FrancophonIA/ELRC3.0 huggingface dataset:
English: Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in mice or rats at exposures ≥ 20- or ≥ 17- fold the human clinical exposure at a daily dose of 55 micrograms umeclidinium, based on AUC respectively.
Croatian: Umeklidinij se nije pokazao genotoksičnim u standardnom skupu ispitivanja niti kancerogenim u ispitivanjima cjeloživotne inhalacije na miševima odnosno štakorima pri razinama izloženosti
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trelegy Ellipta 92 /55 /22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Trelegy Ellipta 92/55/22 µg prašak inhalata Fluticasone furoate/Umeclidinium/Vilanterol
English: In a pre- and post-natal study, subcutaneous administration of umeclidinium to rats resulted in lower maternal body weight gain and food consumption and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose (approximately 61-fold the human clinical exposure of umeclidinium at a daily dose of 55 micrograms, based on AUC).
Croatian: U prenatalnom i postnatalnom ispitivanju supkutana primjena umeklidinija u štakora smanjila je prirast majčine tjelesne težine i unos hrane te blago smanjila tjelesnu težinu mladunčadi prije prestanka sisanja u ženki koje su primale dozu od
English: • itchy, runny or blocked nose
Croatian: • svrbež nosa, curenje iz nosa ili začepljen nos
English: • inflammation of the sinuses
Croatian: • upala sinusa
English: There was no increase in tumour incidence in rats or mice at exposures 0.9- or 22-fold, respectively, the human clinical exposure of vilanterol at a daily dose of 22 micrograms based on AUC.
Croatian: 0,9 odnosno 22 puta veće od kliničke izloženosti u ljudi nakon primjene dnevne doze vilanterola od 22 mikrograma, što je utvrđeno na temelju AUC-a.
English: The absolute bioavailability of inhaled vilanterol was 27%, with negligible contribution from oral absorption.
Croatian: Apsolutna bioraspoloživost inhaliranog vilanterola iznosila je 27%,
English: Once the tray is opened Trelegy Ellipta is ready to use.
Croatian: Trelegy Ellipta spreman je za uporabu odmah nakon otvaranja podloška.
English: Umeclidinium
Croatian: Umeklidinij
English: No clinically relevant effects of hypokalaemia were observed in clinical studies with Trelegy Ellipta at the recommended therapeutic dose.
Croatian: U kliničkim ispitivanjima nisu primijećeni klinički značajni učinci hipokalijemije kod primjene lijeka
English: What Trelegy Ellipta looks like and contents of the pack The Ellipta inhaler consists of a light grey plastic body, a beige coloured mouthpiece cover and a dose counter.
Croatian: Inhalator Ellipta sastoji se od svijetlosivog plastičnog tijela, bež poklopca nastavka za usta i brojača doza.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: Treatment difference 95% CI
Croatian: (95% CI) Trelegy u odnosu na FF/VI
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Trelegy Ellipta inhaler:
Croatian: Ako se neposredno nakon primjene lijeka Trelegy Ellipta jave stezanje u prsnom košu, kašalj, piskanje pri disanju ili nedostatak zraka:
English: Treatment with Trelegy Ellipta should be discontinued immediately if paradoxical bronchospasm occurs.
Croatian: U slučaju paradoksalnog bronhospazma potrebno je odmah prekinuti liječenje lijekom
English: After inhalation, patients should rinse their mouth with water without swallowing.
Croatian: Za inhalaciju morate usnama obujmiti nastavak za usta uz označeni rub.
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate, 65 micrograms umeclidinium bromide equivalent to 55 micrograms umeclidinium and 22 micrograms of vilanterol (as trifenatate).
Croatian: Jedna pojedinačna inhalacija osigurava isporučenu dozu (doza koja izlazi iz nastavka za usta) od 92 mikrograma flutikazonfuroata, 65 mikrograma umeklidinijeva bromida, što odgovara količini od
English: No effect on umeclidinium AUC or Cmax was observed at a dose 8-fold higher than the therapeutic dose.
Croatian: Pri primjeni doze 8 puta veće od terapijske nije primijećen učinak na AUC niti Cmax umeklidinija.
English: Mouthpiece Air vent
Croatian: Nastavak za usta Otvor za zrak
English: FEV1= forced expiratory volume in 1 second; L= litres; LS=least squares; SE= standard error; N= number in the intentto-treat population; CI= confidence interval; a Statistically significant treatment differences for FF/UMEC/VI vs. FF/VI and FF/UMEC/VI vs. UMEC/VI were also observed at the other assessment timepoints (Weeks 4, 16, 28, and 40).
Croatian: aStatistički značajna razlika između liječenja za FF/UMEK/VI u odnosu na FF/VI i za FF/UMEK/VI u odnosu na UMEK/VI opažena je i u drugim vremenskim točkama u kojima se provodila ocjena ( 4., 16., 28. i 40. tjedan).
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Trelegy Ellipta Lijek čuvajte izvan pogleda i dohvata djece.
English: Cough Oropharyngeal pain
Croatian: Poklopac podloška
English: INSTRUCTIONS ON USE
Croatian: Ova uputa
English: Study 200812 was a 24-week, non-inferiority study (N=1,055) that compared Trelegy Ellipta (92/55/22 micrograms) with FF/VI (92/22 micrograms) + UMEC (55 micrograms), co-administered once daily as a multi-inhaler therapy in patients with a history of moderate or severe exacerbations within the prior 12 months.
Croatian: Ispitivanje 200812 bilo je 24-tjedno ispitivanje neinferiornosti (N = 1055) u kojem se Trelegy Ellipta (92/55/22 mikrograma) uspoređivao s flutikazonfuroatom/vilanterolom (92/22 mikrograma) +
English: Other long acting antimuscarinics and long acting beta2- adrenergic agonists
Croatian: LAMA) i dugodjelujućeg agonista beta2-adrenergičkih receptora (engl. long-acting beta2-adrenergic agonist, LABA) (IKS/LAMA/LABA).
English: In vitro plasma protein binding in human plasma was on average 94%.
Croatian: Stupanj vezivanja za proteine u ljudskoj plazmi in vitro u prosjeku je iznosio
English: In 113 East Asian subjects with COPD (Japanese and East Asian Heritage), who received FF/UMEC/VI from a single inhaler (27% subjects), fluticasone furoate AUC(ss) estimates were on average 30% higher compared with Caucasian subjects.
Croatian: Procijenjene vrijednosti AUC(ss) flutikazonfuroata u 113 ispitanika s KOPB-om iz istočne Azije
English: June 2019
Croatian: lipanj 2019.
English: Your doctor will perform:
Croatian: Vaš liječnik će obaviti:
English: The trial is ongoing.
Croatian: Ispitivanje je u tijeku.
English: b Measured in peripheral blood.
Croatian: b Mjereno u perifernoj krvi.
English: Resistant or Intolerant
Croatian: Rezistentan ili intolerantan
English: Iclusig blocks this signal, thereby stopping the production of these cells.
Croatian: Iclusig blokira taj signal i tako zaustavlja stvaranje tih stanica.
English: Take your next dose at your regular time.
Croatian: Svoju sljedeću dozu uzmite u redovno vrijeme.
English: Do not stop taking Iclusig without your doctor's permission.
Croatian: Nemojte prestati uzimati Iclusig bez dopuštenja svog liječnika.
English: Your doctor may want to take additional precautions.
Croatian: Vaš liječnik možda će željeti poduzeti dodatne mjere opreza.
English: Make sure you take Iclusig daily for as long as it is prescribed.
Croatian: Pobrinite se da uzimate Iclusig svakodnevno sve dok Vam je propisan.
English: Do not give this medicine to children under 18 years because no data are available in children.
Croatian: Ovaj lijek nemojte davati djeci mlađoj od 18 godina jer nema raspoloživih podataka za djecu.
English: Iclusig is available as:
Croatian: Iclusig je dostupan kao:
English: • inability to develop or maintain an erection
Croatian: • nesposobnost postizanja ili održavanja erekcije
English: What Iclusig is and what it is used for
Croatian: Što je Iclusig i za što se koristi
English: An updated RMP should be submitted:
Croatian: Dopunjeni RMP treba dostaviti:
English: • pain in one or both legs when walking or exercising, which disappears after some minutes of rest
Croatian: • bol u jednoj ili obje noge pri hodu ili vježbanju, koja nakon nekoliko minuta odmora nestaje
English: If you take more Iclusig than you should
Croatian: Ako uzmete više Iclusiga nego što ste trebali
English: An alternative or additional method of contraception should be used.
Croatian: Potrebno je koristiti alternativne ili dodatne metode kontracepcije.
English: Vascular occlusive events occurred in 44 of these 132 patients.
Croatian: Događaji vaskularne okluzije javili su se u 44 od tih 132 bolesnika.
English: Key elements of the Healthcare Professional Brochure:
Croatian: Ključni elementi Brošure za zdravstvene radnike:
English: Talk to your doctor immediately if this occurs.
Croatian: Odmah obavijestite svog liječnika ako se to dogodi.
English: Other possible side effects that may occur with the following frequencies are:
Croatian: Druge moguće nuspojave koje se mogu pojaviti sa sljedećom učestalosti su:
English: Swallow the tablets whole, with a glass of water.
Croatian: Tablete gutajte cijele, s čašom vode.
English: Symptoms are severe pain in the stomach and back.
Croatian: Simptomi su jaka bol u želucu i leđima.
English: • night sweats, increased sweating
Croatian: • noćno znojenje, pojačano znojenje
English: The safety and efficacy of Iclusig in patients less than 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost u bolesnika mlađih od 18 godina još nije utvrđena.
English: The MAH shall complete, within the stated timeframe, the below measures: Description
Croatian: Nositelj odobrenja će, unutar navedenog vremenskog okvira, provesti niže navedene mjere: Opis
English: Seek medical attention immediately if you experience any of the following serious side effects.
Croatian: Odmah zatražite liječničku pomoć ako iskusite bilo koju od sljedećih ozbiljnih nuspojava.
English: Continue Iclusig at the same dose
Croatian: Nastavite s lijekom Iclusig pri istoj dozi
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 July 2013
Croatian: Datum prvog odobrenja: 1. srpnja 2013.
English: Treatment should be continued as long as the patient does not show evidence of disease progression or unacceptable toxicity.
Croatian: Liječenje treba nastaviti sve dok bolesnik ne pokazuje znakove napredovanja bolesti ili neprihvatljive toksičnosti.
English: What Iclusig is and what it is used for What you need to know before you take Iclusig How to take Iclusig
Croatian: Što je Iclusig i za što se koristi Što morate znati prije nego počnete uzimati Iclusig Kako uzimati Iclusig
English: Other medicines and Iclusig
Croatian: Drugi lijekovi i Iclusig
English: Efficacy results are summarized in Table 6, Table 7, and Table 8.
Croatian: Rezultati djelotvornosti sažeti su u Tablici 6, Tablici 7 i Tablici 8.
English: Your doctor may reduce your dose or tell you to temporarily stop taking Iclusig if:
Croatian: Vaš liječnik može smanjiti Vašu dozu ili Vam reći da privremeno prekinete uzimati Iclusig:
English: 93055 Regensburg, Germany
Croatian: 93055 Regensburg, Njemačka
English: Bottles are packed within a cardboard box.
Croatian: Boce su pakirane u kartonsku kutiju.
English: An updated RMP shall be submitted by 24 November 2014.
Croatian: Dopunjeni Plan upravljanja rizikom treba biti podnesen do 24. studenog 2014..
English: Maintained MMR
Croatian: Održani MMR
English: Afterwards it is performed monthly or as indicated by the doctor.
Croatian: Nakon toga provodit će se mjesečno ili prema preporukama liječnika.
English: • evaluations of your heart function and the condition of your arteries and veins
Croatian: • procjenu rada Vašeg srca i stanje Vaših arterija i vena
English: In each Member State, the Marketing Authorisation Holder shall agree the format and content of the educational programme, including communication media, distribution modalities, and any other aspects of the programme with the National Competent Authority.
Croatian: U svakoj državi članici nositelj odobrenja će se o obliku i sadržaju edukacijskog programa, uključujući medije komunikacije, načine distribucije, te o svakom drugom vidu programa dogovoriti s nacionalnim nadležnim tijelom.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovog lijeka.
English: Some patients experienced more than 1 type of event.
Croatian: Neki su bolesnici imali više od 1 vrste događaja.
English: Maintained MCyR
Croatian: Održani MCyR
English: The tablets should be swallowed whole.
Croatian: Tablete treba progutati cijele.
English: Management of toxicities:
Croatian: Zbrinjavanje toksičnosti:
English: A proportion of patients did not undergo any dose reduction, based on an individual benefit-risk assessment.
Croatian: Jedan udio bolesnika nije podvrgnut nikakvom smanjenju doze, na osnovu individualne procjene koristi i rizika.
English: The effects were shown to be reversible after withdrawal of the treatment.
Croatian: Učinci su se pokazali reverzibilnim nakon prestanka liječenja.
English: What Iclusig looks like and contents of the pack
Croatian: Kako Iclusig izgleda i sadržaj pakiranja
English: Surrey KT22 9AD, United Kingdom
Croatian: Surrey KT22 9AD, Velika Britanija
English: The tablets can be taken with or without food.
Croatian: Tablete možete uzeti s ili bez hrane.
English: The clinical relevance of this finding is unknown.
Croatian: Važnost ovog nalaza za kliničku praksu nije poznat.
English: • Available data on the relationship between dose and risk of vascular occlusive events.
Croatian: • Dostupni podatci o povezanosti doze i rizika za događaje vaskularne okluzije.
English: • a history of alcohol abuse
Croatian: • anamnezu zlouporabe alkohola
English: If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Croatian: Ako se primjenjuje tijekom trudnoće, bolesnica mora biti obaviještena o potencijalnoj opasnosti za fetus.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Outer Carton:
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Kutija:
English: Talk to your doctor or pharmacist before taking Iclusig if you have:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Iclusig ako imate:
English: • Importance of assessing the risks before starting treatment with ponatinib.
Croatian: • Važnost procjene rizika prije početka liječenja ponatinibom.
English: Some patients experienced more than one type of event.
Croatian: Neki su bolesnici imali više od jedne vrste događaja.
English: Patients with hepatic impairment may receive the recommended starting dose.
Croatian: Bolesnici s oštećenjem jetre mogu primiti preporučenu početnu dozu.
English: If dose reduction is undertaken, close monitoring of response is recommended.
Croatian: Ako se poduzme smanjenje doze, preporučuje se pomno praćenje odgovora.
English: Your doctor may evaluate your response to the treatment at regular intervals.
Croatian: Vaš liječnik će možda trebati procijeniti Vaš odgovor na liječenje u redovitim razmacima.
English: Iclusig has a minor influence on the ability to drive and use machines.
Croatian: Iclusig ima mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: Myelosuppression was commonly reported in all patient populations.
Croatian: Mijelosupresija je često prijavljena u svim populacijama bolesnika.
English: *ANC = absolute neutrophil count
Croatian: *ABN = apsolutni broj neutrofila
English: Therefore, caution should be recommended when driving or operating machines.
Croatian: Stoga se preporučuje oprez prilikom upravljanja vozilima i strojevima.
English: Iclusig film-coated tablets are white, round and rounded on the upper and lower side.
Croatian: Iclusig filmom obložene tablete su bijele, okrugle i zaobljene s gornje i donje strane.
English: Total safety population N=449
Croatian: Ukupna populacija u ispitivanju sigurnosti N=449
English: Only use Iclusig during pregnancy if your doctor tells you it is absolutely necessary, as potential risks exist for the unborn child.
Croatian: Koristite Iclusig tijekom trudnoće samo ako Vam liječnik savjetuje da je to prijeko potrebno jer postoje rizici za nerođeno dijete.
English: The median dose intensity was 36 mg or, 80% of the expected 45 mg dose.
Croatian: Medijan intenziteta doze iznosio je 36 mg ili 80% od očekivane doze od 45 mg.
English: BCR-ABL mutation detected at entry, n (%) None
Croatian: BCR-ABL mutacija otkrivena pri ulasku u ispitivanje, n (%) Nema
English: Very common decreased appetite
Croatian: Vrlo često smanjen apetit
English: There are no adequate data from the use of Iclusig in pregnant women.
Croatian: Nema dovoljno podataka o primjeni Iclusiga u trudnica.
English: Most of these events occurred at the dose at which the patient achieved MCyR; fewer events occurred after dose reduction.
Croatian: Većina tih događaja javila se pri dozi s kojom su bolesnici postigli MCyR; manje događaja se javilo nakon smanjenja doze.
English: The educational programme is aimed at providing information that helps identify patients eligible for therapy, understand how ponatinib should be used safely, the risks for patients and the important adverse reactions for which monitoring and dose adjustment are recommended.
Croatian: Edukacijski program ima za cilj pružanje informacija koje pomažu identificirati bolesnike podobne za liječenje, razumjeti kako sigurno primjenjivati ponatinib, rizike za bolesnike i važne nuspojave za koje se preporučuje praćenje i prilagodba doze.
English: All Patients (N=449)
Croatian: Svi bolesnici (N=449)
English: In addition, results from logistic regression analyses of data from patients in the phase 1 trial, suggest a relationship between systemic exposure (AUC) and occurrence of arterial thrombotic events.
Croatian: Dodatno, rezultati analize podataka logističkom regresijom u bolesnika u ispitivanju faze 1, ukazuju na povezanost sistemske izloženosti (AUC) i pojave arterijskih trombotičkih događaja.
English: The following medicines can affect or be affected by Iclusig:
Croatian: Sljedeći lijekovi mogu utjecati na Iclusig ili Iclusig može utjecati na njih:
English: Iclusig belongs to a group of medicines called tyrosine kinase inhibitors.
Croatian: Iclusig pripada skupini lijekova zvanih inhibitori tirozin kinaze.
English: Patients should be monitored for response according to standard clinical guidelines.
Croatian: Mora se pratiti odgovor bolesnika u skladu sa standardnim kliničkim smjernicama.
English: Fertility The effect of Iclusig on male and female fertility is unknown.
Croatian: Plodnost Učinak lijeka Iclusig na plodnost muškaraca i žena nije poznat.
English: If you stop taking Iclusig
Croatian: Ako prestanete uzimati Iclusig
English: Patients should not crush or dissolve the tablets.
Croatian: Bolesnici ne smiju drobiti ili otapati tablete.
English: Pancreatitis and serum lipase
Croatian: Pankreatitis i serumska lipaza
English: Iclusig is used to treat adults with the following leukaemia types who are no longer benefiting from treatment with other medicines, or have a certain genetic difference known as a T315I mutation:
Croatian: Iclusig se koristi za liječenje odraslih bolesnika sa sljedećim tipovima leukemije koji više nemaju koristi od liječenja drugim lijekovima ili imaju određenu genetsku razliku poznatu kao mutacija T315I:
English: If you have been told by your doctor that you have an intolerance to milk sugar (lactose) contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite mliječni šećer (laktozu) obratite se svom liječniku prije uzimanja ovog lijeka.
English: Recommendation for close monitoring of response if a dose reduction is undertaken.
Croatian: Preporuka za pomno praćenje odgovora ako se poduzme smanjenje doze.
English: Single doses of 165 mg and an estimated 540 mg in two patients did not result in any clinically significant adverse reactions.
Croatian: Pojedinačne doze od 165 mg i procijenjena doza od 540 mg u dva bolesnika nisu uzrokovale bilo kakve klinički značajne nuspojave.
English: Baseline demographic characteristics are described in Table 5 below.
Croatian: Početne demografske karakteristike opisane su u Tablici 5 u nastavku.
English: For all patients, additional secondary efficacy endpoints included: confirmed MCyR, time to response, duration of response, progression free survival, and overall survival.
Croatian: Za sve bolesnike dodatni sekundarni ishod djelotvornosti uključivao je: potvrđeni MCyR, vrijeme do odgovora, trajanje odgovora, preživljenje bez napredovanja i ukupno preživljavanje.
English: * of 427 patients reporting prior TKI therapy with dasatinib or nilotinib
Croatian: * od 427 bolesnika koji su prijavili prethodnu TKI terapiju dasatinibom ili nilotinibom
English: • fever, often with other signs of infection due to decreased number of white blood cells
Croatian: • vrućica, često s drugim znacima infekcije, povezano s padom broja bijelih krvnih stanica
English: Of the 449 patients in the clinical study of Iclusig, 155 (35%) were ≥ 65 years of age.
Croatian: Od 449 bolesnika u kliničkom ispitivanju lijeka Iclusig, 155 (35%) bili su u dobi od 65 godina i stariji.
English: Cerebral haemorrhage and gastrointestinal haemorrhage were the most commonly reported serious bleeding events.
Croatian: Cerebralna hemoragija i gastrointestinalna hemoragija bile su najčešće prijavljeni događaji ozbiljnog krvarenja.
English: The analysis of the dose intensity-safety relationship in the phase 2 trial concluded that after adjusting for covariates, the overall dose intensity is significantly associated with an increased risk of vascular occlusion, with an odds ratio of approximately 1.6 for each 15 mg increase.
Croatian: Analizom odnosa jačina doze-sigurnost u ispitivanju faze 2 zaključeno je da je nakon prilagodbe za kovarijable, ukupna jačina doze značajno povezana s povećanim rizikom za vaskularnu okluziju, s omjerom šansi od približno 1,6 za svako povećanje od 15 mg.
English: Keep the canister in the bottle.
Croatian: Spremnik držite u boci.
English: The frequency of pancreatitis is greater in the first 2 months of use.
Croatian: Učestalost pankreatitisa je veća u prva 2 mjeseca liječenja.
English: What Iclusig contains
Croatian: Što Iclusig sadrži
English: Iclusig may be taken with or without food.
Croatian: Iclusig se može uzeti s hranom ili bez nje.
English: In these patients, alternative treatment options should also be considered before starting treatment with ponatinib.
Croatian: Za takve bolesnike treba također razmotriti alternativne načine liječenja prije početka liječenja ponatinibom.
English: *Reported using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Croatian: *prema Zajedničkim kriterijima terminologije za nuspojave Nacionalnog instituta za karcinome, verzija 4.0.
English: Blast Phase CML
Croatian: Blastična faza KML
English: It is unknown whether ponatinib affects the effectiveness of systemic hormonal contraceptives.
Croatian: Nije poznato utječe li ponatinib na učinkovitost sistemskih hormonalnih kontraceptiva.
English: Most haemorrhagic events, but not all, occurred in patients with grade 3/4 thrombocytopenia.
Croatian: Većina događaja hemoragije, ali ne svi, javila se u bolesnika s trombocitopenijom stupnja 3/4.
English: Most patients who ultimately reduced dose to 15 mg initially had their dose reduced to 30 mg for a period.
Croatian: Većina bolesnika kojima je na kraju doza smanjena na 15 mg, u početku je u nekom razdoblju primala dozu smanjenu na 30 mg.
English: Available pharmacodynamic and toxicological data cannot exclude potential excretion in human milk.
Croatian: Dostupni farmakodinamski i toksikološki podatci ne mogu isključiti mogućnost izlučivanja u majčino mlijeko.