FrancophonIA/ELRC3.0 huggingface dataset:
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 Extavia.
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, ki so takoj prejeli zdravilo Extavia.
English: For relapsing-remitting multiple sclerosis, 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: To reconstitute and inject your medicine you will need to use an ExtaviPro 30G application kit (supplied separately to your medicine), which contains the following components and instructions on how to use them:
Slovenian: Za rekonstitucijo in injiciranje zdravila boste morali uporabiti komplet ExtaviPro 30G (dobite ga ločeno), ki vsebuje naslednje pripomočke in navodila za njihovo uporabo:
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 način samoinjiciranja, še zlasti, če se pojavijo reakcije na mestu injiciranja.
English: Experience with Extavia in patients with multiple sclerosis (MS) is limited, consequently those adverse events which occur very rarely may not yet have been observed.
Slovenian: Izkušnje z zdravilom Extavia so pri bolnikih z multiplo sklerozo (MS) pomanjkljive, zato je mogoče, da neželeni učinki, ki se pojavljajo zelo redko, še niso bili opaženi.
English: • Patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Slovenian: • bolnikov s sekundarno progresivno multiplo sklerozo, pri katerih je bolezen aktivna, kar se kaže z recidivi.
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 najresnejših učinkih so poročali pri bolnikih, ki so dobivali še druga zdravila ali so imeli bolezni, ki vplivajo na jetra (npr. zloraba alkohola, resne okužbe).
English: ► Stop using Extavia and tell your doctor immediately if any of these happens to you.
Slovenian: ► Takoj prenehajte uporabljati zdravilo Extavia in obvestite svojega zdravnika, če se vam zgodi karkoli od naštetega.
English: The recommended dose is every other day (once every two days), 1.0 ml of the prepared Extavia solution (see Annex “Self-injection procedure” in the second part of this leaflet) injected under the skin (subcutaneously).
Slovenian: Priporočeni odmerek je vsak drugi dan (enkrat na dva dni) 1,0 ml pripravljene raztopine zdravila Extavia (glejte prilogo "Postopek samoinjiciranja" v drugem delu tega Navodila za uporabo) injicirane pod kožo (subkutano).
English: Hypersensitivity to natural or recombinant interferon beta, human albumin or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na naravni ali rekombinantni interferon beta, humani albumin ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Patients with anaemia, thrombocytopenia or 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 ali levkopenijo (samo ali v kateri koli kombinaciji) bo morda potrebno pozornejše spremljanje celotne krvne slike, diferencialne krvne slike in števila trombocitov.
English: The powder is white to off-white in colour.
Slovenian: Prašek je bele do belkaste barve.
English: Between 43% and 55% of these patients converted to a stable antibody negative status (based on two consecutive negative titres) during the subsequent observational period of the trial concerned.
Slovenian: Od 43 % do 55 % teh bolnikov je med poznejšim opazovalnim obdobjem posameznega preskušanja prišlo do konverzije v stabilni antigensko negativni status (na osnovi dveh zaporednih negativnih titrov).
English: What you need to know before you use Extavia
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Extavia
English: Your doctor will closely monitor you during treatment.
Slovenian: Med zdravljenjem vas bo zdravnik pozorno nadziral.
English: Nephrotic syndrome, glomerulosclerosis (see section 4.4)* , #
Slovenian: Bolezni sečil nefrotski sindrom, glomeruloskleroza (glejte poglavje 4.4)*
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 napade ali relapse, med katerimi se simptomi znatno poslabšajo.
English: In general, treatment should be started at a low dose of 0.25 ml (62.5 microgram).
Slovenian: Na splošno je treba zdravljenje začeti z majhnim, 0,25-mililitrskim odmerkom (62,5 mikrograma).
English: If you become depressed while you are on Extavia, you may need special treatment and your doctor will closely monitor you and may also consider stopping your treatment.
Slovenian: Če postanete med jemanjem zdravila Extavia depresivni, vas bo morda treba posebej zdraviti, zdravnik pa vas bo pozorno nadziral ali pretehtal možnost prekinitve zdravljenja.
English: 7 - Discard the syringe in the disposal unit.
Slovenian: 7- Brizgo zavrzite v posodo za odstranjevanje.
English: There is no evidence of an effect of Extavia on the duration of relapses or on symptoms in between relapses, and no significant effect was seen on the progression of the disease in relapsing-remitting multiple sclerosis.
Slovenian: Ni dokazov, da bi zdravilo Extavia vplivalo na trajanje recidivov ali na simptome med recidivi, in opazili niso nobenega pomembnega vpliva na napredovanje bolezni pri recidivno-remitentni multipli sklerozi.
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 takšne produkte so izmerili v serumski in celični frakciji krvi bolnikov, zdravljenih z interferonom beta-1b.
English: A large amount of data (more than 1,000 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: Veliko število podatkov (več kot 1000 izidov nosečnosti) iz registra izpostavljenosti nosečnic interferonu beta, nacionalnih registrov in izkušenj uporabe po prihodu zdravila na trg ne kaže, da bi izpostavljenost zdravilu pred spočetjem oziroma v prvem trimesečju nosečnosti povečevala tveganje za pomembne prirojene nepravilnosti.
English: During the post-marketing period very rare reports have been received of temporary worsening of cardiac status at the start of Extavia therapy in patients with pre-existing significant cardiac disease.
Slovenian: V obdobju trženja so prejeli zelo redka poročila o prehodnem poslabšanju bolezni srca na začetku zdravljenja z zdravilom Extavia pri bolnikih z obstoječo boleznijo srca.
English: Other medicines and Extavia Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: The procedure for self-administration by the patient should be reviewed periodically, especially if injection site reactions have occurred.
Slovenian: Bolnikov postopek samoinjiciranja je treba redno kontrolirati, zlasti če so se pojavile reakcije na mestu aplikacije.
English: The risk for progression to CDMS within two years in patients with monofocal onset was 47% for placebo and 24% for Extavia, without gadolinium (Gd-) enhancement 41% and 20%, with less than 9 T2 lesions 39% and 18%.
Slovenian: Tveganje za napredovanje do CDMS v dveh letih pri bolnikih z monofokalnim začetkom je bilo pri placebu 47 % in 24 % pri zdravilu Extavia, brez ojačitve z gadolinijem (Gd) 41 % in 20 %, z manj kot 9 lezij T2 39 % in 18 %.
English: Patients with mild disease and those unable to walk were not studied.
Slovenian: Bolnikov z blago boleznijo in bolnikov, nezmožnih hoje, niso proučevali.
English: PART III: EXTAVIA Medication record
Slovenian: DEL III: Kartica o uporabi zdravila EXTAVIA
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 Extavia.
Slovenian: Pri bolnikih z obstoječimi pomembnimi srčnimi boleznimi, kot so kongestivna srčna odpoved, bolezen koronarnih arterij ali aritmija, je treba spremljati poslabšanje bolezni srca, zlasti pri začetku zdravljenja z zdravilom Extavia.
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 sta depresija in samomorilno razmišljanje med bolniki z multiplo sklerozo in v povezavi z uporabo interferona pogostejša.
English: Changes to liver function values occurred in patients treated with Extavia during clinical studies.
Slovenian: Spremembe vrednosti preiskav delovanja jeter so se pojavile pri bolnikih, ki so jih med kliničnimi študijami zdravili z zdravilom Extavia.
English: There have been no formal clinical trials undertaken in children or adolescents.
Slovenian: Formalnih kliničnih preskušanj pri otrocih in mladostnikih niso opravili.
English: Extavia should also be used with caution in patients who suffer from pre-existing cardiac disorders.
Slovenian: Zdravilo Extavia je treba uporabljati previdno pri bolnikih, ki imajo že obstoječe bolezni srca.
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 dolgotrajna bolezen, ki vpliva na osrednje živčevje (OŽ), še zlasti na delovanje možganov in hrbtenjače.
English: - Be consistent - use this medicine as described in section 3 of the leaflet, “How to use Extavia”.
Slovenian: - Bodite dosledni - to zdravilo uporabljajte, kot je opisano v poglavju 3.
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 rotirali mesta injiciranja, priporočamo, da si datum in mesto zapišete.
English: - severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs (pulmonary arterial hypertension), (frequency unknown).
Slovenian: - hudo zoženje krvnih žil v pljučih, katerega posledica je visok krvni tlak v žilah, po katerihkri teče iz srca v pljuča (pljučna arterijska hipertenzija), (pogostnost neznana).
English: In order to obtain adequate efficacy, a dose of 250 microgram (1.0 ml) every other day should be reached.
Slovenian: Za doseganje ustrezne učinkovitosti je treba doseči odmerek 250 mikrogramov (1,0 ml) vsak drugi dan.
English: Extavia prolonged the time to CDMS by 363 days, from 255 days in the placebo group to 618 days in the Extavia group (based on the 25th percentiles).
Slovenian: Zdravilo Extavia je podaljšalo čas do CDMS za 363 dni, od 255 pri bolnikih, ki so prejemali placebo, na 618 dni pri bolnikih, ki so prejemali zdravilo Extavia (na temelju 25. percentila).
English: What Extavia is and what it is used for What you need to know before you use Extavia How to use Extavia
Slovenian: Kaj je zdravilo Extavia in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Extavia Kako uporabljati zdravilo Extavia Možni neželeni učinki
English: In the different controlled clinical trials, between 23% and 41% of the patients developed serum interferon beta-1b neutralising activity confirmed by at least two consecutive positive titres.
Slovenian: V različnih nadzorovanih kliničnih preskušanjih se je pri 23 % do 41 % bolnikov pojavila nevtralizacijska aktivnost interferona beta-1b v serumu, ki so jo potrdili z vsaj dvema zaporednima pozitivnima titroma.
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: Priporočeno je redno spremljanje zgodnjih znakov oziroma simptomov, kot so edemi, proteinurija in zmanjšana ledvična funkcija, zlasti pri bolnikih s povečanim tveganjem za ledvične bolezni.
English: - severe loss of appetite leading to weight loss (anorexia), (rare).
Slovenian: - huda izguba apetita, ki povzroči zmanjšanje telesne mase (anoreksija) (redki).
English: When you use the solution, warm it up by holding the syringe or vial in your hands before injecting to avoid pain.
Slovenian: Ko želite raztopino uporabiti, jo segrejte tako, da brizgo ali vialo pred injiciranjem nekaj časa držite med dlanmi, da bi preprečili bolečino pri injiciranju.
English: However, the duration of exposure during the first trimester is uncertain, because data were collected when interferon beta use was contraindicated during pregnancy, and treatment was likely interrupted when the pregnancy was detected and/or confirmed.
Slovenian: Podatki o izpostavljenosti v prvem trimesečju nosečnosti so pri tem nezanesljivi, saj so podatke zbirali v času, ko je bila uporaba interferona beta v času nosečnosti kontraindicirana, tako da so zdravljenje večinoma prekinili, ko so odkrili in/ali potrdili nosečnost.
English: 250 microgram (8.0 million IU) per ml after reconstitution.
Slovenian: 250 mikrogramov (8,0 milijonov i.e.) na ml po rekonstituciji
English: Extavia can be used during breast-feeding.
Slovenian: Zdravilo Extavia se lahko uporablja med dojenjem.
English: The Extavia powder is provided in a 3-millilitre vial.
Slovenian: Prašek zdravila Extavia je na voljo v 3-mililitrski viali.
English: In the second trial of Extavia in secondary progressive multiple sclerosis, no delay in the time to disability progression was observed.
Slovenian: V drugi raziskavi zdravila Extavia pri sekundarno progresivni multipli sklerozi niso opazili odloga do napredovanja invalidnosti.
English: • Alcohol swabs
Slovenian: • alkoholne blazinice
English: 1 - Choose a site for the injection (refer to the section “Choosing an injection site” and the diagrams at the end of this leaflet) and make a note of it in your medication record.
Slovenian: 1 - Izberite mesto injiciranja (glejte poglavje “Izbira mesta injiciranja” in diagrame ob koncu tega navodila) in dogodek zabeležite v kartici uporabe zdravila.
English: Secondary progressive multiple sclerosis (SP-MS) Two controlled clinical trials were performed with Extavia involving a total of 1,657 patients with secondary progressive multiple sclerosis (baseline EDSS 3 to 6.5, i.e. patients were able to walk).
Slovenian: Sekundarno progresivna multipla skelroza (SPMS) Narejeni sta bili dve kontrolirani klinični raziskavi z zdravilom Extavia, ki sta skupaj zajeli 1.657 bolnikov s sekundarno progresivno multiplo sklerozo (izhodiščni EDSS 3 do 6,5, tj. bolniki so lahko hodili).
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 1 do 8.
English: Table 1 Adverse events and laboratory abnormalities with incidence rates ≥10% and the respective percentages under placebo; significantly associated side effects <10% based on reports from clinical trials
Slovenian: Preglednica 1 Neželeni učinki in nenormalni rezultati laboratorijskih preiskav s pogostnostjo ≥10 % in ustrezni odstotki pri placebu; statistično značilno povezani neželeni učinki <10 % na podlagi poročil iz kliničnih študij
English: If you forget to use Extavia
Slovenian: Če ste pozabili uporabiti zdravilo Extavia
English: The two studies showed inconsistent results for the primary endpoint time to confirmed progression, representing delay of disability progression:
Slovenian: Izsledki obeh raziskav niso konsistentni, kar zadeva primarno končno točko do potrjenega napredovanja, ki pomeni odlog napredovanja invalidnosti.
English: Extavia serum levels were followed in patients and volunteers by means of a bioassay that was not completely specific.
Slovenian: Koncentracijo zdravila Extavia v serumu so pri bolnikih in prostovoljcih spremljali z ne povsem specifičnim biološkim preizkusom.
English: It can be extensive and may involve muscle fascia as well as fat and therefore can result in scar formation.
Slovenian: Lahko je razširjena in lahko zajame mišično fascijo in maščobe, kar lahko povzroči nastanek brazgotin.
English: The dose should be increased at every fourth injection in four steps (0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml).
Slovenian: Odmerek je treba v štirih korakih povečati ob vsaki četrti injekciji (0,25 ml, 0,5 ml, 0,75 ml, 1,0 ml).
English: Push the plunger down slowly so that the liquid runs down the inside of the vial.
Slovenian: Bat brizge počasi potisnite navzdol, da steče tekočina navzdol po notranjosti viale.
English: Your doses will then be increased gradually to the full dose of 1.0 ml (250 microgram).
Slovenian: Odmerek vam bodo nato postopoma večali do končnega odmerka 1,0 ml (250 mikrogramov).
English: The following adverse event listings are based on reports from clinical trials (Table 1, adverse events and laboratory abnormalities) and from post-marketing surveillance (Table 2, frequencies - where known - 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)) of Extavia use.
Slovenian: Spodnja seznama neželenih učinkov temeljita na poročilih iz kliničnih raziskav (preglednica 1, neželeni učinki in nenormalni rezultati laboratorijskih preiskav) in iz nadzora v obdobju trženja zdravila Extavia (preglednica 2, pogostnosti, ki - kjer je to znano - temeljijo na združenih podatkih iz kliničnih študij (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: Suicide attempt (see also section 4.4), Emotional lability
Slovenian: Psihiatrične motnje stanje zmedenosti poskus samomora (glejte tudi poglavje 4.4), emocionalna labilnost
English: Any disease other than multiple sclerosis that could better explain signs and symptoms of the patient had to be excluded.
Slovenian: Izključena je morala biti kakršna koli bolezen, ki bi bolje ustrezala bolnikovim znakom in simptomom.
English: If the patient experiences any break in the skin, which may be associated with swelling or drainage of fluid from the injection site, the patient should be advised to consult with his/her physician before continuing injections with Extavia.
Slovenian: Če bolnik opazi poškodbo kože, ki je lahko povezana z otekanjem ali vlaženje na mestu injiciranja, mu je treba svetovati, da se pred nadaljevanjem injiciranja zdravila Extavia posvetuje z zdravnikom.
English: Carcinogenicity studies have not been performed.
Slovenian: Študije karcinogenosti ni bilo.
English: ► Stop injecting Extavia and talk to your doctor.
Slovenian: ► prenehajte z injiciranjem zdravila Extavia in se posvetujte z zdravnikom;
English: What Extavia is used for Extavia is for use in patients ► who have experienced for the first time symptoms which indicate a high risk of developing multiple sclerosis.
Slovenian: Zdravilo Extavia je namenjeno za uporabo pri bolnikih ► ki so prvič imeli simptome, ki predstavljajo veliko tveganje za razvoj multiple skleroze.
English: The best places for injections are where the skin is loose and soft, and away from joints, nerves and bones, for example the abdomen, arm, thigh or buttocks.
Slovenian: Najboljše mesto za injiciranje je predel, kjer je koža mlahava in mehka, proč od sklepov, živcev in kosti, na primer trebuh, roka, stegno ali zadnjica.
English: The reconstituted product should be inspected visually before use.
Slovenian: Pripravljeno zdravilo je treba pred uporabo pregledati.
English: Using Extavia 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 Extavia z drugimi zdravili, ki spreminjajo odziv imunskega sistema, ni priporočena; 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 obstoječo monoklonsko gamopatijo je povezana z razvojem sindroma sistemske kapilarne krvavitve s simptomi, podobnimim šoku in smrtnim izidom.
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 human in vivo studies.
Slovenian: Delovanje interferona beta-1b je omejeno na vrsto, zato najrelevantnejše informacije o farmakologiji interferona beta-1b izvirajo iz raziskav človeških celic v kulturah in iz in vivo študij pri ljudeh.
English: In patients receiving Extavia there was a reduction in the frequency (30%) and severity of clinical relapses and in the number of hospitalisations due to disease.
Slovenian: Bolniki, ki so dobivali zdravilo Extavia, so imeli redkejše (30 %) in manj hude klinične recidive in manj hospitalizacij zaradi bolezni.
English: Extavia 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 Extavia morate previdno uporabljati pri bolnikih s predhodnimi ali trenutnimi depresivnimi motnjami, zlasti pri tistih, ki so že imeli samomorilna razmišljanja (glejte poglavje 4.3).
English: Although no natural rubber latex is detected in the cap, the safe use of Extavia pre-filled syringe in latex-sensitive individuals has not been studied and there is therefore a potential risk for hypersensitivity reactions which cannot be completely ruled out.
Slovenian: V pokrovčku sicer niso našli samega naravnega lateksa, vendar varnosti uporabe napolnjene injekcijske brizge z zdravilom Extavia niso proučevali pri osebah, ki so preobčutljive na lateks, in tako obstaja možnost tveganja za preobčutljivostne reakcije, ki je ni mogoče povsem izključiti.
English: Patients treated with Extavia should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Slovenian: Bolnikom, ki dobivajo zdravilo Extavia, je treba naročiti, naj o morebitnih simptomih depresije ali samomorilnega razmišljanja nemudoma obvestijo zdravnika, ki je predpisal zdravilo.
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, se boste na prvi predel (npr. na desno stran trebuha) vrnili po 8 injekcijah (16 dneh).
English: - Extavia contains human albumin and therefore carries a potential risk for transmission of viral diseases.
Slovenian: - Zdravilo Extavia vsebuje humani albumin, zato obstaja morebitno tveganje za prenos virusnih bolezni.
English: After mixing Extavia, you should administer the injection immediately (if this medicine is not used immediately, see section 5 of the leaflet, “How to store Extavia”).
Slovenian: Ko zmešate zdravilo Extavia, ga morate nemudoma injicirati (če tega zdravila ne porabite takoj, glejte poglavje 5.
English: During Extavia treatment you are likely to experience injection site reactions.
Slovenian: Med zdravljenjem z zdravilom Extavia se bodo verjetno pojavile reakcije na mestu injiciranja.