FrancophonIA/ELRC3.0 huggingface dataset:
English: EPIPEN JUNIOR 150 mikrogramm oldatos injekció előre töltött tollban microgramm /0,3 ml
Danish: EPIPEN JUNIOR 150 mikrogramm oldatos injekció előre töltött tollban mikrogram/0,3 ml
English: Adrenaline tartrate Emerade mikrogram
Danish: Adrenalin tartrate Emerade
English: EpiPen 150 micrograme 150 micrograms/ dose
Danish: EpiPen 150 micrograme 150 mikrogram/dosi s
English: Adrenaline tartrate Jext
Danish: Adrenalin tartrate JEXT
English: Adrenaline tartrate JEXT
Danish: Adrenalin tartrate Jext
English: EpiPen 300 micrograme 300 micrograms/ dose
Danish: EpiPen 300 micrograme 300 mikrogram/dosi s
English: Sweden Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton Salisbury SP20AH
Danish: Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton Salisbury SP20AH
English: EpiPen 300 microgram/dosis microgram/ dosis
Danish: EpiPen 300 microgram/dosis
English: 0,3 mg per dose (0,3 mg/0,3 ml)
Danish: 0,3 mg per dosis (0,3 mg/0,3 ml)
English: EPIPEN 300 mikrogramm oldatos injekció előre töltött tollban microgramm /0,3 ml
Danish: EPIPEN 300 mikrogramm oldatos injekció előre töltött tollban mikrogram/0,3 ml
English: ANAPEN 300 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben microgramm /0,3 ml
Danish: ANAPEN 300 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben mikrogram/0,3 ml
English: Alk Abello A/S Boge Alle 6-8 2970 Horsholm Denmark
Danish: ALK-Abelló A/S Bøge Allé 6-8 2970 Hørsholm Denmark
English: Nepipe Junior mikrogram
Danish: Nepipe Junior
English: Unit 8, Wilton Business Centre, Wilton SP2 0AH Salisbury United Kingdom
Danish: Lincoln Medical Ltd Unit 8, Wilton Business Centre, Wilton SP2 0AH Salisbury United Kingdom
English: Anapen microgram/ 0,3 ml
Danish: Anapen mikrogram/0,3 ml
English: Skyway House, Parsonage Road, Takeley Bishops Stortford CM22 6PU
Danish: Skyway House, Parsonage Road, Takeley
English: Germany MEDA Pharma GmbH & Co. KG
Danish: Tyskland MEDA Pharma GmbH & Co.
English: Adrenaline tartrate Jext 150 microgramos solución inyectable en pluma precargada
Danish: Adrenalin tartrate Jext 150 microgramos solución inyectable en pluma precargada
English: Adrenaline tartrate Jext 300 microgramos solución inyectable en pluma precargada
Danish: Adrenalin tartrate Jext 300 microgramos solución inyectable en pluma precargada
English: Solution for infusion Intramuscular use
Danish: Intramuskulær/subk utan anvendelse
English: MEDA Pharma GmbH & Co. KG
Danish: MEDA Pharma GmbH & Co.
English: Jext 300 micrograms solution for injection in pre-filled pen micrograms
Danish: Jext 300 micrograms solution for injection in pre-filled pen
English: Epipen Junior 150 micrograms solution for injection in pre-filled pen micrograms
Danish: Epipen Junior 150 micrograms solution for injection in pre-filled pen
English: Epipen 300 micrograms solution for injection in pre-filled pen micrograms
Danish: Epipen 300 micrograms solution for injection in pre-filled pen
English: ANAPEN JUNIOR 150 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben microgramm /0,3 ml
Danish: ANAPEN 150 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben mikrogram/0,3 ml
English: Jext 150 micrograms solution for injection in pre-filled pen micrograms
Danish: Jext 150 micrograms solution for injection in pre-filled pen
English: Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe micrograms in 0.3ml solution
Danish: Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe
English: Adrenaline tartrate Jext 300 micrograms solution for injection in pre-filled pen micrograms
Danish: Adrenalin tartrate Jext 300 micrograms solution for injection in pre-filled pen
English: Jext 300 microgram, oplossing voor injectie microgram/ dosis
Danish: Jext 300 microgram, oplossing voor injectie
English: Adrenaline tartrate Emerade 500 micrograms solution for injection in pre-filled pen micrograms
Danish: Adrenalin tartrate Emerade 500 micrograms solution for injection in pre-filled pen
English: Adrenaline tartrate Jext 150 micrograms solution for injection in pre-filled pen micrograms
Danish: Adrenalin tartrate Jext 150 micrograms solution for injection in pre-filled pen
English: Solution for infusion in prefilled syringe/pen
Danish: Infusionsvæske, opløsning i fyldt sprøjte/pen
English: Denmark Lincoln Medical Ltd Unit 8 Wilton Business Centre
Danish: Danmark Lincoln Medical Ltd Unit 8 Wilton Business Centre
English: MEDA PHARMA S.P.A. Viale Brenta 18
Danish: Viale Brenta 18
English: Anapen Junior 150 micrograms in 0.3ml solution for injection in a pre-filled syringe micrograms/ 0.3ml
Danish: Anapen 150 micrograms in 0.3ml solution for injection in a pre-filled syringe
English: Epipen 150 micrograms solution for injection in pre-filled pen micrograms
Danish: Epipen 150 micrograms solution for injection in pre-filled pen
English: Adrenaline tartrate Emerade 300 micrograms solution for injection in pre-filled pen micrograms
Danish: Adrenalin tartrate Emerade 300 micrograms solution for injection in pre-filled pen
English: 0,3 mg/dose Solution for injection Intramuscular use
Danish: 0,3 mg/dosis Injektionsvæske, opløsning
English: Adrenaline tartrate Emerade 150 micrograms solution for injection in pre-filled pen micrograms
Danish: Adrenalin tartrate Emerade 150 micrograms solution for injection in pre-filled pen
English: Luxembourg Alk Abello A/S Boge Alle 6-8
Danish: Luxembourg ALK-Abelló A/S Bøge Allé 6-8
English: Denmark ALK-Abello A/S Bøge Alle 6-8
Danish: Danmark ALK-Abelló A/S Bøge Allé 6-8
English: Lithuania Lincoln Medical Ltd Unit 8, Wilton Business Centre
Danish: Lincoln Medical Ltd Unit 8, Wilton Business Centre
English: 150 mcg/0,3 ml
Danish: 150 mikrog/ 0,3 ml
English: Germany ALK-ABELLO A/S Boge Alle 6-8
Danish: Tyskland ALK-Abelló A/S Bøge Allé 6-8
English: Jext 150 mikrogramov 150 µg/dose Solution for injection in pre-filled pen
Danish: Jext 150 mikrogramov 150 µg/dosis Injektionsvæske, opløsning i fyldt pen
English: Jext 300 mikrogramov 300 µg/dose Solution for injection in pre-filled pen
Danish: Jext 300 mikrogramov 300 µg/dosis Injektionsvæske, opløsning i fyldt pen
English: 150 mcg/ 0,3ml
Danish: 150 mikg/0,3 ml
English: 300 mcg/0,3 ml
Danish: 300 mikg/0,3 ml
English: Lincoln Medical Limited Unit 8, Wilton Business Centre,
Danish: Lincoln Medical Ltd Unit 8, Wilton Business Centre,
English: ALK-ABELLÓ A/S Boge Alle 6-8
Danish: Spanien ALK-Abelló A/S Bøge Allé 6-8
English: Lithuania SIA Meda Pharma Vienibas gatve 109
Danish: SIA Meda Pharma Vienibas gatve 109 Riga LV-1058
English: Germany Lincoln Medical Ltd. Unit 8 Wilton Buisiness Centre
Danish: Tyskland Lincoln Medical Ltd Unit 8 Wilton Business Centre
English: Mikrogramm
Danish: KG
English: It should be ensured that all of the content is taken.
Danish: Det skal sikres, at alt indholdet indtages.
English: Adults, including the elderly
Danish: Voksne, inklusive ældre
English: NS: not significant
Danish: NS: ikke signifikant
English: • The medicine takes one to two days to work.
Danish: • Medicinen skal tages en til to dage for at virke.
English: • Then take the next dose as usual at your normal time.
Danish: • Tag derefter den næste dosis som sædvanligt på det normale tidspunkt.
English: Talk to your doctor immediately if these symptoms become severe.
Danish: Fortæl det straks til din læge, hvis disse symptomer bliver alvorlige.
English: Date of first authorisation: 22 March 2018
Danish: Dato for første markedsføringstilladelse: 22. marts 2018
English: The suspension can be taken with or without food.
Danish: Suspensionen kan indtages med eller uden føde.
English: • Do not take this starting dose for more than three days.
Danish: • Tag ikke denne startdosis i mere end tre dage.
English: • You can take this medicine with or without meal.
Danish: • Du kan tage dette lægemiddel med eller uden et måltid.
English: Do not give this medicine to children and adolescents under 18 years of age.
Danish: Du må ikke give dette lægemiddel til børn og unge under 18 år.
English: Treatment was discontinued on study exit (Day 365).
Danish: Behandlingen blev seponeret ved udgang af studiet (dag 365).
English: • This is to make sure you are getting the correct dose.
Danish: • Dette skal gøres for at sikre, at du får den korrekte dosis.
English: Not known (frequency cannot be estimated from the available data).
Danish: Ikke kendt (kan ikke vurderes ud fra tilgængelige data).
English: • Try to take Lokelma at the same time each day.
Danish: • Forsøg at tage Lokelma på samme tidspunkt hver dag.
English: In addition, clinical studies have shown it not to be systemically absorbed.
Danish: Derudover har kliniske studier vist, at det ikke absorberes systemisk.
English: To open, cut across top.
Danish: Åbnes ved at klippe toppen af.
English: The risk of interaction with X-rays
Danish: Risiko for interaktion med røntgenstråler
English: Correction Phase (CP)
Danish: Korrigeringsfase(CP)
English: • Rinse the glass with more water and drink it all up to take all the medicine.
Danish: • Skyl glasset med mere vand, og drik det hele for at få al medicinen.
English: Do not take any more until you have spoken to a doctor.
Danish: Du må ikke tage mere, før du har talt med en læge.
English: These include:
Danish: Disse lægemidler omfatter:
English: Powder for oral suspension.
Danish: Pulver til oral suspension.
English: There are no other ingredients in this medicine.
Danish: Der er ingen andre indholdsstoffer i dette lægemiddel.
English: The powder will not dissolve.
Danish: Pulveret bliver ikke opløst.
English: Do not use this medicine during pregnancy because there is no information on its use in pregnancy.
Danish: Du må ikke bruge dette lægemiddel, hvis du er gravid, da der ikke er nogen information om brug under graviditet.
English: Do not use this medicine after the expiry date which is stated on the carton and the sachet after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og brevet efter "EXP".
English: If you take more of this medicine than you should, talk to a doctor straight away.
Danish: Hvis du har taget mere af dette lægemiddel, end du skulle, skal du straks tale med en læge.
English: Tell your doctor or nurse if you experience any of the following: Common side effects (may affect up to 1 in 10 people).
Danish: Fortæl det til lægen eller sundhedspersonalet, hvis du oplever noget af følgende: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer).
English: The sachets are supplied in a carton containing 3, 28 or 30 sachets.
Danish: Brevene leveres i en karton, der indeholder 3, 28 eller 30 breve.
English: • Your doctor may decide that you need more (10 g once a day) or less than this (5 g every other day).
Danish: • Lægen kan afgøre, om du har brug for mere (10 g en gang dagligt) eller mindre end dette (5 g hver anden dag).
English: Note: One subject had a post-dose value that was more than 1 day after last dose.
Danish: Bemærk: En forsøgsperson havde en post-dosisværdi, der var fra mere end 1 dag efter sidste dosis.
English: The adverse reactions identified from controlled trials are shown in Table 1.
Danish: De bivirkninger, der blev fundet i de kontrollerede studier, er vist i Tabel 1.
English: List of adverse reactions in clinical studies System Organ class
Danish: Liste over bivirkninger i kliniske studier Systemorganklasse
English: Do not take Lokelma • If you are allergic to the active substance.
Danish: Tag ikke Lokelma: • Hvis du er allergisk over for det aktive stof.
English: If normokalaemia is not achieved after 72 hours of treatment, other treatment approaches should be considered.
Danish: Hvis der ikke opnås normokaliæmi efter 72 timers behandling, skal andre behandlingstiltag overvejes.
English: 5 or 10 g of powder in sachets made of a PET/alu/LLDPE or PET/LDPE/alu/EAA/LLDPE laminate
Danish: 5 eller 10 g pulver i breve fremstillet af et PET/alu/LLDPE eller PET/LDPE/alu/EAA/LLDPE-laminat
English: This is because the effects of Lokelma in children and adolescents are not known.
Danish: Dette skyldes, at virkningen af Lokelma hos børn og unge ikke er kendt.
English: Long-term exposure Clinical trials with Lokelma have not included exposure longer than one year.
Danish: Langtidseksponering De kliniske studier med Lokelma har ikke omfattet eksponering i mere end 1 år.
English: Maintenance phase
Danish: Vedligeholdelsesfase
English: At the end of the maintenance period, when Lokelma was no longer administered, average potassium levels increased to near baseline levels.
Danish: Ved afslutning af vedligeholdelsesperioden, da Lokelma ikke længere blev administreret, steg de gennemsnitlige kaliumniveauer til omkring baseline-niveauer.
English: No consistent effect on systolic and diastolic blood pressure has been observed.
Danish: Der er ikke set nogen konsekvent indvirkning på systolisk og diastolisk blodtryk.
English: If this happens, stir the liquid again and drink it all up.
Danish: Hvis dette sker, skal du omrøre væsken igen og drikke det hele.
English: • The powder does not dissolve and the liquid appears cloudy.
Danish: • Pulveret vil ikke blive opløst, og væsken ser uklar ud.
English: Also, tell your doctor or nurse if you are taking any of the following:
Danish: Du skal også fortælle lægen eller sygeplejersken, hvis du tager noget af følgende:
English: If patients are still hyperkalaemic after 48 hours of treatment, the same regimen can be continued for an additional 24 hours.
Danish: Hvis patienterne stadig er hyperkaliæmiske efter 48 timers behandling, kan fortsættes med samme dosering i yderligere 24 timer.
English: If the patient is having abdominal X-rays, radiographers should keep this in mind.
Danish: Hvis patienten skal have taget abdominale røntgenbilleder, skal radiografen være opmærksom herpå.
English: Use of diuretics and RAAS inhibitors was reported by 51 and 70% of subjects, respectively.
Danish: Brug af diuretika og RAAS-hæmmere blev rapporteret af henholdsvis 51 % og 70 % af forsøgspersonerne.
English: Do not reduce the dose of this medicine or stop taking it without talking to the doctor who prescribed it.
Danish: Du må ikke nedsætte dosis eller stoppe med at tage medicinen uden først at have talt med den læge, der har udskrevet det.
English: Pack sizes: 3, 28 or 30 sachets
Danish: Pakningsstørrelser: 3, 28 eller 30 breve
English: The primary endpoint was the rate of change in serum potassium from baseline throughout the initial 2 days of treatment.
Danish: Det primære endepunkt var hastigheden i ændring af serumkalium fra baseline i de første 2 dage af behandlingen.
English: If a patient misses a dose they should be instructed to take the next usual dose at their normal time.
Danish: Hvis patienten glemmer en dosis, skal han eller hun instrueres i at tage næste dosis på det normale tidspunkt.
English: Your doctor or nurse will check your blood potassium level when you start taking this medicine:
Danish: Lægen eller sundhedspersonalet vil kontrollere indholdet af kalium i dit blodet, når du starter med at tage dette lægemiddel:
English: • Stir well and drink the tasteless liquid straight away.
Danish: • Rør godt rundt, og drik straks den smagsløse væske.
English: These events were mild to moderate in nature, none were reported as serious and were generally resolved while the patient continued treatment.
Danish: Disse bivirkninger var lette til moderate, ingen blev rapporteret som værende alvorlige, og de gik generelt over, mens patienten fortsat var i behandling.
English: Patients with higher starting potassium levels had a greater response to Lokelma.
Danish: Patienter med højere startniveauer af kalium havde et større respons på Lokelma.
English: In particular, tell them about any medicines which can change your blood potassium levels because your dose of Lokelma may need to be changed.
Danish: Du skal især fortælle dem om lægemidler, der kan ændre indholdet af kalium i blodet, da din dosis af Lokelma måske skal ændres.
English: The risk for intestinal perforation with the use of Lokelma is currently unknown.
Danish: Risikoen for intestinal perforation ved anvendelse af Lokelma er på nuværende tidspunkt ikke kendt.
English: The following convention was used for frequency of adverse reactions: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Følgende kategorier blev anvendt til angivelse af bivirkningshyppigheden: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Fertility There were no adverse effects on embryo-foetal development in treated rats or in rabbits.
Danish: Der var ingen skadelige påvirkninger af den embryoføtale udvikling hos behandlede rotter og kaniner.
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).
Danish: • du begynder at ophobe væske i dine væv, hvilket medfører hævelser i hele kroppen (normalt i fødder og ankler).
English: No dietary restrictions were imposed; patients were instructed to continue their usual diet without any specified alterations.
Danish: Forsøgspersonerne blev ikke pålagt kostændringer; patienterne blev derimod instrueret i at fortsætte deres normale kost uden særlige forandringer.
English: Therefore, the subject was eligible for the Correction Phase ITT Population; however, the time point was excluded from the analysis.
Danish: Derfor var denne forsøgsperson egnet til korrigeringsfase-ITT-populationen, men tidspunktet blev udelukket fra analysen.
English: n/N Proportion 95% CI
Danish: 95 % CI
English: The tasteless liquid should be drunk while still cloudy.
Danish: Den smagsløse væske skal drikkes, mens den endnu er uklar.
English: Typically, normokalaemia is achieved within 24 to 48 hours.
Danish: Typisk opnås normokaliæmi inden for 24 til 48 timer.
English: During maintenance phase, 75.6% of subjects maintained normokalaemia, despite use of RAAS inhibitors.
Danish: Under vedligeholdelsesfasen opretholdt 75,6 % af forsøgspersonerne normokaliæmi på trods af brug af RAAS-hæmmere.
English: Summary of the safety profile The most commonly reported adverse reactions were hypokalaemia (4.1%) and oedema related events
Danish: Sammenfatning af sikkerhedsprofilen De hyppigst rapporterede bivirkninger var hypokaliæmi (4,1 %) og ødemrelaterede bivirkninger
English: No statistically significant changes in urinary sodium excretion were observed.
Danish: Der blev ikke observeret statistisk signifikante ændringer i udskillelsen af natrium i urinen.
English: Correction (hour)
Danish: Korrigering (time)
English: All three studies tested the initial effect of Lokelma to correct hyperkalaemia during a 48-hour period and two studies also tested maintenance of normokalaemia effect obtained.
Danish: Alle tre studier undersøgte Lokelmas initiale virkning til korrektion af hyperkaliæmi i løbet af en periode på 48 timer, og to studier undersøgte også opretholdelse af den opnåede normokaliæmiske effekt.
English: This is because you may get high potassium levels in your blood again.
Danish: Dette skyldes, at du kan få et højt indhold af kalium i blodet igen.
English: Lokelma lowers the high levels of potassium in your body and helps to keep it at a normal level.
Danish: Lokelma nedsætter det høje indhold af kalium i kroppen og hjælper med at opretholde et normalt niveau.
English: • Treatment may be stopped if your blood potassium level becomes too low.
Danish: • Behandlingen kan blive stoppet, hvis kalium i blodet bliver for lavt.
English: The safety profile of Lokelma was evaluated in clinical trials involving 1760 patients with 507 patients exposed for one year.
Danish: Sikkerhedsprofilen af Lokelma blev evalueret i kliniske studier, der inkluderede 1.760 patienter, hvor 507 patienter var eksponeret i 1 år.
English: Serum potassium levels should be monitored regularly during treatment.
Danish: Serumkalium skal monitoreres regelmæssigt under behandlingen.
English: Lokelma 10 g three times daily (N=749)
Danish: Lokelma 10 g tre gange dagligt (N=749)
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.
Danish: Blandt de patienter, der brugte RAAS-hæmmere ved baseline afbrød 89 % ikke behandlingen med RAAS-hæmmere, 74 % var i stand til at fastholde samme dosis under vedligeholdelsesfasen, og blandt dem, der ikke blev behandlet med RAAS-hæmmere ved baseline, var 14 % i stand til at påbegynde denne behandling.
English: Reductions in potassium were observed 1 hour after the first 10 g dose of Lokelma.
Danish: Der blev observeret reduktion af kalium 1 time efter den første dosis af 10 g Lokelma.
English: These subjects had a mean reduction of 1.37 mmol/L at the end of the correction phase.
Danish: Disse forsøgspersoner oplevede en gennemsnitlig reduktion på 1,37 mmol/l ved korrigeringsfasens afslutning.
English: • you start to feel tired, or have muscle weakness or cramps, this may be a sign that your blood potassium has become too low.
Danish: • du begynder at føle dig træt, dine muskler bliver svage, eller du får muskelkramper; dette kan være et tegn på, at indholdet af kalium i dit blod er blevet for lavt.
English: No more than 10 g once daily should be used for maintenance therapy.
Danish: Der må ikke anvendes mere end 10 g en gang dagligt til vedligeholdelsesbehandling.
English: When normokalaemia is achieved, the maintenance regimen should be followed (see below).
Danish: Når normokaliæmi er opnået, skal vedligeholdelsesdosering følges (se nedenfor).
English: No dose adjustments or separation of time of dosing are required for any of these medicinal products.
Danish: Dosisjustering eller interval mellem doseringstidspunkterne er ikke nødvendig for nogen af disse lægemidler.
English: • diuretics (medicines that increase urine production)
Danish: • diuretika (vanddrivende medicin, som øger mængden af urin)
English: Median time to normokalaemia was 2.2 hours with 66% of patients achieving normokalaemia at 24 hours and 88% at 48 hours.
Danish: Mediantiden til normokaliæmi var 2,2 timer, og 66 % af patienterne opnåede normokaliæmi efter 24 timer og 88 % efter 48 timer.
English: The potassium-lowering effects of Lokelma have been demonstrated in three randomised, double-blind, placebo-controlled trials in patients with hyperkalaemia.
Danish: De kaliumreducerende virkninger af Lokelma er blevet vist i tre randomiserede, dobbeltblinde, placebokontrollerede studier med patienter med hyperkaliæmi.
English: Due to the open label study design, a causal relationship between these events and Lokelma cannot be definitively established.
Danish: På grund af studiets ublindede design, kan en kausal sammenhæng mellem disse bivirkninger og Lokelma ikke endeligt fastslås.
English: Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphatemia, ATC code: V03AE10
Danish: Farmakoterapeutisk klassifikation: Lægemidler til behandling af hyperkaliæmi og hyperfosfatæmi, ATC-kode: V03AE10
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: Ikke-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions-og udviklingstoksicitet.
English: Exit=Last Visit within 1 day of Last Dose, EOS=End of Study (7 days +/- 1 day after Last Dose) *Given three times daily
Danish: Exit=Sidste besøg inden for 1 dag efter sidste dosis, EOS=Studiets afslutning (End of Study) (7 dage +/- 1 dag efter sidste dosis) *Gives tre gange dagligt
English: The dose may be raised or lowered based on your blood potassium level.
Danish: Dosis kan sættes op eller ned, alt efter kaliumniveauet i dit blod.
English: The white powder will settle in the glass quickly.
Danish: Det hvide pulver vil hurtigt lægge sig på bunden.