FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: Palbociklib ni vplival na parjenje ali plodnost samic podgan pri nobenem testiranem odmerku do 300 mg/kg/dan (približno 3-kratnik klinične izpostavljenosti pri ljudeh na osnovi vrednosti AUC) prav tako v študijah toksičnosti ponavljajočih se odmerkov do 300 mg/kg/dan pri podganah in 3 mg/kg/dan pri psih (približno 5- oziroma 3-kratnik klinične izpostavljenosti pri ljudeh na osnovi vrednosti AUC) niso opazili nobenih neželenih učinkov na reproduktivna tkiva samic.
English: 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).
Slovenian: Skupno 666 žensk v postmenopavzi so randomizirali v razmerju 2:1 v skupino s palbociklibom in letrozolom ali v skupino s placebom in letrozolom in jih stratificirali glede na mesto bolezni (visceralna v primerjavi z nevisceralno), interval brez bolezni od konca (neo)adjuvantnega zdravljenja do ponovitve bolezni (metastatska bolezen de novo v primerjavi z  12 meseci v primerjavi z > 12 meseci) in glede na vrsto predhodnega (neo)adjuvantnega zdravljenja raka (predhodno hormonsko zdravljenje v primerjavi z odsotnostjo predhodnega hormonskega zdravljenja).
English: MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG
Slovenian: Pfizer Europe MA EEIG
English: Use of preparations containing St. John's Wort (see section 4.5).
Slovenian: Uporaba pripravkov s šentjanževko (glejte poglavje 4.5).
English: Placebo plus fulvestrant (N=174)
Slovenian: Placebo in fulvestrant (n = 174)
English: 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.
Slovenian: Podatki iz farmakokinetičnega preskušanja pri preskušancih z različnimi stopnjami delovanja jeter kažejo, da se je izpostavljenost nevezanemu palbociklibu (nevezana AUCinf) zmanjšala za 17 % pri preskušancih z blago (razred A po klasifikaciji Child-Pugh) okvaro jeter ter povečala za 34 % pri preskušancih z zmerno (razred B po klasifikaciji Child-Pugh) in za 77 % pri preskušancih s hudo (razred C po klasifikaciji Child-Pugh) okvaro jeter v primerjavi s preskušanci z normalnim delovanjem jeter.
English: 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]).
Slovenian: To so opazili pri ženskah v pred-/perimenopavzi (HR 0,46 [95 % IZ: 0,28; 0,75]) in ženskah v postmenopavzi (HR 0,52 [95 % IZ: 0,40; 0,66]) ter pri bolnicah z metastatsko boleznijo na visceralnem mestu (HR 0,50 [95 % IZ: 0,38; 0,65]) in metastatsko boleznijo na nevisceralnem mestu (HR 0,48 [95 % IZ: 0,33; 0,71]).
English: Based on in vitro data, palbociclib is predicted to inhibit intestinal P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) mediated transport.
Slovenian: Podatki in vitro kažejo, da palbociklib lahko zavira prenos, posredovan s P-glikoproteinom (P-gp) v prebavilih in beljakovino odpornosti pri raku dojk (BCRP - Breast Cancer Resistance Protein).
English: IBRANCE 100 mg hard capsules EU/1/16/1147/003
Slovenian: IBRANCE 100 mg trde kapsule EU/1/16/1147/003
English: The following medicines may have increased risk of side effects when given with IBRANCE:
Slovenian: Pri naslednjih zdravilih lahko obstaja povečano tveganje za pojav neželenih učinkov, kadar jih jemljete skupaj z zdravilom IBRANCE:
English: • Carbamazepine and phenytoin, used to stop seizures or fits.
Slovenian: • karbamazepin in fenitoin, ki se uporabljata za zdravljenje epileptičnih napadov ali krčev,
English: IBRANCE 125 mg hard capsules EU/1/16/1147/005
Slovenian: IBRANCE 125 mg trde kapsule EU/1/16/1147/005
English: Dose reductions or dose modifications due to any adverse reaction occurred in 38.4% of patients receiving IBRANCE in randomised clinical studies regardless of the combination.
Slovenian: V randomiziranih kliničnih preskušanjih je do zmanjšanja ali prilagajanja odmerka zaradi kateregakoli neželenega učinka prišlo pri 38,4 % bolnikov, ki so prejemali zdravilo IBRANCE, ne glede na kombinacijo.
English: Kaplan-Meier plot of overall survival (intent-to-treat population) - PALOMA-3 study (13 April 2018 cutoff)
Slovenian: Kaplan-Meierjev graf celokupnega preživetja (populacija z namenom zdravljenja)preskušanje PALOMA-3 (datum zaključka 13. april 2018)
English: Non-visceral Disease
Slovenian: Nevisceralna bolezen
English: Efficacy results in patients with visceral or non-visceral disease from PALOMA-2 study (intent-to-treat population; 31-May-2017 cutoff date) Visceral Disease
Slovenian: Rezultati učinkovitosti iz preskušanja PALOMA-2 pri bolnicah z visceralno in nevisceralno boleznijo (populacija z namenom zdravljenja; datum zaključka zajema podatkov 31. maj 2017)
English: 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.
Slovenian: Učinkovitost palbocikliba v kombinaciji z letrozolom v primerjavi z letrozolom in placebom so ocenjevali v mednarodnem, randomiziranem, dvojno slepem, s placebom nadzorovanem multicentričnem preskušanju z vzporednima skupinama, opravljenem pri ženskah z ER-pozitivnim, HER2-negativnim lokalno napredovalim rakom dojk, ki ga ni moč zdraviti kirurško ali z obsevanjem, ali metastatskim rakom dojk, ki predhodno niso prejele nobenega sistemskega zdravljenja za svojo napredovalo bolezen.
English: 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.
Slovenian: C] palbocikliba, se je povprečno 92 % celotnega danega radioaktivnega odmerka izločilo v 15 dneh; glavna pot izločanja je bila z blatom (74 % odmerka), medtem ko se je z urinom izločilo 17 % odmerka.
English: • Pravastatin and rosuvastatin used to treat high cholesterol levels.
Slovenian: • pravastatin in rosuvastatin, ki se uporabljata za zdravljenje zvišanih ravni holesterola v krvi,
English: IBRANCE plus fulvestrant (N=206)
Slovenian: Zdravilo IBRANCE in fulvestrant (n = 206)
English: 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.
Slovenian: Največja izpostavljenost palbociklibu (cmax) se je povečala za 17 % pri blagi, 12 % pri zmerni in 15 % pri hudi okvari ledvic v primerjavi s preskušanci z normalnim delovanjem ledvic.
English: How to take IBRANCE
Slovenian: Kako jemati zdravilo IBRANCE
English: Efficacy results in visceral and non-visceral disease from PALOMA-3 study
Slovenian: Rezultati učinkovitosti iz preskušanja PALOMA-3 za visceralno in nevisceralno bolezen (populacija z namenom zdravljenja) Visceralna bolezen
English: 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.
Slovenian: Podatki iz kliničnega preskušanja pri bolnikih z rakom dojk so pokazali, da med sočasno uporabo palbocikliba in fulvestranta ni bilo nobenega klinično pomembnega medsebojnega delovanja med tema zdraviloma.
English: IBRANCE contains lactose
Slovenian: Zdravilo IBRANCE vsebuje laktozo
English: 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]).
Slovenian: Opazili so tudi korist, ne glede na število linij predhodnega zdravljenja v okviru zdravljenja metastatske bolezni, bodisi 0 (HR 0,59 [95 % IZ: 0,37; 0,93]), 1 (HR 0,46 [95 % IZ: 0,32; 0,64]), 2 (HR 0,48 [95 % IZ: 0,30; 0,76]) ali ≥ 3 linije (HR 0,59 [95 % IZ: 0,28; 1,22]).
English: Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them: Contact your doctor immediately if you have any of these symptoms:
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: e Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
Slovenian: e. Anemija vključuje naslednje PT: anemija, zmanjšanje vrednosti hemoglobina, zmanjšanje vrednosti hematokrita.
English: 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.
Slovenian: Učinkovitost palbocikliba v kombinaciji s fulvestrantom v primerjavi s fulvestrantom in placebom so ocenjevali v mednarodnem, randomiziranem, dvojno slepem, multicentričnem preskušanju z vzporednima skupinama, opravljenem pri ženskah s HR-pozitivnim, HER2-negativnim lokalno napredovalim rakom dojk, ki ga ni moč zdraviti kirurško ali z obsevanjem, ali metastatskim rakom dojk ne glede na njihov menopavzalni status, pri katerih je bolezen napredovala po predhodnem endokrinem zdravljenju v okviru (neo)adjuvantnega zdravljenja ali zdravljenja metastatske bolezni.
English: - The other ingredients are: Capsule content: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate type A, colloidal anhydrous silica, magnesium stearate.
Slovenian: Vsebinakapsule: mikrokristalna celuloza, laktoza monohidrat, natrijev karboksimetilškrob tip A, koloidni brezvodni silicijev dioksid, magnezijev stearat.
English: IBRANCE recommended dose modifications for adverse reactions Dose level
Slovenian: Priporočene prilagoditve odmerkov zdravila IBRANCE zaradi neželenih učinkov Raven odmerka
English: b ANC: Grade 1: ANC < LLN - 1500/mm3; Grade 2: ANC 1000 - <1500/mm3;
Slovenian: b. ANC: stopnja 1: ANC < SMN - 1.500/mm
English: Hazard ratio (95% CI) and 1-sided p-value
Slovenian: razmerje ogroženosti (95 % IZ) in 1-stranska vrednost p
English: 4.5 Interaction with other medicinal products and other forms of interaction Palbociclib is primarily metabolised by CYP3A and sulphotransferase (SULT) enzyme SULT2A1.
Slovenian: Palbociklib se v glavnem presnavlja preko CYP3A in encima iz skupine sulfotransferaz (SULTSulfotransferase) SULT2A1.
English: 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.
Slovenian: Na poln želodec (vnos obroka z zmerno vsebnostjo maščob) je sočasna uporaba večkratnih odmerkov zaviralca protonske črpalke (PPI - Proton Pump Inhibitor), rabeprazola, skupaj z enkratnim odmerkom 125 mg zdravila IBRANCE zmanjšala cmax palbocikliba za 41 %, vendar je imela omejen učinek na AUCinf (13 % zmanjšanje) v primerjavi s samostojno uporabo enkratnega odmerka 125 mg zdravila IBRANCE.
English: 63 hard capsules
Slovenian: 21 trdih kapsul
English: Drug-drug interaction between palbociclib and oral contraceptives
Slovenian: Medsebojna delovanja med palbociklibom in peroralnimi kontraceptivi
English: IBRANCE plus fulvestrant (N=141)
Slovenian: Zdravilo IBRANCE in fulvestrant (n = 141)
English: 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.
Slovenian: Podatki iz dela kliničnega preskušanja z oceno medsebojnih delovanj vrste zdravilo-zdravilo (DDIDrug-Drug Interactions) pri bolnikih z rakom dojk so pokazali, da med sočasno uporabo palbocikliba in letrozola ni bilo nobenega medsebojnega delovanja med tema zdraviloma.
English: An updated analysis of the primary and secondary endpoints was performed after an additional 15 months of follow up (data cutoff date: 31-May-2017).
Slovenian: Po dodatnih 15 mesecih spremljanja (datum zaključka zajema podatkov: 31. maj 2017) so izvedli posodobljeno analizo primarnega in sekundarnih opazovanih dogodkov.
English: 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.
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): okužbe zmanjšanje števila belih krvnih celic, rdečih krvnih celic in krvnih ploščic občutek utrujenosti pomanjkanje teka vnetje ust in ustnic (stomatitis), občutek siljenja na bruhanje, bruhanje, driska izpuščaj izguba las in dlak oslabelost vročina nenormalni izvidi krvnih preiskavdelovanja jeter suha koža
English: Therefore, you may be at greater risk of getting an infection while you are taking IBRANCE.
Slovenian: Zato ste med jemanjem zdravila IBRANCE lahko izpostavljeni povečanemu tveganju za okužbo.
English: h Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.
Slovenian: h. Izpuščaj vključuje naslednje PT: izpuščaj, makulopapulozni izpuščaj, pruritični izpuščaj, eritemski izpuščaj, papulozni izpuščaj, dermatitis, akneiformni dermatitis, toksični kožni izpuščaj.
English: Visceral Disease
Slovenian: Visceralna bolezen
English: The median age of patients enrolled in this study was 62 years (range 28-89), 48.3% of patients had received chemotherapy and 56.3% had received antihormonal therapy in the (neo)adjuvant setting prior to their diagnosis of advanced breast cancer while 37.2% of patients had received no prior systemic therapy in the (neo)adjuvant setting.
Slovenian: Pred diagnozo napredovalega raka dojk je 48,3 % bolnic prejemalo kemoterapijo, 56,3 % bolnic pa protihormonsko zdravljenje v okviru (neo)adjuvantnega zdravljenja, medtem ko 37,2 % bolnic ni prejelo nobenega sistemskega zdravljenja v okviru (neo)adjuvantnega zdravljenja.
English: The primary target organ findings of potential relevance to humans included haematolymphopoietic and male reproductive organ effects in rats and dogs in studies up to 39 weeks duration.
Slovenian: V študijah na podganah in psih, ki so trajale do 39 tednov, so ugotovitve glede primarnih ciljnih organov, ki so potencialno relevantne za ljudi, vključevale učinke na hematolimfopoetske in moške reprodukcijske organe.
English: 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).
Slovenian: Palbociklib pri transgenih miših v odmerkih do 60 mg/kg/dan ni bil kancerogen (raven brez opaznega učinka [NOEL - No Observed Effect Level] je bila približno 11-kratnik klinične izpostavljenosti pri ljudeh na osnovi vrednosti AUC).
English: Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD)/pneumonitis (see section 4.4).
Slovenian: Pri bolnikih s hudo intersticijsko boleznijo pljuč (ILD - Interstitial Lung Disease)/pnevmonitisom je treba zdravljenje z zdravilom IBRANCE trajno prekiniti (glejte poglavje 4.4).
English: These findings were observed in rats and/or dogs at exposures  9 times or subtherapeutic compared to human clinical exposure based on AUC, respectively.
Slovenian: Te učinke so opažali pri podganah in psih pri izpostavljenostih, ki so bile pri podganah za  9-krat večje od klinične izpostavljenosti pri ljudeh na osnovi vrednosti AUC, in pri psih pri izpostavljenostih, manjših od terapevtskih.
English: IBRANCE plus Letrozole (N = 444)
Slovenian: Zdravilo IBRANCE in letrozol (n = 444)
English: Grade 3 n (%)
Slovenian: n (%)
English: No dose adjustments are required for moderate CYP3A inducers (see section 4.4).
Slovenian: Pri zmernih induktorjih CYP3A prilagajanje odmerkov ni potrebno (glejte poglavje 4.4).
English: In addition, cardiovascular effects (QTc prolongation, decreased heart rate, and increased RR interval and systolic blood pressure) were identified in telemetered dogs at ≥4 times human clinical exposure based on Cmax.
Slovenian: Poleg tega so na telemetrično obravnavanih psih pri ≥ 4-kratniku klinične izpostavljenosti pri ljudeh na podlagi cmax, ugotovili srčno-žilne učinke (podaljšanje QTc, upočasnjen srčni utrip ter podaljšan interval RR in povišan sistolični krvni tlak).
English: Palbociclib was the major circulating drug-derived entity in plasma.
Slovenian: Palbociklib je bil v plazmi poglavitna spojina, ki izhaja iz zdravila.
English: g Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
Slovenian: g. Stomatitis vključuje naslednje PT: aftozni stomatitis, heilitis, glositis, glosodinija, razjede v ustih, vnetje sluznice, bolečine v ustih, nelagodje v ustih in žrelu, bolečine v ustih in žrelu, stomatitis.
English: The primary endpoint of the study was investigator-assessed PFS evaluated according to RECIST 1.1.
Slovenian: Primarni opazovani dogodek preskušanja je bilo preživetje brez napredovanja bolezni (PFS), ki ga je raziskovalec ocenjeval v skladu z merili RECIST 1.1.
English: Progression-Free Survival by Investigator Assessment Number of events (%) Median PFS [months (95% CI)]
Slovenian: Preživetje brez napredovanja bolezni po oceni raziskovalca število dogodkov (%) mediano PFS [meseci (95 % IZ)]
English: A total of 335 patients in the palbociclib plus fulvestrant arm and 166 patients in the fulvestrant only arm completed the questionnaire at baseline and at least 1 postbaseline visit.
Slovenian: Vprašalnik je ob izhodišču in vsaj 1 obisku po izhodišču izpolnilo skupno 335 bolnic iz skupine s palbociklibom in fulvestrantom in 166 bolnic iz skupine s samim fulvestrantom.
English: No dose adjustments are needed for mild and moderate CYP3A inhibitors.
Slovenian: Pri blagih in zmernih zaviralcih CYP3A prilagajanje odmerkov ni potrebno.
English: Placebo plus Letrozole (N = 222)
Slovenian: Placebo in letrozol (n = 222)
English: 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.
Slovenian: V primarni in posodobljeni analizi so v korist skupini s palbociklibom in letrozolom pri vsaki posamezni podskupini bolnic, opredeljeni glede na stratifikacijske dejavnike in izhodiščne značilnosti, opazili zmanjšanje tveganja za napredovanje bolezni ali smrt.
English: 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.
Slovenian: Največja izpostavljenost nevezanemu palbociklibu (nevezana cmax) se je povečala za 7 % pri blagi, 38 % pri zmerni in 72 % pri hudi okvari jeter v primerjavi s preskušanci z normalnim delovanjem jeter.
English: • St. John's Wort, an herbal product used to treat mild depression and anxiety.
Slovenian: • šentjanževka, zdravilo rastlinskega izvora, ki se uporablja za zdravljenje blage depresije in tesnobe.
English: System Organ Class Frequency Preferred Terma
Slovenian: Organski sistem Pogostnost
English: 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).
Slovenian: Pri podganah so pri odmerku 300 mg/kg/dan (3-kratnik klinične izpostavljenosti pri ljudeh na osnovi vrednosti AUC), ki je bil toksičen za samico mater, opazili zmanjšanje telesne mase ploda, pri zajcih pa so pri odmerku 20 mg/kg/dan (4-kratnik klinične izpostavljenosti pri ljudeh na osnovi vrednosti AUC), ki je bil toksičen za samico mater, opazili povečano incidenco skeletnih sprememb, vključno z majhnimi falangami sprednjih okončin.
English: Palbociclib in combination with fulvestrant in pre/perimenopausal women has only been studied in combination with an LHRH agonist.
Slovenian: Pri ženskah v pred- in perimenopavzi so sočasno jemanje palbocikliba in fulvestranta preučevali le v kombinaciji z agonistom LHRH.
English: Drug-drug interaction between palbociclib and fulvestrant
Slovenian: Medsebojna delovanja med palbociklibom in fulvestrantom
English: IBRANCE 75 mg hard capsules IBRANCE 100 mg hard capsules IBRANCE 125 mg hard capsules
Slovenian: IBRANCE 75 mg trde kapsule IBRANCE 100 mg trde kapsule IBRANCE 125 mg trde kapsule
English: Partial reversibility of male reproductive organ effects was observed in the rat and dog following a 4- and 12-week nondosing period, respectively.
Slovenian: Pri podganah in psih so po 4- oziroma 12-tedenskem obdobju brez odmerjanja opažali delno reverzibilnost učinkov na reprodukcijske organe samcev.
English: Progression-Free Survival by Independent Assessment Number of events (%) Median PFS [months (95% CI)]
Slovenian: Preživetje brez napredovanja bolezni po neodvisni oceni število dogodkov (%) mediano PFS [meseci (95 % IZ)]
English: For the 51 patients IHC negative for Rb expression, the difference between treatment arms was not statistically significant (HR of 0.868 [95% CI: 0.424, 1.777], mPFS 23.2 versus 18.5 months) for the palbociclib plus letrozole arm versus the placebo plus letrozole arm, respectively.
Slovenian: Pri 51 bolnicah, pri katerih je bil IHC za ekspresijo beljakovine Rb negativen, razlika med zdravljenima skupinama, od katerih je ena prejemala palbociklib in letrozol v primerjavi z drugo skupino, ki je prejemala placebo in letrozol, ni bila statistično pomembna (HR 0,868 [95 % IZ: 0,424; 1,777], mPFS 23,2 meseca v primerjavi z 18,5 meseca).
English: • Colchicine used to treat gout.
Slovenian: • kolhicin, ki se uporablja za zdravljenje protina,