FrancophonIA/ELRC3.0 huggingface dataset:
English: In general, the safety profile observed in paediatric patients was similar to that seen in adults.
Croatian: U načelu je sigurnosni profil opažen u pedijatrijskih bolesnika bio sličan onome u odraslih.
English: You should brush your teeth thoroughly twice daily and have regular dental examinations.
Croatian: Trebali biste temeljito prati zube dva puta dnevno i redovito ići na preglede kod stomatologa.
English: Monotherapy for hepatitis C should only be considered in case of contraindication to other medicinal products.
Croatian: Monoterapija za hepatitis C treba biti razmatrana samo u slučajevima kada postoje kontraindikacije za primjenu drugih lijekova.
English: What Pegasys contains
Croatian: Što Pegasys sadrži
English: Injury or poisoning: Substance overdose
Croatian: Ozljede ili trovanje: predoziranje djelatnom tvari lijeka
English: The recommended total duration of therapy is 48 weeks.
Croatian: Preporučeno ukupno trajanje liječenja iznosi 48 tjedana.
English: The terminal half-life may not only reflect the elimination phase of the compound, but may also reflect the sustained absorption of Pegasys.
Croatian: Terminalni poluvijek ne odražava samo eliminacijsku fazu spoja, nego i kontinuiranu apsorpciju lijeka Pegasys.
English: In patients with compensated cirrhosis (e.g., Child-Pugh A), Pegasys has been shown to be effective and safe.
Croatian: U bolesnika s kompenziranom cirozom (Child-Pugh stadij A), Pegasys se pokazao učinkovitim i sigurnim.
English: ● if you are being treated with telbivudine, a medicine for hepatitis B infection (see “Other medicines and Pegasys”).
Croatian: • ako se liječite telbivudinom, lijekom za liječenje infekcije hepatitisom B ( pogledajte „Drugi lijekovi i Pegasys“).
English: Table 3: Dose adjustment for adverse reactions in adult patients (for further guidance see also text above)
Croatian: Tablica 3: Prilagodba doze kod nuspojava u odraslih bolesnika (za daljnje upute također vidjeti tekst iznad)
English: The use of Pegasys had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Croatian: Primjena lijeka Pegasys nije imala vidljiv negativan učinak na kontrolu HIV viremije tijekom liječenja ili razdoblja praćenja.
English: Patients who develop dizziness, confusion, somnolence or fatigue should be cautioned to avoid driving or operating machinery.
Croatian: Bolesnike sa simptomima omaglice, konfuzije, pospanosti ili zamora treba upozoriti da ne voze odnosno da ne upravljaju strojevima.
English: Appropriate antiinfective therapy should be started immediately and discontinuation of therapy should be considered.
Croatian: Treba odmah započeti odgovarajuće antimikrobno liječenje, a potrebno je razmotriti i prekid liječenja.
English: Co-administration of ribavirin and didanosine is not recommended.
Croatian: Ne preporučuje se istovremena primjena ribavirina i didanozina.
English: If your female partner is not pregnant now, but is of childbearing potential, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Croatian: Ako Vaša partnerica trenutno nije trudna, ali može zatrudnjeti, mora se testirati na trudnoću svaki mjesec tijekom trajanja Vašeg liječenja i 7 mjeseci nakon njegova prestanka.
English: No data is available on long-term follow-up posttreatment in these patients (see section 4.4).
Croatian: Nema dostupnih podataka o dugoročnom praćenju tih bolesnika nakon liječenja (vidjeti dio 4.4).
English: Group B** Untreated (N=50)
Croatian: Skupina B** Neliječeni bolesnici (N=50)
English: ● if you are infected with both the hepatitis C virus and the human immunodeficiency virus, and your liver does not work properly (e.g. your skin has become yellow).
Croatian: • ako ste zaraženi i virusom hepatitisa C i virusom humane imunodeficijencije, a jetra Vam ne radi pravilno (npr. koža Vam je požutjela).
English: Pegasys contains benzyl alcohol.
Croatian: Pegasys sadrži benzilni alkohol.
English: A total of 283/1351 (21%) of patients had advanced fibrosis or cirrhosis, 85/1351 (6%) had cirrhosis.
Croatian: Ukupno je 283/1351 (21%) bolesnika imalo uznapredovalu fibrozu ili cirozu, a 85/1351 (6%) imalo je cirozu.
English: The percentage of patients with cirrhosis who withdrew from treatment was similar to that of the overall population in each treatment group.
Croatian: Postotak bolesnika s cirozom koji su se povukli iz liječenja sličan je postotku ukupne populacije u svakoj liječenoj skupini.
English: Tell your doctor or pharmacist if you are being treated with telbivudine.
Croatian: Obavijestite svog liječnika ili ljekarnika ako se liječite telbivudinom.
English: Exposure to didanosine or its active metabolite (dideoxyadenosine 5'-triphosphate) is increased in vitro when didanosine is coadministered with ribavirin.
Croatian: Izloženost didanozinu ili njegovim aktivnim metabolitima (5'-dideoksiadenozin trifosfat) povećava se in vitro ako se didanozin primjenjuje istodobno s ribavirinom.
English: Psychiatric evaluation abnormal
Croatian: Pretrage abnormalni rezultati psihijatrijske evaluacije
English: What Pegasys looks like and contents of the pack
Croatian: Kako Pegasys izgleda i sadržaj pakiranja
English: Patients with advanced fibrosis were assigned to Pegasys treatment (group C, n=10).
Croatian: Bolesnicima s uznapredovalom fibrozom dodijeljeno je liječenje lijekom Pegasys (skupina C, n=10).
English: For spontaneous reports of undesirable effects from post-marketing experience, the frequency is not known (cannot be estimated from the available data).
Croatian: Za spontane prijave nuspojava nakon stavljanja lijeka u promet učestalost je nepoznata (ne može se procijeniti iz dostupnih podataka).
English: It is important to consider the treatment with Pegasys +/- ribavirin induced a growth inhibition during treatment, the reversibility of which is uncertain.
Croatian: Važno je uzeti u obzir da je liječenje lijekom Pegasys +/- ribavirinom izazvalo zastoj u rastu tijekom liječenja čija reverzibilnost nije sigurna.
English: The Pegasys prefilled pens do not allow for appropriate adjustment of dosing in these patients.
Croatian: Pegasys napunjene brizgalice ne omogućuju odgovarajuću prilagodbu doze u tih bolesnika.
English: In the same study, a 25% increase in the AUC of theophylline (marker of cytochrome P450 1A2 activity) was observed, demonstrating that Pegasys is an inhibitor of cytochrome P450 1A2 activity.
Croatian: U istom ispitivanju zamijećeno je 25%-tno povećanje AUC-a teofilina (pokazatelja aktivnosti citokroma P450 1A2), čime se Pegasys pokazao kao inhibitor aktivnosti citokroma P450 1A2.
English: Increased alanine aminotransferase (ALT)
Croatian: Povišene vrijednosti alanin aminotransferaze
English: ● a 1 ml syringe
Croatian: ● štrcaljka od 1 ml
English: Haemoglobin - no cardiac disease
Croatian: Hemoglobin - bolesnik bez bolesti srca
English: Prior to initiation of Pegasys therapy, TSH and T4 levels should be evaluated.
Croatian: Prije početka liječenja lijekom Pegasys, potrebno je izmjeriti razine TSH i T4.
English: Pegasys has minor or moderate influence on the ability to drive and use machines.
Croatian: Pegasys malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Croatian: Smanjenje broja CD4+ stanica reverzibilno je nakon smanjenja doze ili prekida liječenja.
English: Modified Assessment
Croatian: Modificirana procjena
English: Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Croatian: Bolesnici trebaju temeljito prati zube dva puta dnevno i redovito ići na preglede kod stomatologa.
English: In addition some patients may experience vomiting.
Croatian: Osim toga, kod nekih bolesnika može doći do povraćanja.
English: The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials on a case by case basis (see sections 4.8 and 5.1).
Croatian: Očekivanu korist od liječenja potrebno je u svakom pojedinom slučaju pažljivo odvagnuti u odnosu na podatke o sigurnosti primjene u djece i adolescenata iz kliničkih ispitivanja (vidjeti dijelove 4.8 i 5.1).
English: Because of the potential for adverse reactions in breastfed infants, breastfeeding should be discontinued prior to initiation of treatment.
Croatian: Zbog mogućih nuspojava u dojenčadi, dojenje treba prekinuti prije početka liječenja.
English: In both studies the treatment duration was 48 weeks, with 24 weeks of treatment-free follow-up.
Croatian: U oba ispitivanja liječenje je trajalo 48 tjedana, uz praćenje kroz dodatna 24 tjedna bez liječenja.
English: Treatment should normally not be initiated if ALT is >10x ULN .
Croatian: Liječenje se obično ne započinje ako je ALT >10x GGN.
English: Allow the refrigerated pre-filled pen to adjust to room temperature for about 20 minutes.
Croatian: Pustite da napunjena brizgalica, koja je bila u hladnjaku, dosegne sobnu temperaturu kroz otprilike 20 minuta.
English: This would be particularly important in patients with a known history of zidovudine induced anaemia.
Croatian: To je naročito važno za bolesnike kod kojih je već zabilježena anemija uzrokovana zidovudinom.
English: Use of alfa interferons has been associated with exacerbation or provocation of psoriasis and sarcoidosis.
Croatian: Primjena alfa interferona povezana je s pojavom ili pogoršanjem psorijaze i sarkoidoze.
English: The duration of combination treatment in children with chronic hepatitis C varies from 6 to 12 months depending on the type of virus your child is infected with and their response to therapy.
Croatian: Trajanje kombiniranog liječenja u djece s kroničnim hepatitisom C kreće se u rasponu od 6 do 12 mjeseci, ovisno o vrsti virusa kojim je dijete zaraženo te o odgovoru na liječenje.
English: copies/ml.
Croatian: kopija/ml.
English: Haematological tests should be repeated after 2 and 4 weeks and biochemical tests should be performed at 4 weeks.
Croatian: Hematološke pretrage treba ponoviti nakon 2 odnosno 4 tjedna, a biokemijske pretrage nakon 4. tjedna liječenja.
English: The metabolism of Pegasys is not fully characterised; however studies in rats indicate that the kidney is a major organ for excretion of radiolabelled material.
Croatian: Premda metabolizam lijeka Pegasys nije potpuno opisan, istraživanja na štakorima ukazuju da je bubreg glavni organ kojim se izlučuju radioaktivno označene tvari.
English: The extent of available data is not sufficient to conclude that growth inhibition due to Pegasys exposure is always reversible.
Croatian: Podaci iz dugoročnog praćenja nisu dovoljni kako bi se zaključilo da je zastoj u rastu uslijed izloženosti lijeku Pegasys uvijek reverzibilan.
English: HCV genotype 2 and 3
Croatian: HCV genotipa 2 i 3
English: Duration of therapy when Pegasys is used in combination with other medicinal products
Croatian: Trajanje liječenja kada je Pegasys korišten u kombinaciji s drugim lijekovima
English: You will find the expiration date on the box as well as on the label of the pre-filled pen itself.
Croatian: Rok valjanosti naći ćete na kutiji te na naljepnici na samoj napunjenoj brizgalici.
English: < 10 g/dl, and ≥ 8.5 g/dl
Croatian: <10 g/dl i ≥8,5 g/dl
English: Positive predictive values of 45% (50/110) and 70% (59/84) were observed for genotype 1 and genotype 2/3 HIV-HCV co-infected patients receiving combination therapy.
Croatian: Pozitivne prediktivne vrijednosti od 45% (50/110) i 70% (59/84) uočene su za genotip 1 i genotip 2/3 u bolesnika koinficiranih HIV-HCV-om koji se liječe kombiniranom terapijom.
English: The study demonstrated that the post-treatment recovery in growth at 2 years post-treatment was maintained to 6 years post-treatment.
Croatian: Ispitivanje je pokazalo da se oporavak rasta zabilježen 2 godine nakon liječenja održao do 6 godina nakon liječenja.
English: Once the cap is removed, the pre-filled pen should be used immediately.
Croatian: Nakon što skinete zatvarač, napunjenu brizgalicu treba odmah upotrijebiti.
English: Multiple regression and pooled group analyses evaluating the influence of treatment duration and use of induction dosing clearly identified treatment duration for 72 weeks as the primary driver for achieving a sustained virological response.
Croatian: Multipla regresija i analiza na združenom skupu podataka s ciljem procjene utjecaja trajanja liječenja i primjene početnog doziranja, jasno su pokazale da je liječenje u trajanju od 72 tjedna primarni poticaj za postizanje trajnog virološkog odgovora.
English: ● if you develop signs of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while on this medication, seek medical help immediately.
Croatian: • ako tijekom liječenja primijetite znakove teške alergijske reakcije (kao što su poteškoće u disanju, piskanje ili koprivnjača) odmah potražite medicinsku pomoć.
English: The ribavirin dose should be administered with food.
Croatian: Navedene doze ribavirina treba uzimati s hranom.
English: Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
Croatian: Prijavljeno je pogoršanje anemije uslijed primjene ribavirina dok je zidovudin bio dio režima liječenja HIV-a, iako se točan mehanizam još treba razjasniti.
English: Once you have started Pegasys treatment, talk to your doctor, nurse or pharmacist:
Croatian: Nakon što ste započeli liječenje lijekom Pegasys, obratite se svom liječniku, medicinskoj sestri ili ljekarniku:
English: • HIV-HCV patients with cirrhosis and a Child-Pugh score ≥ 6, except if only due to indirect hyperbilirubinemia caused by medicinal products such as atazanavir and indinavir
Croatian: • bolesnici koinficirani HIV-om i HCV-om s cirozom i Child-Pugh indeksom ≥ 6, osim ako se radi o indirektnoj hiperbilirubinemiji uzrokovanoj lijekovima kao što su atazanavir i indinavir
English: Your doctor will monitor you for signs and symptoms of these conditions.
Croatian: Vaš će liječnik pomno pratiti pojavljuju li se kod vas znakovi i simptomi navedenih stanja.
English: Please check with your doctor and follow the recommended duration of treatment.
Croatian: Posavjetujte se sa svojim liječnikom i pridržavajte se preporučenog trajanja liječenja.
English: Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su poredane u padajućem nizu prema ozbiljnosti.
English: StevensJohnson syndrome, toxic epidermal necrolysis, angioedema, erythema multiforme
Croatian: StevensJohnsonov sindrom, toksična epidermalna nekroliza, angioedem, multiformni eritem
English: ● Keep this leaflet.
Croatian: • Sačuvajte ovu uputu.
English: Paediatric patients 5 years of age and older
Croatian: Pedijatrijski bolesnici u dobi od 5 godina i stariji
English: ● Allow the solution to reach room temperature before injection or warm the syringe between your palms.
Croatian: Pustite da otopina postigne sobnu temperaturu prije primjene ili zagrijte štrcaljku među dlanovima.
English: The instructions below should be used as a general guide for proper disposal: Recapping is not required.
Croatian: Niže navedene upute valja slijediti kao opće smjernice za pravilno odlaganje:
English: ● if you develop symptoms associated with a cold or other respiratory infection (such as cough, fever or any difficulty in breathing).
Croatian: • ako se pojave simptomi vezani uz prehladu ili drugu infekciju dišnog sustava (kao što su kašalj, vrućica ili bilo kakav oblik otežanog disanja).
English: A total of 151 patients without advanced fibrosis were 2:1 randomized to Pegasys (group A, n=101) or untreated control (group B, n=50), respectively.
Croatian: Ukupno je 151 bolesnik bez uznapredovale fibroze randomiziran u omjeru 2:1 u skupinu koja je primala Pegasys (skupina A, n=101) ili u neliječenu kontrolnu skupinu (skupina B, n=50).
English: ● Do contact your healthcare provider.
Croatian: Obratite se svojemu zdravstvenom radniku.
English: Physicians considering treatment in these patients should carefully weigh the risks versus the benefits of re-treatment.
Croatian: Liječnici koji razmatraju liječenje u takvih bolesnika moraju pažljivo procijeniti odnos rizika i koristi ponovnog liječenja.
English: Weight decreased
Croatian: Pretrage smanjenje težine
English: Take your next injection on the regularly scheduled day.
Croatian: Iduću injekciju trebate primiti prema redovitom rasporedu predviđenog dana.
English: Other medicines and Pegasys
Croatian: Drugi lijekovi i Pegasys
English: Patients in groups A and C (n=111) were treated with Pegasys once weekly for 48 weeks according to BSA categories, whereas patients in group B were observed for a period of 48 weeks (principal observation period).
Croatian: Bolesnici u skupinama A i C (n=111) primali su Pegasys jedanput tjedno tijekom 48 tjedana prema kategorijama tjelesne površine, dok se bolesnike u skupini B promatralo tijekom 48 tjedana (glavno razdoblje promatranja).
English: The posology of Pegasys in paediatric patients is based on the Body Surface Area (BSA).
Croatian: Doziranje lijeka Pegasys u pedijatrijskih bolesnika temelji se na tjelesnoj površini (engl. body surface area, BSA).
English: ● if you develop any signs of bleeding or unusual bruising, check with your doctor immediately.
Croatian: • ako se pojave znakovi krvarenja ili neobične modrice, odmah se obratite liječniku.
English: 5) Remove cap
Croatian: 5) Uklonite zatvarač
English: Differences in sustained virological response (SVR) based on treatment duration, demographics and best responses to previous treatment are displayed in Table
Croatian: Razlike u trajnom virološkom odgovoru (SVR) na temelju trajanja liječenja, demografskih faktora i najboljih odgovora na ranije liječenje, prikazane su u tablici 19.
English: ● if the patient is a child who has ever had serious psychiatric conditions such as severe depression or thoughts of committing suicide.
Croatian: • ako je bolesnik dijete koje je nekada bolovalo od ozbiljnog psihijatrijskog stanja poput teške depresije ili razmišljalo o samoubojstvu.
English: Avoid your navel and areas that could be irritated by a belt or waistband.
Croatian: Izbjegavajte pupak i područja koja se mogu nadražiti pojasom.
English: While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever, particularly serious infections (bacterial, viral, fungal) must be ruled out, especially in patients with neutropenia.
Croatian: Premda vrućica može biti povezana sa sindromom sličnim gripi koji se često pojavljuje za vrijeme liječenja interferonima, u slučaju tvrdokorne vrućice treba isključiti druge uzroke, naročito ozbiljne infekcije (bakterijske, virusne, gljivične), posebno u bolesnika s neutropenijom.
English: Needle-shield (only visible once cap is removed in Step 5)
Croatian: Štitnik igle (vidljiv tek kad se skine zatvarač u 5. koraku)
English: Pegylated interferon Interferon plus ribavirin Pegylated interferon plus ribavirin
Croatian: Pegilirani interferon Interferon i ribavirin Pegilirani interferon i ribavirin
English: Appropriate training is recommended for non-healthcare professionals administering this medicinal product.
Croatian: Preporučuje se odgovarajuća obuka osoba koje će primjenjivati lijek, a koje nisu zdravstveni radnici.
English: The solution is clear and colourless to light yellow.
Croatian: Otopina je bistra i bezbojna do svijetložuta.
English: Caution is therefore warranted in the treatment of patients with low CD4 counts.
Croatian: Stoga je potreban oprez prilikom liječenja bolesnika s niskim brojem CD4 stanica.
English: If you have the impression that the effect of Pegasys is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako Vam se čini da je učinak lijeka Pegasys prejak ili preslab, obratite se svom liječniku ili ljekarniku.
English: The non-clinical toxicity studies conducted with Pegasys were limited due to species specificity of interferons.
Croatian: Neklinička ispitivanja toksičnosti lijeka Pegasys bila su ograničena zbog specifičnosti djelovanja interferona na različite vrste.
English: Patients should be closely monitored during therapy and even after treatment discontinuation.
Croatian: Bolesnike treba pomno nadzirati tijekom pa i nakon obustave liječenja.
English: None of these patients experienced unusual, serious or treatment-limiting events.
Croatian: Nijedan od tih bolesnika nije imao niti neočekivane niti ozbiljne tegobe, kao ni tegobe koje bi ograničavala daljnje liječenje.
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon alfa products, notably in patients with risk factors for PAH (such as portal hypertension, HIV infection, cirrhosis).
Croatian: Slučajevi plućne arterijske hipertenzije (PAH) prijavljeni su s lijekovima koji sadrže interferon alfa, posebice u bolesnika s faktorima rizika za PAH (poput portalne hipertenzije, infekcije HIV-om, ciroze).
English: ≥2 log10 decline
Croatian: Sniženje ≥ 2 log10
English: p value
Croatian: p-vrijednost
English: This syndrome is a granulomatous inflammatory disorder affecting the eyes, auditory system, meninges, and skin.
Croatian: Ovaj sindrom je granulomatozno upalni poremećaj koji zahvaća oči, slušni sustav, moždane ovojnice i kožu.
English: The side effect may develop at various time points during treatment, typically several months after starting treatment with Pegasys.
Croatian: Nuspojava se može razviti u različitim vremenskim točkama tijekom liječenja, najčešće nekoliko mjeseci nakon početka liječenja s lijekom Pegasys.
English: For persistent or increasing elevations ≥5 but <10 x ULN, reduce dose with a 1 level adjustment and monitor weekly ALT level to ensure it is stable or decreasing.
Croatian: Kod stalnog ili progresivnog povišenja vrijednosti od ≥ 5, ali < 10 puta iznad GGN-a, smanjiti dozu za 1 razinu i tjedno kontrolirati vrijednosti ALT-a kako biste bili sigurni da su stabilne ili se smanjuju.
English: Odds Ratio (95% CI)
Croatian: Omjer izgleda (95% CI)
English: ● the expiration date has passed.
Croatian: ● je istekao rok valjanosti.
English: Ribavirin had no significant effect on the initial viral kinetics over the first 4 to 6 weeks in patients treated with the combination of ribavirin and pegylated interferon alfa-2a or interferon alfa.
Croatian: Ribavirin nije imao značajnoga učinka na početnu kinetiku virusa u prvih 4-6 tjedana u bolesnika koji su liječeni kombinacijom ribavirina i pegiliranog interferona alfa-2a odnosno interferona alfa.
English: * For HBeAg-positive patients: HBV DNA < 105 copies/ml For HBeAg-negative/anti-HBe-positive patients: HBV DNA < 2 x 104 copies/ml
Croatian: * Za HBeAg-pozitivne bolesnike: HBV DNK < 105 kopija/ml Za HBeAg-negativne / anti-HBe-pozitivne bolesnike: HBV DNK < 2 x 10
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7.
English: If patients infected with virus genotype 1, not responding to prior treatment with peginterferon and ribavirin are considered for treatment, the recommended total duration of therapy is 72 weeks (see section 5.1).
Croatian: Ako se razmatra liječenje bolesnika zaraženih virusom genotipa 1 koji prethodno nisu odgovorili na liječenje peginterferonom i ribavirinom, preporučeno ukupno trajanje liječenja iznosi 72 tjedna (vidjeti dio 5.1).
English: ● if you are an adult who has or had a history of substance abuse (e.g. alcohol or drugs)
Croatian: • ako ste odrasla osoba i zlorabite ili ste u prošlosti zlorabili sredstva ovisnosti (npr. alkohol ili droge)
English: Do not exceed the recommended dose.
Croatian: Ne prekoračujte preporučenu dozu.