natgillin/translations-raw huggingface dataset:
I et studie med raske forsøgspersoner, som fik Lokelma 5 g eller 10 g én gang dagligt i fire dage, blev den dosisafhængige reduktion af serumkalium og den totale udskillelse af kalium i urinen ledsaget af middelstigninger i den fækale udskillelse af kalium. 
In a study of healthy subjects given Lokelma 5 g or 10 g once daily for four days, dosedependent reduction in serum potassium concentration and total urinary potassium excretion were accompanied by mean increases in faecal potassium excretion.
Hvert brev indeholder 10 g. 
Each sachet contains 10 g.
I et klinisk lægemiddelinteraktionsstudie udført på raske forsøgspersoner resulterede samtidig administration af natriumzirconiumcyclosilicat og amlodipin, clopidogrel, atorvastatin, furosemid, glipizid, warfarin, losartan eller levothyroxin ikke i klinisk signifikante interaktioner. 
In a clinical drug-drug interaction study conducted in healthy subjects co-administration of sodium zirconium cyclosilicate with amlodipine, clopidogrel, atorvastatin, furosemide, glipizide, warfarin, losartan or levothyroxine did not result in clinically meaningful drugdrug interactions.
Ødemrelaterede bivirkninger, herunder overhydrering, væskeretention, generaliseret ødem, hypervolæmi, lokalt ødem, ødem, perifert ødem og perifere hævelser, blev rapporteret hos 5,7 % af Lokelma-patienterne. 
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.
For en sikkerheds skyld bør Lokelma undgås under graviditet. 
As a precautionary measure, it is preferable to avoid the use of Lokelma during pregnancy.
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). 
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).
In vitro er natriumzirconiumcyclosilicat meget selektivt for kaliumioner, selv ved tilstedeværelse af andre kationer, såsom calcium og magnesium. 
Sodium zirconium cyclosilicate is highly selective for potassium ions, even in the presence of other cations, such as calcium and magnesium, in vitro.
Der blev bibeholdt normokaliæmi, mens patienterne var i fortsat behandling med lægemidlet, og det gennemsnitlige serumkalium steg efter seponering. 
Normokalaemia was maintained while patients remained on drug and the mean serum potassium increased following discontinuation.
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. 
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.
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. 
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.
Det er også vist, at natriumzirconiumcyclosilicat binder ammonium in vitro og in vivo, hvorved ammonium fjernes og serumhydrogencarbonat stiger. 
Sodium zirconium cyclosilicate has also been shown to bind ammonium in vitro and in vivo, thereby removing ammonium and increasing serum bicarbonate levels.
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. 
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.
28 breve 
28 sachets
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. 
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.
Sådan tages medicinen 
Taking this medicine
Serumkalium skal kontrolleres og kaliumtilskud gives efter behov. 
Serum potassium should be checked and potassium supplemented as needed.
Der forventes ingen påvirkning af nyfødte/spædbørn, som ammes, da den systemiske eksponering af den ammende kvinde for Lokelma er ubetydelig. 
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to Lokelma is negligible.
Kontrol 
Monitoring
Figur2 illustrerer det gennemsnitlige serumkalium i korrigerings-og vedligeholdelsesfasen i studiet. 
Figure 2 illustrates the mean serum potassium over the correction and maintenance phases of the study.
Natriumzirconiumcyclosilicat påvirker ikke serumcalcium eller -magnesium eller udskillelsen af natrium i urinen. 
Sodium zirconium cyclosilicate does not affect serum calcium or magnesium concentrations, or urinary sodium excretion.
På grund af natriumzirconiumcyclosilicats fysiokemiske egenskaber absorberes det ikke systemisk og forventes ikke at blive udskilt i human mælk. 
Due to its physicochemical properties, sodium zirconium cyclosilicate is not systemically absorbed and is not expected to be excreted in breast milk.
Når Lokelma passerer gennem maven og tarmene, forbinder det sig med kalium, og de to stoffer forlader kroppen sammen med afføringen. 
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.
Serumkalium med 95 % CI (mmol/l) 
Serum Potassium with 95% CI (mmol/L)
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 %). 
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%).
Figur 2: Korrigerings- og vedligeholdelsesfasen i det ublindede studie over 12 måneder (studie 4) gennemsnitligt serumkalium over tid med 95 % CI 
Figure 2: Correction and maintenance phases in 12-month open-label study (Study 4) - mean serum potassium over time with 95% CI
Hvis pulveret lægger sig på bunden af glasset, skal der omrøres igen. 
If the powder settles, the water should be stirred again.
Vedligeholdelsesstudierne omfattede patienter med kronisk nyresygdom (58 %), hjertesvigt (10 %), diabetes mellitus (62 %) og patienter, som fik behandling med RAAS-hæmmere (68 %). 
The maintenance studies included patients with chronic kidney disease (58%), heart failure (10%), diabetes mellitus (62%) and RAAS inhibitor therapy (68%).
Natriumzirconiumcyclosilicat kan være intransparante for røntgenstråler. 
Sodium zirconium cyclosilicate may be opaque to X-rays.
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. 
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.
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). 
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.
Patienter med nedsat nyre-/leverfunktion Dosisjustering ikke nødvendig hos patienter med nedsat nyre- eller leverfunktion. 
Patients with renal/hepatic impairment No changes from the normal doses are required for patients with renal or hepatic impairment.
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. 
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.
Der forventes ingen påvirkning af ammede nyfødte/spædbørn, da den systemiske eksponering af den ammende kvinde for natriumzirconiumcyclosilicat er ubetydelig. 
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to sodium zirconium cyclosilicate is negligible.
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). 
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).
5.2Farmakokinetiske egenskaber 
5.2 Pharmacokinetic properties
som fik Lokelma, hvoraf 507 blev eksponeret i mindst 360 dage. 
These five studies included 1760 patients given doses of Lokelma; 507 exposed for at least 360 days.
Lokelma kan anvendes under amning. 
Lokelma can be used during breast-feeding.
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. 
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.
Langtidseksponering 
Long term exposure
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. 
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.
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). 
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).
Lokelma er indiceret til behandling af hyperkaliæmi hos voksne patienter (se pkt. 
Lokelma is indicated for the treatment of hyperkalaemia in adult patients (see section 4.4 and 5.1).
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. 
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.
Trafik- og arbejdssikkerhed Lokelma påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner. 
Driving and using machines This medicine has no or negligible influence on your ability to drive or to use machines.
Serumkalium bør monitoreres regelmæssigt og Lokelma-dosis titreres som beskrevet i pkt. 
Serum potassium should be monitored periodically and the Lokelma dose titrated as described in section 4.2 Posology and Method of Administration.
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. 
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.
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. 
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.
Begrænsninger i de kliniske data Patienter i dialysebehandling 
Limitations of the clinical data
Titreret vedligeholdelsesdosis (dag) 
Maintenance fixed dose (day)
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. 
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.
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. 
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.
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). 
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).
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. 
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.
Udskillelsen af kalium i urinen nedsættes på grund af reduktion af serumkalium. 
There is a reduction in urinary potassium excretion which is a consequence of a reduction in serum potassium concentration.
Serumkalium 3,5 til 5,0mmol/l, inklusive 
Serum potassium 3.5 to 5.0 mmol/L, inclusive
Graviditet og amning 
Pregnancy and breast feeding
Figur 1: Korrigerings- og vedligeholdelsesfaser (Studie 2): gennemsnitlige serumkaliumniveauer over tid med 95 % CI 
Correction and maintenance phases (Study 2): mean serum potassium over time with 95% CI
Lokelma indeholder det aktive stof natriumzirconiumcyclosilicat. 
Lokelma contains the active substance sodium zirconium cyclosilicate.
Lokelma skal seponeres hos patienter med svær hypokaliæmi og patienten revurderes. 
In patients with severe hypokalaemia, Lokelma should be discontinued and the patient re-evaluated.
Dage n Dage 
Days
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 
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
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). 
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).
Lokelma-dosis i korrigeringsfasen n 
Correction phase Lokelma dose N Days n
Elimination Natriumzirconiumcyclosilicat udskilles via fæces. 
Elimination Sodium zirconium cyclosilicate is eliminated via the faeces.
30 breve 
30 sachets
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 
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
Natriumzirconiumcyclosilicat kan administreres samtidig med orale lægemidler, der ikke udviser pH-afhængig biotilgængelighed, uden interval mellem doseringstidspunkterne. 
Sodium zirconium cyclosilicate can be co-administered without spacing of dosing times with oral medications that do not exhibit pH-dependent bioavailability.
Lokelma 5 g pulver til oral suspension Lokelma 10 g pulver til oral suspension 
Lokelma 5 g powder for oral suspension Lokelma 10 g powder for oral suspension
Indtagelse af medicinen 
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Pulveret til oral suspension er et hvidt, fritflydende pulver, der i det væsentlige er frit for klumper og partikler. 
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.
Serumkalium 3,5 til 5,5mmol/l, inklusive n/N Andel 
Serum potassium 3.5 to 5.5 mmol/L, inclusive n/N Proportion 95% CI
3 breve 
3 sachets
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). 
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.
Hvert brev indeholder 10 g natriumzirconiumcyclosilicat. 
Each sachet contains 10 g of sodium zirconium cyclosilicate.
Hvert brev indeholder 5 g natriumzirconiumcyclosilicat. 
Each sachet contains 5 g of sodium zirconium cyclosilicate.
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). 
If any of the above apply to you (or you are not sure), tell your doctor, pharmacist or nurse before taking this medicine.
Lokelma 10 g pulver til oral suspension Hvert brev indeholder 10 g pulver. 
Lokelma 10 g powder for oral suspension Each sachet contains 10 g of powder.
Lokelma 5 g pulver til oral suspension Hvert brev indeholder 5 g pulver. 
Lokelma 5 g powder for oral suspension Each sachet contains 5 g of powder.
Sådan skal du tage Lokelma 
How to take Lokelma
Lokelma 5 g pulver til oral suspension Lokelma 10 g pulver til oral suspension natriumzirconiumcyclosilicat 
Lokelma 5 g powder for oral suspension Lokelma 10 g powder for oral suspension sodium zirconium cyclosilicate
Lokelma 5 g pulver til oral suspension Hvert brev indeholder 5 g natriumzirconiumcyclosilicat 
Lokelma 5 g powder for oral suspension Each sachet contains 5 g sodium zirconium cyclosilicate
Lokelma 10 g pulver til oral suspension Hvert brev indeholder 10 g natriumzirconiumcyclosilicat 
Lokelma 10 g powder for oral suspension Each sachet contains 10 g sodium zirconium cyclosilicate
6.1Hjælpestoffer 
6.1 List of excipients
Lokelma 5 g pulver til oral suspension natriumzirconiumcyclosilicat Oral anvendelse 
Lokelma 5 g powder for oral suspension sodium zirconium cyclosilicate Oral use
Lokelma 10 g pulver til oral suspension: Hvert brev indeholder 10 g natriumzirconiumcyclosilicat. 
Lokelma 10 g powder for oral suspension Each sachet contains 10 g of sodium zirconium cyclosilicate.
Lokelma 5 g pulver til oral suspension: Hvert brev indeholder 5 g natriumzirconiumcyclosilicat. 
Lokelma 5 g powder for oral suspension Each sachet contains 5 g of sodium zirconium cyclosilicate.
Lokelma 10 g pulver til oral suspension natriumzirconiumcyclosilicat Oral anvendelse 
Lokelma 10 g powder for oral suspension sodium zirconium cyclosilicate Oral use
Lokelma 5 g pulver til oral suspension natriumzirconiumcyclosilicat 
Lokelma 5 g powder for oral suspension sodium zirconium cyclosilicate
Lokelma 10 g pulver til oral suspension natriumzirconiumcyclosilicat 
Lokelma 10 g powder for oral suspension sodium zirconium cyclosilicate
Pulveret er indkapslet i et brev. 
It comes in a sachet.
Hvis du har taget for meget Lokelma 
If you take more Lokelma than you should:
• Produkterne kan fortsat anvendes som anbefalet. 
• The products can continue to be used as recommended.
Indehaveren af markedsføringstilladelsen for begge lægemidler er samme virksomhed, Bayer Pharma AG. 
The marketing authorisation holder for both medicines is the same company, Bayer Pharma AG.
Den 20. februar 2014 EMA/108793/2014 
20 February 2014 EMA/108793/20144
Octocog alfa i disse produkter har samme struktur som naturlig faktor VIII (“fuld længde”). 
The octocog alfa in these products has the same structure as natural factor VIII (‘full-length').
Fordelene opvejer fortsat risiciene hos tidligere ubehandlede patienter 
Benefits continue to outweigh risks in previously untreated patients