FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you feel depressed, anxious, or have thoughts of suicide, or have unusual mood changes
Croatian: • ako se osjećate depresivno, tjeskobno, imate suicidalne misli ili neuobičajene promjene raspoloženja
English: • if you have ever had or are having suicidal thoughts or actions, depression, anxiety, or mood problems
Croatian: • ako ste ikad imali ili imate suicidalne misli ili ponašanje, depresiju, tjeskobu ili probleme s raspoloženjem
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity (including safety pharmacology endpoints and assessment of fertility-related endpoints), and toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza (uključujući mjere ishoda sigurnosne farmakologije i procjenu mjera ishoda u vezi s plodnošću) te ispitivanja reproduktivne i razvojne toksičnosti.
English: • Do not leave the syringe in direct sunlight.
Croatian: • Nemojte ostavljati štrcaljku na izravnom sunčevom svjetlu.
English: Brodalumab is a monoclonal antibody and is expected to be present in the first milk and at low levels afterwards.
Croatian: Brodalumab je monoklonsko protutijelo i očekuje se da će biti prisutno u prvom mlijeku i u malim količinama nakon toga.
English: • your stomach area (abdomen), except for a 5-centimetre area right around your belly button
Croatian: • bedro • trbuh (abdomen), osim u područje od 5 centimetara neposredno oko pupka.
English: If you use more Kyntheum than you should
Croatian: Ako primijenite više lijeka Kyntheum nego što ste trebali
English: The Star Medicines Importers Co. Ltd.
Croatian: The Star Medicines Importers Co.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Kyntheum 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 lijekom Kyntheum uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Population pharmacokinetic analysis indicated that gender did not have an effect on brodalumab pharmacokinetics.
Croatian: Populacijska farmakokinetička analiza pokazala je da spol nema učinak na farmakokinetiku brodalumaba.
English: Call your doctor,
Croatian: obavijestite svog liječnika.
English: No evidence of altered pharmacokinetic profile, clinical response, or safety profile was associated with anti-brodalumab antibody development.
Croatian: Nema dokaza o promijenjenom farmakokinetičkom profilu, kliničkom odgovoru ili sigurnosnom profilu povezanom s razvojem protutijela protiv brodalumaba.
English: LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark
Croatian: LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Danska
English: No cases of active tuberculosis were reported from clinical trials.
Croatian: U kliničkim ispitivanjima nisu prijavljeni slučajevi aktivne tuberkuloze.
English: AMAGINE-2 and AMAGINE-3
Croatian: AMAGINE-2 i AMAGINE-3
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka treba jasno evidentirati.
English: Brodalumab clearance decreases with increasing dose and exposure increases in a greater than doseproportional manner.
Croatian: Klirens brodalumaba smanjuje se kako se povećava doza, a izloženost se povećava više nego proporcionalno u odnosu na dozu.
English: Due to re-randomisation to other explored dose regimens, n-in maintenance is substantially lower than n-randomised in several arms.
Croatian: Uslijed ponovnog randomiziranja za druge istraživane režime doziranja, broj n u fazi održavanja je u nekoliko skupina značajno manji od broja n pri randomiziranju.
English: No data are available on the response to live vaccines or the risk of infection, or transmission of infection after the administration of live vaccines in patients receiving Kyntheum.
Croatian: Nema dostupnih podataka o odgovoru na živa cjepiva ili riziku infekcije, ili prijenosu infekcije nakon primjene živih cjepiva u bolesnika koji primaju Kyntheum.
English: The pharmacokinetics of brodalumab was similar between Japanese and non-Japanese patients with psoriasis.
Croatian: Farmakokinetika brodalumaba bila je slična u japanskih i drugih bolesnika s psorijazom.
English: The maintenance phase in AMAGINE-2 and -3 did not include placebo.
Croatian: Faza održavanja u ispitivanju AMAGINE-2 i -3 nije obuhvaćala placebo.
English: Tell your doctor or pharmacist:
Croatian: Obavijestite svog liječnika ili ljekarnika:
English: • if you have recently received or are scheduled to receive a vaccination.
Croatian: • ako ste nedavno primili ili ćete primiti cjepivo.
English: Always use this medicine exactly as your doctor, pharmacist or nurse has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik, ljekarnik ili medicinska sestra.
English: AMAGINE-2 and AMAGINE-3 were identical placebo- and ustekinumab-controlled trials conducted in 1831 and 1881 patients, respectively.
Croatian: AMAGINE-2 i AMAGINE-3 bila su identična placebom, odnosno ustekinumabom kontrolirana ispitivanja, provedena na 1831, odnosno 1881 bolesniku.
English: Clinically important active infections (e.g. active tuberculosis, see section 4.4).
Croatian: Klinički važne aktivne infekcije (npr. aktivna tuberkuloza, vidjeti dio 4.4).
English: H. Using slow and constant pressure, push the plunger all the way down until it stops moving
Croatian: Polagano i ravnomjerno potisnite klip skroz do kraja dok se ne prestane pomicati
English: • Do not remove the grey needle cap until you are ready to inject.
Croatian: • Nemojte uklanjati sivi zatvarač igle dok niste spremni za injiciranje.
English: Leave the syringe at room temperature for at least 30 minutes before injecting.
Croatian: Ostavite štrcaljku na sobnoj temperaturi najmanje 30 minuta prije injiciranja.
English: If a patient suffers from new or worsening symptoms of depression and/or suicidal ideation or behaviour is identified, it is recommended to discontinue treatment with Kyntheum.
Croatian: Ako bolesnik pati od novih ili pogoršanih simptoma depresije i/ili su utvrđene suicidalne misli ili ponašanje, preporučuje se prekinuti liječenje lijekom Kyntheum.
English: Self-administration instructions
Croatian: Upute za samostalnu primjenu
English: Kyntheum is given as an injection under the skin (known as a subcutaneous injection).
Croatian: Kyntheum se daje kao injekcija pod kožu (poznato kao supkutana injekcija).
English: Kyntheum is available in unit packs containing 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.
Croatian: Kyntheum je dostupan u jediničnim pakiranjima koja sadrže 2 napunjene štrcaljke i u višestrukim pakiranjima koja sadrže 6 (3 pakiranja po 2) napunjenih štrcaljki.
English: Your doctor will then help you decide whether to stop breast-feeding or stop using Kyntheum.
Croatian: Liječnik će Vam potom pomoći da odlučite hoćete li prestati dojiti ili prestati primjenjivati
English: The European Medicines Agency has deferred the obligation to submit the results of trials with Kyntheum in plaque psoriasis in one or more subsets of the paediatric population (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Kyntheum u jednoj ili više podskupina pedijatrijske populacije s plak psorijazom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Concomitant immunosuppressive therapy
Croatian: Istodobna imunosupresivna terapija
English: See the detailed “Instructions for Use” that comes with this medicine for information on the right way to store, prepare, and give your injections at home.
Croatian: U detaljnim "Uputama za uporabu" priloženima uz ovaj lijek potražite informacije o ispravnom načinu čuvanja, pripreme i davanja injekcija kod kuće.
English: No serious infections were associated with neutropenia.
Croatian: Nema ozbiljnih infekcija povezanih sa slučajevima neutropenije.
English: Once Kyntheum has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 14 days or discarded.
Croatian: Nakon što se Kyntheum izvadi iz hladnjaka i dosegne sobnu temperaturu (do 25°C) mora se iskoristiti u roku od 14 dana ili baciti.
English: Before you use a Kyntheum pre-filled syringe, read this important information: Storing your Kyntheum pre-filled syringes
Croatian: Prije primjene napunjene štrcaljke lijeka Kyntheum pročitajte ove važne informacije: Čuvanje lijeka Kyntheum u napunjenim štrcaljkama
English: • Do not recycle the syringe or sharps disposal container or throw them into household rubbish.
Croatian: • Nemojte reciklirati štrcaljku ili spremnik za odlaganje oštrih predmeta niti ih bacati u kućni otpad.
English: Baseline static Physician Global Assessment (sPGA) score ranged from “3 (moderate)” (58%) to “5 (very severe)”
Croatian: Početni rezultat prema statičkoj općoj procjeni liječnika (engl. static Physician's Global Assessment, sPGA) bio je u rasponu od "3 (umjereno)" (58%) do "5 (vrlo teško)" (5%).
English: After proper training in subcutaneous injection technique, patients may self-inject Kyntheum when deemed appropriate by a physician.
Croatian: Nakon odgovarajuće obuke o tehnici potkožnog injiciranja, bolesnici mogu sami injicirati Kyntheum ako liječnik smatra da je to prikladno.
English: Suicidal ideation and behaviour, including completed suicide, have been reported in patients treated with Kyntheum.
Croatian: Suicidalne misli i ponašanje, uključujući izvršeni suicid, prijavljeni su u bolesnika liječenih lijekom Kyntheum.
English: No dose adjustment is recommended.
Croatian: Ne preporučuje se prilagođavati dozu.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu..
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: PASI 75 Week 52 (%)
Croatian: PASI 75 u 12. tjednu (%) PASI 75 u 52. tjednu (%)
English: • Do not freeze.
Croatian: • Ne zamrzavati.
English: A causal association between treatment with Kyntheum and increased risk of suicidal ideation and behaviour has not been established.
Croatian: Nije utvrđena uzročna veza između liječenja lijekom Kyntheum i povećanog rizika od suicidalnih misli i ponašanja.
English: • if you have been told by your doctor that you have developed Crohn's disease
Croatian: • ako vam je liječnik rekao da ste razvili Crohnovu bolest
English: Women of childbearing potential should use an effective method of contraception during treatment and for at least 12 weeks after treatment.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i još najmanje 12 tjedana nakon liječenja.
English: PSI = Psoriasis Symptom Inventory.
Croatian: PSI (Psoriasis Symptom Inventory) = upitnik za simptome psorijaze.
English: Do not try to inject yourself until your healthcare provider has shown you the right way to give the injections.
Croatian: Ne pokušavajte sami injicirati lijek dok Vam zdravstveni djelatnik ne pokaže kako ispravno davati injekcije.
English: If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and should use adequate contraception while using Kyntheum and for at least 12 weeks after the last dose of Kyntheum.
Croatian: Ako ste žena reproduktivne dobi, preporučuje se da izbjegavate trudnoću i trebali biste koristiti odgovarajuću kontracepciju dok primjenjujete Kyntheum i još najmanje 12 tjedana nakon posljednje doze lijeka Kyntheum.
English: In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Croatian: Osim toga, odgovarajuća kategorija učestalosti za svaku nuspojavu definirana je na sljedeći način: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko
English: The mutagenic potential of brodalumab was not evaluated; however, monoclonal antibodies are not expected to alter DNA or chromosomes.
Croatian: Nije procijenjen mutageni potencijal brodalumaba, no ne očekuje se da bi monoklonska protutijela mogla promijeniti DNK ili kromosome.
English: Approximately 21% of patients had a history of psoriatic arthritis.
Croatian: Približno 21% ispitanika imalo je psorijatični artritis u povijesti bolesti.
English: Upper arm Stomach area (abdomen)
Croatian: Nadlaktica Trbuh (abdomen)
English: The majority of patients with suicidal behaviour had a history of depression and/or suicidal ideation or behaviour.
Croatian: Većina bolesnika sa suicidalnim ponašanjem imala je u anamnezi depresiju i/ili suicidalne misli ili ponašanje.
English: No data are available on the effect of brodalumab on human fertility.
Croatian: Nema dostupnih podataka o učinku brodalumaba na plodnost ljudi.
English: The subcutaneous bioavailability of brodalumab estimated by population pharmacokinetic modelling was 54.7% (relative standard error [RSE] = 4.25%).
Croatian: Potkožna bioraspoloživost brodalumaba procijenjena uz pomoć populacijskog farmakokinetičkog modeliranja bila je 54,7% (relativna standardna pogreška [RSE] = 4,25%).
English: Serum concentrations in monkey infants and in foetal rabbits indicated considerable passage of brodalumab from the mother to the foetus at the end of pregnancy.
Croatian: Koncentracije u serumu u dojenčadi majmuna i fetusima kunića pokazale su značajan prelazak brodalumaba s majke na plod na kraju trudnoće.
English: • Do not touch this area again before injecting.
Croatian: • Nemojte dodirivati to područje prije injiciranja.
English: Non-responder imputation is used to impute missing data.
Croatian: Dodavanje bolesnika bez odgovora upotrebljava se kako bi se uveli podaci koji nedostaju.
English: What you need to know before using Kyntheum".
Croatian: Što morate znati prije nego počnete primjenjivati lijek Kyntheum".
English: Important: Always keep the sharps disposal container out of the sight and the reach of children.
Croatian: Važno: Spremnik za odlaganje oštrih predmeta držite uvijek izvan pogleda i dohvata djece.
English: The risk and benefit of treatment with Kyntheum should be carefully weighed for patients with a history of depression and/or suicidal ideation or behaviour, or for patients who develop such symptoms.
Croatian: Rizik i korist od liječenja lijekom Kyntheum treba pažljivo procijeniti u bolesnika koji boluju od depresije i/ili imaju suicidalne misli ili ponašanje, ili bolesnika koji razviju takve simptome.
English: Human IgG2 is known to cross the placental barrier and brodalumab is a human IgG2, therefore, brodalumab has the potential to be transmitted from the mother to the developing foetus.
Croatian: Poznato je da ljudski IgG2 prolazi kroz placentu, a brodalumab je ljudski IgG2, što znači da se brodalumab može prenijeti s majke na plod u razvoju.
English: With the grey needle cap off, insert the syringe into your skin at somewhere between 45 and 90 degrees
Croatian: Štrcaljku s koje je uklonjen sivi zatvarač igle umetnite u kožu pod kutom od 45 do 90 stupnjeva
English: • mouth or throat pain
Croatian: • bol u ustima ili grlu
English: • Keep in the refrigerator (2°C to 8°C).
Croatian: • Čuvati u hladnjaku (2°C - 8°C).
English: Doses up to 700 mg intravenously have been administered in clinical trials with no evidence of dose limiting toxicity.
Croatian: U kliničkim su ispitivanjima intravenski primjenjivane doze do 700 mg bez dokaza o toksičnosti ograničenoj dozom.
English: Using Kyntheum will benefit you by leading to improvements of skin clearance and reducing psoriasis signs and symptoms, such as itch, redness, scaling, burning, stinging, cracking, flaking and pain.
Croatian: Primjena lijeka Kyntheum pomoći će Vam tako što će poboljšati čišćenje kože i ublažiti znakove i simptome psorijaze, kao što su svrbež, crvenilo, ljuštenje, žarenje, peckanje, pucanje, ljuskanje i bol.
English: K. Check the injection site
Croatian: Provjerite mjesto injiciranja
English: Impact of weight on pharmacokinetics
Croatian: Učinak tjelesne težine na farmakokinetiku
English: Throw away Kyntheum if it is not used within 14 days of storage at room temperature.
Croatian: Bacite Kyntheum ako se ne upotrijebi u roku od 14 dana čuvanja na sobnoj temperaturi.
English: If a patient develops a serious infection, the patient should be closely monitored and Kyntheum should not be administered until the infection resolves.
Croatian: Ako se u bolesnika razvije ozbiljna infekcija, potrebno ga je pažljivo nadzirati i prekinuti liječenje lijekom Kyntheum dok se infekcija ne povuče.
English: - The active substance is brodalumab.
Croatian: - Djelatna tvar je brodalumab.
English: If there is blood, press a cotton ball or gauze pad on your injection site.
Croatian: Ako krvari, pritisnite pamučnu vaticu ili tupfer od gaze na mjesto injiciranja.
English: Based on the magnitude of change in exposure of midazolam, no dose adjustment of CYP3A4/3A5 substrates is necessary when administered concomitantly with Kyntheum.
Croatian: Na temelju veličine promjene u izloženosti midazolamu, nije potrebno prilagođavanje doze supstrata CYP3A4/3A5 kada se primjenjuje istodobno s lijekom Kyntheum.
English: Although a role for interleukin (IL)-17A and IL-17RA in the regulation of CYP450 enzymes has not been reported, the effect of brodalumab on CYP3A4/3A5 activity was evaluated in a disease-drug-drug interaction study.
Croatian: Iako nije prijavljena uloga interleukina (IL)-17A i IL-17RA u reguliranju enzima CYP450, učinak brodalumaba na aktivnost enzima CYP3A4/3A5 procijenjena je u ispitivanju interakcija bolest-lijek-lijek.
English: The pre-filled syringe should not be used if it has been dropped on a hard surface.
Croatian: Napunjena štrcaljka ne smije se upotrijebiti ako je pala na tvrdu površinu.
English: Figure 1: PASI 100 during induction and maintenance phase for Kyntheum and ustekinumab (AMAGINE-2 and AMAGINE-3, pooled)
Croatian: Slika 1: PASI 100 tijekom indukcijske faze i faze održavanja za Kyntheum i ustekinumab (AMAGINE-2 i AMAGINE-3, zbirno)
English: Retreatment was available at or after Week 16 for patients with return of disease and rescue treatment was available after 12 weeks of retreatment.
Croatian: Ponovno liječenje bilo je dostupno u 16. tjednu ili nakon njega za bolesnike kod kojih se bolest vratila, a simptomatsko liječenje bilo je dostupno nakon 12 tjedana ponovnog liječenja.
English: Kyntheum is a medicine that contains the active substance brodalumab.
Croatian: Kyntheum je lijek koji sadrži djelatnu tvar brodalumab.
English: Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Croatian: Nekim bolesnicima koji na početku ostvare djelomičan odgovor stanje se može naknadno poboljšati nastavkom liječenja nakon 16 tjedana.
English: Most adverse reactions of Kyntheum-associated neutropenia observed were mild, transient and reversible.
Croatian: Većina nuspojava neutropenije povezane s lijekom Kyntheum bila je blaga, prolazna i reverzibilna.
English: Call your doctor, pharmacist or nurse immediately.
Croatian: Odmah nazovite svog liječnika, ljekarnika ili medicinsku sestru.
English: • alcohol wipes
Croatian: • vatice natopljene alkoholom
English: Animal studies did not show any effects on male and female reproductive organs and on sperm count, motility and morphology (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala nikakav učinak na muške i ženske reproduktivne organe, na broj spermija, njihovu pokretljivost ni morfologiju (vidjeti dio 5.3).
English: PSIBaseline score (mean±SD) PSIresponder Week 12 (%)
Croatian: PSIOsnovni rezultat (prosjek±SD) PSIispitanik u 12. tjednu (%)
English: Based on an exploratory descriptive analysis, no relationship was observed between exposure and incidence of serious infections and infestations, candida infections, viral infections, and suicidal ideation and behaviour events.
Croatian: Na temelju eksploratorne deskriptivne analize nije opažen odnos između izloženosti i incidencije ozbiljnih infekcija i infestacije, kandidijaza,
English: Please read all the instructions before using the Kyntheum pre-filled syringe.
Croatian: Pročitajte sve upute prije primjene napunjene štrcaljke lijeka Kyntheum.
English: • redness, pain, itching, bruising, or bleeding at injection site
Croatian: • crvenilo, bol, svrbež, stvaranje modrica ili krvarenje na mjestu injiciranja
English: C. Collect all the materials you need
Croatian: Pripremite potrebne materijale
English: Do not rub the injection site.
Croatian: Nemojte trljati mjesto injiciranja.
English: • Do not shake the pre-filled syringe before use.
Croatian: • Ne tresite napunjenu štrcaljku prije uporabe.
English: Pharmacokinetic/pharmacodynamic relationship(s) A population pharmacokinetic/pharmacodynamic model, developed using all available data indicated that at a dose of 210 mg every 2 weeks, 90% of all patients would be predicted to maintain a trough concentration greater than the estimated IC90 value of 1.51 mcg/ml.
Croatian: Farmakokinetički/farmakodinamički odnos(i) Populacijski farmakokinetički/farmakodinamički model razvijen uz pomoć svih dostupnih podataka pokazao je da bi pri dozi od 210 mg svaka 2 tjedna 90% svih bolesnika zadržalo najnižu koncentraciju lijeka veću od procijenjene IC90 vrijednosti od 1,51 mcg/ml.
English: Kyntheum has no or negligible influence on the ability to drive and use machines.
Croatian: Kyntheum ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Most of these side effects are mild to moderate.
Croatian: Većina je tih nuspojava blaga do umjerena.
English: Brodalumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells.
Croatian: Brodalumab je rekombinantno ljudsko monoklonsko protutijelo proizvedeno u stanicama jajnika kineskog hrčka (engl.
English: It is therefore preferable to avoid the use of Kyntheum during pregnancy.
Croatian: Stoga se preporučuje izbjegavati primjenu lijeka Kyntheum tijekom trudnoće.
English: IL-17RA is a protein expressed on the cell surface and is a required component of receptor complexes utilized by multiple IL-17 family cytokines.
Croatian: IL-17RA je bjelančevina izražena na površini stanica i nužni dio receptorskih kompleksa koje koristi više citokina iz obitelji IL-17.
English: Ustekinumab n-randomised n-completed Week 12 n-in maintenance
Croatian: Ustekinumab n-randomizirano n-navršen 12. tjedan n-u fazi održavanja n-navršen 52. tjedan
English: This medicine works by blocking the activity of IL-17 proteins, which are present at increased levels in diseases such as psoriasis.
Croatian: Ovaj lijek djeluje tako da blokira aktivnost bjelančevina IL-17, čija je razina povećana u bolestima kao što je psorijaza.
English: Place finger or thumb on edge of tray to secure it while you remove syringe.
Croatian: Postavite prst ili palac na rub podloška da biste ga učvrstili dok vadite štrcaljku.
English: Solution for injection Multipack: 6 (3 packs of 2) pre-filled syringes
Croatian: Otopina za injekciju Višestruko pakiranje: 6 (3 pakiranja po 2) napunjene štrcaljke
English: Antibodies to brodalumab developed in 2.7% (122/4461) of patients treated with Kyntheum for up to 52 weeks in psoriasis clinical trials (0.3% of these patients had anti-brodalumab antibodies at baseline).
Croatian: Protutijela na brodalumab razvila su se u 2,7% (122/4461) bolesnika koji su primali Kyntheum do 52 tjedna u kliničkim ispitivanjima psorijaze (0,3% tih bolesnika imalo je protutijela protiv brodalumaba na samom početku).
English: No pharmacokinetic data are available in patients with impaired renal or hepatic function.
Croatian: Nema dostupnih farmakokinetičkih podataka u bolesnika s oštećenjem funkcije bubrega ili jetre.