natgillin/translations-raw huggingface dataset:
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.
Vse ugotovljene presnovke tvori izoencim citokrom CYP3A4, razen 4Odeacetilvinflunina (DVFL), ki je edini aktivni presnovek ter glavni presnovek v krvi.
Posology The recommended dose is 320 mg/m² vinflunine as a 20 minute intravenous infusion every 3 weeks.
Odmerjanje Priporočeni odmerek je 320 mg/m² vinflunina v obliki 20-minutne intravenske infuzije vsake 3 tedne.
The main toxic effect due to an overdose with vinflunine is bone marrow suppression with a risk of severe infection.
Glavni toksični učinek v primeru prevelikega odmerjanja z vinfluninom je supresija kostnega mozga s tveganjem hude okužbe.
A pharmacokinetic and tolerability phase I study in patients with altered liver functions test has been completed (see section 5.2).
Zaključena je farmakokinetična in študija prenašanja I faze pri bolnikih s spremenjenimi preizkusi jetrnih funkcij (glejte točko 5.2).
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).
Pogostnost neželenih reakcij je opredeljena z naslednjimi dogovorjenimi skupinami: zelo pogosti (≥1/10); pogosti (≥1/100, <1/10); občasni (≥1/1.000,< 1/100);
Therefore, regular monitoring of serum sodium levels is recommended during treatment with vinflunine.
Zato je med zdravljenjem z vinfluninom priporočljivo redno spremljanje ravni natrija v serumu.
A pharmacokinetic interaction between vinflunine and pegylated/liposomal doxorubicin was observed, resulting in a 15% to 30% apparent increase in vinflunine exposure and a 2 to 3-fold apparent decrease of doxorubicin AUC, whereas for doxorubicinol, the concentrations of the metabolite were not affected.
Opazili so farmakokinetične interakcije med vinfluninom in pegeliranim/liposomskim doksorubicinom, ki povzroči od 15 % do 30 % navidezno zvišanje izpostavljenosti vinfluninu ter od 2 do 3-kratno navidezno zmanjšanje AUC doksorubicina, medtem ko so koncentracije presnovka doksorubicinola ostale nespremenjene.
Preclinical data revealed moderate to severe neutropenia and mild anaemia, in all species tested, with liver toxicity in dogs and rats (characterized by dose-dependent increases in liver transaminases and hepatic necrosis/hepatocellular alterations at high doses).
Predklinični podatki so pokazali zmerno do hudo nevtropenijo ter blago anemijo pri vseh preskušenih vrstah ter jetrno toksičnost pri psih in podganah (z katero so bila značilna od odmerka odvisna zvišanja ravni jetrnih transaminaz ter hepatična nekroza/hepatocelularne spremembe pri velikih odmerkih).
2nd consecutive event
Drugi zaporedni dogodek
The following information is intended for medical or healthcare professionals only:
Naslednje informacije so namenjene samo zdravstvenemu osebju: NAVODILO ZA UPORABO
- “Syndrome of inappropriate antidiuretic hormone secretion”, which is a condition that causes low levels of blood sodium - tumour pain.
- »sindrom neustreznega izločanja antidiuretičnega hormona« - stanje, ki povzroči nizke ravni natrija v krvi,
Protein binding mainly involves high density lipoproteins and serum albumin and is non-saturable on the range of vinflunine concentrations observed in patients.
Vezava na beljakovine obsega lipoproteine visoke gostote in serumski albumin ter je nenasičeno v razponu koncentracij vinflunina pri bolnikih.
• The Javlor solution for infusion should be infused over 20 minutes.
• Infuzija zdravila Javlor raztopina za injiciranje naj traja 20 minut.
It comes in clear glass vials closed by a rubber stopper containing 2 mL, 4 mL or 10 mL of concentrate.
Dobavlja se v z gumastim zamaškom zaprtih vialah iz prozornega stekla z 2 ml, 4 ml ali 10 ml koncentrata.
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.
V študiji prenatalnega in postnatalnega razvoja pri podganah je vinflunin induciral malformacije maternice in nožnice pri 2 samicah ter negativno vplival na parjenje in/ali vsaditev jajčeca ter zmanjšal število zanositev.
Mucositis Grade 2 is defined as “moderate”, Grade 3 as “severe” and Grade 4 as “life-threatening”.
Mukozitis 2. stopnje je definiran kot ”zmeren”, 3. stopnje kot ”hud” in 4. stopnje kot ”življenjsko nevaren”.
Severe anaemia and thrombocytopenia were less common (respectively 8.8 and 3.1 %).
Huda anemija in trombocitopenija sta bili redkejši (8,8 % oz. 3,1 %).
Special attention is recommended when vinflunine is administered to patients with prior history of myocardial infarction/ischaemia or angina pectoris (see section 4.8).
Posebna pozornost je priporočljiva, če vinflunin dajete bolniku z anamnezo miokardnega infarkta/ishemije ali angine pektoris (glejte poglavje 4.8).
Advice on conservation of sperm should be sought prior to treatment because of the possibility of irreversible infertility due to therapy with vinflunine.
Pred zdravljenjem se morajo bolniki posvetovati o možnosti shranjevanja sperme zaradi možnosti ireverzibilne neplodnosti zaradi terapije z vinfluninom.
You should not be given Javlor if you are pregnant, unless it is absolutely necessary.
Če ste noseči, ne smete prejeti zdravila Javlor, razen če je to nujno potrebno.
Median PFS was 3.0 months (vinflunine + BSC) vs 1.5 months (BSC) (p=0.0012).
Mediana preživetja brez napredovanja bolezni je bila 3,0 meseca (vinflunin + NPO) oz. 1,5 meseca (NPO) (p=0,0012).
The pharmacokinetic results of this study indicated a reduction of vinflunine clearance when CrCl is decreased.
Farmakokinetični rezultati te študije kažejo, da se pri zmanjšanem OK
Neutropenia Grade 4 (ANC < 500/mm3) > 7 days
Nevtropenija stopnje 4 (AŠN <500/mm3), ki traja >7 dni
Grade 3 vomiting as ≥ 6 episodes in 24 hours over pretreatment; or need for intravenous fluids.
Bruhanje 3. stopnje je definirano z ≥ 6 dogodki v 24 urah po predzdravljenju ali s potrebo po intravenskem dodajanju tekočin.
In vivo, vinflunine displays significant antitumor activity against a broad spectrum of human xenografts in mice both in terms of survival prolongation and tumour growth inhibition.
Vinflunin ima in vivo znatno protitumorsko aktivnost proti širokemu spektru človeških ksenogenskih presadkov v miših v obliki podaljšanja preživetja in zavrtja rasti tumorja.
In clinical studies, patients with CrCl (creatinine clearance) > 60 mL/min were included and treated at the recommended dose.
V klinične študije so bili vključeni bolniki z OK (očistek kreatinina) >60 ml/min, ki so bili tudi zdravljeni s priporočenim odmerkom.
All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Pri vseh prenosih morate natančno upoštevati aseptične tehnike in po možnosti uporabiti zaščitno komoro z navpičnim laminarnim tokom zraka.
A phase I study evaluating the effect of ketoconazole treatment (a potent CYP3A4 inhibitor) on vinflunine pharmacokinetics indicated that co-administration of ketoconazole (400 mg orally once daily for 8 days) resulted in a 30% and 50% increase in blood exposures to vinflunine and its metabolite 4Odeacetyl-vinflunine (DVFL), respectively.
V študiji I. faze, kjer so preučevali učinek zdravljenja s ketokonazolom (močnim zaviralcem CYP3A4) na farmakokinetiko vinflunina, je bilo nakazano, da sočasna uporaba ketokonazola (400 mg peroralno enkrat dnevno 8 dni) povzroči 30 % povečanje krvne izpostavitve vinfluninu oz. 50 % povečanje krvne izpostavitve njegovemu presnovku 4Odeacetil-vinfluninu (DVFL).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi o citotoksičnih zdravilih.
- with transaminases ≤ 2.5xULN ( < 5xULN only in case of liver metastases).
- pri bolnikih s transaminazami ≤ 2,5x ZMNR (zgornja meja normale) ( < 5x ZMNR samo v primerih jetrnih metastaz.)
Javlor is for single use only.
Zdravilo Javlor je samo za enkratno uporabo.
Vinflunine clearance was significantly decreased in patients ≥ 80 years old as compared to a control group of younger patients < 70 years.
Očistek vinflunina se je, glede na kontrolno skupino mlajših bolnikov <70 let, bistveno zmanjšal pri bolnikih, starejših od 80 let.
Nevertheless, vinflunine should be used with caution in patients with increase of the proarrhythmic risk (e.g. congestive heart failure, known history of QT interval prolongation, hypokalaemia) (see section 4.8).
Kljub temu je treba zdravilo Javlor previdno uporabljati pri bolnikih z večjim proaritmijskim tveganjem (npr. srčno popuščanje, anamneza podaljšanja intervala QT, hipokalemija) (glejte poglavje 4.8).
Pharmacokinetics of vinflunine was not modified for patients 70 ≤ age < 75 years and 75 ≤ age < 80 years.
Farmakokinetika vinflunina ni bila spremenjena pri bolnikih starosti med 70 in 75 let in starosti med 75 in 80 let.
Febrile Neutropenia (ANC < 1,000/mm3 and fever ≥ 38,5 °C)
Febrilna nevtropenija (AŠN <1.000/mm3 in zvišana telesna temperatura ≥38,5 °C)
Day 1 treatment administration
Izvajanje zdravljenja - 1 dan
Grade 3/4 ileus reported in 1.9% of patients was reversible when managed by medical care.
Pri 1,9 % bolnikov so ugotovili ileus stopnje 3/4, ki je bil reverzibilen po zdravstveni oskrbi.
In the multi-centre, open-label controlled phase III clinical trial, 253 patients were randomised to treatment with vinflunine + BSC (best supportive care) and 117 patients to the BSC arm.
V multicentričnem, nezaslepljenem kontroliranem kliničnem preskušanju III. faze so naključno razporedili 253 bolnikov v skupino, ki se je zdravila z vinfluninom + NPO (najboljša podporna oskrba), 11 bolnikov pa v skupino, ki je prejemala le NPO.
Vinflunine pharmacokinetics was not modified in those patients, however based on hepatic biologic parameter modifications following vinflunine administration (gamma glutamyl transferases (GGT), transaminases, bilirubin), the dose recommendations are as follows:
Farmakokinetika vinflunina se pri teh bolnikih ne spremeni, na spremembah jetrnih bioloških parametrov (gama-glutamil-transferaze (GGT), transaminaze, bilirubin)
- Delay until recovery to mild toxicity or none, or to initial baseline status and adjust the dose if necessary (see table 2) - Discontinuation if recovery has not occurred within 2 weeks
- Odložite do vrnitve na blago ali nikakršno toksičnost ali na začetno osnovno stanje in, če je potrebno, odmerek prilagodite (glejte tabelo 2).
In a population pharmacokinetic analysis in 372 patients (656 pharmacokinetic profiles), the total blood clearance was 40 l/h with low inter and intra-individual variability (25% and 8%, respectively, expressed as coefficient of variation).
V populacijski farmakokinetični analizi pri 372 bolnikih (656 farmakokinetičnih profilov) je bil skupni krvni očistek 40 l/min z nizko variabilnostjo med preiskovanci (koeficient variacije 25 %) in pri posameznem preiskovancu (koeficient variacije 8 %).
The typical clinical symptoms are, with various degrees: neurological (headache, confusion, seizure, visual disorders), systemic (hypertension), and gastrointestinal (nausea, vomiting).
Značilni, različno močno izraženi klinični simptomi so: nevrološki (glavobol, zmedenost, krči, motnje vida), sistemski (hipertenzija) in gastrointestinalni (navzea, bruhanje).
Javlor is a clear, colourless to pale yellow solution.
Zdravilo Javlor je bistra, brezbarvna do bledo rumena raztopina.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
C. DRUGI POGOJI ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
Both male and female patients should take adequate contraceptive measures up to three months after the discontinuation of the therapy.
Kontracepcija pri moških in ženskah Moški in ženske morajo uporabljati primerno kontracepcijo še tri mesece po prekinitvi zdravljenja.
Any other toxicity Grade ≥ 3 (severe or life-threatening) (except Grade 3 vomiting or nausea2) *National Cancer Institute, Common Toxicity Criteria Version 2.0 (NCI CTC v 2.0) 1 NCI CTC Grade 2 constipation is defined as requiring laxatives, Grade 3 as an obstipation requiring manual evacuation or enema, Grade 4 as an obstruction or toxic megacolon.
Vse druge toksičnosti stopnje ≥3 (hude ali življenjsko nevarne) (razen bruhanja in navzee stopnje 32) *National Cancer Institute, splošni kriteriji toksičnosti, različica 2.0 (NCI CTC v 2.0) 1Zaprtost 2. stopnje po NCI CTC zahteva zdravljenje z odvajali, zaprtje 3. stopnje zahteva ročno praznjenje ali enemo, zaprtje 4. stopnje pa je definirano kot obstrukcija ali toksični megakolon.
Definitive Treatment discontinuation
dokončna prekinitev zdravljenja
3rd consecutive event
Tretji zaporedni dogodek
The most frequent treatment-related adverse reactions reported in the two phase II and one phase III trials in patients with transitional cell carcinoma of the urothelium (450 patients treated with vinflunine) were haematological disorders, mainly neutropenia and anaemia; gastrointestinal disorders, especially constipation, anorexia, nausea, stomatitis/mucositis, vomiting, abdominal pain and diarrhoea, and general disorders such as asthenia/fatigue.
preskušanju III. faze pri bolnikih s prehodnoceličnim karcinomom urotelija (450 bolnikov, zdravljenih z vinfluninom), so bile hematološke bolezni, večinoma nevtropenija in anemija; bolezni prebavil, zlasti zaprtost, anoreksija, navzea, stomatitis/mukozitis, bruhanjem bolečine v trebuhu in driska; ter splošne bolezni, kot sta astenija/utrujenost.
When infused through a peripheral vein, vinflunine can induce venous irritation (see section 4.4).
Če vinflunin infundirate v periferno veno, lahko povzroči vensko draženje (glejte poglavje 4.4).
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 vezavna mesta alkaloidov rožnatega zimzelena na tubulinu ali blizu njih in s tem zavre polimerizacijo v mikrotubule, kar povzroči supresijo dinamike citoskeleta, prekinitev dinamike mikrotubulov, zaustavitev celice v mitozi in sproži celično smrt z apoptozo.
Vinflunine pharmacokinetics is linear in the range of administered doses (from 30 mg/m² to 400 mg/m2) in cancer patients.
Farmakokinetika vinflunina je pri bolnikih z rakom linearna v razponu uporabljenih odmerkov (od 30 mg/m² do 400 mg/m2).
Javlor may cause side effects such as tiredness and dizziness.
Zdravilo Javlor lahko povzroča neželene učinke, kot sta utrujenost in omotica.
Vinflunine is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Javlor.
Vinflunin je citotoksično zdravilo proti raku, zato je pri ravnanju z zdravilom Javlor kot pri drugih potencialno toksičnih spojinah potrebna previdnost.
Table 4 Adverse reactions observed in patients with transitional cell carcinoma of the urothelium treated with vinflunine
Tabela 4 Neželeni učinki pri bolnikih s prehodnoceličnim karcinomom urotelija, ki so bili zdravljeni z vinfluninom
Based on both PK and safety data, dose reductions are recommended in the elder groups: 75 ≤ age < 80 years; and age ≥ 80 years.
Na osnovi FK in varnostnih podatkov priporočamo zmanjšanje odmerka pri starostnikih , starih od75 do 80 let in pri starostnikih, starejših od 80 let.
Therefore the concomitant use of vinflunine and potent CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole and grapefruit juice) or inducers (such as rifampicin and Hypericum perforatum (St John's wort)) should be avoided since they may increase or decrease vinflunine and DVFL concentrations (see section 4.4 and 5.2).
ketokonazol, itrakonazol in sok grenivk) oz. močnih induktorjev CYP3A4 (kot sta rifampicin in Hypericum perforatum (šentjanževka)), ker lahko zvišajo oz. znižajo koncentracijo vinflunina in DVFL (glejte poglavji 4.4 in 5.2).
B. CONDITIONS OR RESTRICTIONS REGARDING THE SUPPLY AND USE
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
Dose delay or discontinuation due to toxicity
Odložitev odmerka ali prekinitev zdravljenja v primeru toksičnih učinkov
Diluted solution The diluted solution should be use immediately
Redčeno raztopino je treba nemudoma uporabiti.
Glucose 50 mg/mL (5%) solution for infusion may also be used.
Uporabite lahko tudi raztopino glukoze 50 mg/ml (5 %) za infundiranje.
Uncommon Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) a
Bolezni endokrinega sistema občasni sindrom neustreznega izločanja antidiuretičnega hormona (SIADH)a
For further cycles, the dose should be adjusted in the event of toxicities, as shown in table 3 below.
V naslednjih ciklih zdravljenja se mora odmerek v primeru toksičnosti prilagajati, kot je prikazano v spodnji tabeli 3.
Efficacy was demonstrated in both patients with or without prior cisplatin use.
Učinkovitost je bila dokazana pri bolnikih s predhodnim zdravljenjem s cisplatinom in bolnikih brez takšnega predhodnega zdravljenja.
Cardiac ischaemia in patients with prior history of myocardial infarction or angina pectoris
Srčna ishemija pri bolnikih z anamnezo miokardnega infarkta ali angine pektoris.
Either peripheral lines or a central catheter can be used for vinflunine administration.
Za dajanje vinflunina lahko uporabite bodisi periferno ožilje ali centralni kateter.
If you get any side effects, talk to your doctor.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
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.
Pri 25 bolnikih z različnimi stopnjami okvare jeter niso ugotovili razlik v farmakokinetiki vinflunina in DVFL v primerjavi z bolniki z normalno jetrno funkcijo.
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).
Javlor za vse podskupine pediatrične populacije za zdravljenje raka sečevoda in sečnega mehurja in za zdravljenje raka dojk (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Vinflunine treatment should be initiated under the responsibility of a physician qualified in the use of anticancer chemotherapy and is confined to units specialised in the administration of cytotoxic chemotherapy.
4.2 Odmerjanje in način uporabe Zdravljenje z vinfluninom se mora začeti po nadzorom zdravnika, ki je usposobljen za uporabo kemoterapevtikov proti raku in je omejeno na zdravstvene enote, specializirane za dajanje citotoksičnih kemoterapij.
After dilution of the Javlor concentrate, the solution for infusion will be administered as follows:
Po redčenju Javlor koncentrata raztopino za infundiranje uporabite po naslednjem postopku:
Infections and infestations Common Neutropenic infection Infections (viral, bacterial, fungal) Uncommon Neutropenic sepsis
Infekcijske in parazitske bolezni pogosti nevtropenična okužba okužbe (virusne, bakterijske, glivne)
The median overall survival was 6.9 months (vinflunine + BSC) vs. 4.6 months (BSC), but the difference did not reach statistical significance; hazard ratio 0.88 (95% CI 0.69, 1.12).
Mediana skupnega preživetja je bila 6,9 meseca (vinflunin + NPO) oz. 4,6 meseca (NPO), vendar rezultat ni dosegel statistične pomembnosti; razmerje ogroženosti 0,88 (95-odstotni interval zaupanja
Before each cycle, adequate monitoring of complete blood counts should be conducted to verify the absolute neutrophil count (ANC), platelets and haemoglobin as neutropenia, thrombocytopenia and anaemia are frequent adverse reactions of vinflunine.
Pred vsakim ciklom je treba opraviti natančen pregled celotne krvne slike, z določitvijo absolutnega števila nevtrofilcev (AŠN), trombocitov in hemoglobina, saj so nevtropenija, trombocitopenija in anemija pogosti neželeni učinki vinflunina.
In patients with severe renal impairment (20 mL/min ≤ CrCl < 40 mL/min) the recommended dose is 250 mg/m² every 3 weeks (see section 5.2).
Za bolnike s hudo okvaro ledvic (20 ml/min ≤ OK < 60 ml/min) je priporočeni odmerek 250 mg/m² vsake 3 tedne (glejte poglavje 5.2).
Sensory peripheral neuropathy is a class effect of the vinca alkaloids.
Bolezni živčevja Senzorična periferna nevropatija je učinek alkaloidov rožnatega zimzelena.
Grade ≥ 3 constipation occurred in 15.3% of treated patients.
Pri 15,3 % zdravljenih bolnikov se je pojavila zaprtost stopnje ≥ 3.
In vitro studies showed that vinflunine is a Pgp-substrate like other vinca alkaloids, but with a lower affinity.
V študijah in vitro so ugotovili, da je vinflunin substrat Pgp, kot drugi alkaloidi rožnatega zimzelena,
Javlor 25 mg/mL sterile concentrate vinflunine
Javlor 25 mg/ml sterilni koncentrat vinflunin
The concomittant use of two or more QT/QTc interval prolonging substances is not recommended (see section 4.5).
Sočasna uporaba vsaj dveh zdravil, ki podaljšujejo interval QT, ni priporočljiva (glejte poglavje 4.5).
Common (may affect up to 1 in 10 people)
Pogosti (pojavijo se lahko pri 1 od 10 bolnikov)
- protected from light in polyethylene or polyvinylchloride infusion bag: for up to 6 days in a refrigerator (2°C-8°C) or for up to 24 hours at 25°C;
- zaščiteno pred svetlobo v polietilenski ali polivinilkloridni infuzijski vreči do 6 dni v hladilniku (od 2 °C do 8 °C) ali do 24 ur pri 25 °C , - izpostavljeno svetlobi v polietilenskem ali polivinilkloridnem infuzijskem kompletu do 1 uro pri 25 °C.
For further cycles, the dose should be adjusted in the event of toxicities, as shown in table 3 below:
Pri naslednjih ciklih se mora odmerek v primeru toksičnosti prilagajati, kot je navedeno v spodnji tabeli 3:
Javlor solution for infusion should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Zdravilo Javlor lahko pripravlja in daje le osebje, ki je ustrezno usposobljeno za ravnanje s citotoksičnimi snovmi.
In patients with moderate renal impairment (40 mL/min ≤ CrCl ≤ 60 mL/min), the recommended dose is 280 mg/m² given once every 3 weeks.
Za bolnike z zmerno okvaro ledvic (40 ml/min ≤ OK ≤ 60 ml/min) je priporočeni odmerek 280 mg/m² vsake 3 tedne.
Constipation is managed by medical care (see section 4.4).
Zaprtost obravnavamo z zdravstveno oskrbo (glejte poglavje 4.4).
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Običajno se redčeno zdravilo hrani pri 2 °C do 8 °C do 24 ur, razen če se zdravilo redči v kontroliranih in validiranih aseptičnih pogojih.
However a statistically significant effect was seen on progression-free survival.
Kljub temu so dokazali, da ima vinflunin statistično pomemben učinek na preživetje brez napredovanja bolezni.
One 2 mL vial contains 50 mg of vinflunine (as ditartrate) One 4 mL vial contains 100 mg of vinflunine (as ditartrate) One 10 mL vial contains 250 mg of vinflunine (as ditartrate)
Ena viala 2 ml vsebuje 50 mg vinflunina (v obliki ditartrata) Ena viala 4 ml vsebuje 100 mg vinflunina (v obliki ditartrata) Ena viala 10 ml vsebuje 250 mg vinflunina (v obliki ditartrata)
The concomitant use of potent inhibitors or potent inducers of CYP3A4 with vinflunine should be avoided (see section 4.5).
Sočasno z vinfluninom ne uporabite močnih zaviralcev ali močnih induktorjev CYP3A4 (glejte poglavje 4.5).
Grade 3 was experienced by 0.6% patients.
Pri 0,6 % bolnikov so opazili stopnjo 3.
Blood pressure should be controlled in patients developing symptoms of PRES. To confirm the diagnosis, brain imaging is recommended.
Pri bolnikih, ki razvijajo znake PRES-a, je potreben nadzor krvnega tlaka.