FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profile of Lokelma was evaluated in clinical trials involving 1760 patients with 507 patients exposed for one year.
Maltese: Il-profil tas-sigurtà ta' Lokelma ġie evalwat fi provi kliniċi li involvew 1760 pazjent b'507 pazjenti esposti għal sena.
English: Subjects who achieved normokalaemia (3.5-5.0 mmol/L, inclusive) within 72 hours entered the maintenance phase of the study.
Maltese: Individwi li kisbu normokalaemija (3.5-5.0 mmol/L, inklussivi) fi żmien 72 siegħa daħlu fil-fażi ta' manteniment tal-istudju.
English: Maintenance phase (12 days, Study 1): Mean number of normokalaemic days Maintenance phase treatment (once daily)
Maltese: Tabella 3. Fażi ta' manteniment (12-il jum, Studju 1): Numru medju ta' jiem normokalemiċi
English: Summary of the safety profile The most commonly reported adverse reactions were hypokalaemia (4.1%) and oedema related events
Maltese: L-aktar reazzjonijiet avversi rrapportati b'mod komuni kienu ipokalimja (4.1 %) u avvenimenti relatati mal-edema (5.7 %).
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
Maltese: EU/1/17/1173/003 3 qratas EU/1/17/1173/006 28 qartas EU/1/17/1173/004 30 qartas EU/1/17/1173/009 3 qratas EU/1/17/1173/012 28 qartas EU/1/17/1173/010 30 qartas
English: Detailed information on this medicine is also available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
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%).
Maltese: Il-proporzjon ta' individwi b'medja ta' potassium fis-serum < 5.1 mmol/L mill-Jum ta' Studju 8 sa 29 (perjodu ta' tliet ġimgħat) kien akbar fid-dożi ta' darba kuljum ta' 5 g, 10 g u 15 g ta' Lokelma (80%, 90% u 94%, rispettivament), meta mqabbel mal-plaċebo (46%).
English: Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphatemia, ATC code: V03AE10
Maltese: Mediċini għall-kura ta' iperkalimja u iperfosfatemja, Kodiċi ATC:
English: Lokelma 5 g powder for oral suspension Lokelma 10 g powder for oral suspension
Maltese: Lokelma 5 g trab għal sospensjoni orali Lokelma 10 g trab għal sospensjoni orali
English: 2.5 g three times daily 5 g three times daily 10 g three times daily NS: not significant
Maltese: 2.5 g tliet darbiet kuljum 5 g tliet darbiet kuljum 10 g tliet darbiet kuljum NS: mhux sinifikanti
English: Sodium zirconium cyclosilicate may be opaque to X-rays.
Maltese: Sodium zirconium cyclosilicate jista' jkun opak għar-raġġi X.
English: An in vivo mass balance study in rats showed that sodium zirconium cyclosilicate was recovered in the faeces with no evidence of systemic absorption.
Maltese: Studju tal-bilanċ fil-massa in vivo fil-firien wera li sodium zirconium cyclosilicate kien irkuprat flippurgar mingħajr evidenza ta' assorbiment sistemiku.
English: Maintenance fixed dose (day)
Maltese: Doża fissa ta' manteniment (jum)
English: Serum potassium should be monitored when clinically indicated, including after changes are made to medicinal products that affect the serum potassium concentration (e.g. renin-angiotensin-aldosterone system (RAAS) inhibitors or diuretics) and after the Lokelma dose is titrated.
Maltese: Il-potassium fis-serum għandu jkun immonitorjat meta indikat klinikament, inkluż wara bidliet filprodotti mediċinali li jaffettwaw il-konċentrazzjoni ta' potassium fis-serum (eż. inibituri tas-sistema renin-angiotensin-aldosterone (RAAS) jew dijuretiċi) u wara li d-doża ta' Lokelma tiġi titrata.
English: Sodium zirconium cyclosilicate is an inorganic, insoluble compound that is not subject to enzymatic metabolism.
Maltese: Sodium zirconium cyclosilicate huwa kompost inorganiku, li ma jinħallx li mhuwiex suġġett għal metaboliżmu enżimatiku.
English: One hundred and twenty-six patients had a baseline serum potassium ≥ 6.0 mmol/L (mean baseline potassium 6.28 mmol/L).
Maltese: Mija u sitta u għoxrin pazjent kellum potassium fis-serum fil-linja bażi ≥ 6.0 mmol/L (potassium fil-linja bażi medju 6.28 mmol/L).
English: Sodium zirconium cyclosilicate is a non-absorbed, non-polymer inorganic powder with a uniform micropore structure that preferentially captures potassium in exchange for hydrogen and sodium cations.
Maltese: Sodium zirconium cyclosilicate huwa trab inorganiku li ma jiġix assorbit, mhux polimeru bi struttura uniformi ta' mikropori li preferibbilment taqbad il-potassium bi skambju għal katjoni tal-hydrogen u tas-sodium.
English: Correction phase (Study 4): proportion of subjects with serum potassium concentrations between 3.5 and 5.0 mmol/L, inclusive, or between 3.5 and 5.5 mmol/L, inclusive, by correction phase study dayITT population
Maltese: Fażi ta' korrezzjoni (Studju 4): proporzjon ta' individwi b'konċentrazzjonijiet talpotassium fis-serum ta' bejn 3.5 u 5.0 mmol/L, inklussiv, jew bejn 3.5 u 5.5 mmol/L, inklussiv, skont il-jum ta' studju tal-fażi ta' korrezzjoni - popolazzjoni ITT
English: OTHER
Maltese: Jiem
English: Sodium zirconium cyclosilicate is highly selective for potassium ions, even in the presence of other cations, such as calcium and magnesium, in vitro.
Maltese: Sodium zirconium cyclosilicate huwa selettiv ħafna għal joni tal-potassium, anke filpreżenża ta' katjoni oħrajn, bħall-calcium u l-magnesium, in vitro.
English: The safety and efficacy of Lokelma in children and adolescents (< 18 years) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Lokelma fit-tfal u adolexxenti ≤ 18-il sena ma ġewx determinti s'issa.
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).
Maltese: [5 g (n=45), 10 g (n=51), jew 15 g (n=56)] jew plaċebo (n=85) mogħtija darba kuljum għal 28 jum (il-fażi double-blind randomizzata ta' rtirar).
English: No more than 10 g once daily should be used for maintenance therapy.
Maltese: Ma għandhomx jintużaw aktar minn 10 g darba kuljum għat-terapija ta' manteniment.
English: Elimination Sodium zirconium cyclosilicate is eliminated via the faeces.
Maltese: Eliminazzjoni Sodium zirconium cyclosilicate huwa eliminat permezz tal-ippurgar.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5
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.
Maltese: Pazjenti kkurati b'Lokelma esperjenzaw żieda ta' 1.1 mmol/L b'5 g darba kuljum, 2.3 mmol/L b'10 g darba kuljum, u 2.6 mmol/L bi 15-il g darba kuljum fil-bicarbonate meta mqabbel ma' żieda medja ta' 0.6 mmol/L għal dawk li jirċievu lplaċebo.
English: Figure 2: Correction and maintenance phases in 12-month open-label study (Study 4) - mean serum potassium over time with 95% CI
Maltese: Figura 2: Fażijiet ta' korrezzjoni u manteniment fi studju bit-tikketta mikxufa ta' 12-il xahar (Studju 4) - potassium fis-serum medju maż-żmien b'CI ta' 95%
English: • Do not take a maintenance dose of more than 10 g once a day.
Maltese: • Tiħux doża ta' manteniment ta' aktar minn 10 g darba kuljum.
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.
Maltese: Pazjenti b'livelli tal-potassium ta' qabel il-kura aktar minn 5.5 mmol/L (linja bażi medja 5.8 mmol/L) raw tnaqqis medju ta' 1.1 mmol/L fi 48 siegħa waqt li dawk b'livelli talpotassium fil-bidu ta' jew taħt 5.3 mmol/L kellhom tnaqqis medju ta' 0.6 mmol/L bl-ogħla doża.
English: No dietary restrictions were imposed; patients were instructed to continue their usual diet without any specified alterations.
Maltese: Ma ġewx imposti restrizzjonijiet tad-dieta; il-pazjenti ngħataw struzzjonijiet sabiex ikomplu bid-dieta tas-soltu tagħhom mingħajr ebda alterazzjoni speċifikata.
English: In an environment where other factors affecting renin and aldosterone were not controlled, Lokelma demonstrated a dose-independent change in mean serum aldosterone levels (range: -30% to -31%) compared with the placebo group (+14%).
Maltese: F'ambjent fejn fatturi oħra li jaffettwaw ir-renin u l-adosterone ma kinux ikkontrollati, Lokelma wera bidla indipendenti mid-doża fil-livelli medji ta' aldosterone fis-serum (firxa: -30% sa -31%) meta mqabbel mal-grupp tal-plaċebo (+14%).
English: Figure 2 illustrates the mean serum potassium over the correction and maintenance phases of the study.
Maltese: Figura 2 turi l-potassium fis-serum medju mal-fażijiet ta' korrezzjoni u manteniment tal-istudju.
English: In the studies, Lokelma reduced serum potassium and maintained normal serum potassium levels regardless of the underlying cause of hyperkalaemia, age, sex, race, comorbid disease or concomitant use of RAAS inhibitors.
Maltese: Fl-istudji, Lokelma naqqas il-potassium fis-serum u żamm il-livelli tal-potassium fis-serum għan-normal irrispettivament mill-kawża sottostanti taliperkalimja, età, sess, razza, aktar minn marda waħda jew użu konkomitanti ta' inibituri RAAS.
English: These five studies included 1760 patients given doses of Lokelma; 507 exposed for at least 360 days.
Maltese: Dawn il-ħames studji inkludew 1760 pazjent mogħtija dożi ta' Lokelma; b'507 esposti għal mill-anqas 360 jum.
English: The adverse reactions identified from controlled trials are shown in Table 1.
Maltese: Ir-reazzjonijiet avversi identifikati mill-provi kkontrollati huma murija f'Tabella 1.
English: Monitoring frequency will depend upon a variety of factors including other medications, progression of chronic kidney disease and dietary potassium intake.
Maltese: Ilmonitoraġġ tal-frekwenza se jiddependi fuq varjetà ta' fatturi inklużi medikazzjonijiet oħra, ilprogressjoni tal-mard kroniku fil-kliewi u t-teħid tal-potassium fid-dieta.
English: Lokelma 10 g powder for oral suspension sodium zirconium cyclosilicate
Maltese: Lokelma 10 g trab għal sospensjoni orali sodium zirconium cyclosilicate
English: Sodium zirconium cyclosilicate does not affect serum calcium or magnesium concentrations, or urinary sodium excretion.
Maltese: Sodium zirconium cyclosilicate ma jaffettwax il-konċentrazzjonijiet tal-calcium jew tal-magnesiumfis-serum, jew eliminazzjoni tas-sodium fl-awrina.
English: Lokelma 5 g powder for oral suspension sodium zirconium cyclosilicate
Maltese: Lokelma 5 g trab għal sospensjoni orali sodium zirconium cyclosilicate
English: Maintenance phase
Maltese: Fażi ta' manteniment
English: Lokelma at the 10 g dose and the 3 g dose resulted in mean maximal reductions of 0.92 mmol/L and 0.43 mmol/L, respectively.
Maltese: 92 mmol/L u 0.43 mmol/L, rispettivament.
English: • renin inhibitors such as aliskiren (for high blood pressure)
Maltese: • inibituri ta' renin bħal aliskirenn (għal pressjoni tad-demm għolja)
English: The potassium-lowering effects of Lokelma have been demonstrated in three randomised, double-blind, placebo-controlled trials in patients with hyperkalaemia.
Maltese: L-effetti li jbaxxu l-potassium ta' Lokelma ntwerew fi tliet provi randomizzati, double-blind, ikkontrollati bi plaċebo f'pazjenti bl-iperkalimja.
English: 1.25 g three times daily
Maltese: 1.25 g tliet darbiet kuljum
English: Severe hyperkalaemia There is limited experience in patients with serum potassium concentrations greater than 6.5 mmol/L.
Maltese: Hemm esperjenza limitata f'pazjenti b'konċentrazzjonijiet ta' potassium fis-serum ta' aktar minn 6.5 mmol/L.
English: Consistent with co-administration of dabigatran with other gastric acid modifiers, dabigatran Cmax and AUC values were approximately 40% lower when co-administered with sodium zirconium cyclosilicate.
Maltese: B'mod konsistenti mal-amministrazzjoni fl-istess ħin ta' dabigatran ma' modifikaturi oħra tal-aċidu gastriku, bejn wieħed u ieħor, il-valuri ta' dabigatran Cmax u ta' AUC kienu madwar 40 % aktar baxxi meta ngħataw flimkien ma' sodium zirconium cyclosilicate.
English: OUTER CARTON
Maltese: Esponiment fit-tul
English: Among those patients using RAAS inhibitors at baseline, 89% did not discontinue RAAS inhibitor therapy, 74% were able to maintain the same dose during the maintenance phase and among those not on RAAS inhibitors at baseline, 14% were able to initiate this therapy.
Maltese: Fost dawk il-pazjenti li jużaw inibituri RAAS fil-linja bażi, 89% ma waqfux itterapija ta' inibituri RAAS, 74% kienu kapaċi jżommu l-istess doża matul il-fażi ta' manteniment u fost dawk li ma kinux fuq inibituri RAAS fil-linja bażi, 14% kienu kapaċi jibdew din it-terapija.
English: The sachets are supplied in a carton containing 3, 28 or 30 sachets.
Maltese: Il-qratas huma fornuti f'kartuna li fiha 3, 28 jew 30 qartas.
English: During the correction phase, 10 g of Lokelma was administered three times daily for at least 24 hours and up to 72 hours.
Maltese: Matul il-fażi ta' korrezzjoni, 10 g ta' Lokelma ngħataw tliet darbiet kuljum għal mill-inqas 24 siegħa u sa 72 siegħa.
English: Correction (hour)
Maltese: Korrezzjoni (siegħa)
English: Kaplan-Meier estimates of time to relapse for maintenance phase showed dose dependence in time to relapse with median time for 5 g dose ranging from 4 to 21 days depending on the baseline serum potassium values.
Maltese: Stimi ta' Kaplan-Meier taż-żmien għar-rikaduta għall-fażi ta' manteniment urew dipendenza fuq iddoża fiż-żmien għar-rikaduta biż-żmien medjan għal doża ta' 5 g li jvarja bejn 4 u 21 jum skont ilvaluri bażali ta' potassium fis-serum.
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.
Maltese: Sodium zirconium cyclosilicate jaqbad il-potassium tul l-apparat gastrointestinali (GI) kollu u jnaqqas il-konċentrazzjoni talpotassium ħieles fil-lumen GI, biex b'hekk inaqqas il-livelli tal-potassium fis-serum u jżid leliminazzjoni tal-potassium fl-ippurgar sabiex l-iperkalimja tirriżolva ruħha.
English: Patients on dialysis
Maltese: Pazjenti fuq dijaliżi
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.
Maltese: Ma huwa mistenni ebda effett fuq it-trabi peress li l-esponiment sistemiku tal-mara li tredda' għal sodium zirconium cyclosilicate huwa negliġibbli.
English: QT Prolongation
Maltese: Titwil tal-QT
English: Sodium zirconium cyclosilicate has also been shown to bind ammonium in vitro and in vivo, thereby removing ammonium and increasing serum bicarbonate levels.
Maltese: Intwera wkoll li sodium zirconium cyclosilicate jorbot l-ammonium in vitro u in vivo, b'hekk ineħħi l-ammonium u jżid il-livelli tal-bikarbonat fis-serum.
English: 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.
Maltese: Fi studju ta' individwi f'saħħithom mogħtija Lokelma 5 g jew 10 g darba kuljum għal erbat ijiem, it-tnaqqis dipendenti fuq id-doża tal-konċentrazzjoni tal-potassium fis-serum u l-eliminazzjoni totali tal-potassium fis-serum kienu akkumpanjati minn żidiet medji fl-eliminazzjoni tal-potassium fl-ippurgar.
English: No events of intestinal perforation have been reported with Lokelma.
Maltese: Ebda avveniment ta' perforazzjoni intestinali ma ġie rrappurtat b'Lokelma.
English: Lokelma 5 g powder for oral suspension Lokelma 10 g powder for oral suspension sodium zirconium cyclosilicate
Maltese: Lokelma 5 g trab għal sospensjoni orali Lokelma 10 g trab għal sospensjoni orali sodium zirconium cyclosilicate
English: Titrated dose Off treatment
Maltese: TAL-PRODOTT MEDIĊINALI
English: When normokalaemia has been achieved, the minimal effective dose of Lokelma to prevent recurrence of hyperkalaemia should be established.
Maltese: Meta tinkiseb in- normokalaemia, għandha tiġi stabbilità d-doża effettiva minima ta' Lokelma biex tiġi evitata r-rikorrenza tal-iperkalemija.
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).
Maltese: Ġbir tal-awrina ta' erba' u għoxrin siegħa wera li Lokelma naqqas l-eliminazzjoni talpotassium fl-awrina mil-linja bażi bi 15.8 mmol/24 siegħa meta mqabbel mal-plaċebo, żieda bi 8.9 mmol/24
English: Do not use this medicine after the expiry date which is stated on the carton and the sachet after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-qartas wara ‘JIS'.
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.
Maltese: Fil-fażi tal-korrezzjoni tal-istudju, 258 pazjent bl-iperkalimja (linja bażi medja 5.6, firxa 4.17.2 mmol/L) irċevew 10 g ta' Lokelma mogħtija tliet darbiet kuljum għal 48 siegħa.
English: Effect of sodium zirconium cyclosilicate on other medicinal products As sodium zirconium cyclosilicate is not absorbed or metabolised by the body, and does not meaningfully bind other medicinal products, there are limited effects on other medicinal products.
Maltese: Effett ta' sodium zirconium cyclosilicate fuq prodotti mediċinali oħrajn Minħabba li sodium zirconium cyclosilicate mhuwiex assorbit jew metabolizzat mill-ġisem, u ma jeħilx sostanzjalment ma' prodotti mediċinali oħrajn, hemm effetti limitati fuq prodotti mediċinali oħrajn.
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.
Maltese: Sodium zirconium cyclosilicate jista' jżid il-pH gastriku b'mod temporanju billi jassorbi ljoni tal-idroġenu u jista' jwassal għal bidliet fil-kinetiċi tas-solubbiltà u l-assorbiment għal prodotti mediċinali li jingħataw flimkien ma' bijodisponibbiltà li tiddependi fuq il-pH.
English: Figure 1 illustrates the mean serum potassium over the correction and maintenance phases of the study.
Maltese: Figura 1 turi l-potassium fis-serum medju skont il-fażijiet ta' korrezzjoni u manteniment tal-istudju.
English: • you start to have a build up of fluid in the tissues, leading to swelling anywhere in your body (usually in the feet and ankles).
Maltese: • jibda jkollok akkumulazzjoni ta' fluwidu fit-tessuti, li jwassal għal nefħa fi kwalunkwe post fil-ġisem tiegħek (ġeneralment fis-saqajn u fl-għekiesi).
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.
Maltese: Fi provi kliniċi, 4.1 % tal-pazjenti b'Lokelma żviluppaw l-ipokalimja b'valur ta' potassium fis-serum inqas minn 3.5 mmol/L, li ssolviet b'aġġustament fid-doża jew bit-twaqqif ta' Lokelma.
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.
Maltese: Effett ta' prodotti mediċinali oħrajn fuq sodium zirconium cyclosilicate Minħabba li sodium zirconium cyclosilicate mhuwiex assorbit jew metabolizzat mill-ġisem, m'hemmx effetti mistennija ta' prodotti mediċinali oħrajn fuq l-azzjoni farmakoloġika ta' sodium zirconium cyclosilicate.
English: Each sachet contains 5 g of sodium zirconium cyclosilicate.
Maltese: Kull qartas fih 5 grammi ta' sodium zirconium cyclosilicate
English: There is a close correlation between starting serum potassium levels and effect size; patients with higher starting serum potassium levels have greater reductions in serum potassium.
Maltese: Hemm korrelazzjoni mill-qrib bejn il-livelli tal-potassium fis-serum tal-bidu u d-daqs tal-effett; il-pazjenti b'livelli ogħla tal-potassium fis-serum għandhom tnaqqis akbar tal-potassium fis-serum.
English: Each sachet contains 10 g of sodium zirconium cyclosilicate.
Maltese: Kull qartas fih 10 grammi ta' sodium zirconium cyclosilicate
English: Serum potassium should be monitored periodically and the Lokelma dose titrated as described in section 4.2 Posology and Method of Administration.
Maltese: Ma ġie osservat l-ebda effett konsistenti fuq ilpressjoni tad-demm sistolika u dijastolika.
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.
Maltese: L-individwi kollha fil-fażi ta' manteniment irċevew Lokelma b'doża tal-bidu ta' 5 g darba kuljum li setgħet tiżdied f'inkrimenti ta' 5 g darba kuljum (għal massimu ta' 15 g darba kuljum) jew titnaqqas (għal minimu ta' 5 g darba jum iva u jum le) abbażi tar-reġimen ta' titrazzjoni.
English: Fertility There were no adverse effects on embryo-foetal development in treated rats or in rabbits.
Maltese: Fertilità Ma kienx hemm effetti avversi fuq l-iżvilupp embrijo-fetali f'firien u fi fniek ikkurati.
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: h (NS)).
English: Do not take Lokelma • If you are allergic to the active substance.
Maltese: • Jekk inti allerġiku/a għas-sustanza attiva.
English: Each sachet contains 10 g.
Maltese: Kull qartas fih 10 g.
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).
Maltese: L-effetti fit-tul (sa 12-il xahar) ta' Lokelma ġew ivvalutati f'dan l-istudju f'751 individwu b'iperkalemija (medja tal-linja bażi ta' 5.59 mmol/L; medda ta' 4.3-7.6 mmol/L).
English: Correction phase Lokelma dose N Days n
Maltese: Kif għandek tieħu Lokelma
English: Lokelma 10 g powder for oral suspension Each sachet contains 10 g of sodium zirconium cyclosilicate.
Maltese: Lokelma 10 g trab għal sospensjoni orali Kull qartas fih 10 g ta' sodium zirconium cyclosilicate.
English: Lokelma 10 g powder for oral suspension Each sachet contains 10 g sodium zirconium cyclosilicate
Maltese: Lokelma 10 g trab għal sospensjoni orali Kull qartas fih 10 g sodium zirconium cyclosilicate
English: Maintenance phase with Lokelma titration (open-label) results: 123 patients entered the 11-month open-label phase.
Maltese: Riżultati tal-fażi ta' manteniment b'titrazzjoni ta' Lokelma (tikketta mikxufa): 123 pazjent daħlu filfażi tat-tikketta mikxufa ta' 11-il xahar.
English: • you have sudden or severe pain in your abdomen as this may be a sign of a problem that is observed with other medications that work in the gastrointestinal tract.
Maltese: • ikollok uġigħ f'daqqa jew sever fl-addome tiegħek peress li dan jista' jkun sinjal ta' problema li hi osservata b'medikazzjonijiet oħrajn li jaħdmu fil-passaġġ gastrointestinali.