FrancophonIA/ELRC3.0 huggingface dataset:
English: What benefits of Ebymect have been shown in studies?
Croatian: Koje su koristi od lijeka Ebymect utvrđene u ispitivanjima?
English: In one main study, when dapagliflozin was used at a dose of 5 mg twice a day in addition to metformin (the same combination as in Ebymect), it decreased HbA1c (glycosylated haemoglobin) levels by 0.65% after 16 weeks, compared with a reduction of 0.30% with placebo (a dummy treatment) and metformin.
Croatian: U jednom glavnom ispitivanju, kada se dapagliflozin davao u dozi od 5 mg dvaput dnevno kao dodatak metforminu (u istoj kombinaciji kao i za Ebymect), razina HbA1c (glikoziliranog hemoglobina) snizila se za 0,65 % nakon 16 tjedana, u usporedbi sa smanjenjem od 0,30 % kada je primjenjivan placebo (prividno liječenje) i metformin.
English: Further studies confirmed that different doses of dapagliflozin with metformin decreased HbA1c more than placebo plus comparable doses of metformin, and that dapagliflozin plus metformin was at least as effective in reducing HbA1c levels as the diabetes medicine glipizide (a type of medicine known as a sulphonylurea).
Croatian: Dodatnim ispitivanjima potvrđeno je da se različitim dozama dapagliflozina s metforminom snižava razina HbA1c više nego primjenom placeba i usporedivih doza metformina te da je dapagliflozin s metforminom u najmanju ruku jednako učinkovit u snižavanju razine HbA1c kao i glipizid, lijek protiv dijabetesa (vrsta lijeka poznata pod nazivom sulfonilureja).
English: By blocking the action of SGLT2, dapagliflozin causes the kidneys to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.
Croatian: Blokiranjem djelovanja bjelančevine SGLT2, dapagliflozin omogućuje izlučivanje veće količine glukoze mokraćom iz bubrega, čime se smanjuje razina glukoze u krvi.
English: One study showed that after 24 weeks of treatment, patients taking dapagliflozin plus metformin had an average reduction in body weight of around 2 kg more than those taking placebo plus metformin.
Croatian: U jednom ispitivanju utvrđeno je da su bolesnici, koji su primali dapagliflozin i metformin, nakon terapije od 24 tjedna izgubili u prosjeku oko 2 kg tjelesne težine više od onih koji su primali placebo i metformin.
English: Two other studies showed that dapagliflozin taken with metformin and another diabetes medicine, sitagliptin or insulin, for 24 weeks, further decreased HbA1c: the dapagliflozin combination decreased HbA1c levels by 0.40% more than placebo and metformin when added to sitagliptin, and by 0.61% more than placebo and metformin when added to insulin.
Croatian: U dvama drugim ispitivanjima utvrđeno je da je dapagliflozin, kada se tijekom 24 tjedna uzimao s metforminom i još jednim lijekom protiv dijabetesa (sitagliptinom ili inzulinom), dodatno snizio razinu HbA1c: kombinacijom koja sadrži dapagliflozin snižena je razina HbA1c za 0,40 % više nego primjenom placeba i metformina kao dodataka sitagliptinu te za 0,61 % više nego primjenom placeba i metformina kao dodataka inzulinu.
English: For the full list of side effects with Ebymect, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Ebymect potražite u uputi o lijeku.
English: • in combination with other diabetes medicines when these medicines together with metformin are not controlling the diabetes well enough.
Croatian: Ebymect se primjenjuje: kao monoterapija u bolesnika čiju se bolest ne može odgovarajuće kontrolirati samo metforminom, u kombinaciji s drugim lijekovima za liječenje dijabetesa ako se tim lijekovima u kombinaciji s metforminom ne postiže dovoljno dobra kontrola dijabetesa.
English: The Agency considered Ebymect to be effective for treating type 2 diabetes; it also leads to weight loss, which is considered beneficial in patients with diabetes.
Croatian: Osim toga, njime se postiže i gubitak težine, što se smatra korisnim za osobe s dijabetesom.
English: Each cycle has a duration of 28 days.
Croatian: Svakih ciklus traje 28 dana.
English: Ελλάδα ΒΙΑΝΕΞ Α.Ε.
Croatian: ΒΙΑΝΕΞ Α.Ε.
English: 2) Last tumour response as assessed by the investigator.
Croatian: 2) Zadnji tumorski odgovor koji je procijenio ispitivač.
English: The safety and efficacy of Blitzima in children below 18 years has not been established.
Croatian: Sigurnost i djelotvornost lijeka Blitzima u djece mlađe od 18 godina nisu ustanovljene.
English: 1) Estimates were calculated by hazard ratios
Croatian: 1) Procjene su izračunate prema omjerima hazarda
English: Egis Gyógyszergyár Zrt.
Croatian: Magyarország Egis Gyógyszergyár Zrt.
English: Unopened vial 4 years
Croatian: Neotvorena bočica 4 godine
English: Infections Tell your doctor immediately if you get signs of an infection including:
Croatian: Infekcije Odmah obavijestite liječnika ako dobijete znakove infekcije, uključujući:
English: • heart beating faster than normal
Croatian: • brže kucanje srca nego obično
English: Do not have Blitzima if you have an active infection or a serious problem with your immune system.
Croatian: Ne smijete primiti lijek Blitzima ako imate aktivnu infekciju ili ozbiljne poteškoće s imunološkim sustavom.
English: Blitzima may also cause changes in laboratory tests carried out by your doctor.
Croatian: Blitzima može uzrokovati i promjene u nalazima laboratorijskih pretraga koje provodi Vaš liječnik.
English: Study Treatment, N
Croatian: Liječenje, N
English: Your doctor may decide to stop your Blitzima treatment if these reactions are serious.
Croatian: Liječnik može odlučiti prekinuti liječenje lijekom Blitzima ako su te reakcije ozbiljne.
English: Do not have Blitzima if any of the above apply to you.
Croatian: Nemojte primiti lijek Blitzima ako se nešto od navedenoga odnosi na Vas.
English: • The importance of sharing this information with their partner or caregiver
Croatian: • Važno je da te informacije podijele sa svojim partnerom ili skrbnikom
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.
English: Patients should receive Blitzima for at least 24 months after achievement of remission (absence of clinical signs and symptoms).
Croatian: Bolesnici trebaju primati lijek Blitzima najmanje 24 mjeseca nakon postizanja remisije (odsutnost kliničkih znakova i simptoma bolesti).
English: If you can get pregnant, you and your partner must use an effective method of contraception while using Blitzima.
Croatian: Ako ste u dobi kada možete zatrudnjeti, Vi i Vaš partner morate koristiti učinkovitu kontracepciju tijekom liječenja lijekom Blitzima.
English: Kaplan-Meier Estimate of Median Time to Event (months)
Croatian: Kaplan-Meierova procjena medijana vremena do pojave događaja (mjeseci)
English: When should I not have Blitzima?
Croatian: Kada ne smijem primiti lijek Blitzima?
English: • mood disorders such as irritability and depression
Croatian: • poremećaji raspoloženja poput razdražljivosti i depresije
English: Your doctor will check if you should have any vaccines before you receive Blitzima.
Croatian: Vaš će liječnik provjeriti morate li primiti neko cjepivo prije nego što primite lijek Blitzima.
English: Other medicines and Blitzima
Croatian: Drugi lijekovi i Blitzima
English: What Blitzima looks like and contents of the pack
Croatian: Kako Blitzima izgleda i sadržaj pakiranja
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: This is because in a few cases, Blitzima could cause hepatitis B to become active again, which can be fatal in very rare cases.
Croatian: Naime, u nekim slučajevima Blitzima može ponovno aktivirati hepatitis B, što u vrlo rijetkim slučajevima može biti smrtonosno.
English: 95.1%b CI (−3.2%, 24.3%) a
Croatian: CI (−3,2 %, 24,3 %)
English: Blitzima can be given alone or with other medicines called “chemotherapy”.
Croatian: Blitzima se može primjenjivati samostalno ili s drugim lijekovima koji se nazivaju „kemoterapijom“.
English: Blitzima in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.
Croatian: Blitzima u kombinaciji s kemoterapijom uništava te stanice koje se postupno uklanjaju iz tijela biološkim procesima.
English: Significant difference from placebo at the primary time point: * p < 0.05, **p < 0.001 ***p ≤ 0.0001 MCID HAQ-DI ≥0.22, MCID SF-36 PHS >5.42, MCID SF-36 MHS >6.33
Croatian: Značajna razlika u odnosu na placebo u primarnoj vremenskoj točki: * p < 0,05, **p < 0,001, ***p ≤ 0,0001 MCID HAQDI ≥ 0,22, MCID SF-36 PHS > 5,42, MCID SF-36 MHS > 6,33
English: This is because there is not much information about the use of Blitzima in children and young people.
Croatian: Naime, nema mnogo informacija o primjeni lijeka Blitzima u djece i mladih osoba.
English: Blitzima 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: Blitzima 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: • Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your Blitzima.
Croatian: Karticu pokažite svakom liječniku, medicinskoj sestri ili stomatologu koje posjećujete, a ne samo liječniku specijalistu koji Vam propisuje lijek Blitzima.
English: • If you respond well to treatment, you may be given Blitzima every 2 or 3 months for two years.
Croatian: Ako dobro odgovorite na liječenje, možda ćete primati lijek Blitzima svaka 2 ili 3 mjeseca tijekom dvije godine.
English: - * Worst case imputation a Non-inferiority was demonstrated since the lower bound (−3.2%) was higher than the pre-determined non-inferiority margin (− 20%).
Croatian: CI = interval pouzdanosti * pretpostavka najgoreg slučaja a Neinferiornost je dokazana jer je donja granica (−3,2 %) veća od prethodno postavljene granice neinferiornosti (−20 %).
English: Blitzima will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Croatian: Lijek Blitzima će Vam dati liječnik ili medicinska sestra s iskustvom u primjeni te vrste lijekova.
English: If you are having Blitzima with other medicines, some of the side effects you may get may be due to the other medicines.
Croatian: Ako lijek Blitzima primate zajedno s drugim lijekovima, neke od nuspojava koje će se možda pojaviti mogu biti uzrokovane drugim lijekovima.
English: Duration of response* Disease free survival (DFS)** Time to new treatment
Croatian: Trajanje odgovora* Preživljenje bez bolesti (DFS)** Vrijeme do novog liječenja
English: Rarely Blitzima can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Croatian: Blitzima rijetko može uzrokovati ozbiljnu infekciju mozga koja se naziva 'progresivna multifokalna leukoencefalopatija' ili PML.
English: Percentage of Patients with First Major Relapse
Croatian: Postotak bolesnika s prvim teškim relapsom
English: • pain in the muscles
Croatian: • bol u mišićima
English: Blitzima is a biosimilar medicinal product.
Croatian: Blitzima je biosličan lijek.
English: Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia.
Croatian: Kronična limfocitna leukemija (KLL) je najčešći oblik leukemije u odraslih.
English: Blitzima will be given to you once a week for 4 weeks.
Croatian: Lijek Blitzima primat ćete jedanput na tjedan tijekom 4 tjedna.
English: The final efficacy analysis included all randomised patients (197 CHOP, 202 R-CHOP), and had a median follow-up duration of approximately 31 months.
Croatian: Završna analiza djelotvornosti obuhvatila je sve randomizirane bolesnike (197 CHOP, 202 R-CHOP), a medijan praćenja iznosio je približno 31 mjesec.
English: 1 includes reactivation and primary infections; frequency based on R-FC regimen in relapsed/refractory CLL 2 see also section infection below
Croatian: 1 uključuje reaktivaciju i primarne infekcije; učestalost se temelji na R-FC režimu u relapsirajućem/refraktornom KLL-u 2 Vidjeti i dio o infekcijama u nastavku.
English: Toxicity studies in cynomolgus monkeys have shown no other effect than the expected pharmacological depletion of B cells in peripheral blood and in lymphoid tissue.
Croatian: Ispitivanja toksičnosti na Cynomolgus majmunima nisu pokazala druge učinke osim očekivane farmakološke deplecije B-stanica u perifernoj krvi i limfoidnom tkivu.
English: Blitzima may be used for the treatment of several different conditions in adults.
Croatian: Blitzima se može primjenjivati za liječenje nekoliko različitih bolesti u odraslih bolesnika.
English: This is because Blitzima can affect the way some other medicines work.
Croatian: To je važno jer Blitzima može utjecati na način djelovanja nekih lijekova.
English: - CI = confidence interval.
Croatian: CI: interval pouzdanosti
English: Patient subpopulations - rituximab combination therapy Elderly patients (≥ 65 years)
Croatian: Podskupine bolesnika - liječenje rituksimabom u kombinaciji Stariji bolesnici (≥ 65 godina)
English: Further, significantly higher proportion of patients achieved MCIDs for these scores (Table 14).
Croatian: Nadalje, značajno je veći udio bolesnika postigao MCID za ove rezultate (Tablica 14).
English: The cells that are affected by Blitzima help to fight infection and you should wait until the infection has passed before you are given Blitzima.
Croatian: Blitzima utječe na stanice koje pomažu u borbi protiv infekcija pa stoga morate pričekati dok infekcija ne prođe prije nego što primite lijek Blitzima.
English: You should also tell them about your Blitzima treatment.
Croatian: Recite im i da se liječite lijekom Blitzima.
English: Blitzima is a clear, colourless solution, supplied as a concentrate for solution for infusion in a glass vial.
Croatian: Blitzima je bistra, bezbojna otopina, dostupna u obliku koncentrata za otopinu za infuziju u staklenoj bočici.
English: Respiratory system Cases of interstitial lung disease, some with fatal outcome, have been reported.
Croatian: Dišni sustav Prijavljeni su slučajevi intersticijske bolesti pluća, neki sa smrtnim ishodom.
English: The recommended initial rate for infusion is 50 mg/h; after the first 30 minutes, it can be escalated in 50 mg/h increments every 30 minutes, to a maximum of 400 mg/h.
Croatian: Preporučena početna brzina infuzije je 50 mg/sat; nakon prvih 30 minuta može se povećavati za 50 mg/sat svakih 30 minuta, do najviše 400 mg/sat.
English: For patients who may be at higher risk for relapse, physicians should consider a longer duration of Blitzima 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 Blitzima (do 5 godina).
English: Your doctor may need to take special care of you during your treatment with Blitzima.
Croatian: Liječnik će Vas možda morati osobito pažljivo nadzirati tijekom liječenja lijekom Blitzima.
English: Elderly 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 MAH must ensure that all physicians who are expected to prescribe Blitzima are provided with the following:
Croatian: Nositelj odobrenja mora osigurati da svi liječnici za koje se očekuje da će propisivati lijek Blitzima dobiju sljedeće materijale:
English: Also some other medicines can affect the way Blitzima works.
Croatian: Isto tako neki lijekovi mogu utjecati na način djelovanja lijeka Blitzima.
English: What Blitzima is and what it is used for What you need to know before you use Blitzima How to use Blitzima
Croatian: Što je Blitzima i za što se koristi Što morate znati prije nego počnete primati lijek Blitzima
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: If you respond well to treatment, you may be given Blitzima as a maintenance treatment.
Croatian: Ako dobro odgovorite na liječenje, možda ćete primati lijek Blitzima kao terapiju održavanja.
English: • Keep this card with you all the timesuch as in your wallet or purse.
Croatian: Karticu uvijek nosite sa sobomprimjerice, u novčaniku ili u torbici.
English: Your doctor will decide if you should receive concomitant supportive therapy.
Croatian: Vaš liječnik će odlučiti trebate li primiti popratnu terapiju
English: There are no data on the safety of rituximab in patients with moderate heart failure (NYHA class III) or severe, uncontrolled cardiovascular disease.
Croatian: Nema podataka o sigurnosti lijeka rituksimaba u bolesnika s umjerenim zatajenjem srca (NYHA stupanj III) ili teškom, nekontroliranom bolešću srca i krvnih žila.
English: When Blitzima is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Croatian: Kad se Blitzima primjenjuje u kombinaciji s kemoterapijom, moraju se primijeniti uobičajena smanjenja doze kemoterapijskih lijekova.
English: Keep this card with you for 2 years after your last dose of Blitzima.
Croatian: Karticu nosite sa sobom još 2 godine nakon što primite posljednju dozu lijeka Blitzima.
English: In patients treated for haematological malignancies, B cell recovery began within 6 months of treatment and generally returned to normal levels within 12 months after completion of therapy, although in some patients this may take longer (up to a median recovery time of 23 months post-induction therapy).
Croatian: U bolesnika liječenih zbog hematoloških zloćudnih bolesti obnova B-stanica počela je unutar 6 mjeseci od liječenja te su se vratile na normalnu razinu unutar 12 mjeseci nakon završetka liječenja, iako u nekih bolesnika to može trajati dulje (do medijana vremena obnove od 23 mjeseca nakon uvođenja liječenja).
English: Median FU, months
Croatian: Medijan praćenja, mjeseci
English: This is because Blitzima can across the placenta and may affect your baby.
Croatian: To je potrebno zato što Blitzima može proći kroz posteljicu i naškoditi djetetu.
English: The reported cases had recognised risk factors for PRES/RPLS, including the patients' underlying disease, hypertension, immunosuppressive therapy and/or chemotherapy.
Croatian: U prijavljenim slučajevima postojali su faktori rizika za PRES/RPLS, uključujući osnovnu bolest bolesnika, hipertenziju, terapiju imunosupresivima i/ili kemoterapiju.
English: The overall incidence of IRRs in clinical trials was 23% with the first infusion and decreased with subsequent infusions.
Croatian: Ukupna incidencija reakcija povezanih s infuzijom u kliničkim ispitivanjima bila je 23 % nakon prve infuzije te se smanjivala s narednim infuzijama.
English: Hazard ratio (95% CI)
Croatian: Omjer hazarda (95 % CI)
English: No dose reductions of Blitzima are recommended.
Croatian: Ne preporučuje se smanjenje doze lijeka Blitzima.
English: See section 5.1 for further information.
Croatian: Za dodatne informacije, vidjeti dio 5.1.
English: Table 17 Complete remission at 6-months by disease status Rituximab
Croatian: Potpuna remisija nakon 6 mjeseci prema statusu bolesti Rituksimab
English: In patients where the treatment is working, Blitzima may be continued for 2 years after completing the initial treatment.
Croatian: U bolesnika u kojih se liječenje pokaže djelotvornim, Blitzima se može nastaviti primjenjivati tijekom 2 godine nakon završetka početnog liječenja.
English: • you have ever had heart problems (such as angina, palpitations or heart failure) or breathing problems.
Croatian: • ako ste ikada imali srčane tegobe (poput angine pektoris, osjećaja lupanja srca ili zatajenja srca) ili dišne tegobe.
English: Astro-Pharma GmbH Tel: +43 1 97 99 860
Croatian: Ö sterreich Astro-Pharma GmbH Tel: +43 1 97 99 860
English: 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
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba): alergijske reakcije koje su najvjerojatnije tijekom infuzije, ali se mogu javiti do 24 sata nakon infuzije dugotrajna depresija opadanje kose
English: • The need to monitor patients for infections, especially PML, during and after Blitzima treatment
Croatian: • Bolesnike je potrebno nadzirati zbog mogućeg razvoja infekcija, osobito PML-a, tijekom i nakon liječenja lijekom Blitzima.
English: If you are not sure, talk to your doctor, pharmacist or nurse before you are given Blitzima.
Croatian: Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite lijek Blitzima.
English: Of 356 patients evaluated for anti-drug antibody (ADA), 1.1% (4 patients) were positive.
Croatian: Od 356 bolesnika ispitivanih na antitijela na lijek , pozitivno je bilo njih 1,1 % (četiri bolesnika).
English: • The need to check, prior to Blitzima treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned, vaccination
Croatian: • Prije liječenja lijekom Blitzima potrebno je provjeriti status bolesnika s obzirom na infekcije, imunosupresiju, prethodnu/trenutačnu primjenu lijekova koji djeluju na imunološki sustav te nedavna ili planirana cijepljenja.
English: A total of 197 patients aged 15 years or older with severe active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicentre, non-inferiority trial.
Croatian: Ukupno je 197 bolesnika u dobi od 15 ili više godina s teškom aktivnom granulomatozom s poliangiitisom (75 %) i mikroskopskim poliangiitisom (24 %) sudjelovalo i liječeno u randomiziranom, dvostruko slijepom, multicentričnom, aktivnim lijekom kontroliranom ispitivanju neinferiornosti.
English: Event free survival Response rate (CR, nPR, or PR)
Croatian: Preživljenje bez događaja Stopa odgovora (CR, nPR, ili PR)
English: • Information on the Patient Alert Card
Croatian: • Informaciju o Kartici s upozorenjima za bolesnika
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti definirane su kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Blitzima or patients refractory to previous Blitzima plus chemotherapy.
Croatian: Dostupni su samo ograničeni podaci o djelotvornosti i sigurnosti za bolesnike prethodno liječene monoklonskim antitijelima uključujući lijek Blitzima, kao i za bolesnike refraktorne na prethodno liječenje lijekom Blitzima u kombinaciji s kemoterapijom.
English: Blitzima should be used in combination with CHOP chemotherapy.
Croatian: Blitzima se treba davati u kombinaciji s CHOP kemoterapijom.
English: Orion Pharma Puh/Tel: + 358 10 4261
Croatian: Suomi/Finland Orion Pharma Puh/Tel: + 358 10 4261
English: Name and address of the manufacturer of the biological active substance
Croatian: Naziv i adresa proizvođača biološke djelatne tvari CELLTRION Inc.,