natgillin/translations-raw huggingface dataset:
You must tell your doctor or nurse if you are pregnant, breast-feeding, think you may be pregnant, or are planning to have a baby. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali medicinsko sestro.
Pharmacological activity of mogamulizumab was noted in foetuses as was evident from a decrease in CCR4 expressing lymphocytes. 
Pri plodovih so opazili tudi farmakološko aktivnost mogamulizumaba, razvidno iz zmanjšanja števila limfocitov z izraženostjo CCR4.
Package leaflet: Information for the patient POTELIGEO 4 mg/mL concentrate for solution for infusion mogamulizumab This medicine is subject to additional monitoring. 
Navodilo za uporabo POTELIGEO 4 mg/ml koncentrat za raztopino za infundiranje mogamulizumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
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). 
Resne neželene reakcije na zdravilo, o katerih so poročali pri več kot enem bolniku, so bile razvrščene v skupine organskih sistemov »infekcijske in parazitske bolezni« (7 [2,2 %] bolnikov), »splošne težave in spremembe na mestu aplikacije« (5 [1,6 %] bolnikov), »bolezni dihal, prsnega koša in mediastinalnega prostora« (4 [1,3 %] bolniki), »bolezni mišično-skeletnega sistema in vezivnega tkiva« (3 [0,9 %] bolniki), »bolezni jeter, žolčnika in žolčevodov« (2 [0,6 %] bolnika) ter »poškodbe,
When the symptoms go away, POTELIGEO can normally continue to be given, but more slowly. 
POTELIGEO običajno uporablja še naprej, vendar ga je treba dajati počasneje.
Table 1: Adverse drug reactions occurring in patients receiving POTELIGEO (N=184) System organ class (SOC) 
Preglednica 1: neželeni učinki pri bolnikih, ki so prejemali zdravilo POTELIGEO (N = 184)
This medicinal product contains less than 1 mmol sodium per dose, that is to say essentially ‘sodium free'. 
To zdravilo vsebuje manj kot 1 mmol natrija na odmerek, kar v bistvu pomeni »brez natrija«.
It should be administered by intravenous infusion only, over at least 60 minutes. 
Dajati se sme samo v obliki intravenske infuzije, ki traja najmanj 60 minut.
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). 
Bolniki v stadiju IB/II, ki so bili zdravljeni z mogamulizumabom, so imeli potrjeno SSO 17,6 % v primerjavi z 8,3 % pri bolnikih, zdravljenih z vorinostatom, in višje stopnje odziva po telesnih predelih (kri, koža, bezgavke) kot bolniki, zdravljeni z vorinostatom (Preglednica 3).
Vorinostat was administered at a starting dose of 400 mg orally, once daily beginning on day 1 for 28day cycles. 
28-dnevnih krogih zdravljenja 1. in 15. dan. Vorinostat so dobivali v začetnem odmerku 400 mg peroralno, enkrat na dan, v 28-dnevnih krogih zdravljenja z začetkom odmerjanja na 1. dan kroga.
The safety profile in elderly patients (≥ 65 years) was generally consistent with that of adult patients, 
Varnostni profil pri starejših bolnikih (≥ 65 let) je bil na splošno skladen s tistim pri odraslih bolnikih, razen pri dermatoloških reakcijah in reakcijah, povezanih z infundiranjem, ki so se pogosteje pojavljale pri starejših bolnikih.
Discard the vial if cloudiness, discolouration or particulates are observed. 
Vialo zavrzite, če opazite motnost, obarvanost ali delce.
If an IRR occurs, the infusion should be interrupted and appropriate medical management instituted. 
Če se pojavi reakcija, povezana z infundiranjem, je treba infuzijo prekiniti in uvesti ustrezno medicinsko oskrbo.
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). 
Farmakokinetiko (FK) mogamulizumaba so ocenili pri odraslih bolnikih s T-celično levkemijo/limfomom (ATL) in CTCL z večkratnimi odmerki v razponu od 0,01 do 1 mg/kg in odmerjanjem vsak teden ali vsaka 2 tedna na podlagi priporočenega odmerka 1,0 mg/kg in režima odmerjanja (1., 8., 15. in 22. dan v prvem 28-dnevnem krogu ter 1. in 15. dan v nadaljnjih 28-dnevnih krogih).
How to store POTELIGEO Contents of the pack and other information 
Shranjevanje zdravila POTELIGEO Vsebina pakiranja in dodatne informacije
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. 
Vsi bolniki v skupinah z mogamulizumabom oziroma vorinostatom so imeli histološko potrjeno diagnozo fungoidne mikoze (FM) (56,5 %; 53,2 %) ali Sézaryjevega sindroma (SS) (43,5 %; 46,8 %) in so predhodno prejeli vsaj eno sistemsko zdravljenje.
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. 
Zdravilo smejo bolnikom dajati samo zdravstveni delavci v okolju, kjer je na voljo oprema za oživljanje.
Carcinogenicity or genotoxicity studies have not been conducted with mogamulizumab. 
Študij kancerogenosti in genotoksičnosti mogamulizumaba niso izvedli.
If an infusion reaction occurs, administer pre-medication for subsequent POTELIGEO infusions. 
Če se pojavi reakcija na infuzijo, je treba tudi pred nadaljnjimi infuzijami zdravila
- 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 
- zmanjšanje števila belih krvnih celic (nevtropenija in levkopenija) ali limfocitov - preiskave krvi, ki kažejo zvišane koncentracije jetrnih encimov
Vorinostat patients with disease progression or unacceptable toxicities were permitted to cross over to mogamulizumab therapy. 
Bolnikom v skupini z vorinostatom, pri katerih je bolezen napredovala ali so se pojavili nesprejemljivi toksični učinki, je bilo dovoljeno preiti na zdravljenje z mogamulizumabom.
<1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). 
Neželeni učinki so razvrščeni po organskih sistemih in kategorijah pogostnosti, ki so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Tell your doctor immediately if you experience any of the serious side effects listed in Section 4 after starting POTELIGEO treatment. 
Nemudoma obvestite svojega zdravnika, če se po začetku zdravljenja z zdravilom POTELIGEO pri vas pojavi kateri koli resen neželeni učinek, naveden v poglavju 4.
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. 
Bolniki s FM ali SS imajo povečano tveganje za resno okužbo zaradi poslabšane celovitosti dermisa, ki jo povzroča kožna bolezen, in zaradi imunosupresivnih učinkov ekstrakutane bolezni.
Mogamulizumab exhibits linear PK from the dose in a dose range of 0.01 mg/kg to 1 mg/kg. 
Mogamulizumab kaže linearno FK v razponu odmerkov od 0,01 mg/kg do 1 mg/kg.
• Do not mix POTELIGEO with, or administer as an infusion with, other medicinal products. 
• Zdravilo POTELIGEO se ne sme mešati z drugimi zdravili ali dajati v infuziji skupaj z drugimi zdravili.
POTELIGEO contains the active substance mogamulizumab, which belongs to a group of medicines called monoclonal antibodies. 
Zdravilo POTELIGEO vsebuje zdravilno učinkovino mogamulizumab, ki spada v skupino zdravil, imenovanih monoklonska protitelesa.
Overall response rate (ORR), n (%) Compartment: 
Splošna stopnja odziva (SSO), n (%) Telesni predel:
POTELIGEO does not contain a preservative. 
Zdravilo POTELIGEO ne vsebuje konzervansa.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity. 
Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
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. 
Simptomi lahko vključujejo kožni izpuščaj ali mehurje, siljenje na bruhanje ali drisko, ki ne izgine, bolečine v želodcu ali bruhanje, boleče ali toge sklepe, suhe ali razdražene oči ali zamegljen vid, rane v ustih, draženje ali bolečino, kašelj, ki ne izgine, ali oteženo dihanje, občutljivost spolnih organov, zlatenico (rumeno obarvana koža), temen urin in kakršne koli otekline.
If you can get pregnant, you will need to use effective contraception during and for at least six months after receiving this treatment. 
Če pri vas obstaja možnost zanositve, boste morali med zdravljenjem in še najmanj 6 mesecev po njem uporabljati učinkovito kontracepcijo.
Each mL of concentrate contains 4 mg of mogamulizumab. 
En ml koncentrata vsebuje 4 mg mogamulizumaba.
POTELIGEO has not been studied in patients with severe hepatic impairment (see section 5.2). 
Zdravila POTELIGEO niso preučili pri bolnikih s hudo okvaro jeter (glejte poglavje 5.2).
Unopened vial: Store in a refrigerator (2ºC - 8ºC). 
Neodprta viala: Shranjujte v hladilniku (2 °C - 8 °C).
One case of acute myocardial infarction has been observed in a clinical trial patient with MF / SS receiving mogamulizumab. 
Poročali so o enem primeru akutnega miokardnega infarkta pri bolniku s FM/SS, ki je prejemal mogamulizumab v kliničnem preskušanju.
The metabolic pathway of mogamulizumab has not been characterised. 
Presnovna pot mogamulizumaba ni ugotovljena.
All remaining SOCs reported SADRs in one patient (0.3%). 
V vseh drugih skupinah organskih sistemov so poročali o resni neželeni reakciji na zdravilo pri enem bolniku (0,3 %).
Very common Fatigue, oedema peripheral, pyrexia 
Splošne težave in spremembe na mestu aplikacije zelo pogosti utrujenost, periferni edem, pireksija
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). 
Učinek okvare ledvic na očistek mogamulizumaba je bil ocenjen z analizo populacijske FK pri bolnikih z blago (kreatininski očistek [CrCL] med 60 in 89, n = 157), zmerno (CrCL med 59 in 30,
You will need to use effective contraception during and for at least six months after receiving this treatment. 
Med zdravljenjem in še najmanj 6 mesecev po njem boste morali uporabljati učinkovito kontracepcijo.
Based on a population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild to severe renal impairment (see section 5.2). 
Glede na analizo populacijske farmakokinetike se za bolnike z blago do hudo okvaro ledvic ne priporoča prilagoditev odmerjanja (glejte poglavje 5.2).
Citric acid monohydrate, glycine, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections. 
Citronska kislina monohidrat, glicin, polisorbat 80, natrijev hidroksid, klorovodikova kislina, voda za injekcije.
- Each vial contains 20 mg of mogamulizumab in 5 mL of concentrate, corresponding to 4 mg/mL. 
- Ena viala vsebuje 20 mg mogamulizumaba v 5 ml koncentrata, kar ustreza 4 mg/ml.
P value 
Vrednost Pa
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. 
Učinek okvare jeter na očistek mogamulizumaba je bil ocenjen z analizo populacijske FK pri bolnikih z blago okvaro jeter (raven skupnega bilirubina [TB], nižja ali enaka kot zgornja meja normalne vrednosti [ULN] in vrednost AST, višja od ULN, ali vrednost TB, nižja od 1- do 1,5-kratne ULN, in kakršna koli vrednost AST, n = 80) ali zmerno okvaro jeter (vrednost TB, višja od 1,5- do 3-kratne ULN, in kakršna koli vrednost AST; n = 3).
The Kaplan-Meier curve for PFS is shown Figure 1. 
Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni je prikazana na Slika 1.
Nodal (n) Response Rate (n, %) 95% CIa M=mogamulizumab. 
Bezgavke (n) Stopnja odziva (n, %) 95-odstotni IZa M = mogamulizumab, V = vorinostat
Reporting suspected adverse reactions 
Poročanje o domnevnih neželenih učinkih
There is no information on overdose with mogamulizumab. 
Informacij o prevelikem odmerjanju mogamulizumaba ni.
A small percentage of patients receiving POTELIGEO tested positive for treatment emergent (treatment induced or treatment boosted) anti mogamulizumab antibodies. 
Majhen odstotek bolnikov, ki so prejemali zdravilo POTELIGEO, je imel pozitiven rezultat testa protiteles proti mogamulizumabu kot učinka, sproženega ali povečanega zaradi zdravljenja.
Mix diluted solution by gentle inversion. 
Razredčeno raztopino premešajte z nežnim preobračanjem.
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. 
Učinkovitost mogamulizumaba pri zdravljenju bolnikov s fungoidno mikozo (FM) ali Sézaryjevim sindromom (SS) je bila ugotovljena v multicentrični odprti študiji 3. faze (0761-010), ki je vključevala
Each vial contains 20 mg of mogamulizumab in 5 mL, corresponding to 4 mg/mL. 
Ena viala vsebuje 20 mg mogamulizumaba v 5 ml, kar ustreza 4 mg/ml.
Each vial of 5 mL contains 20 mg of mogamulizumab. 
Ena 5-ml viala vsebuje 20 mg mogamulizumaba.
No trend in latency to event onset was identified for drug eruptions and rashes; both early and late-onset events occurred. 
Pri kožnih reakcijah/izpuščaju niso opazili nobenega trenda v zakasnitvi nastopa reakcij; nekatere so se pojavile zgodaj in druge pozno.
POTELIGEO is unlikely to affect your ability to drive and use machines. 
Malo verjetno je, da bo zdravilo POTELIGEO vplivalo na vašo sposobnost vožnje ali upravljanja strojev.
POTELIGEO is for intravenous use. 
Zdravilo POTELIGEO je namenjeno za intravensko uporabo.
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. 
V toksikoloških študijah s ponavljajočimi se odmerki pri spolno zrelih opicah, ki so trajale do 26 tednov, niso opazili nobenih toksičnih učinkov, povezanih z mogamulizumabom, na reproduktivne organe samcev ali samic.
- The other excipients are citric acid monohydrate, glycine, polysorbate 80, sodium hydroxide, hydrochloric acid, and water for injections. 
- Pomožne snovi so citronska kislina monohidrat, glicin, polisorbat 80, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
The incidence of infusion related reactions was highest after the first infusion (28.8% of subjects), 
Pojavnost reakcij, povezanih z infundiranjem, je bila največja po prvi infuziji (28,8 % bolnikov) in se je po dveh ali več infuzijah zmanjšala na ≤ 3,8 % bolnikov.
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. 
Po podatkih, zbranih do decembra 2016, so bolniki, ki so zamenjali zdravilo, prejeli od 1 do 94 infuzij mogamulizumaba (do 46 mesecev zdravljenja).
There are no clinical data available on the effect of mogamulizumab on human fertility. 
O vplivu mogamulizumaba na plodnost pri ljudeh ni na voljo nobenih kliničnih podatkov.
Uncommon side effects (may affect up to 1 in 100 people) 
- premalo aktivna ščitnica Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov)
Fatigue may occur following administration of mogamulizumab (see section 4.8). 
Po prejemu mogamulizumaba se lahko pojavi utrujenost (glejte poglavje 4.8).
- chest pain, shortness of breath, fast or slow heartbeat, sweating, dizziness, nausea or vomiting, weakness, feeling faint and feeling unwell. 
- bolečina v prsih, zasoplost, hiter ali počasen srčni utrip, znojenje, omotica, siljenje na bruhanje ali bruhanje, šibkost, občutek, da boste omedleli, in splošno slabo počutje.
POTELIGEO 4 mg/mL concentrate for solution for infusion mogamulizumab 
POTELIGEO 4 mg/ml koncentrat za raztopino za infundiranje mogamulizumab
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 
a folikulitis, celulitis, kandidiaza, pljučnica, sepsa, okužba kože, vnetje sluhovoda, herpes zoster, stafilokokna okužba kože, okužba sečil, herpes simpleks in citomegalovirus
Based on a population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild or moderate hepatic impairment. 
Okvara jeter Glede na analizo populacijske farmakokinetike se za bolnike z blago ali zmerno okvaro jeter ne priporoča prilagoditev odmerjanja.
Risk Diff (M vs. V) 
Razlika v tveganju (M v prim.
Tumour lysis syndrome (TLS) has been observed in patients receiving mogamulizumab. 
Pri bolnikih, ki so prejemali mogamulizumab, so opazili sindrom tumorske lize (TLS).
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. 
Pri uporabi mogamulizumaba pri bolnikih s T-celičnimi limfomi razen FM ali SS v kliničnih preskušanjih so pri manj kot 1 % bolnikov poročali o pojavu resnih kožnih reakcij, vključno s StevensJohnsonovim sindromom (SJS) in toksično epidermalno nekrolizo (TEN).
See section 4.2 for premedication and dose modification information. 
Informacije o predhodnem zdravljenju in prilagoditvah odmerjanja so v poglavju 4.2.
Pre-medication with anti-pyretic and anti-histamine is recommended for the first POTELIGEO infusion. 
Pri prvi infuziji zdravila POTELIGEO se priporoča predhodno zdravljenje z antipiretikom in antihistaminikom.
What POTELIGEO looks like and contents of the pack 
Izgled zdravila POTELIGEO in vsebina pakiranja
In general, IgG molecules are known to cross the placental barrier and mogamulizumab concentrations in foetus plasma were detected. 
Na splošno je znano, da molekule IgG prehajajo skozi placentarno pregrado.
Based on a population PK analysis, the geometric mean [% coefficient of variation (CV%)] central volume of distribution (Vc) was 3.57 L (20.1%). 
osrednjega volumna porazdelitve (Vc) 3,57 l (20,1 %).
Tell the person giving you the infusion or get medical help straight away if you experience a reaction during or after any POTELIGEO infusion. 
Če med infuzijo zdravila POTELIGEO ali po njej doživite reakcijo, to povejte zdravstvenemu delavcu, ki vam je dal infuzijo, oziroma takoj poiščite zdravniško pomoč.
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. 
Ključni sekundarni opazovani dogodki so bili skupna stopnja odziva (SSO), SSO po zamenjavi zdravila, trajanje odziva (TO) ter spremembe od izhodišča v simptomih in na funkcionalni lestvici
Very common Constipation, diarrhoea, nausea, stomatitis 
Bolezni prebavil zelo pogosti zaprtost, driska, navzea, stomatitis pogosti bruhanje
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. 
V prvem 28-dnevnem krogu zdravljenja se zdravilo daje v tedenskih presledkih 1., 8., 15. in 22. dan, temu pa sledijo infuzije v dvotedenskih presledkih 1. in 15. dan vsakega nadaljnjega
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). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z mogamulizumabom za vse podskupine pediatrične populacije s kožnim T-celičnim limfomom (CTCL) (FM in SS sta podtipa CTCL).
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. 
V prvem 28-dnevnem krogu zdravljenja so bolniki dobivali infuzije mogamulizumaba v odmerku 1 mg/kg enkrat na teden (1., 8., 15. in 22. dan) in v nadaljnjih
Patients receiving mogamulizumab have experienced drug rash (drug eruption), some of which were severe and/or serious. 
Pri bolnikih, ki so prejemali mogamulizumab, se je pojavil medikamentozni izpuščaj (kožna reakcija na zdravilo); nekateri primeri so bili hudi in/ali resni.
• POTELIGEO should be permanently discontinued for a life-threatening (Grade 4) infusion-related reaction (see section 4.4). 
• Ob pojavu življenjsko nevarne reakcije, povezane z infundiranjem (stopnja 4), je treba zdravljenje z zdravilom POTELIGEO trajno opustiti (glejte poglavje 4.4).
Uncommon Hepatitis acute, hepatitis 
Bolezni jeter, žolčnika in žolčevodov občasni akutni hepatitis, hepatitis
Response Rate (n, %) 95% CIa 
Stopnja odziva (n, %) 95-odstotni IZa
POTELIGEO 4 mg/mL concentrate for solution for infusion. 
POTELIGEO 4 mg/ml koncentrat za raztopino za infundiranje
Overall response rate (confirmed CR + PR, %) 95% CI 
Skupna stopnja odziva (potrjen CR + PR, %) 95-odstotni IZ
If you are breast-feeding, you should discuss with your doctor whether you can breast-feed during or after treatment with POTELIGEO. 
ali smete dojiti med zdravljenjem z zdravilom POTELIGEO ali po njem.
• The infusion of POTELIGEO should be temporarily interrupted for mild to severe (Grades 1-3) infusion-related reactions and symptoms treated. 
• Če se pojavijo blage do hude reakcije (stopnje 1-3), povezane z infundiranjem, je treba infundiranje zdravila POTELIGEO začasno prekiniti in zdraviti simptome.
How POTELIGEO is given 
Kako se daje zdravilo POTELIGEO
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. 
Razmerje med koristmi in tveganji mogamulizumaba pri bolnikih s prizadetim drobovjem je trenutno nejasno zaradi pomanjkanja podatkov.