FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you are allergic to tezacaftor, ivacaftor, or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na tezakaftor, ivakaftor ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: • If more than 6 hours have passed, do not take the forgotten tablet.
Croatian: • Ako je proteklo više od 6 sati, nemojte uzeti zaboravljenu tabletu.
English: Tell your doctor right away if you have any symptoms of liver problems.
Croatian: Odmah obavijestite svog liječnika ako imate bilo kakve simptome problema s jetrom.
English: Pharmacotherapeutic group: Other respiratory system products; ATC code: R07AX31
Croatian: Farmakoterapijska skupina: ostali pripravci za respiratorni sustav; ATK oznaka: R07AX31
English: NA 1.4 (-1.0, 3.9)
Croatian: NP 1,4 (-1,0; 3,9)
English: In particular, tell your doctor if you take any of the medicines listed below.
Croatian: Osobito obavijestite svog liječnika ako uzimate neki od niže navedenih lijekova.
English: More than one dose of either tablet should not be taken at the same time.
Croatian: Ne smije se uzeti više od jedne doze istodobno, bilo jedne ili druge tablete.
English: tacrolimus, sirolimus and everolimus.
Croatian: takrolimus, sirolimus i everolimus.
English: See the end of section 2 for important information about the contents of Symkevi.
Croatian: Pogledajte kraj dijela 2 za važne informacije o tome što Symkevi sadrži.
English: The potential relevance of these findings in humans is unknown.
Croatian: Nije poznato koja je moguća važnost ovih nalaza za ljude.
English: Assessments of transaminases (ALT or AST) are recommended for all patients prior to initiating treatment, every 3 months during the first year of treatment, and annually thereafter.
Croatian: U svih se bolesnika preporučuje procijeniti transaminaze (ALT ili AST) prije početka liječenja, svaka 3 mjeseca u prvoj godini liječenja te jedanput godišnje nakon toga.
English: (mcg∙h/mL)*
Croatian: (μg∙h/ml)*
English: These include digoxin.
Croatian: Oni uključuju digoksin.
English: (mcg/mL)
Croatian: (μg/ml)
English: No dose adjustment specific to this patient population is required (see section 5.2).
Croatian: Nije potrebna posebna prilagodba doze za ovu populaciju bolesnika (vidjeti dio 5.2).
English: Other medicinal products for which exposure may be increased include glimepiride and glipizide; these medicinal products should be used with caution.
Croatian: Drugi lijekovi kojima izloženost može biti povećana uključuju glimepirid i glipizid; ove je lijekove potrebno primjenjivati s oprezom.
English: What Symkevi looks like and contents of the pack
Croatian: Kako Symkevi izgleda i sadržaj pakiranja
English: Tezacaftor 6.52 (1.83) 156 (52.7)
Croatian: Tezakaftor 6,52 (1,83) 156
English: Patients should be instructed to swallow the tablets whole.
Croatian: Bolesnicima treba savjetovati da tablete progutaju cijele.
English: If you have liver problems, either moderate or severe, your doctor may need to reduce the dose of your tablets, because your liver will not process the medicine as fast as usual.
Croatian: Ako imate probleme s jetrom, bilo umjerene ili teške, liječnik će Vam možda trebati sniziti dozu tableta, zato što Vaša jetra neće moći razgraditi lijek uobičajenom brzinom.
English: Possible signs of liver problems
Croatian: Mogući znakovi problema s jetrom
English: • Pain or discomfort in the upper right area of the stomach (abdominal) area
Croatian: • bol ili nelagoda u gornjem desnom području trbuha (abdomena)
English: Symkevi and ivacaftor are not expected to modify the efficacy of hormonal contraceptives.
Croatian: Ne očekuje se da će Symkevi i ivakaftor promijeniti djelotvornost hormonskih kontraceptiva.
English: There are no known risks due to overdose with Symkevi and there is no specific antidote available in the event of overdose.
Croatian: Nema poznatih rizika zbog predoziranja lijekom Symkevi i nema posebnog antidota koji bi bio dostupan u slučaju predoziranja.
English: • Your doctor may do eye examinations before and during treatment with Symkevi.
Croatian: • Liječnik Vam može napraviti pregled očiju prije i tijekom liječenja lijekom Symkevi.
English: Symkevi taken with ivacaftor helps your breathing by improving your lung function.
Croatian: Symkevi uziman s ivakaftorom pomaže Vam kod disanja tako što poboljšava plućnu funkciju.
English: • Talk to your doctor before starting treatment if you have received an organ transplant.
Croatian: • Obratite se svom liječniku prije početka liječenja ako Vam je presađen organ.
English: What you need to know before you take Symkevi Do not take Symkevi:
Croatian: Što morate znati prije nego počnete uzimati Symkevi Nemojte uzimati Symkevi:
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja ovim lijekom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: If you feel dizzy, do not drive, cycle or use machines unless you are not affected.
Croatian: Ako osjećate omaglicu, nemojte upravljati vozilima, voziti bicikl ili rukovati strojevima osim ako na Vas tako ne utječe.
English: Do not use this medicine after the expiry date that is stated on the package after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake EXP.
English: Effect on liver function tests
Croatian: Učinak na pretrage funkcije jetre
English: Following resolution of transaminase elevations, the benefits and risks of resuming treatment should be considered (see section 4.8).
Croatian: Nakon normalizacije povišenih transaminaza, potrebno je razmotriti koristi i rizike nastavka liječenja (vidjeti dio 4.8).
English: *Indicates statistical significance confirmed in the hierarchical testing procedure.
Croatian: *Označava statističku značajnost potvrđenu postupkom hijerarhijskog testiranja.
English: What Symkevi is and what it is used for
Croatian: Što je Symkevi i za što se koristi
English: Less than 1% of the administered dose was excreted in urine as unchanged tezacaftor, showing that renal excretion is not the major pathway of tezacaftor elimination in humans.
Croatian: Manje od 1% primijenjene doze izlučeno je u mokraći kao nepromijenjen tezakaftor, čime se pokazalo da izlučivanje bubrezima nije glavni put eliminacije tezakaftora u ljudi.
English: Tezacaftor is approximately 99% bound to plasma proteins, primarily to albumin.
Croatian: Približno je 99% tezakaftora vezano za proteine plazme, prvenstveno za albumin.
English: Adolescents aged 12 years and older Adolescents were included together with adults in the trials.
Croatian: Adolescenti u dobi od 12 i više godina Adolescenti su bili uključeni u ispitivanja zajedno s odraslima.
English: M2-TEZ is much less pharmacologically active than tezacaftor or M1-TEZ, and M5-TEZ is not considered pharmacologically active.
Croatian: M2-TEZ je znatno manje farmakološki aktivan nego tezakaftor ili M1-TEZ, a M5-TEZ se ne smatra farmakološki aktivnim.
English: M1-IVA and M6-IVA are the two major metabolites of ivacaftor in humans.
Croatian: M1-IVA i M6-IVA dva su glavna metabolita ivakaftora u ljudi.
English: Exposures of tezacaftor (administered alone or in combination with ivacaftor) increase in an approximately dose-proportional manner with increasing doses from 10 mg to 300 mg once daily.
Croatian: Izloženost tezakaftoru (primijenjenom samom ili u kombinaciji s ivakaftorom) povećava se približno proporcionalno dozi kod povišenja doza od 10 mg do 300 mg jedanput dnevno.
English: clarithromycin, erythromycin, rifampicin and rifabutin.
Croatian: klaritromicin, eritromicin, rifampicin i rifabutin.
English: Tezacaftor had no effects on fertility and reproductive performance indices in male and female rats at doses up to 100 mg/kg/day.
Croatian: Tezakaftor nije utjecao na plodnost i indikatore reproduktivne funkcije u mužjaka i ženki štakora u dozama do 100 mg/kg na dan.
English: For patients with a history of transaminase elevations, more frequent monitoring should be considered.
Croatian: U bolesnika s povišenjem transaminaza u povijesti bolesti potrebno je razmotriti češće praćenje.
English: Neither tezacaftor nor ivacaftor partition preferentially into human red blood cells.
Croatian: Ni tezakaftor niti ivakaftor nisu se prvenstveno raspodjeljivali u ljudske crvene krvne stanice.
English: Pack size of 28 tablets (4 blister cards of 7 tablets each).
Croatian: Veličina pakiranja od 28 tableta (4 blister-kartice, svaka sa 7 tableta).
English: As a precautionary measure, it is preferable to avoid the use of therapy during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka tijekom trudnoće.
English: Do not chew, crush or break the tablets before swallowing.
Croatian: Nemojte žvakati, drobiti ni lomiti tablete prije gutanja.
English: Neither tezacaftor nor ivacaftor prolong the QTcF interval in healthy subjects at 3 times the therapeutic dose.
Croatian: Ni tezakaftor niti ivakaftor ne produljuju QTcF-interval u zdravih ispitanika u dozi 3 puta višoj od terapijske.
English: • fluconazole
Croatian: • flukonazol
English: Combination repeat-dose toxicity studies in rats and dogs involving the co-administration of tezacaftor and ivacaftor to assess the potential for additive and/or synergistic toxicity did not produce any unexpected toxicities or interactions.
Croatian: Kombinirana ispitivanja toksičnosti ponovljenih doza u štakora i pasa, koja su uključivala istodobnu primjenu tezakaftora i ivakaftora radi procjene moguće aditivne i/ili sinergističke toksičnosti, nisu proizvela nikakve neočekivane toksičnosti niti interakcije.
English: The magnitude of increase in exposure in these patients is unknown but is expected to be higher than that observed in patients with moderate hepatic impairment.
Croatian: Nije poznato koliko je veliko povećanje izloženosti u ovih bolesnika, ali očekuje se da je veće od onog opaženog u bolesnika s umjerenim oštećenjem funkcije jetre.
English: • Avocados, hummus, soy-based products (tofu)
Croatian: • avokado, humus, proizvodi od soje (tofu)
English: M6-IVA is not considered pharmacologically active.
Croatian: M6-IVA se ne smatra farmakološki aktivnim.
English: Patients experiencing dizziness should be advised not to drive or use machines until symptoms abate.
Croatian: Bolesnicima koji imaju omaglicu savjetuje se da ne upravljaju vozilima i ne rukuju strojevima dok se simptomi ne povuku.
English: The safety, efficacy and pharmacokinetics of Symkevi in combination with ivacaftor have been examined in a limited number of elderly patients.
Croatian: Sigurnost, djelotvornost i farmakokinetika lijeka Symkevi u kombinaciji s ivakaftorom ispitane su u ograničenog broja starijih bolesnika.
English: If the patient's genotype is unknown, an accurate and validated genotyping method should be performed to confirm the presence of an indicated mutation using a genotyping assay.
Croatian: Ako genotip bolesnika nije poznat, potrebno je napraviti genotipizaciju pomoću točne i validirane metode kako bi se prisutnost indicirane mutacije potvrdila genotipizacijskim testom.
English: • If you forget to take either your morning Symkevi or evening ivacaftor tablet, and you remember within 6 hours of the scheduled time you should have taken the tablet, take the forgotten tablet at once.
Croatian: • Ako zaboravite uzeti bilo jutarnju tabletu lijeka Symkevi, bilo večernju tabletu ivakaftora i sjetite se u roku od 6 sati od vremena kad ste je prema rasporedu trebali uzeti, odmah uzmite zaboravljenu tabletu.
English: Yellow, capsule-shaped tablet debossed with “V100” on one side and plain on the other (dimensions 15.9 mm x 8.5 mm).
Croatian: Žuta tableta u obliku kapsule s utisnutom oznakom „V100“ na jednoj strani i bez oznaka na drugoj (dimenzija 15,9 mm x 8,5 mm).
English: It is not known if Symkevi is safe and effective in children under 12.
Croatian: Nije poznato je li Symkevi siguran i djelotvoran u djece mlađe od 12 godina.
English: Symkevi contains two active substances, tezacaftor and ivacaftor.
Croatian: Symkevi sadrži dvije djelatne tvari, tezakaftor i ivakaftor.
English: These include ketoconazole,
Croatian: Oni uključuju ketokonazol,
English: One patient (0.2%) on therapy and two patients (0.4%) on placebo permanently discontinued treatment for elevated transaminases.
Croatian: Jedan bolesnik (0,2%) koji je primao terapiju i dva bolesnika (0,4%) koja su primala placebo trajno su prekinula liječenje zbog povišenih transaminaza.
English: Symkevi is available in the following pack size: Pack size of 28 tablets (4 blister cards, each with 7 tablets).
Croatian: Symkevi je dostupan u sljedećim veličinama pakiranja: Veličina pakiranja od 28 tableta (4 blister kartice, svaka sa 7 tableta).
English: Very limited PK data indicate comparable exposure to tezacaftor in white (n=652) and non-white (n=8) patients.
Croatian: Vrlo ograničeni farmakokinetički podaci pokazuju usporedivu izloženost tezakaftoru u bolesnika koji su bijelci (n=652) i onih koji nisu bijelci (n=8).
English: Table 1: Dosing recommendations for concomitant use with moderate CYP3A inhibitors Day 1 Day 2 Day 3 Day 4*
Croatian: Tablica 1: Preporuke za doziranje kod istodobne primjene s umjerenim inhibitorima CYP3A 1. dan 2. dan 3. dan 4. dan*
English: For ivacaftor to function CFTR protein must be present at the cell surface.
Croatian: Da bi ivakaftor djelovao, protein CFTR mora biti prisutan na površini stanice.
English: The mean (SD) elimination half-lives for M1-IVA and M6-IVA were 11.3 (2.12) h and 14.4 (6.14) h, respectively.
Croatian: Srednja vrijednost (SD) poluvijeka eliminacije M1-IVA iznosila je 11,3 (2,12) sati, a M6-IVA 14,4 (6,14) sati.
English: At steady-state, the accumulation ratio is approximately 2.3 for tezacaftor and 3.0 for ivacaftor.
Croatian: Omjer nakupljanja u stanju dinamičke ravnoteže iznosi približno 2,3 za tezakaftor i 3,0 za ivakaftor.
English: Ivacaftor and its metabolites are substrates of BCRP in vitro.
Croatian: Ivakaftor i njegovi metaboliti supstrati su BCRP-a in vitro.
English: These include St. John's wort (Hypericum perforatum).
Croatian: Oni uključuju gospinu travu (Hypericum perforatum).
English: Paediatric population The safety profile is generally consistent among adolescents and adult patients.
Croatian: Pedijatrijska populacija Sigurnosni profil u adolescenata uglavnom je sukladan onome u odraslih bolesnika.
English: Clinical trials of Symkevi in combination with ivacaftor did not include patients over 75 years of age.
Croatian: Klinička ispitivanja lijeka Symkevi u kombinaciji s ivakaftorom nisu uključila bolesnike starije od 75 godina.
English: • Upper respiratory tract infection (the common cold), including sore throat and nasal congestion
Croatian: • infekcija gornjih dišnih puteva (obična prehlada), uključujući grlobolju i začepljenost nosa
English: In such cases, Symkevi should be used at a reduced dose (see sections 4.4 and 5.2).
Croatian: U takvim slučajevima Symkevi treba primjenjivati u sniženoj dozi (vidjeti dijelove 4.4 i 5.2).
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na na djelatnu(e) tvar(i) ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Symkevi in combination with ivacaftor has been studied with an estrogen/progesterone oral contraceptive and was found to have no significant effect on the exposures of the hormonal contraceptive.
Croatian: Symkevi u kombinaciji s ivakaftorom ispitan je s estrogensko-progesteronskim peroralnim kontraceptivima i pronađeno je da nema značajnog učinka na izloženost hormonskim kontraceptivima.
English: ±Nominal p value, based on hierarchical testing procedure.
Croatian: ±Nominalna P vrijednost, na temelju postupka hijerarhijskog testiranja.
English: There is no experience of the use of Symkevi in patients with severe hepatic impairment (Child-Pugh Class C); therefore, its use is not recommended unless the benefits outweigh the risks.
Croatian: Ne postoji iskustvo s primjenom lijeka Symkevi u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C); stoga se njegova primjena ne preporučuje, osim ako su koristi veće od rizika.
English: • Yellowing of the skin or the white part of the eyes
Croatian: • žuta boja kože i bjeloočnica
English: No dose-adjustment of tezacaftor and ivacaftor is considered necessary.
Croatian: Prilagodba doze tezakaftora i ivakaftora ne smatra se potrebnom.
English: • Medicines for diabetes.
Croatian: • Lijekovi za šećernu bolest.
English: As presented in Table 8, the pharmacokinetic parameters of tezacaftor and ivacaftor in adolescents (12 to 17 years) are comparable to those in adults when given in combination.
Croatian: Kako je prikazano u tablici 8, farmakokinetički parametri tezakaftora i ivakaftora u adolescenata (u dobi od 12 do 17 godina) bili su usporedivi s onima u odraslih kad su se davali u kombinaciji.
English: CYP3A, digoxin and other P-gp Substrates
Croatian: CYP3A, digoksin i drugi supstrati P-gp-a
English: The median (range) tmax of ivacaftor was approximately 6 hours (3 to 10 hours) in the fed state.
Croatian: Medijan (raspon) tmax ivakaftora bio je približno 6 sati (od 3 do 10 sati) u sitom stanju.
English: • Herbal medicines.
Croatian: • Biljni lijekovi.
English: • Changes in the type of bacteria in mucus
Croatian: • promjena vrste bakterija u sluzi
English: These include telithromycin,
Croatian: Oni uključuju telitromicin,
English: • Breast-feeding: It is not known if tezacaftor or ivacaftor pass into breast milk.
Croatian: • Dojenje: Nije poznato prelaze li tezakaftor ili ivakaftor u majčino mlijeko.
English: There are no data available on the effect of tezacaftor on fertility in humans.
Croatian: Nema dostupnih podataka o učinku tezakaftora na plodnost u ljudi.
English: Available pharmacokinetic/toxicological data in animals have shown excretion of tezacaftor and ivacaftor into the milk of lactating female rats (see section 5.3).
Croatian: Dostupni farmakokinetički/toksikološki podaci u životinja pokazuju da se tezakaftor i ivakaftor izlučuju u mlijeko ženki štakora u laktaciji (vidjeti dio 5.3).
English: The evening dose of ivacaftor should not be taken (see sections 4.4 and 4.5).
Croatian: Večernju se dozu ivakaftora ne uzima (vidjeti dijelove 4.4 i 4.5).
English: ** Linear Mixed Effects model with treatment, period, and study baseline ppFEV1 as fixed effects and subject as a random effect.
Croatian: **Linearni model miješanih učinaka s liječenjem, razdobljem i ppFEV1 na početku ispitivanja kao fiksnim učincima i ispitanikom kao nasumičnim učinkom.
English: Co-administration with grapefruit juice, which contains one or more components that moderately inhibit CYP3A, may increase exposure of ivacaftor and tezacaftor; therefore, food or drink containing grapefruit or Seville oranges should be avoided during treatment (see section 4.2).
Croatian: Istodobna primjena sa sokom od grejpfruta, koji sadrži jednu ili više komponenti koje umjereno inhibiraju CYP3A, može povećati izloženost ivakaftoru i tezakaftoru; stoga je tijekom liječenja potrebno izbjegavati hranu ili pića koja sadrže grejpfrut ili naranče sorte Seville (vidjeti dio 4.2).
English: • ketoconazole, itraconazole, posaconazole, and voriconazole
Croatian: • ketokonazol, itrakonazol, posakonazol i vorikonazol
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Symkevi in combination with ivacaftor in children aged less than 12 years in cystic fibrosis, as per PIP decision in the granted indication.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Symkevi u kombinaciji s ivakaftorom u djece mlađe od 12 godina za cističnu fibrozu, prema PIP-u za odobrenu indikaciju.
English: Due to its high intrinsic permeability and low likelihood of being excreted intact, co-administration of BCRP inhibitors is not expected to alter exposure of ivacaftor and M1-IVA, while any potential changes in M6-IVA exposures are not expected to be clinically relevant.
Croatian: Zbog njegove visoke intrinzične permeabilnosti i male vjerojatnosti da će biti izlučen u neizmijenjenom obliku, ne očekuje se da će istodobna primjena inhibitora BCRP-a promijeniti izloženost ivakaftoru i njegovu metabolitu M1-IVA, dok se za potencijalne promjene u izloženosti metabolitu M6-IVA ne očekuje da će biti klinički relevantne.
English: The impact of severe hepatic impairment (Child-Pugh Class C, score 10 to 15) on the pharmacokinetics of tezacaftor and ivacaftor has not been studied.
Croatian: Utjecaj teškog oštećenja funkcije jetre (Child-Pugh stadij C, rezultat od 10 do 15) na farmakokinetiku tezakaftora i ivakaftora nije ispitan.
English: The tablets should not be chewed, crushed, or broken before swallowing.
Croatian: Tablete se prije gutanja ne smiju žvakati, drobiti niti lomiti.
English: *Nominal p-value, based on hierarchical testing procedure.
Croatian: *Nominalna p-vrijednost, temeljena na postupku hijerarhijskog testiranja.
English: Another minor circulating metabolite, M3-TEZ, is formed by direct glucuronidation of tezacaftor.
Croatian: Drugi manji cirkulirajući metabolit, M3-TEZ, nastaje izravnom glukuronidacijom tezakaftora.
English: BMI increased in both treatment groups (Symkevi in combination with ivacaftor: 0.18 kg/m2, placebo: 0.12 kg/m2).
Croatian: ITM se povećao u obje terapijske skupine (Symkevi u kombinaciji s ivakaftorom: 0,18 kg/m2, placebo: 0,12 kg/m2).
English: Race had no clinically meaningful effect on the PK of ivacaftor in white (n=379) and non-white (n=29) patients based on a population PK analysis.
Croatian: Etnička pripadnost nije imala klinički značajan utjecaj na farmakokinetiku ivakaftora u bolesnika koji su bijelci (n=379) i onih koji nisu bijelci (n=29) na temelju analize populacijske farmakokinetike.
English: Patients had a percent predicted forced expiratory volume in one second (ppFEV1) at screening between 40 to 90%.
Croatian: Bolesnici su na probiru imali postotak predviđenog forsiranog ekspiratornog volumena u jednoj sekundi (ppFEV1) između 40% i 90%.
English: Symkevi is normally taken with ivacaftor, another medicine.
Croatian: Symkevi se obično uzima s ivakaftorom, drugim lijekom.
English: Symkevi in combination with ivacaftor was associated with a lower event rate per year of severe pulmonary exacerbations requiring hospitalization or IV antibiotic therapy (0.29) compared to placebo (0.54).
Croatian: Symkevi u kombinaciji s ivakaftorom bio je povezan s nižom godišnjom stopom događaja teških plućnih egzacerbacija koje su zahtijevale hospitalizaciju ili i.v. terapiju antibioticima (0,29) u usporedbi s placebom (0,54).
English: Some medicines can affect how Symkevi works or may make side effects more likely.
Croatian: Neki lijekovi mogu utjecati na djelovanje lijeka Symkevi ili povećati vjerojatnost nastanka nuspojava.
English: Avoid food or drinks containing grapefruit or Seville oranges (marmalade oranges) during treatment as these may increase the side effects of Symkevi by increasing the amount of Symkevi in your body.
Croatian: Tijekom liječenja izbjegavajte hranu ili pića koja sadrže grejpfrut ili naranče vrste Seville (naranče za marmeladu) jer povećavaju količinu lijeka Symkevi u tijelu što može pojačati njegove nuspojave.
English: Co-administration with (oral) midazolam, a sensitive CYP3A substrate, did not affect midazolam exposure.
Croatian: Istodobna primjena s (peroralnim) midazolamom, osjetljivim supstratom CYP3A, nije utjecala na izloženost midazolamu.
English: If more than 6 hours have passed since the missed morning or evening dose, the patient should not take the missed dose.
Croatian: Ako je od propuštene jutarnje ili večernje doze proteklo više od 6 sati, bolesnik ne smije uzeti propuštenu dozu.