FrancophonIA/ELRC3.0 huggingface dataset:
English: PegIntron vials are for single use only.
Slovenian: Viale PegIntron so le za enkratno uporabo.
English: Other medicines and PegIntron Please tell your doctor or pharmacist if you, or the child you are caring for: - are taking or have recently taken any other medicines or vitamins/nutritional supplements, including medicines obtained without a prescription.
Slovenian: Druga zdravila in zdravilo PegIntron Obvestite zdravnika ali farmacevta, če vi ali otrok, za katerega skrbite: - jemljete ali ste pred kratkim jemali katero koli zdravilo ali vitamine/prehranska dopolnila, vključno z zdravili, ki ste jih dobili brez recepta.
English: PegIntron is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Slovenian: Zdravilo PegIntron lahko med nosečnostjo uporabljate le, če potencialne koristi upravičijo potencialno tveganje za plod.
English: Acceptable baseline values that may be considered as a guideline prior to initiation of PegIntron therapy are:
Slovenian: Sprejemljive začetne vrednosti, ki vam lahko služijo kot smernica pred uvedbo terapije z zdravilom PegIntron, so naslednje:
English: Treatment with PegIntron in combination with ribavirin was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Slovenian: Zdravljenje z zdravilom PegIntron v kombinaciji z ribavirinom je bilo povezano z zmanjšanjem absolutnega števila celic CD4+ v prvih 4 tednih, brez zmanjšanja odstotka celic CD4+.
English: While being treated with PegIntron, your doctor may advise to drink extra fluids to help prevent low blood pressure.
Slovenian: Med zdravljenjem z zdravilom PegIntron vam bo zdravnik morda svetoval, da pijte več tekočine, da bi preprečili pojav nizkega krvnega tlaka.
English: Water for injection and PegIntron powder are provided in separate ampoules.
Slovenian: Voda za injekcije in PegIntron prašek sta na voljo v ločenih ampulah.
English: No studies have been conducted in juvenile animals to examine the effects of treatment with PegIntron on growth, development, sexual maturation, and behaviour.
Slovenian: Študij pri mladih živalih, pri katerih bi spremljali vpliv zdravljenja z zdravilom PegIntron na rast, razvoj, spolno dozorevanje in obnašanje, niso izvedli.
English: Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of PegIntron in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
Slovenian: Zaradi poročil, da lahko interferon alfa poslabša obstoječo psoriazo in sarkoidozo je uporaba zdravila PegIntron pri bolnikih s psoriazo ali sarkoidozo priporočena le, če možne koristi zdravljenja odtehtajo morebitno tveganje.
English: Important information about some of the ingredients of PegIntron Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila PegIntron Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze in galaktoze ali pomanjkanjem saharaza-izomaltaze ne smejo jemati tega zdravila.
English: These adverse reactions were common (≥1/100 to < 1/10) in clinical trials in patients treated with PegIntron monotherapy.
Slovenian: Ti neželeni učinki so bili pogosti (≥1/100 do < 1/10) v kliničnih preskušanjih pri bolnikih, zdravljenih z zdravilom PegIntron v monoterapiji.
English: Patients may self-inject PegIntron if their physician determines that it is appropriate and with medical follow-up as necessary.
Slovenian: Bolniki si lahko zdravilo PegIntron injicirajo sami, če njihov zdravnik odloči, da je to primerno, in jih po potrebi spremlja.
English: Prepare the dose by adding water for injection to PegIntron powder just before you intend to inject it and use it immediately.
Slovenian: Odmerek si pripravite z dodajanjem vode za injekcije v PegIntron prašek, tik preden ga nameravate injicirati, in ga uporabite takoj.
English: Manufacturer SP Labo N.V.
Slovenian: Izdelovalec SP Labo N.V.
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of PegIntron therapy.
Slovenian: Srčne aritmije (predvsem supraventrikularne) se običajno odzovejo na konvencionalno zdravljenje, vendar pa lahko zahtevajo prekinitev zdravljenja z zdravilom PegIntron.
English: As adherence might be of importance for outcome of therapy, the dose of PegIntron and ribavirin should be kept as close as possible to the recommended standard dose.
Slovenian: Ker je privrženost terapiji pomembna za njeno uspešnost, mora biti odmerek zdravila PegIntron in ribavirina čim bliže standardnemu priporočenemu odmerku.
English: What PegIntron is and what it is used for
Slovenian: Kaj je zdravilo PegIntron in za kaj ga uporabljamo
English: No specific antidote for PegIntron is available; therefore, symptomatic treatment and close observation of the patient are recommended in cases of overdose.
Slovenian: Specifičen antidot za zdravilo PegIntron ni na voljo, zato v primeru prevelikega odmerjanja priporočamo simptomatsko zdravljenje in skrbno opazovanje bolnika.
English: Women of childbearing potential/contraception in males and females PegIntron is recommended for use in fertile women only when they are using effective contraception during the treatment.
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah Zdravilo PegIntron priporočamo za uporabo pri plodnih ženskah le, če med zdravljenjem uporabljajo učinkovito kontracepcijo.
English: Table 8 Sustained virological response (% patients HCV negative) PegIntron monotherapy
Slovenian: Preglednica 8 Trajni virološki odziv (% HCV negativnih bolnikov) PegIntron monoterapija
English: What you need to know before you use PegIntron
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo PegIntron
English: PegIntron increases the risk of hepatic decompensation and death in patients with cirrhosis.
Slovenian: Zdravilo PegIntron poveča tveganje za jetrno dekompenzacijo in smrt pri bolnikih s cirozo.
English: In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm 3 was observed in 4 %
Slovenian: V študiji 1 (glejte poglavje 5.1) so opazili zmanjšanje absolutnega števila nevtrofilcev pod 500 celic/mm
English: This medicine, when given alone, is usually given at a dose of 0.5 or 1.0 microgram per kilogram of body weight once a week, for 6 months to 1 year.
Slovenian: Kadar se to zdravilo uporablja samostojno, je odmerek običajno 0,5 ali 1,0 mikrogram na kilogram telesne mase enkrat na teden, 6 mesecev do 1 leto.
English: Use in adults - PegIntron alone
Slovenian: Uporaba pri odraslih - zdravilo PegIntron samo
English: The potential interaction of peginterferon alfa-2b (PegIntron) on substrates of metabolic enzymes was evaluated in 3 multiple-dose clinical pharmacology studies.
Slovenian: Morebitno medsebojno delovanje peginterferona alfa-2b (zdravila PegIntron) in substratov metabolnih encimov so ocenili v 3 kliničnih farmakoloških študijah večkratnih odmerkov.
English: - Remove the protective cap from the PegIntron vial.
Slovenian: - Odstranite zaščitni pokrovček z viale zdravila PegIntron.
English: If you forget to take PegIntron
Slovenian: Če ste pozabili vzeti zdravilo PegIntron
English: PegIntron is likely to also cause this effect.
Slovenian: Tudi zdravilo PegIntron ima verjetno enak učinek.
English: The side effect may develop at various time points during treatment, typically several months after starting treatment with PegIntron.
Slovenian: Neželeni učinek se lahko pojavi ob različnih časovnih točkah zdravljenja, običajno nekaj mesecev po začetku zdravljenja z zdravilom PegIntron.
English: Anaemia (hemoglobin < 9.4 g/dl) was reported in 12 % (23/194) of patients treated with PegIntron in combination with ribavirin.
Slovenian: O anemiji (hemoglobin < 9,4 g/dl) so poročali pri 12 % (23/194) bolnikov, zdravljenih z zdravilom PegIntron v kombinaciji z ribavirinom.
English: dizziness), decrease in certain white blood cells (that makes you more susceptible to different infections), - pain in joints and muscles, muscle and bone pain.
Slovenian: zmanjšanje nekaterih belih krvnih celic (ki vas naredi bolj dovzetne za različne okužbe), - bolečine v sklepih in mišicah, mišične in kostne bolečine.
English: Therefore, the combination of PegIntron with telbivudine is contraindicated (see section 4.3).
Slovenian: Kombinacija zdravila PegIntron in telbivudina je zato kontraindicirana (glejte poglavje 4.3).
English: Do not inject PegIntron into an area where the skin is irritated, red, bruised, infected, or has scars, stretch marks, or lumps.
Slovenian: Zdravila PegIntron ne injicirajte v predele, kjer je koža razdražena, pordela, podpluta, okužena, ali kjer so brazgotine, proge (strije) ali bule.
English: ** For patients > 120 kg, the PegIntron dose should be calculated based on the individual patient weight.
Slovenian: ** Za bolnike, ki so težji od 120 kg, mora biti odmerek izračunan individualno glede na telesno maso bolnika.
English: Mean (SD) PegIntron elimination half-life is approximately 40 hours (13.3 hours), with apparent clearance of 22.0 ml/hr/kg.
Slovenian: Srednja (SD) razpolovna doba eliminacije zdravila PegIntron je približno 40 ur (13,3 ure), navidezni očistek zdravila pa je 22,0 ml/h/kg.
English: The negative predictive value for sustained response in patients treated with PegIntron in monotherapy was 98 %.
Slovenian: Negativna napovedna vrednost za trajni odziv pri bolnikih, zdravljenih z zdravilom PegIntron v monoterapiji, je bila 98 %.
English: PegIntron 1.5 micrograms/kg/week in combination with ribavirin capsules.
Slovenian: PegIntron 1,5 mikrogramov/kg/teden v kombinaciji s kapsulami ribavirina.
English: Patients who develop fatigue, somnolence or confusion during treatment with PegIntron are cautioned to avoid driving or operating machines.
Slovenian: Bolniki, ki postanejo utrujeni, zaspani ali zmedeni med zdravljenjem z zdravilom PegIntron, naj ne vozijo in ne upravljajo strojev.
English: The use of this medicine in children and adolescents with existence of or history of severe psychiatric conditions is not allowed (see section “Do not use PegIntron” above).
Slovenian: Uporaba tega zdravila pri otrocih in mladostnikih z obstoječo ali s hudo psihično boleznijo v preteklosti ni dovoljena (glejte zgoraj poglavje "Ne uporabljajte zdravila PegIntron").
English: This may require combinations of various PegIntron dose strengths and volumes.
Slovenian: To lahko zahteva kombiniranje različnih jakosti in volumnov zdravila PegIntron.
English: Data are not available for the use of PegIntron in patients with creatinine clearance < 15 ml/minute (see section 5.2).
Slovenian: Ni podatkov o uporabi zdravila PegIntron pri bolnikih z očistkom kreatinina < 15 ml/minuto (glejte poglavje 5.2).
English: Do not use PegIntron
Slovenian: Ne uporabljajte zdravila PegIntron
English: The dose of PegIntron for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Slovenian: Odmerek zdravila PegIntron v monoterapiji je treba zmanjšati pri bolnikih z zmerno ali hudo ledvično okvaro (glejte poglavji 4.2 in 4.4).
English: The clinical incidence of neutralising factors in patients who received PegIntron 0.5 micrograms/kg is 1.1 %.
Slovenian: Klinična pojavnost nevtralizacijskih dejavnikov pri bolnikih, ki so prejemali zdravilo PegIntron v odmerku 0,5 mikrograma/kg, je bila 1,1 %.
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).
Slovenian: Priporočeni odmerek zdravila PegIntron je 60 g/m²/teden subkutano v kombinaciji z ribavirinom 15 mg/kg/dan peroralno v dveh ločenih odmerkih s hrano (zjutraj in zvečer).
English: As with all interferons, discontinue treatment with PegIntron in patients who develop prolongation of coagulation markers which might indicate liver decompensation.
Slovenian: Kot pri vseh interferonih morate zdravljenje z zdravilom PegIntron prekiniti pri bolnikih, pri katerih se podaljšajo koagulacijski parametri, ki lahko kažejo na jetrno dekompenzacijo.
English: Reduce only PegIntron dose (see note 2) if:
Slovenian: Zmanjšajte le odmerek zdravila PegIntron (glejte opombo 2) v primeru:
English: The relative non-toxicity of monomethoxy-polyethylene glycol (mPEG), which is liberated from PegIntron 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.
Slovenian: Relativna netoksičnost monometoksipolietilenglikola (mPEG), ki se sprošča iz zdravila PegIntron ob njegovi presnovi in vivo, je bila potrjena v predkliničnih študijah akutne in subkronične toksičnosti pri glodalcih in opicah, v standardnih raziskavah embriofetalnega razvoja in s testi mutagenosti in vitro.
English: In general, the adverse events seen in overdose cases involving PegIntron are consistent with the known safety profile for PegIntron; however, the severity of the events may be increased.
Slovenian: Na splošno so neželeni učinki, ki so jih opazili v primerih prevelikega odmerjanja zdravila PegIntron, doslej ustrezali znanemu profilu varnosti zdravila PegIntron, vendar so lahko močnejši.
English: The safety and efficacy of PegIntron therapy has not been evaluated in patients with severe hepatic dysfunction, therefore PegIntron must not be used for these patients.
Slovenian: Varnost in učinkovitost zdravljenja z zdravilom PegIntron pri bolnikih s hudo jetrno okvaro nista bili ovrednoteni, zato zdravila PegIntron ne smete uporabljati pri teh bolnikih.
English: Concomitant administration of peginterferon alfa-2b (PegIntron) with caffeine or desipramine modestly increased the exposure of caffeine and desipramine.
Slovenian: Sočasna uporaba peginterferona alfa-2b (zdravila PegIntron) s kofeinom ali dezipraminom je zmerno povečala izpostavljenost kofeinu in dezipraminu.
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.
Slovenian: Če psihiatrični simptomi trajajo dlje časa ali se celo poslabšajo ali če ugotovite, da ima bolnik samomorilne ali morilske misli, je priporočljivo, da se zdravljenje z zdravilom PegIntron ukine in da bolnika spremljate, po potrebi tudi s psihiatrično intervencijo.
English: PegIntron should therefore not be used as long term maintenance monotherapy.
Slovenian: Zdravila PegIntron torej ne smete uporabljati za dolgoročno vzdrževalno monoterapijo.
English: There are no data available regarding potential effects of PegIntron treatment on male or female fertility.
Slovenian: Plodnost Podatki o možnih učinkih zdravljenja z zdravilom PegIntron na plodnost moških in žensk niso na voljo.
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).
Slovenian: V teh študijah so raziskali učinke režimov z večkratnimi odmerki peginterferona alfa-2b (zdravila PegIntron) pri preiskovancih s hepatitisom C (1,5 mcg/teden) in zdravih preiskovancih (1 mcg/teden ali 3 mcg/teden) (preglednica 4).
English: If such a reaction develops during treatment with PegIntron, discontinue treatment and institute appropriate medical therapy immediately.
Slovenian: Če se med zdravljenjem z zdravilom PegIntron pojavi taka reakcija, morate takoj prekiniti zdravljenje in uvesti ustrezno zdravljenje.
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.
Slovenian: V kliničnem preskušanju pri 107 otrocih in mladostnikih (starih od 3 do 17 let), zdravljenih s kombinirano terapijo zdravila PegIntron in ribavirina, je bila potrebna prilagoditev odmerka pri 25 % bolnikov, najpogosteje zaradi anemije, nevtropenije in izgube telesne mase.
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 PegIntron with ribavirin needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Slovenian: Populacija bolnikov, vključenih v preskušanje, je bila sestavljena predvsem iz otrok z blagim do zmernim hepatitisom C. Zaradi pomanjkanja podatkov pri otrocih z močno napredovalo boleznijo in zaradi nevarnosti za pojav neželenih učinkov je treba pri tej populaciji skrbno pretehtati razmerje med tveganji in koristmi zdravljenja s kombinacijo zdravila PegIntron in ribavirina (glejte poglavja 4.1, 4.4 in 4.8).
English: Table 5 Precautions for co-administration (PegIntron should be administered with care when co-administered with the following medicines)
Slovenian: Preglednica 5 Previdnost pri sočasni uporabi (zdravilo PegIntron je treba uporabljati previdno, kadar se uporablja sočasno z naslednjimi zdravili)
English: - Then insert the needle through the rubber top of the PegIntron vial.
Slovenian: Nato zabodite iglo skozi gumijasti zgornji del viale zdravila PegIntron.
English: A clinically significant pharmacokinetic interaction was not observed between peginterferon alfa-2b (PegIntron) and tolbutamide, midazolam or dapsone; therefore, no dosing adjustment is necessary when peginterferon alfa-2b (PegIntron) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.
Slovenian: Klinično pomembnih farmakokinetičnih interakcij med peginterferonom alfa-2b (zdravilom PegIntron) in tolbutamidom, midazolamom ali dapsonom niso opazili, zato prilagoditev odmerka ni potrebna, kadar se peginterferon alfa-2b (zdravilo PegIntron) uporablja sočasno z zdravili, ki se presnovijo s CYP2C9, CYP3A4 in N-acetiltransferazo.
English: 3 was observed in 4 % (8/194) of patients receiving PegIntron in combination with ribavirin.
Slovenian: 3 pri 4 % (8/194) bolnikov, ki so prejemali zdravilo PegIntron v kombinaciji z ribavirinom.
English: How to self-inject PegIntron?
Slovenian: Kako si sami injicirate zdravilo PegIntron?
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).
Slovenian: Bolniki, ki prejemajo kombinirano terapijo z zdravilom PegIntron in ribavirinom ter zidovudin, imajo povečano tveganje za pojav anemije, zato sočasna uporaba te kombinacije z zidovudinom ni priporočljiva (glejte poglavje 4.5).
English: Renal clearance appears to account for 30 % of total clearance of PegIntron.
Slovenian: Kaže, da izločanje zdravila skozi ledvica predstavlja 30 % celotnega očistka zdravila PegIntron.
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.
Slovenian: Med zdravljenjem z zdravilom PegIntron so priporočljivi občasni pregledi vida, še posebej pri bolnikih z motnjami ali boleznimi, ki so lahko povezane z retinopatijo, kot sta sladkorna bolezen ali hipertenzija.
English: Use in adults - PegIntron in combination treatment This medicine, when given with ribavirin capsules, is usually given at a dose of 1.5 microgram per kilogram of body weight once a week.
Slovenian: Uporaba pri odraslih - zdravilo PegIntron v kombiniranem zdravljenju Kadar uporabljate to zdravilo skupaj s kapsulami ribavirina, je odmerek običajno 1,5 mikrograma na kilogram telesne mase enkrat na teden.
English: Interferon neutralising factor assays were performed on serum samples of patients who received PegIntron in the clinical trial.
Slovenian: Preiskave za določanje dejavnikov, ki nevtralizirajo interferon, so opravili na serumskih vzorcih bolnikov, ki so prejemali zdravilo PegIntron v kliničnem preskušanju.
English: Following single doses of PegIntron between 0.25 and 2.0 micrograms/kg/week, serum neopterin concentration was increased in a dose-related manner.
Slovenian: Po enkratnih odmerkih zdravila PegIntron med 0,25 in 2,0 mikrogramov/kg/teden se je serumska koncentracija neopterina povečala v odvisnosti od odmerka.
English: In the presence of thyroid dysfunction, PegIntron treatment may be continued if TSH levels can be maintained in the normal range by medicine.
Slovenian: V primeru motenj delovanja ščitnice lahko zdravljenje z zdravilom PegIntron nadaljujete, če lahko z zdravilom ohranjate vrednosti TSH v normalnem razponu.
English: The use of PegIntron in combination with ribavirin had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Slovenian: Uporaba zdravila PegIntron v kombinaciji z ribavirinom ni imela opaznega negativnega vpliva na nadzor viremije HIV med samim zdravljenjem ali pozneje, med spremljanjem bolnikov.
English: Be sure the tip of needle is in the PegIntron reconstituted solution.
Slovenian: Prepričajte se , da je vrh igle v rekonstituirani raztopini PegIntron.
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.
Slovenian: Najpogostejši z zdravljenjem povezani neželeni učinki, o katerih so poročali pri odraslih bolnikih med kliničnimi preskušanji z zdravilom PegIntron v kombinaciji z ribavirinom in so ji opazili pri več kot polovici preiskovancev v teh preskušanjih, so bili utrujenost, glavobol in reakcija na mestu injiciranja.
English: Boceprevir must not be administered in the absence of PegIntron and ribavirin.
Slovenian: Boceprevirja se ne sme uporabiti brez zdravila PegIntron in ribavirina.
English: Response week 12 was defined as undetectable HCV-RNA after 12 weeks of treatment.
Slovenian: Odziv v 12. tednu so opredelili kot nemerljivo HCV-RNA po 12 tednih zdravljenja.
English: In vitro and in vivo studies suggest that the biological activity of PegIntron is derived from its interferon alfa-2b moiety.
Slovenian: Študije in vitro in in vivo kažejo, da biološka aktivnost zdravila PegIntron temelji na njegovem interferon alfa-2b delu molekule.
English: What PegIntron is and what it is used for What you need to know before you use PegIntron How to use PegIntron
Slovenian: Kaj je zdravilo PegIntron in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo PegIntron Kako uporabljati zdravilo PegIntron Možni neželeni učinki
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.
Slovenian: Vendar pa se je pokazalo, da je bila stopnja odziva v tem preskušanju odvisna tudi od odmerka ribavirina, prejetega v kombinaciji z zdravilom PegIntron ali interferonom alfa-2b.
English: Dose modification guidelines for adult patients who use PegIntron monotherapy are shown in Table 3a.
Slovenian: Smernice za prilagoditev odmerka pri odraslih bolnikih, ki zdravilo PegIntron uporabljajo v monoterapiji, so podane v preglednici 3a.
English: Approximately 21 % of children treated with PegIntron/ribavirin combination therapy developed increase in thyroid stimulating hormone (TSH).
Slovenian: Pri približno 21 % otrok, zdravljenih s kombinirano terapijo z zdravilom PegIntron/ribavirin, se je pojavilo povečanje vrednosti tiroidnega stimulirajočega hormona (TSH).