FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from intravenous studies with fentanyl suggest that elderly patients may have reduced clearance, a prolonged half-life, and they may be more sensitive to the drug than younger patients.
Croatian: Podaci iz ispitivanja intravenskog fentanila pokazuju da stariji bolesnici mogu imati smanjen klirens,
English: The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic active substances such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with active substances which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]).
Croatian: Pri istodobnoj primjeni lijekova koji djeluju na serotoninergički sustav, poput selektivnih inhibitora ponovne pohrane serotonina (engl.
English: The potential for serious or life-threatening hypoventilation exists even if the lowest dose of DUROGESIC is used in initiating therapy in opioid-naïve patients (see sections 4.4 and
Croatian: Mogućnost nastupa ozbiljne ili po život opasne hipoventilacije postoji čak i kada se liječenje bolesnika koji prethodno nisu primali opioide započinje najnižom dozom lijeka
English: Keep all patches (used and unused) out of the sight and reach of children.
Croatian: Dlake na mjestu primjene (bolje je flaster nanijeti na mjesto gdje nema dlaka) treba prije stavljanja flastera ošišati (ne obrijati).
English: within 14 days of stopping these medicines.
Croatian: DUROGESIC unutar 14 dana nakon završetka liječenja ovim lijekovima - pogledajte detaljnije informacije u nastavku
English: Opioid withdrawal symptoms (such as nausea, vomiting, diarrhoea, anxiety, and shivering) are possible in some patients after conversion from their previous opioid analgesic to DUROGESIC or if therapy is stopped suddenly (see section 4.2).
Croatian: Kod nekih se bolesnika nakon prelaska s dotadašnjih opioidnih analgetika na DUROGESIC ili naglog prekida liječenja mogu javiti simptomi ustezanja od opioida (poput mučnine, povraćanja, proljeva,
English: 5.3 Preclinical safety data
Croatian: 6.1 Popis pomoćnih tvari
English: Do not apply the patch on
Croatian: Nemojte primijeniti flaster:
English: Opioid-naïve and not opioid-tolerant states
Croatian: Bolesnici koji prethodno nisu primali opioide
English: A fentanyl dose decrease and careful monitoring is warranted in anticipation of stopping concomitant treatment with a CYP3A4 inducer.
Croatian: Ako se predviđa prestanak istodobnog liječenja induktorom CYP3A4, potrebno je smanjiti dozu fentanila i pažljivo nadzirati bolesnika.
English: • Some medicines used to treat depression or Parkinson's disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine).You should not take DUROGESIC
Croatian: • lijekove za opuštanje mišića (npr. ciklobenzaprin ili diazepam) • neke lijekove koji se koriste za liječenje depresije, a zovu se SSRI (selektivni inhibitori ponovnog unosa serotonina) ili SNRI (inhibitori ponovnog unosa serotonina i noradrenalina) (npr. citalopram, duloksetin, escitalopram, fluoksetin, fluvoksamin, paroksetin, sertralin ili venlafaksin) - pogledajte detaljnije informacije u nastavku
English: Each cycle has a duration of 28 days.
Croatian: Svaki ciklus traje 28 dana.
English: Why have I been given this card?
Croatian: Zašto sam dobio ovu karticu?
English: Date of first authorization: 15 June 2017
Croatian: Datum prvog odobrenja: 15. lipnja 2017.
English: This may be months from now.
Croatian: To može biti i za nekoliko mjeseci.
English: − CI = confidence interval.
Croatian: − CI = interval pouzdanosti
English: • What to do if you think you might be getting an infection.
Croatian: • što trebate učiniti ako mislite da se možda razvija infekcija
English: • Changes in laboratory tests carried out by your doctor.
Croatian: • promjene u nalazima laboratorijskih pretraga koje provodi Vaš liječnik.
English: Study Treatment, N
Croatian: Ispitivanje Liječenje, N
English: For non-oncology indications:
Croatian: Za neonkološke indikacije:
English: The safety and efficacy of rituximab in children below 18 years have not been established.
Croatian: Sigurnost i djelotvornost rituksimaba u djece mlađe od 18 godina nisu ustanovljene.
English: Similar effects have been observed in animal studies (see section 5.3).
Croatian: Slični su učinci primijećeni i u istraživanjima na životinjama (vidjeti dio 5.3).
English: Binet stage A Binet stage B Binet stage C CI: Confidence Interval
Croatian: A Binet stadij B Binet stadij C CI: interval pouzdanosti
English: The prespecified non-inferiority margin for the treatment difference was 20%.
Croatian: Prethodno postavljena granica neinferiornosti za razliku između terapija bila je 20 %.
English: − * Worst case imputation a Non-inferiority was demonstrated since the lower bound (− 3.2%) was higher than the predetermined non-inferiority margin (− 20%).
Croatian: − * pretpostavka najgoreg slučaja a Neinferiornost je dokazana jer je donja granica (−3,2 %) veća od prethodno postavljene granice neinferiornosti (−20 %).
English: Preparation should be: - performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
Croatian: Priprema mora biti: - izvedena u aseptičkim uvjetima i mora je provesti uvježbano osoblje u skladu s pravilima dobre prakse naročito u pogledu aseptičke pripreme lijekova za parenteralnu primjenu.
English: As the Patient Alert Card is part of the product information in the outer packaging, the content will be centrally approved for all EU/EEA languages without need of further approval by National Authorities.
Croatian: Budući da je Kartica s upozorenjima za bolesnika dio informacija o lijeku u vanjskom pakiranju, njezin će se sadržaj centralno odobriti za sve jezike EU-a/EGP-a i nema potrebe za dodatnim odobrenjem od strane nacionalnih tijela.
English: • Excess fluid retention in the face and body
Croatian: • prekomjerno zadržavanje tekućine na licu i u tijelu
English: Tell your doctor immediately if you experience any of these symptoms.
Croatian: Odmah obavijestite svog liječnika ako primijetite neki od tih simptoma.
English: • you have a weak immune system.
Croatian: • ako imate oslabljen imunološki sustav
English: • high or low blood pressure (low blood pressure especially when standing upright)
Croatian: • visok ili nizak krvni tlak (pad krvnog tlaka osobito nakon podizanja u uspravan položaj)
English: Your doctor will decide if you should receive concomitant supportive therapy.
Croatian: Vaš liječnik će odlučiti trebate li primiti popratnu potpornu terapiju.
English: The most frequent reported or observed serious adverse drug reactions (ADRs) were:
Croatian: Najčešće prijavljene ili opažene ozbiljne nuspojave bile su:
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: Rixathon is indicated in adults for the following indications:
Croatian: Rixathon je indiciran u odraslih u sljedećim indikacijama:
English: Do not have Rixathon if you have an active infection or a serious problem with your immune system.
Croatian: Ne smijete primiti lijek Rixathon ako imate aktivnu infekciju ili ozbiljne poteškoće s imunološkim sustavom.
English: • a reduction in white blood cells which does not happen straight away
Croatian: • smanjenje broja bijelih krvnih stanica koje ne nastupa odmah
English: Some infections may be severe (please see information on Infections within this section).
Croatian: Neke infekcije mogu biti ozbiljne (vidjeti informacije u odjeljku Infekcije u ovom dijelu Upute).
English: The incidence of serious infections was similar in both arms (approximately 12%).
Croatian: Incidencija ozbiljnih infekcija bila je slična u obje liječene skupine (približno 12 %).
English: Contents of the pack and other information What Rixathon contains
Croatian: Sadržaj pakiranja i druge informacije Što Rixathon sadrži
English: Mean change in SF-36 PHS
Croatian: Srednja vrijednost promjene SF-36 PHS
English: Available data suggest that clinical response is usually achieved within 16 to 24 weeks of an initial treatment course.
Croatian: Dostupni podaci upućuju na to da se klinički odgovor obično postiže u roku od 16 - 24 tjedna od početnog liječenja.
English: If you feel dizzy, do not drive or use any tools or machines.
Croatian: Ako osjećate omaglicu, nemojte upravljati vozilima niti raditi s alatima ili strojevima.
English: Premedication and prophylactic medications
Croatian: Premedikacija i profilaktične medikacije
English: • ringing sound in the ears, ear pain
Croatian: • zvonjava u ušima, bol u uhu
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, treba primjenjivati aseptičku tehniku.
English: Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite ovaj lijek ako ste Vi ili Vaše dijete mlađi od 18 godina.
English: Rixathon may also cause changes in laboratory tests carried out by your doctor.
Croatian: Rixathon može uzrokovati i promjene u nalazima laboratorijskih pretraga koje provodi Vaš liječnik.
English: Complete remission All patients Newly diagnosed Relapsing
Croatian: Potpuna remisija Svi bolesnici Novodijagnosticirani Relaps
English: Retreatment should be given at that time if residual disease activity remains, otherwise retreatment should be delayed until disease activity returns.
Croatian: Liječenje tada treba ponoviti ako je i dalje prisutna aktivna bolest, a u protivnom ga treba odgoditi dok se bolest ponovno ne aktivira.
English: • raised blood pressure
Croatian: • povišen krvni tlak
English: It is important to check the medicinal product labels to ensure that the appropriate formulation is being given to the patient, as prescribed.
Croatian: Važno je provjeriti tekst na pakiranju lijeka kako bi se osiguralo da bolesnik primi odgovarajuću formulaciju lijeka, u skladu s onime što je propisano.
English: Table 14 Physical Function and Quality of Life outcomes at week 24 in Trial 1
Croatian: Tablica 14 Ishodi vezani uz fizičku funkciju i kvalitetu života u 24. tjednu u Ispitivanju 1
English: Your doctor may decide to stop your Rixathon treatment if these reactions are serious.
Croatian: Liječnik može odlučiti prekinuti liječenje lijekom Rixathon ako su te reakcije ozbiljne.
English: • reduced platelets number just after the infusion - this can be reversed, but can be fatal in rare cases
Croatian: • smanjenje broja krvnih pločica neposredno nakon infuzije - može se povući, ali u rijetkim slučajevima može imati i smrtni ishod
English: The need for further courses should be evaluated 24 weeks following the previous course.
Croatian: Potrebu za daljnjim ciklusima liječenja potrebno je procijeniti 24 tjedna nakon prethodnog ciklusa.
English: For these reasons Rixathon should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Croatian: Zbog tih se razloga Rixathon ne smije primjenjivati u trudnica, osim ako moguća korist od liječenja nadilazi potencijalni rizik.
English: It remains unknown if early detection of PML and suspension of rituximab therapy may lead to similar stabilisation or improved outcome.
Croatian: Ostaje nepoznato mogu li rano otkrivanje PML-a i prekid liječenja rituksimabom dovesti do slične stabilizacije ili poboljšanog ishoda.
English: • Cardiovascular events, see section 4.4.
Croatian: • kardiovaskularni događaji, vidjeti dio 4.4.
English: • becoming very red in the face and other areas of the skin as a consequence of dilation of the blood vessels
Croatian: • jako crvenilo u licu i na drugim dijelovima kože kao posljedica proširenja krvnih žila
English: Depending on the signs and symptoms of your disease, your doctor will decide when you should receive more Rixathon.
Croatian: Ovisno o znakovima i simptomima bolesti liječnik će odlučiti kada morate ponovo primiti lijek Rixathon.
English: This is because in a few cases, Rixathon could cause hepatitis B to become active again, which can be fatal in very rare cases.
Croatian: Naime, u nekim slučajevima Rixathon može ponovno aktivirati hepatitis B, što u vrlo rijetkim slučajevima može biti smrtonosno.
English: Do not have Rixathon if any of the above apply to you.
Croatian: Nemojte primiti lijek Rixathon ako se nešto od navedenoga odnosi na Vas.
English: Other medicines and Rixathon
Croatian: Drugi lijekovi i Rixathon
English: Currently, there are limited data on possible interactions with other medicinal products and rituximab.
Croatian: Trenutno su dostupni ograničeni podaci o mogućim interakcijama drugih lijekova s rituksimabom.
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 infuzije može doći do vrućice, zimice i drhtavice.
English: If you can get pregnant, you and your partner must use an effective method of contraception while using Rixathon.
Croatian: Ako ste u dobi kada možete zatrudnjeti, Vi i Vaš partner morate koristiti učinkovitu kontracepciju tijekom liječenja lijekom Rixathon.
English: Significance levels were defined as * p <0.05, ** p < 0.001, *** p < 0.0001.
Croatian: Razine značajnosti definirane su kao *p < 0,05, **p < 0,001, ***p < 0,0001
English: • you have severe heart failure or severe uncontrolled heart disease and have rheumatoid arthritis,
Croatian: • ako imate teško zatajenje srca ili tešku nekontroliranu srčanu bolest i imate reumatoidni artritis,
English: • asthma, too little oxygen reaching the body organs
Croatian: • astma, dotok premale količine kisika u tjelesne organe
English: • Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your Rixathon.
Croatian: • Karticu pokažite svakom liječniku, medicinskoj sestri ili stomatologu koje posjećujete, a ne samo liječniku specijalistu koji Vam propisuje lijek Rixathon.
English: • Fungal foot infection (athlete's foot)
Croatian: • gljivična infekcija stopala (atletsko stopalo)
English: • eating disorders, not eating enough, leading to weight loss
Croatian: • poremećaji u prehrani, nedovoljan unos hrane koji dovodi do gubitka težine
English: These include a decrease in the amount of some specific proteins in the blood (immunoglobulins) which help protect against infection.
Croatian: To uključuje smanjenje razine nekih specifičnih proteina u krvi (imunoglobulina) koji pomažu u zaštiti od infekcije.
English: Rixathon slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to do normal daily activities.
Croatian: Rixathon usporava oštećenje zglobova uzrokovano reumatoidnim artritisom i poboljšava sposobnost obavljanja uobičajenih dnevnih aktivnosti.
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: Patients should receive Rixathon for at least 24 months after achievement of remission (absence of clinical signs and symptoms).
Croatian: Rixathon najmanje 24 mjeseca nakon postizanja remisije (odsutnost kliničkih znakova i simptoma bolesti).
English: This is because there is not much information about the use of rituximab in children and young people.
Croatian: Naime, nema mnogo informacija o primjeni rituksimaba u djece i mladih osoba.
English: When should I not have Rixathon?
Croatian: Kada ne smijem primiti lijek Rixathon?
English: • inflammation of blood vessels including those leading to skin symptoms
Croatian: • upale krvnih žila, uključujući one koje izazivaju kožne simptome
English: Rixathon in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.
Croatian: Rixathon u kombinaciji s kemoterapijom uništava te stanice koje se postupno uklanjaju iz tijela biološkim procesima.
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: This card tells you:
Croatian: U ovoj se kartici navodi
English: Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01X C02
Croatian: Farmakoterapijska skupina: antineoplastici, monoklonska antitijela; ATK oznaka: L01X C02
English: 9.32 years
Croatian: 9,32 godine
English: In clinical trials more than 3,100 patients received at least one treatment course and were followed for periods ranging from 6 months to over 5 years; approximately 2,400 patients received two or more courses of treatment with over 1,000 having received 5 or more courses.
Croatian: U kliničkim je ispitivanjima više od 3100 bolesnika primilo barem jedan ciklus liječenja, a praćeni su u razdobljima od 6 mjeseci do više od 5 godina; približno 2400 bolesnika primilo je dva ili više ciklusa liječenja dok je više od 1000 bolesnika primilo pet ili više ciklusa.
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: Figure 2: ACR responses for 4 treatment courses (24 weeks after each course (within patient, within visit) in patients with an inadequate response to TNF-inhibitors (n=146)
Croatian: ACR odgovori u 4 ciklusa liječenja (24 tjedna nakon svakog ciklusa (intraindividualno, unutar posjeta) u bolesnika koji nisu dovoljno dobro odgovorili na TNF-inhibitore (n = 146)
English: What Rixathon looks like and contents of the pack
Croatian: Kako Rixathon izgleda i sadržaj pakiranja
English: Rixathon will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Croatian: Lijek Rixathon će Vam dati liječnik ili medicinska sestra s iskustvom u primjeni te vrste lijekova.
English: These findings were replicated at week 48, where autoantibody seropositivity also significantly increased the probability of achieving ACR70.
Croatian: 48. tjednu, kada je seropozitivnost na autoantitijela također uzrokovala značajno veću vjerojatnost postizanja odgovora ACR70.
English: Your doctor will check if you should have any vaccines before you receive Rixathon.
Croatian: Vaš će liječnik provjeriti morate li primiti neko cjepivo prije nego što primite lijek Rixathon.
English: Patients with positive hepatitis B serology (either HBsAg or HBcAb) should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
Croatian: Bolesnici s pozitivnim serološkim nalazima na hepatitis B (bilo HBsAg ili HBcAb) trebaju prije početka liječenja konzultirati stručnjake za jetrene bolesti te ih treba nadzirati i liječiti sukladno lokalnim standardima s ciljem prevencije reaktivacije hepatitisa B.
English: Limited information from one study in relapsed/refractory CLL patients suggests that rituximab treatment may also worsen the outcome of primary hepatitis B infections.
Croatian: Ograničeni podaci iz jednog ispitivanja u bolesnika s relapsirajućim/refraktornim KLLom ukazuju da liječenje rituksimabom može također pogoršati ishod primarne infekcije hepatitisom B.
English: The proliferation of these abnormal B-lymphocytes is the cause of symptoms you may have.
Croatian: Bujanje tih abnormalnih B-limfocita uzrokuje simptome koje možda imate.
English: Both tests are commonly positive in rheumatoid arthritis and aid in confirming the diagnosis.
Croatian: Oba su testa obično pozitivna u slučaju reumatoidnog artritisa te olakšavaju potvrdu dijagnoze.
English: Cranial neuropathy, loss of other senses5
Croatian: kranijalna neuropatija, gubitak drugih osjeta5
English: • Rixathon will be given to you once a week for 4 weeks.
Croatian: Lijek Rixathon primat ćete jedanput na tjedan tijekom 4 tjedna.
English: Mild or moderate infusion-related reactions (IRR) (section 4.8) usually respond to a reduction in the rate of infusion.
Croatian: Blage ili umjerene reakcije na infuziju (dio 4.8) obično se povlače nakon smanjenja brzine infuzije.
English: The majority of patients (81%) showed signs of B cell return, with counts > 10 cells/μL by month 12, increasing to 87% of patients by month 18.
Croatian: Većina je bolesnika (81 %) pokazala znakove povrata B stanica, uz vrijednosti od > 10 stanica/µl do 12. mjeseca, što se povećalo na 87 % bolesnika do 18. mjeseca.
English: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.
Croatian: Nastavak terapije valja pažljivo razmotriti u bolesnika u kojih u tom razdoblju nema vidljivih znakova koristi terapije.
English: Rixathon is usually taken together with another medicine called methotrexate.
Croatian: Rixathon se obično primjenjuje zajedno s drugim lijekom koji se zove metotreksat.
English: • High cholesterol levels in the blood
Croatian: • povišena razina kolesterola u krvi
English: The incidence of infections that were serious or required intravenous antibiotics was approximately 4 per 100 patient years.
Croatian: Incidencija infekcija koje su bile ozbiljne ili zahtijevale intravensku primjenu antibiotika iznosila je otprilike 4 na 100 bolesnik-godina.
English: 9.25 years
Croatian: 9,25 godina
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: Rixathon is a biosimilar medicinal product.
Croatian: Rixathon je biosličan lijek.
English: Examples of these serious viral infections are infections caused by the herpes viruses (Cytomegalovirus, Varicella Zoster Virus and Herpes Simplex Virus), JC virus (progressive multifocal leukoencephalopathy [PML]) and hepatitis C virus.
Croatian: Primjeri takvih ozbiljnih virusnih infekcija su infekcije izazvane herpes virusima (citomegalovirus, varičela zoster virus i herpes simpleks virus), JC virusom (progresivna multifokalna leukoencefalopatija [PML]) te virusom hepatitisa C.
English: Rarely Rixathon can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Croatian: Rixathon rijetko može uzrokovati ozbiljnu infekciju mozga koja se naziva 'progresivna multifokalna leukoencefalopatija' ili PML.
English: Rixathon 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: Rixathon 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: Rituximab was detectable in the serum of patients 3 to 6 months after completion of last treatment.
Croatian: Rituksimab je bilo moguće otkriti u serumu bolesnika 3 - 6 mjeseci nakon završetka liječenja.
English: If you are having Rixathon with other medicines, some of the side effects you may get may be due to the other medicines.
Croatian: Ako lijek Rixathon primate zajedno s drugim lijekovima, neke od nuspojava koje će se možda pojaviti mogu biti uzrokovane drugim lijekovima.
English: Before you are given Rixathon you will be given other medicines (premedication) to prevent or reduce possible side effects.
Croatian: Prije nego primite lijek Rixathon, primit ćete druge lijekove (premedikaciju) koji sprječavaju ili ublažavaju moguće nuspojave.
English: 1 Events were considered ADRs only after thorough assessment and where a causal relationship between the medicinal product and the adverse event was at least a reasonable possibility.
Croatian: 1 Događaji su se smatrali nuspojavama lijeka tek nakon što je provedena temeljita ocjena i utvrđena barem razumna mogućnost uzročne povezanosti između lijeka i štetnog događaja.