FrancophonIA/ELRC3.0 huggingface dataset:
English: Viraferon (interferon alfa-2b) modifies the response of the body's immune system to help fight infections and severe diseases.
Slovenian: Zdravilo Viraferon (interferon alfa-2b) spremeni imunski odziv telesa in pomaga pri obrambi proti okužbam in hudim boleznim.
English: Your doctor will determine the exact dosage schedule and regimen according to your needs.
Slovenian: Natančen odmerek in režim odmerjanja zdravil bo določil vaš zdravnik glede na vaše potrebe.
English: 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).
Slovenian: Najboljša mesta za injiciranje so tkiva s plastjo maščevja med kožo in mišicami: stegno, zunanja površina nadlahti (tu boste morda potrebovali pomoč druge osebe), trebuh (razen popka ali pasu).
English: With your other hand, pick up the pen and hold it as you would a pencil.
Slovenian: Z drugo roko primite peresnik in ga držite kot svinčnik.
English: International Units are determined by comparison of the activity of the recombinant interferon alfa-2b with the activity of the international reference preparation of human leukocyte interferon established by the World Health Organisation.
Slovenian: Število mednarodnih enot se določi s primerjavo aktivnosti rekombinantnega interferona alfa-2b z aktivnostjo mednarodnega referenčnega pripravka interferona iz človeških levkocitov, ki ga je uvedla Svetovna zdravstvena organizacija.
English: Tell your doctor if you are taking theophylline or aminophylline for asthma, and about all other medication you are taking, or have taken recently, even those not prescribed, as the dose of some medications may have to be adjusted while you are treated with Viraferon.
Slovenian: Svojemu zdravniku povejte tudi, če jemljete teofilin ali aminofilin zaradi astme, 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 Viraferon potrebna prilagoditev odmerka nekaterih zdravil.
English: This can be discussed with your doctor.
Slovenian: O tem se lahko pogovorite s svojim zdravnikom.
English: Two trials have been conducted in patients co-infected with HIV and HCV.
Slovenian: Opravljeni sta bili dve preskušanji pri bolnikih, ki so bili sočasno okuženi z virusoma HCV in HIV.
English: There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
Slovenian: Ni nobenih poročil o prenosu virusov z albuminom, izdelanim po specifikacijah Evropske farmakopeje z uveljavljenimi postopki.
English: 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.
Slovenian: Izsledki reprodukcijskih raziskav na živalih kažejo, da rekombinantni interferon alfa-2b ni teratogen za podgane in kunce in da ne vpliva negativno na nosečnost, razvoj ploda ali reprodukcijsko sposobnost potomcev zdravljenih podgan.
English: Be sure the solution is at room temperature up to 25°C.
Slovenian: Raztopina mora biti pri sobni temperaturi do 25°C.
English: 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.
Slovenian: 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.
English: In adult patients receiving interferon in combination with ribavirin, the achieved sustained response rate is 47 %.
Slovenian: Pri odraslih bolnikih, ki so prejemali interferon v kombinaciji z ribavirinom je bil trajen virološki odziv 47 %.
English: if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing, or hives) while on this medication seek medical help immediately.
Slovenian: - če se med jemanjem tega zdravila pojavijo simptomi hude alergijske reakcije (npr. težave z dihanjem, piskanje v pljučih ali koprivnica), nemudoma poiščite zdravniško pomoč.
English: The elimination half-lives of interferon injections were approximately two to three hours, and six to seven hours, respectively.
Slovenian: Razpolovna doba eliminacije interferona po injiciranju je bila približno 2 do 3 ure oz. 6 do 7 ur.
English: Tmax (hr) Cmax (ng/ml) AUC* Apparent clearance l/hr/kg
Slovenian: Tmax (h) Cmax (ng/ml) AUC* Navidezni očistek l/h/kg ni bil določen
English: To set the correct dose, turn the cap as many times as indicated as follows:
Slovenian: Pravilni odmerek nastavite tako, da obrnete pokrovček tolikokrat, kot je navedeno:
English: The solution should be used immediately after reconstitution.
Slovenian: Raztopino morate uporabiti takoj po rekonstituciji.
English: The pharmacokinetics of Viraferon and ribavirin (dose-normalized) are similar in adults and children or adolescents.
Slovenian: Farmakokinetika Viraferon in ribavirina (z normaliziranim odmerkom) je podobna pri odraslih in otrocih ali mladostnikih.
English: If you forget to take Viraferon
Slovenian: Če ste pozabili vzeti zdravilo Viraferon
English: This medicine contains human albumin solution as an excipient.
Slovenian: To zdravilo vsebuje raztopino humanega albumina kot pomožno snov.
English: The mechanism by which Viraferon may alter thyroid status is unknown.
Slovenian: Mehanizem, prek katerega lahko Viraferon vpliva na ščitnico, ni znan.
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of Viraferon therapy.
Slovenian: Srčne aritmije (predvsem supraventrikularne) se običajno odzovejo na konvencionalno terapijo, vendar je pri njih lahko potrebna ukinitev terapije z zdravilom Viraferon.
English: 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).
Slovenian: - če ste imeli kdaj v preteklosti avtoimunsko bolezen ali presaditev organa in jemljete zdravila, ki zavirajo imunski sistem (imunski sistem ščiti telo pred okužbami).
English: This also applies to unknown or emerging viruses and other pathogens.
Slovenian: To velja tudi za še neznane ali nove viruse in druge povzročitelje bolezni.
English: The pen is now ready to use.
Slovenian: Peresnik je pripravljen za uporabo.
English: Children and adolescents should be monitored every 3 months for evidence of thyroid dysfunction (e.g. TSH).
Slovenian: Otroke in mladostnike morate spremljati na vsake 3 mesece glede morebitnih znakov motenj delovanja žleze ščitnice (npr. TSH).
English: If you use more Viraferon than you should Contact your doctor or healthcare professional as soon as possible.
Slovenian: Če ste uporabili večji odmerek zdravila Viraferon, kot bi smeli Čimprej pokličite svojega zdravnika ali drugega zdravstvenega delavca.
English: Press the injection site with a small bandage or sterile gauze if necessary for several seconds.
Slovenian: Po potrebi pritisnite na mesto injiciranja z majhno obvezo ali sterilno gazo za nekaj sekund.
English: Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Slovenian: Proizvajalci teh zdravil v predelavo krvi ali plazme tudi vključijo postopke za inaktivacijo ali odstranjevanje virusov.
English: If there is bleeding, cover with an adhesive bandage.
Slovenian: Če pride do krvavitve, pokrijte mesto s samolepilnim obližem.
English: 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.
Slovenian: 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.
English: Vials must be reconstituted with 1 ml of water for injections.
Slovenian: Viale morate rekonstituirati z 1 ml vode za injekcije.
English: Do not massage the injection site.
Slovenian: Mesta injiciranja ne smete masirati.
English: Any thyroid abnormality detected at that time must be treated with conventional therapy.
Slovenian: Vse ščitnične motnje, ki jih takrat ugotovite, morate zdraviti s konvencionalno terapijo.
English: Depending upon your dose, you may have extra needles and swabs left in the pack.
Slovenian: Odvisno od vašega odmerka imate lahko levo v pakiranju dodatne igle in čistilne robčke.
English: Patients are to be advised that they may develop fatigue, somnolence, or confusion during treatment with Viraferon, and therefore it is recommended that they avoid driving or operating machinery.
Slovenian: Bolnike poučite, da bodo lahko med zdravljenjem z zdravilom Viraferon utrujeni, zaspani ali zmedeni, zato je priporočljivo, da se izogibajo vožnji ali delu s stroji.
English: Like all medicines, Viraferon can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Viraferon neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Immediately contact the doctor or seek emergency care if they display any unusual behavioural symptoms, feel depressed, or feel they want to harm themselves or others.
Slovenian: Takoj poiščite nujno medicinsko pomoč, če otrok kaže neobičajne simptome obnašanja, se počuti depresiven ali če otrok želi škodovati sebi ali drugim.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation : 9 March 2000
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 9. marec 2000
English: In these patients, the addition of ribavirin to Viraferon increased by as much as 10-fold the efficacy of Viraferon used alone in the treatment of chronic hepatitis C (48.6 % vs. 4.7 %).
Slovenian: Pri teh bolnikih je dodatek ribavirina zdravilu Viraferon povečal učinkovitost samega zdravila Viraferon v monoterapiji kroničnega hepatitisa C za kar 10-krat (48,6 % v primerjavi s 4,7 %).
English: Physicians are advised to monitor the growth of children taking ribavirin in combination with interferon alfa-2b.
Slovenian: Zdravnikom torej svetujemo, naj spremljajo rast otrok, ki jemljejo ribavirin v kombinaciji z interferonom alfa-2b.
English: 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.
Slovenian: Izsledki številnih raziskav kažejo, da sproži interferon po vezavi na celično membrano zapleteno kaskado znotrajceličnih procesov, med drugim indukcijo nekaterih encimov.
English: If you have set a wrong dose, simply turn the cap back (anti-clockwise) as far as you can until the push button is fully home and start again.
Slovenian: Če ste nastavili napačen odmerek, preprosto obrnite pokrovček nazaj (nasprotno smeri urnega kazalca) do konca, dokler ne bo pritisni gumb spet v začetnem položaju, in začnite ponovno.
English: The effect on human pregnancy is not known.
Slovenian: Učinek interferonov na nosečnost pri človeku ni znan.
English: Your doctor may prescribe a different dose of Viraferon alone or in combination with other medicines (e.g. ribavirin).
Slovenian: Zdravnik vam lahko predpiše tudi drugačen odmerek zdravila Viraferon, samostojno ali skupaj z drugimi zdravili (npr. s ribavirinom).
English: Insert the needle into the pinched skin at an angle of approximately 45°.
Slovenian: Vbodite iglo v kožno gubo pod kotom približno 45°.
English: Skin laceration
Slovenian: laceracije na koži
English: Using a sterilised injection syringe and injection needle, inject 1 ml water for injections into the vial of Viraferon.
Slovenian: Z uporabo sterilizirane injekcijske brizge in injekcijske igle injicirajte 1 ml vode za injekcije v vialo zdravila Viraferon.
English: if you develop symptoms associated with a cold or other respiratory infection, such as fever, cough, or any difficulty in breathing, tell your doctor.
Slovenian: - če se pri vas pojavijo simptomi prehlada ali druge okužbe dihal, npr. zvišana telesna temperatura, kašelj ali kakršnekoli težave z dihanjem, obvestite svojega zdravnika.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Slovenian: Med standardne ukrepe za preprečevanje okužb kot posledica uporabe zdravil, izdelanih iz človeške krvi ali plazme, sodijo selekcija darovalcev, presejalno testiranje posameznih darovanih enot in skupne količine zbrane plazme na specifične markerje okužbe in uporaba učinkovitih proizvodnih postopkov za inaktivacijo oz. odstranjevanje virusov.
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection White to cream coloured powder.
Slovenian: FARMACEVTSKA OBLIKA Prašek in vehikel za raztopino za injiciranje Prašek bele do krem barve.
English: WHAT VIRAFERON IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO VIRAFERON IN ZA KAJ GA UPORABLJAMO
English: Injections of human recombinant interferon alfa-2b for up to three months have shown no evidence of toxicity in mice, rats, and rabbits.
Slovenian: Po injiciranju človeškega rekombinantnega interferona alfa-2b do 3 mesece niso opažali nobenih znakov toksičnosti zdravila pri miših, podganah in kuncih.
English: These undesirable effects have also been reported with Viraferon alone.
Slovenian: O teh neželenih učinkih so poročali tudi pri monoterapiji z zdravilom Viraferon.
English: Recombinant interferon alfa-2b is a water-soluble protein with a molecular weight of approximately 19,300 daltons.
Slovenian: Rekombinantni interferon alfa-2b je vodotopna beljakovina z molekulsko maso približno 19.300 daltonov.
English: Growth rate decrease (height and/or weight decrease for age)§
Slovenian: zmanjšana rast (premajhna telesna višina in/ali masa glede na starost)§
English: If not used immediately, it must be stored at 2°C - 8°C in the refrigerator and used within 24 hours.
Slovenian: Če raztopine ne uporabite takoj, jo morate shraniti v hladilniku pri temperaturi 2°C - 8°C in jo uporabiti v 24 urah.
English: The increased response rate to the combination of Viraferon + ribavirin, compared with Viraferon alone, is maintained across all subgroups.
Slovenian: Povečana pogostnost odziva na kombinacijo zdravila Viraferon in ribavirina, v primerjavi s samim zdravilom Viraferon, se ohrani v vseh podskupinah.
English: Viraferon (3 MIU 3 times a week) I/R Viraferon (3 MIU 3 times a week) + ribavirin (1,000/1,200 mg/day)
Slovenian: Viraferon (3 mio i.e. trikrat na teden) I/R Viraferon (3 mio i.e. trikrat na teden) + ribavirin (1.000/1.200 mg/dan)
English: Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
Slovenian: Preliminarni podatki kažejo, da je lahko zdravljenje z interferonom alfa povezano z večjo pogostnostjo zavrnitve ledvičnega presadka.
English: Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism.
Slovenian: Četudi natančen mehanizem delovanja rekombinantnega interferona alfa-2b proti virusom ni znan, kaže, da spremeni presnovo celice gostiteljice.
English: Cleanse and disinfect the skin where the injection is to be made.
Slovenian: Očistite in dezinficirajte si kožo na mestu, kjer boste injicirali zdravilo.
English: If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Viraferon be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Slovenian: Če psihiatrični simptomi ne prenehajo ali se celo poslabšajo ali če ugotovite, da ima bolnik samomorilne misli, je priporočljivo, da prekinete zdravljenje z zdravilom Viraferon in bolnika spremljate, po potrebi tudi s psihiatrično intervencijo.
English: 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.
Slovenian: Vaš zdravnik bo opravil preiskave krvi, da zagotovi, da je vaše število levkocitov (celice, ki se bojujejo proti okužbi), število eritrocitov (celice z železom za prenos kisika), število trombocitov (celice za strjevanje krvi), pa tudi drugi vaši laboratorijski izvidi sprejemljivi.
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Slovenian: Študija 2 pa (P02080) je bila randomizirana enocentrična študija, v katero je bilo vključenih 95 predhodno nezdravljenih odraslih bolnikov s kroničnim hepatitisom C, ki so bili sočasno okuženi z virusom HIV.
English: Pull back on the plunger slowly to draw the correct dose as prescribed by your doctor into the syringe.
Slovenian: Počasi povlecite bat nazaj, da posesate ustrezen odmerek zdravila, kot ga je predpisal vaš zdravnik, v brizgo.
English: The adverse reactions listed in Table 1 are based on experience from clinical trials and post-marketing.
Slovenian: Neželeni učinki, podani v Preglednici 1, so povzeti iz kliničnih preskušanj in iz postmarketinških izkušenj.
English: Virological response in previously untreated paediatric patients Viraferon 3 MIU/m2 3 times a week ribavirin 15 mg/kg/day
Slovenian: Virološki odziv pri predhodno nezdravljenih pediatričnih bolnikih Viraferon 3 mio i.e./m2 3 - krat na teden ribavirin 15 mg/kg/dan
English: If a 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.
Slovenian: Če ocenite, da je potrebno zdravljenje z interferonom alfa-2b pri odraslih bolnikih s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi, ga smete uvesti šele potem, ko ste zagotovili ustrezno individualno diagnostično in terapevtsko obravnavo psihiatrične motnje.
English: Both subcutaneous and intramuscular administration resulted in bioavailabilities greater than 100 %.
Slovenian: Tako pri subkutani uporabi kot pri intramuskularni uporabi je bila biološka uporabnost zdravila večja od 100 %.
English: Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders, who require Viraferon therapy, must be closely monitored.
Slovenian: Odrasle bolnike s kongestivnim srčnim popuščanjem ali miokardnim infarktom v pretekli anamnezi in/ali s predhodnimi ali obstoječimi aritmijami, ki potrebujejo terapijo z zdravilom Viraferon, morate skrbno spremljati.
English: Caution must be observed also in patients with coagulation disorders (e.g., thrombophlebitis, pulmonary embolism) or severe myelosuppression.
Slovenian: Previdnost je potrebna tudi pri bolnikih z motnjami koagulacije (npr. tromboflebitisom, pljučno embolijo) ali hudo mielosupresijo.
English: After each complete turn make sure that the triangle is opposite the dosage indicator (see Diagram O).
Slovenian: Po vsakem polnem obratu mora biti trikotnik nasproti kazalnika odmerkov (glejte sliko O).
English: Viraferon should be given alone mainly in case of intolerance or contraindication to ribavirin.
Slovenian: Zdravilo Viraferon uporabljajte samostojno predvsem v primeru intolerance ali kontraindikacij za ribavirin.
English: Combination therapy with ribavirin: Ribavirin causes serious birth defects when administered during pregnancy.
Slovenian: Kombinirana terapija z ribavirinom: Ribavirin lahko povzroči hude poškodbe plodu, če se uporablja med nosečnostjo.
English: In a large study, 1,071 patients were enrolled after treatment in a prior non pegylated interferon alfa-2b 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.
Slovenian: 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 stalnega virološkega odziva in ocenili vpliv nadaljnjih negativnih izvidov določanja virusa na klinične izide.
English: Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Slovenian: Študija 1 (RIBAVIC; P01017) je bila randomizirana, multicentrična študija, v katero je bilo vključenih 412 predhodno nezdravljenih odraslih bolnikov s kroničnim hepatitisom C, ki so bili sočasno okuženi z virusom HIV.
English: 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.
Slovenian: Snemite zaščitni pokrovček igle, ne da bi se dotaknili igle, in napolnite brizgo z zrakom, tako da potegnete bat nazaj do črte, ki predstavlja odmerek zdravila, ki vam ga je predpisal zdravnik.
English: Sodium chloride,
Slovenian: Natrijev klorid
English: Do not exceed the recommended dosage, and take Viraferon for as long as prescribed.
Slovenian: Ne prekoračite priporočenega odmerka in zdravilo jemljite tako dolgo, kot je bilo predpisano.
English: 3 times a week plus ribavirin 15 mg/kg per day for 1 year followed by 6 months follow-up after-treatment.
Slovenian: trikrat na teden skupaj z ribavirinom v odmerku 15 mg/kg na dan v času enega leta, čemur je sledilo 6mesečno spremljanje po zdravljenju.
English: 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 Viraferon therapy.
Slovenian: Pri vseh bolnikih velja, da če po 3 do 4 mesecih zdravljenja ne ugotavljate nobenega izboljšanja serumske vrednosti HBV-DNA (ob največjem odmerku, ki ga bolnik še prenaša), morate terapijo z zdravilom Viraferon ukiniti.
English: Pharmacotherapeutic group: Immunostimulants, cytokines and immunomodulators, interferons, interferon alfa-2b, ATC code: L03A B05
Slovenian: Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, citokini in imunomodulatorji, interferoni, interferon alfa-2b, oznaka ATC: L03A B05
English: Hypotension may occur during Viraferon therapy or up to two days post-therapy and may require supportive treatment.
Slovenian: Med terapijo z zdravilom Viraferon ali do dva dni po prenehanju terapije lahko nastopi hipotenzija, zaradi katere je lahko potrebna podporna terapija.
English: This action inhibits viral replication or if replication occurs, the progeny virions are unable to leave the cell.
Slovenian: Tako zavira replikacijo virusov, če pa do replikacije kljub temu pride, potomski virioni ne morejo zapustiti celice.
English: 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 Viraferon.
Slovenian: 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 Viraferon in redno med sistemsko terapijo z njim.