FrancophonIA/ELRC3.0 huggingface dataset:
English: If Pazenir contacts mucous membranes, the membranes should be flushed thoroughly with water.
Croatian: Ako Pazenir dođe u dodir sa sluznicama, potrebno ih je temeljito isprati vodom.
English: Patient-reported taxane toxicity was assessed using the 4 subscales of the Functional Assessment of Cancer Therapy (FACT)-Taxane questionnaire.
Croatian: Toksičnost povezana s taksanom prema samoprocjeni bolesnika dobivena je na temelju 4 podljestvice upitnika za funkcionalnu procjenu terapije raka taksanom (engl.
English: Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Croatian: Nositelj odobrenja za stavljanje lijeka u promet ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm
English: For patients treated with human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine, the median time to first occurrence of Grade 3 peripheral neuropathy was 140 days.
Croatian: Za bolesnike liječene paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma u kombinaciji s gemcitabinom medijan vremena do prve pojave periferne neuropatije 3. stupnja iznosio je 140 dana.
English: Pazenir should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Croatian: Pazenir se smije primjenjivati samo pod nadzorom kvalificiranog onkologa na odjelima koji su specijalizirani za primjenu citotoksičnih lijekova.
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: To treba uzeti u obzir kod bolesnika na dijeti s ograničenim unosom natrija.
English: Pregnant staff should not handle Pazenir.
Croatian: Trudne zdravstvene radnice ne smiju rukovati lijekom Pazenir.
English: The paclitaxel exposure (AUC) increased linearly from 2653 to 16736 ng.hr/ml following dosing from 80 to 300 mg/m2.
Croatian: 2653 na 16 736 ng.h/ml nakon primjenjivanih doza od 80 do 300 mg/m2.
English: Human serum albumin-paclitaxel nanoparticles were administered to patients (N=521) as an intravenous infusion over 30 minutes at a dose of 100 mg/m2 on Days 1, 8 and 15 of each 21-day cycle without any steroid premedication and without granulocyte colony stimulating factor prophylaxis.
Croatian: Paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma bio je primijenjen bolesnicima (N = 521) kao intravenska infuzija tijekom 30 minuta u dozi od 100 mg/m2 davanoj 1., 8. i 15. dana svakog 21-dnevnog ciklusa bez premedikacije sterodima i bez profilaktičke primjene G-CSF-a.
English: When reconstituted, Pazenir concentrate contains 4.2 mg of sodium per ml.
Croatian: Nakon rekonstitucije koncentrat lijeka Pazenir sadrži 4,2 mg natrija po ml.
English: For patients with mild hepatic impairment (total bilirubin > 1 to ≤ 1.5 x ULN and aspartate aminotransferase [AST] ≤ 10 x ULN), no dose adjustments are required, regardless of indication.
Croatian: Bolesnici s oštećenjem jetrene funkcije U bolesnika s blagim oštećenjem jetrene funkcije (ukupni bilirubin od > 1 do ≤ 1,5 x GGN i aspartat aminotransferaza [AST] ≤ 10 x GGN), prilagodbe doze nisu potrebne bez obzira na indikaciju.
English: There is limited experience of human serum albumin-paclitaxel nanoparticles/carboplatin use in patients 75 years or older.
Croatian: Ograničeno je iskustvo s primjenom paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma s karboplatinom u bolesnika u dobi od 75 ili više godina.
English: The protein binding of paclitaxel following human serum albumin-paclitaxel nanoparticles was evaluated by ultrafiltration in a within-patient comparison study.
Croatian: Vezanje paklitaksela na proteine nakon primjene paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma procijenjeno je postupkom ultrafiltracije u ispitivanju s usporedbom nalaza istog bolesnika.
English: Pazenir should not be administered until neutrophil counts recover to >1500 cells/mm3.
Croatian: Pazenir se ne smije primjenjivati sve dok broj neutrofila ne poraste na > 1500 stanica/mm3.
English: The usual dose for advanced pancreatic cancer is 125 mg/m2 of body surface area given over a 30 minute period.
Croatian: Uobičajena doza za uznapredovali rak gušterače iznosi 125 mg/m2 tjelesne površine i daje se tijekom 30 minuta.
English: • Pain at site of tumour, death of the tumour
Croatian: • nastanak modrica • bol na mjestu tumora, odumiranje tumora
English: Arthralgia occurred in 32% of patients on human serum albumin-paclitaxel nanoparticles and was severe in 6% of cases.
Croatian: Artralgija se javila u 32% bolesnika koji su primali paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma i bila je teška u 6% slučajeva.
English: • Nausea, diarrhoea, constipation, sore mouth, loss of appetite
Croatian: • mučnina, proljev, zatvor, ranice u ustima, gubitak apetita
English: Very common: Decreased appetite Common: Dehydration
Croatian: Vrlo često: smanjeni apetit Često: dehidracija
English: Pazenir is available in glass vials containing 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Croatian: Pazenir je dostupan u staklenim bočicama koje sadrže 100 mg paklitaksela u obliku nanočestica vezanih na albumin.
English: Non-small cell lung cancer The recommended dose of Pazenir is 100 mg/m2 administered as an intravenous infusion over
Croatian: Rak pluća nemalih stanica Preporučena doza lijeka Pazenir je 100 mg/m2 primijenjena kao intravenska infuzija tijekom 30 minuta
English: a
Croatian: I
English: • Gas, stomach cramps, painful or sore gums, rectal bleeding
Croatian: • plinovi, grčevi u želucu, bolne ili ranjene desni, krvarenje iz rektuma
English: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Pazenir over a minimum of 1 minute.
Croatian: Uporabom sterilne štrcaljke, 20 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za infuziju treba polako injicirati u bočicu s lijekom Pazenir tijekom najmanje 1 minute.
English: • Paclitaxel is the part of the medicine that affects the cancer, it works by stopping cancer cells from dividing - this means that they die.
Croatian: Djeluje tako da zaustavlja dijeljenje stanica raka - to znači da one umiru.
English: • Infection, fever with decrease in the number of a type of white blood cell (neutrophils) in the blood, flushing, thrush, severe infection in your blood which may be caused by reduced white blood cells
Croatian: • svrbež, suha koža, poremećaji noktiju • infekcija, vrućica s padom broja jedne vrste bijelih krvnih stanica (neutrofila) u krvi, navale crvenila, afte, teške infekcije krvi koje mogu biti uzrokovane smanjenim brojem bijelih krvnih stanica
English: Therefore, in the absence of a PK drug-drug interaction study, caution should be exercised when administering paclitaxel concomitantly with medicinal products known to inhibit either CYP2C8 or CYP3A4 (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.
Croatian: potreban je oprez prilikom primjene paklitaksela istodobno s lijekovima za koje je utvrđeno da inhibiraju bilo CYP2C8 ili CYP3A4 (primjerice, ketokonazol i drugi imidazolni antifungici, eritromicin, fluoksetin, gemfibrozil, klopidogrel, cimetidin, ritonavir, sakvinavir, indinavir i nelfinavir)
English: Grade 2 or 3 cutaneous toxicity Grade 3 diarrhoea Grade 3 mucositis ≥ Grade 3 peripheral neuropathy Any other Grade 3 or 4 non- haematologic toxicity
Croatian: Kožna toksičnost 2. ili 3. stupnja Proljev 3. stupnja Mukozitis 3. stupnja Periferna neuropatija ≥ 3. stupnja
English: Reconstituted dispersion For storage conditions after reconstitution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon rekonstitucije lijeka vidjeti u dijelu 6.3.
English: 56.4 [45.1, 76.9] (n = 131)
Croatian: *Preživljenje [95% CI] (tjedni) > 1. linije terapije 56,4 [45,1; 76,9] (n = 131) 46,7 [39,0; 55,3] (n = 136)
English: Common: Tachycardia, arrhythmia, supraventricular tachycardia Rare: bradycardia, cardiac arrest, left ventricular dysfunction, congestive heart failure, atrioventricular block2
Croatian: Rijetko: bradikardija, srčani arest, disfunkcija lijeve klijetke, kongestivno zatajenje srca, atrioventrikularni blok2
English: Table 12: Overall response rate in randomized non-small cell lung cancer trial (intentto-treat population)
Croatian: Tablica 12: Ukupna stopa odgovora u randomiziranom kliničkom ispitivanju bolesnika s rakom pluća nemalih stanica (populacija s namjerom liječenja)
English: The following are the most common and clinically relevant adverse reactions related to 229 patients with metastatic breast cancer who were treated with 260 mg/m2 human serum albumin-paclitaxel nanoparticlesonce every three weeks in the pivotal phase III clinical study.
Croatian: Slijede najčešće i klinički značajne nuspojave zabilježene u 229 bolesnika s metastatskim rakom dojke koji su bili liječeni s 260 mg/m2 paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma svaka tri tjedna u fazi III ključnog kliničkog ispitivanja.
English: HRA+G/G (95%Cl)
Croatian: HRA+G/G(95% Cl)a P-vrijednostb
English: For Grade 3 sensory neuropathy, withhold treatment until resolution to Grade 1 or 2, followed by a dose reduction for all subsequent courses.
Croatian: Kod senzorne neuropatije 3. stupnja potrebno je obustaviti liječenje do oporavka na stupanj 1 ili 2, nakon čega slijedi smanjivanje doze za sve naredne cikluse liječenja.
English: The active substance is paclitaxel.
Croatian: Djelatna tvar je paklitaksel.
English: • Effect on peripheral nerves (pain, numbness, tingling or loss of feeling)
Croatian: • smanjenje broja krvnih pločica (trombocita) u krvi • učinak na periferne živce (bol, utrnulost, trnci ili gubitak osjeta)
English: In one study, human serum albumin-paclitaxel nanoparticles were administered as a 30-minute infusion at a dose of 175 mg/m2 to 43 patients with metastatic breast cancer.
Croatian: U jednom ispitivanju paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma primijenjen je kao 30-minutna infuzija u dozi od 175 mg/m2 u 43 bolesnika s metastatskim rakom dojke.
English: Uncommon: Metastatic pain, tumour necrosis
Croatian: Manje često: metastatska bol, nekroza tumora
English: The frequencies of adverse reactions associated with the administration of human serum albuminpaclitaxel nanoparticles are listed in Table 6 (human serum albumin-paclitaxel nanoparticles as monotherapy) and Table 7 (human serum albumin-paclitaxel in combination with gemcitabine), and Table 9 (human serum albumin-paclitaxel nanoparticles in combination with carboplatin).
Croatian: Učestalosti nuspojava povezanih s primjenom paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma navedene su u tablici 6 (paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma kao monoterapija), u tablici 7 (paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma u kombinaciji s gemcitarabinom) i u tablici 9 (paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma u kombinaciji s karboplatinom).
English: Sepsis was reported at a rate of 5% in patients with or without neutropenia who received human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine during the conduct of a trial in pancreatic adenocarcinoma.
Croatian: Sepsa u stopi od 5% zabilježena je u bolesnika s neutropenijom ili bez nje koji su primali paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma u kombinaciji s gemcitabinom u ispitivanju adenokarcinoma pankreasa.
English: Pazenir 5 mg/ml powder for dispersion for infusion paclitaxel
Croatian: Pazenir 5 mg/ml prašak za disperziju za infuziju paklitaksel
English: Pneumonitis occurred in 1% of patients when human serum albumin-paclitaxel nanoparticles was used as monotherapy and in 4% of patients when Pazenir was used in combination with gemcitabine.
Croatian: Pneumonitis se razvio u 1% bolesnika kada je paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma primjenjivan kao monoterapija, i u 4% bolesnika kada se Pazenir primjenjivao u kombinaciji s gemcitabinom.
English: • Increased weight, increased lactate dehydrogenase in the blood, decreased kidney function, increased blood sugar, increased phosphorus in the blood
Croatian: • povećana tjelesna težina, povišena razina laktatdehidrogenaze u krvi, smanjena funkcija bubrega, povišeni šećer u krvi, povišena razina fosfora u krvi
English: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 100 mg vial of Pazenir over a minimum of 1 minute.
Croatian: Uporabom sterilne štrcaljke, 20 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za infuziju treba polako injicirati u bočicu sa 100 mg lijeka Pazenir tijekom najmanje 1 minute.
English: Of the 514 patients with non-small cell lung cancer in the randomized study who received human serum albumin-paclitaxel nanoparticles in combination with carboplatin, 31% were 65 years or older and 3.5% were 75 years or older.
Croatian: Od 514 bolesnika s rakom pluća nemalih stanica koji su u randomiziranom ispitivanju primali paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma u kombinaciji s karboplatinom, 31% bolesnika bili su u dobi od 65 ili više godina, a 3,5% u dobi od 75 ili više godina.
English: Grade 4 cutaneous toxicity, diarrhoea, or mucositis
Croatian: 4. stupanj kožne toksičnosti, proljeva ili mukozitisa
English: There were no clinically relevant pharmacokinetic interactions between human serum albumin-paclitaxel nanoparticlesand carboplatin.
Croatian: Nije bilo klinički značajnih farmakokinetičkih interakcija paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma i karboplatina.
English: Pazenir should be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Croatian: Pazenir primjenjuje se pod nadzorom iskusnog onkologa na odjelima koji su specijalizirani za primjenu citotoksičnih lijekova.
English: Full dose
Croatian: Cijela doza
English: After reconstitution, each ml of dispersion contains 5 mg of paclitaxel formulated as albumin bound nanoparticles.
Croatian: Nakon rekonstitucije, svaki ml disperzije sadrži 5 mg paklitaksela u obliku nanočestica vezanih na albumin.
English: In a study in patients with advanced solid tumours, the pharmacokinetic characteristics of paclitaxel following human serum albumin-paclitaxel nanoparticles administered intravenously at 260 mg/m2 over 30 minutes were compared with those following 175 mg/m2 of the solvent-based paclitaxel injection administered over 3 hours.
Croatian: U ispitivanju na bolesnicima s uznapredovalim solidnim tumorima uspoređivane su farmakokinetičke značajke paklitaksela nakon intravenske primjene paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma u dozi od 260 mg/m2 tijekom 30 minuta s onima nakon primjene injekcije paklitaksela baziranog na otapalu u dozi od 175 mg/m2 tijekom 3 sata.
English: Solvent- based paclitaxel was administered to patients (N=531) at a dose of 200 mg/m2 as an intravenous infusion over 3 hours with standard premedication, immediately followed by carboplatin administered intravenously at AUC = 6 mg•min/mL.
Croatian: Paklitaksel baziran na otapalu primijenjen je bolesnicima (N = 531) u dozi od 200 mg/m2 kao intravenska infuzija tijekom 3 sata uz standardnu premedikaciju, iza čega je odmah slijedila intravenska primjena karboplatina u dozi
English: The study compared human serum albumin-paclitaxel nanoparticles in combination with carboplatin versus solvent-based paclitaxel in combination with carboplatin as first-line treatment in patients with advanced non-small cell lung cancer.
Croatian: U ispitivanju se uspoređivao paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma u kombinaciji s karboplatinom i paklitaksel na bazi otapala u kombinaciji s karboplatinom kao prva linija liječenja bolesnika s uznapredovalim rakom pluća nemalih stanica.
English: Non-small cell lung cancer A multicenter, randomized, open-label study was conducted in 1052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer.
Croatian: Multicentrično, randomizirano, otvoreno ispitivanje provedeno je u 1052 bolesnika s rakom pluća nemalih stanica IIIb/IV stadija, koji prije nisu bili liječeni kemoterapijom.
English: A higher median cumulative dose of gemcitabine was delivered in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm (11400 mg/m2) when compared with the gemcitabine arm (9000 mg/m2).
Croatian: Bolesnici u skupini koja je primala paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma/gemcitabin (11 400 mg/m2) primili su veći medijan kumulativne doze gemcitabina u usporedbi sa skupinom koja je primala gemcitabin (9000 mg/m2).
English: Patients with hepatic impairment
Croatian: Bolesnici s oštećenjem bubrežne funkcije
English: CI = confidence interval; HRA/T = hazard ratio of Human serum albumin-paclitaxel nanoparticles/carboplatin to solventbased paclitaxel/carboplatin; pA/pT = response rate ratio of Human serum albumin-paclitaxel nanoparticles/carboplatin to solvent-based paclitaxel/carboplatin.
Croatian: CI = interval pouzdanosti, HRA/T = omjer hazarda za paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma s karboplatinom naspram paklitaksela baziranog na otapalu s karboplatinom; pA/pT = omjer stope odgovora za paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma s karboplatinom naspram paklitaksela baziranog na otapalu s karboplatinom a
English: Table 8 provides the frequency and severity of haematologic laboratory-detected abnormalities for patients treated with human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine or with gemcitabine.
Croatian: U tablici 8 navedene su učestalosti i težine hematoloških abnormalnosti ustanovljenih laboratorijskim pretragama u bolesnika liječenih paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma u kombinaciji s gemcitabinom, ili samo gemcitabinom.
English: The rare side effects may affect up to 1 in 1,000 people:
Croatian: Rijetke nuspojave mogu se pojaviti u do 1 na 1000 osoba:
English: Cutaneous Toxicity:
Croatian: Kožna toksičnost:
English: The very common side effects may affect more than 1 in 10 people:
Croatian: Vrlo česte nuspojave mogu se pojaviti u više od 1 na 10 osoba:
English: For non-small cell lung cancer patients treated with paclitaxel and carboplatin, the median time to first occurrence of Grade 3 treatment related peripheral neuropathy was 121 days, and the median time to improvement from Grade 3 treatment related peripheral neuropathy to Grade 1 was 38 days.
Croatian: medijan vremena do prve pojave periferne neuropatije 3. stupnja povezane s liječenjem iznosio je 121 dan, a medijan vremena do poboljšanja periferne neuropatije s 3. stupnja na 1. stupanj bio je
English: Uncommon: Increased blood pressure, increased weight, increased blood lactate dehydrogenase, increased blood creatinine, increased blood glucose, increased blood phosphorus, decreased blood potassium, increased bilirubin
Croatian: Manje često: povišeni krvni tlak, povećana tjelesna težina, povišena razina laktat-dehidrogenaze, povišen kreatinin u krvi, povišena glukoza u krvi, povišen fosfor u krvi, snižena razina kalija u krvi, povišeni bilirubin
English: Rare reports of congestive heart failure and left ventricular dysfunction have been observed among individuals receiving human serum albumin-paclitaxel nanoparticles.
Croatian: Zabilježeni su rijetki slučajevi kongestivnog zatajenja srca i disfunkcije lijeve klijetke u osoba koje primaju paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma.
English: Rare: Cystoid macular oedema2
Croatian: Rijetko: cistoidni makularni edem2
English: Reconstituted Pazenir dispersion is administered intravenously using an infusion set incorporating a 15 µm filter.
Croatian: Rekonstituiranu disperziju lijeka Pazenir primjenjuje se intravenski, s pomoću kompleta za infuziju opremljenog filtrom od 15 µm.
English: Uncommon: Dysuria, pollakiuria, haematuria, nocturia, polyuria, urinary incontinence
Croatian: Manje često: dizurija, polakiurija, hematurija, nokturija, poliurija, inkontinencija urina
English: • Decreased blood pressure when standing up, coldness in your hands and feet
Croatian: • sniženi krvni tlak prilikom ustajanja, hladnoća šaka i stopala • otežano hodanje, otečenost
English: • Low levels of potassium in the blood
Croatian: • niske razine kalija u krvi
English: • if you experience any abnormal bruising, bleeding, or signs of infections such as a sore throat or a fever;
Croatian: • ako opazite abnormalnu pojavu modrica, krvarenja ili znakove infekcija kao što su grlobolja ili vrućica; • ako osjetite utrnulost, trnce, osjećaj bockanja, osjetljivost na dodir ili slabost u mišićima;
English: Very common: Peripheral neuropathy2 Common: Dysgeusia, headache, dizziness
Croatian: Vrlo često: periferna neuropatija2 Često: disgeuzija, glavobolja, omaglica
English: • Coughing with phlegm, shortness of breath when walking or climbing stairs, runny nose, or dry nose, decreased breath sounds, water on the lung, loss of voice, blood clot in the lung, dry throat
Croatian: • bol u uhu, zvonjava u ušima • kašalj sa sluzi, nedostatak zraka prilikom hodanja ili penjanja stepenicama, curenje iz nosa ili suhi nos, utišano disanje, voda u plućima, gubitak glasa, krvni ugrušak u plućima, suhoća grla
English: Common: Abdominal pain, abdominal distension, upper abdominal pain, dyspepsia, gastrooesophageal reflux disease, oral hypoaesthesia
Croatian: Često: bol u abdomenu, distenzija abdomena, bol u gornjem dijelu abdomena, dispepsija, gastroezofagealna refluksna bolest, oralna hipoestezija
English: The usual dose for non-small cell lung cancer is 100 mg/m2 of body surface area given over a 30 minute period.
Croatian: Uobičajena doza za rak nemalih stanica pluća iznosi 100 mg/m2 tjelesne površine i daje se tijekom 30 minuta.
English: The recommended dose of Pazenir in combination with gemcitabine is 125 mg/m2 administered intravenously over 30 minutes on Days 1, 8 and 15 of each 28-day cycle.
Croatian: Preporučena doza lijeka Pazenir u kombinaciji s gemcitabinom iznosi 125 mg/m2, a primjenjuje se intravenski tijekom 30 minuta 1., 8. i 15. dana svakog 28-dnevnog ciklusa.
English: Uncommon: Polyneuropathy, areflexia, dyskinesia, hyporeflexia, neuralgia, sensory loss, syncope, postural dizziness, neuropathic pain, tremor
Croatian: Manje često: polineuropatija, arefleksija, diskinezija, hiporefleksija, neuralgija, gubitak osjeta, sinkopa, posturalna omaglica, neuropatska bol, tremor
English: Table 5: Dose reductions for non-haematologic toxicities in patients with non-small cell lung cancer
Croatian: Tablica 5: Smanjivanje doze zbog nehematoloških toksičnosti u bolesnika s rakom pluća nemalih stanica
English: Uncommon: Chest wall pain, muscular weakness, neck pain, groin pain, muscle spasms, musculoskeletal pain, flank pain, limb discomfort, muscle weakness
Croatian: Manje često: bol u stijenci prsnog koša, mišićna slabost, bol u vratu, bol u preponama, spazam mišića, mišićno-koštani bol, bol u slabinama, nelagoda u udovima, slabost mišića
English: • Increased bilirubin in the blood
Croatian: • akutno zatajenje bubrega • povišeni bilirubin u krvi
English: Stability of reconstituted dispersion in the vial
Croatian: Stabilnost rekonstituirane disperzije u bočici
English: For febrile neutropenia, withhold Pazenir and gemcitabine until fever resolves and ANC ≥ 1500 cells/mm3, then resume treatment at reduced dose levels (see section 4.2).
Croatian: U slučaju febrilne neutropenije, treba obustaviti liječenje lijekom Pazenir u kombinaciji s gemcitabinom dok se vrućica ne povuče i ne dosegne ABN ≥ 1500 stanica/mm3, a potom nastaviti liječenje pri smanjenoj razini doza (vidjeti dio 4.2).