natgillin/translations-raw huggingface dataset:
Tell your doctor if you have ever had a heart attack or a heart problem; if you have a history of breathing irregularities or pneumonia, problems with blood clotting, liver condition, thyroid problems, diabetes, or high or low blood pressure. 
Zdravniku povejte, če ste kdaj imeli srčni napad ali težave s srcem, ali če ste imeli v preteklosti kdaj motnje dihanja ali pljučnico, težave s strjevanjem krvi, jetrno bolezen, težave s ščitnico, sladkorno bolezen ali visok ali nizek krvni tlak.
If psychiatric symptoms persist or worsen, or suicidal or homicidal ideation is identified, it is recommended that treatment with IntronA be discontinued, and the patient followed, with psychiatric intervention as appropriate. 
Če psihiatrični simptomi ne prenehajo ali se celo poslabšajo ali če ugotovite, da ima bolnik samomorilne ali morilske misli, priporočamo, da zdravljenje z zdravilom IntronA prekinete in bolnika spremljate, po potrebi tudi s psihiatrično intervencijo.
IntronA is also used in adult patients for the treatment of chronic hepatitis B or C, which are viral infections of the liver. 
Zdravilo IntronA se pri odraslih bolnikih uporablja tudi za zdravljenje kroničnega hepatitisa B ali C, ki sta virusni okužbi jeter.
Obtundation, coma and encephalopathy 
Otopelost, koma in encefalopatija
CHOP-like regimens are advised, but clinical experience is available only with CHVP (combination of cyclophosphamide, doxorubicin, teniposide and prednisolone). 
Svetujemo uporabo sheme, podobne CHOP zdravljenju, klinične izkušnje pa so na voljo le za shemo CHVP (kombinacija ciklofosfamida, doksorubicina, tenipozida in prednizolona).
Male patients or their female partners must use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SPC). 
Moški bolniki ali njihove partnerke morajo učinkovito kontracepcijo uporabljati med zdravljenjem in še 7 mesecev po zaključku zdravljenja (glejte SPC za ribavirin).
Final adult height was available for 14 of those children and demonstrated that 12 continued to show height deficits > 15 percentiles, 10 to 12 years after the end of treatment. 
Za 14 od teh otrok je bila na voljo končna telesna višina in pokazalo se je, da se je pri 12-ih še naprej kazalo zmanjšanje telesne višine za > 15 percentilov 10 do 12 let po končanem zdravljenju.
A total of 107 patients received treatment of whom 52 % were female, 89 % Caucasian, 67 % with HCV Genotype 1 and 63 % < 12 years of age. 
Zdravilo se je skupno 107 bolnikov, od tega je bilo 52 % žensk, 89 % belcev, 67 % jih je imelo HCV genotipa 1 in 63 % jih je bilo starih < 12 let.
Appropriate dose form and strength must be selected. 
Pozorno morate izbrati primerno obliko in jakost.
§, asthenia, 
§, manija,
Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders, who require IntronA therapy, must be closely monitored. 
Odrasle bolnike s kongestivnim srčnim popuščanjem ali miokardnim infarktom v pretekli anamnezi in/ali s predhodnimi ali obstoječimi aritmijami, ki potrebujejo terapijo z zdravilom IntronA, morate skrbno spremljati.
What IntronA is and what it is used for 
Kaj je zdravilo IntronA in zakaj ga uporabljamo
The study results are summarized in Table 6. 
Povzetek izsledkov študije je podan v Preglednici 6.
Treatment should be discontinued in case of severe leukopaenia (< 1,200/mm 3), severe neutropaenia (< 750/mm or severe thrombocytopaenia (< 70,000/mm 
Zdravljenje ukinite v primeru hude levkopenije (< 1.200/mm 3), hude nevtropenije (< 750/mm 3) ali hude trombocitopenije
During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV-RNA below lower limit of detection) did not become sustained virologic responders (HCVRNA below lower limit of detection six months after withdrawal of treatment). 
Bolniki, pri katerih v kliničnih preskušanjih po 6 mesecih zdravljenja ni prišlo do virološkega odziva (HCV-RNA pod spodnjo mejo detekcije), tudi kasneje niso dosegli trajnega virološkega odziva (HCVRNA pod spodnjo mejo detekcije 6 mesecev po prenehanju zdravljenja).
If you take telbivudine with a pegylated interferon alfa-2a or any type of injectable interferon product, your risk of developing peripheral neuropathy (numbness, tingling and/or burning sensations in the arms and/or legs) is higher. 
Če jemljete telbivudin s pegiliranim interferonom alfa-2a ali katerim koli interferonskim zdravilom za injiciranje, imate povečano tveganje za nastanek periferne nevropatije (odrevenelost, mravljinci in/ali pekoč občutek v rokah in/ali nogah).
Your doctor may prescribe a different dose of IntronA alone or in combination with other medicines (e.g., cytarabine, ribavirin). 
Zdravnik vam lahko predpiše tudi drugačen odmerek zdravila IntronA, samega ali skupaj z drugimi zdravili (npr. s citarabinom, ribavirinom).
Contact your doctor or pharmacist if needed. 
Po potrebi se posvetujte z zdravnikom ali farmacevtom.
Hold the IntronA vial upright without touching the cleaned top of the vial with your hands. 
Vialo zdravila IntronA držite pokončno, ne da bi se pri tem z rokami dotaknili očiščenega vrha viale.
Because of the risk of increased toxicity, careful adjustments of doses are required for IntronA and for the concomitant chemotherapeutic agents (see section 4.5). 
Zaradi nevarnosti povečane toksičnosti je potrebno skrbno prilagajanje odmerkov zdravila IntronA in sočasno uporabljenih kemoterapevtikov (glejte poglavje 4.5).
In Table 1 the frequency of patients reporting (treatment related) undesirable effects is presented from clinical trials in naïve patients treated for one year. 
V Preglednici 1 je podana pogostnost (z zdravljenjem povezanih) neželenih učinkov, o katerih so poročali pri predhodno nezdravljenih bolnikih v kliničnih preskušanjih, v katerih so se zdravili eno leto.
- if you are being treated with telbivudine (see section "Other medicines and IntronA"). 
- če se zdravite s telbivudinom (glejte poglavje "Druga zdravila in zdravilo IntronA").
Your doctor will test your blood to ensure that your white blood cell (cells that fight infection) and red blood cell (cells that carry iron and oxygen) counts, platelets (blood clotting cells) and other laboratory values are at acceptable levels. 
Zdravnik bo opravil preiskave krvi, da zagotovi, da so število levkocitov (celice, ki se bojujejo proti okužbi), število eritrocitov (celice, ki prenašajo železo in kisik), število trombocitov (celice za strjevanje krvi) pa tudi drugi vaši laboratorijski izvidi sprejemljivi.
Within the 5 years follow-up post-treatment period, the children had a mean height of th percentile, which was below the median of the normative population and less than their mean baseline height (48 
V obdobju 5-letnega spremljanja bolnikov po zaključku zdravljenja je bila srednja višina otrok v 44. percentilu, kar je pod mediano vrednostjo normativne populacije in manj od srednje vrednosti njihove višine na začetku zdravljenja (48. percentil).
- when receiving IntronA, you may temporarily have a greater risk of getting an infection. 
- med prejemanjem zdravila IntronA ste lahko začasno bolj nagnjeni k okužbam.
Tell your doctor if you have ever been treated for depression or any other psychiatric disorder; confusion; unconsciousness; thoughts of suicide or attempted suicide, or have a history of substance abuse (e.g., alcohol or drugs). 
Zdravniku povejte, če ste se kdaj zdravili zaradi depresije ali katere koli druge duševne motnje, zmedenosti, nezavesti, samomorilnih misli ali poskusa samomora ali ste v preteklosti zlorabljali opojne substance (npr. alkohol ali droge).
Injections of human recombinant interferon alfa-2b for up to three months have shown no evidence of toxicity in mice, rats, and rabbits. 
Po injiciranju humanega rekombinantnega interferona alfa-2b do 3 mesece niso opažali nobenih znakov toksičnosti zdravila pri miših, podganah in kuncih.
Combination therapy with ribavirin Ribavirin therapy is contraindicated in women who are pregnant. 
Kombinirana terapija z ribavirinom Zdravljenje z ribavirinom je kontraindicirano pri nosečnicah.
- if you are being treated for mental illness or had treatment in the past for any other nervous or mental disorder, including depression (such as feelings of sadness, dejection) or suicidal or homicidal behaviour (see section 4 “Possible side effects”). 
- če se zdravite zaradi duševne bolezni ali ste se v preteklosti zdravili zaradi katere koli bolezni živčevja ali duševne motnje, vključno z depresijo (kot je občutek žalosti, potrtosti) ali s samomorilnim ali morilskim vedenjem (glejte poglavje 4.
As adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e.g., patients with primary or recurrent (clinical or pathological) lymph node involvement. 
Kot dodatno zdravljenje pri bolnikih, ki so po kirurškem posegu ozdravljeni, vendar pri njih še vedno obstaja veliko tveganje za sistemsko ponovitev bolezni, npr. pri bolnikih s primarno ali ponavljajočo prizadetostjo bezgavk (klinično ali patološko).
During concomitant therapy with xanthine agents, serum theophylline levels must be monitored and dose adjusted if necessary. 
Med sočasno terapijo s ksantinskimi učinkovinami morate spremljati serumsko koncentracijo teofilina in po potrebi prilagoditi odmerek zdravila.
Your doctor or his/her assistant will instruct you how to selfinject IntronA. 
Zdravnik ali medicinska sestra vas bosta poučila, kako si sami injicirate zdravilo IntronA.
Some children have had a decrease in their rate of growth (height and weight). 
Pri nekaterih otrocih se je upočasnila rast (telesna višina in masa).
For short term travelling, the solution can be kept out of the refrigerator at or below 25°C for a period up to seven days before use. 
Za kratkotrajen prevoz lahko raztopino shranjujete zunaj hladilnika pri temperaturi do vključno 25 °C, do 7 dni pred uporabo.
What IntronA is and what it is used for What you need to know before you use IntronA How to use IntronA 
Kaj je zdravilo IntronA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo IntronA Kako uporabljati zdravilo IntronA Možni neželeni učinki
if you have received an organ transplant, either kidney or liver, interferon treatment may increase the risk of rejection. 
če ste prejemnik presajenega organa, bodisi ledvice ali jeter, lahko zdravljenje z interferonom poveča tveganje za njegovo zavrnitev.
Standard haematological tests and blood chemistries (complete blood count and differential, platelet count, electrolytes, liver enzymes, serum protein, serum bilirubin and serum creatinine) are to be conducted in all patients prior to and periodically during systemic treatment with IntronA. 
Standardne hematološke preiskave in biokemične preiskave krvi (celotna krvna slika in diferencialna krvna slika, število trombocitov, določanje elektrolitov, jetrnih encimov, serumskih beljakovin, bilirubina v serumu in serumskega kreatinina) morate opraviti pri vseh bolnikih, in sicer pred terapijo z zdravilom IntronA in redno med sistemsko terapijo z njim.
Your doctor has prescribed IntronA specifically for you and your current condition; do not share this medicine with anyone else. 
Zdravnik je zdravilo IntronA predpisal prav vam in za vaše trenutne zdravstvene težave, zato ga ne smete dati drugim.
Detailed instructions for subcutaneous administration are provided with this leaflet (see section “HOW TO SELF INJECT INTRONA” at the end of the leaflet). 
Podrobna navodila za podkožno injiciranje so priložena temu navodilu (glejte poglavje “KAKO SI LAHKO SAMI INJICIRATE ZDRAVILO INTRONA” - na koncu navodil).
These undesirable effects have also been reported with IntronA alone. 
O teh neželenih učinkih so poročali tudi pri monoterapiji z zdravilom IntronA.
The mechanism by which IntronA may alter thyroid status is unknown. 
Mehanizem, prek katerega lahko zdravilo IntronA vpliva na ščitnico, ni znan.
In these patients, the addition of ribavirin to IntronA increased by as much as 10-fold the efficacy of IntronA used alone in the treatment of chronic hepatitis C (48.6 % vs. 4.7 %). 
Pri teh bolnikih je dodatek ribavirina zdravilu IntronA povečal učinkovitost zdravila IntronA v monoterapiji kroničnega hepatitisa C za kar 10-krat (48,6 % v primerjavi s 4,7 %).
Interferon neutralising factor assays were performed on serum samples of patients who received IntronA in Schering-Plough monitored clinical trials. 
Testi za določanje nevtralizacijskega faktorja za interferon so bili opravljeni na vzorcih seruma pri bolnikih, ki so prejeli zdravilo IntronA v kliničnih preskušanjih, ki so potekala pod nadzorom družbe Schering-Plough.
Hairy cell leukaemia Treatment of patients with hairy cell leukaemia. 
Dlakastocelična levkemija Zdravljenje bolnikov z dlakastocelično levkemijo.
Children and adolescent population 
Otroci in mladostniki
In particular, decrease in mean height percentile from baseline to the end of the longterm follow-up was most prominent in prepubertal age children (see section 4.4). 
Zmanjšanje srednjega percentila višine od začetka zdravljenja do konca dolgoročnega spremljanja bolnikov pa je bilo najbolj izrazito pri otrocih pred puberteto (glejte poglavje 4.4).
If necessary, an inter-disciplinary approach including a mental health care provider or addiction specialist should be considered to evaluate, treat and follow the patient. 
Če je potrebno, uporabite interdisciplinarni pristop z vključitvijo specialista s področja duševnega zdravja ali odvisnosti, za oceno stanja, zdravljenje in spremljanje takega bolnika.
Hypotension may occur during IntronA therapy or up to two days post-therapy and may require supportive treatment. 
Med terapijo z zdravilom IntronA ali do dva dni po prenehanju terapije lahko nastopi hipotenzija, zaradi katere je lahko potrebna podporna terapija.
Therefore, it is recommended that children and adolescent patients receiving IntronA/ribavirin combination be discontinued from therapy if their week 12 HCV-RNA dropped < 2 log10 compared to pretreatment, or if they have detectable HCV-RNA at treatment week 24. 
Zato je priporočljivo, da otrokom in mladostnikom, ki prejemajo kombinacijo zdravila IntronA in ribavirina, zdravljenje ukinete, če jim vrednost HCV-RNA v 12. tednu upade za < 2 log10 v primerjavi s stanjem pred zdravljenjem ali če imajo v krvi merljivo količino HCV-RNA v 24. tednu zdravljenja.
Any patient complaining of changes in visual acuity or visual fields, or reporting other ophthalmologic symptoms during treatment with IntronA, must have a prompt and complete eye examination. 
Vsi bolniki, ki tožijo o spremembah ostrine vida ali vidnega polja ali ki imajo druge oftalmološke simptome med zdravljenjem z zdravilom IntronA, morajo biti takoj poslani na celoten oftalmološki pregled.
During ALT flare, the following liver function tests must be monitored at two-week intervals: ALT, prothrombin time, alkaline phosphatase, albumin and bilirubin. 
Med povečanjem vrednosti ALT morate na vsaka dva tedna opravljati naslednje preiskave delovanja jeter: določanje vrednosti ALT, protrombinskega časa, alkalne fosfataze, albumina in bilirubina.
Driving and using machines Do not drive or use machines if you become drowsy, tired, or confused from using this medicine. 
Vpliv na sposobnost upravljanja vozil in strojev Če postanete zaradi tega zdravila zaspani, utrujeni ali zmedeni, ne vozite in ne upravljajte strojev.
In general, the adverse reaction profile in the limited children and adolescent population studied was similar to that observed in adults, although there is a paediatric- specific concern regarding growth inhibition as decrease in height percentile (mean percentile decrease of 9 percentile) and weight percentile (mean percentile decrease of 13 percentile) were observed during treatment. 
Na splošno je bil profil neželenih učinkov v omejeni proučevani populaciji otrok in mladostnikov podoben kot pri odraslih, čeprav obstaja za pediatrične bolnike še posebna skrb glede zastoja rasti, saj so med zdravljenjem opazili zmanjšanje percentila višine (srednje zmanjšanje za 9 percentilov) in percentila telesne mase (srednje zmanjšanje za 13 percentilov).
Insert the needle into the vial containing the IntronA solution and inject air into the vial. 
Vstavite iglo v vialo z raztopino zdravila IntronA in injicirajte zrak v vialo.
Any patient developing liver function abnormalities during treatment with IntronA must be monitored closely and treatment discontinued if signs and symptoms progress. 
Vse bolnike, pri katerih se med zdravljenjem z zdravilom IntronA pojavijo motnje delovanja jeter, morate natančno spremljati in zdravljenje prekiniti, če se znaki in simptomi slabšajo.
Clinical experience indicates that a haematological and cytogenetic major/minor response is obtainable in the majority of patients treated. 
Klinične izkušnje kažejo, da je pri večini zdravljenih bolnikov možno doseči večji ali manjši hematološki in citogenetski odziv.
Patients with debilitating medical conditions 
Bolniki z izčrpavajočimi bolezenskimi stanji
Due to the lack of data in these two multicentre trials for children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8). 
Zaradi pomanjkanja podatkov v teh dveh multičentričnih preskušanjih pri otrocih s hudim napredovanjem bolezni in možnostjo pojava neželenih učinkov je potrebno pred uporabo kombinacije ribavirina in interferona alfa-2b v tej populaciji skrbno pretehtati razmerje med koristnostjo zdravljenja in tveganjem (glejte poglavja 4.1, 4.4 in 4.8).
Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo. 
Rekombinantni interferon alfa-2b zavira tudi replikacijo virusov in vitro in in vivo.
Results of animal reproduction studies indicate that recombinant interferon alfa-2b was not teratogenic in rats or rabbits, nor did it adversely affect pregnancy, foetal development or reproductive capacity in offspring of treated rats. 
Izsledki študij o vplivu na sposobnost razmnoževanja na živalih kažejo, da rekombinantni interferon alfa-2b ni bil teratogen za podgane in kunce in da ni negativno vplival na brejost, razvoj ploda ali na sposobnost razmnoževanja potomcev zdravljenih podgan.
Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis Bacterial infection 
faringitis*, virusna okužba* bronhitis, sinusitis, herpes simpleks (rezistenca), rinitis bakterijska okužba pljučnica
For all patients, if no improvement on serum HBV-DNA is observed after 3 to 4 months of treatment (at the maximum tolerated dose), discontinue IntronA therapy. 
Pri vseh bolnikih velja, da če po 3 do 4 mesecih zdravljenja ne ugotovite nobenega izboljšanja serumske vrednosti HBV-DNA (ob največjem odmerku, ki ga bolnik še prenaša), morate terapijo z zdravilom IntronA ukiniti.
Any thyroid abnormality detected at that time must be treated with conventional therapy. 
Vse motnje v delovanju ščitnice, ki jih takrat ugotovite, morate zdraviti s konvencionalno terapijo.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100, <1/10). 
V posameznih organskih sistemih so neželeni učinki razvrščeni po pogostnosti v naslednji dve kategoriji: zelo pogosti (≥1/10), pogosti (≥1/100, <1/10).
It is obtained from a clone of E. coli, which harbours a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes. 
Pridobiva se iz klona E. coli, v katerega je vgrajen plasmidni hibrid, izdelan z genetskim inženiringom, ki vsebuje gen za interferon alfa-2b iz človeških levkocitov.
(affects less than 1 user in 10,000) 
(pojavijo se pri manj kot 1 bolniku od 10.000 bolnikov)
In a large study, 1,071 patients were enrolled after treatment in a prior non-pegylated interferon alfa2b or non-pegylated interferon alfa-2b/ribavirin study to evaluate the durability of sustained virologic response and assess the impact of continued viral negativity on clinical outcomes. 
V veliko študijo so vključili skupaj 1.071 bolnikov, ki so bili predhodno vključeni v študijo z nepegiliranim interferonom alfa-2b ali z nepegiliranim interferonom alfa-2b in ribavirinom, da bi ovrednotili trajanje trajnega virološkega odziva in ocenili vpliv nadaljnjih negativnih izvidov določanja virusa na klinične izide.
The side effect may develop at various time points during treatment, typically several months after starting treatment with IntronA. 
Neželeni učinek se lahko pojavi ob različnih časovnih točkah zdravljenja, običajno nekaj mesecev po začetku zdravljenja z zdravilom IntronA.
The dosage will vary according to the disease being treated. 
Odmerki zdravila IntronA se razlikujejo glede na bolezen, ki jo zdravimo.
If you are exceptionally thin, use only the thigh or outer surface of the arm for injection. 
Če ste izjemno suhi, za mesto injiciranja izberite le stegno ali zunanjo površino roke.
The pharmacokinetics of IntronA were studied in healthy volunteers following single 5 million IU/m and 10 million IU doses administered subcutaneously, at 5 million IU/m2 administered intramuscularly and as a 30-minute intravenous infusion. 
Farmakokinetiko zdravila IntronA so raziskovali pri zdravih prostovoljcih po enkratnih subkutanih odmerkih po 5 milijonov i.e./m2 in 10 milijonov i.e., po intramuskularnem dajanju 5 milijonov i.e./m in po 30-minutni intravenski infuziji.
When IntronA is used with hydroxyurea, the frequency and severity of cutaneous vasculitis may be increased. 
Pri uporabi zdravila IntronA skupaj s hidroksisečnino se lahko poveča pogostnost in resnost kožnega vaskulitisa.
With one hand, pinch a fold of loose skin. 
Z eno roko oblikujte kožno gubo.
What IntronA looks like and contents of the pack 
Izgled zdravila IntronA in vsebina pakiranja
During combination therapy for up to 48 weeks with IntronA and ribavirin, growth inhibition was observed that resulted in reduced final adult height in some patients. 
V času kombinirane terapije z zdravilom IntronA in ribavirinom, ki je trajala do 48 tednov, so opazili zastoj rasti, ki je imel pri nekaterih bolnikih za posledico manjšo končno telesno višino.
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/mL (Amplicor) who were treated for 24 weeks with a 6-month follow-up period. 
Zdravljenje je trajalo 48 tednov, z nadaljnjim 6-mesečnim obdobjem spremljanja bolnikov, razen pri tistih, ki so bili okuženi z genotipoma 2 ali 3 in so imeli virusno breme < 800.000 i.e./ml (Amplicor) - njih so zdravili 24 tednov z nadaljnjim 6-mesečnim obdobjem spremljanja.
When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that resulted in reduced final adult height in some patients. 
Pri odločitvi glede odložitve zdravljenja do odrasle dobe je pomembno upoštevati, da je kombinirana terapija povzročila zastoj rasti, ki je imel pri nekaterih bolnikih za posledico manjšo končno telesno višino.
It is important to consider that the combination therapy induced a growth inhibition that resulted in reduced final adult height in some patients. 
Pomembno je upoštevati, da je kombinirana terapija povzročila zastoj rasti, ki je imel pri nekaterih bolnikih za posledico manjšo končno telesno višino.
Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be reassessed (see also section 4.4 Chronic hepatitis C, Monotherapy (thyroid abnormalities) and section 4.8). 
Bolnike z znaki ali simptomi, ki bi lahko bili združljivi z avtoimuno boleznijo, morate skrbno preiskati ter pri njih ponovno oceniti razmerje med koristmi in tveganji nadaljnje terapije z interferonom (glejte tudi poglavji 4.4 Kronični hepatitis C, monoterapija (motnje ščitnice) in 4.8).
Take the needle and place it firmly onto the tip of the syringe. 
Vzemite iglo in jo trdno pričvrstite na vrh brizge.