FrancophonIA/ELRC3.0 huggingface dataset:
English: In studies in pregnant animals, interferons have sometimes caused miscarriage.
Slovenian: V študijah na brejih živalih so interferoni včasih povzročili splav.
English: - have severe medical conditions that leave you very weak.
Slovenian: - imate kakšno hujšo bolezen, zaradi katere se počutite zelo šibki.
English: While these effects are generally reversible, in a few patients full resolution took up to three weeks.
Slovenian: Ti učinki so običajno reverzibilni, vendar je pri nekaj bolnikih trajalo do tri tedne, da so popolnoma minili.
English: Patients should be closely monitored during therapy and even after treatment discontinuation.
Slovenian: Bolnike je treba natančno spremljati med zdravljenjem in celo po ukinitvi zdravljenja.
English: Disposal of the injection materials
Slovenian: Odstranitev materiala za injiciranje
English: Although not all of these side effects may occur, they may need medical attention if they do.
Slovenian: Čeprav ni nujno, da se bodo pojavili vsi navedeni neželeni učinki, boste morda potrebovali zdravniško pomoč, če se pojavijo.
English: Treatment with ViraferonPeg in combination with ribavirin was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Slovenian: Zdravljenje z zdravilom ViraferonPeg v kombinaciji z ribavirinom je bilo povezano z zmanjšanjem absolutnega števila celic CD4+ v prvih 4 tednih, brez zmanjšanja odstotka celic CD4+.
English: You may develop gum disease, which could lead to loss of teeth.
Slovenian: Lahko se vam razvijejo bolezni dlesni, kar lahko pripelje do izgube zob.
English: Other medicines and ViraferonPeg Please tell your doctor or pharmacist if you, or the child you are caring for: - are taking or have recently taken any other medicines or vitamins/nutritional supplements, including medicines obtained without a prescription.
Slovenian: Druga zdravila in zdravilo ViraferonPeg Obvestite zdravnika ali farmacevta, če vi ali otrok, za katerega skrbite: - jemljete ali ste pred kratkim jemali katero koli zdravilo ali vitamine/prehranska dopolnila, vključno z zdravili, ki ste jih dobili brez recepta.
English: If you have a medical condition that may lead to future eye problems (e.g. diabetes or high blood pressure), you should receive regular eye exams during therapy.
Slovenian: Če vaše zdravstveno stanje lahko v prihodnje vodi do težav z očmi (npr. sladkorna bolezen ali visok krvni tlak), morate imeti med zdravljenjem redne preglede oči.
English: In addition, children and adolescents must not use this medicine if they have had serious nervous or mental problems, such as severe depression or thoughts of suicide.
Slovenian: Poleg tega otroci in mladostniki ne smejo uporabljati tega zdravila, če so kdaj imeli resno bolezen živčevja ali resno duševno bolezen, kot na primer hudo depresijo ali misli na samomor.
English: Prepare the dose just before you intend to inject it and use it immediately.
Slovenian: Odmerek si pripravite, tik preden ga nameravate injicirati, in ga uporabite takoj.
English: Do not use this medicine after the expiry date which is stated on the carton, after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP.
English: Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.
Slovenian: Bolniki, katerih odmerek ribavirina je zmanjšan na 600 mg na dan, naj prejmejo po eno 200 mg kapsulo zjutraj in dve 200 mg kapsuli zvečer.
English: The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Slovenian: Zmanjšanje števila celic CD4+ je bilo reverzibilno po zmanjšanju odmerka ali po prekinitvi terapije.
English: Insert the needle into the pinched skin at an angle of approximately 45°.
Slovenian: Zabodite iglo v stisnjeno kožo pod kotom približno 45.
English: This may occur in particular in patients with risk factors such as HIV infection or severe liver problems (cirrhosis).
Slovenian: Pojavi se lahko zlasti pri bolnikih z dejavniki tveganja, kot so okužba z virusom HIV ali hude težave z jetri (ciroza).
English: All patients in the selected 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.
Slovenian: Vsi bolniki iz izbranih študij kroničnega hepatitisa C so imeli pred vključitvijo v študijo jetrno biopsijo, vendar je v določenih primerih (tj. pri bolnikih z genotipom 2 in 3) zdravljenje možno brez histološke potrditve.
English: ViraferonPeg is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Slovenian: Zdravilo ViraferonPeg lahko med nosečnostjo uporabljate le, če potencialne koristi upravičijo potencialno tveganje za plod.
English: Mechanism of action is unknown, but it is considered that both medicines have bone marrow depressive effects.
Slovenian: Mehanizem delovanja ni znan, vendar velja, da obe zdravili zavirata delovanje kostnega mozga.
English: Cmax (90% CI)
Slovenian: Cmax (90 % IZ)
English: Table 15 Sustained virological response rates (n a,b
Slovenian: Preglednica 15 Deleži trajnega virološkega odziva (n a,b
English: This should be discussed with your doctor.
Slovenian: O tem se morate pogovoriti z zdravnikom.
English: Description of selected adverse reactions in adults
Slovenian: Opis izbranih neželenih učinkov pri odraslih
English: Negative predictive value
Slovenian: Negativna napovedna vrednost
English: Hypertriglyceridemia and aggravation of hypertriglyceridemia, sometimes severe, have been observed.
Slovenian: Opažali so hipertrigliceridemijo in poslabšanje hipertrigliceridemije, ki je včasih hudo.
English: All patients should have a baseline eye examination.
Slovenian: Vsi bolniki morajo opraviti osnovni pregled oči.
English: Twenty-four % had bridging fibrosis or cirrhosis (Knodell 3/4).
Slovenian: 24 % bolnikov je imelo premostitveno fibrozo ali cirozo (Knodell 3/4).
English: HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
Slovenian: HCV genotip in virusno breme na začetku sta prognostična dejavnika, za katera je znano, da vplivata na stopnjo odziva.
English: o With zidovudine or stavudine, it is not certain if ribavirin will change the way these medicines work.
Slovenian: o Pri jemanju skupaj z zidovudinom ali stavudinom ni gotovo, če ribavirin spremeni delovanje teh zdravil.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Histological response: Liver biopsies were obtained before and after treatment in Study 1 and were available for 210 of the 412 subjects (51 %).
Slovenian: V študiji 1 so biopsijo jeter opravili pred in po zdravljenju - na voljo so bili podatki za 210 od 412 preiskovancev (51 %).
English: Limited historical data indicate that treatment for 48 weeks might be associated with a higher sustained response rate (11/11) and with a lower risk of relapse (0/11 as compared to 7/96 following 24 weeks of treatment).
Slovenian: Omejena količina predhodnih podatkov kaže, da je lahko zdravljenje, ki traja 48 tednov, povezano z večjo stopnjo trajnega virološkega odziva (11/11) in z manjšim tveganjem za ponovitev bolezni (0/11 v primerjavi s 7/96 po 24 tednih zdravljenja).
English: If you have kidney disease, your dose may be lower, depending upon your kidney function.
Slovenian: Če imate ledvično bolezen, bo vaš odmerek lahko manjši, odvisno od delovanja ledvic.
English: Administer once weekly (ml)
Slovenian: Enkrat na teden (ml)
English: The most frequently reported adverse reactions were mostly mild to moderate in severity and were manageable without the need for modification of doses or discontinuation of therapy.
Slovenian: Najpogosteje poročani neželeni učinki so bili po jakosti večinoma blagi do zmerni in so jih lahko obvladali brez prilagoditve odmerka ali ukinitve zdravljenja.
English: This medicine is used for the treatment of chronic hepatitis C, a viral infection of the liver.
Slovenian: To zdravilo se uporablja za zdravljenje kroničnega hepatitisa C, ene od virusnih okužb jeter.
English: If you have a medical condition making use of ribavirin dangerous or if you already have had a problem taking it, your doctor will likely prescribe this medicine alone.
Slovenian: Če je za vaše zdravstveno stanje uporaba ribavirina nevarna ali če ste že imeli težave pri uporabi ribavirina, vam bo zdravnik najverjetneje predpisal samo to zdravilo.
English: If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Slovenian: Če ni uporabljeno takoj, je za čas shranjevanja in pogoje shranjevanja pred uporabo odgovoren uporabnik in običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C.
English: Paediatric population (bitherapy only) - Duration of treatment
Slovenian: Pediatrična populacija (samo dvojna terapija) - trajanje zdravljenja
English: The best sites for injection are tissues with a layer of fat between skin and muscle.
Slovenian: Najprimernejša mesta za injiciranje so predeli, kjer je med kožo in mišicami plast maščobnega tkiva.
English: Do not aim the stream directly at the white solid or powder, or inject the liquid quickly, as this causes a greater amount of bubbles.
Slovenian: Curka ne smete usmeriti naravnost v belo trdno snov oz. prašek ali tekočine vbrizgati hitro, saj bi to povzročilo več mehurčkov.
English: You should tell your doctor before starting treatment if you, or the child you are caring for: - are allergic to peginterferon alfa-2b or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Pred začetkom zdravljenja morate povedati zdravniku, če za vas ali otroka, za katerega skrbite, velja kaj od naštetega: - ste alergični na peginterferon alfa-2b ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: While being treated with ViraferonPeg, your doctor may advise to drink extra fluids to help prevent low blood pressure.
Slovenian: Med zdravljenjem z zdravilom ViraferonPeg vam bo zdravnik morda svetoval, da pijte več tekočine, da bi preprečili pojav nizkega krvnega tlaka.
English: Organ transplant recipients
Slovenian: Prejemniki presajenih organov
English: Any patient complaining of ocular symptoms, including loss of visual acuity or visual field must have a prompt and complete eye examination.
Slovenian: Vsak bolnik, ki toži o očesnih simptomih, vključno z zmanjšanjem ostrine vida ali vidnega polja, potrebuje takojšen in celoten oftalmološki pregled.
English: - are diabetic or have high blood pressure, your doctor may ask you, or the child you are caring for to have an eye examination.
Slovenian: - imate sladkorno bolezen ali visok krvni tlak; zdravnik bo vas ali otroka, za katerega skrbite, morda napotil na pregled oči.
English: Side effects of unknown frequency (frequency cannot be estimated from the available data): - pure red cell aplasia (a condition where the body stopped or reduced the production of red blood cells).
Slovenian: Neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): - aplazija rdečih krvnih celic (stanje, pri katerem telo preneha ali zmanjša izdelovanje rdečih krvnih celic).
English: ** For patients > 120 kg, the ViraferonPeg dose should be calculated based on the individual patient weight.
Slovenian: ** Za bolnike, ki so težji od 120 kg, mora biti odmerek izračunan individualno glede na telesno maso bolnika.
English: Treatment should be initiated and monitored only by a physician experienced in the management of patients with hepatitis C.
Slovenian: Zdravljenje s tem zdravilom lahko uvede in spremlja le zdravnik, ki ima izkušnje z zdravljenjem bolnikov s hepatitisom C.
English: Look at the date printed on the carton after EXP to make sure that the expiration date has not passed.
Slovenian: Preverite datum, ki je natisnjen na škatli poleg oznake EXP, in se tako prepričajte, da se rok uporabnosti zdravila še ni iztekel.
English: Patients may self-inject ViraferonPeg if their physician determines that it is appropriate and with medical follow-up as necessary.
Slovenian: Bolniki si lahko zdravilo ViraferonPeg injicirajo sami, če njihov zdravnik odloči, da je to primerno, in jih po potrebi spremlja.
English: The appropriate dose can then be withdrawn with a sterilised injection syringe and injected.
Slovenian: Ustrezen odmerek lahko potem izvlečete s sterilno injekcijsko brizgo in ga injicirate.
English: Discontinue combination therapy if:
Slovenian: Ukinite kombinirano terapijo v primeru:
English: As adherence might be of importance for outcome of therapy, the dose of ViraferonPeg and ribavirin should be kept as close as possible to the recommended standard dose.
Slovenian: Ker je privrženost terapiji pomembna za njeno uspešnost, mora biti odmerek zdravila ViraferonPeg in ribavirina čim bliže standardnemu priporočenemu odmerku.
English: Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of ViraferonPeg in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
Slovenian: Zaradi poročil, da lahko interferon alfa poslabša obstoječo psoriazo in sarkoidozo je uporaba zdravila ViraferonPeg pri bolnikih s psoriazo ali sarkoidozo priporočena le, če možne koristi zdravljenja odtehtajo morebitno tveganje.
English: You must not use ViraferonPeg if any of the conditions above should apply to you, or the child you are caring for.
Slovenian: Zdravila ViraferonPeg ne smete uporabljati, če katero od zgoraj naštetih stanj velja za vas ali otroka, za katerega skrbite.
English: It is important to brush your teeth thoroughly twice a day, rinse your mouth out if you vomit, and have regular dental check-ups.
Slovenian: Pomembno je, da si temeljito ščetkate zobe dvakrat na dan, če bruhate, da si temeljito sperete usta, in da redno hodite na pregled k zobozdravniku.
English: Although data are limited, no evidence of long-term effects on sexual maturation was noted in the 5-year observational follow-up study.
Slovenian: Podatkov je sicer malo, a med 5-letno opazovalno spremljevalno študijo ni bilo dokazov o dolgoročnih učinkih na spolno dozorevanje.
English: Because of the potential for adverse reactions in breast-fed infants, breast-feeding should be discontinued prior to initiation of treatment.
Slovenian: Zaradi nevarnosti neželenih učinkov pri dojenih dojenčkih naj matere dojenje prekinejo pred začetkom zdravljenja.
English: Once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Slovenian: Po vezavi na celično membrano interferon sproži kompleksno zaporedje znotrajceličnih reakcij, ki vključujejo indukcijo določenih encimov.
English: This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Slovenian: Takšno delovanje lahko poveča tveganje za pojav laktacidoze, ki jo povzročajo analogi purinskih nukleozidov (npr. didanozin ali abakavir).
English: If it cannot be used immediately, the solution may be refrigerated for up to 24 hours.
Slovenian: Če je ne morete uporabiti takoj, lahko raztopino hranite v hladilniku do 24 ur.
English: Medicines
Slovenian: Zdravila
English: Steatosis was significantly improved in patients infected with HCV Genotype 3.
Slovenian: Steatoza se je pri bolnikih, okuženih z genotipom 3 virusa HCV, pomembno izboljšala.
English: The Kaplan-Meier estimate for continued sustained response over 5 years for all patients is 99 % (95 % CI: 98-100 %).
Slovenian: Kaplan-Meierjeva ocena ohranitve trajnega virološkega odziva v obdobju 5 let je pri vseh bolnikih znašala 99 % (95 % IZ: 98-100 %).
English: Side effects in children and adolescents The following effects have occurred in children and adolescents:
Slovenian: Neželeni učinki pri otrocih in mladostnikih Pri otrocih in mladostnikih so se pojavili naslednji neželeni učinki:
English: Do not attempt to administer an injection until you are sure you understand how to use the pre-filled pen.
Slovenian: Ne poskušajte si injicirati zdravila, dokler niste prepričani, da razumete, kako se napolnjeni injekcijski peresnik uporablja.
English: A total of 107 patients received treatment of whom 52 % were female, 89 % Caucasian, 67 % with HCV Genotype 1 and 63 % < 12 years of age.
Slovenian: Skupaj so zdravili 107 bolnikov, od tega je bilo 52 % žensk, 89 % belcev, 67 % jih je imelo HCV genotipa 1 in 63 % jih je bilo starih < 12 let.
English: 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 virusinfected 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.
Slovenian: Menijo, da je ta proces vsaj deloma odgovoren za različne celične odzive na interferon, vključno z zaviranjem razmnoževanja virusa v okuženih celicah, supresijo celične proliferacije in imunomodulatornimi učinki, kot je okrepitev fagocitozne aktivnosti makrofagov in povečanje specifične citotoksičnosti limfocitov za tarčne celice.
English: Note: The pre-filled pen will make a clicking sound for up to 10 seconds - depending on your dose.
Slovenian: Opomba: Napolnjeni injekcijski peresnik bo klikal do 10 sekund - odvisno od vašega odmerka.
English: Decrease in mean height percentile at year 1 of long-term follow-up was most prominent in prepubertal age children.
Slovenian: Znižanje srednjega percentila telesne višine po 1 letu po začetku spremljanja je bilo najbolj izrazito pri otrocih pred puberteto.
English: Water for injection and ViraferonPeg powder are provided in separate ampoules.
Slovenian: Voda za injekcije in ViraferonPeg prašek sta na voljo v ločenih ampulah.
English: Important information about some of the ingredients of ViraferonPeg Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila ViraferonPeg Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze in galaktoze ali pomanjkanjem saharaza-izomaltaze ne smejo jemati tega zdravila.
English: HCV-RNA should be measured periodically during treatment (see section 4.2).
Slovenian: Vrednost HCV-RNA morate med zdravljenjem periodično meriti (glejte poglavje 4.2).
English: - have advanced, uncontrolled liver disease (other than hepatitis C).
Slovenian: - imate napredovalo, nenadzorovano jetrno bolezen (razen hepatitisa C).
English: If you are injecting this medicine yourself, you will be instructed how to prepare and give the injection.
Slovenian: Če si zdravilo injicirate sami, boste dobili navodila, kako pripraviti in si ga injicirati.
English: However, if a week 12 response was achieved, there was little difference in SVR regardless of prior treatment or prior response.
Slovenian: Če pa so se v 12. tednu odzvali na zdravljenje, je bila razlika v trajnem virološkem odzivu (SVR) majhna, ne glede na predhodno zdravljenje ali predhodni odziv na zdravljenje.
English: No response at treatment week
Slovenian: Ni odziva v tednu zdravljenja
English: Ribavirin causes serious birth defects when administered during pregnancy, therefore ribavirin therapy is contraindicated in women who are pregnant.
Slovenian: Ribavirin povzroča hude poškodbe ploda, če se uporablja med nosečnostjo, zato je zdravljenje z ribavirinom kontraindicirano pri nosečnicah.
English: It is not known whether this medicine is present in human milk.
Slovenian: Ni znano, ali je to zdravilo prisotno v materinem mleku.
English: Treatment regimen
Slovenian: Režim zdravljenja
English: The mechanism behind these events is not known (see sections 4.3, 4.4 and 4.5 of the telbivudine SmPC).
Slovenian: Mehanizem nastanka periferne nevropatije v tem primeru ni znan (glejte poglavja 4.3, 4.4 in 4.5 v SmPC-ju za telbivudin).
English: Male patients or their female partners must use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SmPC).
Slovenian: Moški bolniki ali njihove partnerke morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še 7 mesecev po zaključku zdravljenja (glejte SmPC za ribavirin).
English: HCV Genotype
Slovenian: HCV genotip
English: Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface.
Slovenian: Interferoni kažejo svoje celične učinke preko vezave na specifične membranske receptorje na celični površini.
English: If your female partner is not pregnant but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Slovenian: Če vaša partnerka sicer trenutno ni noseča, a je v rodni dobi, mora opraviti test nosečnosti vsak mesec med vašim zdravljenjem in še 7 mesecev po koncu zdravljenja.
English: Among 480 patients with > 2 log viral reduction but detectable virus at week 12, altogether 188 patients continued therapy.
Slovenian: Med 480 bolniki z zmanjšanjem količine virusa za > 2 log enoti, vendar še vedno z zaznavnim virusom v 12. tednu zdravljenja, je z zdravljenjem nadaljevalo skupaj 188 bolnikov.
English: Sustained response
Slovenian: Trajni odziv
English: Diabetic ketoacidosis
Slovenian: diabetična ketoacidoza
English: Growth rate decrease (height and/or weight decrease for age)
Slovenian: zmanjšana hitrost rasti (glede na leta manjša telesna masa in/ali višina)
English: However, an overall 24 weeks treatment duration may be associated with a higher risk of relapse than a 48 weeks treatment duration (see section 5.1).
Slovenian: Skupna dolžina zdravljenja 24 tednov pa je lahko povezana z večjim tveganjem za ponovitev bolezni kot pri skupni dolžini zdravljenja 48 tednov (glejte poglavje 5.1).
English: No studies have been conducted in juvenile animals to examine the effects of treatment with ViraferonPeg on growth, development, sexual maturation, and behaviour.
Slovenian: Študij pri mladih živalih, pri katerih bi spremljali vpliv zdravljenja z zdravilom ViraferonPeg na rast, razvoj, spolno dozorevanje in obnašanje, niso izvedli.
English: These adverse reactions were common (≥1/100 to < 1/10) in clinical trials in patients treated with ViraferonPeg monotherapy.
Slovenian: Ti neželeni učinki so bili pogosti (≥1/100 do < 1/10) v kliničnih preskušanjih pri bolnikih, zdravljenih z zdravilom ViraferonPeg v monoterapiji.
English: If necessary, an inter-disciplinary approach including a mental health care provider or addiction specialist should be considered to evaluate, treat and follow the patient.
Slovenian: Če je potrebno, uporabite interdisciplinarni pristop z vključitvijo specialista s področja duševnega zdravja ali odvisnosti za oceno stanja, zdravljenje in spremljanje takega bolnika.
English: • Lay the pre-filled pen on a flat clean surface and wait until it reaches room temperature (but not more than 25
Slovenian: • Napolnjeni injekcijski peresnik položite na ravno, čisto površino in počakajte, da doseže sobno temperaturo (vendar ne več kot 25 °C).
English: These time points (treatment week 4 and treatment week 12) have been shown to be predictive for sustained response (Table 12).
Slovenian: Za navedene časovne točke (4. teden zdravljenja in 12. teden zdravljenja) so pokazali, da napovedujejo trajni virološki odziv (preglednica 12).
English: General information about taking this medicine
Slovenian: Splošni podatki o uporabi tega zdravila