FrancophonIA/ELRC3.0 huggingface dataset:
English: The company carried out ‘bioequivalence' studies to show that taking Stalevo produces the same levels of levodopa, carbidopa and entecapone in the blood as taking separate tablets containing entacapone and the combination of levodopa and carbidopa.
Danish: Virksomheden foretog ”bioækvivalens”-undersøgelser til påvisning af, at Stalevo giver samme koncentration i blodet af levodopa, carbidopa og entakapon, som når de aktive stoffer tages som separate tabletter indeholdende entakapon og tabletter indeholdende en kombination af levodopa og carbidopa.
English: The CHMP decided that Stalevo's benefits are greater than its risks for the treatment of patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase inhibitor treatment.
Danish: CHMP konkluderede, at fordelene ved Stalevo opvejer risiciene til behandling af patienter med Parkinsons sygdom ved motoriske end-of-dose fluktuationer, der ikke stabiliseres ved behandling med levodopa/dopa decarboxylasehæmmere.
English: What is Stalevo?
Danish: Hvad er Stalevo?
English: phaeochromocytoma (a tumour of the adrenal gland); a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Danish: alvorlig leversygdom, snævervinklet grøn stær (for højt væsketryk i øjet), fæokromocytom (en svulst i binyrerne), tidligere malignt neuroleptikasyndrom (en farlig nervesygdom, sædvanligvis forårsaget af antipsykotiske lægemidler) eller rhabdomyolyse (nedbrydning af muskelfibrene).
English: They should be used with caution in patients with mild to moderate problems with their liver or severe problems with their kidneys.
Danish: Hos patienter med let til moderat leversygdom eller alvorlig nyresygdom bør de anvendes med forsigtighed.
English: Both carbidopa and entacapone block some of the enzymes that are involved in the breakdown of levodopa in the body: carbidopa blocks the enzyme dopa decarboxylase, and entacapone blocks the enzyme catechol-O-methyl transferase (COMT).
Danish: Carbidopa hæmmer enzymet dopa decarboxylase, og entakapon hæmmer enzymet catechol-O-methyltransferase (COMT).
English: How has Stalevo been studied?
Danish: Hvordan blev Stalevo undersøgt?
English: What benefit has Stalevo shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Stalevo?
English: Stalevo must not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Danish: Stalevo må ikke anvendes samme med anden medicin af typen MAO-hæmmere (en type antidepressiver, der hæmmer enzymet monoaminoxidase).
English: What is Stalevo used for?
Danish: Hvad anvendes Stalevo til?
English: See the Summary of Product Characteristics (also part of the EPAR) for full instructions on how patients should be switched to Stalevo, and on how the dose is adjusted during treatment.
Danish: Fuldstændige anvisninger for, hvordan patienten skal skifte til Stalevo, og hvordan dosis skal justeres under behandlingen, fremgår af produktresuméet, der ligeledes er en del af EPAR.
English: How is Stalevo used?
Danish: Hvordan anvendes Stalevo?
English: How does Stalevo work?
Danish: Hvordan virker Stalevo?
English: See the summary of product characteristics (also part of the EPAR) for full details.
Danish: De nærmere oplysninger fremgår af produktresuméet, der også er en del af denne EPAR.
English: White horehound should only be used in adults and adolescents aged over 12 years.
Danish: Kransburre bør kun anvendes hos voksne og unge over 12 år.
English: • in patients with a temporary loss of appetite.
Danish: • til patienter med midlertidig appetitløshed
English: At the time of the HMPC assessment, no side effects had been reported with these medicines.
Danish: På tidspunktet for HMPC's vurdering var der ikke indberettet nogen bivirkninger med disse lægemidler.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Danish: Det betyder, at selv om der ikke foreligger tilstrækkelig dokumentation fra kliniske undersøgelser, kan det antages, at disse plantelægemidler har en virkning, og at der er dokumentation for, at de har været anvendt sikkert på denne måde i mindst 30 år (heraf mindst 15 år i EU).
English: In addition, there were published experimental studies suggesting a number of properties that could plausibly help in patients with mild dyspepsia.
Danish: Desuden viser publicerede eksperimentelle undersøgelser en række egenskaber, der formodes at kunne hjælpe patienter med let fordøjelsesbesvær.
English: What is white horehound?
Danish: Hvad er kransburre?
English: White horehound is the common name for the plant Marrubium vulgare L. The plant is cultivated or gathered to obtain the above-ground parts for medicinal use.
Danish: Kransburre er fællesnavnet for planten Marrubium vulgare L. Planten dyrkes eller indsamles for at høste de overjordiske dele til medicinsk anvendelse.
English: White horehound
Danish: Kransburre
English: • for treating mild dyspepsia symptoms, such as bloating and flatulence;
Danish: • til behandling af mildt fordøjelsesbesvær såsom oppustethed og tarmluft
English: • as an expectorant (a medicine to help bring up phlegm) in patients with cough associated with a cold;
Danish: • som slimløsnende middel (ekspektorans) til patienter med hoste i forbindelse med forkølelse
English: White horehound can also be found in combination with other herbal substances in some herbal medicines.
Danish: Kransburre findes desuden kombineret med andre droger i visse plantelægemidler.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing white horehound.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder kransburre.
English: Other information about white horehound medicines
Danish: Andre oplysninger om lægemidler, der indeholder kransburre
English: Any applications for the licensing of medicines containing white horehound have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder kransburre, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til til HMPC's videnskabelige konklusioner.
English: Information on the use and licensing of white horehound medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder kransburre, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: For detailed information on the data assessed by the HMPC, see the HMPC assessment report.
Danish: Nærmere oplysninger om de undersøgelser/informationer der indgår i HMPCs vurdering , findes i HMPC's vurderingsrapport.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of white horehound.
Danish: Dette er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner om den medicinske anvendelse af kransburre.
English: Detailed instruction on how to take white horehound medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger for, hvordan lægemidler med kransburre skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: Further information on the HMPC assessment of white horehound medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder kransburre, herunder detaljerede oplysninger om udvalgets konklusioner, findes under fanebladet “All documents” på det europæiske lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with white horehound medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder kransburre, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet “All documents” på det europæiske lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: How are white horehound medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder kransburre, i EU?
English: In its assessment the HMPC considered the well documented and longstanding use of white horehound in the approved indications.
Danish: I sin vurdering tog HMPC hensyn til den veldokumenterede og langvarige anvendelse af kransburre til disse formål.
English: EMA/HMPC/446032/2013
Danish: EMA/HMPC/446032/2013 Udvalget for Plantelægemidler (HMPC)
English: Herbal medicines containing white horehound are usually available in a comminuted form for herbal tea, or in solid or liquid forms to be taken by mouth.
Danish: Plantelægemidler indeholdende kransburre fås sædvanligvis i fast eller flydende form til indtagelse gennem munden eller i findelt form til fremstilling af urtethe.
English: This summary is not intended to provide practical advice on how to use medicines containing white horehound.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder kransburre anvendes.
English: The HMPC noted that the bitter substances and essential oils the medicine contains may stimulate appetite and secretions from the lining of the airways.
Danish: HMPC bemærkede, at kransburres indhold af bitterstoffer og æteriske olier kan stimulere appetitten og slimproduktionen i luftvejene.
English: What are the risks associated with white horehound medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder kransburre?
English: If symptoms of cough persist for longer than one week, patients should consult a qualified healthcare practitioner.
Danish: Ved hoste af længere varighed end én uge bør der søges lægehjælp.
English: For dyspepsia and loss of appetite, patients are advised to consult healthcare practitioner if symptoms last longer than two weeks.
Danish: Ved fordøjelsesbesvær og appetitløshed af længere varighed end to uger rådes patienterne til at søge lægehjælp.
English: What evidence supports the use of white horehound medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af kransburre?
English: White horehound EMA/HMPC/446032/2013
Danish: Kransburre EMA/385469/2015
English: The HMPC concluded that, on the basis of its long-standing use, white horehound can be used in the following ways:
Danish: På baggrund af den mangeårige anvendelse, har HMPC konkluderet, at kransburre kan anvendes:
English: For more information about treatment with white horehound medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder kransburre, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The HMPC conclusions on the use of white horehound medicines in patients with cough, dyspepsia symptoms and loss of appetite are based on their ‘traditional use'.
Danish: ”HMPC's konklusioner vedrørende brugen af lægemidler med kransburre er baseret på lægemidlernes ”traditionelle anvendelse” til hhv hoste, fordøjelsesbesvær eller appetitløshed.
English: For practical information about using white horehound medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med kransburre, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: White horehound preparations are obtained by comminuting (reducing into tiny pieces) or powdering the above-ground parts of the plant, by making a liquid extract or pressing the juice from the plant.
Danish: Der kan ligeledes fremstilles et flydende ekstrakt eller saften kan presses ud af planten.
English: The administration started within 2-20 hours prior to surgery.
Danish: Administrationen blev påbegyndt 2-20 timer før operationen.
English: This was supported since it is of interest in the states where both formulations are used.
Danish: Dette blev støttet, da det har interesse i lande, hvor begge formuleringer anvendes.
English: Furthermore, not all indications are approved in each country.
Danish: Desuden er ikke alle indikationer godkendt i alle lande.
English: The studies presented at renewals of marketing authorization in EU were also screened and reviewed.
Danish: Også de undersøgelser, der blev forelagt ved fornyelsen af markedsføringstilladelserne i EU, blev screenet og gennemgået.
English: Not all strengths and pharmaceutical forms are registered in each country.
Danish: Ikke alle styrker og lægemiddelformer er registreret i alle lande.
English: This section contains general parts as well as separate sub-sections for each indication.
Danish: Dette punkt indeholder generelle afsnit samt separate underafsnit for hver indikation.
English: At the time of submission, patients of 17 years of age maximum qualified as “children”.
Danish: På indsendelsestidspunktet blev patienter på højst 17 år rubriceret som “børn”.
English: The promising benefit was offset by the renal dysfunction and hypertension.
Danish: De lovende fordele blev opvejet af renal dysfunktion og hypertension.
English: A number of areas of disharmony in the Product Information have been considered as follows:
Danish: En række uoverensstemmelser mellem produktinformationerne er blevet afklaret som følger:
English: Overall summary of the scientific evaluation of Sandimmun Neoral and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Sandimmun Neoral og relaterede navne (se bilag I)
English: Switching between oral ciclosporin formulations
Danish: Skift mellem de orale formuleringer af ciclosporin
English: 15 EU countries already have exactly the proposed label and in those which do not, the deviations are not considered large.
Danish: 15 EU-lande har i forvejen nøjagtigt den foreslåede produktinformation, og hvor dette ikke er tilfældet, anses afvigelserne ikke for at være store.
English: Pediatric data from controlled and uncontrolled studies were also provided.
Danish: Der blev desuden forelagt pædiatriske data fra kontrollerede og ukontrollerede undersøgelser.
English: • Clinical aspects
Danish: • Kliniske aspekter
English: Section 4.5 - Interaction with Other Medicinal Products and Other Forms of Interaction
Danish: Punkt 4.5 - Interaktion med andre lægemidler og andre former for interaktion
English: Subsequent, studies using lower doses showed a better risk-benefit ratio.
Danish: Efterfølgende undersøgelser med lavere doser viste et mere gunstigt risk/benefit-forhold.
English: Recommendation
Danish: Anbefaling
English: The CHMP noted that the majority of patients benefited from ciclosporin treatment in all reports.
Danish: CHMP bemærkede, at størstedelen af patienterne havde fordel af behandlingen med ciclosporin i alle rapporterne.
English: Although the proposed text was already approved in the majority of EU countries, the CHMP is of the opinion that some structural modification of the text was needed.
Danish: Skønt den foreslåede tekst i forvejen var godkendt i størstedelen af EU-landene, fandt CHMP behov for nogen ændring af tekstens struktur.
English: Sections 4.3 to 4.9 - from “Contraindications” to “Overdose”
Danish: Punkt 4.3 til 4.9 - fra “Kontraindikationer” til “Overdosering”
English: The CHMP endorses this proposal
Danish: CHMP tilslutter sig dette forslag
English: This type of information is in line with SmPCs of several Member States.
Danish: Denne type angivelse er i overensstemmelse med produktresuméerne i flere medlemsstater.
English: Switching from Sandimmun to Sandimmun Neoral
Danish: Skift fra Sandimmun til Sandimmun Neoral
English: Renal dysfunction above the critical threshold, defined as creatinine increased by 3050% over baseline, was less of a problem when starting with a dose of 2.5 mg/kg/day.
Danish: Renal dysfunktion over den kritiske tærskel, defineret som en stigning i kreatinin til 30-50 % over baseline, var et mindre problem, når behandlingen begyndte med en dosis på 2,5 mg/kg/dag.
English: The control groups were either using placebo, or azathioprine, or D-penicillamine.
Danish: Til kontrolgrupperne anvendtes enten placebo, azathioprin eller D-penicillamin.
English: Moreover, recent trials have confirmed the benefit of Sandimmun Neoral in different forms of nephrotic syndrome in children and adults.
Danish: Desuden har nylige undersøgelser bekræftet fordelene ved Sandimmun Neoral til forskellige former af nefrotisk syndrom hos børn og voksne.
English: The review of the original Sandimmun Dossiers from major markets such as France, the U.S. and UK which contains the clinical results from a total of 15 global studies has been performed.
Danish: Der er foretaget en gennemgang af de oprindelige dossierer for Sandimmun fra større markeder såsom Frankrig, USA og Det Forenede Kongerige med de kliniske resultater af i alt 15 globale undersøgelser.
English: Section 4.7 - Effects on Ability to Drive and Use Machines
Danish: Punkt 4.7 - Virkning på evnen til at føre motorkøretøj og betjene maskiner
English: Lastly the CHMP was of the view that further additions to the lists of interactants would be of value, based on an updated survey.
Danish: Endvidere var CHMP af den opfattelse, at det ville være værdifuldt at supplere listerne over interaktioner på grundlag af en opdateret undersøgelse.
English: The CHMP agreed that general information applicable to all these indications was relevant to include.
Danish: CHMP var enig i, at det var relevant at medtage generelle oplysninger for alle disse indikationer.
English: The MAH proposed two different wordings for each of the paragraphs on transplantation:
Danish: Indehaveren af markedsføringstilladelsen foreslog to forskellige versioner af ordlyden til hvert afsnit om transplantation:
English: In addition, Sandimmun Neoral produces a more uniform exposure to ciclosporin throughout the day and from day to day on a maintenance regimen.
Danish: Desuden medfører Sandimmun Neoral en mere ensartet eksponering for ciclosporin i løbet af døgnet og fra dag til dag på et vedligeholdelsesregime.
English: These paragraphs were not included in the CSP.
Danish: Disse afsnit indgik ikke i de centrale sikkerhedsoplysninger.
English: This approach was acceptable to the CHMP and final wordings in sections 4.2 and 4.4.were agreed accordingly.
Danish: Dette blev godkendt af CHMP, og den endelige ordlyd til punkt 4.2 og 4.4 blev fastsat i overensstemmelse hermed.
English: The indication aplastic anemia is only approved in France.
Danish: Indikationen aplastisk anæmi er kun godkendt i Frankrig.
English: In the European Union (EU), Sandimmum and Sandimmun Neoral are registered via national procedures.
Danish: I EU er Sandimmun og Sandimmun Neoral registreret via nationale procedurer.
English: The CHMP is of the view that the indication should be limited to primary glomerulonephritis cases as specified above.
Danish: CHMP er af den opfattelse, at indikationen bør begrænses til tilfælde af primær glomerulonefritis som angivet ovenfor.
English: In the following, the entire section 4.2 is reviewed, sub-section by sub-section.
Danish: I det følgende gennemgås de enkelte underafsnit i hele punkt 4.2.
English: In parallel of these 9 performed studies, 2 double-blind placebo controlled multicenter studies and 1 multicenter study comparing ciclosporin with cyclophosphamide in steroidresistant patients had to be stopped prematurely because of a lack of suitable patients consenting to receive placebo or a cytostatic agent.
Danish: Ud over disse 9 gennemførte undersøgelser er 2 dobbeltblindede, placebokontrollerede multicenterundersøgelser og 1 multicenterundersøgelse, der sammenlignede ciclosporin med cyclophosphamid hos steroidresistente patienter, ophørt før tid på grund af mangel på egnede patienter, der samtykkede i at få placebo eller et cytostatisk middel.
English: Seven trials were conducted for the prevention of graft-versus host disease (GVHD), one trial for the treatment of acute GVHD.
Danish: Syv undersøgelser vedrørte forebyggelse af graft-versus host disease (GVHD), og én undersøgelse vedrørte behandling af akut GVHD.
English: The CHMP is of the opinion that the available data confirms the use of ciclosporin in the following indication: “Treatment of severe, active rheumatoid arthritis.”
Danish: CHMP er af den opfattelse, at de foreliggende data underbygger anvendelsen af ciclosporin til følgende indikation: “Behandling af svær, aktiv reumatoid arthritis.”
English: General monitoring of posology.
Danish: Generel monitorering af doseringen.
English: The MAH agreed with the CHMP that no specific organ transplantations should be mentioned in section 4.1 unless not appropriate to use.
Danish: Indehaveren af markedsføringstilladelsen aftalte med CHMP, at specifikke organtransplantationer ikke nævnes i punkt 4.1, medmindre anvendelsen er uegnet.
English: However the CHMP had concerns over the fact that current indication was too broad as use in secondary glomerulonephritis is controversial.
Danish: CHMP havde dog betænkeligheder ved, at den nuværende indikation var for bred, da anvendelsen ved sekundær glomerulonefritis er kontroversiel.
English: In the original Sandimmun studies, initial doses in the range 14-18 mg/kg/day have been used and these were subsequently reduced to a maintenance dose in the range 6-10 mg/kg/day.
Danish: I de oprindelige undersøgelser med Sandimmun var initialdosis i området 14-18 mg/kg/dag, der efterfølgende blev reduceret til en vedligeholdelsesdosis i området 6-10 mg/kg/dag.
English: The CHMP also raised questions regarding the risk of aggravation of the neurological manifestations of Behcet's disease by Ciclosporin.
Danish: CHMP rejste desuden spørgsmål om risikoen for, at ciclosporin kan forværre de neurologiske manifestationer af Behçets sygdom.
English: Finally in this section, the MAH proposed two additions to this section, under the format of two new sub-sections on Acute and chronic nephrotoxicity and Paediatric population.
Danish: Endelig foreslog indehaveren af markedsføringstilladelsen to tilføjelser til dette afsnit i form af to nye underafsnit om Akut og kronisk nefrotoksicitet og Pædiatrisk population.
English: The rationale given by the MAH for the proposed indication was based on the following data: the initial pilot study in active rheumatoid arthritis used a dose of 10 mg/kg/day, half the dose used in solid organ transplantation at that time.
Danish: Markedsføringstilladelsesindehaverens rationale for den foreslåede indikation byggede på følgende data: Ved den indledende pilotundersøgelse ved aktiv reumatoid arthritis anvendtes en dosering på 10 mg/kg/dag, dvs. det halve af den dosis, der på daværende tidspunkt blev anvendt ved organtransplantation.