FrancophonIA/ELRC3.0 huggingface dataset:
English: Patient-reported symptoms were assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 and its Breast Cancer Module (EORTC QLQ-BR23).
Croatian: European Organisation for Research and Treatment) i njegovog Modula za karcinom dojke (EORTC QLQ-BR23).
English: How to store IBRANCE
Croatian: Kako čuvati IBRANCE
English: All Grades n (%)
Croatian: Preporučeni pojam n (%)
English: Patients were well matched for baseline demographics and prognostic characteristics between the palbociclib plus letrozole arm and the placebo plus letrozole arm.
Croatian: Bolesnice su bile dobro uparene prema početnim vrijednostima demografskih i prognostičkih karakteristika između skupine koja je primala palbociklib i letrozol i skupine koja je primala placebo i letrozol.
English: It is unknown whether palbociclib is excreted in human milk.
Croatian: Nije poznato izlučuje li se palbociklib u majčino mlijeko.
English: ANC=absolute neutrophil counts; CTCAE=Common Terminology Criteria for Adverse Events; LLN=lower limit of normal.
Croatian: ABN=apsolutni broj neutrofila; CTCAE=Zajednička terminologija za nuspojave (engl.
English: Efficacy results in visceral and non-visceral disease from PALOMA-3 study
Croatian: Tablica 9. Rezultati djelotvornosti u bolesnica s visceralnom i bez visceralne bolesti iz PALOMA-3 ispitivanja (populacija predviđena za liječenje)
English: 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).
Croatian: Kako IBRANCE izgleda i sadržaj pakiranja - IBRANCE 75 mg je neprozirna, tvrda kapsula sa svijetlo narančastim tijelom (s otisnutim „PBC 75“ u bijeloj boji) te sa svijetlo narančastom kapicom (otisnuto „Pfizer“ u bijeloj boji).
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.
Croatian: Vršna izloženost nevezanom palbociklibu (nevezani Cmax) povećala se za 7%, 38% odnosno 72% u slučaju blagog, umjerenog i teškog oštećenja jetre, u usporedbi s ispitanicima s normalnom funkcijom jetre.
English: 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).
Croatian: Primijenite IBRANCE s oprezom u bolesnica s umjerenim ili teškim oštećenjem bubrega uz pažljivo praćenje znakova toksičnosti (vidjeti dijelove 4.2 i 5.2).
English: Placebo plus fulvestrant (N=174)
Croatian: Placebo i fulvestrant (N=174)
English: AST Increased
Croatian: Povišen AST
English: Hazard ratio [(95% CI) and p-value]
Croatian: Omjer hazarda [(95% CI) i p-vrijednost]
English: Drug-drug interaction between palbociclib and fulvestrant
Croatian: Interakcije između lijekova palbocikliba i fulvestranta
English: Placebo plus fulvestrant (N=105)
Croatian: Placebo fulvestrant (N=105)
English: 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.
Croatian: Progression Free Survival) procijenjeno u skladu s Kriterijima procjene odgovora kod solidnih tumora (RECIST; engl.
English: Platelets decreased
Croatian: Tablični popis nuspojava
English: IBRANCE 75 mg hard capsules
Croatian: IBRANCE 75 mg tvrde kapsule
English: Figure 3.
Croatian: Slika 3.
English: IBRANCE dose modification and management - Haematological toxicities CTCAE Grade
Croatian: Tablica 2. Promjena doze lijeka IBRANCE i postupci kod liječenja hematološke toksičnosti CTCAE stupanj
English: OR (measurable disease) [% (95% CI)] CBR [% (95% CI)]
Croatian: OR (mjerljiva bolest) [%] (95 % CI)
English: Kaplan-Meier plot of progression-free survival (investigator assessment, intent-to-treat population) - PALOMA-3 study (23 October 2015 cutoff)
Croatian: Kaplan-Meierova krivulja preživljenja (procjena ispitivača, populacija predviđena za liječenje) - ispitivanje - PALOMA-3 (zaključni datum prikupljanja podataka od 23. listopada 2015.)
English: Placebo plus Letrozole (N = 222)
Croatian: Placebo i letrozol (N=222)
English: Laboratory abnormalities
Croatian: Odstupanja u laboratorijskim nalazima
English: 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.
Croatian: U uvjetima natašte, istodobna primjena višestrukih doza inhibitora protonske pumpe (IPP) rabeprazola s pojedinačnom dozom od 125 mg lijeka IBRANCE smanjila je AUCinf odnosno Cmax palbocikliba za 62% i 80%.
English: IBRANCE 75 mg hard capsules IBRANCE 100 mg hard capsules IBRANCE 125 mg hard capsules
Croatian: IBRANCE 75 mg tvrde kapsule IBRANCE 100 mg tvrde kapsule IBRANCE 125 mg tvrde kapsule
English: IBRANCE plus fulvestrant (N=141)
Croatian: fulvestrant (N=141)
English: Grade 3 n (%)
Croatian: n (%)
English: IBRANCE recommended dose modifications for adverse reactions Dose level
Croatian: Preporučena promjena doze lijeka IBRANCE kod nuspojava Razina doze
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.
Croatian: Rb razlika između terapijskih skupina nije bila statistički značajna (HR od 0,868 [95% CI: 0,424; 1,777], mPFS 23,2 mjeseca naspram 18,5 mjeseci) za skupinu koja je primala palbociklib i letrozol u odnosu na skupinu koja je primala placebo i letrozol.
English: IBRANCE 100 mg hard capsules
Croatian: IBRANCE 100 mg tvrde kapsule
English: Critical visceral disease
Croatian: Teška visceralna bolest
English: Placebo plus fulvestrant (N=69)
Croatian: Placebo i fulvestrant (N=69)
English: Drug-drug interaction between palbociclib and letrozole
Croatian: Interakcije između lijekova palbocikliba i letrozola
English: 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).
Croatian: Infekcije stupnja 3 i 4 dogodile su se u 4,5 % odnosno u 0,7 % bolesnica liječenih lijekom IBRANCE u bilo kojoj kombinaciji (vidjeti dio 4.8).
English: No dose adjustment of IBRANCE is necessary in patients ≥65 years of age (see section 5.2).
Croatian: ≥ 65 godina (vidjeti dio 5.2).
English: - if you are allergic to palbociclib or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na palbociklib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - uzimanje preparata sa gospinom travom je potrebno izbjegavati dok uzimate IBRANCE.
English: Laboratory abnormalities observed in pooled dataset from 3 randomised studies (N=872)
Croatian: Tablica 5. Odstupanja u laboratorijskim nalazima zabilježena u objedinjenim podacima prikupljenima iz 3 randomizirana ispitivanja (N=872)
English: IBRANCE dose modification and management - Non-haematological toxicities CTCAE Grade
Croatian: Tablica 3. Promjena doze lijeka IBRANCE i postupci kod nehematološke toksičnosti CTCAE stupanj
English: Secondary efficacy endpoints included objective response (OR), clinical benefit response (CBR), safety, and change in quality of life (QoL).
Croatian: Clinical Benefit Response), sigurnost i promjenu u kvaliteti života (QoL; engl.
English: - IBRANCE 125 mg hard capsule: each capsule contains 125 mg palbociclib.
Croatian: - IBRANCE 125 mg tvrde kapsule: jedna kapsula sadrži 125 mg palbocikliba.
English: Each hard capsule contains 93 mg of lactose (as monohydrate).
Croatian: Pomoćne tvari s poznatim učinkom Jedna tvrda kapsula sadrži 93 mg laktoze (u obliku hidrata).
English: - IBRANCE 75 mg hard capsule: each capsule contains 75 mg palbociclib.
Croatian: - IBRANCE 75 mg tvrde kapsule: jedna kapsula sadrži 75 mg palbocikliba.
English: IBRANCE plus letrozole (N=230)
Croatian: IBRANCE i letrozol (N=230)
English: Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis (see section 4.2).
Croatian: Trajno prekinite primjenu lijeka IBRANCE u bolesnika s teškim IBP-om ili pneumonitisom (vidjeti dio 4.2).
English: - IBRANCE 100 mg hard capsule: each capsule contains 100 mg palbociclib.
Croatian: - IBRANCE 100 mg tvrde kapsule: jedna kapsula sadrži 100 mg palbocikliba.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - 75 MG CAPSULES
Croatian: NALJEPNICA NA BOČICI - KAPSULE 75 MG
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - 125 MG CAPSULES
Croatian: NALJEPNICA NA BOČICI - KAPSULE 125 MG
English: 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.
Croatian: C]palbocikliba ljudima, glavne primarne metaboličke putanje za palbociklib uključivale su oksidaciju i sulfonaciju s acetilacijom i glukoronidacijom kao doprinosom minornim putanjama.
English: Yellow iron oxide (E172)
Croatian: Crveni željezov oksid (E172) Žuti željezov oksid (E172) Titanijev dioksid (E171)
English: Microcrystalline cellulose Lactose monohydrate Sodium starch glycolate type A Colloidal anhydrous silica Magnesium stearate
Croatian: Natrijev škroboglikolat, vrsta A Koloidni silicijev dioksid, bezvodni Magnezijev stearat
English: IBRANCE 125 mg hard capsules
Croatian: IBRANCE 125 mg tvrde kapsule
English: Placebo plus letrozole (N=110)
Croatian: Placebo i letrozol (N=110)
English: EU/1/16/1147/005 (21 hard capsules) EU/1/16/1147/009 (63 hard capsules)
Croatian: EU/1/16/1147/005 (21 tvrda kapsula) EU/1/16/1147/009 (63 tvrde kapsule)
English: IBRANCE 75 mg hard capsules IBRANCE 100 mg hard capsules IBRANCE 125 mg hard capsules palbociclib
Croatian: IBRANCE 75 mg tvrde kapsule IBRANCE 100 mg tvrde kapsule IBRANCE 125 mg tvrde kapsule palbociklib
English: EU/1/16/1147/003 (21 hard capsules) EU/1/16/1147/008 (63 hard capsules)
Croatian: EU/1/16/1147/003 (21 tvrda kapsula) EU/1/16/1147/008 (63 tvrde kapsule)
English: Placebo plus letrozole (N=112)
Croatian: Placebo i letrozol (N=112)
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.
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba): Vrućica s padom broja bijelih krvnih stanica (febrilna neutropenija) Zamagljen vid, pojačano suzenje, suho oko Promjena osjeta okusa (disguezija) Krvarenje iz nosa
English: 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.
Croatian: Istodobna primjena višestrukih doza modafinila od 400 mg, umjerenog induktora CYP3A, s pojedinačnom dozom lijeka IBRANCE od 125 mg smanjila je AUCinf i Cmax palbocikliba za 32%, odnosno 11% u usporedbi s pojedinačnom dozom lijeka IBRANCE od 125 mg primijenjenog samog.
English: IBRANCE plus letrozole (N=214)
Croatian: IBRANCE i letrozol (N=214)
English: Comparator arms*
Croatian: Skupine koje su primale usporedni lijek*
English: b ANC: Grade 1: ANC < LLN - 1500/mm3; Grade 2: ANC 1000 - <1500/mm3;
Croatian: ABN: stupanj 1: ABN < DGN - 1500/mm
English: Capsule shell
Croatian: Ovojnica kapsule
English: - 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).
Croatian: - IBRANCE 125 mg je neprozirna, tvrda kapsula s tijelom karamel boje (s otisnutim „PBC 125“ u bijeloj boji) te sa kapicom karamel boje (otisnuto „Pfizer“ u bijeloj boji).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - 100 MG CAPSULES
Croatian: NALJEPNICA ZA BOČICU - KAPSULE 100 MG
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika ili medicinsku sestru.
English: Hazard ratio (95% CI) and 1-sided p-value
Croatian: Omjer hazarda (95% CI) i jednostrana p-vrijednost
English: Each hard capsule contains 56 mg of lactose (as monohydrate).
Croatian: Pomoćne tvari s poznatim učinkom Jedna tvrda kapsula sadrži 56 mg laktoze (u obliku hidrata).
English: 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.
Croatian: Istodobna primjena višestrukih doza itrakonazola od 200 mg s pojedinačnom dozom palbocikliba od 125 mg povećala je ukupnu izloženost palbociklibu (AUCinf) i vršnu koncentraciju (Cmax) palbocikliba za približno 87%, odnosno 34% u odnosu na pojedinačnu dozu palbocikliba od 125 mg primijenjenu samu.
English: Each hard capsule contains 74 mg of lactose (as monohydrate).
Croatian: Pomoćne tvari s poznatim učinkom Jedna tvrda kapsula sadrži 74 mg laktoze (u obliku hidrata).
English: Non-visceral Disease
Croatian: Bez visceralne bolesti
English: h Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.
Croatian: h. Osip uključuje sljedeće preporučene pojmove: Osip, makulopapularni osip, pruritični osip, eritematozni osip, papularni osip, dermatitis, akneiformni dermatitis, toksična erupcija kože. i.
English: - 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).
Croatian: - IBRANCE 100 mg je neprozirna, tvrda kapsula sa svijetlo narančastim tijelom (s otisnutim „PBC 100“ u bijeloj boji) te sa kapicom karamel boje (otisnuto „Pfizer“ u bijeloj boji).
English: Supportive PFS analyses were based on an Independent Central Radiology Review.
Croatian: Primarna mjera ishoda ispitivanja bio je PFS procijenjen od strane ispitivača u skladu s RECIST 1.1. Suportivne analize PFS-a temeljile su se na neovisnoj središnjoj radiološkoj procjeni.
English: f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
Croatian: f. Trombocitopenija uključuje sljedeće preporučene pojmove: Trombocitopenija, smanjen broj trombocita.
English: Final overall survival (OS) (13 April 2018 cutoff) Number of events (%) Median [months (95% CI)] Hazard ratio (95% CI) and p-value†
Croatian: Konačno ukupno preživljenje (OS) (zaključni datum prikupljanja podataka od 13. travnja 2018.) Broj događaja (%)
English: Opaque, hard capsule, with a light orange body (printed “PBC 75” in white) and a light orange cap (printed “Pfizer” in white).
Croatian: Neprozirna, tvrda kapsula sa svijetlo narančastim tijelom (s otisnutim „PBC 75“ u bijeloj boji) te sa svijetlo narančastom kapicom (otisnuto „Pfizer“ u bijeloj boji).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 100 MG CAPSULES
Croatian: VANJSKA KUTIJA - KAPSULE 100 MG
English: 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.
Croatian: Istodobna primjena višestrukih doza itrakonazola od 600 mg s pojedinačnom dozom palbocikliba od 125 mg smanjila je AUCinf i Cmax palbocikliba za približno 85%, odnosno 70% u odnosu na pojedinačnu dozu palbocikliba od 125 mg primijenjenu samu.
English: Opaque, hard capsule, with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white).
Croatian: Neprozirna, tvrda kapsula s tijelom karamel boje (s otisnutim „PBC 125“ u bijeloj boji) te sa kapicom karamel boje (otisnuto „Pfizer“ u bijeloj boji).
English: The NOEL for palbociclib-related carcinogenicity effects was 10 mg/kg/day (approximately 2 times the human clinical exposure based on AUC) and
Croatian: Razina pri kojoj nisu uočeni kancerogeni učinci povezani s palbociklibom iznosila je 10 mg/kg/dan (približno 2 puta veća od izloženosti ljudi u kliničkim uvjetima na temelju AUC) i 200 mg/kg/dan (približno 4 puta veća od izloženosti ljudi u kliničkim uvjetima na temelju AUC) u mužjaka, odnosno ženki.
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]).
Croatian: Korist je također uočena neovisno o linijama prethodne terapije u metastatskom okruženju gdje je 0 (HR od 0,59 [95 % CI: 0,37 - 0,93]), 1 (HR od 0,46 [95 % CI:
English: e Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
Croatian: d. Leukopenija uključuje sljedeće preporučene pojmove: Leukopenija, smanjen broj leukocita. e. Anemija uključuje sljedeće preporučene pojmove: Anemija, smanjen hemoglobin, smanjeni hematokrit.
English: Elderly
Croatian: IBRANCE
English: 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.
Croatian: Doza može biti smanjena na neku od raspoloživih jačina lijeka, tj. 100 mg ili 75 mg.
English: NAME OF THE MEDICINAL PRODUCT IBRANCE 100 mg hard capsules palbociclib
Croatian: IBRANCE 100 mg tvrde kapsule palbociklib
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 125 MG CAPSULES
Croatian: VANJSKA KUTIJA - KAPSULE 125 MG
English: Interstitial Lung Disease (narrow).
Croatian: Standardized MedDRA Query) upitom za intersticijsku bolest pluća (uži pojmovi).
English: Opaque, hard capsule, with a light orange body (printed “PBC 100” in white) and a caramel cap (printed “Pfizer” in white).
Croatian: Neprozirna, tvrda kapsula sa svijetlo narančastim tijelom (s otisnutim „PBC 100“ u bijeloj boji) te sa kapicom karamel boje (otisnuto „Pfizer“ u bijeloj boji).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 75 MG CAPSULES
Croatian: VANJSKA KUTIJA - KAPSULE 75 MG
English: Progression-Free Survival by Investigator Assessment Number of events (%) Median PFS [months (95% CI)]
Croatian: Broj događaja (%) Medijan [mjeseci] (95 % CI)
English: Ammonium hydroxide (28% solution)
Croatian: Titanijev dioksid (E171) Amonijev hidroksid (28%-tna otopina) Propilenglikol
English: NAME OF THE MEDICINAL PRODUCT IBRANCE 125 mg hard capsules palbociclib
Croatian: IBRANCE 125 mg tvrde kapsule palbociklib
English: Rashh Alopecia
Croatian: Alopecija
English: 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).
Croatian: Zabilježena je razlika od 6,9 mjeseci u medijanu OS-a između skupine liječene palbociklibom i fulvestrantom te skupine liječene placebom i fulvestrantom.
English: System Organ Class Frequency Preferred Terma
Croatian: Klasifikacija organskih sustava Učestalost
English: Note: Laboratory results are graded according to the NCI CTCAE version 4.0 severity grade.
Croatian: Napomena: laboratorijski rezultati stupnjevani su prema stupnjevima težine Zajedničkih terminoloških kriterija za nuspojave Nacionalnog instituta za rak (engl.
English: NAME OF THE MEDICINAL PRODUCT IBRANCE 75 mg hard capsules palbociclib
Croatian: IBRANCE 75 mg tvrde kapsule palbociklib
English: OR [%, (95% CI)] TTR, Median [months (range)]
Croatian: TTR, medijan [mjeseci (raspon)]
English: ALT increased
Croatian: Povišen ALT
English: Decreased appetite Nervous system disorders
Croatian: Poremećaji probavnog sustava Vrlo često
English: IBRANCE 100 mg hard capsules Each hard capsule contains 100 mg of palbociclib.
Croatian: Jedna tvrda kapsula sadrži 100 mg palbocikliba.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg palbociclib.
Croatian: Jedna kapsula sadrži 100 mg palbocikliba.
English: EU/1/16/1147/007 (63 hard capsules)
Croatian: EU/1/16/1147/001 (21 tvrda kapsula) EU/1/16/1147/007 (63 tvrde kapsule)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 125 mg palbociclib.
Croatian: Jedna kapsula sadrži 125 mg palbocikliba.
English: p=0.0429†*
Croatian: Omjer hazarda (95 % CI) i p-vrijednost p=0,0429
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 75 mg palbociclib.
Croatian: Jedna kapsula sadrži 75 mg palbocikliba.
English: It is used to treat adults and children (including newborn babies) who have:
Croatian: Koristi se za liječenje odraslih osoba i djece (uključujući novorođenčad) koji imaju:
English: Studies in adults
Croatian: Ispitivanja u odraslih
English: Studies in children
Croatian: Ispitivanja u djece
English: Further information on Zinforo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zinforo
Croatian: Više informacija o lijeku Zinforo dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/zinforo
English: What is Zinforo and what is it used for?
Croatian: Što je Zinforo i za što se koristi?
English: However, as there were uncertainties about the effects of Zinforo in patients with certain very severe infections these effects will be investigated in further studies.
Croatian: Međutim, budući da su postojale nesigurnosti u vezi s učincima lijeka Zinforo u bolesnika s određenim vrlo teškim infekcijama, ti će se učinci istražiti u dodatnim ispitivanjima.
English: This overview was last updated in 06-2019.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 6. 2019.
English: Zinforo received a marketing authorisation valid throughout the EU on 23 August 2012.
Croatian: Lijek Zinforo dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 23. kolovoza 2012.
English: Zinforo is an antibiotic.
Croatian: Zinforo je antibiotik.
English: Prescribers should consider official guidance on the appropriate use of antibiotics.
Croatian: Liječnici koji propisuju lijek trebaju uzeti u obzir službene smjernice za odgovarajuću uporabu antibiotika.
English: What measures are being taken to ensure the safe and effective use of Zinforo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zinforo?
English: Zinforo is given by infusion (drip) into a vein usually over 5 to 60 minutes.
Croatian: Zinforo se primjenjuje intravenskom infuzijom (ukapavanjem) obično u trajanju od 5 do 60 minuta.
English: • community-acquired pneumonia (an infection of the lungs that is caught outside of hospital).
Croatian: • izvanbolnički stečenu upalu pluća (infekcija pluća koja je stečena izvan bolnice).
English: Why is Zinforo authorised in the EU?
Croatian: Zašto je lijek Zinforo odobren u EU-u?
English: In children and adolescents weighing less than 33 kilograms, the dose depends on the patient's weight.
Croatian: U djece i adolescenata koji teže manje od 33 kg doza ovisi o tjelesnoj težini bolesnika.