FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions occurring in patients with transitional cell carcinoma of the urothelium and in patients with other disease than this indication and potentially severe or adverse reactions that are a class effect of the vinca alkaloids are described below:
Slovenian: Neželeni učinki pri vseh indikacijah Spodaj so opisani neželeni učinki pri bolnikih s prehodnoceličnim karcinomom urotelija in pri bolnikih z drugimi vrstami raka ter potencialno resni ali neželeni učinki alkaloidov rožnatega zimzelena:
English: Do not drive or use machines if you experience side effects that affect your ability to concentrate and react.
Slovenian: V primeru pojava neželenih učinkov, ki lahko vplivajo na vašo sposobnost koncentracije in reagiranja, ne vozite ali upravljajte s stroji.
English: In case of Grade 2 constipation, defined as requiring laxatives, for 5 days or more or Grade ≥ 3 of any duration, the dose of vinflunine should be adjusted (see section 4.2).
Slovenian: Prilagoditev odmerka zdravila vinflunin je potrebna, če zaprtje stopnje 2, ki zahteva uporabo laksativov, traja 5 dni ali več, oz. v primeru zaprtja stopnje ≥3, ne glede na trajanje (glejte poglavje 4.2).
English: Dilution of the concentrate
Slovenian: Redčenje koncentrata
English: Vinflunine initial dose of 280 mg/m²
Slovenian: Začetni odmerek vinflunina 280 mg/m²
English: • 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.
Slovenian: • Začnite intravensko infuzijo s polovico 500 ml vreče raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje ali raztopine glukoze 50 mg/ml (5 %) za infundiranje, tj. 250 ml, s prostim tokom za spiranje vene.
English: 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”).
Slovenian: Obvestite svojega zdravnika, če: - imate težave z jetri, ledvicami ali srcem, - ste opazili kakršnekoli nevrološke simptome, kot so glavobol, spremenjeno razpoloženje, ki lahko vodi v zmedenost in komo, krče, motnje vida ali visok krvni tlak.
English: Table 2: Dose adjustments due to toxicity
Slovenian: Prilagoditev odmerka v primeru toksičnih učinkov Tabela 2: Prilagoditve odmerka v primeru toksičnih učinkov
English: Any other toxicity Grade ≥ 3 (severe or life-threatening) (except Grade 3 vomiting or nausea2)
Slovenian: (huda ali življenjsko nevarna) (razen bruhanja in navzee stopnje 3)2
English: Cardiac effects are a known class effect of the vinca alkaloids.
Slovenian: Učinki na srce so učinek alkaloidov rožnatega zimzelena.
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.
Slovenian: Plodne bolnice in bolniki morajo med zdravljenjem in 3 mesece po zadnjem odmerku zdravila Javlor uporabljati primerno metodo kontracepcije.
English: Dose adjustments are recommended in patients with moderate and severe renal impairment (see section 4.2).
Slovenian: Prilagajanje odmerka je priporočljivo pri bolnikih z zmerno ali hudo okvaro ledvic (glejte poglavje 4.2).
English: Treatment discontinuation
Slovenian: - Prekinitev zdravljenja
English: In addition a pre-specified multivariate analysis performed on the ITT population demonstrated that vinflunine had a statistically significant treatment effect (p=0.036) on overall survival when prognostic factors (PS, visceral involvement, alkaline phosphatases, haemoglobin, pelvic irradiation) were taken into consideration; hazard ratio 0.77 (95% CI 0.61, 0.98).
Slovenian: Poleg tega so v predhodno opredeljeni multivariatni analizi, opravljeni na populaciji z namero zdravljenja (ITT), dokazali, da ima vinflunin statistično pomemben terapevtski učinek (p=0,036) na skupno preživetje, če upoštevamo prognostične dejavnike (telesna zmogljivost, visceralna vpletenost,
English: 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.
Slovenian: - pri bolnikih, starejših od 75 let, vendar mlajših od 80 let, 280 mg/m² vinflunina na vsake 3 tedne,
English: Constipation is reversible and can be prevented by special dietary measures such as oral hydration and fibre intake, and by administration of laxatives such as stimulant laxatives or faecal softners from day 1 to day 5 or 7 of the treatment cycle.
Slovenian: Zaprtost je reverzibilna in jo je mogoče preprečiti s posebnimi prehrambnimi ukrepi, kot so peroralna rehidracija, vlakninska prehrana in jemanje odvajal, kot so stimulativna odvajala in mehčalci blata.
English: - in patients 80 years old and above, the dose of vinflunine to be given is 250 mg/m² every 3 weeks.
Slovenian: - pri bolnikih, starih 80 let in več, 250 mg/m² vinflunina na vsake 3 tedne.
English: A pharmacokinetic phase I study was performed in 2 groups of patients with renal impairment classified according to the calculated creatinine clearance (CrCl) values: group 1 (n=13 patients) with moderate impairment (40 mL/min ≤ CrCl ≤ 60 mL/min) and group 2 (n=20 patients) with severe impairment (20 mL/min ≤ CrCl < 40 mL/min).
Slovenian: Skupina 1 (n=13 bolnikov) z zmerno okvaro (40 ml/min ≤ OK ≤ 60 ml/min) in skupina 2 (n=20 bolnikov) s hudo okvaro
English: Precautions to be taken before handling or administering the medicinal product Javlor must be diluted prior to administration.
Slovenian: Previdnostni ukrepi, ki jih morate upoštevati pred rokovanjem ali dajanjem zdravila
English: No pharmacokinetic interaction was observed in patients when vinflunine was combined with doxorubicin.
Slovenian: Prav tako niso opazili farmakokinetičnih interakcij pri bolnikih, ki so prejemali zdravilo vinflunin skupaj z doksorubicinom, vendar pa je bila ta kombinacija povezana s posebej visoko nevarnostjo hematološke toksičnosti.
English: How to use Javlor
Slovenian: Način uporaba zdravila Javlor
English: Intravenous use ONLY, after dilution.
Slovenian: SAMO za intravensko uporabo po redčenju.
English: However, dose adjustments are recommended in patients with liver impairment (see section 4.2).
Slovenian: Vendar je pri bolnikih z okvaro jeter priporočljivo prilagoditi odmerek (glejte poglavje 4.2).
English: How to store Javlor
Slovenian: Shranjevanje zdravila Javlor
English: 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.
Slovenian: faze podpirajo uporabo zdravila Javlor za zdravljenje napredovalega ali metastatskega prehodnoceličnega karcinoma urotelija kot terapija druge izbire po neuspešnem zdravljenju s platino.
English: This leaflet was last revised in MM/YYYY Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/LLLL}
English: Baseline ANC < 1,500/mm3 for the first administration, baseline ANC < 1,000/mm3 for subsequent administrations (see section 4.4).
Slovenian: Izhodiščno AŠN <1.500/mm3 za prvo dajanje, izhodiščno AŠN < 1.000/mm3 za naslednja dajanja
English: Dose
Slovenian: Dajanje
English: In the eligible population, the subgroup analyses according to the prior cisplatin use versus BSC on overall survival (OS) showed a HR (95% CI) = [0.64 (0.40 - 1.03); p=0.0821] in the absence of prior cisplatin, and a HR (95% CI) = [0.80 (0.60 - 1.06); p=0.1263] in the presence of prior cisplatin.
Slovenian: V populaciji primernih bolnikov je analiza podskupin s predhodnim zdravljenjem s cisplatinom in NPO za skupno preživetje pokazala razmerje ogroženosti HR (95-odstotni IZ) = [0,64 (0,40 - 1,03); p=0,0821] brez predhodnega cisplatina in HR (95-odstotni IZ) = [0,80 (0,60 - 1,06); p=0,1263] po predhodno uporabljenem cisplatinu.
English: To prevent constipation you may be given laxatives.
Slovenian: Za preprečevanje zaprtja boste morda prejeli odvajala.
English: 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.
Slovenian: Po korekciji za prognostične dejavnike so analize preživetja brez napredovanja bolezni v podskupinah bolnikov s predhodnim cisplatinom in brez njega pokazale HR (95-odstotni IZ) = [0,51(0,31 - 0,86); p=0,0111] brez predhodnega cisplatina in HR (95-odstotni IZ) = [0,63(0,48 - 0,84); p=0,0016] po predhodno uporabljenem cisplatinu.
English: Thrombocytopenia (platelets < 100,000/mm3)
Slovenian: Nevtropenija (AŠN <1000 /mm3 ) ali trombocitopenija (trombociti <100,000/mm3)
English: Common Insomnia Nervous system disorders Very common Peripheral sensory neuropathy Common Syncope Headache Dizziness Neuralgia Dysgeusia Neuropathy Uncommon Peripheral motor neuropathy 0.4 Rare
Slovenian: Pogosti sinkopa glavobol omotica nevralgija disgevzija nevropatija občasni periferna motorična nevropatija redki posteriorni reverzibilni encefalopatični sindroma
English: In the subgroup analyses of prior cisplatin use versus BSC for progression free survival (PFS), the results were: HR (95% CI) = [0.55 (0.34 - 0.89); p=0.0129] in the absence of prior cisplatin, and a HR (95% CI) = [0.64 (0.48 - 0.85); p=0.0040] in the presence of prior cisplatin.
Slovenian: V analizah podskupin s predhodnim zdravljenjem s cisplatinom in NPO za preživetje brez napredovanja bolezni so bili rezultati: HR (95odstotni IZ) = [0,55 (0,34 - 0,89); p=0,0129] brez predhodnega cisplatina in HR (95-odstotni IZ) = [0,64 (0,48 - 0,85); p=0,0040] po predhodno uporabljenem cisplatinu.
English: In order to flush the vein, administration of diluted Javlor should always be followed by at least an equal volume of sodium chloride 9 mg/mL (0.9%) solution for infusion or of glucose 50 mg/mL (5%) solution for infusion.
Slovenian: Za spiranje ven mora dajanju zdravila Javlor raztopina za injiciranje vedno slediti najmanj enak volumen raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje ali raztopine glukoze 50 mg/ml (5 %) za infundiranje.
English: Pierre Fabre Médicament 45 place Abel Gance F-92100 Boulogne France
Slovenian: Pierre Fabre Médicament 45 place Abel Gance F-92100 Boulogne Francija
English: Pierre Fabre Médicament 45, Place Abel Gance F-92100 Boulogne France
Slovenian: Pierre Fabre Médicament 45, place Abel Gance F-92100 Boulogne Francija
English: Pierre Fabre Médicament 45, place Abel Gance F-92100 Boulogne France
Slovenian: Pierre Fabre Médicament 45, Place Abel Gance F-92100 Boulogne Francija
English: Thus, patients receiving Javlor should be vigilantly monitored by physicians for the occurrence of cardiac events.
Slovenian: Zato morajo biti bolniki, ki prejemajo zdravilo Javlor,
English: You must not breastfeed during treatment with Javlor If you would like to father a child, seek advice from your doctor.
Slovenian: Če želite spočeti otroka, se posvetujte s svojim zdravnikom ali farmacevtom.
English: Musculoskeletal pain
Slovenian: - tumorska bolečina.
English: One 4 mL vial contains 100 mg of vinflunine (as ditartrate).
Slovenian: Ena viala s 4 ml zdravila vsebuje 100 mg vinflunina (v obliki ditartrata).
English: Posterior Reversible Encephalopathy Syndrome (PRES) Cases of PRES have been observed after administration of vinflunine.
Slovenian: Po dajanju zdravila vinflunin so bili opaženi primeri PRES-a.
English: - exposed to light in polyethylene or polyvinylchloride infusion set for up to 1 hour at 25°C.
Slovenian: (2 °C - 8 °C) ali do 24 ur pri 25 °C, - izpostavljeno svetlobi v polietilenskih ali polivinilkloridnih infuzijskih kompletih do 1 uro pri 25 °C.
English: Vinflunine initial dose of 320 mg/m²
Slovenian: Začetni odmerek vinflunina 320 mg/m² Začetni odmerek vinflunina 280
English: - 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 ].
Slovenian: - pri bolnikih z blago okvaro jeter (stopnja A po Child-Pugh-u) ali pri bolnikih s protrombinskim časom ≥ 60% NV in 1.5× ZMNR ≤ bilirubin ≤ 3×ZMNR in ki izpolnjujejo vsaj enega od naslednjih kriterijev [ transaminaze > ZMNR in/ali GGT > 5×ZMNR ], je priporočeni odmerek vinflunina 250 mg/m² enkrat na vsake 3 tedne,
English: Common Hypertension Vein thrombosis Phlebitis
Slovenian: Žilne bolezni pogosti hipertenzija venska tromboza flebitis hipotenzija
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Other side effects may include: Very common (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti (pojavijo se lahko pri 1 od 10 bolnikov)
English: Discontinuation of vinflunine should be considered in patients who develop neurological signs of PRES (see section 4.8).
Slovenian: Če se pri bolnikih pokažejo nevrološki znaki PRES-a, morate proučiti možnost prekinitve zdravljenja z zdravilom vinflunin (glejte poglavje 4.8).
English: Mucositis or Constipation Grade 2 ≥ 5 days or Grade ≥ 3 any duration1
Slovenian: 2, ki traja ≥5 dni ali stopnje ≥3 ne glede na trajanje1
English: Storage conditions
Slovenian: Navodila za shranjevanje:
English: Uncommon Visual disturbance
Slovenian: Očesne bolezni občasni motnje vida
English: Very common Hyponatraemia
Slovenian: Zelo pogosti periferna senzorična nevropatija
English: 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).
Slovenian: Bolnikom je treba svetovati, da ne vozijo in upravljajo s stroji, če se pojavijo neželeni učinki, ki lahko vplivajo na njihovo sposobnost za te dejavnosti (glejte poglavje 4.8.
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila za redčenje pred uporabo glejte poglavje 6.6.
English: - 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.
Slovenian: - pri bolnikih z zmerno okvaro jeter (stopnja B po Child-Pugh-u) ali pri bolnikih s protrombinskim časom ≥ 50% NV in bilirubinom > 3×ZMNR in transaminazami > ZMNR in GGT > ZMNR, je priporočeni odmerek vinflunina 200 mg/m², enkrat na vsake tri tedne.
English: Unopened vials
Slovenian: OVOJNINAH NALEPKA NA VIALI
English: In case of any Grade ≥ 3 gastrointestinal toxicity (except vomiting or nausea) or of mucositis (Grade 2 for 5 days or more or Grade ≥ 3 of any duration) dose adjustment is required.
Slovenian: stopnje ≥3 ali mukozitisa (stopnje 2, ki traja 5 dni ali več oz. stopnje ≥3, ne glede na trajanje).
English: Decreased appetite Common Dehydration
Slovenian: Presnovne in prehranske motnje zelo pogosti hiponatremija Zmanjšan apetit pogosti dehidracija
English: For further cycles the dose should be adjusted in the event of toxicities (see section 4.2).
Slovenian: Ob pojavu toksičnosti morate v naslednjih ciklih zdravljenja odmerek zmanjšati (glejte poglavje 4.2).
English: One 10 mL vial contains 250 mg of vinflunine (as ditartrate).
Slovenian: Ena viala z 10 ml zdravila vsebuje 250 mg vinflunina (v obliki ditartrata).
English: The recommended dose should be reduced in patients with haematological toxicity (see section 4.2).
Slovenian: Pri bolnikih s hematološko toksičnostjo stopnje>3 je treba priporočeni odmerek zmanjšati (glejte poglavje 4.2).
English: Patients with renal impairment
Slovenian: Bolniki z največjo stopnjo po NCI
English: Initiation of vinflunine is contraindicated in subjects with baseline ANC < 1,500/mm3 or platelets < 100,000/mm3.
Slovenian: Vinflunina ne smete dajati bolnikom s številom AŠN <1.500/mm3 ali trombocitov <100.000/mm3 Nadaljevanje dajanja vinflunina je kontraindicirano pri bolnikih z izhodiščnim AŠN <1.000/mm3 ali s trombociti < 100.000//mm3.
English: One mL of concentrate contains 25 mg of vinflunine (as ditartrate).
Slovenian: En ml koncentrata vsebuje 25 mg vinflunina (v obliki ditartrata).
English: In the two multi-centre open-label, single-arm phase II clinical trials a total of 202 patients were treated with vinflunine.
Slovenian: faze brez kontrolne skupine so z vinfluninom zdravili 202 bolnika.
English: Javlor 25 mg/mL concentrate for solution for infusion vinflunine
Slovenian: Javlor 25 mg/ml koncentrat za raztopino za infundiranje vinflunin
English: Javlor 25 mg/mL concentrate for solution for infusion
Slovenian: Javlor 25 mg/ml koncentrat za raztopino za infundiranje
English: vincristine, vindesine, vinorelbine), - if you have had (in the last 2 weeks) or currently have a severe infection, - if you are breast-feeding, - if your levels of white blood cells and/or platelets are too low
Slovenian: - če ste nedavno (v zadnjih 2 tednih) imeli hudo okužbo ali če takšna okužba še poteka, - če dojite,
English: Paediatric population There is no relevant use of Javlor in the paediatric population.
Slovenian: Uporaba zdravila za zdravljenje otrok - Ni relevantne indikacije za uporabo zdravila Javlor za zdravljenje otrok.
English: 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.
Slovenian: V specifičnih okoliščinah bo vaš zdravnik glede na vašo starost in telesno stanje prilagodil začetni odmerek zdravila Javlor:
English: See leaflet
Slovenian: Redčena raztopina
English: Common Dyspnoea Cough
Slovenian: Začetni odmerek vinflunina
English: 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.
Slovenian: - doksorubicin in pegelirani liposomski doksorubicin, ki se uporablja za zdravljenje določenih vrst raka, - rifampicin, ki se uporablja za zdravljenje tuberkuloze in meningitisa,
English: The recommended dose should be reduced in patients with moderate or severe renal impairment (see section 4.2).
Slovenian: Pri bolnikih z zmerno ali hudo okvaro ledvic morate zmanjšati priporočeni odmerek (glejte poglavje 4.2).
English: One 2 mL vial contains 50 mg of vinflunine (as ditartrate).
Slovenian: Ena viala z 2 ml zdravila vsebuje 50 mg vinflunina (v obliki ditartrata).
English: 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
Slovenian: Preiskave zelo pogosti zmanjšanje telesne mase občasni zvišana vrednost transaminaz povečanje telesne mase aNeželeni učinki poročani v obdobju trženja.
English: The veins of the hand dorsum and those close to joints should be avoided.
Slovenian: • Če je možno, ne uporabite ven hrbtišča dlani ali ven v bližini sklepov.
English: Discontinuation of vinflunine should be considered in patients who develop cardiac ischaemia.
Slovenian: Če se pri bolniku pojavi srčna ishemija, morate preučiti možnost prekinitve zdravljenja z zdravilom Javlor.
English: - Discontinuation
Slovenian: Izločanje
English: 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).
Slovenian: Pred vsakim infundiranjem vinflunina je treba opraviti zadostno preverjanje popolne krvne slike s kontrolo vrednosti AŠN, trombocitov in hemoglobina.
English: - abdominal pain, nausea, vomiting - constipation, diarrhoea - inflammation of the mucosa of the mouth - tiredness, muscle pain - lack of sense of touch - weight decrease, decrease of appetite - loss of hair - reactions at injection site (pain, redness, swelling) - fever - low levels of white blood cells, red blood cells and/or platelets (seen in blood test) - low levels of blood sodium (hyponatraemia).
Slovenian: - zmanjšanje telesne mase, zmanjšan apetit, - izpadanje las, - reakcije na mestu injiciranja (bolečina, pordelost, otekanje), - zvišana telesna temperatura,
English: • 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.
Slovenian: 9 mg/ml (0,9 %) za infundiranje ali raztopine glukoze 50 mg/ml (5 %) za infundiranje s pretokom 300 ml/h.
English: Neutropenia, leucopenia, anaemia and thrombocytopenia are frequent adverse reactions of vinflunine.
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti nevtropenija levkopenija anemija trombocitopenija pogosti febrilna nevtropenija
English: Javlor MUST ONLY be administered intravenously.
Slovenian: Zdravilo Javlor MORATE uporabiti intravensko.
English: Patients with hepatic impairment
Slovenian: Psihiatrične motnje pogosti nespečnost
English: • 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.
Slovenian: • Na veliki veni, najbolje na zgornjem delu podlakti, ali s centralnim venskim katetrom pripravite venski dostop za 500-mililitrsko vrečo raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje ali raztopine glukoze 50 mg/ml (5 %) za infundiranje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA
English: Very common Asthenia/Fatigue Injection site reaction Pyrexia
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti astenija/utrujenost reakcija na mestu injiciranja pireksija pogosti bolečine v prsnem košu mrazenje bolečine edem občasni ekstravazacija
English: Neoplasm benign, malignant and unspecified
Slovenian: Benigne, maligne in neopredeljene novotvorbe občasni tumorska bolečina
English: Gastrointestinal disorders Very common Constipation
Slovenian: Bolezni imunskega sistema pogosti preobčutljivost
English: 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.
Slovenian: V 100-mililitrsko vrečo raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje vmešajte količino zdravila Javlor (koncentrata), ki ustreza izračunanemu odmerku vinflunina.
English: Cardiovascular disorders
Slovenian: Bolezni srca in ožilja
English: Recommended co-medication
Slovenian: NAČIN IZDAJANJA ZDRAVILA
English: Package Leaflet: Information for the user Javlor 25 mg/mL concentrate for solution for infusion vinflunine
Slovenian: Navodilo za uporabo Javlor 25 mg/ml koncentrat za raztopino za infundiranje vinflunin