FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended oral dexamethasone dose should be reduced by approximately 50 % when coadministered with netupitant/palonosetron capsules (see section 4.5 and clinical studies administration schedule in section 5.1).
Croatian: Kad se primjenjuje istovremeno s netupitant/palonozetron kapsulama, preporučena doza peroralnog deksametazona treba biti snižena za približno 50% (vidjeti dio 4.5 i raspored primjene u kliničkim ispitivanjima u dijelu 5.1).
English: Overall phase No emesis
Croatian: Bez emeze
English: In 36 healthy male and female subjects given a single oral dose of 0.5 mg palonosetron, maximum plasma concentration (Cmax) was 0.81 ± 1.66 ng/mL (mean ± SD) and time to maximum concentration (Tmax) was 5.1 ± 1.7 hours.
Croatian: U 36 zdravih muškaraca i žena koji su primili jednu peroralnu dozu palonozetrona od 0,5 mg, maksimalna koncentracija palonozetrona u plazmi (Cmax) bila je 0,81 ± 1,66 ng/ml (srednja vrijednost ± SD), a vrijeme do maksimalne koncentracije (Tmax) iznosilo je 5,1 ± 1,7 sati.
English: Netupitant and combination with palonosetron
Croatian: Netupitant i kombinacija s palonozetronom
English: Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Croatian: Ostale nuspojave Obavijestite svoga liječnika, ljekarnika ili medicinsku sestru ako uočite neku od sljedećih nuspojava:
English: • dexamethasone - can be used to treat feeling and being sick
Croatian: • deksametazon - može se koristiti za liječenje mučnine i povraćanja
English: Consequently, concomitant administration with strong CYP3A4 inhibitors (e.g., ketoconazole) should be approached with caution and concomitant administration with strong CYP3A4 inducers (e.g. rifampicin) should be avoided.
Croatian: Zbog toga istovremenoj primjeni s jakim inhibitorima CYP3A4 (npr. ketokonazolom) treba pristupati oprezno, a istovremenu primjenu s jakim induktorima CYP3A4 (npr. rifampicinom) treba izbjegavati.
English: This medicinal product may contain a trace of lecithin derived from soya.
Croatian: Ovaj lijek može sadržavati u tragovima lecitin dobiven od soje.
English: 135 patients who received a single oral dose (netupitant 300 mg and palonosetron 0.5 mg) and 136 patients who received oral palonosetron 0.5 mg alone.
Croatian: Djelotvornost Akynzea procijenjena je u 135 bolesnika koji su primili jednu peroralnu dozu (netupitant 300 mg i palonozetron 0,5 mg) te 136 bolesnika koji su primili samo peroralni palonozetron u dozi od 0,5 mg.
English: Therefore, caution is recommended when netupitant is combined with digoxin or with other P-gp substrates such as dabigatran, or colchicine.
Croatian: Stoga se preporučuje oprez kada se netupitant kombinira s digoksinom ili s drugim supstratima
English: Akynzeo 300 mg/0.5 mg hard capsules
Croatian: Akynzeo 300 mg/0,5 mg tvrde kapsule
English: Helsinn Birex Pharmaceuticals Ltd. Damastown, Mulhuddart Dublin 15,
Croatian: Damastown, Mulhuddart Dublin 15
English: As such, no dosage adjustment is necessary for patients with mild to moderate hepatic impairment.
Croatian: S obzirom na to, prilagodba doze nije potrebna u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
English: Total systemic exposure to intravenous palonosetron increased by approximately 28% in severe renal impairment relative to healthy subjects.
Croatian: Ukupna sistemska izloženost intravenskom palonozetronu povećala se približno 28% u bolesnika s teškim oštećenjem funkcije bubrega u odnosu na zdrave ispitanike.
English: What Akynzeo contains
Croatian: Što Akynzeo sadrži
English: After a single dose of approximately 0.75 mg intravenous palonosetron, the total body clearance of palonosetron in healthy subjects was 160 ± 35 mL/h/kg (mean ± SD) and renal clearance was 66.5± 18.2 mL/h/kg.
Croatian: Nakon jedne doze od približno 0,75 mg intravenski primijenjenog palonozetrona, ukupni tjelesni klirens palonozetrona u zdravih ispitanika iznosio je 160 ± 35 ml/h/kg (srednja vrijednost ± SD), a bubrežni klirens 66,5 ± 18,2 ml/h/kg.
English: QT Prolongation
Croatian: Produljenje QT intervala
English: Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters.
Croatian: Blago do umjereno oštećenje funkcije bubrega ne utječe značajno na farmakokinetičke parametre palonozetrona.
English: Palonosetron is mainly metabolised by CYP2D6, with minor contribution by CYP3A4 and CYP1A2 isoenzymes.
Croatian: Palonozetron se uglavnom metabolizira putem CYP2D6, uz manji doprinos izoenzima CYP3A4 i CYP1A2.
English: What Akynzeo is
Croatian: Što je Akynzeo
English: • numbness, blurred vision
Croatian: • utrnutost, zamućen vid
English: Adverse reactions are listed below by MedDRA body system organ class and frequency.
Croatian: Nuspojave su navedene u nastavku prema MedDRA-inoj klasifikaciji organskih sustava i učestalosti.
English: The signs may include hives, itch, angioedema, low blood pressure, throat tightness, chest tightness, dyspnoea, loss of consciousness.
Croatian: Znakovi mogu uključivati koprivnjaču, svrbež, angioedem, nizak krvni tlak, stezanje u grlu, stezanje u prsnom košu, dispneju, gubitak svijesti.
English: Inhibition of the efflux transported BCRP and glucuronidation isozyme UGT2B7 by netupitant and its metabolites is unlikely and, if it occurs, of scarce clinical relevance.
Croatian: Nije vjerojatno da će netupitant i njegovi metaboliti inhibirati efluksni prijenosnik BCRP i izoenzim glukuronidacije UGT2B7 i, ako se to dogodi, od male je kliničke značajnosti.
English: In vitro metabolism studies have suggested that CYP3A4 and, to a lesser extent, CYP2D6 and CYP2C9 are involved in the metabolism of netupitant.
Croatian: Ispitivanja metabolizma in vitro ukazala su na sudjelovanje CYP3A4, a u manjoj mjeri CYP2D6 i CYP2C9 u metabolizmu netupitanta.
English: Akynzeo is used to help prevent adults with cancer feeling sick (nausea) or being sick (vomiting) while having cancer treatment called ‘chemotherapy'.
Croatian: Akynzeo se primjenjuje kako bi se u odraslih osoba s rakom spriječila mučnina ili povraćanje za vrijeme liječenja protiv raka koje se naziva „kemoterapija“.
English: How to take Akynzeo
Croatian: Kako uzimati Akynzeo
English: Netupitant tablets Microcrystalline cellulose (E460) Sucrose lauric acid esters Povidone K-30
Croatian: Netupitant tablete mikrokristalična celuloza (E460) saharozni esteri lauratne kiseline povidon K-30 umrežena karmelozanatrij koloidni hidratizirani silicijev dioksid natrijev stearilfumarat magnezijev stearat
English: • high levels of creatine phosphokinase/ creatine phosphokinase MB - which indicates sudden decreased blood flow to the heart muscle (shown in blood tests)
Croatian: • visoke razine kreatin fosfokinaze/kreatin fosfokinaze MB - što ukazuje na iznenadni smanjeni priljev krvi u srčani mišić (prema pretragama krvi)
English: Chemotherapeutic medicinal products (docetaxel, etoposide, cyclophosphamide) Exposure to docetaxel and etoposide was increased 37% and 21%, respectively, when co-administered with netupitant/palonosetron capsules.
Croatian: Kemoterapijski lijekovi (docetaksel, etopozid, ciklofosfamid) Kod istovremene primjene s netupitant/palonozetron kapsulama, izloženost docetakselu povećala se 37%, a etopozidu 21%.
English: Table 2: Oral Antiemetic treatment regimen -- HEC study
Croatian: Tablica 2: Režim liječenja peroralnim antiemeticima - ispitivanje visoko emetogene kemoterapije (HEC)
English: Table 4: Oral Antiemetic treatment regimen - MEC study
Croatian: Tablica 4: Režim liječenja peroralnim antiemeticima - ispitivanje umjereno emetogene kemoterapije (MEC)
English: • stomach problems including stomach discomfort, feeling bloated, nausea, pain, indigestion,
Croatian: • tegobe sa želucem uključujući nelagodu u želucu, osjećaj nadutosti, mučninu, bol, probavne tegobe, štucanje, vjetrove ili proljev
English: Rare: (may affect up to 1 in 1,000 people)
Croatian: Rijetko: (mogu se javiti u manje od 1 na 1000 osoba)
English: Co-administration with ketoconazole did not affect the pharmacokinetics of palonosetron.
Croatian: Istovremena primjena ketokonazola nije utjecala na farmakokinetiku palonozetrona.
English: It may also contain a trace of lecithin derived from soya.
Croatian: Ovaj lijek može također sadržavati u tragovima lecitin dobiven od soje.
English: Co-administration of rifampicin did not affect the pharmacokinetics of palonosetron.
Croatian: Istovremena primjena rifampicina nije utjecala na farmakokinetiku palonozetrona.
English: Palonosetron Degeneration of seminiferous epithelium has been observed in rat study (see section 5.3).
Croatian: U ispitivanju na štakorima opažena je degeneracija sjemenskog epitela (vidjeti dio 5.3).
English: Major secondary endpoints Complete response Acute phase
Croatian: Primarni ishod Potpuni odgovor Odgođena faza Glavni sekundarni ishodi Potpuni odgovor Akutna faza Cijela faza§
English: What Akynzeo is used for
Croatian: Za što se Akynzeo koristi
English: Akynzeo is indicated in adults for the: - Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy.
Croatian: Akynzeo je indiciran u odraslih za: - sprječavanje akutne i odgođene mučnine i povraćanja povezanih s visoko emetogenom kemoterapijom protiv raka na bazi cisplatina - sprječavanje akutne i odgođene mučnine i povraćanja povezanih s umjereno emetogenom kemoterapijom protiv raka.
English: Therefore, Akynzeo can be administered without dosage adjustment in patients with renal impairment.
Croatian: Stoga se u bolesnika s oštećenjem funkcije bubrega Akynzeo može primjenjivati bez prilagodbe doze.
English: Akynzeo (Netupitant 300 mg + Palonosetron 0.5 mg) Dexamethasone 12 mg
Croatian: Akynzeo (netupitant 300 mg + palonozetron 0,5 mg) deksametazon 12 mg deksametazon 8 mg jedanput na dan
English: • high level of ‘lymphocytes'- type of white blood cell which help the body fight disease (shown in blood tests)
Croatian: • visoka razina limfocita - vrsta bijelih krvnih stanica koja pomaže tijelu u suzbijanju bolesti
English: Decreased appetite Hypokalaemia
Croatian: Poremećaji metabolizma i prehrane oslabljen apetit hipokalemija
English: Animal data do not indicate direct or indirect harmful effects of palonosetron with the respect to reproductive toxicity (see section
Croatian: Podaci dobiveni na životinjama ne ukazuju na izravan ili neizravan štetan učinak palonozetrona na reprodukciju (vidjeti dio 5.3).
English: What you need to know before you take Akynzeo
Croatian: Što morate znati prije nego počnete uzimati Akynzeo Nemojte uzeti Akynzeo:
English: Akynzeo is taken to help prevent you feeling and being sick when you are having chemotherapy.
Croatian: Akynzeo se uzima da spriječi mučninu i povraćanje dok primate kemoterapiju.
English: Netupitant is a selective antagonist of human substance P/neurokinin 1 (NK1) receptors.
Croatian: P/ neurokinina 1 (NK1) u ljudi.
English: Back pain Pain in extremities
Croatian: • bol u leđima, bol u zglobovima
English: The signs may include hives, skin rash, itching, difficulty breathing or swallowing, swollen mouth, face, lips, tongue or throat and sometimes a drop-in blood pressure.
Croatian: Znakovi mogu uključivati koprivnjaču, osip na koži, svrbež, otežano disanje ili gutanje, otečena usta, lice, usne, jezik ili grlo, a katkad sniženje krvnog tlaka.
English: • medicines for depression or anxiety called SNRIs (serotonin noradrenaline re-uptake inhibitors)
Croatian: • lijekove protiv depresije ili tjeskobe, zvane inhibitori ponovne pohrane serotonina i noradrenalina (SNRI) - kao što su venlafaksin ili duloksetin.
English: Delayed emesis has been associated with the activation of tachykinin family neurokinin 1 (NK1) receptors (broadly distributed in the central and peripheral nervous systems) by substance P. As shown in in vitro and in vivo studies, netupitant inhibits substance P mediated responses.
Croatian: P koja aktivira receptore neurokinina 1 (NK1) iz obitelji tahikinina (široko rasprostranjeni u središnjem i perifernom živčanom sustavu).
English: • low levels of ‘neutrophils' - a kind of white blood cell which fight infections (shown in blood tests)
Croatian: • niske razine neutrofila - vrste bijelih krvnih stanica koje suzbijaju infekcije (prema pretragama krvi)
English: Treatment regimens for the Akynzeo and the palonosetron 0.5 mg arms are displayed in Table below.
Croatian: U tablici ispod prikazani su terapijski režimi skupina koje su primale Akynzeo i palonozetron 0,5 mg.
English: In vitro metabolism studies have suggested that CYP2D6 and to a lesser extent, CYP3A4 and CYP1A2 are involved in the metabolism of palonosetron.
Croatian: Ispitivanja metabolizma in vitro ukazala su na sudjelovanje CYP2D6, a u manjoj mjeri CYP3A4 i CYP1A2 u metabolizmu palonozetrona.
English: Chemotherapy medicines can cause the body to release substances called serotonin and substance P. This stimulates the vomiting centre in the brain, making you feel or be sick.
Croatian: Kemoterapijski lijekovi mogu u tijelu prouzročiti otpuštanje tvari pod nazivom serotonin i tvar P.
English: How Akynzeo works
Croatian: Kako Akynzeo djeluje
English: • haemorrhoids
Croatian: • osjećaj omamljenosti
English: Flushing Hypotension
Croatian: Krvožilni poremećaji hipertenzija navale crvenila hipotenzija
English: How to store Akynzeo
Croatian: Kako čuvati Akynzeo
English: • high levels of the pigment bilirubin - which indicates liver dysfunction (shown in blood tests)
Croatian: • visoke razine pigmenta bilirubina - što ukazuje na poremećaj funkcije jetre (prema pretragama krvi)
English: • low level of white blood cells (shown in blood tests)
Croatian: • niska razina bijelih krvnih stanica (prema pretragama krvi)
English: Each hard capsule contains 300 milligrams of netupitant and 0.5 milligrams of palonosetron (as hydrochloride).
Croatian: Jedna tvrda kapsula sadrži 300 miligrama netupitanta i 0,5 miligrama palonozetrona (u obliku palonozetronklorida).
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta vrtoglavica tinitus
English: Oral administration of Akynzeo in combination with dexamethasone has been shown to prevent acute and delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in two separate pivotal studies.
Croatian: U dva zasebna ključna ispitivanja, pokazalo se da peroralna primjena Akynzea u kombinaciji s deksametazonom sprječava akutnu i odgođenu mučninu i povraćanje povezane s visoko i umjereno emetogenom kemoterapijom protiv raka.
English: • high levels of myoglobin - which indicates muscle injury (shown in blood tests)
Croatian: • visoke razine mioglobina - što ukazuje na oštećenje mišića (prema pretragama krvi)
English: • high levels of troponin - which indicates heart muscle dysfunction (shown in blood tests)
Croatian: • visoke razine troponina - što ukazuje na poremećaj funkcije srčanog mišića (prema pretragama krvi)
English: Each hard capsule contains three tablets (300 mg of netupitant), and one soft capsule (palonosetron hydrochloride equivalent to 0.5 milligrams of palonosetron).
Croatian: Jedna tvrda kapsula sadrži tri tablete (300 mg netupitanta) i jednu meku kapsulu (0,5 miligrama palonozetrona u obliku palonozetronklorida).
English: • high level of white blood cells (shown in blood tests).
Croatian: • visoka razina bijelih krvnih stanica (prema pretragama krvi)
English: The signs may include hives, skin rash, itching, difficulty breathing or swallowing, swollen mouth, face, lips, tongue or throat and sometimes a drop in blood pressure.
Croatian: Ti znakovi mogu uključivati koprivnjaču, kožni osip, svrbež, otežano disanje ili gutanje, otok usta, lica, usana, jezika ili grla te ponekad pad krvnog tlaka.
English: The following convention has been used for classification of frequency: Very common (≥1/10),
Croatian: Učestalosti su klasificirane prema sljedećem dogovoru: vrlo često (≥1/10) često (≥1/100 i <1/10) manje često (≥1/1000 i <1/100) rijetko (≥1/10 000 i <1/1000) vrlo rijetko (<1/10 000) nepoznato (ne može se procijeniti iz dostupnih podataka)
English: You can also report side effects directly via the national reporting system listed in Appendix V By reporting side effects, you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: This is because it is not known whether the medicine passes into breast milk.
Croatian: Nemojte dojiti ako uzimate Akynzeo jer nije poznato prelazi li lijek u majčino mlijeko.
English: Each hard capsule contains 300 mg of netupitant and palonosetron hydrochloride equivalent to 0.5 mg of palonosetron.
Croatian: Jedna tvrda kapsula sadrži 300 mg netupitanta i 0,5 mg palonozetrona u obliku palonozetronklorida.
English: Hypoaesthesia Somnolence
Croatian: Poremećaji živčanog sustava glavobolja omaglica hipoestezija somnolencija
English: Palonosetron Palonosetron 0.5 mg Dexamethasone 20 mg
Croatian: Palonozetron palonozetron 0,5 mg deksametazon 20 mg deksametazon 8 mg dvaput na dan
English: N=725
Croatian: N = 725 % p-vrijednost*
English: • ECG (electrocardiogram) problems (called ‘QT and PR interval prolongation', ‘conduction disorder', ‘tachycardia' and ‘atrioventricular block first degree')
Croatian: intervala, poremećaj provodljivosti, tahikardija i atrioventrikularni blok prvog stupnja)
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Helsinn Birex Pharmaceuticals Ltd.
English: N=136
Croatian: N = 136 % p-vrijednost
English: • heart valve disorder (mitral valve incompetence)
Croatian: • poremećaj srčanog zaliska (insuficijencija mitralnog zaliska)
English: • raised, itchy rash on the skin (hives)
Croatian: • izdignut osip na koži, praćen svrbežom (koprivnjača)
English: Butylhydroxyanisole (E320)
Croatian: Sadržaj kapsule glicerolmonokaprilokaprat (vrsta I) glicerol poligliceriloleat pročišćena voda butilhidroksianizol (E320)
English: The pharmacokinetic profile of netupitant was unchanged when administered in combination with dexamethasone.
Croatian: Kada se davao u kombinaciji s deksametazonom, farmakokinetički profil netupitanta bio je nepromijenjen.
English: Atrioventricular block second degree Conduction disorder Bundle branch block left Tachycardia
Croatian: Srčani poremećaji atrioventrikularni blok prvog stupnja aritmija kardiomiopatija atrioventrikularni blok drugog stupnja poremećaj provodljivosti blok lijeve grane snopa tahikardija blok desne grane snopa insuficijencija mitralnog zaliska ishemija miokarda ventrikularne ekstrasistole
English: • high levels of creatinine - which measures kidney function (shown in blood tests)
Croatian: • visoke razine kreatinina - čime se mjeri funkcija bubrega (prema pretragama krvi)
English: It may contain traces of lecithin - which comes from soya.
Croatian: Ovaj lijek može sadržavati tragove lecitina, koji se dobiva iz soje.
English: Non-cardiac chest pain Product taste abnormal
Croatian: Opći poremećaji i reakcije na mjestu primjene umor astenija osjećaj vrućine nekardijalni bol u prsištu nenormalan okus lijeka
English: - such as venlafaxine or duloxetine.
Croatian: P-gp-a kao što su dabigatran ili kolhicin.
English: 1,4 sorbitan
Croatian: 4.8 Nuspojave
English: No clinically relevant pharmacokinetic interactions have been observed between oral netupitant and oral palonosetron.
Croatian: Između peroralnog netupitanta i peroralnog palonozetrona nisu opažene klinički važne farmakokinetičke interakcije.
English: • high levels of blood urea - which indicates kidney dysfunction (shown in blood tests)
Croatian: • visoke razine ureje u krvi - što ukazuje na poremećenu funkciju bubrega (prema pretragama krvi)
English: • low level of potassium (shown in blood tests)
Croatian: • niska razina kalija (prema pretragama krvi)
English: Electrocardiogram ST-T segment abnormal Myoglobin blood increased Neutrophil count increased Troponin increased
Croatian: Pretrage povišene transaminaze u jetri povišen bilirubin u krvi povišena alkalna fosfataza u krvi povišena kreatin fosfokinaza u krvi povišen kreatinin u krvi povišena kreatin fosfokinaza MB u krvi produljen QT u elektrokardiogramu povišena urea u krvi depresija ST segmenta u elektrokardiogramu nepravilan ST-T segment u elektrokardiogramu povišen mioglobin u krvi povišen broj neutrofila povišen troponin
English: Netupitant and Palonosetron Combinate Capsule:
Croatian: Kombinacija netupitant/palonozetron u obliku kapsule:
English: Tel: +34 902 121 111
Croatian: Vifor Pharma España, S.L. Tel: +34 902 121 111
English: The pharmacokinetic profile of netupitant was unaffected by the concomitant administration of either midazolam or erythromycin.
Croatian: Kod istovremene primjene bilo midazolama bilo eritromicina, farmakokinetički profil netupitanta ostao je nepromijenjen.
English: Bundle branch block right Mitral valve incompetence Myocardial ischaemia Ventricular extrasystoles
Croatian: Poremećaji kože i potkožnog tkiva alopecija eritem urtikarija pruritus osip
English: Dosage adjustment is not considered necessary in patients with mild to severe renal impairment.
Croatian: U bolesnika s blagim do teškim oštećenjem funkcije bubrega ne smatra se potrebnim prilagođavati dozu.
English: Urticaria
Croatian: Česte
English: Contains sucrose and sorbitol.See package leaflet for further information.
Croatian: Sadrži saharozu i sorbitol.
English: Feeling hot
Croatian: • osjećaj umora
English: Dry mouth
Croatian: Primjena kroz usta.
English: Helsinn Birex Pharmaceuticals Ltd. Tel.: + 353 1 822 5404
Croatian: Slovenská republika Angelini Pharma Slovenská republika s.r.o. Tel: +421 2 5920 7320
English: Tel: (+420) 546 123 111
Croatian: Angelini Pharma Česká republika s.r.o. Tel: (+420) 546 123 111
English: Sorbitol
Croatian: Damastown
English: Conjunctivitis Vision blurred
Croatian: Poremećaji oka konjunktivitis zamućen vid
English: Monitoring should continue for at least 24 months.
Croatian: Praćenje je potrebno tijekom najmanje 24 mjeseca.
English: In March 2018, the
Croatian: ožujku 2018.
English: However, the reasons for a possible earlier death seen in this study are not fully understood.
Croatian: Međutim, mogući razlozi ranije smrti zabilježene u ovom ispitivanju nisu u potpunosti poznati.
English: • If you have any questions or concerns about your treatment, speak to your doctor or pharmacist.
Croatian: • Imate li pitanja ili ste zabrinuti u pogledu liječenja, obratite se svojem liječniku ili ljekarniku.
English: In addition, the combination used in this study is now contraindicated.
Croatian: Nadalje, primjena kombinacije korištene u tom ispitivanju sada je kontraindicirana.
English: More information on Xofigo is available on the EMA website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports
Croatian: Više informacija o lijeku Xofigo dostupno je na internetskoj stranici Europske agencije za lijekove: ema.europa.eu/Find medicine/Human medicines/European public assessment reports
English: Medicine to be used only after two previous treatments or when other treatments cannot be taken
Croatian: Lijek treba primjenjivati samo nakon dviju prethodnih terapija ili ako se ne mogu primjenjivati druge terapije
English: The review of Xofigo was initiated on 1 December 2017 at the request of the European Commission, Article 20 of Regulation (EC) No 726/2004.
Croatian: Ocjenjivanje lijeka Xofigo započeto je 1. prosinca 2017. na zahtjev Europske komisije, u skladu s člankom 20. Uredbe (EZ) br. 726/2004.
English: The company that markets Xofigo will have to conduct studies to further characterise these events and clarify the mechanisms behind them.
Croatian: Tvrtka koja stavlja lijek Xofigo na tržište morat će provesti ispitivanja kako bi se dodatno okarakterizirali ti događaji i razjasnili njihovi mehanizmi.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 July 2018 EMA/500948/2018
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28. rujna 2018.
English: Subsequent systemic cancer treatment should not be initiated for at least 30 days after the last administration of Xofigo.
Croatian: Sljedeće sistemsko liječenje protiv raka ne bi trebalo započinjati najmanje 30 dana nakon posljednje primjene lijeka Xofigo.