natgillin/translations-raw huggingface dataset:
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.
Klinička djelotvornost i sigurnost Jedno ispitivanje faze III i dva ispitivanja faze II podržavaju uporabu Javlora za liječenje uznapredovalog ili metastatskog karcinoma prijelaznih stanica urotela kao terapiju druge linije nakon neuspjeha prethodnog protokola s platinom.
Constipation is a very common side effect of Javlor.
Zatvor je vrlo česta nuspojava Javlora.
The recommended dose should be reduced in patients with haematological toxicity (see section 4.2).
Preporučenu dozu treba smanjiti u bolesnika s hematološkom toksičnosti (vidjeti dio 4.2).
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)
Jedna bočica od 2 mL sadrži 50 mg vinflunina (u obliku ditartarata) Jedna bočica od 4 mL sadrži 100 mg vinflunina (u obliku ditartarata) Jedna bočica od 10 mL sadrži 250 mg vinflunina (u obliku ditartarata)
Javlor MUST ONLY be administered intravenously.
Javlor se MORA primjenjivati SAMO intravenski.
In particular, you should tell your doctor if you are taking medicines containing any of the following active substances: - ketoconazole and itraconazole, used to treat fungal infection, - opioids, used to treat pain, - ritonavir, used to treat HIV infection, - doxorubicin and pegylated liposomal doxorubicin, used to treat some kinds of cancer, - rifampicin, used to treat tuberculosis or meningitis, - herbal preparation containing hypericum perforatum (St John's wort) used to treat minor to moderate depression.
opioidi, koji se koriste za liječenje boli, - ritonavir, koji se koristi za liječenje infekcije virusom HIV-a, - doksorubicin i pegilirani liposomalni doksorubicin, koji se koriste za liječenje nekih vrsta raka, - rifampicin, koji se koristi za liječenje tuberkuloze ili meningitisa, - biljni pripravak koji sadrži hypericum perforatum (Gospinu travu) koja se koristi za liječenje blage do umjerene depresije.
Pierre Fabre Médicament 45, Place Abel Gance F-92100 Boulogne France
Pierre Fabre Médicament 45, Place Abel Gance F-92100 Boulogne Francuska
Pierre Fabre Médicament 45, place Abel Gance F-92100 Boulogne France
Pierre Fabre Médicament 45, place Abel Gance F-92100 Boulogne Francuska
Efficacy was demonstrated in both patients with or without prior cisplatin use.
Djelotvornost je bila dokazana i kod bolesnika s prethodnom primjenom cisplatina i kod bolesnika koji prethodno nisu primali cisplatin.
- 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).
koštana bol, bol u uhu - omaglica, nesanica, privremeni gubitak svijesti - otežani tjelesni pokreti - ubrzano kucanje srca, povišeni krvni tlak, sniženi krvni tlak - otežano disanje, kašalj, bol u prsima - oticanje ruku, šaka, stopala, gležnjeva, nogu ili drugih dijelova tijela - upala vena (flebitis).
The volume of Javlor (concentrate) corresponding to the calculated dose of vinflunine should be mixed in a 100 mL bag of sodium chloride 9 mg/mL (0.9%) solution for infusion.
Razrjeđivanje koncentrata Volumen Javlora (koncentrata) koji odgovara izračunatoj dozi vinflunina treba umiješati u 100-mililitarsku vrećicu otopine natrijeva klorida 9 mg/mL (0,9%) za infuziju.
Any other toxicity Grade ≥ 3 (severe or life-threatening) (except Grade 3 vomiting or nausea2)
U slučaju toksičnosti probavnog sustava ≥3. stupnju (osim povraćanja ili mučnine) ili mukozitisa (2.
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.
≥ 38,5°C nepoznatog podrijetla bez klinički mikrobiološki dokumentirane infekcije (NCI CTC
Thus, patients receiving Javlor should be vigilantly monitored by physicians for the occurrence of cardiac events.
Stoga liječnici trebaju pozorno pratiti pojavu srčanih događaja u bolesnika koji primaju Javlor.
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).
Javlor može uzrokovati nuspojave kao što su umor (vrlo često) i omaglica (često) koje mogu dovesti do manjeg ili umjerenog utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.
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
10 bočica od 2 mL 1 bočica od 4 mL 10 bočica od 4 mL 1 bočica od 10 mL 10 bočica od 10 mL
Table 1: Dose delay for subsequent cycles due to toxicity
Odgoda ili prekid liječenja zbog toksičnosti Tablica 1: Odgoda narednog ciklusa zbog toksičnosti Toksičnost
- The recommended dose of vinflunine is 200 mg/m² given once every 3 weeks in patients with moderate liver impairment (Child-Pugh grade B) or in patients with a prothrombin time ≥ 50% NV and bilirubin > 3×ULN and transaminases > ULN and GGT > ULN.
- Preporučena doza vinflunina je 200 mg/m² primijenjena jedanput svaka 3 tjedna u bolesnika s umjerenim oštećenjem jetre (Child-Pugh stadij B) ili u bolesnika s protrombinskim vremenom ≥ 50% NV i bilirubinom > 3×GGN i transaminazama > GGN i GGT > GGN.
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).
Kod primjene vinflunina primijećena je teška hiponatremija, uključujući slučajeve koji su posljedica sindroma neodgovarajućeg izlučivanja antidiuretskog hormona (SIADH) (vidjeti dio 4.8).
Decreased appetite Common Dehydration
Vrlo često Hiponatremija Smanjen apetit
Very common Asthenia/Fatigue Injection site reaction Pyrexia
Vrlo često Astenija/umor Reakcija na mjestu injiciranja
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.
Prije svakog ciklusa potrebno je provesti odgovarajuću provjeru kompletne krvne slike radi provjere apsolutnog broja neutrofila (ABN), trombocita i hemoglobina s obzirom na to da su neutropenija,
For subsequent administrations, vinflunine is contraindicated in subjects with baseline ANC < 1,000/mm3 or platelets < 100,000/mm3.
Za sljedeće primjene vinflunin je kontraindiciran u ispitanika s početnim ABN-om < 1000/mm³ ili trombocitima < 100 000/mm³.
- 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;
Dokazana je kemijska i fizikalna stabilnost razrijeđenog lijeka u sljedećim slučajevima: - zaštićen od svjetlosti u infuzijskoj vrećici od polietilena ili polivinilklorida: do 6 dana u hladnjaku (2°C- 8°C) ili do 24 sata na temperaturi od 25°C; - izložen svjetlosti u infuzijskom kompletu od polietilena ili polivinilklorida do 1 sat na temperaturi od 25°C.
- 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 ].
Nije potrebna prilagodba doze u bolesnika: - s protrombinskim vremenom > 70% NV (normalne vrijednosti) i jednim od navedenog: [ GGN (gornja granica normale) < bilirubin ≤ 1,5×GGN i/ili 1,5xGGN < transaminaze ≤ 2,5×GGN i/ili GGN < GGT ≤ 5×GGN ].
NCI CTC Grade 3 constipation is defined as an obstipation requiring manual evacuation or enema, Grade 4 constipation as an obstruction or toxic megacolon.
Konstipacija 3. stupnja prema kriterijima NCI CTC definira se kao opstipacija koja zahtijeva ručnu evakuaciju stolice ili primjenu klizme, dok se 4. stupanj definira kao opstrukcija ili toksični megakolon.
- visual disturbances - dry skin, redness of the skin - muscle contraction disorders - pain in the throat, gum disorders - weight increase - urinary problems - ringing or buzzing in the ears (tinnitus) - increase in liver enzymes (seen in blood test)
- tegobe s mokrenjem - zvonjenje ili zujanje u ušima (tinitus) - povećanje jetrenih enzima (na temelju krvnih pretraga)
Water for injections as excipient.
POPIS POMOĆNIH TVARI Voda za injekcije kao pomoćna tvar.
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.
- u bolesnika koji imaju najmanje 75 godina, ali manje od 80 godina, doza vinflunina koja se primjenjuje je 280 mg/m² svaka 3 tjedna. - u bolesnika koji imaju 80 ili više godina doza vinflunina koja se primjenjuje je 250 mg/m² svaka 3 tjedna.
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.
U odsustvu bilo kakve hematološke toksičnosti tijekom prvog ciklusa koja bi prouzročila odgodu liječenja ili smanjenje doze,
• After the infusion is completed, the remaining 250 mL from the sodium chloride 9 mg/mL (0.9%) solution for infusion or of glucose 50 mg/mL (5%) solution for infusion bag should be run at a flowing rate of 300 mL/h.
• Po završetku infuzije preostalih 250 mL otopine natrijeva klorida 9 mg/mL (0,9%) za infuziju ili otopine glukoze 50 mg/mL (5%) za infuziju iz vrećice treba pustiti da iscuri pri slobodnom protoku od 300 mL/h.
- 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 ].
- Preporučena doza vinflunina je 250 mg/m² primijenjena jedanput svaka 3 tjedna u bolesnika s blagim oštećenjem jetre (Child-Pugh stadij A) ili u bolesnika s protrombinskim vremenom ≥ 60% NV i 1,5×GGN < bilirubin ≤ 3×GGN i jednim od navedenog: [ transaminaze > GGN i/ili GGT > 5×GGN ].
Recommended co-medication
NAČIN PRIMJENE LIJEKA
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).
DVFL se polako stvara i eliminira sporije nego vinflunin (t½ otprilike 120 h).
- Discontinuation
Prekid
• 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.
• Intravensku infuziju treba početi s polovicom 500-mililitarske vrećice otopine natrijeva klorida 9 mg/mL (0,9%) za infuziju ili otopine glukoze 50 mg/mL (5%) za infuziju, tj. 250 mL uz slobodan protok kako bi se vena isprala.
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.
Vinflunin nije ispitan u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) ili u bolesnika s protrombinskim vremenom < 50%NV ili s bilirubinom > 5xGGN ili s pojedinim transaminazama
Package Leaflet: Information for the user Javlor 25 mg/mL concentrate for solution for infusion vinflunine
Uputa o lijeku: Informacija za korisnika Javlor 25 mg/mL koncentrat za otopinu za infuziju vinflunin
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”).
Odmah obavijestite liječnika ako razvijete bilo koju od sljedećih ozbiljnih nuspojava tijekom liječenja Javlorom: - vrućicu i/ili zimicu koje mogu biti znakovi infekcije, - bol u prsima koja može biti znak srčanog udara, - zatvor koji ne reagira na liječenje laksativima,
Tell your doctor: - if you have liver, kidney or heart problems, - if you experience any neurological symptoms such as headaches, changed mental state which may lead to confusion and coma, convulsions, blurred vision and high blood pressure as you may need to stop taking this medicine, - if you are taking other medicines mentioned in “Using other medicines” below, - if you have constipation, or if you are treated with medicines against pain (opioids), or if you have an abdominal cancer, or if you had abdominal surgery, - if you would like to father a child (see “Pregnancy, breast-feeding and fertility” below).
- ako imate bilo koje neurološke simptome kao što su glavobolje, promjene duševnog stanja koje mogu dovesti do smetenosti i kome, konvulzije, zamućeni vid i visok krvni tlak jer ćete možda morati prestati uzimati ovaj lijek, - ako uzimate druge lijekove navedene u poglavlju
Initiation of vinflunine is contraindicated in subjects with baseline ANC < 1,500/mm3 or platelets < 100,000/mm3.
Započinjanje terapije vinfluninom kontraindicirano je u ispitanika s početnim ABN-om < 1500/mm³ ili trombocitima < 100 000/mm³.
When adjusted on prognostic factors, the analyses of OS in the subgroups of patients without or with prior cisplatin showed a HR (95% CI) = [0.53 (0.32 - 0.88); p=0.0143] and a HR (95% CI) = [0.70 (0.530.94); p=0.0174], respectively.
Nakon prilagodbe za prognostičke čimbenike analize OS-a u podskupinama bolesnika bez prethodne primjene cisplatina ili s njom pokazale su omjer hazarda (HR) (95%-tni CI) = [0,53 (0,32 - 0,88); p=0,0143] odnosno omjer hazarda (HR) (95%-tni CI) = [0,70 (0,53 - 0,94); p=0,0174].
Few QT interval prolongations have been observed after the administration of vinflunine.
Nakon primjene vinflunina primijećen je manji broj produljenja QT intervala.
Vinflunine initial dose of 320 mg/m²
Početna doza vinflunina od 320 mg/m²
Adequate monitoring of complete blood counts should be conducted to verify the ANC, platelet and haemoglobin values before each vinflunine infusion (see section 4.3).
Prije svake infuzije vinflunina treba provesti odgovarajuću kontrolu kompletne krvne slike radi provjere vrijednosti ABN-a, trombocita i hemoglobina (vidjeti dio 4.3).
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE
Your doctor will adjust the starting dose of Javlor based on your age and physical conditions and in specific situations: - if you had a previous irradiation of the pelvis - if you have moderate or severe kidney problems - if you have liver problems.
Liječnik će prilagoditi početnu dozu Javlora ovisno o vašoj dobi i tjelesnom stanju i posebnim okolnostima:
• A venous access should be established for a 500 mL bag of sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for infusion, on a large vein preferably in the upper part of the forearm or using a central venous line.
• Treba pripremiti venski pristup za 500-mililitarsku vrećicu otopine natrijeva klorida 9 mg/mL (0,9%) za injekciju ili otopine glukoze 50 mg/mL (5%) za infuziju u veliku venu, po mogućnosti na gornjem dijelu podlaktice ili koristeći centralni venski kateter.
Very common Weight decreased Uncommon Transaminases increased Weight increased aadverse reactions reported from post-marketing experience bfrequency calculated on the basis of non-TCCU clinical trial
Povećanje tjelesne težine anuspojave prijavljene nakon stavljanja lijeka u promet bučestalost izračunata na temelju kliničkog ispitivanja koje nije povezano s karcinomom tranzicijskih stanica urotela
Vinflunine initial dose of 250 mg/m²
Početna doza vinflunina od 250 mg/m²
Dose adjustments are recommended in patients with moderate and severe renal impairment (see section 4.2).
Preporučuju se prilagodbe doze u bolesnika s umjerenim i teškim oštećenjem bubrega (vidjeti dio 4.2).
Method of administration Javlor is for intravenous use ONLY.
Javlor se primjenjuje SAMO intravenski.
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.
Nakon prilagodbe za prognostičke čimbenike analize PFS-a u podskupinama bolesnika bez prethodne primjene cisplatina ili s njom pokazale su omjer hazarda (HR) (95%-tni CI) = [0,51 (0,31 - 0,86); p=0,0111] odnosno omjer hazarda (HR) (95%-tni CI) = [0,63 (0,48 - 0,84); p=0,0016].
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.
Da bi se vena isprala, primjena razrijeđenog Javlora uvijek mora biti praćena infuzijom najmanje jednakog volumena otopine natrijeva klorida 9 mg/mL (0,9%) za infuziju ili otopine glukoze 50 mg/mL (5%) za infuziju.
In order to flush the vein, administration of Javlor solution for infusion 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.
Da bi se vena isprala, primjena Javlor otopine za infuziju uvijek treba biti popraćena najmanje jednakim volumenom otopine natrijeva klorida 9 mg/mL (0,9%) za infuziju ili otopine glukoze 50 mg/mL (5%) za infuziju.
Hepatic impairment The recommended dose should be reduced in patients with hepatic impairment (see section 4.2).
Oštećenje jetre Preporučenu dozu treba smanjiti u bolesnika s oštećenjem jetre (vidjeti dio 4.2).
Vinflunine initial dose of 280 mg/m²
Početna doza vinflunina od 280 mg/m²
Infections and infestations Common Neutropenic infection Infections (viral, bacterial, fungal) Uncommon Neutropenic sepsis
Neutropenijska infekcija Infekcije (virusne,
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.
U populaciji koja je zadovoljila uključne kriterije, analiza ukupnog preživljenja (OS) u podskupinama bolesnika s prethodnom primjenom cisplatina i onih koji su primali BSC pokazala je omjer hazarda (HR) (95%-tni CI) = [0,64 (0,40 - 1,03); p=0,0821] bez prethodne primjene cisplatina i omjer hazarda (HR) (95%-tni CI) = [0,80 (0,60 - 1,06); p=0,1263] uz prethodnu primjenu cisplatina.
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).
Provedeno je farmakokinetičko ispitivanje faze I na 2 skupine bolesnika s oštećenjem bubrega razvrstanih prema izračunatim vrijednostima klirensa kreatinina (CrCl): skupina 1 (n=13 bolesnika)
If it comes into contact with mucous membranes, the membranes should be flushed thoroughly with water.
Ako dođe u doticaj sa sluznicom, sluznicu treba odmah temeljito isprati vodom.
One 4 mL vial contains 100 mg of vinflunine (as ditartrate).
Jedna bočica od 4 mL sadrži 100 mg vinflunina (u obliku ditartarata).
To prevent constipation you may be given laxatives.
Možda ćete dobiti laksative za sprječavanje zatvora.
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 nije promijenjena u tih bolesnika, međutim, na temelju promjena jetrenih bioloških parametara nakon primjene vinflunina
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.
bili su hematološki poremećaji, uglavnom neutropenija i anemija; poremećaji probavnog sustava, osobito konstipacija, anoreksija, mučnina, stomatitis/mukozitis, povraćanje, bol u abdomenu i proljev i opći poremećaji kao što su astenija/umor.
Posterior Reversible Encephalopathy Syndrome (PRES) Cases of PRES have been observed after administration of vinflunine.
Posteriorni reverzibilni encefalopatski sindrom (PRES)
Each mL of concentrate contains 25 mg of vinflunine (as ditartrate).
Svaki mL koncentrata sadrži 25 mg vinflunina (u obliku ditartarata).
Javlor 25 mg/mL concentrate for solution for infusion vinflunine
Javlor 25 mg/mL koncentrat za otopinu za infuziju vinflunin
Javlor 25 mg/mL concentrate for solution for infusion
Javlor 25 mg/mL koncentrat za otopinu za infuziju
You must not breastfeed during treatment with Javlor If you would like to father a child, seek advice from your doctor.
Ako želite začeti dijete, potražite savjet liječnika.
Stomatitis
Nuspojave
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.
U bolesnika s umjerenim oštećenjem bubrega (40 mL/min ≤ CrCl ≤ 60 mL/min) preporučena doza je
Uncommon Visual disturbance
Manje često Smetnje vida
Common Insomnia Nervous system disorders Very common Peripheral sensory neuropathy Common Syncope Headache Dizziness Neuralgia Dysgeusia Neuropathy Uncommon Peripheral motor neuropathy 0.4 Rare
Vrlo često Periferna senzorna neuropatija
Adverse reactions in all indications
Opći poremećaji i reakcije na mjestu primjene
One mL of concentrate contains 25 mg of vinflunine (as ditartrate).
Jedan mL koncentrata sadrži 25 mg vinflunina (u obliku ditartarata).
One 10 mL vial contains 250 mg of vinflunine (as ditartrate).
Jedna bočica od 10 mL sadrži 250 mg vinflunina (u obliku ditartarata).
Diluted solution
Razrijeđena otopina:
The recommended dose should be reduced in patients with moderate or severe renal impairment (see section 4.2).
Oštećenje bubrega Preporučenu dozu treba smanjiti u bolesnika s umjerenim ili teškim oštećenjem bubrega (vidjeti dio 4.2).
Intravenous use ONLY, after dilution.
NAČIN I PUT(EVI) PRIMJENE LIJEKA Primjenjuje se SAMO u venu, nakon razrjeđivanja.
*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.
1 Konstipacija 2. stupnja prema kriterijima NCI CTC definira se kao konstipacija koja zahtjeva primjenu laksativa, 3. stupanj označava opstipaciju koja zahtjeva ručnu evakuaciju stolice ili primjenu klizme, dok 4. stupanj označava opstrukciju ili toksični megakolon.
Common Rash Urticaria
Urtikarija Pruritus Hiperhidroza