FrancophonIA/ELRC3.0 huggingface dataset:
English: Within each frequency grouping, undesirable effects are presented in order of decreasing frequency.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane slijedom prema sve manjoj učestalosti.
English: In Study 309, a statistically significant improvement in OS was observed in patients randomized to the eribulin arm compared to the control arm.
Croatian: Ispitivanju 309, u bolesnika randomiziranih u skupinu koja je primala eribulin bilo je opaženo statistički značajno poboljšanje ukupnog preživljenja u usporedbi s kontrolnom skupinom.
English: Eribulin exposure (AUC and Cmax) was unaffected by ketoconazole, a CYP3A4 and P glycoprotein (Pgp) inhibitor, and rifampicin, a CYP3A4 inducer.
Croatian: Ketokonazol, inhibitor enzima CYP3A4 i P-glikoproteina (Pgp) i rifampicin, induktor CYP3A4, nisu utjecali na izloženost eribulinu (AUC i Cmax).
English: Fatal cases of febrile neutropenia, neutropenic sepsis, sepsis and septic shock have been reported.
Croatian: Prijavljeni su slučajevi smrtnog ishoda zbog febrilne neutropenije, neutropenične sepse, sepse i septičnog šoka.
English: For information relevant to the handling of cytotoxic medicinal products see section 6.6.
Croatian: Za informacije o rukovanju citotoksičnim lijekovima, vidjeti dio 6.6.
English: Tel.: + 420 242 485 839 Danmark
Croatian: Tel.: + 420 242 485 839
English: Patients with ALT or AST > 3 x ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Croatian: Bolesnici s vrijednostima ALT ili AST > 3 x GGN imali su veću incidenciju neutropenije i febrilne neutropenije 4. stupnja.
English: Study 305 - Updated Overall Survival ( ITT Population)
Croatian: Ispitivanje 305 - kasnija analiza ukupnog preživljenja u populaciji predviđenoj za liječenje (ITT)
English: Dyspnoea (15.2%)a (G3/4: 3.5%)a Cough (15.0%) (G3/4: 0.5%)
Croatian: Dispneja (15,2%)a (G3/4: 3,5%)a Kašalj (15,0%) (G3/4: 0,5%)d
English: The study met its primary endpoint with an overall survival (OS) result that was statistically significantly better in the eribulin group compared to TPC at 55% of events.
Croatian: Ispitivanjem je u 55% događaja postignut primarni ishod uz statistički značajno bolje ukupno preživljenje u skupini koja je primala eribulin nego u skupini koja je primala terapiju po izboru liječnika.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 1.32 mg eribulin in 3 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA Sadrži 1,32 mg eribulina u 3 ml
English: Study 301 - Overall Survival (ITT Population)
Croatian: Ispitivanje 301 - ukupno preživljenje u populaciji predviđenoj za liječenje (ITT)
English: There is no study in patients with hepatic impairment due to cirrhosis.
Croatian: Nisu provedena ispitivanja u bolesnika kojima je funkcija jetre oštećena zbog ciroze.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 0.88 mg eribulin in 2 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA Sadrži 0,88 mg eribulina u 2 ml
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
Croatian: - smanjenje broja bijelih krvnih stanica ili crvenih krvnih stanica - umor ili slabost - mučnina, povraćanje, zatvor, proljev - utrnulost, trnci ili žmarci - vrućica - gubitak apetita, gubitak težine - otežano disanje, kašalj - bol u zglobovima, mišićima te leđima - glavobolja - ispadanje kose
English: Diarrhoea (18.7%) (G3/4: 0.8%) Vomiting (18.1%) (G3/4: 1.0%)
Croatian: Proljev (18,7%) (G3/4: 0,8%) Povraćanje (18,1%) (G3/4: 1,0%)
English: 5 ml type I glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 3 ml of solution.
Croatian: Bočica od 5 ml, od stakla tipa I, s čepom od butilne gume obloženim teflonom i „flip-off“ aluminijskim zaštitnim zatvaračem, koja sadrži 3 ml otopine.
English: 5 ml type I glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 2 ml of solution.
Croatian: Bočica od 5 ml, od stakla tipa I, s čepom od butilne gume obloženim teflonom i „flip-off“ aluminijskim zaštitnim zatvaračem, koja sadrži 2 ml otopine.
English: Lymphopenia (5.7%) (G3/4: 2.1%) Febrile neutropenia (4.5%) (G3/4: 4.4%)
Croatian: Limfopenija (5,7%) (G3/4: 2,1%) Febrilna neutropenija (4,5%) (G3/4: 4,4%)a
English: Median (months) Hazard Ratio (95% CI)
Croatian: Medijan (mjeseci) Omjer hazarda (95% CI)a
English: Using aseptic technique HALAVEN can be diluted up to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Primjenom aseptičke tehnike HALAVEN se može razrijediti u najviše 100 ml otopine za injekcije natrijevog klorida 9 mg/ml (0,9%).
English: Study 309 Liposarcoma Subgroup
Croatian: Ispitivanje 309 Podskupina s liposarkomom
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.
Croatian: U bolesnika u kojih se mogao procijeniti odgovor na terapiju, objektivna stopa odgovora prema RECIST mjerilima bila je prema neovisnoj procjeni 12,2% (95% CI: 9,4%, 15,5%) u skupini koja je primala eribulin, u usporedbi s 4,7% (95% CI: 2,3%, 8,4%) u skupini liječenoj terapijom prema izboru liječnika.
English: Hepatotoxicity (0.8%) (G3/4: 0.6%)
Croatian: Hepatotoksičnost (0,8%) (G3/4: 0,6%)
English: Dacarbazine (n=72)
Croatian: HALAVEN Dakarbazin (n = 72)
English: The dose may be diluted in up to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Doza se može razrijediti u najviše 100 ml otopine za injekciju natrijevog klorida 9 mg/ml (0,9%).
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).
Croatian: Analiza kasnijih podataka o ukupnom preživljenju pokazala je bolje preživljenje u skupini koja je primala eribulin nego u skupini koja je primala terapiju po izboru liječnika u bolesnika koji su prethodno bili liječeni kapecitabinom uz HR od 0,787 (95% CI: 0,645, 0,961) i bolesnika koji prethodno nisu bili liječeni kapecitabinom uz HR od 0,865 (95% CI: 0,606, 1,233).
English: Sepsis (0.5%) (G3/4: 0.5%)a
Croatian: Sepsa (0,5%) (G3/4: 0,5%)a
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.
Croatian: U kasnijoj analizi ukupnog preživljenja, omjer hazarda (HR) za eribulin u odnosu na terapiju po izboru liječnika bio je 0,90 (95% CI: 0,71, 1,14) u korist eribulina kod bolesnika čija je bolest bila refraktorna na taksan i 0,73 (95% CI: 0,56, 0,96) kod bolesnika čija bolest nije bila refraktorna na taksan.
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).
Croatian: Prema neovisnoj procjeni, medijan preživljenja bez progresije bolesti iznosio je 3,7 mjeseci za eribulin u usporedbi s 2,2 mjeseca za skupinu koja je primala terapiju po izboru liječnika (HR 0,865, 95% CI: 0,714, 1,048, p = 0,137).
English: Gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, and stomatitis are among reported undesirable effects.
Croatian: Prijavljene nuspojave uključivale su i gastrointestinalne toksičnosti koje su se očitovale kao anoreksija, mučnina, povraćanje, proljev, konstipacija i stomatitis.
English: In one case of overdose the patient inadvertently received 7.6 mg of eribulin (approximately 4 times the planned dose) and subsequently developed a hypersensitivity reaction (Grade 3) on Day 3 and neutropenia (Grade 3) on Day 7.
Croatian: U jednom slučaju predoziranja bolesniku je nehotično bio primijenjen eribulin u dozi od 7,6 mg (otprilike 4 puta više od planirane doze).
English: Study 309 - Overall Survival in the Liposarcoma Subgroup
Croatian: Ispitivanje 309 - Ukupno preživljenje u podskupini bolesnika s liposarkomom
English: Hyperbilirubinaemia (1.4%) (G3/4: 0.4%)
Croatian: Hiperbilirubinemija (1,4%) (G3/4: 0,4%)
English: Capecitabine (n=548)
Croatian: Kapecitabin (n = 548)
English: Preclinical in vitro studies indicate that eribulin is transported by Pgp.
Croatian: Neklinička ispitivanja in vitro pokazuju da eribulin prenosi P-glikoprotein (Pgp).
English: Study 309 - Progression Free Survival in the Liposarcoma Subgroup
Croatian: Ispitivanje 309 - Preživljenje bez progresije bolesti u podskupini bolesnika s liposarkomom
English: Increased eribulin exposure was seen in some patients with moderately or severely impaired renal function, with high between-subject variability.
Croatian: U nekih bolesnika s umjerenim ili teškim oštećenjem funkcije bubrega bila je opažena povećana izloženost eribulinu, uz visoku varijabilnost između ispitanika.
English: Fatigue/Asthenia (53.2%) (G3/4 : 7.7%) Pyrexia (21.8%) (G3/4: 0.7%)
Croatian: Umor/astenija (53,2%) (G3/4: 7,7%) Pireksija (21,8%) (G3/4: 0,7%)
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
Croatian: - krvni ugrušci - poremećeni rezultati pretraga funkcije jetre (hepatotoksičnost) - zatajenje bubrega, krv ili bjelančevine u mokraći - opsežna upala pluća koja može dovesti do stvaranja ožiljaka - upala gušterače - ranice u ustima
English: In clinical trials, patients with pre-existing neuropathy greater than Grade 2 were excluded.
Croatian: Bolesnici koji su već imali neuropatiju iznad 2. stupnja bili su isključeni iz kliničkih ispitivanja.
English: The positive effect on OS was seen in both taxane-refractory and non-refractory groups of patients .
Croatian: Pozitivan učinak na ukupno preživljenje primijećen je i u skupini bolesnika čija je bolest bila refraktorna na liječenje taksanom i u skupini bolesnika čija bolest nije bila refraktorna na taksan.
English: Very common side effects (may affect more than 1 in 10 people) are:
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba):
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.
Croatian: Preporučena doza eribulina u bolesnika s umjerenim oštećenjem funkcije jetre (Child-Pugh B) iznosi 0,62 mg/m2 i primjenjuje se intravenski u trajanju od 2 do 5 minuta 1. i 8. dana 21-dnevnog ciklusa.
English: Monitoring of complete blood counts should be performed on all patients prior to each dose of eribulin.
Croatian: U svih je bolesnika svaki put prije primjene doze eribulina potrebno napraviti kompletnu krvnu sliku.
English: After administration of 14C-eribulin to patients, approximately 82% of the dose was eliminated in faeces and 9% in urine indicating that renal clearance is not a significant route of eribulin elimination.
Croatian: Nakon davanja 14C-eribulina bolesnicima, otprilike 82% doze eliminiralo se stolicom, a 9%
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.
Croatian: Preporučena doza eribulina u obliku gotove otopine iznosi 1,23 mg/m2 i primjenjuje se intravenski u trajanju od 2 do 5 minuta 1. i 8. dana svakog 21-dnevnog ciklusa.
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.
Croatian: Preporučena doza eribulina u bolesnika s blagim oštećenjem funkcije jetre (Child-Pugh A) iznosi 0,97 mg/m2 i primjenjuje se intravenski u trajanju od 2 do 5 minuta 1. i 8. dana 21-dnevnog ciklusa.
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.
Croatian: U bolesnika s umjerenim i teškim oštećenjem funkcije bubrega opažen je 1,5 puta viši AUC(0-inf) (90% CI: 0,9-2,5) normaliziran za dozu.
English: Pulmonary embolism (1.3%) (G3/4: 1.1%)a
Croatian: Navala vrućine Plućna embolija (1,3%) (G3/4: 1,1%)a
English: Peripheral oedema Pain
Croatian: Periferni edemi Bol
English: Although data are limited, patients with bilirubin >1.5 x ULN also have a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Croatian: Premda su podaci ograničeni, i u bolesnika kod kojih je vrijednost bilirubina > 1,5 x GGN incidencija neutropenije i febrilne neutropenije 4. stupnja također je bila veća.
English: Reoccurrence of any haematological or non-haematological adverse reactions as specified above
Croatian: Ponovna pojava neke gore navedene hematološke ili nehematološke nuspojave
English: Sepsis is uncommon (may affect up to 1 in 100 people) and can be lifethreatening and may result in death.
Croatian: Sepsa je manje česta (može se javiti u manje od 1 na 100 osoba), ali može ugroziti život i može imati smrtni ishod. - bilo kakvo otežano disanje ili oticanje lica, usta, jezika ili grla.
English: Neutropenic sepsis (0.2%) (G3/4: 0.2%)a
Croatian: Neutropenična sepsa (0,2%) (G3/4: 0,2%)a
English: NAME OF THE MEDICINAL PRODUCT HALAVEN 0.44 mg/ml solution for injection Eribulin
Croatian: HALAVEN 0,44 mg/ml otopina za injekciju eribulin
English: Do not drive or use machines if you feel tired or dizzy.
Croatian: Ako osjetite umor ili omaglicu, nemojte voziti ni upravljati strojevima.
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),
Croatian: Farmakokinetika eribulina ocijenjena je u ispitivanju faze 1 u bolesnika s normalnom funkcijom bubrega (klirens kreatinina: ≥ 80 ml/min; n=6), umjerenim (30-50 ml/min; n=7) ili teškim (15-<30 ml/min; n=6) oštećenjem funkcije bubrega.
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,
Croatian: - smanjenje broja krvnih pločica (što može dovesti do nastanka modrica i produženja vremena do zaustavljanja krvarenja) - infekcija s vrućicom, upala pluća, zimica - ubrzani puls, navale crvenila - vrtoglavica, omaglica - povećano stvaranje suza, konjunktivitis (crvenilo i osjetljivost površine oka), krvarenje iz nosa - dehidracija, suha usta, herpes na usni, gljivice u ustima, probavne tegobe, žgaravica, bol i oticanje trbuha - oticanje mekih tkiva, bolovi (osobito u prsištu, leđima i kostima), mišićni grčevi ili slabost - infekcije usta, dišnog sustava i mokraćnih puteva, bol pri mokrenju - osjetljivost grla, osjetljiv nos ili curenje iz nosa, simptomi nalik gripi, grlobolja - poremećeni nalazi pretraga funkcije jetra, promijenjena razina šećera, bilirubina, fosfata, kalija,
English: Capecitabine (n = 380)
Croatian: Kapecitabin (n = 380)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION HALAVEN 0.44 mg/ml injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA HALAVEN 0,44 mg/ml injekcija eribulin i.v.
English: The positive effect on OS was seen both in capecitabine-naïve and in capecitabine pre-treated patient groups.
Croatian: Pozitivan učinak na ukupno preživljenje primijećen je i u bolesnika koji prethodno nisu bili liječeni kapecitabinom, i u onih koji su bili liječeni kapecitabinom.
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).
Croatian: Eribulin ima velik volumen distribucije (raspon prosječnih vrijednosti od 43 do 114 l/m2).
English: Inflammation (6.4%) (G3/4: 0.9%)d
Croatian: Upala sluznica (6,4%) (G3/4: 0,9%)d
English: Capecitabine (n = 83)
Croatian: Kapecitabin (n = 83)
English: Impaired liver function due to metastases
Croatian: Bolesnici s oštećenjem funkcije jetre Oštećenje funkcije jetre zbog metastaza:
English: Rare side effects (may affect up to 1 in 1000 people) are:
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba):
English: Gastrooesophageal reflux disease Abdominal distension
Croatian: Gastroezofagealna refluksna bolest
English: HALAVEN 508 TPC 254
Croatian: HALAVEN 508 TIL
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton 2ml vial
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za bočicu od 2 ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton 3 ml vial
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za bočicu od 3 ml
English: Interstitial lung disease (0.2%) (G3/4:
Croatian: Intersticijska bolest pluća (0,2%) (G3/4: 0,1%)
English: Thrombocytopenia (4.2%) (G3/4: 0.7%)
Croatian: Trombocitopenija (4,2%) (G3/4: 0,7%)
English: Weight decreased (11.4%) (G3/4: 0.4%)d a
Croatian: Smanjenje tjelesne težine (11,4%) (G3/4: 0,4%)d a
English: NAME OF THE MEDICINAL PRODUCT HALAVEN 0.44 mg/ml solution for injection
Croatian: HALAVEN 0,44 mg/ml otopina za injekciju
English: Each 3 ml vial contains eribulin mesilate equivalent to 1.32 mg eribulin.
Croatian: Jedna bočica od 3 ml sadrži 1,32 mg eribulina u obliku eribulinmesilata.
English: OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO CITOTOKSIČNO ROK VALJANOSTI Rok valjanosti:
English: Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin.
Croatian: Jedna bočica od 2 ml sadrži 0,88 mg eribulina u obliku eribulinmesilata.
English: Study 309 Leiomyosarcoma Subgroup
Croatian: Ispitivanje 309 Podskupina s leiomiosarkomom
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 3 ml vial
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica od 3 ml
English: Impaired liver function due to cirrhosis
Croatian: Oštećenje funkcije jetre zbog ciroze:
English: Unchanged eribulin was the major circulating species in plasma following administration of 14C
Croatian: Nakon primjene 14C-eribulina, eribulin je najvećim dijelom cirkulirao u plazmi bolesnika u neizmijenjenom obliku.
English: Ewopharma AG Tel. +370 5 248 73 50
Croatian: Ewopharma d.o.o. Tel: +386 590 848 40
English: EU/1/11/678/002 6 vials
Croatian: EU/1/11/678/001 1 bočica EU/1/11/678/002 6 bočica
English: (G3/4:0.2%)
Croatian: (G3/4: 0,4%)d
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 2 ml vial
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica od 2ml
English: Tachycardia
Croatian: Dizurija
English: Oropharyngeal pain Epistaxis
Croatian: Tablični prikaz nuspojava
English: Lacrimation increased (5.8%) (G3/4: 0.1%)
Croatian: Pojačano suzenje (5,8%) (G3/4: 0,1%)d Konjunktivitis
English: TPC (n = 192)
Croatian: TIL (n = 192)
English: TPC (n = 40)
Croatian: TIL (n = 40)
English: EU/1/11/678/004 6 vials
Croatian: EU/1/11/678/003 1 bočica EU/1/11/678/004 6 bočica
English: Hydrochloric acid (for pH-adjustment)
Croatian: 6.1 Popis pomoćnih tvari etanol bezvodni voda za injekcije kloridna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH)
English: Time (months) NUMBER OF PATIENTS AT RISK: HALAVEN 71 63 51 43 39 34 30 20 15 12 Dacarbazine 72 59 42 33 22 17 12 11 6
Croatian: Dakarbazin 72 59 42 33 22 17 12 11 6
English: TIME (months) NUMBER OF PATIENTS AT RISK
Croatian: BROJ BOLESNIKA POD RIZIKOM
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains eribulin mesilate equivalent to 0.44 mg eribulin.
Croatian: Jedan ml sadrži 0,44 mg eribulina u obliku eribulinmesilata.
English: Nausea (35.7%) (G3/4: 1.1%)d
Croatian: (7,7%) (G3/4: 1,4%)d
English: Pruritus (3.9%) (G3/4: 0.1%)d
Croatian: Osip (4,9%) (G3/4: 0,1%) Pruritus (3,9%)
English: Uncommon side effects (may affect up to 1 in 100 people) are:
Croatian: Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba):
English: Arthralgia and myalgia (20.4%) (G3/4: 1.0%) Back pain (12.8%) (G3/4: 1.5%) Pain in extremity (10.0%) (G3/4: 0.7%)
Croatian: Artralgija i mialgija (20,4%) (G3/4: 1,0%) Bol u leđima
English: Haematuria Proteinuria Renal failure
Croatian: Poremećaji probavnog sustava
English: Common side effects (may affect up to 1 in 10 people) are:
Croatian: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba):
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 3 ml vial contains eribulin mesilate equivalent to 1.32 mg eribulin
Croatian: NAZIV LIJEKA HALAVEN 0,44 mg/ml otopina za injekciju eribulin NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica od 3 ml sadrži 1,32 mg eribulina u obliku eribulinmesilata.
English: Tel.: +48 (22) 620 11 71
Croatian: Ewopharma AG Sp. z o.o. Tel.: +48 (22) 620 11 71
English: TPC (n=254)
Croatian: TIL (n = 254)
English: Mucosal
Croatian: Liposarkom
English: Associated Drug Company Ltd. Tel: + 356 22778000
Croatian: Tel: + 356 22778000
English: Septic Shock (0.2%)
Croatian: Disgeuzija Omaglica (9,0%)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin
Croatian: NAZIV LIJEKA HALAVEN 0,44 mg/ml otopina za injekciju eribulin NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica od 2 ml sadrži 0,88 mg eribulina u obliku eribulinmesilata.
English: Dysuria
Croatian: Zimica
English: OS in ITT Population HALAVEN (n=554)
Croatian: HALAVEN (n = 554)
English: Constipation (22.3%) (G3/4: 0.7%)d
Croatian: Smanjen apetit (G3/4: 0,7%)d
English: (22.5%) (G3/4: 0.7%)d Hypokalaemia (6.8%) Decreased appetite (G3/4: 2.0%)
Croatian: Hipokalijemija (6,8%) (G3/4: 2,0%) Hipomagnezijemija (2,8%) (G3/4: 0,3%) Dehidracija (2,8%)
English: Eisai Ltd. Τηλ: + 44 (0)208 600 1400
Croatian: Τηλ: + 44 (0)208 600 1400 (Ηνωµένο Βασίλειο)
English: Excipients
Croatian: Tahikardija
English: HALAVEN (n=71)
Croatian: (n = 71)
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection
Croatian: OZNAČIVANJE I UPUTA O LIJEKU
English: Bone pain (6.7%) (G3/4: 1.2%) Muscle spasms (5.3%) (G3/4: 0.1%)
Croatian: Bol u kostima (6,7%) (G3/4: 1,2%) Grčevi u mišićima
English: Alanine aminotransferase increased (7.6%) (G3/4: 1.9%)d
Croatian: (7,6%) (G3/4: 1,9%)d
English: Conjunctivitis
Croatian: Konstipacija
English: You must also make sure you get enough carbohydrates.
Croatian: Morate se pobrinuti i da uzimate dovoljno ugljikohidrata.
English: ATC Code: A10AB01.
Croatian: ATK oznaka: A10AB01.
English: • in whom an autonomic neuropathy is present,
Croatian: • u kojih je prisutna autonomna neuropatija
English: Date of first authorisation: 21 February 1997 Date of latest renewal: 21 February 2007
Croatian: Datum posljednje obnove: 21. veljače 2007.
English: • If you forget the dose before a meal:
Croatian: • Ako zaboravite primijeniti dozu prije obroka:
English: The pump system will also be programmed and tested prior to your leaving the hospital.
Croatian: Sustav pumpe također će se programirati i ispitati prije nego što budete otpušteni iz bolnice.
English: • alcohol consumption,
Croatian: • konzumaciju alkohola
English: Dose adjustment may also be required, for example, if:
Croatian: Prilagodba doze može također biti potrebna, primjerice, ako:
English: • Information on the risk management plan, the safety concerns and the risk minimisation measures
Croatian: • informacije o planu upravljanja rizikom, sigurnosnim problemima i mjerama minimizacije rizika
English: These medicines are used for mental problems that affect how you think, feel or act.
Croatian: Ovi se lijekovi koriste za liječenje psihičkih tegoba koje utječu na Vaš način razmišljanja, osjećaje i postupke.