo group.
Danish: I alt 32 (23,5 %) patienter modtog behandling i ≥ 2 år i olaparibgruppen sammenlignet med 5 (3,9 %) patienter i placebogruppen.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before or during treatment with Lynparza:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apoteketspersonalet eller sundhedspersonalet, før eller mens du tager Lynparza:
English: Capsule shell Hypromellose Titanium dioxide (E171) Gellan gum (E418) Potassium acetate
Danish: Kapselskal Hypromellose Titandioxid (E171) Gellangummi (E418) Kaliumacetat
English: The study compared the efficacy of Lynparza capsule maintenance treatment (400 mg [8 x 50 mg capsules] twice daily) taken until progression with placebo treatment in 265 (136 olaparib and 129 placebo) PSR high grade serous ovarian cancer patients who were in response (CR or PR) following completion of platinum-containing chemotherapy.
Danish: Studiet sammenlignede effekten af vedligeholdelsesbehandling med Lynparza kapsler [400 mg (8 x 50 mg kapsler) to gange dagligt], som blev taget indtil progression, med placebobehandling hos 265 (136 olaparib og 129 placebo) patienter med PSR high-grade serøs ovariecancer, som havde respons (CR eller PR) efter fuldførelse af platinholdig kemoterapi.
English: Figure 6 OlympiAD: Kaplan-Meier plot of BICR PFS in patients with gBRCA1/2-mutated HER2-negative metastatic breast cancer (77% maturity) DCO 09 December 2016
Danish: OlympiAD: Kaplan-Meier-plot af BICR PFS hos patienter med gBRCA1/2-muteret HER2-negativ metastatisk brystcancer (77 % modenhed) DCO 9. december 2016
English: HR (95% CI) P value* (2-sided)
Danish: HR (95% CI) P-værdi* (2-sidet)
English: In clinical studies with Lynparza the incidence of CTCAE grade ≥ 2 shifts (elevations) from baseline in blood creatinine was approximately 10%.
Danish: I kliniske studier med Lynparza var forekomsten af skift i CTCAE grad ≥ 2 (stigninger) fra baseline i blodkreatinin ca. 10 %.
English: Patients with BRCA1/2 mutations were identified from germline testing in blood via a local test or by central testing at Myriad.
Danish: Patienter med BRCA1/2-mutationer blev identificeret ved germline-test i blod via en lokal test eller central test hos Myriad.
English: Lynparza capsules (50 mg) should not be substituted for Lynparza tablets (100 mg and 150 mg) on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation.
Danish: Vigtige forskelle i dosering mellem Lynparza kapsler og tabletter Lynparza kapsler (50 mg) må ikke erstattes af Lynparza tabletter (100 mg og 150 mg) på milligram til milligram basis på grund af forskelle i dosering og biotilgængelighed af de individuelle formuleringer.