FrancophonIA/ELRC3.0 huggingface dataset:
English: A risk to the newborn/infant cannot be excluded.
Slovenian: Tveganja za dojenega novorojenca/otroka ne moremo izključiti.
English: In this study in 36 patients, no new safety concerns were reported.
Slovenian: V tej študiji s 36 bolniki niso poročali o morebitnih novih varnostnih vprašanjih.
English: The dose of this medicine depends on your body weight.
Slovenian: Odmerek tega zdravila je odvisen od vaše telesne mase.
English: In general, these types of reactions occur within minutes to several hours following completion of the infusion.
Slovenian: Na splošno se te vrste reakcij pojavijo v nekaj minutah do nekaj urah po končanju infundiranja.
English: Additional follow up and evaluation may be warranted if no alternative diagnosis can be established.
Slovenian: Morda bo potrebno dodatno spremljanje in vrednotenje, če ne bo mogoče postaviti alternativnih diagnoz.
English: The safety and efficacy of ADCETRIS in children less than 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila ADCETRIS pri otrocih, mlajših od 18 let, še nista bili dokazani.
English: Continue with the same dose and schedule
Slovenian: Nadaljujte z enakim odmerkom in režimom.
English: FDG-NEGATIVE
Slovenian: FDG-NEGATIVNO
English: Dose and frequency
Slovenian: Odmerek in pogostnost
English: Final study report: 31/12/2020
Slovenian: Končno poročilo študije: 31. 12. 2020.
English: You should also inform your partner or caregivers about your treatment, since they may notice symptoms that you are not aware of.
Slovenian: O zdravljenju obvestite tudi svojega partnerja ali negovalca, ker lahko opazijo simptome, ki se jih sami ne zavedate.
English: • Two or more prior salvage therapies.
Slovenian: • Dve predhodni reševalni zdravljenji ali več.
English: Number of deaths c
Slovenian: Število smrti c
English: This includes herbal medicines and other medicines you can obtain without a prescription.
Slovenian: To vključuje zdravila rastlinskega izvora in druga zdravila, ki jih lahko dobite brez recepta.
English: Exposures were approximately dose proportional.
Slovenian: Izpostavljenost je bila približno sorazmerna z odmerkom.
English: You and your partner must use two methods of effective contraception during your treatment with this medicine.
Slovenian: Vi in vaš partner morate med uporabo tega zdravila uporabljati dve obliki učinkovite kontracepcije.
English: Serious infections and opportunistic infections
Slovenian: Resne okužbe in oportunistične okužbe
English: The investigator assessments were generally consistent with the independent review of the scans.
Slovenian: Ocena raziskovalca je bila na splošno skladna z neodvisnimi pregledi posnetkov.
English: However, chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C-8 °C.
Slovenian: Vendar pa je dokazana kemična in fizikalna stabilnost uporabe za 24 ur pri temperaturi od 2 °C do 8 °C.
English: Direct the stream toward the wall of the vial and not directly at the cake or powder.
Slovenian: Tok usmerite proti steni viale in ne neposredno na pogačo ali prašek.
English: The safety and efficacy results in these studies were consistent with results in Study C25001.
Slovenian: Rezultati glede varnosti in učinkovitosti iz teh študij se ujemajo z rezultati iz študije C25001.
English: Grade 1 (paraesthesia and/or loss of reflexes, with no loss of function)
Slovenian: 1. stopnja (parestezija in/ali izguba refleksov, brez izgube funkcije)
English: Median per Investigator
Slovenian: Mediana po raziskovalcu
English: If you feel unwell during treatment then do not drive or operate machines.
Slovenian: Če se med zdravljenjem ne počutite dobro, ne vozite vozil in ne upravljajte strojev.
English: However, they may develop more than several hours after completion of the infusion but this is uncommon.
Slovenian: Vendar pa se lahko razvijejo tudi več ur po infundiranju zdravila, čeprav je to neobičajno.
English: The results of these post-hoc analyses suggest increased clinical benefit for patients with two or more risk factors but no difference based on any of the individual risk factors.
Slovenian: Rezultati teh naknadnih analiz nakazujejo povečane klinične prednosti za bolnike z dvema ali več dejavniki tveganja, vendar brez razlike glede na posamične dejavnike tveganja.
English: Eligible patients were required to have at least one of the following risk factors:
Slovenian: Da je bil bolnik primeren, je moral imeti vsaj enega od treh naslednjih dejavnikov tveganja:
English: It is not for use in children.
Slovenian: Zdravilo ni namenjeno za uporabo pri otrocih.
English: Total storage time of the solution from reconstitution to infusion should not exceed 24 hours.
Slovenian: Skupni čas shranjevanja raztopine od rekonstitucije do infundiranja ne sme preseči 24 ur.
English: Table 14 includes the results for ORR4 and other key secondary endpoints.
Slovenian: Preglednica 14 vsebuje rezultate za ORR4 in druge ključne sekundarne opazovane dogodke.
English: Calculated from a weighted Holm's procedure
Slovenian: Izračunana iz utežene Holmove metode
English: Your doctor will perform regular blood tests to make sure that it is safe for you to receive this medicine.
Slovenian: Zdravnik bo redno opravljal krvne preiskave, da se prepriča, ali lahko to zdravilo varno uporabljate.
English: MMAE did not induce any major CYP450 enzymes in primary cultures of human hepatocytes.
Slovenian: MMAE ne inducira nobenih pomembnejših encimov CYP450 v primarnih kulturah človeških hepatocitov.
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Slovenian: Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14(7) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
English: Stratification factors at randomisation.
Slovenian: Dejavniki stratifikacije pri randomizaciji.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
English: Currently available data are described in sections 4.8, 5.1 and 5.2.
Slovenian: Trenutno razpoložljivi podatki so navedeni v poglavjih 4.8, 5.1 in 5.2.
English: Determining dosage amount:
Slovenian: Določanje količine odmerka:
English: It is important to tell your doctor before and during treatment if you are pregnant, think you may be pregnant, or are planning to get pregnant.
Slovenian: Pomembno je, da zdravnika pred zdravljenjem ali med njim obvestite, če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev.
English: Patients with Stage IV Disease
Slovenian: Bolniki z boleznijo stadija IV
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: Indicates results from non-stratified analysis.
Slovenian: Prikazani rezultati nestratificirane analize.
English: Lonza AG Lonzastrasse 3930 Visp Switzerland
Slovenian: Lonza AG Lonzastrasse 3930 Visp Švica
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Stable Disease
Slovenian: Stabilna bolezen
English: The recommended dose of ADCETRIS is infused over 30 minutes.
Slovenian: Priporočeni odmerek zdravila ADCETRIS se infundira v 30 minutah.
English: A lesser amount of MMAE (28%) was excreted in the urine.
Slovenian: Manjša količina MMAE (28%) se je izločila z urinom.
English: Fatal outcomes have been reported.
Slovenian: Poročali so tudi o usodnih izidih.
English: Discontinue treatment a.
Slovenian: Prekinite zdravljenje a.
English: Post-hoc analyses were performed to evaluate the impact of increased risk (number of risk factors) on clinical benefit (Table 8).
Slovenian: Naknadne analize so bile izvedene za ovrednotenje vpliva povečanega tveganja (število dejavnikov tveganja) na klinične prednosti (preglednica 8).
English: Represents pooling of preferred terms.
Slovenian: Predstavlja združene podatke za preferenčne izraze.
English: Investigations Very common:
Slovenian: Preiskave Zelo pogosti:
English: If you are an older patient (≥ 65 years of age) you may experience serious adverse events more frequently.
Slovenian: Če ste starejši bolnik (stari ≥ 65 let), se lahko resni neželeni dogodki pri vas pojavijo pogosteje.
English: These data suggest that efficacy and safety can be extrapolated to other CTCL CD30+ subtypes.
Slovenian: Ti podatki kažejo, da je mogoče učinkovitost in varnost ekstrapolirati na druge CD30-pozitivne podtipe CTCL.
English: Infusion reactions to this medicine may affect more than 1 in 10 people.
Slovenian: Infuzijske reakcije na to zdravilo se lahko pojavijo pri več kot 1 od 10 bolnikov.
English: The dosing recommendations for patients aged 65 and older are the same as for adults.
Slovenian: Priporočeno odmerjanje za bolnike, stare 65 let in več, je enako kot za odrasle.
English: Store in a refrigerator
Slovenian: Shranjujte v hladilniku.
English: Stratified log-rank test was not performed for PFS per Investigator.
Slovenian: Stratificirani test log-rank po raziskovalcu za PFS ni bil opravljen.
English: A negative JCV PCR does not exclude PML.
Slovenian: Negativni test PCR za JCV ne izključuje PML.
English: Per Ann Arbor Staging IPFP = International Prognostic Factor Project
Slovenian: Razvrstitev po klasifikaciji Ann Arbor IPFP = International Prognostic Factor Project (Mednarodni projekt za prognostične dejavnike)
English: Of these 33 patients who received the RP2D, 32 were evaluable for response.
Slovenian: Izmed 33 bolnikov, ki so prejeli odmerek RP2D, je bilo pri 32 mogoče oceniti odziv.
English: One patient in each arm had incomplete staging data and are not included in the table
Slovenian: Pri enem bolniku v vsaki skupini so bili podatki nepopolni in niso vključeni v preglednico.
English: Women must continue using contraception for 6 months following the last dose of Adcetris.
Slovenian: Ženske morajo kontracepcijo uporabljati še 6 mesecev po zadnjem odmerku zdravila Adcetris.
English: The significance of this finding in stage IV HL patients with no extranodal disease is not established due to small patient numbers and low event rates (14 events).
Slovenian: Pomembnosti te ugotovitve za bolnike z HL stadija IV brez ekstranodalne bolezni ni mogoče ovrednotiti zaradi majhnega števila bolnikov in nizke stopnje pojavnosti dogodkov (14 primerov).
English: Death without either prior progression or more than one missed assessment visit.
Slovenian: Smrtni primeri ne vključujejo bolnikov s predhodnim napredovanjem ali več kot enim zgrešenim obiskom za ovrednotenje.
English: If you have these symptoms prior to treatment with this medicine, tell your doctor immediately about any changes in these symptoms.
Slovenian: Če imate te simptome že pred začetkom zdravljenja s tem zdravilom, takoj obvestite zdravnika, če se ti simptomi spremenijo.
English: In vitro, the binding of MMAE to human serum plasma proteins ranged from 68-82%.
Slovenian: In vitro je bil razpon vezave MMAE na beljakovine v serumu človeške plazme med 68-82%.
English: You may be given other medicines such as anti-histamines, corticosteroids or paracetamol to help reduce any of the reactions above if you have already experienced these when receiving this type of medicine.
Slovenian: Morda boste prejeli druga zdravila, kot so - antihistaminiki, kortikosteroidi ali paracetamol, ki pomagajo zmanjšati morebitne zgoraj navedene reakcije, če ste jih pri uporabi te vrste zdravila že doživeli.
English: Number of Risk Factors = 1
Slovenian: Število dejavnikov tveganja = 1
English: See the fertility section below pertaining to advice for women whose male partners are being treated with ADCETRIS.
Slovenian: Glejte spodnje poglavje za plodnost, ki vsebuje nasvet za ženske, katerih moški partnerji se zdravijo z zdravilom ADCETRIS.
English: These features make CD30 a target for therapeutic intervention.
Slovenian: Zaradi teh značilnosti je CD30 tarča za terapevtski poseg.
English: Procedures for proper handling and disposal of anticancer medicines should be considered.
Slovenian: Upoštevati morate postopke za pravilno ravnanje z zdravili proti raku in njihovo odstranjevanje.
English: Date of first authorisation: 25 October 2012
Slovenian: Datum prve odobritve: 25. oktober 2012 Datum zadnjega podaljšanja: 10. september 2018
English: Patients should be carefully monitored during treatment for the emergence of possible serious and opportunistic infections.
Slovenian: Bolnike je treba med zdravljenjem skrbno nadzirati glede pojava možnih resnih in oportunističnih okužb.
English: If you think you have previously had a similar reaction, tell your doctor BEFORE you are given this medicine.
Slovenian: Če menite, da ste že prej imeli podobne reakcije, obvestite zdravnika, PREDEN dobite to zdravilo.
English: Number of patients with disease progression or death a
Slovenian: Število bolnikov z napredovanj em bolezni ali smrtjo a
English: Severe and prolonged (≥ 1 week) neutropenia can occur with this treatment which may increase the risk of patients developing serious infections.
Slovenian: Pri tem zdravljenju se lahko pojavi resna in podaljšana (≥ 1 teden) nevtropenija, ki lahko pri bolnikih poveča tveganje za razvoj resnih okužb.
English: If you have any questions on the use of this medicine, ask the doctor or nurse who is giving you the infusion.
Slovenian: Če imate kakršna koli vprašanja o uporabi tega zdravila, vprašajte zdravnika ali medicinsko sestro, ki vam daje infuzijo.
English: The efficacy results are shown in Table 7.
Slovenian: Rezultati učinkovitosti so prikazani v preglednici 7.
English: What Adcetris is and what it is used for
Slovenian: Kaj je zdravilo Adcetris in za kaj ga uporabljamo
English: Gastrointestinal complications
Slovenian: Gastrointestinalni zapleti
English: Testicular atrophy and degeneration were partially reversible following a 16-week treatment-free period.
Slovenian: Testikularna atrofija in degeneracija sta bili delno reverzibilni po 16-tedenskem obdobju brez zdravljenja.
English: If you develop infusion reactions (as stated previously), your doctor may stop giving this medicine and start support treatment.
Slovenian: Če se razvijejo infuzijske reakcije (kot so navedene zgoraj), lahko zdravnik preneha z dajanjem tega zdravila in uvede podporno zdravljenje.
English: Of the ITT population, 846 patients (64%) had Stage IV disease.
Slovenian: V populaciji ITT je imelo 846 bolnikov (64%) bolezen stadija IV.
English: After reconstitution/dilution, from a microbiological point of view, the product should be used immediately.
Slovenian: Po rekonstituciji/redčenju je treba zdravilo z mikrobiološkega vidika uporabiti takoj.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: For further efficacy results, see Table 12 and Figure 5.
Slovenian: Za nadaljnje rezultate učinkovitosti glejte preglednico 12 in sliko 5.
English: Your doctor or nurse will also monitor you during and after the infusion.
Slovenian: Zdravnik ali medicinska sestra vas bosta nadzirala med infundiranjem in po njem.
English: These results were consistent with the pharmacological effect of MMAE on the mitotic apparatus (disruption of the microtubule network) in cells.
Slovenian: Ti rezultati so skladni s farmakološkim učinkom MMAE na mitotski aparat (prekinitev mikrotubulnega omrežja) v celicah.
English: (95% CI [0.40, 0.81]) Stratified log-rank test p=0.001
Slovenian: (95% IZ [0,40, 0,81]) stratificirani test log-rank P = 0,001
English: The levels of MMAE metabolites have not been measured in human plasma.
Slovenian: Ravni presnovkov MMAE v človeški plazmi niso izmerili.
English: MMAE does not inhibit other isoforms.
Slovenian: MMAE ne zavira drugih izooblik.
English: Like all medicines, this medicine may cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Median per IRF
Slovenian: Mediana po IRF
English: 3.6 vials a.
Slovenian: 3,6 viale a.
English: These infusion reactions can be serious or even fatal (known as an anaphylactic reaction).
Slovenian: Infuzijska reakcija je lahko huda ali celo smrtna (znana kot anafilaktična reakcija).
English: In humans, the mean steady state volume of distribution was approximately 6-10 l for ADC.
Slovenian: Pri ljudeh je bil povprečni volumen porazdelitve v stanju dinamičnega ravnovesja približno 6-10 l za ADC.
English: The median time from onset to resolution or improvement for all events ranged from 16 to 23.4 weeks.
Slovenian: Mediani čas od začetka do prenehanja ali izboljšanja vseh dogodkov je znašal od 16 do 23,4 tedna.
English: Other medicines and Adcetris
Slovenian: Druga zdravila in zdravilo Adcetris
English: The ADC is expected to be catabolised as a protein with component amino acids recycled or eliminated.
Slovenian: Pričakuje se, da se ADC katalizira kot beljakovina, pri čemer se sestavna aminokislina reciklira ali izloči.
English: The frequency of unique serious adverse drug reactions was ≤ 1%.
Slovenian: Pogostost edinstvenih resnih neželenih učinkov zdravila je znašala ≤ 1%.
English: Advanced age was a risk factor for febrile neutropenia in patients in both arms.
Slovenian: Višja starost je bila dejavnik tveganja za febrilno nevtropenijo pri bolnikih v obeh skupinah.
English: MMAE is a substrate of CYP3A4 and possibly CYP2D6.
Slovenian: MMAE je substrat encima CYP3A4 in morda tudi CYP2D6.
English: The median time from initial sALCL diagnosis to first dose with ADCETRIS was 16.8 months.
Slovenian: Mediani čas od prvotne diagnoze sALCL do prvega odmerka zdravila ADCETRIS je bil 16,8 mesecev.
English: Frequencies of adverse reactions described below and in Table 3 have been determined based on data generated from clinical studies.
Slovenian: Pogostnost neželenih učinkov, navedenih v nadaljevanju in v preglednici 3, so določili na osnovi podatkov iz kliničnih študij.
English: HL at increased risk of relapse or progression
Slovenian: HL pri povečanem tveganju ponovitve ali napredovanja bolezni
English: The safety profile in elderly patients was consistent with that of adult patients.
Slovenian: Varnostni profil pri starejših bolnikih se je ujemal z varnostnim profilom pri odraslih bolnikih.
English: Treatment should be continued until disease progression or unacceptable toxicity(see section 4.4).
Slovenian: Zdravljenje je treba nadaljevati do napredovanja bolezni ali nesprejemljive toksičnosti (glejte poglavje 4.4).
English: What Adcetris is and what it is used for What you need to know before you are given Adcetris How Adcetris will be given Possible side effects
Slovenian: Kaj je zdravilo Adcetris in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Adcetris Kako se daje zdravilo Adcetris Možni neželeni učinki
English: Reconstituted/diluted solution: Use immediately or store in a refrigerator (2 C-8 °C) and use within 24 hours.
Slovenian: Rekonstituirana/razredčena raztopina: Uporabite takoj ali shranite v hladilniku (2 C-8 °C) ter porabite v 24 urah.
English: 2.4 vials a.
Slovenian: 2,4 viale a.
English: - are allergic to brentuximab vedotin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na brentuksimab vedotin ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, toda priporočil za odmerjanje ni mogoče podati.
English: Disease control rate (CR + PR + SD) Duration of response
Slovenian: Nadzorovana bolezen (CR + PR + SD) Trajanje odziva
English: There are no data from the use of ADCETRIS in pregnant women.
Slovenian: Podatkov o uporabi zdravila ADCETRIS pri nosečnicah ni.
English: A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from this therapy, taking into account a potential risk of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja, pri čemer je treba pretehtati potencialno tveganje dojenja za otroka in prednosti zdravljenja za mater.
English: Piramal Healthcare UK Ltd. Earls Road, Grangemouth Stirlingshire, Scotland FK3 8XG United Kingdom
Slovenian: Piramal Healthcare UK Ltd. Earls Road, Grangemouth Stirlingshire, Scotland FK3 8XG Velika Britanija
English: PML is a rare demyelinating disease of the central nervous system that results from reactivation of latent JCV and is often fatal.
Slovenian: PML je redka demielinizacijska bolezen osrednjega živčnega sistema, ki je posledica reaktivacije latentnega JCV, in je pogosto smrtna.
English: Estimated 5-year OS Rate a.
Slovenian: Ocenjeno 5-letno celokupno preživetje a.
English: After the first dose of Adcetris in combination with chemotherapy, your doctor may also give you a medicine that will help prevent development or reduce the severity of neutropenia (decrease of white blood cell count) which can increase the risk of infection.
Slovenian: Po prvem odmerku zdravila Adcetris v kombinaciji s kemoterapijo vam lahko zdravnik predpiše tudi zdravilo, ki pomaga preprečiti ali zmanjšati stopnjo resnosti nevtropenije (zmanjšanje števila belih krvnih celic), katera lahko poveča tveganje za okužbe.
English: 40.5 months
Slovenian: 40,5 meseca
English: CTCL is a cancer of a certain type of white blood cell called a ‘T-cell' that mainly affects the skin.
Slovenian: CTCL je rak določene vrste belih krvnih celic, imenovanih limfociti T, ki prizadene predvsem kožo.
English: The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e.g., cognitive, neurological, or psychiatric symptoms).
Slovenian: Zdravnik mora biti zlasti pozoren na simptome, ki nakazujejo na PML, in jih bolnik morda ne opazi (npr. kognitivni, nevrološki ali psihiatrični simptomi).
English: Response to treatment with ADCETRIS was assessed by Independent Review Facility (IRF) using the Revised Response Criteria for Malignant Lymphoma (Cheson, 2007).
Slovenian: Odziv na zdravljenje z zdravilom ADCETRIS je ocenil neodvisen odbor za pregled (IRF) z uporabo revidiranih kriterijev odziva za maligni limfom (“Revised Response Criteria for Malignant Lymphoma”) (Cheson, 2007).
English: If a pregnant woman needs to be treated she should be clearly advised on the potential risk to the foetus.
Slovenian: Če je nosečnico treba zdraviti, jo je treba jasno opozoriti glede možnih tveganj za plod.
English: In the first cycle, higher MMAE exposure was associated with an absolute decrease in neutrophil count.
Slovenian: V prvem ciklusu je bila višja izpostavljenost MMAE povezana z absolutnim znižanjem števila nevtrofilcev.