FrancophonIA/ELRC3.0 huggingface dataset:
English: POTELIGEO is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
Croatian: POTELIGEO je indiciran u liječenju odraslih bolesnika s mycosis fungoides (MF) ili Sézaryjevim sindromom (SS) koji su primili najmanje jednu prethodnu sistemsku terapiju.
English: Very common Headache
Croatian: Vrlo često glavobolja
English: In the clinical trial (0761-010), there were 2 reports of respiratory failure with fatal outcome in patients with severe pneumonia occurring more than 9 months after starting treatment with mogamulizumab.
Croatian: kliničkom ispitivanju (0761-010) bilo je 2 izvještaja o zatajivanju disanja sa smrtnim ishodom u bolesnika s teškom upalom pluća koja se javila više od 9 mjeseci nakon početka liječenja mogamulizumabom.
English: In the mogamulizumab arm, baseline CCR4 expression levels were available in 75% of patients (N=140).
Croatian: U skupini liječenoj mogamulizumabom, početne razine ekspresije CCR4 bile su dostupne u 75% bolesnika (N=140).
English: At 6, 12, 18 and 24 months after the start of randomised treatment, the percent of subjects alive without disease progression was higher for mogamulizumab (55.3%, 38.3%, 28.0%, and 14.1%, respectively) compared to vorinostat (28.8%, 15.3%, 7.2%, and 7.2%, respectively).
Croatian: Nakon 6, 12, 18 i 24 mjeseca od početka randomiziranog liječenja, postotak ispitanika koji su bili živi bez progresije bolesti bio je viši za mogamulizumab (55,3%, 38,3%, 28,0%, odnosno 14,1%) u usporedbi s vorinostatom (28,8%, 15,3%, odnosno 7,2%).
English: Topical steroids or low doses of systemic corticosteroids may be used during treatment with mogamulizumab; however, the risk of serious infection and/or viral reactivation may be higher in case of concomitant administration with systemic immunosuppressive agents.
Croatian: Topikalni steroidi ili niske doze sistemskih kortikosteroida mogu se koristiti tijekom liječenja mogamulizumabom; međutim rizik od ozbiljnih infekcija i/ili reaktivacije virusa može biti viši u slučaju istodobne primjene sistemskih imunosupresivnih lijekova.
English: The recommended dose is 1mg POTELIGEO for each kg of body weight.
Croatian: Preporučena doza je 1 mg lijeka POTELIGEO za svaki kg tjelesne težine.
English: These time limits include storage of the infusion solution in the infusion bag through the duration of infusion.
Croatian: To vremenski razdoblje uključuje čuvanje infuzijske otopine u vrećici za infuziju tijekom same primjene infuzije.
English: Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, lymphocyte count decreased
Croatian: Porast alanin aminotransferaze, porast aspartat aminotransferaze, povišenje alkalne fosfataze u krvi, smanjen broj limfocita
English: Based on a population PK analysis, the geometric mean [% coefficient of variation (CV%)] central volume of distribution (Vc) was 3.57 L (20.1%).
Croatian: Na temelju populacijske farmakokinetičke analize, geometrijska srednja vrijednost [% koeficijent varijacije (CV%)] središnjeg volumena distribucije (Vc) bila je 3,57 litara (20,1%).
English: Figure 1: Plot of Kaplan-Meier curve of progression-free survival by investigator's assessment (ITT) population
Croatian: Slika 1: Dijagram Kaplan-Meierove krivulje preživljenja bez progresije bolesti prema procjeni ispitivača (ITT)
English: - Lack of energy (fatigue) - Constipation - Swollen legs or ankles - Headache
Croatian: - nedostatak energije (umor) - zatvor - oticanje nogu ili gležnjeva - glavobolja
English: Treatment with mogamulizumab resulted in 8 confirmed complete responses (complete clearing of all affected compartments) compared with 0 patients on vorinostat: 4 of these 8 patients were initially randomized to mogamulizumab and 4 had crossed over to mogamulizumab during the study.
Croatian: Liječenje mogamulizumabom rezultiralo je sa 8 potvrđenih potpunih odgovora (kompletno čisti svi zahvaćeni odjeljci) u usporedbi sa 0 bolesnika na vorinostatu: 4 od tih 8 bolesnika bilo je početno randomizirano u skupini mogamulizumaba i 4 je prešlo u skupinu mogamulizumaba tijekom ispitivanja.
English: 5 mL solution in a 10 mL glass vial (type I glass) with a rubber stopper, an aluminium seal and a polypropylene flip-off cap.
Croatian: 5 ml otopine u staklenoj bočici od 10 ml (staklo tip I) s gumenim čepom, aluminijskim prstenom i polipropilenskim „flip-off“ zatvaračem.
English: • Do not mix POTELIGEO with, or administer as an infusion with, other medicinal products.
Croatian: • POTELIGEO nemojte miješati s drugim lijekovima, niti primjenjivati kao infuziju s drugim lijekovima.
English: Response in the viscera could not be evaluated due to limited efficacy data in subjects with visceral involvement; the benefit-risk of mogamulizumab in subjects with visceral involvement is currently undetermined due to lack of data.
Croatian: Odgovor u unutarnjim organima nije se mogao se procijeniti zbog ograničenih podataka djelotvornosti u ispitanika kod kojih su zahvaćeni unutrašnji organi; omjer koristi i rizika mogamulizumaba u ispitanika sa zahvaćenim unutarnjim organima trenutno nisu utvrđeni zbog nedostatka podataka.
English: Fortyone of the 136 cross-over patients (30.1%) responded with either partial or complete response with mogamulizumab.
Croatian: Četrdeset i jedan od 136 bolesnika koji su zamijenili terapiju (30,1%) odgovorilo je djelomičnim ili potpunim odgovorom na mogamulizumab.
English: Subjects with MF or SS treated with mogamulizumab are at increased risk of serious infection and/or viral reactivation.
Croatian: Ispitanici sa MF-om ili SS-om liječeni mogamulizumabom imaju povećani rizik od ozbiljnih infekcija i/ili virusne reaktivacije.
English: POTELIGEO contains the active substance mogamulizumab, which belongs to a group of medicines called monoclonal antibodies.
Croatian: POTELIGEO sadrži djelatnu tvar mogamulizumab, koja pripada skupini lijekova po imenu monoklonska protutijela.
English: POTELIGEO is for intravenous use.
Croatian: POTELIGEO je namijenjen za intravensku primjenu.
English: Mogamulizumab is a defucosylated, humanised IgG1 kappa immunoglobulin that selectively binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs including the skin, resulting in depletion of the target cells.
Croatian: Mogamulizumab je defukoziliran, humaniziran IgG1 κ (kapa) imunoglobulin koji se selektivno veže za CCR4, receptor za CC kemokine spregnut s G proteinom, koji je uključen u procese migracije limfocita do raznih organa uključujući kožu, što rezultira smanjenjem ciljnih stanica.
English: Patients with MF or SS are at increased risk of serious infection due to the disruption of dermal integrity caused by cutaneous disease, as well as the immunosuppressive effects of extracutaneous disease, and treatment with mogamulizumab may increase that risk.
Croatian: Ozbiljne infekcije Bolesnici sa MF-om ili SS-om imaju povećan rizik od ozbiljne infekcije zbog narušavanja dermalnog integriteta prouzročenog kožnom bolesti, kao i imunosupresivnih učinaka izvankožne bolesti, a liječenje mogamulizumabom može povećati taj rizik.
English: CCR4 expression was assessed retrospectively on pretreatment skin biopsies (formalin fixed paraffin embedded) using immunohistochemistry.
Croatian: Ekspresija CCR4 bila je retrospektivno procijenjena na biopsijama kože prije liječenja (fiksiranima u formalinu i uklopljenima u parafinu) koristeći imunohistokemiju.
English: Vorinostat patients with disease progression or unacceptable toxicities were permitted to cross over to mogamulizumab therapy.
Croatian: Bolesnicima na vorinostatu s progresijom bolesti ili neprihvatljivim toksičnostima bio je dopušten prelazak na liječenje mogamulizumabom.
English: Risk Diff (M vs. V)
Croatian: Razlika u riziku (M naspram V)
English: In an animal reproductive and developmental toxicity study, administration of mogamulizumab to pregnant cynomolgus monkeys from the start of organogenesis through delivery did not show a potential for embryo-foetal lethality, teratogenicity, or foetal growth retardation.
Croatian: U ispitivanju reproduktivne i razvojne toksičnosti u životinja, primjena mogamulizumaba u trudnih makaki majmuna od početka organogeneze do poroda nije pokazala potencijal za letalitet embrija i fetusa, teratogenost, ili zastoj u rastu fetusa.
English: In general, IgG molecules are known to cross the placental barrier and mogamulizumab concentrations in foetus plasma were detected.
Croatian: Općenito, poznato je da molekule IgG prolaze placentarnu barijeru i utvrđene su koncentracije mogamulizumaba u plazmi fetusa.
English: Table 2 summarises ORR and DOR, and response by compartment.
Croatian: Tablica 2 sažima ORR i DOR te odgovor po odjeljcima.
English: The pack contains a glass vial containing 5 mL concentrate for solution for infusion.
Croatian: Pakiranje sadrži staklenu bočicu s 5 ml koncentrata za otopinu za infuziju.
English: Table 1: Adverse drug reactions occurring in patients receiving POTELIGEO (N=184) System organ class (SOC)
Croatian: Tablica 1: Nuspojave u bolesnika koji primaju POTELIGEO (N=184) Klasifikacija organskih sustava
English: Concentrate for solution for infusion 20 mg/5 mL
Croatian: Koncentrat za otopinu za infuziju 20 mg/5 ml
English: If you are breast-feeding, you should discuss with your doctor whether you can breast-feed during or after treatment with POTELIGEO.
Croatian: Ako dojite, morate razgovarati s liječnikom o tome smijete li dojiti tijekom ili nakon liječenja lijekom POTELIGEO.
English: POTELIGEO does not contain a preservative.
Croatian: POTELIGEO ne sadrži konzervans.
English: Talk to your doctor if you get any other side effects.
Croatian: Razgovarajte s liječnikom ako primijetite bilo koju nuspojavu.
English: The number of infusions of mogamulizumab administered to crossover patients ranged from 1 to 94 (up to 46 months of treatment) as of the December 2016 datacut.
Croatian: Broj infuzija mogamulizumaba primijenjenih u bolesnika koji su prešli u drugu skupinu varirao je od 1 do 94 (do 46 mjeseci liječenja) počevši od prosinca 2016.
English: • POTELIGEO is intended for intravenous use only, and should not be administered subcutaneously, intramuscularly, as a bolus dose or by rapid intravenous administration.
Croatian: • POTELIGEO je namijenjen samo za intravensku primjenu i ne smije se primjenjivati potkožno, intramuskularno, kao bolusna doza ili brzom intravenskom primjenom.
English: In Study 0761-010 there were 10/290 evaluable patients with CCR4 expression <10%, of which 6 were randomised to mogamulizumab, and 4 were randomised to vorinostat and subsequently crossed over to mogamulizumab.
Croatian: U ispitivanju 0761-010 bilo je 10/290 bolesnika sa CCR4 ekspresijom <10% koje se moglo procijeniti, a od kojih je 6 bilo randomizirano u skupinu mogamulizumaba i 4 u skupinu vorinostata te nakon toga prešlo u skupinu mogamulizumaba.
English: No trend in latency to event onset was identified for drug eruptions and rashes; both early and late-onset events occurred.
Croatian: Nije uočen trend u latenciji do nastupa događaja za kožne promjene uzrokovane lijekom i osip; došlo je i do ranog i do kasnog nastupa nuspojava.
English: In clinical trial patients with other T-cell lymphomas there have been reports of stress cardiomyopathy (one case) and acute myocardial infarction (one case).
Croatian: U bolesnika iz kliničkog ispitivanja koji su imali drukčiji limfom T-stanica prijavljene su stres kardiomiopatija (jedan slučaj) i akutni infarkt miokarda (jedan slučaj).
English: The trial excluded patients with active autoimmune diseases, central nervous system metastasis, and medical conditions that required systemic corticosteroids or other immunosuppressive medicinal products, or an active infection requiring therapy, including HIV, or hepatitis B or C. Patients with ECOG performance status ≥2 were also excluded.
Croatian: Iz ispitivanja su isključeni bolesnici s aktivnim autoimunim bolestima, metastazama središnjeg živčanog sustava te zdravstvenim stanjima koja su zahtijevala sistemske kortikosteroide ili druge imunosupresivne lijekove, ili s aktivnim infekcijama koje su zahtijevale liječenje, uključujući HIV, ili hepatitis B ili C.
English: Of these, SADRs that were reported in more than one patient were coded under the SOCs Infections and infestations (7 [2.2%] patients), General disorders and administration site conditions (5 [1.6%] patients), Respiratory, thoracic and mediastinal disorders (4 [1.3%] patients), Musculoskeletal and connective tissue disorders (3 [0.9%] patients), Hepatobiliary disorders (2 [0.6%] patients), and Injury, poisoning and procedural complications (2 [0.6%] patients).
Croatian: Od tih, ozbiljne nuspojave koje su prijavljene u više od jednog bolesnika svrstane su u klasifikaciji organskih sustava pod Infekcije i infestacije (7 [2,2%] bolesnika), Opći poremećaji i reakcije na mjestu primjene (5 [1,6%] bolesnika), Poremećaji dišnog sustava, prsišta i sredoprsja (4 [1,3%] bolesnika), Poremećaji mišićno-koštanog sustava i vezivnog tkiva (3 [0,9%] bolesnika), Poremećaji jetre i žući (2 [0,6%] bolesnika), i Ozljede, trovanja i proceduralne komplikacije (2 [0,6%] bolesnika).
English: The efficacy of mogamulizumab in the treatment of patients with mycosis fungoides (MF) or Sézary syndrome (SS) was established in a Phase 3, multicentre, open-label, study (0761-010) of 372 adult patients randomised 1:1 to treatment with either mogamulizumab or vorinostat.
Croatian: Djelotvornost mogamulizumaba u liječenju bolesnika s mycosis fungoides (MF) ili Sézaryjevim sindromom (SS) utvrđena je u fazi III multicentričnog, otvorenog ispitivanja (0761-010) u 372 odrasla bolesnika koji su randomizirani 1:1 za liječenje mogamulizumabom ili vorinostatom.
English: The effects of POTELIGEO in pregnancy and breast-feeding are not known.
Croatian: Učinci lijeka POTELIGEO na trudnoću i dojenje nisu poznati.
English: Tabulated list of adverse reactions The adverse reactions are presented by system organ class and frequency categories, defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to
Croatian: Nuspojave su prikazane u skladu s klasifikacijom organskih sustava i prema kategorijama učestalosti definiranima na sljedeći način: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i
English: Warnings and precautions Talk to your doctor or nurse before using POTELIGEO if you:
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primijenite POTELIGEO:
English: Key secondary endpoints were overall response rate (ORR), ORR after crossover, duration of response (DOR), and changes from baseline of the Skindex-29 Symptoms and Functional Scales, and Functional Assessment of Cancer Therapy-General (FACT-G) Physical and Functional Well-being domains.
Croatian: Ključne sekundarne mjere ishoda bili su stopa ukupnog odgovora (engl. overall response rate, ORR), ORR nakon zamjene terapije, trajanje odgovora (engl. duration of response, DOR) i promjene u odnosu na početne vrijednosti na Skindex-29 ljestvicama simptoma i funkcionalnog stanja, i domenama fizičkog i psihičkog blagostanja prema upitniku FACT-G (Functional Assessment of Cancer Therapy-General).
English: Follow patients closely for early evidence of transplant-related complications.
Croatian: Pomno pratite bolesnike za rane znakove komplikacija vezanih uz presađivanje.
English: Carcinogenicity or genotoxicity studies have not been conducted with mogamulizumab.
Croatian: Nisu provedena ispitivanja kancerogenosti ili genotoksičnosti s mogamulizumabom.
English: Store it in the original carton in order to protect from light Reconstituted/diluted solution: Use immediately or store in a refrigerator (2ºC - 8ºC) and use within 4 hours.
Croatian: Rekonstituirana/razrijeđena otopina: Odmah iskoristite ili čuvajte u hladnjaku (2 ºC - 8ºC) i primijenite u roku od 4 sata.
English: Response Rate (n, %) 95% CIa
Croatian: Stopa odgovora (n, %) 95%-tni CIa
English: The metabolic pathway of mogamulizumab has not been characterised.
Croatian: Metabolički put mogamulizumaba nije još utvrđen.
English: - skin pain, itching, skin blisters, skin rash or sore mouth, which are possible signs that you may be developing a severe skin reaction, such as Stevens-Johnson syndrome or toxic epidermal necrolysis.
Croatian: - bol na koži, svrbež, mjehurići na koži, kožni osip ili ranice u ustima, što mogu biti znakovi da vam se javlja teška kožna reakcija, kao što su Stevens-Johnsonov sindrom ili toksična epidermalna nekroliza,
English: What POTELIGEO looks like and contents of the pack
Croatian: Kako POTELIGEO izgleda i sadržaj pakiranja
English: The recommended dose is 1 mg/kg mogamulizumab administered as an intravenous infusion over at least 60 minutes.
Croatian: Preporučena doza mogamulizumaba je 1 mg/kg primijenjena u obliku intravenske infuzije tijekom najmanje 60 minuta.
English: • In the event of a rash (drug related) with severity of Grade 2 or 3 (moderate or severe), treatment with mogamulizumab must be interrupted and the rash should be treated appropriately until rash improves to Grade 1 or less (mild severity), at which time mogamulizumab treatment may be resumed.
Croatian: • U slučaju pojave osipa (povezanog s lijekom) težine 2. ili 3. stupnja (umjeren ili težak), potrebno je prekinuti liječenje mogamulizumabom i prikladno pristupiti zbrinjavanju osipa dok se osip ne poboljša do težine 1. stupnja ili manje (blagi), a tada se liječenje mogamulizumabom može nastaviti.
English: If you can get pregnant, you will need to use effective contraception during and for at least six months after receiving this treatment.
Croatian: Ako možete zatrudnjeti, morate koristiti pouzdanu metodu kontracepcije tijekom i najmanje šest mjeseci nakon primanja liječenja.
English: Crossover patients received up to 46 months of mogamulizumab therapy, as of December 2016 data cut.
Croatian: Bolesnici koji su prešli primili su do 46 mjeseci terapije mogamulizumabom počevši od prosinca 2016.
English: Reporting suspected adverse reactions
Croatian: Prijavljivanje sumnji na nuspojavu
English: - Inflammation of the liver (hepatitis)
Croatian: - upala jetre (hepatitis).
English: If an infusion reaction occurs, administer pre-medication for subsequent POTELIGEO infusions.
Croatian: Ako se pojavi reakcija na infuziju, primijenite premedikaciju prilikom sljedećih infuzija lijeka POTELIGEO.
English: Pharmacological activity of mogamulizumab was noted in foetuses as was evident from a decrease in CCR4 expressing lymphocytes.
Croatian: Farmakološka aktivnost mogamulizumaba zapažena je u fetusima jer je bilo očito smanjenje CCR4 ekspresije na limfocitima.
English: Pre-medication with anti-pyretic and anti-histamine is recommended for the first POTELIGEO infusion.
Croatian: Preporučuje se premedikacija antipireticima ili antihistaminicima prilikom prve infuzije lijeka
English: If an IRR occurs, the infusion should be interrupted and appropriate medical management instituted.
Croatian: Ako se pojavi IRR, infuziju treba prekinuti i reakciju prikladno terapijski zbrinuti.
English: At study baseline, 38% had stage IB-II disease, 10% stage III, 52% stage IV.
Croatian: Isključeni su i bolesnici s ECOG funkcionalnim statusom ≥2. Na početku ispitivanja, 38% je imalo bolest u fazi IBII, 10% u fazi III, 52% u fazi IV.
English: Mogamulizumab should not be administered subcutaneously or intramuscularly, by rapid intravenous administration, or as an intravenous bolus.
Croatian: Mogamulizumab se ne smije primijeniti supkutano ili intramuskularno, brzom intravenskom primjenom, ili intravenskim bolusom.
English: Do not use this medicine if you notice signs of deterioration, such as particulate matter or discolouration.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite znakove odstupanja u kakvoći, kao što su prisutnost čestica ili promjena boje.
English: No mogamulizumab-related toxic effects in the male and female reproductive organs were observed in repeat-dose toxicology studies in sexually mature monkeys up to 26 weeks.
Croatian: Nisu zapaženi toksični učinci na reproduktivne organe mužjaka i ženki vezani uz mogamulizumab u ispitivanjima toksičnosti ponovljenih doza u spolno zrelih majmuna do 26 tjedana.
English: Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Croatian: Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
English: Mogamulizumab has minor influence on the ability to drive and use machines.
Croatian: Mogamulizumab malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Compartmental responses were seen in 3 of 10 evaluable subjects treated with mogamulizumab in the randomised or cross over phase.
Croatian: Odgovori po odjeljku zapaženi su u 3 od 10 procjenjivih ispitanika liječenih mogamulizumabom u fazi randomizacije ili fazi prelaska na drugu terapiju.
English: The primary efficacy endpoint was progression-free survival (PFS) based on investigator assessment using a global composite response criteria that took into account all potentially affected disease compartments (skin, blood, lymph nodes and viscera).
Croatian: Survival, PFS) na temelju procjene ispitivača koristeći kriterij globalnog kompozitnog odgovora koji je uzeo u obzir sve odjeljke koji mogu biti zahvaćeni bolešću (kožu, krv, limfne čvorove i unutarnje organe).
English: The effects of various covariates on the PK s of mogamulizumab were assessed in population PK analyses.
Croatian: Učinci raznih kovarijata na farmakokinetiku mogamulizumaba procijenjeni su u populacijskoj farmakokinetičkoj analizi.
English: You will need to use effective contraception during and for at least six months after receiving this treatment.
Croatian: Morate koristiti pouzdanu metodu kontracepcije tijekom i najmanje šest mjeseci nakon primanja terapije.
English: There are no clinical data available on the effect of mogamulizumab on human fertility.
Croatian: Nema dostupnih kliničkih podataka o učincima mogamulizumaba na plodnost u ljudi.
English: Mogamulizumab infusion was administered at a dose of 1 mg/kg once weekly for the first 28-day cycle (on Days 1, 8, 15 and 22), and on days 1 and 15 of subsequent 28-day cycles.
Croatian: Infuzija mogamulizumaba primijenjivana je u dozi od 1 mg/kg jedanput tjedno u prvom ciklusu od 28 dana (na dan 1., 8., 15. i 22.) te na dane 1. i 15. sljedećih ciklusa od
English: No confirmed responses were observed in these 10 subjects with low (<10%) CCR4 expression.
Croatian: U navedenih 10 ispitanika s niskom (<10%) CCR4 ekspresijom nisu zapaženi potvrđeni odgovori.
English: Based on a population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild or moderate hepatic impairment.
Croatian: Na temelju farmakokinetičke analize populacije ne preporučuje se prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre.
English: • The infusion of POTELIGEO should be temporarily interrupted for mild to severe (Grades 1-3) infusion-related reactions and symptoms treated.
Croatian: • Infuziju lijeka POTELIGEO treba privremeno prekinuti ako se pojave blage do teške reakcije vezane uz infuziju (stupnja 1.-3.), a simptome liječiti.
English: Overall response rate (ORR), n (%) Compartment:
Croatian: Ukupna stopa odgovora (ORR), n (%)
English: - Anaemia (reduced red blood cells) - Reduced blood platelets (thrombocytopenia) - Reduced white blood cells (neutropenia and leucopenia) or reduced lymphocytes - Blood tests showing raised liver enzyme levels - Underactive thyroid
Croatian: - smanjen broj bijelih krvnih stanica (neutropenija i leukopenija) ili smanjeni broj limfocita - krvne pretrage koje pokazuju povišene razine jetrenih enzima
English: No specific studies in animals have been performed to evaluate the effect of mogamulizumab on fertility.
Croatian: Nisu provedena posebna ispitivanja plodnosti na životinjama u svrhu procjene učinka mogamulizumaba na plodnost.