FrancophonIA/ELRC3.0 huggingface dataset:
English: To calculate BSA, it is recommended to use Mosteller's equation:
Croatian: Za izračun tjelesne površine preporučuje se koristiti Mostellerovu jednadžbu:
English: These side effects can be serious and you may need urgent medical attention.
Croatian: Nuspojave mogu biti ozbiljne, pa ćete možda trebati hitnu liječničku pomoć.
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin.
Croatian: Značajni teratogeni i/ ili embriocidni učinci dokazani su u svih životinjskih vrsta izloženih ribavirinu.
English: ● any part of the pre-filled pen appears to be damaged
Croatian: ● bilo koji dio napunjene brizgalice izgleda oštećen
English: D-82377 Penzberg Germany
Croatian: D-82377 Penzberg Njemačka
English: The clinical significance of this finding is unknown; nonetheless, patients should be monitored for the signs and symptoms of methadone toxicity.
Croatian: Klinički značaj ovog nalaza nije poznat; iako se bolesnici moraju pratiti zbog znakova i simptoma metadonske toksičnosti.
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 potražite hitnu liječničku pomoć ako primijetite da postajete depresivni, razmišljate o samoubojstvu ili ste uočili promjene u svom 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 moguće, dijete treba liječiti nakon pubertetskog zamaha rasta kako bi se umanjio rizik od zastoja u rastu.
English: ● expose to excessive forces or shock.
Croatian: ● ne izlažite pretjeranoj sili ili udarcima.
English: The potency of this medicinal product should not be compared to the one of another pegylated or nonpegylated protein of the same therapeutic class.
Croatian: Jačina ovog lijeka ne smije se uspoređivati s nekim od drugih pegiliranih ili nepegiliranih proteina iz iste terapijske skupine.
English: • If your child has or has ever had a psychiatric disorder, talk to your doctor, who will monitor your child for signs or symptoms of depression (see section 4).
Croatian: • Ako Vaše dijete ima ili je ikada imalo psihijatrijski poremećaj, razgovarajte s liječnikom; on će nadzirati Vaše dijete zbog moguće pojave znakova ili simptoma depresije (pogledajte dio 4.).
English: Do not attempt to administer an injection until you are sure that you understand how to use the pre-filled pen.
Croatian: Ne pokušavajte si dati injekciju dok niste sigurni da ste dobro razumjeli kako uporabiti napunjenu brizgalicu.
English: All patients should be closely monitored for any signs or symptoms of psychiatric disorders.
Croatian: Sve bolesnike treba pažljivo promatrati kako bi se opazili bilo kakvi znakovi ili simptomi psihijatrijskih poremećaja.
English: HBV DNA response *
Croatian: HBV DNK odgovor *
English: You can save the swab to clean the skin area where you will inject Pegasys.
Croatian: Vatu možete sačuvati za čišćenje područja na koži gdje ćete ubrizgati Pegasys.
English: If there is any deterioration of cardiovascular status, therapy should be suspended or discontinued.
Croatian: Ukoliko dođe do bilo kakvog pogoršanja kardiovaskularnog statusa, liječenje se mora obustaviti ili prekinuti.
English: ● if you have had a severe nervous or mental disorder.
Croatian: • ako ste ikada bolovali od teških živčanih ili psihičkih poremećaja.
English: The probability for sustained virological response varied depending upon the previous treatment regimen; see Table 20.
Croatian: Vjerojatnost trajnog virološkog odgovora razlikovala se ovisno o prethodnom terapijskom režimu; vidjeti tablicu 20.
English: While most children returned to their projected height within two years after completing treatment, and the majority of the remaining children within six years after completing treatment, it remains possible that Pegasys may affect the final adult height.
Croatian: Dok se većina djece vratila na očekivanu visinu unutar dvije godine nakon završetka liječenja, i većina preostale djece unutar šest godina nakon završetka liječenja, moguće je da Pegasys može utjecati na konačnu visinu u odrasloj dobi.
English: All patients who completed the phase III studies were eligible for entry into a long-term follow-up study (WV16866).
Croatian: Svi bolesnici koji su završili ispitivanja faze III bili su pogodni za uključivanje u ispitivanje dugotrajnog praćenja (WV16866).
English: Take the pre-filled pen out of the refrigerator.
Croatian: Izvadite napunjenu brizgalicu iz hladnjaka.
English: ● manipulate the needle-shield before, during or after use, as this is a safety device.
Croatian: ● ne dirajte štitnik igle prije, tijekom ili poslije uporabe, budući da se radi o sigurnosnoj napravi.
English: • Autoimmune hepatitis
Croatian: • autoimuni hepatitis
English: There is no further accumulation after 8 weeks of once weekly dosing.
Croatian: Nema daljnje akumulacije lijeka nakon 8 tjedana primjene jedanput tjedno.
English: Pegasys is used alone only if you cannot take ribavirin for any reason.
Croatian: Pegasys se koristi sam jedino ako ne možete uzimati ribavirin iz bilo kojeg razloga.
English: Moreover, the benefit of the combination of telbivudine with interferon alfa (pegylated or standard) is not currently established.
Croatian: Osim toga, korist kombinacije telbivudina s interferonom alfa (pegiliranim ili standardnim) nije trenutno potvrđena.
English: - Adequately controlled thyroid function (TSH and T4)
Croatian: - kontrolirana funkcija štitnjače (TSH i T4)
English: If you see any bubbles, pull the plunger slightly back.
Croatian: Ako vidite mjehuriće, povucite klip malo unatrag.
English: If you are injecting this medicine yourself, you will be instructed how to give the injection.
Croatian: Ako sami ubrizgavate lijek, dobit ćete upute kako sebi dati injekciju.
English: Patients who also have HIV infection: Tell your doctor if you are taking anti-HIV therapy.
Croatian: Bolesnici koji su zaraženi i HIV-om: Recite svom liječniku ako uzimate terapiju protiv virusa HIV-a.
English: As an example: Your regular weekly Pegasys injection is on Monday.
Croatian: Na primjer: Svoju redovitu tjednu injekciju lijeka Pegasys primate ponedjeljkom.
English: Pegasys is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: Pegasys se tijekom trudnoće uzima samo ako moguća korist opravdava mogući rizik za fetus.
English: It is not yet known whether they will return to their projected height and weight after completing treatment.
Croatian: Nije još poznato hoće li nakon završetka liječenja dosegnuti predviđenu visinu i težinu.
English: Therefore, do not breast-feed an infant if you are taking Pegasys.
Croatian: Stoga ne dojite dijete ako uzimate Pegasys.
English: Preliminary and limited safety data demonstrated no obvious departure from the known safety profile of the combination in adults with chronic HCV infection, but, importantly, the potential impact on growth has not been reported.
Croatian: Preliminarni i ograničeni podaci o sigurnosti nisu pokazali očito odstupanje od poznatog sigurnosnog profila ove kombinacije u odraslih s kroničnom HVC infekcijom, ali, što je važno, nije prijavljen moguć utjecaj na rast.
English: Additional testing should be performed periodically during therapy (including glucose monitoring).
Croatian: Povremeno treba raditi i dodatne pretrage tijekom liječenja (uključujući praćenje glukoze).
English: 55% (21 of 38) of subjects who completed the original study enrolled in the long-term follow up extending up to 6 years post-treatment.
Croatian: 55% (21 od 38) ispitanika koji su završili originalno ispitivanje uključeno je u dugoročno praćenje u trajanju do 6 godina nakon liječenja.
English: Do not use Pegasys if you are taking telbivudine (see “Do not use Pegasys”) because the combination of these medicines increases the risk of developing peripheral neuropathy (numbness, tingling, and/or burning sensations in the arms and/or legs).
Croatian: Nemojte primjenjivati Pegasys ako uzimate telbivudin (pogledajte “Nemojte primjenjivati Pegasys“) jer kombinacija ovih lijekova povećava rizik od nastanka periferne neuropatije (utrnulosti, trnaca i/ili žarenja u rukama i/ili nogama).
English: A duration of therapy less than 48 weeks has not been adequately studied.
Croatian: Trajanje liječenja kraće od 48 tjedana nije dovoljno ispitano.
English: No single biomarker with a cut-off can be identified to optimize all the operating characteristics (negative predictive value [NPV], sensitivity, specificity) and practical characteristics (simplicity, convenience).
Croatian: Ne može se odrediti nijedan pojedinačni biološki biljeg s graničnom vrijednošću koji optimizira sve mjere valjanosti (negativna prediktivna vrijednost [NPV], osjetljivost, specifičnost) i praktične značajke (jednostavnost, praktičnost).
English: Be sure not to touch the cleaned area prior to injection.
Croatian: Pazite da ne dodirujete očišćeno mjesto prije nego li si date injekciju.
English: You remember on Friday that you forgot to take your injection on Monday (4 days late).
Croatian: U petak se sjetite da ste u ponedjeljak zaboravili primiti injekciju (4 dana kasnije).
English: The difference between treatment regimens was in general not influenced by presence/absence of cirrhosis; therefore treatment recommendations for genotype 1, 2 or 3 are independent of this baseline characteristic.
Croatian: Razlike između načina liječenja općenito nisu ovisile o prisutnosti/odsutnosti ciroze; stoga preporuke za liječenje za genotipove 1, 2 ili 3 ne ovise o ovoj početnoj karakteristici.
English: After the Week 24 follow-up visit, patients from group A, B and C entered a long-term follow-up period (lasting for 5 years after end of treatment).
Croatian: Nakon posjeta u 24. tjednu praćenja, bolesnici iz skupina A, B i C ušli su u dugoročno razdoblje praćenja (koje je trajalo 5 godina nakon završetka liječenja).
English: Must not be given to premature babies or neonates.
Croatian: Ne smije se davati prerano rođenoj djeci i novorođenčadi.
English: A full listing of adverse reactions reported in this treatment group (n=55) is provided in Table 10.
Croatian: Cjeloviti popis nuspojava prijavljenih u toj terapijskoj skupini (n=55) nalazi se u tablici 10.
English: Predictability of response Please refer to section 4.2, in Table 2.
Croatian: Predvidljivost odgovora Vidjeti dio 4.2, u tablici 2.
English: Excipient with known effect: Benzyl alcohol (10 mg/ 1 ml)
Croatian: Pomoćna tvar s poznatim učinkom: benzilni alkohol (10 mg/ 1 ml)
English: The ultimate clinical impact of a shortened initial treatment of 16 weeks instead of 24 weeks is unknown, taking into account the need for re-treating non-responding and relapsing patients.
Croatian: Konačan klinički utjecaj skraćenog početnog liječenja od 16 tjedana umjesto 24 tjedna nije poznat, s obzirom na potrebu za ponovnim liječenjem bolesnika koji ne odgovaraju na liječenje i bolesnika u relapsu.
English: Pegasys must not be given to children below the age of 3 years because it contains benzyl alcohol and may cause toxic reactions and allergic reactions in these children.
Croatian: Pegasys se ne smije davati djeci mlađoj od 3 godine jer sadrži benzilni alkohol pa može izazvati toksične i alergijske reakcije u te djece.
English: ● if you have had an organ transplant (liver or kidney) or have one planned in the near future.
Croatian: • ako ste primili presadak organa (jetre ili bubrega) ili je presađivanje planirano u bliskoj budućnosti
English: Within 24 hours, about 80% of the peak serum concentration is reached.
Croatian: Unutar 24 sata lijek postiže oko 80% svoje maksimalne serumske koncentracije.
English: Although no teratogenic effects were seen in the offspring delivered at term, adverse effects in humans cannot be excluded.
Croatian: Premda nisu zamijećeni nikakvi teratogeni učinci na mladunce koji su se rodili u terminu, ne mogu se isključiti mogući neželjeni učinci u ljudi.
English: The duration of combination treatment varies from 4 to 18 months depending on the type of virus you are infected with, on treatment response and whether you have been treated before.
Croatian: Trajanje kombinirane terapije varira od 4 mjeseca do 18 mjeseci, ovisno o vrsti virusa kojim ste zaraženi, o odgovoru na liječenje i jeste li već ranije liječeni.
English: The mechanism behind these events is not known; thus, co-treatment with telbivudine and other interferons (pegylated or standard) may also entail an excess risk.
Croatian: Mehanizam nastanka ovih događaja nije poznat, stoga istovremena primjena telbivudina i drugih interferona (pegiliranih ili standardnih) može također nositi povećani rizik.
English: You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
Croatian: Bilo bi dobro da člana obitelji ili bliskog prijatelja zamolite da vas upozori ako opazi znakove depresije ili promjene u ponašanju.
English: ● if you have, so called autoimmune hepatitis.
Croatian: • ako bolujete od tzv. autoimunog hepatitisa.
English: HBeAg negative / anti-HBe positive Study WV16241
Croatian: HBeAg negativni / anti-HBe pozitivni ispitivanje WV16241
English: You are now back on your regularly scheduled day and should continue your injections every Monday.
Croatian: Sad ste se vratili natrag na redoviti raspored te biste nadalje injekcije trebali primati svakog ponedjeljka.
English: ● if you have diabetes or high blood pressure, your doctor may ask you to have an eye examination.
Croatian: • ako bolujete od šećerne bolesti ili visokog krvnog tlaka, liječnik Vas može uputiti na očni pregled.
English: If it is not used within 5 minutes, the pre-filled pen should be disposed and a new pre-filled pen should be used.
Croatian: Ne upotrijebi li se unutar 5 minuta, napunjenu brizgalicu treba zbrinuti i upotrijebiti novu.
English:  The pre-filled pen is now unlocked and ready for injection.
Croatian: → Sada je napunjena brizgalica otključana i spremna za injekciju.
English: What Pegasys is and what it is used for
Croatian: Što je Pegasys i za što se koristi
English: Study ML17131
Croatian: Ispitivanje ML17131
English: Treatment difference [95%CI]
Croatian: Razlika između terapija [95%CI]
English: Thus, the lower the BSA of the child, the lower the clearance of the drug and the higher the resultant exposure.
Croatian: Dakle, što je manja tjelesna površina djeteta, manji je klirens lijeka, što rezultira većom izloženošću.
English: Pharmacotherapeutic group: Immunostimulants, interferons, ATC code: L03AB11
Croatian: Farmakoterapijska skupina: Imunostimulatori, interferoni, ATK oznaka: L03AB11
English: 24 weeks or 48 weeks
Croatian: 24 tjedna ili 48 tjedana
English: Histological response was similar across the three treatment groups in each study; however, patients showing a sustained response 24 weeks after the end of treatment were significantly more likely to also show histological improvement.
Croatian: Histološki odgovor bio je sličan u sve tri liječene skupine u svakom ispitivanju; međutim, bilo je vrlo vjerojatno da će bolesnici koji su pokazivali trajni virološki odgovor 24 tjedna nakon završetka liječenja pokazivati i histološki napredak.
English: Some people get depressed when taking Pegasys alone or in combination treatment with ribavirin, and in some cases people have had suicidal thoughts or aggressive behaviour (sometimes directed against others such as thoughts about threatening the life of the others).
Croatian: Neki ljudi postaju depresivni tijekom liječenja lijekom Pegasys u kombinaciji s ribavirinom, a u nekim su slučajevima razmišljali o samoubojstvu ili se ponašali agresivno (ponekad usmjereno prema drugima kao pomisli na ugrožavanje života drugih).
English: ● Do not repeat the injection
Croatian: Ne ponavljajte ubrizgavanje
English: The study efficacy results for these patients are summarised in Table 25.
Croatian: Rezultati ispitivanja djelotvornosti za te bolesnike sažeti su u tablici 25.
English: NOTE: Do not yet attempt to press the activation button.
Croatian: Još uvijek ne pokušavajte pritisnuti aktivacijsko dugme.
English: When Pegasys is used in combination with ribavirin, both male and female patients must take special precautions in their sexual activity if there is any chance for pregnancy to occur, as ribavirin can be very damaging to an unborn baby:
Croatian: Kada se Pegasys koristi u kombinaciji s ribavirinom, i muški i ženski bolesnici moraju poduzeti posebne mjere opreza pri seksualnoj aktivnosti ako postoji bilo kakva mogućnost trudnoće jer ribavirin može biti vrlo opasan za nerođeno dijete:
English: ● the medicine contains particles
Croatian: ● ako lijek sadržava čestice
English: Response Parameter
Croatian: Parametar odgovora
English: Body Surface Area (BSA) range (m2)
Croatian: Raspon tjelesne površine (BSA) (m2)
English: Chronic Hepatitis B: Pegasys is usually used alone.
Croatian: Kronični hepatitis B: Pegasys se obično koristi samostalno.
English: Contact your doctor or pharmacist if you need any help determining how to manage a missed dose of Pegasys.
Croatian: Obratite se liječniku ili ljekarniku ako Vam je potrebna pomoć da odredite kako nadoknaditi propuštenu dozu lijeka Pegasys.
English: 4) Choose and prepare an injection site
Croatian: 4) Izaberite i pripremite mjesto injekcije
English: Treatment should be initiated only by a physician experienced in the treatment of patients with hepatitis B or C.
Croatian: Liječenje smije započeti samo liječnik koji ima iskustva u liječenju bolesnika s hepatitisom B ili C.
English: Studies in animals with interferon alfa-2a have shown reproductive toxicity (see section 5.3) and the potential risk for humans is unknown.
Croatian: Istraživanja interferona alfa-2a u životinja pokazala su njihovu reprodukcijsku toksičnost (vidjeti dio 5.3), a mogući rizik za ljude nije poznat.
English: The syringe, needle and all injection materials are intended for single use and must be discarded after the injection.
Croatian: Štrcaljka, igla i sav materijal za ubrizgavanje namijenjeni su jednokratnoj uporabi te se nakon uporabe moraju baciti.
English: For more information, see section 5.1.
Croatian: Dodatne informacije potražite u dijelu 5.1.
English: All patients were followed up for 24 weeks post-treatment (groups A and C), or post-principal observation period (group B).
Croatian: Svi su bolesnici bili praćeni tijekom 24 tjedna nakon liječenja (skupine A i C) ili glavnog razdoblja promatranja (skupina B).
English: ● attempt to open or dismantle the pre-filled pen.
Croatian: ● ne pokušavajte otvoriti ili rastaviti napunjenu brizgalicu.
English:  The needle-shield will automatically move out and lock to prevent needle injuries.
Croatian: → Štitnik igle automatski će se izvući i zaključati brizgalicu da spriječi ozljede iglom.
English: Progressive decreases after 8 weeks of therapy were infrequent.
Croatian: Nastavak pada nakon 8 tjedana liječenja bio je rijedak.
English: Overall treatment for 16 weeks resulted in lower sustained viral response (65%) than treatment for 24 weeks (76%) (p < 0.0001).
Croatian: Ukupno liječenje od 16 tjedana rezultiralo je slabijim trajnim virološkim odgovorom (65%) nego liječenje od 24 tjedna (76%) (p < 0,0001).
English: The reversibility of growth inhibition is uncertain.
Croatian: Reverzibilnost inhibicije rasta nije izvjesna.
English: The usual dose of Pegasys is based on your child's height and weight.
Croatian: Uobičajena doza lijeka Pegasys temelji se na visini i tjelesnoj težini Vašeg djeteta.
English: ● if you think you are getting an infection (such as pneumonia) as when receiving Pegasys you may temporarily have a greater risk of getting an infection.
Croatian: • ako mislite da ste dobili infekciju (kao što je upala pluća) jer tijekom primanja lijeka Pegasys privremeno možete biti podložniji infekcijama.
English: ● if you have been withdrawn from previous therapy for Hepatitis C because of anaemia or low blood count.
Croatian: • ako Vam je prekinuto ranije liječenje hepatitisa C zbog anemije ili malog broja krvnih stanica.
English: Dispose of the pre-filled pen and use another if:
Croatian: Napunjenu brizgalicu bacite i uzmite drugu ako:
English: Transient rashes do not necessitate interruption of treatment.
Croatian: U slučajevima prolaznih osipa nije potrebno prekidati liječenje.
English: Any patient complaining of decrease or loss of vision must have a prompt and complete eye examination.
Croatian: Bolesnici koji se žale na smanjenje ili gubitak vida moraju čim prije otići na očni pregled.
English: Absolute Neutrophil Count
Croatian: Apsolutni broj neutrofila
English: While holding pre-filled pen firmly in place, press the activation button with your thumb and immediately release the button.
Croatian: Dok čvrsto držite napunjenu brizgalicu na mjestu, pritisnite aktivacijsko dugme palcem i odmah ga otpustite.
English: The dose reduction levels are provided in Table 8.
Croatian: Razine smanjenja doze navedene su u tablici 8.
English: There was no difference in response rate between these patients and those without advanced fibrosis or cirrhosis.
Croatian: Nije bilo razlike u stopi odgovora između navedenih bolesnika i bolesnika bez uznapredovale fibroze ili ciroze.
English: Pegasys pre-filled pens should not be used by children and adolescents who require doses less than 135 micrograms.
Croatian: Pegasys napunjene brizgalice ne smiju se primjenjivati u djece i adolescenata kojima je potrebna doza manja od 135 mikrograma.
English: NPV Sensitivity Specificity HBeAg-positive(a)
Croatian: NPV Osjetljivost Specifičnost HBeAg-pozitivni
English: With respect to the decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1.
Croatian: Za donošenje odluke o uvođenju liječenja u pedijatrijskih bolesnika vidjeti dijelove 4.2, 4.4 i 5.1.
English: Fever/infections
Croatian: Vrućica/infekcije
English: If ALT increase is progressive or persistent, the dose should be reduced initially to 135 micrograms.
Croatian: Ako je porast ALT-a progresivan ili stalan, dozu treba, za početak, smanjiti na 135 mikrograma.
English: In case of persistent or unexplained pulmonary infiltrates or pulmonary function impairment, treatment should be discontinued.
Croatian: U slučaju znakova stalnih ili neobjašnjivih infiltrata odnosno oštećenja funkcije pluća, liječenje se mora prekinuti.
English: Pulmonary changes
Croatian: Plućne promjene
English: Infections: Fungal, viral and bacterial infections.
Croatian: Infekcije: gljivične, virusne i bakterijske infekcije.
English: Consideration for early treatment discontinuation should be evaluated in the context of a particular clinical situation.
Croatian: Kada se razmatra rani prekid liječenja, to treba procijeniti u kontekstu konkretne kliničke situacije.
English: Your doctor or his/her assistant will instruct you on how to give the injections.
Croatian: Vaš liječnik ili njegov pomoćnik će Vam objasniti kako se daje injekcija.
English: What Pegasys is and what it is used for What you need to know before you use Pegasys How to use Pegasys
Croatian: Što je Pegasys i za što se koristi Što morate znati prije nego počnete primjenjivati Pegasys
English: Study NV15496 + NV15497 + NV15801
Croatian: Ispitivanja NV15496+ NV15497+NV15801
English: Take your next doses at 5 day intervals until you return to your regularly scheduled day of the week.
Croatian: Iduće doze trebate primiti u intervalima od 5 dana, sve dok se ne vratite na dan redovitog rasporeda primanja lijeka.
English: 1-5% of patients treated with Pegasys developed neutralising anti-interferon antibodies.
Croatian: 1-5% bolesnika liječenih lijekom Pegasys razvilo je neutralizirajuća antitijela na interferon.
English: Patients who initiate treatment prior to their 18th birthday should maintain paediatric dosing through the completion of therapy.
Croatian: Bolesnici koji započnu liječenje prije 18. rođendana trebaju ostati na pedijatrijskom režimu doziranja do kraja terapije.
English: The solution for injection is for single use only.
Croatian: Otopina za injekciju namijenjena je samo jednokratnoj uporabi.