FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common Drug eruption (including skin rash) a Folliculitis, Cellulitis, Candidiasis, Pneumonia, Sepsis, Skin infection, Otitis externa, Herpes zoster, Staphylococcal skin infection, Urinary tract infection, Herpes simplex and cytomegalovirus
Croatian: Vrlo često izbijanje kožnih promjena uzrokovano lijekom (uključujući kožni osip) a Folikulitis, celulitis, kandidijaza, upala pluća, sepsa, kožna infekcija, otitis externa, herpes zoster, stafilokokna kožna infekcija, infekcija mokraćnog sustava, herpes simplex i citomegalovirus
English: No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3).
Croatian: Nisu opaženi štetni učinci na reproduktivne organe mužjaka i ženki u ispitivanjima toksičnosti ponovljenih doza u makaki majmuna (vidjeti dio 5.3).
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential and males of reproductive potential should use effective contraception during treatment with POTELIGEO and for at least 6 months after treatment.
Croatian: Žene reproduktivne dobi i muškarci u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja lijekom POTELIGEO i najmanje 6 mjeseci nakon liječenja.
English: There are no data from the use of mogamulizumab in pregnant women.
Croatian: Nema podataka o primjeni mogamulizumaba u trudnica.
English: There is no information on overdose with mogamulizumab.
Croatian: Nema informacija o predoziranju s mogamulizumabom.
English: Administration is weekly on days 1, 8, 15 and 22 of the first 28-day cycle, followed by infusions every two weeks on Days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity.
Croatian: nakon čega slijedi infuzija svaka dva tjedna na dan 1. i 15. svakog sljedećeg ciklusa od 28 dana do progresije bolesti ili do pojave neprihvatljive toksičnosti.
English: Based on a population PK analysis, the geometric mean (% coefficient of variation [CV%]) clearance (CL) is 12.0 mL/h (83.7%) and geometric mean elimination half-life (t1/2) is 17 days (65.5%).
Croatian: koeficijenta varijacije [CV%]) je 12,0 ml/h (83,7%), a geometrijska srednja vrijednost poluvijeka eliminacije (t1/2) je 17 dana (65,5%).
English: POTELIGEO has not been studied in patients with severe hepatic impairment (see section 5.2).
Croatian: POTELIGEO nije ispitivan u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dio 5.2).
English: One case of acute myocardial infarction has been observed in a clinical trial patient with MF / SS receiving mogamulizumab.
Croatian: Jedan slučaj akutnog infarkta miokarda opažen je u jednog bolesnika iz kliničkog ispitivanja koji je imao MF/SS i primao mogamulizumab.
English: a: P-value was obtained from Cochran-Mantel-Haenszel test adjusting for disease type, disease stage, and region.
Croatian: Napomena: Ukupna stopa odgovora na temelju rezultata globalnog kompozitnog odgovora. a: P-vrijednost dobivena je iz testa Cochran-Mantel-Haenszel prilagođeno prema vrsti bolesti, fazi bolesti i regiji.
English: Very common side effects (may affect more than 1 in 10 people):
Croatian: To može uključivati: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba):
English: Description of selected adverse reactions
Croatian: Opis odabranih nuspojava Dermatološke reakcije
English: The amount of POTELIGEO you will receive is calculated by your doctor based on your body weight.
Croatian: Količinu lijeka POTELIGEO koju ćete primiti izračunava
English: Based on a population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild to severe renal impairment (see section 5.2).
Croatian: Na temelju farmakokinetičke analize populacije, ne preporučuje se prilagođavati dozu u bolesnika s blagim do teškim oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: The effect of renal impairment on the clearance of mogamulizumab was evaluated by a population PK analysis in patients with mild (creatinine clearance [CrCL] between 60 and 89; n= 157), moderate (CrCL between 59 and 30; n= 80), or severe renal impairment (CrCL less than 30 mL/min; n= 2).
Croatian: Utjecaj oštećenja bubrega na klirens mogamulizumaba procijenjen je u populacijskoj farmakokinetičkoj analizi u bolesnika s blagim (klirens kreatinina [CrCL] između 60 i 89; n= 157), umjerenim (CrCL između 59 i 30; n= 80), ili teškim oštećenjem funkcije bubrega (CrCL manji od 30 ml/min; n= 2).
English: POTELIGEO 4 mg/mL concentrate for solution for infusion mogamulizumab
Croatian: 4 mg/ml koncentrat za otopinu za infuziju mogamulizumab
English: Very common Constipation, diarrhoea, nausea, stomatitis
Croatian: Vrlo često konstipacija, proljev, mučnina,
English: Fatigue may occur following administration of mogamulizumab (see section 4.8).
Croatian: Nakon primjene mogamulizumaba može uslijediti umor (vidjeti dio 4.8).
English: - have had or plan to have a stem cell transplant, either using your own cells or a donor's.
Croatian: - ako su Vam presađene ili će Vam biti presađene krvotvorne matične stanice, bilo da koristite vlastite stanice ili stanice davatelja,
English: Citric acid monohydrate, glycine, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections.
Croatian: Citratna kiselina hidrat, glicin, polisorbat 80, natrijev hidroksid, kloridna kiselina, voda za injekcije.
English: See section 4.2 for dose modification information.
Croatian: Pogledajte dio 4.2 za informacije o prilagodbi doze.
English: The pharmacokinetics (PK) of mogamulizumab was evaluated in adult patients with T-cell leukaemialymphoma (ATL) and CTCL over a dose range of 0.01 to 1 mg/kg administered as multiple doses of mogamulizumab every week or every 2 weeks, and included the recommended 1.0 mg/kg dose and regimen (days 1, 8, 15 and 22 for the first 28-day cycle and on Days 1 and 15 for subsequent 28-day cycles).
Croatian: Adult T-cell leukaemia-lymphoma, ATL) i CTCL-om za raspon doze od 0,01 do 1 mg/kg primijenjenog kao višestruke doze mogamulizumaba svaki tjedan ili svaka 2 tjedna, i uključivala je preporučenu dozu od 1,0 mg/kg i režim (dani 1., 8., 15. i 22. za prvi ciklus od 28 dana i na dane 1. i 15. za sljedeće cikluse od 28 dana).
English: For storage conditions after dilution of the medicinal product, see section 6.3
Croatian: Uvjete čuvanja nakon razrjeđivanja lijeka, vidjeti u dijelu 6.3.
English: P-valuea
Croatian: p-vrijednosta
English: Anaemia, neutropenia, leukopenia, Thrombocytopenia
Croatian: Često anemija, neutropenija, leukopenija, trombocitopenija endokrini poremećaji
English: Each mL of concentrate contains 4 mg of mogamulizumab.
Croatian: Jedan ml koncentrata sadrži 4 mg mogamulizumaba.
English: Very common Infusion related reaction
Croatian: Vrlo često reakcija vezana uz infuziju
English: The following factors had no clinically important effect on the CL of mogamulizumab: age (range: 22 to 101 years), sex, ethnicity (other than Japanese, limited data are available in other ethnic populations), renal impairment, mild or moderate hepatic impairment, disease subtype (mycosis fungoides (MF) or Sézary Syndrome (SS)), degree of CCR4 expression or ECOG status, although it should be noted that patients with ECOG PS ≥2 were excluded from the clinical trials.
Croatian: Sljedeći čimbenici nisu imali značajan klinički učinak na CL mogamulizumaba: dob (raspon: od 22 do 101 godine), spol, etnička pripadnost (drukčija od japanske, ograničeni podaci dostupni su u drugim etničkim populacijama), oštećenje funkcije bubrega, blago ili umjereno oštećenje funkcije jetre, podvrsta bolesti (mycosis fungoides (MF) ili Sézaryjev sindrom
English: POTELIGEO will be given to you through a vein (intravenous infusion) over at least 60 minutes.
Croatian: POTELIGEO ćete primiti u venu (intravenska infuzija) tijekom najmanje 60 minuta.
English: Mogamulizumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Croatian: Mogamulizumab se proizvodi tehnologijom rekombinantne DNK-a na stanicama ovarija kineskog hrčka.
English: When mogamulizumab has been administered to patients with T-cell lymphomas other than MF or SS, serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in less than 1% of patients during clinical trials, and also reported during the post-marketing period; some of these cases were reported with fatal outcomes.
Croatian: ozbiljne reakcije kože, uključujući Stevens-Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN), prijavljene su u manje od 1% bolesnika tijekom kliničkih ispitivanja i također prijavljene nakon stavljanja lijeka u promet; u nekim slučajevima prijavljeni su smrtni ishodi.
English: Exposure-Response analysis indicated that efficacy was not correlated with mogamulizumab exposure in the pivotal study.
Croatian: Analiza odnosa izloženosti i odgovora pokazala je u pivotalnom ispitivanju da djelotvornost nije povezana s izloženošću mogamulizumabu.
English: Response in lymph nodes and viscera was evaluated at 4 weeks, then every 8 weeks in the first year, and then every 16 weeks thereafter.
Croatian: Odgovor na razini limfnih čvorova i unutarnjih organa procijenjen je nakon 4 tjedna, zatim svakih 8 tjedana tijekom prve godine,
English: Mogamulizumab has not been studied in patients with severe hepatic impairment (TB greater than 3 times ULN and any AST).
Croatian: Mogamulizumab nije ispitivan u bolesnika s teškim oštećenjem funkcije jetre (ukupni bilirubin veći od 3-struke vrijednosti
English: - have had tumour lysis syndrome (a complication involving the destruction of cancer cells) after a previous treatment.
Croatian: - ako imate sindrom lize tumora (komplikaciju koja uključuje razaranje tumorskih stanica) nakon prethodnog liječenja, - ako imate srčanih problema.
English: Overall response rate (confirmed CR + PR, %)
Croatian: Ukupna stopa odgovora (potvrđen CR + PR, %)
English: POTELIGEO contains sodium
Croatian: POTELIGEO sadrži natrij
English: Tumour lysis syndrome
Croatian: Manje često sindrom lize tumora
English: Patients with stage IB/II disease treated with mogamulizumab had confirmed ORR of 17.6% compared to 8.3% for vorinostat, and compartment level (blood, skin, lymph node) response rates that were higher than those for vorinostat treated patients (Table 3).
Croatian: Bolesnici s bolešću u stadiju IB/II liječeni mogamulizumabom imali su potvrđenu ukupnu stopu odgovora od 17,6% u usporedbi sa 8,3% za vorinostat i stope odgovora na razini odjeljka (krv, koža,
English: Mogamulizumab exhibits linear PK from the dose in a dose range of 0.01 mg/kg to 1 mg/kg.
Croatian: Linearnost i akumulacija Mogamulizumab pokazuje linearnu farmakokinetiku za doze u rasponu od 0,01 mg/kg do 1 mg/kg.
English: CCR4 is expressed on the surface of some cancer cells including T cell malignancies, such as MF and SS in which CCR4 expression is inherent.
Croatian: CCR4 se eksprimira na površini određenih stanica raka uključujući maligne bolesti T-stanica, kao što su MF i
English: POTELIGEO is unlikely to affect your ability to drive and use machines.
Croatian: Malo je vjerojatno da će POTELIGEO utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: - Each vial contains 20 mg of mogamulizumab in 5 mL of concentrate, corresponding to 4 mg/mL.
Croatian: - Jedna bočica sadrži 20 mg mogamulizumaba u 5 ml koncentrata, što odgovara 4 mg/ml.
English: POTELIGEO 4 mg/mL concentrate for solution for infusion.
Croatian: 4 mg/ml koncentrat za otopinu za infuziju.
English: No clinically important differences in the clearance of mogamulizumab were found between patients with mild to severe renal impairment and patients with normal renal function.
Croatian: Nije pronađena klinički značajna razlika u klirensu mogamulizumaba između bolesnika s blagim do teškim oštećenjem funkcije bubrega i u bolesnika s normalnom bubrežnom funkcijom.
English: Tell your doctor immediately if you experience any of the serious side effects listed in Section 4 after starting POTELIGEO treatment.
Croatian: Odmah se javite liječniku ako nakon početka liječenja lijekom POTELIGEO nastupi bilo koja od ozbiljnih nuspojava navedenih u Dijelu 4: Djeca i adolescenti
English: Each vial contains 20 mg of mogamulizumab in 5 mL, corresponding to 4 mg/mL.
Croatian: Jedna bočica sadrži 20 mg mogamulizumaba u 5 ml, što odgovara 4 mg/ml.
English: The majority of treatment-related dermatologic reactions were Grade 1 or 2, with Grade ≥3 drug rash occurring in 4.3% of patients.
Croatian: Većina dermatoloških reakcija vezanih uz liječenje bila je 1. ili 2. stupnja, a osip prouzročen lijekom težine ≥3. stupnja javio se u u
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: No clinically important differences in the clearance of mogamulizumab were found between patients with mild to moderate hepatic impairment and patients with normal hepatic function.
Croatian: Nisu pronađene klinički značajne razlike u klirensu mogamulizumaba između bolesnika s blagim do umjerenim oštećenjem funkcije jetre i u bolesnika s normalnom funkcijom jetre.
English: Unopened vial: Store in a refrigerator (2ºC - 8ºC).
Croatian: Neotvorena bočica: Čuvati u hladnjaku (2 ºC - 8 ºC).
English: Tumour lysis syndrome (TLS) has been observed in patients receiving mogamulizumab.
Croatian: Sindrom lize tumora Sindrom lize tumora (engl. tumour lysis syndrome, TLS) zapažen je u bolesnika koji primaju mogamulizumab.
English: The effect of hepatic impairment on the clearance of mogamulizumab was evaluated by a population PK analysis in patients with mild hepatic impairment (total bilirubin [TB] less than or equal to the upper limit of normal [ULN] and AST greater than ULN or TB less than 1 to 1.5 times ULN and any AST; n= 80) or moderate (TB greater than 1.5 to 3 times ULN and any AST; n=3) hepatic impairment.
Croatian: Djelovanje oštećenja funkcije jetre na klirens mogamulizumaba procijenjeno je u populacijskoj farmakokinetičkoj analizi u bolesnika s blagim oštećenjem funkcije bubrega (ukupni bilirubin manji ili jednak gornjoj granici normale [GGN] i AST veći od GGN-a ili ukupni bilirubin manji od 1 do 1,5struke vrijednosti GGN i bilo koja vrijednost AST-a; n= 80) ili umjerenim (ukupni bilirubin veći od 1,5 do 3-struke vrijednosti GGN i bilo koja vrijednost AST-a; n= 3) oštećenjem funkcije jetre.
English: Intravenous use after dilution
Croatian: Za intravensku primjenu nakon razrjeđivanja
English: A small percentage of patients receiving POTELIGEO tested positive for treatment emergent (treatment induced or treatment boosted) anti mogamulizumab antibodies.
Croatian: Mali postotak bolesnika koji primaju POTELIGEO imao je pozitivan test na protutijela na mogamulizumab uzrokovana liječenjem
English: It is unknown whether mogamulizumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se mogamulizumab u majčino mlijeko.
English: What you need to know before you use POTELIGEO Do not use POTELIGEO if you are:
Croatian: Što morate znati prije nego počnete primjenjivati POTELIGEO
English: PFS, months ITT Population IB/II III/IV ITT=intent to treat Paediatric population The European Medicines Agency has waived the obligation to submit the results of studies with mogamulizumab in all subsets of the paediatric population in cutaneous T-cell lymphoma (CTCL) (MF and SS are subtypes of CTCL).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja mogamulizumaba u svim podskupinama pedijatrijske populacije za kožni limfom T-stanica (engl. cutaneous T-cell lymphoma, CTCL) (MF i SS su podvrste CTCL-a).
English: The safety profile in elderly patients (≥ 65 years) was generally consistent with that of adult patients,
Croatian: Sigurnosni profil u starijih bolesnika (≥ 65 godina) bio je općenito sličan onom u odraslih bolesnika, izuzev dermatoloških reakcija i reakcija vezanih uz infuziju koje su češće viđene u starijih ispitanika.
English: - chest pain, shortness of breath, fast or slow heartbeat, sweating, dizziness, nausea or vomiting, weakness, feeling faint and feeling unwell.
Croatian: - bol u prsima, nedostatak zraka, brzi ili spori otkucaji srca, znojenje, omaglica, mučnina ili povraćanje, slabost, osjećaj gubitak svijesti i loše osjećanje.
English: All patients had a histologically confirmed diagnosis of mycosis fungoides (MF), 56.5%, 53.2%, or Sézary Syndrome (SS), 43.5%, 46.8%, in the mogamulizumab and vorinostat groups, respectively, and had received at least one prior systemic therapy.
Croatian: ili Sézaryjev sindrom (SS), 43,5% odnosno 46,8%, u skupini koja je primala mogamulizumab, odnosno vorinostat, i primili su najmanje jedno prethodno sistemsko liječenje.
English: The most common prior systemic therapies used by subjects in Europe were bexarotene (70%), interferon (59%), methotrexate (49%), extracorporeal photopheresis (ECP) (31%) and gemcitabine/gemcitabine regimens (28%).
Croatian: Najčešća prethodna sustavna liječenja koja su koristili ispitanici u Europi bila su beksaroten (70%), interferon (59%),
English: The combination of mogamulizumab with systemic immune modulating medicinal products or with other licensed therapies for MF or SS has not been studied and is, therefore, not recommended, especially in consideration of the risk of severe infections in patients treated with mogamulizumab.
Croatian: Kombinacija mogamulizumaba s lijekovima za sistemsko imunološko modeliranje ili s drugim odobrenim terapijama za MF ili SS nije ispitivana i stoga se ne preporučuje,
English: This medicine is used to treat adults with mycosis fungoides and Sézary syndrome, which are types of cancers called cutaneous T-cell lymphomas.
Croatian: Ovaj se lijek koristi za liječenje odraslih osoba sa mycosis fungoides i Sézaryjevim sindromom,
English: How to store POTELIGEO Contents of the pack and other information
Croatian: Sadržaj pakiranja i druge informacije
English: - The other excipients are citric acid monohydrate, glycine, polysorbate 80, sodium hydroxide, hydrochloric acid, and water for injections.
Croatian: - Druge pomoćne tvari su citratna kiselina hidrat, glicin, polisorbat 80, natrijev hidroksid,
English: - signs of infection, which may include a fever, sweats or chills, flu-like symptoms, sore throat or difficulty swallowing, cough, shortness of breath, stomach pain, nausea or vomiting, diarrhoea and feeling very unwell.
Croatian: - znakovi infekcije, koji mogu uključivati vrućicu, znojenje ili zimicu, simptome nalik gripi, grlobolju ili otežano gutanje, kašalj, nedostatak zraka, bol u trbuhu, mučninu ili povraćanje, proljev ili se možete osjećati vrlo loše,
English: Patients should be tested for hepatitis B infection before initiating treatment with mogamulizumab.
Croatian: Prije početka liječenja mogamulizumabom potrebno je testirati bolesnike na hepatitis B.
English: How to store POTELIGEO
Croatian: Kako čuvati POTELIGEO
English: - have heart problems.
Croatian: Vaše tjelesne težine.
English: Your doctor may stop POTELIGEO treatment if your reaction is severe.
Croatian: Vaš liječnik može prekinuti primjenu lijeka POTELIGEO ako je
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari citratna kiselina hidrat glicin polisorbat 80 natrijev hidroksid (za podešavanje pH) kloridna kiselina (za podešavanje pH) voda za injekcije
English: Each vial of 5 mL contains 20 mg of mogamulizumab.
Croatian: Jedna bočica sa 5 ml koncentrata sadrži 20 mg mogamulizumaba.
English: Symptoms may include skin rashes or blistering, nausea or diarrhoea that doesn't go away, stomach pain or vomiting, joint pain or stiffness, dry or irritated eyes or blurred vision, mouth sores, irritation or pain, a cough that does not go away or difficulty breathing, sensitive genitals, jaundice (turning yellow), dark urine, and any swelling.
Croatian: Simptomi mogu uključivati kožne osipe ili plikove, mučninu ili proljev koji ne prolazi, bol u trbuhu ili povraćanje, bol u zglobovima ili ukočenost, suhe ili nadražene oči ili zamućen vid, ranice u ustima, nadraženost ili bol u ustima,
English: Large cell transformation (LCT) There are limited data available on patients with LCT.
Croatian: Dostupni su ograničeni podaci o bolesnicima s transformacijom velikih stanica.
English: • Visually inspect the medicinal product for particulate matter and discolouration prior to administration.
Croatian: • Prije primjene potrebno je vizualno pregledati lijek kako bi se isključila prisutnost čestica i promjena boje.
English: See section 4.2 for premedication and dose modification information.
Croatian: za informacije o premedikaciji i prilagodbi doze.
English: Complications of allogeneic hematopoietic stem cell transplantation (HSCT) after mogamulizumab Complications, including severe graft versus host disease (GVHD), have been reported in patients with T-cell lymphomas other than MF or SS who received allogeneic HSCT after mogamulizumab.
Croatian: GVHD), prijavljene su u bolesnika s limfomima T-stanica drukčijima od MF-a ili SS-a koji su primili alogeni HSCT nakon mogamulizumaba.
English: Discard the vial if cloudiness, discolouration or particulates are observed.
Croatian: Bacite bočicu ako primijetite zamućenost, promjenu boje ili prisutnost čestica.
English: Clear to slightly opalescent, colourless solution.
Croatian: Bistra do blago opalescentna, bezbojna otopina.
English: Patients receiving mogamulizumab have experienced drug rash (drug eruption), some of which were severe and/or serious.
Croatian: Bolesnici koji primaju mogamulizumab dobili su osip prouzročen lijekom (izbijanje kožnih promjena uzrokovanih lijekom), a koji je u nekim slučajevima bio težak i/ili ozbiljan.
English: Mix diluted solution by gentle inversion.
Croatian: Razrijeđenu otopinu promiješajte laganim okretanjem vrećice za infuziju.
English: Median PFS for the mogamulizumab group was 7.70 months (95% CI: 5.67, 10.33) and 3.10 months (95% CI: 2.87, 4.07) for the vorinostat group with resultant hazard ration of 0.53 (95% CI: 0.41, 0.69), p<0.0001 (2sided, stratified log rank test).
Croatian: (95%-tni CI: 2,87; 4,07) za skupinu vorinostata s rezultirajućim omjerom hazarda od 0,53 (95%-tni
English: Patients receiving POTELIGEO have experienced drug rash (drug eruption), some of which were severe and/or serious.
Croatian: Bolesnici koji primaju POTELIGEO dobili su osip prouzročen lijekom (izbijanje kožnih promjena uzrokovanih lijekom), a u nekim slučajevima bio je težak i/ili ozbiljan.
English: P-valuea Skin n=186
Croatian: Koža n= 186
English: Response rate (confirmed CR + PR, %) 95% CI
Croatian: Stopa odgovora (potvrđen CR + PR, %)
English: If SJS/TEN occur, appropriate medical therapy should be administered.
Croatian: potrebno je primijeniti prikladnu terapiju lijekovima.
English: Acute infusion-related reactions (IRRs) have been observed in patients treated with mogamulizumab.
Croatian: U bolesnika liječenih mogamulizumabom zapažene su akutne reakcije vezane uz infuziju (engl. infusion-related reactions, IRR).
English: Upper respiratory tract infection
Croatian: Vrlo često infekcijea Često infekcija gornjih dišnih putova
English: - fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness and/or muscle or joint pain.
Croatian: Iako je malo vjerojatno da je prouzročeno ovim lijekom, to mogu biti znakovi srčanog poremećaja. - vrućica, zimica, mučnina, povraćanje, smetenost, nedostatak zraka, napadaji, nepravilni otkucaji srca, tamna ili zamućena mokraća, neuobičajen umor i/ili bol u mišićima ili zglobovima.
English: • POTELIGEO should be permanently discontinued for a life-threatening (Grade 4) infusion-related reaction (see section 4.4).
Croatian: • Liječenje lijekom POTELIGEO treba trajno prekinuti ako se pojavi po život opasna reakcija (4.
English: POTELIGEO is a clear to slightly opalescent, colourless solution.
Croatian: POTELIGEO je bistra do blago opalescentna, bezbojna otopina.