natgillin/translations-raw huggingface dataset:
NCI CTC Grade 3 constipation is defined as an obstipation requiring manual evacuation or enema, Grade 4 constipation as an obstruction or toxic megacolon.
Zaprtost 3. stopnje je definirana kot zaprtje, ki zahteva ročno praznjenje ali enemo, zaprtost 4. stopnje pa kot obstrukcija ali toksični megakolon.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi voda za injekcije
A pharmacokinetic phase I study of vinflunine was performed in elderly patients (n=46).
Pri starejših bolnikih (n=46) je bila izvedena farmakokinetična študija vinflunina I. faze.
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).
Po uporabi vinflunina so poročali o hudi hiponatriemiji, vključno s primeri zaradi sindroma neustreznega izločanja antidiuretičnega hormona (SIADH) (glejte poglavje 4.8).
Table 1: Dose delay for subsequent cycles due to toxicity
Odložitev odmerka v naslednjih ciklih zaradi toksičnih učinkov
During treatment, your doctor may reduce the dose of Javlor, delay or interrupt the treatment if you experience certain side effects.
Če se vam med zdravljenjem pojavijo določeni neželeni učinki, lahko zdravnik zmanjša odmerek zdravila Javlor, preloži ali prekine zdravljenje.
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
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
Hypersensitivity to the active substance or other vinca alkaloids.
Preobčutljivost za zdravilno učinkovino, druge alkaloide rožnatega zimzelena.
A possible interaction with paclitaxel and docetaxel (CYP3 substrates) has been suggested from an in vitro study (slight inhibition of vinflunine metabolism).
Na podlagi rezultatov študije in vitro je bila predlagana možna interakcija med paklitakselom in docetakselom (substrati CYP3) (rahlo zaviranje presnove vinflunina).
Content of the pack and other information
Shranjevanje zdravila Javlor Vsebina pakiranja in dodatne informacije
- 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 ].
- 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].
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.
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.
What Javlor looks like and contents of the pack
Izgled zdravila Javor in vsebina pakiranja
Grade 3/4 neutropenia was observed in 43.8% of patients.
Pri 43,8 % bolnikov so opazili nevtropenijo stopnje 3/4.
Intrathecal administration of Javlor may be fatal.
Intratekalno dajanje zdravila Javlor lahko povzroči smrt.
Elderly patients (≥ 75 years) The recommended dose should be reduced in patients 75 years old and beyond (see section 4.2).
Pri bolnikih, starih 75 let in več, morate zmanjšati priporočeni odmerek (glejte poglavje 4.2).
No age-related dose modification is required in patients less than 75 years old (see section 5.2).
S starostjo povezano prilagajanje odmerka pri bolnikih, mlajših od 75 let, ni potrebno (glejte točko
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).
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).
Vinflunine (mg/m²)
Starost (l) Število bolnikov Vinflunin (mg/m²)
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.
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.
Overall 8 patients (0.6% of the treated population) died from infection as a complication occurring during neutropenia.
Skupno je umrlo zaradi okužbe, ki je bila zaplet nevtropenije, 8 bolnikov (0,6 % zdravljene populacije).
No pharmacokinetic interaction was observed in patients when vinflunine was combined with either cisplatin, carboplatin, capecitabine or gemcitabine.
Pri bolnikih, ki so prejemali vinflunin v kombinaciji s cisplatinom, karboplatinom, kapecitabinom ali gemcitabinom, niso opazili farmakokinetičnih interakcij.
The concomitant use of vinflunine with others QT/QTc interval prolonging medicinal products should be avoided (see section 4.4).
Sočasna uporaba vinflunina z drugimi zdravili, ki podaljšujejo interval QT, ni priporočljiva (glejte poglavje 4.4).
Javlor contains the active substance vinflunine, which belongs to a group of anticancer medicines called vinca alkaloids.
Zdravilo Javlor vsebuje zdravilno učinkovino vinflunin, ki spada v skupino zdravil proti raku,
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.
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.
If it comes into contact with mucous membranes, the membranes should be flushed thoroughly with water.
Če raztopina pride v stik s sluznico, morate sluznico temeljito sprati z vodo.
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.
Pri 0,5 % bolnikov je prišlo do miokardnega infarkta ali ishemije.
General precautions for preparation and administration.
Splošni varnostni ukrepi za pripravo in dajanje
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).
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
- 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
≥100,000/mm3) in, če je potrebno, prilagodite odmerek (glejte tabelo 2)
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
Zdravilo Javlor je indicirano za monoterapijo pri zdravljenju odraslih bolnikov z napredovalim ali metastatskim prehodnoceličnim karcinomom urotelija po neuspešnem zdravljenju s platino.
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.
Zdravilo Javlor se uporablja za zdravljenje napredovalega ali metastatskega raka sečnega mehurja in sečil po neuspešnem zdravljenju z zdravili, ki vsebujejo platino.
Few QT interval prolongations have been observed after the administration of vinflunine.
Po uporabi vinflunina so opazili nekaj primerov podaljšanja intervala QT.
Constipation is a very common side effect of Javlor.
Zaprtje je zelo pogost neželeni učinek zdravila Javlor.
For detailed instructions on administration, see section 6.6.
Podrobna navodila za dajanje so v poglavju 6.6.
- 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).
- 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,
Febrile Neutropenia (ANC < 1,000/mm3 and fever ≥ 38,5 °C) Mucositis or Constipation Grade 2 ≥ 5 days or Grade ≥ 3 any duration1
< 1,000/mm3 in vročina ≥ 38,5 °C) Mukozitis in zaprtost stopnje 2, ki traja ≥5 dni ali stopnje ≥3, ne glede na trajanje1
• 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.
• 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.
Water for injections as excipient.
Voda za injekcije kot pomožna snov
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).
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.
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:
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:
Do not drive or use machines if you experience side effects that affect your ability to concentrate and react.
V primeru pojava neželenih učinkov, ki lahko vplivajo na vašo sposobnost koncentracije in reagiranja, ne vozite ali upravljajte s stroji.
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).
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).
Dilution of the concentrate
Redčenje koncentrata
Vinflunine initial dose of 280 mg/m²
Začetni odmerek vinflunina 280 mg/m²
• 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.
• 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.
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”).
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.
Table 2: Dose adjustments due to toxicity
Prilagoditev odmerka v primeru toksičnih učinkov Tabela 2: Prilagoditve odmerka v primeru toksičnih učinkov
Any other toxicity Grade ≥ 3 (severe or life-threatening) (except Grade 3 vomiting or nausea2)
(huda ali življenjsko nevarna) (razen bruhanja in navzee stopnje 3)2
Cardiac effects are a known class effect of the vinca alkaloids.
Učinki na srce so učinek alkaloidov rožnatega zimzelena.
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.
Plodne bolnice in bolniki morajo med zdravljenjem in 3 mesece po zadnjem odmerku zdravila Javlor uporabljati primerno metodo kontracepcije.
Dose adjustments are recommended in patients with moderate and severe renal impairment (see section 4.2).
Prilagajanje odmerka je priporočljivo pri bolnikih z zmerno ali hudo okvaro ledvic (glejte poglavje 4.2).
Treatment discontinuation
- Prekinitev zdravljenja
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).
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,
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.
- pri bolnikih, starejših od 75 let, vendar mlajših od 80 let, 280 mg/m² vinflunina na vsake 3 tedne,
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.
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.
- in patients 80 years old and above, the dose of vinflunine to be given is 250 mg/m² every 3 weeks.
- pri bolnikih, starih 80 let in več, 250 mg/m² vinflunina na vsake 3 tedne.
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).
Skupina 1 (n=13 bolnikov) z zmerno okvaro (40 ml/min ≤ OK ≤ 60 ml/min) in skupina 2 (n=20 bolnikov) s hudo okvaro
Precautions to be taken before handling or administering the medicinal product Javlor must be diluted prior to administration.
Previdnostni ukrepi, ki jih morate upoštevati pred rokovanjem ali dajanjem zdravila
No pharmacokinetic interaction was observed in patients when vinflunine was combined with doxorubicin.
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.
How to use Javlor
Način uporaba zdravila Javlor
Intravenous use ONLY, after dilution.
SAMO za intravensko uporabo po redčenju.
However, dose adjustments are recommended in patients with liver impairment (see section 4.2).
Vendar je pri bolnikih z okvaro jeter priporočljivo prilagoditi odmerek (glejte poglavje 4.2).
How to store Javlor
Shranjevanje zdravila Javlor
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.
faze podpirajo uporabo zdravila Javlor za zdravljenje napredovalega ali metastatskega prehodnoceličnega karcinoma urotelija kot terapija druge izbire po neuspešnem zdravljenju s platino.
This leaflet was last revised in MM/YYYY Other sources of information
Navodilo je bilo nazadnje revidirano dne {MM/LLLL}
Baseline ANC < 1,500/mm3 for the first administration, baseline ANC < 1,000/mm3 for subsequent administrations (see section 4.4).
Izhodiščno AŠN <1.500/mm3 za prvo dajanje, izhodiščno AŠN < 1.000/mm3 za naslednja dajanja
Dose
Dajanje
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.
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.
To prevent constipation you may be given laxatives.
Za preprečevanje zaprtja boste morda prejeli odvajala.
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.
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.
Thrombocytopenia (platelets < 100,000/mm3)
Nevtropenija (AŠN <1000 /mm3 ) ali trombocitopenija (trombociti <100,000/mm3)
Common Insomnia Nervous system disorders Very common Peripheral sensory neuropathy Common Syncope Headache Dizziness Neuralgia Dysgeusia Neuropathy Uncommon Peripheral motor neuropathy 0.4 Rare
Pogosti sinkopa glavobol omotica nevralgija disgevzija nevropatija občasni periferna motorična nevropatija redki posteriorni reverzibilni encefalopatični sindroma
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.
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.
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.
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.
Pierre Fabre Médicament 45 place Abel Gance F-92100 Boulogne France
Pierre Fabre Médicament 45 place Abel Gance F-92100 Boulogne Francija
Pierre Fabre Médicament 45, Place Abel Gance F-92100 Boulogne France
Pierre Fabre Médicament 45, place Abel Gance F-92100 Boulogne Francija
Pierre Fabre Médicament 45, place Abel Gance F-92100 Boulogne France
Pierre Fabre Médicament 45, Place Abel Gance F-92100 Boulogne Francija
Thus, patients receiving Javlor should be vigilantly monitored by physicians for the occurrence of cardiac events.
Zato morajo biti bolniki, ki prejemajo zdravilo Javlor,
You must not breastfeed during treatment with Javlor If you would like to father a child, seek advice from your doctor.
Če želite spočeti otroka, se posvetujte s svojim zdravnikom ali farmacevtom.
Musculoskeletal pain
- tumorska bolečina.
One 4 mL vial contains 100 mg of vinflunine (as ditartrate).
Ena viala s 4 ml zdravila vsebuje 100 mg vinflunina (v obliki ditartrata).
Posterior Reversible Encephalopathy Syndrome (PRES) Cases of PRES have been observed after administration of vinflunine.
Po dajanju zdravila vinflunin so bili opaženi primeri PRES-a.
- exposed to light in polyethylene or polyvinylchloride infusion set for up to 1 hour at 25°C.
(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.
Vinflunine initial dose of 320 mg/m²
Začetni odmerek vinflunina 320 mg/m² Začetni odmerek vinflunina 280
- 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 ].
- 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,
Common Hypertension Vein thrombosis Phlebitis
Žilne bolezni pogosti hipertenzija venska tromboza flebitis hipotenzija
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Other side effects may include: Very common (may affect more than 1 in 10 people)
Zelo pogosti (pojavijo se lahko pri 1 od 10 bolnikov)
Discontinuation of vinflunine should be considered in patients who develop neurological signs of PRES (see section 4.8).
Če se pri bolnikih pokažejo nevrološki znaki PRES-a, morate proučiti možnost prekinitve zdravljenja z zdravilom vinflunin (glejte poglavje 4.8).
Mucositis or Constipation Grade 2 ≥ 5 days or Grade ≥ 3 any duration1
2, ki traja ≥5 dni ali stopnje ≥3 ne glede na trajanje1
Storage conditions
Navodila za shranjevanje:
Uncommon Visual disturbance
Očesne bolezni občasni motnje vida
Very common Hyponatraemia
Zelo pogosti periferna senzorična nevropatija
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).
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.
For instructions on dilution of the medicinal product before administration, see section 6.6.
Za navodila za redčenje pred uporabo glejte poglavje 6.6.