FrancophonIA/ELRC3.0 huggingface dataset:
English: Oedema related events, including fluid overload, fluid retention, generalised oedema, hypervolaemia, localised oedema, oedema, oedema peripheral and peripheral swelling, were reported by 5.7% of Lokelma patients.
Danish: Ødemrelaterede bivirkninger, herunder overhydrering, væskeretention, generaliseret ødem, hypervolæmi, lokalt ødem, ødem, perifert ødem og perifere hævelser, blev rapporteret hos 5,7 % af Lokelma-patienterne.
English: As a precautionary measure, it is preferable to avoid the use of Lokelma during pregnancy.
Danish: For en sikkerheds skyld bør Lokelma undgås under graviditet.
English: Twenty-four hour urine collections showed that Lokelma decreased urinary potassium excretion from baseline by 15.8 mmol/24 h compared to placebo increase by 8.9 mmol/24 h (p < 0.001).
Danish: 24 timers urinindsamling viste, at Lokelma reducerede urinudskillelsen af kalium fra baseline med 15,8 mmol/24 timer sammenlignet med en stigning på 8,9 mmol/24 timer for placebo (p < 0,001).
English: Sodium zirconium cyclosilicate is highly selective for potassium ions, even in the presence of other cations, such as calcium and magnesium, in vitro.
Danish: In vitro er natriumzirconiumcyclosilicat meget selektivt for kaliumioner, selv ved tilstedeværelse af andre kationer, såsom calcium og magnesium.
English: Normokalaemia was maintained while patients remained on drug and the mean serum potassium increased following discontinuation.
Danish: Der blev bibeholdt normokaliæmi, mens patienterne var i fortsat behandling med lægemidlet, og det gennemsnitlige serumkalium steg efter seponering.
English: Patients were randomised to receive escalating doses of Lokelma (0.3 g, 3 g and 10 g) or placebo, administered three times a day with meals for two to four days.
Danish: Patienterne blev randomiseret til at få eskalerende doser af Lokelma (0,3 g, 3 g og 10 g) eller placebo, administreret tre gange dagligt i forbindelse med måltider i 2-4 dage.
English: Sodium zirconium cyclosilicate can transiently increase gastric pH by absorbing hydrogen ions and can lead to changes in solubility and absorption kinetics for co-administered medicinal products with pH-dependent bioavailability.
Danish: Natriumzirconiumcyclosilicat kan forbigående øge gastrisk pH ved at absorbere hydrogenioner og kan medføre ændringer i opløseligheden og absorptionskinetikken for samtidigt administrerede lægemidler med pH-afhængig biotilgængelighed.
English: Sodium zirconium cyclosilicate has also been shown to bind ammonium in vitro and in vivo, thereby removing ammonium and increasing serum bicarbonate levels.
Danish: Det er også vist, at natriumzirconiumcyclosilicat binder ammonium in vitro og in vivo, hvorved ammonium fjernes og serumhydrogencarbonat stiger.
English: Lokelma 10 g administered three times daily lowered serum potassium by 0.7 mmol/L at 48 hours (p < 0.001 vs. placebo); statistically significant 14% potassium reduction was observed 1 hour after the first dose.
Danish: Lokelma 10 g administreret tre gange dagligt reducerede serumkalium med 0,7 mmol/l efter 48 timer (p <0,001 versus placebo); statistisk signifikant 14 % reduktion af kalium blev observeret 1 time efter den første dosis.
English: 28 sachets
Danish: 28 breve
English: In clinical trials, 4.1% of Lokelma patients developed hypokalaemia with a serum potassium value less than 3.5 mmol/L, which was resolved with dose adjustment or discontinuation of Lokelma.
Danish: I de kliniske studier udviklede 4,1 % af Lokelma-patienterne hypokaliæmi med serumkalium under 3,5 mmol/l; hypokaliæmi blev håndteret med dosisjustering eller seponering af Lokelma.
English: Taking this medicine
Danish: Sådan tages medicinen
English: Serum potassium should be checked and potassium supplemented as needed.
Danish: Serumkalium skal kontrolleres og kaliumtilskud gives efter behov.
English: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to Lokelma is negligible.
Danish: Der forventes ingen påvirkning af nyfødte/spædbørn, som ammes, da den systemiske eksponering af den ammende kvinde for Lokelma er ubetydelig.
English: Monitoring
Danish: Kontrol
English: Figure 2 illustrates the mean serum potassium over the correction and maintenance phases of the study.
Danish: Figur2 illustrerer det gennemsnitlige serumkalium i korrigerings-og vedligeholdelsesfasen i studiet.
English: Sodium zirconium cyclosilicate does not affect serum calcium or magnesium concentrations, or urinary sodium excretion.
Danish: Natriumzirconiumcyclosilicat påvirker ikke serumcalcium eller -magnesium eller udskillelsen af natrium i urinen.
English: Due to its physicochemical properties, sodium zirconium cyclosilicate is not systemically absorbed and is not expected to be excreted in breast milk.
Danish: På grund af natriumzirconiumcyclosilicats fysiokemiske egenskaber absorberes det ikke systemisk og forventes ikke at blive udskilt i human mælk.
English: As Lokelma passes through your stomach and gut it attaches to potassium and the two are carried together out of the body in your stools, lowering the amount of potassium in the body.
Danish: Når Lokelma passerer gennem maven og tarmene, forbinder det sig med kalium, og de to stoffer forlader kroppen sammen med afføringen.
English: Serum Potassium with 95% CI (mmol/L)
Danish: Serumkalium med 95 % CI (mmol/l)
English: The proportion of subjects with average serum potassium < 5.1 mmol/L from Study Day 8 to 29 (three-week period) was greater at the 5 g, 10 g and 15 g once daily doses of Lokelma (80%, 90% and 94%, respectively), compared with placebo (46%).
Danish: Andelen af forsøgspersoner med gennemsnitligt serumkalium < 5,1 mmol/l fra studiedag 8 til 29 (en periode på 3 uger) var større for Lokelma 5 g, 10 g og 15 g én gang dagligt (henholdsvis 80 %, 90 % og 94 %) sammenlignet med placebo (46 %).
English: Figure 2: Correction and maintenance phases in 12-month open-label study (Study 4) - mean serum potassium over time with 95% CI
Danish: Figur 2: Korrigerings- og vedligeholdelsesfasen i det ublindede studie over 12 måneder (studie 4) gennemsnitligt serumkalium over tid med 95 % CI
English: If the powder settles, the water should be stirred again.
Danish: Hvis pulveret lægger sig på bunden af glasset, skal der omrøres igen.
English: The maintenance studies included patients with chronic kidney disease (58%), heart failure (10%), diabetes mellitus (62%) and RAAS inhibitor therapy (68%).
Danish: Vedligeholdelsesstudierne omfattede patienter med kronisk nyresygdom (58 %), hjertesvigt (10 %), diabetes mellitus (62 %) og patienter, som fik behandling med RAAS-hæmmere (68 %).
English: Sodium zirconium cyclosilicate may be opaque to X-rays.
Danish: Natriumzirconiumcyclosilicat kan være intransparante for røntgenstråler.
English: The proportion of subjects with average serum potassium < 5.1 mmol/L was 88%, the average serum potassium level was 4.66 mmol/L and the proportion of serum potassium measurements below 3.5 mmol/L was less than 1%; between 3.5 and 5.1 mmol/L was 77%; or between 3.5 and 5.5 mmol/L was 93%, irrespective of other factors that might influence the serum potassium.
Danish: Andelen af forsøgspersoner med et gennemsnitligt serumkaliumniveau < 5,1 mmol/l var 88 %, det gennemsnitlige serumkaliumniveau var 4,66 mmol/l, og under 1 % af serumkaliummålingerne var under 3,5 mmol/l; 77 % lå mellem 3,5 og 5,1 mmol/l, og 93 % lå mellem 3,5 og 5,5 mmol/l, uden hensyntagen til andre faktorer, der kan påvirke serumkalium.
English: In addition, mean reductions in blood urea nitrogen (BUN) were observed in the 5 g (1.1 mg/dL) and 10 g (2.0 mg/dL) three times daily groups compared with small mean increases in the placebo (0.8 mg/dL) and low dose sodium zirconium cyclosilicate (0.3 mg/dL) groups.
Danish: Derudover blev der set gennemsnitlige reduktioner i urinstof i blodet (BUN (Blood Urea Nitrogen)) i grupperne, der fik 5 g (1,1 mg/dl) og 10 g (2,0 mg/dl) tre gange dagligt, sammenlignet med små middelstigninger i grupperne, der fik placebo (0,8 mg/dl) og natriumzirconiumcyclosilicat i lav dosis (0,3 mg/dl).
English: Patients with renal/hepatic impairment No changes from the normal doses are required for patients with renal or hepatic impairment.
Danish: Patienter med nedsat nyre-/leverfunktion Dosisjustering ikke nødvendig hos patienter med nedsat nyre- eller leverfunktion.
English: There was a mean decrease in serum potassium of 0.77 mmol/L, 1.10 mmol/L, 1.19 mmol/L and 0.44 mmol/L, respectively, and the proportion of subjects who remained normokalaemic was 71%, 76%, 85% and 48% in the 5 g, 10 g, 15 g once daily doses of Lokelma and placebo groups, respectively.
Danish: Der sås et gennemsnitligt fald i serumkalium på henholdsvis 0,77 mmol/l, 1,10 mmol/l, 1,19 mmol/l og 0,44 mmol/l, og andelen af forsøgspersoner, som forblev normokaliæmiske, var henholdsvis 71 %, 76 %, 85 % og 48 % i grupperne med Lokelma 5 g, 10 g, 15 g én gang dagligt og placebogruppen.
English: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to sodium zirconium cyclosilicate is negligible.
Danish: Der forventes ingen påvirkning af ammede nyfødte/spædbørn, da den systemiske eksponering af den ammende kvinde for natriumzirconiumcyclosilicat er ubetydelig.
English: Patients who achieved normokalaemia (potassium levels between 3.5 and 5 mmol/L) were randomised in a double-blind fashion to one of three doses of Lokelma [5 g (n=45), 10 g (n=51), or 15 g (n=56)] or placebo (n=85) administered once daily for 28 days (the double-blind randomised withdrawal phase).
Danish: Patienter som opnåede normokaliæmi (kaliumniveau mellem 3,5 og 5 mmol/l) blev randomiseret dobbeltblindt til én af tre doser Lokelma [5 g (n=45), 10 g (n=51) eller 15 g (n=56)] eller placebo (n=85) administreret én gang dagligt i 28 dage (den dobbeltblinde randomiserede seponeringsfase).
English: 5.2 Pharmacokinetic properties
Danish: 5.2Farmakokinetiske egenskaber
English: These five studies included 1760 patients given doses of Lokelma; 507 exposed for at least 360 days.
Danish: som fik Lokelma, hvoraf 507 blev eksponeret i mindst 360 dage.
English: Lokelma can be used during breast-feeding.
Danish: Lokelma kan anvendes under amning.
English: Responses were larger in patients with more severe hyperkalaemia; serum potassium fell 0.8, 1.2 and 1.5 mmol/L in patients with baseline serum potassium < 5.5, 5.5-5.9 and ≥ 6 mmol/L, respectively.
Danish: Der var større respons hos patienter med sværere hyperkaliæmi; serumkalium faldt med henholdsvis 0,8, 1,2 og 1,5 mmol/l hos patienter med baseline-serumkalium < 5,5; 5,5-5,9 og ≥ 6,0 mmol/l.
English: Long term exposure
Danish: Langtidseksponering
English: Effect of other medicinal products on sodium zirconium cyclosilicate As sodium zirconium cyclosilicate is not absorbed or metabolised by the body, there are no expected effects of other medicinal products on the pharmacologic action of sodium zirconium cyclosilicate.
Danish: Andre lægemidlers indvirkning på natriumzirconiumcyclosilicat Da natriumzirconiumcyclosilicat ikke absorberes eller metaboliseres i kroppen, forventes det ikke, at andre lægemidler påvirker den farmakologiske virkning af natriumzirconiumcyclosilicat.
English: During the correction phase, patients were randomised to receive Lokelma (1.25 g, 2.5 g, 5 g or 10 g) or placebo, administered three times daily for the initial 48 hours (Table 2).
Danish: I korrigeringsfasen blev patienterne randomiseret til Lokelma (1,25 g, 2,5 g, 5 g eller 10 g) eller placebo, administreret tre gange dagligt i de første 48 timer (Tabel 2).
English: Lokelma is indicated for the treatment of hyperkalaemia in adult patients (see section 4.4 and 5.1).
Danish: Lokelma er indiceret til behandling af hyperkaliæmi hos voksne patienter (se pkt.
English: Lokelma-treated patients experienced an increase of 1.1 mmol/L at 5 g once daily, 2.3 mmol/L at 10 g once daily and 2.6 mmol/L at 15 g once daily in bicarbonate compared with a mean increase of 0.6 mmol/L for those receiving placebo.
Danish: Lokelma-behandlede patienter oplevede en stigning i hydrogencarbonat på 1,1 mmol/l ved 5 g en gang dagligt, 2,3 mmol/l ved 10 g en gang dagligt og 2,6 mmol/l ved 15 g en gang dagligt sammenlignet med en gennemsnitlig stigning på 0,6 mmol/l hos patienter, som fik placebo.
English: Driving and using machines This medicine has no or negligible influence on your ability to drive or to use machines.
Danish: Trafik- og arbejdssikkerhed Lokelma påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Serum potassium should be monitored periodically and the Lokelma dose titrated as described in section 4.2 Posology and Method of Administration.
Danish: Serumkalium bør monitoreres regelmæssigt og Lokelma-dosis titreres som beskrevet i pkt.
English: A two-phase, placebo-controlled correction and maintenance use study A two-part, double-blind, randomised, placebo-controlled clinical trial of 753 patients (mean age of 66 years, range 22 to 93 years) with hyperkalaemia (5 to ≤ 6.5 mmol/L, baseline potassium average 5.3 mmol/L), and included patients with chronic kidney disease, heart failure, diabetes mellitus and those on RAAS inhibitor therapy.
Danish: Et to-faset placebokontrolleret studie af korrigerings- og vedligeholdelsesbehandling Et todelt, dobbeltblindt, randomiseret, placebokontrolleret klinisk studie med 753 patienter (gennemsnitsalder 66 år, interval 22 til 93 år) med hyperkaliæmi (5,0 til ≤ 6,5 mmol/l, baseline-kalium gennemsnitligt 5,3 mmol/l) inkluderede patienter med kronisk nyresygdom, hjertesvigt, diabetes mellitus og patienter i behandling med RAAS-hæmmere.
English: A multi-phase, placebo-controlled maintenance study with an additional open-label phase In the correction phase of the study, 258 patients with hyperkalaemia (baseline average 5.6, range 4.1 - 7.2 mmol/L) received 10 g of Lokelma administered three times daily for 48 hours.
Danish: Et multifaset placebokontrolleret vedligeholdelsesstudie med en ekstra åben fase I studiets korrigeringsfase fik 258 patienter med hyperkaliæmi (baseline-gennemsnit 5,6 mmol/l, interval 4,1-7,2 mmol/l) 10 g Lokelma administreret tre gange dagligt i 48 timer.
English: Limitations of the clinical data
Danish: Begrænsninger i de kliniske data Patienter i dialysebehandling
English: Maintenance fixed dose (day)
Danish: Titreret vedligeholdelsesdosis (dag)
English: Patients with pre-treatment potassium levels in excess of 5.5 mmol/L (average baseline 5.8 mmol/L) saw an average decrease of 1.1 mmol/L at 48 hours while those with starting potassium levels at or below 5.3 mmol/L had an average decrease of 0.6 mmol/L at the highest dose.
Danish: Patienter med serumkalium > 5,5 mmol/l (gennemsnitlig baseline 5,8 mmol/l) før behandling oplevede en gennemsnitlig reduktion på 1,1 mmol/l efter 48 timer, mens patienter, der havde kalium-baselineniveau ≤ 5,3 mmol/l, oplevede en gennemsnitlig reduktion på 0,6 mmol/l ved den højeste dosis.
English: Sodium zirconium cyclosilicate captures potassium throughout the entire gastrointestinal (GI) tract and reduces the concentration of free potassium in the GI lumen, thereby lowering serum potassium levels and increasing faecal potassium excretion to resolve hyperkalaemia.
Danish: Natriumzirconiumcyclosilicat opfanger kalium i hele mave-tarmkanalen og reducerer koncentrationen af frit kalium i mave-tarmlumen, hvorved serumkalium reduceres og fækal udskillelse af kalium øges, således at hyperkaliæmi afhjælpes.
English: A study in chronic kidney disease patients with hyperkalaemia This study was a double-blind placebo-controlled dose-escalating study in 90 patients (60 Lokelma patients; 30 controls) with baseline eGFR between 30-60 ml/min/1.73m2 and hyperkalaemia (baseline serum potassium 5.2 mmol/L, range 4.6-6 mmol/L).
Danish: Et studie med patienter med kronisk nyresygdom og hyperkaliæmi Dette studie var et dobbeltblindt, placebokontrolleret, dosiseskalerende studie med 90 patienter (60 Lokelma-patienter; 30 kontroller) med baseline-eGFR 30-60 ml/min/1,73 m2 og hyperkaliæmi (baseline-serumkalium 5,2 mmol/l, interval 4,6-6 mmol/l).
English: All subjects in the maintenance phase received Lokelma at a starting dose of 5 g once daily which could be increased in increments of 5 g once daily (to a maximum of 15 g once daily) or decreased (to a minimum of 5 g once every other day) based upon the titration regimen.
Danish: startdosis på 5 g én gang dagligt, som kunne øges i trin på 5 g én gang dagligt (til maksimalt 15 g én gang dagligt) eller reduceres (til mindst 5 g én gang hver anden dag) på baggrund af titreringsregimet.
English: There is a reduction in urinary potassium excretion which is a consequence of a reduction in serum potassium concentration.
Danish: Udskillelsen af kalium i urinen nedsættes på grund af reduktion af serumkalium.
English: Serum potassium 3.5 to 5.0 mmol/L, inclusive
Danish: Serumkalium 3,5 til 5,0mmol/l, inklusive
English: Pregnancy and breast feeding
Danish: Graviditet og amning
English: Correction and maintenance phases (Study 2): mean serum potassium over time with 95% CI
Danish: Figur 1: Korrigerings- og vedligeholdelsesfaser (Studie 2): gennemsnitlige serumkaliumniveauer over tid med 95 % CI
English: Lokelma contains the active substance sodium zirconium cyclosilicate.
Danish: Lokelma indeholder det aktive stof natriumzirconiumcyclosilicat.
English: In patients with severe hypokalaemia, Lokelma should be discontinued and the patient re-evaluated.
Danish: Lokelma skal seponeres hos patienter med svær hypokaliæmi og patienten revurderes.
English: Days
Danish: Dage n Dage
English: EU/1/17/1173/001 3 sachets EU/1/17/1173/005 28 sachets EU/1/17/1173/002 30 sachets EU/1/17/1173/007 3 sachets EU/1/17/1173/008 28 sachets EU/1/17/1173/009 30 sachets
Danish: EU/1/17/1173/001 3 breve EU/1/17/1173/005 28 breve EU/1/17/1173/002 30 breve EU/1/17/1173/007 3 breve EU/1/17/1173/008 28 breve EU/1/17/1173/009 30 breve
English: A two-phase, multicenter, multi-dose, open-label safety and efficacy study The long term (up to 12 months) effects of Lokelma were assessed in this study in 751 subjects with hyperkalaemia (baseline average 5.59 mmol/L; range 4.3-7.6 mmol/L).
Danish: Et ublindet multidosis-multicenterstudie af sikkerhed og effekt i to faser Virkning af Lokelma over lang tid (op til 12 måneder) blev vurderet i dette studie med 751 forsøgspersoner med hyperkaliæmi (baseline-gennemsnit var 5,59 mmol/l, interval 4,3-7.6 mmol/l).
English: Correction phase Lokelma dose N Days n
Danish: Lokelma-dosis i korrigeringsfasen n
English: Elimination Sodium zirconium cyclosilicate is eliminated via the faeces.
Danish: Elimination Natriumzirconiumcyclosilicat udskilles via fæces.
English: 30 sachets
Danish: 30 breve
English: EU/1/17/1173/003 3 sachets EU/1/17/1173/006 28 sachets EU/1/17/1173/004 30 sachets EU/1/17/1173/010 3 sachets EU/1/17/1173/011 28 sachets EU/1/17/1173/012 30 sachets
Danish: EU/1/17/1173/003 3 breve EU/1/17/1173/006 28 breve EU/1/17/1173/004 30 breve EU/1/17/1173/010 3 breve EU/1/17/1173/011 28 breve EU/1/17/1173/012 30 breve
English: Sodium zirconium cyclosilicate can be co-administered without spacing of dosing times with oral medications that do not exhibit pH-dependent bioavailability.
Danish: Natriumzirconiumcyclosilicat kan administreres samtidig med orale lægemidler, der ikke udviser pH-afhængig biotilgængelighed, uden interval mellem doseringstidspunkterne.
English: Lokelma 5 g powder for oral suspension Lokelma 10 g powder for oral suspension
Danish: Lokelma 5 g pulver til oral suspension Lokelma 10 g pulver til oral suspension
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: Indtagelse af medicinen
English: What Lokelma looks like and contents of the pack The powder for oral suspension is a white, free flowing powder, essentially free of debris and particulates.
Danish: Pulveret til oral suspension er et hvidt, fritflydende pulver, der i det væsentlige er frit for klumper og partikler.
English: Serum potassium 3.5 to 5.5 mmol/L, inclusive n/N Proportion 95% CI
Danish: Serumkalium 3,5 til 5,5mmol/l, inklusive n/N Andel
English: 3 sachets
Danish: 3 breve
English: Normokalaemia was dependent on baseline potassium concentration, with subjects with the highest baseline serum potassium concentrations having the most prominent decrease after starting the study drug but with the lowest proportion of subjects achieving normokalaemia.
Danish: Normokaliæmi var afhængig af baseline-kaliumkoncentrationen, hvor forsøgspersoner med de højeste baseline-kaliumkoncentrationer i serum oplevede det mest fremtrædende fald efter start med studielægemidlet, men udgør den laveste andel af forsøgspersoner, som opnåede normokaliæmi.126 patienter havde en baseline-serumkalium ≥ 6,0 mmol/l (gennemsnitlig baseline-kalium 6,28 mmol/l).
English: Each sachet contains 10 g of sodium zirconium cyclosilicate.
Danish: Hvert brev indeholder 10 g natriumzirconiumcyclosilicat.
English: Each sachet contains 5 g of sodium zirconium cyclosilicate.
Danish: Hvert brev indeholder 5 g natriumzirconiumcyclosilicat.
English: If any of the above apply to you (or you are not sure), tell your doctor, pharmacist or nurse before taking this medicine.
Danish: Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, inden du tager dette lægemiddel, hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl).
English: Lokelma 10 g powder for oral suspension Each sachet contains 10 g of powder.
Danish: Lokelma 10 g pulver til oral suspension Hvert brev indeholder 10 g pulver.
English: Lokelma 5 g powder for oral suspension Each sachet contains 5 g of powder.
Danish: Lokelma 5 g pulver til oral suspension Hvert brev indeholder 5 g pulver.
English: How to take Lokelma
Danish: Sådan skal du tage Lokelma
English: Lokelma 5 g powder for oral suspension Lokelma 10 g powder for oral suspension sodium zirconium cyclosilicate
Danish: Lokelma 5 g pulver til oral suspension Lokelma 10 g pulver til oral suspension natriumzirconiumcyclosilicat
English: Lokelma 5 g powder for oral suspension Each sachet contains 5 g sodium zirconium cyclosilicate
Danish: Lokelma 5 g pulver til oral suspension Hvert brev indeholder 5 g natriumzirconiumcyclosilicat
English: Lokelma 10 g powder for oral suspension Each sachet contains 10 g sodium zirconium cyclosilicate
Danish: Lokelma 10 g pulver til oral suspension Hvert brev indeholder 10 g natriumzirconiumcyclosilicat
English: 6.1 List of excipients
Danish: 6.1Hjælpestoffer
English: Lokelma 5 g powder for oral suspension sodium zirconium cyclosilicate Oral use
Danish: Lokelma 5 g pulver til oral suspension natriumzirconiumcyclosilicat Oral anvendelse
English: Lokelma 10 g powder for oral suspension Each sachet contains 10 g of sodium zirconium cyclosilicate.
Danish: Lokelma 10 g pulver til oral suspension: Hvert brev indeholder 10 g natriumzirconiumcyclosilicat.
English: Lokelma 5 g powder for oral suspension Each sachet contains 5 g of sodium zirconium cyclosilicate.
Danish: Lokelma 5 g pulver til oral suspension: Hvert brev indeholder 5 g natriumzirconiumcyclosilicat.
English: Lokelma 10 g powder for oral suspension sodium zirconium cyclosilicate Oral use
Danish: Lokelma 10 g pulver til oral suspension natriumzirconiumcyclosilicat Oral anvendelse
English: Lokelma 5 g powder for oral suspension sodium zirconium cyclosilicate
Danish: Lokelma 5 g pulver til oral suspension natriumzirconiumcyclosilicat
English: Lokelma 10 g powder for oral suspension sodium zirconium cyclosilicate
Danish: Lokelma 10 g pulver til oral suspension natriumzirconiumcyclosilicat
English: It comes in a sachet.
Danish: Pulveret er indkapslet i et brev.
English: If you take more Lokelma than you should:
Danish: Hvis du har taget for meget Lokelma
English: • The products can continue to be used as recommended.
Danish: • Produkterne kan fortsat anvendes som anbefalet.
English: The marketing authorisation holder for both medicines is the same company, Bayer Pharma AG.
Danish: Indehaveren af markedsføringstilladelsen for begge lægemidler er samme virksomhed, Bayer Pharma AG.
English: 20 February 2014 EMA/108793/20144
Danish: Den 20. februar 2014 EMA/108793/2014