natgillin/translations-raw huggingface dataset:
462 patients completed at least 5 years of long-term follow-up and only 12 sustained responders' out of 492 relapsed during this study. 
Pri 462 bolnikih se je zaključilo najmanj 5 letno dolgoročno spremljanje in le pri 12 bolnikih s trajnim virološkim odzivom od skupaj 492 bolnikov je prišlo do ponovitve bolezni v času te študije.
Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of IntronA in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk. 
Zaradi poročil, da je interferon alfa poslabšal že obstoječo psoriazo in sarkoidozo, priporočamo, da pri bolnikih s psoriazo in sarkoidozo zdravilo IntronA uporabljate le, če njegove morebitne koristi odtehtajo možno tveganje.
Any size vial may be used to measure the required dose; however, final concentration of interferon in sodium chloride solution must be not less than 0.3 million IU/mL. 
Za odmerjanje potrebnega odmerka se lahko uporabi katerakoli velikost viale, vendar končna koncentracija interferona v raztopini natrijevega klorida ne sme biti manjša od 0,3 milijona i.e./ml.
It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virus-infected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells. 
Menijo, da je ta proces vsaj deloma odgovoren za različne celične odzive na interferon, vključno z zavoro replikacije virusov v celicah okuženih z virusi, supresijo celične proliferacije in oblikami imunomodulacijskega delovanja, kot je okrepitev fagocitne aktivnosti makrofagov in povečanje specifične citotoksičnosti limfocitov za tarčne celice.
Your doctor will determine the exact dosage schedule and regimen according to your needs. 
Natančen odmerek in režim odmerjanja zdravil bo določil zdravnik glede na vaše potrebe.
Tell your doctor if you are taking theophylline or aminophylline for asthma, and about all other medicines you are taking, or have taken recently, even those not prescribed, as the dose of some medicines may have to be adjusted while you are treated with IntronA. 
Zdravniku povejte, če jemljete teofilin ali aminofilin za astmo, pa tudi za vsa druga zdravila, ki jih jemljete ali ste jih jemali nedavno, tudi za tista, ki ste jih dobili brez recepta, saj je lahko med zdravljenjem z zdravilom IntronA potrebna prilagoditev odmerka nekaterih zdravil.
- if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing, or hives) while on this medicine seek medical help immediately. 
- če se med jemanjem tega zdravila pojavijo simptomi hude alergijske reakcije (npr. težave z dihanjem, piskanje v pljučih ali koprivnica), nemudoma poiščite zdravniško pomoč.
*AUC12 (ng.hr/mL) for ribavirin; AUC0-24 (IU.hr/mL) for IntronA 
*AUC12 (ng x h/ml) za ribavirin; AUC0-24 (i.e. x h/ml) za IntronA
With your other hand hold the syringe as you would a pencil. 
Z drugo držite brizgo kot svinčnik.
If such a reaction develops, discontinue the medicine and institute appropriate medical therapy. 
Če se takšna reakcija pojavi, prekinite zdravljenje in uvedite ustrezno medikamentozno terapijo.
If you have this reaction, be sure to rinse your mouth thoroughly afterwards. 
Če pride do te reakcije, si potem zagotovo temeljito sperite usta.
Turn the vial and the syringe upside down in one hand. 
Vialo in brizgo obrnite tako, da je viala zgoraj, in ju držite v eni roki.
All patients in the 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. 
Pri vseh bolnikih, vključenih v raziskave kroničnega hepatitisa C, so pred vključitvijo v raziskavo opravili jetrno biopsijo, vendar je v določenih primerih (tj. pri bolnikih z genotipoma 2 in 3), zdravljenje možno tudi brez histološke potrditve.
Remove the needle guard without touching the needle, and fill the syringe with air by pulling the plunger to the level that represents your dose as prescribed by your doctor. 
Z igle snemite zaščitni pokrovček, ne da bi se je dotaknili, in brizgo napolnite z zrakom tako, da bat potegnete nazaj do črte, ki predstavlja odmerek zdravila, ki vam ga je predpisal zdravnik.
Examine the solution prior to administration: it should be clear and colourless. 
Pred uporabo raztopino preglejte: biti mora bistra in brezbarvna.
3 or alanine aminotransferase/aspartate aminotransferase (ALT/AST) rises to > 5 x upper limit of normal, discontinue treatment temporarily until the adverse event abates. 
3 ali če vrednost alanin-aminotransferaze/aspartat-aminotransferaze (ALT/AST) naraste na > 5-kratno zgornjo mejo normale, začasno prekinite zdravljenje, dokler neželeni učinek ne izzveni.
Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism. 
Čeprav natančen protivirusni način delovanja rekombinantnega interferona alfa-2b ni znan, kaže, da spremeni presnovo celice gostiteljice.
In adult patients receiving interferon in combination with ribavirin, the achieved sustained response rate is 47 %. 
Pri odraslih bolnikih, ki so prejemali interferon v kombinaciji z ribavirinom, je delež trajnega virološkega odziva 47 %.
The increased response rate to the combination of IntronA + ribavirin, compared with IntronA alone, is maintained across all subgroups. 
Povečan delež odziva na kombinacijo zdravila IntronA in ribavirina v primerjavi s samim zdravilom IntronA se ohranja v vseh podskupinah.
IntronA must be used with caution in fertile men. 
Zdravilo IntronA uporabljajte previdno pri plodnih moških.
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. 
Klinično preskušanje, v katerem so proučevali uporabo kombinacije telbivudina, v odmerku 600 mg na dan, in pegiliranega interferona alfa-2a, v odmerku 180 mikrogramov subkutano enkrat na teden, je pokazalo, da je ta kombinacija povezana s povečanim tveganjem za pojav periferne nevropatije.
IntronA is used in adult patients to treat certain disorders that affect the blood, bone marrow, lymph glands, or skin and may extend into the body. 
Zdravilo IntronA se uporablja pri odraslih bolnikih za zdravljenje določenih bolezni, ki prizadenejo kri, kostni mozeg, limfne žleze ali kožo, in se lahko razširijo po telesu.
They exhibit selectivity for human but not murine interferons, suggesting species specificity. 
Selektivni so za človeške, ne pa tudi za glodalske interferone, kar kaže na vrstno specifičnost.
Current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated. 
Sedanje klinične izkušnje kažejo, da vzdrževalno zdravljenje z interferonom alfa-2b podaljša fazo platoja, vendar učinek na skupno preživetje ni bil dokončno dokazan.
- if you develop symptoms associated with a cold or other respiratory infection, such as fever, cough, or any difficulty in breathing, tell your doctor. 
- če se pri vas pojavijo simptomi, povezani s prehladom ali drugimi okužbami dihal, kot so zvišana telesna temperatura, kašelj ali kakršne koli težave z dihanjem, obvestite zdravnika.
In patients with hepatitis, no loss of response was observed apparently due to the low titres. 
Pri bolnikih s hepatitisom niso opažali prenehanja odzivnosti, očitno zaradi majhnih titrov.
If the chest X-ray shows pulmonary infiltrates or there is evidence of pulmonary function impairment, the patient is to be monitored closely, and, if appropriate, discontinue interferon alpha. 
Če rentgenogram pokaže pljučne infiltrate ali znake motenj pljučne funkcije, morate bolnika skrbno nadzorovati in po potrebi ukiniti interferon alfa.
Effect on fertility Interferon may impair fertility (see section 4.6 and section 5.3). 
Vpliv na plodnost Interferon lahko zmanjša plodnost (glejte poglavji 4.6 in 5.3).
- if you have a history of autoimmune disease, or have had an organ transplant and are taking medicine that suppresses your immune system (your immune system helps protect you from infection). 
- če ste imeli kdaj v preteklosti avtoimuno bolezen ali ste prejemnik presajenega organa in jemljete zdravila, ki zavirajo imunski sistem (imunski sistem pomaga ščititi telo pred okužbami).
IntronA (interferon alfa-2b) modifies the response of the body's immune system to help fight infections and severe diseases. 
Zdravilo IntronA (interferon alfa-2b) spremeni imunski odziv telesa in pomaga pri obrambi proti okužbam in hudim boleznim.
Patients are to be advised that they may develop fatigue, somnolence, or confusion during treatment with IntronA, and therefore it is recommended that they avoid driving or operating machinery. 
Bolnike poučite, da bodo med zdravljenjem z zdravilom IntronA lahko utrujeni, zaspani ali zmedeni in da je zato priporočljivo, da se izogibajo vožnji ali upravljanju strojev.
The population enrolled mainly consisted in children with mild to moderate hepatitis C. In the two multicentre trials sustained virological response rates in children and adolescents were similar to those in adults. 
Populacija je vključevala predvsem otroke z blagim do zmernim hepatitisom C. V dveh multicentričnih preskušanjih je bil delež trajnega virološkega odziva pri otrocih in mladostnikih podoben tistemu pri odraslih.
IntronA increases the risk of liver decompensation and death in patients with cirrhosis. 
Zdravilo IntronA poveča tveganje za jetrno dekompenzacijo in smrt pri bolnikih s cirozo.
Rarely reported side effects: pneumonia. 
Redko poročani neželeni učinki: pljučnica.
Children and adolescents are particularly prone to develop depression when being treated with IntronA and ribavirin. 
Otroci in mladostniki so še bolj nagnjeni k depresiji, kadar se zdravijo z zdravilom IntronA in ribavirinom.
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. 
Če se pojavijo takšni simptomi, mora zdravnik, ki predpiše zdravilo, upoštevati potencialno resnost teh neželenih učinkov in razmisliti o potrebi po primernih terapevtskih ukrepih.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of IntronA therapy. 
Srčne aritmije (predvsem supraventrikularne) se običajno odzovejo na konvencionalno terapijo, vendar je pri njih lahko potrebna ukinitev terapije z zdravilom IntronA.
Children and adolescents: - if you have had serious nervous or mental problems, such as severe depression or thoughts of suicide. 
Otroci in mladostniki: - če ste kdaj imeli resno bolezen živčevja ali duševne težave, kot so huda depresija ali samomorilne misli.
This regimen must be maintained unless the disease progresses rapidly or severe intolerance is manifested. 
Ta režim zdravljenja vzdržujte, razen če bolezen hitro napreduje ali če bolnik zelo slabo prenaša zdravljenje.
Carcinoid tumour Treatment of carcinoid tumours with lymph node or liver metastases and with "carcinoid syndrome". 
Zdravljenje karcinoidnih tumorjev z metastazami v bezgavkah ali jetrih in s “karcinoidnim sindromom”.
If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards. 
Če pride do te reakcije, naj si potem temeljito sperejo usta.
if you are also being treated for HIV (see section “Other medicines and IntronA”). 
če se zdravite tudi zaradi okužbe s HIV (glejte poglavje “Druga zdravila in zdravilo IntronA”).
Before initiating treatment with IntronA, consideration should be given to the results from clinical trials comparing IntronA with pegylated interferon (see section 5.1). 
Preden začnete zdravljenje z zdravilom IntronA, upoštevajte rezultate kliničnih preskušanj, ki so primerjala zdravilo IntronA s pegiliranim interferonom (glejte poglavje 5.1).
Improvement in all three haematological variables (granulocyte count, platelet count and haemoglobin level) may require six months or more. 
Za izboljšanje vseh treh hematoloških vrednosti (števila granulocitov, števila trombocitov in vrednosti hemoglobina) pa je lahko potrebnih 6 mesecev ali več.
After intravenous administration, serum interferon levels peaked (135 to 273 IU/mL) by the end of the infusion, then declined at a slightly more rapid rate than after subcutaneous or intramuscular administration of medicinal product, becoming undetectable four hours after the infusion. 
Po intravenski uporabi so bile največje serumske koncentracije interferona (od 135 do 273 i.e./ml) dosežene ob koncu infuzije, potem pa so upadale nekoliko hitreje kot po subkutani ali intramuskularni uporabi zdravila in 4 ure po infuziji niso bile več merljive.
Moderate and usually reversible pancytopenia has been reported. 
Poročali so o zmerni in navadno reverzibilni pancitopeniji.
Relapse patients (adults) 
Bolniki z relapsom bolezni (odrasli)
The best sites for injection are tissues with a layer of fat between skin and muscle: thigh, outer surface of the upper arm (you may need the assistance of another person to use this site), abdomen (except the navel or waistline). 
Najboljša mesta za injiciranje so tkiva s plastjo maščevja med kožo in mišicami: stegno, zunanja površina nadlakti (tu boste morda potrebovali pomoč druge osebe), trebuh (razen popka ali pasu).
This enhancement in efficacy included loss of serum HCV (< 100 copies/mL by PCR), improvement in hepatic inflammation, and normalisation of ALT, and was sustained when measured 6 months after the end of treatment. 
Ta okrepitev učinkovitosti je vključevala odsotnost HCV v serumu (< 100 kopij/ml pri PCR), izboljšanje vnetja jeter in normalizacijo ALT in je bila še ohranjena ob merjenju 6 mesecev po koncu terapije.
The relative benefit of combination therapy with IntronA + ribavirin is particularly significant in the most difficult to treat subgroup of patients (genotype 1 and high virus load) (Table 3). 
Relativna korist kombinirane terapije z zdravilom IntronA in ribavirinom je še posebej pomembna za podskupino bolnikov, ki jih je najtežje zdraviti (genotip 1 in velika virusna obremenitev) (Preglednica 3).
Be sure to tell your doctor if you are taking the Chinese herbal medicine shosaikoto. 
Zdravniku morate povedati tudi, če jemljete kitajski zeliščni pripravek shosaikoto.
§, pneumonitis Pulmonary fibrosis, pulmonary arterial hypertension 
§, pnevmonitis pljučna fibroza, pljučna arterijska hipertenzija
If there is bleeding, cover with an adhesive bandage. 
Če pride do krvavitve, mesto pokrijte s samolepilnim obližem.
Push up the plunger slowly back to the correct dose. 
Bat počasi potisnite nazaj do pravilnega odmerka.
Superior efficacy has been demonstrated with the combination of pegylated interferon with ribavirin (sustained response rate of 61 % achieved in a study performed in naïve patients with a ribavirin dose > 10.6 mg/kg, p < 0.01). 
Boljša učinkovitost pa se je pokazala pri uporabi pegiliranega interferona v kombinaciji z ribavirinom (trajen virološki odziv 61 %, dosežen v študiji, opravljeni pri bolnikih, ki se prej še niso zdravili, z odmerkom ribavirina > 10,6 mg/kg, p < 0,01).
The undesirable effects seen with hepatitis C are representative of those reported when IntronA is administered in other indications, with some anticipated dose-related increases in incidence. 
Neželeni učinki, ki so jih opažali pri hepatitisu C, so skladni s tistimi, o katerih so poročali pri uporabi zdravila IntronA za druge indikacije, z nekaterimi pričakovanimi povečanji pojavnosti v odvisnosti od odmerka zdravila.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rarely (≥1/10,000 to <1/1,000); very rarely (<1/10,000); not known. 
V posameznih organskih sistemih so neželeni učinki razvrščeni po pogostnosti v naslednje kategorije: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) oziroma pogostnost ni znana.
Daily dosing of cynomolgus monkeys with 20 x 10 
Vsakodnevno odmerjanje zdravila pri opicah vrste cynomolgus v odmerku 20 x 10
IntronA (3 MIU 3 times a week) I/R IntronA (3 MIU 3 times a week) + ribavirin (1,000/1,200 mg/day) 
IntronA (3 mio i.e. trikrat na teden) I/R IntronA (3 mio i.e. trikrat na teden) + ribavirin (1.000/1.200 mg/dan)
Abortion was observed in all dose groups (7.5 million, 15 million and 30 million IU/kg), and was statistically significant versus control at the mid- and high-dose groups (corresponding to 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/m2). 
Splav so opažali v vseh skupinah po velikosti odmerka (7,5 milijonov, 15 milijonov in 30 milijonov i.e./kg), in je bil v primerjavi s kontrolno skupino statistično značilno pogostejši pri skupinah s srednjimi in velikimi odmerki (ki so ustrezali 90 oz. 180-kratnemu priporočenemu intramuskularnemu ali subkutanemu odmerku 2 milijona i.e./m2).
If severe adverse events develop during interferon alfa-2b treatment, particularly if granulocytes decrease to < 500/mm 
Če se med zdravljenjem z interferonom alfa-2b pojavijo hudi neželeni učinki, še posebej če število granulocitov pade na < 500/mm
Patients with substance use/abuse: 
Bolniki, ki uživajo/zlorabljajo opojne substance:
Genotype 2, 
Genotipa 2,
This risk should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV co-infection), as well as prognostic factors of response, (HCV genotype and viral load). 
To tveganje je treba pretehtati glede na značilnosti bolezni pri otroku, na primer glede na znake napredovanja bolezni (predvsem fibrozo), druge sočasne bolezni, ki bi lahko negativno vplivale na napredovanje bolezni (npr. sočasno okužbo s HIV), pa tudi prognostične dejavnike odziva na zdravljenje (genotip HCV in virusno breme).
IntronA can be put back in the refrigerator at any time during this seven-day period. 
Zdravilo IntronA lahko kadar koli v tem 7 dnevnem obdobju vrnete nazaj v hladilnik.
HCV genotype and baseline virus load are prognostic factors which are known to affect response rates. 
HCV genotip in virusna obremenitev na začetku zdravljenja sta znana prognostične dejavnika, ki vplivata na delež odziva.
Pyrexia and fatigue were often reversible within 72 hours of interruption or cessation of treatment. 
Zvišana telesna temperatura in utrujenost sta pogosto izginila v roku 72 ur po prekinitvi ali ukinitvi zdravljenja.
If you are injecting IntronA yourself, please be sure that the dose that has been prescribed for you is clearly provided with the package of medicine you receive. 
Če si zdravilo IntronA injicirate sami, se prepričajte, da je predpisani odmerek jasno napisan na pakiranju zdravila, ki ga prejmete.
Patients with existence of, or history of severe psychiatric conditions: 
Bolniki, ki imajo ali so kdaj imeli hude psihiatrične motnje:
For most patients with hairy cell leukaemia, normalisation of one or more haematological variables occurs within one to two months of IntronA treatment. 
Pri večini bolnikov z dlakastocelično levkemijo pride do normalizacije ene ali več hematoloških vrednosti v 1 do 2 mesecih terapije z zdravilom IntronA.
IntronA should be given alone mainly in case of intolerance or contraindication to ribavirin. 
Zdravilo IntronA uporabljajte samostojno predvsem v primeru intolerance ali kontraindikacij za ribavirin.
The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes. 
Izsledki številnih raziskav kažejo, da interferon po vezavi na celično membrano sproži zapleteno kaskado znotrajceličnih procesov, med drugim indukcijo določenih encimov.
The longer term data available in children treated with the combination therapy with standard interferon/ribavirin are also indicative of substantial growth retardation (> 15 percentile decrease in height percentile as compared to baseline) in 21 % of children (n=20) despite being off treatment for more than 5 years. 
Dolgoročnejši podatki, ki so na voljo za otroke, zdravljene s kombinirano terapijo s standardnim interferonom in ribavirinom, tudi kažejo znatno zaostajanje v rasti (zmanjšanje telesne višine za > 15 percentilov v primerjavi z osnovno vrednostjo) pri 21 % otrok (n=20) kljub temu, da se ti že več kot 5 let niso zdravili s tem zdravilom.
The purpose of the study was to annually evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes for patients who were sustained responders 24 weeks post-treatment of the 48-week interferon alfa-2b and ribavirin treatment. 
Namen študije je bil opravljati letne ocene trajanja trajnega virološkega odziva (SVR - sustained virologic response) in oceniti vpliv nadaljnjega negativnega izvida navzočnosti virusa na klinični izid zdravljenja pri bolnikih, ki so pokazali trajni virološki odziv 24 tednov po 48-tedenskem zdravljenju z interferonom alfa-2b in ribavirinom.
Intravenous infusion: 
Intravensko infundiranje:
While this has been reported more often in patients with chronic hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha. 
Četudi so o tem pojavu poročali pogosteje pri bolnikih s kroničnim hepatitisom C, zdravljenih z interferonom alfa, so o njem poročali tudi pri bolnikih z malignimi boleznimi, zdravljenih z interferonom alfa.
For user convenience, the needle protection device can be rotated for ease of injection (Diagram B). 
Za lažje injiciranje lahko pripomoček za zaščito igle obrnete (slika B).
Case by case benefit/risk assessment in children The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials (see sections 4.8 and 5.1). 
Individualna ocena razmerja med koristmi in tveganji pri otrocih Pričakovano korist zdravljenja je treba skrbno pretehtati glede na znane izsledke iz kliničnih preskušanj glede varnosti zdravila pri otrocih in mladostnikih (glejte poglavji 4.8 in 5.1).
During the one year of treatment with IntronA in combination with ribavirin, some children and adolescents did not grow or gain weight as much as expected. 
V času enoletnega zdravljenja z zdravilom IntronA v kombinaciji z ribavirinom nekateri otroci in mladostniki niso zrasli in niso pridobili na telesni masi v tolikšni meri, kot bi pričakovali.
If treatment with interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition. 
Če ocenite, da je zdravljenje z interferonom alfa-2b potrebno pri odraslih bolnikih, ki imajo ali so kdaj imeli hude psihiatrične motnje, ga smete uvesti šele potem, ko ste zagotovili ustrezno individualno diagnostično in terapevtsko obravnavo psihiatričnega stanja.
If you are self-administering treatment, or if you are the caregiver of a child taking IntronA in combination with ribavirin, inject the recommended dose as soon as you remember and continue treatment as usual. 
Če si sami injicirate zdravilo IntronA ali ga dajete otroku v kombinaciji z ribavirinom, injicirajte priporočeni odmerek takoj, ko se spomnite, in nadaljujte z zdravljenjem kot običajno.
- if you have psoriasis, it may get worse during treatment with IntronA. 
- če imate luskavico, saj se ta lahko poslabša med zdravljenjem z zdravilom IntronA.