FrancophonIA/ELRC3.0 huggingface dataset:
English: Binding of larotrectinib to human plasma proteins in vitro was approximately 70% and was independent of drug concentration.
Danish: Bindingen af larotrectinib til humane plasmaproteiner in vitro var ca. 70 %, og det var uafhængigt af lægemiddelkoncentrationen.
English: Nervous system effects (i.e. altered hindlimb functionality and, likely, increases in eyelid closure) demonstrated partial recovery.
Danish: Virkninger i nervesystemet (dvs. ændret funktionalitet i bagbenet og sandsynligvis forøget lukning af øjenlåg) viste delvis bedring.
English: Overview of studies
Danish: Oversigt over studier
English: Before you are given VITRAKVI, your doctor will do a test to check if you have the change in the NTRK gene.
Danish: Før du får VITRAKVI vil din læge udføre en test for at kontrollere, om du har ændringen i NTRKgenet.
English: Put the syringe in the mouth, pointing towards the inside of the cheek - this will help you swallow the medicine naturally.
Danish: - Placer sprøjten i munden, og lad den pege mod indersiden af kinden - det vil hjælpe dig med at sluge lægemidlet naturligt.
English: The tube should be flushed again with at least 10 mL water to ensure VITRAKVI is delivered and to clear the tube.
Danish: Sonden skal gennemskylles igen med mindst 10 ml vand for at sikre, at VITRAKVI tilføres og for at rydde sonden.
English: There was not enough data to investigate the potential influence of race on the systemic exposure of larotrectinib.
Danish: Der var ikke nok data til at undersøge den mulige påvirkning af race på den systemiske eksponering for larotrectinib.
English: If you stop taking VITRAKVI
Danish: Hvis du holder op med at tage VITRAKVI
English: METHOD AND ROUTE(S) OF ADMINISTRATION Swallow whole.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Synkes hele.
English: There is limited experience of overdose with VITRAKVI.
Danish: Der er begrænset erfaring med overdosering af VITRAKVI.
English: Clear yellow to orange solution.
Danish: Klar gul til orange opløsning.
English: Twenty-three percent of all patients had received no prior systemic therapy.
Danish: 23 procent af alle patienterne havde ikke fået nogen tidligere systemisk behandling.
English: The safety profile in the paediatric population (< 18 years) was consistent in types of reported adverse reactions to those observed in the adult population.
Danish: Sikkerhedsprofilen hos den pædiatriske population (< 18 år) var i overensstemmelse med de typer rapporterede bivirkninger, der blev observeret hos den voksne population.
English: - The feeding should be stopped and the tube flushed with at least 10 mL water.
Danish: - Ernæringen skal stoppes, og sonden gennemskylles med mindst 10 ml vand.
English: Neurologic reactions leading to dose modification included dizziness (2%).
Danish: Neurologiske reaktioner, der førte til dosismodifikation, omfattede svimmelhed (2 %).
English: At the time of data cut-off, 8 of 9 enrolled patients with primary CNS tumours were evaluable for response by investigator assessment.
Danish: På tidspunktet for skæring af dataindsamling kunne 8 ud af 9 patienter, der indgik i studiet med primære CNS-tumorer, evalueres for respons i henhold til investigatorens vurdering.
English: Do not breast-feed while taking this medicine and for 3 days after the last dose.
Danish: Du må ikke amme, mens du tager dette lægemiddel, og i 3 dage efter den sidste dosis.
English: Larotrectinib was metabolised predominantly by CYP3A4/5 in vitro.
Danish: Larotrectinib blev primært metaboliseret af CYP3A4/5 in vitro.
English: You should not use VITRAKVI during pregnancy since the effect of VITRAKVI on the unborn is not known.
Danish: Du bør ikke bruge VITRAKVI under graviditet, da virkningen af VITRAKVI på det ufødte barn er ukendt.
English: - Store in a refrigerator (2 °C - 8 °C).
Danish: - Opbevares i køleskab (2 °C - 8 °C).
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter første åbning af lægemidlet, se pkt.
English: 56 capsules
Danish: 56 kapsler
English: Based on the mechanism of action, foetal harm cannot be excluded when administering larotrectinib to a pregnant woman.
Danish: Baseret på virkningsmekanismen, kan fosterskader ikke udelukkes, når larotrectinib administreres til en gravid kvinde.
English: Sucrose: may be harmful to the teeth.
Danish: Saccharose: kan være skadeligt for tænderne.
English: - Do not eat grapefruit or drink grapefruit juice while taking this medicine.
Danish: - Du må ikke spise grapefrugt eller drikke grapefrugtjuice, mens du tager dette lægemiddel.
English: Therefore, women using systemically acting hormonal contraceptives should be advised to add a barrier method.
Danish: Derfor bør kvinder, der bruger systemisk virkende hormonelle kontraceptiva, rådes til at tilføje en barrieremetode.
English: - Your doctor will review your dose and change it as needed.
Danish: - Lægen vil gennemgå din dosis og ændre den efter behov.
English: VITRAKVI blocks the action of TRK fusion proteins and so may slow or stop the growth of the cancer.
Danish: VITRAKVI blokerer TRK-fusionsproteinernes virkning, og kan derfor sænke eller stoppe kræftens vækst.
English: The molecular causes for primary resistance to larotrectinib are not known.
Danish: De molekylære årsager til primær resistens over for larotrectinib er ukendte.
English: VITRAKVI contains:
Danish: VITRAKVI indeholder:
English: Do not eat grapefruit or drink grapefruit juice while taking VITRAKVI.
Danish: Du må ikke spise grapefrugt eller drikke grapefrugtjuice, mens du tager VITRAKVI.
English: 100 mL oral solution
Danish: 100 ml oral opløsning
English: Do not open, chew or crush the capsule as it has a very bitter taste.
Danish: tygges eller knuses, da de har en meget bitter smag.
English: Dizziness and fatigue have been reported in patients receiving larotrectinib, mostly Grade 1 and 2 during the first 3 months of treatment.
Danish: Der er blevet rapporteret svimmelhed og træthed hos patienter, der fik larotrectinib, især grad 1 og 2 i de første 3 måneder af behandlingen.
English: This is because it is not known if VITRAKVI passes into breast milk.
Danish: Det er fordi det er ukendt, om VITRAKVI udskilles i brystmælken.
English: c Paediatric patient (6 months old at enrolment) with locally advanced unresectable infantile fibrosarcoma with complete surgical response.
Danish: c Pædiatrisk patient (6 måneder ved inklusion) med lokalt fremskreden inoperabel infantil fibrosarkom med fuldstændigt kirurgisk respons.
English: VITRAKVI is only used when - these cancers are advanced or have spread to other parts of the body or if a surgery to remove the cancer is likely to cause severe complications and - there are no satisfactory treatment options.
Danish: VITRAKVI anvendes kun, når - kræften er fremskreden eller har spredt sig til andre dele af kroppen, eller hvis det er sandsynligt, at en operation for at fjerne kræften vil forårsage svære komplikationer og - der ikke er nogen tilfredsstillende behandlingsmuligheder.
English: If you miss a dose of VITRAKVI
Danish: Hvis du har glemt en dosis af VITRAKVI
English: The majority of adverse reactions were Grade 1 or 2.
Danish: Hovedparten af bivirkninger var af grad 1 eller 2.
English: Put the oral syringe in the adapter opening.
Danish: Sæt den orale sprøjte på adapteråbningen.
English: The mean absolute bioavailability of larotrectinib was 34% (range: 32% to 37%) following a single 100 mg oral dose.
Danish: Den gennemsnitlige absolutte biotilgængelighed af larotrectinib var 34 % (interval: 32 % til 37 %) efter en enkelt 100 mg oral dosis.
English: 21 years with advanced cancer or with primary CNS tumours
Danish: 21 år med fremskreden cancer eller med primære CNS-tumorer
English: Of these 37 patients, 38% were 28 days to < 2 years (n=14), 41% were 2 years to < 12 years (n=15), and 22% were 12 years to < 18 years (n=8).
Danish: Ud af disse 37 patienter var 38 % 28 dage til < 2 år (n = 14), 41 % var 2 år til < 12 år (n = 15) og 22 % var 12 år til < 18 år (n = 8).
English: The presence of an NTRK gene fusion in a tumour specimen should be confirmed by a validated test prior to initiation of treatment with VITRAKVI.
Danish: Tilstedeværelsen af en NTRK-genfusion i en tumorprøve bør bekræftes med en valideret test, før behandlingen med VITRAKVI kan påbegyndes.
English: No patient permanently discontinued the treatment due to Grade 3-4 ALT and AST increases.
Danish: Ingen patienter seponerede behandlingen permanent som følge af grad 3-4 forhøjelser af ALAT og ASAT.
English: If a dose is missed, the patient should not take two doses at the same time to make up for a missed dose.
Danish: Hvis en dosis glemmes, må patienten ikke tage to doser på samme tid som erstatning for den glemte dosis.
English: Liver function including ALT and AST assessments should be monitored before the first dose and monthly for the first 3 months of treatment, then periodically during treatment, with more frequent testing in patients who develop transaminase elevations.
Danish: Leverfunktionen, herunder ALAT- og ASAT-vurderinger, skal overvåges før den første dosis og månedligt i løbet af de første 3 måneders behandling, dernæst periodisk i løbet af behandlingen med hyppigere tests hos patienter, der udvikler transaminaseforhøjelser.
English: b Children (2 to 11 years): no Grade 4 reactions were reported.
Danish: b Børn (2 til 11 år): Der blev ikke rapporteret grad 4 bivirkninger.
English: At the time of data cut-off, time on treatment ranged from 2.8 to 9.2 months and was ongoing in 6 out of 9 patients.
Danish: På tidspunktet for skæring af dataindsamling varierede tiden i behandlingen fra 2,8 til 9,2 måneder, og behandlingen var i gang hos 6 ud af 9 patienter.
English: Patients with and without documented NTRK gene fusion were allowed to participate in Study 1 and Study 3 (“SCOUT”).
Danish: Patienter med og uden dokumenteret NTRK-genfusion kunne deltage i studie 1 og studie 3 (”SCOUT”).
English: There was a median of 1 prior systemic treatment regimen received.
Danish: Der var en median på 1 tidligere modtaget behandlingsprogram.
English: Propylene glycol: co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates.
Danish: Propylenglycol: samtidig administration med substrater til alkoholdehydrogenase, såsom ethanol, kan fremkalde alvorlige bivirkninger hos nyfødte.
English: - you are allergic to larotrectinib or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for larotrectinib eller et af de øvrige indholdsstoffer i VITRAKVI (angivet i punkt 6).
English: Half-life (t½) is approximately 3 hours and steady state is reached within 8 days with a systemic accumulation of 1.6 fold.
Danish: Halveringstiden (t½) er ca. 3 timer og steady-state nås i løbet af 8 dage med en systemisk akkumulation på 1,6 fold.
English: This leaflet was last revised in <{MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}.
English: Larotrectinib Cmax was reduced by approximately 35% and there was no effect on AUC in healthy subjects administered VITRAKVI after a high-fat and high-calorie meal compared to the Cmax and AUC after overnight fasting.
Danish: Larotrectinib Cmax blev reduceret med ca. 35 %, og der var ingen virkning på AUC hos raske personer, der fik administreret VITRAKVI efter et kalorierigt måltid med højt fedtindhold, sammenlignet med Cmax og AUC efter faste natten over.
English: to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), and not known (cannot be estimated from available data).
Danish: (≥ 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The male growth reduction was associated with delayed puberty.
Danish: Vækstreduktionen hos hanhvalpe var associeret med forsinket pubertet.
English: For these reasons, VITRAKVI should only be used if there are no treatment options for which clinical benefit has been established, or where such treatment options have been exhausted (i.e., no satisfactory treatment options).
Danish: Af disse grunde bør VITRAKVI kun anvendes, hvis der ikke findes behandlingsmuligheder, hvor klinisk fordel er blevet klarlagt, eller hvor sådanne behandlingsmuligheder er blevet opbrugt (dvs. ingen tilfredsstillende behandlingsmuligheder).
English: The adverse drug reactions reported in patients treated with VITRAKVI are shown in Table 2 and Table 3.
Danish: Bivirkningerne rapporteret hos patienter behandlet med VITRAKVI er vist i tabel 2 og tabel 3.
English: The starting dose of VITRAKVI should be reduced by 50% in patients with moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment.
Danish: Startdosis af VITRAKVI bør nedsættes med 50 % hos patienter med moderat (Child-Pugh B) til svært (Child-Pugh C) nedsat leverfunktion.
English: Growth and nervous system effects were seen at 0.5- to 4-times the AUC at the recommended dose.
Danish: Der blev set virkninger i vækst og nervesystemet ved 0,5- til 4 gange AUC ved den anbefalede dosis.
English: In addition, 9 patients with primary CNS tumours and measurable disease at baseline were treated in Study 2 (“NAVIGATE”) and in Study 3 (“SCOUT”).
Danish: Desuden blev 9 patienter med primære CNS-tumorer og målbar sygdom ved baseline behandlet i studie 2 (”NAVIGATE”) og i studie 3 (”SCOUT”).
English: The capsules can be taken with or without food but should not be taken with grapefruit or grapefruit juice.
Danish: Kapslerne kan tages sammen med eller uden mad, men de må ikke tages sammen med grapefrugt eller grapefrugtjuice.
English: The dose volume should be calculated to the nearest 0.2 mL.
Danish: Dosisvolumen bør beregnes til den nærmeste 0,2 ml.
English: - Your child's doctor will review the dose and change it as needed.
Danish: - Dit barns læge vil gennemgå dosis og ændre den efter behov.
English: VITRAKVI is a clear yellow to orange oral solution.
Danish: VITRAKVI er en klar gul til orange oral opløsning.
English: If you are not able to take the medicine as your doctor prescribed talk to your doctor straight away.
Danish: Hvis du ikke er i stand til at tage lægemidlet efter lægens ordination, skal du straks kontakte lægen.
English: Tumour responses were assessed by the investigator using RANO or RECIST v1.1 criteria.
Danish: Tumorresponset blev vurderet af investigatoren ved hjælp af RANO- eller RECIST v1.1-kriterier.
English: criteria c non-secretory
Danish: RECIST v1.1 kriterier c ikke-sekretorisk
English: All the reported Grade 3 adverse reactions occurred in less than 5% of patients, with the exception of anaemia (7%).
Danish: Alle de rapporterede grad 3-bivirkninger forekom hos mindre end 5 % af patienterne, med undtagelse af anæmi (7 %).
English: In 36 healthy adult subjects receiving single doses ranging from 100 mg to 900 mg, VITRAKVI did not prolong the QT interval to any clinically relevant extent.
Danish: Hos 36 raske, voksne personer, der fik enkelte doser fra 100 mg til 900 mg, forlængede VITRAKVI ikke QT-intervallet i klinisk relevant grad.
English: Within each frequency group, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet i rækkefølge efter faldende alvorlighed.
English: Each mL of oral solution contains 295 mg sucrose, 22 mg sorbitol, 1.6 mg propylene glycol and 0.2 mg methyl parahydroxybenzoate.
Danish: Hver ml oral opløsning indeholder 295 mg saccharose, 22 mg sorbitol, 1,6 mg propylenglycol og 0,2 mg methylparahydroxybenzoat.
English: The pooled primary analysis set consisted of 93 patients and did not include primary CNS tumours.
Danish: Det poolede primære analysesæt bestod af 93 patienter og det inkluderede ikke primære CNS-tumorer.
English: Efficacy across tumour types
Danish: Virkning på tværs af tumortyper
English: Identification of NTRK gene fusions relied upon the molecular test methods: next generation sequencing (NGS) used in 98 patients, reverse transcription-polymerase chain reaction (RT-PCR) used in 1 patient and fluorescence in situ hybridization (FISH) used in 6 patients as routinely performed at certified laboratories.
Danish: Identifikation af NTRK-genfusioner afhang af disse molekylære testmetoder: next generation sequencing (NGS), der blev anvendt til 98 patienter, revers transkription-polymerase kædereaktion (RT-PCR), som blev anvendt til 1 patient og fluorescens in situ hybridisering (FISH), der blev anvendt til 6 patienter, som rutinemæssigt blev udført hos certificerede laboratorier.
English: The efficacy and safety of VITRAKVI were studied in three multicentre, open-label, single-arm clinical studies in adult and paediatric cancer patients (Table 4).
Danish: VITRAKVIs sikkerhed og virkning blev undersøgt i 3 åbne, kliniske multicenterstudier med en enkelt arm hos voksne og pædiatriske cancerpatienter (tabel 4).
English: Complete response (CR) Surgical complete responsec
Danish: Fuldstændigt respons (complete response, CR) Kirurgisk fuldstændigt responsc
English: Duration of response (median, months)
Danish: Varighed af respons (median,
English: Larotrectinib was negative in the in vivo mouse micronucleus test at the maximum tolerated dose of 500 mg/kg.
Danish: Larotrectinib var negativt i in vivo mikronukleustest hos mus ved den maksimalt tolererede dosis på 500 mg/kg.
English: In a broad panel of purified enzyme assays, larotrectinib inhibited TRKA, TRKB, and TRKC with IC50 values between 5-11 nM.
Danish: I et bredt panel af oprensede enzymanalyser, hæmmede larotrectinib TRKA, TRKB og TRKC med IC50-værdier fra 5-11 nM.
English: The safety pharmacology of larotrectinib was evaluated in several in vitro and in vivo studies that assessed effects on the CV, CNS, respiratory, and GI systems in various species.
Danish: Sikkerhedsfarmakologien af larotrectinib blev evalueret i flere in vitro- og in vivo-forsøg, der vurderede virkningerne på kardiovaskulært, CNS-, respirations- og mave-tarm-systemet hos forskellige arter.
English: It is used in adults, adolescents and children to treat solid tumours (cancer) in various parts of the body that are caused by a change in the NTRK gene (neurotrophic tyrosine receptor kinase).
Danish: Det anvendes til voksne, unge og børn til at behandle solide tumorer (kræft) i forskellige dele af kroppen, og som er forårsaget af en ændring i NTRK-genet (neurotrofisk tyrosinreceptorkinase).
English: Contents of the pack and other information What VITRAKVI contains
Danish: Pakningsstørrelser og yderligere oplysninger VITRAKVI indeholder:
English: A shortening of QTcF was observed with VITRAKVI dosing, with a maximum mean effect observed between 3 and 24 hours after Cmax, with a geometric mean decrease in QTcF from baseline of -13.2 msec (range -10 to -15.6 msec).
Danish: Der blev observeret en afkortning af QTcF ved dosering af VITRAKVI, hvor en maksimal gennemsnitlig effekt blev observeret mellem 3 og 24 timer efter Cmax, med en geometrisk gennemsnitlig reduktion i QTcF fra baseline på -13,2 msek (interval -10 til -15,6 msek).
English: Withholding, reducing, or discontinuing VITRAKVI dosing should be considered, depending on the severity and persistence of these symptoms (see section 4.2).
Danish: Det bør overvejes at tilbageholde, reducere eller seponere doseringen af VITRAKVI, afhængig af hvor svære og vedvarende disse symptomer er (se pkt.
English: Of 125 patients treated with VITRAKVI, 37 (30%) patients were from 28 days to 18 years of age.
Danish: Ud af de 125 patienter, der blev behandlet med VITRAKVI, var 37 (30 %) patienter fra 28 dage til 18 år.
English: Table 6: Overall response rate and duration of response by tumour type Tumour type
Danish: Tabel 6: Samlet responsrate og varighed af respons pr. tumortype Tumortype
English: Favourable effects of VITRAKVI have been shown on the basis of overall response rate and response duration in a limited number of tumour types.
Danish: Gunstige virkninger af VITRAKVI er blevet vist baseret på den samlede responsrate og responsvarighed i et begrænset antal af tumortyper.
English: Paediatric patients (n=37)
Danish: Pædiatriske patienter (n=37)
English: In rats, larotrectinib accelerated intestinal transit and increased gastric secretion and acidity.
Danish: Hos rotter accelererede larotrectinib tarmpassagen og øgede den gastriske sekretion og surhedsgrad.
English: In the overall safety database (n=125), the maximum grade transaminase elevation observed was Grade 4 ALT increase in 1 patient (<1%).
Danish: I den samlede sikkerhedsdatabase (n = 125) var den maksimale observerede grad af forhøjet transaminase en grad 4 ALAT-forhøjelse hos 1 patient (<1 %).
English: - VITRAKVI should not be mixed with feeding formulas, if administered via nasogastric feeding tube.
Danish: - VITRAKVI bør ikke blandes med ernæringsformuleringer, hvis det administreres via naso gastrisk sonde.
English: Therefore, larotrectinib is unlikely to be affected by pH-modifying agents.
Danish: Derfor er det usandsynligt, at larotrectinib bliver påvirket af pH-modificerende stoffer.
English: Children (n=15)b
Danish: Børn (n=15)b
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicinal product.
Danish: Bør ikke anvendes til patienter med sjælden hereditær fructoseintolerans, glucose/galactosemalabsorption eller sucraseisomaltasemangel, bør ikke anvende lægemidlet.
English: The oral solution can be taken with or without food but should not be taken with grapefruit or grapefruit juice.
Danish: Den orale opløsning kan tages sammen med eller uden mad, men den må ikke tages sammen med grapefrugt eller grapefrugtjuice.
English: Use within 30 days of opening.
Danish: Anvendes inden for 30 dage efter anbrud.
English: Pre-weaning mortality (before PND 21) was observed at the high dose level corresponding to 2.5- to 4-times the AUC at the recommended dose.
Danish: Dødelighed for fravænning (før PND 21) blev observeret ved det høje dosisniveau svarende til 2,5- til 4 gange AUC ved den anbefalede dosis.
English: Body weight gain was decreased in pre-weaning male and female pups, with a post-weaning increase in females at the end of exposure whereas reduced body weight gain was seen in males also post-weaning without recovery.
Danish: Øgning af kropsvægt var nedsat hos han- og hunhvalpe før fravænning, med en øgning efter fravænning hos hunhvalpe ved afslutningen af eksponeringen, hvorimod der sås nedsat øgning i kropsvægt hos hanhvalpe, også efter fravænning og uden bedring.
English: You must use effective methods of contraception while taking VITRAKVI and for at least 1 month after the last dose, if - you are able to become pregnant.
Danish: Du skal anvende en sikker præventionsmetode, mens du tager VITRAKVI, og i mindst én måned efter den sidste dosis, hvis - du kan blive gravid.
English: Avoid co-administration of strong or moderate CYP3A4/P-gp inducers with VITRAKVI due to a risk of decreased exposure (see section 4.5).
Danish: Undgå samtidig administration af potente eller moderate CYP3A4/P-gp-induktorer med VITRAKVI på grund af risiko for nedsat eksponering (se pkt.
English: Point mutations in the TRKC kinase domain with clinically identified acquired resistance to larotrectinib include G623R, G696A, and F617L.
Danish: Punktmutationer i TRKC-kinasedomænet med klinisk identificeret, erhvervet resistens over for larotrectinib, inkluderer G623R, G696A og F617L.
English: No relevant effects on fertility were observed in repeat-dose toxicity studies (see section 5.3).
Danish: Der blev ikke observeret nogen relevante virkninger på fertilitet i toksicitetsstudier med gentagne doser (se pkt.
English: The half-life of larotrectinib in plasma of cancer patients given 100 mg twice daily of VITRAKVI was approximately 3 hours.
Danish: Halveringstiden af larotrectinib i plasma hos cancerpatienter, der fik 100 mg VITRAKVI to gange dagligt var ca. 3 timer.
English: Sodium: this medicine contains less than 1 mmol sodium (23 mg) per 5 mL, that is to say essentially ‘sodium-free'.
Danish: Natrium: dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. 5 ml, dvs. det er i det væsentlige natrium-frit.