FrancophonIA/ELRC3.0 huggingface dataset:
English: Other appropriate measures should be taken, such as blood transfusions, administration of antibiotics and growth factors.
Croatian: Treba poduzeti i druge odgovarajuće mjere kao što su transfuzije krvi, primjena antibiotika i faktora rasta.
English: Hematological toxicity
Croatian: Hematološka toksičnost
English: Studies in animals have shown embryotoxicity and teratogenicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su embriotoksičnost i teratogenost (vidjeti dio 5.3).
English: Instructions for administration should be followed as described in section 6.6.
Croatian: Potrebno je slijediti upute o primjeni kao što je opisano u dijelu 6.6.
English: The recommended dose in adult patients is 320 mg/m² body surface (this is calculated by the doctor based on your weight and your height).
Croatian: Preporučena doza u odraslih bolesnika je 320 mg/m² tjelesne površine (izračunava je liječnik na temelju Vaše težine i visine).
English: Javlor is a concentrate that has to be diluted before administration.
Croatian: Javlor je koncentrat koji se prije primjene mora razrijediti.
English: There are no data available on the use of vinflunine in pregnant women.
Croatian: Nema dostupnih podataka o primjeni vinflunina u trudnica.
English: • The patency should be assessed frequently and extravasation precautions should be maintained throughout the infusion.
Croatian: • Potrebno je često provjeravati protočnost i zadržati mjere opreza za slučaj ekstravazacije cijelo vrijeme trajanja infuzije.
English: Frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Croatian: vrlo česte (≥ 1/10); česte (≥ 1/100 i < 1/10); manje česte (≥ 1/1000 i < 1/100); rijetke (≥ 1/10 000 i < 1/1000); vrlo rijetke (< 1/10 000); nepoznate (ne mogu se procijeniti iz dostupnih podataka).
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se nositelju odobrenja za stavljanje gotovog lijeka u promet.
English: Vinflunine should therefore not be used during pregnancy, unless it is strictly necessary.
Croatian: Stoga vinflunin ne bi trebalo primjenjivati tijekom trudnoće osim u slučaju da je to neophodno.
English: The excretion of vinflunine and its metabolites occurs through faeces (2/3) and urine (1/3).
Croatian: Izlučivanje vinflunina i njegovih metabolita odvija se putem fecesa (2/3) i mokraće (1/3).
English: Efficacy and safety of vinflunine have not been studied in patients with performance status ≥ 2.
Croatian: Djelotvornost i sigurnost vinflunina nisu ispitane u bolesnika s izvedbenim statusom ≥ 2.
English: According to the population pharmacokinetic analysis, neither gender nor performance status (ECOG score) had an impact on vinflunine clearance which is directly proportional to body surface area.
Croatian: Prema populacijskoj farmakokinetičkoj analizi ni spol ni izvedbeni status (prema ECOG ljestvici) nije imao utjecaj na klirens vinflunina koji je izravno proporcionalan površini tijela.
English: Both male and female patients should take adequate contraceptive measures up to three months after the discontinuation of the therapy.
Croatian: I muški i ženski bolesnici trebali bi poduzimati odgovarajuće kontracepcijske mjere do tri mjeseca nakon prekida terapije.
English: Elderly patients (≥ 75 years)
Croatian: Stariji bolesnici (≥ 75 godina)
English: - with transaminases ≤ 2.5xULN ( < 5xULN only in case of liver metastases).
Croatian: - s transaminazama ≤ 2,5xGGN (< 5xGGN samo u slučaju jetrenih metastaza).
English: These medicines affect cancer cell growth by stopping cell division, leading to cell death (cytotoxicity).
Croatian: Ti lijekovi utječu na rast stanica raka zaustavljajući diobu stanica, što dovodi do stanične smrti (citotoksičnost).
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku
English: Constipation is a class effect of the vinca alkaloids: 11.8% of patients experienced severe constipation during treatment with vinflunine.
Croatian: Konstipacija je učinak razreda vinka alkaloida: 11,8% bolesnika imalo je tešku konstipaciju tijekom liječenja vinfluninom.
English: The pharmacokinetic results of this study indicated a reduction of vinflunine clearance when CrCl is decreased.
Croatian: Farmakokinetički rezultati ovog ispitivanja ukazuju na smanjenje klirensa vinflunina kad se smanjuje CrCl.
English: Very common Alopecia
Croatian: Vrlo često Alopecija
English: All metabolites identified are formed by the cytochrome CYP3A4 isoenzyme, except for 4-O-deacetylvinflunine (DVFL), the only active metabolite and main metabolite in blood which is formed by multiple esterases.
Croatian: Sve utvrđene metabolite tvori izoenzim citokroma CYP3A4, osim 4-O-deacetilvinflunina (DVFL), jedinog aktivnog metabolita i glavnog metabolita u krvi kojeg tvori veći broj esteraza.
English: Pharmacotherapeutic group: antineoplasic agents, vinca alkaloids and analogues, ATC code: L01CA05
Croatian: Farmakoterapijska skupina: antineoplastici, vinka alkaloidi i analozi, ATK oznaka: L01CA05 Mehanizam djelovanja
English: Binding to alpha-1 acid glycoprotein and to platelets is negligible (< 5%).
Croatian: Vezanje na alfa-1 kiseli glikoprotein i trombocite je zanemarivo (< 5%).
English: - if you are allergic to the active substance (vinflunine) or to other vinca alkaloids (vinblastine,
Croatian: - ako ste alergični na djelatnu tvar (viniflunin) ili druge vinka alkaloide (vinblastin, vinkristin,
English: You may want to seek counseling on sperm storage before starting your therapy.
Croatian: Ako želite, možete potražiti savjet o pohranjivanju sperme prije početka terapije.
English: The diluted solution should be protected from light until administration (see section 6.3).
Croatian: Razrijeđenu otopinu potrebno je zaštititi od svjetlosti sve do njene primjene (vidjeti dio 6.3).
English: This was further confirmed by the population pharmacokinetic analysis (absence of relationship between vinflunine clearance and biology markers of hepatic impairment).
Croatian: To je dodatno potvrdila populacijska farmakokinetička analiza (izostanak veze između klirensa vinflunina i bioloških markera oštećenja jetre).
English: Rare cases of Posterior Reversible Encephalopathy Syndrome have been reported (see section 4.4).
Croatian: Prijavljeni su rijetki slučajevi posteriornog reverzibilnog encefalopatskog sindroma (vidjeti dio 4.4).
English: Men and women with reproductive potential must use an effective method of contraception during the treatment and up to 3 months after the last vinflunine administration (see section 4.6).
Croatian: Muškarci i žene reproduktivne dobi moraju primjenjivati učinkovitu metodu kontracepcije tijekom liječenja i do 3 mjeseca nakon posljednje primjene vinflunina (vidjeti dio 4.6).
English: Elderly (≥ 75 years)
Croatian: Starije osobe (≥ 75 godina)
English: Worst NCI Grade per patient (%) All grades Grade 3-4
Croatian: Najgori NCI stupanj po bolesniku (%) Svi stupnjevi
English: Pack size of 1 and 10 vials.
Croatian: Veličina pakiranja od 1 i 10 bočica.
English: Patients at high risk of constipation (concomitant treatment with opiates, peritoneal carcinomas, abdominal masses, prior major abdominal surgery) should be medicated with an osmotic laxative from day 1 to day 7 administered once a day in the morning before breakfast.
Croatian: Bolesnike s visokim rizikom konstipacije (istodobno liječenje opijatima, karcinoza peritoneuma, abdominalne mase, prethodna teža operacija abdomena) potrebno je liječiti osmotskim laksativom od 1. do 7. dana koji se uzima jedanput na dan ujutro prije doručka.
English: Table 3: Dose adjustments due to toxicity in renal impaired or elderly patients
Croatian: Tablica 3: Prilagodbe doze zbog toksičnosti u bolesnika s oštećenjem bubrega ili starijih bolesnika
English: If you are a woman or a man of reproductive potential, you should use an adequate method of contraception during treatment and for 3 months after your last dose of Javlor.
Croatian: Ako ste muškarac i ili žena u plodnoj dobi, trebali biste primjenjivati odgovarajuću metodu kontracepcije tijekom liječenja i 3 mjeseca nakon posljednje doze Javlora.
English: In vitro studies showed that vinflunine had neither inducing effects on CYP1A2, CYP2B6 or CYP3A4 activity nor inhibition effects on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4.
Croatian: CYP2B6 ili CYP3A4 ni inhibicijski učinak na CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 i CYP3A4.
English: Vinflunine binds to tubulin at or near to the vinca binding sites inhibiting its polymerisation into microtubules, which results in treadmilling suppression, disruption of microtubule dynamic, mitotic arrest and apoptosis.
Croatian: Vinflunin se veže na tubulin na ili blizu vezivnih mjesta vinka alkaloida inhibirajući njegovu polimerizaciju u mikrotubule, što za posljedicu ima supresiju dinamike citosekeleta, prekid dinamike mikrotubula, mitotski zastoj i apoptozu.
English: All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Croatian: Svi postupci prijenosa zahtijevaju strogu primjenu aseptičkih tehnika, po mogućnosti uporabu zaštitne komore s vertikalnim laminarnim strujanjem zraka.
English: Javlor may cause side effects such as tiredness and dizziness.
Croatian: Javlor može uzrokovati nuspojave kao što su umor i omaglica.
English: It is unknown whether vinflunine or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se vinflunin ili njegovi metaboliti u majčino mlijeko.
English: Ischaemic cardiac events may occur, especially in patients who have underlying cardiac disease.
Croatian: Može doći do razvoja ishemijskih srčanih događaja, osobito u bolesnika koji imaju postojeću srčanu bolest.
English: Vinflunine is moderately bound to human plasma proteins (67.2±1.1%) with a ratio between plasma and whole blood concentrations of 0.80±0.12.
Croatian: Vinflunin se umjereno veže za bjelančevine ljudske plazme (67,2±1,1%) pri čemu je omjer između koncentracija u plazmi i cijeloj krvi 0,80±0,12.
English: IV use ONLY, after dilution
Croatian: SAMO i.v. primjena, nakon razrjeđivanja
English: A pharmacokinetic phase I study of vinflunine was performed in elderly patients (n=46).
Croatian: Farmakokinetičko ispitivanje faze I provedeno je na starijim bolesnicima (n=46).
English: Advice on conservation of sperm should be sought prior to treatment because of the possibility of irreversible infertility due to therapy with vinflunine.
Croatian: Potrebno je potražiti savjet o pohrani sperme prije liječenja zbog mogućnosti ireverzibilne neplodnosti uslijed terapije vinfluninom.
English: Grade 3 vomiting as ≥ 6 episodes in 24 hours over pretreatment; or need for intravenous fluids.
Croatian: Povraćanje 3. stupnja definira se kao ≥ 6 epizoda u 24 sata nakon prethodnog liječenja; ili potreba za intravenskom primjenom tekućine.
English: This is further confirmed by the population pharmacokinetic analysis (56 patients with CrCl between 20 mL/min and 60 mL/min), showing that vinflunine clearance is influenced by the creatinine clearance value (Cockcroft and Gault formula).
Croatian: To je dodatno potvrdila populacijska farmakokinetička analiza (56 bolesnika s CrCl-om između 20 mL/min i 60 mL/min) pokazujući da na klirens vinflunina utječe vrijednost klirensa kreatinina (formula prema Cockcroftu i Gaultu).
English: Platelets < 100,000/mm3(see section 4.4).
Croatian: Trombociti < 100 000/mm³ (vidjeti dio 4.4).
English: Grade 3/4 ileus reported in 1.9% of patients was reversible when managed by medical care.
Croatian: Ileus 3./4.stupnja prijavljen kod 1,9% bolesnika bio je reverzibilan uz primjenu medicinskih sredstava.
English: After dilution of the Javlor concentrate, the solution for infusion will be administered as follows:
Croatian: Nakon razrjeđivanja koncentrata lijeka Javlor, otopina za infuziju primijenit će se na sljedeći način:
English: - “Syndrome of inappropriate antidiuretic hormone secretion”, which is a condition that causes low levels of blood sodium - tumour pain.
Croatian: - "Sindrom neodgovarajućeg izlučivanja antidiuretskog hormona", poremećaj koji uzrokuje niske razine natrija u krvi - tumorska bol.
English: Javlor contains the active substance vinflunine, which belongs to a group of anticancer medicines called vinca alkaloids.
Croatian: Javlor sadrži djelatnu tvar vinflunin koja pripada skupini lijekova protiv raka nazvanih vinka alkaloidi.
English: Blood exposure to vinflunine (AUC), significantly correlated with severity of leucopenia, neutropenia and fatigue.
Croatian: Izloženost vinfluninu u krvi (AUC) u značajnoj je korelaciji s težinom leukopenije, neutropenije i umora.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim dopunama Plana.
English: Median PFS was 3.0 months (vinflunine + BSC) vs 1.5 months (BSC) (p=0.0012).
Croatian: Medijan preživljenja bez progresije bolesti (PFS) bio je 3,0 mjeseca (vinflunin + BSC) naspram 1,5 mjeseci (BSC) (p=0,0012).
English: Neutropenia Grade 4 (ANC < 500/mm3) > 7 days
Croatian: Neutropenija 4. stupnja (ABN< 500/mm³) > 7 dana
English: Paediatric population There is no relevant use of Javlor in the paediatric population.
Croatian: Pedijatrijska populacija Nema bitne indikacije za primjenu lijeka Javlor u pedijatrijskoj populaciji.
English: Uncommon Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) a
Croatian: Manje često Sindrom neodgovarajućeg izlučivanja antidiuretskog hormona (SIADH) a
English: Pregnant staff should not handle Javlor.
Croatian: Trudnice ne smiju rukovati Javlorom.
English: Posterior Reversible Encephalopathy Syndromea
Croatian: Posteriorni reverzibilni encefalopatski sindroma
English: No modification of vinflunine and DVFL pharmacokinetics was observed in 25 patients presenting varying degrees of hepatic impairment, compared to patients with normal hepatic function.
Croatian: Nisu zabilježene nikakve promjene farmakokinetike vinflunina i DVFL-a u 25 bolesnika s različitim stupnjevima oštećenja jetre u usporedbi s bolesnicima s normalnom funkcijom jetre.
English: Posology The recommended dose is 320 mg/m² vinflunine as a 20 minute intravenous infusion every 3 weeks.
Croatian: Doziranje Preporučena doza je 320 mg/m² vinflunina u obliku 20-minutne intravenske infuzije svaka 3 tjedna.
English: Sensory peripheral neuropathy is a class effect of the vinca alkaloids.
Croatian: Periferna senzorna neuropatija je učinak razreda vinka alkaloida.
English: In vitro studies showed that vinflunine is a Pgp-substrate like other vinca alkaloids, but with a lower affinity.
Croatian: Ispitivanja in vitro pokazala su da je vinflunin Pgp-supstrat poput drugih vinka alkaloida, ali s nižim afinitetom.
English: Definitive Treatment discontinuation
Croatian: Konačan prekid liječenja
English: Discontinuation of vinflunine should be considered in patients who develop cardiac ischaemia.
Croatian: Treba razmotriti prekid terapije vinfluninom u bolesnika koji razviju srčanu ishemiju.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Javlor in all subsets of the paediatric population in the treatment of ureter and bladder carcinoma and the treatment of breast carcinoma (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Javlor u svim podskupinama pedijatrijske populacije u indikaciji liječenja karcinoma mokraćovoda i mokraćnog mjehura i liječenja karcinoma dojke (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Therefore, regular monitoring of serum sodium levels is recommended during treatment with vinflunine.
Croatian: Stoga se preporučuje provoditi redovito praćenje razine natrija u serumu tijekom liječenja vinfluninom.
English: Vinflunine pharmacokinetics is linear in the range of administered doses (from 30 mg/m² to 400 mg/m2) in cancer patients.
Croatian: Farmakokinetika vinflunina je linearna u rasponu primijenjenih doza (od 30 mg/m² do 400 mg/m2) u bolesnika s rakom.
English: No pharmacokinetic interaction was observed in patients when vinflunine was combined with either cisplatin, carboplatin, capecitabine or gemcitabine.
Croatian: Nije primijećena farmakokinetička interakcija u bolesnika prilikom kombiniranja vinflunina s cisplatinom, karboplatinom, kapecitabinom ili gemcitabinom.
English: It comes in clear glass vials closed by a rubber stopper containing 2 mL, 4 mL or 10 mL of concentrate.
Croatian: Isporučuje se u prozirnim staklenim bočicama zatvorenim gumenim čepom koje sadrže 2 mL, 4 mL ili 10 mL koncentrata.
English: Grade ≥ 3 constipation occurred in 15.3% of treated patients.
Croatian: Konstipacija ≥ 3. stupnja pojavila se kod 15,3% liječenih bolesnika.
English: Grade 3 was experienced by 0.6% patients.
Croatian: 3. stupanj imalo je 0,6% bolesnika.
English: During the pre- and post-natal development study in rat, vinflunine induced malformations of the uterus and vagina in 2 females, and adversely affected mating and/or ovule implantation and markedly lowered the number of concepti.
Croatian: Tijekom ispitivanja prenatalnog i postnatalnog razvoja u štakora vinflunin je inducirao malformacije maternice i rodnice kod 2 ženke i negativno utjecao na parenje i/ili implantaciju jajašca te značajno smanjio broj zametaka.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su navedene u padajućem slijedu prema ozbiljnosti.
English: Glucose 50 mg/mL (5%) solution for infusion may also be used.
Croatian: Može se upotrijebiti i otopina glukoze 50 mg/mL (5%) za infuziju.
English: Respiratory, thoracic and mediastinal disorders Dyspnoea occurred in 3.2% of the patients but was rarely severe (Grade 3/4: 1.2%).
Croatian: Dispneja se pojavila kod 3,2% bolesnika, no rijetko je bila teška (3./4. stupnja: 1,2%).
English: Due to the possible very harmful effects on the infants, breast-feeding during treatment with vinflunine is contraindicated (see section 4.3).
Croatian: Zbog mogućih vrlo štetnih učinaka na dojenčad, dojenje je tijekom liječenja vinfluninom kontraindicirano (vidjeti dio 4.3).
English: Grade 2 is defined as “moderate”, Grade 3 as “severe” and Grade 4 as “life-threatening” (see Table 2 in section 4.2).
Croatian: 2. stupanj definira se kao "umjeren", 3. stupanj kao "težak", a 4. stupanj kao "opasan po život" (vidjeti Tablicu 2 u dijelu 4.2).
English: The concomitant use of potent inhibitors or potent inducers of CYP3A4 with vinflunine should be avoided (see section 4.5).
Croatian: Potrebno je izbjegavati istodobnu uporabu potentnih inhibitora ili potentnih induktora CYP3A4 s vinfluninom (vidjeti dio 4.5).
English: Procedure for proper handling and disposal of anticancer medicinal products should be considered.
Croatian: Treba razmotriti postupke za pravilno rukovanje i zbrinjavanje protutumorskih lijekova.
English: A pharmacokinetic interaction between vinflunine and pegylated/liposomal doxorubicin was observed, resulting in a 15% to 30% apparent increase in vinflunine exposure and a 2 to 3-fold apparent decrease of doxorubicin AUC, whereas for doxorubicinol, the concentrations of the metabolite were not affected.
Croatian: Primijećena je farmakokinetička interakcija između vinflunina i pegiliranog/liposomalnog doksorubicina koja je za posljedicu imala 15%-tno do 30%-tno prividno povećanje izloženosti vinfluninu i dvostruko do trostruko prividno smanjenje AUC-a doksorubicina, dok za doksorubicinol koncentracije metabolita nisu bile promijenjene.
English: Elderly patients (≥ 75 years) The recommended dose should be reduced in patients 75 years old and beyond (see section 4.2).
Croatian: Stariji bolesnici (≥ 75 godina) Preporučenu dozu treba smanjiti u bolesnika u dobi od 75 i više godina (vidjeti dio 4.2).
English: The main toxic effect due to an overdose with vinflunine is bone marrow suppression with a risk of severe infection.
Croatian: Glavni toksični učinak predoziranja vinfluninom je supresija koštane srži s rizikom od teške infekcije.
English: • The Javlor solution for infusion should be infused over 20 minutes.
Croatian: • Infuzija Javlor otopine za infuziju treba trajati 20 minuta.
English: Vinflunine clearance was significantly decreased in patients ≥ 80 years old as compared to a control group of younger patients < 70 years.
Croatian: Klirens vinflunina značajno se smanjio u bolesnika u dobi od 80 i više godina u usporedbi s kontrolnom skupinom bolesnika mlađih od 70 godina.
English: The typical clinical symptoms are, with various degrees: neurological (headache, confusion, seizure, visual disorders), systemic (hypertension), and gastrointestinal (nausea, vomiting).
Croatian: Tipični klinički simptomi različitog stupnja su: neurološki (glavobolja, konfuzija, napadaji, poremećaji vida), sustavni (hipertenzija) i gastrointestinalni (mučnina, povraćanje).
English: 2nd consecutive event
Croatian: 2. uzastopni događaj
English: Day 1 treatment administration
Croatian: Dan 1 liječenja
English: The median overall survival was 6.9 months (vinflunine + BSC) vs. 4.6 months (BSC), but the difference did not reach statistical significance; hazard ratio 0.88 (95% CI 0.69, 1.12).
Croatian: Medijan ukupnog preživljenja bio je 6,9 mjeseci (vinflunin + BSC) naspram 4,6 mjeseci (BSC), no ova razlika nije dosegla statističku značajnost; omjer hazarda 0,88 (95%-tni CI 0,69, 1,12).
English: Vinflunine treatment should be initiated under the responsibility of a physician qualified in the use of anticancer chemotherapy and is confined to units specialised in the administration of cytotoxic chemotherapy.
Croatian: Liječenje vinfluninom potrebno je započeti pod nadzorom liječnika koji je kvalificiran za primjenu kemoterapije i ograničiti na jedinice koje su specijalizirane za davanje citotoksične kemoterapije.
English: Discontinuation of vinflunine should be considered in patients who develop neurological signs of PRES (see section 4.8).
Croatian: Treba razmotriti prekid terapije vinfluninom u bolesnika koji razvijaju neurološke znakove PRES-a (vidjeti dio 4.8).
English: Severe anaemia and thrombocytopenia were less common (respectively 8.8 and 3.1 %).
Croatian: Teška anemija i trombocitopenija bile su manje česte (8,8% odnosno 3,1%).
English: Adverse reactions are listed below by System Organ Class, frequency and grade of severity (NCI CTC version 2.0).
Croatian: Nuspojave navedene u nastavku su klasificirane prema organskom sustavu, učestalosti i stupnju ozbiljnosti (NCI CTC verzija 2.0).
English: When infused through a peripheral vein, vinflunine can induce venous irritation (see section 4.4).
Croatian: Kad se daje kao infuzija kroz perifernu venu, vinflunin može potaknuti vensku iritaciju (vidjeti dio 4.4).
English: Preclinical data revealed moderate to severe neutropenia and mild anaemia, in all species tested, with liver toxicity in dogs and rats (characterized by dose-dependent increases in liver transaminases and hepatic necrosis/hepatocellular alterations at high doses).
Croatian: Neklinički podaci pokazali su umjerenu do tešku neutropeniju i blagu anemiju kod svih ispitanih vrsta uz jetrenu toksičnost kod pasa i štakora (koju karakteriziraju o dozi ovisna povećanja jetrenih transaminaza i nekroza jetre/hepatoceluralne promjene pri visokim dozama).