FrancophonIA/ELRC3.0 huggingface dataset:
English: Any patient developing fever, cough, dyspnea or other respiratory symptoms must have a chest X-ray taken.
Slovenian: Pri vseh bolnikih, ki dobijo zvišano telesno temperaturo, kašelj, dispnejo ali kakšne druge simptome dihal, morate opraviti rentgensko slikanje prsnega koša.
English: The vial, ampoule and injection materials intended for single use must be discarded.
Slovenian: Vialo, ampulo in pripomočke za injiciranje, ki so namenjeni za enkratno uporabo, morate zavreči.
English: In patients with hepatitis, no loss of response was observed apparently due to the low titres.
Slovenian: Pri bolnikih s hepatitisom niso opažali prenehanja odzivnosti, kar naj bi bilo posledica majhnih titrov.
English: Your doctor or his/her assistant will instruct you how to self-inject Viraferon.
Slovenian: Zdravnik ali sestra vas bosta poučila, kako si sami injicirate zdravilo Viraferon.
English: Then press the push button down fully (see Diagram P).
Slovenian: Zdaj do konca pritisnite na gumb (glejte sliko P).
English: One ampoule of solvent contains 1 ml of water for injections.
Slovenian: Ena ampula z vehiklom vsebuje 1 ml vode za injekcije.
English: 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.
Slovenian: 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.
English: As in adult patients, children and adolescents also experienced other psychiatric adverse events (e.g., depression, emotional lability, and somnolence) (see section 4.4).
Slovenian: Kot odrasli bolniki so imeli tudi otroci in mladostniki še druge psihiatrične neželene dogodke (npr. depresijo, čustveno labilnost in zaspanost) (glejte poglavje 4.4).
English: 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.
Slovenian: 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.
English: Hypertension Peripheral ischaemia, hypotension
Slovenian: hipertenzija periferna ishemija, hipotenzija§
English: when receiving Viraferon, you may temporarily have a greater risk of getting an infection.
Slovenian: - med prejemanjem zdravila Viraferon ste lahko začasno bolj nagnjeni k okužbam.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Priporočamo, da bolnike zdravite z zdravilom Viraferon v monoterapiji najmanj 3 do 4 mesece, potem pa opravite preiskave na HCV-RNA.
English: 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.
Slovenian: 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.
English: Viraferon is available in two different pack sizes:
Slovenian: Viraferon je na voljo v dved različnih velikostih pakiranja:
English: Very rarely sarcoidosis, (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands) has been reported.
Slovenian: 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).
English: Your doctor has determined the exact dosage for administration of Viraferon according to your individual needs.
Slovenian: Odmerek zdravila Viraferon je zdravnik določil natančno glede na vaše individualne potrebe.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Močno priporočamo, da ob vsakem dajanju zdravila Viraferon bolniku zapišete ime in številko serije zdravila, da bi ohranili sledljivost med bolnikom in serijo zdravila.
English: If persistent or recurrent intolerance develops following adequate dosage adjustment, or disease progresses, discontinue treatment with Viraferon.
Slovenian: Če po ustrezni prilagoditvi odmerka ugotavljate trdovratno ali ponavljajočo intoleranco za zdravilo ali če bolezen napreduje, ukinite terapijo z zdravilom Viraferon.
English: Micturition frequency Renal failure, renal insufficiency, nephrotic syndrome
Slovenian: pogosto uriniranje ledvična odpoved, ledvična insuficienca, nefrotski sindrom
English: Solvent: water for injections 1 ml/ampoule
Slovenian: - Vehikel: voda za injekcije 1 ml/ampula.
English: Clean the rubber top of the vial with a cleansing swab.
Slovenian: Očistite gumijasti vrh viale s čistilnim tamponom.
English: Mutagenicity studies with interferon alfa-2b revealed no adverse events.
Slovenian: Raziskave mutagenosti interferona alfa-2b niso pokazale nobenih neželenih dogodkov
English: The reconstituted solution should be clear and colourless.
Slovenian: Rekonstitutirana raztopina mora biti bistra in brezbarvna.
English: Dispose of the syringe and needles safely in a closed container.
Slovenian: Brizgo in igle zavrzite varno, v zaprti posodi.
English: 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).
Slovenian: Pri bolnikih zdravljenih z zdravilom Viraferon v kombinaciji z ribavirinom in zidovudinom, se lahko poveča verjetnost za razvoj anemije (majhno število rdečih krvnih celic).
English: For multidose vials, be sure to return the vial to the refrigerator.
Slovenian: Pri uporabi vial z večimi odmerki ne pozabite vialo po uporabi vrniti nazaj v hladilnik.
English: 4.6 Pregnancy and lactation
Slovenian: 4.6 Nosečnostjo in dojenje
English: With one hand, pinch a fold of loose skin.
Slovenian: S prstoma ene roke oblikujte kožno gubo.
English: While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Slovenian: Kljub tem ukrepom pa pri dajanju zdravil, izdelanih iz človeške krvi ali plazme, ni mogoče popolnoma izključiti možnosti za prenos okužbe.
English: Be sure to discuss this with your doctor.
Slovenian: Pogovorite se o tem s svojim zdravnikom.
English: You can save the swab to clean the skin area where you will inject the dose.
Slovenian: Tega lahko shranite, da si boste z njim očistili tudi predel kože, kamor boste injicirali odmerek zdravila.
English: 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).
Slovenian: 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).
English: Adequate hydration must be maintained in patients undergoing Viraferon therapy since hypotension related to fluid depletion has been seen in some patients.
Slovenian: Pri bolnikih na terapiji z zdravilom Viraferon morate vzdrževati ustrezno hidracijo, saj so pri nekaterih bolnikih opažali hipotenzijo zaradi izgube tekočine.
English: 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.
Slovenian: 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.
English: Be sure the solution is at room temperature at the time of injection.
Slovenian: Pazite, da bo raztopina ob injiciranju na sobni temperaturi.
English: Relapse patients: A total of 345 interferon alpha relapse patients were treated in two clinical trials with Viraferon monotherapy or in combination with ribavirin.
Slovenian: 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.
English: Viraferon solution for injection, may be injected directly after withdrawal of the appropriate doses from the vial with a sterile injection syringe.
Slovenian: Viraferon raztopino za injiciranje lahko injicirate takoj, ko posesate ustrezni odmerek iz viale s sterilno injekcijsko brizgo.
English: What Viraferon is and what it is used for Before you use Viraferon How to use Viraferon
Slovenian: Kaj je zdravilo Viraferon in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Viraferon Kako uporabljati zdravilo Viraferon Možni neželeni učinki
English: Turn the vial and the syringe upside down in one hand.
Slovenian: Obrnite vialo in brizgo narobe in ju držite v eni roki.
English: Severity was generally mild to moderate.
Slovenian: Po jakosti so bili neželeni učinki običajno blagi do zmerni.
English: N=503 C95-132/I95-143
Slovenian: I N=503 C95-132/I95-143
English: Your doctor has prescribed Viraferon specifically for you and your current condition; do not share this medicine with anyone else.
Slovenian: Zdravnik je zdravilo Viraferon predpisal prav vam in za vaše trenutne zdravstvene težave, zato ga ne smete dati drugim.
English: 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.
Slovenian: Močno priporočamo, da se vsakič, ko prejmete odmerek zdravila Viraferon, zapišeta ime in številka serije zdravila za vodenje evidence uporabljenih serij.
English: Other CNS effects including aggressive behaviour (sometimes directed against others), confusion and alterations of mental status have been observed with alpha interferons.
Slovenian: Opažali so tudi druge učinke interferona alfa na CŽS, vključno z agresivnostjo (ki je včasih usmerjena proti drugim), zmedenostjo in spremembami duševnega statusa.
English: After first opening the container: Chemical and physical in-use stability has been demonstrated for 28 days at 2ºC - 8ºC.
Slovenian: Po prvem odpiranju vsebnika: Med uporabo je zdravilo kemično in fizikalno stabilno 28 dni pri temperaturi od 2 do 8 ºC.
English: Rarely:
Slovenian: Redki:
English: Dyspnoea*, coughing*
Slovenian: dispneja*, kašelj*
English: Depression, emotional lability, insomnia Suicidal ideation, aggressive reaction, confusion, behaviour disorder, agitation, somnambulism, anxiety, nervousness, sleep disorder, abnormal dreaming, apathy
Slovenian: depresija, čustvena nestabilnost, nespečnost samomorilne misli, agresivne reakcije, zmedenost, vedenjske motnje, vznemirjenost, somnambulizem, tesnoba, živčnost, motnje spanja, nenormalne sanje, apatija
English: Examine the reconstituted solution prior to administration: it should be clear and colourless.
Slovenian: Preglejte rekonstituirano raztopino pred uporabo: biti mora bistra in brezbarvna.
English: The clear and colourless solution is contained in a glass cartridge.
Slovenian: Bistra in brezbarvna raztopina je v stekleni viali.
English: 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.
Slovenian: Če zdravila ne porabite v 7 dneh, ga ne smete dati nazaj v hladilnik za naslednje obobje shranjevanja, ampak ga morate zavreči.
English: Ribavirin 15 mg/kg/day as 2 divided doses (n = 17)
Slovenian: Ribavirin 15 mg/kg na dan v obliki 2 deljenih odmerkov (n = 17)
English: 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).
Slovenian: 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).
English: 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).
Slovenian: Boljša učinkovitost pa se je pokazala pri uporabi pegiliranega interferona z ribavirinom (v študiji, opravljeni pri bolnikih, ki še niso prejemali tega zdravila, je bil z uporabo ribavirina v odmerku > 10,6 mg/kg, p < 0,01 61 % dosežen trajen virološki odziv na zdravljenje).
English: Adult patients: Viraferon alone or in combination with ribavirin has been studied in 4 randomised Phase III clinical trials in 2,552 interferon-naïve patients with chronic hepatitis C. The trials compared the efficacy of Viraferon used alone or in combination with ribavirin.
Slovenian: Odrasli bolniki: Zdravilo Viraferon v monoterapiji ali v kombinaciji z ribavirinom so raziskovali v 4 randomiziranih kliničnih raziskavah tretje faze pri 2.552 bolnikih, ki še niso bili zdravljeni z interferonom in so imeli kronični hepatitis C. V teh raziskavah so primerjali učinkovitost zdravila Viraferon v monoterapiji ali v kombinaciji z ribavirinom.
English: Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with preexisting CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
Slovenian: Videti je bilo, da kardiovaskularni (KVS) neželeni pojavi, še posebej aritmija, statistično korelirajo predvsem z obstoječo KVS boleznijo in predhodno terapijo s kardiotoksičnimi snovmi (glejte poglavje 4.4).
English: A general reversal of these trends was noted during the 6 months follow-up post treatment.
Slovenian: V času 6-mesečnega spremljanja po zdravljenju so opazili splošni obrat teh trendov.
English: Dispose of the syringe and needle safely in a closed container.
Slovenian: Brizgo in iglo zavrzite varno, v zaprti posodi.
English: The push button scale will show you the dose set (see Diagram N below).
Slovenian: Na lestvici pritisnega gumba je viden nastavljeni odmerek (glejte sliko N spodaj).
English: The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha interferons.
Slovenian: Poročali so o pojavu avtoprotiteles in avtoimunskih bolezni med zdravljenjem z alfa interferoni.
English: Some children have had a decrease in their rate of growth (height and weight).
Slovenian: Pri nekaterih otrocih se je upočasnila rast (telesna višina in masa)
English: Treatment should be discontinued in case of severe leukopaenia (< 1,200/mm3), severe neutropaenia (< 750/mm3) or severe thrombocytopaenia (< 70,000/mm3).
Slovenian: Zdravljenje ukinite v primeru hude levkopenije (< 1.200/mm3), hude nevtropenije (< 750/mm3) ali hude trombocitopenije (< 70.000/mm3).
English: This must be considered during concomitant therapy with medicinal products metabolised by this route, such as the xanthine derivatives theophylline or aminophylline.
Slovenian: Interferoni lahko vplivajo na oksidativne presnovne procese, kar morate upoštevati med sočasno terapijo z zdravili, ki se presnovijo po tej poti, npr. s ksantinskima derivatoma teofilinom in aminofilinom.
English: If the product is not used during this four-week period, it should be discarded.
Slovenian: Če zdravila v teh 4 tednih ne uporabite, ga morate zavreči.
English: Table 3 Sustained virologic response rates with Viraferon + ribavirin (one year of treatment) by genotype and viral load
Slovenian: Preglednica 3: Pogostnosti ohranjenega virološkega odziva pri uporabi zdravila Viraferon in ribavirina (enoletno zdravljenje) glede na genotip in virusno obremenitev
English: To prepare the Viraferon solution insert the needle through the rubber top of the Viraferon vial and gently place the needle tip against the glass wall of the vial without touching the cleaned top of the vial with your hands.
Slovenian: Za pripravo raztopine zdravila Viraferon vbodite iglo skozi gumijasti vrh viale z zdravilom Viraferon in previdno naslonite vrh igle na stekleno steno viale, ne da bi se pri tem z rokami dotaknili očiščenega vrha viale.
English: As in adult patients, children and adolescents experienced other psychiatric adverse events (e.g., depression, emotional lability, and somnolence).
Slovenian: Tako kot pri odraslih bolnikih so tudi pri otroci in mladostniki opazili druge psihiatrične neželene dogodke (npr. depresijo, čustveno labilnost in zaspanost).
English: At the beginning of treatment with Viraferon, you may experience a flu-like reaction, with fever, fatigue, headache, muscle ache, joint pain and chills/rigors.
Slovenian: Na začetku zdravljenja z zdravilom Viraferon boste lahko imeli gripi podobno reakcijo z zvišano telesno temperaturo, utrujenostjo, glavobolom, mišičnimi bolečinami, bolečinami v sklepih in mrzlico ali tresenjem.
English: A new injection needle must be used for each dose.
Slovenian: Za vsak odmerek morate uporabiti novo injekcijsko iglo.
English: Remove the needle guard without touching the needle and keep the syringe with the needle in your hand.
Slovenian: Snemite zaščitni pokrovček igle, ne da bi se dotaknili igle, in držite brizgo z iglo trdno v rokah.
English: Viraferon 3 MIU/m
Slovenian: Viraferon (3 m.i.e.
English: Chronic Hepatitis B: The recommended dosage is in the range 5 to 10 million IU administered subcutaneously three times a week (every other day) for a period of 4 to 6 months.
Slovenian: Kronični hepatitis B: Priporočeni odmerek je v razponu od 5 do 10 milijonov i.e., injiciran subkutano trikrat na teden (vsak drugi dan) v času 4 do 6 mesecev.
English: Sufficient needles and swabs are provided to use the Viraferon pen for administering the smallest measurable doses.
Slovenian: V pakiranju je dovolj igel in tamponov, da si lahko z uporabo peresnika Viraferon bolnik da tudi najmanjše še merljive odmerke.
English: However, the chemical and physical in-use stability has been demonstrated for 24 hours at 25ºC.
Slovenian: Vseeno je zdravilo med uporabo kemično in fizikalno stabilno 24 ur pri temperaturi 25 ºC.
English: Pack of 12 vials
Slovenian: Pakiranje: 12 vial
English: Children and adolescents: Multiple-dose pharmacokinetic properties for Viraferon injection and ribavirin capsules in children and adolescents with chronic hepatitis C, between 5 and 16 years of age, are summarized in Table 6.
Slovenian: Otroci in mladostniki: Farmakokinetične lastnosti pri dajanju večih odmerkov zdravila Viraferon injekcije in ribavirin kapsule pri otrocih in mladostnikih s kroničnim hepatitisom C v starosti od 5 do 16 let so povzete v Preglednici 6.
English: Although not all of these side effects may occur, they may need medical attention if they do.
Slovenian: Ni nujno, da se bodo pojavili vsi navedeni neželeni učinki, če pa se, bo zaradi njih lahko potreben obisk pri zdravniku.
English: Insert the needle into the vial containing the Viraferon solution and inject air into the vial.
Slovenian: Vstavite iglo v vialo z raztopino zdravila Viraferon in injicirajte zrak v vialo.
English: If ALT flares during Viraferon therapy to greater than or equal to 2 times baseline, Viraferon therapy may be continued unless signs and symptoms of liver failure are observed.
Slovenian: Tudi če se med terapijo z zdravilom Viraferon naglo povečajo vrednosti ALT na 2-kratno začetno vrednost ali celo več, lahko terapijo z zdravilom Viraferon nadaljujete, razen če opažate simptome in znake jetrne odpovedi.
English: The reconstituted solutions are isotonic for parenteral administration.
Slovenian: Rekonstituirane raztopine so izotonične za parenteralno uporabo.
English: Patients with existence of or history of severe psychiatric conditions:
Slovenian: Bolniki s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi:
English: Chronic Hepatitis C:
Slovenian: Kronični hepatitis C:
English: Discontinuation of Viraferon therapy has not reversed thyroid dysfunction occurring during treatment (also see Children and adolescents, Thyroid monitoring).
Slovenian: Motnje delovanja žleze ščitnice, ki so se pojavile med terapijo z zdravilom Viraferon, niso minile ob prekinitvi terapije (glejte tudi Otroci in mladostniki, Spremljanje delovanja ščitnice).
English: Completely unscrew the injection needle assembly using an anti-clockwise turning motion as shown in Diagram R. Then carefully lift it off the pen and discard the capped injection needle (see Diagram S).
Slovenian: Do konca odvijte sklop injekcijske igle, nasprotno smeri urnega kazalca, kot je prikazano na sliki R. Potem ga previdno dvignite s peresnika in zavrzite pokrito injekcijsko iglo (glejte sliko S).
English: Viraferon, solution for injection, multidose pen is injected subcutaneously after attaching an injection needle and dialing the prescribed dose.
Slovenian: Viraferon, raztopina za injiciranje v večodmernem peresniku, se injicira subkutano po pritrditvi injekcijske igle in nastavitvi predpisanega odmerka.
English: if you have a history of seizures (convulsions).
Slovenian: - če ste imeli kdaj v preteklosti epileptične napade (konvulzije).
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Slovenian: Kljub temu pa pri dajanju zdravil, izdelanih iz človeške krvi ali plazme, ni mogoče popolnoma izključiti možnosti za prenos povzročiteljev infekcijskih bolezni.