FrancophonIA/ELRC3.0 huggingface dataset:
English: As a consequence, sodium phenylbutyrate reduces elevated plasma ammonia and glutamine levels in patients with urea cycle disorders.
Danish: Som følge heraf reducerer natriumphenylbutyrat forhøjede plasmaammoniak- og glutaminkoncentrationer hos patienter med urinstofcyklusdefekt.
English: Citrulline or arginine supplementation is required for patients diagnosed with neonatal-onset form of carbamyl phosphate synthetase or ornithine transcarbamylase deficiency at a dose of 0.17 g/kg/day or 3.8 g/m2/day.
Danish: Citrullin- eller arginintilskud er nødvendigt til patienter, som har fået diagnosticeret neonatalt indsættende mangel på carbamylphosphatsyntetase eller ornithintranscarbamylase med en dosering på 0,17 g/kg/dag eller 3,8 g/m2/dag.
English: What you need to know before you take PHEBURANE Do not take PHEBURANE if you:
Danish: Det skal du vide, før du begynder at tage PHEBURANE Tag ikke PHEBURANE:
English: In the majority of patients with urea cycle disorders or haemoglobinopathies receiving various doses of phenylbutyrate (300 - 650 mg/kg/day up to 20 g/day) no plasma level of phenylacetate could be detected after overnight fasting.
Danish: Hos størstedelen af patienter med urinstofdefekter eller hæmoglobinopatier, der fik forskellige doser phenylbutyrat (300-650 mg/kg/dag op til 20 g/dag), kunne plasmakoncentrationen af phenylacetat ikke påvises efter faste til dagen efter.
English: Common syncope, headache
Danish: Almindelig synkope, hovedpine,
English: In case of any doubt, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: However PHEBURANE must be used along with a diet reduced in proteins, designed especially for you by the doctor and the dietician.
Danish: PHEBURANE skal imidlertid bruges sammen med en lavproteindiæt, som udarbejdes specielt til dig af en læge eller en kostvejleder.
English: Plasma and urine concentrations of phenylbutyrate and its metabolites have been obtained from fasting normal adults who received a single dose of 5 g of sodium phenylbutyrate and from patients with urea cycle disorders, haemoglobinopathies and cirrhosis receiving single and repeated oral doses up to 20 g/day (uncontrolled studies).
Danish: Plasma og urinkoncentrationer af phenylbutyrat og dets metabolitter er blevet målt på fastende raske voksne, efter at de havde fået en enkelt dosis på 5 g natriumphenylbutyrat og fra patienter med urinstofcyklusdefekter, hæmoglobinopatier og levercirrhose, som fik enkelte og gentagne doser peroralt på op til 20 g/dag (ukontrollerede forsøg).
English: Phenylacetate is a metabolically active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine which is then excreted by the kidneys.
Danish: Phenylacetat er en metabolisk aktiv substans, som konjugeres med glutamin ved acetylering for at danne phenylacetylglutamin, som derefter udskilles af nyrerne.
English: Each gram of sodium phenylbutyrate contains 124 mg (5.4 mmol) of sodium and 768 mg of sucrose.
Danish: Hvert gram natriumfenylbutyrat indeholder 124 mg (5,4 mmol) natrium og 768 mg saccharose.
English: PHEBURANE 483 mg/g {For carton only}
Danish: PHEBURANE 483 mg/g {Kun karton}
English: PHEBURANE contains sodium and sucrose
Danish: PHEBURANE indeholder natrium og saccharose.
English: Their cognitive performance remained relatively stable during phenylbutyrate therapy.
Danish: Patienternes kognitive præstationer forblev relativt uændrede under behandlingen med phenylbutyrat.
English: Each bottle contains 174g of granules.
Danish: Hver flaske indeholder 174 g granulat.
English: Women of childbearing potential must use effective contraception during treatment.
Danish: Kvinder i den fertile alder skal bruge en effektiv antikonception.
English: If you forget to take PHEBURANE
Danish: Hvis du har glemt at tage PHEBURANE:
English: Common anaemia, thrombocytopenia, leukopenia, leukocytosis, thrombocytosis
Danish: Blod og lymfesystem Almindelig anæmi, trombocytopeni, leukopeni, leukocytose, trombocytose
English: After a single oral dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylbutyrate were detected 15 minutes after dosing.
Danish: Efter en enkelt oral dosis på 5 g natriumphenylbutyrat i form af granulat blev der påvist målbare koncentrationer i plasma af phenylbutyrat 15 minutter efter indgift.
English: Carton: One bottle with 174 g granules.
Danish: Karton: 1 flaske med 174 g granulat.
English: After a single dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylacetate and phenylacetylglutamine were detected 30 and 60 minutes respectively after dosing.
Danish: Efter en enkelt dosis på 5 g natriumphenylbutyrat i granulatform blev der påvist målelige plasmakoncentrationer af phenylacetat og phenylacetylglutamin henholdsvis 30 og 60 minutter efter indgift.
English: A calibrated dosing spoon is provided which dispenses up to 3g of sodium phenylbutyrate by graduation of 250 mg.
Danish: Der medfølger en måleske, som afmåler op til 3 g natriumphenylbutyrat med en graduering på 250 mg.
English: Phenylbutyrate is known to be oxidised to phenylacetate which is enzymatically conjugated with glutamine to form phenylacetylglutamine in the liver and kidney.
Danish: Man ved, at phenylbutyrat bliver oxyderet til phenylacetat, som enzymatisk konjugeres med glutamin for at danne phenylacetylglutamin i leveren og nyren.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients sugar spheres (sucrose and maize starch), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25.
Danish: Saccharosekugler (saccharose og majsstivelse), hypromellose, ethylcellulose N7, macrogol 1500, povidon K25.
English: Bottle: 174 g granules.
Danish: Flaske: 174 g granulat.
English: The daily dose of PHEBURANE will be based on your body weight or body surface and adjusted according to your protein tolerance and diet. You will need regular blood tests to determine the correct daily dose.
Danish: Den daglige dosis PHEBURANE beregnes på baggrund af din legemsvægt eller legemsoverflade og justeres efter din proteinbalance og kost.
English: This medicine contains 124 mg (5.4 mmol) of sodium per 1 g of sodium phenylbutyrate.
Danish: Dette lægemiddel indeholder 124 mg (5,4 mmol) natrium pr. g natriumphenylbutyrat.
English: • headache,
Danish: • hovedpine
English: Package leaflet: Information for the patient PHEBURANE 483 mg/g granules
Danish: Indlægsseddel: Information til brugeren PHEBURANE granulat, 483 mg/g
English: Other medicines and PHEBURANE
Danish: Brug af anden medicin sammen med PHEBURANE
English: Uncommon arrhythmia
Danish: Ikke almindelig arytmi
English: The mean time to peak concentration was 1 hour and the mean peak concentration 195 μg/ml.
Danish: og den gennemsnitlige maksimumkoncentration var 195 µg/ml.
English: Clinical efficacy and safety Based on studies of phenylacetylglutamine excretion in patients with urea cycle disorders it is possible to estimate that, for each gram of sodium phenylbutyrate administered, between 0.12 and 0.15 g of phenylacetylglutamine nitrogen are produced.
Danish: Baseret på undersøgelser af udskillelsen af phenylacetylglutamin hos patienter med urinstofcyklusdefekter er det muligt at skønne, at der dannes mellem 0,12 og 0,15 g phenylacetylglutaminkvælstof, for hvert gram natriumphenylbutyrat, der er indgivet.
English: Pheburane is contra-indicated during breast-feeding (see section 4.3).
Danish: Pheburane er kontraindiceret under amning (se pkt.
English: A calibrated measuring spoon is provided.
Danish: Der medfølger en inddelt måleske.
English: This medicine contains 768 mg of sucrose per 1 g of sodium phenylbutyrate.
Danish: Dette lægemiddel indeholder 768 mg saccharose pr. g natriumphenylbutyrat.
English: On a molar basis, phenylacetylglutamine is comparable to urea (each containing 2 moles of nitrogen) and therefore provides an alternate vehicle for waste nitrogen excretion.
Danish: På molær basis er natriumphenylbutyrat sammenlignelig med urinstof (indeholder begge 2 mol nitrogen).
English: White to off-white granules.
Danish: Granulat Hvidt til let gulligt granulat.
English: Increased blood alkaline phosphatase, transaminases, bilirubin, uric acid, chloride, phosphate and sodium.
Danish: Almindelig nedsat indhold i blodet af kalium, albumin, total protein og fosfat, forhøjet indhold i blodet af alkalisk fosfatase, transaminaser, bilirubin, urinsyre, chlorid, fosfat og natrium, vægtøgning
English: • are allergic to sodium phenylbutyrate or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er overfølsom (allergisk) over for phenylbutyrat eller et af de øvrige indholdsstoffer
English: Each gram of granules contains 483 mg of sodium phenylbutyrate.
Danish: Hvert gram af granulatet indeholder 483 mg natriumphenylbutyrat.
English: How to take PHEBURANE
Danish: Sådan skal du tage PHEBURANE
English: EXP After the first opening, to be used within 45 days.
Danish: EXP Skal anvendes inden for 45 dage efter anbrud af emballagen.
English: Common metabolic acidosis, alkalosis, decreased appetite
Danish: Ikke almindelig aplastisk anæmi, ekkymose Metabolisme og ernæring Almindelig metabolisk acidose, alkalose, nedsat appetit Psykiske lidelser
English: Name and address of the manufacturer(s) responsible for batch release Lucane Pharma
Danish: Navn og adresse på fremstilleren (fremstillerne) ansvarlig(e) for batchfrigivelse
English: • impaired memory,
Danish: • svækket hukommelse
English: Tabulated list of adverse reactions
Danish: Tabel over uønskede hændelser
English: Adverse reaction
Danish: Uønsket hændelse
English: After the first opening, to be used within 45 days.
Danish: Skal anvendes inden 45 dage efter anbrud af emballagen.
English: If you take more PHEBURANE than you should
Danish: Hvis du har taget for meget PHEBURANE
English: PHEBURANE 483 mg/g granules
Danish: PHEBURANE granulat, 483 mg/g
English: • changes in taste (taste disturbances),
Danish: • smagsforstyrrelser
English: A calibrating measuring spoon which dispenses up to 3 g of sodium phenylbutyrate is provided with the medicine.
Danish: Der medfølger en inddelt måleske, som kan afmåle op til 3 gram natriumphenylbutyrat.
English: • PHEBURANE is considered high in sodium.
Danish: • PHEBURANE anses for at have et højt natrium-indhold, Dette bør især tages i betragtning hos patienter på en diæt med lavt saltindhold.
English: • If you have any further questions, ask your doctor or pharmacist.
Danish: • Spørg lægen eller på apoteketspersonalet, hvis der er mere, du vil vide.
English: If you are uncertain if your medicines contain these substances, you should check with your doctor or pharmacist.
Danish: Spørg din læge eller på apoteket, hvis du er usikker på, om din medicin indeholder disse stoffer.
English: Common oedema
Danish: Mave-tarmkanalen
English: However, the relevance to humans is unknown.
Danish: Relevansen for mennesker er dog ukendt.
English: *Represents a pooling of preferred terms
Danish: *Repræsenterer en sammenlægning af foretrukne termer
English: Response was assessed every 4 weeks until disease progression.
Danish: Responsen blev vurderet hver 4. uge indtil sygdomsprogression.
English: Your doctor will examine you and you will be monitored closely during treatment.
Danish: Lægen undersøger dig, og du vil blive overvåget nøje under behandlingen.
English: The doctor may also adjust the doses of the other medicines.
Danish: Lægen kan også justere dosis af de to andre lægemidler.
English: • Do not let the contents of the capsule come into contact with your skin.
Danish: • Lad ikke indholdet i kapslen komme i kontakt med din hud.
English: Age, gender, race
Danish: Alder, køn og race
English: PFS results are summarised in Table 4 and Figure 1.
Danish: Resultaterne for PFS er opsummeret i tabel 4 og figur 1.
English: The mean absolute oral bioavailability is 58%.
Danish: Den gennemsnitlige absolutte orale biotilgængelighed er 58%.
English: Second reduction to
Danish: Anden reduktion til
English: ‡ORR = CR+VGPR+PR §Based on responders in the response-evaluable population
Danish: ‡ORR = CR+VGPR+PR §Baseret på responders i den respons-evaluerbare population
English: Transporter-based interactions
Danish: Transportørbaserede interaktioner
English: Lenalidomide is structurally related to thalidomide.
Danish: Lenalidomid er strukturelt beslægtet med thalidomid.
English: Time to Response, months Median
Danish: Tid til respons, måneder Median
English: A risk to newborns/infants cannot be excluded and therefore breast-feeding should be discontinued.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes, og derfor skal amning ophøre.
English: Eighty five percent of the population was White, 9% Asian and 2% Black.
Danish: 85% af populationen var hvide, 9% asiater og 2% sorte.
English: NINLARO is taken once a week (on the same day of the week) for the first 3 weeks of this cycle.
Danish: NINLARO tages én gang om ugen (på samme ugedag) i de første 3 uger i denne cyklus.
English: Each blister contains one capsule).
Danish: Hvert blisterkort indeholder én kapsel).
English: Primary refractory, defined as best response of stable disease or disease progression on all prior therapies, was documented in 6% of patients.
Danish: Primær refraktær, defineret som bedste respons af stabil sygdom eller sygdomsprogression på alle tidligere behandlinger, blev dokumenteret hos 6% af patienterne.
English: The median age was 66 years, range 38-91 years; 58% of patients were older than 65 years.
Danish: Medianalderen var 66 år (38-91 år); 58% af patienterne var over 65 år.
English: Median overall survival was not reached in either regimen.
Danish: Medianen for samlet overlevelse (OS) blev ikke nået i nogen af grupperne.
English: Duration of the treatment with NINLARO You should continue treatment until your doctor tells you to stop.
Danish: Varighed af behandlingen med NINLARO Du skal fortsætte behandlingen, indtil lægen siger, du skal stoppe.
English: No animal data are available.
Danish: Der foreligger ingen data fra dyrestudier.
English: The patient should be evaluated for underlying causes and provide supportive care, as necessary.
Danish: Patienten skal vurderes med henblik på underliggende årsager og eventuelt gives understøttende pleje.
English: You should read the Package Leaflets of these other medicines for further information on their use and effects.
Danish: Du skal læse indlægssedlerne for de to andre lægemidler for at få yderligere oplysninger om deres anvendelse og virkning.
English: Note: ADRs included as preferred terms are based on MedDRA version 16.0.
Danish: Bemærk: De bivirkninger, der er angivet som foretrukne termer, er baseret på MedDRA-version 16.0.
English: Before starting NINLARO and during treatment, you will have blood tests to check that you have enough blood cells.
Danish: Før du begynder at tage NINLARO og under behandlingen, vil der blive taget blodprøver for at sikre, at du har blodceller nok.
English: You may feel tired and dizzy while taking NINLARO.
Danish: Du kan føle dig træt og svimmel, mens du tager NINLARO.
English: Effect of ixazomib on other medicinal products
Danish: Ixazomibs indvirkning på andre lægemidler
English: Recommended actions
Danish: Anbefalede handlinger
English: Direct contact with the capsule contents should be avoided.
Danish: Undgå direkte kontakt med kapslens indhold.
English: A hazard ratio less than 1 indicates an advantage for the ixazomib regimen.
Danish: En hazard ratio under 1 indikerer en fordel for ixazomib-regimet.
English: Reproductive and embryo-foetal development
Danish: Reproduktiv og embryo-føtal udvikling
English: Clinical data is limited but doses up to 12 mg have been reported in the randomised controlled trial.
Danish: De kliniske data er begrænsede, men der er rapporteret om doser på op til 12 mg i det randomiserede kontrollerede studie.
English: Consider adding G-CSF as per clinical guidelines.
Danish: Overvej at tilføje G-CSF i henhold til de kliniske retningslinjer.
English: As data are limited in these patients, a careful risk-benefit assessment is recommended before initiating the ixazomib regimen.
Danish: Da der foreligger begrænsede data for disse patienter, anbefales en omhyggelig risk/benefit-vurdering, før et ixazomib-regime påbegyndes.
English: These medicines should be avoided as they may reduce the effectiveness of NINLARO.
Danish: Disse lægemidler skal undgås, da de kan nedsætte virkningen af NINLARO.
English: • Swallow the capsule whole with water.
Danish: • Slug kapslen hel sammen med vand.
English: Figure 2: Forest plot of progression-free survival in subgroups
Danish: Figur 2: Forest-plot af progressionsfri overlevelse i alle undergrupper
English: Do not take NINLARO if you are allergic to ixazomib or to any of the other any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke NINLARO hvis du er allergisk over for ixazomib eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Children and adolescents NINLARO is not recommended for use in children and adolescents aged under 18 years.
Danish: Børn og unge NINLARO anbefales ikke til børn og unge på under 18 år.
English: Of the 5 patients in the placebo regimen, 2 had a confirmed very good partial response.
Danish: Af de 5 patienter i placebogruppen havde 2 bekræftet meget god delvis respons.
English: For the purposes of this study, refractory disease was defined as disease progression on treatment or progression within 60 days after the last dose of lenalidomide or a proteasome inhibitor.
Danish: I dette studie blev refraktær sygdom defineret som sygdomsprogression under behandling eller progression inden for 60 dage efter den sidste dosis af lenalidomid eller en proteasomhæmmer.
English: The recommended dose is one 4 mg capsule taken by mouth.
Danish: Den anbefalede dosis er én 4 mg kapsel, der skal indtages gennem munden.
English: The improvement in PFS in the ixazomib regimen was supported by improvements in overall response rate.
Danish: Forbedringen i PFS i ixazomib-gruppen blev understøttet af forbedringer i den samlede responsrate.
English: This is because other medicines can affect the way NINLARO works.
Danish: Det skyldes, at anden medicin kan påvirke den måde, NINLARO fungerer på.
English: It is unknown whether ixazomib or its metabolites are excreted in human milk.
Danish: Det er ukendt, om ixazomib eller dets metabolitter udskilles i human mælk.
English: The baseline demographics and disease characteristics were balanced and comparable between the study regimens.
Danish: De demografiske data og sygdomskarakteristika ved baseline var afbalancerede og sammenlignelige mellem de to forsøgsgrupper.
English: The patient should be monitored for symptoms of peripheral neuropathy.
Danish: Patienten skal overvåges for symptomer på perifer neuropati.
English: A plasma cell is a blood cell that normally produces proteins to fight infections.
Danish: En plasmacelle er en blodcelle, der normalt danner proteiner for at bekæmpe infektioner.
English: Tell doctor right away if you or your partner becomes pregnant while receiving NINLARO.
Danish: Fortæl straks lægen, hvis du eller din partner bliver gravid under behandlingen med NINLARO.
English: The conditions of the Pregnancy Prevention Programme for lenalidomide must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential.
Danish: Betingelserne i graviditetsforebyggelsesprogrammet for lenalidomid skal overholdes hos alle patienter, medmindre der er pålidelig evidens for, at patienten ikke er fertil.
English: In case of severe gastrointestinal events, monitoring of serum potassium level is recommended.
Danish: I tilfælde af alvorlige gastrointestinale bivirkninger anbefales monitorering af serum-kalium.
English: If the powder accidentally comes into contact with your skin, wash it off thoroughly with soap and water.
Danish: Hvis pulveret ved et uheld kommer i kontakt med din hud, skal du vaske huden grundigt med vand og sæbe.
English: FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Danish: Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14a, stk. 4, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: If you vomit after taking a dose, do not take an extra dose.
Danish: Hvis du kaster op efter at have taget en dosis, skal du ikke tage en ekstra dosis.
English: In the Phase 3 study (C16010), 10 patients (5 in each treatment regimen) had severe renal impairment at baseline.
Danish: I fase 3-studiet (C16010) havde 10 patienter (5 i hver behandlingsgruppe) svært nedsat nyrefunktion ved baseline.
English: • not feeling like eating (decreased appetite)
Danish: • manglende lyst til at spise (appetitløshed)
English: † Standardised MedDRA Queries (SMQs)
Danish: † Standardiserede MedDRA-retningslinjer (SMQ'er)
English: • lowered blood pressure (hypotension)
Danish: • lavt blodtryk (hypotension)
English: Prior to initiating a new cycle of therapy:
Danish: Før en ny behandlingscyklus påbegyndes:
English: • Take NINLARO at least one hour before or at least two hours after food.
Danish: • Tag NINLARO mindst én time før eller mindst to timer efter indtagelse af føde.
English: Of the 5 patients in the ixazomib regimen, one patient had a confirmed partial response and 3 confirmed stable disease (however 2 were unconfirmed partial response and 1 was an unconfirmed very good partial response).
Danish: Af de 5 patienter i ixazomib-gruppen havde én patient bekræftet delvis respons og 3 bekræftet stabil sygdom (2 havde dog ikke-bekræftet delvis respons, og 1 havde ikke-bekræftet meget god delvis respons).
English: *P-value is based on the stratified log-rank test. †Hazard ratio is based on a stratified Cox's proportional hazard regression model.
Danish: *p-værdien er baseret på den stratificerede log rank test. †Hazard ratio er baseret på den stratificerede Cox-regressionsmodel.
English: Patients should be advised not to drive or operate machines if they experience any of these symptoms.
Danish: Patienterne skal informeres om ikke at føre motorkøretøj og betjene maskiner, hvis de oplever nogen af disse -bivirkninger.
English: The following convention is used for the classification of the frequency of an adverse drug reaction (ADR): 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: Der anvendes følgende konventioner til klassificering af hyppigheden af bivirkninger (ADR): 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: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 November 2016
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 21. november 2016 Dato for seneste fornyelse: 16. september 2019
English: Fifty seven percent of patients were male.
Danish: 57% af patienterne var mænd.
English: The terminal half-life (t1/2) of ixazomib was 9.5 days.
Danish: Den terminale halveringstid (t1/2) for ixazomib er 9,5 dage.
English: More frequent monitoring should be considered during the first three cycles as per the lenalidomide SmPC.
Danish: Hyppigere monitorering skal overvejes i de første tre cyklusser i henhold til produktresuméet for lenalidomid.
English: Each pack contains 3 hard capsules (three single cartons, each containing a blister sealed inside a wallet.
Danish: Hver pakning indeholder 3 hårde kapsler (tre enkeltpakninger, som hver indeholder et blisterkort forseglet i en mappe.
English: For these toxicities, the first dose modification step is to withhold/reduce lenalidomide.
Danish: Ved disse bivirkninger er første dosisjustering at pausere/reducere lenalidomid.