FrancophonIA/ELRC3.0 huggingface dataset:
English: (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • Uncontrolled severe hypertension.
Croatian: • Nekontrolirana teška hipertenzija.
English: Steady state concentrations are achieved within 3 days.
Croatian: Koncentracije u stanju dinamičke ravnoteže postižu se unutar 3 dana.
English: If you become pregnant while you are taking Roteas, immediately tell your doctor, who will decide how you should be treated.
Croatian: Ako zatrudnite dok uzimate Roteas, odmah obavijestite liječnika, koji će odlučiti kako Vas liječiti.
English: • Importance of treatment compliance
Croatian: • važnost pridržavanja liječenja
English: Other medicines and Roteas
Croatian: Drugi lijekovi i Roteas
English: The volume of distribution is 107 (19.9) L mean (SD).
Croatian: Volumen distribucije je 107 (19,9) l srednja vrijednost (SD).
English: • The signs or symptoms of bleeding and when to seek attention
Croatian: • znakovi i simptomi krvarenja i kada potražiti pomoć
English: What Roteas looks like and contents of the pack
Croatian: Kako Roteas izgleda i sadržaj pakiranja
English: These medicinal products should not be administered simultaneously.
Croatian: Ovi se lijekovi ne smiju primjenjivati istovremeno.
English: • Do not start any other medications (including over the counter) without consulting your doctor.
Croatian: • Nemojte početi uzimati nikakve druge lijekove (uključujući one u slobodnoj prodaji) a da se prethodno niste posavjetovali s liječnikom.
English: Your doctor may change your anticoagulant treatment as follows:
Croatian: Liječnik Vam može promijeniti antikoagulacijsku terapiju na sljedeći način:
English: Menstrual bleeding may be intensified and/or prolonged.
Croatian: Menstrualno krvarenje može biti pojačano i/ili produljeno.
English: This method is recommended when assessing patients' CrCL prior to and during Roteas treatment.
Croatian: Ova se metoda preporučuje kad se procjenjuje CrCL bolesnika prije i tijekom liječenja Roteas.
English: Signature of physician:
Croatian: Potpis liječnika:
English: Overall list of possible side effects:
Croatian: Ukupni popis mogućih nuspojava:
English: Do not take a double dose on the same day to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu istog dana kako biste nadoknadili zaboravljenu dozu.
English: If you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
Croatian: Ako znate da imate bolest koja se naziva antifosfolipidni sindrom (poremećaj imunološkog sustava koji uzrokuje povećani rizik od nastanka krvnih ugrušaka), obavijestite o tome svog liječnika koji će odlučiti postoji li potreba za izmjenom terapije.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, or phototoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti ili fototoksičnosti.
English: Roteas can be taken with or without food.
Croatian: Roteas se može uzimati s hranom ili bez nje.
English: Patients with antiphospholipid syndrome
Croatian: Bolesnici s antifosfolipidnim sindromom
English: • recent bleeding in your brain (intracranial or intracerebral bleeding)
Croatian: • nedavno krvarenje u mozak (intrakranijalno ili intracerebralno krvarenje)
English: p-value < 0.0001 (non-inferiority)
Croatian: p-vrijednost < 0,0001 (neinferiornost)
English: Edoxaban increases the risk of bleeding and can cause serious, potentially fatal bleeding.
Croatian: Edoksaban povećava rizik od krvarenja i može uzrokovati ozbiljna, potencijalno smrtonosna krvarenja.
English: The treatment duration was from 3 months up to 12 months, determined by the investigator based on the patient's clinical features.
Croatian: Liječenje je trajalo od 3 mjeseca do najviše 12 mjeseci, što je određivao ispitivač na temelju kliničke slike bolesnika.
English: It works by blocking the activity of factor Xa, which is an important component of blood clotting.
Croatian: Djeluje tako što blokira djelovanje faktora Xa, koji je važna komponenta zgrušavanja krvi.
English: There may be situations that warrant a change in anticoagulation therapy (Table 2).
Croatian: Mogu postojati situacije koje zahtijevaju promjenu antikoagulacijske terapije (tablica 2).
English: Blood type: Other medications/conditions:
Croatian: Krvna grupa: Drugi lijekovi/bolesti:
English: There is no information on its use in children and adolescents.
Croatian: Nema podataka o njezinoj primjeni u djece i adolescenata.
English: • Lesion or condition, if considered to be a significant risk for major bleeding.
Croatian: • Lezija ili stanje, ako se smatra da nosi značajan rizik od većeg krvarenja.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 April 2017
Croatian: Datum prvog odobrenja: 20. travnja 2017.
English: INFORMATION FOR HEALTHCARE PROFESSIONALS
Croatian: INFORMACIJE ZA ZDRAVSTVENE RADNIKE
English: Recombinant factor VIIa (r-FVIIa) can also be considered.
Croatian: Može se razmotriti i primjena rekombinantnog faktora VIIa (r-FVIIa).
English: Edoxaban has a half-life of approximately 10 to 14 hours (see section 5.2).
Croatian: Edoksaban ima poluvijek od približno 10 do 14 sati (vidjeti dio 5.2).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja.
English: • Roteas may increase the risk of bleeding.
Croatian: • Roteas može povećati rizik od krvarenja.
English: Roteas 15 mg is not indicated as monotherapy, as it may result in decreased efficacy.
Croatian: Roteas 15 mg nije indiciran kao monoterapija, jer to može rezultirati smanjenom djelotvornošću.
English: Edoxaban is poorly soluble at pH of 6.0 or higher.
Croatian: Edoksaban je slabo topiv pri pH 6,0 ili višem.
English: PRESCRIBER INFORMATION For more information or in case of emergency, please contact: Physician's name:
Croatian: Za dodatne informacije ili u hitnom slučaju, obratite se: Ime liječnika:
English: • Renal function should also be assessed when a change in renal function is suspected during treatment (e.g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products).
Croatian: • Funkciju bubrega također treba procijeniti kad se sumnja na promjenu funkcije bubrega tijekom liječenja (npr. hipovolemija, dehidracija i u slučaju istovremene primjene određenih lijekova).
English: Vaginal bleeds were reported commonly in women under the age of 50 years, while it was uncommon in women over the age of 50 years.
Croatian: Vaginalna krvarenja bila su često prijavljena u žena mlađih od 50 godina, dok su bila manje česta u žena starijih od
English: Your doctor may decide to keep you under closer observation or change your medicine.
Croatian: Liječnik može odlučiti hoće li Vas zadržati pod pažljivim nadzorom ili će Vam promijeniti lijek.
English: Roteas is not recommended in children and adolescents under 18 years of age.
Croatian: Ne preporučuje se primjena Roteasa u djece i adolescenata mlađih od 18 godina.
English: Patients should not take a loading dose of VKA in order to promptly achieve a stable INR between 2 and 3.
Croatian: Bolesnici ne smiju uzeti udarnu dozu AVK-a da bi brzo postigli stabilni INR između 2 i 3.
English: (mm/yy)
Croatian: (mm/gg)
English: What you need to know before you take Roteas
Croatian: Što morate znati prije nego počnete uzimati Roteas
English: • Clinically significant active bleeding.
Croatian: • Klinički značajno aktivno krvarenje.
English: c 'Any Confirmed Bleeding' includes those that the adjudicator defined as clinically overt.
Croatian: c Bilo koje potvrđeno krvarenje' uključuje krvarenja koja je procjenitelj definirao kao klinički vidljiva.
English: There is a decreasing event rate at increasing CrCL in both treatment groups.
Croatian: Stopa događaja smanjuje se s povećanjem CrCL u obje terapijske skupine.
English: Prior to initiating Roteas, liver function testing should be performed.
Croatian: Prije početka primjene Roteasa, potrebno je provesti testove jetrene funkcije.
English: Present it to your healthcare professional, pharmacist, surgeon or dentist before any medical treatment or intervention.
Croatian: Pokažite je liječniku, ljekarniku, kirurgu ili zubaru prije svakog liječenja ili zahvata.
English: TREATMENT INFORMATION (To be completed by physician)
Croatian: INFORMACIJE O LIJEČENJU (Ispunjava liječnik)
English: Aspartate aminotransferase increased
Croatian: Povišena aspartat aminotransferaza
English: • Contraindications
Croatian: • kontraindikacije
English: The anticoagulant effect of edoxaban cannot be reliably monitored with standard laboratory testing.
Croatian: Antikoagulacijski učinak edoksabana ne može se pouzdano nadzirati pomoću standardnih laboratorijskih testova.
English: • Nose bleeds or cuts that take a long time to stop bleeding
Croatian: • krvarenje iz nosa ili posjekotine kojima treba puno vremena da prestanu
English: • Bleeding from the mouth and/or throat
Croatian: • krvarenje iz usta i/ili grla
English: • medicines to prevent organ rejection after transplantation (e.g. ciclosporin)
Croatian: • lijekove za sprječavanje odbacivanja organa nakon transplantacije (npr. ciklosporin)
English: If you take more Roteas than recommended, you may have an increased risk of bleeding.
Croatian: Ako uzmete više Roteasa nego što je preporučeno, možete imati povećan rizik od krvarenja.
English: 85276 Pfaffenhofen, Bayern Germany
Croatian: 85276 Pfaffenhofen, Bayern
English: Laboratory coagulation parameters
Croatian: Laboratorijski parametri koagulacije
English: The Patient alert card should contain the following key safety messages:
Croatian: Kartica s upozorenjima za bolesnika treba sadržavati sljedeće ključne poruke o sigurnosti primjene:
English: Roteas can be taken with or without food (see section 5.2).
Croatian: Roteas se može uzimati s hranom ili bez nje (vidjeti dio 5.2).
English: It is important that you take your medication exactly as instructed by your doctor.
Croatian: Važno je da uzimate ovaj lijek točno prema uputama liječnika.
English: • Pregnancy and breast-feeding (see section 4.6).
Croatian: • Trudnoća i dojenje (vidjeti dio 4.6).
English: If any of the above apply to you, tell your doctor before taking Roteas, because the effect of Roteas may be reduced.
Croatian: Ako se nešto od gore navedenog odnosi na Vas, obavijestite o tome svog liječnika prije nego što uzmete Roteas, jer učinak Roteasa može biti smanjen.
English: a On-Treatment: Time from first dose of study drug to last dose plus 3 days.
Croatian: a Tijekom liječenja: vrijeme od prve doze ispitivanog lijeka do zadnje doze plus 3 dana.
English: Intracranial haemorrhage (ICH)
Croatian: Intrakranijalno krvarenje (ICH)
English: The Prescriber Guide for healthcare professionals shall contain the following key elements:
Croatian: Vodič za zdravstvene djelatnike koji propisuju lijek sadržavat će sljedeće ključne elemente:
English: c The p-value is for the pre-defined non-inferiority margin of 1.5.
Croatian: P-vrijednost odnosi se na unaprijed definiranu marginu neinferiornosti od 1,5.
English: c The two-sided p-value is based on the non-inferiority margin of 1.38.
Croatian: Dvostrana p-vrijednost temelji se na margini neinferiornosti od 1,38.
English: The method used to estimate renal function (CrCL in mL/min) during the clinical development of Roteas was the Cockcroft-Gault method.
Croatian: Metoda koja se koristila za procjenu funkcije bubrega (CrCL u ml/min) tijekom kliničkog razvoja Roteasa bila je Cockcroft-Gaultova metoda.
English: Tell your doctor before taking Roteas, because these medicines may increase the effects of Roteas and the chance of unwanted bleeding.
Croatian: Obavijestite svog liječnika prije nego što uzmete Roteas, zato što ovi lijekovi mogu pojačati učinke Roteasa i vjerojatnost neželjenog krvarenja.
English: In deciding whether a procedure should be delayed until 24 hours after the last dose of Roteas, the increased risk of bleeding should be weighed against the urgency of the intervention.
Croatian: Kod odlučivanja treba li postupak odgoditi dok nije proteklo 24 sata od zadnje doze Roteasa, potrebno je procijeniti povećan rizik od krvarenja u odnosu na hitnost intervencije.
English: Do not use this medicine after the expiry date which is stated on the carton and on each blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i svakom blisteru iza EXP.
English: RISK OF BLEEDING
Croatian: Rizik od krvarenja
English: Non-fatal PE DVT only
Croatian: PE bez smrtnog ishoda Samo DVT
English: If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately.
Croatian: Ako Vam se dogodi bilo kakvo krvarenje koje ne prestaje samo od sebe ili se pojave znakovi opsežnog krvarenja (iznimna slabost, umor, bljedilo, omaglica, glavobolja ili neobjašnjeno oticanje), odmah potražite savjet liječnika.
English: Pharmacotherapeutic group: Other antithrombotic agents, ATC code: B01AF03
Croatian: Farmakoterapijska skupina: drugi antitrombotici, ATK oznaka: B01AF03
English: Renal function in NVAF
Croatian: Funkcija bubrega kod NVAF-a
English: Its active metabolite is a substrate for OATP1B1.
Croatian: Njegov djelatni metabolit je supstrat prijenosnika OATP1B1.
English: Parenteral anticoagulants
Croatian: Parenteralni antikoagulansi
English: 30 mg once daily
Croatian: 30 mg jedanput na dan
English: Patients with active cancer
Croatian: Bolesnici s aktivnim karcinomom
English: TEE-guided (within 3 days of initiation) or conventional cardioversion (at least 21 days of pre-treatment) was employed.
Croatian: 3 dana od početka liječenja) ili konvencionalna kardioverzija (uz najmanje 21 dan predliječenja).
English: Superiority testing was performed on the ITT Overall Study Period.
Croatian: Provjera superiornosti provedena je za cjelokupno ITT razdoblje ispitivanja.
English: • If you miss a dose, take it immediately and then continue the following day as normal - do not take double the prescribed dose in a single day.
Croatian: • Ako propustite dozu, odmah je uzmite i zatim nastavite sljedećeg dana prema uobičajenom rasporedu - nemojte istog dana uzeti dvostruko veću dozu od propisane.
English: CrCL (mL/min)
Croatian: Podskupina prema CrCL (ml/min)
English: • Reduced number of platelets in your blood (which can affect clotting)
Croatian: • smanjen broj trombocita u krvi (što može utjecati na zgrušavanje krvi)
English: Like other similar medicines (medicines to reduce blood clotting), Roteas may cause bleeding which may potentially be life-threatening.
Croatian: Kao i drugi slični lijekovi (lijekovi koji smanjuju zgrušavanje krvi), Roteas može uzrokovati krvarenje koje potencijalno može ugroziti život.
English: • Roteas is an oral anticoagulant factor Xa inhibitor.
Croatian: • Roteas je oralni antikoagulans, inhibitor faktora Xa.
English: Subjects with ESRD undergoing peritoneal dialysis had 93% higher total exposure compared with healthy subjects.
Croatian: Ispitanici s ESRD-om na peritonejskoj dijalizi imali su 93% veću ukupnu izloženost u usporedbi sa zdravim ispitanicima.
English: No dose modification is necessary when Roteas is administered with digoxin.
Croatian: Nije potrebna prilagodba doze kad se Roteas primjenjuje s digoksinom.
English: • The need to inform Health Care Professionals that they are taking Roteas if they need to have any surgery or invasive procedure
Croatian: • potreba da obavijeste zdravstvene djelatnike o tome da uzimaju lijek Roteas ako se moraju podvrgnuti nekom kirurškom zahvatu ili invazivnom postupku.
English: • Guidance regarding surgery or invasive procedure, and temporary discontinuation
Croatian: • smjernice u vezi s kirurškim zahvatom ili invazivnim postupkom te privremenim prekidom primjene
English: This is considered to be due to the carry-over effect of dabigatran treatment, however, this did not lead to a prolongation of bleeding time.
Croatian: To se smatra posljedicom prenesenog učinka (engl. carry-over effect) liječenja dabigatranom, međutim, to nije dovelo do produljenja vremena krvarenja.
English: Short duration of therapy (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation) and longer durations should be based on permanent risk factors or idiopathic DVT or PE.
Croatian: Kratko trajanje terapije (najmanje 3 mjeseca) treba temeljiti na prolaznim čimbenicima rizika (npr. nedavni kirurški zahvat, trauma, imobilizacija), dok dulje trajanje treba temeljiti na trajnim čimbenicima rizika ili idiopatskim DVT-ima ili PE-ima.
English: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare
Croatian: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i
English: PE with or without DVT Fatal PE or Death where PE cannot be ruled out
Croatian: PE sa ili bez DVT-a PE sa smrtnim ishodom/smrt gdje se PE
English: Therefore, use of edoxaban is not recommended in these patients.
Croatian: Stoga se ne preporučuje primjena edoksabana u ovih bolesnika.
English: Prevention of stroke and systemic embolism
Croatian: Prevencija moždanog udara i sistemske embolije
English: For all patients undergoing cardioversion: Confirmation should be sought prior to cardioversion that the patient has taken Roteas as prescribed.
Croatian: Za sve bolesnike koji će biti podvrgnuti postupku kardioverzije: Prije postupka kardioverzije potrebno je potvrditi da je bolesnik uzeo Roteas kako je propisano.
English: • endstage kidney disease or if you are on dialysis
Croatian: • završni stadij bolesti bubrega ili ako ste na dijalizi
English: Several sub-groups of patients, as detailed below, are at increased risk of bleeding.
Croatian: U nekoliko podskupina bolesnika, detaljnije opisanih u nastavku, postoji povećani rizik od krvarenja.
English: In a population pharmacokinetic analysis of the ENGAGE AF-TIMI 48 study, peak and total exposure in Asian patients and non-Asian patients were comparable.
Croatian: U analizi populacijske farmakokinetike u ispitivanju ENGAGE AF-TIMI 48, vršna i ukupna izloženost u azijatskih bolesnika i ne-azijatskih bolesnika bile su usporedive.
English: How to take Roteas).
Croatian: Kako uzimati Roteas).
English: Assessment of renal function: CrCL should be monitored at the beginning of the treatment in all patients and afterwards when clinically indicated (see section 4.2).
Croatian: Procjena funkcije bubrega: CrCL treba pratiti na početku liječenja u svih bolesnika te nakon toga kad postoji klinička indikacija (vidjeti dio 4.2).
English: Any unexplained fall in haemoglobin or blood pressure should lead to a search for a bleeding site.
Croatian: Kod svakog neobjašnjenog sniženja vrijednosti hemoglobina ili krvnog tlaka potrebno je potražiti mjesto krvarenja.
English: The educational programme is aimed at mitigating the risk of serious bleeds or haemorrhage in patients treated with Roteas by ensuring prescriber awareness and providing guidance on appropriate patient selection, correct dosing as well as management of the risk.
Croatian: Cilj edukacijskog programa je smanjiti rizik od ozbiljnih krvarenja ili hemoragija u bolesnika liječenih lijekom Roteas tako što će liječnici koji propisuju lijek biti o tome obaviješteni i što će dobiti smjernice za odgovarajući odabir bolesnika, ispravno doziranje, kao i upravljanje rizikom.
English: If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take Roteas at the times your doctor tells you to prevent blood clots in the brain and other blood vessels in your body.
Croatian: Ako je potrebno poremećeni srčani ritam vratiti u normalan provedbom postupka koji se naziva kardioverzija, uzmite Roteas u vrijeme koje Vam odredi liječnik kako biste spriječili nastanak krvnih ugrušaka u mozgu i drugim krvnim žilama u tijelu.
English: Table 10: Efficacy Results from the Hokusai-VTE Study - mITT population, overall study period Primary endpointa
Croatian: Tablica 10: Rezultati za djelotvornost u ispitivanju Hokusai-VTE - mITT populacija, cjelokupno trajanje ispitivanja Primarni ishoda
English: • Low body weight ≤ 60 kg
Croatian: • niska tjelesna težina ≤ 60 kg
English: Prior to launch of Roteas in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka Roteas u promet u pojedinoj državi članici, nositelj odobrenja za stavljanje lijeka u promet mora s nadležnim nacionalnim tijelom dogovoriti sadržaj i oblik edukacijskog programa, uključujući načine priopćavanja, oblike distribucije i sve druge vidove programa.
English: • Dizziness or sudden headache
Croatian: • omaglica ili iznenadna glavobolja
English: The patient should not take double the prescribed dose on the same day to make up for a missed dose.
Croatian: Bolesnik ne smije uzeti dvostruko veću dozu od propisane istog dana da bi nadoknadio propuštenu dozu.
English: Due to the potential reproductive toxicity, the intrinsic risk of bleeding and the evidence that edoxaban passes the placenta, Roteas is contraindicated during pregnancy (see section 4.3).
Croatian: Zbog moguće reproduktivne toksičnosti, intrinzičkog rizika od krvarenja i dokaza da edoksaban prelazi placentu, Roteas je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
English: • Please read the Patient Information Leaflet found inside each pack of Roteas.
Croatian: • Molimo da pročitate Uputu o lijeku koju možete pronaći u svakom pakiranju Roteasa.
English: This recommendation is based on standard treatment of drug overdose and data available with similar compounds, as the use of activated charcoal to reduce absorption of edoxaban has not been specifically studied in the edoxaban clinical programme.
Croatian: Ova se preporuka temelji na standardnom liječenju predoziranja lijekom i podacima koji su dostupni za slične spojeve, jer primjena aktivnog ugljena da bi se smanjila apsorpcija edoksabana nije posebno ispitivana u programu kliničkog ispitivanja edoksabana.
English: This medicine helps to prevent blood clots from forming.
Croatian: Ovaj lijek pomaže u sprječavanju stvaranja krvnih ugrušaka.
English: Thus, in addition to adequate clinical surveillance, laboratory testing of haemoglobin/haematocrit could be of value to detect occult bleeding, as judged to be appropriate.
Croatian: Stoga, osim adekvatnog kliničkog praćenja, laboratorijsko određivanje hemoglobina/hematokrita može biti vrijedno za otkrivanje okultnog krvarenja, ako se procjeni da je to prikladno.
English: • Bleeding following an injury (puncture)
Croatian: • krvarenje nakon ozljede (uboda)
English: Once a stable INR of ≥ 2.0 is achieved, the parenteral anticoagulant should be discontinued and the VKA continued.
Croatian: Jednom kad se postigne stabilan INR od ≥ 2,0, primjenu parenteralnog antikoagulansa treba prekinuti i nastaviti s primjenom AVK-a.
English: Roteas can be initiated or continued in patients who may require cardioversion.
Croatian: S primjenom lijeka Roteas može se započeti ili nastaviti u bolesnika kojima je potrebna kardioverzija.
English: > 110 to ≤ 130 497 20
Croatian: > 110 do ≤ 130 497 20
English: • Recommendations for dose adjustment in at risk populations, including patients with renal or hepatic impairment, low body weight and concomitant use of some P-gp inhibitors
Croatian: • preporuke za prilagodbu doze u rizičnim populacijama, uključujući bolesnike s oštećenjem funkcije bubrega ili jetre, niskom tjelesnom težinom i one koji istovremeno uzimaju neke inhibitore P-gp-a