natgillin/translations-raw huggingface dataset:
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/1/09/550/004 (kutija s 10 bočica od 4 mL sa sivim čepom) EU/1/09/550/005 (kutija s 1 bočicom od 10 mL sa sivim čepom) EU/1/09/550/006 (kutija s 10 bočica od 10 mL sa sivim čepom) EU/1/09/550/007 (kutija s 1 bočicom od 2 mL s crnim čepom) EU/1/09/550/008 (kutija s 10 bočica od 2 mL s crnim čepom) EU/1/09/550/009 (kutija s 1 bočicom od 4 mL s crnim čepom) EU/1/09/550/010 (kutija s 10 bočica od 4 mL s crnim čepom) EU/1/09/550/011 (kutija s 1 bočicom od 10 mL s crnim čepom) EU/1/09/550/012 (kutija s 10 bočica od 10 mL s crnim čepom)
One patient died after myocardial infarction and another one due to a cardiopulmonary arrest.
Jedan je bolesnik umro nakon infarkta miokrada, a drugi zbog kardiopulmonarnog zastoja.
Store in a refrigerator (2°C-8°C).
Čuvati u hladnjaku (2°C- 8°C).
Intrathecal administration of Javlor may be fatal.
Intratekalna primjena Javlora može biti smrtonosna.
General precautions for preparation and administration.
Opće mjere opreza za pripremu i primjenu.
In case of small or sclerosed veins, lymphoedema or recent venipuncture of the same vein, the use of a central catheter may be preferred.
U slučaju malih ili sklerotičnih vena, limfedema ili nedavne venepunkcije iste vene, može se preferirati uporaba centralnog katetera.
The terminal volume of distribution is large, 2422±676 litres (about 35 l/kg) suggesting extensive distribution into tissues.
Terminalni volumen distribucije je velik, 2422±676 litara (oko 35 l/kg), što upućuje na opsežnu distribuciju u tkiva.
If the solution comes into contact with the skin, this should be washed immediately and thoroughly with soap and water.
Ako otopina dođe u doticaj s kožom, kožu treba odmah temeljito oprati sapunom i vodom.
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.
Infarkt miokarda ili ishemiju doživjelo je 0,5% bolesnika, a većina ih je prethodno imala kardiovaskularnu bolest ili faktore rizika.
In case of overdose, the patient should be kept in a specialised unit and vital functions should be closely monitored.
U slučaju predoziranja bolesnika treba zadržati u specijaliziranoj jedinici i pomno nadzirati njegove vitalne funkcije.
No specific clinical studies of vinflunine in combination with these compounds have been carried out yet.
Još nisu provedena specifična klinička ispitivanja vinflunina u kombinaciji s tim spojevima.
From a microbiological point of view, the product should be used immediately after dilution.
S mikrobiološkog gledišta, lijek treba primijeniti odmah nakon razrjeđivanja.
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.
Vaša krvna slika redovito će se provjeravati prije i tijekom liječenja jer je niska razina krvnih stanica vrlo česta nuspojava primjene Javlora.
Javlor should be administered by a 20-minute intravenous infusion and NOT be given by rapid intravenous bolus.
Javlor je potrebno primijeniti 20-minutnom intravenskom infuzijom, a NE ga davati kao brzi intravenski bolus.
The concomitant use of opioids could enhance the risk of constipation.
Istodobna uporaba opioida mogla bi povećati rizik konstipacije.
The carcinogenic potential of vinflunine has not been studied.
Karcinogeni potencijal vinflunina nije ispitivan.
This effect may lead to an increased risk of ventricular arrhythmias although no ventricular arrhythmias were observed with vinflunine.
Ovaj učinak može dovesti do povećanog rizika od ventrikularnih aritmija iako kod primjene vinflunina nisu primijećene nikakve ventrikularne aritmije.
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.
Prema jednom in vitro ispitivanju, takve promjene mogu se povezati s adsorpcijom vinflunina na liposome i promijenjenom distribucijom obaju spojeva u krvi.
Clinical and radiological features usually resolved rapidly without sequelae after treatment discontinuation.
Klinički i radiološki znakovi obično bi brzo nestali bez posljedica nakon prekida liječenja.
What you need to know before you use Javlor Do not use Javlor
Što morate znati prije nego počnete primjenjivati Javlor
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
• Periodička izvješća o neškodljivosti Nositelj odobrenja za stavljanje lijeka u promet će podnositi periodička izvješća o neškodljivosti za ovaj lijek u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
Other appropriate measures should be taken, such as blood transfusions, administration of antibiotics and growth factors.
Treba poduzeti i druge odgovarajuće mjere kao što su transfuzije krvi, primjena antibiotika i faktora rasta.
Hematological toxicity
Hematološka toksičnost
Studies in animals have shown embryotoxicity and teratogenicity (see section 5.3).
Ispitivanja na životinjama pokazala su embriotoksičnost i teratogenost (vidjeti dio 5.3).
Instructions for administration should be followed as described in section 6.6.
Potrebno je slijediti upute o primjeni kao što je opisano u dijelu 6.6.
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).
Preporučena doza u odraslih bolesnika je 320 mg/m² tjelesne površine (izračunava je liječnik na temelju Vaše težine i visine).
Javlor is a concentrate that has to be diluted before administration.
Javlor je koncentrat koji se prije primjene mora razrijediti.
There are no data available on the use of vinflunine in pregnant women.
Nema dostupnih podataka o primjeni vinflunina u trudnica.
• The patency should be assessed frequently and extravasation precautions should be maintained throughout the infusion.
• Potrebno je često provjeravati protočnost i zadržati mjere opreza za slučaj ekstravazacije cijelo vrijeme trajanja infuzije.
Frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
vrlo česte (≥ 1/10); česte (≥ 1/100 i < 1/10); manje česte (≥ 1/1000 i < 1/100); rijetke (≥ 1/10 000 i < 1/1000); vrlo rijetke (< 1/10 000); nepoznate (ne mogu se procijeniti iz dostupnih podataka).
For any information about this medicine, please contact the Marketing Authorisation Holder.
Za sve informacije o ovom lijeku obratite se nositelju odobrenja za stavljanje gotovog lijeka u promet.
Vinflunine should therefore not be used during pregnancy, unless it is strictly necessary.
Stoga vinflunin ne bi trebalo primjenjivati tijekom trudnoće osim u slučaju da je to neophodno.
The excretion of vinflunine and its metabolites occurs through faeces (2/3) and urine (1/3).
Izlučivanje vinflunina i njegovih metabolita odvija se putem fecesa (2/3) i mokraće (1/3).
Efficacy and safety of vinflunine have not been studied in patients with performance status ≥ 2.
Djelotvornost i sigurnost vinflunina nisu ispitane u bolesnika s izvedbenim statusom ≥ 2.
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.
Prema populacijskoj farmakokinetičkoj analizi ni spol ni izvedbeni status (prema ECOG ljestvici) nije imao utjecaj na klirens vinflunina koji je izravno proporcionalan površini tijela.
Both male and female patients should take adequate contraceptive measures up to three months after the discontinuation of the therapy.
I muški i ženski bolesnici trebali bi poduzimati odgovarajuće kontracepcijske mjere do tri mjeseca nakon prekida terapije.
Elderly patients (≥ 75 years)
Stariji bolesnici (≥ 75 godina)
- with transaminases ≤ 2.5xULN ( < 5xULN only in case of liver metastases).
- s transaminazama ≤ 2,5xGGN (< 5xGGN samo u slučaju jetrenih metastaza).
These medicines affect cancer cell growth by stopping cell division, leading to cell death (cytotoxicity).
Ti lijekovi utječu na rast stanica raka zaustavljajući diobu stanica, što dovodi do stanične smrti (citotoksičnost).
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku
Constipation is a class effect of the vinca alkaloids: 11.8% of patients experienced severe constipation during treatment with vinflunine.
Konstipacija je učinak razreda vinka alkaloida: 11,8% bolesnika imalo je tešku konstipaciju tijekom liječenja vinfluninom.
The pharmacokinetic results of this study indicated a reduction of vinflunine clearance when CrCl is decreased.
Farmakokinetički rezultati ovog ispitivanja ukazuju na smanjenje klirensa vinflunina kad se smanjuje CrCl.
Very common Alopecia
Vrlo često Alopecija
All metabolites identified are formed by the cytochrome CYP3A4 isoenzyme, except for 4-O-deacetylvinflunine (DVFL), the only active metabolite and main metabolite in blood which is formed by multiple esterases.
Sve utvrđene metabolite tvori izoenzim citokroma CYP3A4, osim 4-O-deacetilvinflunina (DVFL), jedinog aktivnog metabolita i glavnog metabolita u krvi kojeg tvori veći broj esteraza.
Pharmacotherapeutic group: antineoplasic agents, vinca alkaloids and analogues, ATC code: L01CA05
Farmakoterapijska skupina: antineoplastici, vinka alkaloidi i analozi, ATK oznaka: L01CA05 Mehanizam djelovanja
Binding to alpha-1 acid glycoprotein and to platelets is negligible (< 5%).
Vezanje na alfa-1 kiseli glikoprotein i trombocite je zanemarivo (< 5%).
- if you are allergic to the active substance (vinflunine) or to other vinca alkaloids (vinblastine,
- ako ste alergični na djelatnu tvar (viniflunin) ili druge vinka alkaloide (vinblastin, vinkristin,
You may want to seek counseling on sperm storage before starting your therapy.
Ako želite, možete potražiti savjet o pohranjivanju sperme prije početka terapije.
The diluted solution should be protected from light until administration (see section 6.3).
Razrijeđenu otopinu potrebno je zaštititi od svjetlosti sve do njene primjene (vidjeti dio 6.3).
This was further confirmed by the population pharmacokinetic analysis (absence of relationship between vinflunine clearance and biology markers of hepatic impairment).
To je dodatno potvrdila populacijska farmakokinetička analiza (izostanak veze između klirensa vinflunina i bioloških markera oštećenja jetre).
Rare cases of Posterior Reversible Encephalopathy Syndrome have been reported (see section 4.4).
Prijavljeni su rijetki slučajevi posteriornog reverzibilnog encefalopatskog sindroma (vidjeti dio 4.4).
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).
Muškarci i žene reproduktivne dobi moraju primjenjivati učinkovitu metodu kontracepcije tijekom liječenja i do 3 mjeseca nakon posljednje primjene vinflunina (vidjeti dio 4.6).
Elderly (≥ 75 years)
Starije osobe (≥ 75 godina)
Worst NCI Grade per patient (%) All grades Grade 3-4
Najgori NCI stupanj po bolesniku (%) Svi stupnjevi
Pack size of 1 and 10 vials.
Veličina pakiranja od 1 i 10 bočica.
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.
Bolesnike s visokim rizikom konstipacije (istodobno liječenje opijatima, karcinoza peritoneuma, abdominalne mase, prethodna teža operacija abdomena) potrebno je liječiti osmotskim laksativom od 1. do 7. dana koji se uzima jedanput na dan ujutro prije doručka.
Table 3: Dose adjustments due to toxicity in renal impaired or elderly patients
Tablica 3: Prilagodbe doze zbog toksičnosti u bolesnika s oštećenjem bubrega ili starijih bolesnika
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.
Ako ste muškarac i ili žena u plodnoj dobi, trebali biste primjenjivati odgovarajuću metodu kontracepcije tijekom liječenja i 3 mjeseca nakon posljednje doze Javlora.
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.
CYP2B6 ili CYP3A4 ni inhibicijski učinak na CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 i CYP3A4.
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.
Vinflunin se veže na tubulin na ili blizu vezivnih mjesta vinka alkaloida inhibirajući njegovu polimerizaciju u mikrotubule, što za posljedicu ima supresiju dinamike citosekeleta, prekid dinamike mikrotubula, mitotski zastoj i apoptozu.
All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Svi postupci prijenosa zahtijevaju strogu primjenu aseptičkih tehnika, po mogućnosti uporabu zaštitne komore s vertikalnim laminarnim strujanjem zraka.
Javlor may cause side effects such as tiredness and dizziness.
Javlor može uzrokovati nuspojave kao što su umor i omaglica.
It is unknown whether vinflunine or its metabolites are excreted in human milk.
Nije poznato izlučuju li se vinflunin ili njegovi metaboliti u majčino mlijeko.
Ischaemic cardiac events may occur, especially in patients who have underlying cardiac disease.
Može doći do razvoja ishemijskih srčanih događaja, osobito u bolesnika koji imaju postojeću srčanu bolest.
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 umjereno veže za bjelančevine ljudske plazme (67,2±1,1%) pri čemu je omjer između koncentracija u plazmi i cijeloj krvi 0,80±0,12.
IV use ONLY, after dilution
SAMO i.v. primjena, nakon razrjeđivanja
A pharmacokinetic phase I study of vinflunine was performed in elderly patients (n=46).
Farmakokinetičko ispitivanje faze I provedeno je na starijim bolesnicima (n=46).
Advice on conservation of sperm should be sought prior to treatment because of the possibility of irreversible infertility due to therapy with vinflunine.
Potrebno je potražiti savjet o pohrani sperme prije liječenja zbog mogućnosti ireverzibilne neplodnosti uslijed terapije vinfluninom.
Grade 3 vomiting as ≥ 6 episodes in 24 hours over pretreatment; or need for intravenous fluids.
Povraćanje 3. stupnja definira se kao ≥ 6 epizoda u 24 sata nakon prethodnog liječenja; ili potreba za intravenskom primjenom tekućine.
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 je dodatno potvrdila populacijska farmakokinetička analiza (56 bolesnika s CrCl-om između 20 mL/min i 60 mL/min) pokazujući da na klirens vinflunina utječe vrijednost klirensa kreatinina (formula prema Cockcroftu i Gaultu).
Platelets < 100,000/mm3(see section 4.4).
Trombociti < 100 000/mm³ (vidjeti dio 4.4).
Grade 3/4 ileus reported in 1.9% of patients was reversible when managed by medical care.
Ileus 3./4.stupnja prijavljen kod 1,9% bolesnika bio je reverzibilan uz primjenu medicinskih sredstava.
After dilution of the Javlor concentrate, the solution for infusion will be administered as follows:
Nakon razrjeđivanja koncentrata lijeka Javlor, otopina za infuziju primijenit će se na sljedeći način:
- “Syndrome of inappropriate antidiuretic hormone secretion”, which is a condition that causes low levels of blood sodium - tumour pain.
- "Sindrom neodgovarajućeg izlučivanja antidiuretskog hormona", poremećaj koji uzrokuje niske razine natrija u krvi - tumorska bol.
Javlor contains the active substance vinflunine, which belongs to a group of anticancer medicines called vinca alkaloids.
Javlor sadrži djelatnu tvar vinflunin koja pripada skupini lijekova protiv raka nazvanih vinka alkaloidi.
Blood exposure to vinflunine (AUC), significantly correlated with severity of leucopenia, neutropenia and fatigue.
Izloženost vinfluninu u krvi (AUC) u značajnoj je korelaciji s težinom leukopenije, neutropenije i umora.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim dopunama Plana.
Median PFS was 3.0 months (vinflunine + BSC) vs 1.5 months (BSC) (p=0.0012).
Medijan preživljenja bez progresije bolesti (PFS) bio je 3,0 mjeseca (vinflunin + BSC) naspram 1,5 mjeseci (BSC) (p=0,0012).
Neutropenia Grade 4 (ANC < 500/mm3) > 7 days
Neutropenija 4. stupnja (ABN< 500/mm³) > 7 dana
Paediatric population There is no relevant use of Javlor in the paediatric population.
Pedijatrijska populacija Nema bitne indikacije za primjenu lijeka Javlor u pedijatrijskoj populaciji.
Uncommon Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) a
Manje često Sindrom neodgovarajućeg izlučivanja antidiuretskog hormona (SIADH) a
Pregnant staff should not handle Javlor.
Trudnice ne smiju rukovati Javlorom.
Posterior Reversible Encephalopathy Syndromea
Posteriorni reverzibilni encefalopatski sindroma
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.
Nisu zabilježene nikakve promjene farmakokinetike vinflunina i DVFL-a u 25 bolesnika s različitim stupnjevima oštećenja jetre u usporedbi s bolesnicima s normalnom funkcijom jetre.
Posology The recommended dose is 320 mg/m² vinflunine as a 20 minute intravenous infusion every 3 weeks.
Doziranje Preporučena doza je 320 mg/m² vinflunina u obliku 20-minutne intravenske infuzije svaka 3 tjedna.
Sensory peripheral neuropathy is a class effect of the vinca alkaloids.
Periferna senzorna neuropatija je učinak razreda vinka alkaloida.
In vitro studies showed that vinflunine is a Pgp-substrate like other vinca alkaloids, but with a lower affinity.
Ispitivanja in vitro pokazala su da je vinflunin Pgp-supstrat poput drugih vinka alkaloida, ali s nižim afinitetom.
Definitive Treatment discontinuation
Konačan prekid liječenja
Discontinuation of vinflunine should be considered in patients who develop cardiac ischaemia.
Treba razmotriti prekid terapije vinfluninom u bolesnika koji razviju srčanu ishemiju.
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).
Pedijatrijska populacija Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Javlor u svim podskupinama pedijatrijske populacije u indikaciji liječenja karcinoma mokraćovoda i mokraćnog mjehura i liječenja karcinoma dojke (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Therefore, regular monitoring of serum sodium levels is recommended during treatment with vinflunine.
Stoga se preporučuje provoditi redovito praćenje razine natrija u serumu tijekom liječenja vinfluninom.
Vinflunine pharmacokinetics is linear in the range of administered doses (from 30 mg/m² to 400 mg/m2) in cancer patients.
Farmakokinetika vinflunina je linearna u rasponu primijenjenih doza (od 30 mg/m² do 400 mg/m2) u bolesnika s rakom.
No pharmacokinetic interaction was observed in patients when vinflunine was combined with either cisplatin, carboplatin, capecitabine or gemcitabine.
Nije primijećena farmakokinetička interakcija u bolesnika prilikom kombiniranja vinflunina s cisplatinom, karboplatinom, kapecitabinom ili gemcitabinom.
It comes in clear glass vials closed by a rubber stopper containing 2 mL, 4 mL or 10 mL of concentrate.
Isporučuje se u prozirnim staklenim bočicama zatvorenim gumenim čepom koje sadrže 2 mL, 4 mL ili 10 mL koncentrata.
Grade ≥ 3 constipation occurred in 15.3% of treated patients.
Konstipacija ≥ 3. stupnja pojavila se kod 15,3% liječenih bolesnika.
Grade 3 was experienced by 0.6% patients.
3. stupanj imalo je 0,6% bolesnika.
During the pre- and post-natal development study in rat, vinflunine induced malformations of the uterus and vagina in 2 females, and adversely affected mating and/or ovule implantation and markedly lowered the number of concepti.
Tijekom ispitivanja prenatalnog i postnatalnog razvoja u štakora vinflunin je inducirao malformacije maternice i rodnice kod 2 ženke i negativno utjecao na parenje i/ili implantaciju jajašca te značajno smanjio broj zametaka.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Unutar svake skupine učestalosti nuspojave su navedene u padajućem slijedu prema ozbiljnosti.
Glucose 50 mg/mL (5%) solution for infusion may also be used.
Može se upotrijebiti i otopina glukoze 50 mg/mL (5%) za infuziju.
Respiratory, thoracic and mediastinal disorders Dyspnoea occurred in 3.2% of the patients but was rarely severe (Grade 3/4: 1.2%).
Dispneja se pojavila kod 3,2% bolesnika, no rijetko je bila teška (3./4. stupnja: 1,2%).
Due to the possible very harmful effects on the infants, breast-feeding during treatment with vinflunine is contraindicated (see section 4.3).
Zbog mogućih vrlo štetnih učinaka na dojenčad, dojenje je tijekom liječenja vinfluninom kontraindicirano (vidjeti dio 4.3).
Grade 2 is defined as “moderate”, Grade 3 as “severe” and Grade 4 as “life-threatening” (see Table 2 in section 4.2).
2. stupanj definira se kao "umjeren", 3. stupanj kao "težak", a 4. stupanj kao "opasan po život" (vidjeti Tablicu 2 u dijelu 4.2).
The concomitant use of potent inhibitors or potent inducers of CYP3A4 with vinflunine should be avoided (see section 4.5).
Potrebno je izbjegavati istodobnu uporabu potentnih inhibitora ili potentnih induktora CYP3A4 s vinfluninom (vidjeti dio 4.5).
Procedure for proper handling and disposal of anticancer medicinal products should be considered.
Treba razmotriti postupke za pravilno rukovanje i zbrinjavanje protutumorskih lijekova.