natgillin/translations-raw huggingface dataset:
Samtidig brug af potente CYP3A-induktorer, herunder, men ikke begrænset til carbamazepin, enzalutamid, phenytoin, rifampicin og perikon bør undgås (se pkt. 
The concomitant use of strong CYP3A inducers including, but not limited to: carbamazepine, enzalutamide, phenytoin, rifampin, and St. John's Wort should be avoided (see sections 4.3 and 4.4).
Ved metastatisk sygdom blev der også observeret en fordel, uanset om antallet af forudgående behandlingslinjer var 0 (HR 0,59 [95 % CI: 0,37-0,93]), 1 (HR 0,46 [95 % CI: 0,320,64]), 2 (HR 0,48 [95 % CI: 0,30-0,76]), eller ≥ 3 (HR 0,59 [95 % CI: 0,28-1,22]). 
Benefit was also observed regardless of lines of prior therapy in the metastatic setting, whether 0 (HR of 0.59 [95% CI: 0.37, 0.93]), 1 (HR of 0.46 [95% CI: 0.32, 0.64]), 2 (HR of 0.48 [95% CI: 0.30, 0.76]), or ≥3 lines (HR of 0.59 [95% CI: 0.28, 1.22]).
Data fra lægemiddelinteraktionsdelen af et klinisk studie med patienter med brystkræft viste, at der ikke var nogen interaktion mellem palbociclib og letrozol, når disse to lægemidler blev administreret samtidigt. 
Data from the drug-drug interaction (DDI) evaluation portion of a clinical study in patients with breast cancer showed that there was no drug interaction between palbociclib and letrozole when the 2 medicinal products were coadministered.
d. Leukopeni omfatter følgende foretrukne termer: Leukopeni, nedsat antal leukocytter. 
d Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased.
e. Anæmi omfatter følgende foretrukne termer: Anæmi, nedsat hæmoglobin, nedsat hæmatokrit. 
e Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
3, grad 2: ANC 1.000 - < 1.500/mm 
b ANC: Grade 1: ANC < LLN - 1500/mm3; Grade 2: ANC 1000 - <1500/mm3;
Maksimalværdi for palbociclib ubundet eksponering (ubundet Cmax) blev forøget med henholdsvis 7 %, 38 % og 72 % for let, moderat og svært nedsat leverfunktion i forhold til personer med normal leverfunktion. 
Peak palbociclib unbound exposure (unbound Cmax) was increased by 7%, 38% and 72% for mild, moderate and severe hepatic impairment, respectively, relative to subjects with normal hepatic function.
Sekundære endepunktsresultater er baseret på bekræftet og ubekræftet respons iht. 
Secondary endpoint results are based on confirmed and unconfirmed responses according to RECIST 1.1.
• Perikon, som er et naturlægemiddel, der anvendes til behandling af let depression og angst. 
• St. John's Wort, an herbal product used to treat mild depression and anxiety.
Hud og subkutane væv Meget almindelig Udslæt 
Skin and subcutaneous tissue disorders
Tør hud 
Dry eye
Dosisjustering er ikkenødvendig ved samtidig administration af palbociclib og moderate CYP3A-induktorer (se pkt. 
No dose adjustments are required for coadministration of palbociclib with moderate CYP3A inducers (see section 4.5).
f. Trombocytopeni omfatter følgende foretrukne termer: Trombocytopeni, nedsat trombocyttal. 
f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
IBRANCE 100 mg hårde kapsler 
IBRANCE 100 mg hard capsules
Sådan skal du tage IBRANCE 
How to take IBRANCE
stomatitis. 
Stomatitisg
Foretrukken term n (%) 
All Grades n (%)
I ikke-fastende tilstand (efter indtagelse af et måltid med moderat fedtindhold) medførte samtidig administration af flere doser af protonpumpehæmmeren (PPI) rabeprazol og en enkelt dosis IBRANCE 125 mg nedsættelse af palbociclib Cmax med 41 %, men havde begrænset indvirkning på AUCinf (13 % nedsættelse) sammenlignet med en enkelt dosis palbociclib 125 mg givet alene. 
Under fed conditions (intake of a moderate-fat meal), coadministration of multiple doses of the proton pump inhibitor (PPI) rabeprazole with a single dose of 125 mg IBRANCE decreased palbociclib Cmax by 41%, but had limited impact on AUCinf (13% decrease) compared with a single dose of 125 mg IBRANCE administered alone.
Risk/benefit skal overvejes nøje inden samtidig administration. 
Coadministration should only be considered after careful evaluation of the potential benefits and risks.
Resultaterne krydsede den præspecificerede Haybittle-Peto-effektgrænse (α = 0,00135) og viste en statistisk signifikant forlængelse af PFS og en klinisk relevant virkning af behandlingen. 
The study met its primary endpoint of prolonging investigator-assessed PFS at the interim analysis conducted on 82% of the planned PFS events; the results crossed the prespecified Haybittle-Peto efficacy boundary (α=0.00135), demonstrating a statistically significant prolongation in PFS and a clinically meaningful treatment effect.
Anbefalet dosisjustering og håndtering af IBRANCE- Hæmatologiske bivirkninger CTCAE-grad 
IBRANCE dose modification and management - Haematological toxicities CTCAE Grade
Interaktion mellem palbociclib og letrozol 
Drug-drug interaction between palbociclib and letrozole
På grund af aromatase-hæmmerens virkningsmekanisme er ablation eller suppression af ovarierne med en LHRH-agonist et krav, når præ-/perimenopausale kvinder gives palbociclib i kombination med en aromatasehæmmer. 
Ovarian ablation or suppression with an LHRH agonist is mandatory when pre/perimenopausal women are administered IBRANCE in combination with an aromatase inhibitor, due to the mechanism of action of aromatase inhibitors.
IBRANCE 75 mg hårde kapsler IBRANCE 100 mg hårde kapsler IBRANCE 125 mg hårde kapsler 
IBRANCE 75 mg hard capsules IBRANCE 100 mg hard capsules IBRANCE 125 mg hard capsules
Fald i leukocytter Fald i neutrofile Anæmi 
WBC decreased Neutrophils decreased Anaemia
Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 93 mg lactose (som monohydrat). 
Each hard capsule contains 93 mg of lactose (as monohydrate).
Endokrinterapi skal kombineres med en luteiniserende hormon-frigivende hormon (LHRH)-agonist hos præ- og perimenopausale kvinder. 
In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
Palbociclib cirkulerede primært som uomdannet lægemiddel i plasma. 
Palbociclib was the major circulating drug-derived entity in plasma.
Maksimal (Cmax) eksponering for palbociclib blev forøget med henholdsvis 17 %, 12 % og 15 % for let, moderat og svært nedsat nyrefunktion. 
Peak palbociclib exposure (Cmax) was increased by 17%, 12%, and 15% for mild, moderate, and severe renal impairment, respectively, relative to subjects with normal renal function.
Dette lægemiddel indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption. 
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Passende monitorering er nødvendig (se pkt. 
Appropriate monitoring should be performed (see sections 4.2 and 4.8).
Seponer IBRANCE permanent hos patienter med alvorlig ILS eller pneumonitis (se pkt. 
Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis (see section 4.2).
IBRANCE plus letrozol (N = 444) 
IBRANCE plus Letrozole (N = 444)
IBRANCE 75 mg hårde kapsler 
IBRANCE 75 mg hard capsules
Samtidig administration af multiple doser på 400 mg modafinil daglig, en moderat CYP3A-induktor, og en enkelt dosis IBRANCE 125 mg reducerede AUCinf og Cmax af palbociclib med henholdsvis 32 % og 11 % i forhold til en enkelt dosis IBRANCE 125 mg givet alene. 
Coadministration of multiple 400 mg daily doses of modafinil, a moderate CYP3A inducer, with a single 125 mg IBRANCE dose decreased palbociclib AUCinf and Cmax by 32% and 11%, respectively, relative to a single 125 mg IBRANCE dose given alone.
IBRANCE 125 mg hårde kapsler 
IBRANCE 125 mg hard capsules
IBRANCE skal anvendes med forsigtighed hos patienter med moderat eller svært nedsat leverfunktion, og der skal overvåges nøje for tegn på toksicitet (se pkt. 
Administer IBRANCE with caution to patients with moderate or severe renal impairment, with close monitoring of signs of toxicity (see sections 4.2 and 5.2).
I fastende tilstand medførte samtidig administration af flere doser af protonpumpehæmmeren (PPI) rabeprazol og en enkelt dosis IBRANCE 125 mg nedsættelse af palbociclib AUCinf og Cmax med henholdsvis 62 % og 80 %. 
Under fasting conditions, the coadministration of multiple doses of the proton pump inhibitor (PPI) rabeprazole with a single dose of 125 mg IBRANCE decreased palbociclib AUCinf and Cmax by 62% and 80%, respectively.
5,2 % af patienter, som fik IBRANCE i randomiserede kliniske studier, seponerede permanent på grund af en bivirkning uafhængigt af kombinationen. 
Permanent discontinuation due to an adverse reaction occurred in 5.2% of patients receiving IBRANCE in randomised clinical studies regardless of the combination.
Der blev observeret en 6,9 måneders forskel i median OS i palbociclib plus fulvestrant-armen sammenlignet med placebo plus fulvestrant-armen. 
A 6.9-month difference in median OS in the palbociclib plus fulvestrant arm compared with the placebo plus fulvestrant arm was observed; this result was not statistically significant at the prespecified significance level of 0.0235 (1-sided).
Det observerede NOEL for palbociclib-relateret karcinogenecitet var på henholdsvis 10 mg/kg/dag (ca. 2 gange den kliniske humane eksponering baseret på AUC) og 200 mg/kg/dag (ca. 4 gange den kliniske humane eksponering baseret på AUC) hos hanner og hunner. 
The NOEL for palbociclib-related carcinogenicity effects was 10 mg/kg/day (approximately 2 times the human clinical exposure based on AUC) and
Udseende og pakningstørrelser - IBRANCE 75 mg leveres som uigennemsigtige, hårde kapsler med en lys orange underdel (mærket ”PBC 75” med hvid skrift) og en lys orange overdel (mærket ”Pfizer” med hvid skrift). 
What IBRANCE looks like and contents of the pack - IBRANCE 75 mg is supplied as opaque, hard capsules, with a light orange body (printed “PBC 75” in white) and a light orange cap (printed “Pfizer” in white).
g. Stomatitis omfatter følgende foretrukne termer: Aftøs stomatitis, cheilitis, glossitis, glossalgi, 
g Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. 
The primary endpoint of the study was progression-free survival (PFS) evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as assessed by investigator.
• Tør hoste 
• chest pain
IBRANCE 75 mg hårde kapsler IBRANCE 100 mg hårde kapsler IBRANCE 125 mg hårde kapsler palbociclib 
IBRANCE 75 mg hard capsules IBRANCE 100 mg hard capsules IBRANCE 125 mg hard capsules palbociclib
Grad 3 og grad 4 infektioner forekom hos henholdsvis 4,5 % og 0,7 % af patienterne behandlet med IBRANCE i alle kombinationer (se pkt. 
Infections have been reported at a higher rate in patients treated with IBRANCE in randomised clinical studies compared to patients treated in the respective comparator arm. Grade 3 and Grade 4 infections occurred respectively in 4.5% and 0.7% of patients treated with IBRANCE in any combination (see section 4.8).
Forhøjet ASAT 
AST increased
N = antal patienter; CI = konfidensinterval; OR = objektiv respons baseret på bekræftet og ubekræftet respons iht. 
N=number of patients; CI=confidence interval; OR=objective response based on confirmed and unconfirmed responses according to RECIST 1.1; TTR=time to first tumour response.
Placebo plus letrozoll (N = 222) 
Placebo plus Letrozole (N = 222)
- IBRANCE 125 mg leveres som uigennemsigtige, hårde kapsler, med en karamelfarvet underdel (mærket ”PBC 125” med hvid skrift) og en karamelfarvet overdel (mærket ”Pfizer” med hvid skrift). 
- IBRANCE 125 mg is supplied as opaque, hard capsules, with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white).
• Sulfasalazin, som anvendes til behandling af leddegigt. 
• Sulfasalazine used to treat rheumatoid arthritis.
Smagsforstyrrelser (dysgeusi) 
Dysgeusia Eye disorders
Unormale leverblodprøver 
Infectionsb Blood and lymphatic system disorders
Tillæg af palbociclib til fulvestrant resulterede i en symptomfordel ved væsentligt at forsinke tiden til forværring af smertesymptomer sammenlignet med placebo plus fulvestrant (median 8,0 måneder versus 2,8 måneder. 
Addition of palbociclib to fulvestrant resulted in a symptom benefit by significantly delaying time-to-deterioration in pain symptom compared with placebo plus fulvestrant (median 8.0 months versus 2.8 months; HR of 0.64 [95% CI: 0.49, 0.85]; p<0.001).
Anbefalede dosisjusteringer af IBRANCE ved bivirkninger 
IBRANCE recommended dose modifications for adverse reactions Dose level
Der blev observeret en reduktion i risikoen for sygdomsprogression eller død til fordel for palbociclib plus letrozol-armen i alle patientundergrupper, defineret iht. 
A reduction in the risk of disease progression or death in favour of the palbociclib plus letrozole arm was observed in all individual patient subgroups defined by stratification factors and baseline characteristics in the primary and in the updated analysis.
Samtidig administration af flere doser itraconazol 200 mg og en enkelt dosis palbociclib 125 mg øgede den samlede eksponering (AUCinf) og peak-koncentration (Cmax) af palbociclib med henholdsvis ca. 87 % og 34 % i forhold til en enkelt dosis palbociclib 125 mg givet alene. 
Coadministration of multiple 200 mg doses of itraconazole with a single 125 mg palbociclib dose increased palbociclib total exposure (AUCinf) and the peak concentration (Cmax) by approximately 87% and 34%, respectively, relative to a single 125 mg palbociclib dose given alone.
Titandioxid (E171) Ammoniumhydroxid (28% opløsning) Propylenglykol 
Ammonium hydroxide (28% solution)
Nedsat leverfunktion 
Platelets decreased
Patienterne var ligeligt fordelt mellem palbociclib plus letrozol-armen og placebo plus letrozol-armen mht. demografiske data ved baseline og prognostiske karakteristika. 
Patients were well matched for baseline demographics and prognostic characteristics between the palbociclib plus letrozole arm and the placebo plus letrozole arm.
Indehaver af markedsføringstilladelsen Pfizer Europe MA EEIG Boulevard de la Plaine 17 
NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG
Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 74 mg lactose (som monohydrat). 
Each hard capsule contains 74 mg of lactose (as monohydrate).
Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 56 mg lactose (som monohydrat). 
Each hard capsule contains 56 mg of lactose (as monohydrate).
EU/1/16/1147/005 (21 hårde kapsler) EU/1/16/1147/009 (63 hårde kapsler) 
EU/1/16/1147/005 (21 hard capsules) EU/1/16/1147/009 (63 hard capsules)
Bivirkning identificeret efter markedsføring. 
* Adverse Drug Reaction (ADR) identified post-marketing.
- IBRANCE 100 mg leveres som uigennemsigtige, hårde kapsler, med en lys orange underdel (mærket ”PBC 100” med hvid skrift) og en karamelfarvet overdel (mærket ”Pfizer” med hvid skrift). 
- IBRANCE 100 mg is supplied as opaque, hard capsules, with a light orange body (printed “PBC 100” in white) and a caramel cap (printed “Pfizer” in white).
EU/1/16/1147/003 (21 hårde kapsler) EU/1/16/1147/008 (63 hårde kapsler) 
EU/1/16/1147/003 (21 hard capsules) EU/1/16/1147/008 (63 hard capsules)
Virkning af syrenedsættende stoffer 
Effect of acid reducing agents
IBRANCE plus letrozol (N=230) 
IBRANCE plus letrozole (N=230)
IBRANCE 125 mg hårde kapsler Hver hård kapsel indeholder 125 mg palbociclib. 
IBRANCE 125 mg hard capsules Each hard capsule contains 125 mg of palbociclib.
IBRANCE plus letrozol (N=206) 
IBRANCE plus fulvestrant (N=206)
IBRANCE 100 mg hårde kapsler Hver hård kapsel indeholder 100 mg palbociclib. 
IBRANCE 100 mg hard capsules Each hard capsule contains 100 mg of palbociclib.
IBRANCE 75 mg hårde kapsler Hver hård kapsel indeholder 75 mg palbociclib. 
IBRANCE 75 mg hard capsules Each hard capsule contains 75 mg of palbociclib.
- IBRANCE 125 mg hård kapsel: Hver kapsel indeholder 125 mg palbociclib. 
- IBRANCE 125 mg hard capsule: each capsule contains 125 mg palbociclib.
Placebo plus letrozol (N=110) 
Placebo plus letrozole (N=110)
- IBRANCE 75 mg hård kapsel: Hver kapsel indeholder 75 mg palbociclib. 
- IBRANCE 75 mg hard capsule: each capsule contains 75 mg palbociclib.
Placebo plus letrozol (N=112) 
Placebo plus letrozole (N=112)
IBRANCE plus letrozol (N=214) 
IBRANCE plus letrozole (N=214)
- IBRANCE 100 mg hård kapsel: Hver kapsel indeholder 100 mg palbociclib. 
- IBRANCE 100 mg hard capsule: each capsule contains 100 mg palbociclib.
IBRANCE 100 mg hårde kapsler palbociclib 
NAME OF THE MEDICINAL PRODUCT IBRANCE 100 mg hard capsules palbociclib
Patienterne var ligeligt fordelt mellem palbociclib plus fulvestrant-armen og placebo plus fulvestrantarmen mht. demografiske data ved baseline og prognostiske karakteristika. 
Patients were well matched for baseline demographics and prognostic characteristics between the palbociclib plus fulvestrant arm and the placebo plus fulvestrant arm.
ANC = absolute neutrofiltal, CTCAE = Common Terminology Criteria for Adverse Events, LLN = nedre normalgrænse a. Skemaet gælder for alle hæmatologiske bivirkninger undtagen lymfopeni (medmindre de er forbundet med kliniske hændelser, som for eksempel opportunistiske infektioner) b. ANC: Grad 1: ANC < LLN - 1.500/mm 
ANC=absolute neutrophil counts; CTCAE=Common Terminology Criteria for Adverse Events; LLN=lower limit of normal.
Samtidig administration af flere doser rifampin 600 mg med en enkelt dosis palbociclib 125 mg reducerede den samlede eksponering (AUCinf) og peak-koncentration (Cmax) af palbociclib med henholdsvis 85 % og 70 % i forhold til en enkelt dosis palbociclib 125 mg givet alene. 
Coadministration of multiple 600 mg doses of rifampin with a single 125 mg palbociclib dose decreased palbociclib AUCinf and Cmax by 85% and 70%, respectively, relative to a single 125 mg palbociclib dose given alone.
Uigennemsigtig hård kapsel med en lys orange underdel (mærket ”PBC 75” med hvid skrift) og en lys orange overdel (mærket ”Pfizer” med hvid skrift). 
Opaque, hard capsule, with a light orange body (printed “PBC 75” in white) and a light orange cap (printed “Pfizer” in white).
IBRANCE plus letrozol (N=141) 
IBRANCE plus fulvestrant (N=141)
YDRE KARTON - 100 MG KAPSLER 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 100 MG CAPSULES
Dosisjustering er ikke nødvendig ved administration samtidig med moderate CYP3A-induktorer (se pkt. 
No dose adjustments are required for moderate CYP3A inducers (see section 4.4).
ETIKET TIL BEHOLDER - 100 MG KAPSLER 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - 100 MG CAPSULES
Rød jernoxid (E172) Gul jernoxid (E172) Titandioxid (E171) 
Red iron oxide (E172)
IBRANCE 125 mg hårde kapsler palbociclib 
NAME OF THE MEDICINAL PRODUCT IBRANCE 125 mg hard capsules palbociclib
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer): Feber med nedsat antal hvide blodlegemer Sløret syn, øget tåreflåd, tørre øjne 
Other side effects with IBRANCE may include: Very common side effects (may affect more than 1 in 10 people): Infections Reduction in white blood cells, red blood cells, and blood platelets Feeling of tiredness Decreased appetite Inflammation of the mouth and lips (stomatitis), nausea, vomiting, diarrhoea Rash Hair loss Weakness Fever Abnormalities in liver blood tests Dry skin Common side effects (may affect up to 1 in 10 people): Fever with a drop in the white blood cell count (febrile neutropenia) Blurred vision, increased tearing, dry eye Alteration in taste (dysgeusia) Nosebleed Reporting of side effects If you get any side effects, talk to your doctor, pharmacist, or nurse.
IBRANCE 75 mg hårde kapsler palbociclib 
NAME OF THE MEDICINAL PRODUCT IBRANCE 75 mg hard capsules palbociclib
YDRE KARTON - 125 MG KAPSLER 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 125 MG CAPSULES
Uigennemsigtig hård kapsel med en karamelfarvet underdel (mærket ”PBC 125”med hvid skrift) og en karamelfarvet overdel (mærket ”Pfizer” med hvid skrift). 
Opaque, hard capsule, with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white).
Skema 7. 
Table 7.
Placebo plus letrozol (N=105) 
Placebo plus fulvestrant (N=105)
ETIKET TIL BEHOLDER - 125 MG KAPSLER 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - 125 MG CAPSULES
Placebo plus letrozol (N=69) 
Placebo plus fulvestrant (N=69)
Præparater, som indeholder perikon (se pkt. 
Use of preparations containing St. John's Wort (see section 4.5).
Henholdsvis 2 % og 7 % af den administrerede dosis blev genfundet som uomdannet palbociclib i fæces og urin. 
Excretion of unchanged palbociclib in faeces and urine was 2% and 7% of the administered dose, respectively.
sygdomsplacering (visceral versus ikkevisceral), sygdomsfrit interval fra slutningen af (neo)-adjuverende behandling til sygdomsrecidiv (de novo metastatisk versus  12 måneder versus > 12 måneder), og iht. 
A total of 666 postmenopausal women were randomised 2:1 to the palbociclib plus letrozole arm or placebo plus letrozole arm and were stratified by site of disease (visceral versus nonvisceral), disease-free interval from the end of (neo)adjuvant treatment to disease recurrence (de novo metastatic versus 12 months versus >12 months), and by the type of prior (neo)adjuvant anticancer therapies (prior hormonal therapy versus no prior hormonal therapy).
Uigennemsigtig hård kapsel med en lys orange underdel (mærket ”PBC 100” med hvid skrift) og en karamelfarvet overdel (mærket ”Pfizer” med hvid skrift). 
Opaque, hard capsule, with a light orange body (printed “PBC 100” in white) and a caramel cap (printed “Pfizer” in white).
Pfizer Europe MA EEIG (som logo) 
MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG
Nedsat nyrefunktion 
Lacrimation increased
C]palbociclib til mennesker blev palbociclib primært metaboliseret via oxidation og sulfatering medacylatering og glukuronidering som mindre væsentlige metaboliseringsveje. 
Following oral administration of a single 125 mg dose of [14C]palbociclib to humans, the major primary metabolic pathways for palbociclib involved oxidation and sulphonation, with acylation and glucuronidation contributing as minor pathways.
ETIKET TIL BEHOLDER - 75 MG KAPSLER 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - 75 MG CAPSULES
C] palbociclib, blev der mediant genfundet 92 % af den samlede administrerede radioaktive dosis efter 15 dage. 
In 6 healthy male subjects given a single oral dose of [14C]palbociclib, a median of 92% of the total administered radioactive dose was recovered in 15 days; faeces (74% of dose) was the major route of excretion, with 17% of the dose recovered in urine.
YDRE KARTON - 75 MG KAPSLER 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 75 MG CAPSULES
Præ-/perimenopausale kvinder skal behandles med en LHRH-agonist i henhold til lokal klinisk praksis inden start af behandling med kombinationen palbociclib plus fulvestrant og under hele behandlingen. 
Prior to the start of treatment with the combination of palbociclib plus fulvestrant, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.
Median måneder (95 % CI) Hazard ratio (95 % CI) og p-værdi 
Progression-free survival (PFS) Number of events (%) Median [months (95% CI)] Hazard ratio (95% CI) and p-value
Alopeci 
Rashh Alopecia
Dosis kan nedsættes til en af de lavere tilgængelige styrker 100 mg eller 75 mg. 
The dose may be lowered to one of the other available strengths 100 mg or 75 mg. Take IBRANCE once a day at about the same time every day with food, preferably a meal.
Skema 6. 
Table 6.
h. Udslæt omfatter følgende foretrukne termer: Pruritus, makulopapuløst udslæt, kløende udslæt, 
h Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.
Grad 3 % Grad 4 % Alle grader 
Grade 4 n (%)
Dosisniveau 
Posology