FrancophonIA/ELRC3.0 huggingface dataset:
English: Yeonsu-gu, Incheon, 22014, Republic of Korea Name and address of the manufacturers responsible for batch release Biotec House, Central Park, Western Avenue
Slovenian: Yeonsu-gu, Incheon, 22014, Republika Koreja Ime in naslov izdelovalcev, odgovornih za sproščanje serij
English: Infusion related adverse reactions of all kinds have been observed in 77% of patients treated with rituximab (including cytokine release syndrome accompanied by hypotension and bronchospasm in 10 % of patients) see section 4.8.
Slovenian: Z infuzijo povezane neželene reakcije vseh vrst so opazili pri 77 % bolnikov, ki so se zdravili z rituksimabom (vključno s sindromom sproščanja citokinov, ki sta ga spremljala hipotenzija in bronhospazem pri 10 % bolnikov), glejte poglavje 4.8.
English: However, because maternal IgG is excreted in human milk, and rituximab was detectable in milk from lactating monkeys, women should not breastfeed while treated with rituximab and for 12 months following rituximab treatment.
Slovenian: A zaradi dejstva, da se materini IgG izločajo v materino mleko, in da so rituksimab našli v mleku doječih opic, ženske med zdravljenjem z rituksimabom in 12 mesecev po njem ne smejo dojiti.
English: This card tells you:
Slovenian: V tej kartici je
English: Table 7 Percentage of patients who achieved complete remission at 6 months Cyclophosphamide (n = 98)
Slovenian: Odstotek bolnikov, ki so po 6 mesecih dosegli popolno remisijo (populacija, ki so Ciklofosfamid (n = 98)
English: What Rituzena is and what it is used for What you need to know before you use Rituzena
Slovenian: Kaj je zdravilo Rituzena in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Rituzena
English: This is because in a few cases, Rituzena could cause hepatitis B to become active again, which can be fatal in very rare cases.
Slovenian: V maloštevilnih primerih namreč lahko bolezen zaradi zdravila Rituzena ponovno izbruhne; to je lahko v zelo redkih primerih smrtno.
English: Keep the container in the outer carton in order to protect from
Slovenian: Vsebnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred
English: This is because Rituzena may pass into breast milk.
Slovenian: Zdravilo Rituzena namreč lahko prehaja v materino mleko.
English: The proportion of patients with IgG levels below the LLN was about 60% in the rituximab group throughout the 2 year treatment period, while it decreased in the observation group (36% after 2
Slovenian: Delež bolnikov s koncentracijo IgG pod spodnjo mejo normalne vrednosti je bil med 2-letnim zdravljenjem približno 60 % v skupini, ki je prejemala rituksimab, v opazovani skupini pa se je zmanjšal (36 % po
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and very rare (<1/10,000).
Slovenian: Pogostnost je opredeljena kot zelo pogosta (≥ 1/10), pogosta (≥ 1/100 do < 1/10), občasna (> 1/1.000 do ≤ 1/100) in zelo redka (≤ 1/10.000).
English: Your doctor may prescribe Rituzena for the treatment of:
Slovenian: Zdravnik vam lahko zdravilo Rituzena predpiše za zdravljenje:
English: Rituzena is a biosimilar medicinal product.
Slovenian: Zdravilo Rituzena je podobno biološko zdravilo.
English: No dose reductions of Rituzena are recommended.
Slovenian: Odmerka zdravila Rituzena ni priporočljivo zmanjšati.
English: Before you are given Rituzena, you will be given other medicines (pre-medication) to prevent or
Slovenian: Preden boste dobili zdravilo Rituzena, boste dobili druga zdravila (to imenujemo premedikacija) za preprečitev ali zmanjšanje možnih neželenih učinkov.
English: Vaccination should be completed at least 4 weeks prior to first administration of rituximab.
Slovenian: Cepljenje naj bo zaključeno najmanj 4 tedne pred prvo aplikacijo
English: Measure blood neutrophils prior to each course of rituximab, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
Slovenian: Pozna nevtropenija Število nevtrofilcev v krvi je treba določiti pred vsakim ciklom rituksimaba in redno do 6 mesecev po končanem zdravljenju ter pri znakih ali simptomih okužbe (glejte poglavje 4.8).
English: No studies on the effects of rituximab on the ability to drive and use machines have been performed, although the pharmacological activity and adverse reactions reported to date suggest that rituximab would have no or negligible influence on the ability to drive and use machines.
Slovenian: Študij o vplivu rituksimaba na sposobnost za vožnjo in upravljanje s stroji niso izvedli, čeprav opisano farmakološko delovanje in neželeni učinki kažejo, da vpliva na to ni ali je le zanemarljiv.
English: There was no cumulative toxicity in terms of infections reported over a 2 year treatment period.
Slovenian: Pri okužbah, o katerih so poročali med dveletnim zdravljenjem, kumulativne toksičnosti ni bilo.
English: Also please tell your doctor if you have had a lot of infections in the past or
Slovenian: Zdravniku povejte tudi, če imate pogoste ali hude okužbe;
English: System organ class Very common Common
Slovenian: Organski sistem Zelo pogosti
English: Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Rituzena or patients refractory to previous Rituzena plus chemotherapy.
Slovenian: Na voljo so le omejeni podatki glede učinkovitosti in varnosti pri bolnikih, ki so se predhodno zdravili z monoklonskimi protitelesi, vključno z zdravilom Rituzena, ali pri bolnikih, ki se na prejšnje zdravljenje z zdravilom Rituzena in kemoterapijo niso odzvali.
English: This is because Rituzena can transfer across the placenta and may affect your baby.
Slovenian: Zdravilo Rituzena namreč lahko prehaja skozi posteljico (placento) in lahko škoduje otroku.
English: Treatment difference (Rituximab --cyclophosphamide)
Slovenian: Razlika zdravljenj (rituksimabciklofosfamid)
English: Infectious events (predominantly bacterial and viral) occurred in approximately 30-55% of patients during clinical trials in patients with NHL and in 30-50% of patients during clinical trials in patients with CLL
Slovenian: Okužbe (predvsem bakterijske in virusne) so v kliničnih preskušanjih opazili pri 30-55 % bolnikov z neHodgkinovim limfomom in pri 30-50 % bolnikov s KLL.
English: This is because some people have a fall in their blood pressure while they are being given Rituzena.
Slovenian: Nekaterim ljudem se namreč med prejemanjem zdravila Rituzena krvni tlak zniža;
English: • low number of red blood cells (anaemia), low number of all blood cells
Slovenian: majhno število rdečih krvnih celic (anemija), majhno število vseh krvnih celic,
English: Rituzena should be used in combination with CHOP chemotherapy.
Slovenian: Zdravilo Rituzena je treba uporabljati v kombinaciji s kemoterapijo CHOP.
English: The available data indicate that the rate of clinically relevant infection is unchanged when such therapies are used in patients previously treated with rituximab, however patients should be closely observed for signs of infection if biologic agents and/or DMARDs are used following rituximab
Slovenian: Podatki, ki so na voljo, nakazujejo, da je pojavnost klinično pomembnih okužb nespremenjena, ko ta zdravila uporabimo pri bolnikih, ki so jih prej zdravili z rituksimabom, vendar jih moramo skrbno opazovati glede znakov okužbe, če po zdravljenju z rituksimabom prejmejo biološka
English: When remission with rituximab has been achieved, continued immunosuppressive therapy may be considered to prevent relapse.
Slovenian: Ko je z rituksimabom dosežena remisija, lahko nadaljnje imunosupresivno zdravljenje smatramo za preprečitev ponovne aktivnosti bolezni.
English: What Rituzena looks like and contents of the pack
Slovenian: Izgled zdravila Rituzena in vsebina pakiranja
English: If you have granulomatosis with polyangiitis or microscopic polyangiitis also tell your doctor
Slovenian: Če imate granulomatozo s poliangiitisom ali mikroskopski poliangiitis, zdravniku povejte tudi:
English: 6 observed mainly in patients with prior cardiac condition and/or cardiotoxic chemotherapy and were mostly associated
Slovenian: 6 Opaženi v glavnem pri bolnikih z obstoječimi boleznimi srca in/ali kardiotoksično kemoterapijo ter pretežno v zvezi z
English: Talk to your doctor, pharmacist or nurse before you are given Rituzena if:
Slovenian: Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, preden dobite zdravilo Rituzena:
English: • you have ever had heart problems (such as angina, palpitations or heart failure) or breathing
Slovenian: • če ste kdaj imeli težave s srcem (npr. angino pektoris, razbijanje srca ali srčno popuščanje) ali
English: 1 includes reactivation and primary infections; frequency based on R-FC regimen in relapsed/refractory CLL 2 see also section infection below
Slovenian: 1 Vključuje reaktivacijo in primarne okužbe; pogostnost temelji na režimu R-FC pri bolnikih s KLL, pri katerih se je bolezen
English: In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1000 mg per day is recommended prior to the first infusion of Rituzena (the last dose of methylprednisolone may be given on the same day as the first infusion of Rituzena).
Slovenian: Pri bolnikih z granulomatozo s poliangiitisom (Wegenerjevo granulomatozo) ali mikroskopskim poliangiitisom je pred prvo infuzijo zdravila Rituzena priporočljiva intravenska uporaba metilprednizolona, ki se ga daje od 1 do 3 dni v odmerku 1.000 mg na dan (zadnji odmerek metilprednizolona je lahko uporabljen na dan prve infuzije zdravila Rituzena).
English: PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Rituzena Alert Card for patients with non-oncology diseases
Slovenian: BESEDILO OPOZORILNE KARTICE ZA BOLNIKA Z NEONKOLOŠKO INDIKACIJO Opozorilna kartica za bolnike, ki prejemajo zdravilo Rituzena za neonkološke bolezni
English: No long-term animal studies have been performed to establish the carcinogenic potential of rituximab.
Slovenian: Dolgoročnih študij na živalih za ugotavljanje kancerogenega potenciala rituksimaba niso
English: Rituzena should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available (see
Slovenian: Zdravilo Rituzena je treba dajati pod nadzorom izkušenega zdravnika in v okolju, kjer so vsi pripomočki za oživljanje nemudoma na voljo (glejte poglavje 4.4).
English: Some cases of late neutropenia occurring more than four weeks after the last infusion of rituximab were reported.
Slovenian: ki se je pojavila več kot 4 tedne po zadnji infuziji rituksimaba.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: All patients treated with rituximab for rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis must be given the patient alert card with each infusion.
Slovenian: Vsem bolnikom, ki se z rituksimabom zdravijo za revmatoidni artritis, granulomatozo s poliangiitisom in mikroskopski poliangiitis, je treba ob vsaki infuziji dati opozorilno kartico za bolnike.
English: IRRs in the GPA and MPA clinical trial were defined as any adverse event occurring within 24 hours of an infusion and considered to be infusion-related by investigators in the safety population.
Slovenian: Reakcije, povezane z infuzijo, so bile v kliničnem preskušanju pri GPA in MPA opredeljene kot neželeni učinki, ki so se pojavili v 24 urah po infuziji in so jih raziskovalci v varnostni populaciji ocenili kot povezane z infuzijo.
English: It is not known whether Rituzena has an effect on you being able to drive or use any tools or
Slovenian: Ni znano, ali zdravilo Rituzena vpliva na vašo sposobnost za upravljanje vozil ali strojev.
English: What you need to know before you use Rituzena
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Rituzena
English: Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue rituximab.
Slovenian: Glede na resnost z infuzijo povezanih reakcij in potrebne ukrepe, je treba rituksimab ukiniti ali ga začasno prekiniti.
English: <Justification for not including Braille accepted.>
Slovenian: Sprejeta je utemeljitev, da Braillova pisava ni potrebna
English: A total of 810 patients (403 R-FC, 407 FC) for the first-line study (Table 5a and Table 5b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 6) were analysed for efficacy.
Slovenian: V analizo učinkovitosti je bilo vključenih skupno 810 bolnikov (403 R-FC, 407 FC) iz študije pri bolnikih v prvi liniji zdravljenja (preglednici 5a ter 5b) ter 552 bolnikov (276 R-FC, 276 FC) iz študije pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (preglednica 6).
English: Patients with active hepatitis B disease should not be treated with rituximab.
Slovenian: Bolniki z aktivno boleznijo, ki jo povzroči virus hepatitisa B, se ne smejo zdraviti z rituksimabom.
English: The overall response rate (ORR) in the intent-to-treat (ITT) population was 48 % (CI95% 41% - 56%) with a 6% complete response (CR) and a 42% partial response (PR) rate.
Slovenian: Celokupen odgovor (ORR, overall response rate) v populaciji z namenom zdraviti (ITT, the intent-totreat) je bil 48 % (95-% interval zaupanja 41−56 %), od tega popoln odgovor (CR, complete response) pri 6 %, delni odgovor (PR, partial response) pa pri 42 %.
English: The proportions of patients experiencing cardiac reactions (all or serious) did not increase over multiple courses.
Slovenian: Delež bolnikov, pri katerih so se pojavili neželeni učinki, povezani s srcem (vsi ali resni), se z nadaljnjimi cikli
English: Table 4 Summary of key results from four phase III randomised studies evaluating the benefit of rituximab with different chemotherapy regimens in follicular lymphoma
Slovenian: Povzetek ključnih rezultatov štirih randomiziranih preskušanj III. faze, ki so ocenjevala korist rituksimaba v kombinaciji z različnimi shemami kemoterapije pri
English: These are listed below under “Other side effects”.
Slovenian: Naštete so spodaj pod naslovom Drugi
English: The benefit in terms of PFS was consistently observed in most patient subgroups analysed according to disease risk at baseline (i.e. Binet stages A-C) (Table 5b).
Slovenian: Korist v smislu preživetja brez napredovanja bolezni so konsistentno opažali pri večini podskupin, ki so jih analizirali glede na tveganje bolezni pred vključitvijo (npr. stopnjo po Binetu A-C) (preglednica 5b).
English: • high blood sugar level, weight loss, swelling in the face and body, high levels of the enzyme “lactate dehydrogenase (LDH)” in the blood, low calcium levels in the blood
Slovenian: velika koncentracija krvnega sladkorja, hujšanje, oteklost obraza in telesa, visoka raven encima laktat dehidrogenaza (LDH) v krvi, majhna koncentracija kalcija v krvi,
English: No incompatibilities between rituximab and polyvinyl chloride or polyethylene bags or infusion sets
Slovenian: Med rituksimabom in vrečkami iz polivinilklorida ali polietilena ali infuzijskimi seti niso ugotovili
English: When Rituzena is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Slovenian: Če zdravilo Rituzena uporabimo v kombinaciji s kemoterapijo, je treba uporabiti standardno zmanjšanje odmerkov citostatikov.
English: Safety and efficacy of Rituzena have not been established in combination with other chemotherapies in diffuse large B cell non-Hodgkin's lymphoma.
Slovenian: Varnosti in učinkovitosti zdravila Rituzena v kombinaciji z drugimi kemoterapijami pri difuznem velikoceličnem B ne-Hodgkinovem limfomu niso ugotavljali.
English: The incidence of ADRs of any grade was similar in
Slovenian: Incidenca neželenih učinkov katere koli stopnje je bila v obeh skupinah podobna.
English: • swelling of the hands or ankles
Slovenian: otekanje dlani ali gležnjev.
English: Nervous system disorders paraesthesia, hypoaesthesia, agitation,
Slovenian: Bolezni živčevja parestezije, hipestezija, agitiranost,
English: Rituximab should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
Slovenian: Rituksimab se ne sme dajati bolnikom z aktivno, hudo okužbo (npr. tuberkulozo, sepso ali oportunističnimi okužbami, glejte poglavje 4.3).
English: transient increase in serum IgM levels3
Slovenian: prehodno zvečanje koncentracije IgM v serumu3
English: If you are not sure, talk to your doctor, pharmacist or nurse before you are given Rituzena.
Slovenian: Če ste negotovi, se posvetuje z zdravnikom, farmacevtom ali medicinsko sestro, preden dobite zdravilo Rituzena.
English: In studies evaluating rituximab in combination with chemotherapy, the incidence of grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial flutter/fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group (3 patients, 1.5%).
Slovenian: V študijah z rituksimabom v kombinaciji s kemoterapijo je bila incidenca motenj srčnega ritma 3. ali 4. stopnje, predvsem supraventrikularnih aritmij, kot sta tahikardija in atrijska fibrilacija/undulacija, višja v skupini R-CHOP (14 bolnikov, 6,9 %) kot pa v skupini CHOP (3 bolniki,
English: Should non-live vaccinations be required whilst receiving rituximab therapy, these should be completed at least 4 weeks prior to commencing the next course of rituximab.
Slovenian: Če je potrebno cepljenje z mrtvimi cepivi med zdravljenjem z rituksimabom, mora biti zaključeno najmanj 4 tedne pred
English: Patients received 2 x 1,000 mg of rituximab separated by an interval of two weeks; in addition to methotrexate (10-25 mg/week).
Slovenian: Bolniki so prejeli 2 x 1.000 mg rituksimaba v razmiku 2 tednov in metotreksat (10 do 25 mg/teden).
English: Granulomatosis with polyangiitis and microscopic polyangiitis Rituzena, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Slovenian: Granulomatoza s poliangiitisom in mikroskopski poliangiitis Zdravilo Rituzena je v kombinaciji z glukokortikoidi indicirano za indukcijo remisije pri odraslih bolnikih s hudo, aktivno granulomatozo s poliangiitisom (GPA, Wegenerjevo granulomatozo) in z
English: • The need to check, prior to Rituzena treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned,
Slovenian: • informacije o nujnosti, da pred dajanjem zdravila Rituzena preverijo, ali je bolnik morda okužen, imunsko oslabljen, ali jemlje zdravila, ki vplivajo na imunski sistem, ali jih je jemal v preteklosti, ali se je nedavno cepili oziroma to namerava,
English: Non-oncology indications: The MAH must ensure that all physicians who are expected to prescribe Rituzena are provided with
Slovenian: Neonkološke indikacije: Imetnik dovoljenja za promet mora zagotoviti, da zdravniki, ki lahko predpišejo zdravilo Rituzena,
English: During the treatment period (induction treatment phase comprising of R-CHOP for at most eight cycles), four patients (2 %) treated with R-CHOP, all with cardiovascular risk factors, experienced thromboembolic cerebrovascular accidents during the first treatment cycle.
Slovenian: Med obdobjem zdravljenja (faza indukcijskega zdravljenja, ki je obsegalo R-CHOP vsaj osem ciklov) so se pri štirih bolnikih (2 %), zdravljenih z R-CHOP, ki so vsi imeli kardiovaskularne dejavnike tveganja,
English: The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by centre): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1 % for patients in the CVP group．
Slovenian: Razlika med terapevtskima skupinama glede celokupnega preživetja je pokazala značilno klinično razliko (p = 0,029, log-rang test s stratifikacijo po centru): po 53 mesecih je bil delež preživetja v skupini z R-CVP 80,9 % in v skupini s CVP 71,1 %.
English: Rituzena is used for inducing remission in granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
Slovenian: Zdravilo Rituzena se uporablja za spodbujanje umirjanja bolezni pri granulomatozi s poliangiitisom (prej imenovani Wegenerjeva granulomatoza) ali pri mikroskopskem poliangiitisu; daje se v kombinaciji s kortikosteroidi.
English: In general toxicity studies in cynomolgus monkeys no deleterious effects on reproductive organs in males or females were observed.
Slovenian: V študijah splošne toksičnosti pri opicah Cynomolgus niso opažali škodljivih učinkov na reproduktivne organe samcev ali
English: Aseptically withdraw the necessary amount of Rituzena, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride9 mg/mL (0.9%) solution for injection or 5 % D-Glucose in water.
Slovenian: Aseptično odvzamemo potrebno količino zdravila Rituzena in jo razredčimo, da dobimo izračunano koncentracijo od 1 do 4 mg/ml rituksimaba v infuzijski vrečki, ki vsebuje sterilno apirogeno 0,9-% raztopino natrijevega klorida za injiciranje (9 mg/ml) ali 5-% raztopino D-glukoze v vodi.
English: Medicines given before each Rituzena administration
Slovenian: Zdravila, ki jih boste dobili pred vsakim dajanjem zdravila Rituzena
English: anaphylaxis tumour lysis syndrome, cytokine release syndrome4, serum sickness infusion-relate d acute reversible thrombocytop enia4
Slovenian: anafilaksija sindrom lize tumorja, sindrom sproščanja citokinov4, serumska bolezen z infuzijo povezana akutna reverzibilna trombocitopenija4
English: This should be followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need)
Slovenian: 1 mg/kg/dan prednizona peroralno (odmerek ne sme preseči 80 mg/dan in ga je treba zmanjšati, kolikor hitro je mogoče glede na klinične potrebe) med zdravljenjem z zdravilom Rituzena in po njem.
English: Consideration should be given to the use of a reduced infusion rate for the first infusion in these patients or a split dosing over two days during the first cycle and any subsequent cycles if the lymphocyte count is still >25 x 109/L.
Slovenian: Že za prvo infuzijo pri teh bolnikih razmislimo o zmanjšanju pretoka ali delitvi odmerka na dva dneva v prvem ciklu in, če je število limfocitov še vedno večje od 25 x 109/l, tudi v vseh nadaljnjih ciklih.
English: Rituzena is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine,
Slovenian: Zdravilo Rituzena je indicirano za zdravljenje bolnikov s CD20-pozitivnim difuznim velikoceličnim B ne-Hodgkinovim limfomom v kombinaciji s kemoterapijo CHOP (ciklofosfamid, doksorubicin,
English: Cases of hepatitis B reactivation,have been reported, the majority of which were in patients receiving rituximab in combination with cytotoxic chemotherapy.
Slovenian: Poročali so o reaktivaciji virusa hepatitisa B, večinoma pri bolnikih, ki so prejemali rituksimab v kombinaciji s citotoksično kemoterapijo.