FrancophonIA/ELRC3.0 huggingface dataset:
English: Injection site necrosis has been reported in patients using Extavia (see section 4.8).
Slovenian: Pri bolnikih, ki prejemajo zdravilo Extavia, so poročali o nekrozi na mestu injiciranja (glejte poglavje 4.8).
English: What Extavia contains The active substance is interferon beta-1b.
Slovenian: Kaj vsebuje zdravilo Extavia Učinkovina je interferon beta-1b.
English: ► Tell your doctor immediately: - if you get some or all of these symptoms: foamy urine, fatigue, swelling, particularly and the ankles and eyelids, and weight gain, as they may be signs of a possible kidney problem.
Slovenian: - če opazite vse navedene simptome ali nekatere izmed njih: penast urin, utrujenost, otekanje, zlasti gležnjev in očesnih vek, ter pridobivanje telesne mase, saj so to lahko znaki morebitnih težav z ledvicami.
English: Single clinical event suggestive of multiple sclerosis One controlled clinical trial with Extavia was performed in patients with a single clinical event and Magnetic Resonance Imaging (MRI) features suggestive of multiple sclerosis (at least two clinically silent lesions on the T2-weighted MRI).
Slovenian: Enkratni demielinizacijski dogodek, ki nakazuje multiplo sklerozo Pri bolnikih z enim samim kliničnim dogodkom in izvidi magnetno resonančnega slikanja (MRIMagnetic Resonance Imaging), ki kažejo na multiplo sklerozo (vsaj dve klinično tihi leziji na T2poudarjenem magnetnoresonančnem slikanju) so opravili kontrolirano klinično preskušanje.
English: ► Rare (may affect up to 1 in 1,000 people):
Slovenian: ► Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
English: Do not use Extavia - if you are allergic to natural or recombinant interferon beta, human albumin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Extavia - če ste alergični na naravni ali rekombinantni interferon beta, humani albumin ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate trenutno hudo depresijo, samomorilne misli ali oboje (glejte Opozorila in previdnostni ukrepi in poglavje 4.
English: Side effects reported on the marketed product (frequencies - where known - based on clinical trials):
Slovenian: Seznam 2: Neželeni učinki, o katerih so poročali v času uporabe trženega zdravila (znane pogostnosti temeljijo na podatkih iz kliničnih študij):
English: Patients with monofocal or multifocal onset of the disease were included (i.e. patients with clinical evidence of a single or at least two lesions, respectively, of the central nervous system).
Slovenian: Vključili so bolnike z monofokalnim (bolnike s kliničnimi znaki ene lezije osrednjega živčevja) in multifokalnim (bolnike s kliničnimi znaki vsaj dveh lezij osrednjega živčevja) začetkom bolezni.
English: One of the two studies demonstrated a statistically significant delay in the time to disability progression (Hazard Ratio = 0.69, 95% confidence interval (0.55, 0.86), p=0.0010, corresponding to a 31% risk reduction due to Extavia) and in the time to becoming wheelchair-bound (Hazard Ratio = 0.61, 95% confidence interval (0.44, 0.85), p=0.0036, corresponding to a 39% risk reduction due to Extavia) in patients who received Extavia.
Slovenian: Prva od njiju je pri bolnikih, ki so dobivali zdravilo Extavia, ugotovila statistično značilen odlog do napredovanja invalidnosti (razmerje tveganja = 0,69, 95 % interval zaupanja (0,55, 0,86), p=0,0010, kar ustreza 31 % zmanjšanju tveganja zaradi zdravila Extavia) in do priklenjenosti na voziček (razmerje tveganja = 0,61, 95 % interval zaupanja (0,44, 0,85), p=0,0036, kar ustreza 39 % zmanjšanju tveganja zaradi zdravila Extavia).
English: - serious allergic (anaphylactic) reactions, - the thyroid gland does not work properly(thyroid disorders), too much hormone is produced (hyperthyroidism), - inflammation of the pancreas (pancreatitis), see section 2 “Warnings and precautions”, - blood clots in the small blood vessels that can affect your kidneys (thrombotic thrombocytopenic purpura or haemolytic uraemic syndrome).
Slovenian: - resne alergijske (anafilaksijske) reakcije - nepravilno delovanje ščitnice (bolezni ščitnice) proizvaja se preveč hormona (hipertiroidizem) - vnetje trebušne slinavke (pankreatitis), glejte poglavje 2 Opozorila in previdnostni ukrepi - krvni strdki v majhnih krvnih žilah, ki lahko vplivajo na delovanje ledvic (trombotična trombocitopenična purpura ali hemolitično-uremični sindrom).
English: Cessation of therapy with Extavia should be considered (see also sections 4.3 and 4.8).
Slovenian: V poštev pride prekinitev zdravljenja z zdravilom Extavia (glejte tudi poglavji 4.3 in
English: Patients with single lesions may continue on Extavia provided the necrosis is not too extensive, as some patients have experienced healing of injection site necrosis whilst on Extavia.
Slovenian: Če nekroza ni preveč razširjena, lahko bolniki s posameznimi lezijami nadaljujejo zdravljenje z zdravilom Extavia, ker je pri nekaterih bolnikih med jemanjem zdravila Extavia prišlo do celjenja nekroze na mestu injiciranja.
English: RelapsingRemitting Multiple Sclerosis
Slovenian: recidivnoremitentna multipla skleroza
English: 8 - Holding the vial and adapter securely, screw the syringe fully onto the vial adapter.
Slovenian: 8 - Trdno držite vialo z adapterjem in brizgo do konca privijte na adapter.
English: It reduces the number of hospital stays due to the disease and prolongs the time without relapses.
Slovenian: Pokazali so, da zdravilo Extavia zmanjša pogostnost in resnost napadov, zmanjša število dni v bolnici zaradi bolezni in podaljša čas brez relapsa.
English: Work through each rotation cycle in turn.
Slovenian: Zaporedoma obdelajte cikel rotiranja.
English: Extavia 250 microgram/ml powder and solvent for solution for injection.
Slovenian: Extavia 250 mikrogramov/ml prašek in vehikel za raztopino za injiciranje
English: Stopping Extavia is not known to cause acute withdrawal symptoms.
Slovenian: Če nehate uporabljati zdravilo Extavia, ni pričakovati akutnih odtegnitvenih simptomov.
English: Solvent for reconstitution of Extavia 1.2 ml sodium chloride solution 5.4 mg/ml
Slovenian: Vehikel za rekonstitucijo zdravila Extavia 1,2 ml raztopine natrijevega klorida 5,4 mg/ml
English: Swirl the syringevial assembly gently until the powder is completely dissolved.
Slovenian: Nežno jo obračajte, dokler se prašek povsem ne raztopi.
English: Nervous system disorders Headache 
Slovenian: Bolezni živčevja glavobol 
English: - 3-month multipack containing 42 (3x14) vials with powder and 42 (3x14) pre-filled syringes with solvent - 3-month multipack containing 45 (3x15) vials with powder and 45 (3x15) pre-filled syringes with solvent - 3-month multipack containing 42 (3x14) vials with powder and 45 (3x15) pre-filled syringes with solvent
Slovenian: - 3-mesečno skupno pakiranje, ki vsebuje 42 (3x14) vial s praškom in 42 (3x14) napolnjenih injekcijskih brizg z vehiklom - 3-mesečno skupno pakiranje, ki vsebuje 45 (3x15) vial s praškom in 45 (3x15) napolnjenih injekcijskih brizg z vehiklom - 3-mesečno skupno pakiranje, ki vsebuje 42 (3x14) vial s praškom in 45 (3x15) napolnjenih injekcijskih brizg z vehiklom
English: - problems with your small blood vessels (capillaries) may develop when using medicines like Extavia (systemic capillary leak syndrome), (frequency unknown).
Slovenian: - pri uporabi zdravil, kakršno je zdravilo Extavia, lahko pride do težav z majhnimi krvnimi žilami (s kapilarami) (sistemski sindrom zvečane prepustnosti kapilar) (pogostnost neznana).
English: Symptoms include redness, swelling, change in skin colour, inflammation, pain, and hypersensitivity.
Slovenian: Simptomi vključujejo rdečico, otekanje, spremembo barve kože, vnetje, bolečino in preobčutljivost.
English: Events were reported at various time points including up to several years after starting treatment with interferon beta.
Slovenian: O dogodkih so poročali ob različnih časovnih točkah, tudi več let po začetku zdravljenja z interferonom beta.
English: - the number of platelets (which help the blood to clot) may fall (thrombocytopenia), - a certain type of blood fats (triglycerides) may increase (will show up in blood tests), see section 2 “Warnings and precautions”, - suicide attempts, - mood swings, - convulsion, - a specific liver enzyme (gamma GT) which is produced by your liver, may rise (this will show up in blood tests), - inflammation of the liver (hepatitis), - skin discolouration.
Slovenian: - lahko se zmanjša število trombocitov (ki pomagajo pri strjevanju krvi) (trombocitopenija) - lahko se zvišajo vrednosti določenih maščob v krvi (trigliceridov) (to pokažejo krvne preiskave), glejte poglavje 2 Opozorila in previdnostni ukrepi - poskusi samomora - nihanje razpoloženja - konvulzije - v krvi se lahko zveča vrednost specifičnega jetrnega encima (gama GT), ki nastaja v jetrih (to pokažejo krvne preiskave) - vnetje jeter (hepatitis) - obarvanje kože
English: Please refer to section 3 of the leaflet, “How to use Extavia”, for further details on how to use Extavia.
Slovenian: Kako uporabljati zdravilo Extavia v Navodilu za uporabo glede nadaljnjih podrobnosti o uporabi zdravila Extavia.
English: * The titration period may be adjusted if any significant adverse reaction occurs.
Slovenian: * Če se pojavijo resni neželeni učinki, se lahko obdobje titracije prilagodi.
English: After the placebo-controlled phase, patients entered a pre-planned follow-up phase with Extavia to evaluate the effects of immediate versus delayed start of Extavia treatment, comparing patients initially randomised to Extavia (“immediate treatment group”) or to placebo (“delayed treatment group”).
Slovenian: Med seboj so primerjali bolnike, ki so bili na začetku naključno razvrščeni na zdravilo Extavia (“skupina s takojšnjim zdravljenjem”) ali pa na placebo (“skupina z odloženim zdravljenjem”).
English: Adults and adolescents from 12-17 years of age The recommended dose of Extavia is 250 microgram (8.0 million IU), contained in 1 ml of the reconstituted solution (see section 6.6), to be injected subcutaneously every other day.
Slovenian: Priporočeni odmerek zdravila Extavia je 250 mikrogramov (8,0 milijonov i.e.), kolikor ga vsebuje 1 ml pripravljene raztopine (glejte poglavje 6.6), ki ga je treba injicirati subkutano vsak drugi dan.
English: After reconstitution immediate use is recommended.
Slovenian: Zdravilo je priporočljivo uporabiti takoj po pripravi.
English: - If you experience loss of appetite, tiredness, feeling sick (nausea), repeated vomiting, and especially if you notice widespread itching, yellowing of the skin or of the whites of the eyes, or easy bruising.
Slovenian: - če pride do izgube apetita, utrujenosti, občutka slabosti (navzee), ponavljajočega bruhanja in predvsem če opazite srbenje po vsem telesu, rumeno obarvanje kože in očesnih beločnic ter nagnjenost k podplutbam.
English: The solvent is a clear/colourless solution.
Slovenian: Vehikel je bistra/brezbarvna raztopina.
English: Thrombocytopenia Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome#
Slovenian: Bolezni krvi in limfatičnega sistema anemija trombocitopenija trombotična mikroangiopatija, vključno s trombotično trombocitopenično purpuro/hemolitičnouremičnim sindromom#
English: Solvent - clear/colourless solution.
Slovenian: Vehikel - bistra/brezbarvna raztopina.
English: In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests (e.g. aspartate aminotransferase serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase serum glutamate pyruvate transaminase (SGPT) and gamma glutamyltransferase), are recommended prior to initiation and at regular intervals following introduction of Extavia therapy, and then periodically thereafter in the absence of clinical symptoms.
Slovenian: Poleg laboratorijskih preiskav, ki se običajno uporabljajo pri spremljanju bolnikov z multiplo sklerozo, je pred začetkom zdravljenja z zdravilom Extavia, ob rednih presledkih med zdravljenjem ter, če ni kliničnih simptomov, občasno po zdravljenju, priporočljivo opraviti celotno krvno sliko, diferencialno krvno sliko levkocitov, število trombocitov in biokemične krvne preiskave, vključno s preizkusi delovanja jeter (npr. aspartat-aminotransferaza (AST), alanin-aminotransferaza (ALT), in -glutamiltransferaza).
English: 17 - Leave the needle cap on. You are now ready to manually inject yourself or to use the ExtaviPro 30G auto-injector for the administration of Extavia.
Slovenian: Sedaj ste pripravljeni, da si sami zdravilo injicirate klasično ali pa uporabite avtoinjektor ExtaviPro 30G.za injiciranje zdravila Extavia.
English: Abnormal vision Ear and labyrinth disorders Ear pain
Slovenian: Ušesne bolezni, vključno z motnjami labirinta bolečine v ušesu
English: This will give each injection site a chance to fully recover before receiving another injection.
Slovenian: Tako se bo mesto injiciranja povsem opomoglo, preden ga boste ponovno uporabili za injiciranje.
English: Metabolism and nutrition disorders Blood glucose decreased (<55 mg/dl)
Slovenian: Presnovne in prehranske motnje zmanjšana raven glukoze (<55 mg/dl) Psihiatrične motnje depresija tesnoba
English: Advice on which areas to choose is given in the first part of this Annex.
Slovenian: Nasvet o predelih, primerih za injiciranje, je v prvem delu Dodatka.
English: - if you have a severe liver disease (see “Warnings and precautions”, “Other medicines and Extavia” and section 4, “Possible side effects”).
Slovenian: Možni neželeni učinki); - če imate hudo bolezen jeter (glejte Opozorila in previdnostni ukrepi, Druga zdravila in zdravilo Extavia in poglavje 4.
English: Extavia 250 microgram (Placebo) n=292 (n=176)
Slovenian: Extavia mikrogramov (Placebo) n=292 (n=176)
English: - During treatment with Extavia, kidney problems that may reduce your kidney function, including scarring (glomerulosclerosis), may occur.
Slovenian: - Med zdravljenjem z zdravilom Extavia lahko pride do težav z ledvicami, ki lahko zmanjšajo delovanje ledvic, med drugim do brazgotinjenja (glomeruloskleroze).
English: Attach it to the vial by pushing down until the vial adapter penetrates and locks around the top of the vial.
Slovenian: Namestite ga na vialo in ga potisnite navzdol tako, da predre zamašek in se zaskoči okrog vrha viale.
English: 6 - Holding the edges securely, remove and discard the packaging ensuring the vial adapter remains on the vial.
Slovenian: 6 - Trdno primite robove ovojnine in jo odstranite, tako da adapter za vialo ostane na viali.
English: Extavia 250 microgram (Placebo) n=124 (n=123)
Slovenian: Extavia mikrogramov (placebo) n=124 (n=123)
English: Capillary leak syndrome in preexisting monoclonal gammopathy*
Slovenian: Bolezni imunskega sistema anafilaktične reakcije sindrom zvečane prepustnosti kapilar pri že prisotni monoklonski gamopatiji*
English: Middle right section of each area
Slovenian: Desna roka sredina noge
English: Extavia 250 microgram/ml powder and solvent for solution for injection interferon beta-1b
Slovenian: Extavia 250 mikrogramov/ml prašek in vehikel za raztopino za injiciranje interferon beta-1b
English: ► If you have only one sore injection site (lesion) and the tissue damage (necrosis) is not too extensive you may continue using Extavia.
Slovenian: ► lahko nadaljujete z jemanjem zdravila Extavia, če je poškodovano le eno mesto injiciranja (lezija) in poškodbe tkiva (nekroza) niso obsežne;
English: Symptoms can be redness, swelling, discolouration, inflammation, pain, hypersensitivity, tissue damage (necrosis).
Slovenian: Simptomi so lahko rdečica, otekanje, obarvanje, vnetje, bolečina, preobčutljivost, odmiranje tkiva (nekroza).
English: Extavia 250 microgram/ml powder for solution for injection interferon beta-1b
Slovenian: Extavia 250 mikrogramov/ml prašek za raztopino za injiciranje interferon beta-1b subkutana uporaba
English: Cardiac disorders Palpitation *
Slovenian: Srčne bolezni palpitacije *
English: This equals 250 microgram (8.0 million IU) interferon beta-1b.
Slovenian: To ustreza 250 mikrogramom (8,0 milijonom i.e.) interferona beta-1b.
English: Regular thyroid function tests are recommended in patients with a history of thyroid dysfunction or as clinically indicated.
Slovenian: Pri bolnikih z anamnezo motenega delovanja ščitnice so priporočljive redne preiskave delovanja ščitnice, kot je klinično indicirano.
English: 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: V času zdravljenja z interferonom beta so poročali o primerih nefrotskega sindroma z različnimi osnovnimi nefropatijami, med katerimi so kolapsna fokalna segmentna glomeruloskleroza, sindrom z minimalnimi spremembami, membranoproliferativni glomerulonefritis in membranska glomerulopatija.
English: 1 vial contains 300 microgram (9.6 million IU) interferon beta-1b.
Slovenian: 1 viala vsebuje 300 mikrogramov (9,6 milijonov i.e.) interferona beta-1b.
English: Blood and lymphatic system disorders Lymphocyte count decreased (<1500/mm³)
Slovenian: Bolezni krvi in limfatičnega sistema zmanjšano število limfocitov (<1500/mm³) zmanjšano absolutno število nevtrofilcev (<1500/mm³) zmanjšano število levkocitov (<3000/mm³) limfadenopatija
English: ► Injection site reactions.
Slovenian: ► Reakcije na mestu injiciranja.
English: - If you experience symptoms such as irregular heartbeat, swelling such as of the ankles or legs, or shortness of breath.
Slovenian: - če imate simptome, kot so nepravilnost srčnega utripa, otekanje gležnjev ali nog ali kratka sapa.
English: • Important tips to keep in mind
Slovenian: • Pomembni napotki
English: 3 - Clean the top of the vial with an alcohol swab, moving the swab in one direction only.
Slovenian: 3 - Z alkoholno blazinico očistite vrh viale.
English: If the patient has multiple lesions Extavia should be discontinued until healing has occurred.
Slovenian: Če ima bolnik več lezij, je treba zdravljenje z zdravilom Extavia do njihove zacelitve prekiniti.
English: Extavia 250 microgram (Placebo) n=360 (n=358)
Slovenian: Extavia mikrogramov (placebo) n=360 (n=358)
English: Dispose of the vial and the remaining unused portion of the solution into the disposal unit.
Slovenian: Vialo in raztopino, ki je ostala v njej, zavrzite v posodo za odpadke.
English: Storage after reconstitution
Slovenian: Shranjevanje rekonstituiranega zdravila
English: 11 - Examine the solution carefully.
Slovenian: 11 - Raztopino pozorno preglejte.
English: See section 2 “Warnings and precautions” and follow the instructions under “Rotating injection sites” in the Annex at the back of this leaflet.
Slovenian: Mesto injiciranja morate redno menjati (glejte poglavje 2 Opozorila in previdnostni ukrepi in upoštevajte navodila Menjavanje mest injiciranja v Dodatku na hrbtni strani tega navodila).
English: Giving many times the dose of Extavia recommended for the treatment of multiple sclerosis has not led to life-threatening situations.
Slovenian: Če ste uporabili večji odmerek zdravila Extavia, kot bi smeli Uporaba odmerka zdravila Extavia, ki je večkrat presegel odmerek priporočen za zdravljenje multiple skleroze, ni imela smrtno nevarnih posledic.
English: Respiratory, thoracic and mediastinal disorders Upper respiratory infection
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora okužbe zgornjih dihal sinuzitis stopnjevanje kašlja dispneja *
English: Extavia 250 microgram (Placebo) n=317 (n=308)
Slovenian: Extavia mikrogramov (placebo) n=317 (n=308)
English: Extavia must be used with caution, and your doctor will monitor you for worsening of your heart condition, particularly at the start of treatment.
Slovenian: Vaš zdravnik bo nadziral morebitno poslabšanje bolezni srca, še zlasti ob začetku zdravljenja.
English: As for other beta interferons, severe liver damage, including cases of liver failure, have been reported rarely in patients taking Extavia.
Slovenian: Kot pri drugih interferonih beta so pri bolnikih, ki so jemali zdravilo Extavia, opisali redke primere hude okvare jeter, vključno s primeri odpovedi jeter.
English: Table A Schedule for dose titration*
Slovenian: Preglednica A Razpored titriranja odmerka* dan zdravljenja odmerek prostornina
English: - painful periods (dysmenorrhoea), menstrual disorder, heavy uterine bleeding (metrorrhagia) especially between menstrual periods, impotence - injection site reaction (including redness, swelling, discolouration, inflammation, pain, allergic reaction, see section 2 “Warnings and precautions”), skin breakdown and tissue damage (necrosis) at injection site (see section 2 “Warnings and precautions”) - flu-like symptoms, fever, pain, chest pain, accumulation of fluid in arm, leg or face (peripheral oedema), lack/loss of strength (asthenia), chills, sweating, general feeling of being unwell.
Slovenian: - zvišane vrednosti jetrnih encimov v krvi (pokažejo krvne preiskave) - bolezni kože, izpuščaj - otrdelost mišic (hipertonija), bolečina v mišicah (mialgija), mišična šibkost (miastenija), bolečina v hrbtu, bolečine v okončinah, npr. v prstih na nogah in rokah - zastoj seča (retencija urina), beljakovine v seču (pokažejo urinske preiskave), pogosto mokrenje, nezmožnost zadrževanja urina (urinska inkontinenca), nuja na mokrenje - boleče mesečne krvavitve (dismenoreja), menstruacijske motnje, močne maternične krvavitve (metroragija), zlasti v vmesnem obdobju med dvema menstruacijama, impotenca - reakcije na mestu injiciranja (vključno z rdečico, otekanjem, obarvanjem, vnetjem, bolečino, alergijskimi reakcijami, glejte poglavje 2 Opozorila in previdnostni ukrepi), razpadanje kože in odmiranje tkiva (nekroza) na mestu injiciranja (glejte poglavje 2 Opozorila in previdnostni ukrepi) - gripi podobni simptomi, zvišana telesna temperatura, bolečine, bolečine v prsih, kopičenje tekočine v rokah, nogah ali obrazu (periferni edem), pomanjkanje/izguba moči (astenija), mrzlica, potenje, splošno slabo počutje
English: if you experience loss of appetite, tiredness, feeling sick (nausea), repeated vomiting, especially if you notice widespread itching, yellowing of the skin, or of the whites of the eyes or easy bruising.
Slovenian: - če izgubite apetit, ste utrujeni, vam je slabo (navzea), se pojavi ponavljajoče se bruhanje, predvsem, če opazite srbenje po vsem telesu, rumeno obarvanje kože in očesnih beločnic ter nagnjenost k podplutbam;
English: Injection site reactions occurred frequently after administration of Extavia.
Slovenian: Po uporabi zdravila Extavia pogosto pride do reakcij na mestu aplikacije.
English: It has been demonstrated in vitro that Extavia cross-reacts with natural interferon beta.
Slovenian: In vitro je dokazano, da zdravilo Extavia navzkrižno reagira z naravnim interferonom beta, vendar to ni raziskano in vivo; klinični pomen tega ni gotov.
English: 3-month multipack: 42 (3 packs of 14) vials with powder and 42 (3 packs of 14) pre-filled syringes with 1.2 ml solvent.
Slovenian: 3-mesečno skupno pakiranje: 42 (3 pakiranja po 14) vial s praškom in 42 (3 pakiranja po 14) napolnjenih injekcijskih brizg z 1,2 ml vehikla.
English: 13 - Turn the syringe-vial-assembly so that the vial is at the top.
Slovenian: 13 - Obrnite sestavo brizge in viale tako, da bo viala zgoraj.
English: Events were reported at various time points during treatment and may occur after several years of treatment with interferon beta.
Slovenian: O teh neželenih učinkih so poročali ob različnih časih v poteku zdravljenja, lahko se pojavijo tudi po več letih zdravljenja z interferonom beta.
English: Asymptomatic elevations of serum transaminases, in most cases mild and transient, occurred very commonly in patients treated with Extavia during clinical trials.
Slovenian: Med kliničnimi preskušanji so se pri bolnikih, ki so dobivali zdravilo Extavia, zelo pogosto pojavila asimptomatska zvišanja serumskih transaminaz, ki so bila večinoma blaga in prehodna.