FrancophonIA/ELRC3.0 huggingface dataset:
English: The combination of mogamulizumab with systemic immune modulating medicinal products or with other licensed therapies for MF or SS has not been studied and is, therefore, not recommended, especially in consideration of the risk of severe infections in patients treated with mogamulizumab.
Slovenian: Kombinacij mogamulizumaba s sistemskimi imunomodulirajočimi zdravili ali drugimi odobrenimi zdravili za zdravljenje FM ali SS niso preučili in zato niso priporočljive, zlasti ob upoštevanju tveganja za pojav resnih okužb pri bolnikih, ki se zdravijo z mogamulizumabom.
English: Figure 1: Plot of Kaplan-Meier curve of progression-free survival by investigator's assessment (ITT) population
Slovenian: Slika 1: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni po oceni raziskovalca - populacija ITT
English: - Inflammation of the liver (hepatitis)
Slovenian: - vnetje jeter (hepatitis)
English: Mogamulizumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Slovenian: Mogamulizumab je pridobljen iz ovarijskih celic kitajskega hrčka s tehnologijo rekombinantne DNK.
English: Patients were included in the analysis for a specific compartment if they had presence of disease in that compartment at baseline, or had any post-baseline response assessment for that compartment.
Slovenian: Bolniki so bili vključeni v analizo za določen telesni predel, če so ob izhodišču imeli bolezen na tem predelu ali če so imeli po izhodišču kakršno koli oceno odziva na tem predelu.
English: If reaction recurs, discontinuing the infusion should be considered (see section 4.4).
Slovenian: Če se reakcija ponovi, je treba razmisliti o opustitvi infundiranja (glejte poglavje 4.4).
English: There are limited efficacy data in patients with low (<10%) CCR4 expression in the skin.
Slovenian: Podatki o učinkovitosti pri bolnikih z nizko (< 10 %) izraženostjo CCR4 v koži so omejeni.
English: 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.
Slovenian: CCR4 je izražen na površini nekaterih rakavih celic, vključno z malignimi T-celičnimi novotvorbami, kot sta FM in SS, pri katerih je izraženost CCR4 inherentna.
English: The most common prior systemic therapies used by subjects in Europe were bexarotene (70%), interferon (59%), methotrexate (49%), extracorporeal photopheresis (ECP) (31%) and gemcitabine/gemcitabine regimens (28%).
Slovenian: Najpogostejše vrste predhodnega sistemskega zdravljenja, ki so jih uporabljali preskušanci v Evropi, so bile beksaroten (70 %), interferon (59 %), metotreksat (49 %), zunajtelesna fotofereza (ECP) (31 %) in gemcitabin/režimi zdravljenja z gemcitabinom (28 %).
English: 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.
Slovenian: Odziv bezgavk in drobovja so ovrednotili po 4 tednih, nato vsakih 8 tednov v prvem letu in pozneje vsakih 16 tednov.
English: Infusion interruptions occurred in approximately 6% of patients, most of which (approximately 90%) occurred within the first cycle of treatment with mogamulizumab.
Slovenian: Prekinitve infundiranja so bile potrebne pri približno 6 % bolnikov, pri čemer je bila večina prekinitev (približno 90 %) v prvem krogu zdravljenja z mogamulizumabom.
English: Tell your doctor or nurse or get medical help immediately if you have any of the following symptoms after starting POTELIGEO:
Slovenian: Nemudoma obvestite svojega zdravnika ali medicinsko sestro oziroma poiščite zdravniško pomoč, če se po začetku uporabe zdravila POTELIGEO pri vas pojavi kateri koli od naslednjih simptomov:
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.
Slovenian: V kliničnem preskušanju (0761-010) so poročali o dveh primerih respiratorne odpovedi s smrtnim izidom pri bolnikih s hudo pljučnico, ki je nastopila več kot 9 mesecev po začetku zdravljenja z mogamulizumabom.
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.
Slovenian: Zdravljenje z mogamulizumabom je doseglo 8 potrjenih popolnih odzivov (popolna ozdravitev vseh prizadetih predelov) v primerjavi z 0 bolniki v skupini z vorinostatom: 4 od teh 8 bolnikov so bili že na začetku razvrščeni v skupino z mogamulizumabom, 4 pa so med študijo prešli na mogamulizumab.
English: If they occur, POTELIGEO should be interrupted and treatment should not restart unless SJS or TEN is ruled out and cutaneous reaction has resolved to Grade 1 or less.
Slovenian: Če se pojavijo, je treba odmerjanje zdravila POTELIGEO prekiniti, zdravljenje pa se ne sme ponovno začeti, dokler SJS ali TEN nista izključena in se kožna reakcija izboljša do stopnje 1 ali nižje.
English: Patients were a median age of 64 years at the time of screening (range 25 to 101 years), 49.5% were 65 years or older, and 58.1% were male.
Slovenian: Ob presejanju je bila mediana starost bolnikov 64 let (razpon od 25 do 101 leta), 49,5 % bolnikov je bilo starih 65 let ali več in 58,1 % je bilo moških.
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, monoclonal antibodies ATC code: L01XC25
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe in imunomodulatorji, monoklonska protitelesa; oznaka ATC: L01XC25
English: Mogamulizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Slovenian: Pričakuje se, da bo mogamulizumab razpadel na manjše peptide in aminokisline po katabolnih poteh tako kot endogeni IgG.
English: Mogamulizumab targets cancer cells which are then destroyed by the immune system (the body's defence).
Slovenian: Mogamulizumab ciljno deluje na rakave celice, ki jih nato uniči imunski sistem (naravna obramba telesa).
English: Based on a population PK analysis, the steady-state concentrations of mogamulizumab were reached after 12 weeks of repeated dosing when administered using the recommended regimen, and systemic accumulation was 1.7-fold.
Slovenian: Na podlagi analize populacijske FK so bile koncentracije mogamulizumaba v stanju dinamičnega ravnovesja dosežene po 12 tednih ponavljajočega se odmerjanja, če se je uporabljal priporočeni režim odmerjanja, sistemsko kopičenje pa je bilo 1,7-kratno.
English: The pack contains a glass vial containing 5 mL concentrate for solution for infusion.
Slovenian: Pakiranje vsebuje stekleno vialo, ki vsebuje 5 ml koncentrata za raztopino za infundiranje.
English: This medicine is used to treat adults with mycosis fungoides and Sézary syndrome, which are types of cancers called cutaneous T-cell lymphomas.
Slovenian: To zdravilo se uporablja za zdravljenje odraslih s fungoidno mikozo in Sézaryjevim sindromom, ki sta tipa raka, imenovanega »kožni T-celični limfom«.
English: In the mogamulizumab arm, baseline CCR4 expression levels were available in 75% of patients (N=140).
Slovenian: V skupini z mogamulizumabom so bile izhodiščne ravni izraženosti CCR4 na voljo pri 75 % bolnikov (N = 140).
English: As a precautionary measure, it is preferable to avoid the use of mogamulizumab during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi mogamulizumaba bolje izogibati.
English: The most frequently reported adverse reactions were infusion-related reaction and rash (drug eruption); most of these reactions were non-serious and Grades 1 or 2.
Slovenian: Najpogosteje opažena neželena učinka sta bila z infuzijo povezana reakcija in medikamentozni izpuščaj (kožna reakcija na zdravilo); večina teh reakcij ni bila resna - stopnja 1 ali 2.
English: Of the 320 subjects exposed to mogamulizumab in Study 0761-010, 21 (6.6%), experienced at least one serious adverse drug reaction (SADR) that occurred within 90 days from the date of last study drug administration.
Slovenian: Od 320 preskušancev, ki so bili izpostavljeni mogamulizumabu v študiji 0761-010, jih je 21 (6,6 %) imelo vsaj eno resno neželeno reakcijo na zdravilo, ki se je pojavila v 90 dneh od datuma zadnjega odmerka preskušanega zdravila.
English: The safety of treatment with mogamulizumab after autologous or allogeneic HSCT has not been studied.
Slovenian: Varnost zdravljenja z mogamulizumabom po avtologni ali alogenski presaditvi HSCT ni raziskana.
English: CCR4 was detected on ≥1% of lymphocytes in 100% of patients, and 96% (134/140) had CCR4 detected on ≥10% of skin lymphocytes.
Slovenian: Pri 100 % so odkrili CCR4 v ≥ 1 % limfocitov in pri 96 % (134/140) bolnikov so odkrili CCR4 v ≥ 10 % limfocitov v koži.
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.
Slovenian: V študiji 0761-010 je bilo 10/290 ocenljivih bolnikov z izraženostjo CCR4 < 10 %, od katerih jih je bilo 6 že ob izhodišču razvrščenih v skupino z mogamulizumabom, 4 pa v skupino z vorinostatom in so nato prešli na mogamulizumab.
English: What you need to know before you use POTELIGEO Do not use POTELIGEO if you are:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo POTELIGEO Ne uporabljajte zdravila POTELIGEO:
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.
Slovenian: Mogamulizumab je defukoziliran, humaniziran kapaimunoglobulin IgG1, ki se selektivno veže na CCR4, tj. na G-proteine vezan receptor za CC-kemokine, ki sodeluje pri prenašanju limfocitov v različne organe, vključno s kožo, kar povzroči izčrpavanje ciljnih celic.
English: 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%).
Slovenian: Na podlagi analize populacijske FK je geometrična sredina (% koeficient variacije [CV%]) očistka (CL) 12,0 ml/h (83,7 %), geometrična sredina razpolovnega časa izločanja (t1/2) pa 17 dni (65,5 %).
English: No confirmed responses were observed in these 10 subjects with low (<10%) CCR4 expression.
Slovenian: Pri teh 10 preiskovancih z nizko (< 10 %) izraženostjo CCR4 ni bilo potrjenih odzivov.
English: Store in a refrigerator (2ºC to 8ºC).
Slovenian: Shranjujte v hladilniku (2 °C - 8 °C).
English: Mogamulizumab should not be infused concomitantly in the same intravenous line with other medicinal products.
Slovenian: Mogamulizumab se ne sme infundirati sočasno z drugimi zdravili skozi isto intravensko linijo.
English: See section 2 “POTELIGEO contains sodium”.
Slovenian: Glejte poglavje 2 »Zdravilo POTELIGEO vsebuje natrij«.
English: Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Mogamulizumab has not been studied in patients with severe hepatic impairment (TB greater than 3 times ULN and any AST).
Slovenian: Mogamulizumaba niso raziskali pri bolnikih s hudo okvaro jeter (vrednost TB, višja od 3-kratne ULN, in kakršna koli vrednost AST).
English: Treatment with mogamulizumab continued until disease progression or unacceptable toxicity.
Slovenian: Zdravljenje z mogamulizumabom je trajalo do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
English: Overall, the median period of progression free survival for stage IB/II subjects treated with mogamulizumab was 4.7 months compared to 3.9 months for vorinostat-treated patients (Table 4).
Slovenian: Na splošno je bilo mediano obdobje preživetja brez napredovanja bolezni pri bolnikih v stadiju IB/II, zdravljenih z mogamulizumabom, 4,7 meseca v primerjavi s 3,9 meseca pri bolnikih, zdravljenih z vorinostatom (preglednica 4).
English: The majority of treatment-related dermatologic reactions were Grade 1 or 2, with Grade ≥3 drug rash occurring in 4.3% of patients.
Slovenian: Večina kožnih reakcij, povezanih z zdravljenjem, je bila 1. ali 2. stopnje, medtem ko se je izpuščaj stopnje ≥ 3 pojavil pri 4,3 % bolnikov.
English: The exposure to mogamulizumab increased proportionally with dose over the dose range of 0.1 to 1.0 mg/kg.
Slovenian: Izpostavljenost mogamulizumabu se je večala sorazmerno z odmerkom v razponu od 0,1 do 1,0 mg/kg.
English: 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.
Slovenian: Naslednji dejavniki niso imeli klinično pomembnega vpliva na CL mogamulizumaba: starost (razpon od 22 do 101 leta), spol, etnična pripadnost (razen Japoncev je za druge etnične skupine na voljo malo podatkov), okvara ledvic, blaga ali zmerna okvara jeter, podtip bolezni (fungoidna mikoza (FM) ali Sézaryjev sindrom (SS)), stopnja izraženosti CCR4 ali status ECOG, vendar je treba upoštevati, da so bili bolniki s telesno zmogljivostjo ECOG ≥ 2 izključeni iz kliničnih preskušanj.
English: 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.
Slovenian: Pri bolnikih z boleznijo stadija IB/II ni mogoče sklepati o trajanju odziva glede na omejeno število odzivnih oseb in nezrelost podatkov.
English: No specific studies in animals have been performed to evaluate the effect of mogamulizumab on fertility.
Slovenian: Pri živalih niso izvedli specifičnih študij za oceno vpliva mogamulizumaba na plodnost.
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).
Slovenian: 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 %).
English: Aseptically withdraw the required volume of POTELIGEO into the syringe and transfer into an infusion bag containing 9mg per ml (0.9%) sodium chloride solution for injection.
Slovenian: 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).
English: Severe adverse reactions included Grade 4 respiratory failure (1.1%) and Grade 5 reactions were polymyositis and sepsis (0.5% each).
Slovenian: Hudi neželeni učinki so vključevali respiratorno odpoved 4. stopnje (1,1 %) ter polimiozitis in sepso 5. stopnje (0,5 % pri obeh učinkih).
English: Elderly No dose adjustment is required in elderly patients (see section 5.2).
Slovenian: Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: What POTELIGEO is and what it is used for
Slovenian: Kaj je zdravilo POTELIGEO in za kaj ga uporabljamo
English: 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.
Slovenian: 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.
English: Although mogamulizumab crosses the placental barrier in cynomolgous monkey, apart from the pharmacological effect in foetuses, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Slovenian: 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).
English: The recommended dose is 1mg POTELIGEO for each kg of body weight.
Slovenian: Priporočeni odmerek je 1 mg zdravila POTELIGEO na vsak kilogram telesne mase.
English: Mogamulizumab has minor influence on the ability to drive and use machines.
Slovenian: Mogamulizumab ima blag vpliv na sposobnost vožnje in upravljanja strojev.
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.
Slovenian: 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.
English: Management of TLS may include aggressive hydration, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care.
Slovenian: lahko vključuje agresivno hidracijo, korekcijo nenormalnih ravni elektrolitov, zdravljenje hiperurikemije in podporno oskrbo.
English: If an anaphylactic reaction occurs, administration of mogamulizumab should be immediately and permanently discontinued and appropriate medical therapy should be administered.
Slovenian: Če se pojavi anafilaktična reakcija, je treba dajanje mogamulizumaba takoj in trajno ustaviti ter bolnika ustrezno zdraviti.
English: Duration of response (months) Median (95% CI) Response by compartment Blood n=124
Slovenian: Trajanje odziva (meseci) Mediana (95-odstotni IZ) Odziv po telesnih predelih Kri n = 124
English: Concentrate for solution for infusion 20 mg/5 mL
Slovenian: koncentrat za raztopino za infundiranje 20 mg/5 ml
English: Very common side effects (may affect more than 1 in 10 people):
Slovenian: Ti lahko vključujejo: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
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.
Slovenian: Rekonstituirana/razredčena raztopina: Uporabite jo takoj ali shranite v hladilniku (2 °C - 8 °C) in uporabite v 4 urah.
English: There are no data from the use of mogamulizumab in pregnant women.
Slovenian: Nosečnost Podatkov o uporabi mogamulizumaba pri nosečnicah ni.
English: • POTELIGEO is intended for intravenous use only, and should not be administered subcutaneously, intramuscularly, as a bolus dose or by rapid intravenous administration.
Slovenian: • Zdravilo POTELIGEO je namenjeno samo intravenski uporabi in se ne sme dajati subkutano, intramuskularno, kot bolusni odmerek ali s hitrim intravenskim injiciranjem.
English: Patients should be carefully monitored during and after infusion.
Slovenian: Bolnike je treba med infuzijo in po njej skrbno nadzorovati.
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.
Slovenian: 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.
English: Mogamulizumab should not be administered subcutaneously or intramuscularly, by rapid intravenous administration, or as an intravenous bolus.
Slovenian: Mogamulizumab se ne sme dajati subkutano ali intramuskularno, s hitrim intravenskim dajanjem ali kot intravenski bolus.
English: Subjects with MF or SS treated with mogamulizumab are at increased risk of serious infection and/or viral reactivation.
Slovenian: Pri bolnikih s FM ali SS, zdravljenih z mogamulizumabom, obstaja večje tveganje za resno okužbo in/ali ponovno aktivacijo virusa.
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.
Slovenian: • 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).
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«.
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.
Slovenian: 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.
English: Compartmental responses were seen in 3 of 10 evaluable subjects treated with mogamulizumab in the randomised or cross over phase.
Slovenian: Odzive na posameznih telesnih predelih so opazili pri 3 od 10 ocenljivih bolnikov, zdravljenih z mogamulizumabom v randomizirani fazi ali fazi prehoda.
English: CCR4 expression was assessed retrospectively on pretreatment skin biopsies (formalin fixed paraffin embedded) using immunohistochemistry.
Slovenian: Izraženost CCR4 je bila naknadno ocenjena na biopsijskih kožnih vzorcih, pridobljenih pred zdravljenjem (fiksiranih v formalinu in vdelanih v parafin), z uporabo imunohistokemije.
English: The majority of treatment-related infusion-related reactions were Grade 1 or 2 and occurred during or shortly after the first infusion.
Slovenian: Reakcije, povezane z infundiranjem, so bile večinoma 1. ali 2. stopnje in so se pojavile med prvo infuzijo ali kmalu po njej.
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.
Slovenian: 5 ml raztopine v 10-ml stekleni viali (steklo tipa I) z gumijastim zamaškom, aluminijastim tesnilom in polipropilensko zaporko s snemljivim pokrovčkom.
English: - have had tumour lysis syndrome (a complication involving the destruction of cancer cells) after a previous treatment.
Slovenian: - če ste kdaj imeli sindrom tumorske lize (zaplet, povezan z uničenjem rakavih celic) po predhodnem zdravljenju;
English: Follow patients closely for early evidence of transplant-related complications.
Slovenian: Bolnike natančno spremljajte in bodite pozorni na zgodnje znake zapletov,