FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the magnitude of the effect seems unlikely to result in clinically important drug-drug interactions.
Slovenian: Vendar glede na obseg tega učinka ni verjetno, da bi povzročil klinično pomembna medsebojna delovanja med zdravili.
English: Sources of variability within the BENCHMRK study may include differences in co-administration with food and concomitant medicines.
Slovenian: Razlogi za variabilnost v študiji BENCHMRK so lahko razlike v sočasnem jemanju s hrano in sočasno uporabljanimi zdravili.
English: It is important that you take DUTREBIS exactly as your doctor has instructed.
Slovenian: Pomembno je, da tablete DUTREBIS jemljete natanko tako, kot vam je naročil zdravnik.
English: Achieved ≥1 log10 HIV RNA drop from baseline or
Slovenian: Dosežen ≥ 1 log10 padec HIV RNA od izhodišča
English: • kidney stones; urination at night; kidney cyst
Slovenian: • ledvični kamni, uriniranje ponoči, ledvična cista
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Slovenian: Praviloma so takšne reakcije opažali v prvih nekaj tednih ali mesecih po začetku kombiniranega protiretrovirusnega zdravljenja.
English: Pack size: 1 bottle containing 60 tablets.
Slovenian: Velikost pakiranja: 1 plastenka s 60 tabletami.
English: Clinical examination should include evaluation for physical signs of fat redistribution.
Slovenian: Klinični pregled mora obsegati tudi iskanje telesnih znakov prerazporeditve maščevja.
English: NL-2031 BN Haarlem The Netherlands
Slovenian: NL-2031 BN Haarlem Nizozemska
English: zidovudine Cmax  28 % zidovudine AUC ↔
Slovenian: Cmax zidovudina  28 % AUC zidovudina ↔
English: Tell your doctor if you notice any of the following signs of osteonecrosis:
Slovenian: Zdravnika morate obvestiti, če opazite katerega od naslednjih znakov osteonekroze:
English: This may be more likely with long-term HIV treatment, more severe damage to the immune system, overweight, or the use of alcohol or other medicines called corticosteroids.
Slovenian: To je verjetneje med dolgotrajnim zdravljenjem HIV, v primeru hude okvare imunskega sistema, prekomerne telesne teže ter uživanja alkohola ali drugih zdravil, imenovanih kortikosteroidi.
English: Of the 126 patients, 96 received the recommended dose of raltegravir (see section 4.2).
Slovenian: Od 126 bolnikov jih je 96 prejemalo priporočeni odmerek raltegravirja (glejte poglavje 4.2).
English: Safety profiles in the subgroup of patients in Phase III studies taking proton pump inhibitors or H2 antagonists were comparable with those who were not taking these antacids.
Slovenian: Varnostni profili v podskupini bolnikov v kliničnih študijah III. faze, ki so jemali zaviralce protonske črpalke ali antagoniste H2, so bili primerljivi s tistimi pri bolnikih, ki niso jemali teh antacidov.
English: The mean (CV) AUC over a dosing interval of 12 hours is 4.7 μg•h/ml (18 %).
Slovenian: Povprečna vrednost AUC (KV) v odmernem intervalu 12 ur je 4,7 µg•h/ml (18 %).
English: What you need to know before you take DUTREBIS
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo DUTREBIS
English: Exposure (AUC∞), Cmax, and half-life increased with diminishing renal function (as expressed by creatinine clearance).
Slovenian: Izpostavljenost (AUC∞), Cmax in razpolovni čas so se povečevali z zmanjševanjem delovanja ledvic (izraženim z očistkom kreatinina).
English: Lipid disorders should be managed as clinically appropriate (see section 4.8).
Slovenian: Motnje lipidov je treba obravnavati, kot je klinično ustrezno (glejte poglavje 4.8).
English: The apparent terminal half-life of raltegravir is approximately 9 hours, with a shorter α-phase half-life (~1 hour) accounting for much of the AUC.
Slovenian: Navidezni razpolovni čas raltegravirja je približno 9 ur s krajšim razpolovnim časom α-faze (~1 ura), ki predstavlja velik del AUC.
English: With twice-daily dosing of raltegravir, pharmacokinetic steady state is achieved rapidly, within approximately the first 2 days of dosing.
Slovenian: Med uporabo raltegravirja dvakrat na dan je farmakokinetično stanje dinamičnega ravnovesja doseženo hitro, v približno prvih 2 dneh uporabe.
English: Non-completer is failure imputation: patients who discontinued prematurely are imputed as failure thereafter.
Slovenian: Nedokončano zdravljenje je označeno kot neuspešno: zdravljenje pri bolnikih, ki so predčasno prenehali z zdravljenjem, je tako označeno kot neuspešno.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko pomanjkanja laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: What DUTREBIS is and what it is used for What you need to know before you take DUTREBIS
Slovenian: Kaj je zdravilo DUTREBIS in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo DUTREBIS
English: If you take more DUTREBIS than you should Do not take more tablets than the doctor recommends.
Slovenian: Če ste vzeli večji odmerek zdravila DUTREBIS, kot bi smeli Ne vzemite večjega števila tablet, kot vam jih je predpisal zdravnik.
English: As waste and fluids accumulate, other body systems are affected, potentially leading to complications
Slovenian: Kopičenje odpadnih snovi in tekočin prizadene še druge organske sisteme in lahko povzroči zaplete.
English: However, raltegravir is secreted in the milk of lactating rats.
Slovenian: Vendar se raltegravir izloča v mleko doječih podgan.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment should be considered.
Slovenian: Če se pri takšnih bolnikih pojavijo znaki poslabšanja bolezni jeter, je treba razmisliti o začasni ali trajni prekinitvi zdravljenja.
English: DUTREBIS must not be used with the following medicines.
Slovenian: Zdravila DUTREBIS se ne sme uporabljati z naslednjimi zdravili.
English: Lamivudine was not genotoxic in vivo at doses that gave plasma concentrations around 40-50 times higher than the anticipated clinical plasma levels.
Slovenian: Lamivudin in vivo ni bil genotoksičen v odmerkih, ki so povzročili koncentracije v plazmi 40- do 50-krat večje od pričakovanih kliničnih koncentracij v plazmi.
English: What DUTREBIS looks like and contents of the pack The film-coated tablet is oval-shaped, green, marked with "144" on one side.
Slovenian: Izgled zdravila DUTREBIS in vsebina pakiranja Filmsko obložena tableta je ovalne oblike, zelene barve in ima na eni strani oznako "144".
English: Interaction not studied
Slovenian: Medsebojno delovanje ni raziskano.
English: Other medicinal products (e.g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine.
Slovenian: Druga zdravila (npr. ranitidin, cimetidin) se le delno izločajo s tem mehanizmom in zanje je dokazano, da z lamivudinom medsebojno ne delujejo.
English: This is because of changes in fat distribution:
Slovenian: Vzrok tega je spremenjena porazdelitev
English: Adults, adolescents, and children (6 through 11 years of age weighing at least 30 kg) The recommended dosage is one tablet (150 mg lamivudine/300 mg raltegravir) twice daily.
Slovenian: Odrasli, mladostniki in otroci (od 6. do 11. leta starosti, ki tehtajo vsaj 30 kg) Priporočeni odmerek je ena tableta (150 mg lamivudina/300 mg raltegravirja) dvakrat na dan.
English: In two studies of HIV-1 infected patients who received raltegravir 400 mg twice daily, raltegravir was readily detected in the cerebrospinal fluid.
Slovenian: V dveh študijah pri bolnikih, okuženih z virusom HIV-1, ki so prejemali 400 mg raltegravirja mg dvakrat na dan, so raltegravir zlahka odkrili v cerebrospinalni tekočini.
English: Clinical status including liver aminotransferases should be monitored and appropriate therapy initiated.
Slovenian: Spremljati je treba klinično stanje (vključno z jetrnimi aminotransferazami) in uvesti ustrezno zdravljenje.
English: It is not yet known what causes these changes, or whether they have any long-term effects.
Slovenian: Ni še znano, kaj povzroči te spremembe.
English: Frequency Lamivudine and/or Raltegravir (alone or in combination with other ART)*
Slovenian: Pogostnost Lamivudin in/ali raltegravir (sama ali v kombinaciji z drugimi protiretrovirusnimi zdravili)*
English: The active moiety, intracellular lamivudine triphosphate, has a prolonged terminal half-life in the cell (16 to 19 hours) compared to the plasma lamivudine half-life (5 to 7 hours).
Slovenian: Aktivna oblika, znotrajcelični lamivudin trifosfat, ima v celici daljši končni razpolovni čas (od 16 do 19 ur) kot ga ima lamivudin v plazmi (od 5 do 7 ur).
English: Studies with raltegravir in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije z raltegravirjem na živalih so pokazale toksičen vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Therefore, whenever possible, DUTREBIS should be administered with another active ART to minimise the potential for virological failure and the development of resistance (see section 5.1).
Slovenian: Če je le mogoče, je zato treba zdravilo DUTREBIS uporabiti z drugo protiretrovirusno učinkovino, da se zmanjša možnost za virološki neuspeh in razvoj odpornosti (glejte poglavje 5.1).
English: • Women with HIV should not breast-feed their infants because babies can be infected with HIV
Slovenian: • Z virusom HIV okužene ženske ne smejo dojiti, kajti otrok se lahko preko materinega mleka okuži z virusom HIV.
English: Raltegravir achieved virologic responses (using Not Completer=Failure approach) of HIV RNA < 50 copies/ml in 61.7 % of patients at Week 16, in 62.1 % at Week 48 and in 57.0 % at Week 96.
Slovenian: Raltegravir je dosegel virološke odzive (z uporabo metode nedokončanje = neuspeh) HIV RNA < 50 kopij/ml pri 61,7 % bolnikov po 16 tednih, pri 62,1 % po 48 tednih in pri 57,0 % po 96 tednih.
English: In vitro studies indicate that raltegravir is not a substrate of cytochrome P450 (CYP) enzymes, does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A, does not induce CYP3A4 and does not inhibit P-glycoprotein-mediated transport.
Slovenian: Študije in vitro kažejo, da raltegravir ni substrat za encime citokroma P450 (CYP), ne zavira CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali CYP3A, ne inducira CYP3A4 in ne zavira s P-glikoproteinom posredovanega transporta.
English: Caution should be exercised when administering NRTIs to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Slovenian: Previdnost je potrebna pri uporabi NRTI-jev pri katerem koli bolniku (predvsem bolnicah s prekomerno telesno maso) s hepatomegalijo, hepatitisom ali drugimi znanimi dejavniki tveganja za bolezni jeter in steatozo jeter (vključno z določenimi zdravili in alkoholom).
English: • rash (more often when used in combination with darunavir)
Slovenian: • izpuščaj (pogosteje, če je to zdravilo uporabljeno v kombinaciji z darunavirjem)
English: Dizziness has been reported in some patients during treatment with regimens containing raltegravir, which may influence some patients' ability to drive and use machines (see section 4.8).
Slovenian: Pri nekaterih bolnikih, zdravljenih z režimi, ki so vključevali raltegravir, so poročali o pojavu omotice, kar lahko pri nekaterih bolnikih vpliva na sposobnost vožnje in upravljanja s stroji (glejte poglavje 4.8).
English: The adverse reactions seen in clinical studies and in post-marketing experience are listed below by body system, organ class and absolute frequency.
Slovenian: Neželeni učinki, opaženi v kliničnih študijah in pri spremljanju v obdobju trženja, so navedeni spodaj po organskem sistemu in absolutni pogostnosti.
English: These changes are not considered clinically meaningful; therefore, DUTREBIS may be administered with or without food.
Slovenian: Te spremembe ne veljajo za klinično pomembne in zdravilo DUTREBIS se lahko jemlje s hrano ali brez nje.
English: • Do not take this medicine after the expiry date which is stated on the bottle after EXP.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega
English: No specific information is available on the treatment of overdose with raltegravir.
Slovenian: Specifičnih informacij o zdravljenju v primeru prevelikega odmerjanja raltegravirja ni.
English: Once absorbed the lamivudine and raltegravir distribution, metabolism, and excretion are similar to those of the reference components administered individually as described in the following paragraphs.
Slovenian: Po absorpciji so porazdelitev, presnova in izločanje lamivudina in raltegravirja podobne kot pri posamezno uporabljenih referenčnih učinkovinah, kot je opisano v naslednjih odstavkih.
English: The rashes observed in clinical studies were mild to moderate in severity and did not result in discontinuation of therapy (see section 4.4).
Slovenian: Izpuščaji, ki so jih opazili v kliničnih študijah, so bili po jakosti blagi do zmerni in niso povzročili prenehanja zdravljenja (glejte poglavje 4.4).
English: When concomitant administration of DUTREBIS is warranted, patients should be monitored clinically.
Slovenian: Če je potrebna sočasna uporaba zdravila DUTREBIS, je treba bolnike klinično spremljati.
English: In interaction studies, raltegravir did not have a clinically meaningful effect on the pharmacokinetics of etravirine, maraviroc, tenofovir, hormonal contraceptives, methadone, midazolam, or boceprevir.
Slovenian: V študijah medsebojnega delovanja raltegravir ni klinično pomembno vplival na farmakokinetiko etravirina, maraviroka, tenofovirja, hormonskih kontraceptivov, metadona, midazolama ali boceprevirja.
English: Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Slovenian: Pozornost je treba nameniti merjenju koncentracije lipidov v serumu in glukoze v krvi na tešče.
English: Following oral administration, lamivudine was excreted in breast milk at similar concentrations to
Slovenian: Po peroralni uporabi se je lamivudin izločal v materino mleko v podobnih koncentracijah, kot so bile
English: Factors that reduced the likelihood of developing resistance included lower baseline viral load and use of other active anti-retroviral agents.
Slovenian: Med dejavniki, ki zmanjšajo verjetnost pojava odpornosti, sta manjše izhodiščno virusno breme in uporaba drugih aktivnih protiretrovirusnih zdravil.
English: Rifampicin may decrease your levels of raltegravir (one of the medicines in DUTREBIS).
Slovenian: Rifampicin lahko zniža koncentracijo raltegravirja (ene od zdravilnih učinkovin v zdravilu DUTREBIS).
English: In addition, tenofovir may increase plasma levels of raltegravir, however, the mechanism for this effect is unknown (see Table 1).
Slovenian: Poleg tega lahko koncentracijo raltegravirja v plazmi poveča tudi tenofovir, vendar mehanizem tega učinka ni znan (glejte preglednico 1).
English: The pharmacokinetics of DUTREBIS in the paediatric patient population has not been studied in clinical studies.
Slovenian: Farmakokinetika zdravila DUTREBIS v populaciji pediatričnih bolnikov v kliničnih študijah ni bila raziskana.
English: If you notice within 6 hours, you must take the tablet immediately.
Slovenian: Če v 6 urah ugotovite, da ste pozabili vzeti zdravilo, morate tableto vzeti takoj.
English: Lamivudine has no effect on the pharmacokinetics of trimethoprim or sulfamethoxazole.
Slovenian: Lamivudin ne vpliva na farmakokinetiko trimetoprima ali sulfametoksazola.
English: The likelihood of metabolic interactions of lamivudine with other medicinal products is low due to the small extent of hepatic metabolism (5-10 %) and low plasma protein binding.
Slovenian: Verjetnost za presnovna medsebojna delovanja lamivudina z drugimi zdravili je majhna zaradi majhnega obsega presnove v jetrih (od 5 do 10 %) in majhne vezave na beljakovine v plazmi.
English: Patients receiving lamivudine or any other ART may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with associated HIV diseases.
Slovenian: Bolnikom, ki prejemajo lamivudin ali katero drugo protiretrovirusno zdravilo, se lahko še naprej pojavljajo oportunistične okužbe in drugi zapleti okužbe s HIV, zato morajo ostati pod skrbnim nadzorom zdravnikov, izkušenih z zdravljenjem bolnikov, ki imajo bolezni, povezane s HIV.
English: A carcinogenicity study of raltegravir in mice did not show any carcinogenic potential.
Slovenian: Študija karcinogenosti raltegravirja pri miših ni pokazala nobenega karcinogenega potenciala.
English: In clinical studies, the number of HIV patients taking raltegravir who developed cancer was similar to that of patients taking other HIV medicines.
Slovenian: V kliničnih študijah je bilo število bolnikov s HIV, ki so jemali raltegravir in se je pri njih pojavil rak, podobno številu bolnikov, ki so jemali druga zdravila za HIV.
English: Treatment with NRTIs should be discontinued in the setting of symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Slovenian: Zdravljenje z NRTI-ji je treba v primeru simptomatske hiperlaktatemije in metabolične acidoze/laktacidoze, napredujoče hepatomegalije ali hitrega zviševanja vrednosti aminotransferaz
English: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Slovenian: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU Velika Britanija
English: Overall, considerable variability was observed in the pharmacokinetics of raltegravir.
Slovenian: Na splošno je bila opažena znatna spremenljivost farmakokinetičnih lastnosti raltegravirja.
English: What DUTREBIS is and what it is used for
Slovenian: Kaj je zdravilo DUTREBIS in za kaj ga uporabljamo
English: Overall, the results of the clinical pharmacology studies with DUTREBIS demonstrate similar drug exposures compared to the individual components of lamivudine and raltegravir, including similar variability in raltegravir C12hr and Cmax.
Slovenian: V celoti rezultati kliničnih farmakoloških študij z zdravilom DUTREBIS kažejo podobno izpostavljenost učinkovinama kot s posamezno uporabljenima lamivudinom in raltegravirjem, vključno s podobno variabilnostjo C12ur in Cmax raltegravirja.
English: The impact of other strong inducers of drug metabolizing enzymes, such as phenytoin and phenobarbital, on UGT1A1 is unknown.
Slovenian: Vpliv drugih močnih induktorjev encimov, ki presnavljajo zdravila, kot sta fenitoin in fenobarbital, na UGT1A1 ni znan.
English: The effect of severe hepatic insufficiency on the pharmacokinetics of raltegravir has not been studied (see sections 4.2 and 4.4).
Slovenian: Vpliva hude jetrne insuficience na farmakokinetiko raltegravirja niso raziskovali (glejte poglavji 4.2 in 4.4).
English: Lamivudine is eliminated mainly by active renal secretion via the organic cationic transport system.
Slovenian: Lamivudin se izloča predvsem z aktivnim izločanjem skozi ledvice, ki poteka preko transportnega sistema organskih kationov.
English: The mean ratio CSF/serum lamivudine concentration 2-4 hours after oral administration was approximately 0.12.
Slovenian: Povprečno razmerje med koncentracijo lamivudina v CSF in serumu od 2 do 4 ure po peroralni uporabi je bilo približno 0,12.
English: It should be taken into account that raltegravir is presented for clinical use as the potassium salt.
Slovenian: Upoštevati je treba, da je raltegravir za klinično uporabo na voljo v obliki kalijeve soli.
English: Following oral administration, the mean time (tmax) to maximal serum concentrations (Cmax) is about an hour.
Slovenian: Povprečni čas (tmax) do največje koncentracije v serumu (Cmax) je po peroralni uporabi približno eno uro.
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited binding to the major plasma protein albumin (< 16 % - 36 % to serum albumin in in vitro studies).
Slovenian: Lamivudin ima v razponu terapevtskih odmerkov linearno farmakokinetiko in majhno vezavo na glavno plazemsko beljakovino albumin (< 16 % do 36 % na albumin v serumu v študijah in vitro).
English: Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure, or renal
Slovenian: Umrljivost zaradi laktacidoze je visoka in je lahko povezana s pankreatitisom, odpovedjo jeter ali
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Slovenian: Ustrezni primeri so citomegalovirusni retinitis, generalizirane in/ali žariščne mikobakterijske okužbe in pljučnica zaradi Pneumocystis carinii.
English: Mutations at amino acid 143 confer greater resistance to raltegravir than to elvitegravir, and the E92Q mutation confers greater resistance to elvitegravir than to raltegravir.
Slovenian: Mutacije aminokisline 143 so povezane z večjo odpornostjo na raltegravir kot na elvitegravir, mutacija E92Q pa je povezana z večjo odpornostjo na elvitegravir kot na raltegravir.
English: At the highest dosage levels, minor effects on indicators of liver and kidney function were seen together with occasional reductions in liver weight.
Slovenian: Ob največjih odmerkih so zabeležili manjše učinke na kazalce delovanja jeter in ledvic, kakor tudi občasno zmanjšanje mase jeter.
English: The clinical relevance of these findings is not established.
Slovenian: Klinični pomen teh izsledkov ni ugotovljen.
English: In a single-cycle infection assay, raltegravir inhibited infection of 23 HIV isolates representing 5 non-B subtypes and 5 circulating recombinant forms with IC50 values ranging from 5 to 12 nM.
Slovenian: V enem infekcijskem ciklu je raltegravir zavrl okužbo 23 izolatov HIV, ki so predstavljali 5 podtipov, razen podtipa B, in 5 cirkulirajočih rekombinantnih oblik z vrednostmi IC50 od 5 do 12 nM.
English: • erectile dysfunction; breast enlargement in men; menopausal symptoms
Slovenian: • motnje erekcije, povečanje prsi pri moških, simptomi menopavze
English: Apparent total oral clearance (Cl/F) of lamivudine decreased as creatinine clearance decreased.
Slovenian: Navidezni celotni peroralni očistek (CL/F) lamivudina se je z zmanjšanjem očistka kreatinina zmanjšal.
English: Non-clinical toxicology studies, including conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, developmental toxicity and juvenile toxicity, have been conducted with raltegravir, in mice, rats, dogs and rabbits.
Slovenian: Predklinične toksikološke študije, vključno z običajnimi študijami farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, škodljivega vpliva na razvoj in juvenilnimi študijami toksičnosti so bile z raltegravirjem izvedene na miših, podganah, psih in kuncih.
English: • medicines containing lamivudine - used to treat HIV or hepatitis B.
Slovenian: • zdravila, ki vsebujejo lamivudin - uporabljajo se za zdravljenje okužbe z virusom HIV ali hepatitisa B
English: Factors associated with failure include high baseline viral load and OBT that did not include at least one potent active agent.
Slovenian: Med dejavniki, povezanimi z neuspehom, so visoko izhodiščno virusno breme in OBT, ki ni vključevalo vsaj enega
English: • feeling anxious; feeling of confusion; depressed mood; mood changes; panic attack
Slovenian: • občutek tesnobe, občutek zmedenosti, depresivno razpoloženje, spremembe razpoloženja,
English: In the event of an overdose, it is reasonable to employ the standard supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required.
Slovenian: V primeru prevelikega odmerjanja so primerni standardni podporni ukrepi, npr. odstranitev neabsorbiranega zdravila iz prebavil in uvedba kliničnega nadzora (vključno s spremljanjem elektrokardiograma).