natgillin/translations-raw huggingface dataset:
Dosages that are to be administered 3 times a week are best given every other day. 
Pri odmerjanju zdravila 3-krat na teden je najbolje, da ga jemljete vsak drugi dan.
Slowly inject the diluent, aiming the stream of liquid at the glass wall of the vial in order to avoid production of air bubbles. 
Počasi injicirajte topilo v vialo, curek tekočine pa usmerite proti stekleni steni viale, da preprečite nastajanje zračnih mehurčkov.
Viraferon is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4). 
Viraferon je indiciran za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, ki imajo povečane vrednosti transaminaz brez dekompenzacije jeter in pozitivne izvide za serumsko HCV-RNA ali anti-HCV (glejte poglavje 4.4).
Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo. 
Rekombinantni interferon alfa-2b tudi zavira replikacijo virusov in vitro in in vivo.
The vial and injection materials intended for single use must be discarded. 
Vialo in pripomočke za injiciranje, ki so namenjeni za enkratno uporabo, morate zavreči.
These are all very serious side effects. 
Vsi ti neželeni učinki so zelo resni.
If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing up, until the bubbles disappear. 
Če opazite kakšne mehurčke, potegnite bat nekoliko nazaj in nežno potrkajte po brizgi, pri čemer naj bo igla usmerjena navzgor, dokler ne bodo mehurčki izginili.
More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses. 
Pri nekaterih bolnikih so ugotavljali močnejšo otopelost in komo, vključno s primeri encefalopatije, običajno pri starostnikih, zdravljenih z večjimi odmerki.
Do not use Viraferon if you notice changes in the appearance of Viraferon. 
Ne uporabljajte zdravila Viraferon, če opazite spremembe videza zdravila Viraferon.
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 motenosti pljučne funkcije, morate bolnika skrbno nadzorovati in po potrebi ukiniti interferon alfa.
Interferon neutralising factor assays were performed on serum samples of patients who received Viraferon 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 Viraferon v kliničnih raziskavah, ki so potekale pod nadzorom družbe Schering-Plough.
Any patient developing liver function abnormalities during treatment with Viraferon must be monitored closely and treatment discontinued if signs and symptoms progress. 
Vse bolnike, pri katerih se med zdravljenjem z zdravilom Viraferon pojavijo motnje delovanja jeter, morate natančno spremljati in zdravljenje prekiniti, če se znaki in simptomi slabšajo.
Gently push the injection needle onto the pen as shown in Diagram E. (Notice that the rear portion of the injection needle will pierce through the rubber membrane that you disinfected previously). 
Nežno potisnite injekcijsko iglo na peresnik, kot je prikazano na sliki E. (Opomba: Zadnji del injekcijske igle bo predrl skozi gumijasto opno, ki ste jo prej dezinficirali).
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 živčno ali duševno bolezen, npr. hudo depresijoali samomorilne misli.
If you are injecting Viraferon 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 Viraferon injicirate sami, pazite, da bo predpisani odmerek jasno napisan na pakiranju zdravila, ki ga jemljete.
Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “How to self inject Viraferon”). 
Natančna navodila za subkutano uporabo zdravila so opisana v navodilu za uporabo (nanaša se na "Kako si sami injicirate zdravilo Viraferon").
The adverse reactions listed in Table 2 are based on experience from paediatric clinical trials. 
Neželeni učinki, ki so navedeni v Preglednici 2, so povzeti iz pediatričnih kliničnih preskušanj.
Replace the pen cap with the triangle once again opposite the dosage indicator as shown in Diagram T. Then return the pen to the refrigerator. 
Pokrovček peresnika postavite nazaj na peresnik, pri čemer naj bo trikotnik spet nasproti kazalnika odmerkov, kot je prikazano na sliki T. Vrnite peresnik v hladilnik.
In clinical trials conducted in the hepatitis C population, patients were treated with Viraferon alone or in combination with ribavirin for one year. 
V kliničnih preskušanjih pri skupini bolnikov s hepatitisom C so bolnike eno leto zdravili z zdravilom Viraferon samostojno ali v kombinaciji z ribavirinom.
Pack of 1, 6 or 12. 
Pakiranje po 1, 6 ali 12.
Increase in serum ALT/AST (SGPT/SGOT) levels have been noted as an abnormality in some non-hepatitis subjects and also in some patients with chronic hepatitis B coincident with clearance of viral DNAp. 
Povečanje serumske vrednosti ALT/AST (SGPT/SGOT) so opažali kot motnjo pri nekaterih bolnikih brez hepatitisa in tudi pri nekaterih bolnikih s kroničnim hepatitisom B, in je sovpadalo z očistkom virusne DNAp.
a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week pegylated interferon alfa-2b and subjects ≥ 75 kg received 150 µg/week pegylated interferon alfa-2b. 
= milijonov mednarodnih enot; TIW = trikrat na teden a: vrednost p na podlagi Cochran-Mantel Haenszelovega testa hi-kvadrat b: vrednost p na podlagi testa hi-kvadrat c: preiskovanci s telesno maso < 75 kg so prejemali odmerek 100 µg/teden pegiliranega interferona alfa-2b in preiskovanci s telesno maso ≥ 75 kg so prejemali 150 µg/teden pegiliranega interferona alfa-2b.
Moderate to severe adverse experiences may require modification of the patient's dosage regimen, or in some cases, termination of Viraferon therapy. 
Pri zmernih do hudih neželenih učinkih je lahko potrebna prilagoditev režima odmerjanja, v nekaterih primerih pa tudi prekinitev terapije z zdravilom Viraferon.
Male patients and their female partners must each use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SPC). 
Tudi bolniki in njihove partnerke morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še 7 mesecev po zaključku zdravljenja (glejte SPC za ribavirin).
The use of interferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3). 
Uporaba interferona alfa-2b pri otrocih in mladostnikih s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi je kontraindicirana (glejte poglavje 4.3).
It is recommended that those patients who have pre-existing cardiac abnormalities and/or are in advanced stages of cancer have electrocardiograms taken prior to and during the course of treatment. 
Priporočamo, da pri bolnikih z obstoječimi srčnimi motnjami in/ali tistih, ki so v napredovalih stadijih maligne bolezni, posnamete EKG pred in po terapiji.
Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCVRNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received Viraferon 3 MIU/m 
Otroci in mladostniki, stari od 3 do 16 let in s kompenziranim kroničnim hepatitisom C in merljivimi količinami HCV RNA (kar je ocenil osrednji laboratorij z uporabo raziskovalnega testa RT-PCR), so bili vključeni v dve multicentrični preskušanji in so zdravilo Viraferon prejemali v odmerku 3 mio i.e./m2
Prior to initiation of Viraferon therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating hormone (TSH) levels. 
Pred uvedbo terapije z zdravilom Viraferon za zdravljenje kroničnega hepatitisa C določite serumsko koncentracijo tirotropnega hormona (TSH).
This leaflet was last approved on 
Navodilo je bilo odobreno
Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 100 copies/ml), a liver biopsy consistent with a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT. 
Bolniki, primerni za vključitev v te raziskave, so imeli kronični hepatitis C, ki je bil potrjen s pozitivnim izvidom testa polimerazne verižne reakcije za HCV-RNA (PCR) (> 100 kopij/ml), izvidom jetrne biopsije, ki je histološko potrdil diagnozo kroničnega hepatitisa brez drugega vzroka za kronični hepatitis, ter nenormalno serumsko vrednostjo ALT.
Pack sizes of 1, 2 or 8 
Velikosti pakiranj: 1, 2 ali 8 kompletov.
What Viraferon looks like and contents of the pack 
Izgled zdravila Viraferon in vsebina pakiranja
This syndrome is a granulomatous inflammatory disorder affecting the eyes, auditory system, meninges, and skin. 
To je granulomatozna vnetna bolezen, ki vpliva na oči, ušesa, možganske ovojnice in kožo.
The usual starting dose for each condition follows; however, individual doses may vary, and the doctor may change your dose based on your specific needs: 
Odmerjanje pa je individualno in zdravnik bo lahko vaš odmerek prilagodil vašim potrebam:
Very rarely reported side effects (less than 1 in every 10,000 patients): low blood pressure, puffy face, diabetes, leg cramps, back pain, kidney problems, nerve damage, bleeding gums, aplastic anaemia. 
Zelo redko opisani neželeni učinki (pri manj kot 1 na vsakih 10.000 bolnikov): nizek krvni tlak, zabuhel obraz, sladkorna bolezen, krči v nogah, bolečine v hrbtu, težave z ledvicami, poškodbe živcev, krvavitev iz dlesni, aplastična anemija.
The pen is now ready to set the dose. 
Peresnik je zdaj pripravljen za nastavitev odmerka.
Any patient developing fever, cough, dyspnea or other respiratory symptoms must have a chest X-ray taken. 
Pri vseh bolnikih, ki dobijo zvišano telesno temperaturo, kašelj, dispnejo ali kakšne druge simptome dihal, morate opraviti rentgensko slikanje prsnega koša.
The vial, ampoule and injection materials intended for single use must be discarded. 
Vialo, ampulo in pripomočke za injiciranje, ki so namenjeni za enkratno uporabo, morate zavreči.
In patients with hepatitis, no loss of response was observed apparently due to the low titres. 
Pri bolnikih s hepatitisom niso opažali prenehanja odzivnosti, kar naj bi bilo posledica majhnih titrov.
Your doctor or his/her assistant will instruct you how to self-inject Viraferon. 
Zdravnik ali sestra vas bosta poučila, kako si sami injicirate zdravilo Viraferon.
Then press the push button down fully (see Diagram P). 
Zdaj do konca pritisnite na gumb (glejte sliko P).
One ampoule of solvent contains 1 ml of water for injections. 
Ena ampula z vehiklom vsebuje 1 ml vode za injekcije.
Children and adolescents: The efficacy and safety of Viraferon in combination with ribavirin has been studied in children and adolescents who have not been previously treated for chronic hepatitis C. 
Otroci in mladostniki: Varnost in učinkovitost zdravljenja s kombinacijo zdravila Viraferon in ribavirina so ocenjevali pri otrocih in mladostnikih, ki jih predhodno še niso zdravili za hepatitis C.
As in adult patients, children and adolescents also experienced other psychiatric adverse events (e.g., depression, emotional lability, and somnolence) (see section 4.4). 
Kot odrasli bolniki so imeli tudi otroci in mladostniki še druge psihiatrične neželene dogodke (npr. depresijo, čustveno labilnost in zaspanost) (glejte poglavje 4.4).
If air bubbles do form, wait until the solution has settled and all bubbles have risen to the top of the solution and disappeared before withdrawing your dose from the vial. 
Če zračni mehurčki kljub vsemu nastanejo, počakajte, da se raztopina posede in se vsi mehurčki dvignejo na vrh raztopine ter izginejo, šele potem lahko posesate odmerek zdravila iz viale.
Hypertension Peripheral ischaemia, hypotension 
hipertenzija periferna ishemija, hipotenzija§
when receiving Viraferon, you may temporarily have a greater risk of getting an infection. 
- med prejemanjem zdravila Viraferon ste lahko začasno bolj nagnjeni k okužbam.
Viraferon must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e.g., chronic obstructive pulmonary disease) or diabetes mellitus prone to ketoacidosis. 
Zdravilo Viraferon morate uporabljati previdno pri bolnikih z izčrpujočimi boleznimi in motnjami, npr. pri tistih s pljučno boleznijo v anamnezi (npr. kronična obstruktivna pljučna bolezen) ali sladkorna bolezen z nagnjenostjo h ketoacidozi.
Keeping the push button down, leave the injection needle in place for a few seconds to allow the Viraferon, solution for injection, to distribute under the skin, then remove. 
Še naprej pritiskajte na gumb in pustite injekcijsko iglo v koži nekaj sekund, da se bo lahko Viraferon raztopina za injiciranje porazdelila pod kožo, potem potegnite iglo ven.
It is recommended that patients be treated with Viraferon alone for at least 3 to 4 months, at which point HCV-RNA status should be determined. 
Priporočamo, da bolnike zdravite z zdravilom Viraferon v monoterapiji najmanj 3 do 4 mesece, potem pa opravite preiskave na HCV-RNA.
If adverse events develop during the course of treatment with Viraferon for any indication, modify the dosage or discontinue therapy temporarily until the adverse events abate. 
Če se v teku zdravljenja z zdravilom Viraferon za katerokoli od indikacij pojavijo neželeni dogodki, prilagodite odmerjanje zdravila ali začasno ukinite zdravljenje, dokler se neželeni dogodki ne ublažijo.
Viraferon is available in two different pack sizes: 
Viraferon je na voljo v dved različnih velikostih pakiranja:
Very rarely sarcoidosis, (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands) has been reported. 
Zelo redko so poročali o sarkoidozi (bolezni, za katero je značilna trdovratna zvišana temperatura, hujšanje, bolečine v sklepih in otekanje sklepov, kožne lezije in oteklost žlez).
Your doctor has determined the exact dosage for administration of Viraferon according to your individual needs. 
Odmerek zdravila Viraferon je zdravnik določil natančno glede na vaše individualne potrebe.
Periodic visual examinations during Viraferon therapy are recommended particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension. 
Med zdravljenjem z zdravilom Viraferon priporočamo redne preglede vida, še posebej pri tistih z boleznimi, ki so lahko povezane z retinopatijo, npr. sladkorna bolezen ali hipertenzija.
It is strongly recommended that every time that Viraferon is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product. 
Močno priporočamo, da ob vsakem dajanju zdravila Viraferon bolniku zapišete ime in številko serije zdravila, da bi ohranili sledljivost med bolnikom in serijo zdravila.
If persistent or recurrent intolerance develops following adequate dosage adjustment, or disease progresses, discontinue treatment with Viraferon. 
Če po ustrezni prilagoditvi odmerka ugotavljate trdovratno ali ponavljajočo intoleranco za zdravilo ali če bolezen napreduje, ukinite terapijo z zdravilom Viraferon.
Micturition frequency Renal failure, renal insufficiency, nephrotic syndrome 
pogosto uriniranje ledvična odpoved, ledvična insuficienca, nefrotski sindrom
Solvent: water for injections 1 ml/ampoule 
- Vehikel: voda za injekcije 1 ml/ampula.
Clean the rubber top of the vial with a cleansing swab. 
Očistite gumijasti vrh viale s čistilnim tamponom.
Mutagenicity studies with interferon alfa-2b revealed no adverse events. 
Raziskave mutagenosti interferona alfa-2b niso pokazale nobenih neželenih dogodkov
The reconstituted solution should be clear and colourless. 
Rekonstitutirana raztopina mora biti bistra in brezbarvna.
Dispose of the syringe and needles safely in a closed container. 
Brizgo in igle zavrzite varno, v zaprti posodi.
Additionally, patients treated with Viraferon and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia (low number of red blood cells). 
Pri bolnikih zdravljenih z zdravilom Viraferon v kombinaciji z ribavirinom in zidovudinom, se lahko poveča verjetnost za razvoj anemije (majhno število rdečih krvnih celic).
For multidose vials, be sure to return the vial to the refrigerator. 
Pri uporabi vial z večimi odmerki ne pozabite vialo po uporabi vrniti nazaj v hladilnik.
4.6 Pregnancy and lactation 
4.6 Nosečnostjo in dojenje
With one hand, pinch a fold of loose skin. 
S prstoma ene roke oblikujte kožno gubo.
While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out. 
Četudi je zvišana telesna temperatura lahko povezana z gripoznim sindromom, ki je pogost med zdravljenjem z interferonom, morate najprej izključiti druge vzroke za trdovratno zvišanje telesne temperature.
In general, the adverse event profile in the limited paediatric population studied was similar to that observed in adults, although there is a paediatric specific concern regarding growth inhibition as decrease in height (mean percentile decrease of growth velocity of 9 %) and weight (mean percentile decrease of 13 %) percentile were observed during treatment (see section 4.4). 
Na splošno je bil profil neželenih dogodkov v omejeni pediatrični populaciji, ki je bila vključena v študije, podoben profilu pri odraslih, se je pri njih pojavila dodatna skrb glede zaviranja rasti, saj so med zdravljenjem opažali zmanjšanje percentila telesne višine (srednje percentilno zmanjšanje hitrosti rasti za 9 %) in telesne mase (srednje percentilno zmanjšanje za 13 %) (glejte poglavje 4.4).
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. 
Kljub tem ukrepom pa pri dajanju zdravil, izdelanih iz človeške krvi ali plazme, ni mogoče popolnoma izključiti možnosti za prenos okužbe.
Be sure to discuss this with your doctor. 
Pogovorite se o tem s svojim zdravnikom.
You can save the swab to clean the skin area where you will inject the dose. 
Tega lahko shranite, da si boste z njim očistili tudi predel kože, kamor boste injicirali odmerek zdravila.
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). 
Vse bolnike z znaki ali simptomi, ki bi lahko kazali na avtoimunsko bolezen, morate skrbno pregledati in preiskati ter pri njih oceniti razmerje med koristmi in tveganji nadaljnje terapije z interferonom (glejte tudi poglavji 4.4 Kronični hepatitis C, monoterapija (ščitnične motnje) in 4.8).
Adequate hydration must be maintained in patients undergoing Viraferon therapy since hypotension related to fluid depletion has been seen in some patients. 
Pri bolnikih na terapiji z zdravilom Viraferon morate vzdrževati ustrezno hidracijo, saj so pri nekaterih bolnikih opažali hipotenzijo zaradi izgube tekočine.
Since a small amount of air may collect in the injection needle and reservoir during storage, the next step is to remove any air bubbles. 
Ker se lahko med skladiščenjem v injekcijski igli in rezervoarju nabere majhna količina zraka, morate najprej odstraniti morebitne zračne mehurčke, kar imenujemo injiciranje v zrak.
Be sure the solution is at room temperature at the time of injection. 
Pazite, da bo raztopina ob injiciranju na sobni temperaturi.
Relapse patients: A total of 345 interferon alpha relapse patients were treated in two clinical trials with Viraferon monotherapy or in combination with ribavirin. 
Bolniki s ponovitvijo oz. relapsom bolezni: Skupaj 345 bolnikov z interferon alfa relapsom je bilo zdravljenih v dveh kliničnih raziskavah z zdravilom Viraferon, v monoterapiji ali v kombinaciji z ribavirinom.
Viraferon solution for injection, may be injected directly after withdrawal of the appropriate doses from the vial with a sterile injection syringe. 
Viraferon raztopino za injiciranje lahko injicirate takoj, ko posesate ustrezni odmerek iz viale s sterilno injekcijsko brizgo.
What Viraferon is and what it is used for Before you use Viraferon How to use Viraferon 
Kaj je zdravilo Viraferon in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Viraferon Kako uporabljati zdravilo Viraferon Možni neželeni učinki
Turn the vial and the syringe upside down in one hand. 
Obrnite vialo in brizgo narobe in ju držite v eni roki.
Severity was generally mild to moderate. 
Po jakosti so bili neželeni učinki običajno blagi do zmerni.
Your doctor has prescribed Viraferon specifically for you and your current condition; do not share this medicine with anyone else. 
Zdravnik je zdravilo Viraferon predpisal prav vam in za vaše trenutne zdravstvene težave, zato ga ne smete dati drugim.
It is strongly recommended that every time you receive a dose of Viraferon the name and batch number of the product are recorded in order to maintain a record of the batches used. 
Močno priporočamo, da se vsakič, ko prejmete odmerek zdravila Viraferon, zapišeta ime in številka serije zdravila za vodenje evidence uporabljenih serij.
Other CNS effects including aggressive behaviour (sometimes directed against others), confusion and alterations of mental status have been observed with alpha interferons. 
Opažali so tudi druge učinke interferona alfa na CŽS, vključno z agresivnostjo (ki je včasih usmerjena proti drugim), zmedenostjo in spremembami duševnega statusa.
After first opening the container: Chemical and physical in-use stability has been demonstrated for 28 days at 2ºC - 8ºC. 
Po prvem odpiranju vsebnika: Med uporabo je zdravilo kemično in fizikalno stabilno 28 dni pri temperaturi od 2 do 8 ºC.
Rarely: 
Redki:
Dyspnoea*, coughing* 
dispneja*, kašelj*
Depression, emotional lability, insomnia Suicidal ideation, aggressive reaction, confusion, behaviour disorder, agitation, somnambulism, anxiety, nervousness, sleep disorder, abnormal dreaming, apathy 
depresija, čustvena nestabilnost, nespečnost samomorilne misli, agresivne reakcije, zmedenost, vedenjske motnje, vznemirjenost, somnambulizem, tesnoba, živčnost, motnje spanja, nenormalne sanje, apatija
Examine the reconstituted solution prior to administration: it should be clear and colourless. 
Preglejte rekonstituirano raztopino pred uporabo: biti mora bistra in brezbarvna.
The clear and colourless solution is contained in a glass cartridge. 
Bistra in brezbarvna raztopina je v stekleni viali.
If the product is not used during the seven-day period, it cannot be put back in the refrigerator for a new storage period and must be discarded. 
Če zdravila ne porabite v 7 dneh, ga ne smete dati nazaj v hladilnik za naslednje obobje shranjevanja, ampak ga morate zavreči.
Ribavirin 15 mg/kg/day as 2 divided doses (n = 17) 
Ribavirin 15 mg/kg na dan v obliki 2 deljenih odmerkov (n = 17)
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 okviru razvrstitve po organskih sistemih so neželeni učinki dodatno razvrščeni po pogostnosti v naslednji dve kategoriji: zelo pogosti (≥1/10), pogosti (≥1/100, <1/10).