FrancophonIA/ELRC3.0 huggingface dataset:
English: Mechanism of action is unknown, but it is considered that both medicines have bone marrow depressive effects.
Croatian: Mehanizam djelovanja nije poznat, no smatra se da oba lijeka imaju depresivne učinke na koštanu srž.
English: The average molecular mass is approximately 31,300 daltons of which the protein moiety constitutes approximately 19,300.
Croatian: Prosječna molekularna masa iznosi oko 31 300 daltona, od čega proteinski dio čini približno 19 300.
English: Contact your doctor immediately if you notice any of the following serious side effects occurring during treatment:
Croatian: Odmah se javite svom liječniku ako se tijekom liječenja pojavi bilo koja od sljedećih ozbiljnih nuspojava:
English: Your doctor will determine the correct dose for you.
Croatian: Liječnik će odrediti točnu dozu za Vas.
English: Your doctor will test your blood before you begin therapy and throughout the treatment to make sure that the therapy you are getting is safe and effective.
Croatian: Liječnik će provesti pretrage krvi prije početka i za vrijeme liječenja kako bi provjerio je li terapija koju primate sigurna i djelotvorna.
English: In case of any changes in vision, you must tell your doctor and have a prompt and complete eye examination.
Croatian: U slučaju bilo kakvih promjena vida, morate obavijestiti svog liječnika i bez odlaganja obaviti kompletan očni pregled.
English: Do not massage the injection site.
Croatian: Nemojte masirati mjesto injekcije.
English: During treatment, some patients may experience eye problems, or loss of vision in rare instances.
Croatian: Za vrijeme liječenja neki bolesnici mogu imati tegobe s očima ili u rijetkim slučajevima izgubiti vid.
English: Histological response: Liver biopsies were obtained before and after treatment in Study 1 and were available for 210 of the 412 subjects (51 %).
Croatian: Histološki odgovor: Biopsije jetre učinjene su prije i nakon liječenja u Ispitivanju 1, a nalazi su bili dostupni za 210 od 412 ispitanika (51%).
English: Alanine aminotransferase (ALT)
Croatian: Alanin aminotransferaza (ALT)
English: Growth rate decrease (height and/or weight decrease for age)
Croatian: smanjena brzina rasta (smanjenje visine i/ili težine za dob)
English: If you are injecting this medicine yourself, please be sure that the dose that has been prescribed is clearly provided on the package of medicine you receive.
Croatian: Ako sami sebi dajete injekcije ovog lijeka, molimo budite sigurni da je doza koja Vam je propisana jasno navedena na pakiranju lijeka koji uzimate.
English: Keep your work area, your hands, and the injection site clean to decrease the risk of infection.
Croatian: Radnu površinu, ruke i mjesto injekcije držite čistima kako bi se umanjio rizik od infekcije.
English: Long-term efficacy data - paediatric population
Croatian: Podaci o dugoročnoj djelotvornosti - pedijatrijska populacija
English: Ask a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
Croatian: Zatražite pomoć člana obitelji ili bliskog prijatelja koji će Vas upozoriti na znakove depresije ili promjene u Vašem ponašanju.
English: Whenever possible the child should be treated after the pubertal growth spurt, in order to reduce the risk of growth inhibition.
Croatian: Kad god je to moguće, dijete treba liječiti nakon pubertetskog zamaha rasta kako bi se smanjio rizik od zastoja u rastu.
English: Do not drive or operate any tools or machines if you feel tired, sleepy or confused while taking this medicine.
Croatian: Nemojte upravljati vozilom niti rukovati alatima ili strojevima ako se osjećate umorno, pospano ili smeteno dok uzimate ovaj lijek.
English: From a microbiological point of view, the product is to be used immediately.
Croatian: S mikrobiološkog stajališta, lijek treba odmah primijeniti.
English: The response to treatment in both of these trials is presented in Table 13.
Croatian: Terapijski odgovor u oba ispitivanja prikazan je u Tablici 13.
English: - if you are a man who is taking ribavirin: do not have sex with a pregnant woman unless you use a condom.
Croatian: - ako ste muškarac koji uzima ribavirin: ne smijete imati spolne odnose s trudnicom bez uporabe kondoma.
English: Ninety-four of 107 subjects enrolled in the 5 year long-term follow-up trial.
Croatian: Devedeset i četiri od 107 djece uključeno je u 5-godišnje dugotrajno ispitivanje praćenja.
English: Although data are limited, no evidence of long-term effects on sexual maturation was noted in the 5-year observational follow-up study.
Croatian: Iako su podaci ograničeni, u 5-godišnjem opservacijskom ispitivanju praćenja nisu pronađeni dokazi dugoročnih učinaka na spolno sazrijevanje.
English: Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Croatian: Bolesnici moraju temeljito prati zube dvaput na dan i redovito obavljati preglede zuba.
English: While these effects are generally reversible, in a few patients full resolution took up to three weeks.
Croatian: Premda su ovi učinci općenito reverzibilni, nekolicini je bolesnika za potpun oporavak trebalo do tri tjedna.
English: Effects on fertility have not been determined.
Croatian: Učinci na plodnost nisu utvrđeni.
English: The decision to extend therapy to one year of treatment should be based on prognostic factors (e.g., genotype, age > 40 years, male gender, bridging fibrosis).
Croatian: Odluku o produljenju liječenja na godinu dana treba temeljiti na prognostičkim čimbenicima (npr. genotip, dob > 40 godina, muški spol, premoštavajuća fibroza).
English: You might hear a soft sound when pushing on the needle.
Croatian: Možda ćete čuti nježan zvuk dok budete pritiskali iglu.
English: The solution may appear cloudy or bubbly for a few minutes.
Croatian: Otopina se može nekoliko minuta doimati mutnom ili zapjenjenom.
English: Neuropathy, neuropathy peripheral
Croatian: neuropatija, periferna neuropatija
English: Positive predictive value
Croatian: Pozitivna prediktivna vrijednost
English: Adults - Dose to be administered
Croatian: Odrasli - doza koju treba primijeniti
English: Viral infection *, pharyngitis
Croatian: virusna infekcija*, faringitis*
English: Sustained Virologic Response
Croatian: Trajan virološki odgovor
English: • Choose an injection site on your stomach area (abdomen) or thigh.
Croatian: • Odaberite mjesto injekcije na području trbuha (abdomena) ili bedra.
English: # Calculated from urine data collected over an interval of 48-hours ## Calculated from urine data collected over an interval of 24-hours
Croatian: # Izračunato na temelju podataka dobivenih iz mokraće prikupljene tijekom intervala od 48 sati ## Izračunato na temelju podataka dobivenih iz mokraće prikupljene tijekom intervala od 24 sata
English: It is important to brush your teeth thoroughly twice a day, rinse your mouth out if you vomit, and have regular dental check-ups.
Croatian: Važno je temeljito prati zube dvaput na dan, isprati usta ako povraćate i redovito odlaziti na preglede zuba.
English: However, certain monkey species, e.g., Rhesus monkeys are susceptible to pharmacodynamic stimulation upon exposure to human type 1 interferons.
Croatian: Ipak, određene vrste majmuna, npr. Rhesus majmuni, osjetljive su na farmakodinamičku stimulaciju nakon izloženosti humanim interferonima tipa 1.
English: For disposal instructions, see section 5 “How to store ViraferonPeg”.
Croatian: Za upute o zbrinjavanju vidjeti dio 5 "Kako čuvati ViraferonPeg".
English: ViraferonPeg showed no genotoxic potential.
Croatian: ViraferonPeg nije pokazao genotoksičan potencijal.
English: It is not known whether the components of this medicinal product are excreted into experimental animal or human milk (see section 4.6 for relevant human data on pregnancy and lactation).
Croatian: Nije poznato izlučuju li se sastojci ovog lijeka u mlijeko eksperimentalnih životinja ili u majčino mlijeko (vidjeti dio 4.6 za relevantne podatke o trudnoći i dojenju u ljudi).
English: ViraferonPeg is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: ViraferonPeg se smije koristiti tijekom trudnoće jedino ako moguća korist opravdava mogući rizik za plod.
English: Negative predictive value
Croatian: Negativna prediktivna vrijednost
English: 24 cleansing swabs.
Croatian: 24 tupfera za čišćenje
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 štetne događaje (npr. depresiju, emocionalnu labilnost i somnolenciju).
English: Ask your healthcare provider or pharmacist for an appropriate container.
Croatian: Obratite se zdravstvenom radniku ili ljekarniku za odgovarajući spremnik.
English: In addition, children and adolescents must not use this medicine if they have had serious nervous or mental problems, such as severe depression or thoughts of suicide.
Croatian: Osim toga, djeca i adolescenti ne smiju uzimati ovaj lijek ako su imali ozbiljne neurološke ili psihičke tegobe poput teške depresije ili razmišljanja o samoubojstvu.
English: Discontinue combination therapy if:
Croatian: Obustaviti kombiniranu terapiju ako:
English: General information about taking this medicine
Croatian: Opći podaci o uzimanju ovog lijeka
English: Children and adolescents are particularly prone to develop depression when being treated with this medicine and ribavirin.
Croatian: Djeca i adolescenti su osobito skloni razvoju depresije dok se liječe ovim lijekom i ribavirinom.
English: In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm
Croatian: U Ispitivanju 1 (vidjeti dio 5.1) smanjenje apsolutnog broja neutrofila na manje od 500 stanica/mm
English: Immediately contact the doctor or seek emergency treatment if they display any unusual behavioural symptoms, feel depressed, or feel they want to harm themselves or others.
Croatian: Odmah se obratite liječniku ili zatražite hitnu pomoć ako primijetite bilo koje simptome neuobičajenog ponašanja, ako su depresivni ili osjećaju da žele nauditi sebi ili drugima.
English: If it is very close to your next injection, do not double the dose to make up for the forgotten dose, but continue your treatment as usual.
Croatian: Ako je preostalo vrlo malo vremena do sljedeće injekcije, ne smijete uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu, nego nastavite s liječenjem po uobičajenom rasporedu.
English: This leaflet was last revised in MM/YYYY
Croatian: Ova uputa je zadnji puta revidirana u MM/GGGG.
English: Table 15 Sustained virological response rates (n a,b
Croatian: Tablica 15 Stopa trajnog virološkog odgovora (n a,b
English: • Hold the pre-filled pen against the skin for 15 seconds.
Croatian: • Držite napunjenu brizgalicu na koži 15 sekundi.
English: The study results are summarized in Table 15.
Croatian: Rezultati ispitivanja sažeti su u Tablici 15.
English: • Press the pre-filled pen against the skin as shown in Figure 10.
Croatian: • Pritisnite napunjenu brizgalicu na kožu kao što je prikazano na Slici 10.
English: Adverse events not observed in clinical trials were not seen in toxicity studies in monkeys.
Croatian: Štetni događaji koji nisu zabilježeni tijekom kliničkih ispitivanja nisu opaženi ni tijekom istraživanja toksičnosti na majmunima.
English: Decrease in mean height percentile at year 1 of long-term follow-up was most prominent in prepubertal age children.
Croatian: Prosječno smanjenje na percentilnoj krivulji rasta nakon godinu dana dugoročnog praćenja bilo je najizraženije u djece pretpubertetske dobi.
English: - have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
Croatian: - ako imate ili ste prethodno imali infekciju virusom hepatitisa B, jer će Vas liječnik možda htjeti pomnije pratiti.
English: Pull back the plunger very slightly with one hand.
Croatian: Jednom rukom vrlo polagano povucite klip.
English: Aspartate aminotransferase (AST)
Croatian: ili aspartat aminotransferaza (AST)
English: - pulmonary arterial hypertension - a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Croatian: - plućna arterijska hipertenzija - bolest jakog suženja krvnih žila u plućima što rezultira visokim krvnim tlakom u krvnim žilama koje prenose krv iz srca u pluća.
English: Ribavirin concentration in seminal fluid is approximately two-fold higher compared to serum.
Croatian: Koncentracija ribavirina u sjemenoj tekućini je približno dva puta veća u odnosu na koncentraciju u serumu.
English: If it cannot be used immediately, the solution may be refrigerated for up to 24 hours.
Croatian: Ako se ne može odmah upotrijebiti, može se čuvati u hladnjaku najdulje 24 sata.
English: Be sure the solution is at room temperature up to 25°C.
Croatian: Provjerite je li otopina na sobnoj temperaturi do 25°C.
English: You may develop a dry mouth or vomiting, both of which can damage your teeth.
Croatian: Možda ćete imati suha usta ili povraćati, što može oštetiti zube.
English: By week 12*** (n=915)
Croatian: Do 12. tjedna *** (n=915)
English: You must not use ViraferonPeg if any of the conditions above should apply to you, or the child you are caring for.
Croatian: Ne smijete primjenjivati ViraferonPeg ako se bilo što od gore navedenoga odnosi na Vas ili dijete za koje skrbite.
English: With your other hand, hold the syringe as you would a pencil.
Croatian: Drugom rukom uzmite štrcaljku i držite je kao olovku.
English: The effects on growth were less in those subjects treated for 24 weeks than those treated for 48 weeks.
Croatian: Učinci na rast bili su manji u djece liječene 24 tjedna nego u one liječene 48 tjedana.
English: The high sustained response rate in this subgroup of patients was identified in an interim analysis (n=49) and prospectively confirmed (n=48).
Croatian: Visok udio trajnog odgovora u ovoj podskupini bolesnika utvrđen je preliminarnom analizom (n=49) te je prospektivno potvrđen (n=48).
English: Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur: - if you are a girl or a woman of childbearing age who is taking ribavirin: you must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped.
Croatian: Stoga, Vi i Vaš partner morate koristiti posebne mjere zaštite pri spolnom odnosu, ako postoji bilo kakva mogućnost trudnoće: - ako ste djevojka ili žena u reproduktivnoj dobi, koja uzima ribavirin: morate imati negativan test na trudnoću prije liječenja, svaki mjesec za vrijeme liječenja te tijekom 4 mjeseca nakon prestanka liječenja.
English: You are ready to inject
Croatian: Spremni ste za injiciranje
English: The potency of this product should not be compared to that of another pegylated or non-pegylated protein of the same therapeutic class (see section 5.1).
Croatian: Jačina ovog lijeka ne smije se uspoređivati s jačinom drugih pegiliranih ili nepegiliranih proteina iz istog terapijskog razreda (vidjeti dio 5.1).
English: Pharmacologically, ribavirin increases phosphorylated metabolites of purine nucleosides in vitro.
Croatian: Farmakološki gledano, ribavirin povećava razinu fosforiliranih metabolita purinskih nukleozida in vitro.
English: Some people get depressed when taking this medicine alone or in combination treatment with ribavirin, and in some cases people have had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others).
Croatian: Neke osobe postanu depresivne kad uzimaju ovaj lijek samostalno 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: While being treated with ViraferonPeg, your doctor may advise to drink extra fluids to help prevent low blood pressure.
Croatian: Za vrijeme liječenja lijekom ViraferonPeg liječnik Vam može savjetovati da pijete više tekućine kako bi se spriječio razvoj niskog krvnog tlaka.
English: Do not attempt to inject yourself unless you are sure you understand the procedure and requirements of selfinjection.
Croatian: Ne pokušavajte si dati injekciju ako niste sigurni da razumijete postupak i uvjete davanja injekcije.
English: Treatment should be initiated and monitored only by a physician experienced in the management of patients with hepatitis C.
Croatian: Liječenje smije započeti i nadzirati samo liječnik s iskustvom u liječenju bolesnika s hepatitisom C.
English: 327 patients completed at least 5 years of long-term follow-up and only 3 out of 366 sustained responders relapsed during the study.
Croatian: Najmanje 5 godina dugotrajnog praćenja dovršilo je 327 bolesnika, a samo su 3 od 366 bolesnika s trajnim virološkim odgovorom doživjela relaps tijekom ispitivanja.
English: Do not attempt to administer an injection until you are sure you understand how to use the pre-filled pen.
Croatian: Ne pokušavajte si dati injekciju dok ne budete sigurni da razumijete kako koristiti napunjenu brizgalicu.
English: This medicine is used for the treatment of chronic hepatitis C, a viral infection of the liver.
Croatian: Ovaj lijek se koristi za liječenje kroničnog hepatitisa C, virusne infekcije jetre.
English: Growth and development (children and adolescents):
Croatian: Rast i razvoj (djeca i adolescenti):
English: Paediatric population - Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicidal attempt.
Croatian: Pedijatrijska populacija - postojeće ili u anamnezi teško psihijatrijsko stanje, osobito teška depresija, suicidalne misli ili pokušaj samoubojstva.
English: The clinical significance of this finding is unknown; however, patients should be monitored for signs and symptoms of increased sedative effect, as well as respiratory depression.
Croatian: Klinički značaj ovog nalaza nije poznat, međutim, bolesnike treba nadzirati kako bi se uočili znakovi i simptomi mogućeg pojačanog sedativnog učinka kao i depresije disanja.
English: (%)) in previously untreated children and adolescents by genotype and treatment duration - All subjects n = 107 24 weeks
Croatian: (%)) u djece i adolescenata koji nisu bili prethodno liječeni, prema genotipu i trajanju liječenja - Svi ispitanici n = 107 24 tjedna
English: Limited historical data indicate that treatment for 48 weeks might be associated with a higher sustained response rate (11/11) and with a lower risk of relapse (0/11 as compared to 7/96 following 24 weeks of treatment).
Croatian: Ograničeni prethodni podaci pokazuju da bi liječenje u trajanju od 48 tjedana moglo biti povezano s većom stopom trajnog odgovora (11/11) i manjim rizikom od relapsa (0/11 u odnosu na 7/96 nakon 24 tjedna liječenja).
English: The mechanism behind these events is not known (see sections 4.3, 4.4 and 4.5 of the telbivudine SmPC).
Croatian: Mehanizam u podlozi tih događaja nije poznat (vidjeti dijelove 4.3, 4.4 i 4.5 u Sažetku opisa svojstava lijeka za telbivudin).
English: • Pinch a fold of loose skin in the area you have cleaned for injection.
Croatian: • Prstima uhvatite nabor labave kože na području koje ste očistili za injekciju.
English: If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Croatian: Ne primijeni li se odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika, te ne bi smjeli biti dulji od 24 sata pri 2°C - 8°C.
English: However, an overall 24 weeks treatment duration may be associated with a higher risk of relapse than a 48 weeks treatment duration (see section 5.1).
Croatian: Međutim, liječenje u ukupnom trajanju od 24 tjedna može biti povezano s većim rizikom od relapsa nego liječenje u trajanju od 48 tjedana (vidjeti dio 5.1).
English: Before reconstitution, this medicine may appear either as a white tablet-shaped solid that is whole or in pieces, or as a white powder.
Croatian: Prije pripreme za primjenu, ovaj lijek može biti u obliku bijele tablete koja moža biti cijela ili razlomljena na komadiće, ili bijelog praška.
English: Studies with other interferons have demonstrated species specificity.
Croatian: Ispitivanja s drugim interferonima pokazala su da su oni specifični za vrstu.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8ºC.
Croatian: Dokazana je kemijska i fizikalna stabilnost lijeka u uporabi tijekom 24 sata pri 2°C - 8°C.
English: This medicine contains sucrose.
Croatian: Ovaj lijek sadrži saharozu.
English: Table 1 Dosing for combination therapy* Body weight (kg)
Croatian: Tablica 1 Doziranje u kombiniranoj terapiji* Tjelesna težina (kg)
English: What ViraferonPeg is and what it is used for
Croatian: Što je ViraferonPeg i za što se koristi
English: Interferons are made by your body's immune system to help fight infections and severe diseases.
Croatian: Interferone proizvodi Vaš imunološki sustav kako bi pomogli u borbi protiv infekcija i teških bolesti.
English: Patients may self-inject ViraferonPeg if their physician determines that it is appropriate and with medical follow-up as necessary.
Croatian: Bolesnici si mogu samostalno injicirati ViraferonPeg ako liječnik odredi da je to prikladno i po potrebi uz medicinsko praćenje.
English: This may occur in particular in patients with risk factors such as HIV infection or severe liver problems (cirrhosis).
Croatian: Ovo može nastupiti posebice u bolesnika s faktorima rizika poput infekcije HIV-om ili teških problema s jetrom (ciroza).
English: If it gets worse, your doctor will decide whether or not your ribavirin treatment needs to be changed.
Croatian: Ako se pogoršava, liječnik će odlučiti je li potrebno promijeniti terapiju ribavirinom.
English: No sustained response
Croatian: Bez trajnog odgovora
English: < 12 g/dl after four weeks of dose reduction
Croatian: < 12 g/dl nakon 4 tjedna liječenja smanjenom dozom
English: The Kaplan-Meier estimate for continued sustained response over 5 years for all patients is 99 % (95 % CI: 98-100 %).
Croatian: Kaplan-Meierova procjena održivosti trajnog virološkog odgovora tijekom 5 godina za sve bolesnike iznosi 99% (95% CI: 98-100%).
English: Your doctor should carry out an eye examination before starting your treatment.
Croatian: Liječnik Vas prije početka liječenja mora uputiti na očni pregled.
English: Dose reduction of boceprevir is not recommended.
Croatian: Ne preporučuje se smanjivati dozu boceprevira.
English: Acceptable baseline values that may be considered as a guideline prior to initiation of ViraferonPeg therapy are:
Croatian: Prihvatljive početne vrijednosti koje se mogu koristiti kao smjernice prije početka liječenja lijekom ViraferonPeg su sljedeće:
English: Laboratory evaluations are to be conducted at weeks 2 and 4 of therapy, and periodically thereafter as clinically appropriate.
Croatian: Laboratorijske pretrage moraju se napraviti u 2. i 4. tjednu liječenja, a kasnije povremeno, prema kliničkoj procjeni.
English: These time points (treatment week 4 and treatment week 12) have been shown to be predictive for sustained response (Table 12).
Croatian: Pokazalo se da ove vremenske točke (4. i 12. tjedan liječenja) imaju prediktivnu vrijednost za trajan odgovor (Tablica 12).
English: Pharmacotherapeutic group: Immunostimulants, Interferons, ATC code: L03AB10.
Croatian: Farmakoterapijska skupina: Imunostimulatori, Interferoni, ATK oznaka: L03AB10.
English: Doses up to 10.5 times the intended dose have been reported.
Croatian: Prijavljeni su slučajevi primjene do 10,5 puta veće doze od preporučene.
English: This medicine is injected into your body to work with your immune system.
Croatian: Ovaj lijek se injicira u tijelo kako bi djelovao na imunološki sustav.
English: Discontinue ribavirin if CrCL < 50ml/min
Croatian: Obustaviti davanje ribavirina ako je CrCL < 50 ml/min