natgillin/translations-raw huggingface dataset:
In pigs, Contacera is used to reduce the symptoms of lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move) and for supportive therapy together with appropriate antibiotic therapy in the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome).
Pri prašičih se zdravilo Contacera uporablja za ublažitev simptomov šepavosti in vnetij pri neinfekcijskih boleznih gibal (boleznih, ki vplivajo na zmožnost gibanja) ter pri zdravljenju bolezni po oprasitvi, kot sta puerperalna septikemija in toksemija (sindrom mastitis-metritis-agalactia), skupaj z ustreznim antibiotičnim zdravljenjem.
Contacera is used in cattle, together with appropriate antibiotic therapy, to reduce clinical signs of disease in acute respiratory infection (infection of the lungs and airways) and to treat acute mastitis (inflammation of the udder).
Zdravilo Contacera se pri govedu uporablja skupaj z ustreznim antibiotičnim zdravljenjem za zmanjšanje kliničnih bolezenskih znakov pri akutni okužbi dihal (okužbi pljuč in dihalnih poti) in za zdravljenje mastitisa (vnetja vimena).
Based on the findings of the studies, Contacera was considered to be bioequivalent to the reference medicine.
V študijah je bilo ugotovljeno, da je zdravilo Contacera biološko enakovredno referenčnemu zdravilu.
In horses, Contacera is used for the relief of pain associated with colic (abdominal pain) and for the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.
Pri konjih se zdravilo Contacera uporablja za lajšanje bolečin, povezanih s kolikami (trebušnimi bolečinami) ter vnetja in bolečin pri akutnih in kroničnih kostno-mišičnih obolenjih.
Since Contacera is a generic medicine, studies have been conducted to show that Contacera has the same characteristics as the reference medicine, Metacam.
Ker je zdravilo Contacera generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Metacam.
Side effects that occurred with the oral suspension in horses included isolated cases of adverse reactions typically associated with NSAIDs (slight urticaria and diarrhoea).
Pri dajanju peroralne suspenzije konjem so se pojavili neželeni učinki, ki so značilni za nesteroidna protivnetna zdravila (blažja urtikarija, driska).
What is Contacera?
Kaj je zdravilo Contacera?
A slight temporary swelling at the injection site following injection under the skin was observed in cattle and pigs.
Pri govedu in prašičih so opazili blago prehodno oteklino na mestu injiciranja v podkožje.
How does Contacera work?
Kako zdravilo Contacera deluje?
The treatment will be repeated every 3 weeks.
Zdravljenje se ponovi vsake 3 tedne.
Therefore, risks of clinically significant interactions should be unlikely.
Zato tveganje klinično pomembnih interakcij ni verjetno.
Unopened vial 3 years.
Neodprta viala 3 leta.
Recent (within 2 weeks) or current severe infection.
Nedavna (v zadnjih 2 tednih) ali potekajoča huda okužba.
The use of gloves, goggles and protective clothing is recommended.
Priporočamo uporabo zaščitnih rokavic, zaščitnih očal in zaščitnih oblačil.
All cases resolved rapidly without treatment discontinuation.
Vsi primeri so izzveneli hitro brez prekinitve zdravljenja.
First Event
Prvi dogodek
This is considered the most relevant population for the efficacy analysis, as it most closely reflects the population intended for treatment.
Ta se šteje za najbolj pomembno populacijo za analizo učinkovitosti, saj najbolj odraža populacijo, ki se lahko zdravi.
Therefore, caution should be excercised when this type of combination is used.
Zato je pri uporabi tovrstnih kombinacij potrebna previdnost.
Date of first authorisation: 21 September 2009 Date of the latest renewal: 16 May 2014
Datum prve odobritve: 09/2009 Datum zadnjega podaljšanja: 05/2014
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali boste morda začeli jemati katero koli drugo zdravilo.
Genetic counselling is also recommended for patients wishing to have children after therapy.
Genetsko posvetovanje je priporočljivo za bolnike, ki želijo imeti otroke po zdravljenju.
The carcinogenic potential of vinflunine has not been studied.
Karcinogeni potencial vinflunina ni bil preučen.
Used in children and adolescents
Uporaba pri otrocih in mladostnikih
Javlor with food and drink
Zdravilo Javlor skupaj s hrano in pijačo
Store in a refrigerator.
Zdravilo shranjujte v hladilniku.
Other appropriate measures should be taken, such as blood transfusions, administration of antibiotics and growth factors.
Uvesti je treba druge ustrezne ukrepe, kot so transfuzije krvi, dajanje antibiotikov in rastnih faktorjev.
You should tell your doctor if you are drinking grapefruit juice since it may increase the effect of Javlor.
Zdravniku povejte, če pijete sok grenivk, ker lahko poveča učinek zdravila Javlor
You should also drink water and eat high fibre foods.
Piti morate vodo in uživati živila z visoko vsebnostjo vlaknin.
Procedure for proper handling and disposal of anticancer medicinal products should be considered.
Upoštevati morate postopek za pravilno ravnanje in odstranjevanje zdravil proti raku.
EU/1/09/550/001 (box of 1 vial of 2 mL with grey stopper) EU/1/09/550/002 (box of 10 vials of 2 mL with grey stopper) EU/1/09/550/003 (box of 1 vial of 4 mL with grey stopper) EU/1/09/550/004 (box of 10 vials of 4 mL with grey stopper) EU/1/09/550/005 (box of 1 vial of 10 mL with grey stopper) EU/1/09/550/006 (box of 10 vials of 10 mL with grey stopper) EU/1/09/550/007 (box of 1 vial of 2 mL with black stopper) EU/1/09/550/008 (box of 10 vials of 2 mL with black stopper) EU/1/09/550/009 (box of 1 vial of 4 mL with black stopper) EU/1/09/550/010 (box of 10 vials of 4 mL with black stopper) EU/1/09/550/011 (box of 1 vial of 10 mL with black stopper) EU/1/09/550/012 (box of 10 vials of 10 mL with black stopper)
EU/1/09/550/001 (škatla z 1 vialo z 2 ml s sivim zamaškom) EU/1/09/550/002 (škatla z 10 vialami po 2 ml s sivim zamaškom) EU/1/09/550/003 (škatla z 1 vialo s 4 ml s sivim zamaškom) EU/1/09/550/004 (škatla z 10 vialami po 4 ml s sivim zamaškom) EU/1/09/550/005 (škatla z 1 vialo z 10 ml s sivim zamaškom) EU/1/09/550/006 (škatla z 10 vialami po 10 ml s sivim zamaškom) EU/1/09/550/007 (škatla z 1 vialo z 2 ml s črnim zamaškom) EU/1/09/550/008 (škatla z 10 vialami po 2 ml s črnim zamaškom) EU/1/09/550/009 (škatla z 1 vialo s 4 ml s črnim zamaškom) EU/1/09/550/010 (škatla z 10 vialami po 4 ml s črnim zamaškom) EU/1/09/550/011 (škatla z 1 vialo z 10 ml s črnim zamaškom) EU/1/09/550/012 (škatla z 10 vialami po 10 ml s črnim zamaškom)
All resolved during the study.
V vseh primerih je stanje izzvenelo med študijo.
Vinflunine did not induce peripheral neuropathy in animals.
Vinflunin ni induciral periferne nevropatije pri živalih.
Each pack contains 1 or 10 vials.
Pakiranje vsebuje 1 ali 10 vial.
Radiological signs are white matter abnormalities in the posterior regions of the brain.
Radiološki znaki so nepravilnosti v beli možganovini zadnjih regij možganov.
To avoid extravasations it is important to be sure that the needle is correctly introduced before starting the infusion.
Za preprečevanje ekstravazacij je pomembno, da se pred začetkom infundiranja prepričate, ali je igla pravilno vstavljena.
No specific clinical studies of vinflunine in combination with these compounds have been carried out yet.
Specifične klinične študije vinflunina v kombinaciji s tema spojinama niso bile opravljene.
Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before starting your therapy.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
There are no data available on the use of vinflunine in pregnant women.
Nosečnost Ni podatkov o uporabi vinflunina pri nosečnicah.
These toxic effects were dose-related and fully or-partially reversible following a 1-month recovery period.
Ti toksični učinki so bili odvisni od odmerka ter popolnoma ali delno reverzibilni po enomesečnem obdobju okrevanja.
Vinflunine should therefore not be used during pregnancy, unless it is strictly necessary.
Zato vinflunina ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
If the solution comes into contact with the skin, this should be washed immediately and thoroughly with soap and water.
Če raztopina pride v stik s kožo, morate ta predel kože nemudoma in temeljito umiti z milom in vodo.
On the basis of the results of animal studies and the pharmacological action of the medicinal product, there is a potential risk of embryonic and foetal abnormalities.
Na osnovi rezultatov študij na živalih in farmakološkega delovanja zdravila obstaja potencialno tveganje nenormalnosti zarodka in plodu.
In case of overdose, the patient should be kept in a specialised unit and vital functions should be closely monitored.
V primeru prevelikega odmerjanja mora biti bolnik v specializirani enoti z natančnim spremljanjem življenjskih funkcij.
The terminal volume of distribution is large, 2422±676 litres (about 35 l/kg) suggesting extensive distribution into tissues.
Terminalni volumen porazdelitve je velik, tj. 2422±676 litrov (približno 35 l/kg), kar nakazuje obsežno porazdelitev v tkivih.
Javlor must not be given intrathecally (into the spine).
Zdravilo Javlor se ne sme dajati intratekalno (v hrbtenico).
Efficacy and safety of vinflunine have not been studied in patients with performance status ≥ 2.
Učinkovitost in varnost vinflunina nista bili preučeni pri bolnikih s telesno zmogljivostjo ≥ 2.
Studies in animals have shown embryotoxicity and teratogenicity (see section 5.3).
Študije na živalih so pokazale embriotoksičnost in teratogenost (glejte poglavje 5.3).
Organ toxicity: moderate, severe or life threatening
Na posamezen organ usmerjena toksičnost: zmerna, huda, življenjsko nevarna
Javlor is not intended for use in children and adolescents.
Zdravilo Javlor ni namenjeno zdravljenju otrok in mladostnikov.
One patient died after myocardial infarction and another one due to a cardiopulmonary arrest.
En bolnik je umrl po miokardnem infarktu, en bolnik pa zaradi kardiopulmonalnega zastoja.
Other medicines and Javlor
Druga zdravila in zdravilo Javlor
- No dose adjustment is necessary in patients:
- Prilagoditev odmerka ni potrebna:
If pregnancy occurs during treatment, the patient should be informed about the risk for the unborn child and be monitored carefully.
Če med zdravljenjem bolnica zanosi, jo je treba obvestiti o tveganju za nerojenega otroka in natančno spremljati.
What Javlor is and what it is used for What you need to know before you use Javlor How to use Javlor
Kaj je zdravilo Javlor in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Javlor Kako uporabljati zdravilo Javlor
In vitro studies showed that vinflunine had neither inducing effects on CYP1A2, CYP2B6 or CYP3A4 activity nor inhibition effects on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4.
V študijah in vitro so ugotovili, da vinflunin ne inducira aktivnosti CYP1A2, CYP2B6 ali CYP3A4, niti ne zavira CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP3A4.
The possibility of genetic counselling should be considered.
Lahko se opravi tudi genetsko posvetovanje.
- The other ingredient is water for injections.
- Pomožna snov je voda za injekcije.
This effect may lead to an increased risk of ventricular arrhythmias although no ventricular arrhythmias were observed with vinflunine.
Ta učinek lahko povzroči večje tveganje ventrikularnih aritmij, čeprav pri uporabi vinflunina teh niso opazili.
These medicines affect cancer cell growth by stopping cell division, leading to cell death (cytotoxicity).
Ta zdravila vplivajo na rast rakastih celic s prekinitvijo delitve celic, kar povzroči uničenje celic (citotoksičnost).
According to an in vitro study, such changes could be related to adsorption of vinflunine on the liposomes and a modified blood distribution of both compounds.
V študiji in vitro so ugotovili, da so takšne spremembe morda povezane z adsorpcijo vinflunina na liposome in z modificiranim porazdeljevanjem obeh spojin v krvi.
In case of small or sclerosed veins, lymphoedema or recent venipuncture of the same vein, the use of a central catheter may be preferred.
V primerih majhnih ali sklerotičnih ven, limfedema ali nedavne venipunkcije v isti veni je priporočena uporaba centralnega katetra.
Respiratory, thoracic and mediastinal disorders Dyspnoea occurred in 3.2% of the patients but was rarely severe (Grade 3/4: 1.2%).
Bolezni dihal, prsnega koša in mediastinalnega prostora Pri 3,2 % bolnikov se je pojavila dispneja, ki pa je bila v redkih primerih huda (stopnja 3/4: 1,2 %).
Javlor will be given to you by a qualified healthcare professional as an intravenous infusion (drip into your vein) lasting 20 minutes.
Zdravilo Javlor vam bo dal usposobljen zdravstveni delavec v obliki intravenske infuzije (zdravilo gre direktno v veno), ki traja 20 minut.
Storage conditions are detailed in the section intended for medicinal or heathcare professionals.
Pogoji shranjevanja so podrobno opisani v poglavju, namenjenem zdravstvenemu osebju.
According to the population pharmacokinetic analysis, neither gender nor performance status (ECOG score) had an impact on vinflunine clearance which is directly proportional to body surface area.
V populacijski farmakokinetični analizi so ugotovili, da niti spol niti zmogljivost (rezultat po lestvici ECOG) ne vplivata na očistek vinflunina, ki je neposredno sorazmeren s površino telesa.
The concomitant use of opioids could enhance the risk of constipation.
Sočasna uporaba opioidov lahko poveča tveganje zaprtosti.
Men and women with reproductive potential must use an effective method of contraception during the treatment and up to 3 months after the last vinflunine administration (see section 4.6).
Moški in ženske v reproduktivni dobi morajo med zdravljenjem uporabljati učinkovito metodo kontracepcije in do 3 mesece po zadnjem odmerku vinflunina (glejte poglavje 4.6).
Pregnant staff should not handle Javlor.
Nosečnice ne smejo delati z zdravilom Javlor.
This was further confirmed by the population pharmacokinetic analysis (absence of relationship between vinflunine clearance and biology markers of hepatic impairment).
To so dodatno potrdili s populacijsko farmakokinetično analizo (odsotnost povezave med očistkom vinflunina in biološkimi označevalci okvare jeter).
You may want to seek counseling on sperm storage before starting your therapy.
Če želite, se posvetujte glede shrambe sperme pred začetkom zdravljenja.
Vinflunine is moderately bound to human plasma proteins (67.2±1.1%) with a ratio between plasma and whole blood concentrations of 0.80±0.12.
Vinflunin se zmerno veže na beljakovine človeške plazme (67,2±1,1 %) tako, da je razmerje med koncentracijo v plazmi in polni krvi 0,80±0,12.
What you need to know before you use Javlor Do not use Javlor
Kaj morate vedeti, preden boste uporabili zdravilo Javlor Ne uporabljate zdravila Javlor
The excretion of vinflunine and its metabolites occurs through faeces (2/3) and urine (1/3).
Izločanje vinflunina in njegovih presnovkov je preko blata (2/3) in urina (1/3).
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).
Vinflunin se eliminira z večeksponentnim koncentracijskim razpadom s terminalno razpolovno dobo (t1/2) približno 40 h. DVFL se tvori počasi in se eliminira počasneje od vinflunina (t1/2 približno 120 h).
The diluted solution should be protected from light until administration (see section 6.3).
Razredčeno raztopino morate zavarovati pred svetlobo vse do dajanja (glejte poglavje 6.3).
It is unknown whether vinflunine or its metabolites are excreted in human milk.
Ni znano, ali se vinflunin oz. njegovi presnovki izločajo v materinem mleku.
Binding to alpha-1 acid glycoprotein and to platelets is negligible (< 5%).
Vezava na alfa-1 kisli glikoprotein in trombocite je zanemarljiva (<5 %).
Javlor should be administered by a 20-minute intravenous infusion and NOT be given by rapid intravenous bolus.
Zdravilo Javlor morate dati z 20-minutno infuzijo in NIKOLI s hitrim intravenskim bolusom.
The recommended dose in adult patients is 320 mg/m² body surface (this is calculated by the doctor based on your weight and your height).
Priporočeni odmerek za odraslega bolnika je 320 mg/m² telesne površine (ki jo zdravnik izračuna iz vaše telesne mase in višine).
Javlor is a concentrate that has to be diluted before administration.
Zdravilo Javlor je koncentrat, ki ga je treba pred uporabo razredčiti.
Patients at high risk of constipation (concomitant treatment with opiates, peritoneal carcinomas, abdominal masses, prior major abdominal surgery) should be medicated with an osmotic laxative from day 1 to day 7 administered once a day in the morning before breakfast.
Bolniki z velikim tveganjem zaprtosti (sočasno zdravljenje z opiati, peritonealni karcinomi, abdominalne mase, predhodni obsežni abdominalni kirurški poseg) morajo od 1. do 7. dneva zdravljenja prejemati ozmotski laksativ enkrat na dan, in sicer zjutraj pred zajtrkom.
Platelets < 100,000/mm3(see section 4.4).
Trombociti <100.000/mm3 (glejte poglavje 4.4).
Ischaemic cardiac events may occur, especially in patients who have underlying cardiac disease.
Lahko pride do ishemičnih srčnih dogodkov, zlasti pri bolnikih z obstoječo srčno boleznijo.
Rare cases of Posterior Reversible Encephalopathy Syndrome have been reported (see section 4.4).
Opaženi so bili redki primeri posteriornega reverzibilnega encefalopatičnega sindroma (glejte poglavje 4.4).
Elderly patients (≥ 75 years)
Starostniki (≥75 let)
Table 3: Dose adjustments due to toxicity in renal impaired or elderly patients
Tabela 3: Prilagajanje odmerka zaradi toksičnosti pri bolnikih z okvaro ledvic ali pri starejših bolnikih
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/.
Grade 2 is defined as “moderate”, Grade 3 as “severe” and Grade 4 as “life-threatening” (see Table 2 in section 4.2).
Stopnja 2 je definirana kot »zmerna«, stopnja 3 kot «huda«, stopnja 4 pa kot »življenjsko nevarna« (glejte tabelo 2 v poglavju 4.2).
Posterior Reversible Encephalopathy Syndromea
Posteriorni reverzibilni encefalopatični sindrom (PRES)
Vinflunine doses were adjusted according to 3 age groups as shown below:
Odmerki vinflunina so bili glede na 3 starostne skupine prilagojeni, kot je prikazano spodaj:
Content of the pack and other information What Javlor contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Javlor
Caution should be exercised in patients with a history of cardiac disease and the benefit / risk assessment should be carefully evaluated regularly.
Pri bolnikih z anamnezo srčne bolezni je potrebna previdnost in redno vrednotenje koristnih učinkov ter tveganja.
From a microbiological point of view, the product should be used immediately after dilution.
Z mikrobiološkega vidika morate zdravilo uporabiti nemudoma po redčenju.
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.
Če med prvim ciklom ne ugotovite nobene hematološke toksičnosti, zaradi katere bi zdravljenje odložili ali zmanjšali odmerek, v naslednjih ciklih povečajte odmerek na 320 mg/m² vsake 3 tedne.
Pack size of 1 and 10 vials.
Velikosti pakiranja po 1 in 10 vial.
Chemical and physical in-use stability has been demonstrated for the diluted medicinal product as follows:
Kemijska in fizikalna stabilnost med uporabo sta bili dokazani za redčeno zdravilo, in sicer:
Pharmacotherapeutic group: antineoplasic agents, vinca alkaloids and analogues, ATC code: L01CA05
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, alkaloidi rožnatega zimzelena in analogi, oznaka ATC: L01CA05
What Javlor is and what it is used for
Kaj je zdravilo Javlor in zakaj ga uporabljamo
Instructions for administration should be followed as described in section 6.6.
Upoštevati morate navodila za dajanje, ki so opisana v poglavju 6.6.
• The patency should be assessed frequently and extravasation precautions should be maintained throughout the infusion.
• pogosto preverjajte pretočnost in ves čas infundiranja izvajajte varnostne ukrepe za primer ekstravazacije.
This is further confirmed by the population pharmacokinetic analysis (56 patients with CrCl between 20 mL/min and 60 mL/min), showing that vinflunine clearance is influenced by the creatinine clearance value (Cockcroft and Gault formula).
To so dodatno potrdili s populacijsko farmakokinetično analizo (56 bolnikov z OK med 20 ml/min in 60 ml/min), kar kaže na očistek vinflunina vpliva vrednost očistka kreatinina (formula po Cockcroftu in Gaultu).
There is no known antidote for vinflunine overdose.
Ni znanega antidota za preveliko odmerjanje z vinfluninom.
2 NCI CTC Grade 3 nausea is defined as no significant intake, requiring intravenous fluids.
2 Navzea 3. stopnje po NCI CTC je definirana kot nepomemben vnos, ki zahteva intravensko dodajanje tekočin.
Imaging distribution studies following radioactive vinflunine in rats, illustrated that the compound levels in lungs, kidneys, liver, salivary and endocrine glands, and gastrointestinal tract were rapidly higher than those in blood.
Študije slikovne porazdelitve po odmerku radioaktivnega vinflunina pri podganah so pokazale, da koncentracije spojine v pljučih, ledvicah, jetrih, slinavkah in endokrinih žlezah ter prebavilih hitreje narastejo kot v krvi.
Blood exposure to vinflunine (AUC), significantly correlated with severity of leucopenia, neutropenia and fatigue.
Krvna izpostavljenost vinfluninu (AUC) se dobro ujema z resnostjo levkopenije, nevtropenije in utrujenosti.
- if you are allergic to the active substance (vinflunine) or to other vinca alkaloids (vinblastine,
- če ste alergični na zdravilno učinkovino (vinflunin) ali na druge alkaloide rožnatega zimzelena
Clinical and radiological features usually resolved rapidly without sequelae after treatment discontinuation.
Klinični in radiološki znaki po prekinitvi zdravljenja običajno hitro izginejo brez posledic.
Infection with Grade 3/4 neutropenia was observed in 2.8 % of patients.
Okužbo z nevtropenijo stopnje 3/4 so opazili pri 2,8 % bolnikov.
It is most unlikely that you will be asked to store this medicine yourself.
Tega zdravila vam ne bo potrebno shranjevati.
Adverse reactions are listed below by System Organ Class, frequency and grade of severity (NCI CTC version 2.0).
V spodnji preglednici so navedeni neželeni učinki po organskem sistemu, pogostnosti in stopnji resnosti (NCI CTC različica 2.0).
When infused through a peripheral vein, vinflunine can induce Grade 1 (22% of the patients, 14.1% of the cycles), Grade 2 (11.0% of the patients, 6.8% of the cycles) or Grade 3 (0.8% of the patients, 0.2% of the cycles) venous irritation.
Pri infundiranju v periferno veno lahko vinflunin inducira vensko draženje stopnje 1 (22 % bolnikov, 14,1 % ciklov), stopnje 2 (11,0 % bolnikov, 6,8 % ciklov) ali stopnje 3 (0,8 % bolnikov, 0,2 % ciklov).
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.
Febrilno nevtropenijo, ki je bila opredeljena kot AŠN <1.000/mm3 z zvišano telesno temperaturo ≥38,5 °C neznanega vzroka brez klinično mikrobiološko dokumentirane okužbe (NCI CTC različica 2.0), so opazili pri 5,2 % bolnikov.