natgillin/translations-raw huggingface dataset:
Kaplan-Meier estimate of median time to event (months)
Kaplan-Meierjeva ocena mediane časa do dogodka (meseci)
Of 356 patients evaluated for anti-drug antibody (ADA), 1.1% (4 patients) were positive.
Od 356 bolnikov, pri katerih so ocenjevali prisotnost protiteles proti zdravilu (anti-drug antibody -ADA), so bili pozitivni 4 bolniki (1,1%).
It remains unknown if early detection of PML and suspension of rituximab therapy may lead to similar stabilisation or improved outcome.
Ni znano, ali lahko zgodnje odkritje PML in ukinitev zdravljenja z zdravilom rituksimab doseže podobno stabilizacijo ali izboljšanje izida.
• you have a weak immune system
• imate oslabel imunski sistem;
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.
Eksplorativne analize koristi vzdrževalnega zdravljenja so pokazale manj izrazit učinek pri starejših bolnikih (> 70 let), vendar je bil vzorec majhen.
Ritemvia will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Zdravilo Ritemvia vam bo dal zdravnik ali medicinska sestra, ki ima izkušnje z uporabo takšnih zdravil.
Final analysis (median FU: 9.0 years)
Končna analiza (mediana spremljanja: 9,0 let)
Population pharmacokinetic analysis revealed that BSA and gender were the most significant covariates to explain inter-individual variability in pharmacokinetic parameters.
Populacijska farmakokinetična analiza je pokazala, da sta bila telesna površina in spol najbolj pomembni so-spremenljivki za razlago variabilnosti v farmakokinetičnih parametrih med posamezniki.
Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection.
Bolnike, ki so kdaj imeli okužbo z virusom hepatitisa B, bo zdravnik skrbno spremljal glede znakov te okužbe;
Complete remission All Patients Newly diagnosed Relapsing
Popolna remisija Vsi bolniki Novoodkriti Ponovitev
Name:_______________________ Doctor's
Datum zadnjega infundiranja:____________ Datum prvega infundiranja:______________ Bolnikovo ime: _______________________ Zdravnikovo ime:______________________ Zdravnikov telefon:____________________
Before you are given Ritemvia, you will be given other medicines (pre-medication) to prevent or reduce possible side effects.
Preden boste dobili zdravilo Ritemvia, boste dobili druga zdravila (to imenujemo premedikacija) za preprečitev ali zmanjšanje možnih neželenih učinkov.
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.
Za izboljšanje sledljivosti bioloških zdravil je treba lastniško ime in številko serije uporabljenega zdravila jasno zabeležiti (navesti) v bolnikovo kartoteko.
• if you think you may have an infection, even a mild one like a cold.
• če menite, da bi lahko imeli okužbo, četudi blago, kot je prehlad.
After adjusting for BSA, male subjects had a larger volume of distribution and a faster clearance than female subjects.
Po prilagoditvi za telesno površino so imeli moški večji volumen distribucije in večji očistek kot ženske.
When should I not have Ritemvia?
Kdaj ne smete prejeti zdravila Ritemvia?
The pre-specified non-inferiority margin for the treatment difference was 20%.
Vnaprej opredeljena meja neinferiornosti za razliko zdravljenj je bila 20%.
Secondary efficacy
Sekundarna učinkovitost
Rarely, some of these reactions have been fatal.
Redko so bili nekateri od teh neželenih učinkov smrtni.
The primary endpoint was the proportion of patients who achieved an ACR20 response at week 24.
Primarni cilj študije je bil ugotoviti delež bolnikov, ki so po 24 tednih dosegli odziv ACR20.
Patients were followed beyond week 24 for long-term endpoints, including radiographic assessment at 56 weeks and at 104 weeks.
Bolnike so od 24. tedna spremljali za dolgoročne cilje študije in naredili tudi radiološko oceno po 56 tednih ter 104 tednih.
Note: Patients were censored at month 28 if they had no event.
Opomba: Podatki so bili krnjeni, če so bili bolniki ob 28. mesecu brez dogodka.
Ritemvia will be given to you once a week for 4 weeks.
ga boste prejeli enkrat na teden 4 tedne.
Your doctor will check if you should have any vaccines before you receive Ritemvia.
Vaš zdravnik bo preveril, ali bi morali biti cepljeni, preden boste dobili zdravilo Ritemvia.
Outcome†
Izid†
5 Includes fatal cases
5Vključujejo smrtne primere.
Contraception in males and females
Kontracepcija za moške in ženske
You must tell your doctor or nurse if you are pregnant, think that you might be pregnant or are planning to become pregnant.
Nosečnost in dojenje Zdravniku ali medicinski sestri morate povedati, če ste noseči, menite, da ste noseči, ali načrtujete zanositev.
Risk Reduction
Zmanjšanje tveganja
Patients were between 19 and 79 years of age and had not received prior therapies for pemphigus.
Bolniki so bili stari od 19 do 79 let in predhodno niso prejemali zdravljenja za pemfigus.
For patients randomised to the maintenance phase of the trial, the median observation time was 28 months from maintenance randomisation.
Za bolnike, randomizirane v vzdrževalni del preskušanja, je bil mediani čas opazovanja 28 mesecev od randomizacije na vzdrževanje.
These findings were replicated at Week 48, where autoantibody seropositivity also significantly increased the probability of achieving ACR70.
Ti izsledki so se ponovili 48. teden, ko je seropozitivnost prav tako značilno povečala verjetnost za doseganje odziva ACR70.
Physical function and quality of life outcomes
Funkcijska zmogljivost in vpliv na kakovost življenja
The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e.g. cognitive, neurological or psychiatric symptoms).
Zdravnik mora biti še posebno pozoren na simptome, ki nakazujejo na PML in jih bolniki sami morda ne opazijo (npr. kognitivne, nevrološke ali psihiatrične).
Rituximab was detectable in the serum of patients 3 - 6 months after completion of last treatment.
Rituksimab je bilo mogoče zaznati v serumu bolnikov 3 do 6 mesecev po zaključku zadnjega zdravljenja.
For these reasons rituximab should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Zato nosečnice ne smejo prejemati zdravila rituksimab, razen če je pričakovana korist večja od možnega tveganja.
The incidence of IRR symptoms was highest during or after the first infusion (9%) and decreased with subsequent infusions (< 4%).
Pojavnost simptomov IRR je bila največja med prvo infuzijo ali po njej (9%) in se je ob nadaljnjih infuzijah zmanjšala (< 4%).
Tell your doctor or nurse if you are taking or have previously taken medicines which may affect your immune system this includes chemo-therapy.
Zdravniku ali medicinski sestri povejte, če jemljete ali ste jemali zdravila, ki lahko vplivajo na vaš imunski sistem, kar vključuje tudi kemoterapijo.
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.
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.
Further treatment of patients after complete resolution of signs and symptoms has rarely resulted in repeated severe cytokine release syndrome.
Nadaljnje zdravljenje bolnikov je po popolnem izginotju znakov in simptomov redko povzročilo ponoven hud sindrom sproščanja citokinov.
Before giving a subsequent course of rituximab treatment, patients should be re-evaluated for any potential risk for infections.
Pred dajanjem nadaljnjega cikla zdravila rituksimab je treba bolnike ponovno oceniti glede možnega tveganja za okužbe.
Of 67 patients evaluated for human anti-mouse antibody (HAMA), no responses were noted.
Pri 67 bolnikih, pri katerih so analizirali prisotnost humanih protimišjih protiteles (human anti-mouse antibody - HAMA), teh niso opazili.
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.
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.
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.
Granulomatoza s poliangiitisom in mikroskopski poliangiitis sta dve obliki vnetja krvnih žil, ki večinoma prizadeneta pljuča in ledvice, a lahko prizadeneta tudi druge organe.
Therefore, patients with a history of cardiac disease and/or cardiotoxic chemotherapy should be monitored closely.
Zato je treba bolnike z anamnezo srčne bolezni in/ali kardiotoksične kemoterapije skrbno nadzorovati.
If you respond well to treatment, you may be given Ritemvia as a maintenance treatment.
Če se boste na zdravilo dobro odzvali, boste lahko zdravilo Ritemvia prejemali kot vzdrževalno zdravljenje.
The risk of disease progression was reduced by 46% and the risk of relapse by 51%.
Tveganje za napredovanje bolezni je bilo manjše za 46 %, tveganje za ponovitev bolezni pa za 51%.
Initial treatment, in combination with chemotherapy
Začetno zdravljenje v kombinaciji s kemoterapijo
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.
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.
A slight but not significant improvement in overall survival was reported in the R-FC compared to the FC arm.
Poročali so o rahlem, vendar ne pomembnem izboljšanju celokupnega preživetja v skupini R-FC v primerjavi s skupino FC.
Eligible patients had active rheumatoid arthritis, diagnosed according to the criteria of the American College of Rheumatology (ACR).
Vključeni bolniki so imeli aktiven revmatoidni artritis, diagnosticiran po merilih Ameriškega revmatološkega združenja (ACR, American College of Rheumatology).
• painful joints or back
boleči sklepi ali hrbet,
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.
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.
In the event of relapse, patients may receive 1000 mg IV.
V primeru recidiva lahko bolniki dobijo 1.000 mg intravensko.
This medicinal product contains sodium.
To zdravilo vsebuje natrij.
Not known (it is not known how often these side effects happen):
Neznana pogostnost (kako pogosto se pojavijo naslednji neželeni učinki, ni znano):
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.
Te analize kažejo, da prilagoditev odmerka rituksimaba s katerokoli od testiranih spremenljivk verjetno ne bo pomembno zmanjšala njegove farmakokinetične variabilnosti.
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.
Celice, ki jih zdravilo Ritemvia uniči, pomagajo pri borbi proti okužbam, zato morate počakati, da se okužba pozdravi, preden prejmete zdravilo Ritemvia.
Ritemvia is indicated in adults for the following indications:
Zdravilo Ritemvia je pri odraslih indicirano za naslednje indikacije:
Data in approximately 180 patients pre-treated with rituximab have demonstrated clinical benefit (including CR) and are supportive for rituximab re-treatment.
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.
Immunomodulatory medicinal products may increase the risk of malignancy.
Imunomodulirajoča zdravila lahko povečajo tveganje za razvoj malignih bolezni.
 Cardiovascular events, see section 4.4.
• kardiovaskularni dogodki, glejte poglavje 4.4.
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.
Clinical manifestations of anaphylaxis may appear similar to clinical manifestations of the cytokine release syndrome (described above).
Klinična manifestacija anafilakse je lahko podobna manifestaciji sindroma sproščanja citokinov (opisano zgoraj).
Rituximab was given in combination with intravenous glucocorticoids which may reduce the incidence and severity of these events.
Rituksimab so dajali v kombinaciji z intravenskimi glukokortikoidi, ki lahko zmanjšajo incidenco in izrazitost teh učinkov.
Efficacy was observed both for patients with newly diagnosed disease and for patients with relapsing disease (Table 17).
Učinkovitost so ugotovili tako pri bolnikih z novoodkrito boleznijo kot pri bolnikih s ponovitvijo bolezni (preglednica 17).
The most frequently reported events were tachycardia (4%) and atrial fibrillation (3%) (see section 4.4).
Najpogosteje opisana neželena učinka sta bila tahikardija (4%) in atrijska fibrilacija (3 %) (glejte poglavje 4.4).
They will watch you closely while you are being given this medicine.
Med dajanjem tega zdravila vas bodo skrbno nadzorovali.
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.
Tega boste dobili v 2 ločenih infuzijah v presledku 2 tednov, nadaljevalo pa se bo z 1 infuzijo vsakih 6 mesecev najmanj 2 leti.
The incidence of infections that were serious or required IV antibiotics, was approximately 4 per 100 patient years.
Incidenca okužb, ki so bile resne ali so zahtevale uporabo intravenskega antibiotika, je bila približno 4 na 100 bolnik-let.
Rarely Ritemvia can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Redko lahko zdravilo Ritemvia povzroči resno možgansko okužbo, imenovano progresivna multifokalna levkoencefalopatija ali PML.
Mild or moderate infusion-related reactions (IRRs) (section 4.8) usually respond to a reduction in the rate of infusion.
Blage ali zmerne reakcije, povezane z infuzijo (poglavje 4.8), lahko običajno zmanjšamo z manjšim infuzijskim pretokom.
• What the signs of an infection are
• Kateri so znaki okužbe
Ritemvia should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available (see section 4.4).
Zdravilo Ritemvia je treba dajati pod nadzorom izkušenega zdravnika in v okolju, kjer so vsi pripomočki za oživljanje nemudoma na voljo (glejte poglavje 4.4).
Median TTF/PFS/ EFS mo
Mediane TTF/PFS/EFS (meseci)
Other medicines and Ritemvia
Druga zdravila in zdravilo Ritemvia
On the basis of limited experience with rituximab in rheumatoid arthritis patients (see section 4.8) the present data do not seem to suggest any increased risk of malignancy.
Na osnovi omejenih izkušenj z rituksimabom pri zdravljenju revmatoidnega artritisa (glejte poglavje 4.8) sedanji podatki ne kažejo kakršnegakoli povečanega tveganja za razvoj malignih bolezni.
The rate of serious infections was approximately 25 per 100 patient years.
Delež resnih okužb je bil približno 25 na 100 bolnik-let.
Only the highest frequency observed in the trials is reported
Navedena je samo največja pogostnost, ugotovljena v preskušanjih.
Signs and symptoms suggestive of an infusion-related reaction were reported in more than 50% of patients in clinical trials, and were predominantly seen during the first infusion, usually in the first one to two hours.
O znakih in simptomih, ki bi lahko nakazovali reakcije, povezane z infuzijo, so poročali pri več kot 50% bolnikov v kliničnih preskušanjih; večinoma so jih opazili med prvo infuzijo, po navadi v prvih dveh urah.
At week 48 seropositive patients were 2-3 times more likely to achieve ACR responses compared to seronegative patients.
48. teden je bila pri seropozitivnih bolnikih 2- do 3-krat večja verjetnost, da dosežejo odzive ACR, kot pri seronegativnih bolnikih.
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 zdravilom rituksimab, je treba nemudoma pregledati in primerno zdraviti.
Rituximab is not indicated for these patients, since the safety data about long-term rituximab treatment are insufficient, in particular concerning the risk of development of malignancies and PML.
Rituksimab ni indicirano za uporabo pri teh bolnikih zaradi nezadostnih podatkov o varnosti dolgoročnega zdravljenja z rituksimabom, še posebej v zvezi s tveganjem za razvoj malignih bolezni ter PML.
The incidence of all grade infections was similar between the arms.
Pojavnost okužb vseh stopenj je bila med skupinama podobna.
No dose reductions of Ritemvia are recommended.
Odmerka zdravila Ritemvia ni priporočljivo zmanjšati.
Contents of the pack and other information What Ritemvia contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ritemvia
Body system
Organski sistem
It is not known whether Ritemvia has an effect on you being able to drive or use any tools or machines.
Ni znano, ali zdravilo Ritemvia vpliva na vašo sposobnost za upravljanje vozil ali strojev.
6.11 years
6,11 let
The rate of all ADRs following first rituximab exposure was highest during the first 6 months and declined thereafter.
Delež vseh neželenih učinkov, ki so se pojavili po prvi izpostavitvi rituksimabu, je bil najvišji v prvih 6 mesecih in se je potem zmanjševal.
Neurologic events
Nevrološki dogodki
Patients who develop severe cytokine release syndrome should have their infusion interrupted immediately (see section 4.2) and should receive aggressive symptomatic treatment.
Bolnikom, pri katerih se pojavi hud sindrom sproščanja citokinov, je treba infundiranje nemudoma prekiniti (glejte poglavje 4.2) in dobiti morajo agresivno simptomatsko zdravljenje.
Worst case imputation is applied for patients with missing data
Za bolnike z manjkajočimi podatki so uporabili imputacijo za najslabši primer.
What you need to know before you use Ritemvia Do not take Ritemvia if:
Kaj morate vedeti, preden boste uporabili zdravilo Ritemvia Ne uporabljajte zdravila Ritemvia, če:
Mean Cmax was 16 to 19% higher following second infusion compared to the first infusion for both doses.
Povprečna Cmax je bila za 16 do 19 % večja po drugi infuziji v primerjavi s prvo infuzijo pri obeh odmerkih.
In patients where the treatment is working, Ritemvia may be continued for 2 years after completing the initial treatment.
Pri bolnikih, pri katerih takšno zdravljenje deluje, je mogoče zdravila Ritemvia nadaljevati še dve leti po dokončanju začetnega zdravljenja.
Included patients were 21 to 75 years of age and had newly diagnosed or relapsing disease in complete remission after combined treatment with glucocorticoids and pulse cyclophosphamide.
Vključeni bolniki so bili stari od 21 do 75 let in so imeli novodiagnosticirano bolezen ali recidiv bolezni v popolni remisiji po kombiniranem zdravljenju z glukokortikoidi in pulznim ciklofosfamidom.
In a long-term observational safety study, 97 GPA/MPA patients received treatment with rituximab (mean of 8 infusions [range 1-28]) for up to 4 years, according to their physician's standard practice and discretion.
V dolgoročni opazovalni študiji varnosti je 97 bolnikov z GPA/MPA prejemalo zdravljenje z rituksimab (v povprečju 8 infuzij [razpon od 1 do 28]) do 4 leta, v skladu s standardno prakso in presojo njihovega zdravnika.
The consequences of long term B cell depletion in paediatric patients are unknown.
Posledice dolgotrajnega zmanjšanja števila celic B pri pediatričnih bolnikih niso znane.
On the basis of standardised incidence ratios, the incidence of malignancies appears to be similar to that previously reported in patients with ANCA-associated vasculitis.
Na podlagi standardiziranih incidenčnih razmerij je incidenca malignih bolezni podobna, kot je bila pred tem opisana pri bolnikih z vaskulitisom, povezanim z ANCA.
Skin papilloma * Infusion-related reactions included symptoms collected on the next scheduled visit after each infusion, and adverse events occurring on the day of or one day after the infusion.
kožni papilomi * Z infundiranjem povezane reakcije so vključevale simptome, zbrane ob naslednjem načrtovanem obisku po vsaki infuziji, in neželene dogodke, ki so se pojavili na dan infuzije ali en dan po njej.
Primary analysis (median FU: 25 months)
Primarna analiza (mediana spremljanja: 25 mesecev)
Cumulative incidence over time of first major relapse
Kumulativna incidenca glede na čas prvega hujšega recidiva
What are the signs of getting an infection?
Kateri so znaki okužbe?
3 Reactions occurring during or within 24 hours of infusion.
3Reakcije, ki so se pojavile med infuzijo ali v prvih 24 urah po njej.
• If you respond well to treatment, you may be given Ritemvia every 2 or 3 months for two years.
Če se boste dobro odzvali na zdravljenje, boste lahko zdravilo Ritemvia dobivali na dva meseca ali tri, in sicer dve leti.
Very common side effects (may affect more than 1 in 10 people): allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion long lasting depression loss of hair
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): alergijske reakcije, ki se najverjetneje pojavijo med infuzijo, a se lahko pojavijo tudi do 24 ur po infuziji, dolgotrajna depresija, izpadanje las.
• tremors (shakiness, often in the hands)
tremor (tresenje, pogosto tresenje rok),
Patients could receive 1000 mg IV at the time of relapse (see section 5.1).
Bolniki so lahko dobili 1.000 mg intravensko ob času recidiva (glejte poglavje 5.1).
Read the leaflet for further information.
Za dodatne informacije preberite navodilo za uporabo.
These studies support the use of rituximab with any chemotherapy.
Te študije podpirajo uporabo rituksimaba s katerokoli kemoterapijo.
These are listed below under “Other side effects”.
Naštete so spodaj pod naslovom Drugi neželeni učinki.
Infections Tell your doctor immediately if you get signs of an infection including:
Zdravniku nemudoma povejte, če se vam pojavijo znaki okužbe, na primer:
Patients who develop evidence of severe reactions, especially severe dyspnoea, bronchospasm or hypoxia should have the infusion interrupted immediately.
Pri bolnikih, pri katerih se pojavijo hude reakcije, zlasti huda dispneja, bronhospazem ali hipoksija, moramo infuzijo takoj prekiniti.
Patient subpopulations - rituximab combination therapy Elderly patients (≥ 65 years)
Podskupine bolnikov - kombinirano zdravljenje z rituksimabom Starejši bolniki (≥ 65 let)
Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01XC02.
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC02.
This antigen does not internalize upon antibody binding and is not shed from the cell surface.
Po vezavi s protitelesom ne vstopa v notranjost celice, niti se ne odcepi s celične površine.
This compares favourably with the TTP achieved after the prior course of rituximab (12.4 months).
To je lepo primerljivo s časom do napredovanja bolezni, ki je bil dosežen po predhodnem zdravljenju z rituksimabom (12,4 meseca).
Seropositive patients also had a significantly greater decrease in DAS28-ESR compared to seronegative patients (Figure 1).
Seropozitivni bolniki so imeli tudi značilno večje zmanjšanje v DAS28-ESR kot seronegativni bolniki (slika 1).