natgillin/translations-raw huggingface dataset:
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). 
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).
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. 
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.
The effects of POTELIGEO in pregnancy and breast-feeding are not known. 
Učinci lijeka POTELIGEO na trudnoću i dojenje nisu poznati.
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 
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
Warnings and precautions Talk to your doctor or nurse before using POTELIGEO if you: 
Obratite se svom liječniku ili medicinskoj sestri prije nego primijenite POTELIGEO:
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. 
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).
Follow patients closely for early evidence of transplant-related complications. 
Pomno pratite bolesnike za rane znakove komplikacija vezanih uz presađivanje.
Carcinogenicity or genotoxicity studies have not been conducted with mogamulizumab. 
Nisu provedena ispitivanja kancerogenosti ili genotoksičnosti s mogamulizumabom.
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. 
Rekonstituirana/razrijeđena otopina: Odmah iskoristite ili čuvajte u hladnjaku (2 ºC - 8ºC) i primijenite u roku od 4 sata.
Response Rate (n, %) 95% CIa 
Stopa odgovora (n, %) 95%-tni CIa
The metabolic pathway of mogamulizumab has not been characterised. 
Metabolički put mogamulizumaba nije još utvrđen.
- 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. 
- 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,
What POTELIGEO looks like and contents of the pack 
Kako POTELIGEO izgleda i sadržaj pakiranja
The recommended dose is 1 mg/kg mogamulizumab administered as an intravenous infusion over at least 60 minutes. 
Preporučena doza mogamulizumaba je 1 mg/kg primijenjena u obliku intravenske infuzije tijekom najmanje 60 minuta.
• 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. 
• 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.
If you can get pregnant, you will need to use effective contraception during and for at least six months after receiving this treatment. 
Ako možete zatrudnjeti, morate koristiti pouzdanu metodu kontracepcije tijekom i najmanje šest mjeseci nakon primanja liječenja.
Crossover patients received up to 46 months of mogamulizumab therapy, as of December 2016 data cut. 
Bolesnici koji su prešli primili su do 46 mjeseci terapije mogamulizumabom počevši od prosinca 2016.
Reporting suspected adverse reactions 
Prijavljivanje sumnji na nuspojavu
- Inflammation of the liver (hepatitis) 
- upala jetre (hepatitis).
If an infusion reaction occurs, administer pre-medication for subsequent POTELIGEO infusions. 
Ako se pojavi reakcija na infuziju, primijenite premedikaciju prilikom sljedećih infuzija lijeka POTELIGEO.
Pharmacological activity of mogamulizumab was noted in foetuses as was evident from a decrease in CCR4 expressing lymphocytes. 
Farmakološka aktivnost mogamulizumaba zapažena je u fetusima jer je bilo očito smanjenje CCR4 ekspresije na limfocitima.
Pre-medication with anti-pyretic and anti-histamine is recommended for the first POTELIGEO infusion. 
Preporučuje se premedikacija antipireticima ili antihistaminicima prilikom prve infuzije lijeka
If an IRR occurs, the infusion should be interrupted and appropriate medical management instituted. 
Ako se pojavi IRR, infuziju treba prekinuti i reakciju prikladno terapijski zbrinuti.
At study baseline, 38% had stage IB-II disease, 10% stage III, 52% stage IV. 
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.
Mogamulizumab should not be administered subcutaneously or intramuscularly, by rapid intravenous administration, or as an intravenous bolus. 
Mogamulizumab se ne smije primijeniti supkutano ili intramuskularno, brzom intravenskom primjenom, ili intravenskim bolusom.
Do not use this medicine if you notice signs of deterioration, such as particulate matter or discolouration. 
Ovaj lijek se ne smije upotrijebiti ako primijetite znakove odstupanja u kakvoći, kao što su prisutnost čestica ili promjena boje.
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. 
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.
Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine. 
Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
Mogamulizumab has minor influence on the ability to drive and use machines. 
Mogamulizumab malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Compartmental responses were seen in 3 of 10 evaluable subjects treated with mogamulizumab in the randomised or cross over phase. 
Odgovori po odjeljku zapaženi su u 3 od 10 procjenjivih ispitanika liječenih mogamulizumabom u fazi randomizacije ili fazi prelaska na drugu terapiju.
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). 
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).
The effects of various covariates on the PK s of mogamulizumab were assessed in population PK analyses. 
Učinci raznih kovarijata na farmakokinetiku mogamulizumaba procijenjeni su u populacijskoj farmakokinetičkoj analizi.
You will need to use effective contraception during and for at least six months after receiving this treatment. 
Morate koristiti pouzdanu metodu kontracepcije tijekom i najmanje šest mjeseci nakon primanja terapije.
There are no clinical data available on the effect of mogamulizumab on human fertility. 
Nema dostupnih kliničkih podataka o učincima mogamulizumaba na plodnost u ljudi.
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. 
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
No confirmed responses were observed in these 10 subjects with low (<10%) CCR4 expression. 
U navedenih 10 ispitanika s niskom (<10%) CCR4 ekspresijom nisu zapaženi potvrđeni odgovori.
Based on a population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild or moderate hepatic impairment. 
Na temelju farmakokinetičke analize populacije ne preporučuje se prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre.
• The infusion of POTELIGEO should be temporarily interrupted for mild to severe (Grades 1-3) infusion-related reactions and symptoms treated. 
• Infuziju lijeka POTELIGEO treba privremeno prekinuti ako se pojave blage do teške reakcije vezane uz infuziju (stupnja 1.-3.), a simptome liječiti.
Overall response rate (ORR), n (%) Compartment: 
Ukupna stopa odgovora (ORR), n (%)
- 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 
- smanjen broj bijelih krvnih stanica (neutropenija i leukopenija) ili smanjeni broj limfocita - krvne pretrage koje pokazuju povišene razine jetrenih enzima
No specific studies in animals have been performed to evaluate the effect of mogamulizumab on fertility. 
Nisu provedena posebna ispitivanja plodnosti na životinjama u svrhu procjene učinka mogamulizumaba na plodnost.
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 
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
No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3). 
Nisu opaženi štetni učinci na reproduktivne organe mužjaka i ženki u ispitivanjima toksičnosti ponovljenih doza u makaki majmuna (vidjeti dio 5.3).
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. 
Žene reproduktivne dobi i muškarci u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja lijekom POTELIGEO i najmanje 6 mjeseci nakon liječenja.
There are no data from the use of mogamulizumab in pregnant women. 
Nema podataka o primjeni mogamulizumaba u trudnica.
There is no information on overdose with mogamulizumab. 
Nema informacija o predoziranju s mogamulizumabom.
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. 
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.
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%). 
koeficijenta varijacije [CV%]) je 12,0 ml/h (83,7%), a geometrijska srednja vrijednost poluvijeka eliminacije (t1/2) je 17 dana (65,5%).
POTELIGEO has not been studied in patients with severe hepatic impairment (see section 5.2). 
POTELIGEO nije ispitivan u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dio 5.2).
One case of acute myocardial infarction has been observed in a clinical trial patient with MF / SS receiving mogamulizumab. 
Jedan slučaj akutnog infarkta miokarda opažen je u jednog bolesnika iz kliničkog ispitivanja koji je imao MF/SS i primao mogamulizumab.
a: P-value was obtained from Cochran-Mantel-Haenszel test adjusting for disease type, disease stage, and region. 
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.
Very common side effects (may affect more than 1 in 10 people): 
To može uključivati: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba):
Description of selected adverse reactions 
Opis odabranih nuspojava Dermatološke reakcije
The amount of POTELIGEO you will receive is calculated by your doctor based on your body weight. 
Količinu lijeka POTELIGEO koju ćete primiti izračunava
Based on a population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild to severe renal impairment (see section 5.2). 
Na temelju farmakokinetičke analize populacije, ne preporučuje se prilagođavati dozu u bolesnika s blagim do teškim oštećenjem funkcije bubrega (vidjeti dio 5.2).
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). 
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).
POTELIGEO 4 mg/mL concentrate for solution for infusion mogamulizumab 
4 mg/ml koncentrat za otopinu za infuziju mogamulizumab
Very common Constipation, diarrhoea, nausea, stomatitis 
Vrlo često konstipacija, proljev, mučnina,
Fatigue may occur following administration of mogamulizumab (see section 4.8). 
Nakon primjene mogamulizumaba može uslijediti umor (vidjeti dio 4.8).
- have had or plan to have a stem cell transplant, either using your own cells or a donor's. 
- ako su Vam presađene ili će Vam biti presađene krvotvorne matične stanice, bilo da koristite vlastite stanice ili stanice davatelja,
Citric acid monohydrate, glycine, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections. 
Citratna kiselina hidrat, glicin, polisorbat 80, natrijev hidroksid, kloridna kiselina, voda za injekcije.
See section 4.2 for dose modification information. 
Pogledajte dio 4.2 za informacije o prilagodbi doze.
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). 
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).
For storage conditions after dilution of the medicinal product, see section 6.3 
Uvjete čuvanja nakon razrjeđivanja lijeka, vidjeti u dijelu 6.3.
P-valuea 
p-vrijednosta
Anaemia, neutropenia, leukopenia, Thrombocytopenia 
Često anemija, neutropenija, leukopenija, trombocitopenija endokrini poremećaji
Each mL of concentrate contains 4 mg of mogamulizumab. 
Jedan ml koncentrata sadrži 4 mg mogamulizumaba.
Very common Infusion related reaction 
Vrlo često reakcija vezana uz infuziju
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. 
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
POTELIGEO will be given to you through a vein (intravenous infusion) over at least 60 minutes. 
POTELIGEO ćete primiti u venu (intravenska infuzija) tijekom najmanje 60 minuta.
Mogamulizumab is produced in Chinese hamster ovary cells by recombinant DNA technology. 
Mogamulizumab se proizvodi tehnologijom rekombinantne DNK-a na stanicama ovarija kineskog hrčka.
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. 
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.
Exposure-Response analysis indicated that efficacy was not correlated with mogamulizumab exposure in the pivotal study. 
Analiza odnosa izloženosti i odgovora pokazala je u pivotalnom ispitivanju da djelotvornost nije povezana s izloženošću mogamulizumabu.
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. 
Odgovor na razini limfnih čvorova i unutarnjih organa procijenjen je nakon 4 tjedna, zatim svakih 8 tjedana tijekom prve godine,
Mogamulizumab has not been studied in patients with severe hepatic impairment (TB greater than 3 times ULN and any AST). 
Mogamulizumab nije ispitivan u bolesnika s teškim oštećenjem funkcije jetre (ukupni bilirubin veći od 3-struke vrijednosti
- have had tumour lysis syndrome (a complication involving the destruction of cancer cells) after a previous treatment. 
- ako imate sindrom lize tumora (komplikaciju koja uključuje razaranje tumorskih stanica) nakon prethodnog liječenja, - ako imate srčanih problema.
Overall response rate (confirmed CR + PR, %) 
Ukupna stopa odgovora (potvrđen CR + PR, %)
POTELIGEO contains sodium 
POTELIGEO sadrži natrij
Tumour lysis syndrome 
Manje često sindrom lize tumora
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). 
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,
Mogamulizumab exhibits linear PK from the dose in a dose range of 0.01 mg/kg to 1 mg/kg. 
Linearnost i akumulacija Mogamulizumab pokazuje linearnu farmakokinetiku za doze u rasponu od 0,01 mg/kg do 1 mg/kg.
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. 
CCR4 se eksprimira na površini određenih stanica raka uključujući maligne bolesti T-stanica, kao što su MF i
POTELIGEO is unlikely to affect your ability to drive and use machines. 
Malo je vjerojatno da će POTELIGEO utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
- Each vial contains 20 mg of mogamulizumab in 5 mL of concentrate, corresponding to 4 mg/mL. 
- Jedna bočica sadrži 20 mg mogamulizumaba u 5 ml koncentrata, što odgovara 4 mg/ml.
POTELIGEO 4 mg/mL concentrate for solution for infusion. 
4 mg/ml koncentrat za otopinu za infuziju.
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. 
Nije pronađena klinički značajna razlika u klirensu mogamulizumaba između bolesnika s blagim do teškim oštećenjem funkcije bubrega i u bolesnika s normalnom bubrežnom funkcijom.
Tell your doctor immediately if you experience any of the serious side effects listed in Section 4 after starting POTELIGEO treatment. 
Odmah se javite liječniku ako nakon početka liječenja lijekom POTELIGEO nastupi bilo koja od ozbiljnih nuspojava navedenih u Dijelu 4: Djeca i adolescenti
Each vial contains 20 mg of mogamulizumab in 5 mL, corresponding to 4 mg/mL. 
Jedna bočica sadrži 20 mg mogamulizumaba u 5 ml, što odgovara 4 mg/ml.
The majority of treatment-related dermatologic reactions were Grade 1 or 2, with Grade ≥3 drug rash occurring in 4.3% of patients. 
Većina dermatoloških reakcija vezanih uz liječenje bila je 1. ili 2. stupnja, a osip prouzročen lijekom težine ≥3. stupnja javio se u u
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'. 
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
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. 
Nisu pronađene klinički značajne razlike u klirensu mogamulizumaba između bolesnika s blagim do umjerenim oštećenjem funkcije jetre i u bolesnika s normalnom funkcijom jetre.
Unopened vial: Store in a refrigerator (2ºC - 8ºC). 
Neotvorena bočica: Čuvati u hladnjaku (2 ºC - 8 ºC).
Tumour lysis syndrome (TLS) has been observed in patients receiving mogamulizumab. 
Sindrom lize tumora Sindrom lize tumora (engl. tumour lysis syndrome, TLS) zapažen je u bolesnika koji primaju mogamulizumab.