FrancophonIA/ELRC3.0 huggingface dataset:
English: If psychiatric symptoms persist or worsen, or suicidal or homicidal ideation is identified, it is recommended that treatment with PegIntron 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 PegIntron te pratiti stanje bolesnika i po potrebi osigurati intervenciju psihijatra.
English: In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of PegIntron and ribavirin.
Croatian: Uz to, i suhoća usta može štetno djelovati na zube i sluznicu usta tijekom dugotrajne kombinirane terapije lijekom PegIntron i ribavirinom.
English: The negative predictive value for sustained response in patients treated with PegIntron in monotherapy was 98 %.
Croatian: Negativna prediktivna vrijednost za trajan virološki odgovor u bolesnika liječenih lijekom PegIntron u monoterapiji bila je 98%.
English: PegIntron monotherapy - Adults
Croatian: PegIntron u monoterapiji - odrasli
English: In a clinical trial with 107 children and adolescent patients (3 to 17 years of age) treated with combination therapy of PegIntron and ribavirin, dose modifications were required in 25 % of patients, most commonly for anaemia, neutropenia and weight loss.
Croatian: U kliničkom ispitivanju sa 107 djece i adolescenata (3 do 17 godina) liječenih kombiniranom terapijom lijekom PegIntron i ribavirinom bilo je potrebno prilagoditi dozu u 25% bolesnika, najčešće zbog anemije, neutropenije i gubitka tjelesne težine.
English: During combination therapy for up to 48 weeks with PegIntron and ribavirin, growth inhibition was observed that resulted in reduced height in some patients (see section 4.4).
Croatian: Tijekom kombinirane terapije lijekom PegIntron i ribavirinom u razdoblju do 48 tjedana zabilježen je zastoj u rastu, koji je u nekih bolesnika rezultirao smanjenom visinom (vidjeti dio 4.4).
English: The negative predictive value for sustained response in HCV/HIV co-infected patients treated with PegIntron 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 PegIntron u kombinaciji s ribavirinom iznosila je 99% (67/68; Ispitivanje 1) (vidjeti dio 5.1).
English: Boceprevir must not be administered in the absence of PegIntron and ribavirin.
Croatian: Boceprevir se ne smije primijeniti bez lijeka PegIntron i ribavirina.
English: There are no data available regarding potential effects of PegIntron treatment on male or female fertility.
Croatian: Plodnost Nema dostupnih podataka o mogućim učincima liječenja lijekom PegIntron na plodnost muškaraca ili žena.
English: The potential interaction of peginterferon alfa-2b (PegIntron) on substrates of metabolic enzymes was evaluated in 3 multiple-dose clinical pharmacology studies.
Croatian: Moguća interakcija peginterferona alfa-2b (PegIntron) sa supstratima metaboličkih enzima ocijenjena je u 3 klinička farmakološka ispitivanja s primjenom višekratnih doza.
English: The most common treatment-related adverse reactions reported during clinical trials with PegIntron in combination with ribavirin in adults, seen in more than half of the study subjects, were fatigue, headache, and injection site reaction.
Croatian: Najčešće nuspojave prijavljene u kliničkim ispitivanjima, povezane s liječenjem lijekom PegIntron u kombinaciji s ribavirinom u odraslih bolesnika i opažene u više od polovice ispitanika, bile su umor, glavobolja i reakcije na mjestu injiciranja.
English: Detailed instructions for subcutaneous administration are provided at the end of this leaflet (see ANNEX TO THE PACKAGE LEAFLET “How to use the PegIntron pre-filled pen”).
Croatian: Detaljne upute za potkožnu primjenu se nalaze na kraju ove upute (vidjeti DODATAK UPUTI O LIJEKU "Kako koristiti PegIntron napunjenu brizgalicu").
English: In patients of African American origin (which is known to be a poor prognostic factor for HCV eradication), treatment with PegIntron (1.5 µg/kg)/ribavirin combination therapy resulted in a higher sustained virologic response rate compared to PegIntron 1 µg/kg dose.
Croatian: U bolesnika afroameričkog podrijetla (što je poznat slabi prognostički faktor za eradikaciju HCV-a), liječenjem kombinacijom PegIntron (u dozi od 1,5 µg/kg)/ribavirin postignuta je veća stopa trajnog virološkog odgovora u odnosu na primjenu doze lijeka PegIntron od 1 µg/kg.
English: Solvent for PegIntron Water for injections
Croatian: Otapalo za PegIntron voda za injekcije
English: P 1.5/R PegIntron (1.5 micrograms/kg) + ribavirin (800 mg) P 0.5/R PegIntron (1.5 to 0.5 microgram/kg) + ribavirin (1,000/1,200 mg) I/R
Croatian: P 1,5/R PegIntron (1,5 mikrograma/kg) + ribavirin (800 mg) P 0,5/R PegIntron (1,5 do 0,5 mikrograma/kg) + ribavirin (1000/1200 mg) I/R
English: Patients who develop fatigue, somnolence or confusion during treatment with PegIntron are cautioned to avoid driving or operating machines.
Croatian: Bolesnike koji tijekom liječenja lijekom PegIntron osjete umor, somnolenciju ili konfuziju treba upozoriti da izbjegavaju upravljanje motornim vozilima i rad sa strojevima.
English: Therefore, the combination of PegIntron with telbivudine is contraindicated (see section 4.3).
Croatian: Stoga je kombinacija lijeka PegIntron s telbivudinom kontraindicirana (vidjeti dio 4.3).
English: In this trial, the combination of PegIntron (1.5 micrograms/kg/week) and ribavirin was significantly more effective than the combination of interferon alfa-2b and ribavirin (Table 8), particularly in patients infected with Genotype 1 (Table 9).
Croatian: U ovom je ispitivanju kombinacija lijeka PegIntron (1,5 mikrograma/kg na tjedan) i ribavirina bila značajno djelotvornija od kombinacije interferona alfa-2b i ribavirina (Tablica 8), osobito u bolesnika inficiranih genotipom 1 (Tablica 9).
English: Response week 12 was defined as undetectable HCV-RNA after 12 weeks of treatment.
Croatian: Odgovor u 12. tjednu definiran je kao nemjerljiva HCV-RNK nakon 12 tjedana liječenja.
English: PegIntron is a well characterized polyethylene glycol-modified (“pegylated”) derivative of interferon alfa-2b and is predominantly composed of monopegylated species.
Croatian: PegIntron je dobro karakteriziran derivat interferona alfa-2b modificiran polietilenglikolom ("pegiliran"), pretežno sastavljen od monopegiliranih vrsta.
English: When the total amount of solvent is combined with the full amount of PegIntron powder, the solution will be at the correct concentration to measure your dose (i.e., the labelled amount is contained in 0.5 ml).
Croatian: Kada se cijela količina otapala pomiješa s cijelom količinom PegIntron praška, otopina će imati točnu koncentraciju koja Vam je potrebna za odmjeravanje doze (tj. 0,5 ml otopine sadrži deklariranu količinu lijeka).
English: Periodic visual examinations are recommended during PegIntron therapy, particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
Croatian: Za vrijeme liječenja lijekom PegIntron preporučuje se periodički obavljati pregled vida, osobito u bolesnika s poremećajima koji mogu biti povezani s retinopatijom, poput šećerne bolesti ili hipertenzije.
English: This study showed that PegIntron was superior to interferon alfa-2b (Table 8).
Croatian: Ovo ispitivanje je pokazalo da je PegIntron superioran interferonu alfa-2b (Tablica 8).
English: As with all interferons, discontinue treatment with PegIntron in patients who develop prolongation of coagulation markers which might indicate liver decompensation.
Croatian: Kao i sve interferone, primjenu lijeka PegIntron treba obustaviti u bolesnika u kojih se razvije produljenje koagulacijskih parametara jer to može ukazivati na dekompenzaciju jetre.
English: PegIntron is injected subcutaneously after reconstituting the powder as instructed, attaching a needle and setting the prescribed dose.
Croatian: PegIntron se primjenjuje supkutanom injekcijom nakon rekonstitucije praška prema uputama, pričvršćivanja igle i odmjeravanja propisane doze.
English: Dose modification guidelines for adult patients who use PegIntron monotherapy are shown in Table 3a.
Croatian: Smjernice za prilagodbu doze u odraslih bolesnika koji se liječe lijekom PegIntron u monoterapiji prikazane su u Tablici 3a.
English: Patients treated with PegIntron and ribavirin combination therapy and zidovudine are at increased risk of developing anaemia and therefore the concomitant use of this combination with zidovudine is not recommended (see section 4.5).
Croatian: Bolesnici liječeni kombiniranom terapijom lijekom PegIntron i ribavirinom te zidovudinom izloženi su povećanom riziku za razvoj anemije te se stoga ne preporučuje istodobna primjena ove kombinacije sa zidovudinom (vidjeti dio 4.5).
English: Do not use PegIntron
Croatian: Nemojte primjenjivati PegIntron
English: PegIntron pharmacodynamics were assessed in a rising single-dose trial in healthy subjects by examining changes in oral temperature, concentrations of effector proteins such as serum neopterin and 2'5'oligoadenylate synthetase (2'5'-OAS), as well as white cell and neutrophil counts.
Croatian: Farmakodinamika lijeka PegIntron ocijenjena je u ispitivanju u kojemu su zdravim ispitanicima davane sve veće pojedinačne doze lijeka, i to mjerenjem promjena oralne temperature, koncentracije efektornih proteina poput serumskog neopterina i 2'5'-oligoadenilat-sintetaze (2'5'-OAS) te promjena broja leukocita i neutrofila.
English: No specific antidote for PegIntron is available; therefore, symptomatic treatment and close observation of the patient are recommended in cases of overdose.
Croatian: Ne postoji specifičan protulijek za PegIntron te je, stoga, u slučaju predoziranja preporučeno simptomatsko liječenje uz pomni nadzor bolesnika.
English: Contusion class effect of interferon-alfa containing products - reported with standard interferon therapy in adult and paediatric patients; with PegIntron reported in adult patients.
Croatian: kontuzija učinak razreda kod svih lijekova koji sadrže interferon alfa - prijavljeni kod liječenja standardnim interferonima u odraslih i pedijatrijskih bolesnika; kod lijeka PegIntron prijavljeni u odraslih bolesnika.
English: Interferon neutralising factor assays were performed on serum samples of patients who received PegIntron in the clinical trial.
Croatian: Ispitivanja čimbenika koji neutraliziraju interferon provedena su na uzorcima seruma bolesnika koji su u kliničkom ispitivanju primali PegIntron.
English: Data from elderly patients treated with a single dose of PegIntron suggest no alteration in PegIntron dose is necessary based on age (see section 5.2).
Croatian: Podaci prikupljeni u starijih bolesnika kojima je primijenjena jedna doza lijeka PegIntron ukazuju na to da nije potrebno prilagođavati dozu lijeka PegIntron s obzirom na dob (vidjeti dio 5.2).
English: Fatigue, alopecia, pruritus, nausea, anorexia, weight decreased, irritability and insomnia occur at a notably lower rate in patients treated with PegIntron monotherapy compared to those treated with combination therapy (see Table 6).
Croatian: Umor, alopecija, pruritus, mučnina, anoreksija, gubitak tjelesne težine, razdražljivost i nesanica javljaju se zamjetno rjeđe u bolesnika liječenih lijekom PegIntron u monoterapiji u odnosu na bolesnike liječene kombiniranom terapijom (vidjeti Tablicu 6).
English: Approximately 21 % of children treated with PegIntron/ribavirin combination therapy developed increase in thyroid stimulating hormone (TSH).
Croatian: U približno 21% djece liječene kombiniranom terapijom lijekom PegIntron i ribavirinom povećala se koncentracija hormona koji stimulira štitnjaču (TSH).
English: The data suggest that no alteration in PegIntron dosage is necessary based on advancing age.
Croatian: Podaci pokazuju da nije potrebno prilagođavati dozu lijeka PegIntron zbog starije dobi.
English: Prior to initiation of PegIntron therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Croatian: Prije početka liječenja lijekom PegIntron mora se izmjeriti koncentracija TSH-a i svaki poremećaj funkcije štitnjače koji se tada otkrije mora se liječiti konvencionalnom terapijom.
English: Reduce PegIntron to one-half dose if:
Croatian: Smanjiti dozu lijeka PegIntron na polovicu ako su:
English: Subjects treated with PegIntron showed mild dose-related elevations in body temperature.
Croatian: Ispitanici liječeni lijekom PegIntron pokazali su blag, dozi sukladan porast tjelesne temperature.
English: Because of marked inter-subject variability in interferon pharmacokinetics, it is recommended that patients with severe renal impairment be closely monitored during treatment with PegIntron (see section 4.2)
Croatian: Zbog izražene interindividualne varijabilnosti u farmakokinetici interferona preporučuje se tijekom liječenja lijekom PegIntron pomno nadzirati bolesnike s teškim oštećenjem funkcije bubrega (vidjeti dio 4.2).
English: How to self-inject PegIntron?
Croatian: Kako da si sami date injekciju lijeka PegIntron?
English: While changes in laboratory values were observed in some patients treated with PegIntron used in combination with ribavirin in the clinical trial, values returned to baseline levels within a few weeks after the end of therapy.
Croatian: Iako su u nekih bolesnika liječenih lijekom PegIntron u kombinaciji s ribavirinom tijekom kliničkog ispitivanja opažene promjene laboratorijskih vrijednosti, te su se vrijednosti vratile na početnu razinu unutar nekoliko tjedana od prestanka terapije.
English: In the presence of thyroid dysfunction, PegIntron treatment may be continued if TSH levels can be maintained in the normal range by medicine.
Croatian: U slučaju poremećaja rada štitnjače liječenje lijekom PegIntron može se nastaviti ako se koncentracija TSH-a može lijekovima održavati unutar granica normale.
English: In these studies, the effects of multiple-dose regimens of peginterferon alfa-2b (PegIntron) were investigated in Hepatitis C subjects (1.5 mcg/week) or healthy subjects (1 mcg/week or 3 mcg/week) (Table 4).
Croatian: U tim su ispitivanjima učinci režima višekratnih doza peginterferona alfa-2b (PegIntron) ispitivani u osoba s hepatitisom C (1,5 μg na tjedan) ili u zdravih ispitanika (1 μg na tjedan ili 3 μg na tjedan) (Tablica 4).
English: Metabolism of theophylline is suppressed by inhibitory action of the product (PegIntron) on CYP1A2.
Croatian: Metabolizam teofilina potisnut je zbog inhibitornog djelovanja ovog lijeka (PegIntron) na CYP1A2.
English: Preclinical juvenile toxicity results have demonstrated a minor, dose-related decrease in overall growth in neonatal rats dosed with ribavirin (see section 5.3 of Rebetol SmPC if PegIntron is to be administered in combination with ribavirin).
Croatian: Rezultati pretkliničkih istraživanja toksičnosti na mladunčadi pokazali su malo, o dozi ovisno, smanjenje ukupnog rasta novorođenih štakora kojima se davao ribavirin (vidjeti dio 5.3 Sažetka opisa svojstava lijeka za Rebetol ako se PegIntron daje u kombinaciji s ribavirinom).
English: How to use the PegIntron pre-filled pen
Croatian: Kako koristiti PegIntron napunjenu brizgalicu
English: Data are not available for the use of PegIntron in patients with creatinine clearance < 15 ml/minute (see section 5.2).
Croatian: Nema podataka o primjeni lijeka PegIntron u bolesnika s klirensom kreatinina < 15 ml/min (vidjeti dio 5.2).
English: However, renal elimination may account for a minority (approximately 30 %) of PegIntron apparent clearance.
Croatian: Međutim, eliminacija putem bubrega čini manji dio (oko 30%) prividnog klirensa lijeka PegIntron.
English: However, response rates in this trial were shown to be dependent also on the dose of ribavirin administered in combination with PegIntron or interferon alfa-2b.
Croatian: Međutim, u ovom se ispitivanju pokazalo da stopa odgovora ovisi i o dozi ribavirina primijenjenoj u kombinaciji s lijekom PegIntron ili interferonom alfa-2b.
English: Table 2b Two-step dose reduction of PegIntron in combination therapy in adults First dose reduction to PegIntron 1 µg/kg
Croatian: Tablica 2b Smanjenje doze lijeka PegIntron u dva koraka u kombiniranoj terapiji u odraslih Prvo smanjenje doze lijeka PegIntron na
English: The lowest PegIntron strength available is 50 µg/0.5 ml; therefore for patients prescribed 0.5 µg/kg/week, doses must be adjusted by volume as shown in Table 2.
Croatian: Najmanja dostupna jačina lijeka PegIntron je 50 µg/0,5 ml pa se u bolesnika kojima je propisana doza od 0,5 µg/kg na tjedan volumen doze mora prilagoditi kako je prikazano u Tablici 2.
English: The recommended dose of PegIntron is 60 g/m2/week subcutaneously in combination with ribavirin 15 mg/kg/day orally in two divided doses with food (morning and evening).
Croatian: Preporučena doza lijeka PegIntron je 60 μg/m na tjedan, primijenjena supkutano u kombinaciji s 15 mg/kg na dan ribavirina, primijenjenog peroralno, uz obrok, u dvije odvojene doze (ujutro i navečer).
English: Haematological abnormalities were more frequently reported in patients receiving PegIntron in combination with ribavirin when compared to patients receiving interferon alfa-2b in combination with ribavirin.
Croatian: Hematološki poremećaji prijavljeni su češće u bolesnika koji su primali PegIntron u kombinaciji s ribavirinom u odnosu na bolesnike koji su primali interferon alfa-2b u kombinaciji s ribavirinom.
English: Renal clearance appears to account for 30 % of total clearance of PegIntron.
Croatian: Čini se da je bubrežni klirens odgovoran za 30% ukupnog klirensa lijeka PegIntron.
English: When used in combination with ribavirin, PegIntron did not cause any effects not previously seen with either active substance alone.
Croatian: Kada se primjenjivao u kombinaciji s ribavirinom, PegIntron nije prouzročio učinke koji već nisu bili opaženi prilikom zasebne primjene tih dvaju lijekova.
English: PegIntron should be administered as a subcutaneous injection.
Croatian: PegIntron se primjenjuje supkutanom injekcijom.
English: Paediatric population PegIntron can be used in combination with ribavirin in paediatric patients 3 years of age and older.
Croatian: PegIntron se u kombinaciji s ribavirinom može primjenjivati u pedijatrijskih bolesnika u dobi od 3 i više godina.
English: Patients with severe renal dysfunction (creatinine clearance 15-29 ml/minute) should have the starting dose of PegIntron reduced by 50 %.
Croatian: Bolesnicima s teškim oštećenjem bubrežne funkcije (klirens kretinina 15-29 ml/min) treba smanjiti početnu dozu lijeka PegIntron za 50%.
English: There are no apparent age-related effects on the pharmacokinetics of PegIntron.
Croatian: Nema očitih dobno uvjetovanih učinaka na farmakokinetiku lijeka PegIntron.
English: As with interferon alfa-2b, adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders, receiving PegIntron therapy require close monitoring.
Croatian: Kao i kod liječenja interferonom alfa-2b, odrasle bolesnike s kongestivnim zatajenjem srca, infarktom miokarda i/ili prethodnim ili postojećim poremećajima srčanog ritma u anamnezi mora se pomno nadzirati tijekom liječenja lijekom PegIntron.
English: - The use of PegIntron in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
Croatian: - Kontraindicirana je primjena lijeka PegIntron u djece i adolescenata s postojećim teškim psihijatrijskim bolestima ili anamnezom takvih bolesti (vidjeti dio 4.3).
English: Metabolism of thioridazine is suppressed by inhibitory action of the product (PegIntron) on CYP2D6.
Croatian: Metabolizam tioridazina potisnut je zbog inhibitornog djelovanja ovog lijeka (PegIntron) na CYP2D6.
English: For HCV/HIV co-infected patients receiving PegIntron in combination with ribavirin, other undesirable effects (that were not reported in mono-infected patients) which have been reported in the larger studies with a frequency > 5 % were: oral candidiasis (14 %), lipodystrophy acquired (13 %), CD4 lymphocytes decreased (8 %), appetite decreased (8 %), gamma-glutamyltransferase increased (9 %), back pain (5 %), blood amylase increased (6 %), blood lactic acid increased (5 %), cytolytic hepatitis (6 %), lipase increased (6 %) and pain in limb (6 %).
Croatian: U bolesnika s istodobnom infekcijom HCV-om i HIV-om koji su primali PegIntron u kombinaciji s ribavirinom ostali neželjeni učinci (koji nisu prijavljeni u bolesnika inficiranih samo jednim virusom) prijavljeni u većim kliničkim ispitivanjima s učestalošću od > 5% uključuju: oralnu kandidijazu (14%), stečenu lipodistrofiju (13%), smanjen broj CD4 limfocita (8%), oslabljen tek (8%), povišene vrijednosti gama-glutamiltransferaze (9%), bol u leđima (5%), povišene vrijednosti amilaze u krvi (6%), povišene vrijednosti mliječne kiseline u krvi (5%), citolitički hepatitis (6%), povišene vrijednosti lipaze (6%) i bol u udovima (6%).
English: Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during PegIntron therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Croatian: Psihijatrijski poremećaji i bolesti središnjeg živčanog sustava (SŽS) U nekih su bolesnika primijećeni teški štetni učinci na SŽS, osobito depresija, suicidalne misli i pokušaj samoubojstva, za vrijeme liječenja lijekom PegIntron te čak i nakon obustave liječenja, uglavnom tijekom šestomjesečnog razdoblja praćenja.
English: Dose reduction of PegIntron in adults may be accomplished by reducing the prescribed volume or by utilizing a lower dose strength as shown in Table 2b.
Croatian: Smanjivanje doze lijeka PegIntron u odraslih bolesnika može se postići smanjivanjem propisanog volumena ili primjenom doze niže jačine, kako je prikazano u Tablici 2b.
English: At the PegIntron 1.5 µg/kg plus ribavirin dose, sustained virologic response rates were lower in patients with cirrhosis, in patients with normal ALT levels, in patients with a baseline viral load > 600,000 IU/ml, and in patients > 40 years old.
Croatian: Kod primjene lijeka PegIntron u dozi od 1,5 µg/kg uz ribavirin, stopa trajnog virološkog odgovora bila je manja u bolesnika s cirozom, bolesnika s normalnim koncentracijama ALT-a, bolesnika s početnim virusnim opterećenjem > 600 000 IU/ml i bolesnika starijih od 40 godina.
English: Table 3a Dose modification guidelines for PegIntron monotherapy in adults based on laboratory parameters
Croatian: Tablica 3a Smjernice za prilagodbu doze u monoterapiji lijekom PegIntron u odraslih na temelju laboratorijskih parametara
English: Clinical efficacy and safety - Adults Tritherapy with PegIntron, ribavirin and boceprevir Refer to the SmPC for boceprevir.
Croatian: Djelotvornost i sigurnost u kliničkoj primjeni - odrasli Trojna terapija lijekom PegIntron, ribavirinom i boceprevirom Pročitajte Sažetak opisa svojstava lijeka za boceprevir.
English: PegIntron (1.5 µg/kg/ week) + ribavirin (800 mg)
Croatian: PegIntron (1,5 μg/kg na tjedan) + ribavirin (800 mg)
English: Also see SmPCs for ribavirin and boceprevir if PegIntron is to be administered in combination therapy in patients with chronic hepatitis C.
Croatian: Pročitajte i Sažetak opisa svojstava lijeka za ribavirin i boceprevir ako će se PegIntron primjenjivati u kombiniranom liječenju u bolesnika s kroničnim hepatitisom C.
English: The dose of PegIntron is determined by a calculation accounting for both height and weight.
Croatian: Doza lijeka PegIntron izračunava se prema tjelesnoj visini i težini.