FrancophonIA/ELRC3.0 huggingface dataset:
English: * at end of maintenance/observation; final analysis results based on median follow-up of 73 months.
Croatian: *Na kraju održavanja/promatranja; rezultati završne analize temelje se na medijanu praćenja od 73 mjeseca.
English: MabThera induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients.
Croatian: MabThera uzrokuje depleciju B-stanica u oko 70-80% bolesnika, ali se povezuje sa smanjenom razinom serumskih imunoglobulina samo kod malog broja bolesnika.
English: This analysis suggests that dose adjustment of MabThera with any of the tested covariates is not expected to result in a meaningful reduction in its pharmacokinetic variability.
Croatian: Ova analiza upućuje na zaključak da prilagodba doze lijeka MabThera prema bilo kojoj od testiranih kovarijanti vjerojatno neće znatno smanjiti njegove farmakokinetičke varijabilnosti.
English: MabThera will be given to you once a week for 4 weeks.
Croatian: Lijek MabThera primat ćete jedanput na tjedan tijekom 4 tjedna.
English: Names and addresses of the manufacturers of the biological active substance
Croatian: Nazivi i adrese proizvođača biološke djelatne tvari
English: The hypodermic injection needle must only be attached to the syringe immediately prior to administration to avoid potential needle clogging.
Croatian: Hipodermička igla za injekciju smije se pričvrstiti za štrcaljku samo neposredno prije primjene kako bi se izbjeglo moguće začepljenje igle.
English: Treatment Difference (MabTheraCyclophosphamide)
Croatian: Razlika između terapija (MabTheraciklofosfamid)
English: Severe (grade 3/4) neutropenia was reported in 4.2%, anaemia in 1.1% and thrombocytopenia in 1.7% of the patients.
Croatian: Teška neutropenija (stupanj 3/4) prijavljena je u 4,2%, anemija u 1,1%, a trombocitopenija u 1,7% bolesnika.
English: 1 Frequency category derived from laboratory values collected as part of routine laboratory monitoring in clinical trials
Croatian: 1 Kategorija učestalosti dodijeljena na temelju laboratorijskih vrijednosti prikupljenih tijekom rutinskih laboratorijskih kontrola u kliničkim ispitivanjima
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Croatian: Nositelj odobrenja je dužan unutar navedenog vremenskog roka, provesti niže navedene mjere: Opis
English: The information provided in this section pertains to the use of MabThera in oncology.
Croatian: Informacije u ovom dijelu odnose se na primjenu lijeka MabThera u onkologiji.
English: Immunomodulatory drugs may increase the risk of malignancy.
Croatian: Imunomodulacijski lijekovi mogu povećati rizik od zloćudnih bolesti.
English: • if you have ever taken medicines which affect your immune system - such as chemotherapy or immune-suppressive medicines.
Croatian: · ako ste ikada uzimali lijekove koji mogu utjecati na imunološki sustav, kao što su kemoterapija ili lijekovi koji potiskuju imunološki sustav (imunosupresivi).
English: Abbreviations: NA, not available; ORR: overall response rate; CR: complete response; PR: partial response
Croatian: Skraćenice: ND: nije dostupno, ORR: stopa ukupnog odgovora na liječenje, CR: potpun odgovor, PR: djelomičan odgovor
English: Premedication with glucocorticoids should also be considered.
Croatian: Treba razmotriti i premedikaciju glukokortikoidima.
English: If not used immediately, preparation should take place in controlled and validated aseptic conditions.
Croatian: lijek treba pripremiti u kontroliranim i validiranim aseptičkim uvjetima.
English: What MabThera looks like and contents of the pack
Croatian: Kako MabThera izgleda i sadržaj pakiranja
English: Observation N=513
Croatian: Opservacijska skupina N=513
English: If you are having MabThera with other medicines, some of the side effects you may get may be due to the other medicines.
Croatian: Ako lijek MabThera primate zajedno s drugim lijekovima, neke od nuspojava koje će se možda pojaviti mogu biti uzrokovane drugim lijekovima.
English: MabThera 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).
Croatian: MabThera se treba primjenjivati pod izravnim nadzorom iskusnog zdravstvenog radnika i u okruženju u kojem su izravno dostupni svi uređaji za oživljavanje (vidjeti dio 4.4).
English: All healthcare professionals administering MabThera subcutaneous formulation will be provided with an Educational Material (« step by step guide » and « comparison card ») to minimise the risk of off label use and administration route error.
Croatian: Svi zdravstveni radnici koji primjenjuju supkutanu formulaciju lijeka MabThera dobit će edukacijski materijal („vodič korak-po-korak“ i „kartica usporedbe“) kako bi se minimizirao rizik od primjene u neodobrenim indikacijama i pogrešnoga puta primjene.
English: This is because there is not much information about the use of MabThera in children and young people.
Croatian: Naime, nema mnogo informacija o primjeni lijeka MabThera u djece i mladih osoba.
English: Mean Change in SF-36 PHS
Croatian: Srednja vrijednost promjene SF-36 PHS
English: This will be administered 1 year and 18 months after the initial treatment and then every 6 months as needed or your doctor may change this, depending on how you respond to the medicine.
Croatian: U tom slučaju, lijek ćete primiti nakon 12 mjeseci i nakon 18 mjeseci od početnog liječenja, a zatim svakih 6 mjeseci prema potrebi ili Vaš liječnik može odrediti drukčije, ovisno o tome koliko dobro odgovorite na liječenje.
English: The rate of serious cardiac events was 2.1 per 100 patient years (95% CI 3 -15).
Croatian: Stopa ozbiljnih srčanih događaja iznosila je 2,1 na 100 bolesnik-godina (95% CI 3 -15).
English: • hearing loss, loss of other senses b) If you are being treated for rheumatoid arthritis Very common side effects (may affect more than 1 in 10 people):
Croatian: • gubitak sluha, gubitak drugih osjeta b) Bolesnici koji se liječe od reumatoidnog artritisa Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba):
English: No dose reductions of MabThera are recommended.
Croatian: Ne preporučuje se smanjenje doze lijeka MabThera.
English: 60%, NS
Croatian: 60%, NZ
English: Your doctor will decide when to start MabThera injections.
Croatian: Liječnik će odlučiti kada započeti s primjenom injekcija lijeka MabThera.
English: Table 12 Clinical response outcomes at primary endpoint in Trial 1(ITT population) Outcome†
Croatian: Tablica 12 Klinički odgovor u trenutku primarne mjere ishoda ispitivanja 1 (ITT populacija)
English: On the basis of limited experience with MabThera in rheumatoid arthritis patients (see section 4.8) the present data do not seem to suggest any increased risk of malignancy.
Croatian: Na temelju ograničenog iskustva s lijekom MabThera u bolesnika s reumatoidnim artritisom (vidjeti dio 4.8), trenutno dostupni podaci ne ukazuju na povećan rizik od zloćudnih bolesti.
English: Also some other medicines can affect the way MabThera works.
Croatian: Isto tako neki lijekovi mogu utjecati na način djelovanja lijeka MabThera.
English: However, the higher incidence of neutropenia in patients treated with MabThera and chemotherapy was not associated with a higher incidence of infections and infestations compared to patients treated with chemotherapy alone.
Croatian: Međutim, veća incidencija neutropenije u bolesnika liječenih lijekom MabThera i kemoterapijom nije bila povezana s većom incidencijom infekcija i infestacija u usporedbi s bolesnicima liječenima samo kemoterapijom.
English: Based on the mechanism of action of MabThera and the knowledge that B cells play an important role in maintaining normal immune response, patients have an increased risk of infection following MabThera therapy (see section 5.1).
Croatian: S obzirom na mehanizam djelovanja lijeka MabThera i činjenicu da B stanice igraju važnu ulogu u održavanju normalnog imunološkog odgovora, nakon terapije lijekom MabThera bolesnici su izloženi povećanom riziku od infekcija (vidjeti dio 5.1).
English: Serious infections, including fatalities, can occur during therapy with MabThera (see section 4.8).
Croatian: Ozbiljne infekcije, uključujući one sa smrtnim ishodom, mogu se pojaviti tijekom terapije lijekom MabThera (vidjeti dio 4.8).
English: The rate of all ADRs following first MabThera exposure was highest during the first 6 months and declined thereafter.
Croatian: Stopa učestalosti svih nuspojava nakon prve izloženosti lijeku MabThera bila je najveća tijekom prvih 6 mjeseci, a potom se smanjivala.
English: Keep this card with you for 2 years after your last dose of MabThera.
Croatian: Karticu nosite sa sobom još 2 godine nakon što primite posljednju dozu lijeka MabThera.
English: This is usually given every 3 weeks up to 8 times.
Croatian: 3 tjedna, najviše 8 puta.
English: Number of responders (response rate [%]) ap-value is from Fisher's exact test with mid-p correction b 95% confidence interval is corrected Newcombe interval
Croatian: Broj bolesnika s odgovorom (stopa odgovora [%]) ap-vrijednost dobivena je Fisherovim egzaktnim testom uz korekciju srednje p-vrijednosti bInterval pouzdanosti od 95% je korigirani Newcombeov interval
English: Part 2 N = 176
Croatian: 2. dio N = 176
English: This is because MabThera can affect the way some other medicines work.
Croatian: To je važno jer MabThera može utjecati na način djelovanja nekih lijekova.
English: The rate of serious infections did not show any significant increase following multiple courses of MabThera.
Croatian: Stopa ozbiljnih infekcija nije se značajno povećala nakon višestrukih ciklusa lijeka MabThera.
English: MabThera is usually taken together with another medicine called methotrexate.
Croatian: MabThera se obično primjenjuje zajedno s drugim lijekom koji se zove metotreksat.
English: No dose adjustment is required in elderly patients (aged >65 years).
Croatian: Nije potrebno prilagođavati dozu u starijih bolesnika (u dobi od > 65 godina).
English: The incidence of infections that were serious or required IV antibiotics was approximately 4 per 100 patient years.
Croatian: Incidencija infekcija koje su bile ozbiljne ili zahtijevale i.v. primjenu antibiotika iznosila je otprilike 4 na 100 bolesnik-godina.
English: A small proportion of patients had prolonged peripheral B cell depletion lasting 2 years or more after their last dose of MabThera.
Croatian: Malen udio bolesnika imao je dugotrajnu depleciju perifernih B stanica u trajanju od 2 godine ili više nakon posljednje doze lijeka MabThera.
English: Recombinant human hyaluronidase (rHuPH20) L-histidine
Croatian: rekombinantna humana hijaluronidaza (rHuPH20) L-histidin
English: Higher time-dependenet clearance in subjects with higher disease burden would lead to lower initial exposure and longer time needed to achieve the same exposure as in subjects with lower burden of the disease.
Croatian: Veća vrijednost vremenski uvjetovanog klirensa u ispitanika s većim opterećenjem bolešću doveo bi do niže početne izloženosti i duljeg vremena potrebnog za postizanje izloženosti jednake onoj koja se postiže u bolesnika s manjim opterećenjem bolešću.
English: The MAH must ensure that all physicians who are expected to prescribe MabThera are provided with the following:
Croatian: Nositelj odobrenja mora osigurati da svi liječnici za koje se očekuje da će propisivati lijek MabThera dobiju sljedeće materijale:
English: The cells that are affected by MabThera help to fight infection and you should wait until the infection has passed before you are given MabThera.
Croatian: MabThera utječe na stanice koje pomažu u borbi protiv infekcija pa stoga morate pričekati dok infekcija ne prođe prije nego što primite lijek MabThera.
English: There are limited data from clinical trials to fully assess the safety of the sequential use of other DMARDs (including TNF inhibitors and other biologics) following MabThera (see section 4.5).
Croatian: Premalo je podataka iz kliničkih ispitivanja da bi se u potpunosti mogla procijeniti sigurnost sekvencijske primjene drugih DMARD-a (uključujući TNF-inhibitore i ostale biološke lijekove) nakon lijeka MabThera (vidjeti dio 4.5).
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Croatian: · Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Of the patients originally receiving methotrexate alone, 81 % received MabThera either as rescue between weeks 16-24 or in the extension trial, before week 56.
Croatian: Od bolesnika koji su prvotno primali samo metotreksat, njih je 81% primilo lijek MabThera ili kao „spasonosnu“ terapiju između 16. i 24. tjedna ili tijekom produljenja ispitivanja, prije 56. tjedna.
English: • Place all used needles and syringes into a sharps container (puncture-proof disposable container).
Croatian: · Sve upotrijebljene igle i štrcaljke treba odložiti u spremnik za oštre predmete (neprobojan spremnik za jednokratnu uporabu).
English: 2Details on infusion related reactions are provided in the description of selected adverse drug reactions section.
Croatian: Pojedinosti o reakcijama povezanima s infuzijom navedene su u odlomku „Opis odabranih nuspojava“.
English: Your doctor may need to take special care of you during your treatment with MabThera.
Croatian: Liječnik će Vas možda morati osobito pažljivo nadzirati tijekom liječenja lijekom MabThera.
English: For patients who may be at higher risk for relapse, physicians should consider a longer duration of MabThera maintenance therapy, up to 5 years.
Croatian: U bolesnika koji bi mogli biti izloženi većem riziku od relapsa liječnici trebaju razmotriti dulje trajanje terapije održavanja lijekom MabThera (do 5 godina).
English: • If you respond well to treatment, you may be given MabThera as a maintenance treatment every 2 or 3 months for two years.
Croatian: · Ako dobro odgovorite na liječenje, možda ćete primati lijek MabThera kao terapiju održavanja svaka 2 ili 3 mjeseca tijekom dvije godine.
English: MabThera is used to treat rheumatoid arthritis in people who have already tried some other medicines which have either stopped working, have not worked well enough or have caused side effects.
Croatian: MabThera se primjenjuje za liječenje reumatoidnog artritisa u osoba koje su već koristile neke druge lijekove, koji su prestali djelovati, nisu djelovali dovoljno dobro, ili su uzrokovali nuspojave.
English: Patients should be observed for at least 15 minutes following MabThera subcutaneous administration.
Croatian: Bolesnike treba nadzirati najmanje 15 minuta nakon supkutane primjene lijeka MabThera.
English: • you have a severe active infection at the moment • you have a weak immune system.
Croatian: · ako trenutno imate tešku aktivnu infekciju · ako imate oslabljen imunološki sustav
English: Of 67 patients evaluated for HAMA, no responses were noted.
Croatian: U 67 bolesnika ispitivanih na HAMA nije prijavljena nijedna reakcija.
English: The final efficacy analysis included all patients randomized to both parts of the trial.
Croatian: Konačna analiza djelotvornosti obuhvatila je sve bolesnike randomizirane u oba dijela ispitivanja.
English: 53%, NS
Croatian: 53%, NZ
English: From month 12 to month 18, 8 relapses were observed in the MabThera group compared with four in the cyclophosphamide group.
Croatian: Od 12. do 18. mjeseca zabilježeno je 8 relapsa u skupini koja je primala lijek MabThera u usporedbi s četiri u skupini liječenoj ciklofosfamidom.
English: Mean Cmax was 16 to 19% higher following second infusion compared to the first infusion for both doses.
Croatian: Prosječni Cmax za obje je doze bio 16% do 19% veći nakon druge infuzije u usporedbi s prvom infuzijom.
English: Severe infusion-related reactions (such as bronchospasm, hypotension) occurred in up to 12 % of the cases.
Croatian: Teške reakcije povezane s infuzijom (npr. bronhospazam i hipotenzija) pojavile su se u najviše 12% slučajeva.
English: Cardiovascular reactions during clinical trials with MabThera monotherapy were reported in 18.8% of patients with the most frequently reported events being hypotension and hypertension.
Croatian: Kardiovaskularne reakcije tijekom kliničkih ispitivanja monoterapije lijekom MabThera prijavljene su u 18,8% bolesnika, pri čemu su najčešće reakcije bile hipotenzija i hipertenzija.
English: Date of most recent infusion: ____________ Date of first infusion: ___________________ Patient's Name:________________________ Doctor's Name:________________________ Doctor's contact details:_________________
Croatian: Datum prve infuzije: _____________________ Ime bolesnika: __________________________
English: MabThera may be used for the treatment of several different conditions in adults.
Croatian: MabThera se može primjenjivati za liječenje nekoliko različitih bolesti u odraslih bolesnika.
English: Table 2 Efficacy results for SAWYER (BO25341) (Intent to Treat Population)
Croatian: Tablica 2 Rezultati za djelotvornost u ispitivanju SAWYER (BO25341) (populacija s namjerom liječenja)
English: Following subcutaneous administration, the absorption of rituximab is slow, reaching maximal concentrations about 3 days after administration.
Croatian: Nakon supkutane primjene apsorpcija rituksimaba je spora pa se maksimalne koncentracije dosežu približno 3 dana nakon primjene.
English: As typical for monoclonal antibodies, rituximab PK parameters depended on body size measures.
Croatian: Kao što je i uobičajeno za monoklonska antitijela, farmakokinetički parametri rituksimaba ovisili su o površini tijela.
English: • After aseptic dilution in D-glucose solution
Croatian: • Nakon aseptičkog razrjeđivanja u otopini glukoze
English: Neutropenia was not associated with an observed increase in serious infection in MabThera-treated patients.
Croatian: Neutropenija nije bila povezana s opaženim porastom ozbiljnih infekcija u bolesnika liječenih lijekom MabThera.
English: Patients with active hepatitis B disease should not be treated with MabThera.
Croatian: Bolesnici s aktivnom hepatitis B bolešću ne smiju biti liječeni lijekom MabThera.
English: Efficacy outcomes in MabThera treated patients were analysed based on autoantibody status prior to commencing treatment.
Croatian: Ishodi djelotvornosti u bolesnika liječenih lijekom MabThera analizirani su na temelju statusa autoantitijela prije početka liječenja.
English: key efficacy results for the pooled analysis of 410 patients in SABRINA stages 1 and 2 are shown in table 2.
Croatian: Ključni rezultati za djelotvornost prema analizi objedinjenih podataka prikupljenih u 410 bolesnika u prvom i drugom dijelu ispitivanja SABRINA prikazani su u Tablici 2.
English: In order to improve traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded (or stated) in the patient file.
Croatian: Kako bi se poboljšala sljedljivost biološkog lijeka, naziv i broj serije primijenjenog lijeka treba jasno zabilježiti (navesti) u bolesničkom kartonu.
English: • inflammation of blood vessels including those leading to skin symptoms
Croatian: · upale krvnih žila, uključujući one koje izazivaju kožne simptome
English: ACR20 ACR50 ACR70 EULAR Response (Good/Moderate) Mean Change in DAS
Croatian: ACR20 ACR50 ACR70 EULAR odgovor (dobar/umjeren) Srednja vrijednost promjene rezultata aktivnosti bolesti (DAS)
English: The proportion of patients experiencing an infusionrelated reaction was 29% (11 patients), 40% (15 patients), 13% (5 patients), and 10% (4 patients) following the first, second, third, and fourth infusions, respectively.
Croatian: Udio bolesnika koji su imali reakciju povezanu s infuzijom iznosio je 29% (11 bolesnika) kod prve infuzije, 40% (15 bolesnika) kod druge, 13% (5 bolesnika) kod treće i 10% (4 bolesnika) kod četvrte infuzije.
English: Rarely MabThera can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Croatian: MabThera rijetko može uzrokovati ozbiljnu infekciju mozga koja se naziva 'progresivna multifokalna leukoencefalopatija' ili PML.
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 MabThera and for 12 months following MabThera treatment.
Croatian: No, budući da se majčin IgG izlučuje u majčino mlijeko, a rituksimab je otkriven u mlijeku majmunica u laktaciji, žene ne smiju dojiti tijekom liječenja lijekom MabThera ni idućih 12 mjeseci nakon liječenja.
English: The safety information collected during post marketing experience reflects the expected adverse reaction profile as seen in clinical trials for MabThera (see section 4.4).
Croatian: Informacije o sigurnosti prikupljene nakon stavljanja lijeka u promet odražavaju očekivani profil nuspojava koji je bio vidljiv u kliničkim ispitivanjima lijeka MabThera (vidjeti dio 4.4).
English: L-histidine hydrochloride monohydrate α,α-trehalose dihydrate L-methionine
Croatian: L-histidinklorid hidrat α,α-trehaloza dihidrat
English: % SF-36 PHS MCID Mean change in SF-36 MHS % SF-36 MHS MCID
Croatian: % bolesnika sa SF-36 PHS MCID Srednja vrijednost promjene SF-36 MHS % bolesnika sa SF-36 MHS MCID
English: Some local cutaneous reactions occurred more than 24 hours after the MabThera subcutaneous administration.
Croatian: Neke lokalne kožne reakcije pojavile su se više od 24 sata nakon supkutane primjene lijeka MabThera.
English: Serious IRRs were uncommon (0.5% of patients) and were predominantly seen during the initial course.
Croatian: Ozbiljne reakcije povezane s infuzijom bile su manje česte (0,5% bolesnika) i pretežno su uočene tijekom početnog ciklusa.
English: Clinical laboratory findings
Croatian: Klinički laboratorijski nalazi
English: If a patient develops PML, the dosing of MabThera must be permanently discontinued.
Croatian: Ako se u bolesnika razvije PML, primjena lijeka MabThera mora se trajno obustaviti.
English: The highest intravenous dose of MabThera tested in humans to date is 5000 mg (2250 mg/m2), tested in a dose escalation study in patients with CLL.
Croatian: Najviša do sada ispitivana intravenska doza lijeka MabThera u ljudi iznosi 5000 mg (2250 mg/m2), a testirana je u sklopu ispitivanja postupnog povećanja doze u bolesnika s KLL-om.
English: Key results from all four trials are summarized in table 3.
Croatian: Najvažniji rezultati svih četiriju ispitivanja sažeti su u Tablici 3.
English: This is because in a few cases, MabThera could cause hepatitis B to become active again, which can be fatal in very rare cases.
Croatian: MabThera može ponovno aktivirati hepatitis B, što u vrlo rijetkim slučajevima može biti smrtonosno.
English: MabThera in combination with methotrexate significantly increased the proportion of patients achieving at least a 20 % improvement in ACR score compared with patients treated with methotrexate alone (Table 12).
Croatian: MabThera je u kombinaciji s metotreksatom znatno povećala udio bolesnika koji su postigli najmanje 20%-tno poboljšanje ACR rezultata u usporedbi s bolesnicima koji su liječeni samo metotreksatom (Tablica 12).
English: • you are allergic to rituximab, other proteins which are like rituximab, or any of the other ingredients of this medicine (listed in section 6)
Croatian: · ako ste alergični na rituksimab, druge proteine slične rituksimabu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)