FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking this medicine • Swallow the tablet whole with water.
Croatian: • Progutajte cijelu tabletu s vodom.
English: derived from postmarketing experience see section 4.4
Croatian: a podatak iz iskustva nakon stavljanja lijeka u promet b vidjeti dio 4.4
English: Iron oxide black (E172) Iron oxide red (E172)
Croatian: talk željezov oksid, crni (E172) željezov oksid, crveni (E172)
English: Cationic substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Croatian: Kationske tvari koje se izlučuju putem bubrežne tubularne sekrecije (npr. cimetidin) mogu stupiti u interakciju s metforminom tako da se natječu za zajedničke bubrežne tubularne prijenosne sustave.
English: Difference from placebo (97.5% CI)
Croatian: Razlika od placeba (97,5 % CI)
English: Glycaemic efficacy and cardivascular outcomes have been assessed in a total of 10,366 patients with type 2 diabetes who were treated in 9 double-blind, placebo or active-controlled clinical studies of at least 24 weeks duration, of which 2950 patients received empagliflozin 10 mg and 3701 received empagliflozin 25 mg as add-on to metformin therapy.
Croatian: Glikemijska djelotvornost i kardiovaskularni ishodi bili su ocijenjeni u ukupno 10 366 bolesnika sa šećernom bolešću tipa 2 u 9 dvostruko slijepih, placebom ili aktivno kontroliranih kliničkih ispitivanja u minimalnom trajanju od 24 tjedna, od kojih je 2950 bolesnika primilo empagliflozin 10 mg, a njih 3701 empagliflozin 25 mg kao dodatak terapiji metforminom.
English: Table 8 Efficacy results at 18 and 78 weeks in a placebo-controlled study of empagliflozin as add on to basal insulin with metformin
Croatian: Rezultati djelotvornosti u 18. i 78. tjednu u placebom kontroliranom ispitivanju empagliflozina kao dodatka bazalnom inzulinu s metforminom
English: Table 10 Efficacy results at 12 week in a placebo-controlled study of empagliflozin in patients with type 2 diabetes and uncontrolled blood pressure Placebo empagliflozin
Croatian: Rezultati djelotvornosti u 12. tjednu placebom kontroliranog ispitivanja empagliflozina u bolesnika sa šećernom bolešću tipa 2 i nekontroliranim krvnim tlakom
English: Table 4: Efficacy results at 24 week comparing empagliflozin in combination with metformin to the individual components
Croatian: Tablica 4: Rezultati djelotvornosti u 24. tjednu za empagliflozin u kombinaciji s metforminom u usporedbi s pojedinačnim komponentama Empagliflozin 10 mg
English: The steady state mean plasma AUC and Cmax were 1870 nmol.h and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h and 687 nmol/l with empagliflozin 25 mg once daily.
Croatian: Srednje vrijednosti plazmatskog AUC i Cmax u stanju dinamičke ravnoteže iznosile su 1870 nmol.h i 259 nmol/l uz empagliflozin 10 mg te 4740 nmol.h i 687 nmol/l uz empagliflozin 25 mg primijenjenim jedanput dnevno.
English: respectively, were total cholesterol 5.0% and 5.2% versus 3.7%; HDL-cholesterol 4.6% and 2.7% versus -0.5%; LDL-cholesterol 9.1% and 8.7% versus 7.8%; triglycerides 5.4% and 10.8% versus
Croatian: Srednje vrijednosti postotnih povećanja od početne vrijednosti za empagliflozin 10 mg odnosno 25 mg naspram placeba bile su: ukupni kolesterol 5,0 % i 5,2 % naspram 3,7 %; HDL-kolesterol 4,6 % i 2,7 % naspram -0,5 %; LDL-kolesterol 9,1 % i 8,7 % naspram 7,8 %; trigliceridi 5,4 % i 10,8 % naspram 12,1 %.
English: Table 2 Adverse reactions reported in placebo-controlled studies System organ class
Croatian: Nuspojave prijavljene u placebom kontroliranim ispitivanjima
English: Whereas
Croatian: Ako
English: • a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034,
Croatian: • značajno smanjenje apsolutnog rizika od bilo koje komplikacije povezane s šećernom bolešću u skupini liječenoj metforminom (29,8 događaja/1 000 bolesnik-godina) naspram samo režima prehrane (43,3 događaja/1 000 bolesnik-godina), p= 0,0023 te naspram skupina liječenih kombinacijom sa sulfonilurejom i inzulinom u monoterapiji (40,1 događaja/1 000 bolesnikgodina), p= 0,0034,
English: - Film coating: hypromellose, macrogol 400, titanium dioxide (E171), talc.
Croatian: Film ovojnica hipromeloza makrogol 400 titanijev dioksid (E171)
English: Table 7: Efficacy results at 18 and 52 weeks in a placebo-controlled study of empagliflozin as add-on to multiple daily doses of insulin with concomitant metformin therapy
Croatian: Rezultati djelotvornosti u 18. i 52. tjednu u placebom kontroliranom ispitivanju empagliflozina kao dodatka višekratnim dnevnim dozama inzulina uz istodobnu terapiju metforminom.
English: See subsections below for additional information Identified adverse reactions of empagliflozin monotherapy Identified adverse reactions of metformin monotherapy Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia) Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Croatian: Za dodatne informacije vidjeti niže navedene odjeljke Identificirane nuspojave monoterapije empagliflozinom Identificirane nuspojave monoterapije metforminom Dugotrajno liječenje metforminom bilo je povezano sa smanjenom apsorpcijom vitamina B12 što vrlo rijetko može rezultirati klinički značajnom deficijencijom vitamina B12 (npr. megaloblastična anemija).
English: Time to first event of CV death, non-fatal MI, or non-fatal stroke) N (%) Hazard ratio vs. placebo (95.02% CI) p−value for superiority CV Death N (%) Hazard ratio vs. placebo (95% CI) p-value Non-fatal MI N (%) Hazard ratio vs. placebo (95% CI) p−value Non-fatal stroke N (%) Hazard ratio vs. placebo (95% CI) p−value All-cause mortality N (%) Hazard ratio vs. placebo (95% CI) p-value Non-CV mortality N (%) Hazard ratio vs. placebo (95% CI) CV = cardiovascular, MI = myocardial infarction Treated set (TS), i.e. patients who had received at least one dose of study drug Pooled doses of empagliflozin 10 mg and 25 mg Since data from the trial were included in an interim analysis, a two-sided 95.02% confidence interval applied which corresponds to a p-value of less than 0.0498 for significance.
Croatian: Omjer hazarda naspram placeba (95 % CI) p−vrijednost Moždani udar bez smrtnog ishoda N (%) Omjer hazarda naspram placeba (95 % CI) p−vrijednost Mortalitet svih uzroka N (%) Omjer hazarda naspram placeba (95 % CI) p-vrijednost Nekardiovaskularni mortalitet N (%) Omjer hazarda naspram placeba (95 % CI) Liječeni set ispitanika, tj. bolesnici koji su primili najmanje jednu dozu ispitivanog lijeka.
English: • redness of the skin (erythema) or an itchy rash (hives)
Croatian: • crvenilo kože (eritem) ili osip koji svrbi (koprivnjača)
English: Erythema Urticaria
Croatian: Prijavljivanje nuspojava
English: Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post marketing in patients treated with SGLT2 inhibitors, including empagliflozin.
Croatian: Tijekom kliničkih ispitivanja i nakon stavljanja lijeka u promet, u bolesnika liječenih SGLT2 inhibitorima, uključujući empagliflozin, prijavljeni su rijetki slučajevi dijabetičke ketoacidoze (DKA), uključujući i slučajeve opasne po život.
English: Synjardy 5 mg/850 mg film-coated tablets are yellowish white, oval, biconvex.
Croatian: Synjardy 5 mg/850 mg filmom obložene tablete su žućkasto bijele, ovalne, bikonveksne.
English: However, temporary interruption of treatment should be considered in patients with complicated urinary tract infections.
Croatian: Međutim, u bolesnika s kompliciranim infekcijama mokraćnog sustava potrebno je razmotriti privremeni prekid liječenja.
English: EU/1/15/1003/025 EU/1/15/1003/026 EU/1/15/1003/027
Croatian: EU/1/15/1003/014 EU/1/15/1003/038 EU/1/15/1003/015 EU/1/15/1003/016 EU/1/15/1003/017 EU/1/15/1003/018
English: Of these, a total of 794 patients received empagliflozin as add-on to metformin plus insulin, of which 266 patients were treated with empagliflozin 10 mg and 264 with empagliflozin 25 mg.
Croatian: Od toga je 266 ili 264 bolesnika bilo liječeno empagliflozinom 10 mg ili 25 mg kao dodatkom metforminu plus inzulin.
English: HbA1c (%) at week 52 Baseline (mean) Change from baseline
Croatian: HbA1c (%) u 52. tjednu
English: HbA1c (%) at week 78 Baseline (mean) Change from baseline Difference from placebo
Croatian: HbA1c (%) u 78. tjednu
English: b, 3
Croatian: Tablica 3:
English: HbA1c (%) Baseline (mean) Change from baseline
Croatian: HbA1c (%) Početna vrijednost (srednja vrijednost)
English: Mean percent increases from baseline for empagliflozin 10 mg and 25 mg versus placebo,
Croatian: Doze empagliflozina 10 mg i 25 mg, združeno.
English: After first reconstitution the suspension should be used immediately.
Croatian: Nakon prve rekonstitucije, potrebno je odmah upotrijebiti suspenziju.
English: Post-marketing experience
Croatian: Postmarketinško iskustvo
English: Injury, poisoning and procedural complications
Croatian: Ozljeda, trovanje i proceduralne komplikacije
English: If this happens to you, do not drive or use any tools or machines.
Croatian: Ako se to dogodi Vama, nemojte voziti ni rukovati alatima ili strojevima.
English: (PT at Risk)
Croatian: (bolesnici pod rizikom)
English: The reconstituted suspension should be milky and homogenous without visible precipitates.
Croatian: Rekonstituirana suspenzija treba biti mliječne boje i homogena, bez vidljivih taloga.
English: Like all medicines, this medicine can cause side effects, although not everyone gets them.
Croatian: Kao i svi drugi lijekovi, ovaj lijek može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
English: Reconstituted suspension
Croatian: Rekonstituirana suspenzija:
English: Day 1 < 1500
Croatian: 1. dan < 1500
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).
Croatian: Učestalost nuspojava definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000).
English: Patients were treated without steroid pre-treatment or planned G-CSF support.
Croatian: Bolesnici su liječeni bez premedikacije steroidima ili planiranom potpornom primjenom G-CSF-a.
English: 1 The frequency of hypersensitivity reactions is calculated based on one definitely related case in a population of 789 patients.
Croatian: 1 Učestalost reakcija preosjetljivosti izračunata je na temelju jednog jasno povezanog slučaja u populaciji od 789 bolesnika.
English: Lactation (see section 4.6).
Croatian: Laktacija (vidjeti dio 4.6).
English: OR < 100,000
Croatian: ILI < 100000
English: OR < 50,000
Croatian: ILI < 50 000
English: nevirapine)
Croatian: nevirapin)
English: This is because Abraxane can affect the way some other medicines work.
Croatian: Tako je zbog toga što Abraxane može utjecati na način djelovanja nekih drugih lijekova.
English: However, from a microbiological point of view, unless the method of reconstituting and filling of the infusion bags precludes the risks of microbial contamination, the product should be used immediately after reconstitution and filling of the infusion bags.
Croatian: Međutim, s mikrobiološkog stajališta, osim ako metoda rekonstitucije ili punjenja vrećica za infuziju isključuje rizik od mikrobiološke kontaminacije, lijek se mora primijeniti odmah nakon rekonstitucije i punjenja vrećica za infuziju.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet podnosit će ažurirane verzije periodičkih izvješća o neškodljivosti za ovaj lijek u skladu s referentnim popisom datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenom na europskom internetskom portalu za lijekove.
English: • if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of Abraxane (listed in section 6);
Croatian: • ako ste alergični (preosjetljivi) na paklitaksel ili neki drugi sastojak lijeka Abraxane (naveden u dijelu 6);
English: The median relative dose intensity of Abraxane was 81%.
Croatian: Medijan relativnog intenziteta doze za Abraxane bio je 81%.
English: • Ear pain, ringing in your ears
Croatian: • bol u uhu, zvonjava u ušima
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja pripremljenog lijeka odgovornost su korisnika.
English: The safety and efficacy of Abraxane in children and adolescents aged 0-17 years has not been established.
Croatian: Sigurnost i djelotvornost lijeka Abraxane u djece i adolescenata u dobi od 0 do 17 godina nisu još ustanovljene.
English: Limiting the infusion of Abraxane to 30 minutes, as directed, reduces the likelihood of infusion-related reactions.
Croatian: Ograničavanje trajanja infuzije lijeka Abraxane na 30 minuta, kao što je preporučeno, smanjuje vjerojatnost reakcija povezanih s infuzijom.
English: Sensory neuropathy occurs frequently with Abraxane, although development of severe symptoms is less common.
Croatian: Senzorna neuropatija često nastaje uz Abraxane, iako je razvoj teških simptoma manje čest.
English: Date of first authorisation: 11 January 2008 Date of latest renewal: 14 January 2013
Croatian: Datum posljednje obnove odobrenja: 14. siječnja 2013.
English: The carcinogenic potential of paclitaxel has not been studied.
Croatian: Kancerogeni potencijal paklitaksela nije ispitivan.
English: What you need to know before you are given Abraxane
Croatian: Što morate znati prije nego počnete primjenjivati Abraxane
English: Your doctor or pharmacist is responsible for disposing of any unused Abraxane correctly.
Croatian: Vaš liječnik ili ljekarnik odgovoran je za pravilno zbrinjavanje neupotrijebljenog lijeka Abraxane.
English: Other medicines and Abraxane
Croatian: Drugi lijekovi i Abraxane
English: Based on population pharmacokinetic analysis, the total volume of distribution is approximately 1741 L; the large volume of distribution indicates extensive extravascular distribution and/or tissue binding of paclitaxel.
Croatian: Na temelju analize populacijske farmakokinetike, ukupni volumen distribucije iznosi približno 1741 L; taj veliki volumen distribucije upućuje na opsežnu ekstravaskularnu distribuciju i/ili vezanje paklitaksela u tkivima.
English: Each drug was administered on Day 1 of each 21-day cycle.
Croatian: Svaki lijek davan je 1. dana svakog 21-dnevnog ciklusa.
English: • Breast cancer which has spread to other parts of the body (this is called “metastatic” breast cancer).
Croatian: • Rak dojke koji se proširio na druge dijelove tijela (to se naziva metastatski rak dojke).
English: UNIQUE IDENTIFIER - 2D BARCODE 2 D bar code carrying the unique identifier
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
English: Also, some other medicines can affect the way Abraxane works.
Croatian: Osim toga, drugi lijekovi mogu utjecati na način na koji djeluje Abraxane.
English: Then, the vial should gently and slowly be swirled and/or inverted for at least 2 minutes until complete resuspension of any powder occurs.
Croatian: Potom bočicu treba nježno i polako okretati i/ili prevrtati najmanje 2 minute sve do potpune resuspenzije praška.
English: How often will you receive Abraxane?
Croatian: Kako ćete često primati Abraxane?
English: *This data is based on Clinical Study Report: CA012-0 Addendum dated Final (23 March-2005) a Chi-squared test b Log-rank test
Croatian: *Ovi se podaci temelje na Izvješću kliničkog ispitivanja: CA012-0, konačna dopuna datirana 23. ožujka 2005. a Hi-kvadrat test b Log-rang test
English: 2 As reported in the post-marketing surveillance of Abraxane.
Croatian: 2 Kako je zabilježeno u postmarketinškom praćenju lijeka Abraxane.
English: Gloves, goggles and protective clothing should be used.
Croatian: Treba upotrebljavati rukavice, zaštitne naočale i zaštitnu odjeću.
English: Powder for suspension for infusion.
Croatian: Prašak za suspenziju za infuziju.
English: Following the analysis of case reports of scleroderma, published in literature during the reporting period, describing the temporal relationship with administration of the drug or reduction of the dose, a causal association for nab-paclitaxel is considered likely.
Croatian: Nakon analize prijave slučajeva skleroderme, objavljene u literaturi tijekom izvještajnog razdoblja, u kojem se opisuje vremenska povezanost s primjenom lijeka ili smanjenjem doze, uzročna povezanost za nab-paklitaksel smatra se vjerojatnom.
English: Very common: Anorexia
Croatian: Vrlo često: anoreksija
English: Abraxane may cause adverse reactions such as tiredness (very common) and dizziness (common) that may affect the ability to drive and use machinery.
Croatian: Abraxane može uzrokovati nuspojave kao što su umor (vrlo često) i omaglica (često) koji mogu utjecati na sposobnost vožnje i rada na strojevima.
English: Sur vi val
Croatian: Su rvi val
English: Talk to your doctor or nurse if you experience any of these conditions whilst being treated with Abraxane, your doctor may wish to stop treatment or reduce the dose:
Croatian: Obratite se liječniku ili medicinskoj sestri ako tijekom liječenja lijekom Abraxane opazite bilo koje od ovih stanja; liječnik će možda htjeti prekinuti liječenje ili smanjiti dozu:
English: Anaemia (Hb < 10 g/dl) was observed in 46% of patients on Abraxane, and was severe (Hb < 8 g/dl) in three cases.
Croatian: Anemija (Hb < 10 g/dl) je opažena u 46% bolesnika koji su primali Abraxane i bila je teška (Hb < 8 g/dl) u tri slučaja.
English: Do not breast feed when taking Abraxane as it is not known if the active ingredient paclitaxel passes into the mother's milk.
Croatian: Nemojte dojiti za vrijeme primjene lijeka Abraxane jer nije poznato prelazi li djelatna tvar paklitaksel u majčino mlijeko.
English: Alopecia was observed in >80% of the patients treated with Abraxane.
Croatian: Alopecija je opažena u > 80% bolesnika liječenih lijekom Abraxane.
English: ABRAXANE+Gemcitabine Gemcitabine
Croatian: ABRAXANE+gemcitabin gemcitabin
English: Some settling of the reconstituted suspension may occur.
Croatian: Moguća je pojava laganog taloženja rekonstituirane suspenzije.
English: This may be followed by storage in the infusion bag for 4 hours below 25°C.
Croatian: Nakon toga moguće je čuvanje u vrećici za infuziju u trajanju od 4 sata ispod 25°C.
English: The reconstituted suspension has a pH of 6-7.5 and an osmolality of 300-360 mOsm/kg.
Croatian: Rekonstituirana suspenzija ima pH od 6-7,5 te osmolalnost od 300-360 mOsm/kg.
English: The effectiveness and safety of Abraxane in patients with central nervous system (CNS) metastases has not been established.
Croatian: Učinkovitost i sigurnost lijeka Abraxane u bolesnika s metastazama u središnjem živčanom sustavu (SŽS) još nisu ustanovljene.
English: The natural course of peripheral neuropathy to resolution to baseline due to cumulative toxicity of Abraxane after > 6 courses of treatment was not evaluated and remains unknown.
Croatian: Prirodni tijek izlječenja periferne neuropatije u odnosu na početno stanje zbog kumulativne toksičnosti lijeka Abraxane nakon > 6 ciklusa liječenja nije procijenjen i ostaje nepoznat.
English: If precipitates or settling are visible, the vial should be gently inverted again to ensure complete resuspension prior to use.
Croatian: Ako su nakupine ili talozi vidljivi, bočicu treba ponovno nježno preokrenuti da bi se osigurala potpuna resuspenzija prije primjene.
English: Complications due to the underlying pancreatic cancer, especially biliary obstruction or presence of biliary stent, were identified as significant contributing factors.
Croatian: Komplikacije zbog osnovnog karcinoma pankreasa, osobito bilijarne opstrukcije ili prisutnosti bilijarnog stenta ustanovljene su kao značajan dodatni čimbenik.
English: • Increased bilirubin in the blood
Croatian: • povišeni bilirubin u krvi
English: The reduced dose may be escalated to the dose for patients with normal hepatic function if the patient is tolerating the treatment for at least two cycles (see sections 4.4 and 5.2).
Croatian: Smanjena doza može se povećati do doze za bolesnike s normalnom jetrenom funkcijom ako se u najmanje dva ciklusa pokaže da bolesnik podnosi liječenje (vidjeti dijelove 4.4 i 5.2).
English: There is limited experience of Abraxane/carboplatin use in patients 75 years or older.
Croatian: Ograničeno je iskustvo s primjenom Abraxanea/karboplatina u bolesnika u dobi od 75 ili više godina.
English: Following intravenous administration of radiolabelled paclitaxel to rats on days 9 to 10 postpartum, concentrations of radioactivity in milk were higher than in plasma and declined in parallel with the plasma concentrations.
Croatian: Nakon intravenske primjene radioaktivno označenog paklitaksela ženkama štakora između 9. i 10. postpartalnog dana koncentracije radioaktivnosti u mlijeku bile su više nego u plazmi i smanjivale su se usporedno s koncentracijama u plazmi.
English: Take care and speak to your doctor when taking Abraxane at the same time as any of the following:
Croatian: Budite oprezni i posavjetujte se s liječnikom kada primjenjujete Abraxane istodobno s nekim od sljedećih lijekova:
English: The response rates in all patients were 39.5% (95% CI: 24.9%-54.2%) and 47.6% (95% CI: 35.3%-60.0%), respectively.
Croatian: Stope odgovora u svih bolesnika iznosile su 39,5% (95% CI: 24,9%-54,2%) i 47,6% (95% CI: 35,3%-60,0%).
English: Reconstitution of 250 mg:
Croatian: Rekonstitucija 250 mg:
English: No toxicities occurred notably more frequently among patients at least 65 years of age who received Abraxane.
Croatian: Nije opažen znatno učestaliji razvoj toksičnosti među bolesnicima u dobi od najmanje 65 godina koji su primali Abraxane.
English: Of the patients with treatment interrupted due to peripheral neuropathy, 44% (31/70 patients) were able to resume Abraxane at a reduced dose.
Croatian: Od bolesnika kojima je liječenje prekinuto zbog periferne neuropatije, 44% (31/70 bolesnika) moglo je nastaviti liječenje Abraxaneom pri smanjenoj dozi.
English: The primary efficacy endpoint was overall response rate defined as the percentage of patients who achieved an objective confirmed complete response or partial response based on an independent, central, blinded radiological review using RECIST (Version 1.0).
Croatian: Primarni ishod djelotvornosti bila je ukupna stopa odgovora definirana kao postotak bolesnika koji su postigli objektivno potvrđen potpuni odgovor ili djelomični odgovor prema neovisnoj, centralnoj, maskiranoj radiološkoj procjeni na temelju smjernica RECIST (verzija 1.0).
English: Animal studies with Abraxane showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.
Croatian: Ispitivanja lijeka Abraxane na životinjama pokazala su nepovratne, toksične učinke na muške reproduktivne organe pri klinički značajnim razinama izloženosti.
English: • Effect on peripheral nerves (pain, numbness, tingling or loss of feeling)
Croatian: • učinak na periferne živce (bol, utrnulost, trnci ili gubitak osjeta)
English: Pharmacokinetic/pharmacodynamic modeling indicates that there is no correlation between hepatic function (as indicated by the baseline albumin or total bilirubin level) and neutropenia after adjusting for Abraxane exposure.
Croatian: Farmakokinetičko/farmakodinamičko modeliranje pokazuje da ne postoji korelacija između jetrene funkcije (kako pokazuje početna razina albumina ili ukupnog bilirubina) i neutropenije nakon podešavanja za izloženost lijeku Abraxane.