FrancophonIA/ELRC3.0 huggingface dataset:
English: Palonosetron Hospira should be used only before chemotherapy administration.
Danish: Palonosetron Hospira bør kun anvendes før indgift af kemoterapi.
English: • impaired vision or eye irritation
Danish: • nedsat syn eller øjenirritation
English: Palonosetron Hospira is indicated in paediatric patients 1 month of age and older for:
Danish: Palonosetron Hospira er hos pædiatriske patienter i alderen 1 måned og ældre indiceret til:
English: 24 - 120 hours 0 - 120 hours No Nausea (Likert Scale)
Danish: 24 - 120 timer 0 - 120 timer Ingen kvalme (Likert Scale)
English: Type I glass vial with a chlorobutyl rubber stopper and aluminium seal.
Danish: Type I glas hætteglas med en chlorobutyl-gummiprop og aluminiumsforsegling.
English: The second paediatric trial was a multicenter, double-blind, double-dummy, randomised, parallel group, active control, single-dose non-inferiority study, comparing intravenous palonosetron (1 μg/kg, max
Danish: Det andet pædiatriske studie var et multicenter, dobbeltblindet, dobbelt-dummy, randomiseret enkeltdosis-noninferioritetsstudie med parallelle grupper og aktiv kontrol, der sammenlignede intravenøst palonosetron (1 μg/kg, maks.
English: • weakness, tiredness, fever or flu like symptoms
Danish: • svaghed, træthed, feber eller influenza-lignende symptomer
English: Since the 97.5% confidence interval (stratum adjusted Mantel-Haenszel test) of the difference in CR0-24h between palonosetron 20 μg/kg and ondansetron was [-11.7%, 12.4%], the 20 μg/kg palonosetron dose demonstrated non-inferiority to ondansetron.
Danish: Da 97,5 % konfidensintervallet (stratum-justeret MantelHaenszel-test) for forskel i CR0-24t mellem palonosetron 20 μg/kg og ondansetron var [-11,7 %; 12,4 %], viste 20 μg/kg palonosetron-dosen noninferioritet over for ondansetron.
English: • decrease or loss of appetite
Danish: • nedsat appetit eller appetitløshed
English: There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone or in combination with other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs).
Danish: Der har været rapporter om serotonergt syndrom ved anvendelse af 5-HT3-antagonister, enten alene eller i kombination med andre serotonerge lægemidler (herunder selektive serotoningenoptagshæmmere (selective serotonin reuptake inhibitors, SSRI'er) og serotoninnoradrenalingenoptagshæmmere (serotonin noradrenaline reuptake inhibitors, SNRI'er).
English: • abnormally high or low levels of potassium in the blood
Danish: • unormalt høje eller lave niveauer af kalium i blodet
English: • SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
Danish: • SSRI'er (selektive serotoningenoptagshæmmere), der anvendes til at behandle depression og/eller angst, herunder fluoxetin, paroxetin, sertralin, fluvoxamin, citalopram, escitalopram;
English: Common (may affect up to 1 in 10 people): • headache
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer): • hovedpine
English: Only limited data from animal studies are available regarding the placental transfer (see section 5.3).
Danish: Der findes kun begrænsede data fra dyrestudier vedrørende passage over placenta (se pkt.
English: In vitro metabolism studies have shown that CYP2D6 and to a lesser extent, CYP3A4 and CYP1A2 isoenzymes are involved in the metabolism of palonosetron.
Danish: In vitro metabolismestudier har vist, at CYP2D6- og i mindre omfang CYP3A4og CYP1A2-isoenzymerne er involveret i metabolismen af palonosetron.
English: The efficacy of palonosetron for the prevention of chemotherapy-induced nausea and vomiting in paediatric cancer patients was demonstrated in a second non-inferiority pivotal trial comparing a single intravenous infusion of palonosetron versus an intravenous ondansetron regimen.
Danish: Palonosetrons virkning til forebyggelse af kemoterapifremkaldt kvalme og opkastning hos pædiatriske cancerpatienter blev vist i et andet pivotalt non-inferioritetsstudie, der sammenlignede en enkelt intravenøs infusion med palonosetron versus et regimen med intravenøst ondansetron.
English: Paediatric Cancer Patients
Danish: Pædiatriske cancerpatienter
English: It is not recommended to receive Palonosetron Hospira in the days following chemotherapy unless you are receiving another chemotherapy cycle.
Danish: Det frarådes at få Palonosetron Hospira i dagene efter kemoterapi, medmindre du får en ny kemoterapicyklus.
English: Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for Palonosetron Hospira overdose.
Danish: På grund af det store fordelingsvolumen er det dog usandsynligt, at dialyse vil være en effektiv behandling af overdosering af Palonosetron Hospira.
English: • numbness, burning, prickling or tingling sensations on the skin
Danish: • følelsesløshed, brændende, prikkende eller stikkende fornemmelse på huden
English: In paediatric clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic chemotherapy, 402 patients received a single dose of palonosetron (3, 10 or 20 mcg/kg).
Danish: I pædiatriske kliniske studier af forebyggelse af kvalme og opkastning induceret af kemoterapi med moderat eller kraftigt kvalmefremkaldende virkning fik 402 patienter en enkelt dosis palonosetron (3, 10 eller 20 mikrog/kg).
English: In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers (dexamethasone and rifampicin) and inhibitors (including amiodarone, celecoxib, chlorpromazine, cimetidine, doxorubicin, fluoxetine, haloperidol, paroxetine, quinidine, ranitidine, ritonavir, sertraline or terbinafine).
Danish: I en populations-farmakokinetisk analyse er det blevet vist, at der ikke var nogen signifikant virkning på palonosetrons clearance, når det blev givet sammen med CYP2D6-induktorer (dexamethason og rifampicin) og -hæmmere (herunder amiodaron, celecoxib, chlorpromazin, cimetidin, doxorubicin, fluoxetin, haloperidol, paroxetin, quinidin, ranitidin, ritonavir, sertralin eller terbinafin).
English: Single-dose intravenous palonosetron pharmacokinetic data was obtained from a subset of paediatric cancer patients (n=280) that received 10 μg/kg or 20 μg/kg.
Danish: Farmakokinetiske enkeltdosisdata for intravenøst palonosetron blev indhentet fra en undergruppe af pædiatriske cancerpatienter (n=280), der fik 10 μg/kg eller 20 μg/kg.
English: Hospira Enterprises B.V. Randstad 22-11 Almere NL-1316 BN The Netherlands
Danish: Randstad 22-11 Almere NL-1316 BN Holland
English: What Palonosetron Hospira looks like and contents of the pack Palonosetron Hospira solution for injection is a clear, colourless solution and is supplied in a pack of one Type I glass vial with a chlorobutyl rubber stopper and aluminium cap, which contains 5 ml of the solution.
Danish: Palonosetron Hospira injektionsvæske, opløsning, er en klar og farveløs opløsning, der leveres i en pakning med ét type I-hætteglas med en chlorbutyl-gummiprop og aluminiumshætte, der indeholder 5 ml af opløsningen.
English: The efficacy of Palonosetron Hospira in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy.
Danish: Effekten af Palonosetron Hospira ved forebyggelse af kvalme og opkastning fremkaldt af kemoterapi med kraftigt kvalmefremkaldende virkning kan forstærkes ved at supplere med et kortikosteroid indgivet inden kemoterapien.
English: You must not be given Palonosetron Hospira:
Danish: Du må ikke få Palonosetron Hospira:
English: • sleepiness or trouble sleeping
Danish: • søvnighed eller søvnbesvær
English: The safety and efficacy of palonosetron intravenously at single doses of 3 μg/kg and 10 μg/kg was investigated in the first clinical study in 72 patients in the following age groups, >28 days to 23 months (12 patients), 2 to 11 years (31 patients), and 12 to 17 years of age (29 patients), receiving highly or moderately emetogenic chemotherapy.
Danish: Sikkerheden og virkningen af palonosetron indgivet intravenøst i enkeltdoser på 3 μg/kg og 10 μg/kg blev undersøgt i det første kliniske studie med 72 patienter i følgende aldersgrupper: > 28 dage til 23 måneder (12 patienter), 2 til 11 år (31 patienter) og 12 til 17 år (29 patienter), som fik kraftigt eller moderat emetogen kemoterapi.
English: <2 y 2 to <6 y 6 to <12 y 12 to <17 y μg/kg
Danish: <2 år 2 til <6 år 6 til <12 år
English: Palonosetron Hospira should not be used to prevent or treat nausea and vomiting in the days following chemotherapy if not associated with another chemotherapy administration.
Danish: Palonosetron Hospira bør ikke anvendes til at forebygge og behandle kvalme og opkastning i dagene efter kemoterapi, medmindre det sker i forbindelse med anden indgift af kemoterapi.
English: Palonosetron Hospira may cause dizziness or tiredness.
Danish: Palonosetron Hospira kan fremkalde svimmelhed eller træthed.
English: Also contains: mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide, hydrochloric acid.
Danish: Indeholder også: mannitol, dinatriumedetat, natriumcitrat, citronsyremonohydrat, vand til injektionsvæsker, natriumhydroxid, saltsyre.
English: The safety and efficacy of palonosetron intravenously at single doses of 1 μg/kg and 3 μg/kg was compared in the first clinical study in 150 patients in the following age groups, >28 days to 23 months (7 patients), 2 to 11 years (96 patients), and 12 to 16 years of age (47 patients) undergoing elective surgery.
Danish: Sikkerheden og virkningen af palonosetron indgivet intravenøst i enkeltdoser på 1 μg/kg og 3 μg/kg blev sammenlignet i det første kliniske studie med 150 patienter i aldersgrupperne > 28 dage til 23 måneder (7 patienter), 2 til 11 år (96 patienter) og 12 til 16 år (47 patienter), som fik foretaget elektiv kirurgi.
English: • electrocardiogram abnormalities (QT prolongation)
Danish: • unormalt ekg (QT-forlængelse)
English: After a single intravenous dose of 10 micrograms/kg [14C]-palonosetron, approximately 80 % of the dose was recovered within 144 hours in the urine with palonosetron representing approximately 40 % of the administered dose, as unchanged active substance.
Danish: C]-palonosetron blev ca. 80 % af dosis genfundet indenfor 144 timer i urinen med palonosetron udgørende ca. 40 % af den indgivne dosis som uændret aktivt stof.
English: Palonosetron was non-inferior versus the comparators in the acute phase of emesis both in moderately and highly emetogenic setting.
Danish: Palonosetron var ikke dårligere sammenlignet med de stoffer, det blev sammenlignet med, i den akutte fase af kvalme og opkastning både under regimener med moderat og kraftigt kvalmefremkaldende behandling.
English: Palonosetron Hospira is indicated in adults for:
Danish: Palonosetron Hospira er hos voksne indiceret til:
English: Common ARs (≥1/100 to<1/10)
Danish: Almindelige bivirkninger (≥1/100 til <1/10)
English: Each vial contains 250 micrograms palonosetron (as hydrochloride) in 5 ml (50 micrograms/ml)
Danish: Hvert hætteglas indeholder 250 mikrogram palonosetron (som hydrochlorid) i 5 ml (50 mikrograms/ml)
English: There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic drugs (including SSRIs and SNRIs).
Danish: Serotonerge lægemidler (fx SSRI'er og SNRI'er) Der har været rapporter om serotoninsyndrom efter samtidig anvendelse af 5-HT3-antagonister og andre serotonerge lægemidler (herunder SSRI'er og SNRI'er).
English: Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations.
Danish: Baseret på in vitro-studier hæmmer eller fremmer palonosetron ikke CYP450 isoenzym i klinisk relevante koncentrationer.
English: • The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid (for pH adjustment).
Danish: • Øvrige indholdstoffer: mannitol, dinatriumedetat, natriumcitrat, citronsyremonohydrat, vand til injektionsvæsker, natriumhydroxid og saltsyre (til justering af pH).
English: Single use only
Danish: Kun til engangsbrug.
English: The recommended dose of Palonosetron Hospira is 250 micrograms given as a rapid injection into a vein.
Danish: Den anbefalede dosis af Palonosetron Hospira er 250 mikrogram, givet som en hurtig injektion (bolusinjektion) i en blodåre.
English: haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone;
Danish: haloperidol, chlorpromazin, quetiapin, thioridazin eller domperidon;
English: Read the package leaflet before use.
Danish: Læs indlægssedlen inden brug Intravenøs anvendelse Kun til engangsbrug
English: What you need to know before you are given Palonosetron Hospira 3.
Danish: Det skal du vide, før du får Palonosetron Hospira 3.
English: • high levels of certain liver enzymes
Danish: • høje niveauer af bestemte leverenzymer
English: Allergic reactions to Palonosetron Hospira.
Danish: Overfølsomhedsreaktioner som følge af indgift af Palonosetron Hospira.
English: • elevated moods or feelings of anxiousness
Danish: • hævet stemningsleje eller angstfølelse
English: What Palonosetron Hospira contains
Danish: Palonosetron Hospira indeholder:
English: Electrocardiogram QT prolonged conduction disorder, sinus tachycardia
Danish: QT-forlængelse i elektrokardiogram, ledningsforstyrrelser, sinustakykardi
English: After intravenous administration of palonosetron 0.25 mg once daily for 3 days in 12 healthy subjects, the mean (± SD) increase in plasma palonosetron concentration from Day 1 to Day 3 was 110 ± 45
Danish: Efter intravenøs indgift af palonosetron 0,25 mg én gang dagligt i tre dage i 12 raske studiedeltagere var den gennemsnitlige stigning (± SD) i plasma-palonosetronkoncentration fra dag 1 til dag 3 110 ± 45 %.
English: • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Danish: • forebyggelse af akut kvalme og opkastning i forbindelse med cancerkemoterapi med kraftigt kvalmefremkaldende virkning og forebyggelse af kvalme og opkastning i forbindelse med cancerkemoterapi med moderat kvalmefremkaldende virkning.
English: PK parameters expressed as Arithmetic mean (SD) Clearance and Volume of distribution in paediatric patients were calculated weight-adjusted from both 10 μg /kg and 20 μg /kg dose groups combined.
Danish: Clearance og fordelingsvolumen hos pædiatriske patienter blev beregnet med vægtjustering fra de kombinerede dosisgrupper med 10 μg/kg og 20 μg/kg.
English: How Palonosetron Hospira is given 4.
Danish: Sådan gives Palonosetron Hospira 4.
English: What you need to know before you are given Palonosetron Hospira
Danish: Det skal du vide, før du får Palonosetron Hospira
English: Table 2: Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus dolasetron
Danish: Tabel 2: Procentdel af patienter a, der responderer ud fra behandlingsgruppe og fase i studiet med moderat kvalmefremkaldende kemoterapi a sammenlignet med dolasetron
English: Palonosetron Hospira 250 micrograms solution for injection palonosetron (as hydrochloride)
Danish: Palonosetron Hospira 250 mikrogram injektionsvæske, opløsning palonosetron (som hydrochlorid)
English: Table 1: Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus ondansetron
Danish: Tabel 1: Procentdel af patienter a, der responderer ud fra behandlingsgruppe og fase i studiet med moderat kvalmefremkaldende kemoterapi sammenlignet med ondansetron
English: AUC0-∞, h·μg/L
Danish: AUC0-∞, h·μg/l t½, timer
English: How Palonosetron Hospira is given
Danish: Sådan gives Palonosetron Hospira
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including:
Danish: Brug af anden medicin sammen med Palonosetron Hospira Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig, herunder:
English: Table 3: Percentage of patients a responding by treatment group and phase in the Highly Emetogenic Chemotherapy study versus ondansetron
Danish: Tabel 3: Procentdel af patienter a, der responderer ud fra behandlingsgruppe og fase i studiet med kraftigt kvalmefremkaldende kemoterapi a sammenlignet med ondansetron
English: • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,
Danish: • forebyggelse af akut kvalme og opkastning i forbindelse med cancerkemoterapi med kraftigt kvalmefremkaldende virkning,
English: Each ml of solution contains 50 micrograms palonosetron (as hydrochloride).
Danish: Hver ml opløsning indeholder 50 mikrogram palonosetron (som hydrochlorid).
English: Each ml of solution contains 50 micrograms palonosetron.
Danish: Hver ml opløsning indeholder 50 mikrogram palonosetron.
English: A total of 493 paediatric patients, aged 64 days to 16.9 years, receiving moderately (69.2%) or highly emetogenic chemotherapy (30.8%) were treated with palonosetron 10 μg/kg (maximum 0.75 mg), palonosetron 20 μg/kg (maximum 1.5 mg) or ondansetron (3 x 0.15 mg/kg , maximum total dose 32 mg) 30 minutes prior to the start of emetogenic chemotherapy during Cycle 1.
Danish: I alt 493 pædiatriske patienter i alderen 64 dage til 16,9 år, der fik kemoterapi med moderat (69,2 %) eller kraftigt (30,8 %) kvalmefremkaldende virkning, blev behandlet med palonosetron 10 μg/kg (maks.
English: In two randomised, double-blind studies with a total of 1,132 patients receiving moderately emetogenic chemotherapy that included cisplatin ≤50 mg/m 2, carboplatin, cyclophosphamide ≤1,500 mg/m 2 and doxorubicin >25 mg/m2, palonosetron 250 micrograms and 750 micrograms were compared with ondansetron 32 mg (half-life 4 hours) or dolasetron 100 mg (half-life 7.3 hours) administered intravenously on Day 1, without dexamethasone.
Danish: 1.500 mg/m og doxorubicin > 25 mg/m 2, blev palonosetron 250 mikrogram og 750 mikrogram sammenlignet med ondansetron 32 mg (halveringstid 4 timer) eller dolasetron 100 mg (halveringstid 7,3 timer) indgivet intravenøst på dag 1 uden dexamethason.
English: For palonosetron no clinical data on exposed pregnancies are available.
Danish: Der foreligger ingen kliniske data fra anvendelse af palonosetron til gravide.
English: Palonosetron 250 micrograms (n= 223)
Danish: Palonosetron 250 mikrogram (n= 223)
English: Chemotherapeutic agents
Danish: Kemoterapeutika
English: • hiccups, flatulence, dry mouth or indigestion
Danish: • hikke, luft i maven, tør mund eller fordøjelsesbesvær
English: In a randomised, double-blind study with a total of 667 patients receiving highly emetogenic chemotherapy that included cisplatin ≥60 mg/m2, cyclophosphamide >1,500 mg/m2 and dacarbazine, palonosetron
Danish: I et randomiseret, dobbeltblind studie med sammenlagt 667 patienter, der fik kraftigt kvalmefremkaldende kemoterapi omfattende cisplatin ≥ 60 mg/m2, cyclophosphamid > 1.500 mg/m og dacarbazine, blev palonosetron 250 mikrogram og 750 mikrogram sammenlignet med ondansetron 32 mg indgivet intravenøst på dag 1.
English: • abnormal heart rate
Danish: • unormal puls
English: Palonosetron Hospira250 micrograms solution for injection.
Danish: Palonosetron Hospira 250 mikrogram injektionsvæske, opløsning.
English: Palonosetron Hospira 250 micrograms solution for injection palonosetron
Danish: Palonosetron Hospira 250 mikrogram injektionsvæske, opløsning palonosetron
English: • nosebleed
Danish: • næseblod
English: Palonosetron 250 micrograms (n= 189)
Danish: Palonosetron 250 mikrogram (n= 189)
English: Palonosetron 250 micrograms (n= 185)
Danish: Palonosetron 250 mikrogram (n= 185)
English: • coughing or shortness of breath
Danish: • hoste eller stakåndethed
English: • if you have a personal or family history of alterations in heart rhythm (QT prolongation);
Danish: • hvis der i din egen eller i din families sygehistorie har været tilfælde af hjerterytmeforstyrrelser
English: If you have any further questions on the use of this medicine, ask your doctor.
Danish: Spørg lægen, hvis der er noget, du er i tvivl om.
English: Deltyba received a marketing authorisation valid throughout the European Union on 28 April 2014.
Danish: Deltyba fik en markedsføringstilladelse med gyldighed i hele EU den 28. april 2014.
English: In addition, a majority of patients who entered the main study were followed up for up to 24 months afterwards.
Danish: Derudover blev størstedelen af de patienter, der deltog i hovedstudiet, fulgt i op til 24 måneder bagefter.
English: Deltyba has been given ‘conditional authorisation'.
Danish: Deltyba har fået en "betinget godkendelse".
English: The medicine is available as tablets (50 mg) and the recommended dose is two tablets twice a day taken with food.
Danish: Lægemidlet fås som tabletter (50 mg), og den anbefalede dosis er to tabletter to gange dagligt sammen med mad.
English: Treatment with these medicines should continue after Deltyba treatment, as recommended by official guidelines.
Danish: Behandlingen med disse lægemidler bør fortsætte efter Deltyba-behandlingen som anbefalet i de officielle retningslinjer.
English: The safety profile was considered manageable and several measures were introduced to minimise the risks, including a study to confirm the long-term safety.
Danish: Sikkerhedsprofilen blev fundet håndterbar, og adskillige forholdsregler blev truffet for at minimere risiciene, herunder gennemførelse af et studie, der skal undersøge sikkerheden på lang sigt.
English: Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis (M. tuberculosis).
Danish: Tuberkulose er en infektion, der forårsages af bakterien Mycobacterium tuberculosis (M. tuberculosis).
English: As for all medicines, data on the use of Deltyba are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Deltyba løbende overvåget.
English: Deltyba is given for 6 months together with other tuberculosis medicines.
Danish: Deltyba gives i 6 måneder sammen med andre lægemidler mod tuberkulose.
English: What measures are being taken to ensure the safe and effective use of Deltyba?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Deltyba?
English: It is used together with other tuberculosis medicines and only when other standard medicine cannot be used either because the disease is resistant to them or because of their side effects.
Danish: Det anvendes sammen med andre lægemidler mod tuberkulose og kun, når andre standardlægemidler ikke kan anvendes, enten fordi sygdommen er resistent over for dem, eller fordi patienten ikke kan tåle bivirkningerne ved dem.
English: Further information on Deltyba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Deltyba findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tuberculosis is rare in the EU, and Deltyba was designated an ‘orphan medicine' (a medicine used in rare diseases) on 1 February 2008.
Danish: Tuberkulose er en sjælden sygdom i EU, og Deltyba blev udpeget som "lægemiddel til sjældne sygdomme" den 1. februar 2008.
English: Although the main study was of short duration and the follow-up studies had shortcomings, the Agency considered that the effects shown after the initial 2 months of treatment are likely to be sustained for the full treatment duration.
Danish: Selvom hovedstudiet var af kort varighed og opfølgningsstudierne havde en række mangler, vurderede agenturet, at den virkning, der er påvist efter 2 måneders behandling, sandsynligvis vil vare ved i hele behandlingsforløbet.