FrancophonIA/ELRC3.0 huggingface dataset:
English: Pack sizes of 1 and/or 30.
Slovenian: Velikosti pakiranj po 1 in/ali30.
English: All patients with these tumours should be carefully monitored in order to avoid any eventual progression in tumour size under treatment.
Slovenian: Vse bolnike s takšnimi tumorji je treba skrbno spremljati, da bi se izognili morebitnemu večanju tumorja med zdravljenjem.
English: Pfizer Health AB Mariefredsvagen 37 645 41 Strängnäs Sweden
Slovenian: Pfizer Health AB Mariefredsvagen 37 645 41 Strängnäs Švedska
English: I can see some air in the syringe.
Slovenian: V injekcijski brizgi vidim nekaj zraka.
English: Clinical data are too limited (one reported case) to draw any conclusion on the excretion of pegvisomant in human breast milk.
Slovenian: Klinični podatki so preveč omejeni (en sam poročan primer), da bi na njihovi podlagi sklepali o izločanju pegvisomanta v materino mleko pri človeku.
English: Upon re-administration, symptoms did not re-occur in all patients.
Slovenian: Pri ponovni uporabi do vnovičnega pojava simptomov ni prišlo pri vseh bolnikih.
English: Treatment by pegvisomant does not reduce tumour size.
Slovenian: Zdravljenje s pegvisomantom ne zmanjša velikosti tumorjev.
English: The therapeutic benefits of a reduction in IGF-I concentration which results in improvement of the patient's clinical condition could potentially increase fertility in female patients.
Slovenian: Terapevtsko ugodno zmanjšanje koncentracije IGF-I, ki izboljša klinično stanje bolnikov, lahko pri bolnicah morda zveča plodnost.
English: Serum IGF-1 monitoring
Slovenian: Spremljanje serumske koncentracije IGF-1
English: SOMAVERT is injected under the skin.
Slovenian: Zdravilo SOMAVERT se injicira pod kožo.
English: Elevated, but less than or equal to 3 times ULN
Slovenian: Zvečane, vendar manjše ali enake 3-kratniku ZMN
English: The powder may take a few minutes to dissolve fully, so continue swirling the vial gently until the liquid is completely clear.
Slovenian: Da se prašek povsem raztopi, lahko traja nekaj minut, zato nadaljujte z nežnim mešanjem viale, dokler ni tekočina povsem bistra.
English: The pharmacokinetics of pegvisomant are similar in normal healthy volunteers and acromegaly patients, although heavier individuals tend to have a higher total body clearance of pegvisomant than lighter individuals, and may thus require greater doses of pegvisomant.
Slovenian: Farmakokinetika pegvisomanta je pri normalnih zdravih prostovoljcih in bolnikih z akromegalijo podobna, vendar imajo težji posamezniki praviloma večji celotni telesni očistek pegvisomanta kot lažji, zato utegnejo potrebovati večje odmerke pegvisomanta.
English: The antibodies do not seem to stop this medicine from working.
Slovenian: Kaže, da protitelesa ne preprečujejo učinka tega zdravila.
English: This gives your skin and the area under your skin time to recover from one injection before it receives another one in the same place.
Slovenian: Tako si bosta lahko koža in predel pod njo po injekciji opomogla, preden boste na isto mesto dali drugo injekcijo.
English: • May treat with SOMAVERT; however, monitor LTs monthly for at least 1 year after initiation of therapy and then bi-annually for the next year.
Slovenian: • Lahko zdravite z zdravilom SOMAVERT, vendar je treba vsaj 1 leto po uvedbi zdravljenja mesečno spremljati jetrne teste ter nato dvakrat letno v naslednjem letu.
English: The mean extent of absorption of a subcutaneous dose was 57% relative to an intravenous dose.
Slovenian: Povprečni delež absorpcije subkutanega odmerka v primerjavi z intravenskim je 57 %.
English: It should be considered whether to continue treatment with somatostatin analogues.
Slovenian: Razmisliti je treba o nadaljevanju zdravljenja z analogi somatostatina.
English: The list below contains adverse reactions seen in clinical trials or that were spontaneously reported, classified by system organ class and frequency.
Slovenian: V spodnji preglednici so navedeni neželeni učinki, ki so bili zabeleženi v kliničnih preskušanjih ali so o njih poročali spontano; razvrščeni so po organskih sistemih in pogostnosti.
English: What should I do with the syringe if it has been dropped?
Slovenian: Kaj naj storim z injekcijsko brizgo, če mi je padla na tla?
English: In cases of overdose, administration of this medicine should be discontinued and not resumed until IGF-I levels return to within or above the normal range.
Slovenian: V primeru prevelikega odmerjanja je treba uporabo pegvisomanta prekiniti in se ga ne sme znova uporabiti, dokler se raven IGF-I ne vrne v ali nad normalno območje.
English: • If LTs normalize (regardless of whether an alternative cause of the liver dysfunction is discovered), consider cautious reinitiation of therapy with SOMAVERT, with frequent LT monitoring.
Slovenian: • Če se jetrni testi normalizirajo (ne glede na to, ali odkrijete drug vzrok motnje delovanja jeter), razmislite o previdni ponovni uvedbi zdravljenja z zdravilom SOMAVERT s pogostim spremljanjem jetrnih testov.
English: To avoid this, use a slightly different place for your injection each time, as described in Step 2 of the ‘instructions for preparing and giving an injection of Somavert' section of this leaflet.
Slovenian: Da bi to preprečili, zdravilo vsakič injicirajte nekoliko drugam, tako kot je opisano v 2. koraku poglavja "Navodila za pripravo in injiciranje zdravila Somavert" tega navodila.
English: Most injection site reactions characterised as localised erythemas and soreness, spontaneously resolved with local symptomatic treatment, while pegvisomant therapy continued.
Slovenian: Večina reakcij na mestu injiciranja, opisanih kot lokaliziran eritem in bolečina, je z lokalnim simptomatskim zdravljenjem spontano minila, medtem ko se je zdravljenje s pegvisomantom nadaljevalo.
English: In clinical studies, for patients treated with pegvisomant (n=550), the majority of adverse reactions to pegvisomant were of mild to moderate intensity, of limited duration and did not require discontinuation of treatment.
Slovenian: V kliničnih študijah je bila pri bolnikih, zdravljenih s pegvisomantom (n = 550), večina neželenih učinkov blagih do zmernih, omejenega trajanja in ni zahtevala prekinitve zdravljenja.
English: Abbreviations: ALT = alanine aminotransferase; AST = aspartate transaminase; LT = liver test; ULN = upper limit of normal.
Slovenian: Okrajšave: ALT = alanin-aminotransferaza; AST = aspartat-aminotransferaza; ZMN = zgornja meja normale.
English: However, monitor LTs weekly to determine if further increases occur (see below).
Slovenian: Vendar pa tedensko spremljajte jetrne teste glede nadaljnjih zvečanj (glejte spodaj).
English: • Allergic reaction after administration (fever, rash, pruritus and, in severe cases, difficulty to breathe, rapid swelling of skin, requiring urgent medical attention).
Slovenian: • alergijska reakcija po uporabi (vročina, izpuščaj, srbenje in v hudih primerih težave z dihanjem, hitro otekanje kože, zaradi katerih so potrebni nujni zdravstveni ukrepi);
English: It is important to keep using all your medicines as well as SOMAVERT unless you are told otherwise by your doctor, pharmacist or nurse.
Slovenian: Pomembno je, da še naprej jemljete vsa svoja zdravila in tudi zdravilo SOMAVERT, razen če vam zdravnik, farmacevt ali medicinska sestra naročijo drugače.
English: If you forget to give yourself an injection you should inject the next dose as soon as you remember and then continue to inject SOMAVERT as prescribed by your doctor.
Slovenian: Če si pozabite dati injekcijo, si naslednji odmerek injicirajte, čim se spomnite, potem pa z injiciranjem zdravila SOMAVERT nadaljujte tako, kot vam je predpisal zdravnik.
English: Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: Pharmacotherapeutic group: Other anterior pituitary lobe hormones and analogues, ATC code: H01AX01.
Slovenian: Farmakoterapevtska skupina: drugi hormoni prednjega režnja hipofize in sorodne učinkovine, oznaka ATC: H01AX01.
English: The most commonly reported adverse reactions occurring in  10% of patients with acromegaly treated with pegvisomant during the clinical trials were headache 25%, arthralgia 16% and diarrhoea
Slovenian: Najpogosteje opisani neželeni učinki, ki so se v kliničnih preskušanjih pojavili pri  10 % bolnikov z akromegalijo, zdravljenih s pegvisomantom, so bili glavobol (25 %), artralgija (16 %) in diareja
English: How can I tell if there is any foam in the vial?
Slovenian: Kako vem, da so v viali pene?
English: What SOMAVERT is and what it is used for
Slovenian: Kaj je zdravilo SOMAVERT in za kaj ga uporabljamo
English: Pegvisomant is slowly eliminated from serum, with mean estimates of half-life generally ranging from 74 to 172 hours following either single or multiple-doses.
Slovenian: Pegvisomant se iz seruma odstranjuje počasi; povprečne ocene razpolovnega časa na splošno so od 74 do 172 ur po posamičnem ali večkratnih odmerkih.
English: • The syringe and needle should NEVER be reused.
Slovenian: • Brizge in igle ne smete NIKOLI ponovno uporabiti.
English: • Determine if cholelithiasis or choledocholithiasis is present, particularly in patients with a history of prior therapy with somatostatin analogs.
Slovenian: • Ugotovite, ali je prisotna holelitiaza ali holedoholitiaza, še zlasti pri bolnikih, ki so se v preteklosti že zdravili z analogi somatostatina.
English: Do not spray the liquid directly onto the powder, as this creates foam.
Slovenian: Ne brizgajte tekočine neposredno na prašek, saj tako nastanejo pene.
English: • Rapid swelling of skin and underlying tissue and inner lining (mucosa) of organs
Slovenian: • hitro otekanje kože in podkožnega tkiva ter notranje obloge (sluznice) organov
English: Frequency Not Known (Cannot Be Estimated From Available Data)
Slovenian: Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
English: Do not use this medicine after the expiry date which is stated on the vial and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli.
English: This ensures that all air is removed from the syringe before you draw off the dose.
Slovenian: Tako boste zagotovo odstranili ves zrak iz brizge, preden izvlečete odmerek.
English: • If liver injury is confirmed, the drug should be discontinued.
Slovenian: • V primeru potrditve poškodbe jeter je treba zdravljenje z zdravilom prekiniti.
English: • Severe breathlessness (laryngospasm)
Slovenian: • huda zasoplost (laringospazem)
English: • Clean the injection area with the alcohol swab as instructed by your healthcare provider.
Slovenian: • Mesto injiciranja očistite z alkoholnim zložencem, kot vam je naročil zdravstveni delavec.
English: The pre-filled solvent syringe may be stored at room temperature.
Slovenian: Napolnjene injekcijske brizge lahko shranjujete pri sobni temperaturi.
English: Uncommon (≥1/1,000 to <
Slovenian: Občasni (≥ 1/1.000 in
English: A cohort of 38 acromegalic subjects has been followed in a long-term, open-label, dose-titration study for at least 12 consecutive months of daily dosing with pegvisomant (mean = 55 weeks).
Slovenian: Kohorto 38 preskušancev z akromegalijo so spremljali v dolgoročni, odprti študiji s titriranjem odmerka vsaj 12 zaporednih mesecev vsakodnevne uporabe pegvisomanta (povprečje = 55 tednov).
English: Do not inject a double dose to make up for forgotten individual doses.
Slovenian: Ne injicirajte dvojnega odmerka, če ste pozabili uporabiti prejšnjega.
English: • Continue swirling the liquid until all the powder has fully dissolved.
Slovenian: • Nadaljujte z mešanjem tekočine, dokler se ves prašek ne raztopi.
English: A single Somavert pack containing:
Slovenian: Eno pakiranje zdravila Somavert vsebuje:
English: • Clean the vial stopper with a fresh alcohol wipe, and leave it to dry completely.
Slovenian: • Očistite zamašek viale s svežim alkoholnim zložencem in pustite, da se posuši.
English: • Decreased platelets in the blood, increased or decreased white cells in the blood, tendency to bleed.
Slovenian: • zmanjšano število krvnih ploščic v krvi, zvečano ali zmanjšano število belih krvnih celic v krvi, nagnjenost h krvavitvam
English: • Only mix Somavert and the solvent when you are ready to inject your dose.
Slovenian: • Zdravilo Somavert in vehikel zmešajte šele, ko ste pripravljeni na injiciranje odmerka.
English: The excretion of pegvisomant in breast milk has not been studied in animals.
Slovenian: Izločanje pegvisomanta v materino mleko ni bilo preučeno na živalih.
English: • Do not treat with SOMAVERT until a comprehensive workup establishes the cause of the patient's liver dysfunction.
Slovenian: • Ne zdravite z zdravilom SOMAVERT, dokler s celostnim diagnostičnim pregledom ne ugotovite vzroka motnje delovanja jeter pri bolniku.
English: Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).The potential risk for humans is unknown.
Slovenian: Študij na živalih o učinkih na nosečnost, razvoj zarodka/ploda, porod ali poporodni razvoj ni dovolj (glejte poglavje 5.3).
English: In the one reported incident of acute overdose, where 80 mg/day was administered for 7 days, the patient experienced a slight increase in fatigue and dry mouth.
Slovenian: Opisan je en primer akutnega prevelikega odmerjanja pri uporabi 80 mg/dan 7 dni; bolnik je bil nekoliko bolj utrujen in je imel suha usta.
English: Statistically significant differences from placebo (p<0.05) were observed for improvements in the total signs and symptoms score for all dose groups compared to placebo.
Slovenian: V vseh odmernih skupinah so ugotovili statistično pomembno (p < 0,05) razliko izboljšanja celotne ocene simptomov in znakov v primerjavi s placebom.
English: If you forget to use SOMAVERT
Slovenian: Če ste pozabili uporabiti zdravilo SOMAVERT
English: * Excipient with known effect
Slovenian: Pomožna snov z znanim učinkom
English: 1/100 to <1/10
Slovenian:  1/100 in < 1/10
English: Growth hormone-secreting pituitary tumours may sometimes expand, causing serious complications (for example, visual field defects).
Slovenian: Hipofizni tumorji, ki izločajo rastni hormon, se včasih lahko zvečajo in povzročijo resne zaplete (npr. izpade v vidnem polju).
English: • Check that the plunger rod has not moved-if it has, then push it back all the way into the syringe.
Slovenian: • Preverite, da se bat ni premaknil - če se je, ga do konca potisnite nazaj v injekcijsko brizgo.
English: Bubbles or air gaps that float to the top of the liquid should be pushed back out into the vial.
Slovenian: Mehurčke ali zračne vrzeli, ki se dvigujejo na gladino, potisnite nazaj v vialo.
English: How to store SOMAVERT Contents of the pack and other information
Slovenian: Shranjevanje zdravila SOMAVERT Vsebina pakiranja in dodatne informacije
English: • Release the pinched skin and pull the needle straight out.
Slovenian: • Izpustite stisnjeno kožo in iglo izvlecite naravnost iz kože.
English: The injection must not be mixed in the same syringe or vial as any other medicine.
Slovenian: Zdravila se v isti brizgi ali viali ne sme mešati z nobenim drugim zdravilom.
English: • Tiny air bubbles in the liquid are normal and are safe to inject.
Slovenian: • Majhni zračni mehurčki v tekočini so običajni.
English: Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerated.
Slovenian: Zdravljenje odraslih bolnikov z akromegalijo, ki se na operacijo in/ali obsevanje niso ustrezno odzvali in pri katerih ustrezna farmakoterapija z analogi somatostatina ni normalizirala koncentracije IGF-I oz. takšne farmakoterapije niso prenašali.
English: Pegvisomant is not recommended during pregnancy (see section 4.6).
Slovenian: Pegvisomanta ni priporočljivo uporabljati med nosečnostjo (glejte poglavje
English: The injection can be self-administered or given by another person, for example your doctor or his/her assistant.
Slovenian: Injekcijo si lahko daste sami ali vam jo da kdo drug, npr. zdravnik ali medicinska sestra.
English: • Choose a different location within an area for each injection.
Slovenian: • Za vsako injiciranje izberite drugo mesto znotraj predela injiciranja.
English: Absorption of pegvisomant following subcutaneous administration is slow and prolonged, and peak serum pegvisomant concentrations are not generally attained until 33-77 hours after administration.
Slovenian: Absorpcija pegvisomanta po subkutani aplikaciji je počasna in podaljšana; največja koncentracija pegvisomanta v serumu je praviloma dosežena šele od 33 do 77 ur po uporabi.
English: What you need to know before you use SOMAVERT
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo SOMAVERT
English: Do not use any other liquid to mix with Somavert.
Slovenian: Za mešanje z zdravilom Somavert ne uporabljajte drugih tekočin.
English: Inhibition of growth hormone action with pegvisomant leads to decreased serum concentrations of insulin-like growth factor-I (IGF-I), as well as other growth hormone-responsive serum proteins such as free IGF-I, the acid-labile subunit of IGF-I (ALS), and insulin-like growth factor binding protein-3 (IGFBP-3).
Slovenian: Zavrtje delovanja rastnega hormona s pegvisomantom povzroči zmanjšanje koncentracije insulinu podobnega rastnega faktorja I (IGF-I) v serumu, pa tudi drugih serumskih beljakovin, odzivnih na rastni hormon, npr. prostega IGF-I, kislinsko labilne podenote IGF-I (ALS) in beljakovine 3, ki veže insulinu podobni rastni faktor (IGFBP-3).
English: However, monitor LTs monthly to determine if further increases occur.
Slovenian: Vendar pa mesečno spremljajte jetrne teste glede nadaljnjih zvečanj.
English: Is it OK to shake the vial if the powder is not dissolving?
Slovenian: Ali lahko vialo stresem, če se prašek ni raztopil?
English: • If necessary, use a clean cotton ball and press lightly on the injection area.
Slovenian: • Če je treba, uporabite čist kos vate in ga rahlo pritisnite na mesto injiciranja.
English: Dose-dependent, statistically significant reductions in mean IGF-I (p<0.0001), free IGF-I (p<0.05), IGFBP-3 (p<0.05) and ALS (p<0.05) were observed at all post-baseline visits in the pegvisomant treatment groups.
Slovenian: V skupini, ki je prejemala pegvisomant, so na vseh poizhodiščnih pregledih ugotavljali od odmerka odvisno, statistično pomembno zmanjšanje povprečnega IGF-I (p < 0,0001), prostega IGF-I (p < 0,05), IGFBP-3 (p < 0,05) in ALS (p < 0,05).
English: Choose injection area
Slovenian: Izberite mesto injiciranja
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Slovenian: Po pripravi: Za pogoje shranjevanja po pripravi zdravila glejte poglavje 6.3.
English: Other medicines and SOMAVERT
Slovenian: Druga zdravila in zdravilo SOMAVERT
English: • Protein in the urine, increased urine, kidney problems.
Slovenian: • beljakovine v urinu, večje izločanje urina, težave z ledvicami
English: The data from 145 patients in two long-term studies who received daily doses of 10, 15, or 20 mg, demonstrate pegvisomant mean serum concentrations (± SD) of approximately 8800 ± 6300, 13200 ± 8000 and 15600 ± 10300 ng/ml, respectively.
Slovenian: Podatki dveh dolgoročnih študij s skupno 145 bolniki, ki so prejemali dnevne odmerke 10, 15 ali 20 mg, kažejo naslednje povprečne koncentracije (± SD) pegvisomanta v serumu: približno 8.800 ± 6.300 ng/ml (10 mg), 13.200 ± 8.000 ng/ml (15 mg) in 15.600 ± 10.300 ng/ml (20 mg).
English: *produced in Escherichia coli cells by recombinant DNA technology.
Slovenian: *pridobljen s tehnologijo rekombinantne DNA iz bakterije Escherichia coli.
English: The study conducted with pegvisomant in diabetic patients treated either by insulin or by oral hypoglycaemic medicinal products revealed the risk of hypoglycaemia in this population.
Slovenian: Študija pegvisomanta pri diabetikih, zdravljenih z insulinom ali peroralnimi antidiabetiki, je pokazala veliko tveganje za hipoglikemijo v tej populaciji.
English: • Remove a single Somavert pack from the refrigerator and allow it to come to room temperature naturally in a safe place.
Slovenian: • Eno pakiranje zdravila Somavert vzemite iz hladilnika in pustite, da se na varnem mestu segreje na sobno temperaturo.
English: What SOMAVERT is and what it is used for What you need to know before you use SOMAVERT How to use SOMAVERT
Slovenian: Kaj je zdravilo SOMAVERT in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo SOMAVERT Kako uporabljati zdravilo SOMAVERT Možni neželeni učinki
English: • Immediately perform a comprehensive hepatic workup.
Slovenian: • Takoj opravite celosten diagnostični pregled jeter.
English: The mean total body systemic clearance of pegvisomant following multiple doses is estimated to be 28 ml/h for subcutaneous doses ranging from 10 to 20 mg/day.
Slovenian: Ocenjeni povprečni celotni telesni sistemski očistek pegvisomanta po večkratnem odmerjanju je 28 ml/uro pri subkutanih odmerkih od 10 do 20 mg/dan.
English: • Lack of interest, feeling confused, increased sex drive, panic attack, loss of memory, problems sleeping.
Slovenian: • pomanjkanje zanimanja, občutek zmedenosti, zvišan libido, napad panike, izguba spomina, težave s spanjem
English: • Pull the needle out of the vial.
Slovenian: • Iglo izvlecite iz viale.
English: - If you experience disturbed vision or headaches while using SOMAVERT you must contact your doctor immediately.
Slovenian: Če se vam med uporabo zdravila SOMAVERT pojavijo motnje vida ali glavoboli, se morate nemudomaposvetovati z zdravnikom.
English: Two weeks after stopping treatment, leukocytosis and moderate bleeding from injection and vein puncture sites was observed which were considered possibly related to pegvisomant.
Slovenian: Dva tedna po prekinitvi zdravljenja so opazili levkocitozo in zmerno krvavitev z injekcijskih in venepunkcijskih mest; ocenili so, da so te spremembe lahko povezane s pegvisomantom.
English: In the week following discontinuation of treatment the adverse reactions noted were: insomnia, increased fatigue, oedema peripheral, tremor, and weight gain.
Slovenian: V tednu po prekinitvi zdravljenja so zabeležili naslednje neželene učinke: nespečnost, večjo utrujenost, periferni edem, tremor in zvečanje telesne mase.
English: • Do not withdraw the needle yet.
Slovenian: • Igle še ne izvlecite.
English: • Increased fatty substances in the blood, increased appetite.
Slovenian: • zvišana raven maščob v krvi, povečan apetit
English: These substances decrease the action of GH and levels of IGF-I circulating in the blood.
Slovenian: Ta snov zmanjšuje delovanje rastnega hormona in raven IGF-I v krvnem obtoku.
English: Dose adjustments should be based on serum IGF-I levels.
Slovenian: Odmerek je treba prilagajati na podlagi vrednosti IGF-I v serumu.
English: Add liquid
Slovenian: Dodajte tekočino
English: The syringe and needle should never be reused.
Slovenian: Brizge in igle ne smete ponovno uporabiti.
English: • No-never shake the vial.
Slovenian: • Ne, viale nikoli ne stresajte.
English: • Do not use if: o the medicine is cloudy or hazy; o the medicine has any colour at all; o there are any particles or there is a layer of foam in the vial.
Slovenian: • Zdravila ne uporabljajte, če: o je motno ali megleno; o je obarvano; o so v njem delci ali je v viali plast pene.
English: You should not breast-feed while taking SOMAVERT unless your doctor has discussed this with you.
Slovenian: Med uporabo zdravila SOMAVERT ne smete dojiti, razen če ste se o tem posvetovali z zdravnikom.
English: At least 5 times ULN, or transaminase elevations at least 3 times ULN associated with any increase in serum TBIL (with or without signs/symptoms of hepatitis or other liver injury)
Slovenian: Vsaj 5-kratnik ZMN oz. zvečanja vrednosti transaminaz za vsaj 3-kratnik ZMN, povezana s kakršnimkoli povečanjem vrednosti TBIL v serumu (z znaki/simptomi hepatitisa ali druge poškodbe jeter ali brez njih)
English: • Flu-like illness, fatigue.
Slovenian: • gripi podobni simptomi, utrujenost