natgillin/translations-raw huggingface dataset:
Uncommon Acute respiratory distress syndrome 
Manje često Akutni respiratorni distres sindrom
- The active substance is vinflunine. 
- Djelatna tvar je vinflunin.
How to store Javlor 
Kako primjenjivati Javlor
The concomitant use of vinflunine with others QT/QTc interval prolonging medicinal products should be avoided (see section 4.4). 
Treba izbjegavati istodobnu primjenu vinflunina s drugim lijekovima koji produljuju QT/QTc interval (vidjeti dio 4.4).
Grade 3/4 neutropenia was observed in 43.8% of patients. 
Neutropenija 3./4. stupnja zabilježena je kod 43,8% bolesnika.
Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen 
Javlor je indiciran u monoterapiji za liječenje odraslih bolesnika s uznapredovalim ili metastatskim karcinomom prijelaznih stanica urotelijalnog trakta nakon neuspjeha prethodnog protokola koji je sadržavao platinu.
Blood pressure should be controlled in patients developing symptoms of PRES. To confirm the diagnosis, brain imaging is recommended. 
Potrebno je kontrolirati krvni tlak u bolesnika koji razvijaju simptome PRES-a.
In the two multi-centre open-label, single-arm phase II clinical trials a total of 202 patients were treated with vinflunine. 
U dva multicentrična otvorena klinička ispitivanja faze II s jednim krakom, 202 bolesnika liječena su vinfluninom.
Infection with Grade 3/4 neutropenia was observed in 2.8 % of patients. 
Infekcija s neutropenijom 3./4. stupnja zabilježena je kod 2,8% bolesnika.
Vinflunine is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Javlor. 
Vinflunin je citotoksični protutumorski lijek pa je pri rukovanju s Javlorom, kao i s drugim potencijalno toksičnim spojevima, potreban oprez.
• At the request of the European Medicines Agency; 
Nadalje, nadopunjeni RMP treba dostaviti: • Na zahtjev Europske agencije za lijekove:
Bronchospam was reported in one patient treated with vinflunine for a different setting from the indication. 
Bronhospazam je prijavljen kod jednog bolesnika koji je primao vinflunin u drugoj indikaciji.
For further cycles, the dose should be adjusted in the event of toxicities, as shown in table 3 below: 
Za daljnje cikluse dozu je potrebno prilagoditi u slučaju toksičnosti kako je prikazano u tablici 3 u nastavku:
- Delay until recovery to mild toxicity or none, or to initial baseline status and adjust the dose if necessary (see table 2) - Discontinuation if recovery has not occurred within 2 weeks 
Odgoditi do oporavka tj. blage ili nikakve toksičnosti ili do postizanja početnog stanja i prilagoditi dozu ako je potrebno (vidjeti tablicu 2)
A possible interaction with paclitaxel and docetaxel (CYP3 substrates) has been suggested from an in vitro study (slight inhibition of vinflunine metabolism). 
Jedno in vitro ispitivanje uputilo je na moguću interakciju s paklitakselom i docetakselom (supstrati CYP3) (blaga inhibicija metabolizma vinflunina).
Neutropenia, leucopenia, anaemia and thrombocytopenia are frequent adverse reactions of vinflunine. 
Neutropenija, leukopenija, anemija i trombocitopenija česte su nuspojave vinflunina.
Javlor 25 mg/mL sterile concentrate vinflunine 
Javlor 25 mg/mL sterilni koncentrat vinflunin
A statistically significant difference on overall survival (p=0.040) was also seen in the eligible population (which excluded 13 patients with clinically significant protocol violations at baseline who were not eligible for treatment); hazard ratio 0.78 (95% CI 0.61, 0.99). 
Uočena je i statistički značajna razlika u ukupnom preživljenju (p=0,040) populacije koja je zadovoljila uključne kriterije (iz koje je isključeno 13 bolesnika s klinički značajnim kršenjima protokola na početku ispitivanja koji nisu bili zadovoljili uključne kriterije); omjer hazarda 0,78 (95%-tni interval pouzdanosti (CI 0,61, 0,99).
Vinflunine has shown to be clastogenic (induces chromosome breakage) in the in vivo micronucleus test in rat as well as mutagenic and clastogenic in a mouse lymphoma assay (without metabolic activation). 
Mikronukleus test in vivo na štakorima pokazao je da je vinflunin klastogen (inducira lomove kromosoma), dok se u testu mišjeg limfoma pokazao kao mutagen i klastogen (bez metaboličke aktivacije).
Table 4 Adverse reactions observed in patients with transitional cell carcinoma of the urothelium treated with vinflunine 
Tablica 4 Nuspojave zabilježene u bolesnika s karcinomom prijelaznih stanica urotela liječenih vinfluninom
For storage conditions after dilution of the medicinal product, see section 6.3. 
Uvjete čuvanja nakon razrjeđivanja lijeka, vidjeti u dijelu 6.3.
Javlor is a clear, colourless to pale yellow solution. 
Javlor je bistra, bezbojna do blijedožuta otopina.
For further cycles, the dose should be adjusted in the event of toxicities, as shown in table 3 below. 
Za daljnje cikluse dozu je potrebno prilagoditi u slučaju toksičnosti kako je prikazano u tablici 3 u nastavku.
Ear and Labyrinth disorders 
Poremećaji uha i labirinta
Either peripheral lines or a central catheter can be used for vinflunine administration. 
Za primjenu vinflunina mogu se koristiti periferni put ili centralni kateter.
3rd consecutive event 
3. uzastopni događaj
Thrombocytopenia (platelets < 100,000/mm3) 
Trombocitopenija (trombociti < 100 000/mm³)
A phase I study evaluating the effect of ketoconazole treatment (a potent CYP3A4 inhibitor) on vinflunine pharmacokinetics indicated that co-administration of ketoconazole (400 mg orally once daily for 8 days) resulted in a 30% and 50% increase in blood exposures to vinflunine and its metabolite 4Odeacetyl-vinflunine (DVFL), respectively. 
na farmakokinetiku vinflunina pokazalo je da je istodobna primjena ketokonazola (400 mg oralno jedanput na dan tijekom 8 dana) za posljedicu imala 30%-tno i 50%-tno povećanje izloženosti vinfluninu u krvi, odnosno njegovu metabolitu
Vinflunine doses were adjusted according to 3 age groups as shown below: 
Doze vinflunina bile su prilagođene prema 3 dobne skupine kako je prikazano u nastavku: Dob (y)
Storage conditions 
Uvjeti čuvanja
Javlor is used to treat advanced or metastatic cancer of the bladder and urinary tract when a previous therapy with platinum-containing medicines has failed. 
Javlor se koristi za liječenje uznapredovalog ili metastatskog raka mokraćnog mjehura i mokraćnih puteva nakon neuspjeha prethodne terapije koja je uključivala platinu.
One phase III and two phase II trials support the use of Javlor for treatment of advanced or metastatic transitional cell carcinoma of the urothelium as second-line therapy after failure of a prior platinumcontaining regimen. 
Klinička djelotvornost i sigurnost Jedno ispitivanje faze III i dva ispitivanja faze II podržavaju uporabu Javlora za liječenje uznapredovalog ili metastatskog karcinoma prijelaznih stanica urotela kao terapiju druge linije nakon neuspjeha prethodnog protokola s platinom.
Constipation is a very common side effect of Javlor. 
Zatvor je vrlo česta nuspojava Javlora.
The recommended dose should be reduced in patients with haematological toxicity (see section 4.2). 
Preporučenu dozu treba smanjiti u bolesnika s hematološkom toksičnosti (vidjeti dio 4.2).
One 2 mL vial contains 50 mg of vinflunine (as ditartrate) One 4 mL vial contains 100 mg of vinflunine (as ditartrate) One 10 mL vial contains 250 mg of vinflunine (as ditartrate) 
Jedna bočica od 2 mL sadrži 50 mg vinflunina (u obliku ditartarata) Jedna bočica od 4 mL sadrži 100 mg vinflunina (u obliku ditartarata) Jedna bočica od 10 mL sadrži 250 mg vinflunina (u obliku ditartarata)
Javlor MUST ONLY be administered intravenously. 
Javlor se MORA primjenjivati SAMO intravenski.
In particular, you should tell your doctor if you are taking medicines containing any of the following active substances: - ketoconazole and itraconazole, used to treat fungal infection, - opioids, used to treat pain, - ritonavir, used to treat HIV infection, - doxorubicin and pegylated liposomal doxorubicin, used to treat some kinds of cancer, - rifampicin, used to treat tuberculosis or meningitis, - herbal preparation containing hypericum perforatum (St John's wort) used to treat minor to moderate depression. 
opioidi, koji se koriste za liječenje boli, - ritonavir, koji se koristi za liječenje infekcije virusom HIV-a, - doksorubicin i pegilirani liposomalni doksorubicin, koji se koriste za liječenje nekih vrsta raka, - rifampicin, koji se koristi za liječenje tuberkuloze ili meningitisa, - biljni pripravak koji sadrži hypericum perforatum (Gospinu travu) koja se koristi za liječenje blage do umjerene depresije.
Pierre Fabre Médicament 45, Place Abel Gance F-92100 Boulogne France 
Pierre Fabre Médicament 45, Place Abel Gance F-92100 Boulogne Francuska
Pierre Fabre Médicament 45, place Abel Gance F-92100 Boulogne France 
Pierre Fabre Médicament 45, place Abel Gance F-92100 Boulogne Francuska
Efficacy was demonstrated in both patients with or without prior cisplatin use. 
Djelotvornost je bila dokazana i kod bolesnika s prethodnom primjenom cisplatina i kod bolesnika koji prethodno nisu primali cisplatin.
- chills, excessive sweating - allergy, dehydration, headache, skin rash, itching - digestive problems, pain in the mouth, on the tongue and toothache, taste alteration - muscular weakness, pain in jaw, pain in extremity, back pain, pain in joints, muscular pain, bone pain, ear pain - dizziness, insomnia, transiant loss of consciousness - difficulties with body movements - fast heartbeat, raised blood pressure, reduced blood pressure - breathing difficulties, cough, chest pain - swelling of your arms, hands, feet, ankles, legs or other parts of your body - inflammation of the veins (phlebitis). 
koštana bol, bol u uhu - omaglica, nesanica, privremeni gubitak svijesti - otežani tjelesni pokreti - ubrzano kucanje srca, povišeni krvni tlak, sniženi krvni tlak - otežano disanje, kašalj, bol u prsima - oticanje ruku, šaka, stopala, gležnjeva, nogu ili drugih dijelova tijela - upala vena (flebitis).
The volume of Javlor (concentrate) corresponding to the calculated dose of vinflunine should be mixed in a 100 mL bag of sodium chloride 9 mg/mL (0.9%) solution for infusion. 
Razrjeđivanje koncentrata Volumen Javlora (koncentrata) koji odgovara izračunatoj dozi vinflunina treba umiješati u 100-mililitarsku vrećicu otopine natrijeva klorida 9 mg/mL (0,9%) za infuziju.
Any other toxicity Grade ≥ 3 (severe or life-threatening) (except Grade 3 vomiting or nausea2) 
U slučaju toksičnosti probavnog sustava ≥3. stupnju (osim povraćanja ili mučnine) ili mukozitisa (2.
Febrile neutropenia defined as ANC < 1,000/mm3and fever ≥ 38.5°C of unknown origin without clinically microbiologically documented infection (NCI CTC version 2.0) was observed in 5.2% of patients. 
≥ 38,5°C nepoznatog podrijetla bez klinički mikrobiološki dokumentirane infekcije (NCI CTC
Thus, patients receiving Javlor should be vigilantly monitored by physicians for the occurrence of cardiac events. 
Stoga liječnici trebaju pozorno pratiti pojavu srčanih događaja u bolesnika koji primaju Javlor.
Javlor may cause adverse reactions such as fatigue (very common) and dizziness (common) which may lead to a minor or moderate influence on the ability to drive and use machines..Patients should be advised not to drive or use machines if they experience any adverse reaction with a potential impact on the ability to perform these activities (see section 4.8). 
Javlor može uzrokovati nuspojave kao što su umor (vrlo često) i omaglica (često) koje mogu dovesti do manjeg ili umjerenog utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.
1 vial of 2 mL 10 vials of 2 mL 1 vial of 4 mL 10 vials of 4 mL 1 vial of 10 mL 10 vials of 10 mL 
10 bočica od 2 mL 1 bočica od 4 mL 10 bočica od 4 mL 1 bočica od 10 mL 10 bočica od 10 mL
Table 1: Dose delay for subsequent cycles due to toxicity 
Odgoda ili prekid liječenja zbog toksičnosti Tablica 1: Odgoda narednog ciklusa zbog toksičnosti Toksičnost
- The recommended dose of vinflunine is 200 mg/m² given once every 3 weeks in patients with moderate liver impairment (Child-Pugh grade B) or in patients with a prothrombin time ≥ 50% NV and bilirubin > 3×ULN and transaminases > ULN and GGT > ULN. 
- Preporučena doza vinflunina je 200 mg/m² primijenjena jedanput svaka 3 tjedna u bolesnika s umjerenim oštećenjem jetre (Child-Pugh stadij B) ili u bolesnika s protrombinskim vremenom ≥ 50% NV i bilirubinom > 3×GGN i transaminazama > GGN i GGT > GGN.
Severe hyponatraemia, including cases due to syndrome of inappropriate antidiuretic hormone secretion (SIADH), has been observed with the use of vinflunine (see section 4.8). 
Kod primjene vinflunina primijećena je teška hiponatremija, uključujući slučajeve koji su posljedica sindroma neodgovarajućeg izlučivanja antidiuretskog hormona (SIADH) (vidjeti dio 4.8).
Decreased appetite Common Dehydration 
Vrlo često Hiponatremija Smanjen apetit
Very common Asthenia/Fatigue Injection site reaction Pyrexia 
Vrlo često Astenija/umor Reakcija na mjestu injiciranja
Before each cycle, adequate monitoring of complete blood counts should be conducted to verify the absolute neutrophil count (ANC), platelets and haemoglobin as neutropenia, thrombocytopenia and anaemia are frequent adverse reactions of vinflunine. 
Prije svakog ciklusa potrebno je provesti odgovarajuću provjeru kompletne krvne slike radi provjere apsolutnog broja neutrofila (ABN), trombocita i hemoglobina s obzirom na to da su neutropenija,
For subsequent administrations, vinflunine is contraindicated in subjects with baseline ANC < 1,000/mm3 or platelets < 100,000/mm3. 
Za sljedeće primjene vinflunin je kontraindiciran u ispitanika s početnim ABN-om < 1000/mm³ ili trombocitima < 100 000/mm³.
- protected from light in polyethylene or polyvinylchloride infusion bag: for up to 6 days in a refrigerator (2°C-8°C) or for up to 24 hours at 25°C; 
Dokazana je kemijska i fizikalna stabilnost razrijeđenog lijeka u sljedećim slučajevima: - zaštićen od svjetlosti u infuzijskoj vrećici od polietilena ili polivinilklorida: do 6 dana u hladnjaku (2°C- 8°C) ili do 24 sata na temperaturi od 25°C; - izložen svjetlosti u infuzijskom kompletu od polietilena ili polivinilklorida do 1 sat na temperaturi od 25°C.
- with a prothrombin time > 70% NV (Normal Value) and presenting at least one of the following criteria: [ ULN (Upper Limit of Normal) < bilirubin ≤ 1.5×ULN and/or 1.5xULN < transaminases ≤ 2.5×ULN and/or ULN < GGT ≤ 5×ULN ]. 
Nije potrebna prilagodba doze u bolesnika: - s protrombinskim vremenom > 70% NV (normalne vrijednosti) i jednim od navedenog: [ GGN (gornja granica normale) < bilirubin ≤ 1,5×GGN i/ili 1,5xGGN < transaminaze ≤ 2,5×GGN i/ili GGN < GGT ≤ 5×GGN ].
NCI CTC Grade 3 constipation is defined as an obstipation requiring manual evacuation or enema, Grade 4 constipation as an obstruction or toxic megacolon. 
Konstipacija 3. stupnja prema kriterijima NCI CTC definira se kao opstipacija koja zahtijeva ručnu evakuaciju stolice ili primjenu klizme, dok se 4. stupanj definira kao opstrukcija ili toksični megakolon.
- visual disturbances - dry skin, redness of the skin - muscle contraction disorders - pain in the throat, gum disorders - weight increase - urinary problems - ringing or buzzing in the ears (tinnitus) - increase in liver enzymes (seen in blood test) 
- tegobe s mokrenjem - zvonjenje ili zujanje u ušima (tinitus) - povećanje jetrenih enzima (na temelju krvnih pretraga)
Water for injections as excipient. 
POPIS POMOĆNIH TVARI Voda za injekcije kao pomoćna tvar.
The doses recommended in patients of at least 75 years old are as follows: - in patients of at least 75 years old but less than 80 years, the dose of vinflunine to be given is 280 mg/m² every 3 weeks. 
- u bolesnika koji imaju najmanje 75 godina, ali manje od 80 godina, doza vinflunina koja se primjenjuje je 280 mg/m² svaka 3 tjedna. - u bolesnika koji imaju 80 ili više godina doza vinflunina koja se primjenjuje je 250 mg/m² svaka 3 tjedna.
In the absence of any haematological toxicity during the first cycle causing treatment delay or dose reduction, the dose will be increased to 320 mg/m² every 3 weeks for the subsequent cycles. 
U odsustvu bilo kakve hematološke toksičnosti tijekom prvog ciklusa koja bi prouzročila odgodu liječenja ili smanjenje doze,
• After the infusion is completed, the remaining 250 mL from the sodium chloride 9 mg/mL (0.9%) solution for infusion or of glucose 50 mg/mL (5%) solution for infusion bag should be run at a flowing rate of 300 mL/h. 
• Po završetku infuzije preostalih 250 mL otopine natrijeva klorida 9 mg/mL (0,9%) za infuziju ili otopine glukoze 50 mg/mL (5%) za infuziju iz vrećice treba pustiti da iscuri pri slobodnom protoku od 300 mL/h.
- The recommended dose of vinflunine is 250 mg/m² given once every 3 weeks in patients with mild liver impairment (Child-Pugh grade A) or in patients with a prothrombin time ≥ 60% NV and 1.5×ULN < bilirubin ≤ 3×ULN and presenting at least one of the following criteria: [ transaminases > ULN and/or GGT > 5×ULN ]. 
- Preporučena doza vinflunina je 250 mg/m² primijenjena jedanput svaka 3 tjedna u bolesnika s blagim oštećenjem jetre (Child-Pugh stadij A) ili u bolesnika s protrombinskim vremenom ≥ 60% NV i 1,5×GGN < bilirubin ≤ 3×GGN i jednim od navedenog: [ transaminaze > GGN i/ili GGT > 5×GGN ].
Recommended co-medication 
NAČIN PRIMJENE LIJEKA
Vinflunine is eliminated following a multi-exponential concentration decay, with a terminal half-life (t1/2) close to 40 h. DVFL is slowly formed and more slowly eliminated than vinflunine (t1/2 of approximately 120 h). 
DVFL se polako stvara i eliminira sporije nego vinflunin (t½ otprilike 120 h).
- Discontinuation 
Prekid
• The intravenous infusion should be started with half of the 500 mL bag of sodium chloride 9 mg/mL (0.9%) solution for infusion or of glucose 50 mg/mL (5%) solution for infusion, i.e. 250 mL, at a free flowing rate to flush the vein. 
• Intravensku infuziju treba početi s polovicom 500-mililitarske vrećice otopine natrijeva klorida 9 mg/mL (0,9%) za infuziju ili otopine glukoze 50 mg/mL (5%) za infuziju, tj. 250 mL uz slobodan protok kako bi se vena isprala.
Vinflunine has not been evaluated in patients with severe hepatic impairment (Child-Pugh grade C), or in patients with a prothrombin time < 50%NV or with bilirubin > 5xULN or with isolated transaminases > 2.5xULN ( ≥ 5xULN only in case of liver metastases) or with GGT > 15xULN. 
Vinflunin nije ispitan u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) ili u bolesnika s protrombinskim vremenom < 50%NV ili s bilirubinom > 5xGGN ili s pojedinim transaminazama
Package Leaflet: Information for the user Javlor 25 mg/mL concentrate for solution for infusion vinflunine 
Uputa o lijeku: Informacija za korisnika Javlor 25 mg/mL koncentrat za otopinu za infuziju vinflunin
Tell your doctor immediately if you develop any of the following serious side effects while being treated with Javlor: - fever and / or chills which could be signs of infection, - chest pain which could be sign of heart attack, - constipation that resists to laxative treatment, - headaches, changed mental state which may lead to confusion and coma, convulsions, blurred vision and high blood pressure, which could be sign of a neurological disorder such as “posterior reversible encephalopathy syndrome” (see section 2 “warnings and precautions”). 
Odmah obavijestite liječnika ako razvijete bilo koju od sljedećih ozbiljnih nuspojava tijekom liječenja Javlorom: - vrućicu i/ili zimicu koje mogu biti znakovi infekcije, - bol u prsima koja može biti znak srčanog udara, - zatvor koji ne reagira na liječenje laksativima,
Tell your doctor: - if you have liver, kidney or heart problems, - if you experience any neurological symptoms such as headaches, changed mental state which may lead to confusion and coma, convulsions, blurred vision and high blood pressure as you may need to stop taking this medicine, - if you are taking other medicines mentioned in “Using other medicines” below, - if you have constipation, or if you are treated with medicines against pain (opioids), or if you have an abdominal cancer, or if you had abdominal surgery, - if you would like to father a child (see “Pregnancy, breast-feeding and fertility” below). 
- ako imate bilo koje neurološke simptome kao što su glavobolje, promjene duševnog stanja koje mogu dovesti do smetenosti i kome, konvulzije, zamućeni vid i visok krvni tlak jer ćete možda morati prestati uzimati ovaj lijek, - ako uzimate druge lijekove navedene u poglavlju
Initiation of vinflunine is contraindicated in subjects with baseline ANC < 1,500/mm3 or platelets < 100,000/mm3. 
Započinjanje terapije vinfluninom kontraindicirano je u ispitanika s početnim ABN-om < 1500/mm³ ili trombocitima < 100 000/mm³.
When adjusted on prognostic factors, the analyses of OS in the subgroups of patients without or with prior cisplatin showed a HR (95% CI) = [0.53 (0.32 - 0.88); p=0.0143] and a HR (95% CI) = [0.70 (0.530.94); p=0.0174], respectively. 
Nakon prilagodbe za prognostičke čimbenike analize OS-a u podskupinama bolesnika bez prethodne primjene cisplatina ili s njom pokazale su omjer hazarda (HR) (95%-tni CI) = [0,53 (0,32 - 0,88); p=0,0143] odnosno omjer hazarda (HR) (95%-tni CI) = [0,70 (0,53 - 0,94); p=0,0174].
Few QT interval prolongations have been observed after the administration of vinflunine. 
Nakon primjene vinflunina primijećen je manji broj produljenja QT intervala.
Vinflunine initial dose of 320 mg/m² 
Početna doza vinflunina od 320 mg/m²
Adequate monitoring of complete blood counts should be conducted to verify the ANC, platelet and haemoglobin values before each vinflunine infusion (see section 4.3). 
Prije svake infuzije vinflunina treba provesti odgovarajuću kontrolu kompletne krvne slike radi provjere vrijednosti ABN-a, trombocita i hemoglobina (vidjeti dio 4.3).
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE
Your doctor will adjust the starting dose of Javlor based on your age and physical conditions and in specific situations: - if you had a previous irradiation of the pelvis - if you have moderate or severe kidney problems - if you have liver problems. 
Liječnik će prilagoditi početnu dozu Javlora ovisno o vašoj dobi i tjelesnom stanju i posebnim okolnostima:
• A venous access should be established for a 500 mL bag of sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for infusion, on a large vein preferably in the upper part of the forearm or using a central venous line. 
• Treba pripremiti venski pristup za 500-mililitarsku vrećicu otopine natrijeva klorida 9 mg/mL (0,9%) za injekciju ili otopine glukoze 50 mg/mL (5%) za infuziju u veliku venu, po mogućnosti na gornjem dijelu podlaktice ili koristeći centralni venski kateter.
Very common Weight decreased Uncommon Transaminases increased Weight increased aadverse reactions reported from post-marketing experience bfrequency calculated on the basis of non-TCCU clinical trial 
Povećanje tjelesne težine anuspojave prijavljene nakon stavljanja lijeka u promet bučestalost izračunata na temelju kliničkog ispitivanja koje nije povezano s karcinomom tranzicijskih stanica urotela
Vinflunine initial dose of 250 mg/m² 
Početna doza vinflunina od 250 mg/m²
Dose adjustments are recommended in patients with moderate and severe renal impairment (see section 4.2). 
Preporučuju se prilagodbe doze u bolesnika s umjerenim i teškim oštećenjem bubrega (vidjeti dio 4.2).
Method of administration Javlor is for intravenous use ONLY. 
Javlor se primjenjuje SAMO intravenski.
When adjusted on prognostic factors, the analyses of PFS in the subgroups of patients without or with prior cisplatin showed a HR (95% CI) = [0.51(0.31 - 0.86); p=0.0111] and a HR (95% CI) = [0.63(0.48 - 0.84); p=0.0016], respectively. 
Nakon prilagodbe za prognostičke čimbenike analize PFS-a u podskupinama bolesnika bez prethodne primjene cisplatina ili s njom pokazale su omjer hazarda (HR) (95%-tni CI) = [0,51 (0,31 - 0,86); p=0,0111] odnosno omjer hazarda (HR) (95%-tni CI) = [0,63 (0,48 - 0,84); p=0,0016].