FrancophonIA/ELRC3.0 huggingface dataset:
English: Stability of the reconstituted suspension in the infusion bag Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C followed by 4 hours at 25°C, protected from light.
Slovenian: Stabilnost rekonstituirane suspenzije v infuzijski vrečki Kemična in fizikalna stabilnost po rekonstituciji sta dokazani za 24 ur pri 2 °C - 8 °C, in še 4 ure pri 25 °C, zaščiteno pred svetlobo.
English: For febrile neutropenia, withhold Abraxane and gemcitabine until fever resolves and ANC ≥ 1500 cells/mm3, then resume treatment at reduced dose levels (see section 4.2).
Slovenian: Pri febrilni nevtropeniji prekinite zdravljenje z zdravilom Abraxane in gemcitabinom, dokler vročina ne izzveni in ni ANC ≥ 1.500 celic/mm3, nato nadaljujte zdravljenje z zmanjšano ravnijo odmerkov (glejte poglavje 4.2).
English: Arthralgia occurred in 32% of patients on Abraxane and was severe in 6% of cases.
Slovenian: Artralgija se je pojavila pri 32 % bolnikov, ki so prejemali zdravilo Abraxane, od tega je bilo 6 % hudih primerov.
English: For patients with normal baseline CA 19-9 levels the survival HR was 1.07 (95% CI 0.692, 1.661).
Slovenian: Pri bolnikih z normalno izhodiščno ravnijo CA 19-9 je bilo razmerje tveganja za preživetje 1,07 (95 % IZ 0,692;
English: For combination use of Abraxane and carboplatin, if Grade 3 or higher peripheral neuropathy develops, treatment should be withheld until improvement to Grade 0 or 1 followed by a dose reduction for all subsequent courses of Abraxane and carboplatin (see section 4.2).
Slovenian: Če se pri kombiniranem zdravljenju z zdravilom Abraxane in karboplatinom razvije periferna nevropatija 3. ali višje stopnje, je treba zdravljenje prekiniti do izboljšanja na 0. ali 1. stopnjo, nato pa zmanjšajte odmerek za vse naslednje cikle zdravila Abraxane in karboplatina (glejte poglavje 4.2).
English: Table 10: Results for overall response rate, median time to disease progression, and progression-free survival as assessed by the investigator Efficacy variable
Slovenian: Preglednica 10: Rezultati stopenj celokupnega odziva, mediane časa do napredovanja bolezni in preživetja brez napredovanja bolezni, kot jih je ocenil raziskovalec Spremenljivka učinkovitosti zdravilo Abraxane (260 mg/m2)
English: Abbreviations: ANC=Absolute Neutrophil Count; WBC=white blood cell
Slovenian: Kratica: ANC = absolutno število nevtrofilcev (ANC=Absolute Neutrophil Count)
English: The recommended dose of Abraxane is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks.
Slovenian: Priporočeni odmerek zdravila Abraxane je 260 mg/m2, ki se daje intravensko 30 minut na vsake 3 tedne.
English: If foaming or clumping occurs, the solution must stand for at least 15 minutes until foam subsides.
Slovenian: Če se pojavi pena ali skupki, naj raztopina stoji vsaj 15 minut, dokler se pena ne posede.
English: Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Slovenian: Zdravilo Abraxane je v kombinaciji s karboplatinom indicirano kot zdravilo prvega izbora za zdravljenje nedrobnoceličnega pljučnega raka pri odraslih bolnikih, ki niso primerni za operativno zdravljenje in/ali zdravljenje z obsevanjem.
English: Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Abraxane.
Slovenian: Moški bolniki naj se posvetujejo o shranitvi semenske tekočine pred začetkom zdravljenja zaradi možne ireverzibilne neplodnosti kot posledice zdravljenja z zdravilom Abraxane.
English: The use of medical devices containing silicone oil as a lubricant (i.e. syringes and IV bags) to reconstitute and administer Abraxane may result in the formation of proteinaceous strands.
Slovenian: brizge in infuzijske vrečke) za rekonstituiranje in dajanje zdravila Abraxane, lahko povzroči nastajanje beljakovinskih vlaken.
English: Abraxane was administered to patients (N = 431) as an intravenous infusion over 30-40 minutes at a dose of 125 mg/m2 followed by gemcitabine as an intravenous infusion over 30-40 minutes at a dose of 1000 mg/m2 given on Days 1, 8 and 15 of each 28-day cycle.
Slovenian: Zdravilo Abraxane so dajali bolnikom (N = 431) v obliki intravenske infuzije v času 30-40 minut v odmerku 125 mg/m2, nato je sledil gemcitabin v obliki intravenske infuzije v času 30-40 minut v odmerku 1.000 mg/m2, ki so ga bolniki prejemali 1., 8. in 15. dan vsakega 28-dnevnega cikla.
English: The following are the most common and important incidences of adverse reactions related to 421 patients with metastatic adenocarcinoma of the pancreas who were treated with 125 mg/m2 Abraxane in combination with gemcitabine at a dose of 1000 mg/m2 given on Days 1, 8 and 15 of each 28-day cycle in the phase III clinical study.
Slovenian: V nadaljevanju so navedena najpogostejša in najpomembnejša pojavljanja neželenih učinkov pri 421 bolnikih z metastatskim adenokarcinomom trebušne slinavke, zdravljenih s 125 mg/m2 zdravila Abraxane v kombinaciji z gemcitabinom v odmerku 1.000 mg/m2 1., 8. in 15. dan vsakega 28dnevnega cikla v klinični študiji faze III.
English: Women of childbearing potential should have a pregnancy test prior to starting treatment with Abraxane.
Slovenian: Ženske v rodni dobi morajo pred začetkom zdravljenja z zdravilom Abraxane opraviti test nosečnosti.
English: For combination use of Abraxane and gemcitabine, if Grade 3 or higher peripheral neuropathy develops, withhold Abraxane; continue treatment with gemcitabine at the same dose.
Slovenian: Če se razvije periferna nevropatija 3. ali višje stopnje, ko se zdravilo Abraxane uporablja v kombinaciji z gemcitabinom, prekinite zdravljenje z zdravilom Abraxane; zdravljenje nadaljujte z enakimi odmerki gemcitabina.
English: The second trial utilised a dose of 300 mg/m2 as a 30 minute infusion in 63
Slovenian: Pri drugi raziskavi so uporabili odmerek 300 mg/m2 kot 30
English: Very common: Alopecia, rash
Slovenian: Zelo pogosti: alopecija, izpuščaj
English: • Stuffy nose
Slovenian: • zamašen nos
English: Peripheral Neuropathy: Grade 3 or 4
Slovenian: Periferna nevropatija: 3. ali 4. stopnje
English: Non-small cell lung cancer (Abraxane administered in combination with carboplatin)
Slovenian: Nedrobnocelični pljučni rak (zdravilo Abraxane uporabljeno v kombinaciji s karboplatinom)
English: Cutaneous Toxicity: Grade 2 or 3
Slovenian: Toksičnost za kožo: 2. ali 3. stopnje
English: Breast cancer (Abraxane administered as monotherapy)
Slovenian: Rak dojk (zdravilo Abraxane uporabljeno kot monoterapija)
English: Discontinue treatment
Slovenian: Ukinite zdravljenje
English: No patients treated with Abraxane and carboplatin experienced Grade 4 peripheral neuropathy.
Slovenian: Noben bolnik, zdravljen z zdravilom Abraxane in karboplatinom, ni imel periferne nevropatije 4. stopnje.
English: It may harm them, even if their signs of illness are the same as yours.
Slovenian: 16,1 [15,0; 18,3] (n = 135)
English: Reconstituted Abraxane suspension is administered intravenously using an infusion set incorporating a 15 µm filter.
Slovenian: Rekonstituirano suspenzijo zdravila Abraxane dajajte intravensko z infuzijskim sistemom, ki vključuje 15 µm filter.
English: When reconstituted, each ml of Abraxane concentrate contains 0.183 mmol sodium, which is 4.2 mg of sodium.
Slovenian: Po rekonstituciji 1 ml koncentrata zdravila Abraxane vsebuje 0,183 mmola natrija, kar ustreza 4,2 mg natrija.
English: Abraxane contains sodium
Slovenian: Zdravilo Abraxane vsebuje natrij
English: Very common: Dyspnoea
Slovenian: Zelo pogosti: dispneja
English: No patients treated with Abraxane in combination with gemcitabine had Grade 4 peripheral neuropathy.
Slovenian: Noben bolnik, zdravljen z zdravilom Abraxane v kombinaciji z gemcitabinom, ni imel periferne nevropatije 4. stopnje.
English: Overall Survival Number of deaths (%) Median Overall Survival, months (95% CI) HRA+G/G (95% CI)a P-valueb
Slovenian: Celokupno preživetje Število smrti (%) Mediana celokupnega preživetja, meseci (95 % IZ) HRA+G/G (95 % IZ)a p-vrednostb
English: • Difficulty walking, swelling
Slovenian: • težave s hojo, otekanje
English: The use of specialized di(2-ethylhexyl)phthalate (DEHP)-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions.
Slovenian: Ni nujno, da pri pripravi ali dajanju infuzij zdravila Abraxane uporabljate specializirane vsebnike ali komplete za dajanje zdravila brez di(2-etilheksil)ftalata (DEHP).
English: The total combined storage time of reconstituted medicinal product in the vial and in the infusion bag when refrigerated and protected from light is 24 hours.
Slovenian: V primeru shranjevanja v hladilniku in zaščiteno pred svetlobo je skupni čas shranjevanja rekonstituiranega zdravila v viali in infuzijski vrečki 24 ur.
English: NAME OF THE MEDICINAL PRODUCT Abraxane 5 mg/ml powder for suspension for infusion paclitaxel
Slovenian: IME ZDRAVILA Abraxane 5 mg/ml prašek za suspenzijo za infundiranje
English: Table 9 lists adverse reactions associated with the administration of Abraxane in combination with carboplatin.
Slovenian: V preglednici 9 so navedeni neželeni učinki, povezani z uporabo zdravila Abraxane v kombinaciji s karboplatinom.
English: Abraxane should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Slovenian: Abraxane sme pripraviti in dajati le osebje, ki je ustrezno usposobljeno za rokovanje s citotoksičnimi zdravili.
English: Of the 514 patients with non-small cell lung cancer in the randomized study who received Abraxane in combination with carboplatin, 31% were 65 years or older and 3.5% were 75 years or older.
Slovenian: Od 514 bolnikov z nedrobnoceličnim pljučnim rakom v randomizirani študiji, ki so prejemali zdravilo Abraxane v kombinaciji s karboplatinom, jih je bilo 31 % starih 65 let in več, 3,5 % pa jih je bilo starih 75 let in več.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C in the original carton, protected from light.
Slovenian: Kemična in fizikalna stabilnost po rekonstituciji sta dokazani za 24 ur pri 2 °C - 8 °C, v originalni ovojnini, zaščiteno pred svetlobo.
English: Table 7 lists adverse reactions assessed in patients with pancreatic adenocarcinoma treated with Abraxane in combination with gemcitabine.
Slovenian: V preglednici 7 so navedeni neželeni učinki, ugotovljeni pri bolnikih z adenokarcinomom trebušne slinavke, zdravljenih z zdravilom Abraxane v kombinaciji z gemcitabinom.
English: Myalgia occurred in 24% of patients on Abraxane and was severe in 7% of cases.
Slovenian: Mialgija se je pojavila pri 24 % bolnikov, ki so prejemali zdravilo Abraxane, od tega je bilo 7 % hudih primerov.
English: Abraxane is available in glass vials containing 100 mg or 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Slovenian: Zdravilo Abraxane je na voljo v steklenih vialah, ki vsebujejo 100 mg ali 250 mg paklitaksela, vezanega na albuminske nanodelce.
English: Pharmacokinetic data are not available for patients with total bilirubin >5 x ULN or for patients with metastatic adenocarcinoma of the pancreas (see section 4.2).
Slovenian: Za bolnike s celokupnim bilirubinom > 5 x ULN in za bolnike z metastatskim adenokarcinomom trebušne slinavke farmakokinetični podatki niso na voljo (glejte poglavje 4.2).
English: Non-small cell lung cancer:
Slovenian: Nedrobnocelični pljučni rak:
English: No toxicities occurred notably more frequently among patients at least 65 years of age who received Abraxane.
Slovenian: Pri bolnikih, ki so bili stari vsaj 65 let in so prejemali zdravilo Abraxane, niso opazili pogostejše toksičnosti.
English: Uncommon: Oral candidiasis, nasopharyngitis, cellulitis, herpes simplex, viral infection, pneumonia, catheter-related infection, fungal infection, herpes zoster, injection site infection, sepsis2, neutropenic sepsis2
Slovenian: Občasni: oralna kandidoza, nazofaringitis, celulitis, herpes simpleks, virusna okužba, pljučnica, okužbe, povezane s katetrom, glivične okužbe, pasavec, okužba na mestu vboda, sepsa2, nevtropenična sepsa2
English: Common: Dehydration, decreased appetite, hypokalaemia Uncommon: Hypophosphataemia, fluid retention, hypoalbuminaemia, polydipsia, hyperglycaemia, hypocalcaemia, hypoglycaemia, hyponatraemia
Slovenian: Pogosti: dehidracija, zmanjšan apetit, hipokaliemija Občasni: hipofosfatemija, zadrževanje tekočine, hipoalbuminemija, polidipsija, hiperglikemija, hipokalciemija, hipoglikemija, hiponatriemija
English: Frequent monitoring of blood cell counts should be performed during Abraxane therapy.
Slovenian: Med zdravljenjem z zdravilom Abraxane je treba pogosto preverjati število krvnih celic.
English: Abraxane should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Slovenian: Zdravilo Abraxane se sme uporabljati samo pod nadzorom ustrezno usposobljenega onkologa v enotah, specializiranih za uporabo citotoksičnih snovi.
English: Abraxane should not be administered on Day 1 of a cycle until absolute neutrophil count (ANC) is ≥1500 cells/mm3 and platelet count is ≥100,000 cells/mm3.
Slovenian: Zdravila Abraxane ni dovoljeno dati 1. dan cikla, če ni absolutno število nevtrofilcev (ANC) ≥1.500 celic/mm3 in število trombocitov ≥100.000 celic/mm3.
English: Sepsis was reported at a rate of 5% in patients with or without neutropenia who received Abraxane in combination with gemcitabine.
Slovenian: O sepsi so poročali pri 5 % bolnikov z nevtropenijo ali brez nje, ki so prejemali zdravilo Abraxane skupaj z gemcitabinom.
English: Sepsis was reported at a rate of 5% in patients with or without neutropenia who received Abraxane in combination with gemcitabine during the conduct of a trial in pancreatic adenocarcinoma.
Slovenian: O sepsi so poročali pri 5 % bolnikov z nevtropenijo ali brez nje, ki so prejemali zdravilo Abraxane v kombinaciji z gemcitabinom med preskušanjem pri adenokarcinomu trebušne slinavke.
English: pA+G/pG (95% CI)
Slovenian: HRA+G/G (95 % IZ)a p-vrednostb
English: Women of childbearing potential should use effective contraception during treatment and up to 1 month after receiving treatment with Abraxane.
Slovenian: Ženske v rodni dobi morajo uporabljati zanesljivo kontracepcijo med zdravljenjem z zdravilom Abraxane in do en mesec po zdravljenju.
English: Of the 421 patients with pancreatic adenocarcinoma in the randomized study who received Abraxane in combination with gemcitabine, 41% were 65 years and older and 10% were 75 years and older.
Slovenian: Od 421 bolnikov z adenokarcinomom trebušne slinavke v randomizirani študiji, ki so prejemali zdravilo Abraxane v kombinaciji z gemcitabinom, jih je bilo 41 % starih 65 let in več, 10 % pa 75 let in več.
English: Common: Decreased weight, increased alanine aminotransferase, increased aspartate aminotransferase, decreased haematocrit, decreased red blood cell count, increased body temperature, increased gamma-glutamyltransferase, increased blood alkaline phosphatase
Slovenian: Pogosti: zmanjšana telesna masa, zvišana alanin-aminotransferaza, zvišana aspartat-aminotransferaza, znižana vrednost hematokrita, manjše število rdečih krvnih celic, zvišana telesna temperatura, zvišana gamaglutamiltransferaza, zvišana alkalna fosfataza v krvi
English: The pharmacokinetics of total paclitaxel following 30- and 180-minute infusions of Abraxane at dose levels of 80 to 375 mg/m2 were determined in clinical studies.
Slovenian: V kliničnih študijah je bila določena farmakokinetika celokupnega paklitaksela po 30- in 180-minutni infuziji zdravila Abraxane pri odmerkih od 80 do 375 mg/m2.
English: Peripheral neuropathy (mostly Grade 1 or 2 sensory neuropathy) was observed in 68% of patients on Abraxane with 10% being Grade 3, and no cases of Grade 4.
Slovenian: Periferno nevropatijo (večinoma senzorično nevropatijo 1. ali 2. stopnje) so opazili pri 68 % bolnikov, ki so prejemali zdravilo Abraxane.
English: In some patients previously exposed to capecitabine, reports of palmar-plantar erythrodysaesthesiae have been reported as part of the continuing surveillance of Abraxane.
Slovenian: V okviru nadaljnjega spremljanja zdravila Abraxane so pri nekaterih bolnikih, ki so predhodno prejemali kapecitabin, poročali o palmarno-plantarni eritrodisesteziji.
English: Table 6: Adverse reactions reported with Abraxane monotherapy at any dose in clinical studies Infections and infestations
Slovenian: Preglednica 6: Neželeni dogodki, o katerih so poročali pri monoterapiji z zdravilom Abraxane v katerem koli odmerku v kliničnih študijah
English: Abraxane should not be administered until neutrophil counts recover to >1500 cells/mm3.
Slovenian: Zdravila Abraxane ni dovoljeno dajati, dokler število nevtrofilcev ne doseže vrednosti > 1.500 celic/mm3.
English: Abraxane (100 mg/m2/week) + carboplatin (N=521)
Slovenian: Zdravilo Abraxane (100 mg/m2/teden) + karboplatin (N=521)
English: Abraxane should be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Slovenian: Zdravilo Abraxane se jemlje pod nadzorom ustrezno usposobljenega onkologa v enoti, ki je specializirana za uporabo citotoksičnih snovi.
English: 100 ml vial (type 1 glass) with a stopper (butyl rubber), with an overseal (aluminium), containing 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Slovenian: Viala 100 ml (steklo tipa 1) z zamaškom (butilna guma), z zaporko (aluminij), ki vsebuje 250 mg paklitaksela, vezanega na albuminske nanodelce.
English: Pancreatic adenocarcinoma (Abraxane administered in combination with gemcitabine)
Slovenian: Adenokarcinom trebušne slinavke (zdravilo Abraxane uporabljeno skupaj z gemcitabinom)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/428/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/428/001
English: At the clinical dose range of 80 to 300 mg/m2, the mean plasma clearance of paclitaxel ranges from 13 to 30 L/h/m2, and the mean terminal half-life ranges from 13 to 27 hours.
Slovenian: V mejah kliničnih odmerkov od 80 do 300 mg/m2 je povprečni plazemski očistek paklitaksela med 13
English: Women of childbearing age should use effective contraception during and up to 1 month after receiving treatment with Abraxane.
Slovenian: Ženske v rodni dobi morajo uporabljati zanesljivo kontracepcijo med zdravljenjem z zdravilom Abraxane in do 1 mesec po njem.
English: Gastrointestinal Toxicity: Grade 3 mucositis or diarrhoea
Slovenian: Toksičnost za prebavila: mukozitis 3. stopnje ali driska
English: Uncommon: Polyneuropathy, areflexia, dyskinesia, hyporeflexia, neuralgia, sensory loss, syncope, postural dizziness, neuropathic pain, tremor
Slovenian: Občasni: polinevropatija, arefleksija, diskinezija, hiporefleksija, nevralgija, senzorična izguba, sinkopa, posturalna omotičnost, nevropatska bolečina, tremor
English: The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions.
Slovenian: Ni nujno, da pri pripravi ali dajanju infuzij zdravila Abraxane uporabljate specializirane vsebnike ali komplete za dajanje zdravila brez DEHP.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 100 mg paklitaksela, vezanega na albuminske nanodelce.
English: The recommended dose of Abraxane is 100 mg/m2 administered as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of each 21-day cycle.
Slovenian: Priporočeni odmerek zdravila Abraxane je 100 mg/m2, ki se daje kot intravenska infuzija v času 30 minut 1., 8. in 15. dan vsakega 21-dnevnega cikla.
English: toxic epidermal necrolysis)
Slovenian: Nehematološka toksičnost
English: Common: Insomnia, depression, anxiety Uncommon: Restlessness
Slovenian: Pogosti: nespečnost, depresivnost, anksioznost Občasni: nemirnost
English: Beginning immediately after the end of Abraxane administration, carboplatin at a dose of AUC = 6 mg•min/mL was administered intravenously on Day 1 only of each 21-day cycle.
Slovenian: Takoj po končanem dajanju zdravila Abraxane so bolnikom samo 1. dan vsakega 21-dnevnega cikla dali karboplatin intravensko v odmerku AUC = 6 mg•min/ml.
English: Day 15: IF Day 8 doses were withheld: Day 15 ≥ 1000
Slovenian: 15. dan: Če bolnik ni prejel odmerkov 8. dne: 15. dan ≥ 1.000
English: • Fingernail pain, fingernail discomfort, loss of fingernails, hives, skin pain, red skin from sunlight,
Slovenian: • bolečine nohtov, neugoden občutek nohtov, izguba nohtov, kožna bolečina, pordela koža zaradi sončne svetlobe, razbarvanje kože, povečano znojenje, nočno znojenje, bela območja na koži,
English: Table 7: Adverse reactions reported with Abraxane in combination with gemcitabine (N =421) Infections and infestations
Slovenian: Preglednica 7: Neželeni učinki, o katerih so poročali pri zdravilu Abraxane v kombinaciji z gemcitabinom (N =421)
English: Unopened vials: Keep the vial in the outer carton in order to protect from light.
Slovenian: Neodprte viale: Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Solvent-based paclitaxel (200 mg/m2 every 3 weeks) + carboplatin (N=531)
Slovenian: Paklitaksel na bazi topila (200 mg/m2 vsake 3 tedne) + karboplatin (N=531)
English: After reconstitution, each ml of suspension contains 5 mg of paclitaxel formulated as albumin bound nanoparticles.
Slovenian: Po rekonstituciji vsebuje 1 ml suspenzije 5 mg paklitaksela, vezanega na albuminske nanodelce.
English: Cycle Day
Slovenian: Dan cikla
English: Common: Infection, urinary tract infection, folliculitis, upper respiratory tract infection, candidiasis, sinusitis
Slovenian: Pogosti: okužbe, okužbe sečil, folikulitis, okužbe zgornjih dihal, kandidoza, sinusitis
English: Patients should not be retreated with subsequent cycles of Abraxane until neutrophils recover to >1500 cells/mm3 and platelets recover to >100,000 cells/mm3 (see section
Slovenian: Nadaljnjih ciklov zdravila Abraxane ne smete začeti, dokler se nevtrofilci ne vrnejo na vrednost > 1.500 celic/mm3, trombociti pa na vrednost > 100.000 celic/mm3 (glejte poglavje 4.2).
English: Day 15: If Day 8 doses were given without modification: Day 15 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Slovenian: 15. dan: Če so bili odmerki 8. dne dani brez sprememb: 15. dan ≥ 500 ali
English: There was a significant difference in overall response rate in the Abraxane/carboplatin arm compared to the control arm in patients with non-small cell lung cancer of squamous histology (N=450, 41% vs. 24%, p<0.001), however this difference did not translate into a difference in PFS or OS.
Slovenian: V skupini z zdravilom Abraxane/karboplatinom se je stopnja celokupnega odziva značilno razlikovala od kontrolne skupine pri bolnikih z nedrobnoceličnim pljučnim rakom s ploščatocelično histologijo (N=450, 41 % proti 24 %, p<0,001), vendar se ta razlika ni prenesla v razliko v PFS ali OS. Razlike v ORR med zdravljenima skupinama pri bolnikih z neploščatocelično histologijo ni bilo (N=602, 26 % proti 25 %, p=0,808).
English: Very common: Neutropenia, anaemia, leukopenia, thrombocytopenia, lymphopenia, bone marrow suppression Common: Febrile neutropenia
Slovenian: Zelo pogosti: nevtropenija, anemija, levkopenija, trombocitopenija, limfopenija, supresija kostnega mozga Pogosti: febrilna nevtropenija
English: Common: Nail disorder, pruritus, dry skin, erythema, nail pigmentation/discolouration, skin hyperpigmentation, onycholysis, nail changes
Slovenian: Pogosti: motnje nohtov, srbenje, suha koža, eritem, obarvanje/razbarvanje nohtov, hiperpigmentacija kože, oniholiza, spremembe nohtov
English: The other ingredient is human albumin (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).
Slovenian: Pomožna snov je humani albumin (ki vsebuje natrij, natrijev kaprilat in N-acetil DL triptofanat).