FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose should be individually adjusted in order to maintain normal ammonia plasma levels.
Danish: Dosis skal justeres individuelt for at kunne opretholde normale ammoniakniveauer i blodet.
English: Carbaglu 200 mg dispersible tablets
Danish: Carbaglu 200 mg dispergible tabletter
English: HOW TO TAKE CARBAGLU
Danish: SÅDAN SKAL DE/DU TAGE CARBAGLU
English: 5 dispersible tablets
Danish: 5 dispergibel tabletter
English: You should check with your doctor or pharmacist if you are unsure.
Danish: Spørg lægen eller på apoteket, hvis der er noget, De er i tvivl om.
English: • hyperammonaemia due to isovaleric acidaemia.
Danish: • Hyperammonæmi på grund af isovalerianeacidæmi.
English: - This medicine has been prescribed for you personally and you should not pass it on to others.
Danish: Lad derfor være med at give det til andre.
English: Carbaglu 200 mg dispersible tablets Carglumic acid
Danish: Carbaglu 200 mg dispergibel tabletter Cargluminsyre
English: 15 dispersible tablets
Danish: 15 dispergibel tabletter
English: Not known: rash
Danish: Ikke kendt:udslæt
English: OUTER CARTON BOX AND TABLET CONTAINER LABEL X 60 TABLETS
Danish: YDRE KARTONÆSKE OG ETIKET PÅ TABLETBEHOLDER X 60 TABLETTER
English: - The other ingredients are microcrystalline cellulose, sodium laurilsulfate, hypromellose,
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, natriumlaurilsulfat, hypromellose, croscarmelosenatrium, silica, kolloid vandfri, natriumstearylfumarat.
English: OUTER CARTON BOX AND TABLET CONTAINER LABEL X 5 TABLETS
Danish: YDRE KARTONÆSKE OG ETIKET PÅ TABLETBEHOLDER X 5 TABLETTER
English: • For N-acetylglutamate synthase deficiency:
Danish: • N-acetylglutamatsyntasemangel:
English: - If you have further questions, please ask your doctor or your pharmacist.
Danish: Er De i tvivl, så spørg lægen eller apoteket
English: • hyperammonaemia due to methymalonic acidaemia.
Danish: • Hyperammonæmi på grund af methylmalonacidæmi.
English: BEFORE YOU TAKE CARBAGLU
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE CARBAGLU
English: • hyperammonaemia due to propionic acidaemia.
Danish: • Hyperammonæmi på grund af propionacidæmi.
English: Marketing Authorisation Holder Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux
Danish: Indehaveren af markedsføringstilladelsen Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux
English: OUTER CARTON BOX AND TABLET CONTAINER LABEL X 15 TABLETS
Danish: YDRE KARTONÆSKE OG ETIKET PÅ TABLETBEHOLDER X 15 TABLETTER
English: Do not take Carbaglu:
Danish: Carbaglu indeholder:
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: - Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her
English: What Carbaglu contains - The active substance is carglumic acid.
Danish: - Aktivt stof: cargluminsyre.
English: Do not take Carbaglu during breast-feeding
Danish: De må ikke tage Carbaglu, mens De ammer.
English: It should then be adjusted individually in order to maintain normal ammonia plasma levels (see section 4.4).
Danish: Dosis skal dernæst justeres individuelt for at opretholde normale plasmaniveauer af ammoniak (se pkt.
English: Nevertheless, as carglumic acid has been shown to be present in the milk of lactating rats with potential toxic effects for their fed pups, you should not breast feed your baby if you are taking Carbaglu.
Danish: Ikke desto mindre bør De ikke amme Deres barn, hvis De tager Carbaglu, da tilstedeværelse af cargluminsyre er blevet påvist i mælken hos ammende rotter med potentielt toksiske virkninger for ungerne.
English: Recordati Rare Diseases Immeuble ‘Le Wilson' 70, avenue du Général de Gaulle F-92800 Puteaux France or
Danish: Recordati Rare Diseases Immeuble ‘Le Wilson' 70, avenue du Général de Gaulle F - 92800 Puteaux Frankrig
English: Gastrointestinal disorders
Danish: Cargluminsyre-responstest
English: One metabolite that has been identified in the faeces is glutamic acid.
Danish: Glutaminsyre er en metabolit, der er identificeret i fæces.
English: • For isovaleric acidaemia, methylmalonic acidaemia and propionic acidaemia: The treatment should start upon hyperammonaemia in organic acidaemia patients.
Danish: Behandlingen skal starte ved hyperammonæmi hos patienter med organisk acidæmi.
English: The European Commission issued a decision on 6 August 2009.
Danish: Europa-Kommissionen traf en afgørelse den 6. august 2009.
English: The Committee noted that this product was previously authorised in a number of other Member States on the basis of the same data.
Danish: Udvalget bemærkede, at lægemidlet tidligere var blevet godkendt i en række andre medlemsstater på baggrund af de samme data.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Danish: To lægemidler er bioækvivalente, når de producerer samme niveauer af det aktive stof i kroppen.
English: These countries are Austria, Denmark, Finland, Germany, Greece, Norway, Portugal, Spain, Sweden and the United Kingdom.
Danish: Disse lande er: Østrig, Danmark, Finland, Tyskland, Grækenland, Norge, Portugal, Spanien, Sverige og Det Forenede Kongerige.
English: Ref. EMEA/CHMP/563259/2009 EMEA/H/A-29/1060
Danish: : EMEA/CHMP/559820/2009 EMEA/H/A-29/1060
English: Dr Pieter Neels (Belgium)
Danish: Dr. Pieter Neels (Belgien)
English: London, 17 August 2009 Doc.
Danish: London, den 17. august 2009 Ref.dok.
English: Prof. Michal Pirożynski (Poland)
Danish: Prof. Michal Pirożynski (Polen)
English: The company wanted the authorisation to be recognised in Bulgaria, the Czech Republic, Estonia, France, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Slovenia and Slovakia (the ‘concerned Member States').
Danish: Virksomheden ansøgte om at få markedsføringstilladelsen anerkendt i Bulgarien, Den Tjekkiske Republik, Estland, Frankrig, Ungarn, Italien, Letland, Litauen, Polen, Rumænien, Slovenien og Slovakiet (de "berørte medlemsstater").
English: This means that it is similar to a ‘reference medicine' already authorised in the EU called Clarityne.
Danish: Det betyder, at det ligner et "referencelægemiddel" kaldet Clarityne, som allerede er godkendt i EU.
English: Loratadine is an antihistamine.
Danish: Loratadin er et antihistamin.
English: However, these Member States were not able to reach an agreement and the Dutch medicines regulatory agency referred the matter to the CHMP for arbitration on 31 July 2008.
Danish: Disse medlemsstater kunne imidlertid ikke nå til enighed, og den nederlandske lægemiddelkontrolmyndighed indbragte den 31. juli 2008 sagen for CHMP med henblik på voldgift.
English: ‘Idiopathic' means that the cause of the urticaria is not known.
Danish: "Idiopatisk" betyder, at årsagen til nældefeberen er ukendt.
English: The review was carried out under an ‘Article 29' referral1.
Danish: Undersøgelsen blev gennemført i henhold til en artikel 291-indbringelse.
English: Questions and answers on the referral for Loratadine Sandoz 10 loratadine 10 mg tablets
Danish: Spørgsmål og svar vedrørende indbringelsen af sagen om Loratadine Sandoz 10 loratadin 10 mg tabletter
English: authorisation should not be granted in the concerned Member States.
Danish: ikke kunne udstedes markedsføringstilladelse i de berørte medlemsstater.
English: 29 May 2009
Danish: 29. maj 2009
English: Loratadine Sandoz 10 is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy such as hay fever or allergy to dust mites) and long-term idiopathic urticaria (itching and patches on the skin).
Danish: Loratadine Sandoz 10 anvendes til lindring af symptomer på allergisk rhinitis (betændelse i næsepassagen forårsaget af allergi, såsom høfeber eller støvmideallergi) og langvarig idiopatisk nældefeber (kløe og afskallende pletter på huden).
English: When the receptors are blocked, histamine cannot have its effect, which leads to a decrease in the symptoms of allergy.
Danish: Når receptorerne er blokeret, virker histaminet ikke, og dette forårsager en reduktion i symptomerne på allergi.
English: The CHMP recommended that the authorisations in these countries should also be suspended.
Danish: CHMP anbefalede, at også markedsføringstilladelserne i disse lande skulle suspenderes.
English: The grounds for the referral were a disagreement from the Czech Republic and Poland, which were of the opinion that ‘bioequivalence' with the reference medicine had not been shown.
Danish: Grundlaget for indbringelsen var, at der blev gjort indsigelser fra Den Tjekkiske Republik og Polen, som var af den opfattelse, at "bioækvivalensen" med referencelægemidlet ikke var blevet påvist.
English: The marketing authorisation in the Netherlands should also be suspended.
Danish: Endvidere bør markedsføringstilladelsen i Nederlandene suspenderes.
English: It works by blocking the receptors that histamine, a substance in the body that causes allergic symptoms, normally attaches to.
Danish: Det virker ved at blokere de receptorer, som histaminet, et stof i kroppen, der forårsager allergiske symptomer, normalt binder sig til.
English: Loratadine Sandoz 10 is a ‘generic medicine'.
Danish: Loratadine Sandoz 10 er et "generisk lægemiddel".
English: In addition, the Committee also required that the company carried out additional studies to show bioequivalence of Loratadine Sandoz 10 and Clarityne in accordance with the current guidelines.
Danish: Udvalget krævede endvidere, at virksomheden foretog yderligere undersøgelser med henblik på at påvise bioækvivalensen mellem Loratadine Sandoz 10 og Clarityne i overensstemmelse med de aktuelle retningslinjer.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP was of the opinion that bioequivalence between Loratadine Sandoz 10 and the reference medicine had not been sufficiently demonstrated.
Danish: På baggrund af en evaluering af de data, der er tilgængelige på nuværende tidspunkt, og den faglige drøftelse i udvalget, var CHMP af den opfattelse, at bioækvivalensen mellem Loratadine Sandoz 10 og referencelægemidlet ikke var blevet tilstrækkeligt påvist.
English: The CHMP therefore concluded that Loratadine Sandoz 10 could not be considered a generic medicine of Clarityne, and therefore that the marketing
Danish: CHMP konkluderede derfor, at Loratadine Sandoz 10 ikke kunne betragtes som et generisk lægemiddel svarende til Clarityne, og at der derfor
English: What is Loratadine Sandoz 10?
Danish: Hvad er Loratadine Sandoz 10?
English: Why was Loratadine Sandoz 10 reviewed?
Danish: Hvorfor blev Loratadine Sandoz 10 vurderet igen?
English: Sandoz B.V. submitted Loratadine Sandoz 10 for mutual recognition on the basis of the initial authorisation granted in the Netherlands on 22 July 2001.
Danish: indsendte ansøgning om gensidig anerkendelse af Loratadine Sandoz 10 på baggrund af den første tilladelse, der blev udstedt af Nederlandene den 22. juli 2001.
English: The Czech Republic and Poland argued that the original study presented by the company was not in line with current guidance, and did not show bioequivalence of Loratadine Sandoz 10 and Clarityne.
Danish: I Den Tjekkiske Republik og Polen fremførte man, at den oprindelige undersøgelse, som virksomheden havde fremlagt, ikke var i overensstemmelse med de aktuelle retningslinjer og ikke påviste bioækvivalens mellem Loratadine Sandoz 10 og Clarityne.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Loratadine Sandoz 10 do not outweigh its risks, and the marketing authorisation granted in the Netherlands cannot be recognised in other Member States of the EU.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har afsluttet en voldgiftsprocedure efter uenighed mellem medlemsstater i Den Europæiske Union (EU) om markedsføringstilladelsen for lægemidlet Loratadine Sandoz 10. EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Loratadine Sandoz 10 ikke opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Nederlandene, ikke kan anerkendes i andre medlemsstater i EU.
English: Until the results of these studies are assessed, the marketing authorisation for Loratadine Sandoz 10 in the Netherlands should be suspended.
Danish: Markedsføringstilladelsen for Loratadine Sandoz 10 i Nederlandene bør suspenderes, indtil resultaterne af disse undersøgelser er blevet vurderet.
English: Company responses provided on: 23 March 2009 Opinion date:
Danish: Dato for virksomhedens svar:
English: 26 (28%) had never smoked.
Danish: 26 (28 %) havde aldrig røget.
English: This will increase the chance of remembering to take the capsules.
Danish: Dette vil øge chancen for at huske at tage kapslerne.
English: Most cases were asymptomatic and reversible.
Danish: De fleste tilfælde var asymptomatiske og reversible.
English: Your doctor needs to know if you:
Danish: Lægen skal vide, hvis du:
English: Defined as confirmed complete + partial response.
Danish: Defineret som komplet respons + partiel respons.
English: Your doctor will monitor you periodically.
Danish: Lægen vil tjekke dig regelmæssigt.
English: Median PFS after cross-over was 4.4 months.
Danish: Median-PFS efter cross-over var 4,4 måneder.
English: Tafinlar is for oral use.
Danish: Tafinlar er til oral anvendelse.
English: The effects of Tafinlar in people younger than 18 years old are not known.
Danish: Virkningerne af Tafinlar hos personer, der er yngre end 18 år, kendes ikke.
English: Conditions you may need to look out for
Danish: Tilstande, som du skal holde øje med
English: Endpoints/ assessment
Danish: Endepunkter/ vurdering
English: Uveitis may develop rapidly and the symptoms include:
Danish: Uveitis kan udvikles hurtigt, og symptomerne er:
English: The safety profile observed in these patients appears to be consistent with the integrated safety profile of the combination.
Danish: Den observerede sikkerhedsprofil hos disse patienter er tilsyneladende konsistent med den integrerede sikkerhedsprofil for kombinationen.
English: Groups of medicinal products that can be affected include, but are not limited to:
Danish: Grupper af lægemidler, hvis effekt kan påvirkes, omfatter, men er ikke begrænset til:
English: It is more likely to affect people who have an existing heart problem.
Danish: Der er større sandsynlighed for, at dette påvirker personer, der i forvejen har et hjerteproblem.
English: This means that
Danish: Dette betyder, at
English: If you notice any of the following:
Danish: Hvis du bemærker noget af følgende:
English: Estimated Survival Function
Danish: Estimeret overlevelsesfunktion
English: Fertility - both men and women
Danish: Frugtbarhed - både mænd og kvinder
English: Descriptions of these effects can be found in sections 2 and 4.
Danish: Beskrivelser af disse bivirkninger kan findes i punkt 2 og punkt 4.
English: Signs and symptoms of heart problems include:
Danish: Tegn og symptomer på hjerteproblemer omfatter:
English: Patients were not censored at the time of cross-over
Danish: Patienterne blev ikke censureret ved tidspunktet for skiftet
English: You may also have blood tests.
Danish: Du vil også få taget blodprøver.
English: No clinical data are available.
Danish: Der foreligger ingen kliniske data.
English: Then carry on taking your capsules at regular times as usual.
Danish: Fortsæt herefter med at tage dine kapsler på de sædvanlige tidspunkter, som du plejer.
English: There is also a risk of increased formation of active metabolites of these medicinal products.
Danish: Der er også en risiko for en øget dannelse af aktive metabolitter af disse lægemidler.
English: Cohorts were enrolled sequentially:
Danish: Kohorterne blev inkluderet sekventielt:
English: Do not take Tafinlar:
Danish: Tag ikke Tafinlar:
English: In the first line population, 68% of patients had not progressed after 9 months.
Danish: I førstelinjepopulationen havde 68 % af patienterne ikke progredieret efter 9 måneder.
English: Not known (frequency cannot be estimated from the available data)
Danish: Ikke kendt (kan ikke vurderes ud fra tilgængelige data)
English: The median DoR and PFS were not yet estimable (Table 15).
Danish: Median DoR og PFS kunne endnu ikke estimeres (tabel 15).
English: The observed RFS benefit was consistently demonstrated across subgroups of patients including age, sex and race.
Danish: Den observerede RFS-fordel blev påvist konsistent på tværs af undergrupper af patienter inklusive alder, køn og race.
English: It may be good for you to get into the habit of taking both medicines at the same times each day.
Danish: Det kan være en god idé, at du vænner dig til at tage begge lægemidler på samme tid hver dag.
English: • Red, painful hands and feet
Danish: • røde, smertefulde hænder og fødder
English: They will carry out tests to find out if there are other causes for the fever and treat the problem.
Danish: Lægen vil foretage nogle undersøgelser for at finde ud af, om der er andre årsager til feberen, og behandle problemet.
English: Tafinlar is not recommended for children and adolescents.
Danish: Tafinlar anbefales ikke til børn og unge.
English: Any prior systemic anti-cancer treatment, including radiotherapy, was not allowed.
Danish: Tidligere systemisk anti-cancerbehandling, inklusive strålebehandling, var ikke tilladt.
English: Grade 2 (Intolerable) or Grade 3
Danish: Grad 2 (intolerabel) eller grad 3
English: This mutation in the gene may have caused the cancer to develop.
Danish: Denne ændring i genet kan have været årsagen til udviklingen af kræften.
English: Avoid driving or using machines if you have problems with your vision or if you feel tired or weak, or if your energy levels are low.
Danish: Undgå at føre motorkøretøj og betjene maskiner, hvis du har problemer med dit syn, eller hvis du føler dig træt eller svag, eller hvis dit energiniveau er lavt.
English: The number of affected medicinal products is expected to be large; although the magnitude of the interaction will vary.
Danish: Antallet af lægemidler, hvis effekt påvirkes, forventes at være højt, selvom graden af interaktion vil variere.
English: ORR, DoR and PFS were also assessed by an Independent Review Committee (IRC) as a sensitivity analysis.
Danish: ORR, DoR og PFS blev også vurderet af en uafhængig bedømmelseskomité (IRC) som en sensitivitetsanalyse.
English: Interactions with many medicinal products eliminated through metabolism or active transport is expected.
Danish: Der forventes interaktioner med mange lægemidler, som elimineres via metabolisering eller aktiv transport.
English: • Increase in some substances (enzymes) produced by the liver
Danish: • stigning i nogle stoffer (enzymer), som produceres af leveren
English: By Investigator
Danish: Af investigator
English: Date of first authorisation: 26 August 2013 Date of latest renewal: 08 May 2018
Danish: Dato for første markedsføringstilladelse: 26. august 2013 Dato for seneste fornyelse: 8. maj 2018
English: Treatment should continue until the patient no longer derives benefit or the development of unacceptable toxicity (see Table 2).
Danish: Behandlingen bør fortsættes, indtil patienten ikke længere har fordel heraf, eller indtil der udvikles uacceptabel toksicitet (se tabel 2).
English: The majority of these cases were Grade 1 or 2 and did not require any dose interruptions or dose reductions.
Danish: Størstedelen af disse tilfælde var af grad 1 eller 2 og krævede ikke pausering eller dosisreduktion.
English: • have or have ever had any kidney problems.
Danish: • har eller har haft nyreproblemer.
English: Don't chew or crush the capsules, since they will otherwise lose their effect.
Danish: Du må ikke tygge eller knuse kapslerne, da de så vil miste deres virkning.
English: Patients should be instructed to immediately inform their physician if new lesions develop.
Danish: Patienterne skal instrueres i omgående at informere deres læge, hvis de udvikler nye hudlæsioner.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetningeer for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Women of childbearing potential/Contraception in females
Danish: Kvinder i den fertile alder/kontraception hos kvinder
English: Take Tafinlar for as long as your doctor recommends.
Danish: Tag Tafinlar så længe, som lægen foreskriver.
English: 28 capsules 120 capsules
Danish: 28 kapsler 120 kapsler
English: • Papilloma (a type of skin tumour which is usually not harmful)
Danish: • papillom (en form for hudtumor, som normalt ikke er farlig)
English: You need to use another effective method of birth control so you do not become pregnant while you are taking this medicine.
Danish: Det er nødvendigt, at du bruger en anden sikker svangerskabsforebyggende metode, så du ikke bliver gravid, mens du tager dette lægemiddel.
English: The capsules are to be swallowed whole with water.
Danish: Kapslerne skal synkes hele sammen med vand.
English: Mean accumulation AUC Day 18/Day 1 ratios was 0.73.
Danish: Gennemsnitlig akkumulation AUC dag 18/dag 1-ratio var 0,73.
English: Oncogenic mutations in BRAF lead to constitutive activation of the RAS/RAF/MEK/ERK pathway.
Danish: Onkogene mutationer i BRAF fører til konstitutiv aktivering af RAS/RAF/MEK/ERK-pathway.
English: They should not be chewed or opened and should not be mixed with food or liquids due to chemical instability of dabrafenib.
Danish: De må ikke tygges eller åbnes og må ikke blandes med mad eller væsker på grund af den kemiske ustabilitet af dabrafenib.
English: Don't take more Tafinlar than your doctor has recommended, since this may increase the risk of side effects.
Danish: Tag ikke mere Tafinlar, end lægen har foreskrevet, da det kan øge risikoen for at få bivirkninger.
English: Therefore, transient inhibition of CYP3A4 may be observed during the first few days of treatment.
Danish: Derfor kan der muligvis observeres forbigående hæmning af CYP3A4 i de første få dage af behandlingen.
English: June 25, 2012
Danish: 25. juni 2012
English: Study BRF113928
Danish: Studie BRF113928
English: Dabrafenib binds to human plasma protein and is 99.7% bound.
Danish: Dabrafenib binder sig til humant plasmaprotein og er 99,7 % bundet.
English: a, BRF113928, and
Danish: a, BRF113928 og
English: Take Tafinlar twice a day, on an empty stomach.
Danish: Tag Tafinlar to gange om dagen på tom mave.
English: • have heart problems such as heart failure or problems with the way your heart beats.
Danish: • om du har hjerteproblemer såsom hjertesvigt eller problemer med den måde, dit hjerte slår på.
English: Some people taking Tafinlar develop other conditions, which can be serious.
Danish: Nogle personer, der tager Tafinlar, udvikler andre tilstande, der kan være alvorlige.
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Danish: Hvis der sker en overdosering, skal patienten have den nødvendige understøttende behandling med relevant monitorering.
English: By Investigator By IRC
Danish: Af investigator Af IRC
English: Figure 3 Kaplan-Meier curves of overall survival (BREAK-3) (18 December 2012)
Danish: Figur 3 Kaplan-Meier-kurver over den samlede overlevelse (BREAK-3) (18. december 2012)
English: Recommended dose level reductions and recommendations for dose modifications are provided in Tables 1 and 2, respectively.
Danish: Anbefalede reduktioner af dosisniveau og anbefalinger til dosisjusteringer er anført i henholdsvis tabel 1 og 2.
English: • Take Tafinlar twice daily and take trametinib once daily.
Danish: • Tag Tafinlar to gange dagligt, og tag trametinib en gang dagligt.
English: Secondary endpoints included DoR, PFS, OS, safety and population pharmacokinetics.
Danish: Sekundære endepunkter inkluderede DoR, PFS, OS, sikkerhed og populationsfarmakokinetik.