FrancophonIA/ELRC3.0 huggingface dataset:
English: Important information about some of the ingredients of ViraferonPeg Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.
Croatian: Važne informacije o nekim sastojcima lijeka ViraferonPeg Bolesnici s rijetkim nasljednim poremećajima nepodnošenja fruktoze, malapsorpcijom glukoze i galaktoze ili insuficijencijom saharaza-izomaltaza ne bi trebali uzimati ovaj lijek.
English: If blood comes into the syringe, the needle has entered a blood vessel.
Croatian: Ako u štrcaljku uđe krv, to znači da je igla probola krvnu žilu.
English: If you are uncertain, contact your doctor or pharmacist or the doctor or pharmacist of the child you are caring for.
Croatian: Ako niste sigurni, obratite se liječniku ili ljekarniku, odnosno liječniku ili ljekarniku djeteta o kojem skrbite.
English: It may be used in adults who have not been previously treated for HCV infection or who have previously used medicines called interferons and pegylated interferons.
Croatian: Može se koristiti u odraslih koji prethodno nisu liječili HCV infekciju ili koji su ranije koristili lijekove koji se zovu interferoni i pegilirani interferoni.
English: It is recommended that patients who have pre-existing cardiac abnormalities have electrocardiograms taken prior to and during the course of treatment.
Croatian: U bolesnika s već postojećim srčanim poremećajima preporučuje se snimiti elektrokardiograme prije i tijekom liječenja.
English: If VKH syndrome is suspected, antiviral treatment should be withdrawn and corticosteroid therapy discussed (see section 4.8).
Croatian: Ako se posumnja na VKH sindrom, treba prekinuti antivirusno liječenje i razmotriti liječenje kortikosteroidima (vidjeti dio 4.8).
English: ViraferonPeg pre-filled pen is to be removed from the refrigerator before administration to allow the solvent to reach room temperature (not more than 25°C).
Croatian: ViraferonPeg napunjenu brizgalicu treba prije primjene izvaditi iz hladnjaka kako bi otapalo dostiglo sobnu temperaturu (ne iznad 25°C).
English: Total daily ribavirin dose (mg)
Croatian: Ukupna dnevna doza ribavirina (mg)
English: - Stand the vial upright and let any bubbles present in the solution rise to the top of the solution.
Croatian: - Postavite bočicu uspravno i pustite da svi mjehurići prisutni u otopini dođu na vrh.
English: Paediatric population (bitherapy only) - Duration of treatment
Croatian: Pedijatrijska populacija (samo dvojna terapija) - trajanje liječenja
English: The mechanisms involved in clearance of interferons in man have not yet been fully elucidated.
Croatian: Mehanizmi uključeni u klirens interferona u čovjeka još nisu u potpunosti razjašnjeni.
English: The purpose of the study was to evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes.
Croatian: Svrha ispitivanja bila je procjena održivosti trajnog virološkog odgovora i utjecaja kontinuirano negativnog nalaza virusa na klinički ishod bolesti.
English: Press the injection site with a small bandage or sterile gauze if necessary for several seconds.
Croatian: Po potrebi pritisnite mjesto injiciranja nekoliko sekundi malim tupferom ili sterilnom gazom.
English: 3 was observed in 4 %
Croatian: 3 zabilježeno je u 4% (8/194)
English: If this medicine is used in combination with ribavirin, your doctor should monitor you, or the child you are caring for more carefully for a decrease in red blood cell count.
Croatian: Ako se ovaj lijek primjenjuje u kombinaciji s ribavirinom, liječnik mora Vas ili dijete o kojem skrbite pažljivije nadzirati zbog mogućeg smanjenja broja crvenih krvnih stanica.
English: Tongue pigmentation
Croatian: pigmentacija jezika
English: Do not aim the stream directly at the white solid or powder, or inject the liquid quickly, as this causes a greater amount of bubbles.
Croatian: Nemojte usmjeravati mlaz izravno na tabletu ili prašak i nemojte tekućinu ubrizgati naglo jer će se stvoriti previše mjehurića.
English: The recommended duration of treatment with bitherapy is 24 weeks.
Croatian: Preporučeno trajanje liječenja dvojnom terapijom je 24 tjedna.
English: Upper limit of normal
Croatian: * GGN - gornja granica normalnog raspona
English: • TSH level must be within normal limits
Croatian: mora biti u granicama normalnih vrijednosti
English: Dysgeusia, syncope, disturbance in attention, somnolence, poor quality sleep
Croatian: disgeuzija, sinkopa, poremećaj pažnje, somnolencija, loša kvaliteta spavanja
English: However, ribavirin systemic exposure of a female partner after sexual intercourse with a treated patient has been estimated and remains extremely limited compared to therapeutic plasma concentration of ribavirin.
Croatian: Međutim, procijenjena je sistemska izloženost ribavirinu u partnerice nakon spolnog odnosa s liječenim bolesnikom koja i dalje ostaje iznimno mala u odnosu na terapijsku koncentraciju ribavirina u plazmi.
English: This medicinal product should only be reconstituted with the solvent provided (see section 6.6).
Croatian: Ovaj lijek se smije rekonstituirati samo s priloženim otapalom (vidjeti dio 6.6).
English: Metabolic disturbances
Croatian: Metabolički poremećaji
English: Guidelines were developed in clinical trials for dose modification.
Croatian: U kliničkim ispitivanjima utvrđene su smjernice za prilagodbu doze.
English: Fluid replacement may be necessary.
Croatian: Možda će biti potrebna nadoknada tekućine.
English: This decline was significant among responders (-0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among non-responders.
Croatian: To je smanjenje bilo značajno u bolesnika koji su odgovorili na liječenje (-0,3 za Metavir i -1,2 za Ishak) te stabilno (-0,1 za Metavir i0,2 za Ishak) u bolesnika bez odgovora.
English: What ViraferonPeg is and what it is used for What you need to know before you use ViraferonPeg How to use ViraferonPeg
Croatian: Što je ViraferonPeg i za što se koristi Što morate znati prije nego počnete primjenjivati ViraferonPeg Kako primjenjivati ViraferonPeg Moguće nuspojave
English: A clinical trial investigating the combination of telbivudine, 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration, indicates that this combination is associated with an increased risk of developing peripheral neuropathy.
Croatian: Kliničko ispitivanje, u kojemu se ispitivala kombinacija telbivudina u dozi od 600 mg na dan s pegiliranim interferonom alfa-2a primijenjenim supkutano u dozi od 180 mikrograma jedanput na tjedan, pokazuje da je ova kombinacija povezana s povećanim rizikom za razvoj periferne neuropatije.
English: Note: The needle shield will automatically SNAP UP as you dial (see Figure 9).
Croatian: Napomena: Zaštita za iglu automatski će ISKOČITI kako budete okretali vijak za doziranje (vidjeti Sliku 9).
English: In this subgroup, there was a 92 % (89/97) sustained virological response rate.
Croatian: U toj je podskupini udio trajnog terapijskog odgovora iznosio 92% (89/97).
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: Interferon monotherapy, including ViraferonPeg, is indicated mainly in case of intolerance or contraindication to ribavirin.
Croatian: Monoterapija interferonom, uključujući ViraferonPeg, indicirana je uglavnom u slučaju nepodnošenja ribavirina ili kada je njegova primjena kontraindicirana.
English: Number of patients Response at end of treatment Sustained response
Croatian: Broj bolesnika Odgovor na kraju liječenja
English: Psychiatric and central nervous system:
Croatian: Psihijatrijske nuspojave i nuspojave središnjeg živčanog sustava:
English: Children and adolescents This medicine is not recommended for use in patients under the age of 3 years.
Croatian: Ne preporučuje se primjena ovog lijeka u bolesnika mlađih od 3 godine.
English: The decision to treat should be made on a case by case basis (see section 4.4).
Croatian: Odluku o liječenju treba donijeti za svakog bolesnika pojedinačno (vidjeti dio 4.4).
English: Long-term data available in children treated with the combination therapy of pegylated interferon/ribavirin are indicative of substantial growth retardation.
Croatian: Dostupni dugoročni podaci u djece liječene kombiniranom terapijom pegiliranim interferonom/ribavirinom ukazuju na znatno usporenje rasta.
English: What you need to know before you use ViraferonPeg
Croatian: Što morate znati prije nego počnete primjenjivati ViraferonPeg
English: A five-year long-term, observational, follow-up study enrolled 94 paediatric chronic hepatitis C patients after treatment in a multicentre trial.
Croatian: U 5-godišnje opservacijsko ispitivanje praćenja uključena su 94 pedijatrijska bolesnika s kroničnim hepatitisom C nakon završetka liječenja u multicentričnom ispitivanju.
English: Look at the date printed on the carton after EXP to make sure that the expiration date has not passed.
Croatian: Provjerite datum otisnut na kutiji iza "Rok valjanosti" kako biste bili sigurni da rok valjanosti nije istekao.
English: Women of childbearing potential/contraception in males and females ViraferonPeg is recommended for use in fertile women only when they are using effective contraception during the treatment.
Croatian: Žene generativne dobi/kontracepcija u muškaraca i žena Primjena lijeka ViraferonPeg u plodnih žena preporučuje se samo ako tijekom liječenja koriste učinkovitu kontracepciju.
English: Class label for interferon products, see below Pulmonary arterial hypertension.
Croatian: Značajka skupine lijekova koji sadrže interferon, vidjeti niže Plućna arterijska hipertenzija.
English: The negative predictive value for sustained response in HCV/HIV co-infected patients treated with ViraferonPeg in combination with ribavirin was 99 % (67/68; Study 1) (see section 5.1).
Croatian: Negativna prediktivna vrijednost za trajan odgovor u bolesnika s istodobnom infekcijom HCV-om i HIV-om liječenih lijekom ViraferonPeg u kombinaciji s ribavirinom iznosila je 99% (67/68; Ispitivanje 1) (vidjeti dio 5.1).
English: This would be particularly important in patients with a known history of zidovudine-induced anaemia.
Croatian: To je osobito važno u bolesnika koji su prethodno imali anemiju uzrokovanu zidovudinom.
English: Children and adolescents should be monitored every 3 months for evidence of thyroid dysfunction (e.g. TSH).
Croatian: Djecu i adolescente treba kontrolirati svaka 3 mjeseca kako bi se uočili eventualni znakovi poremećaja funkcije štitnjače (npr. TSH).
English: Combination therapy with ribavirin
Croatian: Kombinirana terapija s ribavirinom
English: Important treatment-emergent adverse reactions that occurred in this patient population were nervousness (8 %), aggression (3 %), anger (2 %), depression/depressed mood (4 %) and hypothyroidism (3 %) and 5 subjects received levothyroxine treatment for hypothyroidism/elevated TSH.
Croatian: Važne nuspojave koje su se pojavile tijekom liječenja u ovoj populaciji bolesnika su nervoza (8%), agresivnost (3%), ljutnja (2%), depresija/depresivno raspoloženje (4%) i hipotireoza (3%), a 5 je ispitanika uzimalo levotiroksin za liječenje hipotireoze/povišenih razina TSH-a.
English: The 6 month treatment duration in this trial was better tolerated than one year of treatment in the pivotal combination trial; for discontinuation 5 % vs. 14 %, for dose modification 18 % vs. 49 %.
Croatian: Šestomjesečno liječenje u ovom ispitivanju podnosilo se bolje nego jednogodišnje liječenje u pivotalnom ispitivanju kombinirane terapije: obustava liječenja u 5% naspram 14% bolesnika, a prilagodba doze u 18% naspram 49%.
English: Do not inject ViraferonPeg into an area where the skin is irritated, red, bruised, infected, or has scars, stretch marks, or lumps.
Croatian: Nemojte injicirati ViraferonPeg na mjesta na kojima je koža nadražena, crvena, gdje su prisutne modrice, infekcija, ožiljci, strije ili izbočine.
English: Mean (SD) ViraferonPeg elimination half-life is approximately 40 hours (13.3 hours), with apparent clearance of 22.0 ml/hr/kg.
Croatian: Srednja vrijednost (SD) poluvremena eliminacije lijeka ViraferonPeg iznosi oko 40 sati (13,3 sata), uz prividni klirens od 22,0 ml/h/kg.
English: The major treatment-related change was a reversible, mild to moderate anaemia, the severity of which was greater than that produced by either active substance alone.
Croatian: Najveća promjena vezana uz liječenje bila je blaga do umjerena reverzibilna anemija, koja je bila teža od anemija prouzročenih samo jednim ili drugim lijekom.
English: These adverse reactions were common (≥1/100 to < 1/10) in clinical trials in patients treated with ViraferonPeg monotherapy.
Croatian: * Ove su nuspojave bile česte (≥ 1/100 i < 1/10) u kliničkim ispitivanjima bolesnika liječenih lijekom ViraferonPeg u monoterapiji.
English: There are no data available regarding potential effects of ViraferonPeg treatment on male or female fertility.
Croatian: Nema dostupnih podataka o mogućim učincima liječenja lijekom ViraferonPeg na plodnost muškaraca ili žena.
English: Plasma HCV-RNA is measured with a research-based quantitative polymerase chain reaction assay by a central laboratory *Intent to treat population includes 7 patients for whom at least 12 weeks of prior therapy could not be confirmed.
Croatian: HCV-RNK u plazmi mjerila se na istraživanju utemeljenim postupkom kvantitativne lančane reakcije polimerazom u centralnom laboratoriju. * U populaciju s namjerom liječenja uključeno je i 7 bolesnika za koje se nije moglo potvrditi prethodno liječenje u trajanju od najmanje 12 tjedana
English: HCV-RNA should be measured periodically during treatment (see section 4.2).
Croatian: Tijekom liječenja treba povremeno mjeriti HCV-RNK (vidjeti dio 4.2).
English: ViraferonPeg increases the risk of hepatic decompensation and death in patients with cirrhosis.
Croatian: ViraferonPeg povećava rizik od dekompenzacije jetre i smrti u bolesnika s cirozom.
English: After injection of the dose, discard the pen in an appropriate container.
Croatian: Nakon injiciranja doze, brizgalicu zbrinite u odgovarajući spremnik.
English: If such a reaction develops during treatment with ViraferonPeg, discontinue treatment and institute appropriate medical therapy immediately.
Croatian: Razvije li se takva reakcija tijekom liječenja lijekom ViraferonPeg, treba odmah obustaviti liječenje i uvesti odgovarajuću terapiju.
English: Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of ViraferonPeg in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
Croatian: S obzirom da je prijavljeno da interferon alfa uzrokuje egzacerbaciju postojeće psorijaze i sarkoidoze, primjena lijeka ViraferonPeg u bolesnika s psorijazom i sarkoidozom preporučuje se samo ako očekivana korist opravdava mogući rizik.
English: Insert the needle into the pinched skin at an angle of approximately 45°.
Croatian: Ubodite iglom nabor kože koji držite između prstiju, pod kutom od približno 45°.
English: Water for injection and ViraferonPeg powder are provided in separate ampoules.
Croatian: Voda za injekcije i ViraferonPeg prašak dolaze u odvojenim ampulama.
English: A clinically significant pharmacokinetic interaction was not observed between peginterferon alfa-2b (ViraferonPeg) and tolbutamide, midazolam or dapsone; therefore, no dosing adjustment is necessary when peginterferon alfa-2b (ViraferonPeg) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.
Croatian: Nije primijećena klinički značajna farmakokinetička interakcija između peginterferona alfa-2b (ViraferonPeg) i tolbutamida, midazolama ili dapsona; stoga nije potrebna prilagodba doze kada se peginterferon alfa-2b (ViraferonPeg) primjenjuje s lijekovima koji se metaboliziraju posredstvom CYP2C9, CYP3A4 i N-acetiltransferaze.
English: The recommended duration of treatment with bitherapy is 1 year.
Croatian: Preporučeno trajanje liječenja dvojnom terapijom je godinu dana.
English: The shield will automatically glide back to allow the needle to inject the medicine.
Croatian: Zaštita za iglu automatski će kliznuti unatrag kako bi se igla oslobodila za injiciranje lijeka.
English: Standard methods to increase elimination of the medicinal product, e.g., dialysis, have not been shown to be useful.
Croatian: Pokazalo se da standardne mjere za ubrzano uklanjanje lijeka, primjerice dijaliza, u ovom slučaju nisu korisne.
English: Table 5 Precautions for co-administration (ViraferonPeg should be administered with care when co-administered with the following medicines)
Croatian: Tablica 5 Mjere opreza za istodobnu primjenu (ViraferonPeg treba primjenjivati uz oprez kada se primjenjuje istodobno sa sljedećim lijekovima)
English: ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Croatian: ViraferonPeg 1,5 mikrograma/kg na tjedan u kombinaciji s ribavirin kapsulama.
English: One ampoule of solvent contains 0.7 ml of water for injections.
Croatian: Jedna ampula s otapalom sadrži 0,7 ml vode za injekcije.
English: If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
Croatian: Pojave li se takvi simptomi, nadležni liječnik mora imati na umu moguću ozbiljnost ovih nuspojava te razmotriti potrebu za odgovarajućim liječenjem.
English: Healthy Subjects (N=13)
Croatian: Zdravi ispitanici (N=13)
English: The negative predictive value for sustained response in patients treated with ViraferonPeg in monotherapy was 98 %.
Croatian: Negativna prediktivna vrijednost za trajan virološki odgovor u bolesnika liječenih lijekom ViraferonPeg u monoterapiji bila je 98%.
English: All patients in the selected chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i.e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Croatian: Svim bolesnicima uključenima u odabrana ispitivanja kroničnog hepatitisa C učinjena je biopsija jetre prije uključenja, no u nekim je slučajevima (tj. u bolesnika s genotipom 2 ili 3) moguće započeti liječenje bez histološke potvrde bolesti.
English: Bilirubin - indirect
Croatian: Indirektni bilirubin
English: The use of ViraferonPeg in combination with ribavirin had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Croatian: Uporaba lijeka ViraferonPeg u kombinaciji s ribavirinom nije imala vidljivih negativnih učinaka na kontrolu viremije HIV-a tijekom liječenja ili praćenja bolesnika.
English: Among patients with undetectable HCV-RNA at the end of treatment, the relapse rate was 24 %.
Croatian: Među bolesnicima u kojih je na kraju liječenja HCV-RNK bio nemjerljiv, stopa recidiva iznosila je 24%.
English: The relative non-toxicity of monomethoxy-polyethylene glycol (mPEG), which is liberated from ViraferonPeg by metabolism in vivo has been demonstrated in preclinical acute and subchronic toxicity studies in rodents and monkeys, standard embryo-foetal development studies and in in vitro mutagenicity assays.
Croatian: Relativna netoksičnost monometoksipolietilenglikola (mPEG), koji se metabolizmom oslobađa iz lijeka ViraferonPeg in vivo, dokazana je u pretkliničkim ispitivanjima akutne i subkronične toksičnosti u glodavaca i majmuna, u standardnim ispitivanjima embriofetalnog razvoja i testovima mutagenosti in vitro.
English: This means that it is injected through a short needle into the fatty tissue just under the skin.
Croatian: To znači da se kratkom iglom ubrizgava u masno tkivo odmah ispod kože.
English: Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Croatian: Ispitivanje 1 (RIBAVIC; P01017) bilo je randomizirano, multicentrično ispitivanje u koje je uključeno 412 prethodno neliječenih odraslih bolesnika s kroničnim hepatitisom C koji su istodobno bili zaraženi HIV-om.
English: Reduce only ViraferonPeg dose (see note 2) if:
Croatian: Smanjiti samo dozu lijeka ViraferonPeg (vidjeti napomenu 2) ako:
English: There were some cases of more severe neutropenia in patients treated with the recommended doses of ViraferonPeg in combination with ribavirin (WHO grade 3: 39 of 186 [21 %]; and WHO grade 4: 13 of 186 [7 %]).
Croatian: Bilo je slučajeva teže neutropenije u bolesnika liječenih preporučenim dozama lijeka ViraferonPeg u kombinaciji s ribavirinom (SZO stupnja 3 u 39 od 186 bolesnika [21%] i SZO stupnja 4 u 13 od 186 bolesnika [7%]).
English: Signs, Symptoms, and Treatment Mechanism and Risk Factors
Croatian: Znakovi, simptomi i liječenje
English: Mean apparent volume of distribution is 0.99 l/kg.
Croatian: Srednja vrijednost prividnog volumena distribucije iznosi 0,99 l/kg.
English: Among children and adolescents treated with interferon alfa-2b in combination with ribavirin, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4 % vs 1 %) during treatment and during the 6-month follow-up after treatment.
Croatian: Među djecom i adolescentima koji su bili liječeni interferonom alfa-2b u kombinaciji s ribavirinom suicidalne misli i pokušaj samoubojstva su tijekom liječenja i tijekom šestomjesečnog razdoblja praćenja nakon liječenja prijavljeni češće u odnosu na odrasle bolesnike (2,4% naspram 1%).
English: *produced by rDNA technology in E. coli cells harbouring a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes.
Croatian: *proizvedenog tehnologijom rekombinantne DNK na stanicama E.coli pomoću genetskim inženjeringom dobivenog hibrida plazmida koji sadrži gen za interferon alfa-2b iz ljudskih leukocita.
English: If psychiatric symptoms persist or worsen, or suicidal or homicidal ideation is identified, it is recommended that treatment with ViraferonPeg be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Croatian: Ako psihijatrijski simptomi potraju ili se pogoršaju, ili se ustanove misli o samoubojstvu ili ubojstvu, preporučuje se obustaviti liječenje lijekom ViraferonPeg te pratiti stanje bolesnika i po potrebi osigurati intervenciju psihijatra.
English: Because of the potential for adverse reactions in breast-fed infants, breast-feeding should be discontinued prior to initiation of treatment.
Croatian: Zbog mogućnosti razvoja nuspojava u dojenčadi, dojenje se mora prekinuti prije početka liječenja.
English: In general, the adverse events seen in overdose cases involving ViraferonPeg are consistent with the known safety profile for ViraferonPeg; however, the severity of the events may be increased.
Croatian: Štetni događaji zabilježeni u slučajevima predoziranja općenito su u skladu s poznatim sigurnosnim profilom lijeka ViraferonPeg, iako težina tih događaja može biti povećana.
English: The population enrolled mainly consisted of children with mild to moderate hepatitis C. Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ViraferonPeg with ribavirin needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Croatian: Populacija uključena u ispitivanje uglavnom se sastojala od djece s blagim do umjerenim hepatitisom C. Zbog nedostatka podataka u djece s teškom progresivnom bolešću i mogućih neželjenih učinaka u ovoj se populaciji mora pažljivo procijeniti omjer koristi i rizika liječenja kombinacijom lijeka ViraferonPeg i ribavirina (vidjeti dijelove 4.1, 4.4 i 4.8).