FrancophonIA/ELRC3.0 huggingface dataset:
English: Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is:
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom je:
English: Your doctor, nurse or pharmacist should provide you with instructions on how to dispose of your used Avonex Pen, for example into a sharps bin.
Slovenian: Zdravnik, medicinska sestra ali farmacevt vam bo dal navodila o odstranjevanju uporabljenega napolnjenega injekcijskega peresnika Avonex Pen, na primer v odpadke za ostre predmete.
English: It can be used to achieve the ¼ or ½ dose increments.
Slovenian: Uporablja se lahko za povečanja odmerka za ¼ ali ½.
English: However, in case of overdose, patients should be hospitalised for observation and appropriate supportive treatment given.
Slovenian: V primeru prevelikega odmerjanja je potrebno bolnika napotiti v bolnišnico na opazovanje in mu nuditi primerno zdravljenje.
English: Following intramuscular administration of AVONEX, serum antiviral activity levels peak between 5 and 15 hours post-dose and decline with a half-life of approximately 10 hours.
Slovenian: Po intramuskularni aplikaciji zdravila AVONEX doseže serumska protivirusna aktivnost vrh med 5 in 15 urami po odmerku in upada z razpolovnim časom približno 10 ur.
English: The small rectangular window area will disappear.
Slovenian: Predel z majhnim štirioglatim okencem bo izginil.
English: The unused portion of Avonex must not be used.
Slovenian: Neuporabljenega odmerka zdravila Avonex ne smete znova uporabiti.
English: This includes any medicines obtained without a prescription.
Slovenian: To vključuje tudi zdravila, ki ste jih dobili brez recepta.
English: Laboratory abnormalities are associated with the use of interferons.
Slovenian: Laboratorijske motnje so povezane z uporabo interferonov.
English: Try to use Avonex at the same time on the same day each week.
Slovenian: Poskusite uporabljati zdravilo Avonex ob istem času in na isti dan v tednu.
English: • Check the injector shield is fully extended.
Slovenian: • Preverite, ali je zaščita injektorja povsem razširjena.
English: ┼ Class label for interferon products, see below Pulmonary arterial hypertension.
Slovenian: ┼ Označevanje razreda zdravil, ki vsebujejo interferone - glejte Pljučna arterijska hipertenzija spodaj.
English: Tip: The needle cover will come off automatically during step 3, below.
Slovenian: Nasvet: Pokrovček igle se samodejno sname v 3. koraku,
English: Your doctor will advise you for how long you can use Avonex or when to stop.
Slovenian: Zdravnik vam bo svetoval, kako dolgo lahko uporabljate zdravilo Avonex in kdaj naj prenehate.
English: Tell your doctor you are using Avonex:
Slovenian: Povejte zdravniku, da uporabljate zdravilo Avonex:
English: • Apply pressure to the injection site for a few seconds.
Slovenian: • Še nekaj sekund pritiskajte na mesto injiciranja.
English: An alternative titration schedule can be achieved by initiating therapy on approximately a ½ dose of AVONEX once a week before increasing to the full dose.
Slovenian: Alternativen načrt titriranja lahko dosežete tako, da zdravljenje začnete s približno ½ odmerka zdravila AVONEX enkrat na teden, preden dosežete polni odmerek.
English: Avonex is not to be used in children below the age of 12 years.
Slovenian: Zdravilo Avonex se ne sme uporabiti pri otrocih, starih manj kot 12 let.
English: If you get any of these: - Swelling of the face, lips or tongue - Difficulty breathing
Slovenian: Če se pojavi kar koli od naslednjega: - oteklost obraza, ustnic ali jezika,
English: This includes any other medicines including medicines obtained without a prescription.
Slovenian: To vključuje vsa zdravila, vključno s tistimi, ki ste jih dobili brez recepta.
English: This makes the injection more comfortable than using straight from the refrigerator.
Slovenian: Tako bo injiciranje bolj prijetno, kot če uporabite injekcijo, takoj ko jo vzamete iz hladilnika.
English: The safety and efficacy of AVONEX in children below 12 years of age have not yet been established.
Slovenian: Varnost in učinkovitost zdravila AVONEX pri otrocih, mlajših od 12 let, še nista bili dokazani.
English: This assay is limited in that it is sensitive for interferon but lacks specificity for interferon beta.
Slovenian: Omejitev te analize je, da je sicer občutljiva na interferon, vendar ne na specifičnost interferona beta.
English: Please check every time you get your prescription refilled to see if the leaflet has been updated.
Slovenian: Prosimo, da ob vsakem novem receptu preverite, ali je morda navodilo dopolnjeno.
English: Carcinogenesis: No carcinogenicity data for interferon beta-1a are available in animals or humans.
Slovenian: Karcinogeneza: o karcinogenosti interferona beta-1a pri ljudeh in živalih ni na voljo nobenih podatkov.
English: The active substance in Avonex is a protein called interferon beta-1a.
Slovenian: Učinkovina v zdravilu Avonex je protein, ki se imenuje interferon beta-1a.
English: • Use your other hand, and with one quick motion pull up the injector shield (grooved area) over the needle until the needle is fully covered.
Slovenian: • S hitrim gibom druge roke potegnite zaščito injektorja navzgor (zgiban predel) nad iglo, dokler ni igla povsem prekrita.
English: These interferons have overlapping but clearly distinguishable biological activities.
Slovenian: Čeprav se biološke aktivnosti teh interferonov prekrivajo, so med njimi jasne razlike.
English: - If you notice any irritation or skin problems after an injection, talk to your doctor.
Slovenian: - Če opazite draženje kože ali težave z njo po injiciranju, se posvetujte z zdravnikom.
English: • After 10 seconds pull the pen straight out to remove the needle from the injection site.
Slovenian: • Po 10 sekundah izvlecite napolnjen injekcijski peresnik naravnost ven, da potegnete iglo iz mesta injiciranja.
English: Tip: Take care not to press the blue activation button too early.
Slovenian: Nasvet: pazite, da ne boste prezgodaj pritisnili modrega sprožilnega gumba.
English: • Avonex is injected into a muscle, the best area is the upper, outer thigh muscle as shown in the diagram opposite.
Slovenian: • Zdravilo Avonex se injicira v mišico, pri čemer je najboljši predel zgornja, zunanja stegenska mišica, kot prikazuje nasprotni diagram.
English: AVONEX should be administered with caution to patients with a history of seizures, 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: Previdnost je potrebna pri dajanju zdravila AVONEX bolnikom z znano nagnjenostjo h krčem, kot tudi tistim, ki se zdravijo z antiepileptiki, še zlasti, če se njihove epilepsije z antiepileptiki ne da ustrezno obvladovati (glejte poglavji 4.5 in 4.8).
English: Make the injection Insert the injection needle with a quick dart-like thrust at right angles to the skin, into the muscle.
Slovenian: Vbodite injekcijsko igro s hitrim sunkom pod pravim kotom na kožo, v mišico.
English: Avonex works best when you use it: - at the same time - once a week - on a regular basis
Slovenian: Zdravilo Avonex deluje najbolje, če ga uporabljate: - vedno ob istem času, - enkrat tedensko, - redno.
English: Patients may develop antibodies to AVONEX.
Slovenian: Bolniki lahko razvijejo protitelesa za zdravilo AVONEX.
English: You will be provided with an Avostartclip titration kit.
Slovenian: Prejeli boste komplet za titriranje Avostartclip.
English: Cessation of therapy with AVONEX should be considered (see also sections 4.3 and 4.8).
Slovenian: Po potrebi tudi ukinite terapijo z zdravilom AVONEX (glejte poglavji 4.3 in 4.8).
English: It contains less than 23 mg (1 mmol) sodium in each weekly dose.
Slovenian: Vsak tedenski odmerek vsebuje manj kot 23 mg (1 mmol) natrija.
English: The antibodies of some of those patients reduce the activity of interferon beta-1a in vitro (neutralising antibodies).
Slovenian: Protitelesa pri nekaterih bolnikih zmanjšujejo aktivnost interferona beta-1a in vitro (nevtralizirajoča protitelesa).
English: If you have used more than one injection of Avonex in a three-day period, contact your doctor or pharmacist straight away for advice.
Slovenian: Če ste si injicirali več kot eno injekcijo zdravila Avonex v obdobju treh dni, se nemudoma posvetujte z zdravnikom ali farmacevtom.
English: Titration using the pre-filled syringe can be achieved by initiating therapy on ¼ dose increments per week reaching the full dose (30 micrograms/week) by the fourth week.
Slovenian: Titriranje z uporabo napolnjene injekcijske brizge dosežete z uvedbo zdravljenja z večanjem odmerka po ¼ na teden, dokler v četrtem tednu ne dosežete polnega odmerka (30 mikrogramov/teden).
English: Titrating AVONEX at the initiation of therapy has demonstrated a reduction in the severity and incidence of flu-like symptoms.
Slovenian: Titriranje zdravila AVONEX ob uvedbi zdravljenja je pokazalo zmanjšanje resnosti in incidence gripi podobnih simptomov.
English: This means less risk of irritation to your skin and muscle.
Slovenian: S tem se tveganje za draženje kože in mišice zmanjša.
English: If you need to, use an alcohol wipe to clean the skin at the injection site you've chosen.
Slovenian: Če morate, z alkoholno blazinico očistite kožo na izbranem mestu injiciranja.
English: These are the side effects that people reported when Avonex was being tested.
Slovenian: To so neželeni učinki, o katerih so poročali med testiranjem zdravila Avonex.
English: - Just after an injection, your muscles may feel tense or very weak - as though you are having a relapse.
Slovenian: - Takoj po injiciranju boste morda občutili napetost ali izjemno slabotnost v mišicah - kot da se je bolezen ponovila.
English: This is what causes the symptoms of MS. Avonex seems to work by stopping your body's defence system from attacking the myelin.
Slovenian: Kaže, da zdravilo Avonex deluje tako, da onemogoči obrambnemu sistemu vašega telesa, da bi napadel mielin.
English: Excipient(s) with known effect For the full list of excipients, see section 6.1.
Slovenian: Pomožna(e) snov(i) z znanim učinkom: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: With one hand, stretch the skin around the injection site.
Slovenian: Z eno roko napnite kožo okoli mesta injiciranja.
English: Make sure the cap is intact and has not been opened.
Slovenian: Preverite, da je pokrovček nepoškodovan in da ni bil odprt.
English: Patient-time is the sum of individual units of time that the patient in the study has been exposed to AVONEX before experiencing the adverse reaction.
Slovenian: Produkt števila bolnikov in časa je seštevek posameznih enot časa, ko je bil bolnik v študiji izpostavljen zdravilu AVONEX, preden je imel neželeni pojav.
English: Other medicines and AVONEX
Slovenian: Druga zdravila in zdravilo AVONEX
English: - Patients with a history of hypersensitivity to natural or recombinant interferon beta or to any excipients listed in section 6.1.
Slovenian: - Pri bolnikih, ki so že imeli preobčutljivostno reakcijo na naravni ali rekombinantni interferon-β ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: The syringe will not empty.
Slovenian: Injekcijska brizga se ne bo izpraznila.
English: Uncommon (≥1/1, 000 to <1/100 patient-years); Rare (≥1/10, 000 to <1/1,000 patient-years); Very rare (<1/10,000 patient-years);
Slovenian: Občasni (≥1/1.000 do <1/100 bolnikov-let); Redki (≥1/10.000 do <1/1.000 bolnikov-let); Zelo redki (<1/10.000 bolnikov-let);
English: Check the blister tray contains one pre-filled syringe and one injection needle (see picture “Contents of the plastic tray”).
Slovenian: Preverite, ali ovoj vsebuje eno napolnjeno injekcijsko brizgo in eno injekcijsko iglo (glejte sliko „Vsebina plastičnega ovoja“).
English: 3 Give the injection
Slovenian: 3 Dajte injekcijo.
English: Keep the skin stretched tightly or squeeze the skin around the injection site, and pull out the needle.
Slovenian: Izvlecite iglo Držite kožo tesno napeto ali pa kožo okoli mesta vboda stiskajte in izvlecite iglo.
English: This is a specially designed holder to help you with injecting Avonex.
Slovenian: To je posebej zasnovano držalo, ki vam bo v pomoč pri injiciranju zdravila Avonex.
English: Your doctor may want to check your blood pressure, blood (platelet count) and the function of your kidneys.
Slovenian: Zdravnik bo morda želel spremljati vaš krvni tlak, krvno sliko (število krvnih ploščic) in delovanje vaših ledvic.
English: - Feeling faint: Your first injection of Avonex may be given by your doctor.
Slovenian: - Občutek šibkosti: Prvo injekcijo zdravila Avonex vam mora injicirati zdravnik.
English: • Use a different injection site each week.
Slovenian: • Vsak teden uporabite drugo mesto injiciranja.
English: Tip: Do not press the blue activation button at the same time.
Slovenian: Nasvet: modrega sprožilnega gumba ne pritisnite sočasno.
English: AVONEX 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: Previdnost pri dajanju zdravila AVONEX je potrebna pri bolnikih s preteklimi ali trenutno prisotnimi depresivnimi motnjami, zlasti tistimi, ki so povezane s samomorilnimi nagnjenji (glejte poglavje 4.3).
English: Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with AVONEX should be considered.
Slovenian: Zdravljenje nefrotskega sindroma je potrebno hitro začeti in razmisliti je potrebno o prenehanju zdravljenja z zdravilom AVONEX.
English: It is for a single use only.
Slovenian: Primeren je samo za enkratno uporabo.
English: Side effects seen in clinical trials
Slovenian: Neželeni učinki, opaženi v kliničnih preskušanjih
English: Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Slovenian: Podatki kažejo, da interferoni zmanjšujejo aktivnost encimov, odvisnih od jetrnega citokroma P450, pri ljudeh in živalih.
English: Infections and infestations not known injection site abscess1
Slovenian: Infekcijske in parazitske bolezni neznana absces na mestu injiciranja1
English: If you use alcohol wipes, hold one on the injection site.
Slovenian: Če uporabljate alkoholno krpico, jo držite na mestu vboda.
English: Tell your doctor as they may be signs of a possible kidney problem.
Slovenian: To povejte zdravniku, saj so to lahko znaki težav z ledvicami.
English: The estimated risk of a second event was 50% in three years and 39% in two years in the placebo group and 35% (three years) and 21% (two years) in the AVONEX group.
Slovenian: Ocenjeno tveganje drugega dogodka je bilo 50 % v treh letih in 39 % v dveh letih za bolnike, zdravljene s placebom, in 35 % (tri leta) ter
English: If you have been told to gradually increase your dose of Avonex, you may need to use an Avostartclip titration kit provided by your doctor.
Slovenian: Če vam je bilo naročeno, da postopoma povečujete svoj odmerek zdravila Avonex, boste morda morali uporabiti komplet za titriranje Avostartclip, ki vam ga bo priskrbel zdravnik.
English: These include MHC Class I, Mx protein, 2' / 5'-oligoadenylate synthetase, β2-microglobulin, and neopterin.
Slovenian: I, protein Mx, 2' / 5' - oligoadenilat ligazo, β2 mikroglobulin in neopterin.
English: Where to inject
Slovenian: Kam injicirati
English: The instructions on how to inject yourself are at the end of this leaflet (see section 7, How to inject AVONEX).
Slovenian: Navodila za injiciranje zdravila so na koncu teh navodil (glejte poglavje 7, Kako injicirati zdravilo AVONEX).
English: Disability progression was measured as an increase in the Expanded Disability Status Scale (EDSS) of 1.0 point, sustained for at least six months.
Slovenian: Napredovanje prizadetosti se je merilo kot dvig na razširjeni lestvici prizadetosti (EDSS) za 1,0 točke.
English: 5 Check the liquid
Slovenian: 5 Preverite tekočino.
English: 10 seconds.
Slovenian: 1,0 točke.
English: Avonex and allergic reactions.
Slovenian: Zdravilo Avonex in alergijske reakcije.
English: Avonex can be used during breast-feeding.
Slovenian: Zdravilo Avonex se lahko uporablja med dojenjem.
English: • Firmly press the body of the pen down onto the skin to release the safety lock.
Slovenian: • Čvrsto pritisnite ohišje napolnjenega injekcijskega peresnika na kožo, da sprostite varnostno zaporo.
English: B. Preparing the injection
Slovenian: B. Priprava injekcije
English: Biogen Finland Oy
Slovenian: Suomi/Finland Biogen Finland Oy
English: - Blood clots in the small blood vessels that can affect your kidneys (thrombotic thrombocytopenic purpura or haemolytic uremic syndrome).
Slovenian: - Krvni strdki v majhnih krvnih žilah, ki lahko vplivajo na delovanje ledvic (trombotična trombocitopenična purpura ali hemolitično-uremični sindrom).
English: Biogen GmbH
Slovenian: Deutschland Biogen GmbH
English: Your doctor will tell you how long you need to keep using Avonex.
Slovenian: Zdravnik vam bo povedal, kako dolgo morate uporabljati zdravilo Avonex.
English: As you keep using your injections, the flu-like symptoms gradually decrease.
Slovenian: Z nadaljevanjem uporabe injekcij postajajo gripi podobni simptomi postopoma blažji.
English: If you have a preferred day for using Avonex, talk to your doctor about managing the dose, to get back to your preferred day.
Slovenian: Če imate dan, na katerega najraje uporabljate zdravilo Avonex, se z zdravnikom pogovorite o načinu odmerjanja, ki bi omogočil vrnitev na dan, ki ste si ga določili.
English: Flu-like symptoms associated with AVONEX therapy may prove stressful to patients with underlying cardiac conditions.
Slovenian: Gripi podobni simptomi, ki so povezani z zdravljenjem z zdravilom AVONEX, so lahko stresni za bolnike s srčnimi boleznimi.
English: The injection site should be varied each week.
Slovenian: Mesto injiciranje je potrebno zamenjati vsak teden.
English: Flu-like symptoms tend to be most prominent at the initiation of therapy and decrease in frequency with continued treatment.
Slovenian: Gripi podobni simptomi so običajno najbolj izraženi na začetku zdravljenja, z nadaljnjim zdravljenjem pa njihova pogostnost upada.
English: Psychiatric disorders common not known depression (see section 4.4), insomnia suicide, psychosis, anxiety, confusion, emotional lability
Slovenian: Psihiatrične motnje pogosti neznana depresija (glejte poglavje 4.4), nespečnost samomor, psihoza, anksioznost, zmedenost,
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: The right hand pages have the information you will need to use Avonex Pen properly.
Slovenian: Strani na desni strani vsebujejo informacije, ki jih boste potrebovali za pravilno uporabo svojega napolnjenega injekcijskega peresnika Avonex Pen.
English: • Continue to hold the pen on your skin and count slowly for a full
Slovenian: • Še naprej držite napolnjen injekcijski peresnik na kožo in počasi štejte do polnih 10 sekund.
English: Endocrine disorders not known hypothyroidism, hyperthyroidism
Slovenian: Bolezni endokrinega sistema neznana hipotiroidizem, hipertiroidizem
English: The pharmacokinetic profile of AVONEX has been investigated indirectly with an assay that measures interferon antiviral activity.
Slovenian: Farmakokinetični profil zdravila AVONEX je bil preučen posredno, z analizo, ki je merila protivirusno aktivnost interferonov.
English: Your pack of Avonex already includes a needle for injection.
Slovenian: Vaš zavoj zdravila Avonex že vsebuje injekcijsko iglo.
English: This might happen several weeks to several years after starting Avonex.
Slovenian: To se lahko pojavi nekaj tednov do nekaj let po začetku zdravljenja z zdravilom Avonex.
English: Side effects seen in clinical trials.
Slovenian: Neželeni učinki, opaženi v kliničnih preskušanjih.
English: If you have problems handling the syringe, talk to your doctor about using a syringe grip.
Slovenian: Če imate težave pri rokovanju z injekcijsko brizgo, se pogovorite z zdravnikom glede uporabe ročaja za injekcijsko brizgo.
English: There are more details on how to inject using the Avonex Pen: In the fold-out section at the back of this leaflet.
Slovenian: Več podrobnosti o injiciranju z napolnjenim injekcijskim peresnikom Avonex Pen: v zloženem delu na hrbtni strani tega navodila.
English: Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravljenje naj se začne pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem te bolezni.
English: If you miss an injection
Slovenian: Če ste pozabili injicirati
English: Effects of the injection
Slovenian: Učinki injekcije
English: muscle spasticity, hypoesthesia neurological symptoms, syncope3, hypertonia, dizziness, paraesthesia, seizures, migraine
Slovenian: spastičnost mišic, hipestezija nevrološki simptomi, sinkopa3, hipertonija, omotica, parestezije, napadi, migrena
English: Make sure the windows of the pen are visible.
Slovenian: Prepričajte se, da so okna napolnjenega injekcijskega peresnika vidna.
English: Patients should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Slovenian: Bolnikom, ki se zdravijo, naročite, naj zdravnika takoj obvestijo o vseh morebitnih simptomih depresije in/ali samomorilnih mislih.
English: AVONEX is indicated for the treatment of
Slovenian: Zdravilo AVONEX je indicirano za zdravljenje
English: If you are new to Avonex, your doctor may advise you to gradually increase your dose so that you can adjust to the effects of Avonex before taking the full dose.
Slovenian: V kolikor še niste uporabljali zdravila Avonex, vam lahko zdravnik svetuje, da postopoma povečujete vaš odmerek, zato da se lahko, preden uporabite celotni odmerek, navadite na učinke zdravila Avonex.
English: Avonex is made by:
Slovenian: Zdravilo Avonex izdeluje:
English: Multiple sclerosis is linked to nerve (brain or spinal cord) damage.
Slovenian: Kako deluje zdravilo AVONEX Multipla skleroza je povezana s poškodbo živcev (možganski živci ali živci hrbtenjače).
English: Nephrotic Syndrome: Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon-beta products.
Slovenian: Nefrotski sindrom: Med zdravljenjem z zdravili, ki vsebujejo interferon beta, so poročali o primerih nefrotskega sindroma z različnimi osnovnimi nefropatijami, vključno s kolapsno fokalno segmentno glomerulosklerozo (FSGS, collapsing focal segmental glomerulosclerosis), boleznijo minimalnih sprememb (MCD, minimal change disease), membranoproliferativnim glomerulonefritisom (MPGN, membranoproliferative glomerulonephritis) in membransko glomerulopatijo (MGN, membranous glomerulopathy).
English: Each syringe is packed in a sealed plastic tray, which also contains one injection needle for intramuscular use.
Slovenian: Vsaka injekcijska brizga je zapakirana v zaprtem plastičnem ovoju, ki vsebuje tudi eno injekcijsko iglo za intramuskularno uporabo.
English: Transient episodes of hypertonia and/or severe muscular weakness that prevent voluntary movements may occur at any time during treatment.
Slovenian: napadi hipertonije in/ali hude mišične šibkosti, ki preprečujejo hotne gibe.