FrancophonIA/ELRC3.0 huggingface dataset:
English: Carcinoid tumour Treatment of carcinoid tumours with lymph node or liver metastases and with "carcinoid syndrome".
Croatian: Karcinoid Liječenje karcinoida s metastazama u limfnim čvorovima ili jetri i “karcinoidnim sindromom”.
English: IntronA (3 MIU 3 times a week) I/R IntronA (3 MIU 3 times a week) + ribavirin (1,000/1,200 mg/day)
Croatian: IntronA (3 milijuna IU triput na tjedan) I/R IntronA (3 milijuna IU triput na tjedan) + ribavirin (1000/1200 mg na dan)
English: Interferon alfa-2b treatment is to be restarted at 50 % of the previous dose.
Croatian: Ponovno liječenje interferonom alfa-2b mora se započeti 50% nižom dozom od prethodne.
English: If unable to activate, discard immediately into an approved sharps collector.
Croatian: Ako ne možete aktivirati mehanizam, odmah odložite u spremnik odobren za prikupljanje oštrih predmeta.
English: IntronA is used in adult patients to treat certain disorders that affect the blood, bone marrow, lymph glands, or skin and may extend into the body.
Croatian: IntronA se primjenjuje u odraslih bolesnika za liječenje određenih bolesti koje zahvaćaju krv, koštanu srž, limfne čvorove ili kožu, a mogu se proširiti na cijelo tijelo.
English: Pre-existing thyroid disease unless it can be controlled with conventional treatment.
Croatian: - Postojeća bolest štitne žlijezde, osim ako se može kontrolirati konvencionalnom terapijom.
English: Your doctor will test your blood to ensure that your white blood cell (cells that fight infection) and red blood cell (cells that carry iron and oxygen) counts, platelets (blood clotting cells) and other laboratory values are at acceptable levels.
Croatian: Liječnik će obaviti pretrage krvi kako bi provjerio jesu li broj bijelih krvnih stanica (stanice koje se bore protiv infekcije), broj crvenih krvnih stanica (stanice koje prenose željezo i kisik), broj trombocita (stanice važne za zgrušavanje krvi) te druge laboratorijske vrijednosti u prihvatljivim granicama.
English: The relative benefit of combination therapy with IntronA + ribavirin is particularly significant in the most difficult to treat subgroup of patients (genotype 1 and high virus load) (Table 3).
Croatian: Relativna korist od kombinirane terapije lijekom IntronA i ribavirinom osobito je značajna u podskupinama bolesnika koje je najteže liječiti (genotip 1 i veliko virusno opterećenje) (Tablica 3).
English: In adult patients with loss of HBeAg and HBV-DNA, a significant reduction in morbidity and mortality has been observed.
Croatian: U odraslih bolesnika u kojih je došlo do negativizacije HBeAg i HBV-DNK uočeno je značajno smanjenje pobola i smrtnosti.
English: A five-year long-term, observational, follow-up study enrolled 97 paediatric chronic hepatitis C patients after treatment in the standard interferon multicentre trials.
Croatian: U petogodišnju opservacijsku studiju praćenja uključeno je 97 pedijatrijskih bolesnika s kroničnim hepatitisom C nakon završetka liječenja standardnim interferonom u multicentričnim kliničkim ispitivanjima.
English: Patients with psoriasis and sarcoidosis
Croatian: Bolesnici s psorijazom i sarkoidozom
English: This syndrome is a granulomatous inflammatory disorder affecting the eyes, auditory system, meninges, and skin.
Croatian: Taj je sindrom granulomatozni upalni poremećaj koji zahvaća oči, slušni sustav, moždane ovojnice i kožu.
English: Children and adolescents should be monitored every 3 months for evidence of thyroid dysfunction (e.g. TSH).
Croatian: Djecu i adolescente treba kontrolirati svaka 3 mjeseca kako bi se uočili eventualni znakovi poremećaja funkcije štitne žljezde (npr. TSH).
English: It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virus-infected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
Croatian: Smatra se da je taj proces barem djelomično odgovoran za različite stanične odgovore na interferon, uključujući inhibiciju umnožavanja virusa u stanicama inficiranima virusom, supresiju stanične proliferacije te imunomodulirajuća djelovanja poput pojačanja fagocitne aktivnosti makrofaga i povećanja specifične citotoksičnosti limfocita za ciljne stanice.
English: Appropriate dose form and strength must be selected.
Croatian: Treba odabrati odgovarajući farmaceutski oblik i dozu.
English: If you have this reaction, be sure to rinse your mouth thoroughly afterwards.
Croatian: Ako povraćate, svakako nakon toga temeljito isperite usta.
English: §, influenza-like symptoms
Croatian: §, simptomi nalik gripi
English: They are produced and secreted by cells in response to viral infections or various synthetic and biological inducers.
Croatian: Stanice ih proizvode i izlučuju kao odgovor na virusne infekcije ili razne sintetske i biološke tvari koje potiču njihovo izlučivanje.
English: If any of the following side effects happen, stop taking IntronA and tell your doctor immediately or go to the casualty department at your nearest hospital: - swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing; hives; fainting.
Croatian: Ako nastupi neka od sljedećih nuspojava, prestanite uzimati IntronA i odmah obavijestite svog liječnika ili otiđite u hitnu službu najbliže bolnice: - oticanje šaka, stopala, gležnjeva, lica, usana, usta ili grla, koje može prouzročiti otežano gutanje ili disanje; koprivnjača; nesvjestica.
English: Remove the needle guard without touching the needle, and fill the syringe with air by pulling the plunger to the level that represents your dose as prescribed by your doctor.
Croatian: Skinite štitnik igle ne dodirujući iglu i napunite štrcaljku zrakom tako što ćete povući klip do razine koja predstavlja dozu koju Vam je propisao Vaš liječnik.
English: Children and adolescents are particularly prone to develop depression when being treated with IntronA and ribavirin.
Croatian: Djeca i adsolescenti su osobito skloni razvoju depresije dok se liječe lijekom IntronA i ribavirinom.
English: Solution for injection or infusion.
Croatian: Otopina za injekciju ili infuziju.
English: Standard haematological tests and blood chemistries (complete blood count and differential, platelet count, electrolytes, liver enzymes, serum protein, serum bilirubin and serum creatinine) are to be conducted in all patients prior to and periodically during systemic treatment with IntronA.
Croatian: Standardne hematološke i biokemijske pretrage krvi (kompletna i diferencijalna krvna slika, broj trombocita, elektroliti, jetreni enzimi, serumski proteini, serumski bilirubin i serumski kreatinin) moraju se provesti u svih bolesnika prije početka i povremeno tijekom sustavnog liječenja lijekom IntronA.
English: Because of the potential for adverse reactions in nursing infants, nursing should be discontinued prior to initiation of treatment.
Croatian: Zbog mogućeg razvoja nuspojava u dojenčadi, dojenje treba prekinuti prije početka liječenja.
English: The best sites for injection are tissues with a layer of fat between skin and muscle: thigh, outer surface of the upper arm (you may need the assistance of another person to use this site), abdomen (except the navel or waistline).
Croatian: Najbolja mjesta za injekciju su područja gdje se između kože i mišića nalazi sloj masnog tkiva, kao što su: bedro, vanjska strana nadlaktice (možda ćete trebati pomoć druge osobe za ovo mjesto) ili trbuh (osim pupka i područja struka).
English: While this has been reported more often in patients with chronic hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha.
Croatian: Iako su takva stanja prijavljena češće u bolesnika s kroničnim hepatitisom C liječenih interferonom alfa, prijavljena su i u bolesnika s onkološkim bolestima liječenih interferonom alfa.
English: Chronic myelogenous leukaemia
Croatian: Kronična mijeloična leukemija
English: This enhancement in efficacy included loss of serum HCV (< 100 copies/mL by PCR), improvement in hepatic inflammation, and normalisation of ALT, and was sustained when measured 6 months after the end of treatment.
Croatian: Ovo povećanje djelotvornosti uključivalo je nestanak HCV-a iz seruma (< 100 kopija/ml prema PCR-u), poboljšanje upalnih promjena u jetri i normalizaciju ALT-a, a mjerenja su potvrdila da je bilo održano 6 mjeseci nakon završetka liječenja.
English: Your doctor or his/her assistant will instruct you how to selfinject IntronA.
Croatian: Vaš liječnik ili medicinska sestra će Vas naučiti kako da si sami date injekciju lijeka IntronA.
English: Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.
Croatian: Plućni infiltrati, pneumonitis i upala pluća, koji ponekad mogu rezultirati smrtnim ishodom, opaženi su rijetko u bolesnika liječenih interferonom alfa, uključujući i one liječene lijekom IntronA.
English: However, ribavirin systemic exposure of a female partner after sexual intercourse with a treated patient has been estimated and remains extremely limited compared to therapeutic plasma concentration of ribavirin.
Croatian: Ipak, procjena sustavne izloženosti partnerice ribavirinu nakon spolnog odnosa s liječenim bolesnikom pokazuje da je ona izuzetno mala u usporedbi s terapijskim koncentracijama ribavirina u plazmi.
English: In particular, decrease in mean height percentile from baseline to the end of the longterm follow-up was most prominent in prepubertal age children (see section 4.4).
Croatian: Treba naglasiti da je prosječno smanjenje na percentilnoj krivulji rasta od početka ispitivanja do kraja dugotrajnog praćenja bilo najizraženije u djece pretpubertetske dobi (vidjeti dio 4.4).
English: If such a reaction develops, discontinue the medicine and institute appropriate medical therapy.
Croatian: Razvije li se takva reakcija, prekinite davanje lijeka i uvedite odgovarajuću terapiju.
English: Hold the IntronA vial upright without touching the cleaned top of the vial with your hands.
Croatian: Držite bočicu lijeka IntronA uspravno ne dodirujući rukama očišćeni vrh bočice.
English: The longer term data available in children treated with the combination therapy with standard interferon/ribavirin are also indicative of substantial growth retardation (> 15 percentile decrease in height percentile as compared to baseline) in 21 % of children (n=20) despite being off treatment for more than 5 years.
Croatian: Dugoročniji podaci u djece liječene kombiniranom terapijom standardnim interferonom i ribavirinom također ukazuju na značajno usporenje rasta (smanjenje za > 15 percentila na percentilnoj krivulji rasta u odnosu na početnu vrijednost) u 21% djece (n=20), unatoč tome što je od liječenja prošlo više od 5 godina.
English: IntronA is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques.
Croatian: IntronA je sterilan, stabilan pripravak visoko pročišćenog interferona alfa-2b proizvedenog tehnikama rekombinantne DNK.
English: - Severe renal or hepatic dysfunction; including that caused by metastases.
Croatian: - Teško oštećenje bubrežne ili jetrene funkcije, uključujući ono prouzročeno metastazama.
English: CHOP-like regimens are advised, but clinical experience is available only with CHVP (combination of cyclophosphamide, doxorubicin, teniposide and prednisolone).
Croatian: Savjetuje se primjena protokola poput CHOP, premda kliničko iskustvo postoji isključivo s primjenom CHVP protokola (kombinacija ciklofosfamida, doksorubicina, tenipozida i prednizolona).
English: Children and adolescent population
Croatian: Djeca i adolescenti
English: After withdrawal of the dose, any remaining solution must be discarded.
Croatian: Nakon izvlačenja doze, preostala otopina se mora baciti.
English: The following instructions explain how to inject IntronA yourself.
Croatian: Sljedeće upute objašnjavaju kako ćete sami sebi dati injekciju lijeka IntronA.
English: Table 5 Sustained virological response in previously untreated children and adolescents IntronA 3 MIU/m2 3 times a week ribavirin 15 mg/kg/day
Croatian: Tablica 5. Trajan virološki odgovor u djece i adolescenata koji prethodno nisu bili liječeni IntronA 3 milijuna IU/m2 triput na tjedan ribavirin 15 mg/kg na dan
English: If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
Croatian: Pojave li se takvi simptomi, odgovorni liječnik treba imati na umu moguću ozbiljnost ovih nuspojava te razmotriti potrebu za odgovarajućim liječenjem.
English: Abortion was observed in all dose groups (7.5 million, 15 million and 30 million IU/kg), and was statistically significant versus control at the mid- and high-dose groups (corresponding to 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/m2).
Croatian: Pobačaji su zabilježeni u svim doznim skupinama (7,5 milijuna, 15 milijuna i 30 milijuna IU/kg), a njihova je incidencija bila statistički značajna u skupinama koje su primale srednju i visoku dozu (koje su odgovarale 90 odnosno 180 puta većim dozama od preporučenih za intramuskularnu odnosno supkutanu primjenu od 2 milijuna IU/m2) u odnosu na kontrolne životinje.
English: High doses of other forms of interferons alpha and beta are known to produce doserelated anovulatory and abortifacient effects in rhesus monkeys.
Croatian: Poznato je da visoke doze drugih oblika interferona alfa i beta imaju dozi sukladne anovulatorne i abortivne učinke u rezus majmuna.
English: In addition, injection site disorders, pyrexia, anorexia, vomiting, and emotional lability occurred more frequently in children and adolescents compared to adult patients.
Croatian: Dodatno, promjene na mjestu davanja injekcije, pireksija, anoreksija, povraćanje i emocionalna labilnost javljali su se češće u djece i adolescenata nego u odraslih bolesnika.
English: Results of animal reproduction studies indicate that recombinant interferon alfa-2b was not teratogenic in rats or rabbits, nor did it adversely affect pregnancy, foetal development or reproductive capacity in offspring of treated rats.
Croatian: Rezultati istraživanja reprodukcije na životinjama pokazuju da rekombinantni interferon alfa-2b nije bio teratogen u štakora ni kunića, niti je nepovoljno utjecao na skotnost, razvoj fetusa i reproduktivnu sposobnost potomaka štakora koji su primali lijek.
English: Therefore, it is recommended that children and adolescent patients receiving IntronA/ribavirin combination be discontinued from therapy if their week 12 HCV-RNA dropped < 2 log10 compared to pretreatment, or if they have detectable HCV-RNA at treatment week 24.
Croatian: Zato se preporučuje obustaviti liječenje u djece i adolescenata koji primaju kombinaciju IntronA/ribavirin ako im razina HCV-RNK u 12. tjednu padne za < 2 log10 u odnosu na vrijednost prije liječenja ili ako imaju mjerljivu razinu HCV-RNK u 24. tjednu liječenja.
English: The administered dose should be reduced by 50 % in case of occurrence of haematological disorders (white blood cells < 1,500/mm 3, granulocytes < 1,000/mm 3, thrombocytes < 100,000/mm 3).
Croatian: Primijenjenu dozu treba smanjiti za 50% u slučaju pojave hematoloških poremećaja (leukociti < 1500/mm 3, granulociti < 1000/mm 3, trombociti < 100 000/mm 3).
English: The population enrolled mainly consisted in children with mild to moderate hepatitis C. In the two multicentre trials sustained virological response rates in children and adolescents were similar to those in adults.
Croatian: Populaciju uključenih bolesnika pretežno su činila djeca s blagim do umjereno teškim hepatitisom C. U dva multicentrična ispitivanja stope trajnog virološkog odgovora u djece i adolescenata bile su slične onima u odraslih.
English: §, retinopathies (including macular oedema), retinal artery or vein obstruction
Croatian: §, retinopatija (uključujući makularni edem), opstrukcija retinalne arterije ili vene
English: In clinical trials conducted in a broad range of indications and at a wide range of doses (from 6 MIU/m2/week in hairy cell leukaemia up to 100 MIU/m2/week in melanoma), the most commonly reported undesirable effects were pyrexia, fatigue, headache and myalgia.
Croatian: U kliničkim ispitivanjima provedenima u velikom broju indikacija i u širokom rasponu doza (od 6 milijuna IU/m2 na tjedan u liječenju leukemije vlasastih stanica do 100 milijuna IU/m2 na tjedan u liječenju melanoma), najčešće prijavljene nuspojave bile su pireksija, umor, glavobolja i mialgija.
English: The adverse reactions listed in Table 1 are based on experience from clinical trials and post-marketing.
Croatian: Nuspojave prikazane u Tablici 1 temelje se na iskustvu iz kliničkih ispitivanja i nakon stavljanja lijeka u promet.
English: The usual starting dose for each condition follows; however, individual doses may vary, and the doctor may change your dose based on your specific needs:
Croatian: Međutim, doze se mogu razlikovati od bolesnika do bolesnika, a i liječnik može promijeniti dozu s obzirom na Vaše potrebe:
English: When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that resulted in reduced final adult height in some patients.
Croatian: Kad se odlučuje da se liječenje ne odgađa do odrasle dobi, bitno je uzeti u obzir da je kombinirana terapija dovela do zastoja u rastu koji je u nekih bolesnika rezultirao smanjenom konačnom visinom u odrasloj dobi.
English: If you are self-administering treatment, or if you are the caregiver of a child taking IntronA in combination with ribavirin, inject the recommended dose as soon as you remember and continue treatment as usual.
Croatian: Ako si lijek dajete sami ili skrbite o djetetu koje prima IntronA u kombinaciji s ribavirinom, injicirajte preporučenu dozu čim se sjetite i nastavite liječenje prema uobičajenom rasporedu.
English: Very rarely: Not known:
Croatian: vrlo rijetko: nepoznato:
English: The adverse reactions listed in Table 2 are based on experience from the two multicentre children and adolescent clinical trials.
Croatian: Nuspojave navedene u Tablici 2 temelje se na iskustvu iz dva multicentrična klinička ispitivanja u djece i adolescenata.
English: A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1,64 %  12 years of age.
Croatian: Ukupno je uključeno 118 bolesnika: 57% muškog spola, 80% bijelaca, 78% s genotipom 1 virusa, 64% u dobi od ≤ 12 godina.
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Croatian: Ispitivanje 2 (P02080) bilo je randomizirano ispitivanje u jednom centru, u koje je uključeno 95 prethodno neliječenih odraslih bolesnika s kroničnim hepatitisom C koji su istodobno bili zaraženi HIV-om.
English: If you are prescribed IntronA in combination with another medicine, please refer also to the Package Leaflet of the medicine to be used in combination.
Croatian: Ako Vam je IntronA propisan u kombinaciji s drugim lijekom, pročitajte i uputu o lijeku za lijek koji ćete uzimati u kombinaciji.
English: 6 IU/kg/day for 3 months caused no remarkable toxicity.
Croatian: 6 IU/kg na dan tijekom 3 mjeseca cynomolgus majmunima nije uzrokovala značajnu toksičnost.
English: The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/mL (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
Croatian: Liječenje je trajalo 48 tjedana, a razdoblje praćenja 6 mjeseci, osim u bolesnika inficiranih genotipovima 2 ili 3 i virusnim opterećenjem < 800 000 IU/ml (Amplicor), koji su liječeni 24 tjedna uz razdoblje praćenja od 6 mjeseci.
English: Treatment should be discontinued in case of severe leukopaenia (< 1,200/mm 3), severe neutropaenia (< 750/mm or severe thrombocytopaenia (< 70,000/mm
Croatian: Liječenje se mora prekinuti u slučaju teške leukopenije (< 1200/mm 3), teške neutropenije (< 750/mm 3) ili teške trombocitopenije
English: §, hyperuricemia, increased appetite
Croatian: §, hiperuricemija, pojačan tek
English: An improvement in liver histology has been observed.
Croatian: Primijećeno je poboljšanje histološkog nalaza jetre.
English: In general, the adverse reaction profile in the limited children and adolescent population studied was similar to that observed in adults, although there is a paediatric- specific concern regarding growth inhibition as decrease in height percentile (mean percentile decrease of 9 percentile) and weight percentile (mean percentile decrease of 13 percentile) were observed during treatment.
Croatian: Općenito je profil nuspojava koje su zabilježene na malobrojnoj ispitivanoj populaciji djece i adolescenata bio sličan onome u odraslih, premda postoji problem specifičan za pedijatrijsku populaciju koji se odnosi na zastoj u rastu jer su tijekom liječenja zabilježena smanjenja percentila tjelesne visine (prosječno smanjenje za 9 percentila) i percentila tjelesne težine (prosječno smanjenje za 13 percentila).
English: In patients who are in the plateau phase (more than 50 % reduction of myeloma protein) following initial induction chemotherapy, interferon alfa-2b may be administered as monotherapy, subcutaneously, at a dose of 3 million IU/m2 three times a week (every other day).
Croatian: U bolesnika koji su u fazi platoa (smanjenje mijelomskih proteina za više od 50%) nakon početne uvodne kemoterapije, interferon alfa-2b može se primijeniti kao monoterapija, supkutano, u dozi od 3 milijuna IU/m2 triput na tjedan (svaki drugi dan).
English: The side effect may develop at various time points during treatment, typically several months after starting treatment with IntronA.
Croatian: Nuspojave se mogu razviti u različitim vremenskim točkama tijekom liječnja, najčešće nekoliko mjeseci nakon početka liječenja s lijekom IntronA.
English: If psychiatric symptoms persist or worsen, or suicidal or homicidal ideation is identified, it is recommended that treatment with IntronA be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Croatian: Ako psihijatrijski simptomi potraju ili se pogoršaju, ili se ustanove misli o samoubojstvu ili ubojstvu, preporučuje se obustaviti liječenje lijekom IntronA te pratiti stanje bolesnika i po potrebi osigurati intervenciju psihijatra.
English: Children and adolescent population: Growth and development (chronic hepatitis C) During the course of interferon (standard and pegylated)/ribavirin combination therapy lasting up to 48 weeks in patients ages 3 through 17 years, weight loss and growth inhibition were common (see sections 4.8 and 5.1).
Croatian: Djeca i adolescenti: rast i razvoj (kronični hepatitis C) Za vrijeme liječenja kombiniranom terapijom interferonom (standardnim i pegiliranim) i ribavirinom u trajanju do 48 tjedana u bolesnika u dobi od 3 do 17 godina čest je bio gubitak tjelesne težine i zastoj u rastu (vidjeti dijelove 4.8 i 5.1).
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rarely (≥1/10,000 to <1/1,000); very rarely (<1/10,000); not known.
Croatian: Nuspojave su razvrstane prema organskim sustavima i učestalosti pojavljivanja definiranoj 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), nepoznato.
English: Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface.
Croatian: Interferoni u stanicama djeluju na način da se vežu za specifične membranske receptore na površini stanice.