FrancophonIA/ELRC3.0 huggingface dataset:
English: Glycosylation of other proteins is known to affect their stability, activity, biodistribution, and half-life in blood.
Slovenian: Znano je, da lahko glikozilacija drugih proteinov vpliva na njuno stabilnost, aktivnost, bioporazdelitev in razpolovno dobo v krvi.
English: • Patients diagnosed with relapsing multiple sclerosis (MS).
Slovenian: • bolnikov z diagnozo ponavljajoče se multiple skleroze (MS).
English: Dispose of the rubbish properly
Slovenian: Pravilno odstranite odpadke
English: Genesis Pharma Cyprus Ltd
Slovenian: Κύπρος Genesis Pharma Cyprus Ltd
English: Prepare alcohol wipes and sticking plasters (not supplied) if you need them.
Slovenian: Pripravite alkoholne krpice in obliže (niso priloženi), če jih potrebujete.
English: Leave it at room temperature for half an hour.
Slovenian: Za pol ure ga pustite na sobni temperaturi.
English: This may allow you to sleep through the effects.
Slovenian: Morda boste tako učinke prespali.
English: For example, if you are prescribed other medicines, or if you have a blood test, Avonex may affect the other medicines or the test result.
Slovenian: Na primer, če vam predpisujejo druga zdravila ali če izvajajo krvni test, lahko zdravilo Avonex vpliva na druga zdravila ali rezultate testa.
English: Doctors may prescribe a 25 mm, 25 gauge needle to patients for whom such a needle is appropriate to administer an intramuscular injection.
Slovenian: Zdravnik lahko predpiše uporabo 25 mm igle, dimenzije 25 G (gauge) tistim bolnikom, za katere je takšna igla za intramuskularno injiciranje ustrezna.
English: Tip: If you twist the needle cover to remove it, you may accidentally remove the needle as well.
Slovenian: Nasvet: Če boste pokrovček igle zasukali, da ga odstranite, boste morda nenamerno odstranili tudi iglo.
English: Mutagenesis: Limited but relevant mutagenesis tests have been carried out.
Slovenian: Mutageneza: izvedeno je bilo malo število testov mutageneze, vendar so ti pomembni.
English: Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Slovenian: Znano je, da se depresija in samomorilna nagnjenja pogosteje pojavljajo pri populaciji bolnikov z multiplo sklerozo in v povezavi z uporabo interferona.
English: In some cases, these reactions have occurred in the presence of other medicinal products that have been associated with hepatic injury.
Slovenian: V nekaterih primerih so te reakcije nastopile v prisotnosti drugih zdravil, ki so jih že pred tem povezovali s poškodbami jeter.
English: AVONEX exerts its biological effects by binding to specific receptors on the surface of human cells.
Slovenian: Zdravilo AVONEX doseže svoj biološki učinek s tem, da se veže na specifične receptorje na površini človeških celic.
English: After a single intramuscular dose of AVONEX, serum levels of these products remain elevated for at least four days and up to one week.
Slovenian: Po enem samem intramuskularnem odmerku zdravila AVONEX so ostale ravni teh produktov v serumu povišane vsaj štiri dni in do enega tedna.
English: The use of various assays to detect serum antibodies to interferons limits the ability to compare antigenicity among different products.
Slovenian: Uporaba različnih analiz, da bi odkrili serumska protitelesa za interferone, omejuje zmožnost za primerjavo antigenosti med različnimi zdravili.
English: - Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Slovenian: - Pri bolnikih s prisotno hudo depresijo in/ali samomorilnimi nagnjenji (glejte poglavji 4.4 in 4.8).
English: Biogen Norway AS
Slovenian: Norge Biogen Norway AS
English: Tip: Place the pen down on the table before beginning step 2.
Slovenian: Nasvet: Napolnjen injekcijski peresnik položite na mizo, preden začnete s korakom 2.
English: Genesis Pharma SA
Slovenian: Ελλάδα Genesis Pharma SA
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Nosečnost in dojenje Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: Even if you have used Avonex before, some of the information may have changed.
Slovenian: Tudi če ste zdravilo Avonex že uporabljali, so se morda nekateri podatki spremenili.
English: Some of these products have been measured in the serum and cellular fractions of blood collected from patients treated with AVONEX.
Slovenian: Nekatere od teh produktov so merili v frakcijah seruma in celičnih frakcijah krvi bolnikov, ki so se zdravili z zdravilom AVONEX.
English: When myelin is damaged, the messages between the brain and other parts of the body are disrupted.
Slovenian: Zaradi poškodovanega mielina so sporočila med možgani in drugimi deli telesa motena.
English: It is estimated that the plateau for the incidence of neutralising antibody formation is reached after 12 months of treatment.
Slovenian: Ocenjuje se, da je prag, pri katerem se začnejo proizvajati nevtralizirajoča protitelesa, dosežen po 12 mesecih zdravljenja.
English: Do not use two injections to make up for a missed injection.
Slovenian: Ne uporabite dveh injekcij, da bi nadomestili zamujeni odmerek.
English: No studies on the effects of AVONEX on the ability to drive and use machines have been performed.
Slovenian: Študij o vplivu zdravila AVONEX na sposobnost vožnje in upravljanja strojev niso izvedli.
English: Otherwise it may leak.
Slovenian: sicer lahko pušča.
English: It gives you an idea how likely you are to get similar side effects.
Slovenian: Predstavljate si lahko, kakšna je možnost, da bi imeli podobne neželene učinke.
English: The concentration is 30 micrograms per 0.5 ml.
Slovenian: Koncentracija je 30 mikrogramov na 0,5 ml.
English: Do not use any more Avonex until you have spoken to a doctor.
Slovenian: Ne uporabljajte več zdravila Avonex, dokler se ne pogovorite z zdravnikom.
English: Now pull off the plastic needle cover.
Slovenian: Sedaj snemite plastičen pokrovček igle.
English: More about depression
Slovenian: Več o depresiji
English: However, based on the mode of clearance of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
Slovenian: Vendar pa na osnovi podatkov o izločanju učinkovine ni teoretičnega razloga za morebitne zahteve po prilagajanju odmerka pri starejših bolnikih.
English: After you have finished each injection, put the needle and syringe into a special container (such as a sharps bin), not in ordinary rubbish.
Slovenian: Ko končate z injiciranjem, odvrzite iglo in injekcijsko brizgo v poseben zabojnik (zabojnik za ostre predmete) in ne v običajen koš za odpadke.
English: Local Tolerance: Intramuscular irritation has not been evaluated in animals following repeated administration to the same injection site.
Slovenian: Lokalna toleranca: intramuskularna iritacija pri živalih po večkratni aplikaciji zdravila na isto mesto ni bila določena.
English: It is important to continue using Avonex regularly.
Slovenian: Pomembno je, da z uporabo zdravila Avonex nadaljujete redno.
English: The protein in Avonex is made up of exactly the same ingredients as interferon beta that is found in the human body.
Slovenian: Protein v zdravilu Avonex je sestavljen iz natančno enakih sestavin, kot interferon beta, ki se nahaja v človeškem telesu.
English: • Do not remove the needle cover.
Slovenian: • Ne odstranite pokrovčka igle.
English: AVONEX PEN is available in pack sizes of four or twelve.
Slovenian: AVONEX PEN je na voljo v velikosti pakiranja po štiri ali dvanajst.
English: Interferon beta is produced by various cell types including fibroblasts and macrophages.
Slovenian: Interferon beta proizvajajo različni tipi celic, med njimi tudi fibroblasti in makrofagi.
English: In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file.
Slovenian: Da bi izboljšali sledljivost tega zdravila, mora zdravnik ali farmacevt v vašo zdravstveno kartoteko zabeležiti ime in številko serije zdravila, ki ste ga prejeli.
English: Not for children
Slovenian: Ne uporabljajte pri otrocih
English: Patients exhibiting depression should be monitored closely during therapy and treated appropriately.
Slovenian: Bolnike z depresijo morate med zdravljenjem skrbno spremljati in jih ustrezno zdraviti.
English: These effects have been seen in people using Avonex, but we do not know how likely they are to happen.
Slovenian: Te učinke so opazili pri ljudeh, ki so uporabljali zdravilo Avonex, vendar nimamo podatkov o pogostnosti pojavljanja.
English: If clinically needed, the use of Avonex may be considered during pregnancy.
Slovenian: Če je klinično potrebno, se lahko pretehta možnost uporabe zdravila Avonex med nosečnostjo.
English: At very high doses, anovulatory and abortifacient effects in test animals were observed (see section 5.3).
Slovenian: Pri zelo visokih odmerkih so pri poskusnih živalih opazili anovulacijske in abortivne učinke (glejte poglavje 5.3).
English: If you have a fever, drink plenty of water to keep you hydrated.
Slovenian: Če imate zvišano telesno temperaturo, pijte veliko vode, da ne dehidrirate.
English: Recent clinical studies with patients treated up to three years with AVONEX suggest that approximately 5% to 8% develop neutralising antibodies.
Slovenian: Nedavne klinične študije, pri katerih so se bolniki z zdravilom AVONEX zdravili do tri leta, kažejo, da približno 5 % do 8 % bolnikov razvije nevtralizirajoča protitelesa.
English: Find a clean, hard surface to lay out the items needed for your injection.
Slovenian: Najdite čisto in trdno površino, na katero boste položili predmete, ki jih potrebujete za injiciranje.
English: If you have severe depression or thoughts about suicide, you must not use Avonex.
Slovenian: Če imate hudo depresijo ali mislite na samomor, ne smete uporabljati zdravila Avonex.
English: Keep a note of where you have injected each week.
Slovenian: Vsak teden si zabeležite, kam ste zdravilo injicirali.
English: In some cases these symptoms are associated with flu-like symptoms.
Slovenian: V nekaterih primerih so ti simptomi združeni z gripi podobni simptomi.
English: • Patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1).
Slovenian: • bolnikov, ki so doživeli en demielinizacijski napad z aktivnim vnetnim procesom, če je bil dovolj resen, da upravičuje zdravljenje z intravenoznimi kortikosteroidi, če so bile druge možne diagnoze izključene in če je bolnik uvrščen v visoko stopnjo tveganja, da se bo pri njem/njej razvila klinično jasna multipla skleroza (glejte poglavje 5.1).
English: Three simple ways to help reduce the impact of flu-like symptoms:
Slovenian: Trije preprosti načini za zmanjšanje učinkov gripi podobnih simptomov:
English: In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three-years without evidence of continuous progression between relapses; AVONEX slows the progression of disability and decreases the frequency of relapses.
Slovenian: V kliničnih študijah so to opisali kot dva ali več akutnih poslabšanj (relapsov) v preteklih treh letih, brez dokazov o postopnem napredovanju med relapsi; zdravilo AVONEX upočasnjuje napredovanje prizadetosti in zmanjšuje pogostnost relapsov.
English: Tell your doctor if you are using, have recently used or might use any other medicines, especially those used to treat epilepsy or depression.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, še zlasti tista za zdravljenje epilepsije ali depresije.
English: However, the impact of early treatment with AVONEX is unknown even in this high-risk subgroup as the study was mainly designed to assess the time to the second event rather than the long-term evolution of the disease.
Slovenian: Učinek zgodnjega zdravljenja z zdravilom AVONEX niti v tej podskupini z visokim tveganjem ni znan, saj je bila študija namenjena predvsem ocenjevanju časa do drugega napada, ne pa dolgoročnega razvoja bolezni.
English: • Do not use any area of skin that is bruised, sore, or infected, or if there is an open wound.
Slovenian: • Ne uporabljajte predela kože, ki ima modrice, je vnet ali okužen ter predela z odprtimi ranami.
English: Treatment should be discontinued if the patient develops chronic progressive MS.
Slovenian: Zdravljenje je potrebno prekiniti, če se pri bolniku razvije kronična napredujoča MS.
English: Call a doctor immediately as they may be signs of a possible liver problem.
Slovenian: Nemudoma pokličite zdravnika, saj so lahko to znaki težav z jetri.
English: A large amount of data (more than 1000 pregnancy outcomes) from registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure to interferon beta or such exposure during the first trimester of pregnancy.
Slovenian: Številni podatki (več kot 1.000 izidov nosečnosti) iz registrov in na podlagi izkušenj iz obdobja po prihodu zdravila na trg ne kažejo povečanega tveganja za večje kongenitalne anomalije pri izpostavljenosti interferonu beta pred zanositvijo ali v prvem trimesečju nosečnosti.
English: Whether the mechanism of action of AVONEX in MS is mediated by the same pathway as the biological effects described above is not known because the pathophysiology of MS is not well established.
Slovenian: Ni znano, ali mehanizem delovanja zdravila AVONEX poteka pri MS na enak način, kot je opisano zgoraj, ker patofiziologija MS ni dobro pojasnjena.
English: Biogen Inc., 5000 Davis Drive, POB 14627, Research Triangle Park, North Carolina, 27709, USA.
Slovenian: Biogen Inc., 250 Binney Street, Cambridge, Massachusetts 02142, ZDA Biogen Inc., 5000 Davis Drive, POB 14627, Research Triangle Park, North Carolina, 27709, ZDA
English: Avonex can help to reduce the number of relapses that you have and slow down the disabling effects of MS.
Slovenian: Zdravilo Avonex lahko pomaga zmanjšati število ponovitev, ki jih imate, in upočasniti onesposobljujoče učinke MS.
English: The clinical studies indicate that MS patients can receive AVONEX and corticosteroids or ACTH during relapses.
Slovenian: Klinične študije kažejo, da bolniki z MS med relapsi lahko jemljejo zdravilo AVONEX in kortikosteroide ali ACTH.
English: *Class label for interferon beta products (see section 4.4).
Slovenian: *Označevanje razreda zdravil, ki vsebujejo interferon beta (glejte poglavje 4.4).
English: Adverse reactions identified from studies (clinical trials and observational studies, with a period of follow-up ranging from two years to six years) and other adverse reactions identified through spontaneous reporting from the market, with unknown frequency, are provided in the table below.
Slovenian: Neželeni učinki, ki so jih razkrile študije (klinična preskušanja in opazovalne študije z dolžino spremljanja bolnikov od dveh do šestih let), in drugi neželeni učinki, opredeljeni v spontanih poročilih s tržišča, z neznano pogostnostjo, so navedeni v spodnji razpredelnici.
English: You can get a larger print version of this leaflet by calling the local representatives.
Slovenian: Za večjo tiskano različico navodila pokličite svoje lokalno predstavništvo.
English: The liquid should be clear and colourless.
Slovenian: Tekočina mora biti bistra in brezbarvna.
English: At very high doses, anovulatory and abortifacient effects in test animals were observed.
Slovenian: Pri zelo visokih odmerkih so pri poskusnih živalih opazili anovulacijske in abortivne učinke.
English: This medicine is essentially ‘sodium-free'.
Slovenian: Zdravilo je pravzaprav »brez natrija«.
English: Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease.
Slovenian: Priporoča se periodično spremljanje zgodnjih znakov ali simptomov, npr. edema, proteinurije in okvarjenega delovanja ledvic, zlasti pri bolnikih, pri katerih je tveganje za ledvične bolezni večje.
English: Interferons alpha and beta are classified as Type I interferons, and interferon gamma is a Type II interferon.
Slovenian: Interferoni alfa in beta so klasificirani kot interferoni tipa I, interferon gama pa je interferon tipa II.
English: Once the pen is sealed there is no risk of injury.
Slovenian: Ko je napolnjen injekcijski peresnik zaprt, ni več tveganja za poškodbo.
English: Continue injecting on this new day every week.
Slovenian: Z injiciranjem nadaljujte na ta nov dan v tednu.
English: Neutralising antibodies are associated with a reduction in the in vivo biological effects of AVONEX and may potentially be associated with a reduction of clinical efficacy.
Slovenian: Nevtralizirajoča protitelesa so povezana z zmanjševanjem in vivo bioloških učinkov zdravila AVONEX in so lahko povezana z zmanjševanjem klinične učinkovitosti.
English: 5 Disposal
Slovenian: 5 Odstranjevanje.
English: You may get a needle injury.
Slovenian: Obstaja možnost, da se poškodujete z iglo.
English: If you have depression, your doctor may still prescribe Avonex for you, but it's important to let your doctor know if you have had depression or any similar problems affecting your moods.
Slovenian: Če imate depresijo, vam lahko zdravnik sicer predpiše zdravilo Avonex, vendar je pomembno, da zdravnika obvestite, če ste imeli depresijo ali podobne težave, ki vplivajo na vaše razpoloženje.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Sometimes you will need to remind other medical staff that you are being treated with Avonex.
Slovenian: Včasih boste morali drugo zdravstveno osebje opozoriti, da se zdravite z zdravilom Avonex.
English: Furthermore, 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 three months after the initial scan.
Slovenian: Nadalje, trenutno ne obstaja nobena dobro osnovana definicija bolnika z visokim tveganjem, čeprav bolj konzervativen pristop dovoljuje vsaj devet T2 hiperintenzivnih poškodb pri prvem pregledu in vsaj eno novo T2 ali eno novo Gd-stopnjevano poškodbo na naslednjem pregledu, ki mora biti opravljen vsaj tri mesece po prvem pregledu.
English: Using the World Health Organisation (WHO) International Standard for Interferon, 30 micrograms of AVONEX contain 6 million IU of antiviral activity.
Slovenian: Po mednarodnem standardu Svetovne zdravstvene organizacije (SZO) za interferon, 30 mikrogramov zdravila AVONEX vsebuje 6 milijonov i.e. protivirusne aktivnosti.
English: Avonex may affect other medicines or be affected by them.
Slovenian: Zdravilo Avonex lahko vpliva na druga zdravila ali druga zdravila vplivajo nanj.
English: Avonex is used to treat Multiple Sclerosis (MS).
Slovenian: Zdravilo Avonex se uporablja za zdravljenje multiple skleroze (MS).
English: Name and address of the manufacturers responsible for batch release Biogen (Denmark) Manufacturing ApS, Biogen Allé 1, DK-3400 Hillerød, Denmark.
Slovenian: Ime in naslov izdelovalcev, odgovornih za sproščanje serij Biogen (Denmark) Manufacturing ApS, Biogen Allé 1, DK-3400 Hillerød, Danska
English: Central nervous system-related adverse reactions may have a minor influence on the ability to drive and use machines in susceptible patients (see section 4.8).
Slovenian: Neželene reakcije centralnega živčnega sistema lahko pri občutljivih bolnikih nekoliko vplivajo na njihovo sposobnost vožnje in upravljanja strojev (glejte poglavje 4.8).
English: Paediatric population: The safety and efficacy of AVONEX in adolescents aged 12 to 16 years have not yet been established.
Slovenian: Pediatrična populacija: Varnost in učinkovitost zdravila AVONEX pri otrocih, starih od 12 do 16 let, še nista bili dokazani.
English: These episodes are of limited duration, temporally related to the injections and may recur after subsequent injections.
Slovenian: Te epizode trajajo le nekaj časa - časovno so povezane z injekcijami zdravila in se lahko ponovno pojavijo po kasnejših injekcijah.
English: • Press the blue activation button with your thumb to start the injection.
Slovenian: • S palcem pritisnite modri sprožilni gumb, da začnete injicirati.
English: Limited information available on the transfer of interferon beta-1a into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1a excreted in human milk are negligible.
Slovenian: Omejeni podatki glede izločanja interferona beta-1a v materino mleko skupaj s kemijskimi/fiziološkimi lastnostmi interferona beta kažejo, da so ravni interferona beta-1a, ki se izloča v materino mleko, zanemarljive.
English: No additional benefit has been shown by administering a higher dose (60 micrograms) once a week.
Slovenian: Pri dajanju večjega odmerka (60 mikrogramov) enkrat tedensko se niso pokazale dodatne koristi.
English: If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of AVONEX is recommended.
Slovenian: Če je TMA diagnosticirana, je potrebno takojšnje zdravljenje (razmisliti o izmenjavi plazme), priporoča pa se tudi takojšnje prenehanje zdravljenja z zdravilom Avonex.
English: Caution should be exercised when AVONEX 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. some classes of antiepileptics and antidepressants.
Slovenian: Previdno je potrebno ravnati pri dajanju zdravila AVONEX v kombinaciji z zdravili, ki imajo ozek terapevtski indeks in so za odstranitev v veliki meri odvisni od sistema jetrnega citokroma P450, npr. nekatere vrste antiepileptikov in antidepresivov.
English: If it looks like it has been opened, do not use that syringe.
Slovenian: Če izgleda, kot da je bil odprt, te injekcijske brizge ne uporabite.
English: Three major forms of interferons have been distinguished: alpha, beta, and gamma.
Slovenian: Poznamo tri glavne vrste interferonov: alfa, beta in gama.
English: Biogen Hungary Kft.
Slovenian: Magyarország Biogen Hungary Kft.
English: 150 AVONEX-treated patients completed one year on study and 85 completed two years on study.
Slovenian: bolnikov, zdravljenih z zdravilom AVONEX je pri študiji sodelovalo eno leto, 85 bolnikov pa je pri študiji sodelovalo dve leti.
English: The frequencies of adverse reactions are expressed in patient-years, according to the following categories:
Slovenian: Pogostnosti neželenih pojavov so izražene z enoto bolnikov-let, po naslednjih kategorijah:
English: Flu-like symptoms
Slovenian: Gripi podobni simptomi
English: 1Injection site reactions including pain, inflammation and very rare cases of abscess or cellulitis that may require surgical intervention have been reported.
Slovenian: 1Poročali so o reakcijah na mestu injiciranja zdravila, vključno z bolečino, vnetjem in zelo redkimi primeri abscesa ali celulitisa, pri katerih je lahko potreben kirurški poseg.
English: Patients with cardiac disease, such as angina, congestive heart failure or arrhythmia, should be closely monitored for worsening of their clinical condition during treatment with AVONEX.
Slovenian: Bolnike s srčnimi boleznimi, kot so npr. angina pektoris, kongestivno srčno popuščanje ali aritmija, je potrebno natančno opazovati, da se jim klinično stanje med zdravljenjem z zdravilom AVONEX ne poslabša.
English: Biogen Austria GmbH
Slovenian: Österreich Biogen Austria GmbH