FrancophonIA/ELRC3.0 huggingface dataset:
English: These may be symptoms of a fall in your blood cell count or in the number of platelets in your blood (cells, which help the blood to clot).
Slovenian: To so lahko simptomi zmanjšanja števila celic v krvi ali števila trombocitov v krvi (celice, ki pomagajo pri strjevanju krvi).
English: Betaferon is a type of medicine known as interferon used to treat multiple sclerosis.
Slovenian: Zdravilo Betaferon je vrsta zdravila, znanega kot interferon, za zdravljenje multiple skleroze.
English: The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred.
Slovenian: Pri bolniku je treba redno nadzorovati postopek samoinjiciranja, zlasti če so se pojavile reakcije na mestu injiciranja.
English: Every other day (once every two days), 1.0 ml of the prepared Betaferon solution (see Annex ‘Selfinjection procedure' in the second part of this leaflet) injected under the skin (subcutaneously).
Slovenian: Vsak drugi dan (enkrat na dva dni) 1 ml pripravljene raztopine zdravila Betaferon (glejte Dodatek: Postopek samoinjiciranja v drugem delu tega navodila), injicirane pod kožo (subkutano).
English: The most serious were reported in patients taking other medicines or who were suffering from diseases that can affect the liver (e.g. alcohol abuse, severe infection).
Slovenian: O resnih neželenih učinkih so poročali pri bolnikih, ki so jemali še druga zdravila ali so imeli bolezni, ki vplivajo na jetra (npr. zloraba alkohola, resne okužbe).
English: Each cycle will be 8 injections (16 days), given in area 1 through to area 8 in turn.
Slovenian: Vsak cikel sestavlja 8 injekcij (16 dni), ki se zaporedoma dajejo v predele od 1 do 8.
English: This will be done before you start using Betaferon, regularly after treatment with Betaferon has been initiated and periodically whilst you are on it, even if you have no particular symptoms.
Slovenian: Betaferon, redno po začetku zdravljenja z zdravilom Betaferon in v presledkih med njegovo uporabo, tudi če nimate posebnih simptomov.
English: − if you notice any unusual bruising, excessive bleeding after injury or if you seem to be catching a lot of infections.
Slovenian: - če opazite kakršne koli nenavadne modrice, čezmerne krvavitve po poškodbi ali če se vam zdi, da pogosto zbolevate za okužbami.
English: A number of these products have been measured in the serum and cellular fractions of blood collected from patients treated with interferon beta-1b.
Slovenian: Številne od teh produktov so ugotovili v serumski in celični frakciji krvi bolnikov, zdravljenih z interferonom beta-1b.
English: Time to confirmed EDSS progression Kaplan-Meier estimates
Slovenian: Čas do potrjenega napredovanja glede na EDSS Ocena po Kaplan
English: • small amounts of mannitol, a naturally occurring sugar and human albumin, a protein.
Slovenian: • majhne količine manitola (naravni sladkor) in humanega albumina (beljakovina).
English: In the study of patients with a single clinical event suggestive of multiple sclerosis, neutralising activity measured every 6 months was observed at least once in 32% (89) of the patients treated immediately with Betaferon; of these, 60% (53) returned to negative status based on the last available assessment within the 5 year period.
Slovenian: V študiji pri bolnikih z enim samim kliničnim dogodkom, ki kaže na multiplo sklerozo, so nevtralizacijsko aktivnost, izmerjeno vsakih 6 mesecev, opazili vsaj enkrat pri 32 % (89) bolnikov, takoj zdravljenih z zdravilom Betaferon; glede na zadnje ocene, ki so bile na voljo, se jih je v petih letih 60 % (53) vrnilo na negativni status.
English: Patients with pre-existing significant cardiac disease, such as congestive heart failure, coronary artery disease or arrhythmia, should be monitored for worsening of their cardiac condition, particularly during initiation of treatment with Betaferon.
Slovenian: Bolnike s pomembnimi srčnimi boleznimi, kot so kongestivna srčna odpoved, bolezen koronarnih arterij ali aritmija, je treba spremljati zaradi možnega poslabšanja srčne bolezni, zlasti na začetku zdravljenja z zdravilom Betaferon.
English: Occasionally debridement and, less often, skin grafting are required and healing may take up to 6 months.
Slovenian: Manj pogosto je potrebna presaditev kože; celjenje lahko traja do 6 mesecev.
English: If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of Betaferon is recommended.
Slovenian: Če je TMA diagnosticirana, je potrebno takojšnje zdravljenje (razmisliti o izmenjavi plazme), priporoča pa se tudi takojšnje prenehanje zdravljenja z zdravilom Betaferon.
English: Dissolve the powder completely without shaking.
Slovenian: Prašek je treba popolnoma raztopiti, brez stresanja.
English: Central nervous system-related adverse events associated with the use of Betaferon might influence the ability to drive and use machines in susceptible patients.
Slovenian: Neželeni učinki na osrednje živčevje, povezani z uporabo zdravila Betaferon, lahko pri bolj občutljivih bolnikih vplivajo na sposobnost vožnje in upravljanja strojev.
English: Transitory hyperthermia was observed, as well as a significant rise in lymphocytes and a significant decrease in thrombocytes and segmented neutrophils.
Slovenian: Opažali so prehodno hipertermijo, pomembno povečanje števila limfocitov in pomembno zmanjšanje števila trombocitov in segmentiranih nevtrofilcev.
English: Secondary Progressive Multiple Sclerosis (North American Study)
Slovenian: sekundarno progresivna multipla skleroza (severno ameriška študija)
English: However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving Betaferon 8.0 million IU subcutaneously every other day is similar to that seen in adults.
Slovenian: Vendar omejeni objavljeni podatki kažejo, da je varnostni profil pri mladostnikih, starih od 12 do 16 let, ki so vsak drugi dan subkutano prejemali 8,0 milijonov i.e. zdravila Betaferon, podoben varnostnemu profilu pri odraslih.
English: Thrombotic microangiopathy (TMA)
Slovenian: Trombotična mikroangiopatija (TMA)
English: Subgroup analyses according to baseline factors demonstrated evidence of efficacy on progression to CDMS in all subgroups evaluated.
Slovenian: Analiza podskupin glede na izhodiščne dejavnike je dokazala, da zdravljenje vpliva na napredovanje bolezni do CDMS v vseh preučevanih podskupinah.
English: In the pivotal study of patients with a single clinical event suggestive of multiple sclerosis an autoinjector was used in the majority of patients.
Slovenian: V ključni študiji pri bolnikih z enim samim kliničnim dogodkom, ki kaže na multiplo sklerozo, so avtoinjektor uporabili pri večini bolnikov.
English: Relapsing-remitting multiple sclerosis: People with relapsing-remitting MS have occasional attacks or relapses during which symptoms become noticeably worse.
Slovenian: Recidivno-remitentna multipla skleroza: bolniki z recidivno-remitentno MS imajo občasne zagone ali relapse, med katerimi se simptomi znatno poslabšajo.
English: Betaferon can be used during breast-feeding.
Slovenian: Zdravilo Betaferon se lahko uporablja med dojenjem.
English: Year 2 results Placebo-controlled phase
Slovenian: Izsledki v drugem letu s placebom nadzorovane faze
English: For the dose titration at the start of treatment, draw the respective volume as given in section 4.2.
Slovenian: Za titriranje odmerkov je treba na začetku zdravljenja potegniti ustrezno količino raztopine, kot je razloženo v poglavju 4.2.
English: The activities of interferon beta-1b are species-restricted and therefore, the most pertinent pharmacological information on interferon beta-1b is derived from studies of human cells in culture or in human in vivo studies.
Slovenian: Delovanje interferona beta-1b je omejeno na vrsto, zato najbolj ustrezni podatki o farmakologiji interferona beta1b izhajajo iz študij humanih celic v kulturah ali in vivo študij pri ljudeh.
English: In rare cases, pancreatitis was observed with Betaferon use, often associated with hypertriglyceridaemia.
Slovenian: V redkih primerih so pri uporabi zdravila Betaferon opazili pankreatitis, ki je bil pogosto povezan s hipertrigliceridemijo.
English: Absolute neutrophil count decreased (<1,500/mm³) × Λ * °
Slovenian: zmanjšano absolutno število nevtrofilcev (< 1.500/mm³) × Λ * °
English: Limited information available on the transfer of interferon beta-1b into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1b excreted in human milk are negligible.
Slovenian: Omejeni podatki o prehajanju interferona beta-1b v materino mleko, ki so na voljo, skupaj s kemijsko/fiziološkimi lastnostmi interferona beta, kažejo da so ravni interferona beta-1b, izločenega v humanem mleku neznatne.
English: Betaferon prolonged the time to CDMS by 363 days, from 255 days in the placebo group to 618 days in the Betaferon group (based on the 25th percentiles)
Slovenian: za 363 dni, od 255 dni v skupini, ki je dobivala placebo do 618 dni v skupini, ki je dobivala zdravilo Betaferon (glede na 25. percentil)
English: Your doctor will rule out any other reasons which could explain these symptoms before you are treated.
Slovenian: Zdravnik bo pred zdravljenjem izključil možnost kakršnega koli drugega vzroka za te simptome.
English: Any disease other than multiple sclerosis that could better explain signs and symptoms of the patient had to be excluded.
Slovenian: Izključiti je bilo treba kakršno koli bolezen, ki bi bolje ustrezala bolnikovim znakom in simptomom.
English: − 2 alcohol swabs to clean the skin and vial.
Slovenian: - 2 alkoholni blazinici za čiščenje kože in vial.
English: Do not attempt to inject yourself until you are sure that you understand how to prepare the injection solution and give the injection to yourself.
Slovenian: Zdravila si ne poskušajte dajati sami, če niste povsem prepričani, da razumete vse zahteve za pripravo raztopine za injiciranje in njeno samoinjiciranje.
English: The best places for injections are where the skin is loose and soft, and away from joints, nerves, or bones, for example the abdomen, arm, thigh or buttocks.
Slovenian: Najboljše mesto za injiciranje je predel, kjer je koža mlahava in mehka, ne v bližini sklepov, živcev in kosti, na primer trebuh, roka, stegno ali zadnjica.
English: In the second trial of Betaferon in secondary progressive multiple sclerosis, no delay in the time to disability progression was observed.
Slovenian: V drugem preskušanju zdravila Betaferon pri sekundarno progresivni multipli sklerozi niso opazili odložitve do napredovanja invalidnosti.
English: Using Betaferon with other medicines that modify the immune system response is not recommended, except anti-inflammatory medicines called corticosteroids or the adrenocorticotropic hormone (ACTH).
Slovenian: Uporaba zdravila Betaferon z drugimi zdravili, ki spreminjajo odziv imunskega sistema, ni priporočljiva; izjema so protivnetna zdravila imenovana kortikosteroidi in adrenokortikotropni hormon (ACTH).
English: The administration of cytokines to patients with a pre-existing monoclonal gammopathy has been associated with the development of systemic capillary leak syndrome with shock-like symptoms and fatal outcome.
Slovenian: Uporaba citokinov pri bolnikih z monoklonsko gamopatijo je povezana z razvojem sindroma sistemske kapilarne prepustnosti s šoku podobnimi simptomi in smrtnim izidom.
English: − Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Slovenian: − bolniki s hudimi oblikami depresije in/ali samomorilnimi mislimi (glejte poglavji 4.4 in 4.8)
English: To help you rotate the injection sites appropriately, we recommend that you keep a record of the date and location of your injection.
Slovenian: Da bi ustrezno menjavali mesta injiciranja, priporočamo, da si datum in mesto injiciranja zapišete.
English: Due to the lack of clinical experience in multiple sclerosis patients, the use of Betaferon together with immunomodulators other than corticosteroids or ACTH is not recommended.
Slovenian: Zaradi pomanjkanja kliničnih izkušenj z zdravilom Betaferon, se pri bolnikih z multiplo sklerozo ne priporoča uporaba skupaj z drugimi imunomodulatorji (razen kortikosteroidi ali ACTH).
English: Patients with anaemia, thrombocytopenia, leukopenia (alone or in any combination) may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Slovenian: Pri bolnikih z anemijo, trombocitopenijo in levkopenijo (samo ali v kateri koli kombinaciji) bo morda potrebno bolj pogosto spremljanje celotne krvne slike, diferencialne krvne slike in števila trombocitov.
English: Betaferon is injected under the skin so any food or drink you consume is not thought to have any effect on Betaferon.
Slovenian: Zdravilo Betaferon se injicira pod kožo, zato vpliva hrane ali pijače ni mogoče pričakovati.
English: − Keep your syringes and syringe disposal unit out of the sight and reach of children; lock the supplies away if possible.
Slovenian: - Brizge in posode za odstranjevanje brizg shranjujte nedosegljivo otrokom; če je mogoče, hranite pribor zaklenjen.
English: 6 - Hold the blister pack on the outside and place it on top of the vial.
Slovenian: 6 - Pretisni omot držite na zunanji strani in ga namestite na vrh viale.
English: C) Reconstituting the solution, step by step 1 - Wash your hands thoroughly with soap and water before beginning this process.
Slovenian: 1 - Pred začetkom postopka si temeljito umijte roke z milom in vodo.
English: The binding of interferon beta-1b to these receptors induces the expression of a number of gene products that are believed to be the mediators of the biological actions of interferon beta-1b.
Slovenian: Vezava interferona beta-1b na te receptorje inducira ekspresijo številnih genskih produktov, ki veljajo za mediatorje biološkega delovanja interferona beta-1b.
English: 15 - Remove any air bubbles by gently tapping the syringe and pushing the plunger to the 1-ml mark, or to the volume prescribed by your doctor.
Slovenian: 15 - Zračne mehurčke odstranite tako, da nežno potrkate po brizgi, bat pa potisnete do oznake za 1 ml, oziroma do prostornine, ki vam jo je predpisal zdravnik.
English: Interferon beta-1b also enhances the suppressor activity of peripheral blood mononuclear cells.
Slovenian: Poleg tega interferon beta-1b okrepi zaviralno (supresorsko) delovanje mononuklearnih celic v periferni krvi.
English: 8 - Pick up the syringe.
Slovenian: 8 - Vzemite brizgo.
English: − Patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin or to any of the excipients listed in section 6.1.
Slovenian: − bolniki z znano preobčutljivostjo na naravni ali rekombinantni interferon beta, humani albumin ali katero koli pomožno snov, navedeno v poglavju 6.1
English: Remove them by gently tapping the syringe and pushing the plunger to the respective marking on the syringe.
Slovenian: Odstranite jih z rahlim potrkavanjem na brizgo in potisnite bat do ustrezne oznake na brizgi.
English: Interferon beta-1b has been shown to change the response of the immune system and to help to reduce disease activity.
Slovenian: Interferon beta-1b lahko spremeni odziv imunskega sistema in tako pomaga pri zmanjševanju učinka bolezni.
English: In multifocal patients, the risk for CDMS was independent from MRI findings at baseline, indicating a high risk for CDMS because of the dissemination of the disease based on clinical findings.
Slovenian: Pri multifokalnih bolnikih je bilo tveganje za CDMS neodvisno od izvidov magnetnoresonančnega slikanja na začetku preskušanja, kar kaže na veliko tveganje za nastanek CDMS zaradi diseminacije bolezni, in temelji na izsledkih iz kliničnih preskušanj.
English: 1 frequencies based on pooled clinical trials (very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to < 1/100, rare ≥1/10,000 to <1/1,000, very rare < 1/10,000).
Slovenian: 1 pogostnost glede na združene podatke iz kliničnih preskušanj (zelo pogosti ≥1/10, pogosti ≥1/100 do <1/10, občasni ≥1/1.000 do <1/100, redki ≥1/10.000 do <1/1.000, zelo redki <1/10.000).
English: F) Quick review of the process
Slovenian: F) Kratek pregled postopka
English: Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Betaferon should be considered.
Slovenian: V primeru nefrotskega sindroma je potrebno takojšnje zdravljenje; razmisliti pa je treba tudi o prenehanju zdravljenja z zdravilom Betaferon.
English: Your doctor will regularly check the way you inject yourself, particularly if you have experienced injection site reactions.
Slovenian: Zdravnik bo redno preverjal vaš postopek samoinjiciranja, še zlasti, če se pojavijo reakcije na mestu injiciranja.
English: Your doctor may perform tests to check your kidney function.
Slovenian: Zdravnik lahko opravi preiskave za oceno delovanja ledvic.
English: − Betaferon contains human albumin and therefore carries a potential risk for transmission of viral diseases.
Slovenian: - Zdravilo Betaferon vsebuje humani albumin, zato obstaja morebitno tveganje za prenos virusnih bolezni.
English: In retrospective meta-analyses including the data of both studies, an overall treatment effect was found which was statistically significant (p=0.0076; 8.0 million IU Betaferon versus all placebo patients).
Slovenian: V retrospektivni metaanalizi podatkov iz obeh preskušanj so ugotovili statistično pomemben skupni učinek zdravljenja (p = 0,0076; 8,0 milijonov i.e. zdravila Betaferon v primerjavi z vsemi bolniki, ki so prejemali placebo).
English: Your doctor may want to check your blood pressure, blood (platelet count) and the function of your kidney.
Slovenian: Zdravnik bo morda želel spremljati vaš krvni tlak, krvno sliko (število krvnih ploščic) in delovanje vaših ledvic.
English: ► who suffer from relapsing-remitting multiple sclerosis, with at least two relapses within the last two years.
Slovenian: ► z recidivno-remitentno multiplo sklerozo z vsaj dvema relapsoma v zadnjih dveh letih.
English: Generally, dose titration is recommended at the start of treatment.
Slovenian: Na splošno se na začetku zdravljenja priporoča titriranje odmerka.
English: After preparing the solution you should use it immediately.
Slovenian: Po pripravi je treba raztopino nemudoma uporabiti.
English: It can be extensive and may involve muscle fascia as well as fat and therefore can result in scar formation.
Slovenian: Lahko je obsežna in lahko zajame mišično fascijo in maščobno tkivo, kar lahko povzroči nastanek brazgotin.
English: With the titration pack, withdraw solution only up to the mark on the syringe:
Slovenian: Pri pakiranju za titriranje, potegnite vehikel samo do oznake na brizgi:
English: However, the in-use stability has been demonstrated for 3 hours at 2-8 °C.
Slovenian: Stabilnost med uporabo je dokazana za 3 ure pri temperaturi od 2 do 8 °C.
English: This may suggest a disease of the heart muscle (cardiomyopathy) which has been reported rarely in patients using Betaferon.
Slovenian: Morda je to znak bolezni srčne mišice (kardiomiopatija), o kateri v redkih primerih poročajo pri bolnikih, ki jemljejo zdravilo Betaferon.
English: Patients exhibiting depression should be monitored closely during therapy with Betaferon and treated appropriately.
Slovenian: Depresivne bolnike je treba med zdravljenjem z zdravilom Betaferon pozorno spremljati in ustrezno zdraviti.
English: The majority of patients in both treatment groups had no disability progression over the 5-year period.
Slovenian: V petih letih pri večini bolnikov v obeh skupinah, ki sta bili zdravljeni, niso opazili napredovanja invalidnosti.
English: Caution should be exercised when Betaferon is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g. anti-epileptics.
Slovenian: Previdnost je potrebna pri sočasni uporabi zdravila Betaferon in zdravil, ki imajo ozek terapevtski indeks in katerih očistek je v največji meri odvisen od jetrnega sistema citokrom P450 npr. antiepileptiki.
English: 11 - With the syringe assembly still attached, swirl the vial around gently to completely dissolve the dry Betaferon powder.
Slovenian: 11 - Medtem ko je sklop brizge še vedno pritrjen, vialo nežno zavrtite, da se suh prašek zdravila Betaferon povsem raztopi.
English: There have been no formal clinical trials undertaken in children or adolescents.
Slovenian: Otroci in mladostniki Formalnih kliničnih preskušanj pri otrocih ali mladostnikih niso izvedli.
English: The risk for progression to CDMS within 2 years was higher in monofocal patients with at least 9 T2-lesions or Gd-enhancement on brain MRI at baseline.
Slovenian: Tveganje za napredovanje do CDMS v 2 letih je bilo večje pri monofokalnih bolnikih z vsaj 9 lezijami T2 ali ojačanjem z Gd na magnetnoresonančnem slikanju možganov na začetku preskušanja.
English: While Betaferon does not have any known direct-acting cardiac toxicity, symptoms of the flu-like syndrome associated with beta interferons may prove stressful to patients with pre-existing significant cardiac disease.
Slovenian: Čeprav zdravilo Betaferon nima znane neposredne toksičnosti za srce, so lahko gripi podobni simptomi, povezani z uporabo interferonov, stresni za bolnike s pomembno srčno boleznijo.
English: Patients receiving Betaferon showed a reduction in frequency (30%) and severity of clinical relapses, as well as the number of hospitalisations due to disease.
Slovenian: Bolniki, ki so prejemali zdravilo Betaferon, so imeli manj pogoste (30 %) in manj hude klinične recidive in so bili redkeje hospitalizirani zaradi bolezni.
English: If reactions are severe, Betaferon should be discontinued and appropriate medical intervention instituted.
Slovenian: Če so reakcije hude, je treba prenehati zdravljenje z zdravilom Betaferon in ustrezno ukrepati.
English: Patients should be started at 62.5 microgram (0.25 ml) subcutaneously every other day, and increased slowly to a dose of 250 microgram (1.0 ml) every other day (see Table A).
Slovenian: Zdravljenje je treba začeti z odmerkom 62,5 mikrogramov (0,25 ml) subkutano vsak drugi dan, nato pa ga počasi povečevati do odmerka 250 mikrogramov (1 ml) vsak drugi dan (glejte preglednico A).
English: 10 - Hold the syringe assembly at the bottom of the vial.
Slovenian: 10 - Sklop brizge držite na dnu viale.
English: Betaferon should also be used with caution in patients who suffer from pre-existing cardiac disorders.
Slovenian: Zdravilo Betaferon je treba previdno uporabljati pri bolnikih, ki že imajo srčno bolezen.
English: Removing the vial and adapter from the syringe ensures that the solution will flow out from the needle when injected.
Slovenian: Če vialo in adapter odstranite z brizge, boste zagotovili, da bo raztopina pri injiciranju tekla iz igle.
English: In both trials secondary progressive multiple sclerosis patients receiving Betaferon showed a reduction in frequency (30%) of clinical relapses.
Slovenian: V obeh preskušanjih se je pri bolnikih s sekundarno progresivno multiplo sklerozo, ki so prejemali zdravilo Betaferon, pogostnost kliničnih recidivov zmanjšala (30 %).
English: Retrospective analyses in subgroups showed that a treatment effect on disability progression is most likely in patients with active disease before treatment commences (Hazard Ratio 0.72, 95% confidence interval (0.59, 0.88), p=0.0011, corresponding to a 28 % risk reduction due to Betaferon in patients with relapses or pronounced EDSS progression, 8.0 million IU Betaferon versus all placebo patients).
Slovenian: Retrospektivne analize podskupin so pokazale, da je učinek zdravljenja na napredovanje invalidnosti najverjetnejši pri bolnikih, ki imajo aktivno bolezen, preden se začne zdravljenje (razmerje ogroženosti = 0,72, 95-% interval zaupanja (0,59, 0,88), p = 0,0011, kar ustreza 28 % zmanjšanju tveganja zaradi zdravila Betaferon pri bolnikih s poslabšanjem bolezenskih znakov ali izrazitim napredovanjem glede na EDSS, ki so dobivali 8,0 milijonov i.e. zdravila Betaferon v primerjavi z vsemi bolniki, ki so prejemali placebo).