FrancophonIA/ELRC3.0 huggingface dataset:
English: Population pharmacokinetic analysis included patients with normal renal function (n=65), and pre-existing mild (n=61), moderate (n=23), or severe (n=l) renal impairment (according to draft FDA guidance criteria 2010).
Danish: En populationsfarmakokinetisk analyse omfattede patienter med normal nyrefunktion (n=65) og let (n=61), moderat (n=23) eller svært (n=l) nedsat nyrefunktion (i henhold til udkastet til kriterierne for FDA-retningslinjerne 2010).
English: Table 6 lists adverse reactions associated with the administration of Abraxane to patients from studies in which Abraxane has been administered as monotherapy at any dose in any indication (N = 789).
Danish: Tabel 6 angiver bivirkninger forbundet med administration af Abraxane til patienter fra studier, hvor Abraxane er blevet administreret som monoterapi i forskellige doseringer til forskellige indikationer (N = 789).
English: Patients with moderate (total bilirubin >1.5 to ≤3 x ULN) or severe (total bilirubin >3 to ≤5 x ULN) hepatic impairment have a 22% to 26% decrease in the maximum elimination rate of paclitaxel and approximately 20% increase in mean paclitaxel AUC compared with patients with normal hepatic function.
Danish: Patienter med moderat (total bilirubin > 1,5 til ≤ 3 x øvre normalværdi) eller svært (totalbilirubin > 3 til ≤ 5 x øvre normalværdi) nedsat leverfunktion har en 22 % til 26 % reduktion i paclitaxels maksimale eliminationshastighed og en ca. 20 % forhøjet gennemsnitlig paclitaxel-AUC, sammenlignet med patienter med normal leverfunktion.
English: Non-small cell lung cancer (Abraxane administered in combination with carboplatin)
Danish: Ikke-småcellet lungecancer (Abraxane administreret i kombination med carboplatin)
English: Resume Abraxane at reduced dose when peripheral neuropathy improves to Grade 0 or 1 (see section 4.2).
Danish: Genoptag Abraxane med reduceret dosis, når perifer neuropati forbedres til grad 0 eller 1(se pkt.
English: The use of specialized di(2-ethylhexyl)phthalate (DEHP)-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions.
Danish: Det er ikke nødvendigt at anvende specielle di(2-ethylhexyl)phthalat (DEHP)-frie infusionsbeholdere eller administrationssæt til at klargøre eller indgive Abraxane-infusioner.
English: Powder for suspension for infusion.
Danish: Pulver til infusionvæske, suspension.
English: Patients with pancreatic adenocarcinoma aged 75 years and older should be carefully assessed for their ability to tolerate Abraxane in combination with gemcitabine with special consideration to performance status, co-morbidities and increased risk of infections (see section 4.2 and 4.8).
Danish: Patienter i alderen 75 år og ældre med adenokarcinom i pancreas bør nøje vurderes for deres evne til at tolerere Abraxane i kombination med gemcitabin med særlig opmærksomhed på præstationsstatus, komorbiditeter og øget infektionsrisiko (se pkt.
English: The following are the most common and clinically relevant adverse reactions related to 229 patients with metastatic breast cancer who were treated with 260 mg/m2 Abraxane once every three weeks in the pivotal phase III clinical study.
Danish: Følgende bivirkninger er de hyppigste og klinisk mest relevante bivirkninger relateret til 229 patienter med metastatisk brystkræft, som blev behandlet med 260 mg/m2 Abraxane én gang hver 3. uge i det pivotale kliniske fase III-studie.
English: In a study in patients with advanced solid tumours, the pharmacokinetic characteristics of paclitaxel following Abraxane administered intravenously at 260 mg/m2 over 30 minutes were compared with those following 175 mg/m2 of the solvent-based paclitaxel injection administered over 3 hours.
Danish: I et studie af patienter med fremskredne, solide tumorer blev de farmakokinetiske karakteristika af paclitaxel efter intravenøs indgift af 260 mg/m2 Abraxane over 30 minutter sammenlignet med karakteristikaene efter 175 mg/m2 af den solvensbaserede paclitaxelindsprøjtning givet over tre timer.
English: Male patients are advised to use effective contraception and to avoid fathering a child during and up to six months after treatment and should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Abraxane.
Danish: Mænd anbefales at anvende sikker prævention samt at undgå at gøre kvinder gravide under og i op til seks måneder efter behandlingen, og de bør søge rådgivning om opbevaring af sæd forud for behandlingen på grund af risikoen for permanent sterilitet efter behandling med Abraxane.
English: Abraxane (100 mg/m2/week) + carboplatin (N=521)
Danish: Abraxane (100 mg/m2/uge) + carboplatin (N = 521)
English: Non-small cell lung cancer:
Danish: Ikke-småcellet lungecancer:
English: skin discolouration, increased sweating, night sweats, white areas on the skin, sores, swollen face
Danish: hudskjolder, flere svedeture, natlige svedeture, hvide områder på huden, sår, opsvulmet ansigt
English: Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Abraxane.
Danish: Mandlige patienter bør søge rådgivning om opbevaring af sæd forud for behandling på grund af risikoen for permanent sterilitet som følge af behandling med Abraxane.
English: This is because Abraxane can affect the way some other medicines work.
Danish: Det skyldes, at Abraxane kan påvirke virkningen af andre lægemidler, og andre lægemidler kan påvirke virkningen af Abraxane.
English: Anaemia (Hb < 10 g/dl) was observed in 46% of patients on Abraxane, and was severe (Hb < 8 g/dl) in three cases.
Danish: (10 g/dl)) blev observeret hos 46 % af patienterne, der fik Abraxane, og var udtalt (Hb < 5 µmol/l (8 g/dl)) i tre tilfælde.
English: The recommended dose of carboplatin is AUC = 6 mg•min/mL on Day 1 only of each 21-day cycle, beginning immediately after the end of Abraxane administration.
Danish: Den anbefalede dosis af carboplatin er AUC = 6 mg•min/ml kun på Dag 1 i hver 21-dages cyklus umiddelbart efter, administrationen af Abraxane er gennemført.
English: After reconstitution, each ml of suspension contains 5 mg of paclitaxel.
Danish: Efter rekonstituering indeholder hver ml suspension 5 mg paclitaxel.
English: Bone marrow suppression (primarily neutropenia) occurs frequently with Abraxane.
Danish: Knoglemarvssuppression (primært neutropeni) forekommer hyppigt ved behandling med paclitaxel.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Abraxane in all subsets of the paediatric population in the treatment of metastatic breast cancer, pancreatic adenocarcinoma and non-small cell lung cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Abraxane i alle undergrupper af den pædiatriske population ved behandling af metastaserende brystkræft, adenokarcinom i pancreas og ikke-småcellet lungecancer (se pkt.
English: Common: Cardiac failure congestive, tachycardia
Danish: Almindelig: Kronisk hjerteinsufficiens, takykardi
English: A pharmacokinetic study was conducted with Abraxane and carboplatin in non-small cell lung cancer patients.
Danish: Der blev udført et farmakokinetisk studie med Abraxane og carboplatin hos patienter med ikkesmåcellet lungecancer.
English: CI = confidence interval, HRA+G/G = hazard ratio of Abraxane+gemcitabine/gemcitabine, pA+G/pG=response rate ratio of Abraxane+gemcitabine/gemcitabine a stratified Cox proportional hazard model b stratified log-rank test, stratified by geographic region (North America versus others), KPS (70 to 80 versus 90 to 100), and presence of liver metastasis (yes versus no).
Danish: CI = konfidensinterval, HRA+G/G = hazard ratio for Abraxane+gemcitabin/gemcitabin, pA+G/pG=responsrate-forhold af Abraxane+gemcitabin/gemcitabin a stratificeret Cox proportionel hazard-model b stratificeret log-rank-test, stratificeret ved geografisk region (Nordamerika versus andre), KPS (70 til
English: The paclitaxel exposure (AUC) increased linearly from 2653 to 16736 ng.hr/ml following dosing from 80 to 300 mg/m2.
Danish: (AUC) øgedes lineært fra 2.653 til 16.736 ng∙t/ml efter dosering fra 80 til 300 mg/m2.
English: Table 9 lists adverse reactions associated with the administration of Abraxane in combination with carboplatin.
Danish: Tabel 9 angiver bivirkninger forbundet med administration af Abraxane i kombination med carboplatin.
English: Table 10: Results for overall response rate, median time to disease progression, and progression-free survival as assessed by the investigator Efficacy variable
Danish: Tabel 10: Resultater for samlet responsrate, mediantid til sygdomsprogression og progressionsfri og samlet overlevelse, baseret på investigators vurderinger.
English: Thus patients receiving Abraxane should be vigilantly monitored by physicians for the occurrence of cardiac events.
Danish: Patienter, der får Abraxane, bør derfor kontrolleres nøje for udvikling af hjertesymptomer.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for suspension for infusion.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til infusionsvæske, suspension.
English: Pneumonitis occurred in 1% of patients when Abraxane was used as monotherapy and in 4% of patients when Abraxane was used in combination with gemcitabine.
Danish: Pneumonitis opstod hos 1% af patienterne, når Abraxane blev anvendt til monoterapi, og hos 4% af patienterne, når Abraxane blev anvendt i kombination med gemcitabin.
English: Adverse reactions were assessed in 421 patients treated with Abraxane in combination with gemcitabine and 402 gemcitabine monotherapy-treated patients receiving first-line systemic treatment for metastatic adenocarcinoma of the pancreas in a phase III randomized, controlled, open-label trial.
Danish: Der blev vurderet bivirkninger hos 421 patienter, behandlet med Abraxane i kombination med gemcitabin, og hos 402 patienter, behandlet med gemcitabin-monoterapi, der fik systemisk førstelinjebehandling mod metastatisk adenokarcinom i pancreas i et randomiseret, kontrolleret, åbent fase III-studie.
English: If not used immediately, the suspension may be stored in a refrigerator (2°C-8°C) for up to 24 hours in the vial when kept in the outer carton in order to protect it from light.
Danish: Hvis ikke den anvendes med det samme, kan suspensionen opbevares i et køleskab (ved temperaturer på 2 °C-8 °C) i op til 24 timer i hætteglasset, hvis det opbevares i den ydre karton for at beskytte mod lys.
English: The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions.
Danish: Det er ikke nødvendigt at anvende specielle DEHP-frie infusionsbeholdere eller administrationssæt til at klargøre eller indgive Abraxane-infusioner.
English: Cranial nerve palsies, vocal cord paresis, and rare reports of severe hypersensitivity reactions have been reported during post-marketing surveillance of Abraxane.
Danish: Kranienervepareser, parese af stemmebåndene og sjældne tilfælde af kraftige overfølsomhedsreaktioner er blevet rapporteret under postmarketing-overvågning af Abraxane.
English: Patients who experience severe neutropenia (neutrophil count < 500 cells/mm3 for a week or longer) or severe sensory neuropathy during Abraxane therapy should have the dose reduced to 220 mg/m2 for subsequent courses.
Danish: Patienter, der udvikler svær neutropeni (neutrofiltælling på <500 celler/mm3 i en uge eller længere) eller svær sensorisk neuropati under behandling med Abraxane, bør have doseringen reduceret til
English: • medicines used to treat HIV and AIDS (e.g. ritonavir, saquinavir, indinavir, nelfinavir, efavirenz,
Danish: • medicin, der anvendes mod hiv og aids (f.eks. ritonavir, sequinavir, indinavir, nelfinavir,
English: Common: Haemoptysis, epistaxis, cough
Danish: Almindelig: Hæmoptyse, epistaxis, hoste
English: Pneumonitis has been reported at a rate of 4% with the use of Abraxane in combination with gemcitabine.
Danish: Pneumonitis er blevet rapporteret med en hyppighed på 4% under anvendelse af Abraxane i kombination med gemcitabin.
English: Response rate [95% CI] (%)
Danish: Responsrate [95 % CI] (%)
English: Arthralgia occurred in 32% of patients on Abraxane and was severe in 6% of cases.
Danish: Artralgi forekom hos 32 % af patienterne, der fik Abraxane, og var svær i 6 % af tilfældene.
English: Of the 514 patients with non-small cell lung cancer in the randomized study who received Abraxane in combination with carboplatin, 31% were 65 years or older and 3.5% were 75 years or older.
Danish: Ud af de 514 patienter med ikke-småcellet lungecancer i det randomiserede studie, som fik Abraxane i kombination med carboplatin, var 31 % 65 år eller ældre, og 3,5 % var 75 år eller ældre.
English: This may be followed by storage in the infusion bag for 4 hours below 25°C.
Danish: Det rekonstituerede lægemiddel kan efterfølgende opbevares i infusionsposen i 4 timer ved temperaturer under 25 °C.
English: • Severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome,
Danish: • Svær vævsirritation og udslæt på hud og slimhinder (Stevens-Johnsons syndrom, toksisk epidermal nekrolyse)
English: Reconstitution and administration of the product
Danish: Rekonstitution og administration af lægemidlet
English: No patients treated with Abraxane and carboplatin experienced Grade 4 peripheral neuropathy.
Danish: Ingen patienter i behandling med Abraxane og carboplatin oplevede grad 4 perifer neuropati.
English: Solventbased paclitaxel was administered to patients (N=531) at a dose of 200 mg/m2 as an intravenous infusion over 3 hours with standard premedication, immediately followed by carboplatin administered intravenously at AUC = 6 mg•min/mL.
Danish: Solvensbaseret paclitaxel blev administreret til patienter (N=531) med en dosis på 200 mg/m2 som intravenøs infusion i løbet af 3 timer med standard-præmedicinering, umiddelbart efterfulgt af intravenøst administreret carboplatin med en dosis på AUC = 6 mg•min/ml.
English: Abraxane should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Danish: Abraxane bør kun klargøres og administreres af personale, der har modtaget passende træning i håndteringen af cytotoksiske midler.
English: Myalgia occurred in 24% of patients on Abraxane and was severe in 7% of cases.
Danish: Myalgi forekom hos 24 % af patienterne, som fik Abraxane, og var svær i 7 % af tilfældene.
English: ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Danish: ≥ 500 men < 1.000 ELLER ≥ 50.000 men <
English: Table 8 provides the frequency and severity of haematologic laboratory-detected abnormalities for patients treated with Abraxane in combination with gemcitabine or with gemcitabine.
Danish: Tabel 8 angiver hyppigheder og sværhedsgrader af hæmatologiske, laboratoriedetekterede anomalier hos patienter i behandling med Abraxane i kombination med gemcitabin eller med gemcitabin.
English: Women of childbearing age should use effective contraception during and up to 1 month after receiving treatment with Abraxane.
Danish: Kvinder i den fertile alder skal anvende sikker prævention under og i op til en måned efter at have fået behandling med Abraxane.
English: Pharmacokinetic data are not available for patients with total bilirubin >5 x ULN or for patients with metastatic adenocarcinoma of the pancreas (see section 4.2).
Danish: Der foreliggger ingen farmakokinetiske data for patienter med totalbilirubin > 5 x øvre normalværdi eller for patienter med metastatisk adenokarcinom i pancreas (se pkt.
English: Because the toxicity of paclitaxel can be increased with hepatic impairment, administration of Abraxane in patients with hepatic impairment should be performed with caution.
Danish: Da paclitaxels toksicitet kan øges ved nedsat leverfunktion, skal Abraxane gives med forsigtighed til patienter med nedsat leverfunktion.
English: Withhold doses until improves to ≤ Grade 1; resume at next lower dose levela a. See Table 1 for dose level reductions
Danish: Afbryd dosis indtil bedring til ≤ grad 1, genoptag med det næste lavere dosisniveaua aSe Tabel 1 for reduktioner af dosisniveauer
English: UNIQUE IDENTIFIER - 2D BARCODE 2 D bar code carrying the unique identifier 18.
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: Beginning immediately after the end of Abraxane administration, carboplatin at a dose of AUC = 6 mg•min/mL was administered intravenously on Day 1 only of each 21-day cycle.
Danish: Umiddelbart efter afsluttet administration af Abraxane blev carboplatin administreret intravenøst med en dosis på AUC = 6 mg•min/ml på Dag 1 i hver 21-dages cyklus.
English: *Median time to disease progression [95% CI] (weeks)
Danish: *Mediantid til sygdomsprogression [95 % CI] (uger)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om Abraxane findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: What Abraxane contains
Danish: Abraxane indeholder:
English: Day 8 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000
Danish: Dag 8 ≥ 500 men < 1.000 ELLER ≥ 50.000 men <
English: In patients aged 75 years and older who received Abraxane and gemcitabine, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation (see section 4.4).
Danish: Hos patienter på 75 år og ældre, der fik Abraxane og gemcitabin, var der en højere forekomst af alvorlige bivirkninger og bivirkninger, der førte til seponering af behandlingen (se pkt.
English: Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated (see section 4.4).
Danish: Abraxane-monoterapi er indiceret til behandling af metastaserende brystkræft hos voksne patienter ved progression efter førstelinjebehandling, hvor standardbehandling med antracyklinholdigt regime ikke er indiceret (se pkt.
English: The recommended dose of Abraxane is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks.
Danish: Den anbefalede dosis Abraxane er 260 mg/m2 administreret intravenøst over 30 minutter hver 3. uge.
English: Abraxane contains, as its active substance, paclitaxel attached to the human protein albumin, in the form of tiny particles known as nanoparticles.
Danish: Paclitaxel er bundet til det humane protein albumin i form af bittesmå partikler, der kaldes nanopartikler.
English: Reduce 1 dose level and follow with WBC Growth Factors
Danish: Reducer 1 dosisniveau og følg op med vækstfaktorer for WBC
English: Death or progression, n (%) Median PFS (95% CI) (months) HRA/T (95% CI)
Danish: Død eller progression, n (%) Median PFS (95 % CI) (måneder) HRA/T (95 % CI)
English: Abraxane should not be administered until neutrophil counts recover to >1500 cells/mm3.
Danish: Abraxane bør ikke administreres, før neutrofiltallet atter er >1.500 celler/mm3.
English: In addition, Abraxane is not recommended in patients with metastatic adenocarcinoma of the pancreas that have moderate to severe hepatic impairment (total bilirubin > 1.5 x ULN and AST ≤ 10 x ULN) (see section 5.2).
Danish: Desuden anbefales Abraxane ikke hos patienter med metastatisk adenokarcinom i pancreas, der har moderat til svært nedsat leverfunktion (totalbilirubin > 1,5 x øvre normalværdi og ASAT ≤ 10 x ULN (se pkt.
English: The reconstituted suspension in the intravenous drip may be stored in a refrigerator (2°C-8°C) for up to 24 hours protected from light.
Danish: Den rekonstituerede suspension i det intravenøse drop kan opbevares i køleskab (2 °C-8 °C) i op til 24 timer, beskyttet mod lys.
English: For patients treated with Abraxane in combination with gemcitabine, the median time to first occurrence of Grade 3 peripheral neuropathy was 140 days.
Danish: Hos patienter i behandling med Abraxane i kombination med gemcitabin var mediantiden til første forekomst af grad 3 perifer neuropati 140 dage.
English: Table 1: Dose level reductions for patients with pancreatic adenocarcinoma Dose Level
Danish: Tabel 1: Reduktion i dosisniveau for patienter med adenokarcinom i pancreas Dosisniveau
English: Abraxane should not be administered on Day 1 of a cycle until absolute neutrophil count (ANC) is ≥1500 cells/mm3 and platelet count is ≥100,000 cells/mm3.
Danish: Abraxane bør ikke administreres på Dag 1 i en cyklus, før det absolutte neutrofiltal (ANC) er ≥ 1.500 celler/mm3, og trombocyttallet er ≥ 100.000 celler/mm3.
English: Sepsis was reported at a rate of 5% in patients with or without neutropenia who received Abraxane in combination with gemcitabine.
Danish: Sepsis blev rapporteret med en hyppighed på 5% hos patienter med eller uden neutropeni, som fik Abraxane i kombination med gemcitabin.
English: Grade 2 or 3 cutaneous toxicity Grade 3 diarrhoea Grade 3 mucositis ≥ Grade 3 peripheral neuropathy Any other Grade 3 or 4 nonhaematologic toxicity
Danish: Grad 3 mukosit ≥ Grad 3 perifer neuropati Alle andre grad 3 eller 4 ikkehæmatologiske toksiciteter.
English: Pancreatic adenocarcinoma (Abraxane administered in combination with gemcitabine)
Danish: Adenokarcinom i pancreas (Abraxane administreret i kombination med gemcitabin)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/428/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/428/001
English: The following are the most common and important incidences of adverse reactions related to 421 patients with metastatic adenocarcinoma of the pancreas who were treated with 125 mg/m2 Abraxane in combination with gemcitabine at a dose of 1000 mg/m2 given on Days 1, 8 and 15 of each 28-day cycle in the phase III clinical study.
Danish: Følgende er de hyppigste og vigtigste forekomster af bivirkninger hos 421 patienter med metastatisk adenokarcinom i pancreas, som blev behandlet med 125 mg/m2 Abraxane i kombination med gemcitabin ved en dosis på 1.000 mg/m2, der blev givet på Dag 1, 8 og 15 i hver 28-dages cyklus i det kliniske fase III-studie.
English: Inspect the suspension in the vial for particulate matter.
Danish: Inspicer suspensionen i hætteglasset for bundfald.
English: No patients treated with Abraxane in combination with gemcitabine had Grade 4 peripheral neuropathy.
Danish: Ingen patienter i behandling med Abraxane i kombination med gemcitabin havde grad 4 perifer neuropati.
English: Not known side effects (frequency cannot be estimated from the available data):
Danish: Ikke kendt bivirkninger (hyppigheden kan ikke beregnes ud fra tilgængelige data): • Hård hud/fortykkelse af huden (sklerodermi)
English: Patients who have baseline neutrophil counts <1500 cells/mm3.
Danish: Patienter med baseline-neutrofiltal under 1.500 celler/mm3.
English: Of the 229 patients in the randomized study who received Abraxane monotherapy for breast cancer, 13% were at least 65 years of age and < 2% were 75 years and older.
Danish: I et randomiseret studie, hvor 229 patienter fik Abraxane-monoterapi for brystkræft, var 13 % mindst 65 år, og < 2% var 75 år og ældre.
English: Frequent monitoring of blood cell counts should be performed during Abraxane therapy.
Danish: Hyppig blodtælling er nødvendig under behandling med Abraxane.
English: Sepsis was reported at a rate of 5% in patients with or without neutropenia who received Abraxane in combination with gemcitabine during the conduct of a trial in pancreatic adenocarcinoma.
Danish: Sepsis blev rapporteret med en hyppighed på 5% hos patienter med eller uden neutropeni, som fik Abraxane i kombination med gemcitabin i løbet af et studie hos patienter med adenokarcinom i pancreas.
English: When reconstituted, each ml of Abraxane concentrate contains 0.183 mmol sodium, which is 4.2 mg of sodium.
Danish: Efter rekonstitution indeholder hver ml Abraxane-koncentrat 0,183 mmol natrium, hvilket svarer til 4,2 mg natrium.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/428/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/428/002