FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 1323 patients were randomised to receive roflumilast 500 micrograms once a day for 12 weeks (n=443), roflumilast 500 micrograms every other day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (n=439), or roflumilast 250 micrograms once a day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (n=441).
Croatian: Ukupno su 1323 bolesnika randomizirana za primjenu roflumilasta u dozi od 500 mikrograma jedanput na dan tijekom 12 tjedana (n=443), roflumilasta u dozi od 500 mikrograma svaki drugi dan tijekom 4 tjedna, a potom roflumilasta u dozi od 500 mikrograma jedanput na dan tijekom 8 tjedana (n=439) ili roflumilasta u dozi od 250 mikrograma jedanput na dan tijekom 4 tjedna, a potom roflumilasta u dozi od 500 mikrograma jedanput na dan tijekom 8 tjedana (n=441).
English: Post-implantation losses were not seen in rabbits.
Croatian: Kod kunića nije bilo postimplantacijskih gubitaka.
English: Both roflumilast and roflumilast N-oxide have intrinsic phosphodiesterase-4 (PDE4) inhibitory activity.
Croatian: I roflumilast i roflumilast N-oksid snažno inhibiraju fosfodiesterazu 4 (PDE4).
English: In one of two rat embryofetal development studies, a higher incidence of incomplete skull bone ossification was seen at a dose producing maternal toxicity.
Croatian: U jednom od dva ispitivanja embriofetalnog razvoja štakora pri dozama pri kojima se javlja toksično djelovanje na ženke primijećena je povećana incidencija nepotpunog okoštavanja lubanje.
English: • cancer
Croatian: • karcinom
English: The limited experience in patients with latent infections such as tuberculosis, viral hepatitis or herpes infections.
Croatian: Iskustvo je ograničeno kod bolesnika s latentnim infekcijama poput tuberkuloze, virusnog hepatitisa ili infekcije herpesom.
English: Patients receiving a 500 micrograms dose once a day had a median PDE4 inhibitory activity of 1.2 (0.35, 2.03) and those receiving a 250 micrograms dose once a day had a median PDE4 inhibitory activity of 0.6 (0.20, 1.24).
Croatian: Kod bolesnika koji su primali dozu od 500 mikrograma jedanput na dan medijan aktivnosti inhibicije PDE4 iznosio je 1,2 (0,35, 2,03), a kod onih koji su primali dozu od 250 mikrograma jedanput na dan iznosio je 0,6 (0,20, 1,24).
English: How to store Daxas
Croatian: Kako čuvati Daxas
English: The incidence was 2.5% vs 2.2% in patients with a baseline body weight ≥60 kg, treated with roflumilast when compared to those treated with placebo.
Croatian: Incidencija je u bolesnika s početnom tjelesnom težinom ≥60 kg bila 2,5% naspram 2,2%, kad se usporede oni koji su liječeni roflumilastom i oni koji su uzimali placebo.
English: Roflumilast should not be used during breast-feeding.
Croatian: Roflumilast se ne smije primjenjivati tijekom dojenja.
English: Patients should be advised to check their body weight on a regular basis.
Croatian: Bolesnicima treba savjetovati da se redovito važu.
English: Due to lack of relevant experience, treatment with roflumilast should not be initiated or existing treatment with roflumilast should be stopped in patients with severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy), severe acute infectious diseases, cancers (except basal cell carcinoma), or patients being treated with immunosuppressive medicinal products (i.e. methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term; except short-term systemic corticosteroids).
Croatian: Zbog nedostatnog iskustva roflumilast ne treba uvesti, ili postojeću terapiju roflumilastom treba prekinuti, kod bolesnika s teškim imunološkim oboljenjima (npr. HIV-infekcijom, multiplom sklerozom, eritemskim lupusom, progresivnom multifokalnom encefalopatijom), teškim akutnim zaraznim bolestima, karcinomom (osim bazocelularnog karcinoma) ili bolesnika koji se liječe imunosupresivnim lijekovima (npr. metotreksatom, azatioprinom, infliksimabom, etanerceptom, ili dugotrajno uzimaju oralne kortikosteroide; ograničenje se ne odnosi na kratkotrajnu sustavnu primjenu kortikosteroida).
English: A similar reduction was achieved in the subgroup of patients concomitantly treated with LAMA (rate ratio: 0.77; 95% CI: 0.60 to 0.99) and in the subgroup not treated with LAMA (rate ratio: 0.71; 95% CI: 0.42 to 1.20).
Croatian: Slično smanjenje ostvareno je u podskupini bolesnika koji su istodobno liječeni LAMA-om (omjer stope: 0,77; 95% CI: 0,60 do 0,99) i u podskupini bolesnika koji nisu liječeni LAMA-om (omjer stope: 0,71; 95% CI: 0,42 do 1,20).
English: Nervous system disorders Headache
Croatian: Poremećaji živčanog sustava glavobolja tremor vrtoglavica omaglica disgeuzija
English: Roflumilast is not recommended in patients with a history of depression associated with suicidal ideation or behaviour.
Croatian: Roflumilast se ne preporučuje bolesnicima koji u povijesti bolesti imaju depresiju povezanu sa suicidalnim mislima ili ponašanjem.
English: Reductions were achieved in the subgroup of patients concomitantly treated with LAMA (rate ratio: 0.88; 95% CI: 0.75 to 1.04) and in the subgroup not treated with LAMA (rate ratio: 0.83; 95% CI: 0.62 to 1.12).
Croatian: Smanjenja su postignuta u podskupini bolesnika koji su istodobno liječeni s LAMA (omjer stope: 0,88; 95% CI: 0,75 do 1,04) i podskupini bolesnika koji nisu liječeni s LAMA (omjer stope: 0,83; 95% CI: 0,62 do 1,12).
English: Daxas is not recommended in patients with a history of depression associated with suicidal thinking or behaviour.
Croatian: Daxas se ne preporučuje bolesnicima koji u povijesti bolesti imaju depresiju povezanu sa suicidalnim mislima ili ponašanjem.
English: The rate of severe COPD exacerbations and changes in FEV1 were evaluated as key secondary endpoints.
Croatian: Kao ključni sekundarni ishodi ocijenjene su stopa teških egzacerbacija KOPB-a i promjene FEV1.
English: The percentage of patients experiencing a Treatment Emergent Adverse Event (TEAE) of interest, defined as diarrhoea, nausea, headache, decreased appetite, insomnia, and abdominal pain (secondary endpoint), was nominally statistically significantly lower in patients initially receiving roflumilast 250 micrograms once a day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (45.4%) compared to those receiving roflumilast 500 micrograms once a day for 12 weeks (54.2%, Odds Ratio 0.63, 95% CI [0.47, 0.83], p=0.001).
Croatian: Postotak bolesnika s nuspojavama od interesa koje su se javile tijekom liječenja, a obuhvaćale su proljev, mučninu, glavobolju, smanjen apetit, nesanicu i bol u abdomenu (sekundarna mjera ishoda) nominalno je bio statistički značajno manji među bolesnicima koji su najprije primali roflumilast u dozi od 250 mikrograma jedanput na dan tijekom 4 tjedna, a potom roflumilast u dozi od 500 mikrograma jedanput na dan tijekom 8 tjedana (45,4%) u odnosu na bolesnike koji su primali roflumilast u dozi od 500 mikrograma jedanput na dan tijekom 12 tjedana (54,2%, omjer izgleda 0,63; 95% CI [0,47; 0,83]; p=0,001).
English: No dose adjustment is recommended in these patients.
Croatian: Kod tih bolesnika nije potrebno prilagođavati dozu.
English: Over the entire study period of 12 weeks, the percentage of patients discontinuing treatment due to any reason was statistically significantly lower in patients initially receiving roflumilast 250 micrograms once a day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (18.4%) compared to those receiving roflumilast 500 micrograms once a day for 12 weeks (24.6%; Odds Ratio 0.66, 95% CI [0.47, 0.93], p=0.017).
Croatian: Tijekom cijelog 12-tjednog razdoblja ispitivanja postotak bolesnika koji su prekinuli liječenje zbog bilo kojeg razloga bio je statistički značajno manji među bolesnicima koji su najprije primali roflumilast u dozi od 250 mikrograma jedanput na dan tijekom 4 tjedna, a potom roflumilast u dozi od 500 mikrograma jedanput na dan tijekom 8 tjedana (18,4%) u odnosu na bolesnike koji su primali roflumilast u dozi od 500 mikrograma jedanput na dan tijekom 12 tjedana (24,6%; omjer izgleda 0,66%; 95% CI [0,47; 0,93]; p=0,017).
English: Experience is also limited in patients with a previous diagnosis of tuberculosis, viral hepatitis, herpes viral infection or herpes zoster.
Croatian: Iskustvo je također ograničeno s bolesnicima koji su bolovali od tuberkuloze, virusnog hepatitisa, infekcije herpes virusom ili herpes zosterom.
English: Administration of the cytochrome P450 enzyme inducer rifampicin resulted in a reduction in total PDE4 inhibitory activity by about 60%.
Croatian: Pri istodobnoj primjeni s rifampicinom, induktorom enzima citokrom P450, inhibicijska aktivnost PDE4 se smanjila za 60%.
English: Patients with no history of exacerbations were excluded.
Croatian: U ispitivanje nisu bili uključeni bolesnici bez egzacerbacija u anamnezi.
English: The discontinuation rate for those receiving 500 micrograms every other day for 4 weeks followed by 500 micrograms once a day for 8 weeks was not statistically significantly different to those receiving 500 micrograms once a day for 12 weeks.
Croatian: Stopa prekida liječenja među bolesnicima koji su primali dozu od 500 mikrograma svaki drugi dan tijekom 4 tjedna, a potom dozu od 500 mikrograma jedanput na dan tijekom 8 tjedana nije se statistički značajno razlikovala od one kod bolesnika koji su primali dozu od 500 mikrograma jedanput na dan tijekom 12 tjedana.
English: Rescue medicinal products Daxas is not indicated as rescue medicinal product for the relief of acute bronchospasms.
Croatian: Daxas nije indiciran kao lijek za hitno ublažavanje akutnog bronhospazma.
English: Tabulated list of adverse reactions Within the following table, adverse reactions are ranked under the MedDRA frequency classification:
Croatian: U tablici u nastavku, nuspojave su razvrstane prema MedDRA kategorijama učestalosti:
English: Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation.
Croatian: Bolesnike i osobe koje o njima brinu treba upozoriti da obavijeste liječnika o promjeni ponašanja ili raspoloženja te o bilo kakvim suicidalnim mislima.
English: Patients and caregivers should be requested to report any changes in the patient`s behaviour or mood or suicidal ideation.
Croatian: Bolesnike i osobe koje o njima brinu treba upozoriti da prijave svaku promjenu u bolesnikovu ponašanju ili raspoloženju te suicidalne misli.
English: The rate of experiencing a TEAE of interest for those receiving 500 micrograms every other day for 4 weeks followed by 500 micrograms once a day for 8 weeks was not statistically significantly different to those receiving 500 micrograms once a day for 12 weeks.
Croatian: Stopa nuspojava od interesa koje su se javile tijekom liječenja kod bolesnika koji su primali dozu od 500 mikrograma svaki drugi dan tijekom 4 tjedna, a potom dozu od 500 mikrograma jedanput na dan tijekom 8 tjedana nije se statistički značajno razlikovala od one kod bolesnika koji su primali dozu od 500 mikrograma jedanput na dan tijekom 12 tjedana.
English: A higher incidence of sleep disorders (mainly insomnia) in patients ≥75 years or older was observed in Study RO-2455-404-RD for patients treated with roflumilast when compared to those treated with placebo (3.9% vs 2.3%).
Croatian: U ispitivanju RO-2455-404-RD zabilježena je veća incidencija poremećaja spavanja (uglavnom nesanice) u bolesnika u dobi od ≥75 godina koji su liječeni roflumilastom u usporedbi s onima koji su uzimali placebo (3,9% naspram 2,3%).
English: No dose adjustment is necessary in patients receiving these active substances.
Croatian: Kod bolesnika koji primaju ove djelatne tvari nije potrebna prilagodba doze.
English: Simesa S.p.A. Tel: +39 02 9801 1
Croatian: Tel: +39 02 9801 1
English: - The other ingredients are: - Core: lactose monohydrate (see section 2 under “Daxas contains lactose”), maize starch, povidone, magnesium stearate, - Coating: hypromellose, Macrogol 4000, titanium dioxide (E171), and iron oxide yellow (E172).
Croatian: - Ovojnica: hipromeloza, makrogol 4000, titanijev dioksid (E171), željezov oksid žuti (E172).
English: A higher incidence of sleep disorders (mainly insomnia) in patients with a baseline body weight <60 kg was observed in Study RO-2455-404-RD for patients treated with roflumilast when compared to those treated with placebo (6.0% vs 1.7%).
Croatian: U ispitivanju RO-2455-404-RD zabilježena je veća incidencija poremećaja spavanja (uglavnom nesanice) u bolesnika s početnom tjelesnom težinom < 60 kg koji su liječeni roflumilastom u usporedbi s onima koji su uzimali placebo (6,0% naspram 1,7%).
English: Each Daxas 250 micrograms tablet contains 250 micrograms roflumilast.
Croatian: Jedna tableta lijeka Daxas 250 mikrograma sadrži 250 mikrograma roflumilasta.
English: Moderate
Croatian: Umjerena
English: The per-protocol Poisson regression analysis and the non-significant sensitivity to drop-out Poisson regression intention-to-treat analysis rate ratios were 0.81 (95% CI: 0.69 to 0.94) and 0.89 (95% CI: 0.77 to 1.02), respectively.
Croatian: Poissonovoj regresijskoj analizi ispitanika koji su završili liječenje prema planu ispitivanja omjer stope bio je 0,81 (95% CI: 0,69 do 0,94), dok je u Poissonovoj regresijskoj analizi nesignifikantne osjetljivosti ispitanika predviđenih za liječenje a koji su istupili iz ispitivanja omjer stope bio 0,89 (95% CI: 0,77 do 1,02).
English: Each film-coated tablet (tablet) contains 500 micrograms roflumilast.
Croatian: Jedna filmom obložena tableta sadrži 500 mikrograma roflumilasta.
English: Vomiting Gastro-esophageal reflux disease Dyspepsia
Croatian: Poremećaji probavnog sustava proljev mučnina bol u trbuhu gastritis povraćanje gastroezofagealna refluksna bolest dispepsija hematohezija konstipacija
English: daxas 500 mcg
Croatian: daxas 500 mikrograma
English: A total of 2,690 patients were included and randomised in two supportive 1-year studies (M2-111 and M2-112).
Croatian: U dva suportivna jednogodišnja ispitivanja (M2-111 i M2-112) uključeno je i randomizirano ukupno 2690 bolesnika.
English: Roflumilast has been demonstrated to cross the placenta in pregnant rats.
Croatian: Dokazano je da kod skotnih štakora roflumilast prolazi posteljicu.
English: Total PDE4 inhibitory activity decreased by 9% in patients with severe renal impairment (creatinine clearance 10-30 ml/min).
Croatian: Kod bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina 10-30 ml/min) ukupna inhibicijska aktivnost PDE4 smanjena je za 9%.
English: AstraZeneca d.o.o.
Croatian: AstraZeneca A.E.
English: daxas 250 mcg
Croatian: daxas 250 mikrograma
English: Weight decreased Decreased appetite
Croatian: Poremećaji metabolizma i prehrane smanjenje težine smanjenje teka
English: However, Cmax and tmax of roflumilast N-oxide are unaffected.
Croatian: Međutim, Cmax i tmax roflumilast
English: This effect seems to be due to an ADCP (4-Amino-3,5-dichloro-pyridine) N-oxide intermediate specifically formed in rodent olfactory mucosa, with special binding affinity in these species (i.e. mouse, rat and hamster).
Croatian: N-oksid intermedijarnim spojem koji se specifično stvara u olfaktornoj sluznici glodavaca i kod tih vrsta (npr. kod miša, štakora i hrčka) ima specifični afinitet za vezanje.
English: Takeda GmbH Production Site Oranienburg Lehnitzstrasse 70-98
Croatian: Lehnitzstrasse 70-98
English: • Summary of Product Characteristics and Patient Information Leaflet for Daxas
Croatian: Edukacijski paket treba sadržavati sljedeće: • Sažetak opisa svojstava lijeka i uputu o lijeku za Daxas
English: The risks and benefits of starting or continuing treatment with roflumilast should be carefully assessed if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended.
Croatian: Kod bolesnika s poznatim prijašnjim ili sadašnjim psihijatrijskim simptomima, kao i kod onih kojima je potrebno liječenje drugim lijekovima koji mogu izazvati psihijatrijske poremećaje, treba procijeniti rizike i koristi uvođenja ili nastavljanja terapije roflumilastom.
English: Rare instances of suicidal ideation and behaviour, including completed suicide, have been observed in patients with and without a history of depression, usually in the first weeks of treatment.
Croatian: Kod bolesnika sa ili bez prethodne depresije su, najčešće u prvim tjednima liječenja, zabilježeni rijetki primjeri suicidalnih misli i ponašanja, uključujući i počinjeni suicid.
English: Daxas 500 micrograms film-coated tablets
Croatian: Daxas 500 mikrograma filmom obložene tablete
English: Each tablet contains 500 micrograms roflumilast.
Croatian: Jedna tableta sadrži 500 mikrograma roflumilasta.
English: Daxas 250 micrograms tablets
Croatian: Daxas 250 mikrograma tablete
English: Daxas 500 micrograms tablets roflumilast
Croatian: Daxas 500 mikrograma tablete roflumilast
English: Daxas 250 micrograms tablets roflumilast
Croatian: Daxas 250 mikrograma tablete roflumilast
English: The pharmacokinetics of roflumilast 250 micrograms once-daily was tested in 16 patients with mild to moderate hepatic impairment classified as Child-Pugh A and B. In these patients, the total PDE4 inhibitory activity was increased by about 20% in patients with Child-Pugh A and about 90% in patients with Child-Pugh B. Simulations suggest dose proportionality between roflumilast 250 and 500 micrograms in patients with mild and moderate hepatic impairment.
Croatian: Farmakokinetika roflumilasta od 250 mikrograma jedanput na dan ispitana je na 16 bolesnika s blagim do umjerenim oštećenjem funkcije jetre klasificiranim kao Child-Pugh A i B.
English: Daxas 500 micrograms film-coated tablets Roflumilast
Croatian: Daxas 500 mikrograma filmom obložene tablete roflumilast
English: Cardiac disorders
Croatian: Srčani poremećaji palpitacije
English: Magnesium stearate
Croatian: Omjer stope
English: Each tablet contains 250 micrograms roflumilast.
Croatian: Jedna tableta sadrži 250 mikrograma roflumilasta.
English: Manufacturer Takeda GmbH Production site Oranienburg Lehnitzstraße 70-98
Croatian: Lehnitzstraße 70-98
English: Exacerbation Category
Croatian: Kategorija egzacerbacije
English: Gynaecomastia
Croatian: PSUR-om
English: Endocrine disorders
Croatian: Endokrini poremećaji ginekomastija
English: Rate Ratio
Croatian: Tablični prikaz nuspojava
English: That increased exposure might occur in certain populations and increase the risk of persistent intolerability: o Special populations who have increased PDE4 inhibition such as black non smoking females; o Patients concomitantly treated with CYP1A2/2C19/3A4 inhibitors (such as fluvoxamine and cimetidine) or CYP1A2/3A4 inhibitors (such as enoxacin).
Croatian: Moguću povećanu izloženost kod određenih populacija i povećani rizik trajne nepodnošljivosti kod: o Specifičnih populacija koje imaju povećanu inhibiciju PDE4, poput žena crne rase koje ne puše.
English: Gastrointestinal disorders Diarrhoea Nausea
Croatian: Poremećaji imunološkog sustava preosjetljivost angioedem
English: Just carry on with the next dose at the normal time.
Croatian: Samo nastavite sa sljedećom dozom u uobičajeno vrijeme.
English: 40549 Düsseldorf Germany
Croatian: 40549 Düsseldorf
English: Do not take a double dose to make up for forgotten doses.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljene doze.
English: Interaction studies have been conducted in healthy volunteers.
Croatian: Ispitivanja interakcija provedena su u zdravih dobrovoljaca.
English: If you do not regularly eat three meals per day then please tell your doctor.
Croatian: Ako ne jedete redovito tri obroka na dan, molimo da o tome obavijestite liječnika.
English: Tablets should be taken whole.
Croatian: Tablete se trebaju uzimati cijele.
English: Approximately 30% of patients experienced at least one adverse reaction.
Croatian: Približno je 30% bolesnika imalo najmanje jednu nuspojavu.
English: Experience from clinical studies in patients above the age of 75 years is very limited.
Croatian: Iskustvo iz kliničkih ispitivanja u bolesnika starijih od 75 godina je ograničeno.
English: Other medicines and BindRen
Croatian: Drugi lijekovi i BindRen
English: However, if you cannot swallow the contents of a whole sachet at once you can divide the contents of the sachet dose into smaller portions.
Croatian: Međutim, ako ne možete progutati cijeli sadržaj vrećice odjednom, možete podijeliti sadržaj vrećice na manje dijelove.
English: No direct effects of BindRen are thus anticipated.
Croatian: Stoga se ne očekuju nikakvi izravni učinci BindRena.
English: After one year of treatment, a reduction of 1.12% in HbA1c was observed.
Croatian: Nakon jedne godine liječenja bilo je opaženo smanjenje HbA1c za 1,12%.
English: Your doctor may decide to increase this up to a total dose of 15 g per day depending on the level of phosphorus in your blood.
Croatian: Vaš liječnik može odlučiti povisiti dozu do ukupne doze od 15 g na dan ovisno o razini fosfora u krvi.
English: - you have abnormally low levels of calcium in your blood.
Croatian: - imate nenormalno niske razine kalcija u krvi.
English: The following side effects have also been seen in patients taking BindRen:
Croatian: Sljedeće nuspojave također su opažene u bolesnika koji uzimaju BindRen:
English: It is recommended that you take the tablets whole with meals and with a small amount of water.
Croatian: Preporučuje se da uzimate tablete cijele, uz obrok i s malom količinom vode.
English: What BindRen is and what it is used for
Croatian: Što je BindRen i za što se koristi
English: However, reproductive toxicity studies were not conducted at doses higher than 2.5 times the human clinical dose, and the possible reproductive effects related to coagulation and bleeding have not been assessed.
Croatian: Međutim, ispitivanja reproduktivne toksičnosti nisu bila provedena pri dozama višim od 2,5 puta iznad kliničke doze za ljude, a mogući reproduktivni učinci povezani s koagulacijom i krvarenjem nisu bili procijenjeni.
English: *A single case with a fatal outcome
Croatian: *Jedini slučaj sa smrtnih ishodom
English: There are no known antidotes to BindRen.
Croatian: Nema poznatog antidota za BindRen.
English: These measures will help to protect the environment and to prevent accidental access by children.
Croatian: Ove će mjere pomoći u očuvanju okoliša i spriječiti slučajni pristup djece tim lijekovima.
English: Interactions have not been studied at doses >9 g daily, and greater interaction effects at higher doses of BindRen cannot be excluded.
Croatian: Interakcije nisu bile ispitane u dozama >9 g na dan pa se veći učinci interakcija pri višim dozama BindRena ne mogu isključiti.
English: However, other effects of BindRen may affect pregnant and breast-feeding women or influence fertility, see sections 4.4 and 4.5.
Croatian: Međutim, drugi učinci BindRena mogu utjecati na trudnice i dojilje ili na plodnost, vidjeti dio 4.4 i 4.5.
English: Pharmacotherapeutic group: not yet assigned.
Croatian: Farmakoterapijska skupina: nije još dodijeljena.
English: BindRen should not be used in children and adolescents.
Croatian: BindRen se ne smije primjenjivati u djece i adolescenata.
English: Granules should be taken whole as one dose from the sachet.
Croatian: Granule se trebaju uzimati cijele kao jedna doza iz vrećice.
English: BindRen is not absorbed and is not systemically available.
Croatian: BindRen se ne apsorbira i nije sistemski dostupan.
English: Systemic ion balance
Croatian: Sistemska ravnoteža iona
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Slijedom navedenog, nositelj odobrenja će ta izvješća podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.