FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on the HMPC assessment of ginkgo leaf 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 ginkgoblad, 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: Detailed instructions on how to take ginkgo leaf medicines and who can use them can be found in the package leaflets that come with the medicines.
Danish: Detaljerede anvisninger for, hvordan lægemidler med ginkgoblad skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: Information on the use and licensing of ginkgo leaf medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder agermåneurt, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: Further information on the risks associated with ginkgo leaf 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 ginkgoblad, 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: The most relevant clinical trials performed in adults aged 50 years and above indicated that ginkgo leaf medicines containing the dry extract could have beneficial effects on cognitive function in mild dementia.
Danish: De mest relevante kliniske forsøgblev udført med voksne personer på 50 år og derover.Forsøgene pegede på, at lægemidler med ekstrakt af ginkgoblad,muligvis kan have en gunstig indvirkning på den kognitive funktion ved mild demens.
English: Medicines containing the powdered leaf should only be used after serious conditions have been excluded by a doctor.
Danish: Lægemidler, der indeholder det pulveriserede blad, bør kun anvendes, hvis læge har udelukket anden alvorligere sygdom.
English: How does ginkgo leaf work as a medicine?
Danish: Hvordan virker ginkgoblad som lægemiddel?
English: Other information about ginkgo leaf medicines
Danish: Andre oplysninger om lægemidler, der indeholder ginkgoblad
English: What is ginkgo leaf?
Danish: Hvad er ginkgoblad?
English: This summary is not intended to provide practical advice on how to use medicines containing ginkgo leaf.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder ginkgoblad, anvendes.
English: If symptoms of dementia do not improve after 3 months or if symptoms worsen during the treatment, a doctor should be consulted.
Danish: Spørg lægen til råds, hvis symptomerne på demens ikke bedres efter 3 måneder, eller hvis symptomerne bliver værre under behandlingen.
English: The HMPC also concluded that, on the basis of their long-standing use, ginkgo leaf medicines containing the powdered leaf can be used for the relief of heaviness in the legs and the sensation of cold hands and feet that may occur with minor circulation problems.
Danish: På baggrund af traditionel anvendelse har HMPC endvidere konkluderet, at lægemidler med pulveriseret ginkgoblad kan anvendes til lindring af tyngdefølelse i benene samt følelse af kolde hænder og fødder som følge af lette kredsløbsproblemer.
English: The HMPC concluded that ginkgo leaf medicines containing the dry extract can be used to improve the age-related cognitive impairment (worsening of mental abilities) and quality of life of adults with mild dementia.
Danish: HMPC har konkluderet, at det tørre ekstrakt af ginkgoblad kan anvendes til bedring af aldersrelateret kognitiv svækkelse (svigtende mentale evner) og bedre livskvaliteten for voksne med mild demens.
English: The HMPC conclusions on the use of ginkgo leaf medicines for minor circulation problems are based on their ‘traditional use'.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med pulveriseret ginkgoblad til lettere kredsløbsproblemer er baseret på lægemidlernes "traditionelle anvendelse".
English: How are ginkgo leaf medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder ginkgoblad, i EU?
English: What evidence supports the use of ginkgo leaf medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af ginkgoblad?
English: What are the risks associated with ginkgo leaf medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder ginkgoblad?
English: Ginkgo leaf medicines containing these preparations are usually available in liquid and solid forms to be taken by mouth.
Danish: Plantelægemidler med ginkgoblad fås normalt i flydende eller fast form til indtagelse gennem munden.
English: In patients who have a tendency to bleed or who use blood thinning medicines, ginkgo leaf medicines containing the dry extract should only be used after consulting a doctor.
Danish: Patienter med blødningstendens eller i blodfortyndende behandling bør kun anvende lægemidler med ekstrakt af ginkgoblad efter aftale med læge
English: The HMPC conclusions on the use of ginkgo leaf medicines to improve the age-related cognitive impairment and quality of life of adults with mild dementia are based on their ‘well-established use' in this indication.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med ekstrakt af ginkgoblad til bedring af aldersrelateret kognitiv svækkelse og livskvalitet hos voksne med mild demens er baseret den "almindeligt anerkendte anvendelse" til disse formål.
English: At the time of the HMPC assessment, the most common side effect with ginkgo leaf medicines used for the treatment of mild dementia was headache (seen in more than 1 patient in 10).
Danish: Ved behandling af mild demens med ekstrakt af ginkgoblad, er den mest almindelige bivirkning hovedpine (set hos mere end 1 ud af 10).
English: For more information about treatment with ginkgo leaf 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 ginkgoblad, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: For further information, see the HMPC assessment report.
Danish: Nærmere oplysninger om de undersøgelser/informationer der indgår i HMPCs vurdering, findes i HMPC's vurderingsrapport.
English: For practical information about using ginkgo leaf 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 ginkgoblad, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: When used for minor circulation problems, gastrointestinal disorders (side effects affecting the gut), headaches and allergic reactions have been reported.
Danish: Ved behandling af lette kredsløbsproblemer med pulveriseret ginkgoblad, er der blevet rapporteret omgener i mave-tarm-kanalen , hovedpine og allergiske reaktioner.
English: Although clinical studies with ginkgo leaf medicines for minor circulation problems are available, they were too limited to be used as evidence and the HMPC conclusions for this indication are based on the medicines' long-standing use.
Danish: Selv om der findes kliniske undersøgelser af lægemidler med ginkgoblad til behandling af lette kredsløbsproblemer, er disse for begrænsede til at kunne bruges som dokumentation.
English: Ginkgo leaf is the common name for the leaf of the plant Ginkgo biloba L. This summary covers ginkgo leaf medicines containing a specific herbal preparation made by powdering the dried leaf or as dry extract.
Danish: Ginkgoblad er det danske navn for bladet fra planten Ginkgo biloba L.
English: The response to treatment should be assessed two months after starting treatment.
Danish: Behandlingsresponsen bør tages op til vurdering to måneder efter behandlingsstart.
English: This medicine is the same as Ariclaim, which is already authorised in the European Union (EU).
Danish: Dette lægemiddel er identisk med Ariclaim, som allerede har markedsføringstilladelse i EU.
English: It is available as gastroresistant capsules (blue: 20 mg; white and blue: 30 mg; orange: 40 mg; green and blue: 60 mg).
Danish: Det leveres som gastroresistente kapsler (blå: 20 mg, hvide og blå: 30 mg, orange: 40 mg, grønne og blå: 60 mg).
English: Treatment must not be started in patients with uncontrolled high blood pressure, because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Danish: Der må ikke indledes behandling af patienter med ukontrolleret højt blodtryk på grund af risikoen for hypertensive kriser (pludselig farlig blodtryksforhøjelse).
English: Most of these were mild or moderate, starting early in treatment and getting milder as treatment continued.
Danish: De fleste af disse bivirkninger var milde til moderate og startede tidligt i behandlingen, men blev mildere, efterhånden som behandlingen fortsatte.
English: • moderate to severe stress urinary incontinence (SUI) in women.
Danish: • moderat til svær stressinkontinens (SUI) hos kvinder.
English: The benefit of treatment should be re-assessed at regular intervals.
Danish: Fordelen ved behandlingen bør tages op til vurdering med regelmæssige mellemrum.
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Danish: • smerter som følge af diabetisk perifer neuropati (beskadigelse af nerverne i ekstremiteterne, som kan forekomme hos patienter med diabetes).
English: Since these neurotransmitters are also involved in reducing the sensation of pain, blocking their re-uptake into nerve cells may also improve the symptoms of neuropathic pain.
Danish: Da disse neurotransmittere også medvirker til at nedsætte smertefornemmelsen, kan blokeringen af genoptagelsen af disse i nervecellerne også forbedre de neuropatiske smertesymptomer.
English: It should not be used in patients who have certain problems with their liver or severe kidney problems.
Danish: Det bør ikke anvendes til patienter, der lider af visse leversygdomme eller har svære nyreproblemer.
English: Some patients may benefit from starting treatment at a dose of 20 mg twice a day for two weeks before increasing to 40 mg twice a day, to reduce nausea (feeling sick) and dizziness.
Danish: For nogle patienter kan det være en fordel at begynde behandlingen med 20 mg to gange dagligt i to uger, før dosis sættes op til 40 mg to gange dagligt, da de derved får mindre kvalme og svimmelhed.
English: SUI is accidental leaks of urine during physical exertion or when coughing, laughing, sneezing, lifting or exercising;
Danish: SUI er utilsigtet tab af urin ved fysisk belastning eller i forbindelse med hoste, latter, nysen, løft eller gymnastik
English: The main measures of effectiveness were incontinence episode frequency (IEF, the number of episodes of incontinence per week) recorded in patient diaries and the patients' scores on an incontinence-specific quality-of-life (I-QOL) questionnaire.
Danish: De vigtigste mål for virkningen var dels hyppigheden af inkontinensepisoder (IEF, dvs. det ugentlige antal inkontinensepisoder) angivet i dagskemaer, dels patientens opnåede scoreværdi i et spørgeskema om inkontinensrelateret livskvalitet (I-QOL).
English: For diabetic neuropathic pain, the recommended dose is 60 mg once a day, but some patients may need a higher dose of 120 mg per day.
Danish: Den anbefalede dosis til behandling af diabetiske neuropatiske smerter er 60 mg en gang dagligt, men nogle patienter kan have behov for en højere dosis på 120 mg dagligt.
English: The European Commission granted a marketing authorisation valid throughout the EU for Duloxetine Boehringer Ingelheim to Boehringer Ingelheim International GmbH on 8 October 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Duloxetine Boehringer Ingelheim til Boehringer Ingelheim International GmbH den 8. oktober 2008.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Duloxetine Boehringer Ingelheim's benefits are greater than its risks for the treatment of moderate to severe SUI and of diabetic peripheral neuropathic pain in adults.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Duloxetine Boehringer Ingelheim er større end risiciene ved behandling af moderat til svær SUI og diabetiske perifere neuropatiske smerter hos voksne.
English: By closing the urethra more powerfully, Duloxetine Boehringer Ingelheim prevents the unwanted loss of urine during physical stress such as coughing or laughing.
Danish: Ved at styrke lukningen af urinrøret forhindrer Duloxetine Boehringer Ingelheim uønsket tab af urin under fysisk belastning såsom hoste eller latter.
English: In both studies, pain reduction was seen from the first week of treatment for up to 12 weeks, with patients taking Duloxetine Boehringer Ingelheim having pain scores between 1.17 and 1.45 points lower than those taking placebo.
Danish: I begge undersøgelserne kunne der iagttages en smertelindring fra den første uge af behandlingen i op til 12 uger hos patienter, som fik Duloxetine Boehringer Ingelheim, og som havde smertescorer på mellem 1,17 og 1,45 point lavere end dem, der fik placebo.
English: The most common side effects when used to treat diabetic neuropathic pain (seen in more than 1 patient 10) are headache, somnolence (sleepiness), dizziness, nausea and dry mouth.
Danish: De hyppigste bivirkninger, når det blev anvendt til behandling af diabetiske neuropatiske smerter, (som ses hos flere end 1 ud af 10 patienter) er hovedpine, søvntrang, svimmelhed, kvalme og mundtørhed.
English: Duloxetine Boehringer Ingelheim was more effective than placebo only in patients who had more than 14 incontinence episodes per week (moderate to severe SUI) at the start of the study.
Danish: Duloxetine Boehringer Ingelheim var kun mere effektivt end placebo hos patienter, som havde over 14 inkontinensepisoder om ugen (moderat til svær SUI) ved undersøgelsens start.
English: Duloxetine Boehringer Ingelheim must not be used together with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Danish: Duloxetine Boehringer Ingelheim må ikke anvendes sammen med monoaminoxidasehæmmere (en gruppe af antidepressiva), fluvoxamin (et andet antidepressivum) eller ciprofloxacin eller enoxacin (former for antibiotika).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) DULOXETINE BOEHRINGER INGELHEIM EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) DULOXETINE BOEHRINGER INGELHEIM EPAR - sammendrag for offentligheden
English: The company that makes Ariclaim has agreed that its scientific data can be used for Duloxetine Boehringer Ingelheim.
Danish: Den virksomhed, som fremstiller Ariclaim, har givet tilladelse til, at dens videnskabelige data må anvendes til Duloxetine Boehringer Ingelheim.
English: Duloxetine Boehringer Ingelheim is a medicine that contains the active substance duloxetine.
Danish: Duloxetine Boehringer Ingelheim er et lægemiddel, som indeholder det aktive stof duloxetin.
English: Duloxetine Boehringer Ingelheim can be taken with or without food.
Danish: Duloxetine Boehringer Ingelheim kan indtages med eller uden et måltid.
English: For the treatment of diabetic neuropathic pain, Duloxetine Boehringer Ingelheim at doses of 60 mg once or twice a day was more effective at reducing pain than placebo.
Danish: Til behandling af diabetiske neuropatiske smerter var Duloxetine Boehringer Ingelheim ved doser på 60 mg en eller to gange dagligt mere effektivt til at reducere smerter end placebo.
English: The active substance in Duloxetine Boehringer Ingelheim, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Danish: Det aktive stof i Duloxetine Boehringer Ingelheim, duloxetin, er en serotonin-noradrenalin genoptagelseshæmmer.
English: Duloxetine Boehringer Ingelheim should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Danish: Duloxetine Boehringer Ingelheim bør ikke anvendes hos personer, der kan være overfølsomme (allergiske) over for duloxetin eller nogen af indholdsstofferne.
English: The effectiveness of three different doses of Duloxetine Boehringer Ingelheim was compared with that of placebo.
Danish: Virkningen af tre forskellige doser Duloxetine Boehringer Ingelheim blev sammenlignet med virkningen af placebo.
English: For the treatment of diabetic neuropathic pain, Duloxetine Boehringer Ingelheim has been studied in two 12-week studies in 809 diabetic adults who had had pain every day for at least six months.
Danish: Duloxetine Boehringer Ingelheim blev til behandling af diabetiske neuropatiske smerter undersøgt i to 12-ugers undersøgelser af 809 voksne med diabetes, som havde haft smerter hver dag i de sidste seks måneder.
English: The IEF decreased by 52% in the Duloxetine Boehringer Ingelheim group, compared with a decrease of 33% in the placebo-treated group.
Danish: Hyppigheden af inkontinensepisoderne faldt med 52 % i Duloxetine Boehringer Ingelheim-gruppen, sammenholdt med et fald på 33 % i placebogruppen.
English: Duloxetine Boehringer Ingelheim should be used with caution in elderly patients.
Danish: Duloxetine Boehringer Ingelheim skal anvendes med forsigtighed til ældre patienter.
English: The most common side effects with Duloxetine Boehringer Ingelheim when used to treat SUI (seen in more than 1 patient in 10) are nausea, dry mouth, constipation and fatigue (tiredness).
Danish: De hyppigste bivirkninger ved Duloxetine Boehringer Ingelheim, når det blev anvendt som behandling mod SUI, (som ses hos flere end 1 ud af 10 patienter) var kvalme, mundtørhed, forstoppelse og træthed.
English: In all four studies of SUI, the patients treated with Duloxetine Boehringer Ingelheim had fewer episodes of incontinence after 12 weeks, with about four or five fewer episodes of incontinence per week, in comparison with the number before the study.
Danish: I alle fire undersøgelser af SUI havde patienterne efter 12 ugers behandling med Duloxetine Boehringer Ingelheim færre inkontinensepisoder (ca. 4-5 færre ugentlige inkontinensepisoder end før undersøgelsen).
English: For the treatment of SUI, Duloxetine Boehringer Ingelheim has been studied in a total of 2,850 women.
Danish: Duloxetine Boehringer Ingelheim blev til behandling af SUI undersøgt hos i alt 2.850 kvinder.
English: Duloxetine Boehringer Ingelheim must not be used in patients with certain types of liver disease or with severe kidney disease.
Danish: Duloxetine Boehringer Ingelheim må ikke anvendes til patienter med visse former for leversygdomme eller patienter med svære nyresygdomme.
English: The Committee recommended that Duloxetine Boehringer Ingelheim be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Duloxetine Boehringer Ingelheim.
English: The full EPAR for Duloxetine Boehringer Ingelheim is available here.
Danish: Den fuldstændige EPAR for Duloxetine Boehringer Ingelheim findes her.
English: For SUI, the recommended dose of Duloxetine Boehringer Ingelheim is 40 mg twice a day.
Danish: Den anbefalede dosis af Duloxetine Boehringer Ingelheim til behandling af SUI er 40 mg to gange dagligt.
English: How duloxetine works in SUI is not clear but it is thought that by increasing the levels of 5-hydroxytryptamine and noradrenaline at the level of the nerves that control the muscle of the urethra (the tube that leads from the bladder to outside), duloxetine causes a stronger closure of the urethra during urine storage.
Danish: Det vides endnu ikke med sikkerhed, hvordan duloxetin virker på stressinkontinens, men stoffet menes at øge koncentrationen af 5-hydroxytrypamin og noradrenalin omkring de nerver, der kontrollerer urinrørets muskel.
English: The I-QOL questionnaire scores were also improved in the Duloxetine Boehringer Ingelheim group compared with the placebo group.
Danish: Også den opnåede score i IQOL-spørgeskemaerne var bedre i Duloxetine Boehringer Ingelheim-gruppen end i placebogruppen.
English: Other information about Duloxetine Boehringer Ingelheim:
Danish: Andre oplysninger om Duloxetine Boehringer Ingelheim:
English: Duloxetine Boehringer Ingelheim is used to treat:
Danish: Duloxetine Boehringer Ingelheim anvendes til behandling af:
English: What is the risk associated with Duloxetine Boehringer Ingelheim?
Danish: Hvilken risiko er der forbundet med Duloxetine Boehringer Ingelheim?
English: Why has Duloxetine Boehringer Ingelheim been approved?
Danish: Hvorfor blev Duloxetine Boehringer Ingelheim godkendt?
English: For the full list of all side effects reported with Duloxetine Boehringer Ingelheim, see the Package Leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Duloxetine Boehringer Ingelheim fremgår af indlægssedlen.
English: The four main studies involved 1,913 women and lasted 12 weeks, comparing Duloxetine Boehringer Ingelheim (mostly as 40 mg twice a day) with placebo (a dummy treatment).
Danish: Her blev Duloxetine Boehringer Ingelheim (hovedsagelig i en dosis på 40 mg to gange dagligt) sammenlignet med placebo (uvirksom behandling).
English: What is Duloxetine Boehringer Ingelheim?
Danish: Hvad er Duloxetine Boehringer Ingelheim?
English: How has Duloxetine Boehringer Ingelheim been studied?
Danish: Hvordan blev Duloxetine Boehringer Ingelheim undersøgt?
English: Combining Duloxetine Boehringer Ingelheim with pelvic floor muscle training may provide additional benefit.
Danish: Ekstra fordel af behandlingen med Duloxetine Boehringer Ingelheim kan fås ved at kombinere den med bækkenbundstræning.
English: What is Duloxetine Boehringer Ingelheim used for?
Danish: Hvad anvendes Duloxetine Boehringer Ingelheim til?
English: How is Duloxetine Boehringer Ingelheim used?
Danish: Hvordan anvendes Duloxetine Boehringer Ingelheim?
English: How does Duloxetine Boehringer Ingelheim work?
Danish: Hvordan virker Duloxetine Boehringer Ingelheim?
English: What benefit has Duloxetine Boehringer Ingelheim shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Duloxetine Boehringer Ingelheim?
English: Saw palmetto fruit should only be used in male adults and the elderly.
Danish: Savpalmefrugt bør kun anvendes til voksne og ældre mænd.
English: Detailed
Danish: Savpalmefrugt
English: If symptoms persist during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
Danish: Hvis symptomerne varer ved under brugen af lægemidlet, bør der søges råd hos en læge eller en kvalificeret sundhedsperson.
English: Saw palmetto fruit is the common name for the fruit of the plant Serenoa repens (W. Bartram) Small.
Danish: Savpalmefrugt er fællesnavnet for frugten af planten Serenoa repens (W. Bartram) Small.
English: Although a possible effect in relief of lower urinary tract symptoms related to BHP was observed, there were shortcomings in the studies such as too few patients and too short a treatment period.
Danish: Selvom der er observeret en mulig effekt i form af lindring af symptomerne i de nedre urinveje i forbindelse med BHP, var undersøgelserne utilstrækkelige på grund af for få patienter og for kort behandlingsperiode.