FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH should provide a patient/carer reminder card in each pack, the text of which is included in the Package Leaflet.
Slovenian: Imetnik dovoljenja za promet naj pri vsakem pakiranju priloži opozorilno kartico za bolnika/skrbnika, katere besedilo je vključeno v navodilo za uporabo.
English: Limited data are available on the combined use of Ferriprox and deferasirox, and caution should be applied when considering the use of such combination.
Slovenian: O sočasni uporabi zdravila Ferriprox in deferasiroksa so na voljo le omejeni podatki, zato je potrebna previdnost pri odločanju o uvedbi takega zdravljenja.
English: Carcinogenicity/mutagenicity
Slovenian: Karcinogenost/mutagenost
English: Peak serum concentrations of the glucuronide occur 2 to 3 hours after administration of deferiprone.
Slovenian: Najvišje koncentracije glukuronida v serumu nastopijo 2 do 3 ure po dajanju deferiprona.
English: Number of 1000 mg tablets* Morning
Slovenian: Število 1000 mg tablet*
English: The children recovered from these symptoms after Ferriprox discontinuation.
Slovenian: Ti simptomi so se pri otrocih popravili po prekinitvi jemanja zdravila Ferriprox.
English: Given that deferiprone can be associated with neutropenia and agranulocytosis, therapy in immunocompromised patients should not be initiated unless potential benefits outweigh potential risks.
Slovenian: Deferipron je povezan z nevtropenijo in agranulocitozo, zato se zdravljenja ne sme uvesti pri bolnikih ki imajo prizadet imunski sistem, razen če potencialne koristi prevladajo nad tveganji.
English: After starting Ferriprox therapy, it is recommended that serum ferritin concentrations, or other indicators of body iron load, be monitored every two to three months to assess the long-term effectiveness of the chelation regimen in controlling the body iron load.
Slovenian: Po pričetku terapije z zdravilom Ferriprox je priporočljivo koncentracijo serumskega feritina ali drugih pokazateljev količine železa v telesu meriti na vsake dva do tri mesece, da se lahko določi dolgotrajno učinkovitost zdravljenja s kelacijo pri nadzorovanju količine železa v telesu.
English: A positive correlation between MRI T2* values and cardiac function (as measured by Left Ventricular Ejection Fraction (LVEF)) has been documented.
Slovenian: Ugotovljena je bila pozitivna odvisnost med vrednostmi MRI T2* in srčno funkcijo (izmerjeno z iztisnim deležem levega prekata (LVEF)).
English: Based on the reported adverse interaction that can occur between deferoxamine and vitamin C, caution should be used when administering deferiprone and vitamin C concurrently.
Slovenian: Na podlagi poročil o možni interakciji med deferoksaminom in vitaminom C se svetuje dodatna previdnost pri sočasnem dajanju deferiprona in vitamina C.
English: Concurrent use of iron chelators is not recommended in patients whose serum ferritin falls below 500 µg/l due to the risk of excessive iron removal.
Slovenian: Sočasna uporaba kelatorjev železa ni priporočljiva pri bolnikih, pri katerih je vrednost feritina v serumu padla pod 500 µg/l, saj obstaja nevarnost prekomerne odstranitve železa.
English: − If you have any further questions, ask your doctor or pharmacist.
Slovenian: − Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
English: A magnetic resonance imaging (MRI) method, T2*, was also used to quantify myocardial iron load.
Slovenian: Tudi metoda magnetne resonance (MRI), T2*, je bila uporabljena za določitev količine miokardnega železa.
English: If you get any symptoms of infection such as fever, sore throat or flu-like symptoms, immediately seek medical attention.
Slovenian: Če se pri vas pojavijo kakršni koli simptomi okužbe, kot so zvišana telesna temperatura, vneto grlo ali gripi podobni simptomi, takoj poiščite zdravniško pomoč.
English: The effect of Ferriprox in decreasing the body iron is directly influenced by the dose and the degree of iron overload.
Slovenian: Na učinkovitost zdravila Ferriprox pri zmanjševanju količine železa v telesu neposredno vplivata odmerek in stopnja presežne količine železa.
English: Other medicines and Ferriprox
Slovenian: Druga zdravila in zdravilo Ferriprox
English: − increase in liver enzymes
Slovenian: - povečanje jetrnih encimov
English: Following randomization, 32 patients received deferoxamine (34.9 mg/kg/day for 5 days/week) and Ferriprox (75 mg/kg/day) and 33 patients received deferoxamine monotherapy (43.4 mg/kg/day for 5 days/week).
Slovenian: Po randomizaciji je 32 bolnikov prejelo deferoksamin (34,9 mg/kg/dan, 5 dni/teden) in zdravilo Ferripox (75 mg/kg/dan), 33 bolnikov pa je prejelo monoterapijo z deferoksaminom (43,4 mg/kg/dan,
English: Deferiprone is rapidly absorbed from the upper part of the gastrointestinal tract.
Slovenian: Absorpcija Deferipron se hitro absorbira iz zgornjega dela prebavnega trakta.
English: Over the 12-month duration of the study, Ferriprox was superior to deferoxamine in decreasing cardiac iron load.
Slovenian: V času dvanajstmesečne študije se je Ferriprox izkazal za učinkovitejšega od deferoksamina pri zmanjševanju presežne količine železa v srcu.
English: A randomized, placebo-controlled, double-blind trial evaluated the effect of concurrent therapy with Ferriprox and deferoxamine in patients with thalassaemia major, who previously received the standard chelation monotherapy with subcutaneous deferoxamine and had mild to moderate cardiac iron loading (myocardial T2* from 8 to 20 ms).
Slovenian: V randomiziranem, s placebom kontroliranem, dvojno slepim preskušanjem so ovrednotili učinek sočasnega zdravljenja z zdravilom Ferriprox in deferoksaminom pri bolnikih s talasemijo major, ki so pred tem prejeli standardno kelacijsko monoterapijo s podkožno injiciranim deferoksaminom, in so imeli blago do zmerno obremenitev srca z železom (miokardni T2 * od 8 do 20 ms).
English: Have your blood monitored on a weekly basis for the first one year of treatment with Ferriprox and as regularly as your doctor recommends thereafter.
Slovenian: Prvo leto zdravljenja z zdravilom Ferriprox redno hodite na preiskave za spremljanje krvne slike, nato pa tako pogosto, kot vam priporoči zdravnik.
English: − low white blood cell count (agranulocytosis and neutropenia)
Slovenian: - nizka koncentracija belih krvničk (agranulocitoza in nevtropenija)
English: The other ingredients are: purified water; hydroxyethylcellulose; glycerol (E422); hydrochloric acid, concentrated (for pH adjustment); artificial cherry flavour; peppermint oil; Sunset Yellow (E110); sucralose (E955).
Slovenian: Pomožne snovi so: prečiščena voda; hidroksietilceluloza; glicerol (E422); klorovodikova kislina, koncentrirana (za uravnavanje pH); umetna aroma češnje; olje poprove mete; oranžno FCF (E110);
English: Patients should be aware to contact their physician if they experience any symptoms indicative of infection (such as fever, sore throat and flu-like symptoms).
Slovenian: Bolniki morajo vedeti, da morajo svojega zdravnika obvestiti o vsakršnih simptomih, ki kažejo na okužbo (kot so zvišana telesna temperatura, vneto grlo ali simptomi, podobni gripi).
English: Discolored urine is a very common effect and is not harmful.
Slovenian: Sprememba barve urina se pogosto pojavi, vendar ni škodljiva.
English: Fertility No effects on fertility or early embryonic development were noted in animals (see section 5.3).
Slovenian: Učinki na plodnost ali zgodnji razvoj ploda pri živalih niso bile zabeležene (glejte poglavje 5.3).
English: (≥1/100 to <1/10)
Slovenian: POGOSTI (≥ 1/100
English: The neurological disorders progressively regressed after deferiprone discontinuation (see sections 4.4 and 4.9).
Slovenian: Nevrološke funkcije so se progresivno izboljšale po prekinitvi jemanja deferiprona (glejte poglavji 4.4 in 4.9).
English: If you experience nausea or vomiting, it may help to take your Ferriprox with some food.
Slovenian: Če se pri vas pojavita slabost ali bruhanje, bo morda pomagalo, če vzamete zdravilo Ferriprox skupaj s hrano.
English: Do not take medicines known to cause neutropenia or agranulocytosis (see “Do not take Ferriprox”).
Slovenian: Ne jemljite zdravil, za katera je znano, da povzročajo nevtropenijo ali agranulocitozo (glejte poglavje »Ne jemljite zdravila Ferriprox«).
English: Do not use this medicine after the expiry date which is stated on the carton and the label after EXP. Do not store above 30ºC.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in škatli poleg oznake EXP.
English: Take your second dose midday.
Slovenian: Prvi odmerek vzemite zjutraj, drugi odmerek opoldne, tretjega pa zvečer.
English: Ferriprox is used to treat iron overload caused by frequent blood transfusions in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Slovenian: Zdravilo Ferriprox se uporablja za zdravljenje prenasičenosti z železom, ki jo povzročijo pogoste transfuzije krvi pri bolnikih s talasemijo major, če je trenutna kelacijska terapija kontraindicirana ali nezadostna.
English: Iron overload causes concentration-dependent MRI T2* signal loss, thus, increased myocardial iron reduces myocardial MRI T2* values.
Slovenian: Zaradi presežne količine železa pride do izgube signala pri MRI T2*, ki je odvisen od nasičenosti; na ta način povečana količina miokardnega železa zmanjša vrednosti MRI T2*.
English: There is a small chance that you may develop agranulocytosis (very low white blood cell count) while taking Ferriprox, which may lead to a serious infection.
Slovenian: Obstaja majhna možnost, da med jemanjem zdravila Ferriprox pride do agranulocitoze (zelo nizko število belih krvničk), ki lahko vodi do resne okužbe.
English: You must use effective contraception while you are taking Ferriprox.
Slovenian: Med jemanjem tega zdravila morate uporabljati učinkovito kontracepcijo.
English: PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 100 filmsko obloženih tablet
English: The incidences of “Musculoskeletal and connective tissue disorders” and "Renal and urinary disorders" were lower during combination therapy than monotherapy, whereas the incidence of “Cardiac disorders" was higher during combination therapy than monotherapy.
Slovenian: Pojavnost »bolezni mišično-skeletnega sistema in vezivnega tkiva« in »bolezni sečil« je bila nižja med kombinirano terapijo kot med monoterapijo, medtem ko je bila pojavnost »srčnih bolezni« višja med kombinirano terapijo kot med monoterapijo.
English: If you become pregnant while taking Ferriprox, stop taking the medicine immediately and tell your doctor.
Slovenian: Ferriprox zanosite, ga takoj prenehajte jemati in obvestite zdravnika.
English: If you forget to take Ferriprox
Slovenian: Če ste pozabili vzeti zdravilo Ferriprox
English: The tablet is scored.
Slovenian: Tableta ima razdelilno zarezo.
English: Renal or hepatic impairment and liver fibrosis
Slovenian: Bolniki z motnjami v delovanju jeter oziroma ledvic in fibrozo jeter
English: Each ml of oral solution contains 0.4 mg Sunset Yellow (E110).
Slovenian: En ml peroralne raztopine vsebuje 0,4 mg barvila sončno rumeno FCF (E110).
English: Hypromellose 2910 USP/EP
Slovenian: Obloga hipromeloza 2910 USP/EP hidroksipropilceluloza makrogol titanov dioksid
English: Provide protective isolation and if clinically indicated, admit patient to the hospital.
Slovenian: Zagotovite izolacijo bolnika in bolnika hospitalizirajte, če je to klinično indicirano.
English: Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC02
Slovenian: oznaka ATC: V03AC02
English: PHARMACEUTICAL FORM AND CONTENTS 250 ml oral solution
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 250 ml peroralne raztopine
English: The most serious adverse reaction reported in clinical trials with deferiprone was agranulocytosis, defined as an absolute neutrophil count less than 0.5 x 109/l, which occurred in approximately 1% of patients.
Slovenian: Najhujši stranski učinek pri kliničnih testiranjih z deferipronom je bila agranulocitoza, določena z absolutno količino nevtrofilcev manjšo od 0,5 x 109/l, do katere je prišlo pri približno 1% pacientov.
English: Myocardial MRI T2* values of less than 20 ms represent iron overload in the heart.
Slovenian: Miokardne vrednosti MRI T2*, ki znašajo manj kot 20 ms, kažejo, da gre za presežno količino železa v srcu.
English: Because white blood cells help to fight infection, a low neutrophil count may place you at risk of developing a serious and potentially life-threatening infection.
Slovenian: Bele krvničke pomagajo braniti pred okužbo, zato lahko zaradi nizke koncentracije nevtrofilcev tvegate resno in življenjsko nevarno okužbo.
English: Study LA16-0102 compared the efficacy of Ferriprox with that of deferoxamine in decreasing cardiac iron overload and in improving cardiac function (as measured by LVEF) in transfusion-dependent thalassaemia patients.
Slovenian: V študiji LA16-0102 je bila primerjana učinkovitost zdravila Ferriprox in deferoksamina pri zmanjševanju presežne količine kardialnega železa in izboljševanju delovanja srca (izmerjeno z LVEF) pri pacientih s talasemijo, ki so odvisni od transfuzije.
English: No significant effect of renal impairment was seen on systemic exposure to deferiprone.
Slovenian: Pri sistemski izpostavljenosti deferipronu pomembnega učinka ledvične okvare niso opazili.
English: Dose (mg, three times/day)
Slovenian: Odmerek (mg, trikrat/dan)
English: Data from the pooled safety database from clinical trials (1343 patient-years exposure to Ferriprox monotherapy and 244 patient-years exposure to Ferriprox and deferoxamine) showed statistically significant (p<0.05) differences in the incidence of adverse reactions based on System Organ Class for “Cardiac disorders", "Musculoskeletal and connective tissue disorders” and "Renal and urinary disorders".
Slovenian: Podatki iz združenih varnostnih podatkov iz kliničnih preskušanj (1343 bolnikov-let izpostavljenosti monoterapiji s Ferriproxom in 244 bolnikov-let izpostavljenosti Ferriproxu in deferoksaminu) so pokazali statistično značilne razlike (p<0,05) v pojavnosti neželenih učinkov glede na organske sisteme, in sicer za »srčne bolezni«, »bolezni mišično-skeletnega sistema in vezivnega tkiva« in »bolezni sečil«.
English: Ferriprox oral solution contains the colouring agent Sunset Yellow (E110) which may cause allergic reactions.
Slovenian: Peroralna raztopina Ferriprox vsebuje sončno rumeno FCF (E110), ki lahko povzroči alergijsko reakcijo.
English: The most common adverse reactions reported during therapy with deferiprone in clinical trials were nausea, vomiting, abdominal pain, and chromaturia, which were reported in more than 10% of patients.
Slovenian: Najpogosteje omenjeni stranski učinki med terapijo pri kliničnem testiranju z deferipronom pri več kot 10 % vseh pacientov so bili slabost, bruhanje, bolečine v trebuhu in kromaturija.
English: Careful monitoring of cardiac events in patients on combination therapy is warranted (see section 4.4).
Slovenian: Pri bolnikih s kombiniranim zdravljenjem je potrebno skrbno spremljanje srčnih dogodkov (glejte poglavje 4.4).
English: No prenatal and postnatal reproductive studies have been conducted in animals.
Slovenian: Na živalih ni bilo izvedenih prenatalnih in postnatalnih študij vpliva na sposobnost razmnoževanja.
English: Ferriprox is packaged in bottles of 50 tablets.
Slovenian: Ferriprox je pakiran v plastenkah po 50 tablet.
English: Provide this card to your doctor if you develop infection symptoms such as a fever, sore throat or flu-like symptoms.
Slovenian: To kartico pokažite zdravniku, če se pri vas pojavijo simptomi okužbe, kot je zvišana telesna temperatura, vneto grlo ali gripi podobni simptomi.
English: Ferriprox 1000 mg film-coated tablets EU/1/99/108/004
Slovenian: Ferriprox 1000 mg filmsko obložene tablete EU/1/99/108/004
English: There was no significant difference in percentage of patients with cardiac dysfunction at first assessment (13% for Ferriprox vs. 16% for deferoxamine).
Slovenian: Znatna razlika v deležu pacientov s kardialno disfunkcijo pri prvem ocenjevanju ni bila opažena (13% pri Ferriproxu proti
English: - Due to the unknown mechanism of deferiprone-induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section 4.5).
Slovenian: - Zaradi neznanega mehanizma nastanka nevtropenije, ki jo povzroči deferipron, bolniki ne smejo jemati zdravil, povezanih z nevtropenijo, ali takšnih, ki lahko povzročijo agranulocitozo (glejte poglavje 4.5).
English: LIST OF EXCIPIENTS Contains Sunset Yellow (E110); see leaflet for further information.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje sončno rumeno FCF (E110); dodatne informacije najdete v priloženih navodilih.
English: Increased liver enzymes
Slovenian: Preiskave povišane vrednosti jetrnih encimov
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja deferiprona (glejte poglavje 5.3).
English: Following a dose of 25 mg/kg, lower peak serum concentrations have been detected in patients in the fed state (85 µmol/l) than in the fasting state (126 µmol/l), although there was no decrease in the amount of deferiprone absorbed when it was given with food.
Slovenian: (85 µmol/l), kot pri bolnikih, ki so zdravilo vzeli na tešče (126 µmol/l); čeprav se absorpcija deferiprona ni zmanjšala, če je bolnik zdravilo vzel s hrano.
English: Abdominal Pain Vomiting
Slovenian: Bolezni prebavil navzea abdominalna bolečina bruhanje
English: The other ingredients are: Tablet core: Microcrystalline cellulose, Magnesium stearate, Colloidal silicon dioxide.
Slovenian: Druge sestavine so: Jedro tablete: mikrokristalna celuloza, magnezijev stearat, koloiden silicijev dioksid.
English: To obtain a dose of about 75 mg/kg/day, use the volume of oral solution suggested in the following table for the body weight of the patient.
Slovenian: Za odmerek približno 75 mg/kg/dan uporabite količino peroralne raztopine, priporočene v naslednji preglednici za telesno maso bolnika.
English: Please refer to the patient/carer reminder card attached to this leaflet.
Slovenian: Glejte opozorilno kartico za bolnika/skrbnika, priloženo temu navodilu.
English: To monitor for neutropenia, your doctor will ask you to have a blood test (to check your white blood cell count) performed regularly, as frequently as every week, while you are being treated with Ferriprox.
Slovenian: Zdravnik vam bo naročil, da morate med zdravljenjem z zdravilom Ferriprox redno na krvne preiskave za spremljanje nevtropenije (za preverjanje števila belih krvnih celic), ki vam jih bodo opravili morda celo vsak teden.
English: Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Slovenian: Monoterapija z zdravilom Ferriprox je indicirana za zdravljenje preobremenjenosti z železom pri bolnikih s talasemijo major, če je trenutna kelacijska terapija kontraindicirana ali nezadostna.
English: − fatigue
Slovenian: - utrujenost
English: However, chelation therapy may not necessarily protect against iron-induced organ damage.
Slovenian: da bo terapija s keliranjem zaščitila organe pred poškodbami, ki jih povzroča železo.
English: To obtain a dose of about 75 mg/kg/day, use the number of tablets suggested in the following tables for the body weight of the patient.
Slovenian: Za doseganje odmerka 75 mg/kg/dan glede na telesno maso bolnika uporabite število tablet po naslednjih preglednicah.
English: Sixty-one patients with cardiac iron overload, previously treated with deferoxamine, were randomized to continue deferoxamine (average dose 43 mg/kg/day; N=31) or to switch to Ferriprox (average dose 92 mg/kg/day N=29).
Slovenian: Naključno so izbrali 61 pacientov s presežno količino kardialnega železa, ki so se prej zdravili z deferoksaminom, da so nadaljevali z deferoksaminom (povprečen odmerek 43 mg/kg/dan; N = 31) ali pa prešli na Ferriprox (povprečen odmerek 92 mg/kg/dan; N = 29).
English: Caution must be exercised in patients with end stage renal disease or severe hepatic dysfunction.
Slovenian: Pri bolnikih s končno ledvično odpovedjo ali hudo okvarjenim delovanjem jeter je potrebna previdnost.
English: Each 500 mg tablet contains 500 mg deferiprone.
Slovenian: Vsaka 500 mg tableta vsebuje 500 mg deferiprona.
English: Do not take Ferriprox if you are pregnant or if you are trying to become pregnant.
Slovenian: Zdravila Ferriprox ne jemljite, če ste noseči ali poskušate zanositi.
English: There are no data available on the use of deferiprone in patients with end stage renal disease or severe hepatic impairment (see section 5.2).
Slovenian: O uporabi deferiprona pri bolnikih s končno ledvično odpovedjo ali hudo jetrno okvaro podatki niso na voljo (glejte poglavje 5.2).
English: Newly diagnosed cardiac dysfunction occurred in 13 (20.6%) deferoxamine-treated patients and in 2 (4.3%) Ferriprox-treated patients who were cardiac disease-free at the first assessment (p=0.013).
Slovenian: (20,6 %) pacientih, ki so jih zdravili z deferoksaminom in pri 2 (4,3 %) pacientih, ki so jemali Ferriprox in niso imeli srčne bolezni pri prvem ocenjevanju (p = 0,013).
English: - Pregnancy (see section 4.6).
Slovenian: - Anamneza agranulocitoze - Nosečnost (glejte poglavje 4.6) - Dojenje (glejte poglavje 4.6)
English: In the case of iron-induced heart failure, Ferriprox at 75-100 mg/kg/day should be added to deferoxamine therapy.
Slovenian: V primeru srčnega popuščanja zaradi železa je treba terapiji z deferoksaminom dodati zdravilo Ferriprox 75-100 mg/kg/dan.
English: Pack size of 50 tablets.
Slovenian: Pakiranje po 50 tablet.
English: An open-label, non-randomized, parallel group clinical study was conducted to evaluate the effect of impaired renal function on the safety, tolerability, and pharmacokinetics of a single 33 mg/kg oral dose of Ferriprox.
Slovenian: Opravljeno je bilo odprto, nerandomizirano klinično preskušanje z vzporednima skupinama, da bi ocenili učinek okvarjenega delovanja ledvic na varnost, prenašanje in farmakokinetiko enkratnega peroralnega odmerka zdravila Ferriprox 33 mg/kg.
English: MONITORING YOUR WHITE BLOOD CELL COUNT WITH FERRIPROX
Slovenian: SPREMLJANJE ŠTEVILA BELIH KRVNIČK MED JEMANJEM ZDRAVILA FERRIPROX
English: Amber polyethylene terephthalate (PET) bottles with child resistant closure (polypropylene), and a graduated measuring cup (polypropylene).
Slovenian: Rumenkastorjave polietilentereftalatne (PET) plastenke z zamaškom, ki otrokom onemogoča odpiranje (polipropilen), in merilno posodico (polipropilen).
English: The usual dose is 25 mg/kg, 3 times per day, for a total daily dose of 75 mg/kg.
Slovenian: Običajen odmerek je 25 mg/kg trikrat na dan; s tem se doseže skupen dnevni odmerek 75 mg/kg.
English: Manufacturing Authorisation Holder: Eurofins PROXY Laboratories B.V. Archimedesweg 25
Slovenian: Imetnik dovoljenja za izdelavo zdravila: Eurofins PROXY Laboratories B.V.
English: No effects on fertility or early embryonic development were noted in non-iron-loaded male and female rats that received deferiprone orally at doses of up to 75 mg/kg twice daily for 28 days (males) or 2 weeks (females) prior to mating and until termination (males) or through early gestation (females).
Slovenian: ženskega in moškega spola, ki niso bile obremenjene z železom in so prejemale deferipron peroralno v odmerkih do 75 mg/kg dvakrat dnevno 28 dni (samci) ali 2 tedna (samice) pred parjenjem, in do terminacije (samci) ali skozi zgodnjo gestacijo (samice), učinka na plodnost ali zgodnji razvoj ploda ni bilo zaznati.
English: 500 ml oral solution
Slovenian: 500 ml peroralne raztopine
English: Subjects were categorized into 3 groups based on the Child-Pugh classification score: healthy volunteers, mild hepatic impairment (Class A: 5- 6 points), and moderate hepatic impairment (Class B: 7- 9 points).
Slovenian: Preskušanci so bili razvrščeni v 3 skupine na podlagi rezultata po razvrstitvi Child-Pugh: zdravi prostovoljci, blaga jetrna okvara (razred A: 5-6