FrancophonIA/ELRC3.0 huggingface dataset:
English: • Medicines used to treat low blood pressure or migraine such as ergotamine or dihydroergotamine.
Danish: • Lægemidler til behandling af lavt blodtryk eller migræne, fx ergotamin eller dihydroergotamin.
English: The majority of patients included were Caucasian (57.7%), Asian (29.5%) or Black (2.8%) and nearly all patients (99.0%) had a baseline ECOG performance status of 0 or 1.
Danish: Størstedelen af de inkluderede patienter var kaukasiere (57,7 %), asiater (29,5 %) eller sorte (2,8 %), og næsten alle patienter (99,0 %) havde en ECOG performancestatus ved baseline på 0 eller 1.
English: The pharmacokinetics of ribociclib in breast cancer patients with severe renal impairment have not been studied.
Danish: Ribociclibs farmakokinetik hos brystkræftpatienter med svært nedsat nyrefunktion er ikke undersøgt.
English: Based on animal studies, ribociclib may impair fertility in males of reproductive potential (see section 5.3).
Danish: På baggrund af dyrestudier kan ribociclib nedsætte fertiliteten hos fertile mænd (se pkt.
English: • Dizziness or light headedness
Danish: • Svimmelhed eller ørhed
English: This was evident for patients with liver and/or lung metastases (HR of 0.561 [95% CI: 0.424, 0.743], median progression-free survival [mPFS] 24.8 months for Kisqali plus letrozole versus 13.4 months for letrozole alone), or without liver and/or lung metastases (HR of 0.597 [95% CI: 0.426, 0.837], mPFS 27.6 months versus 18.2 months).
Danish: Dette var tydeligt for patienter med lever- og/eller lungemetastaser (HR på 0,561 [95 % CI: 0,424, 0,743], median-progressionsfri overlevelse [mPFS] på henholdsvis 24,8 måneder for Kisqali plus letrozol versus 13,4 måneder for letrozol alene) eller uden lever- og/eller lungemetastaser (HR på 0,597 [95 % CI: 0,426, 0,837], mPFS 27,6 måneder versus 18,2 måneder).
English: At the time of the primary PFS analysis, overall survival data were not mature with 120 (16.5%) deaths (HR 0.670; [95%CI: 0.465, 0.964)].
Danish: Data vedrørende samlet overlevelse var ikke modne på tidspunktet for den primære PFS-analyse med 120 (16,5 %) dødsfald (HR: 0,670 [95 % CI: 0,465; 0,964]).
English: Substances that may decrease ribociclib plasma concentrations
Danish: Stoffer, der kan reducere plasmakoncentrationen af ribociclib
English: Efficacy results for overall response rate (ORR) and clinical benefit rate (CBR) per investigator assessment based on RECIST v1.1 are provided in Table 10.
Danish: Effektresultaterne for samlet responsrate (ORR) og rate for klinisk fordel (CBR) i henhold til investigators vurdering baseret på RECIST v1.1 er vist i tabel 10.
English: Respiratory, thoracic and mediastinal disorders Dyspnoea, cough
Danish: Luftveje, thorax og mediastinum Dyspnø, hoste
English: The concomitant use of strong CYP3A4 inducers should be avoided, including, but not limited to, phenytoin, rifampicin, carbamazepine and St John's Wort (Hypericum perforatum).
Danish: Samtidig anvendelse af potente CYP3A4-induktorer, herunder, men ikke begrænset til phenytoin, rifampicin, carbamazepin og prikbladet perikon (Hypericum perforatum) bør undgås.
English: Other medicines and Kisqali
Danish: Brug af anden medicin sammen med Kisqali
English: Women of childbearing potential who are receiving Kisqali should use effective contraception (e.g. double-barrier contraception) during therapy and for at least 21 days after stopping treatment with Kisqali.
Danish: Fertile kvinder, der får Kisqali, skal anvende sikker prævention (fx prævention med dobbelt barriere) under behandlingen og i mindst 21 dage efter ophør med behandling med Kisqali.
English: Your doctor, pharmacist or nurse will tell you exactly how many tablets to take and which days to take them on.
Danish: Lægen vil fortælle dig, nøjagtig hvor mange Kisqali-tabletter du skal tage.
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 0.492; 95% CI: 0.345, 0.703).
Danish: Resultaterne for PFS baseret på den blindede, uafhængige centrale radiologiske vurdering af en tilfældigt valgt undergruppe på ca. 40 % af de randomiserede patienter understøttede de primære effektresultater baseret på investigators vurdering (hazard ratio på 0,492; 95 % CI: 0,345; 0,703).
English: Substances that may increase ribociclib plasma concentrations
Danish: Stoffer, der kan øge plasmakoncentrationen af ribociclib
English: Neutropenia No dose adjustment is required
Danish: Neutropeni Dosisjustering er ikke nødvendig.
English: 63 film-coated tablets.
Danish: 63 filmovertrukne tabletter.
English: Efficacy results for overall response rate (ORR) and clinical benefit rate (CBR) per investigator assessment based on RECIST v1.1 are provided in Table 13.
Danish: Effektresultaterne for samlet responsrate (ORR) og rate for klinisk fordel (CBR) i henhold til investigators vurdering baseret på RECIST v1.1 er vist i tabel 13.
English: Gastrointestinal disorders Nausea, diarrhoea, vomiting, constipation, stomatitis, abdominal pain
Danish: Mave-tarm-kanalen Kvalme, diarré, opkastning, obstipation, stomatitis, mavesmerter
English: Co-administration of midazolam (CYP3A4 substrate) with multiple doses of Kisqali (400 mg) increased the midazolam exposure by 280% (3.80-fold) in healthy subjects, compared with administration of midazolam alone.
Danish: Samtidig administration af midazolam (CYP3A4-substrat) med flere doser af Kisqali (400 mg) øgede eksponeringen for midazolam med 280 % (3,80 gange) hos raske forsøgspersoner sammenlignet med administration af midazolam alene.
English: Multipack: 63 (3 packs of 21) film-coated tablets Multipack: 126 (3 packs of 42) film-coated tablets Multipack: 189 (3 packs of 63) film-coated tablets
Danish: Multipakning: 63 (3 pakninger med 21) filmovertrukne tabletter Multipakning: 126 (3 pakninger med 42) filmovertrukne tabletter Multipakning: 189 (3 pakninger med 63) filmovertrukne tabletter
English: In vitro data indicate that ribociclib has no potential to induce UGT enzymes or the CYP enzymes CYP2C9, CYP2C19 and CYP3A4 via PXR.
Danish: In vitro-data indikerer, at ribociclib ikke har potentiale for at inducere UGT-enzymer eller CYPenzymerne CYP2C9, CYP2C19 og CYP3A4 via PXR.
English: Hazard ratios based on pre-specified subgroup analysis of the patients treated with Kisqali plus fulvestrant showed consistent benefit across different subgroups including age, prior treatment (early or advanced), prior adjuvant/neoadjuvant chemotherapy or hormonal therapies, liver and/or lung involvement and bone-only metastatic disease.
Danish: Hazard ratio'er, som var baseret på forudspecificeret subgruppeanalyse af patienter, der fik behandling med Kisqali plus fulvestrant, viste en konsistent fordel på tværs af forskellige subgrupper, herunder alder, tidligere behandling (tidlig eller fremskreden), tidligere adjuverende/neoadjuverende kemoterapi eller hormonbehandlinger, lever- og/eller lungeinvolvering og knoglemetastaser alene.
English: Ribociclib has not been studied in breast cancer patients with moderate or severe hepatic impairment.
Danish: Anvendelse af ribociclib er ikke blevet undersøgt hos brystkræftpatienter med moderat eller svært nedsat leverfunktion.
English: • Some medicines used to treat seizures or fits (anti-epileptics) such as carbamazepine and phenytoin.
Danish: • Nogle lægemidler til behandling af kramper eller krampeanfald (epilepsimedicin), fx carbamazepin og phenytoin.
English: Your doctor may ask you to take a lower dose, interrupt your treatment with Kisqali, or stop it permanently.
Danish: Lægen kan bede dig om at tage en lavere dosis, holde en pause med at tage Kisqali eller helt stoppe behandlingen.
English: Table 12 MONALEESA-3 - Efficacy results (PFS) based on investigator radiological assessment
Danish: Tabel 12 MONALEESA-3 - Effektresultater (PFS) baseret på investigators radiologiske vurdering
English: In vitro evaluations indicated that ribociclib has a potential to inhibit the activities of drug transporters P-gp, BCRP, OATP1B1/1B3, OCT1, OCT2, MATE1 and BSEP.
Danish: In vitro-evalueringer indikerede, at ribociclib har et potentiale for at hæmme aktiviteterne af lægemiddeltransportørerne P-gp, BCRP, OATP1B1/1B3, OCT1, OCT2, MATE1 og BSEP.
English: What you need to know before you take Kisqali
Danish: Det skal du vide, før du begynder at tage Kisqali
English: Co-administration of the strong CYP3A4 inducer rifampicin (600 mg daily for 14 days) with a single 600 mg dose of ribociclib decreased the ribociclib AUCinf and Cmax by 89% and 81%, respectively, relative to a single 600 mg ribociclib dose given alone in healthy subjects.
Danish: Samtidig administration af den potente CYP3A4-induktor rifampicin (600 mg daglig i 14 dage) og en enkelt dosis af 600 mg ribociclib reducerede ribociclibs AUCinf og Cmax med henholdsvis 89 % og 81 % i forhold til en enkelt dosis af 600 mg ribociclib alene hos raske forsøgspersoner.
English: Co-administration of caffeine (CYP1A2 substrate) with multiple doses of Kisqali (400 mg) increased the caffeine exposure by 20% (1.20-fold) in healthy subjects, compared with administration of caffeine alone.
Danish: Samtidig administration af koffein (CYP1A2-substrat) med flere doser af Kisqali (400 mg) øgede eksponeringen for koffein med 20 % (1,20 gange) hos raske forsøgspersoner sammenlignet med administration af koffein alene.
English: In non-cancer subjects with severe renal impairment AUCinf increased 1.96-fold, and Cmax increased 1.51-fold compared to healthy subjects with normal renal function (see section 4.2).
Danish: Hos forsøgspersoner uden kræft med svært nedsat nyrefunktion var AUCinf 1,96 gange højere og Cmax var 1,51 gange højere end hos raske forsøgspersoner med normal nyrefunktion (se pkt.
English: Kisqali 600 mg or placebo were given orally daily for 21 consecutive days followed by 7 days off treatment in combination with fulvestrant 500 mg intramuscularly once daily on Days 1 and 15 in Cycle 1 and Day 1 of each subsequent 28-day cycle.
Danish: 600 mg Kisqali eller placebo blev givet oralt dagligt i 21 dage i træk efterfulgt af 7 dage uden behandling i kombination med 500 mg fulvestrant intramuskulært én gang dagligt på dag 1 og 15 i serie 1 og dag 1 i hver efterfølgende serie på 28 dage.
English: If patients must be given a strong CYP3A4 inhibitor concomitantly with ribociclib, the Kisqali dose should be reduced to 400 mg once daily (see section 4.5).
Danish: Hvis patienter om nødvendigt skal have en potent CYP3A4-hæmmer samtidigt med ribociclib, skal dosis af Kisqali reduceres til 400 mg én gang daglig (se pkt.
English: In patients who have had their dose reduced to 200 mg ribociclib daily and in whom initiation of co-administration of a strong CYP3A4 inhibitor cannot be avoided, Kisqali treatment should be interrupted.
Danish: Hos patienter, der har fået reduceret dosis til 200 mg ribociclib dagligt, og hvor initiering af samtidig administration af en potent CYP3A4-hæmmer ikke kan undgås, skal Kisqali seponeres.
English: Microcrystalline cellulose Crospovidone type A Low-substituted hydroxypropylcellulose Magnesium stearate
Danish: Hydroxypropylcellulose, lav-substitueret Magnesiumstearat
English: In vitro evaluations indicated that ribociclib has no potential to inhibit the activities of CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 at clinically relevant concentrations.
Danish: In vitro-evalueringer indikerede, at ribociclib ikke har potentiale for at hæmme aktiviteterne af CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19 og CYP2D6 ved klinisk relevante koncentrationer.
English: Efficacy results are summarised in Table 9 and the Kaplan-Meier curves for PFS are provided in Figure 3.
Danish: Effektresultaterne er opsummeret i tabel 9, og Kaplan-Meier-kurverne for PFS er vist i figur 3.
English: • Sore throat, runny nose, fever (signs of a respiratory tract infection)
Danish: • Ondt i halsen, løbende næse, feber (tegn på en luftvejsinfektion)
English: Ribociclib and its metabolites readily passed into the milk of lactating rats.
Danish: Ribociclib og dets metabolitter passerer let over i mælken hos diegivende rotter.
English: Results in the Kisqali plus NSAI subgroup were consistent across subgroups of age, race, prior adjuvant/ neoadjuvant chemotherapy or hormonal therapies, liver and/or lung involvement and bone-only metastatic disease.
Danish: Resultaterne i Kisqali plus NSAI-subgruppen var konsistente på tværs af subgrupperne alder, race, tidligere adjuverende/neoadjuverende kemoterapi eller hormonbehandlinger, lever- og/eller lungeinvolvering og sygdom med knoglemetastaser alene.
English: • Mouth sores with gum inflammation (stomatitis)
Danish: • Sår i munden med tandkødsbetændelse (stomatitis)
English: The estimated QTcF mean change from baseline for 600 mg Kisqali in combination with NSAI or fulvestrant was 22.0 msec (90% CI: 20.56, 23.44) and 23.7 msec (90% CI: 22.31, 25.08), respectively at the geometric mean Cmax at steady-state compared to 34.7 msec (90% CI: 31.64, 37.78) in combination with tamoxifen (see section 4.4).
Danish: Den estimerede gennemsnitlige QTcF-ændring fra baseline for 600 mg Kisqali i kombination med NSAI eller fulvestrant var henholdsvis 22,0 ms (90 % CI: 20,56; 23,44) og 23,7 ms (90 % CI: 22,31; 25,08) ved den geometriske middelværdi af Cmax ved steady state sammenlignet med 34,7 ms (90 % CI: 31,64; 37,78) i kombination med tamoxifen (se pkt.
English: Investigations Abnormal liver function tests
Danish: Undersøgelser Unormale levertal
English: Placebo plus letrozole N=334
Danish: Placebo plus letrozol N=334
English: Physiologically-based pharmacokinetic simulations suggested that at a 600 mg dose of ribociclib, a moderate CYP3A4 inhibitor (erythromycin) may increase ribociclib steady-state Cmax and AUC 1.2-fold and 1.3-fold, respectively.
Danish: Fysiologisk baserede farmakokinetiske simuleringer tydede på, at ved en dosis på 600 mg ribociclib kan en moderat CYP3A4-hæmmer (erythromycin) øge ribociclibs Cmax og AUC ved steady state med henholdsvis 1,2 og 1,3 gange.
English: Ribociclib has no potential for time-dependent inhibition of CYP1A2, CYP2C9, and CYP2D6.
Danish: Ribociclib har ikke potentiale for tidsafhængig hæmning af CYP1A2, CYP2C9 og CYP2D6.
English: If the strong CYP3A4 inhibitor is discontinued, and after at least 5 half-lives of the CYP3A4 inhibitor (refer to the SmPC of the CYP3A4 inhibitor in question), Kisqali should be resumed at the same dose used prior to the initiation of the strong CYP3A4 inhibitor.
Danish: Hvis den potente CYP3A4-hæmmer seponeres og efter mindst 5 halveringstider af CYP3A4-hæmmeren (se SmPC'et for den pågældende CYP3A4-hæmmer), skal Kisqali-dosis genoptages ved den dosis, der blev anvendt før initiering af den potente CYP3A4-hæmmer.
English: Kisqali is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
Danish: Kisqali er indiceret til behandling af kvinder med hormonreceptor (HR)-positiv, human epidermal vækstfaktorreceptor 2 (HER2)-negativ, lokalt fremskreden eller metastatisk brystkræft i kombination med en aromatasehæmmer eller fulvestrant som indledende endokrin-baseret behandling eller hos kvinder, der tidligere har fået endokrin behandling.
English: In the placebo arm, a QTcF interval increase of >60 msec from baseline occurred in 6/90 (6.7%) patients receiving tamoxifen and in no patients receiving a NSAI (see section 5.2).
Danish: I placebo-armen forekom der en stigning af QTcF-intervallet på >60 ms i forhold til baseline hos 6/90 (6,7 %) patienter, der fik tamoxifen, og ikke hos nogen patienter, der fik en NSAI (se pkt.
English: • Upset stomach, indigestion, heartburn (dyspepsia)
Danish: • Irriteret mave, fordøjelsesbesvær, halsbrand (dyspepsi)
English: Take Kisqali once a day on days 1 to 21 of a 28-day cycle.
Danish: Tag Kisqali én gang om dagen på dag 1 til 21 i en behandlingsserie på 28 dage.
English: A reduction in the risk of disease progression or death in favour of the Kisqali plus letrozole arm was observed in all individual patient subgroups of age, race, prior adjuvant or neoadjuvant chemotherapy or hormonal therapies, liver and/or lung involvement and bone-only metastatic disease.
Danish: Der blev observeret en reduktion i risikoen for sygdomsprogression eller dødsfald til fordel for Kisqali plus letrozol-armen i alle individuelle patientsubgrupper opdelt efter alder, race, tidligere adjuverende eller neoadjuverende kemoterapi eller hormonbehandlinger, lever- og/eller lungeinvolvering og knoglemetastaser alene.
English: Coating material: iron oxide black (E172); iron oxide red (E172); soya lecithin (E322); polyvinyl alcohol (partially hydrolysed); talc; titanium dioxide (E171); xanthan gum.
Danish: Filmovertræk: sort jernoxid (E 172), rød jernoxid (E 172), sojalecithin (E 322), polyvinylalkohol (delvis hydrolyseret), talcum, titandioxid (E 171), xanthangummi.
English: Similar results were observed for the NSAI subgroup, with an HR of 0.660 (95% CI: 0.503, 0.868) and a median PFS2 of 32.3 months (95% CI: 26.9, 38.3) in the placebo arm versus not reached (95% CI: 39.4, NE) in the ribociclib arm.
Danish: Lignende resultater blev observeret for NSAI sub-gruppen med en HR på 0,660 (95% CI: 0,503; 0,868) og en median PFS2 på 32,3 måneder (95% CI: 26,9; 38,3) i placebo-armen og blev ikke opnået (95% CI: 39,4; NE) i ribociclib-armen.
English: Clinical benefit rate b
Danish: Rate for klinisk fordel b
English: The observed clinical benefit rate (CBR) was higher in Kisqali arm (79.1%; 95% CI: 74.8:83.5) compared to placebo arm (69.7%; 95% CI: 64.8:74.6, p=0.002).
Danish: Den observerede rate for klinisk fordel (CBR) var højere i Kisqali-armen (79,1 %; 95 % CI: 74,8; 83,5) sammenlignet med placebo-armen (69,7 %; 95 % CI: 64,8; 74,6; p = 0,002).
English: • Medicines used to treat sleep disorders such as triazolam.
Danish: • Lægemidler til behandling af søvnforstyrrelser, fx triazolam.
English: 21 film-coated tablets.
Danish: 21 filmovertrukne tabletter.
English: Figure 5 MONALEESA-7: Kaplan Meier plot of final OS analysis in patients who received NSAI (30-Nov-18 cut-off)
Danish: Figur 5 MONALEESA-7 - Kaplan-Meier-plot af endelig OS analyse for patienter der fik NSAI (30-Nov-2018 som skæringsdato)
English: Alternative concomitant medicinal products with less potential to inhibit CYP3A4 should be considered and patients should be monitored for ribociclib-related AEs (see sections 4.2, 4.4 and
Danish: Andre samtidige lægemidler med mindre potentiale for at hæmme CYP3A4 bør overvejes som alternativ, og patienter bør monitoreres for ribociclib-relaterede bivirkninger (se pkt.
English: Breast-feeding You should not breast-feed while taking Kisqali and for at least 21 days after the last dose.
Danish: Amning Du bør ikke amme imens du tager Kisqali og i mindst 21 dage efter den sidste dosis.
English: Pregnancy status should be verified prior to starting treatment with Kisqali.
Danish: Graviditetsstatus skal verificeres før opstart af behandling med Kisqali.
English: Kisqali was given orally at a dose of 600 mg daily for 21 consecutive days followed by 7 days off treatment in combination with letrozole 2.5 mg once daily for 28 days.
Danish: Kisqali blev givet oralt ved en dosis på 600 mg daglig i 21 dage i træk efterfulgt af 7 dage uden behandling i kombination med 2,5 mg letrozol én gang daglig i 28 dage.
English: In the pre-specified subgroup analysis of 495 patients who had received Kisqali or placebo in combination with NSAI plus goserelin, the median PFS was 27.5 months (95% CI: 19.1, NE) in the Kisqali plus NSAI subgroup and 13.8 months (95% CI: 12.6, 17.4) in the placebo plus NSAI subgroup [HR: 0.569; 95% CI: 0.436, 0.743].
Danish: I den forudspecificerede subgruppeanalyse af 495 patienter, der havde fået Kisqali eller placebo i kombination med NSAI plus goserelin, var median-PFS 27,5 måneder (95 % CI: 19,1; NE) i Kisqali plus NSAI-subgruppen og 13,8 måneder (95 % CI: 12,6; 17,4) i placebo plus NSAI-subgruppen [HR: 0,569; 95 % CI: 0,436; 0,743].
English: Overall response rate (ORR) per investigator assessment based on RECIST v1.1 was higher in the Kisqali arm (40.9%; 95% CI: 35.6, 46.2) compared to the placebo arm (29.7%; 95% CI: 24.8, 34.6, p=0.00098).
Danish: Den samlede responsrate (ORR) i henhold til investigators vurdering, baseret på RECIST v1.1, var højere i Kisqali-armen (40,9 %; 95 % CI: 35,6; 46,2) sammenlignet med placebo-armen (29,7 %; 95 % CI: 24,8; 34,6; p = 0,00098).
English: A total of 668 patients were randomised in a 1:1 ratio to receive either Kisqali 600 mg and letrozole (n=334) or placebo and letrozole (n=334), stratified according to the presence of liver and/or lung metastases (Yes [n=292 (44%)]) versus No [n=376 (56%)]).
Danish: I alt blev 668 patienter randomiseret i forholdet 1:1 til at få enten 600 mg Kisqali og letrozol (n=334) eller placebo og letrozol (n=334), stratificeret efter tilstedeværelsen af lever- og/eller lungemetastaser (Ja [n=292 (44 %)]) versus Nej [n=376 (56 %)]).
English: Take Kisqali once a day only on days 1 to 21 of a 28-day cycle.
Danish: Tag Kisqali én gang om dagen og kun på dag 1 til 21 i en behandlingsserie på 28 dage.
English: The use of Kisqali with medicinal products known to prolong QTc interval and/or strong CYP3A4 inhibitors should be avoided as this may lead to clinically meaningful prolongation of the QTcF interval (see sections 4.2, 4.5 and 5.1).
Danish: Anvendelse af Kisqali sammen med lægemidler, der vides at forlænge QTc-intervallet, og/eller potente CYP3A4-hæmmere bør undgås, da dette kan føre til klinisk relevant forlængelse af QTcFintervallet (se pkt.
English: Table 13 MONALEESA-3 - Efficacy results (ORR, CBR) based on investigator assessment
Danish: Tabel 13 MONALEESA-3 - Effektresultater (ORR, CBR) baseret på investigators vurdering
English: • Antiarrhythmics such as amiodarone or quinidine.
Danish: • Lægemidler til behandling af hjertearytmi, fx amiodaron eller quinidin.
English: In study E2301 (MONALEESA-7), a QTcF interval increase >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 non-steroidal aromatase inhibitor (NSAI).
Danish: I studie E2301 (MONALEESA-7) blev der observeret en stigning i 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 non-steroid aromatasehæmmer (NSAI).
English: Grade 1* (> ULN3 x ULN)
Danish: Grad 1* (>ULN - 3 x ULN)
English: After initiating treatment, ECG should be repeated at approximately day 14 of the first cycle and at the beginning of the second cycle, then as clinically indicated.
Danish: Efter opstart af behandling skal EKG-optagelser gentages på ca. dag 14 i den første serie og ved starten af den anden serie og herefter ved klinisk behov.
English: If the strong inhibitor is discontinued, the Kisqali dose should be changed to the dose used prior to the initiation of the strong CYP3A4 inhibitor after at least 5 half-lives of the strong CYP3A4 inhibitor (see sections 4.4, 4.5 and 5.2).
Danish: Hvis den potente hæmmer seponeres, bør dosis af Kisqali ændres til den dosis, der blev anvendt før initiering af den potente CYP3A4-hæmmer, efter mindst 5 halveringstider af den potente CYP3A4-hæmmer (se pkt.
English: C] ribociclib to humans, the primary metabolic pathways for ribociclib involved oxidation (dealkylation, C and/or N-oxygenation, oxidation (-2H)) and combinations thereof.
Danish: Efter oral administration af en enkelt 600 mg-dosis af C mærket ribociclib til mennesker involverede de primære metaboliseringsveje for ribociclib oxidation (dealkylering, C- og/eller N-oxygenering, oxidering (-2H)) og kombinationer heraf.