FrancophonIA/ELRC3.0 huggingface dataset:
English: 30,500 28802 Alcalá de Henares (Madrid) Spain
Danish: 30, 500 28802 Alcalá de Henares (Madrid)
English: RECTAGMIGD OL INFANTIL
Danish: RECTAGMIGDO L INFANTIL
English: Bismuth camphocarbonat e
Danish: Bismuth camphocarbonate
English: 181-183 rue André Karman
Danish: 181-183 rue André Karman BP101
English: Hädensa ichthammolum, mentholum ichthammolum 4 mg, mentholum 50 mg
Danish: Hädensa ichthammolum, mentholum ichthammolu m 4 mg, mentholum 50 mg
English: Cineole + Camphor + Gomenol (Niaouli oil)
Danish: Cineol + kamfer + Gomenol (Niaouli oil)
English: SPINDLER 6, Avenue de l'Europe BP51
Danish: 6, Avenue de l'Europe BP51
English: LABORATOIRE HEPATOUM 1 rue de Plaisance 94130 Nogent-surMarne
Danish: LABORATOIRE HEPATOUM 1 rue de Plaisance 94130 Nogent-sur-Marne France
English: Belgium Medgenix benelux NV Vliegveld 21
Danish: Medgenix benelux NV Vliegveld 21
English: Camphor + Eucalyptol + Menthol
Danish: kamfer + Eucalyptol + Menthol
English: SOBREPIN SUPOSITORIO S INFANTIL
Danish: SOBREPIN SUPOSITORIOS INFANTIL
English: BROTA RECTAL SUPOSITORIO S
Danish: BROTA RECTAL SUPOSITORIOS
English: MEDICATION FAMILIALE SAS 37 rue Saint-Romain 69379 Lyon Cedex 08 France
Danish: MERCK MEDICATION FAMILIALE SAS 37 rue Saint-Romain 69379 Lyon Cedex 08 France
English: LABORATOIRES GENEVRIER SA 280 rue de Goa Les trois MoulinsParc de Sophia Antipolis
Danish: LABORATOIRES GENEVRIER SA 280 rue de Goa Les trois Moulins - Parc de Sophia Antipolis 06600 Antibes France
English: OZOTHINE A LA
Danish: BIOCALYPTOL A LA
English: BI-QUI-NOL ENFANTS, suppositoire camphre racémique, cinéole
Danish: BI-QUI-NOL ENFANTS, suppositoire kamfer racémique, cineol
English: 1C, Culliganlaan B-1831 Diegem
Danish: B-1831 Diegem
English: ZAMBON FRANCE 13 rue René Jacques 92138 Issy-lesMoulineaux Cedex France
Danish: ZAMBON FRANCE 13 rue René Jacques 92138 Issy-les-Moulineaux Cedex
English: LABORATOIRES MAYOLY
Danish: LABORATOIRES JOLLY JATEL
English: 93303 Aubervilliers Cedex
Danish: 93303 Aubervilliers Cedex France
English: LABORATOIRES JOLLY JATEL 28 avenue Carnot 78951 Saint-Germain en Laye Cedex France
Danish: 28 avenue Carnot 78951 Saint-Germain en Laye Cedex
English: COQUELUSED AL ENFANTS, suppositoire niaouli
Danish: COQUELUSEDA L ENFANTS, suppositoire niaouli
English: Lipobalsamo Eucalyptol/ guaiacol
Danish: Eucalyptol/ guaiacol
English: CAMPHOCAL YPTOL SIMPLE ENFANTS 0,07 g, suppositoire
Danish: CAMPHOCALYP TOL SIMPLE ENFANTS 0,07 g, suppositoire
English: Meda PharmaProdutos farmacêuticos, S.A. Rua do Centro Cultural, 13 1749-066 Lisboa
Danish: Rua do Centro Cultural, 13 1749-066 Lisboa Portugal
English: EucalyptinePholcodine Enfants camphre eucalyptol gaiacol phenol pholcodine
Danish: EucalyptinePholcodine Enfants kamfer eucalyptol gaiacol phenol pholcodin
English: 42, rue de Longvic BP157
Danish: URGO SOINS & SANTÉ 42, rue de Longvic BP157
English: DIMINEX ANTITUSIGEN O
Danish: DIMINEX ANTITUSIGENO SUPOSITORIOS
English: Eucalyptine Pholcodine Child camphora inn:eucalyptol inn:guaiacol inn:pholcodine inn:phenol
Danish: Eucalyptine Pholcodine Child kamfer inn:eucalyptol inn:guaiacol inn: pholcodin inn:phenol
English: Trophires Compose Nourrissons paracetamol essence d'eucalyptus tenoate de sodium
Danish: Trophires Compose Nourrissons paracetamol Eucalypti aetheroleum tenoate de sodium
English: Eucalyptine camphora inn:eucalyptol inn:guaiacol
Danish: Eucalyptine kamfer inn:eucalyptol inn:guaiacol
English: CAMPHOCAL YPTOL SIMPLE NOURRISSON S 0,06 g, suppositoire
Danish: CAMPHOCALYP TOL SIMPLE NOURRISSONS 0,06 g, suppositoire
English: PILKA
Danish: Lipobalsamo
English: OZOTHINE ENFANTS 30 mg, suppositoire terebenthine (huile essentielle de)
Danish: OZOTHINE ENFANTS 30 mg, suppositoire terpentinolie 0,03g
English: Trophires Bebes eucalyptus huile essentielle tenuate de sodium
Danish: Trophires Bebes Eucalypti aetheroleum tenuate de sodium
English: Ozopulmin Oxidation product of turpentine/pine essential oil
Danish: Ozopulmin oxidationsprodukt af terpentin / Pini silvestris aetheroleum
English: eucalyptus huile essentielle thiophene carboxylate paracetamo
Danish: Eucalypti aetheroleum thiophene carboxylate paracetamol
English: EUCALYPTIN E LE BRUN NOURRISSON S, suppositoire
Danish: EUCALYPTINE LE BRUN NOURRISSONS, suppositoire
English: HEXAPNEUMI NE ENFANTS, suppositoire
Danish: HEXAPNEUMIN E ENFANTS, suppositoire
English: Trophires Enfants eucalyptus huile essentielle thiophene carboxylate paracetamo
Danish: Trophires Enfants Eucalypti aetheroleum thiophene carboxylate paracetamol
English: BRONCHOREC TINE AU CITRAL ENFANTS, suppositoire terpinol, pin, serpolet
Danish: BRONCHORECTI NE AU CITRAL ENFANTS, suppositoire terpinol, fyr, vild timian
English: SUPOSITORIO S
Danish: PILKA SUPOSITORIOS
English: FEBRECTOL NOURRISSON S, suppositoire pin
Danish: FEBRECTOL NOURRISSONS, suppositoire fyr
English: LABORATORIOS VIÑAS, S.A.
Danish: Meda Pharma - Produtos farmacêuticos, S.A.
English: Provenza, 386
Danish: LABORATORIOS VIÑAS, S.A. Provenza, 386 Barcelona, Spain
English: BRONCHOREC TINE AU CITRAL NOURRISSON S, suppositoire terpinol, pin, serpolet
Danish: BRONCHORECTI NE AU CITRAL NOURRISSONS, suppositoire terpinol, fyr, vild timian
English: Luxembourg Sanofi-Aventis Belgium
Danish: Luxemborg Sanofi-Aventis Belgium 1C, Culliganlaan
English: FEBRECTOL ENFANTS, suppositoire pin
Danish: FEBRECTOL ENFANTS, suppositoire fyr
English: 80 mg 30 mg 5 mg 6 mg
Danish: 100 mg 80 mg 30 mg 5 mg 6 mg
English: TERPONE ENFANTS, suppositoire niaouli, huile essentielle d'eucalyptus, terpine, huile essentielle d'aiguilles de pin de siberie
Danish: TERPONE ENFANTS, suppositoire niaouli, Eucalypti aetheroleum, terpin, Pini silvestris aetheroleum
English: NOURRISSON S, suppositoire
Danish: NOURRISSONS, suppositoire
English: EUCALYPTOS PIRINE ENFANTS, suppositoire
Danish: EUCALYPTINE ENFANTS, suppositoire
English: TERPONE NOURRISSON S, suppositoire niaouli, huile essentielle d'eucalyptus, terpine, huile essentielle d'aiguilles de pin de siberie
Danish: TERPONE NOURRISSONS, suppositoire niaouli, Eucalypti aetheroleum, terpin, Pini silvestris aetheroleum
English: BOUCHARA RECORDATI 38 rue MarjolinBP67
Danish: BOUCHARA RECORDATI 38 rue Marjolin - BP67 92302 Levallois-Perret Cedex France
English: 1-13 boulevard Romain Rolland 75014 Paris France
Danish: SANOFI AVENTIS France 1-13 boulevard Romain Rolland
English: BRONCHODE RMINE ENFANTS, suppositoire cinéole, huile essentielle de pin
Danish: BRONCHODERM INE ENFANTS, suppositoire cineol, Pini silvestris aetheroleum
English: This can lead to weakness or even paralysis.
Danish: Dette kan medføre svaghed eller endda lammelse.
English: Elderly population (≥65 years of age)
Danish: Ældre population (≥ 65 år)
English: It should not be taken in its dry form.
Danish: Det må ikke tages i dets tørre form.
English: Overall Population (n=237)
Danish: Samlet population (n=237)
English: Frequencies are defined as:
Danish: Hyppighed defineres således:
English: Veltassa can be taken with or without food.
Danish: Veltassa kan tages sammen med eller uden mad.
English: Do not give Veltassa to children under 18 years, as it has not been studied in this age group.
Danish: Giv ikke Veltassa til børn under 18 år, da det ikke er blevet undersøgt i denne aldersgruppe.
English: Study Visit (week)
Danish: Studiebesøg (uge)
English: ATC code: V03AE09
Danish: ATC-kode: V03AE09
English: Date when taken out of the refrigerator:______
Danish: Dato, hvor lægemidlet blev taget ud af køleskabet: ______
English: Take the prepared Veltassa suspension with or without food, preferably at the same time each day.
Danish: Tag den klargjorte Veltassa-suspension sammen med eller uden mad, helst på samme tid hver dag.
English: Carcinogenicity studies have not been performed.
Danish: Der er ikke udført studier vedrørende karcinogenicitet.
English: Clinical trials with patiromer have not included exposure longer than one year.
Danish: Kliniske forsøg med patiromer har ikke medtaget eksponering længere end et år.
English: The safety and efficacy of Veltassa in children aged under 18 years have not yet been established.
Danish: Sikkerhed og virkning af Veltassa hos børn under 18 år er endnu ikke klarlagt.
English: In Part A, 243 patients were treated with patiromer for 4 weeks.
Danish: I Del A blev 243 patienter behandlet med patiromer i 4 uger.
English: Patients should be instructed not to discontinue therapy without consulting their physicians.
Danish: Patienter skal instrueres i ikke at ophøre med behandlingen uden at konsultere deres læge.
English: The following side effects have been reported: Common, may affect up to 1 in 10 people:
Danish: Følgende bivirkninger er rapporteret: Almindelige - kan forekomme hos op til 1 ud af 10 personer:
English: This may be repeated as needed to ensure the entire dose is administered.
Danish: Dette kan gentages efter behov for at sikre, at den fulde dosis administreres.
English: As a precautionary measure, it is preferable to avoid the use of patiromer during pregnancy.
Danish: Som en sikkerhedsforanstaltning foretrækkes det at undgå brug af patiromer under graviditet.
English: 4.5 Interaction with other medicinal products and other forms of interaction Effect of patiromer on other medicinal products
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Patiromers indvirkning på andre lægemidler
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Danish: Patienter, der har sjældne, arvede problemer med fruktoseintolerance, bør ikke tage dette lægemiddel.
English: The powder will not dissolve.
Danish: Pulveret opløses ikke.
English: Too much potassium in the blood can affect how your nerves control your muscles.
Danish: For meget kalium i blodet kan påvirke, hvordan dine nerver kontrollerer dine muskler.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til oral brug.
English: You may need to do this again to make sure that you have taken all the powder.
Danish: Du kan være nødt til at gøre det igen, indtil du er sikker på, at du har indtaget alt pulveret.
English: However, there was no interaction when patiromer and these medicinal products were taken 3 hours apart.
Danish: Der var imidlertid ingen interaktion, når patiromer og disse lægemidler blev indtaget med 3 timers interval.
English: The onset of action of Veltassa occurs 4 - 7 hours after administration.
Danish: Virkningen af Veltassa indtræder inden for 4-7 timer efter administration.
English: Adverse reactions are listed below by system organ class and by frequency.
Danish: Bivirkninger er anført nedenfor efter systemorganklasse og hyppighed.
English: • You may add more water to the mixture to help you swallow the medicine.
Danish: • Du kan tilføje mere vand til blandingen, hvis det hjælper dig med at synke lægemidlet.
English: You can use apple juice or cranberry juice instead of water.
Danish: Du kan bruge æblejuice eller tranebærjuice i stedet for vand.
English: • if you are allergic to patiromer or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for patiromer eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: It should not replace emergency treatment for life threatening hyperkalaemia.
Danish: Det bør ikke erstatte nødbehandling af livstruende hyperkaliæmi.
English: Due to the insolubility and nonabsorptive characteristics of this medicinal product, many classical pharmacokinetic studies cannot be carried out.
Danish: På grund af dette lægemiddels uopløselige og ikke-absorptive karakteristika kan der ikke udføres klassiske farmakokinetiske studier.
English: Veltassa may affect certain medicines if they are taken by mouth and at the same time, such as:
Danish: Veltassa kan påvirke visse lægemidler, hvis de indtages gennem munden og på samme tid som Veltassa, såsom:
English: Long term exposure
Danish: Eksponering i lang tid
English: Effect of Food
Danish: Virkningen af fødevarer
English: ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLERE ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: If you have missed a dose, take it as soon as possible on the same day.
Danish: Hvis du har glemt at tage en dosis, skal du tage den så hurtigt som muligt den samme dag.
English: Do not use this medicine after the expiry date which is stated on the carton or sachet after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen eller brevet efter ”EXP”.
English: • Add the required number of Veltassa sachets and stir.
Danish: • Tilføj det nødvendige antal Veltassa-breve, og omrør.
English: As patiromer is not absorbed or metabolised by the body, there are limited effects on the function of other medicinal products.
Danish: Da patiromer ikke absorberes eller metaboliseres i kroppen, har det en begrænset indvirkning på virkningen af andre lægemidler.
English: Information about calcium
Danish: Information om calcium
English: For either storage condition, Veltassa should not be used after the expiry date printed on the sachet.
Danish: Uanset opbevaringsforhold bør Veltassa ikke anvendes efter den udløbsdato, der er trykt på brevet.
English: Do not take Veltassa as a dry powder.
Danish: Veltassa må ikke tages som tørt pulver.
English: Calcium is partially released some of which may be absorbed (see section 5.1).
Danish: Calcium frigives delvist, hvoraf noget kan blive absorberet (se pkt.
English: Veltassa should be mixed with water and stirred to a suspension of uniform consistency, according to the following steps:
Danish: Veltassa skal blandes med vand og omrøres til en suspension med en ensartet konsistens i henhold til følgende trin:
English: The missed dose should not be taken with the next dose.
Danish: Den glemte dosis bør ikke tages sammen med den næste dosis.
English: In vitro studies have shown potential interaction of patiromer with quinidine.
Danish: In vitro-studier har vist potentiel interaktion mellem patiromer og quinidin.
English: The benefits and risks of administering this medicinal product should be carefully evaluated in patients at risk of hypercalcaemia.
Danish: Fordelene og risiciene ved administration af dette lægemiddel bør evalueres omhyggeligt hos patienter med risiko for hyperkalcæmi.
English: If it is determined that medical intervention is required, appropriate measures to restore serum potassium may be considered.
Danish: Såfremt det besluttes, at lægelig behandling er nødvendig, kan relevante foranstaltninger til gendannelse af serumkalium overvejes.
English: • had major surgery on your stomach or bowel.
Danish: • fået en større operation i maven eller tarmene.
English: In general, cranberry juice intake should be limited to moderate amounts (for example less than 400 mL per day) due to its potential interaction with other medicinal products.
Danish: Indtag af tranebærjuice bør generelt begrænses til moderate mængder (for eksempel mindre end 400 ml om dagen) på grund af den potentielle interaktion med andre lægemidler.
English: Patients with end-stage renal disease (ESRD)
Danish: Patienter med nyrelidelse i terminalfasen (ESRD)
English: Uncommon, may affect up to 1 in 100 people: nausea vomiting
Danish: Ikke almindelige - kan forekomme hos op til 1 ud af 100 personer: kvalme opkastning
English: No special dose and administration guidelines were applied to these patients in clinical studies.
Danish: Der blev ikke anvendt specielle retningslinjer for dosering og administration til disse patienter i kliniske studier.
English: In patients randomised to patiromer, the mean daily dose was 21 g at the start of Part B and during Part B.
Danish: Hos de patienter, der blev randomiseret til patiromer, var den gennemsnitlige daglige dosis 21 g i begyndelsen af Del B og under Del B.
English: As precautionary measure, and based on the data summarised below, administration of patiromer should therefore be separated by at least 3 hours from other oral medicinal products.
Danish: Som en sikkerhedsforanstaltning, og baseret på dataene opsummeret herunder, bør administration af patiromer derfor ske mindst 3 timer før eller efter andre orale lægemidler.
English: Increases in serum potassium may occur as early as 2 days after the last patiromer dose.
Danish: Stigninger i serumkalium kan opstå så tidligt som 2 dage efter den sidste patiromer-dosis.
English: Information about sorbitol
Danish: Information om sorbitol
English: You should drink only moderate amounts (less than 400 mL per day) of cranberry juice as it can affect other medicines.
Danish: Du bør kun drikke begrænsede mængder (mindre end 400 ml om dagen) tranebærjuice, da det kan påvirke andre lægemidler.
English: Veltassa is available in packs containing 30, 60 or 90 sachets.
Danish: Veltassa fås i pakker indeholdende 30, 60 eller 90 breve.
English: Veltassa is a medicine that contains the active substance patiromer.
Danish: Veltassa er et lægemiddel, der indeholder det aktive stof patiromer.
English: Apple juice or cranberry juice can be used instead of water to prepare the mixture.
Danish: Æblejuice eller tranebærjuice kan anvendes i stedet for vand til at klargøre blandingen.
English: Do not stop taking the medicine without your doctor's approval, as your potassium blood level may increase.
Danish: Du må ikke holde op med at tage lægemidlet uden din læges accept, da niveauet af kalium i dit blod kan stige.
English: Since excessive doses of Veltassa may result in hypokalaemia, serum potassium levels should be monitored.
Danish: Da overdrevne doser af Veltassa kan resultere i hypokaliæmi, bør niveauerne af serumkalium overvåges.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet samt reproduktions- og udviklingstoksicitet.
English: The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range.
Danish: Den daglige dosis kan justeres i intervaller på en uge eller længere baseret på niveauet af serumkalium og det ønskede målinterval.
English: • Prepare about 40 mL (3 tablespoons) of water in a glass.
Danish: • Klargør ca. 40 ml (3 spiseskefulde) vand i et glas.
English: The complete dose should be poured into a glass containing approximately 40 mL of water, then stirred.
Danish: Den fulde dosis skal hældes i et glas med ca. 40 ml vand og herefter omrøres.
English: Gastrointestinal disorder reactions were generally mild to moderate in nature, did not appear to be dose related, generally resolved spontaneously or with treatment, and none were reported as serious.
Danish: Gastrointestinale lidelser var generelt milde til moderate af natur, syntes ikke at være dosisrelaterede, ophørte generelt spontant eller med behandling, og ingen blev rapporteret som alvorlige.
English: Pack sizes: boxes of 30, 60 or 90 sachets.
Danish: Pakningsstørrelser: æsker med 30, 60 eller 90 breve.
English: In an open-label study, 114 patients with hyperkalaemia were randomized to patiromer once daily with food or without food.
Danish: I et ikke-blindet studie blev 114 patienter med hyperkaliæmi randomiseret til patiromer én gang dagligt sammen med eller uden mad.
English: Approximately 97% of patients had hypertension, 57% had type 2 diabetes, and 42% had heart failure.
Danish: Ca. 97 % af patienterne havde forhøjet blodtryk, 57 % havde type 2-diabetes, og 42 % havde hjertesvigt.
English: • Drink the mixture within 1 hour after preparation.
Danish: • Drik blandingen inden for 1 time efter klargøring.
English: Talk to your doctor or pharmacist before taking Veltassa if you have:
Danish: Kontakt lægen eller apotekspersonalet, før du tager Veltassa, hvis du har:
English: Following discontinuation of patiromer, potassium levels remained stable for 24 hours after the last dose, then rose again during a 4-day observation period.
Danish: Efter ophør af behandlingen med patiromer forblev kaliumniveauerne stabile i 24 timer efter den sidste dosis og steg herefter igen over en observationsperiode på 4 dage.
English: Table 1: Patiromer treatment phase (Part A): Primary endpoint Baseline Potassium
Danish: Tabel 1: Fase af behandling med patiromer (Del A): Primært slutpunkt Baseline-kalium
English: Gastrointestinal ischaemia, necrosis and/or intestinal perforation have been reported with other potassium binders.
Danish: Gastrointestinal iskæmi, nekrose og/eller intestinal perforation er rapporteret med andre kaliumbindere.
English: High potassium levels can also result in an abnormal heartbeat, which can cause serious effects on your heart rhythm.
Danish: Høje niveauer af kalium kan også medføre en unormal hjerterytme, hvilket kan påvirke din hjerterytme alvorligt.
English: Administration of Veltassa should be separated by 3 hours from other oral medicinal products (see section 4.5).
Danish: Administration af Veltassa skal ske med 3 timers interval fra indtagelse af andre orale lægemidler (se pkt.
English: Daily urinary calcium excretion increased from baseline by 53 mg/day.
Danish: Den daglige udskillelse af calcium i urinen steg med 53 mg/dag fra baseline.
English: The powder does not dissolve but forms a suspension, which might feel grainy.
Danish: Pulveret opløses ikke men danner en suspension, og det kan have en grynet konsistens.
English: No effects on the breast fed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to patiromer is negligible.
Danish: Der forventes ingen virkning på nyfødte/spædbørn, der ammes, da den systemiske eksponering for patiromer hos kvinder, der ammer, er ubetydelig.
English: There are no data from the use of patiromer in pregnant women.
Danish: Der er ingen data fra anvendelse af patiromer til gravide kvinder.
English: 4.7 Effects on ability to drive and use machines Patiromer has no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Patiromer påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: very common (≥1/10), common (≥1/100 to <1/10) and 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: sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: There is limited experience in patients with serum potassium concentrations greater than 6.5 mmol/L.
Danish: Der er begrænset erfaring med patienter med serumkaliumkoncentrationer på mere end 6,5 mmol/l.
English: No special dose and administration guidelines are recommended for this population.
Danish: Der foreligger ingen anbefalinger om specielle retningslinjer vedrørende dosering og administration i denne population.
English: There is limited data on the use of Veltassa in patients on dialysis.
Danish: Der er begrænsede data vedrørende brug af Veltassa til patienter, der er i dialyse.
English: Stop taking Veltassa and talk to your doctor or pharmacist immediately.
Danish: Stop med at tage Veltassa, og kontakt omgående din læge eller apotekspersonalet.
English: Serum magnesium should be monitored for at least 1 month after initiating treatment, and magnesium supplementation considered in patients who develop low serum magnesium levels.
Danish: Serummagnesium bør overvåges i mindst 1 måned efter påbegyndelse af behandlingen, og magnesiumtilskud bør overvejes til patienter, der udvikler lave niveauer af serummagnesium.