FrancophonIA/ELRC3.0 huggingface dataset:
English: Short courses of corticosteroids can be used in combination with TYSABRI.
Slovenian: Kratkoročno dajanje kortikosteroidov v kombinaciji z zdravilom TYSABRI je dovoljeno.
English: No data are available in MS patients regarding concomitant exposure with immunosuppressant medication.
Slovenian: bolnike ni podatkov v zvezi s sočasno izpostavljenostjo zdravilom, ki zavirajo imunski odziv.
English: Monitoring for development of IRIS, which has occurred within days to several weeks after plasma exchange in TYSABRI treated patients with PML, and appropriate treatment of the associated inflammation during recovery from PML should be undertaken (see the Physician Information and Management Guidelines for further information).
Slovenian: Pri bolnikih s PML, ki so se zdravili z zdravilom TYSABRI, je treba uvesti nadzor za razvoj IRIS (pojavi se v nekaj dneh do nekaj tednih po zamenjavi plazme) ter ustrezno zdravljenje s tem povezane vnetne reakcije v času okrevanja od PML (za nadaljnje informacije glejte Informacije za zdravnike in smernice za zdravljenje bolezni).
English: Progressive Multifocal Leukoencephalopathy (PML) Use of TYSABRI has been associated with an increased risk of PML, an opportunistic infection caused by JC virus, which may be fatal or result in severe disability.
Slovenian: Z jemanjem zdravila TYSABRI je povezano povečanje tveganja za PML, oportunistično okužbo, ki jo povzroča JCV, ki lahko povzroči smrt ali hudo prizadetost.
English: Patients and physicians should continue to follow the same monitoring protocol and be alert for any new signs or symptoms that may be suggestive of PML for approximately 6 months following discontinuation of TYSABRI.
Slovenian: Bolniki in zdravniki naj nadaljujejo s spremljanjem po istem protokolu in naj bodo še približno 6 mesecev po prekinitvi zdravljenja z zdravilom TYSABRI pozorni na morebiten pojav novih znakov ali simptomov, ki bi lahko kazali na PML.
English: In some instances, the reaction reoccurred when TYSABRI was reintroduced.
Slovenian: V nekaterih primerih so se težave pojavile pri ponovnem odmerjanju zdravila TYSABRI.
English: Short courses of steroids used to treat relapses were not associated with increased infections in clinical trials.
Slovenian: Pri kratkoročnem dajanju steroidov za zdravljenje recidivov ni bila ugotovljena povezava s povečanjem okužb pri kliničnih preskušanjih.
English: No studies on the effects on the ability to drive and use machines have been performed with TYSABRI.
Slovenian: Študij vpliva na sposobnost vožnje in upravljanja s stroji za zdravilo TYSABRI niso izvedli.
English: Mean number of T1-hypointense lesions
Slovenian: Povprečno število hipointenzivnih lezij T1
English: Natalizumab showed no effects on in vitro assays of α4-integrin-positive tumour line proliferation or cytotoxicity.
Slovenian: Natalizumab ni kazal učinkov v metodi in vitro α4-integrinpozitivne proliferacije ali citotoksičnosti tumorske linije.
English: o Description of MRI protocols for baseline, routine screening and in case of PML suspicion o Anti-JCV antibody testing, frequency of testing, interpretation of qualitative and quantitative results, seroprevalence of JCV-antibodies and seroconversion rate over time o Monitoring strategy after discontinuation of TYSABRI treatment o The need to inform patients about the benefits and risk of TYSABRI and provide them with:
Slovenian: o Testiranje za protitelesa proti JCV, pogostnost testiranja, interpretacija kvalitativnih in kvantitativnih rezultatov, stopnja seroprevalence protiteles proti JCV in serokonverzije glede na čas o Strategija spremljanja po prekinitvi zdravljenja z zdravilom TYSABRI o Zahtevo, da se bolnike obvesti o koristih in tveganjih zdravljenja z zdravilom TYSABRI in se jim da: kopijo obrazca za uvedbo zdravljenja opozorilno kartico za bolnike, vključno z osnovnim besedilom, s katerim soglaša
English: Physicians must discuss the benefits and risks of TYSABRI therapy with the patient and provide them with a Patient Alert Card.
Slovenian: Zdravnik se mora o koristih in tveganjih zdravljenja z zdravilom TYSABRI posvetovati z bolnikom in bolniku izročiti kartico s posebnimi opozorili.
English: Persistent anti-natalizumab antibodies (one positive test reproducible on retesting at least 6 weeks later) developed in approximately 6% of patients.
Slovenian: Pri približno 6 % bolnikov so se razvila obstojna proti-natalizumabna protitelesa (en pozitivni test, potrjen pri ponovnem testiranju vsaj 6 tednov kasneje).
English: • TYSABRI must not be mixed with other medicinal products or diluents.
Slovenian: • Zdravilo TYSABRI se ne sme mešati z drugimi zdravili ali topili.
English: TYSABRI contains the active substance (natalizumab).
Slovenian: Zdravilo TYSABRI vsebuje zdravilno učinkovino (natalizumab).
English: • Information about any registry or other monitoring system set up in the Member State and how to enter patients
Slovenian: o reakcijah na infuzijo o preobčutljivostnih reakcijah o nastajanju protiteles • Informacije o kakršnemkoli registru ali drugem nadzornem sistemu, ki je bil uveden v državi članici in o načinu vključevanja bolnikov.
English: Within 3 months prior to starting TYSABRI Annually during treatment with TYSABRI More frequent MRIs (e.g. on a 3 to 6 monthly basis) for patients at high risk for PML.
Slovenian: enkrat letno med zdravljenjem z zdravilom TYSABRI Pogostejša MRS (npr. vsake 3 do 6 mesecev) za bolnike z veliki tveganjem za PML.
English: • Information that atypical/opportunistic infections, in particular PML, may occur with TYSABRI and include: o That the risk of PML increases with increasing duration of treatment and that treatment beyond 24 months carries additional risk and other factors associated with an increased risk for the development of PML
Slovenian: • Informacijo, da se lahko pri uporabi zdravila TYSABRI pojavijo atipične/oportunistične okužbe, zlasti PML, vključno z: o Da tveganje PML narašča s trajanjem zdravljenja in da zdravljenje, ki traja dlje kot
English: Only body weight and the presence of anti-natalizumab antibodies were found to influence natalizumab disposition.
Slovenian: Ugotovili so, da na izločevanje natalizumaba vpliva le telesna masa in prisotnost proti-natalizumabnih protiteles.
English: Following the repeat intravenous administration of a 300 mg dose of natalizumab to MS patients, the mean maximum observed serum concentration was 110 ± 52 μg/ml.
Slovenian: Ugotovljena srednja najvišja koncentracija v serumu pri bolnikih z MS po ponavljajočem intravenskem dajanju 300 mg odmerka natalizumaba je bila 110 ± 52 μg/ml.
English: If PML or JCV GCN is suspected, further dosing must be suspended until PML has been excluded.
Slovenian: Pri sumu na progresivno multifokalno levkoencefalopatijo (PML) ali JCV GCN morate s terapijo prenehati, dokler se PML ne izključi.
English: The nature of the infections was generally similar in natalizumab- and placebo-treated patients.
Slovenian: Narava okužb bolnikov, zdravljenih z natalizumabom in tistih, zdravljenih s placebom, je bila na splošno podobna.
English: Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy) have a significantly higher risk of PML.
Slovenian: Pri bolnikih, ki imajo vse tri dejavnike tveganja za PML (tj. so pozitivni na protitelesa proti JCV in so se z zdravilom TYSABRI zdravili več kot 2 leti in so pred tem prejemali imunosupresive), je tveganje za PML značilno večje.
English: Symptoms can include; walking problems, numbness in the face, arms or legs, problems seeing things, tiredness, feeling off-balance or light headed, bladder and bowel problems, difficulty in thinking and concentrating, depression, acute or chronic pain, sexual problems, and stiffness and muscle spasms.
Slovenian: utrujenost, občutek neuravnoteženosti ali slabotnosti, težave z mehurjem ali črevesjem, težave z razmišljanjem in koncentracijo, depresijo, akutne ali kronične bolečine, težave s spolnostjo, otrdelost mišic in mišične krče.
English: In anti-JCV antibody positive TYSABRI treated patients who have not used prior immunosuppressants the level of anti-JCV antibody response (index) is associated with the level of risk for PML.
Slovenian: Pri bolnikih, zdravljenih z zdravilom TYSABRI, pozitivnih na protitelesa proti JCV, ki pred tem niso prejemali imunosupresivov, je raven odziva na protitelesa proti JCV (indeks) povezana z ravnijo tveganja za PML.
English: The symptoms of JCV GCN are similar to PML.
Slovenian: Simptomi JCV GCN so podobni kot pri PML.
English: If there are signs of treatment-related abnormalities these must return to normal before treatment with natalizumab is started.
Slovenian: Pri znakih bolezenskih sprememb, povezanih z zdravljenjem, se mora stanje bolnikov najprej vrniti na normalno raven pred zdravljenjem, preden se lahko daje natalizumab.
English: Progressive multifocal leukoencephalopathy (PML).
Slovenian: Progresivna multifokalna levkoencefalopatija (PML).
English: • Severe anaemia (decrease in your red blood cells which can make your skin pale and can make you feel breathless or lacking energy)
Slovenian: • neobičajne okužbe (tako imenovane »oportunistične okužbe«) • huda anemija (zmanjšanje števila rdečih krvnih celic, kar lahko povzroči bledo kožo in zasoplost ali pomanjkanje energije)
English: • The diluted medicinal product is to be used as soon as possible and within 8 hours of dilution.
Slovenian: • Raztopino uporabite takoj, ko je mogoče in najpozneje 8 ur po razredčitvi.
English: TYSABRI must not be mixed with other medicinal products or diluents.
Slovenian: Zdravila TYSABRI se ne sme mešati z drugimi zdravili ali topili.
English: Progressive Multifocal Leukoencephalopathy (PML)
Slovenian: Progresivna multifokalna levkoencefalopatija (PML)
English: • Physician information about TYSABRI
Slovenian: • Informacije o zdravilu TYSABRI za zdravnike
English: Hazard ratio for disability progression was 0.36 (95% CI: 0.17, 0.76) p = 0.008.
Slovenian: Razmerje nevarnosti za napredovanje prizadetosti je bilo 0,36 (95-% IZ: 0,17; 0,76) p = 0,008.
English: LIST OF EXCIPIENTS sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; sodium chloride; polysorbate 80 (E433) and water for injections.
Slovenian: Natrijev dihidrogenfosfat monohidrat; natrijev hidrogenfosfat heptahidrat; natrijev klorid; polisorbat 80 (E433) in voda za injekcije.
English: Continued therapy must be carefully reconsidered in patients who show no evidence of therapeutic benefit beyond 6 months
Slovenian: Nadaljevanje zdravljenja pri bolnikih, ki po 6 mesecih ne kažejo znakov izboljšanja, je treba skrbno pretehtati.
English: Readministration
Slovenian: Ponovna uporaba
English: Serious, life-threatening, and sometimes fatal cases have been reported in the postmarketing setting in multiple sclerosis patients receiving TYSABRI (see section 4.8).
Slovenian: V obdobju po začetku trženja so poročali o resnih, življenjsko nevarnih in včasih smrtnih primerih pri bolnikih z multiplo sklerozo, ki so se zdravili z zdravilom TYSABRI (glejte poglavje 4.8).
English: • The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 ml/minute.
Slovenian: • Razporejeno na 1 uro infundirajte približno 2 ml razredčene raztopine na minuto.
English: Your doctor can decide whether TYSABRI is not working properly for you by testing your blood and will stop TYSABRI, if necessary.
Slovenian: Zdravnik se lahko na podlagi rezultatov testiranja krvi odloči, ali zdravilo TYSABRI ne deluje pravilno, in po potrebi prekine zdravljenje z zdravilom TYSABRI.
English: MRI evaluations for T1-weighted gadolinium (Gd)-enhancing lesions and T2-hyperintense lesions were performed annually.
Slovenian: Ocene lezij s slikanjem z magnetno resonance, vidnih z gadolinijem in obteženih s T1, in hiperintenzivnih lezij T2, so se izvajale letno.
English: Patients with a treatment history of immunosuppressant medicinal products are at increased risk for PML.
Slovenian: Pri bolnikih z zgodovino zdravljenja z zaviralci imunskega odziva je tveganje PML večje.
English: If the diluted medicinal product is stored at 2°C - 8°C (do not freeze), allow the solution to warm to room temperature prior to infusion.
Slovenian: Raztopina, ki se hrani pri 2 °C - 8 °C (ne zamrzujte), se mora pred infundiranjem segreti na sobno temperaturo.
English: Patients who have experienced a hypersensitivity reaction must be permanently discontinued from treatment with TYSABRI.
Slovenian: Pri bolnikih, ki so doživeli preobčutljivostno reakcijo, je treba zdravljenje z zdravilom TYSABRI trajno prekiniti.
English: Patients can switch directly from beta interferon or glatiramer acetate to natalizumab providing there are no signs of relevant treatment-related abnormalities e.g. neutropenia.
Slovenian: Na voljo morajo biti viri za upravljanje s preobčutljivostnimi reakcijami in dostop do MRS. Bolniki lahko direktno preidejo iz interferona beta ali glatiramer acetata na natalizumab, če ne kažejo znakov pomembnih bolezenskih sprememb, povezanih z zdravljenjem, npr. nevtropenije.
English: • If you have been treated for more than 2 years and you have a lower level of JCV antibodies in your blood.
Slovenian: • nimate protiteles proti virusu JC v krvi ALI • če se zdravite dlje kot 2 leti in imate nižje ravni protiteles proti virusu JC v krvi.
English: • Swelling of your face, lips or tongue
Slovenian: • oteklina obraza, ustnic ali jezika • težave pri dihanju
English: Studies have not been conducted to examine the effects of renal or hepatic impairment.
Slovenian: Kliničnih študij, s katerimi bi raziskali učinke okvare ledvic ali jeter, niso izvedli.
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Navodila za uporabo:
English: • Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy),
Slovenian: To vključuje: • Bolnike, ki imajo vse tri dejavnike tveganja za PML (tj. so pozitivni na protitelesa proti JCV in so se z zdravilom TYSABRI zdravili več kot 2 leti in so pred tem prejemali imunosupresive),
English: • That TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.
Slovenian: • Opozorilo, da naj zdravljenje z zdravilom TYSABRI uvede in neprestano nadzoruje zdravnik specialist z izkušnjami v diagnosticiranju in zdravljenju nevroloških bolezni, v centrih s hitrim dostopom do MRS.
English: TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.
Slovenian: Zdravljenje z zdravilom TYSABRI mora uvesti in neprestano nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju nevroloških bolezni, v centrih s pravočasnim dostopom do MRS.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija pogosti
English: JC virus also causes JCV granule cell neuronopathy (GCN) which has been reported in patients treated with TYSABRI.
Slovenian: JCV nevropatijo zrnatih celic (JCV GCN, granule cell neuronopathy), o kateri so poročali pri bolnikih, zdravljenih z zdravilom TYSABRI.
English: If a patient develops PML the dosing of TYSABRI must be permanently discontinued.
Slovenian: Če bolnik razvije PML med jemanjem zdravila TYSABRI, je treba zdravljenje trajno prekiniti.
English: Name and address of the manufacturers responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije
English: If the diluted medicinal product is stored at 2˚C - 8˚C (do not freeze), allow the solution to warm to room temperature prior to infusion.
Slovenian: Raztopina, ki se hrani pri 2 ˚C - 8 ˚C (ne zamrzujte), se mora pred infundiranjem segreti na sobno temperaturo.
English: The efficacy of re-administration has not been established, for safety see section 4.4.
Slovenian: Napotke v zvezi z varnostjo najdete v poglavju 4.4.
English: Concurrent use of these agents with TYSABRI may increase the risk of infections, including opportunistic infections, and is contraindicated (see section 4.3).
Slovenian: Sočasno jemanje teh učinkovin z zdravilom TYSABRI lahko poveča tveganje okužb, vključno z oportunističnimi okužbami in je kontraindicirano
English: • Treatment discontinuation form
Slovenian: • Obrazec za prekinitev zdravljenja
English: All changes in haematological variables returned to pre-treatment values, usually within 16 weeks of last dose of the medicinal product and the changes were not associated with clinical symptoms.
Slovenian: Vse spremenjene vrednosti hematoloških spremenljivk so se vrnile na raven pred zdravljenjem, običajno
English: When diluted the solution for infusion contains approximately 2.6 mg/ml of natalizumab.
Slovenian: Razredčena raztopina za infundiranje vsebuje približno 2,6 mg/ml natalizumaba.
English: As such, natalizumab may act to suppress inflammatory activity present at the disease site, and inhibit further recruitment of immune cells into inflamed tissues.
Slovenian: Natalizumab lahko kot tak zavira vnetje na mestu bolezni in preprečuje nadaljnjo migracijo imunskih celic k vnetemu tkivu.
English: Rate ratio 0.32 CI95% 0.26 ; 0.40
Slovenian: Razmerje stopnje 0,32 IZ95 % 0,26 ; 0,40
English: Since patients who have received an initial short exposure to TYSABRI and then had an extended period without treatment are at a higher risk of developing anti-natalizumab antibodies and/or hypersensitivity upon redosing, the presence of antibodies should be evaluated and if these remain positive in a confirmatory test after at least 6 weeks, the patient should not receive further treatment with TYSABRI.
Slovenian: nato pa so za dalj časa prekinili zdravljenje, obstaja višje tveganje za razvoj protiteles proti natalizumabu in/ali preobčutljivostnih reakcij po ponovnem odmerjanju zdravila, je pri njih treba oceniti prisotnost protiteles in če potrditveni test po vsaj šestih tednih pokaže njihovo prisotnost, se bolnika ne sme več zdraviti z zdravilom TYSABRI.
English: No differences in incidence rates or the nature of malignancies between natalizumab- and placebo-treated patients were observed over 2 years of treatment.
Slovenian: Malignosti V času 2-letnega zdravljenja ni bilo razlik v incidenci in v naravi malignosti med bolniki zdravljenimi z natalizumabom in tistimi, ki so prejemali placebo.
English: • Immunosuppressant use prior to receiving TYSABRI.
Slovenian: • Uporaba imunosupresivov pred začetkom zdravljenja z zdravilom TYSABRI.
English: Do not use TYSABRI
Slovenian: Ne uporabljajte zdravila TYSABRI:
English: Sodium content in TYSABRI
Slovenian: Vsebnost natrija v zdravilu TYSABRI
English: • Visually inspect the diluted medicinal product for particles or discolouration prior to administration.
Slovenian: • Pred dajanjem vizualno preverite razredčeno raztopino glede delcev ali obarvanja.
English: You should discuss with your doctor whether you choose to breast-feed or to use TYSABRI.
Slovenian: Posvetujte se z zdravnikom, ali boste nehali dojiti ali uporabljati zdravilo TYSABRI.
English: Hazard ratio 0.46, CI95% 0.33; 0.64, p<0.001
Slovenian: Razmerje nevarnosti 0,46, IZ95 % 0,33; 0,64, p<0,001
English: Events reported more commonly with natalizumab than with placebo included dizziness, nausea, urticaria and rigors.
Slovenian: Dogodki, o katerih so v primerjavi z placebom pri natalizumabu pogosteje poročali, vključujejo omotičnost, slabost, urtikarijo in rigor.
English: Physicians should refer to the Physician Information and Management Guidelines for further information on managing the risk of PML in TYSABRI-treated patients.
Slovenian: Zdravniki naj za več informacij o upravljanju tveganja za PML pri bolnikih, zdravljenih z zdravilom TYSABRI, preberejo Informacije za zdravnike in smernice za zdravljenje bolezni.
English: However, observation over longer treatment periods is required before any effect of natalizumab on malignancies can be excluded.
Slovenian: Vendar pa je za izključitev vseh vplivov natalizumaba na malignosti potrebno daljše obdobje opazovanja.
English: Over the 2-year duration of the studies, 43.5% of patients treated with natalizumab reported adverse reactions (placebo: 39.6%).
Slovenian: 43,5 % bolnikov, zdravljenih z natalizumabom, poročalo o neželenih učinkih zdravila (placebo:
English: For the estimation of PML risk in the different patient subgroups, please refer to the Physician Information and Management Guidelines.
Slovenian: Za oceno tveganja za PML pri različnih podskupinah bolnikov glejte
English: If you miss your dose of TYSABRI
Slovenian: Če ste pozabili uporabiti zdravilo TYSABRI
English: The active substance is natalizumab.
Slovenian: Zdravilna učinkovina je natalizumab.
English: Hazard ratio 0.58, CI95% 0.43; 0.73, p<0.001
Slovenian: Razmerje nevarnosti 0,58, IZ95 % 0,43; 0,73, p<0,001
English: Efficacy as monotherapy has been evaluated in one randomised, double-blind, placebo-controlled study lasting 2 years (AFFIRM study) in relapsing-remitting MS patients who had experienced at least 1 clinical relapse during the year prior to entry and had a Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 5.
Slovenian: 2 leti trajajoči študiji (študija AFFIRM) bolnikov z recidivno remitentno MS, ki so imeli najmanj 1 leto pred vključitvijo vsaj en klinični recidiv in po lestvici prizadetosti EDSS (Kurtzke Expanded Disability Status Scale) med 0 in 5 točkami.Povprečna starost je bila 37 let, povprečno trajanje bolezni pa 5 let.
English: A case of cryptosporidium diarrhoea was reported in MS clinical trials.
Slovenian: Pri kliničnih preskušanjih v zvezi z MS so poročali o primeru diareje, povzročene s Cryptosporidiumom.
English: After dilution for use, this medicinal product contains 17.7 mmol (or 406 mg) sodium per dose.
Slovenian: Po redčenju za uporabo vsebuje zdravilo 17,7 mmol (ali 406 mg) natrija na odmerek.
English: Always use this medicine exactly as described in this leaflet or as your doctor has told you.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte napotke v tem navodilu ali navodila svojega zdravnika.
English: Specifically, natalizumab binds to the α4β1 integrin, blocking the interaction with its cognate receptor, vascular cell adhesion molecule-1 (VCAM-1), and ligands osteopontin, and an alternatively spliced domain of fibronectin, connecting segment-1 (CS-1).
Slovenian: adhezijsko molekulo-1 na žilnih celicah (VCAM-1) ter ligandi osteopontinom in fibronektinom oz. njegovo alternativno spojeno domeno t.i. spojnim segmentom-1 (CS-1).
English: In studies conducted in mice, growth and metastasis of melanoma and lymphoblastic leukaemia tumour cells was not increased by the administration of natalizumab.
Slovenian: Pri študijan na miših dajanje natalizumaba ni vplivalo na rast in zasevke celic tumorja melanoma in limfoblastne levkemije.
English: Diluted solution: After dilution, immediate use is recommended.
Slovenian: Priporoča se, da razredčeno raztopino takoj uporabite.
English: The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 ml/minute.
Slovenian: Razporejeno na 1 uro infundirajte približno 2 ml razredčene raztopine na minuto.
English: Patients should be monitored as appropriate for impaired liver function, and be instructed to contact their physician in case signs and symptoms suggestive of liver injury occur, such as jaundice and vomiting.
Slovenian: Bolnike je treba poučiti, da morajo takoj obvestiti svojega zdravnika, če se pojavijo znaki, ki kažejo na okvaro jeter, kot sta zlatenica ali bruhanje.
English: Spontaneous cases of serious liver injuries, increased liver enzymes, hyperbilirubinaemia have been reported during the post marketing phase (see section 4.4).
Slovenian: V obdobju trženja so poročali o primerih resnih okvar jeter, povišanih jetrnih encimih in hiperbilirubinemiji (glejte poglavje 4.4).