FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Equilis Prequenza?
Danish: Hvad er Equilis Prequenza?
English: What benefit has Equilis Prequenza shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Equilis Prequenza?
English: What is Equilis Prequenza used for?
Danish: Hvad anvendes Equilis Prequenza til?
English: How does Equilis Prequenza work?
Danish: Hvordan virker Equilis Prequenza?
English: 1 Dry extract (DER 3-7.4:1), extraction solvent: ethanol 40-70% (V/V).
Danish: 1 Tørret ekstrakt (ekstraktionsratio 3-7,4:1), ekstraktionsmiddel: ethanol 40-70 % (v/v).
English: Although a possible effect in these conditions was observed, several shortcomings were identified.
Danish: Selvom en mulig virkning ved disse tilstande blev observeret, er disse undersøgelser ikke tilstrækkelige.
English: This means that, although there is insufficient evidence from clinical studies, 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 selvom 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 (herunder mindst 15 år i EU).
English: Patients with open wounds, skin problems, high fever, severe infections and severe heart and circulation problems should not have baths with valerian root medicines.
Danish: Patienter med åbne sår, hudproblemer, høj feber, alvorlige infektioner og alvorlige hjerte-karproblemer skal undgå bade med baldrianrod.
English: Valerian root is the common name for the underground parts of the plant Valeriana officinalis L.
Danish: Baldrianrod er fællesnavnet for de underjordiske dele af planten Valeriana officinalis L.
English: Valerian root medicines should be used only in adults and adolescents over the age 12 years.
Danish: Lægemidler med baldrianrod bør kun anvendes til voksne og unge over 12 år.
English: Valerian root
Danish: Baldrianrod
English: DER or drug extract ratio is the ratio between the amount of herbal substance used and the quantity of extract obtained.
Danish: Ekstraktionsratioen er forholdet mellem mængden af anvendt plantestof og mængden af opnået ekstrakt.
English: Results showed improvements in the time it takes to fall asleep and sleep quality.
Danish: Resultaterne viste kortere indsovningstid og bedre søvnkvalitet.
English: Any applications for the licensing of medicines containing valerian root 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 baldrianrod, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: How does valerian root work as a medicine?
Danish: Hvordan virker baldrianrod som lægemiddel?
English: The way valerian root medicines work is not fully known, but from some experiments it is thought that effects on the brain leading to relaxation and sleepiness might play a role.
Danish: Virkningsmekanismen for baldrianrod kendes ikke fuldstændigt, men på baggrund af laboratorieundersøgelser menes, at en effekt på hjernen hvorved der opnås en afslappet og søvnig tilstand, kan spille en rolle.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing valerian root.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder baldrianrod.
English: Valerian root preparations may also be found in combination with other herbal substances in some herbal medicines.
Danish: Tilberedninger af baldrianrod findes desuden kombineret med andre droger i visse plantelægemidler.
English: The other herbal preparations of valerian root are available in solid or liquid form to be taken by mouth.
Danish: De andre tilberedninger af baldrianrod fås i fast eller flydende form til anvendelse gennem munden.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of valerian root.
Danish: Dette dokument er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af baldrianrod.
English: Further information on the HMPC assessment of valerian root 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 baldrianrod, 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 valerian root 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 baldrianrod, herunder passende forholdsregler, der 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: Information on the use and licensing of valerian root medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder baldrianrod, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: Detailed instructions on how to take valerian root medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger på, hvordan lægemidler med baldrianrod bør anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: What is valerian root?
Danish: Hvad er baldrianrod?
English: These include nausea and abdominal cramps.
Danish: Disse bivirkninger omfatter kvalme og mavekramper.
English: The HMPC conclusions only cover valerian root preparations which are obtained by drying and comminuting (reducing into tiny pieces) or powdering the underground parts of the plant, by expressing the juice of the fresh root, and as dry or liquid extracts.
Danish: HMPC's konklusioner omfatter kun tilberedninger af baldrianrod, som fremstilles ved tørring og findeling eller pulverisering af de underjordiske dele af planten, ved presning af saften af den friske rod, eller som tørrede eller flydende ekstrakter.
English: Other information about valerian root medicines
Danish: Andre oplysninger om lægemidler, der indeholder baldrianrod
English: When used for the relief of mild nervous tension and sleep disorders, if symptoms persist or worsen after 2 weeks of continued use with the medicine, a doctor should be consulted.
Danish: Hvis symptomerne varer ved eller forværres efter 2 ugers kontinuerlig anvendelse af lægemidlet til lindring af mild nervøsitet og søvnbesvær, bør der søges råd hos en læge.
English: Therefore, the HMPC conclusions on these uses of valerian root medicines are based on their long-standing use.
Danish: HMPC's konklusioner vedrørende anvendelsen af lægemidler med baldrianrod er derfor baseret på den mangeårige traditionelle anvendelse.
English: Herbal medicines containing comminuted valerian root are usually available as herbal tea to be drunk or as bath additives.
Danish: Plantelægemidler med findelt baldrianrod fås normalt som urtete beregnet til at drikke eller som badeadditiv.
English: How are valerian root medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder baldrianrod, i EU?
English: This summary is not intended to provide practical advice on how to use medicines containing valerian root.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder baldrianrod, skal anvendes.
English: What evidence supports the use of valerian root medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af baldrianrod?
English: What are the risks associated with valerian root medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder baldrianrod?
English: For more information about treatment with valerian root 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 baldrianrod, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The HMPC conclusions on the use of other valerian medicines for relief of mild symptoms of mental stress and to aid sleep are based on their ‘traditional use'.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med baldrianrod til at lindre lettere symptomer på mental stress og gøre det lettere at falde i søvn er baseret på lægemidlernes "traditionelle anvendelse".
English: For practical information about using valerian root 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 baldrianrod, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: In its assessment, the HMPC also considered clinical studies involving patients with mild symptoms of mental stress and insomnia (difficulty sleeping).
Danish: HMPC har desuden vurderet kliniske undersøgelser af patienter med milde symptomer på stress og søvnforstyrrelser.
English: The HMPC also concluded that, on the basis of its long-standing use, the other valerian root preparations described above can be used for relief of mild symptoms of mental stress and to aid sleep.
Danish: På baggrund af den mangeårige anvendelse har HMPC også konkluderet, at baldrianrod i de andre tilberedninger, der er omtalt ovenfor, kan anvendes til at lindre lettere symptomer på mental stress og gøre det lettere at falde i søvn.
English: The HMPC considered that clinical studies with dry ethanol extracts support its use for relief of mild nervous tension and in sleep disorders.
Danish: HMPC har lagt vægt på, at kliniske undersøgelser af tørrede ethanolekstrakter understøtter anvendelse til lindring af mild nervøsitet og søvnbesvær.
English: Extracts are prepared using a technique to extract compounds by putting the plant material in a solvent (such as ethanol, methanol or water) to dissolve compounds and form a liquid extract.
Danish: Ekstrakterne fremstilles ved at udtrække stoffer fra plantematerialet i ethanol, methanol eller vand.
English: The HMPC conclusions on the use of a specific valerian root preparation obtained as dry ethanol extract for the relief of mild nervous tension and sleep disorders are based on their ‘well-established use'.
Danish: HMPC's konklusioner om anvendelsen af en specifik tilberedning af baldrianrod, der fås som tørret ethanolekstrakt til lindring af mild nervøsitet og søvnbesvær, er baseret på den "almindeligt anerkendte anvendelse".
English: The HMPC concluded that a specific valerian root preparation obtained as dry ethanol extract1 can be used for the relief of mild nervous tension and sleep disorders.
Danish: HMPC har konkluderet, at en særlig tilberedning af baldrianrod, der udvindes som et tørret ethanolekstrakt1, kan anvendes til lindring af mild nervøsitet og søvnbesvær.
English: For dry extracts, the solvent is then evaporated off.
Danish: Ved fremstilling af tørekstrakt fordampes opløsningsmidlet herefter for at opnå det tørre ekstrakt.
English: Side effects have been reported with valerian root.
Danish: Der er indberettet bivirkninger ved brug af lægemidler, der indeholder baldrianrod.
English: A doctor or healthcare practitioner should be consulted if symptoms persist during treatment for mental stress and to aid sleep.
Danish: Hvis symptomerne varer ved under behandlingen mod stress og søvnbesvær, bør der søges råd hos en læge eller en kvalificeret sundhedsperson.
English: 1 MU: Million Units
Danish: 1 MU: Million enheder
English: EU - Number
Danish: EU-nummer
English: Form
Danish: Indhold
English: Target Species
Danish: Lægemiddelform Dyrearter,
English: Invented name Strength
Danish: Handelsnavn Styrke
English: Package size Withdrawal period
Danish: Paknings størrelse
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dynastat on 22 March 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Dynastat den 22. marts 2002.
English: Other information about Dynastat:
Danish: Andre oplysninger om Dynastat:
English: The full EPAR for Dynastat can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Dynastat findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This document is a summary of the European public assessment report (EPAR) for Dynastat.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Dynastat.
English: It was generally more effective than placebo and as effective as other painkillers.
Danish: Det havde generelt en bedre virkning end placebo og var mindst lige så effektivt som andre smertestillende midler.
English: Dynastat must not be given to women during the last three months of pregnancy or to breast-feeding women.
Danish: Dynastat bør ikke gives til gravide kvinder i de sidste tre måneder af graviditeten eller til kvinder, der ammer.
English: Dynastat must not be used in patients with:
Danish: Dynastat må ikke anvendes hos patienter der:
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 Dynastat.
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 Dynastat.
English: This means that it is converted to valdecoxib in the body.
Danish: Det betyder, at stoffet omdannes til valdecoxib i kroppen.
English: It must not be used after coronary bypass surgery.
Danish: Det bør ikke anvendes efter en koronar bypass-operation.
English: Dynastat was also shown to reduce the need for morphine, but this reduction did not seem to be accompanied with a reduction in the side effects associated with morphine.
Danish: Det blev også påvist, at Dynastat reducerer behovet for morfin, men denne reduktion syntes dog ikke at medføre en reduktion i bivirkningerne forbundet med morfin.
English: For more information about treatment with Dynastat, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Dynastat, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP decided that Dynastat's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Dynastat opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: As with other medicines in the same group as Dynastat, the risk of heart and blood vessel problems may increase with higher doses and longer durations of Dynastat treatment.
Danish: Som med andre lægemidler i samme gruppe som Dynastat kan risikoen øges for hjerte- og blodkarsygdomme ved højere doser Dynastat og langvarig behandling hermed.
English: By reducing the production of prostaglandins, Dynastat helps to reduce the symptoms of inflammation, including pain.
Danish: Ved at hæmme produktionen af prostaglandiner bidrager Dynastat til at mindske symptomerne på betændelse, herunder smerte.
English: Dynastat can be given at the same time as opioid painkillers (medicines that are related to morphine).
Danish: Dynastat kan gives samtidig med opioide smertestillende midler (lægemidler, der er i familie med morfin).
English: In patients with severe kidney problems or who are likely to develop fluid retention, treatment should start with the lowest dose and the patient's kidneys should be monitored closely.
Danish: Hos patienter med svær leversygdom eller patienter, som sandsynligvis vil få væskeophobninger, bør behandlingen starte med den laveste dosis, og patientens nyrer skal overvåges nøje.
English: Dynastat is used in adults for the short-term treatment of pain after an operation.
Danish: Dynastat anvendes hos voksne til kortvarig behandling af smerter efter en operation.
English: The shortest duration possible and the lowest effective dose of Dynastat should be used.
Danish: Behandlingen bør være af kortest mulig varighed, og den laveste effektive minimumsdosis anvendes.
English: Dynastat is a medicine that contains the active substance parecoxib.
Danish: Dynastat er et lægemiddel, der indeholder det aktive stof parecoxib.
English: What is the risk associated with Dynastat?
Danish: Hvilken risiko er der forbundet med Dynastat?
English: The main measures of effectiveness were changes in pain scores as rated by the patients.
Danish: De primære mål for virkningen var ændringer i smertescore, bedømt af patienterne selv.
English: Dynastat was compared with placebo (a dummy treatment) as well as with other painkillers such as ketorolac, morphine, valdecoxib, ibuprofen and tramadol.
Danish: Dynastat blev sammenlignet med placebo (uvirksom behandling) og med andre smertestillende midler såsom ketorolac, morfin, valdecoxib, ibuprofen og tramadol.
English: The injection may be given rapidly and directly into a vein or into an existing intravenous line (a thin tube running into a vein), or it can be given slowly and deeply into a muscle.
Danish: Injektion kan gives hurtigt og direkte i en blodåre, via et allerede anlagt intravenøst kateter (et tyndt rør, der føres ind i en blodåre), eller gives langsomt og dybt ind i en muskel.
English: It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process.
Danish: Det blokerer COX2enzymet og hæmmer dermed produktionen af prostaglandiner, der medvirker i betændelsesprocessen.
English: The most common side effect with Dynastat (seen in more than 1 patient in 10) is nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Dynastat (som optræder hos flere end 1 ud af 10 patienter) er kvalme.
English: Dynastat was effective in relieving moderate to severe pain after an operation.
Danish: Dynastat var effektivt til at lindre moderate til svære smerter efter en operation.
English: Dynastat is given at a dose of 40 mg, followed by further doses of 20 or 40 mg as required every six to 12 hours, with a maximum dose of 80 mg a day.
Danish: Efterfølgende gives der 20 eller 40 mg efter behov hver 6. til 12. time med en maksimal dosis på 80 mg pr. dag.
English: • stomach ulcers or bleeding in the stomach or gut;
Danish: • har mavesår eller blødninger i maven eller tarmen
English: Dynastat has been studied in 2,582 adults who had undergone a variety of surgical procedures including dental, orthopaedic (bone), gynaecological or coronary (heart) bypass surgery.
Danish: Dynastat blev undersøgt hos 2 582 voksne, som havde fået foretaget forskellige kirurgiske indgreb, herunder dentalkirurgi, ortopædiske eller gynækologiske indgreb samt koronare bypass-operationer.
English: • a history of serious allergic reactions to medicines, especially skin reactions;
Danish: • tidligere har lidt af alvorlige overfølsomhedsreaktioner over for lægemidler, især hudreaktioner
English: Why has Dynastat been approved?
Danish: Hvorfor er Dynastat blevet godkendt?
English: Valdecoxib is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group of medicines called ‘cyclo-oxygenase-2 (COX-2) inhibitors'.
Danish: Valdecoxib er et nonsteroidt antiinflammatorisk lægemiddel (NSAID), der hører til gruppen af lægemidler kaldet cyklooxygenase-2 (COX2)-hæmmere.
English: It is available as a powder to be made up into a solution for injection, in vials containing 20 or 40 mg of parecoxib, with or without a solvent.
Danish: Det leveres som et pulver til opløsning til dannelse af en injektionsvæske og i hætteglas på 20 eller 40 mg parecoxib, med eller uden opløsningsmiddel.
English: The active substance in Dynastat, parecoxib, is a ‘prodrug' of valdecoxib.
Danish: Det aktive stof i Dynastat, parecoxib, er et såkaldt prodrug for valdecoxib.
English: Some of the studies also looked at the impact of giving Dynastat on the patient's use of morphine for additional pain relief after surgery.
Danish: I nogle af undersøgelserne så man også på, hvordan administreringen af Dynestat indvirker på patientens forbrug af morfin som supplerende smertestillende middel efter en operation.
English: For elderly patients weighing less than 50 kg and for patients with moderate liver problems, treatment is with half the usual recommended dose of Dynastat, with a maximum daily dose of 40 mg. Dynastat must not be used in patients with severe liver problems.
Danish: Ved behandling af ældre patienter med en kropsvægt på under 50 kg og patienter med moderate leverproblemer skal dosis nedsættes til halvdelen af den normalt anbefalede dosis af Dynastat med en maksimal daglig indgivelse på 40 mg.
English: For the full list of all side effects reported with Dynastat, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Dynastat fremgår af indlægssedlen.
English: • inflammatory bowel disease;
Danish: • lider af inflammatorisk tarmsygdom
English: What is Dynastat?
Danish: Hvad er Dynastat?
English: • heart failure (an inability of the heart to pump enough blood around the body), ischaemic heart disease (disease of the heart caused by failure in the blood supply), peripheral artery disease
Danish: • har hjerteinsufficiens (hjertets manglende evne til at pumpe tilstrækkeligt blod rundt i kroppen), iskæmisk hjertesygdom (hjertesygdom forårsaget af manglende blodforsyning), perifer arteriesygdom (tillukning af blodkarene i arme og ben), eller cerebrovaskulær sygdom (problemer, der påvirker blodkarrene i hjernen).
English: • severe liver disease;
Danish: • har alvorlig leversygdom,
English: What benefit has Dynastat shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Dynastat?
English: What is Dynastat used for?
Danish: Hvad anvendes Dynastat til?
English: • allergic-type reactions such as bronchospasm (excessive and prolonged contraction of the airway muscles), cold-like symptoms, polyps in the nose, swelling of the face or hives after taking aspirin or NSAIDs, including other COX-2 inhibitors;
Danish: • lider af overfølsomhedslignende reaktioner såsom bronkospasme heftig og langvarig sammentrækning af musklerne i luftvejene), forkølelseslignende symptomer, polypper i næsen,
English: How has Dynastat been studied?
Danish: Hvordan blev Dynastat undersøgt?
English: How is Dynastat used?
Danish: Hvordan anvendes Dynastat?
English: Dynastat must not be used in people who are hypersensitive (allergic) to parecoxib or any of the other ingredients.
Danish: Patienter, der er overfølsomme (allergiske) over for parecoxib eller andre af indholdsstofferne, må ikke anvende Dynastat.
English: How does Dynastat work?
Danish: Hvordan virker Dynastat?
English: Your diabetes may get worse.
Danish: Din diabetes kan muligvis forværres.