FrancophonIA/ELRC3.0 huggingface dataset:
English: ORR: proportion of patients with complete response + partial response CBR: proportion of patients with complete response + partial response + (stable disease or non-complete response/Non-progressive disease ≥24 weeks)
Danish: CBR: andel af patienter med komplet respons + partielt respons (+ stabil sygdom eller ufuldstændigt respons/non-progressiv sygdom ≥24 uger).
English: The results for PFS based on the blinded independent central radiological assessment of a randomly selected subset of approximately 40% of randomised patients were supportive of the primary efficacy results based on the investigator's assessment (hazard ratio of 0.427; 95% CI: 0.288, 0.633).
Danish: Resultaterne for PFS, der var baseret på den blindede, uafhængige centrale radiologiske vurdering af en tilfældigt valgt undergruppe på ca. 40 % af de randomiserede patienter, understøttede de primære effektresultater, der var baseret på investigators vurdering (hazard ratio på 0,427; 95 % CI: 0,288;
English: Based on a pharmacokinetic study in non-cancer subjects with hepatic impairment, mild hepatic impairment had no effect on the exposure of ribociclib (see section 4.2).
Danish: På baggrund af et studie af farmakokinetikken hos forsøgspersoner uden kræft med nedsat leverfunktion havde let nedsat leverfunktion ingen effekt på eksponeringen for ribociclib (se pkt.
English: Co-administration of the strong CYP3A4 inhibitor ritonavir (100 mg twice daily for 14 days) with a single 400 mg dose of ribociclib increased ribociclib exposure (AUCinf) and the peak concentration (Cmax) in healthy subjects 3.2 and 1.7-fold, respectively, relative to a single 400 mg ribociclib dose given alone.
Danish: Samtidig administration af den potente CYP3A4hæmmer ritonavir (100 mg to gange daglig i 14 dage) og en enkelt dosis af 400 mg ribociclib øgede eksponeringen (AUCinf) og maksimumkoncentration (Cmax) for ribociclib hos raske forsøgspersoner med henholdsvis 3,2 og 1,7 gange i forhold til en enkelt dosis på 400 mg ribociclib alene.
English: However, atrophic changes in testes were reported in rat and dog toxicity studies at exposures that were less than or equal to human exposure at the highest recommended daily dose of 600 mg/day based on AUC.
Danish: I studier af toksicitet hos rotter og hunde blev der dog rapporteret atrofiske forandringer af testiklerne ved eksponeringer, der var lavere end eller lig med eksponeringen hos mennesker ved den højeste anbefalede dosis på 600 mg/dag baseret på AUC.
English: Kisqali was evaluated in a randomised, double-blind, placebo-controlled, multicentre phase III clinical study in the treatment of pre- and perimenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer in combination with a NSAI or tamoxifen plus goserelin versus placebo in combination with a NSAI or tamoxifen plus goserelin.
Danish: Kisqali blev evalueret i et randomiseret, dobbeltblindet, placebokontrolleret klinisk multicenterfase III-studie med behandling af præ- og perimenopausale kvinder med hormonreceptor-positiv, HER2-negativ fremskreden brystkræft i kombination med en NSAI eller tamoxifen plus goserelin versus placebo i kombination med en NSAI eller tamoxifen plus goserelin.
English: Skin and subcutaneous tissue disorders Alopecia, rash
Danish: Hud og subkutane væv Alopeci, udslæt
English: Prior to study entry 42.7% of patients had received chemotherapy in the adjuvant and 13.1% in the neoadjuvant setting, while 58.5% had received endocrine therapy in the adjuvant and 1.4% in the neoadjuvant setting and 21% had received prior endocrine therapy in the advanced breast cancer setting.
Danish: Forud for inkludering i studiet havde 42,7 % af patienterne fået adjuverende kemoterapi, og 13,1 % havde fået neoadjuverende kemoterapi, mens 58,5 % havde fået adjuverende endokrin behandling og 1,4 % neoadjuverende endokrin behandling.
English: • Medicines used to treat cardiac disorders such as digoxin
Danish: • Lægemidler til behandling af hjertesygdomme, fx digoxin.
English: A QTcF interval increase of >60 msec from baseline was observed in 14/87 (16.1%) patients receiving Kisqali plus tamoxifen and in 18/245 (7.3%) patients receiving Kisqali plus a NSAI.
Danish: Der blev observeret en stigning af QTcF-intervallet på >60 ms i forhold til baseline hos 14/87 (16,1 %) patienter, der fik Kisqali plus tamoxifen, og hos 18/245 (7,3 %) patienter, der fik Kisqali plus en NSAI.
English: After initiating treatment LFTs should be performed every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, then as clinically indicated.
Danish: Efter opstart af behandling skal der foretages LFT hver 2. uge i de første 2 serier, i starten af hver af de efterfølgende 4 serier og herefter ved klinisk behov.
English: Contains soya lecithin.
Danish: Indeholder sojalecithin.
English: Dose modification for use of Kisqali with strong CYP3A4 inhibitors Concomitant use of strong CYP3A4 inhibitors should be avoided and an alternative concomitant medicinal product with less potential to inhibit CYP3A4 inhibition should be considered.
Danish: Dosisjustering ved anvendelse af Kisqali sammen med potente CYP3A4-hæmmere Samtidig anvendelse af potente CYP3A4-hæmmere bør undgås, og et andet samtidigt lægemiddel med lavere potentiale for CYP3A4-hæmning bør overvejes.
English: Ask your doctor about options for effective contraception.
Danish: Rådfør dig med din læge om sikre præventionsmetoder.
English: Figure 4 MONALEESA-7: Kaplan Meier plot of final OS analysis (30-Nov-2018 cut-off)
Danish: Figur 4 MONALEESA-7 - Kaplan-Meier-plot af endelig OS analyse (30-Nov-2018 som skæringsdato)
English: * Grading according to CTCAE Version 4.03 (CTCAE = Common Terminology Criteria for Adverse Events) ** Baseline = prior to treatment initiation
Danish: *Sværhedsgrad i henhold til CTCAE version 4.03 (CTCAE = Common Terminology Criteria for Adverse Events).
English: Grade 4* (>20 x ULN)
Danish: Grad 4* (>20 x ULN)
English: Kisqali 200 mg film-coated tablets
Danish: Kisqali 200 mg filmovertrukne tabletter
English: Prior to study entry, of these 672 patients, 14% of patients had received prior chemotherapy for metastatic disease, 32.6% of patients had received chemotherapy in the adjuvant and 18.0% in the neoadjuvant setting; 39.6% had received endocrine therapy in the adjuvant setting and 0.7% in the neoadjuvant setting.
Danish: Forud for indtrædelsen i studiet havde 14 % af disse 672 patienter tidligere fået kemoterapi mod metastatisk sygdom, 32,6 % af patienterne havde fået adjuverende kemoterapi, og 18,0 % havde fået neoadjuverende kemoterapi.
English: Table 10 MONALEESA-7 - Efficacy results (ORR, CBR) based on investigator assessment in patients who received NSAI
Danish: Tabel 10 MONALEESA-7 - Effektresultater (ORR, CBR) baseret på investigators vurdering hos patienter, der fik NSAI
English: • Medicines used to treat pulmonary arterial hypertension and erectile dysfunction such as sildenafil.
Danish: • Lægemidler til behandling af forhøjet blodtryk i lungearterierne (pulmonal arteriel hypertension) og impotens (erektil dysfunktion), fx sildenafil.
English: The following pack sizes are available: Packs containing 21, 42 or 63 film-coated tablets and multipacks containing 63 (3 packs of 21), 126 (3 packs of 42) or 189 (3 packs of 63) film-coated tablets.
Danish: Der findes følgende pakningsstørrelser: Pakninger, der indeholder 21, 42 eller 63 filmovertrukne tabletter, og multipakninger, der indeholder 63 (3 pakninger med 21), 126 (3 pakninger med 42) eller 189 (3 pakninger med 63) filmovertrukne tabletter.
English: In vivo, treatment with single-agent ribociclib led to tumour regressions which correlated with inhibition of pRb phosphorylation.
Danish: Behandling med ribociclib som enkeltstof førte til tumorregressioner in vivo, hvilket korrelerede med hæmningen af pRbfosforylering.
English: Data from a clinical study in patients with breast cancer and population pharmacokinetic analysis indicated no drug interaction between ribociclib and letrozole following co-administration of these medicinal products.
Danish: Data fra et klinisk studie hos patienter med brystkræft og populationsfarmakokinetisk analyse tydede ikke på nogen lægemiddelinteraktion mellem ribociclib og letrozol efter samtidig administration af disse lægemidler.
English: If grade 3 recurs, discontinue Kisqali.
Danish: Hvis grad 3 vender tilbage, skal Kisqali seponeres.
English: • Medicines used to treat high blood sugar levels (e.g. diabetes) such as metformin.
Danish: • Lægemidler til behandling af forhøjet blodsukker (fx diabetes), fx metformin.
English: Grade 2* (>3 to 5 x ULN)
Danish: Grad 2* (>3 til 5 x ULN)
English: Figure 1 MONALEESA-2 - Kaplan-Meier plot of PFS based on investigator assessment02 January 2017 cut-off)
Danish: Figur 1 MONALEESA-2 - Kaplan-Meier-plot af PFS baseret på investigators vurdering (skæringsdato 2. januar 2017)
English: • Antipsychotics such as pimozide or quetiapine.
Danish: • Lægemidler til behandling af psykoser, fx pimozid eller quetiapin.
English: Table 8 MONALEESA-2 - Efficacy results (ORR, CBR) based on investigator assessment(02 January 2017 cut-off)
Danish: Tabel 8 MONALEESA-2 - Effektresultater (ORR, CBR) baseret på investigators vurdering (skæringsdato 2. januar 2017)
English: Following oral administration of a single 600 mg dose of [
Danish: Efter en enkelt oral dosis af C
English: No of events Ribociclib: 92, Placebo: 132
Danish: Antal hændelser Ribociclib: 92, Placebo: 132
English: • Medicines used to improve blood fat levels such as simvastatin or lovastatin, pitavastatin,
Danish: • Lægemidler til forbedring af niveauet af fedt i blodet, fx simvastatin eller lovastatin,
English: Kisqali can be administered with or without food (see sections 4.2 and 5.2).
Danish: Kisqali kan administreres med eller uden mad (se pkt.
English: Data from a clinical study in patients with breast cancer indicated no clinically relevant effects of fulvestrant on ribociclib exposure following co-administration of these medicinal products.
Danish: Data fra et klinisk studie hos patienter med brystkræft tydede ikke på nogen klinisk relevant virkning af fulvestrant på ribociclib-eksponering efter samtidig administration af disse lægemidler.
English: Drug-drug interactions between ribociclib and oral contraceptives
Danish: Lægemiddelinteraktioner mellem ribociclib og orale kontraceptiva
English: • with uncontrolled or significant cardiac disease, including recent myocardial infarction,
Danish: • med ukontrolleret eller alvorlig hjertesygdom, herunder nyligt myokardieinfarkt, kongestiv hjertesvigt, ustabil angina pectoris og bradyarytmier
English: A total of 672 patients were randomised in a 1:1 ratio to receive either Kisqali 600 mg plus NSAI/tamoxifen plus goserelin (n=335) or placebo plus NSAI/tamoxifen plus goserelin (n=337), stratified according to: the presence of liver and/or lung metastases (Yes [n=344 (51.2%)] versus No [n=328 (48.8%)]), prior chemotherapy for advanced disease (Yes [n=120 (17.9%)] versus No [n=552 (82.1%)]), and endocrine combination partner (NSAI and goserelin [n=493 (73.4%)] versus tamoxifen and goserelin [n=179 (26.6%)]).
Danish: I alt blev 672 patienter randomiseret i forholdet 1:1 til at få enten 600 mg Kisqali plus NSAI/tamoxifen plus goserelin (n=335) eller placebo plus NSAI/tamoxifen plus goserelin (n=337), stratificeret efter tilstedeværelsen af lever- og/eller lungemetastaser (Ja [n=344 (51,2 %)] versus Nej [n=328 (48,8 %)]), tidligere kemoterapi mod fremskreden sygdom (Ja [n=120 (17,9 %)] versus Nej [n=552 (82,1 %)]) og endokrin kombinationspartner (NSAI og goserelin [n=493 (73,4 %)] versus tamoxifen og goserelin [n=179 (26,6 %)]).
English: The concomitant use of strong CYP3A4 inhibitors including, but not limited to, the following must be avoided: clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir, ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, verapamil and voriconazole (see section 4.4).
Danish: Samtidig anvendelse af potente CYP3A4-hæmmere, herunder, men ikke begrænset til clarithromycin, indinavir, itraconazol, ketoconazol, lopinavir, ritonavir, nefazodon, nelfinavir, posaconazol, saquinavir, telaprevir, telithromycin, verapamil og voriconazol bør undgås (se pkt.
English: Median PFS was 23.8 months (95% CI: 19.2, NE) for Kisqali plus NSAI/tamoxifen plus goserelin treated patients and 13.0 months (95% CI: 11.0, 16.4) for patients receiving placebo plus NSAI/tamoxifen plus goserelin.
Danish: MedianPFS var 23,8 måneder (95 % CI: 19,2; NE) for patienter, der fik behandling med Kisqali plus NSAI/tamoxifen plus goserelin, og 13,0 måneder (95 % CI: 11,0; 16,4) for patienter, der fik placebo plus NSAI/tamoxifen plus goserelin.
English: Your doctor will tell you exactly how many tablets of Kisqali to take; in certain situations your doctor may instruct you to take a lower dose of Kisqali, e.g. 400 mg (2 tablets of 200 mg) once daily or 200 mg (1 tablet of 200 mg) once daily.
Danish: I visse situationer kan lægen bede dig om at tage en lavere dosis af Kisqali, fx 400 mg (2 tabletter med 200 mg) én gang daglig eller 200 mg (1 tablet med 200 mg) én gang daglig.
English: No of events- Ribociclib: 140, Placebo: 205
Danish: Antal hændelser - Ribociclib: 140, Placebo: 205
English: Ribociclib and its metabolites passed readily into rat milk.
Danish: Ribociclib og dets metabolitter går let over i mælken hos rotter.
English: In the overall study population, the efficacy results demonstrated a statistically significant improvement in PFS in patients receiving Kisqali plus NSAI/tamoxifen plus goserelin compared to patients receiving placebo plus NSAI/tamoxifen plus goserelin (hazard ratio of 0.553, 95% CI: 0.441, 0.694, one-sided stratified log-rank test p-value 9.83x10
Danish: I den samlede studiepopulation viste effektresultaterne en statistisk signifikant forbedring i PFS hos patienter, der fik Kisqali plus NSAI/tamoxifen plus goserelin, sammenlignet med patienter, der fik placebo plus NSAI/tamoxifen plus goserelin (hazard ratio på 0,553, 95 % CI: 0,441; 0,694, p-værdi ved ensidet stratificeret log rank-test på 9,83 x 10
English: Table 7 MONALEESA-2 - Efficacy results (PFS) based on investigator radiological assessment (02 January 2017 cut-off)
Danish: Tabel 7 MONALEESA-2 - Effektresultater (PFS) baseret på investigators radiologiske vurdering (skæringsdato 2. januar 2017)
English: • Some medicines used to treat fungal infections, such as ketoconazole, itraconazole,
Danish: • Nogle lægemidler til behandling af svampeinfektioner, fx ketoconazol, itraconazol, voriconazol eller posaconazol.
English: Kisqali packs containing 21 tablets are intended for use by patients taking the lowest ribociclib daily dose of 200 mg (1 tablet once daily).
Danish: Kisqali-pakninger, der indeholder 21 tabletter, er beregnet til patienter, der tager den laveste daglige dosis af ribociclib på 200 mg (1 tablet én gang daglig).
English: Study CLEE011F2301 (MONALEESA-3)
Danish: Studie CLEE011F2301 (MONALEESA-3)
English: No of events Ribociclib: 61, Placebo: 80
Danish: Antal hændelser Ribociclib: 61, Placebo: 80
English: Kisqali packs containing 63 tablets are intended for use by patients taking the full ribociclib daily dose of 600 mg (3 tablets once daily).
Danish: Kisqali-pakninger, der indeholder 63 tabletter, er beregnet til patienter, der tager den fulde daglige dosis af ribociclib på 600 mg (3 tabletter én gang daglig).
English: If grade 2 recurs, resume Kisqali at next lower dose level.
Danish: Hvis grad 2 vender tilbage, genoptages behandlingen med Kisqali ved det næste lavere dosisniveau.
English: Resume Kisqali and reduce by 1 dose level.
Danish: Genoptag behandlingen med Kisqali, og reducér med 1 dosisniveau.
English: Figure 3 MONALEESA-7 - Kaplan-Meier plot of PFS based on investigator assessment in patients who received NSAI
Danish: Figur 3 MONALEESA-7 - Kaplan-Meier-plot af PFS baseret på investigators vurdering hos patienter, der fik NSAI
English: Women of childbearing potential should be advised to use an effective method of contraception while taking Kisqali and for at least 21 days after the last dose (see section 4.6).
Danish: Fertile kvinder skal informeres om at anvende en sikker præventionsmetode under behandlingen med Kisqali og i mindst 21 dage efter den sidste dosis (se pkt.
English: No of events Ribociclib: 83, Placebo: 109
Danish: Antal hændelser Ribociclib: 83, Placebo: 109
English: Figure 2 MONALEESA-7 - Kaplan-Meier plot of PFS in overall population based on investigator assessment
Danish: Figur 2 MONALEESA-7 - Kaplan-Meier-plot af PFS i den samlede population baseret på investigators vurdering
English: Grade 3* (>5 to 20 x ULN)
Danish: Grad 3* (>5 til 20 x ULN)
English: Censoring times Ribociclib+Fulvestrant (N=484) Placebo+Fulvestrant (N=242)
Danish: Censoreringstidspunkter Ribociclib + fulvestrant (N=484) Placebo + fulvestrant (N=242)
English: The study met the primary endpoint at the primary analysis conducted after 318 progression-free survival (PFS) events based on the investigator assessment using RECIST v1.1 criteria in the full analysis set (all randomised patients).
Danish: Studiets primære endepunkt blev mødt ved den primære analyse, der blev foretaget efter 318 hændelser for progressionsfri overlevelse (PFS) i det fulde analysesæt (alle randomiserede patienter) baseret på investigators vurdering ved brug af RECIST v1.1-kriterierne.
English: Figure 6 MONALEESA-3 - Kaplan-Meier plot of PFS based on investigator assessment
Danish: Figur 6 MONALEESA-3 - Kaplan-Meier-plot af PFS baseret på investigators vurdering
English: Unit packs containing 21, 42 or 63 film-coated tablets and multipacks containing 63 (3 packs of 21), 126 (3 packs of 42) or 189 (3 packs of 63) film-coated tablets.
Danish: Enhedspakninger med 21, 42 eller 63 filmovertrukne tabletter og multipakninger med 63 (3 pakninger med 21), 126 (3 pakninger med 42) eller 189 (3 pakninger med 63) filmovertrukne tabletter.
English: The study met the primary endpoint at the primary analysis conducted after 361 progression-free survival (PFS) events based on the investigator assessment and using RECIST v1.1 criteria in the full analysis set (all randomised patients).
Danish: Studiets primære endepunkt blev mødt ved den primære analyse, der blev foretaget efter 361 hændelser for progressionsfri overlevelse (PFS) i det fulde analysesæt (alle randomiserede patienter) baseret på investigators vurdering og ved brug af RECIST v1.1-kriterierne.
English: Kisqali packs containing 42 tablets are intended for use by patients taking the reduced ribociclib daily dose of 400 mg (2 tablets once daily).
Danish: Kisqali-pakninger, der indeholder 42 tabletter, er beregnet til patienter, der tager den lavere daglige dosis af ribociclib på 400 mg (2 tabletter én gang daglig).
English: Study CLEE011A2301 (MONALEESA-2)
Danish: Studie CLEE011A2301 (MONALEESA-2)
English: A total of 726 female patients were randomised in a 2:1 ratio to receive either Kisqali 600 mg and fulvestrant (n=484) or placebo and fulvestrant (n=242), stratified according to the presence of liver and/or lung metastases (Yes [n= 351 (48.3%)] versus No [n=375 (51.7%)]) and according to prior endocrine therapy (A [n=354 (48.8%)] versus B [n=372 (51.2%)]).
Danish: I alt blev 726 kvindelige patienter randomiseret i forholdet 2:1 til at få enten 600 mg Kisqali og fulvestrant (n=484) eller placebo og fulvestrant (n=242), stratificeret efter tilstedeværelsen af leverog/eller lungemetastaser (Ja [n=351 (48,3 %)] versus Nej [n=375 (51,7 %)]) og efter tidligere endokrin behandling (A [n=354 (48,8 %)] versus B [n=372 (51,2 %)]).
English: After initiating treatment CBC should be monitored every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, then as clinically indicated.
Danish: Efter opstart af behandling med Kisqali, skal der foretages CBC hver 2. uge i de første 2 serier, ved starten af hver af de efterfølgende 4 serier og herefter ved klinisk behov.
English: Drug-drug interaction between ribociclib and fulvestrant
Danish: Lægemiddelinteraktion mellem ribociclib og fulvestrant
English: The efficacy results demonstrated a statistically significant improvement in PFS in patients receiving Kisqali plus letrozole compared to patients receiving placebo plus letrozole in the full analysis set (hazard ratio of 0.556, 95% CI: 0.429, 0.720, one sided stratified log-rank test p-value 0.00000329) with clinically meaningful treatment effect.
Danish: Effektresultaterne viste en statistisk signifikant forbedring i PFS hos patienter, der fik Kisqali plus letrozol, sammenlignet med patienter, der fik placebo plus letrozol, i det fulde analysesæt (hazard ratio på 0,556, 95 % CI: 0,429; 0,720, p-værdi ved ensidet stratificeret log rank-test på 0,00000329) med klinisk relevant behandlingseffekt.
English: Median PFS was 20.5 months (95% CI: 18.5, 23.5) for Kisqali plus fulvestrant treated patients and 12.8 months (95% CI: 10.9, 16.3) for patients receiving placebo plus fulvestrant.
Danish: Median-PFS var 20,5 måneder (95 % CI: 18,5; 23,5) for patienter, der fik behandling med Kisqali plus fulvestrant, og 12,8 måneder (95 % CI: 10,9; 16,3) for patienter, der fik placebo plus fulvestrant.
English: If grade 3 recurs, resume Kisqali at the next lower dose level.
Danish: Hvis grad 3 vender tilbage, genoptages behandlingen med Kisqali ved næste lavere dosis.
English: Drug-drug interaction between ribociclib and tamoxifen
Danish: Lægemiddelinteraktion mellem ribociclib og tamoxifen
English: When to take Kisqali
Danish: Hvornår du skal tage Kisqali
English: • Some medicines used to treat epileptic fits or which are used for sedation or anaesthesia such as midazolam.
Danish: • Nogle lægemidler, der anvendes til behandling af epileptiske anfald eller til bedøvelse, fx midazolam.
English: In vivo cardiac safety studies in dogs demonstrated dose and concentration related QTc interval prolongation at an exposure that would be expected to be achieved in patients following the recommended dose of 600 mg.
Danish: In vivo-studier af hjertesikkerhed hos hunde viste dosis- og koncentrationsrelateret forlængelse af QTc-intervallet ved en eksponering, der ville forventes at være opnået hos patienter efter den anbefalede dosis på 600 mg. Der er også potentiale for at inducere tilfælde af præmature ventrikulære sammentrækninger (PVCs) ved forhøjede eksponeringer (ca. 5 gange den forudsete kliniske Cmax).
English: • Watering eyes
Danish: • Øjnene løber i vand
English: Median PFS was 25.3 months (95% CI: 23.0, 30.3) for ribociclib plus letrozole treated patients and 16.0 months (95% CI: 13.4, 18.2) for patients receiving placebo plus letrozole.
Danish: Median-PFS var 25,3 måneder (95 % CI: 23,0; 30,3) for patienter, der fik behandling med ribociclib plus letrozol og 16,0 måneder (95 % CI: 13,4; 18,2) for patienter, der fik placebo plus letrozol.
English: Resume Kisqali at the same dose level.
Danish: Genoptag behandlingen med Kisqali ved samme dosis.
English: Study CLEE011E2301 (MONALEESA-7)
Danish: Studie CLEE011E2301 (MONALEESA-7)
English: Ribociclib is a strong CYP3A4 inhibitor at the 600 mg dose and a moderate CYP3A4 inhibitor at the 400 mg dose.
Danish: Ribociclib er en potent CYP3A4-hæmmer ved en dosis på 600 mg og en moderat CYP3A4-hæmmer ved en dosis på 400 mg. Ribociclib kan derfor interagere med lægemidler, der metaboliseres via CYP3A4.
English: How much Kisqali to take
Danish: Så meget Kisqali skal du tage
English: Based on the observed QT prolongation during treatment, treatment with Kisqali may have to be interrupted, reduced or discontinued as described in Table 4 (see sections 4.2, 4.8 and 5.2).
Danish: Alt efter den observerede QT-forlængelse under behandling, kan det være nødvendigt at afbryde, reducere eller seponere behandling med Kisqali som beskrevet i tabel 4 (se pkt.
English: Data from a clinical study in patients with breast cancer indicated no clinically relevant drug interaction between ribociclib and anastrozole following co-administration of these medicinal products.
Danish: Data fra et klinisk studie hos patienter med brystkræft tydede ikke på nogen klinisk relevant lægemiddelinteraktion mellem ribociclib og anastrozol efter samtidig administration af disse lægemidler.