FrancophonIA/ELRC3.0 huggingface dataset:
English: After adjustment of the strength, the film-coated tablet formulation (360 mg strength) was equivalent to EXJADE dispersible tablets (500 mg strength) with respect to the mean area under the plasma concentration time curve (AUC) under fasting conditions.
Slovenian: Po prilagoditvi jakosti je formulacija filmsko obložene tablete (v jakosti 360 mg) enakovredna zdravilu EXJADE v obliki disperzibilnih tablet (v jakosti 500 mg) glede povprečne površine pod krivuljo, ki prikazuje odvisnost plazemske koncentracije od časa (AUC) v pogojih na tešče.
English: • Persistent abnormality in another marker of renal function (e.g. proteinuria, Fanconi Syndrome).
Slovenian: • vztraja tudi patološka vrednost katerega od drugih označevalcev tubulne funkcije (npr. proteinurija, Fanconijev sindrom).
English: The availability of long-term efficacy and safety data from clinical studies conducted with EXJADE dispersible tablets used at doses above 30 mg/kg is currently limited (264 patients followed for an average of 1 year after dose escalation).
Slovenian: Zaenkrat še ni na voljo veliko podatkov iz izvedenih kliničnih študij o dolgoročni učinkovitosti in varnosti zdravila EXJADE v obliki disperzibilnih tablet v odmerkih nad 30 mg/kg (264 bolnikov so spremljali povprečno 1 leto po postopnem zviševanju odmerka).
English: EXJADE is indicated for the treatment of chronic iron overload due to frequent blood transfusions (7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.
Slovenian: Zdravilo EXJADE je indicirano za zdravljenje kronične preobremenitve z železom zaradi pogostih transfuzij krvi (7 ml/kg/mesec koncentriranih eritrocitov) pri bolnikih z beta talasemijo major, starih 6 let ali več.
English: <7 ml/kg/month of PRBC (approx. <2 units/month for an adult)
Slovenian: <7 ml/kg/mesec koncentriranih eritrocitov (približno <2 enoti/mesec pri odraslem)
English: 28 dispersible tablets
Slovenian: 28 disperzibilnih tablet
English: A food-effect study involving administration of the granules to healthy volunteers under fasting conditions and with a low-fat (fat content = approximately 30% of calories) or high-fat (fat content >50% of calories) meal indicated that the AUC and Cmax were slightly decreased after a low-fat meal (by 10% and 11%, respectively).
Slovenian: V študiji vpliva sočasnega uživanja hrane z zrnci pri zdravih prostovoljcih, ki so zdravilo zaužili na tešče, z obrokom z nizko vsebnostjo maščob (vsebnost maščob je približno 30 % kalorij) ali z obrokom z visoko vsebnostjo maščob (vsebnost maščob >50 % kalorij), se je pokazalo, da sta vrednosti AUC in Cmax nekoliko nižji po zaužitju obroka z nizko vsebnostjo maščob (za 10 % oziroma 11 %).
English: or >1,000 µg/l
Slovenian: >2.000 µg/l
English: In a clinical study using single doses of 20 mg/kg deferasirox dispersible tablets, the average exposure was increased by 16% in subjects with mild hepatic impairment (Child-Pugh Class A) and by 76% in subjects with moderate hepatic impairment (Child-Pugh Class B) compared to subjects with normal hepatic function.
Slovenian: V klinični študiji z enkratnimi odmerki 20 mg/kg deferasiroksa v obliki disperzibilnih tablet je bila pri bolnikih z blago okvaro jeter (Child-Pugh stopnje A) povprečna izpostavljenost za 16 % večja kot pri bolnikih z normalnim delovanjem jeter, pri bolnikih z zmerno okvaro jeter (Child-Pugh stopnje B) pa je bila večja za 76 %.
English: • Patient guide
Slovenian: • Priročnik za bolnika
English: After adjustment of the strength, the granules formulation (4 x 90 mg strength) was equivalent to EXJADE dispersible tablets (500 mg strength) with respect to the mean area under the plasma concentration time curve (AUC) under fasting conditions.
Slovenian: Po prilagoditvi jakosti je formulacija v obliki zrnc (v jakosti 4 x 90 mg) enakovredna zdravilu EXJADE v obliki disperzibilnih tablet (v jakosti 500 mg) glede povprečne površine pod krivuljo, ki prikazuje odvisnost plazemske koncentracije od časa (AUC) v pogojih na tešče.
English: • The maximum recommended daily dose for EXJADE granules:
Slovenian: • Največji priporočeni dnevni odmerek zdravila EXJADE v obliki zrnc je:
English: • Patient information leaflet
Slovenian: • Komplet informacij za bolnike
English: In these patients, closer monitoring of LIC and serum ferritin is essential to avoid overchelation (see section 4.4).
Slovenian: Pri teh bolnikih je nujno natančno spremljati koncentracijo železa v jetrih in feritina v serumu, da ne pride do prekomerne kelacije (glejte poglavje 4.4.).
English: Unit packs containing 30 or 90 film-coated tablets or multipacks containing 300 (10 packs of 30) film-coated tablets.
Slovenian: Posamezno pakiranje vsebuje 30 ali 90 filmsko obloženih tablet, skupno pakiranje pa vsebuje 300 (10 pakiranj po 30) filmsko obloženih tablet.
English: EXJADE is also used to treat chronic iron overload when deferoxamine therapy is contraindicated or inadequate in patients with beta thalassaemia major with iron overload caused by infrequent blood transfusions, in patients with other types of anaemias, and in children aged 2 to 5 years.
Slovenian: Zdravilo EXJADE uporabljamo tudi za zdravljenje kronične preobremenitve z železom v primerih, ko je zdravljenje z deferoksaminom kontraindicirano ali neprimerno pri bolnikih z beta talasemijo major s preobremenitvijo z železom zaradi manj pogostih transfuzij krvi, pri bolnikih z drugimi vrstami slabokrvnosti in pri otrocih, starih od 2 do 5 let.
English: The bioavailability of deferasirox was increased to a variable extent when taken along with food.
Slovenian: Pri jemanju deferaksiroksa s hrano se je njegova biološka uporabnost zvečala v spremenljivem obsegu.
English: EXJADE is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta thalassaemia major aged 6 years and older.
Slovenian: Zdravilo EXJADE uporabljamo za zdravljenje kronične preobremenitve z železom zaradi pogostih transfuzij krvi pri bolnikih z beta talasemijo major, starih 6 let ali več.
English: 1, alopecia
Slovenian: 1, multiformni eritem 1, alopecija
English: 30 film-coated tablets 90 film-coated tablets
Slovenian: filmsko obložene tablete 30 filmsko obloženih tablet 90 filmsko obloženih tablet
English: Interruption of EXJADE therapy should be considered in patients who develop metabolic acidosis.
Slovenian: Pri bolnikih, pri katerih se pojavi metabolna acidoza je treba razmisliti o prekinitvi zdravljenja z zdravilom EXJADE.
English: If you have taken too much EXJADE, or if someone else accidentally takes your granules, contact your doctor or hospital for advice straight away.
Slovenian: Če ste vzeli večji odmerek zdravila EXJADE, kot bi smeli Če ste vzeli preveč zdravila EXJADE ali je vaša zrnca pomotoma zaužil kdo drug, takoj pokličite zdravnika ali v bolnišnico.
English: A placebo-controlled randomised study was performed in 225 patients with MDS (Low/Int-1 risk) and transfusional iron overload.
Slovenian: Pri 225 bolnikih z mielodisplastičnim sindromom (z majhnim/srednjim-1 tveganjem, Low/Int-1 risk) in preobremenitvijo z železom zaradi transfuzij so izvedli s placebom kontrolirano randomizirano študijo.
English: Dispersible tablets
Slovenian: disperzibilne tablete
English: The other ingredients are microcrystalline cellulose; crospovidone; povidone; magnesium stearate; colloidal anhydrous silica and poloxamer.
Slovenian: Druge sestavine zdravila so mikrokristalna celuloza, krospovidon, povidon, magnezijev stearat, brezvoden koloidni silicijev dioksid, poloksamer.
English: Test
Slovenian: Preiskava
English: If only very poor haemosiderosis control is achieved at doses up to 30 mg/kg, a further increase (to a maximum of 40 mg/kg) may not achieve satisfactory control, and alternative treatment options may be considered.
Slovenian: Če je bolnik s hemosiderozo zelo slabo urejen ob zdravljenju z odmerki do 30 mg/kg, morda tudi z nadaljnjim zviševanjem odmerka (do največ 40 mg/kg) ne bo prišlo do zadovoljive urejenosti in bo treba pretehtati možnosti drugih načinov zdravljenja.
English: The absolute bioavailability of the granule formulation has not been determined.
Slovenian: Absolutne biološke uporabnosti zdravila v obliki zrnc niso določali.
English: EXJADE is also used when deferoxamine therapy is contraindicated or inadequate to treat patients aged 10 years or older who have iron overload associated with their thalassaemia syndromes, but who are not transfusion dependent.
Slovenian: Zdravilo EXJADE poleg tega uporabljamo tudi, kadar je zdravljenje z deferoksaminom kontraindicirano ali neprimerno pri bolnikih, ki so stari 10 let ali več in imajo preobremenitev z železom in sindrome talasemije, vendar ti niso posledica transfuzij.
English: • EXJADE 90 mg film-coated tablets are light blue and stamped “90” on one side and “NVR” on the other.
Slovenian: • Filmsko obložene tablete zdravila EXJADE 90 mg so svetlo modre in imajo na eni strani vtisnjeno oznako “90”, na drugi pa “NVR“.
English: Excipient with known effect: Each dispersible tablet contains 136 mg lactose.
Slovenian: Pomožna snov z znanim učinkom: Ena disperzibilna tableta vsebuje 136 mg laktoze.
English: How to take EXJADE
Slovenian: Kako jemati zdravilo EXJADE
English: If you are switching from the film-coated tablets or granules to these dispersible tablets, you will need an adjustment of the dose.
Slovenian: Če prehajate z uporabe filmsko obloženih tablet ali zrnc na uporabo disperzibilnih tablet, vam bo treba prilagoditi odmerek zdravila.
English: EXJADE 125 mg, 250 mg and 500 mg dispersible tablets are available in unit packs containing 28, 84 or 252 dispersible tablets.
Slovenian: EXJADE 125 mg, 250 mg in 500 mg disperzibilne tablete so na voljo v obliki posameznih pakiranj, ki vsebujejo 28, 84 ali 252 disperzibilnih tablet.
English: • EXJADE 360 mg film-coated tablets are dark blue and stamped “360” on one side and “NVR”
Slovenian: • Filmsko obložene tablete zdravila EXJADE 360 mg so temno modre in imajo na eni strani vtisnjeno oznako “360”, na drugi pa “NVR“.
English: Doses above 20 mg/kg are not recommended because there is no experience with doses above this level in patients with non-transfusion-dependent thalassaemia syndromes.
Slovenian: Uporaba odmerkov nad 20 mg/kg ni priporočljiva, saj z odmerki, ki presegajo navedeno vrednost, ni nobenih izkušenj pri bolnikih, ki imajo katerega od sindromov talasemije, neodvisnih od transfuzij.
English: EXJADE is not recommended during pregnancy unless clearly necessary.
Slovenian: Uporaba zdravila EXJADE med nosečnostjo in dojenjem ni priporočljiva, če ni nujno potrebno.
English: Excipient with known effect: Each dispersible tablet contains 272 mg lactose.
Slovenian: Pomožna snov z znanim učinkom: Ena disperzibilna tableta vsebuje 272 mg laktoze.
English: *LIC is the preferred method of iron overload determination.
Slovenian: *merjenje koncentracije železa v jetrih je metoda izbora pri določanju preobremenitve z železom
English: PVC/PVDC/Aluminium blisters.
Slovenian: PVC/PVDC/aluminijski pretisni omoti
English: INTERMEDIATE CARTON OF MULTIPACK (without blue box)
Slovenian: VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ MODREGA OKENCA)
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Slovenian: VMESNA ŠKATLA SKUPNEGA PAKIRANJA (brez modrega okenca)
English: For deferasirox granules, a dose ratio of 3:1 can be considered (i.e. a dose of deferasirox granules that is numerically one third of the deferoxamine dose).
Slovenian: Za odmerjanje deferasiroksa v obliki zrnc je mogoče uporabiti razmerje odmerkov 3:1 (to je odmerek deferasiroksa v obliki zrnc, ki je številčno enak eni tretjini odmerka deferoksamina).
English: Excipient with known effect: Each dispersible tablet contains 544 mg lactose.
Slovenian: Pomožna snov z znanim učinkom: Ena disperzibilna tableta vsebuje 544 mg laktoze.
English: EXJADE film-coated tablets demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation (see section 5.2).
Slovenian: Zdravilo EXJADE filmsko obložene tablete imajo večjo biološko uporabnost v primerjavi z zdravilom EXJADE disperzibilne tablete (glejte poglavje 5.2).
English: Approximate tablet dimensions 17 mm x 6.7 mm.
Slovenian: Približna velikost tablete je 17 mm x 6,7 mm.
English: The film-coated tablets should be taken once a day, preferably at the same time each day, and may be taken on an empty stomach or with a light meal (see sections 4.5 and 5.2).
Slovenian: Filmsko obložene tablete je treba vzeti enkrat na dan, najbolje vsak dan ob istem času, bolnik pa ga lahko zaužije na prazen želodec ali z lahkim obrokom (glejte poglavji 4.5 in 5.2).
English: What EXJADE contains
Slovenian: Kaj vsebuje zdravilo EXJADE
English: Not all strengths may be available in your country.
Slovenian: Morda na vašem trgu ni vseh navedenih jakosti.
English: In case of switching from film-coated tablets/granules to dispersible tablets, the dose of dispersible tablets should be 40% higher than the dose of film-coated tablets/granules, rounded to the nearest whole tablet.
Slovenian: V primeru prehoda s filmsko obloženih tablet/zrnc na disperzibilne tablete mora biti odmerek pri disperzibilnih tabletah za 40 % višji od prejšnjega pri filmsko obloženih tabletah/zrncih, in sicer naj bo odmerek zaokrožen na najbližjo jakost cele tablete.
English: EXJADE 125 mg dispersible tablets EXJADE 250 mg dispersible tablets EXJADE 500 mg dispersible tablets
Slovenian: EXJADE 125 mg disperzibilne tablete EXJADE 250 mg disperzibilne tablete EXJADE 500 mg disperzibilne tablete
English: If you are switching from the dispersible tablets to these granules, you will need an adjustment of the dose.
Slovenian: Če prehajate z uporabe disperzibilnih tablet na uporabo zrnc, vam bo treba prilagoditi odmerek zdravila.
English: 14 mg/kg/day 20 mg/kg/day
Slovenian: 14 mg/kg/dan 20 mg/kg/dan
English: Unit packs containing 30 sachets.
Slovenian: Eno pakiranje vsebuje 30 vrečic.
English: EXJADE is supplied as dispersible tablets.
Slovenian: Zdravilo EXJADE je na voljo v obliki disperzibilnih tablet.
English: EXJADE 90 mg film-coated tablets EXJADE 180 mg film-coated tablets EXJADE 360 mg film-coated tablets
Slovenian: EXJADE 90 mg filmsko obložene tablete EXJADE 180 mg filmsko obložene tablete EXJADE 360 mg filmsko obložene tablete
English: If no satisfactory control is achieved at doses above 30 mg/kg, treatment at such doses should not be maintained and alternative treatment options should be considered whenever possible.
Slovenian: Če bolnik pri zdravljenju z odmerki nad 30 mg/kg ni zadovoljivo urejen, ne sme vztrajati pri zdravljenju s takimi odmerki, ampak je treba, kadar je le mogoče, pretehtati možnosti drugih načinov zdravljenja.
English: In patients whose serum ferritin level has reached the target (usually between 500 and 1,000 µg/l), dose reductions in steps of 5 to 10 mg/kg should be considered to maintain serum ferritin levels within the target range and to minimise the risk of overchelation.
Slovenian: Pri bolnikih, pri katerih je koncentracija feritina dosegla ciljno vrednost (običajno med 500 in 1.000 µg/l), je treba razmisliti o postopnem zniževanju odmerka v korakih po 5 do 10 mg/kg, da bi koncentracijo feritina v serumu lahko obdržali v okviru ciljnih vrednosti in čim bolj zmanjšali tveganje za prekomerno kelacijo.
English: Breast-feeding while taking EXJADE is not recommended.
Slovenian: Dojenje v času jemanja zdravila EXJADE ni priporočljivo.
English: Repeated blood transfusions may be necessary in patients with various types of anaemia (for example thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)).
Slovenian: Bolniki z različnimi vrstami slabokrvnosti (npr. s talasemijo, z boleznijo srpastih celic ali z mielodisplastičnim sindromom - MDS), lahko potrebujejo večkratne transfuzije krvi.
English: What EXJADE is
Slovenian: Kaj je zdravilo EXJADE
English: EXJADE film-coated tablets demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation.
Slovenian: Zdravilo EXJADE filmsko obložene tablete imajo večjo biološko uporabnost v primerjavi z zdravilom EXJADE disperzibilne tablete.
English: Approximate tablet dimensions 14 mm x 5.5 mm.
Slovenian: Približna velikost tablete je 14 mm x 5,5 mm.
English: Approximate tablet dimensions 10.7 mm x 4.2 mm.
Slovenian: Približna velikost tablete je 10,7 mm x 4,2 mm.
English: The patient's serum ferritin should be monitored during and after the combination, and the dose of EXJADE adjusted if necessary.
Slovenian: V obdobju jemanja te kombinacije zdravil in še po njem je treba spremljati bolnikove vrednosti feritina v serumu in po potrebi prilagajati odmerek zdravila EXJADE.
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which could be lifethreatening or fatal, have been reported.
Slovenian: Poročali so hudih kožnih neželenih reakcijah (SCAR - severe cutaneous adverse reactions), med drugim o Stevens-Johnsonovem sindromu (SJS), toksični epidermalni nekrolizi (TEN) in reakciji na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS - drug reaction with eosinophilia and systemic symptoms), ki so lahko življenjsko nevarni oziroma smrtni.
English: The bioavailability (AUC) of deferasirox was moderately (approx. 13-25%) elevated when taken 30 minutes before meals with normal or high fat content.
Slovenian: Če je bil deferasiroks zaužit 30 minut pred obroki z normalno ali visoko vsebnostjo maščob, se je njegova biološka uporabnost (AUC) zmerno (približno 13-25 %) povečala.
English: EXJADE 125 mg dispersible tablets Packs containing 28, 84 or 252 dispersible tablets.
Slovenian: EXJADE 125 mg disperzibilne tablete Pakiranje vsebuje 28, 84 ali 252 disperzibilnih tablet.
English: Approximate tablet dimensions 20 mm x 5.6 mm.
Slovenian: Približna velikost tablete je 20 mm x 5,6 mm.
English: In a healthy volunteer study, the concomitant administration of deferasirox as a CYP1A2 inhibitor (repeated dose of 30 mg/kg/day, dispersible tablet formulation) and the CYP1A2 substrate theophylline (single dose of 120 mg) resulted in an increase of theophylline AUC by 84% (90% CI: 73% to 95%).
Slovenian: Medsebojno delovanje s teofilinom in drugimi zdravili, katerih presnova poteka s CYP1A2 V študiji pri zdravih prostovoljcih je sočasna uporaba deferasiroksa kot zaviralca CYP1A2 (v ponavljajočih se odmerkih po 30 mg/kg/dan v obliki disperzibilnih tablet) in substrata CYP1A2 teofilina (v enkratnem odmerku 120 mg) povečala AUC teofilina za 84 % (90-odstotni IZ: 73 % do 95 %).
English: EXJADE film-coated tablets may be taken either on an empty stomach or with a light meal, preferably at the same time each day (see sections 4.2 and 5.2).
Slovenian: Filmsko obložene tablete zdravila EXJADE je mogoče jemati bodisi na prazen želodec ali z lahkim obrokom, najbolje vsak dan ob istem času (glejte poglavji 4.2 in 5.2).
English: Approximate tablet dimensions 12 mm x 3.6 mm.
Slovenian: Približna velikost tablete je 12 mm x 3,6 mm.
English: • EXJADE 125 mg tablets are stamped “J 125” on one side and “NVR” on the other.
Slovenian: • Tablete zdravila EXJADE 125 mg imajo na eni strani vtisnjeno oznako “J 125”, na drugi pa
English: EXJADE dispersible tablets must be taken once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day (see sections 4.5 and 5.2).
Slovenian: Disperzibilne tablete EXJADE je treba zaužiti enkrat dnevno na prazen želodec vsaj 30 minut pred obrokom, najbolje vsak dan ob istem času (glejte poglavji 4.5 in 5.2).
English: EXJADE 250 mg dispersible tablets Packs containing 28, 84 or 252 dispersible tablets.
Slovenian: EXJADE 250 mg disperzibilne tablete Pakiranje vsebuje 28, 84 ali 252 disperzibilnih tablet.
English: • Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vrečici in škatli poleg oznak Uporabno do in EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: When to take EXJADE
Slovenian: Kdaj jemati zdravilo EXJADE
English: In case of switching from dispersible tablets to film-coated tablets, the dose of the film-coated tablets should be 30% lower than the dose of the dispersible tablets, rounded to the nearest whole tablet.
Slovenian: V primeru prehoda z disperzibilnih tablet na filmsko obložene tablete, mora biti odmerek pri filmsko obloženih tabletah za 30 % nižji od prejšnjega odmerka v obliki disperzibilnih tablet, in sicer naj bo odmerek zaokrožen na najbližjo jakost cele tablete.
English: EXJADE 360 mg film-coated tablets
Slovenian: EXJADE 360 mg filmsko obložene tablete
English: In a healthy volunteer study, the concomitant administration of deferasirox dispersible tablets and midazolam (a CYP3A4 probe substrate) resulted in a decrease of midazolam exposure by 17% (90% CI: 8% - 26%).
Slovenian: Medsebojno delovanje z midazolamom in drugimi zdravili, katerih presnova poteka s CYP3A4 V študiji pri zdravih prostovoljcih je sočasen vnos deferasiroksa v obliki disperzibilnih tablet in midazolama (predstavnika substratov CYP3A4) povzročil zmanjšano izpostavljenost midazolamu za 17 % (90% IZ: 8 %-26 %).
English: In paediatric patients with non-transfusion-dependent thalassaemia syndromes, dosing should not exceed 10 mg/kg.
Slovenian: Pri pediatričnih bolnikih s katerim od sindromov talasemije, neodvisnih od transfuzij, odmerek ne sme preseči 10 mg/kg.
English: EXJADE 180 mg film-coated tablets
Slovenian: EXJADE 180 mg filmsko obložene tablete
English: EXJADE 360 mg film-coated tablets Each film-coated tablet contains 360 mg deferasirox.
Slovenian: EXJADE 360 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 360 mg deferasiroksa.
English: Starting dose The recommended initial daily dose of EXJADE dispersible tablets is 20 mg/kg body weight.
Slovenian: Priporočeni začetni dnevni odmerek zdravila EXJADE v obliki disperzibilnih tablet je 20 mg/kg telesne mase.
English: Approximate tablet dimensions 15 mm x 4.7 mm.
Slovenian: Približna velikost tablete je 15 mm x 4,7 mm.
English: EXJADE 180 mg film-coated tablets Each film-coated tablet contains 180 mg deferasirox.
Slovenian: EXJADE 180 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 180 mg deferasiroksa.
English: Post-marketing cases of hepatic failure, some of which were fatal, have been reported.
Slovenian: V obdobju trženja so poročali o primerih odpovedi jeter, od katerih se jih je nekaj končalo s smrtjo.
English: EXJADE dispersible tablets must therefore be taken on an empty stomach at least 30 minutes before food, preferably at the same time each day (see sections 4.2 and 5.2).
Slovenian: Zato je treba zdravilo EXJADE v obliki disperzibilnih tablet jemati na prazen želodec vsaj 30 minut pred zaužitjem hrane, najbolje vsak dan ob istem času (glejte poglavji 4.2 in 5.2).
English: The MAH shall use distinct outer cartons, blisters and tablets for all formulations (dispersible tablets and film-coated tablets/granules).
Slovenian: Imetnik dovoljenja za promet z zdravilom mora za vsako od vseh formulacij zdravila (disperzibilne tablete in filmsko obložene tablete oziroma zrnca) pripraviti drugačno zunanjo ovojnino (škatlo) ter drugačne pretisne omote in tablete.
English: 30 film-coated tablets.
Slovenian: filmsko obložene tablete 30 filmsko obloženih tablet.
English: After every 3 to 6 months of treatment, a dose increase in increments of 5 to 10 mg/kg should be considered if the patient's LIC is ≥7 mg Fe/g dw, or if serum ferritin is consistently >2,000 µg/l and not showing a downward trend, and the patient is tolerating the medicinal product well.
Slovenian: Po vsakih 3 do 6 mesecih zdravljenja je treba razmisliti o zvišanju odmerka v korakih po 5 do 10 mg/kg, če je pri bolniku koncentracija železa v jetrih ≥7 mg Fe/g suhe teže oziroma ima koncentracijo feritina v serumu ves čas >2.000 µg/l in ta ne kaže trenda zniževanja, bolnik pa zdravilo dobro prenaša.
English: EXJADE 90 mg film-coated tablets EXJADE 180 mg film-coated tablets EXJADE 360 mg film-coated tablets Deferasirox
Slovenian: EXJADE 90 mg filmsko obložene tablete EXJADE 180 mg filmsko obložene tablete EXJADE 360 mg filmsko obložene tablete deferasiroks