FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor or nurse will help you to learn the process of self-administration.
Slovenian: Zdravnik ali medicinska sestra vas bosta naučila postopka samoinjiciranja.
English: However, this did not seem to be associated with a reduction in clinical efficacy (with regard to time to clinically definite multiple sclerosis (CDMS), time to confirmed EDSS progression and relapse rate).
Slovenian: Vendar pa ta ni bil povezan z zmanjšanjem klinične učinkovitosti (glede na čas do klinično potrjene multiple skleroze (CDMS - clinically definite multiple sclerosis), časom do napredovanja potrjenega glede na EDSS in stopnjo recidiva).
English: Three major classes of interferons have been identified: alpha, beta, and gamma.
Slovenian: Znane so tri glavne skupine interferonov: alfa, beta in gama.
English: At present it is not known how long treatment with Betaferon should last.
Slovenian: Trenutno ni znano, kako dolgo mora trajati zdravljenje z zdravilom Betaferon.
English: There is evidence that the patients included in this study had overall less active disease than in the other study in secondary progressive multiple sclerosis.
Slovenian: Obstajajo dokazi, da so imeli bolniki, vključeni v to preskušanje, na splošno manj aktivno bolezen kot v omenjenem prvem preskušanju pri sekundarno progresivni multipli sklerozi.
English: Table A: Schedule for dose titration* treatment day dose volume
Slovenian: Preglednica A: Razpored titriranja odmerka* dan zdravljenja odmerek prostornina
English: However, if you are not able to do so, it will be suitable for use for 3 hours, if kept at 2-8 °C (in a refrigerator).
Slovenian: Če to ni mogoče, jo lahko hranite 3 ure na temperaturi od 2 do 8 °C (v hladilniku).
English: 1 - Choose an area for the injection (see advice at the start and the diagrams at the end of this Annex), and make a note of it in your medication record.
Slovenian: 1 - Izberite mesto injiciranja (glejte nasvet na začetku in diagrame na koncu tega dodatka) in dogodek zabeležite v kartici uporabe zdravila.
English: Inspection prior to use
Slovenian: Pregled pred uporabo
English: In any case, treatment should only be considered for patients classified as high risk.
Slovenian: V vsakem primeru je treba možnost zdravljenja upoštevati le pri bolnikih, pri katerih je tveganje veliko.
English: − Never re-use syringes or needles.
Slovenian: - Brizg ali igel nikoli ne uporabite dvakrat.
English: The decision to continue or discontinue treatment should be based on all aspects of the patient's disease status rather than on neutralising activity status alone.
Slovenian: Pri odločitvi o nadaljevanju ali prenehanju zdravljenja je treba upoštevati celoten status bolezni, ne le prisotnost nevtralizacijske aktivnosti.
English: Therapy with Betaferon was well accepted as indicated by a high rate of trial completion (93% in the Betaferon group).
Slovenian: Zdravljenje z zdravilom Betaferon je bilo dobro sprejeto, na kar kaže veliko število bolnikov, ki so zaključili preskušanje (93 % v skupini, ki je prejemala zdravilo Betaferon).
English: Injection site reactions usually become less frequent over time.
Slovenian: Reakcije na mestu injiciranja postanejo sčasoma manj pogoste.
English: INFORMATION IN BRAILLE Betaferon
Slovenian: PODATKI V BRAILLOVI PISAVI
English: The relation of multiple sclerosis disease activity as measured by MRI and clinical outcome is currently not fully understood.
Slovenian: Razmerje med aktivnostjo multiple skleroze, merjeno z MRS, in kliničnim izidom trenutno ni povsem jasno.
English: As rodents do not react to human interferon beta, repeated dose studies were carried out with rhesus monkeys.
Slovenian: Ker se glodalci ne odzovejo na humani interferon beta, so študije ponavljajočih odmerkov naredili na opicah rhesus.
English: 4 - Gently pinch the skin together around the disinfected injection site (to raise it up a little).
Slovenian: 4 - Kožo okoli dezinficiranega mesta nežno stisnite (da jo nekoliko dvignete).
English: Only hold the blue plastic adapter when removing.
Slovenian: Med odstranjevanjem držite le modri plastični adapter.
English: If you come back to an area after one Rotation Cycle, choose the most distant injection site within this area.
Slovenian: Če se po enem rotacijskem ciklu vrnete na isti predel, izberite mesto injiciranja znotraj tega predela, ki je najbolj oddaljeno od prejšnjega.
English: The treatment effect occurred in patients at all levels of disability investigated and independent of relapse activity.
Slovenian: Učinek zdravljenja se je pojavil pri bolnikih ne glede na preučevano stopnjo invalidnosti in neodvisno od recidivne aktivnosti.
English: The occurrence of elevations in serum transaminases should lead to close monitoring and investigation.
Slovenian: Pri povečanju vrednosti serumskih transaminaz so potrebni skrben nadzor in preiskave.
English: A risk of transmission of Creutzfeld-Jacob disease (CJD) cannot be ruled out.
Slovenian: Tveganja za prenos Creutzfeld-Jakobove bolezni (CJD) ni možno izključiti.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: Odstranjevanje Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: No interaction studies with anti-epileptics have been carried out.
Slovenian: Študij medsebojnega delovanja z antiepileptiki niso izvedli.
English: Let the skin air-dry.
Slovenian: Pustite, da se posuši na zraku.
English: − Always place the used syringes in the proper disposal unit.
Slovenian: - Rabljeno brizgo vedno spravite v ustrezno posodo za odstranjevanje.
English: − If you have a heart disease, the flu-like symptoms, which often occur at the start of treatment, may prove stressful to you.
Slovenian: - Če imate bolezen srca vas bodo morda gripi podobni simptomi, ki se pogosto pojavijo na začetku zdravljenja, močno obremenjevali.
English: If you are injecting less than 1 ml with the titration pack there might not be any air bubbles, however for full dose injection some air bubbles might turn up.
Slovenian: Če ste pri titriranju injicirali manj kot 1 ml, zračni mehurčki verjetno niso prisotni, vendar se pri injiciranju celotnega odmerka zračni mehurčki lahko dvignejo.
English: Betaferon injections given every other day do not lead to serum level increases, and the pharmacokinetics does not seem to change during therapy.
Slovenian: Injiciranje zdravila Betaferon vsak drugi dan ne povzroči povečanja koncentracije v serumu in kot kaže, se farmakokinetika med zdravljenjem ne spremeni.
English: Secondary progressive multiple sclerosis: In some cases people with relapsing-remitting MS find that their symptoms increase and they progress to another form of MS called secondary progressive MS. With this, people find themselves becoming increasingly impaired, whether or not they have relapses.
Slovenian: Sekundarno progresivna multipla skleroza: V nekaterih primerih pri bolnikih z recidivnoremitentno MS ugotovijo večjo izraženost njihovih simptomov in napredovanje v drugo obliko MS, imenovano sekundarno progresivna MS. Bolniki s to obliko postajajo vedno bolj prizadeti, ne glede na to, ali imajo relapse ali ne.
English: This product contains human albumin and hence carries a potential risk for transmission of viral diseases.
Slovenian: Zdravilo vsebuje humani albumin in zato obstaja potencialno tveganje za prenos virusnih bolezni.
English: Betaferon can reduce the number and severity of the attacks, and slow the progression of disability.
Slovenian: Zdravilo Betaferon lahko zmanjša pogostnost in resnost zagonov ter upočasni napredovanje invalidnosti.
English: Patients should be monitored for signs of hepatic injury.
Slovenian: Bolnike je treba nadzorovati glede znakov jetrne okvare.
English: No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Slovenian: Kliničnih preskušanj ali farmakokinetičnih študij pri otrocih ali mladostnikih niso izvedli.
English: Inspect the reconstituted product visually before use.
Slovenian: Rekonstituirano zdravilo je treba pred uporabo vizualno pregledati.
English: Boehringer Ingelheim RCV GmbH & Co KG Dr.-Boehringer-Gasse 5-11
Slovenian: Boehringer Ingelheim RCV GmbH & Co KG
English: Injection site reactions as well as injection site necroses were observed less frequently in this study than in the other pivotal studies.
Slovenian: Reakcije in nekroze na mestu injiciranja so v tej študiji opazili redkeje kot v drugih ključnih študijah.
English: Patients treated with Betaferon should be advised to report any symptoms of depression and/or suicidal ideation to their prescribing physician immediately.
Slovenian: Bolnikom, ki prejemajo zdravilo Betaferon, je treba svetovati, naj o morebitnih simptomih depresije in/ali samomorilnih mislih takoj obvestijo zdravnika, ki jim je predpisal zdravilo.
English: Do not shake the vial.
Slovenian: Ne stresajte viale.
English: If some areas are too difficult for you to reach, you may need a family member or friend to help you with these injections.
Slovenian: Če katera mesta težko dosežete, prosite za pomoč člana družine ali prijatelja, da vam pomaga pri injiciranju.
English: Reproduction studies with rhesus monkeys revealed maternal toxicity and an increased rate of abortion, resulting in prenatal mortality.
Slovenian: Reprodukcijske študije pri opicah rhesus so razkrile maternalno toksičnost in povečano pogostnost splavov, ki sta povzročila prenatalno umrljivost.
English: In the open-label follow-up phase, the treatment effect on CDMS was still evident after 3 and 5 years (Table 3) even though the majority of patients from the placebo-group were treated with Betaferon at least from the second year onwards.
Slovenian: V odprti fazi nadaljevanja študije so bili učinki zdravljenja na CDMS še vedno opazni po 3 in 5 letih (preglednica 3), čeprav je bila večina bolnikov iz skupine, ki je dobivala placebo, zdravljena z zdravilom Betaferon vsaj od drugega leta naprej.
English: Other things to consider when using Betaferon
Slovenian: Drugi dejavniki, ki jih je treba upoštevati pri uporabi zdravila Betaferon
English: Please refer to the rotation schedule at the end of this Annex to learn how to choose an injection site.
Slovenian: Oglejte si načrt menjavanja na koncu tega dodatka, da se naučite izbrati mesto injiciranja.
English: Pharmacotherapeutic group: Cytokines, Interferons, ATC Code: L03 AB 08
Slovenian: Farmakoterapevtska skupina: citokini, interferoni; oznaka ATC: L03AB08 Mehanizem delovanja
English: If you become depressed while you are on Betaferon, you may need special treatment and your doctor will closely monitor you and may also consider stopping your treatment.
Slovenian: Če postanete med uporabo zdravila Betaferon depresivni, vas bo morda treba posebej zdraviti, zdravnik pa vas bo pozorno nadzoroval ali pretehtal možnost prenehanja zdravljenja.
English: If more than 3 hours pass, discard the reconstituted Betaferon solution and prepare a new injection.
Slovenian: Če mine več kot 3 ure, zavrzite rekonstituirano raztopino zdravila Betaferon in pripravite novo injekcijo.
English: Betaferon serum levels were followed in patients and volunteers by means of a not completely specific bioassay.
Slovenian: Koncentracijo zdravila Betaferon v serumu so pri bolnikih in prostovoljcih spremljali z ne povsem specifičnim biološkim preizkusom.
English: The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available data, but the data do not suggest an increased risk so far.
Slovenian: Glede na podatke, ki so na voljo, se tveganja za spontane splave pri nosečnicah, ki so bile izpostavljene interferonu beta, ne da ustrezno oceniti, vendar pa podatki zaenkrat ne kažejo povečanega tveganja.
English: Do not inject a double dose to make up for a forgotten single dose.
Slovenian: Ne injicirajte si dvojnega odmerka, če ste pozabili uporabiti prejšnji odmerek.
English: As you get started, you may find the following helpful:
Slovenian: Na začetku vam bodo v pomoč naslednji koraki:
English: Within this period, the development of neutralising activity was associated with a significant increase in newly active lesions and T2 lesion volume on magnetic resonance imaging.
Slovenian: V tem obdobju je bil razvoj nevtralizacijske aktivnosti povezan s pomembnim povečanjem nove aktivne lezije in T2 lezije pri magnetnoresonančnem slikanju.
English: ► Stop using Betaferon and tell your doctor immediately if any of these happens to you.
Slovenian: ► Takoj prenehajte uporabljati zdravilo Betaferon in obvestite zdravnika, če se vam pojavi kar koli od naštetega.
English: Treatment is not recommended in patients with relapsing-remitting multiple sclerosis who have experienced less than 2 relapses in the previous 2 years or in patients with secondary-progressive multiple sclerosis who have had no active disease in the previous 2 years.
Slovenian: Zdravljenje se ne priporoča pri bolnikih z recidivno-remitentno multiplo sklerozo, ki so v zadnjih dveh letih imeli manj kot dva recidiva, in bolnikih s sekundarno progresivno multiplo sklerozo, ki v zadnjih dveh letih niso imeli aktivne bolezni.
English: This is called a Rotation Cycle.
Slovenian: To je t. i. rotacijski cikel.
English: This study consisted of two phases, a placebo-controlled phase followed by a pre-planned follow-up phase.
Slovenian: Preskušanje je imelo dve obdobji, s placebom nadzorovanem obdobju je sledilo vnaprej načrtovano obdobje spremljanja.
English: To minimise the risk of injection site necrosis patients should be advised to:
Slovenian: Za zmanjšanje tveganja za nekrozo na mestu injiciranja, je treba bolnikom svetovati, da:
English: If you know that you are allergic (hypersensitive) to any of the ingredients or if you become so, you must not use Betaferon.
Slovenian: Če veste, da ste alergični (preobčutljivi) na katero koli sestavino zdravila ali nanjo postanete preobčutljivi, zdravila Betaferon ne smete uporabljati.
English: In the absence of clinical evidence for liver damage and after normalisation of liver enzymes a reintroduction of therapy could be considered with appropriate follow-up of hepatic functions.
Slovenian: V odsotnosti kliničnih znakov jetrne okvare in po normalizaciji vrednosti jetrnih encimov se lahko ponovno uvede zdravljenje z ustreznim nadaljnjim spremljanjem delovanja jeter.
English: 2 - Open the Betaferon vial and put it on the table.
Slovenian: 2 - Odprite vialo z zdravilom Betaferon in jo položite na mizo.
English: List 1: Very common side effects which have occurred in clinical trials with Betaferon(at least 10% of the cases) and at a higher percentage than those observed with placebo.
Slovenian: Seznam 1: Zelo pogosti neželeni učinki, ki so se pojavili v kliničnih preskušanjih zdravila Betaferon (vsaj ≥ 10 % primerov) in v večjem odstotku kot pri placebu.
English: Experience with Betaferon in patients with MS is limited, consequently those adverse events which occur very rarely may not yet have been observed.
Slovenian: Izkušnje z zdravilom Betaferon so pri bolnikih z multiplo sklerozo omejene, zato je mogoče, da neželenih učinkov, ki se pojavljajo zelo redko, še niso opazili.
English: Furthermore, there was a prolongation of the relapse-free interval.
Slovenian: Poleg tega se je podaljšalo obdobje brez recidiva.
English: − Try to give your injection at the same time of day.
Slovenian: - Če je mogoče, si zdravilo injicirajte vedno ob istem času dneva.
English: − If you have ever had seizures or if you are taking medicines to treat epilepsy (antiepileptics), your doctor will monitor your treatment carefully (see also ‘Other medicines and Betaferon' and section 4.
Slovenian: - če ste imeli epileptične napade ali jemljete zdravila za zdravljenje epilepsije (antiepileptike), vas bo zdravnik skrbno nadzoroval (glejte tudi poglavji Druga zdravila in zdravilo Betaferon in poglavje 4.
English: Your doctor will closely monitor you during treatment.
Slovenian: Med zdravljenjem vas bo zdravnik pozorno nadzoroval.
English: Changes to the liver function values occurred in patients treated with Betaferon during clinical studies.
Slovenian: Spremembe v delovanju jeter so se pojavile pri bolnikih, ki so jih med kliničnimi študijami zdravili z zdravilom Betaferon.
English: Fertility No investigations on fertility have been conducted (see section 5.3).
Slovenian: Raziskav o vplivu zdravila na plodnost niso izvedli (glejte poglavje 5.3).
English: 47% versus placebo
Slovenian: 47 % v primerjavi s placebom
English: Please follow in detail the instructions for use below.
Slovenian: Upoštevajte navodila za uporabo, ki so opisana spodaj.
English: Multiple sclerosis (MS) is a long-term condition that affects the central nervous system (CNS), particularly the functioning of the brain and spinal cord.
Slovenian: Mutipla skleroza (MS) je dolgotrajno stanje, ki vpliva na osrednje živčevje, še zlasti na delovanje možganov in hrbtenjače.
English: Your doctor may find changes in your blood and the function of your kidneys.
Slovenian: Zdravnik bo morda ugotovil spremembe v vaši krvni sliki in delovanju vaših ledvic.
English: − During treatment with Betaferon your body may produce substances called neutralising antibodies, which may react with Betaferon (neutralising activity).
Slovenian: - Med zdravljenjem z zdravilom Betaferon lahko vaše telo izdela snovi, imenovane nevtralizacijska protitelesa, ki lahko reagirajo z zdravilom Betaferon (nevtralizacija).
English: # During the BENEFIT follow-up study, no change in the known risk profile of Betaferon was observed.
Slovenian: # V obdobju spremljanja v študiji BENEFIT niso ugotovili sprememb glede varnosti zdravila Betaferon.
English: Depression and suicidal ideation are known to occur with increased frequency in the multiple sclerosis population and in association with interferon use.
Slovenian: Znano je, da se depresija in samomorilne misli pogosteje pojavljajo pri bolnikih z multiplo sklerozo in tistih, ki uporabljajo interferon.
English: Do not use Betaferon if you notice it contains particles or is discoloured.
Slovenian: Ne uporabljajte zdravila Betaferon, če opazite, da vsebuje delce ali je obarvano.
English: If, for some reason, you are not able to inject the Betaferon immediately, you can keep the reconstituted solution in the syringe in a refrigerator for up to 3 hours before using.
Slovenian: Če si zaradi kakršnega koli razloga zdravila Betaferon ne morete vbrizgati takoj, lahko rekonstituirano raztopino v brizgi do 3 ure hranite v hladilniku.
English: Patients with mild disease and those unable to walk were not studied.
Slovenian: Bolnikov z blago boleznijo in bolnikov nezmožnih hoje, niso preučevali.
English: Secondary Progressive Multiple Sclerosis (European Study)
Slovenian: sekundarno progresivna multipla skleroza (evropska študija)
English: Betaferon should be administered with caution to patients with previous or current depressive disorders, in particular to those with antecedents of suicidal ideation (see section 4.3).
Slovenian: Zdravilo Betaferon je treba previdno uporabljati pri bolnikih s predhodnimi ali trenutnimi depresijami, zlasti pri tistih, ki so že imeli samomorilne misli (glejte poglavje 4.3).
English: From day 19 you are injecting the full dose 1.0 ml.
Slovenian: Od 19. dneva zdravljenja injicirajte celoten odmerek 1 ml.
English: - if you are allergic (hypersensitive) to natural or recombinant interferon beta, human albumin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični (preobčutljivi) na naravni ali rekombinantni interferon beta, humani albumin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: Betaferon is available in pack sizes of:
Slovenian: Zdravilo Betaferon je na voljo v pakiranjih, ki vsebujejo:
English: − Patients with decompensated liver disease (see sections 4.4, 4.5 and 4.8).
Slovenian: − bolniki z dekompenzirano jetrno boleznijo (glejte poglavja 4.4, 4.5 in 4.8)
English: If you stop using Betaferon
Slovenian: Če ste prenehali uporabljati zdravilo Betaferon
English: For relapsing-remitting MS, efficacy has been demonstrated for therapy for the first two years.
Slovenian: Pri recidivno-remitentni multipli sklerozi je dokazana učinkovitost zdravljenja za prvi dve leti.
English: A large amount of data (more than 1000 pregnancy outcomes) from interferon beta registries, national registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure or exposure during the first trimester of pregnancy.
Slovenian: Večje število podatkov o uporabi interferona beta pri nosečnicah (več kot 1000 izpostavljenih nosečnosti) iz registrov uporabe interferona beta, nacionalnih registrov in izkušenj v obdobju trženja ne kaže povečanega tveganja za resne prirojene anomalije pri izpostavljenosti zdravilu pred oploditvijo ali izpostavljenosti v prvem trimesečju nosečnosti.
English: − if you feel noticeably more sad or hopeless than before the treatment with Betaferon, or if you develop thoughts of suicide.
Slovenian: - če se počutite izrazito bolj žalostni ali brezupno, kot ste se pred začetkom zdravljenja z zdravilom Betaferon, ali če se pojavijo samomorilne misli.
English: ‘Possible side effects').
Slovenian: Možni neželeni učinki).
English: For the time being there is no well-established definition of a high risk patient, although a more conservative approach is to accept at least nine T2 hyperintense lesions on the initial scan and at least one new T2 or one new Gd-enhancing lesion on a follow-up scan taken at least 1 month after the initial scan.
Slovenian: Do danes dobro utemeljene opredelitve bolnika z velikim tveganjem še ni, vendar je bolj sprejemljiv konzervativen pristop, to pomeni vsaj 9 hiperintenzivnih lezij T2 v prvi preiskavi in vsaj ena nova T2 ali ena nova lezija po ojačanju z Gd v naslednji preiskavi, ki je izvedena vsaj 1 mesec po prvi preiskavi.
English: An abnormal response by the body's immune system is thought to play an important part in the process which damages the CNS.
Slovenian: Predvidevajo, da ima nenormalen odziv imunskega sistema telesa pomembno vlogo v procesu, ki uničuje osrednje živčevje.
English: Betaferon should be administered with caution to patients with a history of seizures and to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with anti-epileptics (see sections 4.5 and 4.8).
Slovenian: Zdravilo Betaferon je treba previdno uporabljati pri bolnikih z anamnezo epileptičnih napadov in bolnikih, ki prejemajo antiepileptična zdravila, zlasti če epilepsija pri njih ni ustrezno nadzorovana z antiepileptičnimi zdravili (glejte poglavji 4.5 in 4.8).
English: A titration pack composed of four triple packs is available for the titration period and the patient's initial treatment with Betaferon.
Slovenian: Set za titriranje je sestavljen iz štirih tridelnih pakiranj, ki so namenjena za obdobje titriranja in začetno zdravljenje bolnikov z zdravilom Betaferon.
English: No acute toxicity studies have been carried out.
Slovenian: Študij akutne toksičnosti niso izvedli.
English: − in the powder: mannitol and human albumin,
Slovenian: − v prašku: manitol in humani albumin,
English: In order to obtain adequate efficacy, a dose of 250 microgram (1.0 ml) every other day should be reached.
Slovenian: Za zagotovitev ustrezne učinkovitosti je treba doseči odmerek 250 mikrogramov (1 ml) vsak drugi dan.
English: At the present time, it is not known how long the patient should be treated for.
Slovenian: Trenutno ni znano, kako dolgo naj traja zdravljenje.
English: By following this schedule, you will come back to your first area (e.g. the right side of the abdomen) after 8 injections (16 days).
Slovenian: Če boste upoštevali takšen časovni razpored, boste prvi predel (npr. na desno stran trebuha) ponovno uporabili po 8 injekcijah (16 dneh).
English: An example of a medication record is also included (see Annex Part III).
Slovenian: Priložen je primer zapisovanja o uporabi zdravila (glejte Dodatek, del III).
English: 7- Discard the syringe in the disposal unit.
Slovenian: 7 - Brizgo zavrzite v posodo za odstranjevanje.