FrancophonIA/ELRC3.0 huggingface dataset:
English: *Proportion of subjects who had HIV-1 < 400 copies/ml and had remained on study treatment
Danish: + 4% (95% CI: -1, 9) (n=19) *Andel af forsøgspersoner som havde hiv-1 < 400 kopier/ml og fortsatte på studie-behandling
English: Fluticasone propionate, 50 µg intranasal 4 times daily:
Danish: Fluticasonpropionat, 50 µg intranasalt 4 gange dagligt: Plasmakoncentrationer ↑ Kortisolniveauer ↓ 86%
English: Increased plasma concentrations of vardenafil (see sections 4.4 and 4.5)
Danish: Forhøjede plasmakoncentrationer af vardenafil (se pkt.
English: Concentrations are expected to increase due to CYP3A inhibition by lopinavir/ritonavir.
Danish: Øget koncentration forventes på grund af lopinavir/ritonavirs hæmning af CYP3A.
English: Lopinavir and ritonavir levels may increase on stopping St John's wort.
Danish: Lopinavir-ritonavir-niveauerne kan stige ved stop af behandling med perikon.
English: Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of pimozide are expected to increase.
Danish: På grund af lopinavir/ritonavirs CYP3A-hæmning af pimozid forventes koncentrationen at stige.
English: Due to CYP3A4 inhibition by lopinavir/ritonavir.
Danish: På grund af lopinavir/ritonavirs hæmning af CYP3A4.
English: • If the ‘ml' mark on the collar is less than the prescribed dose, draw up more solution to the prescribed dose.
Danish: • Hvis ”ml" markering på kraven er mindre end den ordinerede dosis, træk mere opløsning op,
English: Two pack sizes are available for Kaletra oral solution: - 120 ml (2 bottles x 60 ml) with 2 x 2 ml syringes with 0.1 ml graduations
Danish: − 120 ml (2 flasker x 60 ml) med 2 x 2 ml sprøjter med 0,1 ml inddeling til voluminer op til 2 ml.
English: Glecaprevir/pibrentasvir Serum concentrations may be increased due to P-glycoprotein, BCRP and OATP1B inhibition by lopinavir/ritonavir.
Danish: Glecaprevir/pibrentasvir Serumkoncentrationen kan øges på grund af lopinavir/ritonavirs hæmning af P-glycoprotein,
English: Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of quetiapine are expected to increase.
Danish: På grund af lopinavir/ritonavirs hæmning af CYP3A forventes koncentrationen af quetiapin at stige.
English: Increased plasma concentrations of ranolazine which may increase the potential for serious and/or lifethreatening reactions (see section 4.5).
Danish: Forhøjede plasmakoncentrationer af ranolazin, som kan forøge risikoen for alvorlige og/eller livstruende reaktioner (se pkt.
English: • inflammation of the pancreas;
Danish: • betændelse i galdegangen;
English: The use of a once-daily dosing should be limited to those adult patients having only very few protease inhibitor (PI) associated mutations (i.e. less than 3 PI mutations in line with clinical trial results, see section 5.1 for the full description of the population) and should take into account the risk of a lesser sustainability of the virologic suppression (see section 5.1) and higher risk of diarrhoea (see section 4.8) compared to the recommended standard twice-daily dosing.
Danish: Brug af dosering en gang dagligt bør forbeholdes de voksne patienter, som kun har meget få proteasehæmmer(PI)-associerede mutationer ( f.eks. færre end 3 PI-mutationer i tråd med resultaterne fra et klinisk studie, se pkt.
English: Ergot alkaloids
Danish: Sekalealkaloider
English: Due to CYP3A inhibition by lopinavir/ritonavir.
Danish: På grund af lopinavir/ritonavirs hæmning af CYP3A.
English: Concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir.
Danish: Koncentrationerne kan øges på grund af lopinavir/ritonavirs hæmning af CYP3A.
English: • constipation;
Danish: • forstoppelse;
English: Severe hepatic insufficiency.
Danish: Alvorlig nedsat leverfunktion.
English: BSA (m2) = √ (Height (cm) X Weight (kg) / 3600) It is recommended that Kaletra not be administered in combination with efavirenz or nevirapine in patients less than 6 months of age.
Danish: Administration af Kaletra i kombination med efavirenz eller nevirapin til patienter under 6 måneder anbefales ikke.
English: (Lopinavir/ritonavir 400/100 mg BID)
Danish: (Lopinavir/ritonavir 400/100 mg 2 gange dagligt)
English: The adult dose of Kaletra tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2. For children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m2 and able to swallow tablets, please refer to the Kaletra 100 mg/25 mg tablets Summary of Product Characteristics.
Danish: Til børn som vejer mindre end 40 kg eller med en legemsoverflade (BSA) på mellem 0,5 og 1,4 m2 , og som er i stand til at synke tabletter, se produktresuméet for Kaletra 100 mg/25 mg tabletter.
English: Opioids
Danish: Opioider
English: Other side effects that have been reported with Kaletra:
Danish: Pakningsstørrelser og yderligere oplysninger Kaletra indeholder:
English: If a patient is already taking St John's wort, stop St John's wort and if possible check viral levels.
Danish: Påbegyndt behandling med perikon bør stoppes, og hvis det er mulig bør de virale-niveauer kontrolleres.
English: Concomitant administration of Kaletra and alfuzosin is contraindicated (see section 4.3) as alfuzosin-related toxicity, including hypotension, may be increased.
Danish: 4.3) idet alfuzosin-relateret toksicitet, inklusive hypotension, kan være forøget.
English: Contraceptives
Danish: Præventionsmidler
English: Markedly increased plasma concentrations due to CYP3A inhibition by lopinavir/ritonavir.
Danish: Lovastatin, simvastatin: Markant forøgede plasmakoncentrationer på grund af lopinavir/ritonavirs hæmning af CYP3A.
English: AUC: ↑ 153%
Danish: AUC: ↑ 153% Cmax: ↑ 55%
English: The co-administration of riociguat with Kaletra is not recommended (see section 4.4 and refer to riociguat SmPC).
Danish: Samtidig administration af riociguat og Kaletra anbefales ikke (se pkt.
English: Serum concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir.
Danish: Serumkoncentrationen kan øges på grund af lopinavir/ritonavirs hæmning af CYP3A
English: protease inhibitor-experienced patients resulted in a higher incidence of gastrointestinal adverse events and elevations in triglycerides with the combination regimen without increases in virological efficacy, when compared with standard doses of fosamprenavir/ritonavir.
Danish: Samtidig administration af øgede fosamprenavir-doser (1400 mg to gange dagligt med Kaletra (533/133 mg to gange dagligt) til proteasehæmmer-erfarne patienter resulterede i en højere forekomst af gastrointestinale bivirkninger og stigninger i triglycerider med kombinationsregimet uden stigning i den virologiske effekt ved sammenligning med standarddoser af fosamprenavir/ritonavir.
English: The co-administration of vorapaxar with Kaletra is not recommended (see section 4.4 and refer to the vorapaxar SmPC).
Danish: Samtidig administration af vorapaxar og Kaletra anbefales ikke (se pkt.
English: Renal and urinary disorders
Danish: Midler mod urinsyregigt
English: Please refer to the Kaletra 100 mg/25 mg film-coated tablets Summary of Product Characteristics.
Danish: Se produkresuméet for Kaletra 100 mg/25 mg filmovertrukne tabletter.
English: Co-administration of Kaletra with sildenafil is contraindicated (see section 4.3).
Danish: Samtidig administration af Kaletra og quetiapin er kontra-indiceret (se pkt.
English: HIV RNA < 50 copies/ml
Danish: hiv-RNA < 400 kopier/ml hiv-RNA < 50 kopier/ml
English: Increased plasma concentrations of lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section
Danish: Derved øges risikoen for myopati, inklusive rabdomyolyse (se pkt.
English: Lopinavir provides the antiviral activity of Kaletra.
Danish: Lopinavir giver Kaletra dets antivirale effekt.
English: 7.5 mg/ml Solution for injection
Danish: EU/1/04/276/036 Abilify 7,5 mg/ml Injektionsvæske, opløsning
English: Intramuscular use vial (glass)
Danish: Hætteglas (glas)
English: Outcome of a procedure under Article 6(12) of Regulation (EC) 1084/2003 as amended
Danish: Resultat af en indbringelsesprocedure i henhold til artikel 6, stk. 12, i forordning (EF) nr. 1084/2003 med senere ændringer
English: The Committee looked at the studies presented by the company to support the new indication.
Danish: Udvalget så på de undersøgelser, som virksomheden havde fremlagt til støtte for den nye indikation.
English: The European Commission issued a decision on 02 September 2010.
Danish: Europa-Kommissionen traf en afgørelse den 02. september 2010.
English: 1 In all other Member States of the EU, the medicine has received a marketing authorisation at national level.
Danish: 1 I alle andre EU-medlemsstater har lægemidlet opnået markedsføringstilladelse på nationalt plan.
English: What is Genotropin?
Danish: Hvad er Genotropin?
English: These national marketing authorisations are not affected by this referral.
Danish: Disse nationale markedsføringstilladelser berøres ikke af denne indbringelsesprocedure.
English: The Committee concluded that the change to the marketing authorisation cannot be granted.
Danish: Udvalget konkluderede, at ændringen i markedsføringstilladelsen ikke kan godkendes.
English: This variation was to be recognised in Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom
Danish: Frankrig, Tyskland, Grækenland, Irland, Italien, Luxembourg, Nederlandene, Portugal, Spanien, Sverige og Det Forenede Kongerige ("de berørte medlemsstater").
English: Why was Genotropin reviewed?
Danish: Hvorfor blev Genotropin vurderet igen?
English: What are the conclusions of the CHMP?
Danish: Hvilke konklusioner nåede CHMP frem til?
English: The company that makes the medicine is Pfizer.
Danish: Den virksomhed, der fremstiller lægemidlet, er Pfizer.
English: Because the Member States were not able to reach an agreement, the Netherlands referred the matter to the CHMP for arbitration on 28 October 2009.
Danish: Da det ikke lykkedes medlemsstaterne at opnå enighed, indbragte Nederlandene sagen for CHMP med henblik på voldgift den 28. oktober 2009.
English: Genotropin, also marketed under the trade name Genotonorm, is available throughout the European Union (EU).
Danish: Genotropin, der også markedsføres under særnavnet Genotonorm, kan fås i hele Den Europæiske Union (EU).
English: The European Medicines Agency has completed an arbitration procedure for Genotropin and associated names.
Danish: Det Europæiske Lægemiddelagentur har gennemført en voldgiftsprocedure for Genotropin og relaterede navne.
English: In 15 Member States of the EU, Genotropin is authorised under a mutual recognition procedure on the basis of the initial authorisation granted by Denmark on 7 May 19871.
Danish: I 15 EU-medlemsstater er Genotropin godkendt efter en gensidig anerkendelsesprocedure på baggrund af den første markedsføringstilladelse, der blev udstedt af Danmark den 7. maj 19871.
English: 25 January 2010, 3 May 2010 and 24 May 2010
Danish: 25. januar 2010, 3. maj 2010 og 24. maj 2010
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the variation to the marketing authorisation for Genotropin cannot be approved in Denmark as well as in all concerned Member States.
Danish: På grundlag af vurderingen af de tilgængelige data og den faglige drøftelse i udvalget konkluderede CHMP, at ændringen af markedsføringstilladelsen for Genotropin ikke kan godkendes i Danmark og i alle de berørte medlemsstater.
English: In July 2008, Pfizer applied for a change (variation) to the marketing authorisation to add a new indication in Denmark (the ‘reference Member State').
Danish: I juli 2008 ansøgte Pfizer om en ændring af markedsføringstilladelsen med henblik på at medtage en ny indikation i Danmark ("referencemedlemsstaten").
English: Genotropin is a medicine that contains somatropin, which is a copy of natural growth hormone.
Danish: Genotropin er et lægemiddel, der indeholder somatropin, som er en kopi af naturligt væksthormon.
English: Growth hormone promotes growth during childhood and adolescence, and also acts on the way the body handles proteins, fat and carbohydrates.
Danish: Væksthormon fremmer væksten i barndommen og ungdommen og indvirker også på den måde, som kroppen håndterer protein, fedt og kulhydrat på.
English: It also looked at published information on the use of growth hormone in patients with JIA, and convened a meeting of experts, which included experts both in the treatment of hormonal disorders (endocrinologists) and in the treatment of joint diseases (rheumatologists).
Danish: Udvalget undersøgte ligeledes den offentliggjorte information om brugen af væksthormon hos patienter med JIA, og det indkaldte til et ekspertmøde, som omfattede eksperter i både behandlingen af hormonelle sygdomme (endokrinologer) og behandlingen af ledsygdomme (reumatologer).
English: Somatropin is produced by a method known as ‘recombinant DNA technology': it is made by an organism that has received a gene (DNA), which makes it able to produce growth hormone.
Danish: Somatropin fremstilles ved hjælp af en metode, der kaldes "rekombinant dna-teknologi", dvs. ved hjælp af en organisme, der har fået indsat et gen (dna), som gør den i stand til at producere væksthormon.
English: Procedure start date:
Danish: Startdato for indbringelse:
English: It is also used to correct short height in children who have the genetic diseases Turner syndrome and Prader Willi syndrome, and in children who have longstanding kidney problems.
Danish: Det anvendes ligeledes til at korrigere lav højde hos børn, der lider af de genetiske sygdomme Turners syndrom og Prader Willis syndrom, samt hos børn, der i længere tid har haft nyreproblemer.
English: Genotropin is used as replacement therapy in children and adults who have a growth hormone deficiency.
Danish: Genotropin anvendes som erstatningsbehandling hos børn og voksne, der mangler væksthormon.
English: 24 June 2010
Danish: 24. juni 2010
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a change to the marketing authorisation for Genotropin to include a new indication for the treatment of stunted growth caused by the long-term use of steroids in children with juvenile idiopathic arthritis.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) var blevet anmodet om at træffe afgørelse ved voldgift om en ændring af markedsføringstilladelsen for Genotropin med henblik på at medtage en ny indikation for behandlingen af lav vækst som følge af langvarig brug af steroider hos børn med juvenil idiopatisk arthritis.
English: The new indication was the use of Genotropin in children on long-term treatment with steroids for juvenile idiopathic arthritis (JIA), a rare childhood disease causing inflammation of many joints.
Danish: Den nye indikation var anvendelsen af Genotropin hos børn, der får langtidsbehandling med steroider for juvenil idiopatisk arthritis (JIA), som er en sjælden børnesygdom, der forårsager betændelse i mange led.
English: Genotropin was to be used to improve growth and body composition in children with severe JIA in whom the prolonged use of steroids to help control inflammation had led to a slowing down of growth.
Danish: Genotropin skulle anvendes til at forbedre væksten og kropssammensætningen hos børn med svær JIA, hvor længerevarende brug af steroider for at hæmme betændelsen havde ført til nedsat vækst.
English: The grounds for the referral were that fewer patients currently need to use steroids than in the past, because other medicines that do not affect growth have become available to control JIA.
Danish: Begrundelserne for indbringelsen var, at der nu er færre patienter end før, som er nødt til at bruge steroider, eftersom andre lægemidler, der ikke påvirker væksten, er blevet tilgængelige til at kontrollere JIA, og at virksomheden havde fremlagt for få data om den endelige højde, som patienterne opnåede i undersøgelserne.
English: This summary was last updated in 02-2013.
Danish: Dette sammendrag blev sidst ajourført i 02-2013.
English: • Parkinson's disease.
Danish: • Parkinsons sygdom.
English: The dose can then be increased every week until an effective dose is reached.
Danish: Dosis kan dernæst øges hver uge, indtil der opnås en effektiv dosis.
English: This medicine is the same as Neupro, which is already authorised in the European Union (EU).
Danish: Dette lægemiddel er identisk med Neupro, som allerede er godkendt i Den Europæiske Union (EU).
English: Leganto is applied once a day at about the same time every day.
Danish: Leganto påsættes én gang dagligt på omtrent samme tidspunkt hver dag.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Leganto on 16 June 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Leganto den 16. juni 2011.
English: The patients then lose their ability to control their movements reliably.
Danish: Patienterne mister derved evnen til sikker styring af bevægelserne.
English: The patch remains on the skin for 24 hours and is then replaced by a new one in a different place.
Danish: Plasteret skal blive siddende på huden i 24 timer og derefter erstattes af et nyt, der sættes et andet sted.
English: The full EPAR for Leganto can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Leganto findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The same place must not be used again until two weeks later.
Danish: Samme sted på huden må først bruges igen efter to uger.
English: This is a summary of the European public assessment report (EPAR) for Leganto.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Leganto.
English: Each patch releases 1, 2, 3, 4, 6 or 8 mg of the active substance rotigotine over 24 hours.
Danish: Hvert plaster afgiver 1, 2, 3, 4, 6 eller 8 mg af det aktive stof rotigotin over 24 timer.
English: The strength of patch to use at the start of treatment depends on the type and stage of the disease being treated.
Danish: Styrken af det plaster, der anvendes ved behandlingens start, afhænger af arten og stadiet af den sygdom, der behandles.
English: Leganto is used to treat the symptoms of the following diseases in adults:
Danish: Leganto anvendes til behandling af symptomerne på følgende sygdomme hos voksne:
English: Leganto is used when a specific cause for the disorder cannot be identified.
Danish: Leganto anvendes, når det ikke er muligt at fastslå en bestemt årsag til sygdommen.
English: The company that makes Neupro has agreed that its scientific data can be used for Leganto (‘informed consent').
Danish: Virksomheden, som fremstiller Neupro, har indvilget i, at dens videnskabelige oplysninger kan anvendes for Leganto ("informeret samtykke").
English: In patients with Parkinson's disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases.
Danish: Hos patienter med Parkinsons sygdom begynder de celler, der producerer dopamin, at dø, og mængden af dopamin i hjernen falder.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Leganto.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Leganto.
English: Leganto was more effective than placebo in treating Parkinson's disease.
Danish: Leganto var mere effektivt end placebo til behandling af Parkinsons sygdom.
English: Other information about Leganto
Danish: Andre oplysninger om Leganto
English: EPAR summary for the public rotigotine
Danish: EPAR - sammendrag for offentligheden rotigotin
English: For more information about treatment with Leganto, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Leganto, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: To avoid skin burns, Leganto must be removed if the patient has to have magnetic resonance imaging (MRI) or cardioversion (a process that restores the heart's normal rhythm).
Danish: For at undgå forbrænding af huden skal Leganto fjernes, hvis patienten skal have foretaget en magnetisk resonans billeddannelse (MRI-scanning) eller kardioversion (en proces, der genetablerer normal hjerterytme).
English: The main measure of effectiveness was the change in symptoms after six months of treatment with a stable dose, measured using two standard scales.
Danish: Virkningen blev hovedsagelig målt på ændringen af symptomerne efter seks måneders behandling med en stabil dosis målt ved hjælp af to standardskalaer.
English: Rotigotine then stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Danish: Rotigotin stimulerer derefter hjernen på samme måde som dopamin, så patienten kan styre sine bevægelser og får færre tegn og symptomer på Parkinsons sygdom såsom stive og langsomme bevægelser.
English: Leganto delivers a constant supply of rotigotine through the skin into the bloodstream.
Danish: Leganto giver en konstant tilførsel af rotigotin gennem huden til blodbanen.
English: The CHMP decided that Leganto's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Leganto opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The active substance in Leganto, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine.
Danish: Det aktive stof i Leganto, rotigotin, er en dopaminagonist, hvilket vil sige, at den efterligner virkningen af dopamin.
English: The backing layer of Leganto contains aluminium.
Danish: Det yderste lag af Leganto indeholder aluminium.
English: The maximum dose is 8 mg/24 h for early-stage Parkinson's disease and 16 mg/24 h for advanced disease.
Danish: Den maksimale dosis er 8 mg/24 t for Parkinsons sygdom i et tidligt stadium og 16 mg/24 t for fremskreden sygdom.
English: Dopamine is a messenger substance in the parts of the brain that control movement and co-ordination.
Danish: Dopamin virker som signalstof i de dele af hjernen, der styrer bevægelser og koordinering.
English: A special pack with patches of four different strengths is available to help when starting treatment for early-stage Parkinson's disease.
Danish: Der fås en særlig pakke med plastre i fire forskellige styrker som en hjælp til opstart af behandling af Parkinsons sygdom i et tidligt stadium.
English: Leganto was less effective than ropinirole: an improvement was seen in 70% of the patients receiving ropinirole.
Danish: Leganto var mindre effektivt end ropinirol: 70 % af de patienter, som fik ropinirol, oplevede en forbedring.
English: Leganto is a range of transdermal patches (patches that deliver a medicine across the skin).
Danish: Leganto er en serie af forskellige depotplastre (plastre, der afgiver et lægemiddel gennem huden).
English: The studies in advanced disease measured the length of time during the day that the patients recorded as ‘off' (when they had too many Parkinson's disease symptoms to be able to live normally).
Danish: I undersøgelserne af fremskreden sygdom målte man længden af den tid i løbet af dagen, som patienterne anførte som "slået fra" (hvor de havde for mange symptomer på Parkinsons sygdom til at kunne leve normalt).