natgillin/translations-raw huggingface dataset:
If you can get pregnant, you and your partner must use an effective method of contraception while using Rituzena.
Če bi lahko zanosili, morate vi in vaš partner med uporabo zdravila Rituzena uporabljati učinkovito kontracepcijsko zaščito.
Rituzena will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Zdravilo Rituzena vam bo dal zdravnik ali medicinska sestra, ki ima izkušnje z uporabo takšnih zdravil.
In the majority of these cases, rituximab was
V večini teh primerov so rituksimab uporabili
This leaflet was last revised in MM/YYYY
Navodilo je bilo nazadnje revidirano MM/LLLL
• high or low blood pressure (low blood pressure especially when standing upright)
visok ali nizek krvni tlak (nizek krvni tlak zlasti po hitrem vstajanju),
• asthma, too little oxygen reaching the body organs
astma, telesne organe doseže premalo kisika,
Your doctor will check if you should have any vaccines
Zdravnik bo preveril, ali bi morali biti cepljeni, preden boste dobili
Therefore patients with a history of cardiac disease should be monitored closely (see Infusion related reactions, above).
Bolnike z anamnezo bolezni srca je zato treba natančno opazovati (glejte Reakcije, povezane z infuzijo, zgoraj).
Efficacy was observed both for patients with newly diagnosed disease and for patients with relapsing
Učinkovitost so ugotovili tako pri bolnikih z novoodkrito boleznijo kot pri bolnikih s ponovitvijo bolezni
severe cardiac disoders4 and 6
hude srčne bolezni4 in 6
The safety and efficacy of Rituzena in children below 18 years has not been established.
Varnost in učinkovitost zdravila Rituzena pri otrocih do 18 leta starosti nista dokazani.
• bacterial or viral infections, bronchitis
bakterijske ali virusne okužbe, bronhitis,
Severe infusion-related reactions (such as bronchospasm, hypotension) occurred in up to 12% of the cases.
Hude reakcije, povezane z infuzijo (npr. bronhospazem, hipotenzija), so se pojavile pri največ 12 % bolnikov.
Your doctor may need to take special care during your treatment with
Zdravnik bo morda moral biti med zdravljenjem z
The risk of disease progression was reduced by 46 % and the risk of relapse by
Tveganje za napredovanje bolezni je bilo manjše za 46 %, tveganje za ponovitev bolezni pa za 51 %.
• you have severe heart failure or severe uncontrolled heart disease and have granulomatosis with polyangiitis or microscopic polyangiitis.
• imate hudo srčno popuščanje ali hudo, neurejeno srčno bolezen in imate tudi granulomatozo s poliangiitisom ali mikroskopski poliangiitis.
Summary of the safety profile (rheumatoid arthritis)
Povzetek varnostnega profila (revmatoidni artritis)
Before giving a subsequent course of rituximab treatment, patients should be re-evaluated for any potential risk for infections.
Pred dajanjem nadaljnjega cikla rituksimaba je treba bolnike ponovno oceniti glede možnega tveganja za okužbe.
In contrast, three patients (1.5 %) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period.
Nasprotno pa so se cerebrovaskularni dogodki pojavili pri treh bolnikih (1,5 %) v skupini CHOP, vsi med obdobjem spremljanja.
The cells that are affected by Rituzena help to fight infection and you should wait until the infection has passed before you are given Rituzena.
Celice, ki jih zdravilo Rituzena uniči, pomagajo pri borbi proti okužbam, zato morate počakati, da se okužba pozdravi, preden prejmete zdravilo Rituzena.
Patients reporting signs and symptoms of infection following rituximab therapy should be promptly evaluated and treated appropriately.
Bolnike, pri katerih se pojavijo znaki in simptomi okužbe po zdravljenju z rituksimabom, je treba nemudoma pregledati in primerno zdraviti.
Rarely Rituzena can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Redko lahko zdravilo Rituzena povzroči resno možgansko okužbo, imenovano progresivna multifokalna levkoencefalopatija ali PML.
The prepared infusion solution of rituximab is physically and chemically stable for 24 hours at 2 °C - 8 °C and subsequently 12 hours at room temperature (not more than 30 °C).
Pripravljena infuzijska raztopina rituksimaba je fizikalno in kemijsko stabilna 24 ur pri temperaturi 2 do 8 °C in nato še 12 ur pri sobni temperaturi (pri temperaturi do 30 °C).
Only the highest frequency observed in the trials is reported
Navedena je samo največja pogostnost, ugotovljena
When you are treated with Rituzena in combination with chemotherapy, you will receive Rituzena every 28 days until you have received 6 doses.
Ko se boste zdravili z zdravilom Rituzena v kombinaciji s kemoterapijo, boste dobili infuzijo zdravila Rituzena vsakih 28 dni, dokler ne prejmete 6 odmerkov.
Patient subpopulations - rituximab combination therapy Elderly patients (≥ 65 years)
Podskupine bolnikov - samostojno zdravljenje z rituksimabom Starejši bolniki (≥ 65 let)
The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with follicular lymphoma and chronic lymphocytic leukaemia.
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z rituksimabom za vse podskupine pediatrične populacije s folikularnim limfomom in kronično limfocitno levkemijo.
Rituzena is indicated in adults for the following indications:
Zdravilo Rituzena je pri odraslih indicirano za naslednje indikacije:
The alert card contains important safety information for patients regarding potential increased risk of infections, including PML.
Opozorilna kartica vsebuje za bolnika pomembne podatke o varnosti glede možnega povečanega tveganja za okužbe,
For these reasons rituximab should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Zato nosečnice ne smejo prejemati rituksimaba, razen če je pričakovana korist večja od
Contents of the pack and other information What Rituzena contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Rituzena
Your doctor may decide to stop your Rituzena treatment if these reactions are
Zdravnik se lahko odloči za prenehanje zdravljenja z zdravilom Rituzena, če so te reakcije resne.
What Rituzena is and what it is used for
Kaj je zdravilo Rituzena in za kaj ga uporabljamo
If you have heart disease or angina, these infusion reactions might get worse.
Če imate obstoječo bolezen srca in angino pektoris, se lahko te reakcije zaradi infundiranja poslabšajo.
Mean Cmax was 16 to 19% higher following second infusion compared to the first
Povprečna Cmax je bila za 16 do 19 % večja po drugi infuziji v primerjavi s prvo infuzijo pri obeh odmerkih.
Treatment with Rituzena uses four separate infusions given at weekly intervals.
Zdravljenje z zdravilom Rituzena obsega štiri ločene infuzije, ki jih dobite v presledkih enega tedna.
No data are
Podatkov ni na
Based upon investigator judgment, 15 patients received a second course of rituximab therapy for treatment of relapse of disease activity which occurred between 6 and 18 months after the first course of rituximab.
Na podlagi raziskovalčeve presoje je 15 bolnikov prejelo drugi cikel rituksimaba za zdravljenje ponovne aktivnosti bolezni, ki se je pojavila v obdobju od 6. do 18. meseca po prvem ciklu rituksimaba.
Rituzena may be used for the treatment of several different conditions in adults.
Zdravilo Rituzena se uporablja za zdravljenje več različnih bolezni pri odraslih.
Currently, there are limited data on possible medicinal product interactions with rituximab.
Trenutno je le malo podatkov o mogočih medsebojnih učinkih zdravil pri uporabi rituksimaba.
The analysis of overall survival showed a significant benefit of R-FC treatment over FC chemotherapy alone (p = 0.0319, log-rank test) (Table 5a).
Analiza celokupnega preživetja je pokazala signifikantno korist zdravljenja R-FC glede na samo kemoterapijo FC (p = 0,0319, test log rank) (preglednica 5a).
Rituzena in combination with chemotherapy destroys these cells.
Zdravilo Rituzena v kombinaciji s kemoterapijo uniči te celice.
The final analysis confirmed that RCHOP treatment was associated with a clinically relevant and statistically significant improvement in the duration of event-free survival (the primary efficacy parameter; where events were death, relapse or progression of lymphoma, or institution of a new anti-lymphoma treatment) (p = 0.0001).
Končna analiza je potrdila, da je bilo zdravljenje z R-CHOP povezano s klinično pomembnim in statistično značilnim podaljšanjem trajanja preživetja brez dogodkov (primarni parameter učinkovitosti; dogodki so bili smrt, ponovitev bolezni ali napredovanje limfoma, ali uvedba novega protilimfomskega zdravljenja) (p = 0,0001).
• skin rashes, including acne or spots
kožni izpuščaji, vključno z aknami ali lisami,
The transient IgM increase usually returned to at least
Prehodna zvišanja IgM so se običajno vrnila vsaj na raven pred zdravljenjem v 4
Patients who have ever had hepatitis B infection will be carefully checked by their doctor for
Bolnike, ki so kdaj imeli okužbo z virusom hepatitisa B, bo zdravnik skrbno spremljal glede znakov te okužbe;
During or within the first 2 hours of the first infusion you may develop fever, chills and shivering.
V prvih dveh urah se pri prvi infuziji lahko pojavijo zvišana telesna temperatura, mrazenje in drgetanje.
There was a higher incidence of grade 3/4 ADRs in patients with bulky disease than in patients without bulky disease (25.6 % vs. 15.4 %).
Bolniki z obsežno boleznijo so imeli višjo incidenco neželenih učinkov 3. ali 4. stopnje kot bolniki brez obsežne bolezni (25,6 % v primerjavi s 15,4 %).
Developmental toxicity studies have been performed in cynomolgus monkeys at doses up to 100 mg/kg (treatment on gestation days 20-50) and have revealed no evidence of toxicity to the foetus due to rituximab.
Študije razvojne toksičnosti so izvajali na opicah Cynomologus z odmerki do 100 mg/kg (dajanje zdravila od 20. do 50. gestacijskega dne) in niso pokazale znakov toksičnosti za plod zaradi rituksimaba.
CD20 does not circulate in the plasma as a free antigen and, thus, does not compete for antibody binding.
CD20 ne kroži v plazmi kot prosti antigen in zato
Patients with a high tumour burden or with a high number (≥25 x 109/L) of circulating malignant cells such as patients with CLL, who may be at higher risk of especially severe cytokine release syndrome, should only be treated with extreme caution.
Bolnike z veliko tumorsko maso ali velikim številom (≥ 25 x 109/l) krožečih malignih celic, kot so bolniki s KLL, pri katerih obstaja večje tveganje izjemno hudega sindroma sproščanja citokinov, zdravimo le izjemno pazljivo.
The incidence of thrombocytopenia was low (<1% , grade 3/4) and was not different between treatment arms.
Incidenca trombocitopenije je bila nizka (< 1 % 3. ali 4. stopnje) in se med zdravljenima skupinama ni razlikovala.
• pain in the muscles or in the hands or feet • low number of red blood cells (anaemia)
bolečina v mišicah ali dlaneh ali stopalih, nizko število rdečih krvnih celic (anemija),
If a patient develops PML the dosing of rituximab must be permanently discontinued.
Če se pri bolniku razvije PML, je treba uporabo rituksimaba dokončno ukiniti.
The majority of patients (81%) showed signs of B cell return, with counts >10 cells/μL by month 12, increasing to 87% of patients by month 18.
Pri večini bolnikov (81 %) se je število celic B ponovno povečalo na > 10 celic/µl do 12. meseca, do 18. meseca pa
The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
Protitelo je pridobljeno iz suspenzije kulture celic sesalcev (ovarij kitajskega hrčka) in očiščeno z afinitetno kromatografijo ter ionsko izmenjavo, vključno s specifičnimi postopki inaktivacije
Cases of interstitial lung disease, some with fatal outcome, have been reported.
Poročali so o primerih intersticijske bolezni pljuč, nekateri so bili smrtni.
Some vaccines should not be given at the same time as Rituzena or in the months after you receive Rituzena.
Nekatera cepiva se ne smejo dajati sočasno z zdravilom Rituzena ali nekaj mesecev po prejetju tega zdravila.
What you need to know before you use Rituzena Do not take Rituzena if:
Kaj morate vedeti, preden boste uporabili zdravilo Rituzena Ne uporabljajte zdravila Rituzena, če:
Yeonsu-gu, Incheon, 22014, Republic of Korea Name and address of the manufacturers responsible for batch release Biotec House, Central Park, Western Avenue
Yeonsu-gu, Incheon, 22014, Republika Koreja Ime in naslov izdelovalcev, odgovornih za sproščanje serij
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.
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.
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.
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.
This card tells you:
V tej kartici je
Table 7 Percentage of patients who achieved complete remission at 6 months Cyclophosphamide (n = 98)
Odstotek bolnikov, ki so po 6 mesecih dosegli popolno remisijo (populacija, ki so Ciklofosfamid (n = 98)
What Rituzena is and what it is used for What you need to know before you use Rituzena
Kaj je zdravilo Rituzena in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Rituzena
This is because in a few cases, Rituzena could cause hepatitis B to become active again, which can be fatal in very rare cases.
V maloštevilnih primerih namreč lahko bolezen zaradi zdravila Rituzena ponovno izbruhne; to je lahko v zelo redkih primerih smrtno.
Keep the container in the outer carton in order to protect from
Vsebnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred
This is because Rituzena may pass into breast milk.
Zdravilo Rituzena namreč lahko prehaja v materino mleko.
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
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
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).
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).
Your doctor may prescribe Rituzena for the treatment of:
Zdravnik vam lahko zdravilo Rituzena predpiše za zdravljenje:
Rituzena is a biosimilar medicinal product.
Zdravilo Rituzena je podobno biološko zdravilo.
No dose reductions of Rituzena are recommended.
Odmerka zdravila Rituzena ni priporočljivo zmanjšati.
Before you are given Rituzena, you will be given other medicines (pre-medication) to prevent or
Preden boste dobili zdravilo Rituzena, boste dobili druga zdravila (to imenujemo premedikacija) za preprečitev ali zmanjšanje možnih neželenih učinkov.
Vaccination should be completed at least 4 weeks prior to first administration of rituximab.
Cepljenje naj bo zaključeno najmanj 4 tedne pred prvo aplikacijo
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).
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).
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.
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.
There was no cumulative toxicity in terms of infections reported over a 2 year treatment period.
Pri okužbah, o katerih so poročali med dveletnim zdravljenjem, kumulativne toksičnosti ni bilo.
Also please tell your doctor if you have had a lot of infections in the past or
Zdravniku povejte tudi, če imate pogoste ali hude okužbe;
System organ class Very common Common
Organski sistem Zelo pogosti
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.
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.
This is because Rituzena can transfer across the placenta and may affect your baby.
Zdravilo Rituzena namreč lahko prehaja skozi posteljico (placento) in lahko škoduje otroku.
Treatment difference (Rituximab --cyclophosphamide)
Razlika zdravljenj (rituksimabciklofosfamid)
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
Okužbe (predvsem bakterijske in virusne) so v kliničnih preskušanjih opazili pri 30-55 % bolnikov z neHodgkinovim limfomom in pri 30-50 % bolnikov s KLL.
This is because some people have a fall in their blood pressure while they are being given Rituzena.
Nekaterim ljudem se namreč med prejemanjem zdravila Rituzena krvni tlak zniža;
• low number of red blood cells (anaemia), low number of all blood cells
majhno število rdečih krvnih celic (anemija), majhno število vseh krvnih celic,
Rituzena should be used in combination with CHOP chemotherapy.
Zdravilo Rituzena je treba uporabljati v kombinaciji s kemoterapijo CHOP.
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
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
When remission with rituximab has been achieved, continued immunosuppressive therapy may be considered to prevent relapse.
Ko je z rituksimabom dosežena remisija, lahko nadaljnje imunosupresivno zdravljenje smatramo za preprečitev ponovne aktivnosti bolezni.
What Rituzena looks like and contents of the pack
Izgled zdravila Rituzena in vsebina pakiranja
If you have granulomatosis with polyangiitis or microscopic polyangiitis also tell your doctor
Če imate granulomatozo s poliangiitisom ali mikroskopski poliangiitis, zdravniku povejte tudi:
6 observed mainly in patients with prior cardiac condition and/or cardiotoxic chemotherapy and were mostly associated
6 Opaženi v glavnem pri bolnikih z obstoječimi boleznimi srca in/ali kardiotoksično kemoterapijo ter pretežno v zvezi z
Talk to your doctor, pharmacist or nurse before you are given Rituzena if:
Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, preden dobite zdravilo Rituzena:
• you have ever had heart problems (such as angina, palpitations or heart failure) or breathing
• če ste kdaj imeli težave s srcem (npr. angino pektoris, razbijanje srca ali srčno popuščanje) ali
1 includes reactivation and primary infections; frequency based on R-FC regimen in relapsed/refractory CLL 2 see also section infection below
1 Vključuje reaktivacijo in primarne okužbe; pogostnost temelji na režimu R-FC pri bolnikih s KLL, pri katerih se je bolezen
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).
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).
PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Rituzena Alert Card for patients with non-oncology diseases
BESEDILO OPOZORILNE KARTICE ZA BOLNIKA Z NEONKOLOŠKO INDIKACIJO Opozorilna kartica za bolnike, ki prejemajo zdravilo Rituzena za neonkološke bolezni
No long-term animal studies have been performed to establish the carcinogenic potential of rituximab.
Dolgoročnih študij na živalih za ugotavljanje kancerogenega potenciala rituksimaba niso
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
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).
Some cases of late neutropenia occurring more than four weeks after the last infusion of rituximab were reported.
ki se je pojavila več kot 4 tedne po zadnji infuziji rituksimaba.
Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
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.
All patients treated with rituximab for rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis must be given the patient alert card with each infusion.
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.
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.
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.
It is not known whether Rituzena has an effect on you being able to drive or use any tools or
Ni znano, ali zdravilo Rituzena vpliva na vašo sposobnost za upravljanje vozil ali strojev.
What you need to know before you use Rituzena
Kaj morate vedeti, preden boste uporabili zdravilo Rituzena
Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue rituximab.
Glede na resnost z infuzijo povezanih reakcij in potrebne ukrepe, je treba rituksimab ukiniti ali ga začasno prekiniti.
<Justification for not including Braille accepted.>
Sprejeta je utemeljitev, da Braillova pisava ni potrebna