FrancophonIA/ELRC3.0 huggingface dataset:
English: However, if patients require co-administration of a strong CYP3A inhibitor, a 25% cabazitaxel dose reduction should be considered (see sections 4.4 and 4.5).
Croatian: Međutim, ako je bolesnicima potrebna istodobna primjena snažnog inhibitora CYP3A, treba razmotriti smanjenje doze kabazitaksela za 25% (vidjeti dijelove 4.4 i 4.5).
English: Adverse reactions not observed in clinical studies, but seen in rats during repeat-dose toxicity studies at exposure levels higher than clinical exposure levels and with possible relevance to clinical use were eye disorders characterized by subcapsular lens fiber swelling/degeneration.
Croatian: Nuspojave koje nisu zabilježene u kliničkim ispitivanjima, ali su zapažene u štakora tijekom ispitivanja toksičnosti ponovljenih doza pri razinama izloženosti većima od kliničkih, te bi mogle biti značajne za kliničku primjenu, bili su poremećaji oka s oticanjem/degeneracijom subkapsularnog tkiva leće.
English: PRACTICAL INFORMATION FOR MEDICAL OR HEALTHCARE PROFESSIONALS ON PREPARATION, ADMINISTRATION AND HANDLING OF JEVTANA 60 mg CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: PRAKTIČNE INFORMACIJE ZA ZDRAVSTVENE RADNIKE O PRIPREMI, PRIMJENI I RUKOVANJU LIJEKOM JEVTANA 60 mg KONCENTRAT I OTAPALO ZA OTOPINU ZA INFUZIJU
English: Patients received a median duration of 6 cycles of cabazitaxel.
Croatian: Medijan trajanja liječenja kabazitakselom iznosio je 6 ciklusa.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hour at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primjeni odmah, vrijeme i uvjeti čuvanja lijeka u primjeni su odgovornost korisnika i obično ne bi smjeli biti dulji od 24 sata na 2°C - 8°C, osim ako razrjeđivanje nije provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: METHOD OF ADMINISTRATION Use the ENTIRE content for dilution (see package leaflet).
Croatian: Za razrjeđivanje upotrijebiti CJELOKUPAN sadržaj (vidjeti Uputu o lijeku).
English: Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at ambient temperature (including the 1-hour infusion time) and for 48 hours at refrigerated conditions (including the 1-hour infusion time).
Croatian: Dokazana kemijska i fizikalna stabilnost otopine za infuziju je 8 sati, uz čuvanje na temperaturi okoline (uključujući u to i 1-satnu infuziju) te 48 sati ako se čuva u hladnjaku (uključujući u to i 1
English: • feeling anxious
Croatian: • osjećaj tjeskobe
English: Bone marrow suppression manifested as neutropenia, anaemia, thrombocytopenia, or pancytopenia may occur (see “Risk of neutropenia” and “Anaemia” in section 4.4 below).
Croatian: Može doći do supresije koštane srži koja se očituje kao neutropenija, anemija, trombocitopenija ili pancitopenija (vidjeti „Rizik od neutropenije" i „Anemija“ u dijelu 4.4 ispod).
English: Cabazitaxel is active in docetaxel-sensitive tumours.
Croatian: Kabazitaksel je aktivan u tumorima osjetljivima na docetaksel.
English: Clinical neutropenia Urinary tract infection Peripheral sensory neuropathy
Croatian: Infekcija urinarnog trakta Periferna senzorna neuropatija Disgeuzija
English: Cabazitaxel should not be given to patients with severe hepatic impairment (total bilirubin >3 x ULN) (see sections 4.3, 4.4 and 5.2).
Croatian: Kabazitaksel se ne smije davati bolesnicima s teškim oštećenjem jetrene funkcije (ukupan bilirubin >3 x GGN) (vidjeti dijelove 4.3, 4.4 i 5.2).
English: The number of patients who completed the study treatment (10 cycles) was respectively 29.4% and 13.5% in the JEVTANA group and in the comparator group.
Croatian: Udio bolesnika u ispitivanju koji su završili liječenje (10 ciklusa) iznosio je 29,4% u skupini liječenoj lijekom JEVTANA te 13,5% u usporednoj skupini.
English: Serious allergic reactions can occur during treatment with JEVTANA.
Croatian: Tijekom liječenja lijekom JEVTANA mogu nastupiti ozbiljne alergijske reakcije.
English: Magyarország SANOFI-AVENTIS Zrt., Tel.: +36 1 505 0050
Croatian: SANOFI-AVENTIS Zrt., Tel.: +36 1 505 0050
English: 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion
Croatian: 5%-tna otopina glukoze ili otopina za infuziju natrijevog klorida 9 mg/ml (0,9%)
English: Grade ≥ 3 anaemia
Croatian: Anemija stupnja ≥ 3
English: Remove the syringe and needle and mix manually and gently by repeated inversions until obtaining a clear and homogeneous solution.
Croatian: Izvadite štrcaljku i iglu te blago ručno promiješajte otopinu, uzastopnim okretanjem bočice, dok ne dobijete bistru i homogenu otopinu.
English: Step 1: Initial dilution of the concentrate for solution for infusion with the supplied solvent.
Croatian: Korak 1: Početno razrjeđivanje koncentrata za otopinu za infuziju priloženim otapalom.
English: Once reconstituted, the resultant solution contains 10 mg/ml of cabazitaxel.
Croatian: Nakon rekonstitucije, konačna otopina sadrži 10 mg/ml kabazitaksela
English: Cystitis due to radiation recall phenomenon, including haemorrhagic cystitis, were reported uncommonly.
Croatian: Manje često su prijavljeni slučajevi cistitisa zbog fenomena odzivne radijacijske upalne reakcije (engl. radiation recall), uključujući i hemoragični cistitis.
English: Concentratesolvent mixture 10 mg/ml
Croatian: Mješavina koncentrata i otapala 10 mg/ml
English: Renal disorders, have been reported in association with sepsis, severe dehydration due to diarrhoea, vomiting and obstructive uropathy.
Croatian: Prijavljeni su slučajevi poremećaja bubrežne funkcije povezani sa sepsom, teškom dehidracijom zbog proljeva, povraćanjem i opstruktivnom uropatijom.
English: A time interval of 12 hours is recommended before the infusion and at least 3 hours after the end of infusion before administering the OATP1B1 substrates.
Croatian: Preporučuje se primijeniti supstrate OATP1B1 12 sati prije početka infuzije ili najmanje 3 sata nakon završetka infuzije.
English: Inject in a sterile PVC-free container of either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Ubrizgajte u sterilni spremnik bez PVC-a koji sadrži 5% -tnu otopinu glukoze ili otopinu za infuziju natrijevog klorida 9 mg/ml (0,9%).
English: It works by stopping cells from growing and multiplying.
Croatian: Djeluje tako da zaustavlja rast stanica i sprječava njihovo umnožavanje.
English: Grade>3 n (%)
Croatian: n (%)
English: Dose should be reduced for patients with mild (total bilirubin >1 to ≤1.5 x ULN or AST >1.5 x ULN), hepatic impairment (see sections 4.2 and 5.2).
Croatian: Dozu treba smanjiti kod bolesnika s blagim (ukupan bilirubin >1 do ≤1,5 x GGN ili AST >1,5 x GGN) oštećenjem jetrene funkcije (vidjeti dijelove 4.2 i 5.2).
English: Gastrointestinal hemorrhage and perforation, ileus and intestinal obstruction have also been reported (see section 4.4).
Croatian: Prijavljeni su i gastrointestinalno krvarenje i perforacija, ileus i opstrukcija crijeva (vidjeti dio 4.4).
English: Hypotension Deep vein thrombosis Hypertension Orthostatic hypotension Hot flush Flushing
Croatian: Krvožilni poremećaji hipotenzija duboka venska tromboza hipertenzija ortostatska hipotenzija valunzi crvenilo praćeno osjećajem vrućine
English: Neutropenic complications included neutropenic infections (0.5%), neutropenic sepsis (0.8%), and septic shock (1.1%), which in some cases resulted in a fatal outcome.
Croatian: (0,8%) i septički šok (1,1%), koji su u nekim slučajevima rezultirali smrtnim ishodom.
English: In patients with moderate hepatic impairment (total bilirubin >1.5 to ≤ 3.0 x ULN), the maximum tolerated dose (MTD) was 15 mg/m2.
Croatian: Kod bolesnika s umjerenim oštećenjem jetrene funkcije (ukupan bilirubin >1,5 do ≤ 3,0 x GGN), najviša podnošljiva doza bila je 15 mg/m2.
English: The most commonly (≥5%) occurring grade ≥3 adverse reactions in the cabazitaxel group were neutropenia (81.7%), leukopenia (68.2%), anaemia (10.5%), febrile neutropenia (7.5%), diarrhoea
Croatian: Najčešće nuspojave stupnja ≥ 3 u skupini koja je primala kabazitaksel bile su neutropenija (81,7%), leukopenija (68,2%), anemija (10,5%), febrilna neutropenija (7,5%) i proljev (6,2%).
English: The concentrate and solvent vials must be used immediately.
Croatian: Bočice s koncentratom i otapalom moraju se upotrijebiti odmah.
English: From a microbiological point of view, the infusion solution should be used immediately.
Croatian: S mikrobiološkog stajališta, otopina za infuziju mora se primijeniti odmah.
English: Each vial of 1.5 ml (nominal volume) of concentrate contains 60 mg cabazitaxel.
Croatian: Jedna bočica s 1,5 ml koncentrata (nominalni volumen) sadrži 60 mg kabazitaksela.
English: PVC infusion containers and polyurethane infusion sets should not be used.
Croatian: Ne smiju se koristiti PVC infuzijski spremnici niti poliuretanski infuzijski setovi.
English: In vitro cabazitaxel did not inhibit Multidrug-Resistant Proteins (MRP): MRP1 and MRP2 or Organic Cation Transporter (OCT1).
Croatian: Multidrug-Resistant Proteins, MRP) MRP1 i MRP2 niti prijenosnike organskih kationa (engl.
English: After initial dilution with the entire solvent, each ml of solution contains 10 mg cabazitaxel.
Croatian: Nakon početnog razrjeđenja s cjelokupnom količinom otapala, jedan ml otopine sadrži 10 mg kabazitaksela.
English: A statistically significantly higher percentage (p<0.001) of patients showed a PSA response in the 25 mg/m2 group (42.9%) compared to the 20 mg/m2 group (29.5%).
Croatian: (p<0,001) bolesnika u skupini s 25 mg/m2 (42,9%) pokazao je učinak na razinu PSA u usporedbi sa skupinom s 20 mg/m2 (29,5%).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4.5 ml (ethanol 96% and water for injections).
Croatian: 4,5 ml (96%-tni etanol i voda za injekcije).
English: Package leaflet: Information for the patient JEVTANA 60 mg concentrate and solvent for solution for infusion cabazitaxel
Croatian: Uputa o lijeku: Informacije za bolesnika JEVTANA 60 mg koncentrat i otapalo za otopinu za infuziju kabazitaksel
English: (vomiting).
Croatian: satnu infuziju).
English: Solution for IV infusion after final dilution (see package leaflet).
Croatian: Otopina za i.v. infuziju nakon konačnog razrjeđenja (vidjeti Uputu o lijeku).
English: Cabazitaxel should not be used during breast-feeding.
Croatian: . Kabazitaksel se ne smije koristiti tijekom dojenja.
English: • liver problems occur during the treatment.
Croatian: • ako tijekom liječenja razvijete probleme s jetrom.
English: Its common name is cabazitaxel.
Croatian: Uobičajeni naziv je kabazitaksel.
English: Step 2.1
Croatian: Korak 2.1
English: Note: Both the JEVTANA 60 mg/1.5 ml concentrate vial (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and the solvent vial (fill volume: 5.67 ml) contain an overfill to compensate for liquid loss during preparation.
Croatian: Napomena: Obje bočice, bočica s lijekom JEVTANA 60 mg/1,5 ml koncentrat (volumen punjenja: 73,2 mg kabazitaksela/1,83 ml) i bočica s otapalom (volumen punjenja: 5,67 ml) sadrže dodatnu količinu punjenja kako bi se nadoknadio gubitak tekućine tijekom pripreme.
English: Alopecia Dry skin Erythema
Croatian: Poremećaji kože i potkožnog tkiva alopecija suha koža eritem
English: Patients should be re-treated only when neutrophils recover to a level ≥1,500/mm3 (see section 4.3).
Croatian: Bolesnici se smiju ponovno liječiti tek kada se broj neutrofila vrati na razinu od ≥ 1500 stanica/mm3
English: Vaccination with a live attenuated vaccine should be avoided in patients receiving cabazitaxel.
Croatian: U bolesnika koji primaju kabazitaksel potrebno je izbjegavati cijepljenje živim atenuiranim cjepivom.
English: OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJA, AKO JE POTREBNO
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SOLVENT for JEVTANA
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
English: The maximum tolerated dose (MTD) of cabazitaxel was 20 and 15 mg/m2, respectively.
Croatian: Najviša podnošljiva doza kabazitaksela bila je 20, odnosno 15 mg/m2.
English: • you have feeling of numbness, tingling, burning or decreased sensation in your hands or feet.
Croatian: • ako osjećate utrnulost, trnce, pečenje ili imate oslabljen osjet u šakama ili stopalima.
English: Table 4 - Overall survival in EFC11785 study in cabazitaxel 25 mg/m2 arm versus cabazitaxel 20 mg/m2 arm (Intent-to-treat analysis) - Efficacy primary endpoint
Croatian: Ukupno preživljenje u EFC11785 ispitivanju u skupini s 25 mg/m2 kabazitaksela naspram skupine s 20 mg/m2 kabazitaksela (analiza podataka populacije predviđene za liječenje) - Primarna mjera ishoda djelotvornosti
English: This overfill ensures that after dilution with the entire content of the accompanying solvent for JEVTANA, there is a minimal extractable premix volume of 6 ml containing 10 mg/ml JEVTANA which corresponds to the labelled amount of 60 mg per vial.
Croatian: Ova dodatna količina osigurava da se nakon razrjeđivanja s cjelokupnom količinom priloženog otapala za lijek JEVTANA iz bočice može izvući minimalni volumen od 6 ml pripremljene otopine koja sadrži 10 mg/ml lijeka JEVTANA, što odgovara deklariranoj količini lijeka od 60 mg po bočici.
English: Concomitant medicinal products use
Croatian: Istodobna primjena drugih lijekova
English: Treatment delay or dose reduction may be necessary for grade ≥3 diarrhoea (see section 4.2).
Croatian: U slučaju proljeva stupnja ≥ 3 možda će biti nužno odgoditi terapiju ili smanjiti dozu (vidjeti dio 4.2).
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Cabazitaxel is extensively metabolised by the liver.
Croatian: Kabazitaksel se ekstenzivno metabolizira u jetri.
English: Primary prophylaxis with G-CSF should be considered in patients with high-risk clinical features (age >65 years, poor performance status, previous episodes of febrile neutropenia, extensive prior radiation ports, poor nutritional status, or other serious comorbidities) that predispose them to increased complications from prolonged neutropenia.
Croatian: prethodne epizode febrilne neutropenije, prethodno ekstenzivno zračenje, slaba ishranjenost ili drugi ozbiljni komorbiditeti) koje su predispozicija za povećane komplikacije uslijed produljene neutropenije.
English: A dedicated study in 43 cancer patients with hepatic impairment showed no influence of mild (total bilirubin >1 to ≤1.5 x ULN or AST >1.5 x ULN) or moderate (total bilirubin >1.5 to ≤3.0 x ULN) hepatic impairment on cabazitaxel pharmacokinetics.
Croatian: Posebna studija na 43 onkološka bolesnika s oštećenjem jetrene funkcije pokazala je da blago (ukupan bilirubin >1 do ≤ 1,5 x GGN ili AST >1,5 x GGN) ili umjereno (ukupan bilirubin >1,5 do ≤ 3 x GGN) oštećenje jetrene funkcije ne utječe na farmakokinetiku kabazitaksela.
English: Overall survival (OS) was the primary efficacy endpoint of the study.
Croatian: Primarni ishod djelotvornosti studije bilo je ukupno preživljenje (engl. overall survival, OS).
English: Delay treatment until improvement, then reduce cabazitaxel dose from 25 mg/m2 to 20 mg/m2.
Croatian: Odgoditi liječenje do poboljšanja, a zatim smanjiti dozu kabazitaksela s 25 mg/m2 na 20 mg/m2.
English: Preparation steps
Croatian: Koraci za pripremu lijeka
English: Table 5 - Summary of safety data for cabazitaxel 25 mg/m2 arm versus cabazitaxel 20 mg/m2 arm in EFC11785 study
Croatian: Tablica 5 - Sažetak sigurnosnih podataka u skupini s 25 mg/m2 kabazitaksela naspram skupine s 20 mg/m2 kabazitaksela u EFC11785 ispitivanju CBZ20+PRED n=580
English: • blood clot in the leg
Croatian: • krvni ugrušak u nozi
English: Patients treated with cabazitaxel may receive prophylactic G-CSF, as per American Society of Clinical Oncology (ASCO) guidelines and/or current institutional guidelines, to reduce the risk or manage neutropenia complications (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Croatian: Bolesnici koji se liječe kabazitakselom mogu profilaktički primiti G-CSF, sukladno smjernicama ASCO-a (American Society of Clinical Oncology) i/ili važećim smjernicama ustanove u kojoj se liječe,
English: • you have severe or long-lasting diarrhoea, you feel sick (nausea) or you are being sick (vomiting).
Croatian: • ako imate težak ili dugotrajan proljev, ako imate mučninu ili povraćate.
English: Neutropenia was the most common adverse reaction leading to medicinal product discontinuation
Croatian: Neutropenija je bila najčešća nuspojava koja je uzrokovala prekid primjene lijeka (2,4%).
English: This fill volume has been established during the development and the overfill ensures, after the addition of the entire content of the solvent vial to the content of JEVTANA 60 mg concentrate vial, a concentration of the premix solution of 10 mg/ml JEVTANA.
Croatian: Ovaj volumen punjenja utvrđen je tijekom razvoja lijeka i ta dodatna količina osigurava da se nakon dodavanja cjelokupnog sadržaja bočice s otapalom u sadržaj bočice s koncentratom lijeka JEVTANA 60 mg postigne koncentracija pripremljene otopine od 10 mg/ml lijeka JEVTANA.
English: The risk of interaction with OATP1B1 substrates (e.g. statins, valsartan, repaglinide) is possible, notably during the infusion duration (1 hour) and up to 20 minutes after the end of the infusion.
Croatian: (npr. statinima, valsartanom, repaglinidom), naročito za vrijeme trajanja infuzije (1 sat) i do 20 minuta nakon završetka infuzije.
English: There was a significant higher rate of tumour response of 14.4% (95%CI: 9.6-19.3) in patients in the JEVTANA arm compared to 4.4% (95%CI: 1.6-7.2) for patients in the mitoxantrone arm, p=0.0005.
Croatian: Zabilježena je značajno veća stopa tumorskog odgovora od 14,4% (95% CI: 9,6-19,3) u bolesnika liječenih lijekom JEVTANA u odnosu na 4,4% (95% CI: 1,6-7,2) u bolesnika u skupini koja je primala mitoksantron, p = 0,0005.
English: Using a syringe fitted with a needle, aseptically withdraw the entire contents of the supplied solvent by partially inverting the vial.
Croatian: Aseptički izvucite cjelokupan sadržaj priloženog otapala pomoću štrcaljke s iglom, djelomično okrećući bočicu naopako.
English: Do not use JEVTANA if:
Croatian: Nemojte primjenjivati lijek JEVTANA :
English: Pregnant staff should not handle it.
Croatian: Zdravstvene radnice koje su trudne ne smiju rukovati ovim lijekom.
English: After initial dilution of the concentrate with the solvent Chemical and physical in-use stability has been demonstrated for 1 hour at ambient temperature (15°C-30°C).
Croatian: Dokazana kemijska i fizikalna stabilnost lijeka u primjeni je 1 sat, uz čuvanje na temperaturi okoline (15°C - 30°C).
English: Cases of peripheral neuropathy, peripheral sensory neuropathy (e.g., paraesthesias, dysaesthesias) and peripheral motor neuropathy have been observed in patients receiving cabazitaxel.
Croatian: U bolesnika koji su primali kabazitaksel zabilježeni su slučajevi periferne neuropatije, periferne senzorne neuropatije (npr. paraestezije, dizestezije) i periferne motoričke neuropatije.
English: The concentrate vial (fill: 73.2 mg of cabazitaxel/1.83 ml) and the solvent vial (5.67 ml) contain an overfill to compensate for liquid loss during preparation.
Croatian: 73,2 mg kabazitaksela/1,83 ml) i bočica s otapalom (volumen punjenja: 5,67 ml) sadrže dodatnu količinu punjenja kako bi se nadoknadio gubitak tekućine tijekom pripreme.
English: 1 ml concentrate contains 40 mg cabazitaxel.
Croatian: 1 ml koncentrata sadrži 40 mg kabazitaksela.
English: This is common (may affect up to 1 in 10 people).
Croatian: To je česta nuspojava (može se javiti u najviše 1 na 10 osoba).
English: Haematological abnormalitiesc (%)
Croatian: Hematološka odstupanjac (%)
English: There was an improvement in PFS in the JEVTANA arm compared to mitoxantrone arm, 2.8 (2.4-3.0) months versus 1.4 (1.4-1.7) respectively, HR (95%CI) 0.74 (0.64-0.86), p<0.0001.
Croatian: U skupini koja je primala lijek JEVTANA je u odnosu na skupinu koja je primala mitoksantron zabilježeno poboljšanje u preživljenju bez progresije bolesti (PFS) i to 2,8 (2,4-3,0) mjeseci u odnosu na 1,4 (1,4-1,7) mjeseca, HR (95% CI): 0,74 (0,64-0,86), p < 0,0001.
English: Reproductive system and breast disorders
Croatian: Poremećaji reproduktivnog sustava i dojki bol u zdjelici
English: This includes medicines obtained without a prescription.
Croatian: Lijek se izdaje na recept.
English: Grade ≥ 3 adverse reactionsb (%)
Croatian: Nuspojave stupnja ≥ 3b (%) Klinička neutropenija
English: Patients with a hypersensitivity reaction must stop treatment with JEVTANA (see section 4.3).
Croatian: Bolesnici u kojih su se razvile teške reakcije preosjetljivosti ne smiju više primati terapiju lijekom JEVTANA (vidjeti dio 4.3).
English: Patients with mild hepatic impairment (total bilirubin >1 to ≤1.5 x Upper Limit of Normal (ULN) or AST >1.5 x ULN), should have cabazitaxel dose reduced to 20 mg/m2.
Croatian: Kod bolesnika s blagim oštećenjem jetrene funkcije (ukupan bilirubin >1 do ≤1,5 x iznad gornje granice normalnih vrijednosti (GGN) ili AST > 1,5 x GGN), potrebno je smanjiti dozu kabazitaksela na 20 mg/m2.
English: If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Croatian: Ako lijek dođe u dodir sa sluznicom, mjesto treba odmah temeljito isprati vodom.
English: • stomach upsets including feeling sick (nausea), being sick (vomiting), diarrhoea or constipation
Croatian: • nelagoda u trbuhu uključujući mučninu, povraćanje, proljev ili zatvor
English: • feeling of numbness, tingling, burning or decreased sensations in hands and feet
Croatian: • utrnulost, trnci, pečenje ili smanjen osjet u šakama ili stopalima
English: There was a median PSA progression of 6.4 months (95%CI: 5.1-7.3) for patients in JEVTANA arm, compared to 3.1 months (95%CI: 2.2-4.4) in the mitoxantrone arm, HR 0.75 months (95%CI: 0.63-0.90), p=0.0010.
Croatian: Medijan progresije PSA iznosio je 6,4 mjeseci (95% CI: 5,1-7,3) u bolesnika u skupini liječenoj lijekom JEVTANA u usporedbi s 3,1 mjesecom (95% CI: 2,2-4,4) u skupini koja je primala mitoksantron, HR: 0,75 mjeseci (95% CI: 0,63-0,90), p = 0,0010.
English: One single useclear glass vial, closed with a grey chlorobutyl rubber closure sealed by an aluminium cap with a light green plastic flip-off cover, containing 1.5 ml (nominal volume) concentrate.
Croatian: (klorobutil guma) i aluminijskim prstenom sa svijetlozelenim plastičnim "flip-off" poklopcem, koja sadrži 1,5 ml koncentrata (nominalni volumen).
English: The MTD of cabazitaxel in patients with severe hepatic impairment was not established.
Croatian: Najveća podnošljiva doza kabazitaksela u bolesnika s teškim oštećenjem jetrene funkcije nije ustanovljena.
English: • Solvent: 4.5 ml of solvent in a 15 ml clear glass vial (type I) closed with a grey chlorobutyl rubber closure sealed by a gold colour aluminium cap covered with a colourless plastic flip-off cap. Each vial contains 4.5 ml nominal volume (fill volume: 5.67 ml).
Croatian: • otapalo: 4,5 ml otapala u prozirnoj staklenoj bočici od 15 ml (staklo tip I), zatvorenoj sivim gumenim zatvaračem (klorobutil guma), aluminijskim prstenom zlatne boje i bezbojnim plastičnim "flip-off" poklopcem.
English: In vitro studies have shown that cabazitaxel is mainly metabolised through CYP3A (80% to 90%) (see section 5.2).
Croatian: Ispitivanja in vitro pokazala su da se kabazitaksel većinom metabolizira pomoću CYP3A (80% do
English: Adequate hydration should be ensured throughout treatment with cabazitaxel.
Croatian: Tijekom cjelokupnog liječenja kabazitakselom potrebno je osigurati primjerenu hidraciju.
English: The dose of cabazitaxel should be reduced from 25 mg/m2 to 20 mg/m2 for persistent grade >2 peripheral neuropathy (see section 4.2).
Croatian: U slučaju perzistentne periferne neuropatije stupnja ≥ 2 dozu kabazitaksela potrebno je smanjiti s 25 mg/m2 na 20 mg/m2 (vidjeti dio 4.2).