FrancophonIA/ELRC3.0 huggingface dataset:
English: Despite reduction to 0.62 mg/m2
Slovenian: Kljub zmanjšanju na 0,62 mg/m2
English: There is no known antidote for eribulin overdose.
Slovenian: Za preveliko odmerjanje eribulina ni znanega antidota.
English: For information relevant to the handling of cytotoxic medicinal products see section 6.6.
Slovenian: Za informacije glede ravnanja s citotoksičnimi zdravili glejte poglavje 6.6.
English: Median months
Slovenian: Mediana (meseci)
English: Despite reduction to 0.97 mg/m2
Slovenian: Kljub zmanjšanju na 0,97 mg/m2
English: It is used in adults for locally advanced or metastatic breast cancer (breast cancer that has spread beyond the original tumour) when at least one other therapy has been tried but has lost its effect.
Slovenian: Uporablja se pri odraslih za zdravljenje lokalno napredovalega ali metastatskega raka dojke (rak dojke, ki se je razširil zunaj prvotnega tumorja), ko je vsaj en predhoden poskus zdravljenja z drugim zdravilom postal neučinkovit.
English: There is no evidence that eribulin mesilate is a vesicant or an irritant.
Slovenian: Ni znakov, da bi eribulinijev mesilat povzročal mehurje ali dražil.
English: A study evaluated the pharmacokinetics of eribulin in patients with mild (Child-Pugh A; n=7) and moderate (Child-Pugh B; n=4) hepatic impairment due to liver metastases.
Slovenian: V študiji so ocenili farmakokinetiko eribulina pri bolnikih z blagim (stopnje A po Child-Pughu; n = 7) in zmernim (stopnje B po Child-Pughu; n = 4) okvarjenim delovanjem jeter zaradi zasevkov na jetrih.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Breast-feeding
Slovenian: - Preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: An embryofoetal development study in rat confirmed the developmental toxicity and teratogenic potential of eribulin.
Slovenian: Študija razvoja zarodka/plodu pri podganah je potrdila potencial eribulina za vpliv na sposobnost razmnoževanja in teratogenost.
English: The most commonly reported adverse reactions related to HALAVEN, are bone marrow suppression manifested as neutropenia, leucopenia, anaemia, thrombocytopenia with associated infections.
Slovenian: Neželeni učinek, o katerem najpogosteje poročajo v zvezi z zdravilom HALAVEN, je supresija kostnega mozga, ki se kaže kot nevtropenija, levkopenija, anemija, trombocitopenija s pridruženimi okužbami.
English: The positive effect on OS was seen in both taxane-refractory and non-refractory groups of patients .
Slovenian: Pozitivni učinek na OS so opazili v skupini bolnikov, ki se ne odzivajo na taksan, in v skupini bolnikov, ki se odzivajo na taksan.
English: In response evaluable patients, the objective response rate by the RECIST criteria was 12.2% (95% CI: 9.4%, 15.5%) by independent review for the eribulin arm compared to 4.7% (95% CI: 2.3%, 8.4%) for the TPC arm.
Slovenian: Pri bolnikih, ki jih je bilo možno oceniti, je bila stopnja objektivnega odziva po kriterijih RECIST 12,2 % (95-% CI: 9,4 %; 15,5 %) glede na neodvisni pregled za krak z eribulinom in 4,7 % (95-% CI: 2,3 %, 8,4 %) za krak s PIZ.
English: ECG monitoring is recommended if therapy is initiated in patients with congestive heart failure, bradyarrhythmias or concomittant treatment with medicinal products known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities.
Slovenian: Če začnemo zdravljenje pri bolnikih s kongestivnim srčnim popuščanjem, z bradiaritmijami ali s sočasnim zdravljenjem z zdravili, za katera je znano, da podaljšujejo interval QT, vključno z antiaritmiki razreda Ia in III, in z elektrolitskimi motnjami, je priporočljivo spremljanje EKG.
English: Other medicines and HALAVEN Tell your doctor if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The pharmacokinetics of eribulin are characterized by a rapid distribution phase followed by a prolonged elimination phase, with a mean terminal half-life of approximately 40 h. It has a large volume of distribution (range of means 43 to 114 l/m2).
Slovenian: Za farmakokinetiko eribulina je značilna hitra faza porazdelitve, ki ji sledi podaljšana časa izločanja, s povprečno končno razpolovno dobo približno 40 ur.
English: However, patients with pre-existing neuropathy Grade 1 or 2 were no more likely to develop new or worsening symptoms than those who entered the study without the condition.
Slovenian: Pri bolnikih z obstoječo nevropatijo 1. ali 2. stopnje se simptomi niso razvili prej ali se poslabšali kot pri tistih bolnikih, ki ob vstopu v preskušanje niso imeli tega stanja.
English: - Blood clots - Abnormal liver function tests (hepatoxicity) Kidney failure, blood or protein in the urine Widespread inflammation of the lungs which may lead to scarring Inflammation of the pancreas
Slovenian: - krvni strdki - nenormalni testi delovanja jeter (hepatotoksičnost) - odpoved ledvic, kri ali beljakovine v urinu - obsežno vnetje pljuč, ki lahko povzroči brazgotinjenje - vnetje trebušne slinavke - razjede v ustih
English: Study 309 - Overall Survival in the Liposarcoma Subgroup
Slovenian: Študija 309 - celokupno preživetje v podskupini liposarkom
English: Fatal cases of febrile neutropenia, neutropenic sepsis, sepsis and septic shock have been reported.
Slovenian: Poročali so o smrtnih primerih febrilne nevtropenije, nevtropenične sepse, sepse in septičnega šoka.
English: Progression free survival assessed by independent review was similar between eribulin and capecitabine with medians of 4.1 months vs 4.2 months (HR 1.08; [95% CI: 0.932, 1.250]) respectively.
Slovenian: Preživetje brez napredovanja bolezni, ocenjeno z neodvisnim pregledom, je bilo pri eribulinu in kapecitabinu podobno, z medianama 4,1 meseca proti 4,2 meseca (HR 1,08; [95-% CI: 0,932, 1,250]).
English: Hazard Ratio (95% CI) p-value (log rank)
Slovenian: Razmerje tveganja (95-% CI) Vrednost p (test log rank)
English: Eribulin was positive in the mouse lymphoma mutagenesis assay and was clastogenic in the in vivo rat micronucleus assay.
Slovenian: Eribulin je bil pozitiven v testu mutageneze mišjega limfoma in klastogen v in vivo testu podganjih mikrojeder.
English: HALAVEN 508 TPC 254
Slovenian: HALAVEN 508 PIZ
English: In clinical trials, patients with pre-existing neuropathy were as likely to develop new or worsening symptoms as those who entered the study without the condition.
Slovenian: V kliničnih preskušanjih se pri bolnikih z obstoječo nevropatijo simptomi niso razvili prej ali poslabšali kot pri tistih bolnikih, ki ob vstopu v preskušanje niso imeli tega stanja.
English: Following administration, it is recommended that the intravenous line be flushed with sodium chloride 9 mg/ml (0.9%) solution for injection to ensure administration of the complete dose.
Slovenian: Po dajanju zdravila je priporočljivo, da intravensko cevko splaknete z 0,9-odstotno raztopino natrijevega klorida (9 mg/ml) za injiciranje, s čimer boste zagotovili, da bo bolnik prejel ves odmerek.
English: Tel.: + 420 242 485 839 Danmark
Slovenian: Tel.: + 420 242 485 839
English: Dacarbazine HALAVEN Dacarbazine (n=152)
Slovenian: HALAVEN dakarbazin HALAVEN dakarbazin (n=157)
English: The updated OS analysis showed a survival benefit for the eribulin group compared to TPC both in capecitabine pre-treated patients with a HR of 0.787 (95% CI: 0.645, 0.961), and for the capecitabine-naïve patients with a corresponding HR of 0.865 (95% CI: 0.606, 1.233).
Slovenian: Analiza posodobljenega OS je bila v korist preživetja za skupino z eribulinom v primerjavi s PIZ tako pri bolnikih, ki so bili predhodno zdravljeni s kapecitabinom, s HR 0,787 (95-% CI 0,645; 0,961) in pri bolnikih, ki se predhodno niso zdravili s kapecitabinom, z ustreznim HR 0,865 (95-% CI 0,606; 1,233).
English: Although data are limited, patients with bilirubin >1.5 x ULN also have a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Slovenian: Čeprav je podatkov malo, je tudi pri bolnikih z bilirubinom > 1,5 x zgornja meja normale incidenca nevtropenije 4. stopnje in febrilne nevtropenije višja.
English: A 1.5-fold (90% CI: 0.9-2.5) higher dose-normalised AUC(0-inf) was observed in patients with moderate and severe renal impairment.
Slovenian: Pri bolnikih z zmerno in hudo okvaro ledvic so ugotovili 1,5-krat (90 % CI: 0,9-2,5) večjo AUC(0-inf), normalizirano na odmerek.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 1.32 mg eribulin in 3 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Vsebuje 1,32 mg eribulina v 3 ml.
English: Do not drive or use machines if you feel tired or dizzy.
Slovenian: Če ste utrujeni ali omotični, ne vozite in ne upravljajte strojev.
English: Patients with ALT or AST > 3 x ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Slovenian: Pri bolnikih z ALT ali AST > 3 x zgornja meja normale je bila incidenca nevtropenije 4. stopnje in febrilne nevtropenije višja.
English: The dose may be diluted in up to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Odmerek se lahko razredči z do 100 ml 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) za injiciranje.
English: Study 309 - Progression Free Survival in the Liposarcoma Subgroup
Slovenian: Študija 309 - preživetje brez napredovanja bolezni v podskupini liposarkom
English: HALAVEN may cause side effects such as tiredness (very common) and dizziness (common).
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo HALAVEN lahko povzroči neželene učinke, kot sta utrujenost (zelo pogosto) in omotica (pogosto).
English: Eribulin exposure (AUC and Cmax) was unaffected by ketoconazole, a CYP3A4 and P glycoprotein (Pgp) inhibitor, and rifampicin, a CYP3A4 inducer.
Slovenian: Ketokonazol, zaviralec CYP3A4 in P-glikoproteina (Pgp), in rifampicin, induktor CYP3A4, nista vplivala na izpostavljenost eribulinu (AUC in Cmax).
English: The positive effect on OS was seen both in capecitabine-naïve and in capecitabine pre-treated patient groups.
Slovenian: Pozitivni učinek na OS so opazili v skupini bolnikov, ki se še niso zdravili s kapecitabinom, in v skupini, ki se je predhodno zdravila s kapecitabinom.
English: Good peripheral venous access, or a patent central line, should be ensured prior to administration.
Slovenian: Pred dajanjem se prepričajte, da obstaja dober periferni venski dostop ali prehodna centralna linija.
English: What HALAVEN contains
Slovenian: Kaj vsebuje zdravilo HALAVEN
English: The recommended dose of eribulin as the ready to use solution is 1.23 mg/m2 which should be administered intravenously over 2 to 5 minutes on Days 1 and 8 of every 21-day cycle.
Slovenian: Priporočeni odmerek eribulina v obliki raztopine, pripravljene za uporabo, je 1,23 mg/m2 in se daje intravensko v obliki 2- do 5-minutne infuzije 1. in 8. dan vsakega 21-dnevnega cikla.
English: Study 309 Liposarcoma Subgroup
Slovenian: Študija 309 podskupina liposarkom
English: OS in ITT Population HALAVEN (n=554)
Slovenian: OS populacije z namenom zdravljenja HALAVEN (n=554)
English: magnesium or calcium in the blood - Inability to sleep, depression, changed sense of taste - Rash, itching, nail problems, dry or red skin - Excessive sweating (including night sweats) - Ringing in the ears - Blood clots in the lungs - Shingles - Swelling of the skin and numbness of the hands and feet
Slovenian: magnezija ali kalcija v krvi - nezmožnost spanja, depresija, spremenjeno okušanje - težave z dihanjem, kašelj, bolečina v žrelu - izpuščaj, srbenje, težave z nohti, suha ali pordela koža - prekomerno znojenje (vključno z nočnim potenjem) - zvonjenje v ušesih - krvni strdki v pljučih - pasovec - otekanje kože in odrevenelost rok in nog
English: In the OS update, the HR for eribulin versus TPC was 0.90 (95% CI: 0.71, 1.14) in favour of eribulin for taxane-refractory patients and 0.73 (95% CI: 0.56, 0.96) for patients not taxane-refractory.
Slovenian: V posodobljenem OS je bil HR za eribulin v primerjavi s PIZ 0,90 (95-% CI: 0,71; 1,14) v korist eribulina za bolnike, ki se ne odzivajo na taksan in 0,73 (95-% CI: 0,56; 0,96) za bolnike, ki se odzivajo na taksan.
English: Ethanol anhydrous,Water for injections, Hydrochloric acid, Sodium hydroxide See leaflet for further information
Slovenian: SEZNAM POMOŽNIH SNOVI brezvodni etanol, voda za injekcije, klorovodikova kislina, natrijev hidroksid Za nadaljnje informacije glejte navodilo za uporabo.
English: By independent review, the median progression free survival (PFS) was 3.7 months for eribulin compared to 2.2 months for the TPC arm (HR 0.865, 95% CI: 0.714, 1.048, p=0.137).
Slovenian: Pri neodvisnem pregledu je bilo mediano preživetje brez napredovanja bolezni (PFS - progression free survival) v kraku z eribulinom 3,7 meseca, v kraku s TPC pa 2,2 meseca (HR 0,865, 95-% CI (interval zaupanja): 0,714, 1,048, p=0,137).
English: Eisai SA/NV Tél/Tel: +32 (0)800 158 58
Slovenian: Tél/Tel: +32 (0)800 158 58
English: 5 ml type I glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 3 ml of solution.
Slovenian: 5-ml viala iz stekla tipa I z zamaškom iz butilne gume, obloženim s teflonom, in dvižno aluminijasto vrhnjo zaporko prek tesnila, ki vsebuje 3 ml raztopine.
English: Adverse Reactions - all Grades Very Common (Frequency %)
Slovenian: Organski sistem Neželeni učinki vseh stopenj Zelo pogosti (pogostnost %)
English: Study 301 - Overall Survival (ITT Population)
Slovenian: Študija 301 - celokupno preživetje (populacija z namenom zdravljenja)
English: Eribulin mesilate is a microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents.
Slovenian: Eribulinijev mesilat je zaviralec mikrotubularne dinamike, ki sodi v halihondrinski razred zdravil z delovanjem na novotvorbe.
English: 5 ml type I glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 2 ml of solution.
Slovenian: 5-ml viala iz stekla tipa I z zamaškom iz butilne gume, obloženim s teflonom, in dvižno aluminijasto vrhnjo zaporko prek tesnila, ki vsebuje 2 ml raztopine.
English: aCox proportional hazard bStratified by geographic region, HER2/neu status
Slovenian: 0,056b aCoxov regresijski model sorazmernih tveganj bStratificirano po zemljepisnih območjih, stanju HER2/neu
English: Study 305 - Updated Overall Survival ( ITT Population)
Slovenian: Študija 305 - posodobljeni podatki celokupnega preživetja (populacija z namenom zdravljenja)
English: Each 3 ml vial contains eribulin mesilate equivalent to 1.32 mg eribulin.
Slovenian: Ena 3 ml viala vsebuje količino eribulinijevega mesilata, ki ustreza 1,32 mg eribulina.
English: Capecitabine (n=548)
Slovenian: kapecitabin (n=548)
English: TPC (n = 192)
Slovenian: PIZ (n = 192)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton 3 ml vial
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla 3 ml viala
English: The European Medicines Agency has deferred the obligation to submit the results of studies with HALAVEN in one or more subsets of the paediatric population for the treatment of rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom HALAVEN za eno ali več podskupin pediatrične populacije za zdravljenje rabdomiosarkomskih in nerabdomiosarkomskih sarkomov mehkih tkiv (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: ANC < 0.5 x 109/l lasting more than 7 days ANC < 1 x 109/l neutropenia complicated by fever or infection
Slovenian: ANC < 0,5 x 109/l, ki traja več kot 7 dni ANC < 1 x 109/l, nevtropenija z zapletom zaradi povišane telesne temperature ali okužbe Trombociti < 25 x 109/l, trombocitopenija Trombociti < 50 x 109/l, trombocitopenija z zapletom zaradi krvavitev ali potrebe po transfuziji krvi ali trombocitov Nehematološki:
English: Insomnia Depression
Slovenian: Psihiatrične motnje nespečnost depresija
English: Impaired liver function due to metastases
Slovenian: Okvarjeno delovanje jeter zaradi ciroze
English: Lymphopenia (5.7%) (G3/4: 2.1%) Febrile neutropenia (4.5%) (G3/4: 4.4%)
Slovenian: stopnje: 2,1 %) febrilna nevtropenija (4,5 %) (3./4.
English: 1 vial of 2 ml
Slovenian: 1 viala z 2 ml
English: Using aseptic technique HALAVEN can be diluted up to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Z aseptično tehniko se lahko zdravilo HALAVEN razredči z do 100 ml 0,9-odstotne raztopine natrijevega klorida (9 mg/ml).
English: nosebleed - Dehydration, dry mouth, cold sores, oral thrush, indigestion, heartburn, abdominal pain or swelling - Swelling of soft tissues, pains (in particular chest, back and bone pain), muscle spasm or weakness - Mouth, respiratory and urinary tract infections, painful urination - Sore throat, sore or runny nose, flu-like symptoms, throat pain - Liver function test abnormalities, altered level of sugar, bilirubin, phosphates, potassium,
Slovenian: - zmanjšanje števila trombocitov (kar lahko povzroči nastajanje modric ali podaljša čas za ustavitev krvavenja) - okužba z zvišano telesno temperaturo, pljučnica, mrzlica - hiter srčni utrip, oblivanje - vrtoglavica, omotičnost - večje izločanje solz, konjunktivitis (pordelost in vnetje površine očesa), krvavitev iz nosu - dehidracija, suha usta, herpes (boleči mehurčki okrog ustnic), izpuščaji v ustih, prebavne motnje, zgaga, bolečina v trebuhu ali otekanje - otekanje mehkih tkiv, bolečine (zlasti prsi, hrbta in kosti), mišični spazmi ali oslabelost - okužbe ust, dihal ali sečil, bolečine pri uriniranju - vnetje v žrelu, boleč nos ali nahod, gripi podobni simptomi, bolečine v žrelu - nenormalni testi delovanja jeter, spremenjena raven sladkorja, bilirubina, fosfatov, kalija,
English: The recommended dose of eribulin in patients with moderate hepatic impairment (Child-Pugh B) is 0.62 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
Slovenian: Priporočeni odmerek eribulina pri bolnikih z zmerno okvaro delovanja jeter (stopnje B po ChildPughu) je 0,62 mg/m2 v obliki 2- do 5-minutne intravenske infuzije 1. in 8. dan 21-dnevnega cikla.
English: To ensure that the whole dose of HALAVEN is given it is recommended that a saline solution is flushed into the vein after HALAVEN is given.
Slovenian: Priporočljivo je, da se po dajanju zdravila HALAVEN injicira v veno še fiziološka raztopina, da se zagotovi, da boste prejeli ves odmerek zdravila HALAVEN.
English: The pharmacokinetics of eribulin were evaluated in a Phase 1 study in patients with normal renal function (Creatinine clearance: ≥ 80 ml/min; n=6),
Slovenian: Farmakokinetiko eribulina so ovrednotili v študiji Faze 1 pri bolnikih z normalnim delovanjem ledvic (očistek kreatinina: ≥ 80 ml/min; n=6), zmerno (30-50 ml/min; n=7) in s hudo (15-<30 ml/min; n=6) okvaro ledvic.
English: aCox proportional hazard bStratified by geographic region, HER2/neu status, and prior capecitabine therapy.
Slovenian: Nominalna p-vrednost (test log-rank)a aCoxov regresijski model sorazmernih tveganj bStratificirano po zemljepisnih območjih, stanju HER2/neu in predhodnem zdravljenju s kapecitabinom.
English: - Decrease in the number of white blood cells or red blood cells - Tiredness or weakness - Nausea, vomiting, constipation, diarrhoea - Numbness, tingling or prickling sensations - Fever - Loss of appetite, weight loss - Difficulty breathing, cough - Pain in the joints, muscles and back - Headache - Hair loss
Slovenian: - zmanjšanje števila levkocitov ali eritrocitov - utrujenost ali oslabelost - slabost, bruhanje, zaprtje, driska - otopelost, ščemenje ali zbadanje - zvišana telesna temperatura - izguba apetita, hujšanje - oteženo dihanje, kašelj - bolečina v sklepih, mišicah in hrbtu - glavobol - izpadanje las
English: Abdominal pain Stomatitis (11.1%) (G3/4: 1.0%)
Slovenian: bolečina v trebuhu stomatitis (11,1 %) (3./4.
English: TPC (n = 40)
Slovenian: PIZ (n = 40)
English: The recommended dose of eribulin in patients with mild hepatic impairment (Child-Pugh A) is 0.97 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
Slovenian: Priporočeni odmerek eribulina pri bolnikih z blago okvaro delovanja jeter (stopnje A po Child-Pughu) je 0,97 mg/m2 v obliki 2- do 5-minutne intravenske infuzije 1. in 8. dan 21-dnevnega cikla.
English: Gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, and stomatitis are among reported undesirable effects.
Slovenian: Med neželenimi učinki, o katerih poročajo, je toksičnost za prebavila, ki se kaže kot anoreksija, navzea, bruhanje, driska, zaprtost in stomatitis.
English: 6 vials of 2 ml
Slovenian: 6 vial z 2 ml
English: Capecitabine (n = 380)
Slovenian: kapecitabin (n = 380)
English: EU/1/11/678/002 6 vials
Slovenian: EU/1/11/678/001 1 viala EU/1/11/678/002 6 vial
English: For all patients with renal impairment, caution and close safety monitoring is advised.
Slovenian: Pri vseh bolnikih z okvaro ledvic se priporoča pozornost in skrbno nadziranje varnosti (glejte poglavje 5.2).
English: Dysgeusia Dizziness (9.0%) (G3/4: 0.4%)d
Slovenian: disgevzija omotičnost (9,0 %) (3./4.
English: Hyperbilirubinaemia (1.4%) (G3/4: 0.4%)
Slovenian: 0,9 %)d hiperbilirubinemija (1,4 %) (3./4.
English: Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin.
Slovenian: Ena 2 ml viala vsebuje količino eribulinijevega mesilata, ki ustreza 0,88 mg eribulina.
English: NAME OF THE MEDICINAL PRODUCT HALAVEN 0.44 mg/ml solution for injection Eribulin
Slovenian: HALAVEN 0,44 mg/ml raztopina za injiciranje eribulin
English: Capecitabine (n = 83)
Slovenian: kapecitabin (n = 83)
English: How to store HALAVEN
Slovenian: Shranjevanje zdravila HALAVEN
English: Pruritus (3.9%) (G3/4: 0.1%)d
Slovenian: stopnje: 0,1 %) pruritus (3,9 %)
English: EU/1/11/678/004 6 vials
Slovenian: EU/1/11/678/003 1 viala EU/1/11/678/004 6 vial
English: Study 305 Updated Overall Survival ITT Population
Slovenian: Študija 305 - posodobljeno celokupno preživetje populacije z namenom zdravljenja
English: Diarrhoea (18.7%) (G3/4: 0.8%) Vomiting (18.1%) (G3/4: 1.0%)
Slovenian: stopnje: 0,8 %) bruhanje (18,1 %) (3./4.
English: If it contacts mucous membranes, the membranes should be flushed thoroughly with water.
Slovenian: Pri stiku s sluznico moramo sluznico temeljito sprati z vodo.
English: Very common side effects (may affect more than 1 in 10 people) are:
Slovenian: Zelo pogosti neželeni učinki (lahko se pojavijo pri več kot 1 od 10 bolnikov) so:
English: Dyspnoea (15.2%)a (G3/4: 3.5%)a Cough (15.0%) (G3/4: 0.5%)
Slovenian: stopnje: 3,5 %)a kašelj (15,0 %) (3./4.
English: NAME OF THE MEDICINAL PRODUCT HALAVEN 0.44 mg/ml solution for injection
Slovenian: HALAVEN 0,44 mg/ml raztopina za injiciranje
English: Rare side effects (may affect up to 1 in 1000 people) are:
Slovenian: Redki neželeni učinki (lahko se pojavijo pri največ 1 od 1.000 bolnikov) so:
English: Musculoskeletal pain Musculoskeletal chest pain
Slovenian: stopnje: 0,1 %)d mišično-skeletna bolečina mišično-skeletna bolečina v prsih mišična oslabelost
English: Neutropenia resulted in discontinuation in < 1% of patients receiving eribulin.
Slovenian: Pri <1 % bolnikov, ki so dobivali eribulin, je zaradi nevtropenije prišlo do prekinitve zdravljenja.
English: Dehydration (2.8 %) (G3/4: 0.5%)d
Slovenian: dehidracija (2,8 %) (3./4.
English: Hypomagnesaemia (2.8%) (G3/4: 0.3%)
Slovenian: stopnje: 2,0 %) hipomagneziemija (2,8 %) (3./4.
English: Hyperglycaemia Hypophosphataemia Hypocalcaemia
Slovenian: stopnje: 0,5 %)d hiperglikemija hipofosfatemija hipokalciemija
English: Neutropenia (53.6%) (G3/4: 46.0%) Leukopenia (27.9%) (G3/4: 17.0%) Anaemia (21.8%) (G3/4: 3.0%)
Slovenian: stopnje: 46,0 %) levkopenija (27,9 %) (3./4.
English: (G3/4:0.2%)
Slovenian: stopnje: 0,7 %)
English: Hepatotoxicity (0.8%) (G3/4: 0.6%)
Slovenian: hepatotoksičnost stopnje: 0.6%)
English: Hydrochloric acid (for pH-adjustment)
Slovenian: 6.1 Seznam pomožnih snovi brezvodni etanol voda za injekcije klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)