FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 6 lists adverse reactions associated with the administration of human serum albumin-paclitaxel nanoparticles to patients from studies in which human serum albumin-paclitaxel nanoparticles has been administered as monotherapy at any dose in any indication (N = 789).
Croatian: Tablični popis nuspojava Tablica 6 navodi nuspojave povezane s primjenom paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma u ispitivanjima u kojima su paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma primjenjivali bolesnicima kao monoterapiju, u bilo kojoj dozi i za bilo koju indikaciju (N = 789).
English: • if you have a low white blood cell count (baseline neutrophil counts <1500 cells/mm3
Croatian: • ako imate nizak broj bijelih krvnih stanica (početni broj neutrofila < 1500 stanica/mm3 - liječnik će Vas savjetovati o tome).
English: • Deficiency of red blood cells
Croatian: • manjak crvenih krvnih stanica (eritrocita)
English: Withhold doses
Croatian: Obustava doze
English: Of the 421 patients with pancreatic adenocarcinoma in the randomized study who received human serum albumin-paclitaxel nanoparticles in combination with gemcitabine, 41% were 65 years and older and 10% were 75 years and older.
Croatian: U randomiziranom ispitivanju, od 421 bolesnika s adenokarcinomom pankreasa koji su primali paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma u kombinaciji s gemcitabinom, 41% bolesnika bilo je u dobi od 65 i više godina, a 10% u dobi od 75 i više godina.
English: There was a statistically significant improvement in OS for patients treated with human serum albumin-paclitaxel nanoparticles/gemcitabine versus gemcitabine alone, with 1.8 months increase in median OS, 28% overall reduction in risk of death, 59% improvement in 1-year survival, and 125% improvement in 2-year survival rates.
Croatian: 1,8 mjeseci, sveukupnim smanjenjem rizika od smrti od 28%, poboljšanjem stope preživljenja u 1 godini od 59% i poboljšanjem stope preživljenja u 2 godine od 125% .
English: How to use Pazenir
Croatian: Kako primjenjivati Pazenir
English: Common: Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, weight decreased
Croatian: Često: povišena razina alanin aminotransferaze, povišena razina aspartat aminotransferaze, povišena razina alkalne fosfataze u krvi, smanjena težina
English: Population pharmacokinetic analysis included patients with normal renal function (n=65), and preexisting mild (n=61), moderate (n=23), or severe (n=l) renal impairment (according to draft FDA guidance criteria 2010).
Croatian: (n = 65) i one s prethodnim blagim (n = 61), umjerenim (n = 23) ili teškim (n = 1) oštećenjem bubrežne funkcije (prema nacrtu kriterija za smjernice američke Agencije za hranu i lijekove (FDA) iz 2010.).
English: ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Croatian: ≥ 500, ali < 1000 ILI ≥ 50 000, ali < 75 000
English: If patients experience nausea, vomiting and diarrhoea following the administration of Pazenir, they may be treated with commonly used anti-emetics and constipating agents.
Croatian: Ako nakon primjene lijeka Pazenir bolesnici osjećaju mučninu, povraćaju i imaju proljev, može ih se liječiti uobičajenim antiemeticima i lijekovima protiv proljeva.
English: Patients who have baseline neutrophil counts <1500 cells/mm
Croatian: Bolesnici s početnim brojem neutrofila < 1500 stanica/mm3.
English: Table 7 lists adverse reactions assessed in patients with pancreatic adenocarcinoma treated with human serum albumin-paclitaxel nanoparticles in combination with gemcitabine.
Croatian: Tablica 7 navodi nuspojave procijenjene u bolesnika s adenokarcinomom pankreasa koji su liječeni paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma u kombinaciji s gemcitabinom.
English: Tel: +39 0289 17981
Croatian: Teva Italia S.r.l. Tel: +39 0289 17981
English: Delay of next cycle due to persistent neutropenia2 (Nadir
Croatian: Odgoda sljedećeg ciklusa zbog perzistirajuće neutropenije2 (najniža vrijednost ABN < 1500/mm3)
English: Very common: Neutropenia, anaemia, leukopenia, thrombocytopenia, lymphopenia, bone marrow suppression
Croatian: Vrlo često: neutropenija, anemija, leukopenija, trombocitopenija, limfopenija, supresija koštane srži
English: Table 9: Adverse reactions reported with human serum albumin-paclitaxel nanoparticles in combination with carboplatin (N = 514)
Croatian: Tablica 9: Nuspojave zabilježene uz paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma u kombinaciji s karboplatinom (N = 514)
English: Very common: Fatigue, oedema peripheral, pyrexia, asthenia, chills Common: Infusion site reaction
Croatian: Vrlo često: umor, periferni edem, pireksija, astenija, zimica Često: reakcija na mjestu infuzije
English: Grade 4 neutropenia (< 500 cells/mm3) occurred in 9% of patients treated with human serum albuminpaclitaxel nanoparticles.
Croatian: (< 500 stanica/mm3) javila se u 9% bolesnika liječenih paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma.
English: Pazenir contains, as its active substance, paclitaxel attached to the human protein albumin, in the form of tiny particles known as nanoparticles.
Croatian: Kao djelatnu tvar Pazenir sadrži paklitaksel u obliku sićušnih čestica poznatih kao nanočestice,
English: Non-small cell lung cancer (human serum albumin-paclitaxel nanoparticles administered in combination with carboplatin)
Croatian: Rak pluća nemalih stanica (paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma primijenjen u kombinaciji s karboplatinom)
English: The effect of hepatic impairment on population pharmacokinetics of human serum albumin-paclitaxel nanoparticles was studied in patients with advanced solid tumours.
Croatian: Oštećenje jetrene funkcije Učinak oštećenja jetrene funkcije na populacijsku farmakokinetiku paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma ispitivan je u bolesnika s uznapredovalim soldinim tumorima.
English: However, chemical and physical in use stability has been demonstrated for 24 hours at 2°C-8°C in the original carton, and protected from bright light.
Croatian: Međutim, kemijska i fizikalna stabilnost disperzije u primjeni dokazana je tijekom 24 sata na temperaturi od 2°C do 8°C u originalnom pakiranju, uz zaštitu od jake svjetlosti.
English: When Pazenir is used as monotherapy, if Grade 3 sensory neuropathy develops, treatment should be withheld until resolution to Grade 1 or 2 followed by a dose reduction for all subsequent courses of Pazenir is recommended (see section 4.2).
Croatian: Kada se Pazenir primjenjuje kao monoterapija, u slučaju razvoja senzorne neuropatije 3. stupnja liječenje treba obustaviti do oporavka na 1. ili 2. stupanj, nakon čega se preporučuje smanjenje doze za sve naredne cikluse liječenja lijekom Pazenir
English: PA/pT (95.1% Cl)
Croatian: HRA/T (95,1% CI)
English: Uncommon: Sepsis, oral candidiasis
Croatian: Manje često: sepsa, oralna kandidijaza
English: A pharmacokinetic study was conducted with human serum albumin-paclitaxel nanoparticles and carboplatin in non-small cell lung cancer patients.
Croatian: Farmakokinetičko ispitivanje provedeno je s paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma i karboplatinom u bolesnika s rakom pluća nemalih stanica.
English: Common: Flushing, hot flushes, hypertension, lymphoedema Uncommon: Hypotension, peripheral coldness, orthostatic hypotension Rare: Thrombosis
Croatian: Često: navale crvenila, navale vrućine, hipertenzija, limfedem Manje često: hipotenzija, periferna hladnoća, ortostatska hipotenzija
English: Very common: Peripheral neuropathy1, dysgeusia, headache, dizziness Uncommon: VIIth nerve paralysis
Croatian: Vrlo često: periferna neuropatija1, disgeuzija, glavobolja, omaglica Manje često: paraliza VII. živca
English: Two hundred and twenty nine patients treated with human serum albumin-paclitaxel nanoparticles in the randomized, controlled clinical trial were evaluated for safety.
Croatian: U randomiziranom, kontroliranom kliničkom ispitivanju 229 bolesnika liječenih paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma podvrgnuto je procjeni sigurnosti.
English: Table 7: Adverse reactions reported with human serum albumin-paclitaxel nanoparticles in combination with gemcitabine (N=421)
Croatian: Tablica 7: Nuspojave zabilježene uz paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma primijenjen u kombinaciji s gemcitabinom (N = 421)
English: The concurrent recommended dose of gemcitabine is 1000 mg/m2 administered intravenously over 30 minutes immediately after the completion of Pazenir administration on Days 1, 8 and 15 of each 28-day cycle.
Croatian: Istodobna preporučena doza gemcitabina iznosi 1000 mg/m2, primijenjeno intravenski tijekom 30 minuta odmah nakon završene primjene lijeka Pazenir 1., 8. i 15. dana svakog 28-dnevnog ciklusa.
English: 2 As reported in the post-marketing surveillance of human serum albumin-paclitaxel nanoparticles 3 The frequency of pneumonitis is calculated based on pooled data in 1310 patients in clinical trials receiving human serum albumin-paclitaxel nanoparticlesmonotherapy for breast cancer and for other indications using MedDRA SMQ Interstitial lung disease.
Croatian: 3 Učestalost pneumonitisa izračunata je na temelju objedinjenih podataka kliničkih ispitivanja u kojima je 1310 bolesnika primalo paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma kao monoterapiju za rak dojke i za druge indikacije prema onome kako ih MedDRA SMQ navodi za intersticijsku bolest pluća.
English: Myalgia occurred in 24% of patients on human serum albumin-paclitaxel nanoparticles and was severe in 7% of cases.
Croatian: Mijalgija se javila u 24% bolesnika koji su primali paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma i bila je teška u 7%
English: General disorders and administration site conditions Asthenia/Fatigue was reported in 40% of the patients.
Croatian: Astenija/umor prijavljeni su u 40% bolesnika.
English: Dose adjustments during treatment of non-small cell lung cancer Pazenir 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.
Croatian: Pazenir se ne smije primjenjivati 1.dana ciklusa sve dok apsolutni broj neutrofila (ABN) ne bude ≥ 1500 stanica/mm3 a broj trombocita ≥ 100 000 stanica/mm3.
English: Common: Hypotension, hypertension Uncommon: Flushing
Croatian: Često: hipotenzija, hipertenzija Manje često: navale crvenila
English: Table 4: Dose reductions for haematologic toxicities in patients with non-small cell lung cancer Haematologic Toxicity
Croatian: Tablica 4: Smanjivanje doze zbog hematoloških toksičnosti u bolesnika s rakom pluća nemalih stanica
English: Breast cancer (human serum albumin-paclitaxel nanoparticles administered as monotherapy)
Croatian: Rak dojke (paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma primijenjen kao monoterapija)
English: Hypersensitivity to the active substance or to any of the excipients listed in section Breast-feeding (see section 4.6).
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Very common: Nausea, diarrhoea, vomiting, constipation, stomatitis
Croatian: Vrlo često: mučnina, proljev, povraćanje, konstipacija, stomatitis
English: Very common: Alopecia, rash Common: Pruritus, dry skin, nail disorder, flushing
Croatian: Vrlo često: alopecija, osip Često: pruritus, suha koža, poremećaji noktiju, navale crvenila
English: No patients treated with human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine had Grade 4 peripheral neuropathy.
Croatian: Nijedan bolesnik liječen paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma s gemcitabinom nije imao perifernu neuropatiju 4. stupnja.
English: Pazenir contains sodium
Croatian: Pazenir sadrži natrij.
English: Very common: Weight decreased, alanine aminotransferase increased Common: Aspartate aminotransferase increased, blood bilirubin increased, blood creatinine increased
Croatian: Vrlo često: smanjena težina, povišena razina alanin aminotransferaze Često: povišena razina aspartat aminotransferaze, povišena razina bilirubina u krvi, povišen kreatinin u krvi
English: Common: Decreased weight, increased alanine aminotransferase, increased aspartate aminotransferase, decreased haematocrit, decreased red blood cell count, increased body temperature, increased gammaglutamyltransferase, increased blood alkaline phosphatase
Croatian: Često: smanjena težina, povišena razina alanin aminotransferaze, povišena razina aspartat aminotransferaze, smanjeni hematokrit, smanjeni broj eritrocita, povišena tjelesna temperatura, povišena razina gama glutamiltransferaze, povišena razina alkalne fosfataze u krvi
English: This resulted in significantly higher exposure to unbound paclitaxel with human serum albumin-paclitaxel nanoparticles compared with solvent-based paclitaxel, even though the total exposure is comparable.
Croatian: To je rezultiralo značajno većom izloženošću nevezanom paklitakselu iz paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma u usporedbi s paklitakselom baziranom na otapalu,
English: For Grade 2 or 3 cutaneous toxicity, Grade 3 diarrhoea, or Grade 3 mucositis, interrupt treatment until the toxicity improves to ≤ Grade 1, then restart treatment according to the guidelines in Table 5.
Croatian: U slučaju kožne toksičnosti 2. ili 3. stupnja, proljeva 3. stupnja ili mukozitisa 3. stupnja, liječenje prekinite dok se toksičnost ne poboljša na ≤ 1. stupnja, a zatim ponovno započnite liječenje prema smjernicama iz tablice 5. Kod periferne neuropatije ≥ 3. stupnja, liječenje obustavite do poboljšanja na ≤ 1. stupnja.
English: Day 15: If Day 8 doses were given without modification:
Croatian: Ako doze 8. dana nisu bile promijenjene:
English: Human serum albumin-paclitaxel nanoparticles (100 mg/m2/week)+ carboplatin (N=521)
Croatian: Paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma (100 mg/m tjedno) + karboplatin (N = 521)
English: Uncommon: Oral candidiasis, nasopharyngitis, cellulitis, herpes simplex, viral infection, pneumonia, catheter-related infection, fungal infection, herpes zoster, injection site infection, sepsis2, neutropenic sepsis2
Croatian: virusna infekcija, pneumonija, infekcija povezana s kateterom, gljivična infekcija, herpes zoster, infekcija na mjestu injekcije, sepsa2, neutropenijska sepsa2
English: Occurrence Dose of Pazenir (mg/m2)1
Croatian: Pojava Doza lijeka Pazenir (mg/m2)1
English: Progression-free Survival
Croatian: Preživljenje bez progresije bolesti
English: Keep the container in the outer carton until use in order to protect from light.
Croatian: Spremnik čuvati u vanjskom pakiranju do primjene radi zaštite od svjetlosti.
English: Death or progression, n (%) Median PFS (95% CI) (months) HRA/T (95% CI)
Croatian: Smrt ili progresija, n (%) Medijan preživljenja bez progresije (95% CI) (mjeseci)
English: • Infection in the urinary tract
Croatian: • infekcija mokraćnog sustava
English: Table 3: Dose modifications for other adverse drug reactions in patients with pancreatic adenocarcinoma Adverse Drug Reaction (ADR)
Croatian: Tablica 3: Promjene doza zbog drugih nuspojava na lijek u bolesnika s adenokarcinomom pankreasa
English: The pharmacokinetics of total paclitaxel following 30- and 180-minute infusions of human serum albumin-paclitaxel nanoparticles at dose levels of 80 to 375 mg/m2 were determined in clinical studies.
Croatian: 5.2 Farmakokinetička svojstva Farmakokinetika ukupnog paklitaksela određena je u kliničkim ispitivanjima nakon infuzija paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma u trajanju od 30 i 180 minuta u rasponima doze od 80 do 375 mg/m2.
English: Uncommon: Hypophosphataemia, fluid retention, hypoalbuminaemia, polydipsia, hyperglycaemia, hypocalcaemia, hypoglycaemia, hyponatraemia
Croatian: polidipsija, hiperglikemija, hipokalcijemija, hipoglikemija, hiponatrijemija
English: Uncommon: Chest discomfort, abnormal gait, swelling, injection site reaction
Croatian: Manje često: nelagoda u prsnom košu, abnormalni hod, oticanje, reakcija na mjestu injiciranja
English: Efficacy variable human serum albuminpaclitaxel nanoparticles (260 mg/m2)
Croatian: Paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma (260 mg/m2)
English: However chemical and physical in use stability has been demonstrated for 24 hours at 2°C-8°C, protected from light followed by 4 hours at 15°C-25°C.
Croatian: Međutim, kemijska i fizikalna stabilnost disperzije u primjeni dokazana je tijekom 24 sata na temperaturi od 2°C do 8°C, uz zaštitu od svjetlosti, te nakon toga tijekom 4 sata na temperaturi od 15°C do 25°C.
English: Patients should not be retreated with subsequent cycles of Pazenir until neutrophils recover to >1500 cells/mm3 and platelets recover to >100,000 cells/mm3 (see section 4.2).
Croatian: Pazenir sve dok broj neutrofila ne poraste na > 1500 stanica/mm3, a broj trombocita na > 100 000 stanica/mm3 (vidjeti dio 4.2).
English: For metastatic breast cancer patients and non-small cell lung cancer patients with moderate to severe hepatic impairment (total bilirubin > 1.5 to ≤ 5 x ULN and AST ≤ 10 x ULN), a 20% reduction in dose is recommended.
Croatian: Za bolesnike s metastatskim rakom dojke i bolesnike s rakom pluća nemalih stanica s umjerenim do teškim oštećenjem jetrene funkcije (ukupni bilirubin od > 1,5 do ≤ 5 x GGN i AST ≤ 10 x GGN),
English: Return to the Day 1 dose levels and follow with WBC Growth Factors ORTreat with same doses as Day 8
Croatian: Povratak na razine doza 1. dana i zatim primjena čimbenika rasta bijelih krvnih stanica ILI liječenje istim dozama kao 8. dana
English: Unopened vials: Keep the container in the outer carton until use in order to protect from light.
Croatian: Neotvorene bočice: spremnik čuvati u vanjskom pakiranju do primjene radi zaštite od svjetlosti.
English: • People with metastatic breast cancer who received paclitaxel attached to the human protein albumin where another therapy had failed, were more likely to experience a reduction in tumour size, and lived longer than people who took an alternative therapy.
Croatian: • Pazenir koristi se za liječenje metastatskog raka dojke kada se pokušalo s najmanje jednim od drugih oblika liječenja ali nije bio djelotvoran, i kada niste podobni za liječenja koja sadrže skupinu lijekova pod nazivom antraciklini. • U bolesnika s metastatskim rakom dojke koji su primali paklitaksel vezan za ljudski protein albumin kada se druga terapija pokazala neuspješnom, opažena je veća vjerojatnost smanjenja veličine tumora, a bolesnici su živjeli dulje od onih koji su se liječili nekom drugom terapijom.
English: 1st dose level reduction 2nd dose level reduction If additional dose reduction required
Croatian: 1. smanjenje razine doze 2. smanjenje razine doze
English: Uncommon: Productive cough, exertional dyspnoea, sinus congestion, decreased breath sounds, pleural effusion, allergic rhinitis, hoarseness, nasal congestion, nasal dryness, wheezing, pulmonary emboli, pulmonary thromboembolism
Croatian: manje čujno disanje, pleuralni izljev, alergijski rinitis, promuklost, nazalna kongestija, suhoća nosa, piskanje pri disanju, plućni embolusi, plućna tromboembolija
English: • Infection in the lungs
Croatian: • plućna infekcija
English: Day 15 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Croatian: 15. dan ≥ 500, ali < 1000 ILI ≥ 50 000, ali < 75 000
English: Patients received a median treatment duration of 3.9 months in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm and 2.8 months in the gemcitabine arm. 32% of patients in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm compared with 15% of patients in the gemcitabine arm received 6 or more months of treatment.
Croatian: U skupini koja je primala paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma/gemcitabin 32% bolesnika, u usporedbi s 15% bolesnika iz skupine koja je primala gemcitabin, primalo je terapiju tijekom 6 ili više mjeseci.
English: This analysis included patients with normal hepatic function (n=130), and pre-existing mild (n=8), moderate (n=7), or severe (n=5) hepatic impairment (according to NCI Organ Dysfunction Working Group criteria).
Croatian: (n = 8), umjerenim (n = 7) ili teškim (n = 5) oštećenjem jetrene funkcije (prema kriterijima radne skupine za procjenu organske disfunkcije Organ Dysfunction Working Group, američkog Nacionalnog instituta za rak (NCI)).
English: Intravenous use.
Croatian: vrećicu za intravensku infuziju.
English: The common side effects may affect up to 1 in 10 people:
Croatian: Česte nuspojave mogu se pojaviti u do 1 na 10 osoba:
English: ANC count (cells/mm3)
Croatian: ABN (stanice/mm3)
English: Pneumonitis has been reported at a rate of 4% with the use of human serum albumin-paclitaxel nanoparticlesin combination with gemcitabine.
Croatian: Pneumonitis je zabilježen u stopi od 4% bolesnika kada se paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma primjenjivao u kombinaciji s gemcitabinom.
English: Return to Day 1 dose levels and follow with WBC Growth Factors OR Reduce doses 1 dose level from Day 1 doses
Croatian: Povratak na razinu doza 1. dana i zatim primjena čimbenika rasta bijelih krvnih stanica ILI smanjenje razine doza 1. dana za 1 razinu
English: Grade 3 mucositis or diarrhoea
Croatian: mukozitis ili proljev 3. stupnja
English: Grade 3-4
Croatian: Neutropenija 4. stupnja
English: No patients treated with human serum albumin-paclitaxel nanoparticles and carboplatin experienced Grade 4 peripheral neuropathy.
Croatian: Nijedan bolesnik liječen paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma s karboplatinom nije imao perifernu neuropatiju 4. stupnja.
English: Day 8 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Croatian: 8. dan ≥ 500, ali < 1000 ILI ≥ 50 000, ali < 75 000
English: MedDRA = Medical Dictionary for Regulatory Activities; SMQ = Standardized MedDRA Query (a grouping of several MedDRA preferred terms to capture a medical concept).
Croatian: Standardized MedDRA Query) (SMQ je skupina od nekoliko preporučenih pojmova MedDRA-e kojima se opisuje određeni medicinski pojam).
English: Very common: Nausea, diarrhoea, vomiting, constipation, abdominal pain, abdominal pain upper
Croatian: Vrlo često: mučnina, proljev, povraćanje, konstipacija, bol u abdomenu, bol u gornjem dijelu abdomena
English: Because the toxicity of paclitaxel can be increased with hepatic impairment, administration of Pazenir in patients with hepatic impairment should be performed with caution.
Croatian: jer toksičnost paklitaksela može biti povećana usljed veće izloženosti paklitakselu.
English: Treatment should be directed at the major anticipated toxicities, which are bone marrow suppression, mucositis and peripheral neuropathy.
Croatian: Liječenje treba usmjeriti na glavne očekivane toksičnosti kao što su supresija koštane srži,
English: Table 9 lists adverse reactions associated with the administration of human serum albuminpaclitaxel nanoparticles in combination with carboplatin.
Croatian: Tablični popis nuspojava Tablica 9 navodi nuspojave povezane s primjenom paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma u kombinaciji s karboplatinom.
English: Resume Pazenir at reduced dose when peripheral neuropathy improves to Grade 0 or 1 (see section 4.2).
Croatian: Kada se periferna neuropatija poboljša na 0. ili 1. stupanj, treba ponovno uvesti Pazenir u smanjenoj dozi (vidjeti dio 4.2).
English: For storage conditions after reconstitution, see package leaflet.
Croatian: Uvjete čuvanja nakon rekonstitucije vidjeti u uputi o lijeku.
English: Treat with Day 8 dose levels and follow with WBC Growth Factors OR Reduce doses 1 dose level from Day 8 doses
Croatian: Liječenje istim dozama kao 8. dana i zatim primjena čimbenika rasta bijelih krvnih stanica ILI smanjenje razine doza 8. dana za 1 razinu
English: Very common: Arthralgia, myalgia Common: Back pain, pain in extremity, musculoskeletal pain
Croatian: Vrlo često: artralgija, mijalgija Često: bol u šakama i stopalima, bol u kostima, bol u leđima, grčevi u mišićima, bol u udovima