FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy for the treatment of macrophage activation syndrome has not been investigated.
Croatian: Nije ispitana djelotvornost liječenja sindroma makrofagne aktivacije.
English: Resolution of CRS was defined as lack of fever and off vasopressors for at least 24 hours.
Croatian: Povlačenje CRS-a definiralo se kao izostanak vrućice i prestanak primjene vazopresora tijekom najmanje 24 sata.
English: Call your doctor and seek medical attention without delay if you think you might be developing an infection.
Croatian: Obratite se svom liječniku i odmah potražite liječničku pomoć ako mislite da biste mogli imati infekciju.
English: After proper training in injection technique, patients may self-inject with RoActemra if their physician determines that it is appropriate.
Croatian: Nakon propisne obuke o tehnici injiciranja, bolesnici si mogu samostalno injicirati lijek RoActemra ako njihov liječnik odredi da je to prikladno.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: There have been postmarketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi intersticijske bolesti pluća (uključujući pneumonitis i pulmonalnu fibrozu), od kojih su neki imali smrtni ishod.
English: Other medicines and RoActemra
Croatian: Drugi lijekovi i RoActemra
English: TCZ = tocilizumab a = Per Protocol Population
Croatian: TCZ = tocilizumab a = populacija prema protokolu
English: It may also be helpful to write any questions or concerns about the injection so you can ask your healthcare provider.
Croatian: Možda bi bilo dobro i da zapišete sva pitanja i sve što Vas brine u vezi injiciranja, kako biste o tome mogli razgovarati sa svojim zdravstvenim radnikom.
English: If a child or adolescent with pJIA misses or forgets a dose
Croatian: Ako dijete ili adolescent s pJIA propusti ili zaboravi primijeniti dozu
English: Duration of Corticosteroid Therapy During Screening in Study WA28119
Croatian: Tablica 3. Trajanje kortikosteroidne terapije tijekom razdoblja probira u ispitivanju WA28119
English: You will need the following to give your injection: Included in the box:
Croatian: Za injiciranje lijeka trebat ćete sljedeće: Uključeno u pakiranje:
English: • Write the date, time, and specific part of your body where you injected yourself.
Croatian: Zabilježite injekciju · Zapišite datum, vrijeme i dio tijela u koji ste injicirali injekciju.
English: No data are available
Croatian: Nema dostupnih podataka.
English: • If you see drops of blood at the injection site, you can press a sterile cotton ball or gauze over the injection site for approximately 10 seconds.
Croatian: · Ako na mjestu injiciranja vidite kapljice krvi, možete ga pritisnuti sterilnom pamučnom vatom ili gazom približno 10 sekundi.
English: There was no clear relationship between decreases in neutrophils below 1 x 109/L and the occurrence of serious infections.
Croatian: Nije postojala jasna povezanost između smanjenja broja neutrofila na razinu ispod 1 x 109/l i pojave ozbiljnih infekcija.
English: Do not use RoActemra pre-filled pen if the box looks damaged.
Croatian: Nemojte upotrijebiti RoACTEMRA napunjenu brizgalicu ako kutija izgleda oštećeno.
English: Events reported during the infusion were primarily episodes of hypertension; events reported within 24 hours of finishing an infusion were headache and skin reactions (rash, urticaria).
Croatian: Događaji prijavljeni tijekom infuzije sastojali su se uglavnom od epizoda hipertenzije; događaji prijavljeni u roku od 24 sata od završetka infuzije uključivali su glavobolju i kožne reakcije (osip, urtikarija).
English: Choose and Prepare an Injection Site Choose an Injection Site
Croatian: 2. korak: Odaberite i pripremite mjesto za injiciranje Odaberite mjesto za injiciranje
English: The duration of glucocorticoid therapy during screening and before RoActemra (or placebo) was initiated, was similar in all 4 treatment groups (see Table 3).
Croatian: Trajanje terapije glukokortikoidima tijekom razdoblja probira i prije početka primjene lijeka RoActemra (ili placeba) bilo je slično u sve 4 liječene skupine (vidjeti Tablicu 3).
English: Talk to your doctor if you have any questions about giving yourself an injection.
Croatian: Razgovarajte s liječnikom ako imate ikakvih pitanja o samostalnom injiciranju lijeka.
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 web-portal.
Croatian: · Periodička izvješća o neškodljivosti Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom 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: The ACR response rates were numerically lower for patients with prior biologic treatment as shown in Table 9 below.
Croatian: Stope ACR odgovora bile su brojčano niže kod bolesnika koji su prethodno liječeni biološkim lijekovima, kao što je prikazano u tablici 9 u nastavku.
English: Laboratory Value
Croatian: Laboratorijska vrijednost
English: Ninety three percent (93%; n=271) of patients had no progression between week 52 and week 104.
Croatian: U devedeset i tri posto (93%; n=271) bolesnika nije došlo do napredovanja između 52. i 104. tjedna.
English: • Watch the purple indicator until it stops moving to be sure the full dose of medication is injected.
Croatian: · Promatrajte ljubičasti indikator sve dok se ne zaustavi, kako biste bili sigurni da ste injicirali cijelu dozu.
English: • When the purple indicator has stopped moving, release the green button.
Croatian: · Kad se ljubičasti indikator zaustavi, otpustite zeleno dugme.
English: Patients were considered responders if CRS resolved within 14 days of the first dose of tocilizumab, if no more than 2 doses of RoActemra were needed, and no drugs other than RoActemra and corticosteroids were used for treatment.
Croatian: Smatralo se da su bolesnici odgovorili na liječenje ako se CRS povukao unutar 14 dana od primjene prve doze tocilizumaba, ako nije bilo potrebno više od 2 doze lijeka RoActemra i ako za liječenje nisu primijenjeni drugi lijekovi osim lijeka RoActemra i kortikosteroida.
English: In particular, there was no impairment of skeletal growth, immune function and sexual maturation.
Croatian: Točnije, nisu zabilježena oštećenja u rastu kostura, imunološkim funkcijama i spolnom sazrijevanju.
English: Patient advice regarding hypersensitivity reactions (also known as anaphylaxis, if severe)
Croatian: Savjeti za bolesnike o reakcijama preosjetljivosti (poznatima i kao anafilaksija, ako se radi o teškim reakcijama)
English: In this case you will get training on how to inject RoActemra yourself.
Croatian: U tom ćete slučaju proći obuku o tome kako samostalno injicirati lijek RoActemra.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Severe neutropenia may be associated with an increased risk of serious infections, although there has been no clear association between decreases in neutrophils and the occurrence of serious infections in clinical trials with RoActemra to date.
Croatian: Teška neutropenija može biti povezana s povećanim rizikom od ozbiljnih infekcija, premda do sada nije bilo jasne povezanosti između smanjenja broja neutrofila i pojave ozbiljnih infekcija u kliničkim ispitivanjima lijeka RoActemra.
English: The most serious ADRs were serious infections, complications of diverticulitis, and hypersensitivity reactions.
Croatian: Najozbiljnije nuspojave bile su ozbiljne infekcije, komplikacije divertikulitisa i reakcije preosjetljivosti.
English: No adverse reactions were observed.
Croatian: Nisu bile primijećene nikakve nuspojave.
English: Tocilizumab normalises expression of these enzymes.
Croatian: Tocilizumab normalizira ekspresiju tih enzima.
English: Before you use the RoACTEMRA pre-filled pen for the first time, make sure your healthcare provider shows you the right way to use it.
Croatian: Prije nego što prvi put upotrijebite RoACTEMRA napunjenu brizgalicu pobrinite se da Vam zdravstveni radnik pokaže kako je pravilno koristiti.
English: Pharmacotherapeutic group: Immunosupressants, Interleukin inhibitors; ATC code: L04AC07.
Croatian: Farmakoterapijska skupina: Imunosupresivi, inhibitori interleukina; ATK oznaka: L04AC07.
English: > 1 to 3 x Upper Limit of Normal (ULN)
Croatian: > 1 do 3 x iznad gornje granice normale (GGN)
English: Patients with CRS
Croatian: Bolesnici s CRS-om
English: Glucocorticoids should be given according to medical judgement and practice guidelines.
Croatian: Glukokortikoide treba primjenjivati sukladno liječničkoj prosudbi i smjernicama za kliničku praksu.
English: The treatment effect was similar in patients independent of rheumatoid factor status, age, gender, race, number of prior treatments or disease status.
Croatian: Učinak terapije bio je sličan kod svih bolesnika neovisno o statusu reumatoidnog faktora, dobi, spolu, rasi, broju prethodnih liječenja ili statusu bolesti.
English: Patients achieving a JIA ACR70 response were permitted corticosteroid dose reduction.
Croatian: Bolesnicima koji su postigli odgovor JIA ACR70 dopušteno je smanjivanje doze kortikosteroida.
English: Approximately 20% of patients had received prior treatment with DMARDs other than MTX.
Croatian: Približno 20% bolesnika prethodno je liječeno drugim DMARD-ovima osim MTX-a.
English: Elderly No dose adjustment is required in elderly patients >65 years of age.
Croatian: Nije potrebno prilagođavati dozu kod starijih bolesnika u dobi od > 65 godina.
English: Talk to your doctor, pharmacist or nurse before using RoActemra.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite lijek RoActemra.
English: Ask your healthcare provider any questions you may have.
Croatian: Pitajte zdravstvenog radnika sve što Vas zanima.
English: You must press the plunger all the way down to ensure that you get the full dose of medication and to ensure the trigger fingers are completely pushed to the side.
Croatian: Klip morate pritisnuti do kraja kako biste bili sigurni da ste primili cijelu dozu lijeka i da su otpusne kvačice gurnute posve u stranu.
English: • If you have had intestinal ulcers or diverticulitis, tell your doctor.
Croatian: · Ako ste imali ulceracije crijeva ili divertikulitis, obavijestite o tome liječnika.
English: Please also read the Patient Leaflet that comes with the RoActemra syringe for the most important information you need to know about the medicine.
Croatian: Pročitajte i Uputu o lijeku priloženu u pakiranju RoActemra štrcaljke za najvažnije informacije koje morate znati o lijeku.
English: Study I evaluated 673 patients who had not been treated with MTX within six months prior to randomisation and who had not discontinued previous MTX treatment as a result of clinically important toxic effects or lack of response.
Croatian: I uključilo je analizu 673 bolesnika koji nisu bili liječeni MTX-om tijekom šest mjeseci prije randomizacije i koji nisu prekinuli prethodno liječenje MTX-om zbog klinički značajnih toksičnih učinaka ili izostanka terapijskog odgovora.
English: If any of these applies to you, tell the doctor or nurse giving you the infusion.
Croatian: Ako se nešto od navedenoga odnosi na Vas, recite to liječniku ili medicinskoj sestri koji Vam daju infuziju.
English: • if you are allergic to tocilizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: · ako ste alergični na tocilizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Keep track of the next dose.
Croatian: Vodite računa o primjeni sljedeće doze.
English: If you still experience difficulty, you should consult your healthcare provider.
Croatian: Ako su poteškoće i dalje prisutne, morate se savjetovati sa svojim zdravstvenim radnikom.
English: Macrophage activation syndrome (MAS) is a serious life-threatening disorder that may develop in sJIA patients.
Croatian: Macrophage-activation syndrome, MAS) je ozbiljan, po život opasan poremećaj koji se može razviti kod bolesnika sa sJIA.
English: Do not repeat the injection with another pre-filled pen.
Croatian: Nemojte ponoviti injekciju drugom napunjenom brizgalicom.
English: Mean haemoglobin levels increased by week 2 and remained within normal range through to week 24.
Croatian: Srednja razina hemoglobina povisila se do 2. tjedna i ostala je unutar raspona normalnih vrijednosti sve do 24. tjedna.
English: - modified Total Sharp Score
Croatian: - modificirani ukupni zbroj bodova na Sharp ljestvici
English: In an independent cohort of 15 patients (range: 9-75 years old) with axicabtagene ciloleucel-induced CRS, 53% responded.
Croatian: U neovisnoj kohorti od 15 bolesnika (raspon dobi: 9 - 75 godina) s CRS-om izazvanim aksikaptagen ciloleucelom, odgovor je ostvarilo njih 53%.
English: Signs of serious infections:
Croatian: Znakovi ozbiljne infekcije:
English: Injection into muscle could result in an uncomfortable injection.
Croatian: Injekcija u mišić mogla bi uzrokovati neugodu.
English: In study II, 65% of patients achieved a DAS28 < 2.6 at week 104 compared to 48% at 52 weeks and 33% of patients at week 24.
Croatian: U ispitivanju II, 65% bolesnika postiglo je DAS28 < 2,6 u 104. tjednu u usporedbi s 48% bolesnika u 52. tjednu i 33% bolesnika u 24. tjednu.
English: No serious adverse reactions were observed in healthy volunteers who received a single dose up to 28 mg/kg, although dose limiting neutropenia was observed.
Croatian: Nisu opažene nikakve ozbiljne nuspojave kod zdravih dobrovoljaca koji su primili jednu dozu od najviše 28 mg/kg, premda je primijećena neutropenija zbog koje se doza više nije smjela povećavati.
English: These proportions were statistically significantly different (p=0.0024).
Croatian: Ti su se udjeli statistički značajno razlikovali (p = 0,0024).
English: The purpose of Part 2 was to describe the long-term safety and maintenance of efficacy after 52 weeks of RoActemra therapy, to explore the rate of relapse and the requirement for RoActemra therapy beyond 52 weeks, and to gain insight into the potential long-term steroid-sparing effect of RoActemra.
Croatian: Svrha 2. dijela bila je opisati dugoročnu sigurnost i održavanje djelotvornosti nakon 52 tjedna liječenja lijekom RoActemra, istražiti stopu relapsa i potrebu za liječenjem lijekom RoActemra i nakon 52 tjedna te steći uvid u potencijalan dugoročni učinak lijeka RoActemra na smanjenje potrebe za steroidima.
English: RoActemra must not be given to children weighing less than 10 kg.
Croatian: RoActemra se ne smije davati djeci koja teže manje od 10 kg.
English: Due to the dependence of total clearance on RoActemra serum concentrations, the half-life of RoActemra is also concentration-dependent and varies depending on the serum concentration level.
Croatian: Zbog ovisnosti ukupnog klirensa o serumskim koncentracijama lijeka RoActemra, poluvijek lijeka RoActemra također ovisi o koncentraciji i varira ovisno o serumskim koncentracijama.
English: Thirty-nine patients (76.5%; 95% CI: 62.5%-87.2%) achieved a response.
Croatian: Odgovor je ostvarilo 39 bolesnika (76,5%; 95% CI: 62,5% - 87,2%).
English: • If your injection is given by another person, this person must also be careful when removing the pre-filled pen and disposing of it to prevent accidental needle stick injury and passing infection.
Croatian: · Ako Vam injekciju daje netko drugi, ta osoba također mora biti vrlo oprezna pri rukovanju napunjenom brizgalicom i njezinu odlaganju, kako bi spriječila nehotičnu ozljedu iglom i prijenos infekcije.
English: The frequency category was estimated as the upper limit of the 95% confidence interval calculated on the basis of the total number of patients exposed to TCZ in clinical trials.
Croatian: Kategorija učestalosti procijenjena je kao gornja granica intervala pouzdanosti od 95% izračunata na temelju ukupnog broja bolesnika izloženih tocilizumabu u kliničkim ispitivanjima.
English: Multiplicity controlled using Bonferroni-Holm Procedure
Croatian: Za kontrolu multipliciteta koristila se Bonferroni-Holmova korekcija.
English: RoActemra is given by injection under the skin (subcutaneously).
Croatian: RoActemra se daje injekcijom pod kožu (supkutano).
English: Patients would be monitored for liver function tests.
Croatian: Kod bolesnika bi se provodili testovi jetrene funkcije.
English: No injection site reaction was reported as a serious adverse event or required treatment discontinuation.
Croatian: Nijedna reakcija na mjestu injekcije nije prijavljena kao ozbiljan štetni događaj niti je zahtijevala prekid liječenja.
English: RA patients have an increased risk for cardiovascular disorders and should have risk factors (e.g. hypertension, hyperlipidaemia) managed as part of usual standard of care.
Croatian: Bolesnici s RA imaju povećan rizik od kardiovaskularnih poremećaja pa se faktori rizika (npr., hipertenzija, hiperlipidemija) u njih moraju liječiti u sklopu uobičajene standardne skrbi.
English: Hepatic transaminases increased, Weight increased, Total bilirubin increased*
Croatian: povećanje tjelesne težine, povišenje ukupnog bilirubina*
English: After 12 weeks or at the time of switching to RoActemra, due to disease worsening, patients were treated in the open label extension phase.
Croatian: Nakon 12 tjedana ili prilikom prijelaza na lijek RoActemra zbog pogoršanja bolesti, bolesnici su liječeni u otvorenoj fazi produžetka ispitivanja.
English: Serious hepatic injury occurred between 2 weeks to more than 5 years after initiation of RoActemra.
Croatian: Ozbiljno oštećenje jetre nastupilo je u razdoblju od 2 tjedna do više od 5 godina nakon početka liječenja lijekom RoActemra.
English: • Take the box containing the syringe out of the refrigerator and open the box.
Croatian: · Izvadite kutiju sa štrcaljkom iz hladnjaka i otvorite kutiju.
English: Lift the pre-filled pen straight off of the injection site at a 90° angle to remove the needle from the skin.
Croatian: Podignite napunjenu brizgalicu ravno s mjesta injiciranja pod kutom od 90° kako biste izvukli iglu iz kože.
English: • Remove the syringe from the box and visually examine the syringe, as well as the medicine in the syringe.
Croatian: · Izvadite štrcaljku iz kutije i pregledajte štrcaljku kao i lijek u njoj.
English: Like all medicines, RoActemra can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, lijek RoActemra može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: An additional analyses of JIA ACR responses, considering observed data at Week 40, regardless of flare status, showed that by Week 40, 95.1% of patients who had received continuous TCZ therapy, had achieved JIA ACR30 or higher.
Croatian: Dodatne analize JIA ACR odgovora, uzimajući o obzir podatke iz 40. tjedna neovisno o statusu pogoršanja upale, pokazale su da je do 40. tjedna 95,1% bolesnika koji su nastavili liječenje tocilizumabom postiglo odgovor JIA ACR30 ili veći.
English: In the open label extension phase (Part II), the overall rate of infections remained similar at 306.6 per 100 patient years.
Croatian: Tijekom otvorene faze produžetka ispitivanja (dijela II) ukupna se stopa infekcija zadržala na sličnoj razini: 306,6 na 100 bolesnik-godina.
English: Impaired lung function may increase the risk for developing infections.
Croatian: Oštećena funkcija pluća može povećati rizik od razvoja infekcija.
English: • Do not hold or push on the plunger while inserting the needle into the skin.
Croatian: · Nemojte držati niti pritiskati klip dok ubadate iglu u kožu.
English: • Keep this leaflet.
Croatian: · Sačuvajte ovu uputu.
English: 3 This adverse reaction was identified through post marketing surveillance but not observed in controlled clinical trials.
Croatian: 3 Ova je nuspojava utvrđena tijekom praćenja nakon stavljanja lijeka u promet, ali nije opažena u kontroliranim kliničkim ispitivanjima.
English: • Open the box, and remove 1 single-use RoACTEMRA pre-filled pen from the box.
Croatian: · Otvorite kutiju i izvadite 1 RoACTEMRA napunjenu brizgalicu za jednokratnu uporabu.
English: RoActemra normalises expression of these enzymes.
Croatian: RoActemra normalizira ekspresiju tih enzima.
English: • To be sure the needle can be inserted correctly under the skin, pinch a fold of loose skin at the clean injection site with your free hand.
Croatian: · Kako biste bili sigurni da iglu možete pravilno ubosti pod kožu, slobodnom rukom uhvatite nabor kože na očišćenom mjestu za injekciju.
English: Table 7: Efficacy Results for Study VI (WA19924) ADA + Placebo (IV) N = 162
Croatian: Tablica 7: Rezultati djelotvornosti za ispitivanje VI (WA19924) ADA + Placebo (i.v.) N = 162
English: Do not remove the green cap while allowing your RoACTEMRA pre-filled pen to reach room temperature.
Croatian: Nemojte skinuti zeleni zatvarač dok čekate da se RoACTEMRA napunjena brizgalica ugrije na sobnu temperaturu.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Croatian: OBLIK Koncentrat za otopinu za infuziju (sterilni koncentrat).
English: Four patients were tested positive for IgE isotype (0.9%).
Croatian: Četiri su bolesnika bila pozitivna na izotip IgE (0,9%).
English: Cases of liver failure resulting in liver transplantation have been reported.
Croatian: Prijavljeni su i slučajevi zatajenja jetre koje je dovelo do transplantacije jetre.
English: The safety profile of RoActemra across these indications remains similar and undifferentiated.
Croatian: Sigurnosni profil lijeka RoActemra u tim je indikacijama sličan i nediferenciran.
English: The safety of subcutaneous RoActemra has been studied in one Phase III study (WA28119) with 251 GCA patients.
Croatian: Sigurnost lijeka RoActemra za supkutanu primjenu ocjenjivala se u jednom ispitivanju faze III (WA28119), u kojem je sudjelovao 251 bolesnik koji je imao GCA.
English: • Do not rub the injection site.
Croatian: · Nemojte trljati mjesto injiciranja.
English: • redness, heat, unusual swelling of skin or joint
Croatian: · crvenila, osjećaja vrućine, neuobičajenog oticanja kože ili zglobova
English: Prescribers are reminded of the risk of false negative tuberculin skin and interferon-gamma TB blood test results, especially in patients who are severely ill or immunocompromised.
Croatian: Liječnike koji propisuju lijek podsjeća se na rizik od lažno negativnog nalaza kožnog tuberkulinskog testa te krvnog testa otpuštanja gama interferona, osobito kod teško bolesnih ili imunokompromitiranih bolesnika.
English: • the medicine is any color besides colorless to yellowish
Croatian: · ako je lijek bilo koje boje osim bezbojan do žućkast
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
English: • skin infection (cellulitis) sometimes with fever and chills
Croatian: · infekcije kože (celulitis) ponekad praćene vrućicom i zimicom
English: Lipid parameters
Croatian: Lipidni parametri
English: At the conclusion of Part I, JIA ACR 30/50/70/90 responses were 89.4%, 83.0%, 62.2%, and 26.1%, respectively.
Croatian: Po završetku dijela I, udjeli odgovora JIA ACR 30/50/70/90 iznosili su 89,4%, 83,0%, 62,2% odnosno
English: If either of these applies to you, tell a doctor.
Croatian: Ako se jedno ili drugo odnosi na Vas, recite to liječniku.