FrancophonIA/ELRC3.0 huggingface dataset:
English: Any other toxicity Grade ≥ 3 (severe or life-threatening) (except Grade 3 vomiting or nausea2) *National Cancer Institute, Common Toxicity Criteria Version 2.0 (NCI CTC v 2.0) 1 NCI CTC Grade 2 constipation is defined as requiring laxatives, Grade 3 as an obstipation requiring manual evacuation or enema, Grade 4 as an obstruction or toxic megacolon.
Slovenian: Vse druge toksičnosti stopnje ≥3 (hude ali življenjsko nevarne) (razen bruhanja in navzee stopnje 32) *National Cancer Institute, splošni kriteriji toksičnosti, različica 2.0 (NCI CTC v 2.0) 1Zaprtost 2. stopnje po NCI CTC zahteva zdravljenje z odvajali, zaprtje 3. stopnje zahteva ročno praznjenje ali enemo, zaprtje 4. stopnje pa je definirano kot obstrukcija ali toksični megakolon.
English: Definitive Treatment discontinuation
Slovenian: dokončna prekinitev zdravljenja
English: 3rd consecutive event
Slovenian: Tretji zaporedni dogodek
English: The most frequent treatment-related adverse reactions reported in the two phase II and one phase III trials in patients with transitional cell carcinoma of the urothelium (450 patients treated with vinflunine) were haematological disorders, mainly neutropenia and anaemia; gastrointestinal disorders, especially constipation, anorexia, nausea, stomatitis/mucositis, vomiting, abdominal pain and diarrhoea, and general disorders such as asthenia/fatigue.
Slovenian: preskušanju III. faze pri bolnikih s prehodnoceličnim karcinomom urotelija (450 bolnikov, zdravljenih z vinfluninom), so bile hematološke bolezni, večinoma nevtropenija in anemija; bolezni prebavil, zlasti zaprtost, anoreksija, navzea, stomatitis/mukozitis, bruhanjem bolečine v trebuhu in driska; ter splošne bolezni, kot sta astenija/utrujenost.
English: When infused through a peripheral vein, vinflunine can induce venous irritation (see section 4.4).
Slovenian: Če vinflunin infundirate v periferno veno, lahko povzroči vensko draženje (glejte poglavje 4.4).
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.
Slovenian: Vinflunin se veže na vezavna mesta alkaloidov rožnatega zimzelena na tubulinu ali blizu njih in s tem zavre polimerizacijo v mikrotubule, kar povzroči supresijo dinamike citoskeleta, prekinitev dinamike mikrotubulov, zaustavitev celice v mitozi in sproži celično smrt z apoptozo.
English: Vinflunine pharmacokinetics is linear in the range of administered doses (from 30 mg/m² to 400 mg/m2) in cancer patients.
Slovenian: Farmakokinetika vinflunina je pri bolnikih z rakom linearna v razponu uporabljenih odmerkov (od 30 mg/m² do 400 mg/m2).
English: Javlor may cause side effects such as tiredness and dizziness.
Slovenian: Zdravilo Javlor lahko povzroča neželene učinke, kot sta utrujenost in omotica.
English: Vinflunine is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Javlor.
Slovenian: Vinflunin je citotoksično zdravilo proti raku, zato je pri ravnanju z zdravilom Javlor kot pri drugih potencialno toksičnih spojinah potrebna previdnost.
English: Table 4 Adverse reactions observed in patients with transitional cell carcinoma of the urothelium treated with vinflunine
Slovenian: Tabela 4 Neželeni učinki pri bolnikih s prehodnoceličnim karcinomom urotelija, ki so bili zdravljeni z vinfluninom
English: Based on both PK and safety data, dose reductions are recommended in the elder groups: 75 ≤ age < 80 years; and age ≥ 80 years.
Slovenian: Na osnovi FK in varnostnih podatkov priporočamo zmanjšanje odmerka pri starostnikih , starih od75 do 80 let in pri starostnikih, starejših od 80 let.
English: Therefore the concomitant use of vinflunine and potent CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole and grapefruit juice) or inducers (such as rifampicin and Hypericum perforatum (St John's wort)) should be avoided since they may increase or decrease vinflunine and DVFL concentrations (see section 4.4 and 5.2).
Slovenian: ketokonazol, itrakonazol in sok grenivk) oz. močnih induktorjev CYP3A4 (kot sta rifampicin in Hypericum perforatum (šentjanževka)), ker lahko zvišajo oz. znižajo koncentracijo vinflunina in DVFL (glejte poglavji 4.4 in 5.2).
English: B. CONDITIONS OR RESTRICTIONS REGARDING THE SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Dose delay or discontinuation due to toxicity
Slovenian: Odložitev odmerka ali prekinitev zdravljenja v primeru toksičnih učinkov
English: Diluted solution The diluted solution should be use immediately
Slovenian: Redčeno raztopino je treba nemudoma uporabiti.
English: Glucose 50 mg/mL (5%) solution for infusion may also be used.
Slovenian: Uporabite lahko tudi raztopino glukoze 50 mg/ml (5 %) za infundiranje.
English: Uncommon Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) a
Slovenian: Bolezni endokrinega sistema občasni sindrom neustreznega izločanja antidiuretičnega hormona (SIADH)a
English: For further cycles, the dose should be adjusted in the event of toxicities, as shown in table 3 below.
Slovenian: V naslednjih ciklih zdravljenja se mora odmerek v primeru toksičnosti prilagajati, kot je prikazano v spodnji tabeli 3.
English: Efficacy was demonstrated in both patients with or without prior cisplatin use.
Slovenian: Učinkovitost je bila dokazana pri bolnikih s predhodnim zdravljenjem s cisplatinom in bolnikih brez takšnega predhodnega zdravljenja.
English: Cardiac ischaemia in patients with prior history of myocardial infarction or angina pectoris
Slovenian: Srčna ishemija pri bolnikih z anamnezo miokardnega infarkta ali angine pektoris.
English: Either peripheral lines or a central catheter can be used for vinflunine administration.
Slovenian: Za dajanje vinflunina lahko uporabite bodisi periferno ožilje ali centralni kateter.
English: If you get any side effects, talk to your doctor.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
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.
Slovenian: Pri 25 bolnikih z različnimi stopnjami okvare jeter niso ugotovili razlik v farmakokinetiki vinflunina in DVFL v primerjavi z bolniki z normalno jetrno funkcijo.
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).
Slovenian: Javlor za vse podskupine pediatrične populacije za zdravljenje raka sečevoda in sečnega mehurja in za zdravljenje raka dojk (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
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.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravljenje z vinfluninom se mora začeti po nadzorom zdravnika, ki je usposobljen za uporabo kemoterapevtikov proti raku in je omejeno na zdravstvene enote, specializirane za dajanje citotoksičnih kemoterapij.
English: After dilution of the Javlor concentrate, the solution for infusion will be administered as follows:
Slovenian: Po redčenju Javlor koncentrata raztopino za infundiranje uporabite po naslednjem postopku:
English: Infections and infestations Common Neutropenic infection Infections (viral, bacterial, fungal) Uncommon Neutropenic sepsis
Slovenian: Infekcijske in parazitske bolezni pogosti nevtropenična okužba okužbe (virusne, bakterijske, glivne)
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).
Slovenian: Mediana skupnega preživetja je bila 6,9 meseca (vinflunin + NPO) oz. 4,6 meseca (NPO), vendar rezultat ni dosegel statistične pomembnosti; razmerje ogroženosti 0,88 (95-odstotni interval zaupanja
English: 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.
Slovenian: Pred vsakim ciklom je treba opraviti natančen pregled celotne krvne slike, z določitvijo absolutnega števila nevtrofilcev (AŠN), trombocitov in hemoglobina, saj so nevtropenija, trombocitopenija in anemija pogosti neželeni učinki vinflunina.
English: In patients with severe renal impairment (20 mL/min ≤ CrCl < 40 mL/min) the recommended dose is 250 mg/m² every 3 weeks (see section 5.2).
Slovenian: Za bolnike s hudo okvaro ledvic (20 ml/min ≤ OK < 60 ml/min) je priporočeni odmerek 250 mg/m² vsake 3 tedne (glejte poglavje 5.2).
English: Sensory peripheral neuropathy is a class effect of the vinca alkaloids.
Slovenian: Bolezni živčevja Senzorična periferna nevropatija je učinek alkaloidov rožnatega zimzelena.
English: Grade ≥ 3 constipation occurred in 15.3% of treated patients.
Slovenian: Pri 15,3 % zdravljenih bolnikov se je pojavila zaprtost stopnje ≥ 3.
English: In vitro studies showed that vinflunine is a Pgp-substrate like other vinca alkaloids, but with a lower affinity.
Slovenian: V študijah in vitro so ugotovili, da je vinflunin substrat Pgp, kot drugi alkaloidi rožnatega zimzelena,
English: Javlor 25 mg/mL sterile concentrate vinflunine
Slovenian: Javlor 25 mg/ml sterilni koncentrat vinflunin
English: The concomittant use of two or more QT/QTc interval prolonging substances is not recommended (see section 4.5).
Slovenian: Sočasna uporaba vsaj dveh zdravil, ki podaljšujejo interval QT, ni priporočljiva (glejte poglavje 4.5).
English: Common (may affect up to 1 in 10 people)
Slovenian: Pogosti (pojavijo se lahko pri 1 od 10 bolnikov)
English: - 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;
Slovenian: - zaščiteno pred svetlobo v polietilenski ali polivinilkloridni infuzijski vreči do 6 dni v hladilniku (od 2 °C do 8 °C) ali do 24 ur pri 25 °C , - izpostavljeno svetlobi v polietilenskem ali polivinilkloridnem infuzijskem kompletu do 1 uro pri 25 °C.
English: For further cycles, the dose should be adjusted in the event of toxicities, as shown in table 3 below:
Slovenian: Pri naslednjih ciklih se mora odmerek v primeru toksičnosti prilagajati, kot je navedeno v spodnji tabeli 3:
English: Javlor solution for infusion should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Slovenian: Zdravilo Javlor lahko pripravlja in daje le osebje, ki je ustrezno usposobljeno za ravnanje s citotoksičnimi snovmi.
English: In patients with moderate renal impairment (40 mL/min ≤ CrCl ≤ 60 mL/min), the recommended dose is 280 mg/m² given once every 3 weeks.
Slovenian: Za bolnike z zmerno okvaro ledvic (40 ml/min ≤ OK ≤ 60 ml/min) je priporočeni odmerek 280 mg/m² vsake 3 tedne.
English: Constipation is managed by medical care (see section 4.4).
Slovenian: Zaprtost obravnavamo z zdravstveno oskrbo (glejte poglavje 4.4).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Običajno se redčeno zdravilo hrani pri 2 °C do 8 °C do 24 ur, razen če se zdravilo redči v kontroliranih in validiranih aseptičnih pogojih.
English: However a statistically significant effect was seen on progression-free survival.
Slovenian: Kljub temu so dokazali, da ima vinflunin statistično pomemben učinek na preživetje brez napredovanja bolezni.
English: 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)
Slovenian: Ena viala 2 ml vsebuje 50 mg vinflunina (v obliki ditartrata) Ena viala 4 ml vsebuje 100 mg vinflunina (v obliki ditartrata) Ena viala 10 ml vsebuje 250 mg vinflunina (v obliki ditartrata)
English: The concomitant use of potent inhibitors or potent inducers of CYP3A4 with vinflunine should be avoided (see section 4.5).
Slovenian: Sočasno z vinfluninom ne uporabite močnih zaviralcev ali močnih induktorjev CYP3A4 (glejte poglavje 4.5).
English: Grade 3 was experienced by 0.6% patients.
Slovenian: Pri 0,6 % bolnikov so opazili stopnjo 3.
English: Blood pressure should be controlled in patients developing symptoms of PRES. To confirm the diagnosis, brain imaging is recommended.
Slovenian: Pri bolnikih, ki razvijajo znake PRES-a, je potreben nadzor krvnega tlaka.
English: NCI CTC Grade 3 constipation is defined as an obstipation requiring manual evacuation or enema, Grade 4 constipation as an obstruction or toxic megacolon.
Slovenian: Zaprtost 3. stopnje je definirana kot zaprtje, ki zahteva ročno praznjenje ali enemo, zaprtost 4. stopnje pa kot obstrukcija ali toksični megakolon.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi voda za injekcije
English: A pharmacokinetic phase I study of vinflunine was performed in elderly patients (n=46).
Slovenian: Pri starejših bolnikih (n=46) je bila izvedena farmakokinetična študija vinflunina I. faze.
English: 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).
Slovenian: Po uporabi vinflunina so poročali o hudi hiponatriemiji, vključno s primeri zaradi sindroma neustreznega izločanja antidiuretičnega hormona (SIADH) (glejte poglavje 4.8).
English: Table 1: Dose delay for subsequent cycles due to toxicity
Slovenian: Odložitev odmerka v naslednjih ciklih zaradi toksičnih učinkov
English: During treatment, your doctor may reduce the dose of Javlor, delay or interrupt the treatment if you experience certain side effects.
Slovenian: Če se vam med zdravljenjem pojavijo določeni neželeni učinki, lahko zdravnik zmanjša odmerek zdravila Javlor, preloži ali prekine zdravljenje.
English: 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
Slovenian: 1 viala z 2 ml zdravila 10 vial z 2 ml zdravila 1 viala s 4 ml zdravila 10 vial s 4 ml zdravila 1 viala z 10 ml zdravila 10 vial z 10 ml zdravila
English: Hypersensitivity to the active substance or other vinca alkaloids.
Slovenian: Preobčutljivost za zdravilno učinkovino, druge alkaloide rožnatega zimzelena.
English: A possible interaction with paclitaxel and docetaxel (CYP3 substrates) has been suggested from an in vitro study (slight inhibition of vinflunine metabolism).
Slovenian: Na podlagi rezultatov študije in vitro je bila predlagana možna interakcija med paklitakselom in docetakselom (substrati CYP3) (rahlo zaviranje presnove vinflunina).
English: Content of the pack and other information
Slovenian: Shranjevanje zdravila Javlor Vsebina pakiranja in dodatne informacije
English: - 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 ].
Slovenian: - pri bolnikih s protrombinskim časom > 70% NV (normalne vrednosti) in pri bolnikih, ki izpolnjujejo vsaj enega od naslednjih kriterijev [ ZMNR (zgornja meja normale) < bilirubin ≤ 1,5×ZMNR in/ali 1,5xZMNR < transaminaze ≤ 2,5× ZMNR in/ali ZMNR < GGT ≤ 5×ZMNR].
English: Your blood cell counts will be checked regularly before and during your treatment, since low counts of blood cells is a very common side effect with Javlor.
Slovenian: Ker so nizke ravni krvnih celic zelo pogost neželeni učinek zdravila Javlor, bodo število celic v vaši krvi pred zdravljenjem in med njim redno spremljali.
English: What Javlor looks like and contents of the pack
Slovenian: Izgled zdravila Javor in vsebina pakiranja
English: Grade 3/4 neutropenia was observed in 43.8% of patients.
Slovenian: Pri 43,8 % bolnikov so opazili nevtropenijo stopnje 3/4.
English: Intrathecal administration of Javlor may be fatal.
Slovenian: Intratekalno dajanje zdravila Javlor lahko povzroči smrt.
English: Elderly patients (≥ 75 years) The recommended dose should be reduced in patients 75 years old and beyond (see section 4.2).
Slovenian: Pri bolnikih, starih 75 let in več, morate zmanjšati priporočeni odmerek (glejte poglavje 4.2).
English: No age-related dose modification is required in patients less than 75 years old (see section 5.2).
Slovenian: S starostjo povezano prilagajanje odmerka pri bolnikih, mlajših od 75 let, ni potrebno (glejte točko
English: In order to prevent constipation, laxatives and dietary measures including oral hydration are recommended from day 1 to day 5 or 7 after each vinflunine administration (see section 4.4).
Slovenian: Priporočeno sočasno zdravljenje Za preprečevanje zaprtja se od 1. do 5. oz. do 7. dne po vsakem odmerku vinflunina priporoča jemanje odvajal in dietno prehrano, vključno s peroralno rehidracijo (glejte poglavje 4.4).
English: Vinflunine (mg/m²)
Slovenian: Starost (l) Število bolnikov Vinflunin (mg/m²)
English: 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.
Slovenian: Uporaba vinflunina ni raziskana pri bolnikih s hudo okvaro jeter (C po lestvici Child-Pugh) niti pri bolnikih s protrombinskim časom <50 % NV ali ravnijo bilirubina >5x ZMNR ali transaminaz >2,5 x ZMNR (≥ 5x ZMNR samo v primeru jetrnih metastaz) ali z CGT >15x ZMNR.
English: Overall 8 patients (0.6% of the treated population) died from infection as a complication occurring during neutropenia.
Slovenian: Skupno je umrlo zaradi okužbe, ki je bila zaplet nevtropenije, 8 bolnikov (0,6 % zdravljene populacije).
English: No pharmacokinetic interaction was observed in patients when vinflunine was combined with either cisplatin, carboplatin, capecitabine or gemcitabine.
Slovenian: Pri bolnikih, ki so prejemali vinflunin v kombinaciji s cisplatinom, karboplatinom, kapecitabinom ali gemcitabinom, niso opazili farmakokinetičnih interakcij.
English: The concomitant use of vinflunine with others QT/QTc interval prolonging medicinal products should be avoided (see section 4.4).
Slovenian: Sočasna uporaba vinflunina z drugimi zdravili, ki podaljšujejo interval QT, ni priporočljiva (glejte poglavje 4.4).
English: Javlor contains the active substance vinflunine, which belongs to a group of anticancer medicines called vinca alkaloids.
Slovenian: Zdravilo Javlor vsebuje zdravilno učinkovino vinflunin, ki spada v skupino zdravil proti raku,
English: In case of WHO/ECOG performance status (PS) of 1 or PS of 0 and prior pelvic irradiation, the treatment should be started at the dose of 280 mg/m².
Slovenian: Če je telesna zmogljivost (TZ) po WHO/ECOG enaka 1 oz. je TZ enaka 0 in je bil bolnik predhodno zdravljen z obsevanjem medenice, je treba začeti z odmerkom 280 mg/m².
English: If it comes into contact with mucous membranes, the membranes should be flushed thoroughly with water.
Slovenian: Če raztopina pride v stik s sluznico, morate sluznico temeljito sprati z vodo.
English: Myocardial infarction or ischaemia were experienced by 0.5% of the patients and most of them had a pre-existing cardiovascular disease or risk factors.
Slovenian: Pri 0,5 % bolnikov je prišlo do miokardnega infarkta ali ishemije.
English: General precautions for preparation and administration.
Slovenian: Splošni varnostni ukrepi za pripravo in dajanje
English: 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).
Slovenian: populacije primernih bolnikov (iz katere so izključili 13 bolnikov s klinično pomembnimi kršitvami protokola študije v izhodišču, ki niso bili primerni za zdravljenje); razmerje ogroženosti 0,78 (95
English: - Delay until recovery (ANC ≥ 1,000/mm3 and platelets ≥ 100,000/mm3) and adjust the dose if necessary (see table 2) - Discontinuation if recovery has not occurred within 2 weeks
Slovenian: ≥100,000/mm3) in, če je potrebno, prilagodite odmerek (glejte tabelo 2)
English: 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
Slovenian: Zdravilo Javlor je indicirano za monoterapijo pri zdravljenju odraslih bolnikov z napredovalim ali metastatskim prehodnoceličnim karcinomom urotelija po neuspešnem zdravljenju s platino.
English: 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.
Slovenian: Zdravilo Javlor se uporablja za zdravljenje napredovalega ali metastatskega raka sečnega mehurja in sečil po neuspešnem zdravljenju z zdravili, ki vsebujejo platino.
English: Few QT interval prolongations have been observed after the administration of vinflunine.
Slovenian: Po uporabi vinflunina so opazili nekaj primerov podaljšanja intervala QT.
English: Constipation is a very common side effect of Javlor.
Slovenian: Zaprtje je zelo pogost neželeni učinek zdravila Javlor.
English: For detailed instructions on administration, see section 6.6.
Slovenian: Podrobna navodila za dajanje so v poglavju 6.6.
English: - 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).
Slovenian: - prebavne motnje, bolečine v ustih, na jeziku ali zobobol, spremenjen občutek okusa, - mišična oslabelost, bolečine v čeljustih, bolečine v okončinah, bolečine v hrbtu, bolečine v sklepih, bolečine v mišicah, oteklina, bolečine v kosteh, bolečine v ušesih,
English: Febrile Neutropenia (ANC < 1,000/mm3 and fever ≥ 38,5 °C) Mucositis or Constipation Grade 2 ≥ 5 days or Grade ≥ 3 any duration1
Slovenian: < 1,000/mm3 in vročina ≥ 38,5 °C) Mukozitis in zaprtost stopnje 2, ki traja ≥5 dni ali stopnje ≥3, ne glede na trajanje1
English: • The Javlor solution for infusion should be piggy-backed to the side injection port closest to the 500 mL bag to further dilute Javlor during administration.
Slovenian: • V stransko mesto za injiciranje, ki je najbližje 500-mililitrski vreči, uvedite zdravilo Javlor raztopina za injiciranje, da se med dajanjem Javlor še dodatno razredči.
English: Water for injections as excipient.
Slovenian: Voda za injekcije kot pomožna snov
English: 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).
Slovenian: V mikronukleusnem testu in vivo pri podganah so ugotovili, da je vinflunin klastogen (inducira kromosomske prelome), v testu mišjega limfoma (brez presnovne aktivacije) pa, da je mutagen in klastogen.