FrancophonIA/ELRC3.0 huggingface dataset:
English: POTELIGEO should be administered within 2 days of the scheduled day.
Croatian: POTELIGEO se treba primijeniti unutar 2 dana od predviđenog dana.
English: There were no positive neutralising antibody responses.
Croatian: Nije bilo pozitivnih na neutralizirajuća protutijela.
English: What POTELIGEO is and what it is used for
Croatian: Što je POTELIGEO i za što se koristi
English: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (at 25°C) under ambient room light.
Croatian: Dokazana kemijska i fizikalna stabilnost lijeka u primjeni je 24 sata pri sobnoj temperaturi (pri 25°C) i sobnoj rasvjeti.
English: If a dose is missed by more than 2 days, the next dose should be administered as soon as possible, after which the dosing schedule should be resumed with doses given based on the new scheduled days.
Croatian: Propusti li bolesnik dozu lijeka dulje od 2 dana, sljedeću dozu treba primijeniti što je prije moguće, nakon čega je potrebno nastaviti režim doziranja s primjenom doza na temelju novih predviđenih dana.
English: Pack of 1 vial.
Croatian: Pakiranje: 1 bočica.
English: See above recommendations in case of infusion-related reaction.
Croatian: Pogledajte gornje preporuke u slučaju reakcija povezanih s infuzijom.
English: In case of overdose, the patient, including their vital signs, should be closely monitored (for at least 1 hour) and supportive treatment should be administered if required.
Croatian: U slučaju predoziranja, potrebno je pažljivo nadzirati bolesnika, uključujući njegove vitalne znakove (najmanje 1 sat) i potrebno je pružiti potporno liječenje po potrebi.
English: If a compartment level response or overall response is not observed after 3 months of treatment, discontinuation of treatment should be considered.
Croatian: Ako se odgovor na razini odjeljka ili ukupan odgovor ne opazi nakon 3 mjeseca liječenja, potrebno je razmotriti prekid liječenja.
English: Mogamulizumab is dosed via intravenous route and therefore is immediately and completely bioavailable.
Croatian: Mogamulizumab se dozira intravenskim putem i stoga je odmah i potpuno bioraspoloživ.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than a total of 4 hours at 2°C - 8°C provided that dilution has taken place under controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika i obično ne bi trebali iznositi dulje od 4 sata na temperaturi od 2°C - 8°C, osim ako se razrjeđivanje nije provelo u kontroliranim i validiranim aseptičkim uvjetima.
English: The safety and efficacy of POTELIGEO in children and adolescents aged below 18 years has not been established.
Croatian: Sigurnost i djelotvornost lijeka POTELIGEO u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: • Administer infusion solution over at least 60 minutes through an intravenous line containing a sterile, low protein binding 0.22 micron (or equivalent) in-line filter.
Croatian: • Primijenite infuzijsku otopinu tijekom najmanje 60 minuta kroz intravensku liniju koja sadrži ugrađen sterilan linijski filter od 0,22 mikrometra (ili ekvivalentno) s niskim vezanjem proteina.
English: A higher risk of transplant complications has been reported if mogamulizumab is given within a short time frame (approximately 50 days) before HSCT.
Croatian: Viši rizik komplikacija presađivanja prijavljen je ako se mogamulizumab daje unutar kratkog vremenskog okvira (približno 50 dana) prije HSCT-a.
English: The safety profile observed in the 90 days following the last dose of mogamulizumab is consistent with the safety profile observed during the study treatment period.
Croatian: Sigurnosni profil opažen tijekom 90 dana nakon zadnje doze mogamulizumaba odgovara sigurnosnom profilu opaženom tijekom razdoblja ispitivanja liječenja.
English: Afterwards POTELIGEO could be used during breast-feeding if clinically needed.
Croatian: Nakon toga se POTELIGEO može koristiti tijekom dojenja ako je klinički potrebno.
English: Time to compartment level response in Stage IB/II patients was approximately 3 months, which is consistent with time to response for the ITT population overall (approximately 3 months).
Croatian: Vrijeme do odgovora na razini odjeljka u bolesnika u stadiju IB/II bilo je približno 3 mjeseca, što je u skladu s vremenom do odgovora za ukupnu ITT populaciju (približno 3 mjeseca).
English: The infusion rate should be reduced by at least 50% when re-starting the infusion after symptoms resolve.
Croatian: Brzinu infuzije treba smanjiti za najmanje 50% kada se ponovno započinje infuzija nakon povlačenja simptoma.
English: - allergic to mogamulizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na mogamulizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Discard any unused portion left in the vial in accordance with local requirements.
Croatian: Bacite sav neiskorišten dio koji je preostao u bočici u skladu s nacionalnim propisima.
English: Severe reactions (Grade 3) were experienced by 4% of patients.
Croatian: Teške reakcije (3. stupnja) javile su se u 4% bolesnika.
English: Overall response was reported as a composite score from measures in each compartment, and a response had to be demonstrated at two successive overall disease assessments (at least 8 weeks apart during the first year and 16 weeks apart thereafter) in order to be confirmed.
Croatian: Ukupan odgovor prijavljen je kao kompozitni rezultat na temelju mjerenja u svakom odjeljku, a odgovor je trebao biti pokazan u dvije uzastopne ukupne procjene bolesti (u razmaku od najmanje 8 tjedana tijekom prve godine i 16 tjedana nakon toga) kako bi bio potvrđen.
English: Less than 1% of patients treated in Study 0761-010 discontinued treatment due to infusion-related reactions.
Croatian: Manje od 1% bolesnika liječenih u Ispitivanju 0761-010 prekinulo je liječenje zbog reakcija vezanih uz infuziju.
English: The destruction of cancer cells and the body's reaction to it can very occasionally lead to a problem called tumour lysis syndrome.
Croatian: Razaranje tumorskih stanica i tjelesna reakcija time uzrokovana mogu vrlo povremeno dovesti do problema koji se naziva sindrom lize tumora.
English: Patients should be monitored closely by appropriate laboratory and clinical tests for electrolyte status, hydration and renal function, particularly in the first month of treatment, and managed according to best medical practice.
Croatian: Bolesnike je potrebno pažljivo pratiti odgovarajućim laboratorijskim i kliničkim pretragama kako bi se ustanovio status elektrolita, hidracija i bubrežna funkcija, naročito tijekom prvog mjeseca liječenja, s kontrolom prema najboljoj medicinskoj praksi.
English: Table 3: Overall and Compartmental Response Rate in Early Disease Stages
Croatian: Tablica 3: Ukupna stopa odgovora i stopa odgovora po odjeljku u ranim stadijima bolesti
English: • The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags.
Croatian: • Razrijeđena otopina kompatibilna je s vrećicama za infuziju od polivinilklorida (PVC) ili poliolefina (PO).
English: Table 2: Response during randomised treatment period in study 0761-010 (intent-to-treat)
Croatian: Tablica 2: Odgovor tijekom razdoblja randomiziranog liječenja u ispitivanju 0761-010 (ITT)
English: No specific studies have been conducted to evaluate potential effects on fertility.
Croatian: Nisu provedena posebna ispitivanja u svrhu procjene potencijalnog učinka na plodnost.
English: Once opened, the medicinal product should be diluted and infused immediately (see section 6.6).
Croatian: Nakon otvaranja, lijek je potrebno razrijediti i odmah primijeniti infuzijom (vidjeti dio 6.6).
English: 56% of patients received mogamulizumab for at least 6 cycles, and 25% of patients received mogamulizumab for at least 12 cycles.
Croatian: 56% bolesnika primilo je mogamulizumab tijekom najmanje 6 ciklusa, a 25% bolesnika primilo je mogamulizumab tijekom najmanje 12 ciklusa.
English: Duration of response (months) Median (95% CI) Response by compartment Blood n=124
Croatian: Trajanje odgovora (u mjesecima) Medijan (95%-tni CI) Odgovor po odjeljku Krv n= 124
English: The final concentration of the diluted solution should be between 0.1 mg/mL to 3.0 mg/mL.
Croatian: Konačna koncentracija razrijeđene otopine mora biti između 0,1 mg/ml i 3,0 mg/ml.
English: Patients should be closely monitored for symptoms or signs that suggest SJS or TEN.
Croatian: Bolesnike treba pažljivo nadzirati kako bi se uočili simptomi ili znakovi koji ukazuju na SJS ili TEN.
English: Infusion interruptions occurred in approximately 6% of patients, most of which (approximately 90%) occurred within the first cycle of treatment with mogamulizumab.
Croatian: Infuzije su prekinute u približno 6% bolesnika, većina (približno 90%) dogodila se tijekom prvog ciklusa liječenja mogamulizumabom.
English: The Kaplan-Meier curve for PFS is shown Figure 1.
Croatian: Kaplan-Meierovu krivulju PFS-a prikazuje Slika 1.
English: Severe adverse reactions included Grade 4 respiratory failure (1.1%) and Grade 5 reactions were polymyositis and sepsis (0.5% each).
Croatian: Teške nuspojave uključivale su zatajivanje disanja 4. stupnja (1,1%), a reakcije 5. stupnja bile su polimiozitis i sepsa (0,5% svaki).
English: Vorinostat was administered at a starting dose of 400 mg orally, once daily beginning on day 1 for 28day cycles.
Croatian: Vorinostat je primijenjen početnom dozom od 400 mg peroralno, jedanput dnevno počevši na dan 1. tijekom ciklusa od 28 dana.
English: • Calculate the required volume of POTELIGEO needed to prepare the infusion solution for the 1 mg/kg dosage based on patient weight (see section 4.2).
Croatian: • Izračunajte volumen lijeka POTELIGEO potreban za pripremu infuzijske otopine za doziranje 1 mg/kg na temelju težine bolesnika (vidjeti dio 4.2).
English: Patients should be monitored for signs and symptoms of infection and treated promptly.
Croatian: Bolesnike treba nadzirati kako bi se uočili znakovi i simptomi infekcije i odmah liječili.
English: Serious infections, including sepsis, pneumonia and skin infections, were experienced by 14.3% of subjects receiving mogamulizumab.
Croatian: Ozbiljne infekcije, uključujući sepsu, upalu pluća i kožne infekcije, javile su se u 14,3% ispitanika koji su primali mogamulizumab.
English: As a precautionary measure, it is preferable to avoid the use of mogamulizumab during pregnancy.
Croatian: Kao mjeru opreza, preporučuje se izbjegavati primjenu mogamulizumaba u trudnoći.
English: For patients who test positive for current/previous hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended for advice concerning appropriate measures against hepatitis B reactivation.
Croatian: U bolesnika kod kojih je test na trenutnu/prethodnu infekciju virusom hepatitisa B pozitivan preporučuje se savjetovanje s liječnikom specijaliziranim za liječenje hepatitisa B vezano uz prikladne mjere protiv reaktivacije hepatitisa B.
English: If reaction recurs, discontinuing the infusion should be considered (see section 4.4).
Croatian: Ako se reakcija ponovno pojavi, potrebno je razmisliti o prekidu primjene infuzija (vidjeti dio 4.4).
English: Reasons for crossover to mogamulizumab were disease progression (109 patients) and treatment intolerance (27 patients).
Croatian: Razlog za prijelaz na mogamulizumab bio je progresija bolesti (109 bolesnika) i nepodnošenje liječenja (27 bolesnika).
English: The most frequently reported serious adverse reactions were pneumonia, pyrexia, infusion related reaction and cellulitis.
Croatian: Najčešće prijavljivane ozbiljne nuspojave bile su upala pluća, pireksija, reakcije povezane uz infuziju i celulitis.
English: Treatment should be continued unless you get serious side effects or the cutaneous T-cell lymphoma starts to get worse.
Croatian: Liječenje treba nastaviti osim ako se ne pojave ozbiljne nuspojave ili se kožni limfom T-stanica počne pogoršavati.
English: CI=confidence interval; CR=complete response; PR=partial response
Croatian: CI (confidence interval) =interval pouzdanosti; CR (complete response) =potpun odgovor; PR (partial response) =djelomičan odgovor; ITT (intent to treat) = populacija predviđena za liječenje
English: Infusion-related reactions have been observed in 33% of patients treated with POTELIGEO.
Croatian: Reakcije vezane uz infuziju zapažene su u 33% bolesnika liječenih lijekom POTELIGEO.
English: Tell the person giving you the infusion or get medical help straight away if you experience a reaction during or after any POTELIGEO infusion.
Croatian: Obavijestite osobu koja vam daje infuziju ili odmah zatražite medicinsku pomoć ako se pojavi reakcija tijekom ili nakon bilo koje infuzije lijeka POTELIGEO.
English: Contents of the pack and other information What POTELIGEO contains
Croatian: Sadržaj pakiranja i druge informacije Što POTELIGEO sadrži
English: There are limited efficacy data in patients with low (<10%) CCR4 expression in the skin.
Croatian: Postoje ograničeni podaci o djelotvornosti u bolesnika s niskom (<10%) CCR4 ekspresijom u koži.
English: The safety of treatment with mogamulizumab after autologous or allogeneic HSCT has not been studied.
Croatian: Sigurnost liječenja mogamulizumabom nakon autolognog ili alogenog HSCT-a nije ispitana.
English: The latency to event onset following the first dose varied considerably.
Croatian: Latencija do nastupa nuspojave nakon prve doze znatno je varirala.
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, monoclonal antibodies ATC code: L01XC25
Croatian: Farmakoterapijska skupina: Antineoplastični i imunomodulirajući lijekovi, monoklonska protutijela ATK oznaka: L01XC25
English: See section 2 “POTELIGEO contains sodium”.
Croatian: Pogledajte dio 2. “POTELIGEO sadrži natrij”.
English: The medicine is for use in patients who have received at least one medicine given by mouth or by injection.
Croatian: Lijek se koristi u bolesnika koji su primili najmanje jedan lijek peroralno ili injekcijom.
English: The median duration of exposure with mogamulizumab was 5.6 months (range: <1 to 45.3 months).
Croatian: Medijan trajanja izlaganja mogamulizumabu bio je 5,6 mjeseci (raspon: <1 do 45,3 mjeseca).
English: Management of TLS may include aggressive hydration, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care.
Croatian: Zbrinjavanje TLS-a može uključivati agresivnu hidraciju, korekciju abnormalnosti elektrolita, terapiju protiv hiperuricemije i potporno liječenje.
English: Patients were a median age of 64 years at the time of screening (range 25 to 101 years), 49.5% were 65 years or older, and 58.1% were male.
Croatian: Medijan dobi bolesnika bio je 64 godine u vrijeme probira (raspon 25 do 101 godine), 49,5% imalo je 65 godina ili više, a 58,1% bili su muškaraci.
English: Due to the mechanism of action of the medicine, it may harm your baby if it is administered when you are pregnant or breast- feeding.
Croatian: Zbog svog mehanizma djelovanja, lijek može naštetiti bebi ako se primijeni tijekom trudnoće ili dojenja.
English: Patients were included in the analysis for a specific compartment if they had presence of disease in that compartment at baseline, or had any post-baseline response assessment for that compartment.
Croatian: Bolesnici su uključeni u analizu za specifičan odjeljak ako je bolest bila prisutna u tom odjeljku na početku, ili ako su imali neku procjenu odgovora nakon početnih vrijednosti za taj odjeljak.
English: Treatment with mogamulizumab continued until disease progression or unacceptable toxicity.
Croatian: Liječenje mogamulizumabom nastavilo se do progresije bolesti ili do pojave neprihvatljive toksičnosti.
English: Uncommon Hepatitis acute, hepatitis
Croatian: Manje često akutni hepatitis, hepatitis
English: • Each vial is for single use only.
Croatian: • Jedna bočica je samo za jednokratnu uporabu.
English: The population PK analysis included 444 patients receiving mogamulizumab in six clinical trials.
Croatian: Populacijska farmakokinetička analiza uključivala je 444 bolesnika koji su primali mogamulizumab u šest kliničkih ispitivanja.
English: The study demonstrated statistically significant improvements in ORR and response by compartment in the blood, skin, and lymph nodes as compared to vorinostat.
Croatian: Ispitivanje je dokazalo statistički značajna poboljšanja u ORR-u i odgovoru po odjeljku u krvi, koži i limfnim čvorovima u usporedbi s vorinostatom.
English: Mogamulizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Croatian: Očekuje se da će se mogamulizumab razgraditi u male peptide i aminokiseline kataboličkim putevima na isti način kao i endogeni IgG.
English: Efficacy, as measured by improvement in PFS based on investigator assessment, was not associated with increasing mogamulizumab exposure.
Croatian: Djelotvornost, izmjerena poboljšanjem PFS-a temeljenom na procjeni ispitivača, nije bila povezana s povećanim izlaganjem mogamulizumabu.
English: Based on a population PK analysis, the steady-state concentrations of mogamulizumab were reached after 12 weeks of repeated dosing when administered using the recommended regimen, and systemic accumulation was 1.7-fold.
Croatian: Na temelju populacijske farmakokinetičke analize, koncentracije mogamulizumaba u stanju dinamičke ravnoteže dostignute su nakon 12 tjedana ponovljenih doziranja kada se primjenjuje prema preporučenom režimu, a sistemska akumulacija bila je 1,7 puta veća.
English: Table 4: Progression Free Survival (PFS) by Treatment Group and Disease Stage (Randomised Treatment Period)
Croatian: Tablica 4: Preživljenje bez progresije bolesti po skupini liječenja i stadiju bolesti (randomizirano razdoblje liječenja)
English: Very common Fatigue, oedema peripheral, pyrexia
Croatian: Vrlo često umor, periferni edem, pireksija
English: Nodal (n) Response Rate (n, %) 95% CIa M=mogamulizumab.
Croatian: Nodalni (n) Stopa odgovora (n, %) 95%-tni CIa M=mogamulizumab.
English: Kyowa Kirin Co., Ltd.
Croatian: Kyowa Kirin Co.
English: Store in a refrigerator (2ºC to 8ºC).
Croatian: Čuvati u hladnjaku (2ºC do 8ºC).
English: Mogamulizumab targets cancer cells which are then destroyed by the immune system (the body's defence).
Croatian: Mogamulizumab cilja tumorske stanice koje zatim uništava imunološki sustav (tjelesna obrana).
English: Treatment must be initiated and supervised by physicians experienced in the treatment of cancer, and should only be administered by healthcare professionals in an environment where resuscitation equipment is available.
Croatian: 4.2 Doziranje i način primjene Liječenje trebaju započeti i nadzirati liječnici s iskustvom u liječenju raka, a trebaju ga primijeniti samo zdravstveni radnici u uvjetima gdje je dostupna oprema za reanimaciju.
English: CCR4 was detected on ≥1% of lymphocytes in 100% of patients, and 96% (134/140) had CCR4 detected on ≥10% of skin lymphocytes.
Croatian: CCR4 je otkriven u ≥1% limfocita kod 100% bolesnika, a u 96% (134/140) bolesnika CCR4 je otkriven u ≥10% kožnih limfocita.
English: It should be administered by intravenous infusion only, over at least 60 minutes.
Croatian: Smije se primijeniti samo intravenskom infuzijom, tijekom najmanje 60 minuta.
English: Aseptically withdraw the required volume of POTELIGEO into the syringe and transfer into an infusion bag containing 9mg per ml (0.9%) sodium chloride solution for injection.
Croatian: Aseptičkom metodom izvucite potreban volumen lijeka POTELIGEO u štrcaljku i prebacite u vrećicu za infuziju koja sadrži 0,9%-tnu (9mg/ml) otopinu natrijeva klorida za injekciju.
English: Mogamulizumab should not be infused concomitantly in the same intravenous line with other medicinal products.
Croatian: Mogamulizumab se ne smije primijeniti infuzijom istovremeno u istu vensku liniju s drugim lijekovima.
English: If an anaphylactic reaction occurs, administration of mogamulizumab should be immediately and permanently discontinued and appropriate medical therapy should be administered.
Croatian: Ako se pojavi anafilaktička reakcija, primjenu mogamulizumaba treba odmah i trajno prekinuti te primijeniti prikladnu terapiju.
English: If they occur, POTELIGEO should be interrupted and treatment should not restart unless SJS or TEN is ruled out and cutaneous reaction has resolved to Grade 1 or less.
Croatian: Ako se pojave, potrebno je prekinuti primjenu lijeka POTELIGEO i liječenje se ne smije ponovno započeti dok se SJS ili TEN ne isključe, a kožne reakcije ne povuku do 1. stupnja ili manje.
English: The exposure to mogamulizumab increased proportionally with dose over the dose range of 0.1 to 1.0 mg/kg.
Croatian: Izloženost mogamulizumabu povećavala se proporcionalno s dozom za raspon doze od 0,1 do 1,0 mg/kg.
English: - if you go on to have a stem cell transplant, it is possible that you could then develop complications (graft versus host disease) that are difficult to manage.
Croatian: - ako ćete imati presađene krvotvorne matične stanice, možete tada razviti komplikacije (reakcije presatka protiv domaćina) koje se teško liječe.
English: Patients with rapidly proliferating tumour and high tumour burden are at risk of TLS.
Croatian: Kod bolesnika s brzo proliferirajućim tumorom i visokim tumorskim opterećenjem postoji rizik od TLS-a.
English: The most frequently reported adverse reactions were infusion-related reaction and rash (drug eruption); most of these reactions were non-serious and Grades 1 or 2.
Croatian: Najčešće prijavljivane nuspojave bile su reakcije vezane uz infuziju i osip (izbijanje kožnih promjena uzrokovano lijekom); većina tih reakcija nije bila ozbiljna i bile su 1. ili 2. stupnja.
English: Of the 320 subjects exposed to mogamulizumab in Study 0761-010, 21 (6.6%), experienced at least one serious adverse drug reaction (SADR) that occurred within 90 days from the date of last study drug administration.
Croatian: Od 320 ispitanika izloženih mogamulizumabu u Ispitivanju 0761-010, 21 (6,6%), iskusilo je najmanje jednu ozbiljnu nuspojavu koja se javila unutar 90 dana od datuma zadnje primjene ispitivanog lijeka.
English: The majority of IRRs occur during or shortly after the first infusion (all within 24 hours of administration), with the incidence decreasing over subsequent treatments.
Croatian: Većina IRR-a pojavila se tijekom ili kratko nakon prve infuzije (sve unutar 24 sata od primjene), a incidencija je opadala tijekom sljedećih primjena.
English: This study included patients regardless of their baseline level of CCR4 expression in skin biopsy.
Croatian: Ispitivanje je uključivalo bolesnike bez obzira na njihovu početnu razinu CCR4 ekspresije u biopsiji kože.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake “EXP”.
English: Of the patients randomised to vorinostat, 136 patients (73.1%) crossed over to mogamulizumab during the study.
Croatian: Od bolesnika randomiziranih u skupinu vorinostata, 136 bolesnika (73,1%) prešlo je u skupinu mogamulizumaba tijekom ispitivanja.
English: The majority of treatment-related infusion-related reactions were Grade 1 or 2 and occurred during or shortly after the first infusion.
Croatian: Većina reakcija vezanih uz infuziju povezanih s liječenjem bile su 1. ili 2. stupnja i javile su se tijekom ili kratko nakon prve infuzije.
English: Although mogamulizumab crosses the placental barrier in cynomolgous monkey, apart from the pharmacological effect in foetuses, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Iako mogamulizumab prolazi placentarnu barijeru u makaki majmuna, osim farmakološkog učinka kod fetusa, ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na reprodukciju (vidjeti dio 5.3).