natgillin/translations-raw huggingface dataset:
In patients with stage IB/II disease, given the limited number of subjects with a response and immaturity of the data, no conclusion on duration of response can be made.
Pri bolnikih z boleznijo stadija IB/II ni mogoče sklepati o trajanju odziva glede na omejeno število odzivnih oseb in nezrelost podatkov.
No specific studies in animals have been performed to evaluate the effect of mogamulizumab on fertility.
Pri živalih niso izvedli specifičnih študij za oceno vpliva mogamulizumaba na plodnost.
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).
6, 12, 18 in 24 mesecev po začetku randomiziranega zdravljenja je bil odstotek bolnikov, ki so preživeli brez napredovanja bolezni, večji v skupini z mogamulizumabom (55,3 %, 38,3 %, 28,0 % in 14,1 %) v primerjavi z vorinostatom (28,8 %, 15,3 %, 7,2 % in 7,2 %).
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.
Z aseptično tehniko odvzemite želeno količino zdravila POTELIGEO v brizgo in jo prenesite v infuzijsko vrečko, ki vsebuje 0,9-odstotno raztopino natrijevega klorida za injiciranje (9 mg/ml).
Severe adverse reactions included Grade 4 respiratory failure (1.1%) and Grade 5 reactions were polymyositis and sepsis (0.5% each).
Hudi neželeni učinki so vključevali respiratorno odpoved 4. stopnje (1,1 %) ter polimiozitis in sepso 5. stopnje (0,5 % pri obeh učinkih).
Elderly No dose adjustment is required in elderly patients (see section 5.2).
Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
What POTELIGEO is and what it is used for
Kaj je zdravilo POTELIGEO in za kaj ga uporabljamo
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.
Ženske v rodni dobi/Kontracepcija pri moških in ženskah Ženske v rodni dobi in plodni moški morajo med zdravljenjem z zdravilom POTELIGEO in še najmanj 6 mesecev po zdravljenju uporabljati učinkovito kontracepcijo.
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).
Čeprav mogamulizumab prehaja skozi placentarno pregrado pri opicah pasme Macaca fascicularis, študije na živalih razen farmakološkega učinka pri plodovih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
The recommended dose is 1mg POTELIGEO for each kg of body weight.
Priporočeni odmerek je 1 mg zdravila POTELIGEO na vsak kilogram telesne mase.
Mogamulizumab has minor influence on the ability to drive and use machines.
Mogamulizumab ima blag vpliv na sposobnost vožnje in upravljanja strojev.
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.
Iz preskušanja so bili izključeni bolniki z aktivnimi avtoimunimi boleznimi, metastazami v osrednjem živčevju, boleznimi, ki jih je treba zdraviti s sistemskimi kortikosteroidi ali drugimi imunosupresivi, aktivno okužbo, ki jo je treba zdraviti, vključno s HIV, ali hepatitisom B ali C. Izključeni so bili tudi bolniki s telesno zmogljivostjo ECOG ≥ 2.
Management of TLS may include aggressive hydration, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care.
lahko vključuje agresivno hidracijo, korekcijo nenormalnih ravni elektrolitov, zdravljenje hiperurikemije in podporno oskrbo.
If an anaphylactic reaction occurs, administration of mogamulizumab should be immediately and permanently discontinued and appropriate medical therapy should be administered.
Če se pojavi anafilaktična reakcija, je treba dajanje mogamulizumaba takoj in trajno ustaviti ter bolnika ustrezno zdraviti.
Duration of response (months) Median (95% CI) Response by compartment Blood n=124
Trajanje odziva (meseci) Mediana (95-odstotni IZ) Odziv po telesnih predelih Kri n = 124
Concentrate for solution for infusion 20 mg/5 mL
koncentrat za raztopino za infundiranje 20 mg/5 ml
Very common side effects (may affect more than 1 in 10 people):
Ti lahko vključujejo: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
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/razredčena raztopina: Uporabite jo takoj ali shranite v hladilniku (2 °C - 8 °C) in uporabite v 4 urah.
There are no data from the use of mogamulizumab in pregnant women.
Nosečnost Podatkov o uporabi mogamulizumaba pri nosečnicah ni.
• POTELIGEO is intended for intravenous use only, and should not be administered subcutaneously, intramuscularly, as a bolus dose or by rapid intravenous administration.
• Zdravilo POTELIGEO je namenjeno samo intravenski uporabi in se ne sme dajati subkutano, intramuskularno, kot bolusni odmerek ali s hitrim intravenskim injiciranjem.
Patients should be carefully monitored during and after infusion.
Bolnike je treba med infuzijo in po njej skrbno nadzorovati.
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.
V študiji toksičnih učinkov na sposobnost razmnoževanja in razvoj pri živalih dajanje mogamulizumaba brejim opicam pasme Macaca fascicularis od začetka organogeneze do skotitve ni pokazalo potenciala za smrtnost zarodka/plodu, teratogenost ali upočasnjeno rast plodu.
Mogamulizumab should not be administered subcutaneously or intramuscularly, by rapid intravenous administration, or as an intravenous bolus.
Mogamulizumab se ne sme dajati subkutano ali intramuskularno, s hitrim intravenskim dajanjem ali kot intravenski bolus.
Subjects with MF or SS treated with mogamulizumab are at increased risk of serious infection and/or viral reactivation.
Pri bolnikih s FM ali SS, zdravljenih z mogamulizumabom, obstaja večje tveganje za resno okužbo in/ali ponovno aktivacijo virusa.
• 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.
• Če se pojavi izpuščaj (ki je povezan z zdravilom) s stopnjo resnosti 2 ali 3 (zmerna ali huda), je treba zdravljenje z mogamulizumabom prekiniti in izpuščaj ustrezno zdraviti, dokler se ne izboljša do stopnje 1 ali nižje (blaga resnost).
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«.
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.
Med zdravljenjem z mogamulizumabom se lahko uporabljajo topikalni steroidi ali majhni odmerki sistemskih kortikosteroidov; vendar je tveganje za resno okužbo in/ali ponovno aktivacijo virusa pri sočasni uporabi s sistemskimi imunosupresivnimi učinkovinami lahko večje.
Compartmental responses were seen in 3 of 10 evaluable subjects treated with mogamulizumab in the randomised or cross over phase.
Odzive na posameznih telesnih predelih so opazili pri 3 od 10 ocenljivih bolnikov, zdravljenih z mogamulizumabom v randomizirani fazi ali fazi prehoda.
CCR4 expression was assessed retrospectively on pretreatment skin biopsies (formalin fixed paraffin embedded) using immunohistochemistry.
Izraženost CCR4 je bila naknadno ocenjena na biopsijskih kožnih vzorcih, pridobljenih pred zdravljenjem (fiksiranih v formalinu in vdelanih v parafin), z uporabo imunohistokemije.
The majority of treatment-related infusion-related reactions were Grade 1 or 2 and occurred during or shortly after the first infusion.
Reakcije, povezane z infundiranjem, so bile večinoma 1. ali 2. stopnje in so se pojavile med prvo infuzijo ali kmalu po njej.
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.
5 ml raztopine v 10-ml stekleni viali (steklo tipa I) z gumijastim zamaškom, aluminijastim tesnilom in polipropilensko zaporko s snemljivim pokrovčkom.
- have had tumour lysis syndrome (a complication involving the destruction of cancer cells) after a previous treatment.
- če ste kdaj imeli sindrom tumorske lize (zaplet, povezan z uničenjem rakavih celic) po predhodnem zdravljenju;
Follow patients closely for early evidence of transplant-related complications.
Bolnike natančno spremljajte in bodite pozorni na zgodnje znake zapletov,
Fortyone of the 136 cross-over patients (30.1%) responded with either partial or complete response with mogamulizumab.
41 od 136 bolnikov, ki so zamenjali zdravilo (30,1 %), je imelo delen ali popoln odziv na zdravljenje z mogamulizumabom.
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.
Shranjevanje ne sme trajati dlje kot 4 ure pri temperaturi od 2 °C do 8 °C, pod pogojem, da je bila razredčitev opravljena v nadzorovanih in preverjeno aseptičnih pogojih.
Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, lymphocyte count decreased
Preiskave pogosti zvišanje ravni alanin-aminotransferaze, zvišanje ravni aspartataminotransferaze, zvišanje ravni alkalne fosfataze v krvi, zmanjšanje števila limfocitov
Table 2 summarises ORR and DOR, and response by compartment.
V Preglednica 2 so povzeti SSO, TO in odziv po telesnih predelih.
The recommended dose is 1 mg/kg mogamulizumab administered as an intravenous infusion over at least 60 minutes.
Priporočeni odmerek mogamulizumaba je 1 mg/kg in se daje v obliki intravenske infuzije, ki traja najmanj 60 minut.
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.
Zdravilo POTELIGEO je indicirano za zdravljenje odraslih bolnikov s fungoidno mikozo (FM) ali Sézaryjevim sindromom (SS), ki so predhodno prejeli vsaj eno sistemsko zdravljenje.
It is unknown whether mogamulizumab is excreted in human milk.
Ni znano, ali se mogamulizumab izloča v materino mleko.
What POTELIGEO is and what it is used for What you need to know before you use POTELIGEO How POTELIGEO is given Possible side effects
Kaj je zdravilo POTELIGEO in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo POTELIGEO Kako se daje zdravilo POTELIGEO
The infusion rate should be reduced by at least 50% when re-starting the infusion after symptoms resolve.
Pri ponovni uvedbi infundiranja po odpravi simptomov je treba zmanjšati hitrost infuzije za najmanj 50 %.
The latency to event onset following the first dose varied considerably.
Zakasnitev dogodka po prvem odmerku se je med bolniki močno razlikovala.
Median PFS for the mogamulizumab group was 7.70 months (95% CI: 5.67, 10.33) and 3.10 months (95% CI: 2.87, 4.07) for the vorinostat group with resultant hazard ration of 0.53 (95% CI: 0.41, 0.69), p<0.0001 (2sided, stratified log rank test).
Mediano preživetje brez napredovanja bolezni je bilo v skupini z mogamulizumabom 7,70 meseca (95-odstotni IZ: 5,67; 10,33) in v skupini z vorinostatom 3,10 meseca (95-odstotni IZ: 2,87; 4,07) s posledičnim razmerjem tveganja 0,53 (95-odstotni IZ: 0,41; 0,69), p < 0,0001 (dvostranski, stratificirani test log rank).
In clinical trial patients with other T-cell lymphomas there have been reports of stress cardiomyopathy (one case) and acute myocardial infarction (one case).
celične limfome, so poročali o stresni kardiomiopatiji (en primer) in akutnem miokardnem infarktu (en primer).
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,