FrancophonIA/ELRC3.0 huggingface dataset:
English: All physicians who are expected to prescribe Rixathon for non-oncology indications are provided with the following: - Product information - HCP educational leaflet - Patient educational leaflet
Croatian: Svi liječnici za koje se očekuje da će propisivati lijek Rixathon za neonkološke indikacije dobit će sljedeće materijale:
English: Also do not breast-feed for 12 months after your last treatment with Rixathon.
Croatian: Ne smijete dojiti dijete tijekom liječenja lijekom Rixathon i još 12 mjeseci nakon posljednje primjene lijeka jer se Rixathon može izlučiti u majčino mlijeko.
English: Cases of hepatitis B reactivation, including those with a fatal outcome, have been reported in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab.
Croatian: U bolesnika s reumatoidnim artritisom, granulomatozom s poliangitisom i mikroskopskim poliangitisom koji su primali rituksimab prijavljeni su slučajevi reaktivacije hepatitisa B, uključujući one sa smrtnim ishodom.
English: All patients Newly diagnosed Relapsing n=99 n=48 n=51
Croatian: Svi bolesnici n = 99
English: • infections such as herpes infections and eye infection
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba): • infekcije poput herpesa i infekcija oka
English: Gastrointestinal perforation in some cases leading to death has been observed in patients receiving rituximab for treatment of non-Hodgkin lymphoma.
Croatian: U bolesnika koji su primali rituksimab za liječenje ne-Hodgkinova limfoma zabilježene su gastrointestinalne perforacije, u nekim slučajevima sa smrtnim ishodom.
English: Hypertension, orthostatic hypotension, hypotension
Croatian: Krvožilni poremećaji hipertenzija, ortostatska hipotenzija, hipotenzija vaskulitis (pretežno kutani), leukocitoklasti čni vaskulitis
English: In particular, tell your doctor:
Croatian: Recite im i da se liječite lijekom
English: Immune system disorders
Croatian: Poremećaji probavnog sustava proljev
English: Hypogammaglobulinaemia (IgG or IgM below the lower limit of normal) has been observed in RA patients treated with rituximab.
Croatian: (IgG ili IgM ispod donje granice normalnih vrijednosti).
English: A higher proportion of patients receiving the original rituximab/MTX treatment also had no erosive progression over 56 weeks (Table 13).
Croatian: 56 tjedana erozija nije napredovala u većem udjelu bolesnika koji su od početka liječeni rituksimabom i metotreksatom (Tablica 13).
English: In a multi-centre, single-arm trial, 37 patients with relapsed or chemoresistant, low grade or follicular B cell NHL received 375 mg/m2 of rituximab as intravenous infusion weekly for eight doses.
Croatian: U objedinjenim podacima iz tri ispitivanja 39 bolesnika s relapsirajućim ili kemorezistentnim proširenim ne-Hodgkinovim limfomom (promjer jedne lezije ≥ 10 cm) niskog stupnja malignosti ili folikularnim B-staničnim ne-Hodgkinovim limfomom primilo je rituksimab u dozi od 375 mg/m2
English: Patients treated with rituximab in combination with methotrexate had a significantly greater reduction in disease activity score (DAS28) than patients treated with methotrexate alone (Table 12).
Croatian: Disease Activity Score) nego u bolesnika koji su liječeni samo metotreksatom (Tablica 12).
English: Severe IRRs with fatal outcome have been reported in rheumatoid arthritis patients in the postmarketing setting.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi teških infuzijskih reakcija sa smrtnim ishodom u bolesnika s reumatoidnim artritisom.
English: A small number of cases of hepatitis-B reactivation, some with fatal outcome, have been reported in granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab in the postmarketing setting.
Croatian: U bolesnika s granulomatozom s poliangitisom i mikroskopskim poliangitisom koji su primali rituksimab nakon njegova stavljanja u promet prijavljen je malen broj slučajeva reaktivacije hepatitisa B, ponekad sa smrtnim ishodom.
English: The HCP educational leaflet about Rixathon for non-oncology indications contains the following key elements: - The need for close supervision during administration in an environment where full resuscitation facilities are immediately available - The need to check, prior to Rixathon treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system, and recent history of, or planned, vaccination, and a history of infusion-related reaction - The need to monitor patients for infections, especially PML, during and after Rixathon treatment - Detailed information on the risk of PML, the need for timely diagnosis of PML and appropriate measures to diagnose PML - The need to advise patients on the risk of infections and PML, including the symptoms to be aware of and the need to contact their doctor immediately if they experience any.
Croatian: - Detaljne informacije o riziku od PML-a, nužnost pravodobne dijagnoze PML-a i odgovarajuće mjere za dijagnosticiranje PML-a - Bolesnicima treba objasniti rizik od infekcija i PML-a, uključujući simptome kojih moraju biti svjesni i napomenuti im da se odmah obrate svom liječniku ako primijete neki od njih.
English: In the pivotal trial, 166 patients with relapsed or chemoresistant low-grade or follicular B cell NHL received 375 mg/m2 of rituximab as an intravenous infusion once weekly for four weeks.
Croatian: B-staničnim ne-Hodgkinovim folikularnim limfomom ili limfomom niskog stupnja malignosti primilo je rituksimab u dozi od 375 mg/m2 putem intravenske infuzije jedanput tjedno tijekom osam tjedana.
English: You might get infections more easily during your treatment with Rixathon.
Croatian: Tijekom liječenja lijekom Rixathon možda ćete biti podložniji infekcijama.
English: Less frequently, some patients may experience pain at the infusion site, blisters, itching, sickness (nausea), tiredness, headache, breathing difficulties, blood pressure raised, wheezing, throat discomfort, tongue or throat swelling, itchy or runny nose, vomiting, flushing or palpitations, heart attack or low number of platelets.
Croatian: Rjeđe se u nekih bolesnika mogu pojaviti bol na mjestu infuzije, plikovi, svrbež, mučnina, umor, glavobolja,
English: In the overall experience of rituximab repeat treatment over one year in rheumatoid arthritis, the proportions of patients with positive antibody titres against S. pneumoniae, influenza, mumps, rubella, varicella and tetanus toxoid were generally similar to the proportions at baseline.
Croatian: Sveukupno iskustvo s ponavljanim ciklusima rituksimaba tijekom godine dana u liječenju reumatoidnog artritisa pokazalo je da su udjeli bolesnika s pozitivnim titrom antitijela protiv S.
English: Abdominal pain upper
Croatian: Poremećaji probavnog sustava bol u gornjem dijelu abdomena
English: An updated RMP should be submitted:
Croatian: • Znakovi PML-a uključuju:
English: Rixathon is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Croatian: e) običnog pemfigusa Rixathon se primjenjuje za liječenje bolesnika s umjerenim do teškim običnim pemfigusom.
English: , leucopenia, +febrile neutropenia, +thrombocyt openia
Croatian: Poremećaji krvi i limfnog sustava neutropenija, leukopenija, +febrilna neutropenija, +trombocitopenij a anemija, +pancitopenija, +granulocitopenij a poremećaji zgrušavanja,
English: Diarrhoea Dyspepsia Constipation
Croatian: Psihijatrijski poremećaji nesanica
English: Repeated treatment courses with Rixathon are possible.
Croatian: Rixathon mogu se ponavljati.
English: Pruritis, rash, +alopecia
Croatian: Poremećaji kože i potkožnog tkiva svrbež, osip, +alopecija urtikarija,
English: (CLL):
Croatian: CR,
English: Patients randomised to the standard-dose prednisone group received an initial 1 mg/kg/day oral prednisone tapered off over 12 months if they had moderate disease or 1.5 mg/kg/day oral prednisone tapered off over 18 months if they had severe disease.
Croatian: Bolesnici randomizirani u skupinu liječenu standardnom dozom prednizona primali su prednizon u početnoj peroralnoj dozi od 1 mg/kg na dan, koja se postupno smanjivala tijekom
English: Treatment difference (rituximabcyclophosphamide)
Croatian: Rituximabum (rituksimab)
English: Lacrimation disorder, conjunctivitis
Croatian: Poremećaji oka poremećaj u izlučivanju suza,
English: 30 ml (10 mg/ml) 1 vial
Croatian: U venu bočica (staklo) 30 ml (10 mg/ml) 1 bočica
English: MA (EU)-number (Invented) Name Strength Pharmaceutical Form
Croatian: Broj (EU) odobrenja
English: EU number
Croatian: EU broj
English: • At the request of the European Medicines Agency.
Croatian: · na zahtjev Europske agencije za lijekove.
English: Distribution/Elimination
Croatian: Distribucija/eliminacija
English: Binet stage A Binet stage B Binet stage C
Croatian: A Binet stadij B Binet stadij C
English: Risk Reduction
Croatian: Smanjenje rizika
English: At minimum this should include HBsAg-status and HBcAb-status.
Croatian: Kao minimum trebaju biti uključeni HBsAg-status i HBcAb-status.
English: In-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Vrijeme i uvjeti prije primjene odgovornost su korisnika.
English: † Outcome at 24 weeks
Croatian: † Ishod nakon 24 tjedna
English: The most frequent reported or observed serious adverse drug reactions were:
Croatian: Najčešće prijavljene ili opažene ozbiljne nuspojave na lijek bile su:
English: • What to do if you think you might be getting an infection.
Croatian: · što trebate učiniti ako mislite da se možda razvija infekcija
English: The safety and efficacy of MabThera in children below 18 years has not been established.
Croatian: Sigurnost i djelotvornost lijeka MabThera u djece mlađe od 18 godina nisu ustanovljene.
English: How much and how often you will receive your treatment
Croatian: Koliko ćete lijeka primiti i koliko često
English: These can be complemented with other appropriate markers as per local guidelines.
Croatian: Oni mogu biti nadopunjeni ostalim odgovarajućim markerima, sukladno lokalnim smjernicama.
English: Subgroup analysis PFS
Croatian: Analiza podskupina PFS
English: 1000 New Horizons Way Vacaville, CA 95688 USA
Croatian: 1000 New Horizons Way Vacaville, CA 95688 SAD
English: UNIQUE IDENTIFIER -- HUMAN READABLE DATA PC:
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC:
English: Date of latest renewal: 2 June 2008
Croatian: Datum posljednje obnove odobrenja: 2. lipnja 2008.
English: (see section 5.1).
Croatian: (vidjeti dio 5.2).
English: The corresponding AUCτ ratios were 1.66, 1.17 and 1.32.
Croatian: Odgovarajući omjeri AUCτ iznosili su 1,66; 1,17 i 1,32.
English: Your doctor or nurse will place the sticker on the syringe before injection.
Croatian: Vaš liječnik ili medicinska sestra zalijepit će tu naljepnicu na štrcaljku prije injekcije.
English: Your doctor may change this, depending on how you respond to the medicine.
Croatian: Vaš liječnik to može promijeniti, ovisno o Vašem odgovoru na liječenje.
English: • you have ever had or might now have a hepatitis infection.
Croatian: · ako ste ikada imali ili možda trenutno imate infekciju hepatitisom.
English: • Keep this card with you all the time - such as in your wallet or purse.
Croatian: · Karticu uvijek nosite sa sobom primjerice, u novčaniku ili u torbici.
English: The prespecified non-inferiority margin for the treatment difference was 20%.
Croatian: Prethodno postavljena granica neinferiornosti za razliku između terapija bila je 20%.
English: Available data suggest that clinical response is usually achieved within 16 - 24 weeks of an initial treatment course.
Croatian: Dostupni podaci upućuju na to da se klinički odgovor obično postiže u roku od 16-24 tjedna od početnog liječenja.
English: 1 Antibody Way Oceanside, CA 92056 5802 USA
Croatian: 1 Antibody Way Oceanside, CA 92056 5802 SAD
English: In addition, central volume was slightly (9%) lower in females compared to males.
Croatian: središnji volumen bio je nešto manji (9%) u žena nego u muškaraca.
English: Take this into account if you are on a low-sodium diet.
Croatian: Ovo uzmite u obzir ako ste na dijeti s ograničenim unosom natrija.
English: MabThera may also cause changes in laboratory tests carried out by your doctor.
Croatian: MabThera može uzrokovati i promjene u nalazima laboratorijskih pretraga koje provodi Vaš liječnik.
English: Trial BP22333 (SparkThera)
Croatian: Ispitivanje BP22333 (SparkThera)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ne primijeni li se odmah, vrijeme i uvjeti prije primjene odgovornost su korisnika i obično ne bi trebali biti dulji od 24 sata na temperaturi od 2°C do 8°C, osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: If you can get pregnant, you and your partner must use an effective method of contraception while using MabThera.
Croatian: Ako ste u dobi kada možete zatrudnjeti, Vi i Vaš partner morate koristiti učinkovitu kontracepciju tijekom liječenja lijekom MabThera.
English: CI: Confidence Interval
Croatian: CI: interval pouzdanosti
English: When should I not have MabThera?
Croatian: Kada ne smijem primiti lijek MabThera?
English: See Section 4.2 for information on paediatric use.
Croatian: Vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni.
English: The risk of disease progression was reduced by 46% and the risk of relapse by 51%.
Croatian: Rizik od progresije bolesti smanjen je za 46%, a rizik od relapsa za 51%.
English: All patients n=99
Croatian: Svi bolesnici n=99
English: If an injection is interrupted it can be resumed at the same site or another location may be used, if appropriate.
Croatian: Ako se injekcija prekine, njezina se primjena može nastaviti na istome mjestu ili, po potrebi, na nekom drugom mjestu.
English: Do not have MabThera if you have an active infection or a serious problem with your immune system.
Croatian: Ne smijete primiti lijek MabThera ako imate aktivnu infekciju ili ozbiljne poteškoće s imunološkim sustavom.
English: Proportion of patients with no radiographic change
Croatian: Udio bolesnika bez radiografskih promjena
English: Figure 3: Cumulative incidence over time of first major relapse
Croatian: Slika 3: Kumulativna incidencija prvog teškog relapsa kroz vrijeme
English: Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease (see section 4.4 regarding other cardiovascular diseases).
Croatian: Teško zatajenje srca (New York Heart Association stupanj IV) ili teška nekontrolirana srčana bolest (vidjeti dio 4.4 za druge kardiovaskularne bolesti).
English: Subcutaneous formulation:
Croatian: Formulacija za supkutanu primjenu:
English: Elderly patients (≥ 65 years):
Croatian: Stariji bolesnici (≥ 65 godina):
English: Do not have MabThera if any of the above apply to you.
Croatian: Nemojte primiti lijek MabThera ako se nešto od navedenoga odnosi na Vas.
English: body surface area.
Croatian: površine tijela.
English: Table 17 Complete remission at 6-months by disease status MabThera
Croatian: Tablica 17 Potpuna remisija nakon 6 mjeseci prema statusu bolesti MabThera
English: Trial BO22334 (SABRINA)
Croatian: Ispitivanje BO22334 (SABRINA)
English: It remains unknown if early detection of PML and suspension of MabThera therapy may lead to similar stabilisation or improved outcome.
Croatian: Ostaje nepoznato mogu li rano otkrivanje PML-a i prekid liječenja lijekom MabThera dovesti do slične stabilizacije ili poboljšanog ishoda.
English: These events were Grade 3 injection site rash and dry mouth.
Croatian: Ti su događaji bili osip na mjestu injekcije 3. stupnja i suha usta.
English: Depending on the signs and symptoms of your disease, your doctor will decide when you should receive more MabThera.
Croatian: Ovisno o znakovima i simptomima bolesti liječnik će odlučiti kada morate ponovo primiti lijek MabThera.
English: serious viral infection2
Croatian: ozbiljne virusne infekcije2
English: Patients should receive MabThera for at least 24 months after achievement of remission (absence of clinical signs and symptoms).
Croatian: Bolesnici trebaju primati lijek MabThera najmanje 24 mjeseca nakon postizanja remisije (odsutnost kliničkih znakova i simptoma bolesti).
English: MabThera is indicated in adults for the following indications:
Croatian: MabThera je indicirana u odraslih u sljedećim indikacijama:
English: The overall trial design was identical among both stages and patients were randomized into the following two treatment groups:
Croatian: Cjelokupan dizajn ispitivanja bio je identičan u oba dijela, a bolesnici su bili randomizirani u sljedeće dvije terapijske skupine:
English: Treatment, N
Croatian: Ispitivanje Liječenje, N
English: Patients were followed beyond week 24 for long term endpoints, including radiographic assessment at 56 weeks and at 104 weeks.
Croatian: Bolesnici su praćeni dulje od 24 tjedna radi utvrđivanja dugoročnih mjera ishoda, uključivo i radiološku procjenu u 56. i 104. tjednu.
English: • Severe vision loss (sign of brain nerves damage).
Croatian: · težak gubitak vida (znak oštećenja moždanih živaca).
English: The most frequently reported events were tachycardia (4%) and atrial fibrillation (3%) (see section 4.4).
Croatian: Najčešće prijavljeni događaji bili su tahikardija (4%) i fibrilacija atrija (3%) (vidjeti dio 4.4).
English: − CI = confidence interval.
Croatian: CI = interval pouzdanosti
English: Other medicines and MabThera
Croatian: Drugi lijekovi i MabThera
English: Final analysis (median FU: 9.0 years)
Croatian: Završna analiza (medijan praćenja: 9,0 godina)
English: The majority of patients (81%) showed signs of B cell return,
Croatian: Većina je bolesnika (81%) pokazala znakove povrata
English: • you are allergic to hyaluronidase (an enzyme that helps to increase the absorption of injected active substance)
Croatian: · ako ste alergični na hijaluronidazu (enzim koji pomaže povećati apsorpciju injicirane djelatne tvari)
English: For these reasons MabThera should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Croatian: Zbog tih se razloga MabThera ne smije primjenjivati u trudnica, osim ako moguća korist od liječenja nadilazi potencijalni rizik.
English: The antigen is expressed on >95 % of all B cell non-Hodgkin's lymphomas.
Croatian: Antigen je izražen u > 95% svih B-staničnih ne-Hodgkinovih limfoma.
English: • What the signs of an infection are
Croatian: · koji su znakovi infekcije
English: • The need to carry the card at all times and to show the card to all treating health care professionals
Croatian: · Karticu uvijek treba nositi sa sobom i pokazati je svim zdravstvenim radnicima koji bolesnika liječe
English: • Warning on the risk of infections and PML, including the symptoms
Croatian: · Upozorenje o riziku od infekcija i PML-a, uključujući simptome
English: Kaplan-Meier Estimate of Median Time to Event (Months)
Croatian: Kaplan-Meierova procjena medijana vremena do pojave događaja (mjeseci)
English: MabThera was given in combination with intravenous glucocorticoids which may reduce the incidence and severity of these events.
Croatian: MabThera se primjenjivala u kombinaciji s intravenskim glukokortikoidima, što može smanjiti incidenciju i težinu tih događaja.
English: In most cases, the infusion can be resumed at a 50% reduction in rate (e.g. from 100 mg/h to 50 mg/h) when symptoms have completely resolved.
Croatian: U većini slučajeva infuzija se može nastaviti uz smanjenje brzine za 50% (npr. sa 100 mg/sat na 50 mg/sat) kada se simptomi u potpunosti povuku.
English: The gender- related pharmacokinetic differences are not considered to be clinically relevant and dose adjustment is not required.
Croatian: Farmakokinetičke razlike s obzirom na spol ne smatraju se klinički značajnima te nije potrebno prilagođavati dozu.
English: There is no evidence of dysmorphogenesis (i.e. teratogenesis) resulting from systemic exposure to rHuPH20.
Croatian: Nema dokaza dismorfogeneze (tj. teratogeneze) kao posljedice sistemske izloženosti rHuPH20.
English: Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue MabThera.
Croatian: Ovisno o težini infuzijske reakcije i potrebnim intervencijama valja privremeno ili trajno prekinuti primjenu lijeka MabThera.
English: Twenty nine (0.48%) post-dose observations (all from trial BP22333) were below the quantification limit.
Croatian: Dvadeset i devet (0,48%) rezultata nakon primjene doze (svi iz ispitivanja BP22333) bilo je ispod granice mjerljivosti.
English: The “primary” statistical test for “response” was the trend test of CR versus PR versus non-response (p < 0.0001)
Croatian: “Primarni” statistički test za “odgovor” bio je trend test: CR u odnosu na PR u odnosu na izostanak odgovora (p < 0,0001)
English: Relapsing n=51
Croatian: Relaps n=51
English: • hearing loss, loss of other senses.
Croatian: · gubitak sluha, gubitak drugih osjeta.
English: Primary analysis (median FU: 25 months)
Croatian: Primarna analiza (medijan praćenja: 25 mjeseci)
English: No data are available on performing the injection in other sites of the body, therefore injections should be restricted to the abdominal wall.
Croatian: Nema dostupnih podataka o injiciranju lijeka na drugim mjestima na tijelu pa primjenu injekcija treba ograničiti na trbušnu stijenku.
English: Re-treatment:
Croatian: Ponovno liječenje:
English: Absorption parameters of subcutaneous formulation, decreased with increasing BMI.
Croatian: Parametri apsorpcije supkutane formulacije smanjivali su se s povećanjem ITM-a.
English: Your doctor will check if you should have any vaccines before you receive MabThera.
Croatian: Vaš će liječnik provjeriti morate li primiti neko cjepivo prije nego što primite lijek MabThera.
English: This compares favourably with the TTP achieved after the prior course of MabThera (12.4 months).
Croatian: To je povoljnije u odnosu na TTP postignut nakon prethodnog ciklusa liječenja lijekom MabThera (12,4 mjeseca).
English: Your doctor may decide to stop your MabThera treatment if these reactions are serious.
Croatian: Vaš liječnik može odlučiti prekinuti liječenje lijekom MabThera ako su te reakcije ozbiljne.
English: Based on popPK analysis an absolute bioavailability of 71% was estimated.
Croatian: Na temelju populacijske farmakokinetičke analize procijenjeno je da apsolutna bioraspoloživost iznosi 71%.
English: Rituximab was detectable in the serum of patients 3 - 6 months after completion of last treatment.
Croatian: Rituksimab je bilo moguće otkriti u serumu bolesnika 3 - 6 mjeseci nakon završetka liječenja.
English: with counts >10 cells/μL by month 12, increasing to 87% of patients by month 18.
Croatian: B stanica, uz vrijednosti od > 10 stanica/µl do 12. mjeseca, što se povećalo na 87% bolesnika do 18. mjeseca.
English: MabThera is not indicated for these patients, since the safety data about long-term MabThera treatment are insufficient, in particular concerning the risk of development of malignancies and PML.
Croatian: MabThera nije indicirana za te bolesnike jer nema dovoljno podataka o sigurnosti dugotrajnog liječenja lijekom MabThera, osobito u pogledu rizika od razvoja zloćudnih bolesti i PML-a.
English: MabThera slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to do normal daily activities.
Croatian: MabThera usporava oštećenje zglobova uzrokovano reumatoidnim artritisom i poboljšava sposobnost obavljanja uobičajenih dnevnih aktivnosti.
English: MabThera will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Croatian: Lijek MabThera će Vam dati liječnik ili medicinska sestra s iskustvom u primjeni te vrste lijekova.
English: • The need for close supervision during administration in an environment where full resuscitation facilities are immediately available
Croatian: · Neophodan je poman nadzor tijekom primjene u okruženju u kojem su izravno dostupni svi uređaji za oživljavanje.