FrancophonIA/ELRC3.0 huggingface dataset:
English: For dose modifications for myelosuppression see Table 2.
Croatian: Za prilagodbe doze kod mijelosupresije vidjeti Tablicu 2.
English: Polivy must be reconstituted using sterile water for injection and diluted into an intravenous infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection, or sodium chloride 4.5 mg/ml (0.45%) solution for injection, or 5% glucose prior to administration.
Croatian: Polivy se prije primjene mora rekonstituirati sterilnom vodom za injekcije i razrijediti dodavanjem u vrećicu za intravensku infuziju koja sadrži otopinu natrijeva klorida za injekciju od 9 mg/ml (0,9%), otopinu natrijeva klorida za injekciju od 4,5 mg/ml (0,45%) ili 5%-tnu otopinu glukoze.
English: Solution for infusion storage conditions1
Croatian: Uvjeti čuvanja otopine za infuziju1
English: Patients should be monitored for IRRs/hypersensitivity reactions during the infusion and for at least 90 minutes following completion of the initial dose.
Croatian: Bolesnike treba nadzirati tijekom infuzije i još najmanje 90 minuta nakon završetka primjene početne doze zbog moguće pojave reakcija povezanih s infuzijom/reakcija preosjetljivosti.
English: Therefore, men being treated with this medicine are advised to have sperm samples preserved and stored before treatment.
Croatian: Stoga se muškarcima koji se liječe ovim lijekom savjetuje da prije liječenja sačuvaju i pohrane uzorke sperme.
English: Each pack of Polivy consists of one vial.
Croatian: Jedno pakiranje lijeka Polivy sadrži jednu bočicu.
English: Embryo-foetal toxicity
Croatian: Embriofetalna toksičnost
English: An antihistamine and antipyretic should be administered prior to the administration of Polivy, and patients should be monitored closely throughout the infusion.
Croatian: Prije primjene lijeka Polivy bolesnicima treba dati antihistaminik i antipiretik te ih pažljivo nadzirati tijekom cijele infuzije.
English: • a burning sensation
Croatian: • osjećaj žarenja
English: • inflammation of the lungs
Croatian: • upala pluća
English: • burning pain when passing urine
Croatian: • žareća bol pri mokrenju
English: As with all therapeutic proteins, there is the potential for an immune response in patients treated with polatuzumab vedotin.
Croatian: Kao i kod svih terapijskih proteina, u bolesnika liječenih polatuzumab vedotinom može doći do imunosnog odgovora.
English: Polivy is administered as an intravenous infusion.
Croatian: Polivy se primjenjuje intravenskom infuzijom.
English: Delayed IRRs as late as 24 hours after receiving Polivy have occurred.
Croatian: Zabilježene su odgođene reakcije povezane s infuzijom, koje su nastupile do čak 24 sata nakon primjene lijeka Polivy.
English: Using a sterile syringe, slowly inject 7.2 mL of sterile water for injection into the 140 mg Polivy vial to yield a single-dose solution containing 20 mg/mL polatuzumab vedotin.
Croatian: Sterilnom štrcaljkom polako injicirajte 7,2 ml sterilne vode za injekcije u bočicu sa 140 mg lijeka Polivy kako biste dobili jednodoznu otopinu koja sadrži polatuzumab vedotin u koncentraciji od 20 mg/ml.
English: The reconstituted solution should appear colourless to slightly brown, clear to slightly opalescent, and free of visible particulates.
Croatian: Rekonstituirana otopina treba biti bezbojna do svjetlosmeđa, bistra do blago opalescentna te ne smije sadržavati vidljive čestice.
English: Drug interactions of rituximab and bendamustine in combination with polatuzumab vedotin
Croatian: Interakcije kod primjene rituksimaba i bendamustina u kombinaciji s polatuzumab vedotinom
English: Chemical and physical stability of the prepared solution for infusion has been demonstrated for the durations listed in Table 1.
Croatian: Kemijska i fizikalna stabilnost pripremljene otopine za infuziju dokazana je tijekom razdoblja navedenih u Tablici 1.
English: Men being treated with Polivy are advised not to father a child during treatment and for up to 6 months following the last dose.
Croatian: Muškarcima koji se liječe lijekom Polivy savjetuje se da odustanu od začeća djeteta tijekom liječenja i do 6 mjeseci nakon posljednje doze.
English: Polivy must be administered using a dedicated infusion line equipped with sterile, non-pyrogenic, low-protein binding in-line or add-on filter (0.2 or 0.22 micrometer pore size) and catheter.
Croatian: Polivy se mora primijeniti kroz posebnu infuzijsku liniju opremljenu sterilnim, nepirogenim, ugrađenim ili pričvrsnim filtrom male sposobnosti vezanja proteina (veličina pora: 0,2 ili 0,22 mikrometra) i kateterom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder for concentrate for solution for infusion contains 140 mg of polatuzumab vedotin.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica praška za koncentrat za otopinu za infuziju sadrži 140 mg polatuzumab vedotina.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 Aktivne teške infekcije (vidjeti dio 4.4)
English: Men being treated with this medicine are advised to have sperm samples preserved and stored before treatment.
Croatian: Muškarcima koji se liječe ovim lijekom savjetuje se da prije liječenja sačuvaju i pohrane uzorke sperme.
English: It should be administered as an intravenous infusion through a dedicated infusion line equipped with a sterile, non-pyrogenic, low-protein binding in-line or add-on filter (0.2 or 0.22 micrometer pore size) and catheter.
Croatian: Treba ga primijeniti intravenskom infuzijom kroz posebnu infuzijsku liniju opremljenu sterilnim, nepirogenim, ugrađenim ili pričvrsnim filtrom male sposobnosti vezanja proteina (veličina pora: 0,2 ili 0,22 mikrometra) i kateterom.
English: Concomitant rituximab is associated with increased antibody conjugated MMAE (acMMAE) plasma AUC by 24% and decreased unconjugated MMAE plasma AUC by 37%, based on population PK analysis.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, istodobna primjena rituksimaba povezana je s povećanjem plazmatskog AUC-a MMAE-a konjugiranog s protutijelom (engl. antibody conjugated MMAE, acMMAE) za 24% i smanjenjem plazmatskog AUC-a nekonjugiranog MMAE-a za 37%.
English: Table 3: Polivy, bendamustine and rituximab dose modifications for Infusion-related reactions (IRRs)
Croatian: Tablica 3: Prilagodbe doze lijeka Polivy, bendamustina i rituksimaba kod reakcija povezanih s infuzijom
English: Based on the population PK analysis, Cycle 3 acMMAE AUC increased by approximately 30% over Cycle 1
Croatian: Prema populacijskoj farmakokinetičkoj analizi, AUC acMMAE-a u 3. ciklusu povećao se približno 30% u odnosu na AUC u 1. ciklusu te je dosegao više od 90% AUC-a zabilježenog u 6. ciklusu.
English: Women of childbearing potential should be advised to use effective contraception during treatment with Polivy and for at least 9 months after the last dose (see section 4.6).
Croatian: Ženama reproduktivne dobi treba savjetovati da koriste učinkovitu kontracepciju tijekom liječenja lijekom Polivy i još najmanje 9 mjeseci nakon posljednje doze (vidjeti dio 4.6).
English: Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.
Croatian: Polivy je u kombinaciji s bendamustinom i rituksimabom indiciran za liječenje odraslih bolesnika s relapsnim/refraktornim difuznim B-velikostaničnim limfomom (engl. diffuse large B-cell lymphoma,
English: A recommended dose has not been determined for patients with CrCL < 30mL/min due to limited data.
Croatian: Zbog ograničenih podataka nije utvrđena preporučena doza za bolesnike kojima je CrCL < 30 ml/min.
English: No dedicated carcinogenicity studies have been performed with polatuzumab vedotin and/or MMAE.
Croatian: Nisu provedena posebna ispitivanja kancerogenosti polatuzumab vedotina i/ili MMAE-a.
English: One patient (2.2%) in the Polivy plus BR arm discontinued treatment due to infection compared to 5.1% of patients in the BR arm.
Croatian: Liječenje je zbog infekcije prekinuo jedan bolesnik (2,2%) u skupini koja je primala Polivy plus BR, u usporedbi s 5,1% bolesnika u skupini koja je primala samo BR.
English: However, results of the 4-week rat toxicity study indicate the potential for polatuzumab vedotin to impair male reproductive function and fertility.
Croatian: Međutim, rezultati 4-tjednog ispitivanja toksičnosti na štakorima ukazuju na mogući štetan utjecaj polatuzumab vedotina na reproduktivnu funkciju i plodnost mužjaka.
English: Table 5 Summary of efficacy in patients with previously treated DLBCL from study GO29365 Polivy + bendamustine + rituximab N = 40
Croatian: Tablica 5 Sažetak podataka o djelotvornosti u bolesnika s prethodno liječenim DLBCL-om iz ispitivanja GO29365
English: Severity of IRR on Day 1 of any cycle
Croatian: Težina periferne neuropatije na 1. dan bilo kojeg ciklusa
English: Polivy was given intravenously at 1.8 mg/kg administered on Day 2 of Cycle 1 and on Day 1 of Cycles 2-6.
Croatian: Polivy se primjenjivao intravenski u dozi od 1,8 mg/kg 2. dana 1. ciklusa i 1. dana 2. - 6. ciklusa.
English: Table 1 Durations for which chemical and physical stability of the prepared solution for infusion have been demonstrated
Croatian: Tablica 1 Razdoblja tijekom kojih je dokazana kemijska i fizikalna stabilnost pripremljene otopine za infuziju
English: Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that preferentially delivers a potent anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, which results in the killing of malignant B-cells.
Croatian: Polatuzumab vedotin je konjugat protutijela i lijeka koji ciljano djeluje na CD79b i preferencijalno dostavlja snažan antimitotik (monometilauristatin E, odnosno MMAE) u B-stanice, čime omogućuje uništavanje zloćudnih B-stanica.
English: In both rats and cynomolgus monkeys, the predominant systemic toxicities associated with administration of MMAE and polatuzumab vedotin included reversible bone marrow toxicity and associated peripheral blood cell effects.
Croatian: Predominantni sistemski toksični učinci povezani s primjenom MMAE-a i polatuzumab vedotina u štakora i makaki majmuna uključivali su reverzibilnu toksičnost za koštanu srž i s time povezane učinke na periferne krvne stanice.
English: Up to 72 hours refrigerated (2 °C − 8 °C) or up to 8 hours at room temperature (9 °C − 25 °C)
Croatian: Do 72 sata u hladnjaku (2°C - 8°C) ili do 8 sati na sobnoj temperaturi (9°C - 25°C)
English: In the Polivy plus BR arm, the median onset to first event of PN was 1.8 months, and 61.1% of patients with PN events reported event resolution.
Croatian: Medijan vremena do prvog nastupa periferne neuropatije u skupini koja je primala Polivy plus BR iznosio je 1,8 mjeseci, a 61,1% bolesnika s perifernom neuropatijom prijavilo je da se nuspojava povukla.
English: Upon binding CD79b, polatuzumab vedotin is rapidly internalized and the linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE.
Croatian: Nakon vezivanja za CD79b, polatuzumab vedotin brzo ulazi u stanicu, gdje lizosomske proteaze raskidaju kovalentnu vezu i tako omogućuju unutarstaničnu isporuku MMAE-a.
English: Serious and severe neutropenia and febrile neutropenia have been reported in patients treated with Polivy as early as the first cycle of treatment.
Croatian: U bolesnika liječenih lijekom Polivy već su u prvom ciklusu liječenja prijavljene ozbiljna i teška neutropenija i febrilna neutropenija.
English: In patients with mild (CrCL 60-89 mL/min, n = 161) or moderate (CrCL 30- 59 mL/min, n = 109) renal impairment, acMMAE and unconjugated MMAE exposures are similar to patients with normal renal function (CrCL ≥ 90 mL/min, n = 185), based on a population PK analysis.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, izloženost acMMAE-u i nekonjugiranom MMAE-u u bolesnika s blagim (CrCL: 60 - 89 ml/min, n=161) ili umjerenim (CrCL: 30 - 59 ml/min; n=109) oštećenjem bubrežne funkcije slična je onoj u bolesnika s normalnom bubrežnom funkcijom (CrCL ≥ 90 ml/min, n=185).
English: The diluted solution must be discarded if storage time exceeds the limits specified in Table 6.
Croatian: Razrijeđena otopina lijeka Polivy mora se baciti ako vrijeme čuvanja premaši razdoblja navedena u Tablici 6.
English: Antibody-conjugated MMAE (acMMAE) plasma exposure increased dose-proportionally over the 0.1 to 2.4 mg/kg polatuzumab vedotin dose range.
Croatian: Izloženost MMAE-u konjugiranom s protutijelom (acMMAE) u plazmi povećavala se proporcionalno dozi u rasponu doza polatuzumab vedotina od 0,1 do 2,4 mg/kg.
English: • diarrhoea or constipation
Croatian: • vrućica ili zimica
English: Tell your doctor or nurse straight away if you:
Croatian: Odmah se obratite svom liječniku ili medicinskoj sestri ako primijetite:
English: Total Polivy dose (mL) to be further diluted = Polivy dose (mg/kg) X patient's weight (kg)
Croatian: doza lijeka Polivy (mg/kg) X tjelesna težina bolesnika (kg) koncentracija rekonstituirane otopine u bočici (20 mg/ml)
English: How to store Polivy
Croatian: Kako čuvati Polivy
English: Based on the population PK analysis there is a decrease of plasma unconjugated MMAE exposure (AUC) after repeated every-three-week dosing.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, nakon ponovljene primjene svaka tri tjedna dolazi do smanjenja plazmatske izloženosti nekonjugiranom MMAE-u (AUC).
English: If primary cause is due to lymphoma, the dose of bendamustine may not need to be reduced.
Croatian: • ako je doza bendamustina prethodno već smanjena na 50 mg/m treba obustaviti primjenu svih lijekova 1Ako je primarni uzrok limfom, možda neće biti potrebno smanjiti dozu bendamustina.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 140 mg
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: More frequent lab monitoring and/or Polivy delays or discontinuation should be considered for patients with Grade 3 or Grade 4 neutropenia and thrombocytopenia (see section 4.2).
Croatian: U bolesnika s neutropenijom i trombocitopenijom 3. ili 4. stupnja treba razmotriti češće laboratorijsko praćenje i/ili odgodu odnosno prekid primjene lijeka Polivy (vidjeti dio 4.2).
English: Table 1 Polivy dose modifications for peripheral neuropathy (PN) Severity of PN on
Croatian: Tablica 1 Prilagodbe doze lijeka Polivy kod periferne neuropatije
English: Grade 2-3
Croatian: Neutropenija 3. - 4. stupnja
English: In nonclinical studies, polatuzumab vedotin has resulted in testicular toxicity, and may impair male reproductive function and fertility (see section 5.3).
Croatian: U nekliničkim je ispitivanjima polatuzumab vedotin bio toksičan za testise pa može utjecati na reproduktivnu funkciju i plodnost muškaraca (vidjeti dio 5.3).
English: Table 4 Summary of ADRs occurring in relapsed or refractory DLBCL patients treated with Polivy in combination with BR Infections and infestations Very common pneumoniaa, herpes virus infectiona, upper respiratory tract infection Common sepsis, cytomegalovirus infection Blood and lymphatic system disorders Very common febrile neutropenia, neutropenia, thrombocytopenia, anaemia, leukopenia, lymphopenia
Croatian: Infekcije i infestacije vrlo često pneumonijaa, infekcija virusom herpesaa, infekcija gornjih dišnih putova često sepsa, citomegalovirusna infekcija Poremećaji krvi i limfnog sustava vrlo često febrilna neutropenija, neutropenija, trombocitopenija, anemija, leukopenija,
English: Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Croatian: Treba razmotriti postupke za pravilno rukovanje protutumorskim lijekovima i njihovo zbrinjavanje.
English: The polatuzumab vedotin molecule consists of MMAE covalently attached to a humanized immunoglobulin G1 monoclonal antibody via a cleavable linker.
Croatian: Molekula polatuzumab vedotina sastoji se od MMAE-a koji je raskidivom poveznicom kovalentno vezan s humaniziranim imunoglobulinskim (G1) monoklonskim protutijelom.
English: In the BR arm, Grade 1 and 2 PN events were reported in 2.6% and 5.1% of patients, respectively.
Croatian: U skupini koja je primala samo BR slučajevi periferne neuropatije 1. i 2. stupnja prijavljeni su u 2,6% odnosno 5,1% bolesnika.
English: No adjustment in the starting dose is required when administering Polivy to patients with mild hepatic impairment (bilirubin greater than ULN to less than or equal to 1.5 × ULN or aspartate transaminase [AST] greater than ULN).
Croatian: Nije potrebno prilagođavati početnu dozu kada se Polivy primjenjuje u bolesnika s blagim oštećenjem jetrene funkcije (bilirubin > GGN i ≤ 1,5 × GGN ili aspartat transaminaza [AST] > GGN).
English: Discard diluted Polivy solution if storage time exceeds the limits specified in Table 1.
Croatian: Razrijeđenu otopinu lijeka Polivy treba baciti ako vrijeme čuvanja premaši razdoblja navedena u Tablici 1.
English: How much Polivy is given
Croatian: Koliko se lijeka Polivy daje
English: Male patients with female partners of childbearing potential should be advised to use effective contraception during treatment with Polivy and for at least 6 months after the last dose (see section 4.6).
Croatian: Bolesnicima čije su partnerice reproduktivne dobi treba savjetovati da koriste učinkovitu kontracepciju tijekom liječenja lijekom Polivy i još najmanje 6 mjeseci nakon posljednje doze (vidjeti dio 4.6).
English: General disorders and administration site conditions Very common fatigue, pyrexia, asthenia, chills Investigations
Croatian: Opći poremećaji i reakcije na mjestu primjene vrlo često umor, pireksija, astenija, zimica
English: No dedicated clinical drug-drug interaction studies with polatuzumab vedotin in humans have been conducted.
Croatian: Nisu provedena posebna klinička ispitivanja interakcija između polatuzumab vedotina i drugih lijekova u ljudi.
English: To be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Croatian: Mora se primjenjivati pod nadzorom liječnika koji ima iskustva s primjenom citotoksičnih lijekova.
English: Very common diarrhoea, nausea, constipation, vomiting, abdominal pain, upper abdominal pain
Croatian: Poremećaji probavnog sustava vrlo često proljev, mučnina, konstipacija, povraćanje, bol u abdomenu, bol u gornjem dijelu abdomena Poremećaji kože i potkožnog tkiva vrlo često pruritus
English: Primary endpoint Complete Response Rate* (IRC-assessed) at End of treatment** Responders (%) Difference in response rate (%) [95% CI] p-value (CMH chi-squared test***) Key secondary and exploratory endpoints Duration of response (INV-assessed) Number of patients included in analysis Number (%) of patients with event Median DOR (95% CI), months HR [95% CI]
Croatian: Ključne sekundarne i eksploracijske mjere ishoda Trajanje odgovora (prema ocjeni ispitivača) Broj bolesnika uključenih u analizu Broj (%) bolesnika s događajem Medijan trajanja odgovora (95% CI), mjeseci HR [95% CI]
English: Polivy contains sodium
Croatian: Polivy sadrži natrij
English: Exposures of unconjugated MMAE, the cytotoxic component of polatuzumab vedotin, increased dose proportionally over the 0.1 to 2.4 mg/kg polatuzumab vedotin dose range.
Croatian: Izloženost nekonjugiranom MMAE-u, citotoksičnoj sastavnici polatuzumab vedotina, povećavala se proporcionalno dozi u rasponu doza polatuzumab vedotina od 0,1 do 2,4 mg/kg.
English: Based on the mechanism of action and nonclinical studies, polatuzumab vedotin can be harmful to the foetus when administered to a pregnant woman.
Croatian: S obzirom na mehanizam djelovanja i podatke iz nekliničkih ispitivanja, polatuzumab vedotin može naškoditi plodu kada se primjenjuje u trudnica.
English: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Croatian: 79639 Grenzach-Wyhlen Njemačka
English: 8.9% of patients in the Polivy plus BR arm discontinued Polivy due to neutropenia compared to 2.6% of patients in the BR arm who discontinued treatment due to neutropenia.
Croatian: Zbog neutropenije je liječenje lijekom Polivy prekinulo 8,9% bolesnika koji su primali Polivy plus BR u odnosu na 2,6% onih koji su primali samo BR.
English: Administer premedication for all cycles.
Croatian: U svim ciklusima treba primijeniti premedikaciju.
English: Bendamustine + rituximab N = 40 Median observation time 22 months
Croatian: Medijan vremena promatranja: 22 mjeseca
English: Table 2 Polivy, bendamustine and rituximab dose modifications for myelosuppression Severity of myelosuppression on
Croatian: Tablica 2 Prilagodbe doze lijeka Polivy, bendamustina i rituksimaba kod mijelosupresije
English: Polivy 140 mg powder for concentrate for solution for infusion polatuzumab vedotin
Croatian: Polivy 140 mg prašak za koncentrat za otopinu za infuziju polatuzumab vedotin
English: After reconstitution each mL contains 20 mg of polatuzumab vedotin.
Croatian: Nakon rekonstitucije jedan ml sadrži 20 mg polatuzumab vedotina.
English: Age did not have an effect on the pharmacokinetics of acMMAE and unconjugated MMAE based on a population PK analysis with patients aged 20-89 years.
Croatian: Prema populacijskoj farmakokinetičkoj analizi podataka prikupljenih u bolesnika u dobi od 20 do 89 godina, dob nije utjecala na farmakokinetiku acMMAE-a ni nekonjugiranog MMAE-a.
English: In patients with mild hepatic impairment [AST or ALT >1.0 to 2.5 × ULN or total bilirubin >1.0 to 1.5 × ULN], n = 54], acMMAE exposures are similar whereas unconjugated MMAE AUC are 40% higher compared to patients with normal hepatic function (n = 399), based on a population PK analysis.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, izloženost acMMAE-u u bolesnika s blagim oštećenjem jetrene funkcije (AST ili ALT > 1,0 do 2,5 × GGN ili ukupni bilirubin > 1,0 do 1,5 × GGN; n=54) slična je kao u bolesnika s normalnom jetrenom funkcijom (n=399), dok je AUC nekonjugiranog MMAE-a 40% veći.
English: Each vial contains 140 milligrams (mg) polatuzumab vedotin.
Croatian: Jedna bočica sadrži 140 miligrama (mg) polatuzumab vedotina.
English: There are insufficient data to assess the impact of severe renal impairment (CrCL 15-29 mL/min, n = 3) on PK. No data are available in patients with end-stage renal disease and/or who are on dialysis.
Croatian: Nema dovoljno podataka da bi se ocijenio utjecaj teškog oštećenja bubrežne funkcije (CrCL: 15 - 29 ml/min; n=3) na farmakokinetiku.
English: Patients should be monitored closely for TLS during treatment with Polivy.
Croatian: Bolesnike treba pažljivo nadzirati zbog mogućeg nastupa sindroma tumorske lize tijekom liječenja lijekom Polivy.
English: Grade 3 or 4 thrombocytopenia or anaemia can also occur with Polivy.
Croatian: Kod primjene lijeka Polivy također se mogu javiti trombocitopenija ili anemija 3. ili 4. stupnja.
English: There are insufficient data to assess the impact of moderate hepatic impairment (total bilirubin > 1.5-3×ULN, n = 2) on PK. No data are available in patients with severe hepatic impairment or liver transplantation.
Croatian: Nema dovoljno podataka da bi se ocijenio utjecaj umjerenog oštećenja jetrene funkcije (ukupni bilirubin > 1,5 - 3 × GGN; n=2) na farmakokinetiku.
English: How Polivy is given
Croatian: Kako se Polivy primjenjuje
English: Grade 3-4 Thrombocytopenia
Croatian: Trombocitopenija 3. - 4. stupnja
English: • problems with your eyesight.
Croatian: • tegobe s vidom
English: Thrombocytopenia events led to discontinuation of treatment in 11.1% of patients in the Polivy plus BR arm and 5.1% of patients in the BR arm. No patients discontinued treatment due to anaemia in either the Polivy plus BR arm or BR arm.
Croatian: Slučajevi trombocitopenije doveli su do prekida liječenja u 11,1% bolesnika koji su primali Polivy plus BR i 5,1% onih koji su primali samo BR.
English: • itchiness
Croatian: • trnci
English: Table 6 Durations for which chemical and physical stability of the prepared solution for infusion have been demonstrated
Croatian: Razdoblja tijekom kojih je dokazana kemijska i fizikalna stabilnost pripremljene otopine za infuziju