FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients from these trials were eligible to roll over into a blinded extension study.
Slovenian: Bolniki iz teh preskušanj so lahko prešli v slepo podaljšano študijo.
English: Use all 7 days' doses before starting a new wallet.
Slovenian: Uporabite vse odmerke za 7 dni, preden odprete novo zloženko.
English: Improvements in ppFEV1 were observed regardless of age, disease severity, sex and geographic region.
Slovenian: Izboljšanje ppFEV1 so ugotovili ne glede na starost, izraženost bolezni, spol in zemljepisno območje.
English: Your child's doctor will determine the correct dose for your child.
Slovenian: Otrokov zdravnik bo določil pravilni odmerek za vašega otroka.
English: † 1 patient out of 738 ‡ 2 patients out of 738
Slovenian: † 1 bolnik od 738 ‡ 2 bolnika od 738
English: The post-dose decline was resolved by Week 16.
Slovenian: Zmanjšanje po odmerku je do 16. tedna izginilo.
English: Lift here to open
Slovenian: Tu privzdignite in odprite.
English: Check you have been given the right tablet (below).
Slovenian: Preverite, ali so vam dali pravo tableto (v nadaljevanju).
English: Examples of other fat-containing foods are:
Slovenian: Primeri drugih mastnih vrst hrane so:
English: It may be better to avoid using Orkambi during pregnancy, if possible, and your doctor will help you decide what is best for you and your child.
Slovenian: Mogoče bo bolje, če se boste uporabi zdravila Orkambi v nosečnosti po možnosti izogibali, zdravnik pa vam bo pomagal pri odločitvi, kaj je najboljše za vas in vašega otroka.
English: If more than 6 hours have passed, the patient should be instructed to wait until the next scheduled dose.
Slovenian: Če je minilo več kot 6 ur, bolniku naročite, naj počaka do naslednjega načrtovanega odmerka.
English: False Positive Urine Tests for THC
Slovenian: Lažno pozitivni urinski testi za THC
English: Ireland
Slovenian: Írsko
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 November 2015
Slovenian: Datum prve odobritve: 19. november 2015.
English: Most of these reactions were mild or moderate in severity and non-serious.
Slovenian: Večina teh učinkov je bila po izraženosti blagih ali zmernih in niso bili resni.
English: That is a total of four tablets per day, to be taken with food containing fat.
Slovenian: To je skupaj štiri tablete na dan, jemlje naj jih z mastno hrano.
English: * A total of 82% (421 of 516 eligible patients) completed 72 weeks of this study; 42% completed 96 weeks.
Slovenian: *Vsega skupaj 82 % (421 od 516 primernih bolnikov) je dokončalo 72 tednov te študije; 42 % je dokončalo 96 tednov.
English: Percent predicted FEV1 was also evaluated as a clinically meaningful other secondary endpoint.
Slovenian: Napovedani FEV1 v odstotkih je bil tudi ocenjen kot klinično pomemben drug sekundarni cilj.
English: Meals and snacks recommended in CF guidelines or meals recommended in standard nutritional guidelines contain adequate amounts of fat.
Slovenian: Obroki in prigrizki, ki jih priporočajo smernice za CF, in obroki, ki jih priporočajo standardne prehranske smernice, vsebujejo dovolj maščob.
English: Drug interactions that have the most clinical relevance are listed first.
Slovenian: Interakcije med zdravili, ki so klinično najpomembnejše, so navedene najprej.
English: Effects on sweat chloride
Slovenian: Učinki na kloride v znoju
English: Based on exposure and indicated doses, the interaction profile is considered to be the same for all strengths and pharmaceutical forms.
Slovenian: Na podlagi izpostavljenosti in indiciranih odmerkov menimo, da je profil medsebojnega delovanja enak za vse jakosti in farmacevtske oblike.
English: No dose adjustments are necessary based on gender.
Slovenian: Prilagoditve odmerkov na podlagi spola niso potrebne.
English: These serious side effects are uncommon (may affect up to 1 in 100 people).
Slovenian: Ti resni neželeni učinki so občasni (lahko se pojavijo pri največ 1 od 100 bolnikov).
English: BT63 5UA
Slovenian: BT63 5UA Velika Britanija
English: Side effects seen in children are similar to those seen in adults and adolescents.
Slovenian: Neželeni učinki pri otrocih so podobni tistim pri odraslih in mladostnikih.
English: This extension trial was designed to evaluate the safety and efficacy of long-term treatment of lumacaftor/ivacaftor.
Slovenian: To podaljšano preskušanje je bilo zasnovano za oceno varnosti in učinkovitosti dolgoročnega zdravljenja z lumakaftorjem/ivakaftorjem.
English: Patients should be monitored closely for breakthrough fungal infections if such drugs are necessary.
Slovenian: Bolnike je treba skrbno spremljati glede izbruha glivičnih okužb, če so taka zdravila potrebna.
English: Like all medicines, this medicine can cause side effects although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: 6 to 11 years
Slovenian: 6 do 11 let
English: Although other risk factors were present in some cases (such as corticosteroid use and exposure to radiation), a possible risk attributable to ivacaftor cannot be excluded (see section 5.3).
Slovenian: Čeprav so bili v nekaterih primerih prisotni drugi dejavniki tveganja (na primer uporaba kortikosteroidov in izpostavljenost sevanju), ni mogoče izključiti možnega tveganja, ki bi ga lahko pripisali ivakaftorju (glejte poglavje 5.3).
English: • Loss of appetite
Slovenian: • izguba apetita,
English: Serious respiratory events were seen more frequently in patients with percent predicted FEV1 (ppFEV1) < 40, and may lead to discontinuation of the medicinal product.
Slovenian: Resne respiratorne dogodke so pogosteje opazili pri bolnikih z napovedanim FEV1 v odstotkih (ppFEV1) < 40 in lahko povzročijo prenehanje jemanja zdravila.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Orkambi in one or more subsets of the paediatric population in cystic fibrosis.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Orkambi za eno ali več podskupin pediatrične populacije pri cistični fibrozi.
English: Your child must keep using all other medicines, unless your child's doctor tells you to stop using any.
Slovenian: Vaš otrok mora še naprej jemati vsa druga zdravila, razen če vam otrokov zdravnik naroči, naj otrok preneha jemati katero od zdravil.
English: Orkambi should only be prescribed by physicians with experience in the treatment of CF.
Slovenian: Zdravilo Orkambi naj predpisujejo le zdravniki, ki imajo izkušnje z zdravljenjem CF.
English: Food or liquid should be at room temperature or below.
Slovenian: Hrana ali tekočina naj bo pri sobni ali nižji temperaturi.
English: Following this period, the recommended daily dose should be continued (see section 4.5).
Slovenian: Po tem obdobju se mora nadaljevati priporočeni dnevni odmerek (glejte poglavje 4.5).
English: ↓ itraconazole,
Slovenian: ↓ itrakonazol,
English: However, increased liver enzymes in the blood have been seen more frequently in younger children than in adults.
Slovenian: Vendar pa so zvišane jetrne encime v krvi pogosteje ugotavljali pri mlajših otrocih kot pri odraslih.
English: The safety profile in these paediatric patients is generally consistent with that in adult patients.
Slovenian: Varnostni profil pri teh pediatričnih bolnikih se je na splošno ujemal z varnostnim profilom pri odraslih bolnikih.
English: The recommendations provided under “Clinical comment” in Table 3 are based on drug interaction studies, clinical relevance, or predicted interactions due to elimination pathways.
Slovenian: Priporočila, navedena pod podnaslovom “Klinični komentar” v preglednici 3, temeljijo na študijah interakcij med zdravili, klinični pomembnosti ali napovedanih interakcijah zaradi poti izločanja.
English: These results were not considered statistically significant within the framework of the testing hierarchy for the individual studies.
Slovenian: Ti rezultati v okviru hierarhije testiranja za posamezne študije niso veljali za statistično signifikantne.
English: The information reported in Table 3 mostly derives from in vitro studies.
Slovenian: Podatki, navedeni v preglednici 3, večinoma izvirajo iz študij in vitro.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Extension Week 96
Slovenian: 96. teden podaljšanja
English: * In each study, a hierarchical testing procedure was performed within each active treatment arm for primary and secondary endpoints vs. placebo; at each step, P ≤ 0.0250 and all previous tests also meeting this level of significance was required for statistical significance.
Slovenian: *V vsaki študiji so izvedli hierarhični postopek testiranja znotraj vsake skupine aktivnega zdravljenja za primarna in sekundarna končna stanja proti placebu; na vsaki stopnji je bila potrebna za statistično signifikantnost P ≤ 0,0250 in vsi predhodni testi so morali tudi dosegati to raven signifikantnosti.
English: • Usual dose: Take one sachet of ORKAMBI granules every 12 hours.
Slovenian: • Običajni odmerek: zaužijte eno vrečico zrnc zdravila Orkambi vsakih 12 ur.
English: The primary efficacy analysis of this extension study included data up to Week 72 of Trial 3 with a sensitivity analysis that included data up to Week 96 of Trial 3.
Slovenian: Primarna analiza učinkovitosti v tej podaljšani študiji je vključevala podatke do 72. tedna preskušanja 3 z analizo občutljivosti, ki je vključevala podatke do 96. tedna preskušanja 3.
English: After Day 15, heart rate was not monitored in the period after dosing in these studies.
Slovenian: Po 15. dnevu v teh študijah v času po odmerjanju srčne frekvence niso spremljali.
English: 1 sachet every morning and 1 sachet in the evening every other day.
Slovenian: 1 vrečica vsako jutro in 1 vrečica zvečer vsak drugi dan
English: No dose adjustment for montelukast is recommended.
Slovenian: Prilagajanja odmerka montelukasta ne priporočajo.
English: Children under 2 years old
Slovenian: Otroci, mlajši od 2 let
English: See Orkambi tablets SmPC for further details
Slovenian: Glejte SPC za tablete zdravila Orkambi za več podrobnosti
English: Patients aged 12 to 17 years were included in Trials 1 and 2.
Slovenian: Bolniki, stari 12 do 17 let, so bili vključeni v preskušanji 1 in 2.
English: The clinical relevance of the magnitude of these changes in children 2 to 5 years with cystic fibrosis has not been clearly ascertained in longer-term treatment.
Slovenian: Klinične pomembnosti velikosti teh sprememb pri otrocih, starih 2 do 5 let, s cistično fibrozo pri dolgoročnejšem zdravljenju niso zanesljivo potrdili.
English: * Based on clinical drug-drug interaction studies.
Slovenian: * Temelji na kliničnih študijah interakcij med zdravili.
English: The treatment difference in this subgroup was comparable to that observed in patients with ppFEV1 ≥ 40.
Slovenian: Razlika zaradi zdravljenja v tej podskupini je bila primerljiva s tisto, ki so jo ugotovili pri bolnikih s ppFEV1 ≥ 40.
English: Investigations very common Bacteria in sputum* common
Slovenian: Preiskave zelo pogosti bakterije v sputumu*
English: Changes in FEV1
Slovenian: Spremembe FEV1
English: No patients had total bilirubin levels > 2 x ULN.
Slovenian: Noben bolnik ni imel ravni celotnega bilirubina > 2 x ULN.
English: Side effects in children
Slovenian: Neželeni učinki pri otrocih
English: The CFTR protein is a chloride channel present at the surface of epithelial cells in multiple organs.
Slovenian: Beljakovina CFTR je kloridni kanalček, ki je prisoten na površini epitelijskih celic v številnih organih.
English: ↓ fluconazole Due to induction by LUM; fluconazole is cleared primarily by renal excretion as unchanged drug; however, modest reduction in fluconazole exposure has been observed with strong inducers
Slovenian: ↓ flukonazol Zaradi indukcije z LUM; flukonazol se odstranjuje predvsem z izločanjem skozi ledvice kot nespremenjeno zdravilo; vendar so opazili zmerno zmanjšanje izpostavljenosti flukonazolu z močnimi induktorji
English: Morning Evening
Slovenian: zjutraj zvečer
English: For standard dosing recommendations see Table 1.
Slovenian: Za standardna priporočila za odmerjanje glejte preglednico 1.
English: Contact your doctor or pharmacist for advice.
Slovenian: Obrnite se na svojega zdravnika ali farmacevta za nasvet.
English: These results are presented in Table 7 below:
Slovenian: Te rezultate kaže preglednica 7 v nadaljevanju:
English: Mean improvement in ppFEV1 was rapid in onset (Day 15) and sustained throughout the 24-week treatment period.
Slovenian: Povprečno izboljšanje ppFEV1 je nastopilo hitro (15. dne) in se vzdrževalo vse 24-tedensko obdobje zdravljenja.
English: *** The event rate per patient-year was annualised to 48 weeks.
Slovenian: *** Pogostnost dogodkov na bolnika-leto je bila preračunana na leto na 48 tednov.
English: The majority of events were mild or moderate in severity, non-serious and did not result in treatment discontinuation (see section 4.4).
Slovenian: Večina dogodkov je bila po izraženosti blagih ali zmernih, niso bili resni in niso povzročili prekinitve zdravljenja (glejte poglavje 4.4).
English: If you experience dizziness, you should not drive or use machines until these symptoms disappear.
Slovenian: Če opazite omotico, ne vozite in ne uporabljajte strojev, dokler ti simptomi ne izginejo.
English: Therefore, use in transplanted patients is not recommended.
Slovenian: Zato uporaba pri bolnikih s presajenimi organi ni priporočljiva.
English: Results from Trial 3 are presented in Figure 1 and Table 6.
Slovenian: Rezultati iz preskušanja 3 so predstavljeni na sliki 1 in v preglednici 6.
English: The worsening of liver function can be fatal.
Slovenian: Poslabšanje delovanja jeter lahko povzroči smrt.
English: Once mixed, the product has been shown to be stable for one hour, and therefore should be ingested during this period.
Slovenian: Dokazali so, da je mešanica stabilna eno uro po pripravi, zato jo je treba pojesti v tem času.
English: For patients aged 6 to 11 years
Slovenian: Za bolnike, stare 6 do 11 let
English: In both trials, treatment with lumacaftor/ivacaftor resulted in a statistically significant improvement in ppFEV1 (Table 5).
Slovenian: V obeh preskušanjih je zdravljenje z lumakaftorjem/ivakaftorjem povzročilo statistično signifikantno izboljšanje ppFEV1 (preglednica 5).
English: Specific studies to evaluate the phototoxic potential of lumacaftor were not conducted; however, evaluation of the available non-clinical and clinical data suggests no phototoxic liability.
Slovenian: Specifičnih študij za ocenjevanje fototoksičnega potenciala niso izvedli; vendar ocena razpoložljivih predkliničnih in kliničnih podatkov ne kaže nagnjenosti k fototoksičnosti.
English: Your doctor will take into account the benefit of breast-feeding for the child and the benefit of therapy for you.
Slovenian: Zdravnik bo pretehtal prednosti dojenja za otroka in prednosti zdravljenja za vas.
English: Pooled (Trial 1 and Trial 2)
Slovenian: Združeno (preskušanje 1 in preskušanje 2)
English: If a child experiences dizziness while taking Orkambi, it is advised that the child does not ride a bike or do anything else that needs their full attention, until their symptoms disappear.
Slovenian: Če otrok med jemanjem zdravila Orkambi postane omotičen, je priporočljivo, da se ne vozi s kolesom ali počne česa drugega, kar zahteva njegovo popolno pozornost, dokler simptomi ne izginejo.
English: Examples of meals or snacks that contain fat are those prepared with butter or oils or those containing eggs.
Slovenian: Primeri obrokov ali prigrizkov, ki vsebujejo maščobe, so tisti, ki so pripravljeni z maslom ali olji, in tisti, ki vsebujejo jajca.
English: Children under 6 years old
Slovenian: Otroci, mlajši od 6 let
English: ** All patients had pancreatic insufficiency at baseline.
Slovenian: ** Vsi bolniki so v izhodišču imeli insuficienco trebušne slinavke.
English: Table 6: Long-term effect of Lumacaftor/Ivacaftor in Trial 3*
Slovenian: Preglednica 6: Dolgoročni učinek lumakaftorja/ivakaftorja v preskušanju 3*
English: These menstrual events occurred more frequently in the subset of female patients who were taking hormonal contraceptives (25.0%) versus patients who were not taking hormonal contraceptives (3.5%) (see section 4.5).
Slovenian: Ti menstrualni dogodki so se pojavljali pogosteje v podskupini bolnic, ki so jemale hormonske kontraceptive (25,0 %), kot pri bolnicah, ki jih niso jemale (3,5 %) (glejte poglavje 4.5).
English: Blood pressure should be monitored periodically in all patients during treatment (see section 4.8).
Slovenian: Pri vseh bolnikih je treba med zdravljenjem občasno spremljati krvni tlak (glejte poglavje 4.8).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity and carcinogenic potential.
Slovenian: Predklinični podatki ne kažejo posebnega tveganja za človeka na osnovi običajnih študij genotoksičnosti in kancerogenega potenciala.
English: Contents of the pack and other information What Orkambi contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Orkambi
English: If you stop taking Orkambi You should keep taking the medicine as your doctor directs even if you feel well.
Slovenian: Če ste prenehali jemati zdravilo Orkambi Zdravilo morate še naprej jemati po zdravnikovih navodilih, tudi če se dobro počutite.
English: Other medicines and Orkambi
Slovenian: Druga zdravila in zdravilo Orkambi
English: Once mixed, the mixture has been shown to be stable for one hour.
Slovenian: Dokazali so, da je mešanica, potem ko je zmešana, stabilna eno uro.
English: Anti-inflammatories: ibuprofen
Slovenian: Protivnetna zdravila: ibuprofen
English: Otherwise, wait until your next scheduled dose as you normally would.
Slovenian: Drugače počakajte in vzemite naslednji načrtovani odmerek, kot bi ga normalno.
English: • Ringing in the ears*
Slovenian: • zvonjenje v ušesih*,
English: Because an association with liver injury cannot be excluded, assessments of liver function tests (ALT, AST and bilirubin) are recommended before initiating lumacaftor/ivacaftor, every 3 months during the first year of treatment, and annually thereafter.
Slovenian: Ker povezave s poškodbo jeter ne moremo izključiti, priporočajo izvedbo testov funkcije jeter (ALT, AST in bilirubin) pred uvedbo lumakaftorja/ivakaftorja, vsake 3 mesece med prvim letom zdravljenja, nato pa enkrat na leto.
English: As a precautionary measure, it is preferable to avoid the use of lumacaftor/ivacaftor during pregnancy unless the clinical condition of the mother requires treatment with lumacaftor/ivacaftor.
Slovenian: Kot previdnostni ukrep je zaželeno, da se izognete uporabi lumakaftorja/ivakaftorja med nosečnostjo, če klinično stanje matere ne zahteva zdravljenja z lumakaftorjem/ivakaftorjem.
English: Clinical comment
Slovenian: Klinični komentar
English: At Week 24, 16% of children had a reduction in sweat chloride below 60 mmol/L, and none below 30 mmol/L.
Slovenian: V 24. tednu se je natrijev klorid pri 16 % otrok znižal pod 60 mmol/l, pri nobenem otroku pa pod 30 mmol/l.
English: Usual dose: Take 2 tablets whole every 12 hours (morning and evening) with fat-containing food.
Slovenian: Običajni odmerek: vzemite 2 celi tableti vsakih 12 ur (zjutraj in zvečer) z mastno hrano.
English: Results indicate no clinically relevant difference in pharmacokinetic parameters for lumacaftor or ivacaftor between males and females.
Slovenian: Rezultati kažejo, da ni klinično pomembne razlike v farmakokinetičnih parametrih za lumakaftor ali ivakaftor med moškimi in ženskami.
English: Effect on blood pressure
Slovenian: Vpliv na krvni tlak
English: • Pain or discomfort in the upper right stomach (abdominal) area
Slovenian: • bolečina ali neugodje v zgornjem desnem predelu trebuha (abdomna),
English: Pharmacotherapeutic group: Other respiratory system products; ATC code: R07AX30
Slovenian: Farmakoterapevtska skupina: Druga zdravila za zdravljenje bolezni dihal; oznaka ATC: R07AX30.
English: Lumacaftor is approximately 99% bound to plasma proteins, primarily to albumin.
Slovenian: Lumakaftor je v približno 99 % vezan na plazemske beljakovine, predvsem na albumin.
English: Of the patients who were initiated lumacaftor/ivacaftor at the full dose, one patient had a serious respiratory event, three patients subsequently had their dose reduced, and three patients discontinued treatment.
Slovenian: Od bolnikov, ki so jim uvedli lumakaftor/ivakaftor v polnem odmerku, je imel en bolnik resen respiracijski dogodek, trem bolnikom so pozneje odmerek zmanjšali, trije bolniki pa so prekinili zdravljenje.
English: Ivacaftor produced a dose-related but transient increase in the blood pressure parameters in dogs at single oral doses up to 60 mg/kg.
Slovenian: Ivakaftor je povzročil z odmerkom povezan, a prehoden porast parametrov krvnega tlaka psov pri enkratnih peroralnih odmerkih do 60 mg/kg.
English: Mean (SD)
Slovenian: povprečje (SD)
English: Since the exposure of ivacaftor is very significantly reduced when dosed in combination with lumacaftor, lumacaftor/ivacaftor should not be used in these patients.
Slovenian: Ker se izpostavljenost ivakaftorju zelo pomembno zmanjša, kadar ga dajemo v kombinaciji z lumakaftorjem, pri teh bolnikih lumakaftorja/ivakaftorja ne smemo uporabljati.
English: The recommended dose for patients aged 2 years and over is indicated in the table below.
Slovenian: Priporočila za odmerjanje za bolnike, stare 2 leti ali več, so navedena v preglednici spodaj.
English: Orkambi granules are packaged in a foil laminate [biaxially-oriented polyethylene terephthalate/polyethylene/foil/polyethylene (BOPET/PE/Foil/PE)] sachet.
Slovenian: Zrnca Orkambi so pakirana v vrečici iz laminirane folije [biaksialno orientiran polietilen tereftalat/ polietilen/folija/polietilen (BOPET/PE/folija/PE)].
English: 14 sachets
Slovenian: 14 vrečic
English: Orkambi has to be taken in the morning and in the evening (12 hours apart) with food containing fat.
Slovenian: Zdravilo Orkambi je treba jemati zjutraj in zvečer (s presledkom 12 ur) z mastno hrano.
English: • Once mixed, give the product to your child immediately.
Slovenian: • Ko je mešanica pripravljena, naj jo otrok takoj zaužije.
English: Your child may experience side effects, including those mentioned in section 4 below.
Slovenian: Vaš otrok bo mogoče dobil neželene učinke, vključno s tistimi, ki so omenjeni v poglavju 4 v nadaljevanju.
English: • Changes in the type of bacteria in mucus*
Slovenian: • spremembe vrste bakterij v sluzi*.
English: Additional adverse reactions from Trial 6 are included in Table 4.
Slovenian: Dodatni neželeni učinki iz preskušanja 6 so vključeni v preglednico 4.
English: 2 tablets in the morning 2 tablets in the evening
Slovenian: 2 tableti zjutraj 2 tableti zvečer
English: Effects in repeated dose studies were observed only at exposures considered sufficiently in excess (> 25-, > 45-, and > 35-fold for mice, rats, and dogs, respectively) of the maximum human exposure of ivacaftor when administered as Orkambi, indicating little relevance to clinical use.
Slovenian: Učinke v študijah ponavljajočih se odmerkov so ugotovili samo pri izpostavljenostih, za katere menimo, da dovolj presegajo (> 25-, > 45- in > 35-krat za miši, podgane oziroma pse) največjo izpostavljenost ivakaftorju pri človeku, kadar ga uporabljamo v obliki zdravila Orkambi, kar kaže na majhen pomen za klinično uporabo.
English: Orkambi tablets should not be used in children under the age of 6 years.
Slovenian: Tablet zdravila Orkambi ne smete uporabljati pri otrocih, mlajših od 6 let.
English: For patients with a history of ALT, AST, or bilirubin elevations, more frequent monitoring should be considered.
Slovenian: Pri bolnikih z anamnezo zvišanja ALT, AST ali bilirubina pride v poštev pogostejše spremljanje.