FrancophonIA/ELRC3.0 huggingface dataset:
English: Any patient complaining of changes in visual acuity or visual fields, or reporting other ophthalmologic symptoms during treatment with IntronA, must have a prompt and complete eye examination.
Croatian: Svakom bolesniku koji se žali na promjene oštrine vida ili vidnog polja ili druge oftalmološke simptome tijekom liječenja lijekom IntronA mora se odmah učiniti temeljit oftalmološki pregled.
English: Superior efficacy has been demonstrated with the combination of pegylated interferon with ribavirin (sustained response rate of 61 % achieved in a study performed in naïve patients with a ribavirin dose > 10.6 mg/kg, p < 0.01).
Croatian: Bolju djelotvornost pokazala je kombinacija pegiliranog interferona i ribavirina (postignuta je stopa trajnog terapijskog odgovora od 61% u ispitivanju bolesnika koji prethodno nisu bili liječeni, uz ribavirin u dozi od > 10,6 mg/kg, p < 0,01).
English: if you have received an organ transplant, either kidney or liver, interferon treatment may increase the risk of rejection.
Croatian: - ako ste primili presadak organa, bilo bubrega ili jetre, liječenje interferonom može povećati rizik odbacivanja presatka.
English: Case by case benefit/risk assessment in children The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials (see sections 4.8 and 5.1).
Croatian: Očekivanu korist od liječenja treba pažljivo odvagnuti u odnosu na nalaze o sigurnosti primjene u djece i adolescenata zabilježene u kliničkim ispitivanjima (vidjeti dijelove 4.8 i 5.1).
English: Your doctor may prescribe a different dose of IntronA alone or in combination with other medicines (e.g., cytarabine, ribavirin).
Croatian: Liječnik Vam može propisati drugačiju dozu lijeka IntronA, bilo da ga uzimate samog ili u kombinaciji s drugim lijekovima (npr. citarabinom ili ribavirinom).
English: - A history of severe pre-existing cardiac disease, e.g., uncontrolled congestive heart failure, recent myocardial infarction, severe arrhythmic disorders.
Croatian: - Teška srčana bolest u anamnezi, primjerice nekontrolirano kongestivno zatajenje srca, nedavni infarkt miokarda, teške aritmije.
English: Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders, who require IntronA therapy, must be closely monitored.
Croatian: Odrasle bolesnike s anamnezom kongestivnog zatajenja srca, infarkta miokarda i/ili prethodnih ili postojećih poremećaja srčanog ritma kojima je potrebno liječenje lijekom IntronA mora se pomno nadzirati.
English: When IntronA is used with hydroxyurea, the frequency and severity of cutaneous vasculitis may be increased.
Croatian: Kada se IntronA primjenjuje s hidroksiurejom, može se povećati učestalost i težina kožnog vaskulitisa.
English: During concomitant therapy with xanthine agents, serum theophylline levels must be monitored and dose adjusted if necessary.
Croatian: Tijekom istodobne terapije ksantinskim lijekovima mora se pratiti razina teofilina u serumu i po potrebi prilagoditi doza lijeka.
English: Hypertension Peripheral ischaemia, hypotension
Croatian: hipertenzija periferna ishemija, hipotenzija
English: During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV-RNA below lower limit of detection) did not become sustained virologic responders (HCVRNA below lower limit of detection six months after withdrawal of treatment).
Croatian: Bolesnici koji u kliničkim ispitivanjima nisu pokazali virološki odgovor (HCV-RNK ispod donje granice mjerljivosti) nakon 6 mjeseci liječenja, nisu razvili trajan virološki odgovor (HCV-RNK ispod donje granice mjerljivosti 6 mjeseci nakon prestanka liječenja).
English: - if you are being treated with telbivudine (see section "Other medicines and IntronA").
Croatian: - ako se liječite telbivudinom (vidjeti dio "Drugi lijekovi i IntronA").
English: The purpose of the study was to annually evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes for patients who were sustained responders 24 weeks post-treatment of the 48-week interferon alfa-2b and ribavirin treatment.
Croatian: Svrha ispitivanja bila je godišnja procjena postojanosti trajnog virološkog odgovora i utjecaja kontinuiranog negativnog nalaza virusa na klinički ishod bolesti u bolesnika koji su pokazali trajan odgovor 24 tjedna nakon 48-tjednog liječenja interferonom alfa-2b i ribavirinom.
English: All patients in the chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i.e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Croatian: Svim bolesnicima uključenima u klinička ispitivanja kroničnog hepatitisa C učinjena je biopsija jetre prije uključenja, no u nekim je slučajevima (tj. u bolesnika s genotipom 2 i 3) moguće započeti liječenje bez histološke potvrde bolesti.
English: Tell your doctor if you have ever been treated for depression or any other psychiatric disorder; confusion; unconsciousness; thoughts of suicide or attempted suicide, or have a history of substance abuse (e.g., alcohol or drugs).
Croatian: Obavijestite svog liječnika ako ste ikada liječeni zbog depresije ili neke druge psihijatrijske bolesti, smetenosti, nesvjestice, razmišljanja o samoubojstvu ili pokušaja samoubojstva ili ako ste u prošlosti zlorabili sredstva ovisnosti (npr. alkohol ili droge).
English: Relapse patients
Croatian: Bolesnici s relapsom
English: The undesirable effects seen with hepatitis C are representative of those reported when IntronA is administered in other indications, with some anticipated dose-related increases in incidence.
Croatian: Nuspojave opažene tijekom liječenja hepatitisa C odgovaraju onima koje su prijavljene pri primjeni lijeka IntronA u drugim indikacijama, uz očekivano povećanje incidencije vezano uz dozu.
English: Caution must be observed also in patients with coagulation disorders (e.g., thrombophlebitis, pulmonary embolism) or severe myelosuppression.
Croatian: Potreban je oprez i u bolesnika s poremećajima koagulacije (npr. tromboflebitisom ili plućnom embolijom) ili teškom mijelosupresijom.
English: As adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e.g., patients with primary or recurrent (clinical or pathological) lymph node involvement.
Croatian: Kao adjuvantna terapija u bolesnika u kojih je tumor kirurški odstranjen, ali u kojih postoji velik rizik od ponovne sistemske pojave bolesti, npr. u bolesnika s primarnom ili rekurentnom (kliničkom ili patološkom) zahvaćenošću limfnih čvorova.
English: In these patients, the addition of ribavirin to IntronA increased by as much as 10-fold the efficacy of IntronA used alone in the treatment of chronic hepatitis C (48.6 % vs. 4.7 %).
Croatian: U tih je bolesnika dodavanje ribavirina lijeku IntronA povećalo djelotvornost lijeka IntronA čak 10 puta u odnosu na monoterapiju u liječenju kroničnog hepatitisa C (48,6% u odnosu na 4,7%).
English: If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing up, until the bubbles disappear.
Croatian: Ako vidite mjehuriće, malo povucite klip; nježno lupkajte po štrcaljki držeći je iglom usmjerenom prema gore dok mjehurići ne nestanu.
English: Treatment of adult patients with Philadelphia chromosome or bcr/abl translocation positive chronic myelogenous leukaemia.
Croatian: Liječenje odraslih bolesnika s Philadelphia kromosomom ili kroničnom mijeloičnom leukemijom s pozitivnim nalazom bcr/abl translokacije.
English: Activate Safety Mechanism of the syringe after removal from the injection site by moving the pushrod completely forward until the pushrod is fully extended and the needle tip is covered (Diagram D).
Croatian: Nakon što štrcaljku izvadite iz mjesta injiciranja, aktivirajte sigurnosni mehanizam tako što ćete klizni zatvarač gurati naprijed sve dok se potpuno ne izravna i prekrije vrh igle (Dijagram D).
English: When the white blood cell count is controlled, administer the maximum tolerated dose of IntronA (4 to 5 million IU/m daily) to maintain haematological remission.
Croatian: Kada je broj bijelih krvnih stanica pod kontrolom, treba primijeniti najveću podnošljivu dozu lijeka IntronA (4 do 5 milijuna IU/m2 na dan) kako bi se održala hematološka remisija.
English: Patients are to be advised that they may develop fatigue, somnolence, or confusion during treatment with IntronA, and therefore it is recommended that they avoid driving or operating machinery.
Croatian: Bolesnike treba upozoriti da za vrijeme liječenja lijekom IntronA mogu osjetiti umor, somnolenciju ili konfuziju te im se stoga preporučuje izbjegavanje upravljanja motornim vozilima ili rukovanje strojevima.
English: Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
Croatian: Preliminarni podaci ukazuju da terapija interferonom alfa može biti povezana s većom stopom odbacivanja presatka bubrega.
English: §, asthenia,
Croatian: §, malaksalost,
English: Your doctor has determined the exact dosage for administration of IntronA according to your individual needs.
Croatian: Liječnik je odredio točnu dozu lijeka IntronA koju trebate primati prema Vašim osobnim potrebama.
English: In patients treated for malignant melanoma, liver function and white blood cell (WBC) count and differential must be monitored weekly during the induction phase of therapy and monthly during the maintenance phase of therapy.
Croatian: U bolesnika koji se liječe od malignog melanoma jetrena funkcija, broj leukocita i diferencijalna krvna slika moraju se pratiti svaki tjedan tijekom uvodne faze liječenja i jednom mjesečno tijekom faze održavanja.
English: For short term travelling, the solution can be kept out of the refrigerator at or below 25°C for a period up to seven days before use.
Croatian: Kod kratkotrajnog transporta, otopina se prije primjene može čuvati izvan hladnjaka na temperaturi od ili ispod 25°C najdulje 7 dana.
English: During combination therapy for up to 48 weeks with IntronA and ribavirin, growth inhibition was observed that resulted in reduced final adult height in some patients.
Croatian: Za vrijeme kombinirane terapije lijekom IntronA i ribavirinom u trajanju do 48 tjedana primijećen je zastoj u rastu koji je u nekih bolesnika rezultirao smanjenom konačnom visinom u odrasloj dobi.
English: Interferon alfa-2b has been shown to have abortifacient effects in Macaca mulatta (rhesus monkeys) at 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/m2.
Croatian: Pokazalo se da interferon alfa-2b ima abortivno djelovanje u Macaca mulatta (rezus majmuna) u dozi 90 odnosno 180 puta većoj od doze preporučene za intramuskularnu odnosno supkutanu primjenu od 2 milijuna IU/m2.
English: Multiple-dose pharmacokinetic properties for IntronA injection and ribavirin capsules in children and adolescents with chronic hepatitis C, between 5 and 16 years of age, are summarized in Table 7.
Croatian: Farmakokinetička svojstva nakon višestrukih doza IntronA injekcija i ribavirin kapsula u djece i adolescenata s kroničnim hepatitisom C, u dobi između 5 i 16 godina, sažeta su u Tablici 7.
English: IntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for hepatitis C virus RNA (HCV-RNA) (see section 4.4).
Croatian: IntronA je indiciran za liječenje odraslih bolesnika s kroničnim hepatitisom C koji imaju povišene vrijednosti transaminaza bez dekompenzacije jetre i pozitivan nalaz RNK virusa hepatitisa C (HCV-RNK) (vidjeti dio 4.4).
English: Take the needle and place it firmly onto the tip of the syringe.
Croatian: Uzmite iglu i čvrsto je nataknite na vrh štrcaljke.
English: Clinically significant laboratory abnormalities, most frequently occurring at doses greater than 10 million IU daily, include reduction in granulocyte and white blood cell counts; decreases in haemoglobin level and platelet count; increases in alkaline phosphatase, LDH, serum creatinine and serum urea nitrogen levels.
Croatian: Klinički značajna odstupanja laboratorijskih nalaza, najčešće pri dozama većim od 10 milijuna IU na dan, uključuju smanjenje broja granulocita i leukocita; sniženje razine hemoglobina i broja trombocita; povećanje razine alkalne fosfataze, LDH-a, serumskog kreatinina i ureje u serumu.
English: Your doctor may recommend that you take paracetamol if you develop these symptoms.
Croatian: U slučaju pojave tih simptoma, liječnik Vam može preporučiti da uzimate paracetamol.
English: The combination of interferon alfa-2b and cytarabine (Ara-C) administered during the first 12 months of treatment has been demonstrated to significantly increase the rate of major cytogenetic responses and to significantly prolong the overall survival at three years when compared to interferon alfa-2b monotherapy.
Croatian: Pokazalo se da kombinacija interferona alfa-2b i citarabina (Ara-C) primijenjena tijekom prvih 12 mjeseci liječenja značajno povećava stopu jakog citogenetskog odgovora i značajno produljuje ukupno trogodišnje preživljenje u odnosu na monoterapiju interferonom alfa-2b.
English: It is obtained from a clone of E. coli, which harbours a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes.
Croatian: Dobiva se iz klona E. coli koji nosi genetičkim inženjeringom stvoren hibridni plazmid s genom za interferon alfa-2b iz ljudskih leukocita.
English: Mutagenicity studies with interferon alfa-2b revealed no adverse events.
Croatian: Istraživanja mutagenosti interferona alfa-2b nisu pokazala štetne učinke.
English: Therefore, the combination of IntronA with telbivudine is contraindicated (see section 4.3).
Croatian: Stoga je kontraindicirana kombinacija lijeka IntronA s telbivudinom (vidjeti dio 4.3).
English: Please make sure to select an appropriate dose form and strength.
Croatian: Treba paziti da se odabere odgovarajući farmaceutski oblik i doza.
English: Tell your doctor if you have ever had a heart attack or a heart problem; if you have a history of breathing irregularities or pneumonia, problems with blood clotting, liver condition, thyroid problems, diabetes, or high or low blood pressure.
Croatian: Obavijestite svog liječnika ako ste ikada imali srčani napad ili srčane tegobe, poteškoće s disanjem ili upalu pluća, probleme sa zgrušavanjem krvi, bolest jetre, tegobe sa štitnjačom, šećernu bolest te visoki ili niski krvni tlak.
English: As in adult patients, children and adolescents experienced other psychiatric adverse events (e.g., depression, emotional lability, and somnolence).
Croatian: Kao i odrasli bolesnici, djeca i adolescenti su imali i druge psihijatrijske nuspojave (npr. depresiju, emocionalnu labilnost i somnolenciju).
English: At the beginning of treatment with IntronA, you may experience a flu-like reaction, with fever, fatigue, headache, muscle ache, joint pain and chills/rigors.
Croatian: U početku liječenja lijekom IntronA možete imati reakciju nalik gripi s vrućicom, umorom, glavoboljom, bolovima u mišićima i zglobovima te zimicom/tresavicom.
English: Any patient developing liver function abnormalities during treatment with IntronA must be monitored closely and treatment discontinued if signs and symptoms progress.
Croatian: Svakog bolesnika u kojeg dođe do poremećaja jetrene funkcije tijekom liječenja lijekom IntronA mora se pomno nadzirati, a liječenje se mora prekinuti u slučaju pogoršanja znakova i simptoma.
English: Administration of IntronA in combination with other chemotherapeutic agents (e.g., Ara-C, cyclophosphamide, doxorubicin, teniposide) may lead to increased risk of toxicity (severity and duration) (see section 4.4).
Croatian: Primjena lijeka IntronA u kombinaciji s drugim kemoterapeuticima (npr. Ara-C, ciklofosfamidom, doksorubicinom i tenipozidom) može dovesti do povećanog rizika toksičnih učinaka (težinu i trajanje) (vidjeti dio 4.4).
English: If adverse events develop during the course of treatment with IntronA for any indication, modify the dose or discontinue therapy temporarily until the adverse events abate.
Croatian: Ako se tijekom liječenja lijekom IntronA u bilo kojoj indikaciji razviju nuspojave, treba prilagoditi dozu ili privremeno prekinuti terapiju dok se nuspojave ne povuku.
English: Patients with substance use/abuse:
Croatian: Bolesnici koji uživaju/zlorabe sredstva ovisnosti:
English: Interferon neutralising factor assays were performed on serum samples of patients who received IntronA in Schering-Plough monitored clinical trials.
Croatian: Ispitivanja čimbenika koji neutraliziraju interferon provedena su na uzorcima seruma bolesnika koji su primali IntronA u kliničkim ispitivanjima pod nadzorom tvrtke Schering-Plough.
English: Study results are summarized in Table 5.
Croatian: Sažeti rezultati ispitivanja prikazani su u Tablici 5.
English: Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be reassessed (see also section 4.4 Chronic hepatitis C, Monotherapy (thyroid abnormalities) and section 4.8).
Croatian: Bolesnike sa znakovima ili simptomima koji odgovaraju autoimunim poremećajima treba pažljivo pregledati te ponovno procijeniti rizik i korist nastavka terapije interferonom (vidjeti i dio 4.4 Kronični hepatitis C, Monoterapija (poremećaji štitne žljezde) i dio 4.8).
English: Additionally, patients treated with IntronA and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia (low number of red blood cells).
Croatian: Nadalje, bolesnici koji se liječe lijekom IntronA i ribavirinom u kombinaciji sa zidovudinom mogu imati povećan rizik za razvoj anemije (smanjen broj crvenih krvnih stanica).
English: Long-term efficacy data
Croatian: Podaci o dugotrajnoj djelotvornosti
English: Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of DNA of hepatitis B virus (HBV-DNA) and hepatitis B antigen (HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis.
Croatian: Liječenje odraslih bolesnika s kroničnim hepatitisom B koji imaju dokazanu replikaciju virusa hepatitisa B (prisutnost DNK virusa hepatitisa B (HBV-DNK) i antigena hepatitisa B (HBeAg)), povišene vrijednosti alanin aminotransferaze (ALT) te histološki dokazanu aktivnu upalu i/ili fibrozu jetre.
English: Be sure the tip of needle is in the IntronA solution.
Croatian: Pazite da se vrh igle nalazi u IntronA otopini.
English: Because of the risk of increased toxicity, careful adjustments of doses are required for IntronA and for the concomitant chemotherapeutic agents (see section 4.5).
Croatian: S obzirom na rizik od povećane toksičnosti, doze lijeka IntronA i istodobno primijenjenih kemoterapeutika moraju se pažljivo prilagoditi (vidjeti dio 4.5).
English: Combination of IntronA with telbivudine.
Croatian: - Kombinirana primjena lijeka IntronA i telbivudina.
English: Remove the needle from the vial and check for air bubbles in the syringe.
Croatian: Izvadite iglu iz bočice i provjerite ima li u štrcaljki mjehurića zraka.
English: The pharmacokinetics of IntronA were studied in healthy volunteers following single 5 million IU/m and 10 million IU doses administered subcutaneously, at 5 million IU/m2 administered intramuscularly and as a 30-minute intravenous infusion.
Croatian: Farmakokinetika lijeka IntronA ispitivana je u zdravih dobrovoljaca nakon jedne supkutano primijenjene doze od 5 milijuna IU/m2 odnosno 10 milijuna IU, nakon intramuskularno primjenjene doze od 5 milijuna IU/m2 i nakon 30-minutne intravenske infuzije.
English: Therefore, the combination of IntronA with telbivudine is contraindicated.
Croatian: Stoga je kombinacija ovog lijeka i telbivudina kontraindicirana.
English: Included are hairy cell leukaemia, chronic myelogenous leukaemia, multiple myeloma, follicular lymphoma, carcinoid tumour, and malignant melanoma.
Croatian: Navedene bolesti uključuju leukemiju vlasastih stanica, kroničnu mijeloičnu leukemiju, multipli mijelom, folikularni limfom, karcinoid i maligni melanom.
English: Preclinical juvenile toxicity results have demonstrated a minor, dose-related decrease in overall growth in neonatal rats dosed with ribavirin (see section 5.3 of Rebetol SPC if IntronA is to be administered in combination with ribavirin).
Croatian: Rezultati pretkliničkih ispitivanja toksičnosti na mladunčadi pokazali su malo, o dozi ovisno smanjenje ukupnog rasta novorođenih štakora kojima se davao ribavirin (vidjeti dio 5.3 i Sažetak opisa svojstava lijeka za Rebetol, ako se IntronA daje u kombinaciji s ribavirinom).
English: Measuring the dose of IntronA
Croatian: Odmjeravanje doze lijeka IntronA
English: c: Patients with genotype 3 low viral load (< 600,000 IU/mL) were to receive 24 weeks of treatment while those with genotype 3 and high viral load (≥ 600,000 IU/mL) were to receive 48 weeks of treatment.
Croatian: c: Bolesnici s genotipom 3 i malim virusnim opterećenjem (< 600 000 IU/ml) liječeni su 24 tjedna, a bolesnici s genotipom 3 i velikim virusnim opterećenjem (≥ 600 000 IU/ml) 48 tjedana.
English: High tumour burden is defined as having at least one of the following: bulky tumour mass (> 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10 %, pyrexia > 38°C for more than 8 days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia.
Croatian: Veliko tumorsko opterećenje definira se kao postojanje najmanje jednog od sljedećih nalaza: velika tumorska masa (> 7 cm), zahvaćenost triju ili više limfnih čvorova (svaki > 3 cm), sustavni simptomi (gubitak tjelesne težine > 10%, pireksija > 38°C dulje od 8 dana ili noćno znojenje), splenomegalija koja prelazi granicu pupka, opstrukcija važnih organa ili kompresijski sindrom, zahvaćenost orbite ili epiduralnih struktura, serozni izljev ili leukemija.
English: Rarely:
Croatian: rijetko:
English: Anorexia Hypertriglyceridemia
Croatian: anoreksija hipertrigliceridemija
English: Severity was generally mild to moderate.
Croatian: Intenzitet nuspojava obično je bio blag do umjeren.
English: Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis Bacterial infection
Croatian: faringitis*, virusna infekcija* bronhitis, sinusitis, herpes simplex (rezistentni), rinitis bakterijska infekcija upala pluća
English: IntronA plus ribavirin
Croatian: IntronA s ribavirinom
English: Cardiomyopathy, that may be reversible upon discontinuation of interferon alpha, has been reported rarely in patients without prior evidence of cardiac disease (see section 4.4).
Croatian: Kardiomiopatija, koja se može povući nakon obustave interferona alfa, prijavljena je rijetko u bolesnika u kojih nije bilo utvrđeno postojanje srčane bolesti (vidjeti dio 4.4).
English: Treatment should be continued for another 6-month period (i.e., a total of 12 months) in patients who exhibit negative HCV-RNA at month 6, and with viral genotype 1 (as determined in a pre-treatment sample) and high pre-treatment viral load.
Croatian: Liječenje treba nastaviti još 6 mjeseci (tj. ukupno 12 mjeseci) u bolesnika koji imaju negativan nalaz HCV-RNK nakon 6 mjeseci terapije, zaraženi su virusom genotipa 1 (što je utvrđeno iz uzorka uzetog prije početka liječenja) i imali su veliko virusno opterećenje prije početka liječenja.