FrancophonIA/ELRC3.0 huggingface dataset:
English: Moreover, the safety and efficacy of telbivudine in combination with interferons for the treatment of chronic hepatitis B has not been demonstrated.
Croatian: Štoviše, nije dokazana sigurnost i djelotvornost telbivudina u kombinaciji s interferonima u liječenju kroničnog hepatitisa B.
English: 9/l (children and adolescents)
Croatian: 9/l (djeca i adolescenti)
English: If there is bleeding, cover with an adhesive bandage.
Croatian: Krvari li, prekrijte ga flasterom.
English: Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
Croatian: Rekombinantni interferon alfa-2b također inhibira virusnu replikaciju in vitro i in vivo.
English: • Take the pre-filled pen out of the refrigerator.
Croatian: • Izvadite napunjenu brizgalicu iz hladnjaka.
English: • Lay the pre-filled pen on a flat clean surface and wait until it reaches room temperature (but not more than 25
Croatian: • Položite napunjenu brizgalicu na ravnu, čistu površinu i pričekajte da dostigne sobnu temperaturu (ali ne iznad 25ºC).
English: If you have a medical condition making use of ribavirin dangerous or if you already have had a problem taking it, your doctor will likely prescribe this medicine alone.
Croatian: Ako je za Vaše zdravstveno stanje uzimanje ribavirina opasno, ili Vam je već izazvao tegobe kad ste ga uzimali, liječnik će Vam vjerojatno propisati samo ovaj lijek.
English: If your female partner is not pregnant 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 reproduktivnoj dobi, mora obavljati test na trudnoću svakog mjeseca za vrijeme Vašeg liječenja te još 7 mjeseci nakon prestanka liječenja.
English: Although not all of these side effects may occur, they may need medical attention if they do.
Croatian: Iako se ne moraju pojaviti sve navedene nuspojave, možda ćete trebati liječničku pomoć ako nastupe.
English: Patients predisposed to the development of autoimmune disorders may be at increased risk.
Croatian: Bolesnici s predispozicijom za razvoj autoimunih poremećaja mogu biti izloženi povećanom riziku.
English: Liver graft rejection has also been reported.
Croatian: Prijavljeno je i odbacivanje presatka jetre.
English: No studies have been conducted in juvenile animals to examine the effects of treatment with ViraferonPeg on growth, development, sexual maturation, and behaviour.
Croatian: Nisu provedena istraživanja na mladim životinjama kojima bi se utvrdili učinci liječenja lijekom ViraferonPeg na rast, razvoj, spolno sazrijevanje i ponašanje.
English: If you are injecting this medicine yourself, you will be instructed how to prepare and give the injection.
Croatian: Ako si sami dajete ovaj lijek, dobit ćete upute kako si pripremiti i dati injekciju.
English: If your eye disorder becomes more severe or if you develop new eye disorders, your treatment will be discontinued.
Croatian: Ako Vam se tegobe s očima pogoršaju ili se pojave nove bolesti očiju, liječenje će se prekinuti.
English: After withdrawal of the dose, any remaining solution must be discarded.
Croatian: Nakon izvlačenja doze, preostala otopina se mora zbrinuti.
English: The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Croatian: Pad broja CD4+ stanica bio je reverzibilan nakon smanjenja doze ili prestanka liječenja.
English: Note: The pre-filled pen will make a clicking sound for up to 10 seconds - depending on your dose.
Croatian: Napomena: Napunjena brizgalica će škljocati tijekom najviše 10 sekundi - ovisno o dozi.
English: • Wipe the injection site with a new alcohol swab.
Croatian: • Očistite mjesto za injiciranje novim tupferom s alkoholom.
English: With up to one year of treatment with this medicine in combination with ribavirin, some children and adolescents did not grow or gain weight as much as expected.
Croatian: Za vrijeme liječenja ovim lijekom u kombinaciji s ribavirinom u trajanju do godine dana, neka djeca i adolescenti nisu narasli niti dobili na težini koliko se očekivalo.
English: Hypertriglyceridemia and aggravation of hypertriglyceridemia, sometimes severe, have been observed.
Croatian: Opaženi su hipertrigliceridemija i pogoršanje hipertrigliceridemije, koje ponekad može biti teško.
English: For patients who exhibit virological response at week 12, treatment should be continued for at least another three-month period (i.e., a total of six months).
Croatian: U bolesnika koji su pokazali virološki odgovor u 12. tjednu, liječenje treba nastaviti još najmanje tri mjeseca (tj. ukupno šest mjeseci).
English: Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.
Croatian: Dodavanje alfa interferona, samih ili u kombinaciji s ribavirinom, može povećati rizik u ovoj podskupini bolesnika.
English: Your other hand will be free to move the plunger.
Croatian: Drugom ćete rukom moći pomicati klip.
English: Monitoring of lipid levels is, therefore, recommended.
Croatian: Stoga se preporučuje praćenje koncentracije lipida.
English: Once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Croatian: Nakon što se veže za staničnu membranu, interferon započinje složeni slijed događaja unutar stanice koji uključuju i indukciju određenih enzima.
English: Ribavirin capsules are to be administered orally each day in two divided doses with food (morning and evening).
Croatian: Ribavirin kapsule primjenjuju se peroralno svaki dan u dvije odvojene doze (ujutro i navečer), s hranom.
English: Patients with severe renal impairment, including those on hemodialysis, should be closely monitored.
Croatian: Bolesnike s teškim oštećenjem bubrežne funkcije, uključujući i one na hemodijalizi, treba pomno nadzirati.
English: Pen (CLEARCLICK)
Croatian: Brizgalica (CLEARCLICK)
English: The duration of treatment is up to 1 year based on the doctor's judgement for you, or the child you are caring for.
Croatian: Liječenje traje najdulje godinu dana, prema procjeni liječnika za Vas ili dijete o kojem skrbite.
English: All Genotypes Genotype 1 Genotype 2 Genotype 3
Croatian: Svi genotipovi Genotip 1 Genotip 2 Genotip 3 Genotip 4
English: Prior response Relapse
Croatian: Prethodni odgovor Relaps
English: Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.
Croatian: Bolesnici kojima je doza ribavirina smanjena na dnevnu dozu od 600 mg uzimaju jednu kapsulu od 200 mg ujutro i dvije kapsule od 200 mg navečer.
English: This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Croatian: To djelovanje može povećati rizik od razvoja laktacidoze izazvane analozima purinskih nukleozida (npr. didanozinom ili abakavirom).
English: Seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour.
Croatian: Zatražite hitnu liječničku pomoć ako primijetite da postajete depresivni, razmišljate o samoubojstvu ili primijetite promjene u svom ponašanju.
English: Adults: Haemoglobin in Patients with history of stable cardiac disease
Croatian: Odrasli: hemoglobin u bolesnika sa stabilnom srčanom bolešću u anamnezi
English: Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism.
Croatian: Iako točan način protuvirusnog djelovanja rekombinantnog interferona alfa-2b nije poznat, čini se da on mijenja metabolizam stanice domaćina.
English: Prepare the dose just before you intend to inject it and use it immediately.
Croatian: Pripremite dozu neposredno prije nego je namjeravate injicirati i odmah je primijenite.
English: Co-administration of ribavirin and didanosine is not recommended.
Croatian: Istodobna primjena ribavirina i didanozina se ne preporučuje.
English: No statistically significant effect on the time to development of the first clinical event (liver decompensation, hepatocellular carcinoma, death and/or liver transplantation) was observed as compared to the absence of treatment.
Croatian: Nije zabilježen statistički značajan učinak na vrijeme do razvoja prvog kliničkog događaja (dekompenzacije jetre, hepatocelularnog karcinoma, smrti i/ili transplantacije jetre) u odnosu na bolesnike koji nisu primali lijek.
English: Description of selected adverse reactions in adults
Croatian: Opis odabranih nuspojava u odraslih osoba
English: The most frequently reported adverse reactions were mostly mild to moderate in severity and were manageable without the need for modification of doses or discontinuation of therapy.
Croatian: Najčešće prijavljene nuspojave bile su uglavnom blagog do umjerenog intenziteta i mogle su se zbrinuti bez potrebe za prilagođavanjem doze ili obustavom liječenja.
English: Suicide, suicide attempt, suicidal ideation, psychosis, hallucination, panic attack
Croatian: samoubojstvo, pokušaj samoubojstva, suicidalne misli, psihoza, halucinacija, napad panike
English: Patients should be closely monitored for any signs or symptoms of psychiatric disorders.
Croatian: Bolesnike treba pomno nadzirati kako bi se uočili znakovi ili simptomi psihijatrijskih poremećaja.
English: ** For patients > 120 kg, the ViraferonPeg dose should be calculated based on the individual patient weight.
Croatian: ** Za bolesnike teže od 120 kg dozu lijeka ViraferonPeg treba izračunati na temelju tjelesne težine pojedinog bolesnika.
English: While pyrexia may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent pyrexia must be ruled out.
Croatian: Iako pireksija može biti povezana sa sindromom nalik gripi koji je prijavljen često tijekom liječenja interferonom, moraju se isključiti drugi uzroci uporne pireksije.
English: The pre-filled pen, needle and all injection materials are intended for single use and must be discarded after the injection.
Croatian: Napunjena brizgalica, igla i sav materijal za injekciju namijenjeni su za jednokratnu uporabu i moraju se zbrinuti nakon injekcije.
English: Interferon neutralising factors are antibodies which neutralise the antiviral activity of interferon.
Croatian: Čimbenici koji neutraliziraju interferon su protutijela koja neutraliziraju protuvirusno djelovanje interferona.
English: Your doctor will determine the correct dose for you, or the child you are caring for.
Croatian: Liječnik će odrediti točnu dozu za Vas ili dijete za koje skrbite.
English: In terms of activity, about one-third of sustained responders showed improvement and none showed worsening.
Croatian: Što se tiče aktivnosti bolesti, do poboljšanja je došlo u približno jedne trećine bolesnika s trajnim odgovorom, dok pogoršanje nije nastupilo niti u jednog.
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, sprječava novonastale virione da napuste stanicu.
English: - pulmonary fibrosis (scarring of the lungs).
Croatian: - plućna fibroza (stvaranje ožiljaka na plućima).
English: Any patient developing pyrexia, cough, dyspnea or other respiratory symptoms must have a chest X-ray taken.
Croatian: U svakog bolesnika koji razvije pireksiju, kašalj, dispneju ili druge respiratorne simptome mora se napraviti rendgenska snimka pluća.
English: Detailed information on this medicinal product is available on the web-site of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: This includes adults also infected with clinically stable HIV (Human Immunodeficiency Virus).
Croatian: To uključuje i odrasle bolesnike koji istodobno imaju i klinički stabilnu infekciju virusom HIV-a (virus humane imunodeficijencije).
English: > 4 mg/dl (for > 4 weeks)
Croatian: > 4 mg/dl (tijekom > 4 tjedna)
English: Treatment with ViraferonPeg in combination with ribavirin was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Croatian: Liječenje lijekom ViraferonPeg u kombinaciji s ribavirinom bilo je povezano sa smanjenjem apsolutnog broja CD4+ stanica u prva 4 tjedna, no bez smanjenja postotka CD4+ stanica.
English: Although, the majority of them could be managed by dose reduction, close monitoring of haematological parameters should be undertaken in this population of patients (see section 4.2 and below “Laboratory tests” and section 4.8).
Croatian: Premda se većina tih poremećaja može zbrinuti smanjivanjem doze, treba pomno nadzirati hematološke parametre u ovoj populaciji bolesnika (vidjeti dio 4.2, "Laboratorijski nalazi" u nastavku i dio 4.8).
English: Anaemia (hemoglobin < 9.4 g/dl) was reported in 12 % (23/194) of patients treated with ViraferonPeg in combination with ribavirin.
Croatian: Anemija (hemoglobin < 9,4 g/dl) je prijavljena u 12% (23/194) bolesnika liječenih lijekom ViraferonPeg u kombinaciji s ribavirinom.
English: Unknown frequency side effects (frequency cannot be estimated from the available data): - Wanting to harm others.
Croatian: Nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka): - želja za ozljeđivanjem drugih.
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of ViraferonPeg therapy.
Croatian: Srčane aritmije (prvenstveno supraventrikularne) obično dobro reagiraju na konvencionalnu terapiju, ali mogu zahtijevati obustavu liječenja lijekom ViraferonPeg.
English: Push up the plunger slowly back to the correct dose.
Croatian: Polagano gurnite klip nazad do točne doze.
English: Side effects in children and adolescents The following effects have occurred in children and adolescents:
Croatian: Nuspojave u djece i adolescenata Sljedeće nuspojave javile su se u djece i adolescenata:
English: Cleanse and disinfect the skin where the injection is to be made.
Croatian: Očistite i dezinficirajte kožu na mjestu gdje ćete dati injekciju.
English: Long-term efficacy data-Adults
Croatian: Podaci o dugoročnoj djelotvornosti - odrasli
English: ViraferonPeg is likely to also cause this effect.
Croatian: Vjerojatno i ViraferonPeg ima ovaj učinak.
English: If you take telbivudine with this medicine 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 ovim lijekom 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: The combination of this medicine, ribavirin and boceprevir is recommended for use for some types of chronic hepatitis C virus infection (also called HCV infection) in adults 18 years of age and older.
Croatian: Kombinacija ovog lijeka, ribavirina i boceprevira preporučuje se za liječenje nekih vrsta kronične infekcije virusom hepatitisa C (naziva se i HCV infekcijom) u odraslih osoba u dobi od 18 i više godina.
English: Treatment regimen
Croatian: Režim liječenja
English: - loss of consciousness has occurred very rarely with alpha interferons, mostly in elderly patients treated at high doses.
Croatian: - gubitak svijesti se javlja vrlo rijetko kod primjene alfa interferona, većinom u starijih bolesnika liječenih visokim dozama.
English: If you have kidney disease, your dose may be lower, depending upon your kidney function.
Croatian: Ako imate bolest bubrega, doza može biti niža, ovisno o funkciji bubrega.
English: As adherence might be of importance for outcome of therapy, the dose of ViraferonPeg and ribavirin should be kept as close as possible to the recommended standard dose.
Croatian: Budući da pridržavanje preporučenih doza može biti važno za ishod liječenja, potrebno je održavati dozu lijeka ViraferonPeg i ribavirina što bliže preporučenoj standardnoj dozi.
English: Events were reported at various time points typically several months after starting treatment with interferon alfa.
Croatian: Događaji su prijavljeni u različitim vremenskim točkama najčešće nekoliko mjeseci nakon početka liječenja inteferonom alfa.
English: All subjects HCV 2  600,000 IU/ml > 600,000 IU/ml HCV 3  600,000 IU/ml > 600,000 IU/ml
Croatian: Svi ispitanici HCV 2  600 000 IU/ml > 600 000 IU/ml HCV 3  600 000 IU/ml > 600 000 IU/ml
English: Side effects of unknown frequency (frequency cannot be estimated from the available data): - pure red cell aplasia (a condition where the body stopped or reduced the production of red blood cells).
Croatian: Nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka): - izolirana aplazija crvene krvne loze (stanje u kojem organizam prestaje proizvoditi ili smanjeno proizvodi crvene krvne stanice).
English: If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing upwards, 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: Bilirubin - direct
Croatian: Direktni bilirubin
English: If you have a medical condition that may lead to future eye problems (e.g. diabetes or high blood pressure), you should receive regular eye exams during therapy.
Croatian: Ako bolujete od neke bolesti koja može izazvati kasnije tegobe s očima (npr. šećerna bolest ili povišen krvni tlak), tijekom liječenja morate redovito obavljati očne preglede.
English: The dose administered in adults depends on whether it is used in combination therapy (bitherapy or tritherapy) or as monotherapy.
Croatian: Primjenjena doza u odraslih ovisi o tome primjenjuje li se u kombiniranoj terapiji (dvojnoj ili trojnoj) ili kao monoterapija.
English: Do not use this medicine if you notice discolouration of the powder, which should be white.
Croatian: Ne smijete upotrijebiti ovaj lijek ako primijetite da je prašak, koji mora biti bijeli, promijenio boju.
English: Pull back on the plunger slowly to draw just more than the dose prescribed by your doctor into the syringe.
Croatian: Polako povlačite klip kako biste u štrcaljku izvukli malo više od točne doze koju Vam je propisao liječnik.
English: However, if HCV-RNA is still detectable at treatment week 24, discontinuation of therapy should be considered.
Croatian: Međutim, ako je u 24. tjednu liječenja HCV-RNK još uvijek mjerljiva, treba razmotriti obustavu liječenja.
English: Once all bubbles have risen to the top of the solution, you should have a clear solution with a small ring of tiny bubbles around the top.
Croatian: Kada se mjehurići popnu na vrh, otopina bi trebala biti bistra, s malim prstenom mjehurića oko vrha.
English: Theophylline, Antipyrine, Warfarin
Croatian: Teofilin, Antipirin, Varfarin
English: Sustained response
Croatian: Trajan odgovor
English: The biologic activity of the pegylated isomers is qualitatively similar, but weaker than free interferon alfa-2b.
Croatian: Biološka aktivnost pegiliranih izomera je kvalitativno slična, ali slabija od aktivnosti slobodnog interferona alfa-2b.
English: Any patient complaining of ocular symptoms, including loss of visual acuity or visual field must have a prompt and complete eye examination.
Croatian: Svakom bolesniku koji se žali na očne simptome, uključujući gubitak oštrine vida ili suženje vidnog polja, odmah se mora učiniti temeljit oftalmološki pregled.
English: Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients.
Croatian: Plućni infiltrati, pneumonitis i pneumonija, koji ponekad mogu rezultirati smrtnim ishodom, opaženi su rijetko u bolesnika liječenih interferonom alfa.
English: When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible 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 u nekih bolesnika može biti ireverzibilan.
English: Among 480 patients with > 2 log viral reduction but detectable virus at week 12, altogether 188 patients continued therapy.
Croatian: Od 480 bolesnika sa smanjenjem virusnog opterećenja za > 2 log, ali još mjerljivim virusom u 12. tjednu, ukupno ih je 188 nastavilo liječenje.
English: If your doctor prescribes this medicine with ribavirin or with ribavirin and boceprevir, please read the Package Leaflets of ribavirin and boceprevir before you begin combination treatment.
Croatian: Ako je liječnik propisao ovaj lijek zajedno s ribavirinom ili s ribavirinom i boceprevirom, molimo pročitajte uputu o lijeku za ribavirin i boceprevir prije nego započnete kombinirano liječenje.
English: Patients should be closely monitored during therapy and even after treatment discontinuation.
Croatian: Bolesnike treba pomno nadzirati tijekom i nakon obustave liječenja.
English: • Turn the dial to number 1 (see Figure 1).
Croatian: • Okrenite vijak za doziranje na broj 1 (vidjeti Sliku 1).
English: You may develop gum disease, which could lead to loss of teeth.
Croatian: Mogu se razviti bolesti desni koje mogu dovesti do gubitka zuba.
English: Two pivotal trials have been conducted, one (C/I97-010) with ViraferonPeg monotherapy; the other (C/I98-580) with ViraferonPeg in combination with ribavirin.
Croatian: Provedena su dva pivotalna ispitivanja: u jednom (C/I97-010) se primjenjivao ViraferonPeg u monoterapiji, a u drugom (C/I98-580) ViraferonPeg u kombinaciji s ribavirinom.
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 virusinfected 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 replikacije 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: The combination of this medicine and ribavirin is recommended for adults 18 years of age and older who have not previously been treated with these medicines.
Croatian: Kombinacija ovog lijeka i ribavirina preporučuje se za odrasle bolesnike u dobi od 18 i više godina koji prethodno nisu bili liječeni ovim lijekovima.
English: Genotype 1* By week 4*** (n=950) HCV-RNA negative 834
Croatian: Genotip 1* Do 4. tjedna *** (n=950) HCV-RNK negativna 834
English: What ViraferonPeg looks like and contents of the pack
Croatian: Kako ViraferonPeg izgleda i sadržaj pakiranja
English: • Turn the dial to your prescribed dose (see Figure 8).
Croatian: • Okrećite vijak za doziranje do doze koja Vam je propisana (vidjeti Sliku 8).
English: Note: Once the pre-filled pen is removed from the skin, the needle shield will lock in place.
Croatian: Napomena: Kad izvučete napunjenu brizgalicu iz kože, zaštita za iglu će automatski zaključati iglu.
English: If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.
Croatian: U tom slučaju bolesnicima treba savjetovati da nakon povraćanja temeljito isperu usta.
English: Following subcutaneous administration, maximal serum concentrations occur between 15-44 hours post-dose, and are sustained for up to 48-72 hours post-dose.
Croatian: Maksimalne koncentracije u serumu nakon supkutane primjene postižu se za 15-44 sati, a održavaju se tijekom 48-72 sati nakon primjene doze.