FrancophonIA/ELRC3.0 huggingface dataset:
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 čuvanja prije primjene odgovornost su korisnika i obično ne bi smjeli 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: Infections Tell your doctor immediately if you get signs of an infection including:
Croatian: Odmah obavijestite liječnika ako dobijete znakove infekcije, uključujući:
English: Complete remission All Patients Newly diagnosed Relapsing
Croatian: Potpuna remisija Svi bolesnici Novodijagnosticirani Relaps
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: Your doctor will check if you should have any vaccines before you receive Ritemvia.
Croatian: Vaš će liječnik provjeriti morate li primiti neko cjepivo prije nego što primite lijek Ritemvia.
English: Of 67 patients evaluated for human anti-mouse antibody (HAMA), no responses were noted.
Croatian: U 67 bolesnika ispitivanih na prisutnost ljudskog antimišjeg antitijela (HAMA) nije prijavljena nijedna reakcija.
English: • low number of red blood cells (anaemia)
Croatian: • nizak broj crvenih krvnih stanica (anemija)
English: The proportions of patients experiencing cardiac reactions (all or serious) did not increase over multiple courses.
Croatian: Udio bolesnika koji su doživjeli srčane nuspojave (sve ili samo ozbiljne) nije se povećao tijekom višestrukih ciklusa.
English: Immunomodulatory medicinal products may increase the risk of malignancy.
Croatian: Imunomodulacijski lijekovi mogu povećati rizik od zloćudnih bolesti.
English: Binet stage A Binet stage B Binet stage C CI: Confidence Interval
Croatian: A Binet stadij B Binet stadij C
English: For these reasons rituximab should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Croatian: Zbog tih se razloga rituksimaba ne smije primjenjivati u trudnica, osim ako moguća korist od liječenja nadilazi potencijalni rizik.
English: • hives, increased sweating, night sweats
Croatian: znojenje, noćno znojenje,
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: The final efficacy analysis included all patients randomised to both parts of the study.
Croatian: Konačna analiza djelotvornosti obuhvatila je sve bolesnike randomizirane u oba dijela ispitivanja.
English: Patients in a severely immunocompromised state.
Croatian: Teško imunokompromitirani bolesnici.
English: The syndrome frequently manifests itself within one or two hours of initiating the first infusion.
Croatian: Taj se sindrom često javlja u roku od jednog do dva sata nakon početka primjene prve infuzije.
English: During or within the first 24 hours of the infusion you may develop fever, chills and shivering.
Croatian: Tijekom ili unutar prva 24 sata nakon prve infuzije može doći do vrućice, zimice i drhtavice.
English: Since initial improvement of clinical symptoms may be followed by deterioration, these patients should be closely monitored until tumour lysis syndrome and pulmonary infiltration have been resolved or ruled out.
Croatian: Budući da nakon početnog poboljšanja kliničkih simptoma može uslijediti pogoršanje, takvi se bolesnici moraju pažljivo nadzirati sve dok se sindrom lize tumora i plućni infiltrat ne riješe ili povuku.
English: Cases of fatal PML that occurred after disease progression and retreatment have also been reported in clinical trials.
Croatian: Slučajevi PML-a sa smrtnim ishodom koji su se pojavili nakon progresije bolesti i ponovnog liječenja prijavljeni su i u kliničkim ispitivanjima.
English: cranial neuropathy, loss of other senses5
Croatian: kranijalna neuropatija, gubitak drugih osjeta5
English: • Information that the product should be administered as IV only to avoid administration route errors.
Croatian: • Informaciju da se lijek smije primjenjivati samo intravenski kako bi se izbjegle pogreške u putu primjene.
English: • If you respond well to treatment, you may be given Ritemvia every 2 or 3 months for two years.
Croatian: Ako dobro odgovorite na liječenje, možda ćete primati lijek Ritemvia svaka 2 ili 3 mjeseca tijekom dvije godine.
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: This is because there is not much information about the use of Ritemvia in children and young people.
Croatian: Naime, nema mnogo informacija o primjeni lijeka Ritemvia u djece i mladih osoba.
English: Since the medicinal product does not contain any anti-microbial preservative or bacteriostatic agents, aseptic technique must be observed.
Croatian: Budući da lijek ne sadrži antimikrobne konzervanse ni bakteriostatike, mora se primjenjivati aseptička tehnika.
English: Patients should receive Ritemvia for at least 24 months after achievement of remission (absence of clinical signs and symptoms).
Croatian: Bolesnici trebaju primati lijek Ritemvia najmanje 24 mjeseca nakon postizanja remisije (odsutnost kliničkih znakova i simptoma bolesti).
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: If PML is suspected, further dosing must be suspended until PML has been excluded.
Croatian: Ako se sumnja na PML, daljnju primjenu treba prekinuti dok se PML ne isključi.
English: Tell your doctor or nurse if you are taking or have previously taken medicines which may affect your immune system this includes chemo-therapy.
Croatian: Recite liječniku ili medicinskoj sestri ako uzimate ili ste ranije uzimali lijekove koji mogu utjecati na imunološki sustav, uključujući kemoterapiju.
English: Ritemvia is a biosimilar medicinal product.
Croatian: Ritemvia je biosličan lijek.
English: Ritemvia can be given alone or with other medicines called “chemotherapy”.
Croatian: Ritemvia se može primjenjivati samostalno ili s drugim lijekovima koji se nazivaju „kemoterapijom“.
English: The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e.g. cognitive, neurological or psychiatric symptoms).
Croatian: Liječnik treba osobitu pozornost pokloniti simptomima koji ukazuju na PML, a koje bolesnik ne mora zamijetiti (npr. kognitivne, neurološke ili psihijatrijske simptome).
English: • changes in the rhythm of the heart, or the heart beating faster than normal
Croatian: • promjene srčanog ritma ili srce kuca brže nego obično
English: Population pharmacokinetic analysis revealed that BSA and gender were the most significant covariates to explain inter-individual variability in pharmacokinetic parameters.
Croatian: Populacijska farmakokinetička analiza pokazala je da su tjelesna površina i spol bili najvažnije kovarijate za objašnjenje varijabilnosti u farmakokinetičkim parametrima između ispitanika.
English: No long-term animal studies have been performed to establish the carcinogenic potential of rituximab.
Croatian: Nisu provedena dugoročna istraživanja na životinjama kako bi se ustanovio kancerogeni potencijal rituksimaba.
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: The primary endpoint was the proportion of patients who achieved an ACR20 response at week 24.
Croatian: Primarna mjera ishoda bila je ustanoviti udio bolesnika koji su postigli odgovor ACR20 do 24. tjedna.
English: • Keep this card with you all the timesuch as in your wallet or purse.
Croatian: Karticu uvijek nosite sa sobom primjerice, u novčaniku ili u torbici.
English: Before you are given Ritemvia, you will be given other medicines (pre-medication) to prevent or reduce possible side effects.
Croatian: Prije nego primite lijek Ritemvia, primit ćete druge lijekove (premedikaciju) koji sprječavaju ili ublažavaju moguće nuspojave.
English: Rituximab was given in combination with intravenous glucocorticoids which may reduce the incidence and severity of these events.
Croatian: Rituksimab se primjenjivao u kombinaciji s intravenskim glukokortikoidima, što može smanjiti incidenciju i težinu tih događaja.
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 bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati (ili navesti) u zdravstvenom kartonu bolesnika.
English: 2Details on infusion related reactions are provided in the description of selected adverse drug reactions section.
Croatian: 2Pojedinosti o reakcijama povezanima s infuzijom navedene su u odlomku „Opis odabranih nuspojava“.
English: A diagnosis of PRES/RPLS requires confirmation by brain imaging.
Croatian: Dijagnozu PRES/RPLS treba potvrditi snimanjem mozga.
English: • Detailed information on the risk of PML, the need for timely diagnosis of PML and appropriate measures to diagnose PML
Croatian: • Detaljne informacije o riziku od PML-a, nužnost pravodobne dijagnoze PML-a i odgovarajuće mjere za dijagnosticiranje PML-a
English: 9.32 years
Croatian: ND 9,32 godine
English: The healthcare provider should also consider resuming or increasing the patient's glucocorticoid dose based on clinical evaluation.
Croatian: Zdravstveni radnik treba razmotriti i nastavak primjene ili povećanje doze glukokortikoida na temelju kliničke ocjene.
English: • Detailed information on the risk of infections and PML
Croatian: • Detaljne informacije o riziku od infekcija i PML-a
English: These are listed below under “Other side effects”.
Croatian: One se navode u dijelu „Ostale nuspojave“.
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.)
English: • Warning on the risk of infections and PML, including the symptoms
Croatian: • Upozorenje o riziku od infekcija i PML-a, uključujući simptome
English: Patients were between 19 and 79 years of age and had not received prior therapies for pemphigus.
Croatian: Bolesnici su bili u dobi od 19 do 79 godina i nisu prethodno primali terapiju za pemfigus.
English: • low number of white blood cells, with or without fever or blood cells called “platelets”
Croatian: nizak broj bijelih krvnih stanica, sa ili bez vrućice, nizak broj krvnih pločica koje se zovu
English: This compares favourably with the TTP achieved after the prior course of rituximab (12.4 months).
Croatian: To je povoljnije u odnosu na TTP postignut nakon prethodnog ciklusa liječenja rituksimabom (12,4 mjeseca).
English: 4 Includes observations collected as part of routine laboratory monitoring.
Croatian: 4 Uključuje opažanja zabilježena tijekom rutinskih laboratorijskih kontrola.
English: 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.
Croatian: Informacije za liječnike i Informacije za bolesnike moraju se prije podjele usuglasiti s nadležnim nacionalnim tijelom, a Kartica s upozorenjima za bolesnika mora biti priložena kao dio unutarnjeg pakiranja.
English: • pain in the muscles or in the hands or feet
Croatian: • bol u mišićima ili u šakama ili stopalima
English: Note: Patients were censored at month 28 if they had no event.
Croatian: Napomena: Ako u bolesnika nije zabilježen nijedan događaj, bili su cenzurirani u 28. mjesecu.
English: 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.
Croatian: Znakovi i simptomi koji upućuju na reakcije povezane s infuzijom prijavljeni su u više od 50 % bolesnika u kliničkim ispitivanjima, a uglavnom su primijećeni za vrijeme prve infuzije, obično tijekom prvih sat ili dva.
English: 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.
Croatian: Ova analiza upućuje na zaključak da prilagodba doze rituksimaba prema bilo kojoj od testiranih kovarijanti vjerojatno neće znatno smanjiti njegove farmakokinetičke varijabilnosti.
English: No patients were withdrawn from treatment due to infusion-related reactions.
Croatian: Nijedan bolesnik nije prekinuo liječenje zbog reakcija povezanih s infuzijom.
English: Rituximab maintenance treatment reduced the risk of death by 56% (95% CI; 22%-75%).
Croatian: Terapija održavanja rituksimabom smanjila je rizik od smrti za 56 % (95 % CI 22 % - 75 %).
English: 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.
Croatian: U svim je razvojnim ispitivanjima korist liječenja za bolesnike bila slična, neovisno o dobi, spolu, tjelesnoj površini, rasi, broju prethodnih liječenja i stanju bolesti.
English: There was no difference between the treatment groups in the incidence of other thromboembolic events.
Croatian: Nije bilo razlika u učestalosti drugih tromboembolijskih događaja među liječenim skupinama.
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: 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: Currently, there are limited data on possible drug interactions with rituximab.
Croatian: Trenutno su dostupni ograničeni podaci o mogućim interakcijama drugih lijekova s lijekom rituksimaba.
English: Mild or moderate infusion-related reactions (IRRs) (section 4.8) usually respond to a reduction in the rate of infusion.
Croatian: Blage ili umjerene reakcije povezane s infuzijom (dio 4.8) obično se povlače nakon smanjenja brzine infuzije.
English: Efficacy was observed both for patients with newly diagnosed disease and for patients with relapsing disease (Table 17).
Croatian: Djelotvornost je opažena i u bolesnika s novodijagnosticiranom bolešću i u bolesnika s relapsirajućom bolešću (Tablica 17).
English: • Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your Ritemvia.
Croatian: Karticu pokažite svakom liječniku, medicinskoj sestri ili stomatologu koje posjećujete, a ne samo liječniku specijalistu koji Vam propisuje lijek Ritemvia.
English: B-lymphocytes are involved in the cause of these conditions.
Croatian: B limfociti igraju ulogu u izazivanju tih bolesti.
English: Pack of 2 vials.
Croatian: Pakiranje od 2 bočice.
English: The rate of all ADRs following first rituximab exposure was highest during the first 6 months and declined thereafter.
Croatian: Stopa učestalosti svih nuspojava nakon prve izloženosti rituksimabu bila je najveća tijekom prvih 6 mjeseci, a potom se smanjivala.
English: The infusion rate may be increased upon improvement of symptoms.
Croatian: Brzina infuzije može se povećati nakon poboljšanja simptoma.
English: If you are having Ritemvia with other medicines, some of the side effects you may get may be due to the other medicines.
Croatian: Ako lijek Ritemvia primate zajedno s drugim lijekovima, neke od nuspojava koje će se možda pojaviti mogu biti uzrokovane drugim lijekovima.
English: Further treatment of patients after complete resolution of signs and symptoms has rarely resulted in repeated severe cytokine release syndrome.
Croatian: Daljnje liječenje bolesnika nakon nestanka svih znakova i simptoma rijetko je rezultiralo ponavljanjem teškog oblika sindroma otpuštanja citokina.
English: Premedication and prophylactic medications
Croatian: Premedikacija i profilaksa
English: Patients with active hepatitis B disease should not be treated with rituximab.
Croatian: Bolesnici s aktivnim hepatitisom B ne smiju se liječiti lijekom rituksimaba.
English: Two patients were re-treated twice in the study.
Croatian: Dva su bolesnika u ispitivanju dvaput primila ponovljeno liječenje.
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: Rituximab induces B-cell depletion in about 70-80% of patients, but was associated with decreased serum immunoglobulins only in a minority of patients.
Croatian: Rituksimab uzrokuje depleciju B-stanica u oko 70-80 % bolesnika, ali se povezuje sa smanjenom razinom serumskih imunoglobulina samo kod malog broja bolesnika.
English: 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.
Croatian: Na temelju ograničenog iskustva s rituksimabom u bolesnika s reumatoidnim artritisom (vidjeti dio 4.8), trenutno dostupni podaci ne ukazuju na povećan rizik od zloćudnih bolesti.
English: Three cases had no reported adverse event.
Croatian: Za tri slučaja nije prijavljena nijedna nuspojava.
English: 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.
Croatian: Granulomatoza s poliangiitisom i mikroskopski poliangiitis su dva oblika upale krvnih žila koji uglavnom zahvaćaju pluća i bubrege, ali mogu zahvatiti i druge organe.
English: When rituximab sticks to the surface of this cell, the cell dies.
Croatian: Kada se rituksimab veže na površinu stanice, ona umire.
English: Depending on the severity of the IRR and the required interventions, temporarily or permanently discontinue rituximab.
Croatian: Ovisno o težini infuzijske reakcije i potrebnim intervencijama valja privremeno ili trajno prekinuti primjenu lijeka rituksimaba.
English: decreased IgG
Croatian: snižene razine IgG
English: This medicinal product contains sodium.
Croatian: Ovaj lijek sadrži natrij.
English: However, response rates to non-live vaccines may be reduced.
Croatian: Međutim, stope odgovora na neživo cjepivo mogu biti smanjene.
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: 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).
Croatian: Ritemvia 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: B cell counts returned to normal in these animals within 6 months of birth and did not compromise the reaction to immunisation.
Croatian: Broj B-stanica u tih se životinja vratio na normalnu razinu unutar 6 mjeseci od rođenja te nije ugrozio reakciju na cijepljenje.
English: Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01XC02.
Croatian: Farmakoterapijska skupina: antineoplastici, monoklonska antitijela; ATK oznaka: L01XC02
English: Only the highest frequency observed in the trials is reported
Croatian: Prijavljena je samo najveća učestalost primijećena tijekom ispitivanja.
English: CD20 is found on both normal and malignant B cells, but not on haematopoietic stem cells, pro-B cells, normal plasma cells or other normal tissue.
Croatian: CD20 se može pronaći i na normalnim i na malignim B-stanicama, ali ne i na hematopoetskim matičnim stanicama, pro-B stanicama, normalnim plazma stanicama ili u drugom normalnom tkivu.
English: Prednisone N=36
Croatian: Prednizon N=36
English: Ritemvia will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Croatian: Lijek Ritemvia će Vam dati liječnik ili medicinska sestra s iskustvom u primjeni te vrste lijekova.
English: The MAH must ensure that all physicians who are expected to prescribe Ritemvia are provided with the following:
Croatian: Nositelj odobrenja mora osigurati da svi liječnici za koje se očekuje da će propisivati lijek Ritemvia dobiju sljedeće materijale:
English: This is because Ritemvia can affect the way some other medicines work.
Croatian: To je važno jer Ritemvia može utjecati na način djelovanja nekih lijekova.
English: Initial treatment, in combination with chemotherapy
Croatian: Početno liječenje u kombinaciji s kemoterapijom
English: 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.
Croatian: Rituksimab nije indiciran za te bolesnike jer nema dovoljno podataka o sigurnosti dugotrajnog liječenja rituksimabom, osobito u pogledu rizika od razvoja zloćudnih bolesti i PML-a.
English: PML, reactivation of hepatitis B
Croatian: PML, reaktivacija hepatitisa B
English: Ritemvia may be used for the treatment of several different conditions in adults.
Croatian: Ritemvia se može primjenjivati za liječenje nekoliko različitih bolesti u odraslih bolesnika.
English: Patients with higher CD19-positive cell counts or tumour lesions had a higher CL2.
Croatian: Bolesnici s većim brojem CD19-pozitivnih stanica ili većim tumorskim lezijama imali su veći CL2.
English: Abbreviation: NS, non significant
Croatian: Skraćenica: NZ, nije značajno
English: This finding was not supported by a stepwise logistic regression analysis in which the following factors were identified as prognostic factors: histological type, bcl-2 positivity at baseline, resistance to last chemotherapy and bulky disease.
Croatian: Ovaj nalaz nije potvrđen stupnjevitom logističkom regresijskom analizom u kojoj su sljedeći faktori identificirani kao prognostički: histološka vrsta, pozitivnost na bcl-2 na početku liječenja, rezistencija na posljednju kemoterapiju i proširenost tumora.
English: No dose reductions of Ritemvia are recommended.
Croatian: Ne preporučuje se smanjenje doze lijeka Ritemvia.
English: 60%, NS
Croatian: 60 %, NZ
English: Also some other medicines can affect the way Ritemvia works.
Croatian: Isto tako neki lijekovi mogu utjecati na način djelovanja lijeka Ritemvia.
English: Patients could receive 1000 mg IV at the time of relapse (see section 5.1).
Croatian: Bolesnici su mogli primiti dozu od 1000 mg i.v. u trenutku relapsa (vidjeti dio 5.1).
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.