FrancophonIA/ELRC3.0 huggingface dataset:
English: At concentrations substantially higher (> 4,000-fold) than those observed in vivo, adefovir did not inhibit any of the following human CYP450 isoforms, CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4.
Slovenian: Pri koncentracijah občutno višjih (> 4.000 krat) kot tistih opaženih in vivo ni adefovir zaviral nobenega od naslednjih humanih CYP450 izoformov: CYP1A2, CYP2D6, CYP2C9, CYP2C19 in CYP3A4.
English: No clinically significant changes in renal function were observed.
Slovenian: Klinično pomembne spremembe ledvične funkcije niso bile opažene.
English: Paediatric population:
Slovenian: Pediatrični populacija:
English: Pharmacotherapeutic group: Nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF08.
Slovenian: Farmakoterapevtska skupina: zaviralci nukleozidne in nukleotidne reverzne transkriptaze, oznaka ATC: J05AF08.
English: See section 2 for more details.
Slovenian: Podrobnosti so v poglavju 2.
English: The available data do not appear to indicate any difference in pharmacokinetics with regard to race.
Slovenian: Podatki, ki so na voljo, ne kažejo nobenih razlik farmakokinetičnih lastnosti glede na raso.
English: • HBeAg positive and HBeAg negative chronic hepatitis B with compensated liver disease.
Slovenian: • HBeAg pozitivnim in HBeAg negativnim kroničnim hepatitisom B s kompenzirano boleznijo jeter.
English: In a long-term safety study of 125 HBeAg negative patients with compensated liver disease, the adverse event profile was overall unchanged after a median exposure of 226 weeks.
Slovenian: V dolgoročni študiji varnosti s 125 HBeAg negativnimi bolniki s kompenzirano boleznijo jeter je bil profil neželenih učinkov na splošno nespremenjen po mediani izpostavljenosti 226 tednov.
English: The recommended dosing frequency according to renal function must not be exceeded (see sections 4.4 and 5.2).
Slovenian: Priporočena pogostnost odmerjanja glede na ledvično funkcijo se ne sme prekoračiti (glejte poglavji 4.4 in 5.2).
English: • Kidney problems may lead to softening of the bones (which causes bone pain and sometimes leads to fractures) and muscle pain or weakness.
Slovenian: • težave z ledvicami lahko povzročijo mehčanje kosti (kar povzroči bolečine v kosteh in včasih zlom), bolečine v mišicah ali mišično oslabelost;
English: d. Paediatric population
Slovenian: d. Pediatrična populacija
English: Hepsera reduces the amount of the virus in your body, and has been shown to reduce liver damage.
Slovenian: Zdravilo Hepsera zmanjša količino virusa v vašem telesu in s tem zmanjša poškodbo jeter.
English: Asthenia c. Description of selected adverse reactions
Slovenian: astenija c. Opis izbranih neželenih učinkov
English: Nonetheless, there is a potential risk of selection of HIV strains resistant to adefovir with possible cross-resistance to other antiviral medicinal products.
Slovenian: Kljub temu pa obstaja potencialno tveganje, da se izbere HIV seve, ki so odporni proti adefovirju z možno navzkrižno odpornostjo na druga protivirusna zdravila.
English: • Also tests may show decreases in phosphate (common) or increases in creatinine (very common) in the blood.
Slovenian: • Preiskave lahko pokažejo tudi znižanje fosfatov (pogosto) ali zvišanje kreatinina (zelo pogosto)
English: Patients were all HBeAg positive and had median CD4 cell count of 441 cells/mm3 (no patient had CD4 count < 200 cells/mm3).
Slovenian: Vsi bolniki so bili pozitivni za HBeAg in so imeli srednje število celic CD4 441 celic/mm3 (pri nobenem bolniku število celic CD4 ni bilo < 200 celic/mm3).
English: These patients should be closely monitored for possible adverse reactions and to ensure efficacy is maintained.
Slovenian: Te bolnike je potrebno skrbno nadzorovati zaradi možnega pojava neželenih učinkov in da se zagotovi ohranitev učinkovitosti.
English: The proposed dose interval modification is based on extrapolation of limited data in patients with end stage renal disease (ESRD) and may not be optimal.
Slovenian: Predlagane spremembe intervalov med odmerki temeljijo na ekstrapolaciji manjšega števila podatkov pri bolnikih z ledvičnim obolenjem v končni fazi (ESRD, end stage renal disease) in morda niso optimalne.
English: The clinical significance of these findings as they relate to histological improvement is not known.
Slovenian: Klinična pomembnost teh odkritij, glede na histološko izboljšanje, ni poznana.
English: Improvements or stabilisation were seen in Child-Pugh-Turcotte score.
Slovenian: Izboljšanje ali stabilizacijo je prikazala lestvica po Child-Pugh-Turcotte.
English: These patients should be closely monitored for possible adverse reactions and to ensure efficacy is maintained (see sections 4.4 and 4.8).
Slovenian: Te bolnike je treba skrbno nadzorovati zaradi možnega pojava neželenih učinkov in zato da se zagotovi ohranitev učinkovitosti (glejte poglavji 4.4 in 4.8).
English: Overall, the safety profile of adefovir dipivoxil in children was consistent with the known safety profile in adult patients.
Slovenian: Varnostni profil dipivoksiladefovirata pri otrocih je bil na splošno podoben znanemu varnostnemu profilu pri odraslih bolnikih.
English: • your doctor should order blood tests every three months to check your medicine is keeping your chronic hepatitis B infection under control.
Slovenian: • mora zdravnik vsake tri mesece naročiti analizo krvi, da preveri, ali je z zdravilom nadzorovana kronična okužba z virusom hepatitisa B.
English: These patients should be followed closely.
Slovenian: Te bolnike je potrebno skrbno nadzorovati.
English: Treatment discontinuation may be considered as follows:
Slovenian: Prekinitev zdravljenja je potrebno presoditi v naslednjih primerih:
English: If viral rebound occurs, resistance testing should be performed.
Slovenian: Če se pojavi virusni povratni odziv, je treba opraviti testiranje za odpornost.
English: Do not store above 30ºC.
Slovenian: Shranjujte pri temperaturi do 30 °C.
English: The tablets are marked with “GILEAD” and “10” on one side and a stylised shape of a liver on the other side.
Slovenian: Na tabletah sta napisa “GILEAD” in “10” na eni strani ter stiliziran obris jeter na drugi.
English: No adverse effects on development were seen at systemic exposures approximately 12 times that achieved in humans at the therapeutic dose.
Slovenian: Nobenih neželenih učinkov za razvoj pa ni bilo opaženih pri približno 12 krat večji sistemski izpostavljenosti, kot je dosežena pri človeku s terapevtskimi odmerki.
English: Therefore, the standard recommended procedures for immunisation of infants should be followed to prevent neonatal acquisition of HBV.
Slovenian: Zato se morajo upoštevati običajna priporočila za imunizacijo dojenčka, da se s tem prepreči okužba novorojenčka s HBV.
English: Not known:
Slovenian: Neznana:
English: Diarrhoea, vomiting, abdominal pain, dyspepsia, nausea, flatulence
Slovenian: diareja, bruhanje, abdominalna bolečina, dispepsija, navzea, flatulenca
English: Other medicines and Hepsera
Slovenian: Druga zdravila in zdravilo Hepsera
English: Hepsera 10 mg tablets
Slovenian: Hepsera 10 mg tablete
English: Even though a pharmacokinetic interaction is unlikely given the two products are eliminated via different pathways, caution is recommended if both products are co-administered.
Slovenian: Čeprav je farmakokinetično medsebojno delovanje manj verjetno, ob upoštevanju tega, da se zdravili izločata prek različnih poti, se pri sočasnem jemanju priporoča previdnost.
English: Some patients have had symptoms or blood tests indicating that their hepatitis has worsened after stopping treatment with Hepsera.
Slovenian: Nekateri bolniki so imeli simptome oziroma rezultate analize krvi, ki so pokazali, da se je po prenehanju zdravljenja z zdravilom Hepsera hepatitis še poslabšal.
English: Improvement was defined as a reduction from baseline of two points or more in the Knodell necro-inflammatory score with no concurrent worsening in the Knodell fibrosis score.
Slovenian: Izboljšanje je bilo definirano kot zmanjšanje za dve ali več točk od začetne vrednosti po Knodellovi nekroinflamatorni lestvici brez sočasnega poslabšanja po Knodellovi fibrozni lestvici.
English: 90 (3 bottles of 30) tablets.
Slovenian: 90 (3 plastenke po 30) tabletami.
English: Hepsera does not reduce the risk of passing on HBV to others through sexual contact or blood contamination.
Slovenian: Zdravilo Hepsera ne zmanjšuje tveganja za prenos okužbe z virusom HBV s spolnimi odnosi ali kontaminacijo krvi.
English: There are only limited data on the safety and efficacy of this dosing interval adjustment guideline.
Slovenian: Podatki o varnosti in učinkovitosti teh smernic za prilagajanje intervalov med odmerki so omejeni.
English: In over two thirds of patients suppression of serum HBV DNA was associated with normalisation of ALT levels.
Slovenian: Pri več kot dveh tretjinah bolnikov je bila supresija serumske HBV DNA povezana z normalizacijo vrednosti ALT.
English: • foscarnet, cidofovir or tenofovir disoproxil fumarate, for viral infections
Slovenian: • foskarnet, cidofovir ali dizoproksiltenofovirat fumarat proti virusnim okužbam;
English: Do not store above 30ºC (86ºF).
Slovenian: Shranjujte pri temperaturi do 30 °C (86 °F).
English: In the event of these patients developing renal insufficiency, see above Renal function.
Slovenian: V primeru, da ti bolniki razvijejo ledvično insuficienco, glejte zgoraj pod Ledvična funkcija.
English: A four-hour period of haemodialysis removed approximately 35 % of the adefovir dose.
Slovenian: S štiri ure trajajočo hemodializo se je izločilo približno 35% odmerka adefovirja.
English: Absorption: The oral bioavailability of adefovir from 10 mg adefovir dipivoxil is 59 %.
Slovenian: Absorbcija: Oralna biološka razpoložljivost adefovirja iz 10 mg dipivoksiladefovirata je 59%.
English: Hepsera can be taken with or without food.
Slovenian: Zdravilo Hepsera se lahko jemlje s hrano ali brez nje.
English: Patients with creatinine clearance between 30 and 49 ml/min:
Slovenian: Bolniki z očistkom kreatinina od 30 do 49 ml/min:
English: Treatment with nucleoside analogues should be discontinued when rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/lactic acidosis of unknown aetiology occur.
Slovenian: Zdravljenje z analogi nukleozidov se mora prekiniti, če se pojavi hitro naraščujoč nivo vrednosti aminotransferaze, napredujoča hepatomegalija ali metabolična acidoza/laktacidoza neznane etiologije.
English: The clinical significance of these observed changes in HBV DNA has not been established.
Slovenian: Klinična pomembnost teh sprememb opaženih za HBV DNA ni ugotovljena.
English: Because of insufficient data on safety and efficacy, Hepsera should not be used in children under the age of 18 years (see Sections 4.2 and 5.1).
Slovenian: Ker so podatki o varnosti in učinkovitosti nezadostni, se zdravilo Hepsera se ne sme uporabljati pri otrocih, starih do 18 let (glejte poglavji 4.2 in 5.1).
English: If you stop taking Hepsera
Slovenian: Če ste prenehali jemati zdravilo Hepsera
English: Due to their limitations, the clinical data available do not allow to draw definitive conclusions on the benefit/risk ratio of the adefovir treatment in children with chronic hepatitis B (see section 4.2).
Slovenian: Zaradi omejenosti razpoložljivih kliničnih podatkov ni mogoče dokončno sklepati o razmerju koristi in tveganja zdravljenja z adefovirjem pri otrocih s kroničnim hepatitisom B (glejte poglavje 4.2).
English: • Lactic acidosis is a serious but very rare side effect of taking Hepsera.
Slovenian: • Laktacidoza je resen, vendar zelo redek neželeni učinek pri jemanju zdravila Hepsera.
English: The median (min-max) renal clearance of adefovir in subjects with normal renal function (Clcr > 80 ml/min) is 211 ml/min (172-316 ml/min), approximately twice calculated creatinine clearance (Cockroft-Gault method).
Slovenian: Mediani (min-max) ledvični očistek adefovirja pri osebah z normalno ledvično funkcijo (CLCR > 80 ml/min) je 211 ml/min (172-316 ml/min), kar je približno dvakratna vrednost očistka kreatinina (Cockroft-Gault metoda).
English: • compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis.
Slovenian: • kompenzirano boleznijo jeter z dokazom aktivne virusne replikacije, z vztrajno povišano vrednostjo serumske alanin-aminotransferaze (ALT) in histološkim dokazom aktivnega vnetja jeter in fibroze.
English: • Once you start taking Hepsera:
Slovenian: • Po začetku jemanja zdravila Hepsera:
English: In patients with decompensated liver disease, adefovir should always be used in combination with a second agent, without cross-resistance to adefovir, to reduce the risk of resistance and to achieve rapid viral suppression.
Slovenian: Pri bolnikih z dekompenzirano boleznijo jeter je treba adefovir vedno uporabiti v kombinaciji z drugo učinkovino, ki ni navzkrižno rezistentna za adefovir, za zmanjšanje tveganja rezistence in doseganje hitrega zavrtja virusa.
English: Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5.1).
Slovenian: O zdravljenju z zdravilom Hepsera razmislite šele, ko uporaba alternativnih protivirusnih učinkovin z višjo gensko pregrado za rezistenco ni na voljo ali ni ustrezna (glejte poglavje 5.1).
English: Elderly: No data are available to support a dose recommendation for patients over the age of 65 years (see section 4.4).
Slovenian: Starejši: Podatkov, na osnovi katerih bi lahko priporočili odmerke za bolnike starejše od 65 let, ni na voljo (glejte poglavje 4.4).
English: • Tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment.
Slovenian: • Takoj povejte zdravniku, če opazite nove ali nenavadne simptome ali poslabšanje simptomov, ki jih opazite po prenehanju zdravljenja.
English: Benign digestive symptoms, such as nausea, vomiting and abdominal pain, might be indicative of lactic acidosis development.
Slovenian: Benigni prebavni simptomi kot so navzea, bruhanje in abdominalna bolečina lahko nakazujejo razvoj laktacidoze.
English: • Tell your doctor at once if you could be allergic to adefovir, adefovir dipivoxil or any of the other ingredients of Hepsera.
Slovenian: • Takoj obvestite svojega zdravnika, če obstaja možnost, da ste alergični na adefovir, dipivoksiladefovirat ali katero koli sestavino zdravila Hepsera.
English: Each bottle contains 30 tablets, silica gel desiccant and fibre packing material.
Slovenian: Vsaka plastenka vsebuje 30 tablet, silikagelsko sušilo in vlaknast ovojni material.
English: However, based on the safety profile and mechanism of action, adefovir dipivoxil is expected to have no or negligible influence on these abilities.
Slovenian: Vendar se na podlagi varnostnega profila in mehanizmov delovanja pričakuje, da dipivoksiladefovirat nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: • Don't stop taking Hepsera without your doctor's advice.
Slovenian: • Zdravila Hepsera ne prenehajte jemati brez posveta z zdravnikom.
English: Contents of the pack and other information What Hepsera contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Hepsera
English: Renal toxicity is an important feature of the safety profile of adefovir dipivoxil in patients with decompensated liver disease.
Slovenian: Toksičnost za ledvice je pomembna lastnost varnostnega profila dipivoksiladefovirata pri bolnikih z dekompenzirano boleznijo jeter.
English: • vancomycin and aminoglycosides, used for bacterial infections
Slovenian: • vankomicin in aminoglikozidi, ki se uporabljajo proti bakterijskim okužbam;
English: Renal failure, abnormal renal function, hypophosphatemia
Slovenian: ledvična odpoved, nenormalna ledvična funkcija, hipofosfatemija
English: • The other ingredients are: pregelatinised starch, croscarmellose sodium, lactose monohydrate, talc and magnesium stearate.
Slovenian: • Druge sestavine zdravila so: predgelirani škrob, natrijev karmelozat, laktoza monohidrat, smukec in magnezijev stearat.
English: The MAH commits to ensure continuous assessment of cross-resistance of adefovir to established and new nucleos(t)ide analogues, and provide reviews of these assessments as new data becomes available.
Slovenian: Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo zagotavljal stalno ocenjevanje navzkrižne odpornosti adefovirja na uveljavljene in nove analoge nukleoz(t)idov ter predložil poročilo o teh ocenah, ko bodo na voljo novi podatki.
English: On the basis of the scientific conclusions for adefovir the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing adefovir is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za adefovir odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) adefovir, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Adefovir can be removed by haemodialysis; the median haemodialysis clearance of adefovir is 104 ml/min.
Slovenian: Adefovir se lahko odstrani s hemodializo; vrednost mediane hemodializnega očistka za adefovir je 104 ml/min.
English: Histological improvement was seen regardless of baseline demographic and hepatitis B characteristics, including prior interferon-alpha therapy.
Slovenian: Histološko izboljšanje so opazili ne glede na začetne demografske značilnosti in ne glede na začetne karakteristike hepatitisa B, vključujoč predhodno zdravljenje z interferonom α.
English: Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Zato bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: By the end of the study, 7 of 12 patients (58 %) with bridging fibrosis or cirrhosis at baseline, had an improved Ishak fibrosis score of ≥ 2 points.
Slovenian: Do konca študije je imelo 7 od 12 bolnikov (58%), ki so imeli na začetku premostitveno fibrozo ali cirozo, izboljšano fibrozno vrednost po Ishakovi lestvici za ≥ 2 točki.
English: On the basis of an algorithm defining possible proximal renal tubulopathy and/or Fanconi syndrome as confirmed abnormalities, 28 cases of proximal renal tubulopathy (including possible Fanconi syndrome) were retrieved in the clinical safety dataset.
Slovenian: Na osnovi algoritma, ki določa morebitno proksimalno ledvično tubulopatijo in/ali Fanconijev sindrom kot potrjeni abnormalnosti, je bilo v kliničnem nizu podatkov o varnosti zbranih 28 primerov proksimalne ledvične tubulopatije (vključno z morebitnim Fanconijevim sindromom).
English: In patients at risk for renal impairment, consideration should be given to more frequent monitoring of renal function.
Slovenian: Pri bolnikih s tveganjem za motnje v delovanju ledvic je treba razmisliti o pogostejšem spremljanju ledvične funkcije.
English: Each tablet contains 113 mg lactose monohydrate.
Slovenian: Ena tableta vsebuje 113 mg laktoze monohidrata.
English: Caution should be exercised when prescribing nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease.
Slovenian: Pri predpisovanju analogov nukleozidov kateremukoli bolniku (še posebej ženskam s prekomerno težo) s hepatomegalijo, hepatitisom ali drugimi znanimi faktorji tveganja za jetrne bolezni je potrebna previdnost.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije
English: For renal safety in patients pre- and post-transplantation with lamivudine-resistant HBV, see section 4.8.
Slovenian: Za varnost za ledvice pri bolnikih pred in po transplantaciji, z na lamivudin odpornim HBV, glejte poglavje 4.8.
English: Infection with the hepatitis B virus leads to damage to the liver.
Slovenian: Okužba z virusom hepatitisa B povzroča okvaro jeter.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
English: If you accidentally take too many Hepsera tablets, contact your doctor or nearest hospital immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Hepsera, kot bi smeli Če ste pomotoma zaužili preveč tablet zdravila Hepsera, nemudoma obvestite zdravnika ali najbližjo bolnišnico.
English: No patients became HBsAg- or HBeAg-negative during the study.
Slovenian: Med študijo noben bolnik ni postal negativen za HBsAg ali HBeAg.
English: • It is especially important to tell your doctor if you are taking or have recently taken any of the following medicines which may damage your kidneys, or interact with Hepsera:
Slovenian: Še zlasti pomembno je, da obvestite zdravnika, če jemljete ali ste pred kratkim jemali katero koli od naštetih zdravil, ki lahko poškodujejo ledvice ali medsebojno vplivajo z zdravilom Hepsera:
English: Clinically and statistically significant improvement in fibrosis was seen in the changes in Ishak scores from the start of adefovir dipivoxil treatment to the end of the study (week 240) (median change: Δ= -1).
Slovenian: Klinično in statistično pomembno izboljšanje fibroze je bilo opaženo pri spremembah na Ishakovi lestvici od začetka zdravljenja z dipivoksiladefoviratom do konca študije (240. teden) (mediana spremembe: Δ= -1).
English: It is recommended that mothers being treated with adefovir dipivoxil do not breast-feed their infants.
Slovenian: Priporoča se, da matere, zdravljenje z dipivoksiladefoviratom, otrok ne dojijo.
English: To differentiate between elevations in transaminases due to response to treatment and increases potentially related to lactic acidosis, physicians should ensure that changes in ALT are associated with improvements in other laboratory markers of chronic hepatitis B.
Slovenian: Da bi razlikovali med zvišanjem vrednosti transaminaz zaradi odziva na zdravljenje in zvišanjem zaradi potencialne povezanosti z laktacidozo, bi morali zdravniki preveriti, če so spremembe vrednosti ALT združene z izboljšanjem drugih laboratorijskih označevalcev kroničnega hepatitisa B.
English: Co-infection with hepatitis C or D: There are no data on the efficacy of adefovir dipivoxil in patients co-infected with hepatitis C or hepatitis D.
Slovenian: Sočasna okužba z hepatitisom C ali D: Ni podatkov o učinkovitosti dipivoksiladefovirata pri bolnikih sočasno okuženih s hepatitisom C ali hepatitisom D.
English: Nephrotoxicity was observed in animals at systemic exposures at least 3-10 times higher than those achieved in humans at the recommended therapeutic dose of 10 mg/day.
Slovenian: Nefrotoksičnost je bila opažena pri živalih pri sistemski izpostavljenosti, ki je bila najmanj 3 do 10 krat višja od dosežene izpostavljenosti pri človeku ob priporočenem terapevtskem odmerku 10 mg na dan.
English: As far as possible, treatment of hepatitis B by adefovir dipivoxil in an HIV co-infected patient should be reserved for patients whose HIV RNA is controlled.
Slovenian: Kolikor je mogoče, naj bi bilo zdravljenje hepatitisa B z dipivoksiladefoviratom pri bolnikih sočasno okuženih s HIV omejeno na bolnike s kontrolirano vrednostjo HIV RNA.
English: • If you do miss a dose of Hepsera, take it as soon as you can, and then take your next scheduled dose at its regular time.
Slovenian: • Če pozabite vzeti odmerek zdravila Hepsera, ga vzemite čim prej in nadaljujte po običajnem urniku odmerjanja.
English: If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.
Slovenian: V primeru prevelikega odmerka je potrebno pri bolniku nadzorovati znake toksičnosti in mu nuditi standardno podporno zdravljenje.