natgillin/translations-raw huggingface dataset:
Skema 5 viser de laboratorieafvigelser, der blev observeret i puljede datasæt fra 3 randomiserede studier. 
Table 5 reports the laboratory abnormalities observed in pooled datasets from 3 randomised studies.
Palbociclib-relaterede neoplastiske fund hos rotter omfattede en øget forekomst af mikroglialcelletumorer i det centrale nervesystem hos hanrotter ved 30 mg/kg/dag; der var ingen neoplastiske fund hos hunrotter ved enhver dosis på op til 200 mg/kg/dag. 
Palbociclib-related neoplastic finding in rats included an increased incidence of microglial cell tumours in the central nervous system of males at 30 mg/kg/day; there were no neoplastic findings in female rats at any dose up to 200 mg/kg/day.
Kapslens længde er 18,0 ± 0,3 mm. 
The capsule length is 18.0 ± 0.3 mm.
Herudover viste en populationsfarmakokinetisk analyse af 183 patienter med fremskreden kræft, hvoraf 40 patienter havde let nedsat leverfunktion baseret på National Cancer Institute (NCI)-klassificeringen (total-bilirubin ≤ øverste grænse for normal (ULN) og aspartat aminotransferase (ASAT) > ULN eller total-bilirubin > 1,0 til1,5 × (ULN) og enhver ASAT), at let nedsat leverfunktion ingen indvirkning har på palbociclibs farmakokinetik (PK). 
In addition, based on a population pharmacokinetic analysis that included 183 patients with advanced cancer, where 40 patients had mild hepatic impairment based on National Cancer Institute (NCI) classification (total bilirubin ≤ Upper Limit of Normal (ULN) and Aspartate Aminotransferase (AST) > ULN, or total bilirubin >1.0 to 1.5 × ULN and any AST), mild hepatic impairment had no effect on the pharmacokinetics of palbociclib.
Kvinder i den fertile alder/prævention 
Women of childbearing potential/Contraception
Trods disse fund på forplantningsorganer hos hanrotter var der ingen påvirkning af parring eller fertilitet hos hanrotter ved forventede eksponeringsniveauer på 13 gange den kliniske humane eksponering baseret på AUC. 
Despite these male reproductive organ findings, there were no effects on mating or fertility in male rats at projected exposure levels 13 times human clinical exposure based on AUC.
Ibrance 75 mg, 100 mg og 125 mg fås i blisterpakninger med 21 eller 63 hårde kapsler og plastbeholder med 21 hårde kapsler. 
IBRANCE 75 mg, 100 mg, and 125 mg are available in blister packs of 21 or 63 hard capsules and in plastic bottles of 21 hard capsules.
Baseret på in vitro-data kan palbociclib hæmme genoptagelses-transportøren, organisk-kationtransportør OCT1 og derved muligvis øge eksponeringen for lægemidler, der er substrater for dette transportprotein (fx metformin). 
Based on in vitro data, palbociclib may inhibit the uptake transporter organic cationic transporter OCT1 and then may increase the exposure of medical product substrates of this transporter (e.g., metformin).
Samtidig brug af potente CYP3A-hæmmere, herunder, men ikke begrænset til clarithromycin, indinavir, itraconazol, ketoconazol, lopinavir/ritonavir, nefazodon, nelfinavir, posaconazol, saquinavir, telaprevir, telithromycin, voriconazol og grapefrugt eller grapefrugtjuice, bør undgås (se pkt. 
The concomitant use of strong CYP3A inhibitors including, but not limited to: clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole, and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4).
Palbociclibs farmakokinetik er ikke blevet undersøgt hos patienter som har behov for hæmodialyse. 
The pharmacokinetics of palbociclib have not been studied in patients requiring haemodialysis.
Derfor kan samtidig administration af palbociclib og lægemidler, som er substrater for P-gp (fx digoxin, dabigatran, colchicin) eller BCRP (fx pravastatin, rosuvastatin, sulfasalazin), medføre øget virkning og øgede bivirkninger af disse lægemidler. 
Therefore, administration of palbociclib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine) or BCRP (e.g., pravastatin, rosuvastatin, sulfasalazine) may increase their therapeutic effect and adverse reactions.
Tamoxifens indvirkning på eksponeringen for palbociclib 
Effect of tamoxifen on palbociclib exposure
Laboratorieafvigelser, der blev observet i puljede datasæt fra 3 randomiserede studier (N=872) 
Laboratory abnormalities observed in pooled dataset from 3 randomised studies (N=872)
Skema 8 - Effektdata - PALOMA-3 (investigatorvurderet, intent-to-treat-population) 
Efficacy results - PALOMA-3 study (investigator assessment, intent-to-treat population)
PAL=palbociclib; LET=letrozol; PCB=placebo. 
PAL=palbociclib; LET=letrozole; PCB=placebo.
Endelig samlet overlevelse (OS) (13. april 2018 som skæringsdato) Antal hændelser (%) Median [måneder (95 % CI)] Hazard ratio (95% CI) og p-værdi p=0,0429 
Final overall survival (OS) (13 April 2018 cutoff) Number of events (%) Median [months (95% CI)] Hazard ratio (95% CI) and p-value†
Kapslens længde er 19,4 ± 0,3 mm. 
The capsule length is 19.4 ± 0.3 mm.
De hyppigste (≥ 2 %) bivirkninger grad ≥ 3 var neutropeni, leukopeni, infektioner, anæmi, forhøjet aspartataminotransferase (ASAT), træthed og forhøjet alaninaminotransferase (ALAT). 
The most common (≥2%) Grade ≥3 adverse reactions of palbociclib were neutropenia, leukopenia, infections, anaemia, aspartate aminotransferase (AST) increased, fatigue, and alanine aminotransferase (ALT) increased.
Bivirkninger baseret på puljede datasæt fra 3 randomiserede studier (N = 872) Systemorganklasse 
Adverse reactions based on pooled dataset from 3 randomised studies (N=872)
Kaplan-Meier-kurver over progressionsfri overlevelse (investigatorvurderet, intent-to-treat-population) - PALOMA-3 studiet (23. oktober 2015 som skæringsdato) 
Kaplan-Meier plot of progression-free survival (investigator assessment, intent-to-treat population) - PALOMA-3 study (23 October 2015 cutoff)
• Carbamazepin og phenytoin, som anvendes til at stoppe krampeanfald. 
• Carbamazepine and phenytoin, used to stop seizures or fits.
Kapselskal: gelatine, rød jernoxid (E172), gul jernoxid (E172), titandioxid (E171). 
Capsule shell: gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).
Printblæk: shellak, titandioxid (E171), ammoniumhydroxid (28% opløsnig), propylenglycol, simeticon (se afsnit 2). 
Printing ink: shellac, titanium dioxide (E171), ammonium hydroxide (28% solution), propylene glycol, simeticone (see section 2 “IBRANCE contains lactose”).
Anbefalet dosisjustering og håndtering af IBRANCE - Ikke-hæmatologiske bivirkninger CTCAE-grad 
IBRANCE dose modification and management - Non-haematological toxicities CTCAE Grade
Mænd bør derfor overveje at få opbevaret sæd i en sædbank, inden de tager IBRANCE. 
Therefore, men may consider sperm preservation before taking IBRANCE.
Der blev også observeret en reduktion i risiko for sygdomsprogression eller død i palbociclib plus letrozolarmen hos 512 patienter med tumor testet positiv for Rb-proteinekspression ved immunhistokemi (IHC) (HR 0,543 [95 % CI: 0,433; 0,681], mPFS 27,4 måneder versus 13,7 måneder). 
Similarly, a reduction in the risk of disease progression or death in the palbociclib plus letrozole arm was observed in 512 patients whose tumour tested positive for Rb protein expression by immunohistochemistry (IHC) (HR of 0.543 [95% CI: 0.433, 0.681], mPFS 27.4 months versus 13.7 months).
Følgende lægemidler kan øge risikoen for bivirkninger, når de gives samtidig med IBRANCE: 
The following medicines may have increased risk of side effects when given with IBRANCE:
Den gennemsnitlige fraktion af ubundet (fu) palbociclib i humant plasma in vivo forøgedes i takt med forværret leverfunktion. 
The mean fraction unbound (fu) of palbociclib in human plasma in vivo increased incrementally with worsening hepatic function.
Data fra et farmakokinetisk studie med forsøgspersoner med varierende grader af leverfunktion indikerer, at eksponering for ubundet palbociclib (ubundet AUCinf) faldt med 17 % hos forsøgspersoner med let nedsat leverfunktion (Child-Pugh-klasse A) og forøgedes med henholdsvis 34 % og 77 % hos forsøgspersoner med moderat (Child-Pugh-klasse B) og svært (Child-Pugh-klasse C) nedsat leverfunktion sammenlignet med forsøgspersoner med normal leverfunktion. 
Data from a pharmacokinetic trial in subjects with varying degrees of hepatic function indicate that palbociclib unbound exposure (unbound AUCinf) decreased by 17% in subjects with mild hepatic impairment (Child-Pugh class A), and increased by 34% and 77% in subjects with moderate (Child-Pugh class B) and severe (Child-Pugh class C) hepatic impairment, respectively, relative to subjects with normal hepatic function.
Palbociclib påvirkede ikke parring eller fertilitet hos hunrotter uanset den testede dosis på op til 300 mg/kg/dag (ca. 3 gange den humane kliniske eksponering baseret på AUC), og der blev ikke observeret negative virkninger på hunlige forplantningsorganer i toksicitetsstudier med gentagen indgift på op til 300 mg/kg/dag hos hunrotter og 3 mg/kg/dag hos hunde (henholdsvis ca. 5 og 3 gange den humane kliniske eksponering baseret på AUC). 
Palbociclib did not affect mating or fertility in female rats at any dose tested up to 300 mg/kg/day (approximately 3 times human clinical exposure based on AUC), and no adverse effects were observed in female reproductive tissues in repeat-dose toxicity studies up to 300 mg/kg/day in the rat and 3 mg/kg/day in the dog (approximately 5 and 3 times human clinical exposure based on AUC, respectively).
Data fra et lægemiddelinteraktionsstudie med raske mandlige forsøgspersoner viste, at eksponeringen for palbociclib var den samme, når en enkelt dosis palbociclib blev administreret samtidigt med flere doser tamoxifen, som når palbociclib blev administreret alene. 
Data from a DDI study in healthy male subjects indicated that palbociclib exposures were comparable when a single dose of palbociclib was coadministered with multiple doses of tamoxifen and when palbociclib was given alone.
Det skal du vide, før du begynder at tage IBRANCE 
What you need to know before you take IBRANCE
Administration af flere doser palbociclib sammen med midazolam øgede midazolam AUCinfog Cmax med henholdsvis 61 % og 37 % sammenlignet med administration af midazolam alene. 
Coadministration of multiple doses of palbociclib with midazolam increased the midazolam AUCinf and Cmax values by 61% and 37%, respectively, as compared with administration of midazolam alone.
Inden administration af IBRANCE anbefales et absolut neutrofiltal (ANC) ≥ 1.000/mm og trombocyttal ≥ 50.000/mm3. 
Absolute neutrophil counts (ANC) of ≥1000/mm3 and platelet counts of ≥50,000/mm3 are recommended to receive IBRANCE.
Shellack 
Shellac
Herudover viste en populationsfarmakokinetisk analyse af 183 patienter med fremskreden kræft, hvoraf 73 patienter havde let nedsat nyrefunktion og 29 patienter havde moderat nedsat nyrefunktion, at let og moderat nedsat nyrefunktion ingen indvirkning har på PK for palbociclib. 
In addition, based on a population pharmacokinetic analysis that included 183 patients with advanced cancer, where 73 patients had mild renal impairment and 29 patients had moderate renal impairment, mild and moderate renal impairment had no effect on the pharmacokinetics of palbociclib.
Hazard ratio ((95 % CI) og p-værdi) 
Hazard ratio [(95% CI) and p-value]
I alt 521 præ-, peri- og postmenopausale kvinder, hvor sygdommen havde progredieret ved eller inden for 12 måneder efter afslutning af adjuverende endokrin terapi eller ved eller inden for 1 måned efter forudgående endokrin terapi for fremskreden sygdom, blev randomiseret i forholdet 2:1 til palbociclib plus fulvestrant eller placebo plus fulvestrant og stratificeret iht. 
A total of 521 pre/peri- and postmenopausal women who had progressed on or within 12 months from completion of adjuvant endocrine therapy or on or within 1 month from prior endocrine therapy for advanced disease, were randomised 2:1 to palbociclib plus fulvestrant or placebo plus fulvestrant and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre/peri- versus postmenopausal), and presence of visceral metastases.
Progressionsfri overlevelese baseret på investigators vurdering Antal hændelser (%) Median PFS (måneder (95 % CI)) 
Progression-Free Survival by Investigator Assessment Number of events (%) Median PFS [months (95% CI)]
Palbociclib var ikke karcinogent hos transgene mus ved doser på op til 60 mg/kg/dag (No Observed Effect Level [NOEL], ca. 11 gange den kliniske humane eksponering baseret på AUC). 
Palbociclib was negative for carcinogenicity in transgenic mice at doses up to 60 mg/kg/day (No Observed Effect Level [NOEL] approximately 11 times human clinical exposure based on AUC).
Skema 4 viser bivirkningerne fra det puljede datasæt fra tre randomiserede studier. 
Table 4 reports the adverse reactions from the pooled dataset of 3 randomised studies.
Se produktresuméet for fulvestrant for yderligere oplysninger. 
Please refer to the Summary of Product Characteristics of fulvestrant.
Behandling af præ- og perimenopausale kvinder med kombinationen palbociclib plus en aromatasehæmmer skal altid kombineres med en LHRH-agonist (se pkt. 
Treatment of pre/perimenopausal women with the combination of palbociclib plus an aromatase inhibitor should always be combined with an LHRH agonist (see section 4.4).
Afbryd straks behandlingen med Ibrance hos patienter, der har nye eller forværrende symptomer og mistanke om ILS/pneumonitis, og vurder patienten. 
In patients who have new or worsening respiratory symptoms and are suspected to have developed ILD/pneumonitis, interrupt IBRANCE immediately and evaluate the patient.
Patienter med fremskreden symptomatisk visceral spredning med risiko for livstruende komplikationer på kort sigt (herunder patienter med massive ukontrollerede effusioner (pleural, perikardial, peritoneal), pulmonal lymfangitis og mere end 50 % leverinvolvering) var ikke egnede til inklusion i studiet. 
Patients with advanced symptomatic, visceral spread, that were at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement), were not eligible for enrolment into the study.
IBRANCE indeholder: - Aktivt stof: palbociclib. 
What IBRANCE contains - The active substance is palbociclib.
Dette var evident for præ-/perimenopausale kvinder (HR 0,46 [95 % CI: 0,28-0,75]) og postmenopausale kvinder (HR 0,52 [95 % CI: 0,40-0,66]) og patienter med visceral metastatisk sygdom (HR 0,50 [95 % CI: 0,38-0,65]) og patienter med ikke-visceral metastatisk sygdom (HR 0,48 [95 % CI: 0,33-0,71]). 
This was evident for pre/perimenopausal women (HR of 0.46 [95% CI: 0.28, 0.75]) and postmenopausal women (HR of 0.52 [95% CI: 0.40, 0.66]) and patients with visceral site of metastatic disease (HR of 0.50 [95% CI: 0.38, 0.65]) and non-visceral site of metastatic disease (HR of 0.48 [95% CI: 0.33, 0.71]).
Virkningen af palbociclib i kombination med letrozol versus letrozol plus placebo blev evalueret i et internationalt, randomiseret, dobbeltblind, placebokontrolleret, multicenterstudie med parallelle grupper hos kvinder med ER-positiv, HER2-negativ lokalt fremskreden brystkræft, hvor kurativ resektion eller strålebehandling ikke var mulig, eller metastatisk brystkræft, som ikke forudgående havde fået systemisk behandling for deres fremskredne sygdom. 
The efficacy of palbociclib in combination with letrozole versus letrozole plus placebo was evaluated in an international, randomised, double-blind, placebo-controlled, parallel-group, multicentre study conducted in women with ER-positive, HER2-negative locally advanced breast cancer not amenable to resection or radiation therapy with curative intent or metastatic breast cancer who had not received prior systemic treatment for their advanced disease.
21 hårde kapsler 
63 hard capsules
Amning Du må ikke amme, mens du tager IBRANCE. 
You should not breast-feed while taking IBRANCE.
Interaktion mellem palbociclib og orale kontraceptiva 
Drug-drug interaction between palbociclib and oral contraceptives
Dosisjustering er ikke nødvendig ved svage og moderate CYP3A-hæmmere. 
No dose adjustments are needed for mild and moderate CYP3A inhibitors.
Skema 9 - Effektdata ved visceral og ikke-visceral sygdom fra PALOMA-3 studiet (intent-totreat population) Visceral sygdom 
Efficacy results in visceral and non-visceral disease from PALOMA-3 study
- Hvis du er allergisk over for palbociclib eller et af de øvrige indholdsstoffer i IBRANCE 
- if you are allergic to palbociclib or any of the other ingredients of this medicine (listed in section 6).
Samtidig behandling med CYP3A4-hæmmere eller -induktorer 
Concomitant treatment with inhibitors or inducers of CYP3A4
* Sekundære endepunktsresultater er baseret på bekræftet og ubekræftet respons iht. 
* Secondary endpoints results are based on confirmed and unconfirmed responses according to RECIST 1.1.
Patienter med fremskreden/metastatisk symptomatisk visceral spredning, der på kort sigt havde risiko for livstruende komplikationer (herunder patienter med massive ukontrollerede effusioner (pleural, perikardial, peritoneal), pulmonal lymfangitis og mere end 50 % leverinvolvering) var ikke egnede til inklusion i studiet. 
Patients with advanced/metastatic, symptomatic, visceral spread, that were at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement), were not eligible for enrolment into the study.
Virkninger af andre lægemidler på palbociclibs farmakokinetik 
Effects of other medicinal products on the pharmacokinetics of palbociclib
Kaplan-Meier-kurver over samlet overlevelse (intent-to-treat-population)PALOMA-3 studiet (13. april 2018 som skæringsdato) 
Kaplan-Meier plot of overall survival (intent-to-treat population) - PALOMA-3 study (13 April 2018 cutoff)
Der blev observeret reduceret fostervægt ved en toksisk dosis på 300 mg/kg/dag hos hunrotter (3 gange den kliniske eksponering baseret på AUC), og en øget forekomst af skeletvariationer, herunder de små falanges i forbenene, ved en toksisk dosis på 20 mg/kg/dag hos hunkaniner (4 gange den kliniske eksponering baseret på AUC). 
Reduced foetal body weights were observed at a maternally toxic dose of 300 mg/kg/day in rats (3 times human clinical exposure based on AUC), and an increased incidence of skeletal variations, including small phalanges in the forelimb was observed at a maternally toxic dose of 20 mg/kg/day in rabbits (4 times human clinical exposure based on AUC).
Der blev dog ikke observeret relation mellem Rb1-ekspression og tumorrespons i et follow-up studie med friske tumorprøver. 
However, in a follow-up study with fresh tumour samples, no relation between RB1 expression and tumour response was observed.
Ved skæringsdatoen for data 31. maj 2017 sås reduktion i risiko i følgende undergrupper fortsat: (1) patienter med enten viscerale metastaser (HR 0,62 [95 % CI: 0,47; 0,81], median progressionsfri overlevelse [mPFS] 19,3 måneder versus 12,3 måneder) eller uden viscerale metastaser (HR 0,50 [95 % CI: 0,37; 0,67], mPFS 35,9 måneder versus 17,0 måneder) og (2) patienter med enten kun knoglesygdom (HR 0,41 [95 % CI: 0,26; 0,63], mPFS 36,2 måneder versus 11,2 måneder) eller uden kun-knoglesygdom (HR 0,62 [95 % CI: 0,50; 0,78], mPFS 24,2 måneder versus 14,5 måneder). 
Based on the 31-May-2017 data cutoff date, this reduction in risk continued to be observed in the following subgroups: (1) patients with either visceral metastases (HR of 0.62 [95% CI: 0.47, 0.81], median progression-free survival [mPFS] 19.3 months versus 12.3 months) or without visceral metastases (HR of 0.50 [95% CI: 0.37, 0.67], mPFS 35.9 months versus 17.0 months) and (2) patients with either bone only disease (HR of 0.41 [95% CI: 0.26, 0.63], mPFS 36.2 months versus 11.2 months) or without bone-only disease (HR of 0.62 [95% CI: 0.50, 0.78], mPFS 24.2 months versus 14.5 months).
Seponer IBRANCE permanent hos patienter med alvorlig interstitiel lungesygdom (ILS)/pneumonitis (se pkt. 
Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD)/pneumonitis (see section 4.4).
Der var ingen indvirkning på brunstcyklus (hunrotter) eller parring og fertilitet hos rotter (han- og hunrotter) i ikke-kliniske reproduktionsstudier, men der er ikke tilgængelige fertilitetsdata for mennesker. 
There were no effects on oestrous cycle (female rats) or mating and fertility in rats (male or female) in nonclinical reproductive studies.
Progressionsfri overlevelse baseret på uafhængig vurdering Antal hændelser (%) Median PFS (måneder (95 % CI)) 
Progression-Free Survival by Independent Assessment Number of events (%) Median PFS [months (95% CI)]
Det er navnlig følgende lægemidler, som kan øge risikoen for bivirkninger med IBRANCE: 
In particular, the following may increase the risk of side effects with IBRANCE:
Der er ikke udført interaktionsstudier med palbociclib og orale kontraceptiva (se pkt. 
DDI studies of palbociclib with oral contraceptives have not been conducted (see section 4.6).
Kapselindhold: mikrokrystallinsk cellulose, lactosemonohydrat, natriumstivelsesglykolat type A, vandfri kolloid silica, magnesiumstearat. 
- The other ingredients are: Capsule content: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate type A, colloidal anhydrous silica, magnesium stearate.
Data fra lægemiddelinteraktionsdelen af et klinisk studie med patienter med brystkræft viste, at der ikke var nogen klinisk relevant interaktion mellem palbociclib og fulvestrant, når disse to lægemidler blev administreret samtidigt. 
Data from a clinical study in patients with breast cancer showed that there was no clinically relevant drug interaction between palbociclib and fulvestrant when the two medicinal products were coadministered.
Hæmatologiske forstyrrelser 
Haematological disorders
Virkningen af palbociclib i kombination med fulvestrant versus fulvestrant plus placebo blev evalueret i et internationalt, randomiseret, dobbeltblind multicenterstudie med parallelle grupper hos kvinder med HR-positiv, HER2-negativ lokalt fremskreden brystkræft, hvor kurativ resektion eller strålebehandling ikke var muligt, eller metastatisk brystkræft, uanset deres menopausale status, hvor sygdommen havde progredieret efter forudgående endokrin terapi i det (neo)-adjuverende eller metastatiske scenario. 
The efficacy of palbociclib in combination with fulvestrant versus fulvestrant plus placebo was evaluated in an international, randomised, double-blind, parallel-group, multicentre study conducted in women with HR-positive, HER2-negative locally advanced breast cancer not amenable to resection or radiation therapy with curative intent or metastatic breast cancer, regardless of their menopausal status, whose disease progressed after prior endocrine therapy in the (neo)adjuvant or metastatic setting.
Der blev observeret en reduktion i risikoen for sygdomsprogression eller død i palbociclib plus fulvestrant-armen i alle patientundergrupper defineret iht. 
A reduction in the risk of disease progression or death in the palbociclib plus fulvestrant arm was observed in all individual patient subgroups defined by stratification factors and baseline characteristics.
IBRANCE 100 mg hårde kapsler EU/1/16/1147/003 
IBRANCE 100 mg hard capsules EU/1/16/1147/003
Palbociclib metaboliseres primært af CYP3A og sulfotransferase (SULT) enzymet SULT2A1. 
4.5 Interaction with other medicinal products and other forms of interaction Palbociclib is primarily metabolised by CYP3A and sulphotransferase (SULT) enzyme SULT2A1.
< 1.000/mm 3, grad 4: ANC < 500/mm 
Grade 3: ANC 500 - <1000/mm3; Grade 4: ANC <500/mm3.
IBRANCE 125 mg hårde kapsler EU/1/16/1147/005 
IBRANCE 125 mg hard capsules EU/1/16/1147/005
Forringelse af fertilitet 
Impairment of fertility
Interaktion mellem palbociclib og fulvestrant 
Drug-drug interaction between palbociclib and fulvestrant
Tag ikke IBRANCE 
Do not take IBRANCE: