FrancophonIA/ELRC3.0 huggingface dataset:
English: • Keep this card with you all the timesuch as in your wallet or purse.
Slovenian: • Kartico imejte vedno ob sebi, na primer v denarnici ali torbici.
English: Your doctor may change this, depending on how you respond to the medicine.
Slovenian: Zdravnik lahko to spremeni, odvisno od tega, kako se odzovete na zdravilo.
English: From a microbiological point of view, the prepared infusion solution should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba pripravljeno infuzijsko raztopino uporabiti takoj.
English: - * Worst case imputation a Non-inferiority was demonstrated since the lower bound (−3.2%) was higher than the pre-determined non-inferiority margin (− 20%).
Slovenian: * Imputacija za najslabši primer a Neinferiornost je bila dokazana, ker je bila spodnja meja (−3,2 %) višja od vnaprej opredeljene meje neinferiornosti (−20 %).
English: When these symptoms go away, or improve, the infusion can be continued.
Slovenian: Ko ti simptomi izginejo ali se izboljšajo, se lahko infuzija nadaljuje.
English: Most side effects are mild to moderate but some may be serious and require treatment.
Slovenian: Večina neželenih učinkov je blagih do zmernih, a nekateri so lahko resni in zahtevajo zdravljenje.
English: Standard tests to investigate mutagenicity have not been carried out, since such tests are not relevant for this molecule.
Slovenian: Standardni testi za raziskovanje mutagenosti niso bili izvedeni, kajti tovrstni testi za to molekulo niso relevantni.
English: The syndrome frequently manifests itself within one or two hours of initiating the first infusion.
Slovenian: Sindrom se pogosto pokaže v eni do dveh urah po začetku prve infuzije.
English: 20 Academy-ro 51 beon-gil Yeonsu-gu, Incheon, 22014, Republic of Korea
Slovenian: 20 Academy-ro 51 beon-gil Yeonsu-gu, Incheon, 22014, Republika Koreja
English: Do not have Ritemvia if you have an active infection or a serious problem with your immune system.
Slovenian: Zdravila Ritemvia ne smete prejeti, če imate aktivno okužbo ali resno težavo s svojim imunskim sistemom.
English: Look out for the following possible signs of infection:
Slovenian: Bodite pozorni na naslednje znake okužbe:
English: The median follow up of patients was 53 months.
Slovenian: Mediana spremljanja bolnikov je bila 53 mesecev.
English: These patients should be very closely monitored throughout the first infusion.
Slovenian: Te bolnike moramo v celotnem teku prve infuzije natančno opazovati.
English: Tell the person giving you the infusion immediately if you develop any of these symptoms, as the infusion may need to be slowed down or stopped.
Slovenian: Nemudoma povejte osebi, ki vam daje infuzijo, če se pri vas pojavi kateri od teh simptomov, ker bo morda treba infuzijo upočasniti ali jo ustaviti.
English: Care must be taken to ensure the sterility of prepared solutions.
Slovenian: Treba je paziti, da zagotovimo sterilnost pripravljene raztopine.
English: Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Slovenian: Bolnikom je treba naročiti, naj o svojem zdravljenju obvestijo partnerja ali skrbnike, ker bodo morda ti opazili simptome, ki se jih bolniki ne zavedajo.
English: The incidence of serious infections was similar in both arms (approximately 12%).
Slovenian: Pojavnost resnih okužb je bila v obeh skupinah podobna (približno 12%).
English: Primary efficacy
Slovenian: Primarna učinkovitost
English: b The 95.1% confidence level reflects an additional 0.001 alpha to account for an interim efficacy analysis.
Slovenian: b 95,1-% interval zaupanja vključuje dodatni 0,001 alfa na račun vmesne analize učinkovitosti.
English: Ritemvia may also cause changes in laboratory tests carried out by your doctor.
Slovenian: Zdravilo Ritemvia lahko vpliva tudi na spremembe laboratorijskih preiskav, ki jih naroči vaš zdravnik.
English: Patients should receive Ritemvia for at least 24 months after achievement of remission (absence of clinical signs and symptoms).
Slovenian: Bolniki morajo zdravilo Ritemvia prejemati vsaj 24 mesecev po doseženi remisiji (odsotnost kliničnih znakov in simptomov).
English: This will be administered 1 year and 18 months after the initial treatment and then every 6 months as needed or your doctor may change this, depending on how you respond to the medicine.
Slovenian: Tega boste dobili 1 leto in 18 mesecev po začetnem zdravljenju in nato vsakih 6 mesecev, če bo treba, a zdravnik vam lahko ta razpored spremeni, odvisno od tega, kako se odzovete na zdravilo.
English: Post-hoc retrospective laboratory evaluation
Slovenian: Post-hoc retrospektivna laboratorijska ocena
English: Tell your doctor immediately if you have any of these symptoms.
Slovenian: Nemudoma povejte svojemu zdravniku, če se pri vas pojavi kateri od teh simptomov.
English: p-value (Wald test, not adjusted)
Slovenian: p-vrednost (test Wald, ni prilagojen)
English: Oncology indications:
Slovenian: Onkološke indikacije:
English: The alert card contains important safety information for patients regarding potential increased risk of infections, including PML.
Slovenian: Opozorilna kartica vsebuje za bolnika pomembne podatke o varnosti glede možnega povečanega tveganja za okužbe, vključno s PML.
English: The gender-related pharmacokinetic differences are not considered to be clinically relevant and dose adjustment is not required.
Slovenian: S spolom povezane razlike v farmakokinetiki ne štejemo za klinično pomembne in prilagajanje odmerkov ni potrebno.
English: 4 Includes observations collected as part of routine laboratory monitoring.
Slovenian: 4Vključujejo opažanja zbrana v okviru rutinskega laboratorijskega spremljanja.
English: 7 includes fatal cases
Slovenian: 7 Vključujejo smrtne primere.
English: B cell counts returned to normal in these animals within 6 months of birth and did not compromise the reaction to immunisation.
Slovenian: Število celic B se je pri teh živalih vrnilo na normalno raven v 6 mesecih po rojstvu in ni ogrožalo reakcije na imunizacijo.
English: CD20 does not circulate in the plasma as a free antigen and, thus, does not compete for antibody binding.
Slovenian: CD20 ne kroži v plazmi kot prosti antigen in zato ne tekmuje za vezavo na protitelo.
English: Block 7, City North Business Campus, Stamullen, Co. Meath K32 YD60, Ireland
Slovenian: Block 7, City North Business Campus, Stamullen, Co. Meath K32 YD60, Irska
English: If you can get pregnant, you and your partner must use an effective method of contraception while using Ritemvia.
Slovenian: Če bi lahko zanosili, morate vi in vaš partner med uporabo zdravila Ritemvia uporabljati učinkovito kontracepcijsko zaščito.
English: You may require additional treatment such as an antihistamine or paracetamol.
Slovenian: Morda boste potrebovali dodatno zdravljenje z zdravili, kot so antihistaminiki ali paracetamol.
English: Your doctor may decide to stop your Ritemvia treatment if these reactions are serious.
Slovenian: Zdravnik se lahko odloči za prenehanje zdravljenja z zdravilom Ritemvia, če so te reakcije resne.
English: 9.32 years
Slovenian: 9,32 let
English: The safety and efficacy of Ritemvia in children below 18 years has not been established.
Slovenian: Varnost in učinkovitost zdravila Ritemvia pri otrocih do 18 leta starosti nista dokazani.
English: • The need for close supervision during administration in an environment where full resuscitation facilities are immediately available
Slovenian: • informacije o nujnosti skrbnega nadzora med aplikacijo v okolju, kjer so vsi pripomočki za oživljanje nemudoma na voljo,
English: Your doctor may decide to treat you longer with Ritemvia (up to 5 years), depending on how you respond to the medicine.
Slovenian: Zdravnik se lahko odloči, da vas bo z zdravilom Ritemvia zdravil dlje (do 5 let), odvisno od tega, kako se odzovete na zdravilo.
English: • Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your Ritemvia.
Slovenian: • Pokažite jo vsem zdravnikom, medicinskim sestram in zobozdravnikom, ki jih obiščete - ne samo specialistu, ki vam predpiše zdravilo Ritemvia.
English: Since the medicinal product does not contain any anti-microbial preservative or bacteriostatic agents, aseptic technique must be observed.
Slovenian: Ker zdravilo ne vsebuje antimikrobnih ali bakteriostatičnih zaščitnih sredstev, je treba upoštevati aseptično tehniko.
English: • if you have ever taken medicines which affect your immune system - such as chemotherapy or immune-suppressive medicines.
Slovenian: • če ste kdaj jemali zdravila, ki vplivajo na imunski sistem - na primer kemoterapijo ali imunosupresivna zdravila.
English: Kaplan-Meier estimate of median time to event (months)
Slovenian: Kaplan-Meierjeva ocena mediane časa do dogodka (meseci)
English: Of 356 patients evaluated for anti-drug antibody (ADA), 1.1% (4 patients) were positive.
Slovenian: Od 356 bolnikov, pri katerih so ocenjevali prisotnost protiteles proti zdravilu (anti-drug antibody -ADA), so bili pozitivni 4 bolniki (1,1%).
English: It remains unknown if early detection of PML and suspension of rituximab therapy may lead to similar stabilisation or improved outcome.
Slovenian: Ni znano, ali lahko zgodnje odkritje PML in ukinitev zdravljenja z zdravilom rituksimab doseže podobno stabilizacijo ali izboljšanje izida.
English: • you have a weak immune system
Slovenian: • imate oslabel imunski sistem;
English: Exploratory analyses of the benefit of maintenance treatment showed a less pronounced effect in elderly patients (> 70 years of age), however sample sizes were small.
Slovenian: Eksplorativne analize koristi vzdrževalnega zdravljenja so pokazale manj izrazit učinek pri starejših bolnikih (> 70 let), vendar je bil vzorec majhen.
English: Ritemvia will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Slovenian: Zdravilo Ritemvia vam bo dal zdravnik ali medicinska sestra, ki ima izkušnje z uporabo takšnih zdravil.
English: Final analysis (median FU: 9.0 years)
Slovenian: Končna analiza (mediana spremljanja: 9,0 let)
English: Population pharmacokinetic analysis revealed that BSA and gender were the most significant covariates to explain inter-individual variability in pharmacokinetic parameters.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da sta bila telesna površina in spol najbolj pomembni so-spremenljivki za razlago variabilnosti v farmakokinetičnih parametrih med posamezniki.
English: Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection.
Slovenian: Bolnike, ki so kdaj imeli okužbo z virusom hepatitisa B, bo zdravnik skrbno spremljal glede znakov te okužbe;
English: Complete remission All Patients Newly diagnosed Relapsing
Slovenian: Popolna remisija Vsi bolniki Novoodkriti Ponovitev
English: Name:_______________________ Doctor's
Slovenian: Datum zadnjega infundiranja:____________ Datum prvega infundiranja:______________ Bolnikovo ime: _______________________ Zdravnikovo ime:______________________ Zdravnikov telefon:____________________
English: Before you are given Ritemvia, you will be given other medicines (pre-medication) to prevent or reduce possible side effects.
Slovenian: Preden boste dobili zdravilo Ritemvia, boste dobili druga zdravila (to imenujemo premedikacija) za preprečitev ali zmanjšanje možnih neželenih učinkov.
English: In order to improve traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded (or stated) in the patient file.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba lastniško ime in številko serije uporabljenega zdravila jasno zabeležiti (navesti) v bolnikovo kartoteko.
English: • if you think you may have an infection, even a mild one like a cold.
Slovenian: • če menite, da bi lahko imeli okužbo, četudi blago, kot je prehlad.
English: After adjusting for BSA, male subjects had a larger volume of distribution and a faster clearance than female subjects.
Slovenian: Po prilagoditvi za telesno površino so imeli moški večji volumen distribucije in večji očistek kot ženske.
English: When should I not have Ritemvia?
Slovenian: Kdaj ne smete prejeti zdravila Ritemvia?
English: The pre-specified non-inferiority margin for the treatment difference was 20%.
Slovenian: Vnaprej opredeljena meja neinferiornosti za razliko zdravljenj je bila 20%.
English: Secondary efficacy
Slovenian: Sekundarna učinkovitost
English: Rarely, some of these reactions have been fatal.
Slovenian: Redko so bili nekateri od teh neželenih učinkov smrtni.
English: The primary endpoint was the proportion of patients who achieved an ACR20 response at week 24.
Slovenian: Primarni cilj študije je bil ugotoviti delež bolnikov, ki so po 24 tednih dosegli odziv ACR20.
English: Patients were followed beyond week 24 for long-term endpoints, including radiographic assessment at 56 weeks and at 104 weeks.
Slovenian: Bolnike so od 24. tedna spremljali za dolgoročne cilje študije in naredili tudi radiološko oceno po 56 tednih ter 104 tednih.
English: Note: Patients were censored at month 28 if they had no event.
Slovenian: Opomba: Podatki so bili krnjeni, če so bili bolniki ob 28. mesecu brez dogodka.
English: Ritemvia will be given to you once a week for 4 weeks.
Slovenian: ga boste prejeli enkrat na teden 4 tedne.
English: Your doctor will check if you should have any vaccines before you receive Ritemvia.
Slovenian: Vaš zdravnik bo preveril, ali bi morali biti cepljeni, preden boste dobili zdravilo Ritemvia.
English: Outcome†
Slovenian: Izid†
English: 5 Includes fatal cases
Slovenian: 5Vključujejo smrtne primere.
English: Contraception in males and females
Slovenian: Kontracepcija za moške in ženske
English: You must tell your doctor or nurse if you are pregnant, think that you might be pregnant or are planning to become pregnant.
Slovenian: Nosečnost in dojenje Zdravniku ali medicinski sestri morate povedati, če ste noseči, menite, da ste noseči, ali načrtujete zanositev.
English: Risk Reduction
Slovenian: Zmanjšanje tveganja
English: Patients were between 19 and 79 years of age and had not received prior therapies for pemphigus.
Slovenian: Bolniki so bili stari od 19 do 79 let in predhodno niso prejemali zdravljenja za pemfigus.
English: For patients randomised to the maintenance phase of the trial, the median observation time was 28 months from maintenance randomisation.
Slovenian: Za bolnike, randomizirane v vzdrževalni del preskušanja, je bil mediani čas opazovanja 28 mesecev od randomizacije na vzdrževanje.
English: These findings were replicated at Week 48, where autoantibody seropositivity also significantly increased the probability of achieving ACR70.
Slovenian: Ti izsledki so se ponovili 48. teden, ko je seropozitivnost prav tako značilno povečala verjetnost za doseganje odziva ACR70.
English: Physical function and quality of life outcomes
Slovenian: Funkcijska zmogljivost in vpliv na kakovost življenja
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 še posebno pozoren na simptome, ki nakazujejo na PML in jih bolniki sami morda ne opazijo (npr. kognitivne, nevrološke ali psihiatrične).
English: Rituximab was detectable in the serum of patients 3 - 6 months after completion of last treatment.
Slovenian: Rituksimab je bilo mogoče zaznati v serumu bolnikov 3 do 6 mesecev po zaključku zadnjega zdravljenja.
English: For these reasons rituximab should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Slovenian: Zato nosečnice ne smejo prejemati zdravila rituksimab, razen če je pričakovana korist večja od možnega tveganja.
English: The incidence of IRR symptoms was highest during or after the first infusion (9%) and decreased with subsequent infusions (< 4%).
Slovenian: Pojavnost simptomov IRR je bila največja med prvo infuzijo ali po njej (9%) in se je ob nadaljnjih infuzijah zmanjšala (< 4%).
English: Tell your doctor or nurse if you are taking or have previously taken medicines which may affect your immune system this includes chemo-therapy.
Slovenian: Zdravniku ali medicinski sestri povejte, če jemljete ali ste jemali zdravila, ki lahko vplivajo na vaš imunski sistem, kar vključuje tudi kemoterapijo.
English: Across all development studies the treatment benefit was similar in patients independent of age, gender, body surface area, race, number of prior treatments or disease status.
Slovenian: V vseh razvojnih študijah je bila korist zdravljenja pri bolnikih podobna, ne glede na starost, spol, telesno površino, raso, število predhodnih zdravljenj ali stanje bolezni.
English: Further treatment of patients after complete resolution of signs and symptoms has rarely resulted in repeated severe cytokine release syndrome.
Slovenian: Nadaljnje zdravljenje bolnikov je po popolnem izginotju znakov in simptomov redko povzročilo ponoven hud sindrom sproščanja citokinov.
English: Before giving a subsequent course of rituximab treatment, patients should be re-evaluated for any potential risk for infections.
Slovenian: Pred dajanjem nadaljnjega cikla zdravila rituksimab je treba bolnike ponovno oceniti glede možnega tveganja za okužbe.
English: Of 67 patients evaluated for human anti-mouse antibody (HAMA), no responses were noted.
Slovenian: Pri 67 bolnikih, pri katerih so analizirali prisotnost humanih protimišjih protiteles (human anti-mouse antibody - HAMA), teh niso opazili.
English: A maintenance infusion of 500 mg IV should be administered at months 12 and 18, and then every 6 months thereafter if needed, based on clinical evaluation.
Slovenian: Vzdrževalno infuzijo 500 mg intravensko je treba uporabiti v 12. in 18. mesecu in nato vsakih 6 mesecev, če je treba na podlagi klinične ocene.
English: Granulomatosis with polyangiitis and microscopic polyangiitis are two forms of inflammation of the blood vessels which mainly affects the lungs and kidneys, but may affect other organs as well.
Slovenian: Granulomatoza s poliangiitisom in mikroskopski poliangiitis sta dve obliki vnetja krvnih žil, ki večinoma prizadeneta pljuča in ledvice, a lahko prizadeneta tudi druge organe.
English: Therefore, patients with a history of cardiac disease and/or cardiotoxic chemotherapy should be monitored closely.
Slovenian: Zato je treba bolnike z anamnezo srčne bolezni in/ali kardiotoksične kemoterapije skrbno nadzorovati.
English: If you respond well to treatment, you may be given Ritemvia as a maintenance treatment.
Slovenian: Če se boste na zdravilo dobro odzvali, boste lahko zdravilo Ritemvia prejemali kot vzdrževalno zdravljenje.
English: The risk of disease progression was reduced by 46% and the risk of relapse by 51%.
Slovenian: Tveganje za napredovanje bolezni je bilo manjše za 46 %, tveganje za ponovitev bolezni pa za 51%.
English: Initial treatment, in combination with chemotherapy
Slovenian: Začetno zdravljenje v kombinaciji s kemoterapijo
English: The Physician information and Patient information must be agreed with the National Competent Authorities prior to distribution and Patient Alert Card should be included as part of inner packaging.
Slovenian: Besedilo informacij za zdravnike in informacij bolnike mora biti pred razdelitvijo dogovorjeno z nacionalnim organom, pristojnim za zdravila, opozorilna kartica za bolnika pa mora biti vključena med notranjo ovojnino.
English: A slight but not significant improvement in overall survival was reported in the R-FC compared to the FC arm.
Slovenian: Poročali so o rahlem, vendar ne pomembnem izboljšanju celokupnega preživetja v skupini R-FC v primerjavi s skupino FC.
English: Eligible patients had active rheumatoid arthritis, diagnosed according to the criteria of the American College of Rheumatology (ACR).
Slovenian: Vključeni bolniki so imeli aktiven revmatoidni artritis, diagnosticiran po merilih Ameriškega revmatološkega združenja (ACR, American College of Rheumatology).
English: • painful joints or back
Slovenian: boleči sklepi ali hrbet,
English: Figure 3:
Slovenian: Slika 3:
English: In general, the proportion of patients experiencing any infusion reaction was higher following the first infusion than following the second infusion of any treatment course.
Slovenian: Na splošno je bil delež bolnikov, pri katerih se je pojavila katerakoli z infuzijo povezana reakcija, višji po prvi infuziji kot po drugi infuziji kateregakoli cikla zdravljenja.
English: In the event of relapse, patients may receive 1000 mg IV.
Slovenian: V primeru recidiva lahko bolniki dobijo 1.000 mg intravensko.
English: This medicinal product contains sodium.
Slovenian: To zdravilo vsebuje natrij.
English: Not known (it is not known how often these side effects happen):
Slovenian: Neznana pogostnost (kako pogosto se pojavijo naslednji neželeni učinki, ni znano):
English: This analysis suggests that dose adjustment of rituximab with any of the tested covariates is not expected to result in a meaningful reduction in its pharmacokinetic variability.
Slovenian: Te analize kažejo, da prilagoditev odmerka rituksimaba s katerokoli od testiranih spremenljivk verjetno ne bo pomembno zmanjšala njegove farmakokinetične variabilnosti.
English: The cells that are affected by Ritemvia help to fight infection and you should wait until the infection has passed before you are given Ritemvia.
Slovenian: Celice, ki jih zdravilo Ritemvia uniči, pomagajo pri borbi proti okužbam, zato morate počakati, da se okužba pozdravi, preden prejmete zdravilo Ritemvia.
English: Ritemvia is indicated in adults for the following indications:
Slovenian: Zdravilo Ritemvia je pri odraslih indicirano za naslednje indikacije:
English: Data in approximately 180 patients pre-treated with rituximab have demonstrated clinical benefit (including CR) and are supportive for rituximab re-treatment.
Slovenian: Podatki, pridobljeni pri približno 180 bolnikih, ki so bili predhodno zdravljeni z rituksimabom, dokazujejo klinično korist (vključno s CR) in podpirajo ponovno zdravljenje z rituksimabom.
English: Immunomodulatory medicinal products may increase the risk of malignancy.
Slovenian: Imunomodulirajoča zdravila lahko povečajo tveganje za razvoj malignih bolezni.
English:  Cardiovascular events, see section 4.4.
Slovenian: • kardiovaskularni dogodki, glejte poglavje 4.4.
English: In contrast, three patients (1.5%) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
Slovenian: Nasprotno pa so se cerebrovaskularni dogodki pojavili pri treh bolnikih (1,5%) v skupini CHOP, vsi med obdobjem spremljanja.
English: Clinical manifestations of anaphylaxis may appear similar to clinical manifestations of the cytokine release syndrome (described above).
Slovenian: Klinična manifestacija anafilakse je lahko podobna manifestaciji sindroma sproščanja citokinov (opisano zgoraj).
English: Rituximab was given in combination with intravenous glucocorticoids which may reduce the incidence and severity of these events.
Slovenian: Rituksimab so dajali v kombinaciji z intravenskimi glukokortikoidi, ki lahko zmanjšajo incidenco in izrazitost teh učinkov.
English: Efficacy was observed both for patients with newly diagnosed disease and for patients with relapsing disease (Table 17).
Slovenian: Učinkovitost so ugotovili tako pri bolnikih z novoodkrito boleznijo kot pri bolnikih s ponovitvijo bolezni (preglednica 17).
English: The most frequently reported events were tachycardia (4%) and atrial fibrillation (3%) (see section 4.4).
Slovenian: Najpogosteje opisana neželena učinka sta bila tahikardija (4%) in atrijska fibrilacija (3 %) (glejte poglavje 4.4).
English: They will watch you closely while you are being given this medicine.
Slovenian: Med dajanjem tega zdravila vas bodo skrbno nadzorovali.
English: This will be administered as 2 separate infusions which are given 2 weeks apart, followed by 1 infusion every 6 months for at least 2 years.
Slovenian: Tega boste dobili v 2 ločenih infuzijah v presledku 2 tednov, nadaljevalo pa se bo z 1 infuzijo vsakih 6 mesecev najmanj 2 leti.