FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients were followed for an additional 6 months after the end of treatment for the determination of sustained virologic response.
Croatian: Svi su bolesnici bili praćeni još 6 mjeseci nakon završetka liječenja kako bi se utvrdio trajan virološki odgovor.
English: Your doctor will monitor you for signs and symptoms of these conditions (Please be sure to read the ribavirin Patient Leaflet also).
Croatian: Liječnik će Vas nadzirati kako bi uočio moguće znakove i simptome navedenih stanja (svakako pročitajte i uputu o lijeku za ribavirin).
English: Preparation of IntronA for intravenous infusion: The infusion is to be prepared immediately prior to use.
Croatian: Priprema lijeka IntronA za intravensku infuziju: Infuzija se mora pripremiti neposredno prije primjene.
English: No studies have been conducted in juvenile animals to examine the effects of treatment with interferon alfa-2b on growth, development, sexual maturation, and behaviour.
Croatian: Nisu provedena istraživanja na mladim životinjama kojima bi se utvrdili učinci liječenja interferonom alfa-2b na rast, razvoj, spolno sazrijevanje i ponašanje.
English: IntronA increases the risk of liver decompensation and death in patients with cirrhosis.
Croatian: IntronA povećava rizik od dekompenzacije jetre i smrti u bolesnika s cirozom.
English: Cmax occurred three to 12 hours after the lower dose and six to eight hours after the higher dose.
Croatian: Cmax je postignut 3 do 12 sati nakon primjene niže doze, odnosno 6 do 8 sati nakon primjene više doze.
English: One dose of IntronA is given on each scheduled day.
Croatian: Primjenjuje se jedna doza lijeka IntronA na dan određen rasporedom.
English: Relapse patients (adults)
Croatian: Bolesnici s relapsom (odrasli)
English: Moreover children treated with interferon alfa-2b experienced a reduced rate of growth and some cases of depression were observed.
Croatian: Štoviše, djeca liječena interferonom alfa-2b imala su usporen rast, a opaženo je i nekoliko slučajeva depresije.
English: - if you have poor kidney or liver function.
Croatian: - ako imate slabu funkciju bubrega ili jetre.
English: Women of childbearing potential/contraception in males and females Women of childbearing potential have to use effective contraception during treatment.
Croatian: Žene generativne dobi/kontracepcija u muškaraca i žena Žene generativne dobi moraju koristiti učinkovitu kontracepciju za vrijeme liječenja.
English: The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Croatian: Rezultati nekoliko istraživanja ukazuju da, nakon što se veže za staničnu membranu, interferon pokreće složeni slijed događaja unutar stanice koji uključuju i indukciju određenih enzima.
English: What you need to know before you use IntronA
Croatian: Što morate znati prije nego počnete primjenjivati IntronA
English: The response to treatment in both of these trials is presented in Table 4.
Croatian: Terapijski odgovor u oba ispitivanja prikazan je u Tablici 4.
English: Children and adolescents: - if you have had serious nervous or mental problems, such as severe depression or thoughts of suicide.
Croatian: Djeca i adolescenti: - ako ste imali teške neurološke ili psihičke tegobe, poput teške depresije ili razmišljanja o samoubojstvu.
English: Some people get depressed when taking IntronA alone or in combination treatment with ribavirin, and in some cases people had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others).
Croatian: Neki bolesnici postanu depresivni kada primaju IntronA sam ili u kombiniranoj terapiji s ribavirinom, a u nekim slučajevima su razmišljali o ugrožavanju života drugih ljudi, o samoubojstvu ili su iskazivali agresivno ponašanje (ponekad usmjereno protiv drugih).
English: Contact your doctor or pharmacist if needed.
Croatian: Po potrebi se javite svom liječniku ili ljekarniku.
English: Interferon alfa-2b (6 MIU/m2 3 times a week for 6 months) has been given to children with chronic active hepatitis B. Because of a methodological flaw, efficacy could not be demonstrated.
Croatian: Interferon alfa-2b (6 milijuna IU/m2 triput na tjedan tijekom 6 mjeseci) se davao djeci s kroničnim aktivnim hepatitisom B. Zbog metodološkog se propusta nije mogla dokazati djelotvornost.
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of IntronA therapy.
Croatian: Srčane aritmije (prvenstveno supraventrikularne) obično dobro reagiraju na konvencionalnu terapiju, ali mogu zahtijevati obustavu liječenja lijekom IntronA.
English: After first opening the container: Chemical and physical in-use stability has been demonstrated for 28 days at 2ºC - 8ºC.
Croatian: Nakon prvog otvaranja spremnika: Dokazana kemijska i fizikalna stabilnost u primjeni je 28 dana na temperaturi od 2°C - 8°C.
English: If you use more IntronA than you should Contact your doctor or healthcare professional as soon as possible.
Croatian: Ako primijenite više lijeka IntronA nego što ste trebali Što prije se javite svom liječniku ili drugom zdravstvenom radniku.
English: These may signal serious side effects that may need urgent medical attention.
Croatian: Ovi simptomi mogu upućivati na ozbiljne nuspojave zbog kojih biste mogli zatrebati hitnu medicinsku pomoć.
English: (See ribavirin capsules SPC for dose of ribavirin capsules and dose modification guidelines for combination therapy.
Croatian: (Pročitajte Sažetak opisa svojstava lijeka ribavirin kapsule za dozu ribavirin kapsula i smjernice za prilagodbu doze u kombiniranoj terapiji.
English: The Kaplan-Meier estimate for continued sustained response over 5 years for all patients is 97 % with a 95 % Confidence Interval of [95 %, 99 %].
Croatian: Kaplan-Meierova procjena održivosti trajnog virološkog odgovora tijekom 5 godina za sve bolesnike iznosi 97%, uz 95%-tni interval pouzdanosti [95%, 99%].
English: Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.
Croatian: Dodavanje interferona alfa, samih ili u kombinaciji s ribavirinom, može povećati rizik u ovoj podskupini bolesnika.
English: A major cytogenetic response is defined by < 34 % Ph+ leukaemic cells in the bone marrow, whereas a minor response is  34 %, but < 90 % Ph+ cells in the marrow.
Croatian: Jaki citogenetski odgovor definiran je kao < 34% Ph+ leukemičnih stanica u koštanoj srži, dok je slabiji odgovor definiran kao ≥ 34%, ali < 90% Ph+ stanica u koštanoj srži.
English: Effect on fertility Interferon may impair fertility (see section 4.6 and section 5.3).
Croatian: Učinak na plodnost Interferon može umanjiti plodnost (vidjeti dijelove 4.6 i 5.3).
English: In studies of interferon use in non-human primates, abnormalities of the menstrual cycle have been observed (see section 4.4).
Croatian: U istraživanjima uporabe interferona u nečovjekolikih primata opaženi su poremećaji menstrualnog ciklusa (vidjeti dio 4.4).
English: Do not touch the tip of the syringe.
Croatian: Nemojte dodirivati vrh štrcaljke.
English: IntronA will add to the effects of substances that slow down your nervous system, possibly causing drowsiness.
Croatian: IntronA pojačat će učinke tvari koje usporavaju rad živčanog sustava što može izazvati omamljenost.
English: Volume to be withdrawn according to the dose:
Croatian: Volumen koji treba izvući za pojedinu dozu:
English: Do not use IntronA - if you are allergic to interferon or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati IntronA - ako ste alergični na interferon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako imate tešku bolest srca.
English: The detectable titres are low in almost all cases and have not been regularly associated with loss of response or any other autoimmune phenomenon.
Croatian: Mjerljivi titar protutijela je nizak u gotovo svim slučajevima i u pravilu nije povezan s gubitkom odgovora na terapiju ili nekom drugom autoimunom pojavom.
English: IntronA (interferon alfa-2b) modifies the response of the body's immune system to help fight infections and severe diseases.
Croatian: IntronA (interferon alfa-2b) mijenja odgovor imunološkog sustava tijela i tako pomaže u borbi protiv infekcija i teških bolesti.
English: If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Croatian: Ako Vaša partnerica nije trudna, ali je u generativnoj dobi, mora obavljati test na trudnoću svakog mjeseca za vrijeme Vašeg liječenja te još 7 mjeseci nakon prestanka liječenja.
English: For most patients with hairy cell leukaemia, normalisation of one or more haematological variables occurs within one to two months of IntronA treatment.
Croatian: U većine bolesnika s leukemijom vlasastih stanica dolazi do normalizacije jedne ili više hematoloških varijabli unutar jednog do dva mjeseca liječenja lijekom IntronA.
English: If the product is not used during the seven-day period, it cannot be put back in the refrigerator for a new storage period and must be discarded.
Croatian: Ako se lijek ne upotrijebi tijekom tog sedmodnevnog razdoblja, ne smije se vratiti u hladnjak na ponovno čuvanje i mora se baciti.
English: Skin laceration
Croatian: laceracije kože
English: For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC.)
Croatian: Za pedijatrijske bolesnike tjelesne težine < 47 kg ili bolesnike koji ne mogu progutati kapsule, vidjeti Sažetak opisa svojstava lijeka ribavirin oralna otopina).
English: Tmax (hr) Cmax (ng/mL) AUC* Apparent clearance L/hr/kg
Croatian: Tmax (h) Cmax (ng/ml) AUC* Prividan klirens l/h/kg
English: - Chronic hepatitis with decompensated cirrhosis of the liver.
Croatian: - Kronični hepatitis s dekompenziranom cirozom jetre.
English: These very serious side effects are very rare.
Croatian: Ovakve vrlo ozbiljne nuspojave javljaju se vrlo rijetko.
English: Recombinant interferon alfa-2b has exhibited antiproliferative effects in studies employing both animal and human cell culture systems as well as human tumour xenografts in animals.
Croatian: Rekombinantni interferon alfa-2b pokazao je antiproliferativne učinke u istraživanjima u kojima su se koristile i životinjske i ljudske stanične kulture kao i presatci ljudskih tumora u životinja.
English: 3 or alanine aminotransferase/aspartate aminotransferase (ALT/AST) rises to > 5 x upper limit of normal, discontinue treatment temporarily until the adverse event abates.
Croatian: 3 ili se vrijednosti alanin aminotransferaze/aspartat aminotransferaze (ALT/AST) povise na > 5 x iznad gornje granice normale, treba privremeno prekinuti liječenje dok se nuspojava ne povuče.
English: Injections of human recombinant interferon alfa-2b for up to three months have shown no evidence of toxicity in mice, rats, and rabbits.
Croatian: Injekcije humanog rekombinantnog interferona alfa-2b tijekom najviše tri mjeseca nisu pokazale toksičnost u miševa, štakora i zečeva.
English: Tell your doctor if you are taking theophylline or aminophylline for asthma, and about all other medicines you are taking, or have taken recently, even those not prescribed, as the dose of some medicines may have to be adjusted while you are treated with IntronA.
Croatian: Obavijestite svog liječnika ako uzimate teofilin ili aminofilin za liječenje astme, ali i o svim drugim lijekovima koje uzimate ili ste nedavno uzimali, pa i onima koji se izdaju bez recepta jer će se doze pojedinih lijekova možda morati prilagoditi dok primate IntronA.
English: Before initiating treatment with IntronA, consideration should be given to the results from clinical trials comparing IntronA with pegylated interferon (see section 5.1).
Croatian: Prije početka liječenja lijekom IntronA treba uzeti u obzir rezultate kliničkih ispitivanja u kojima je IntronA uspoređen s pegiliranim interferonom (vidjeti dio 5.1).
English: Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96 %).
Croatian: Bolesnici koji nisu postigli virološki odgovor u 12. tjednu terapije najvjerojatnije neće postići trajan virološki odgovor (negativna prediktivna vrijednost 96%).
English: For user convenience, the needle protection device can be rotated for ease of injection (Diagram B).
Croatian: Radi praktičnijeg korištenja, uređaj za zaštitu igle može se okretati kako bi se olakšala primjena injekcije (Dijagram B).
English: Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of IntronA in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
Croatian: S obzirom da je prijavljeno da interferon alfa uzrokuje pogoršanje postojeće psorijaze i sarkoidoze, primjena lijeka IntronA u bolesnika s psorijazom ili sarkoidozom preporučuje se samo ako očekivana korist opravdava mogući rizik.
English: This action inhibits viral replication or if replication occurs, the progeny virions are unable to leave the cell.
Croatian: Takvo djelovanje inhibira replikaciju virusa ili, ako do replikacije dođe, sprečava novonastale virione da napuste stanicu.
English: Examine the solution prior to administration: it should be clear and colourless.
Croatian: Prije primjene pregledajte otopinu: mora biti bistra i bezbojna.
English: - if you have a history of autoimmune disease, or have had an organ transplant and are taking medicine that suppresses your immune system (your immune system helps protect you from infection).
Croatian: - ako ste imali napadaje (konvulzije). - ako ste imali neku autoimunu bolest ili ste primatelj presatka organa i uzimate lijekove koji potiskuju aktivnost imunološkog sustava (imunološki sustav Vam pomaže u zaštiti od infekcija).
English: Rarely reported side effects: pneumonia.
Croatian: Rijetko prijavljene nuspojave: upala pluća.
English: After intravenous administration, serum interferon levels peaked (135 to 273 IU/mL) by the end of the infusion, then declined at a slightly more rapid rate than after subcutaneous or intramuscular administration of medicinal product, becoming undetectable four hours after the infusion.
Croatian: Nakon intravenske primjene, razina interferona u serumu dostigla je vršne vrijednosti (135 do 273 IU/ml) do kraja infuzije, a zatim počela opadati nešto većom brzinom nego nakon supkutane ili intramuskularne primjene lijeka, da bi postala nemjerljiva 4 sata nakon infuzije.
English: Treatment should be continued in patients who exhibit negative HCV-RNA.
Croatian: Liječenje treba nastaviti u bolesnika u kojih je nalaz HCV-RNK negativan.
English: Discontinuation of IntronA therapy has not reversed thyroid dysfunction occurring during treatment (also see Thyroid supplemental monitoring specific for children and adolescents).
Croatian: Prekidom primjene lijeka IntronA nije se popravila funkcija štitne žljezde poremećena tijekom liječenja (vidjeti i Dodatno praćenje rada štitnjače specifično za djecu i adolescente).
English: Toxicity was demonstrated in monkeys given 100 x 10
Croatian: Toksičnost je utvrđena u majmuna koji su primali dozu od 100 x 10
English: §, pneumonitis Pulmonary fibrosis, pulmonary arterial hypertension
Croatian: §, pneumonitis plućna fibroza, plućna arterijska hipertenzija
English: Improvement in all three haematological variables (granulocyte count, platelet count and haemoglobin level) may require six months or more.
Croatian: Za poboljšanje svih triju hematoloških varijabla (broj granulocita, broj trombocita i razina hemoglobina) može biti potrebno 6 mjeseci ili dulje.
English: During the one year of treatment with IntronA in combination with ribavirin, some children and adolescents did not grow or gain weight as much as expected.
Croatian: Za vrijeme liječenja lijekom IntronA u kombinaciji s ribavirinom u trajanju do godine dana neka djeca i adolescenti nisu narasli niti dobili na težini koliko se očekivalo.
English: The aetiology has not been defined.
Croatian: Etiologija tih promjena nije utvrđena.
English: Any size vial may be used to measure the required dose; however, final concentration of interferon in sodium chloride solution must be not less than 0.3 million IU/mL.
Croatian: Za odmjeravanje potrebne doze može se koristiti bočica bilo koje veličine, međutim, konačna koncentracija interferona u otopini natrijeva klorida ne smije biti manja od 0,3 milijuna IU/ml.
English: International Units are determined by comparison of the activity of the recombinant interferon alfa-2b with the activity of the international reference preparation of human leukocyte interferon established by the World Health Organisation.
Croatian: Internacionalne jedinice određuju se usporedbom aktivnosti rekombinantnog interferona alfa-2b s aktivnošću internacionalnog referentnog pripravka humanog leukocitnog interferona koji je odredila Svjetska zdravstvena organizacija.
English: Do not use this medicine after the expiry date which is stated on the package.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju.
English: If this is a multidose vial, you will only have to remove the cap when preparing the first dose.
Croatian: Ako imate višedoznu bočicu, zatvarač ćete morati skinuti samo kad budete pripremali prvu dozu.
English: This must be considered during concomitant therapy with medicinal products metabolised by this route, such as the xanthine derivatives theophylline or aminophylline.
Croatian: To se mora uzeti u obzir tijekom istodobne primjene lijekova koji se metaboliziraju tim putem, poput ksantinskih derivata, teofilina ili aminofilina.
English: The mean serum interferon concentrations following subcutaneous and intramuscular injections were comparable.
Croatian: Srednje koncentracije interferona u serumu nakon supkutane i intramuskularne injekcije bile su slične.
English: A clinical trial investigating the combination of telbivudine, 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration, indicates that this combination is associated with an increased risk of developing peripheral neuropathy.
Croatian: Kliničko ispitivanje u kojemu se ispitivala kombinacija telbivudina u dozi od 600 mg na dan s pegiliranim interferonom alfa-2a primijenjenim supkutano u dozi od 180 mikrograma jedanput na tjedan, pokazuje da je ova kombinacija povezana s povećanim rizikom za razvoj periferne neuropatije.
English: If you take telbivudine with a pegylated interferon alfa-2a or any type of injectable interferon product, your risk of developing peripheral neuropathy (numbness, tingling and/or burning sensations in the arms and/or legs) is higher.
Croatian: Ako uzimate telbivudin s pegiliranim interferonom alfa-2a ili bilo kojim inteferonom koji se primjenjuje injekcijom, imate povećan rizik za razvoj periferne neuropatije (utrnulost, trnci i/ili osjeti žarenja u rukama i/ili nogama).
English: If severe adverse events develop during interferon alfa-2b treatment, particularly if granulocytes decrease to < 500/mm
Croatian: Ako se tijekom liječenja interferonom alfa-2b razviju teške nuspojave, osobito ako broj granulocita padne na < 500/mm
English: IntronA solution for injection or infusion may be injected directly after withdrawal of the appropriate doses from the vial with a sterile injection syringe.
Croatian: IntronA otopina za injekciju ili infuziju može se injicirati odmah nakon izvlačenja odgovarajuće doze iz bočice pomoću sterilne injekcijske štrcaljke.
English: IntronA is also used in adult patients for the treatment of chronic hepatitis B or C, which are viral infections of the liver.
Croatian: IntronA se u odraslih bolesnika koristi i za liječenje kroničnog hepatitisa B ili C, što su virusne infekcije jetre.
English: Interferons may cause unusual tiredness; if you are injecting this medicine yourself, or giving it to a child, use it at bedtime.
Croatian: Interferoni mogu izazvati neuobičajen umor pa ako si ovaj lijek injicirate sami ili ga dajete djetetu, učinite to prije odlaska na spavanje.
English: The Kaplan-Meier estimate for continued sustained response over 5 years is 98 % [95 % CI: 95 %, 100 %] for paediatric patients treated with interferon alfa-2b and ribavirin.
Croatian: KaplanMeierova procjena održivosti trajnog virološkog odgovora tijekom 5 godina iznosi 98% [95% CI: 95%, 100%] za pedijatrijske bolesnike liječene interferonom alfa-2b i ribavirinom.
English: Regardless of genotype, patients who received IntronA in combination with ribavirin and received  80 % of their treatment had a higher sustained response 6 months after 1 year of treatment than those who took < 80 % of their treatment (56 % vs. 32 % in trial C/I98-580).
Croatian: Bez obzira na genotip virusa, bolesnici koji su primali IntronA u kombinaciji s ribavirinom koji su primili ≥ 80% propisane terapije imali su veću stopu trajnog odgovora 6 mjeseci nakon jednogodišnjeg liječenja od kojih koji su primili < 80% propisane terapije (56% u odnosu na 32% bolesnika u ispitivanju C/I98-580).
English: Within the 5 years follow-up post-treatment period, the children had a mean height of th percentile, which was below the median of the normative population and less than their mean baseline height (48
Croatian: Tijekom petogodišnjeg praćenja nakon završetka liječenja djeca su imala prosječnu visinu na 44. percentilu, što je bilo niže od medijana vrijednosti normativne populacije i manje od prosjeka njihove visine na početku praćenja (48. percentil).
English: During ALT flare, the following liver function tests must be monitored at two-week intervals: ALT, prothrombin time, alkaline phosphatase, albumin and bilirubin.
Croatian: Dok je ALT povišen, sljedeći se pokazatelji jetrene funkcije moraju pratiti svaka dva tjedna: ALT, protrombinsko vrijeme, alkalna fosfataza, albumin i bilirubin.
English: Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour.
Croatian: Obavezno zatražite hitnu liječničku pomoć ako primijetite da postajete depresivni, razmišljate o samoubojstvu ili primijetite promjene u svom ponašanju.
English: Pure red cell aplasia, a condition where the body stopped or reduced the production of red blood cells, has been reported.
Croatian: Prijavljeni su slučajevi izolirane aplazije crvene loze, stanja u kojem tijelo prestaje stvarati ili smanjeno stvara crvene krvne stanice.
English: Patients with existence of, or history of severe psychiatric conditions:
Croatian: Bolesnici s postojećim ili u anamnezi zabilježenim teškim psihijatrijskim poremećajima:
English: This regimen must be maintained unless the disease progresses rapidly or severe intolerance is manifested.
Croatian: Ovaj se režim liječenja mora održati, osim u slučaju nagle progresije bolesti ili jakih znakova nepodnošenja lijeka.
English: Recombinant interferon alfa-2b is a water-soluble protein with a molecular weight of approximately 19,300 daltons.
Croatian: Rekombinantni interferon alfa-2b je protein topiv u vodi, molekularne težine od oko 19 300 daltona.
English: Current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated.
Croatian: Dosadašnje kliničko iskustvo pokazuje da terapija održavanja interferonom alfa-2b produljuje fazu platoa, međutim učinci na ukupno preživljenje još nisu konačno dokazani.
English: 462 patients completed at least 5 years of long-term follow-up and only 12 sustained responders' out of 492 relapsed during this study.
Croatian: Najmanje 5 godina dugotrajnog praćenja završila su 462 bolesnika, a samo je 12 od 492 bolesnika s trajnim virološkim odgovorom doživjelo relaps tijekom ovog ispitivanja.
English: Possible side effects listed below are grouped by frequency of occurrence: Very common (affects more than 1 user in 10) Common
Croatian: Moguće nuspojave navedene u nastavku razvrstane su prema učestalosti pojavljivanja: Vrlo često (javljaju se u više od 1 na 10 korisnika) Često