FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on the HMPC assessment of lavender oil, 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 lavendelolie, 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: The HMPC concluded that, on the basis of its long-standing use, lavender oil can be used for the relief of mild symptoms of mental stress and exhaustion, and to aid sleep.
Danish: HMPC har konkluderet, at lavendelolie på grundlag af lang tids anvendelse kan anvendes til lindring af milde symptomer på psykisk træthed og udmattelse samt som sovemiddel.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing lavender oil.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder lavendelolie.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of lavender oil.
Danish: Dette er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner om den medicinske anvendelse af lavendelolie.
English: Herbal medicines containing lavender oil are usually available in liquid forms to be taken by mouth or as a bath additive.
Danish: Plantelægemidler med lavendelolie fås normalt i flydende form til indtagelse gennem munden eller som badeolie.
English: What is lavender oil?
Danish: Hvad er lavendelolie?
English: Detailed instruction on how to take lavender oil 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 lavendelolie skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: Further information on the risks associated with lavender oil 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 lavendelolie, 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: EMA/HMPC/530968/2012
Danish: EMA/HMPC/530968/2012 Udvalget for Plantelægemidler (HMPC)
English: This summary is not intended to provide practical advice on how to use medicines containing lavender oil.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder lavendelolie, anvendes.
English: How are lavender oil medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder lavendelolie, i EU?
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: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom undersøgelser, kan det antages, at disse plantelægemidler har en virkning, og der er dokumentation for, at de har været anvendt sikkert på denne måde i mindst 30 år (herunder mindst 15 år inden for EU).
English: Lavender oil
Danish: Lavendelolie
English: Lavender oil is obtained by a current of steam through the flowering tops of the plant.
Danish: Lavendelolie udvindes ved at lede damp gennem planternes blomstrende toppe.
English: What evidence supports the use of lavender oil medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af lavendelolie?
English: The HMPC conclusions on the use of medicines containing lavender oil are based on their ‘traditional use'.
Danish: HMPC's konklusioner om brugen af lægemidler med lavendelolie er baseret på disse lægemidlers "traditionelle anvendelse".
English: Therefore, the HMPC conclusions on the use of lavender oil medicines are based on their long-standing use.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med lavendelolie bygger derfor på, at de har været anvendt i lang tid.
English: What are the risks associated with lavender oil medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder lavendelolie?
English: For more information about treatment with lavender oil, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lavendelolie, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: For practical information about using lavender oil 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 lavendelolie, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The dose for children is based on their body surface area (weight and height).
Danish: Dosen til børn baseres på deres krops overfladeareal (vægt og højde).
English: Further information on Vitrakvi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/vitrakvi.
Danish: Yderligere information om Vitrakvi findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/vitrakvi.
English: In addition, the tumours shrank quickly (within 2 months).
Danish: Desuden blev tumorerne hurtigt mindre (inden for 2 måneder).
English: Vitrakvi has been given ‘conditional authorisation'.
Danish: Vitrakvi har fået en "betinget godkendelse".
English: Other information about Vitrakvi
Danish: Andre oplysninger om Vitrakvi
English: Adult patients should take 100 mg twice a day for as long as the cancer is stable and the side effects are acceptable.
Danish: Voksne patienter bør tage 100 mg to gange dagligt, så længe kræften holder sig stabil og bivirkningerne er tålelige.
English: Vitrakvi is available as a liquid (20 mg per ml) and capsules (25 and 100 mg) and is taken by mouth.
Danish: Vitrakvi fås som en væske (20 mg pr. ml) og kapsler (25 og 100 mg) og tages gennem munden.
English: This means that there is more evidence to come about the medicine, which the company is required to provide.
Danish: Det betyder, at der er flere videnskabelige beviser på vej om lægemidlet, som virksomheden skal fremlægge.
English: As for all medicines, data on the use of Vitrakvi are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Vitrakvi løbende overvåget.
English: It contains the active substance larotrectinib.
Danish: Det indeholder det aktive stof larotrectinib.
English: This data will come from the three ongoing studies which aim to confirm the benefits and safety of Vitrakvi and its longer term effect in children.
Danish: Disse data vil komme fra de tre igangværende studier, der skal bekræfte fordelene og sikkerheden ved Vitrakvi samt den langsigtede virkning hos børn.
English: Since Vitrakvi has been given conditional authorisation, the company that markets Vitrakvi will provide further data on its effects.
Danish: Da Vitrakvi har fået en betinget godkendelse, skal virksomheden, der markedsfører Vitrakvi, fremlægge yderligere data om dets virkninger.
English: The European Medicines Agency therefore concluded that its benefits are greater than its risks and that it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Vitrakvi opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The most common side effects with Vitrakvi (which may affect more than 1 in 5 people) are tiredness, dizziness, constipation, nausea, vomiting, anaemia (low red blood cell counts) and high blood levels of alanine aminotransferase and aspartate aminotransferase (a sign of liver problems).
Danish: De hyppigste bivirkninger ved Vitrakvi (som kan forekomme hos mere end 1 ud af 5 personer) er træthed, svimmelhed, forstoppelse, kvalme, opkastning, anæmi (lavt antal røde blodlegemer) og højt indhold i blodet af alaninaminotransferase og aspartataminotransferase (et tegn på leverproblemer).
English: Most side effects are mild to moderate.
Danish: De fleste bivirkninger er lette til moderate.
English: An overview of Vitrakvi and why it is authorised in the EU
Danish: En oversigt over Vitrakvi, og hvorfor det er godkendt i EU
English: Vitrakvi is used in patients whose tumours are advanced, have spread to other parts of the body or are not amenable to surgery, and who have no satisfactory alternative treatments.
Danish: Vitrakvi anvendes til patienter, hvis tumorer er fremskredne, har spredt sig til andre dele af kroppen eller ikke kan fjernes kirurgisk, og som ikke har tilfredsstillende alternative behandlinger.
English: Side effects reported with Vitrakvi are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Vitrakvi vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: What is Vitrakvi and what is it used for?
Danish: Hvad er Vitrakvi, og hvad anvendes det til?
English: Why is Vitrakvi authorised in the EU?
Danish: Hvorfor er Vitrakvi godkendt i EU?
English: Although studies are still underway, the results released so far show that it is effective at reducing the size of patients' tumours.
Danish: Selv om studierne stadig er i gang, viser de resultater, der hidtil er offentliggjort, at det er effektivt til at reducere størrelsen af patienternes tumorer.
English: In these studies, 67% of patients who took Vitrakvi had a reduction in the size of their tumours, and the tumours on average shrank to less than half their original size.
Danish: I disse studier oplevede 67 % af de patienter, der fik Vitrakvi, at deres tumorer blev mindre, og tumorernes størrelse faldt i gennemsnit til mindre end halvdelen af deres oprindelige størrelse.
English: What measures are being taken to ensure the safe and effective use of Vitrakvi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vitrakvi?
English: The active substance in Vitrakvi, larotrectinib, blocks the action of this protein, preventing the excessive growth of cancer cells and thereby slowing down the worsening of the cancer.
Danish: Det aktive stof i Vitrakvi, larotrectinib, blokerer virkningen af dette protein, forhindrer den overdrevne vækst af kræftceller og sinker dermed kræftens forværring.
English: For more information about using Vitrakvi, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Vitrakvi, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: In addition, the short time taken to shrink the tumours is important in relieving patients' symptoms.
Danish: Desuden er tumorernes korte reduktionstid vigtig i forbindelse med at lindre patienternes symptomer.
English: Vitrakvi differs from many other cancer medicines by targeting certain tumours with a specific gene arrangement wherever they occur in the body.
Danish: Vitrakvi adskiller sig fra mange andre kræftlægemidler ved at angribe bestemte tumorer med en specifik genstruktur, uanset hvor de forekommer i kroppen.
English: Vitrakvi should be started by a doctor experienced in using cancer medicines and can only be obtained with a prescription.
Danish: Behandlingen med Vitrakvi skal iværksættes af en læge med erfaring i brug af kræftlægemidler, og det fås kun på recept.
English: Three ongoing studies in 102 patients with solid tumours with NTRK gene fusion showed that Vitrakvi is effective at reducing the size of patients' tumours.
Danish: Tre igangværende studier omfattende 102 patienter med faste tumorer med NTRK-genfusion viste, at Vitrakvi er effektivt til at reducere størrelsen af patienternes tumorer.
English: NTRK gene fusion is a rare genetic abnormality that can occur in tumours from different parts of the body such as the lungs, thyroid glands and intestines.
Danish: NTRK-genfusion er en sjælden genetisk anomali, der kan forekomme i tumorer i forskellige dele af kroppen, såsom lunger, skjoldbruskkirtel og tarme.
English: As for its safety, the side effects of Vitrakvi appear manageable.
Danish: Hvad sikkerheden angår, anses bivirkningerne ved Vitrakvi for at være håndterbare.
English: What information is still awaited for Vitrakvi?
Danish: Hvilke oplysninger afventes der stadig for Vitrakvi?
English: What are the risks associated with Vitrakvi?
Danish: Hvilke risici er der forbundet med Vitrakvi?
English: Tumours with NTRK gene fusion produce an abnormal protein (TRK fusion protein), which causes the uncontrolled growth of cancer cells.
Danish: Tumorer med NTRK-genfusion producerer et unormalt protein (TRK-fusionsprotein), der får kræftceller til at vokse ukontrolleret.
English: Vitrakvi is a cancer medicine for treating solid tumours with NTRK gene fusion.
Danish: Vitrakvi er et kræftlægemiddel til behandling af faste tumorer med NTRK-genfusion.
English: How is Vitrakvi used?
Danish: Hvordan anvendes Vitrakvi?
English: How does Vitrakvi work?
Danish: Hvordan virker Vitrakvi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vitrakvi have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Vitrakvi.
English: What benefits of Vitrakvi have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Vitrakvi?
English: This summary was last updated in 08-2015.
Danish: Dette sammendrag blev sidst ajourført i 08-2015.
English: The patients were followed up for an average of four and a half years.
Danish: Patienterne blev i gennemsnit fulgt i fire et halvt år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Micardis on 16 December 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Micardis den 16. december 1998.
English: It is available as tablets (20, 40 and 80 mg).
Danish: Det fås som tabletter (20, 40 og 80 mg).
English: Other information about Micardis
Danish: Andre oplysninger om Micardis
English: This is a summary of the European public assessment report (EPAR) for Micardis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Micardis.
English: A risk management plan has been developed to ensure that Micardis is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Micardis anvendes så sikkert som muligt.
English: The combination of the two medicines was no more effective than either medicine taken alone and was linked to an increased risk of side effects.
Danish: Kombinationen af de to lægemidler var ikke mere effektiv end de enkelte lægemidler hver for sig og var forbundet med en øget risiko for bivirkninger.
English: Its use during the first three months of pregnancy is not recommended.
Danish: Det frarådes at anvende lægemidlet i de første tre måneder af graviditeten.
English: Micardis is a medicine that contains the active substance telmisartan.
Danish: Micardis er et lægemiddel, som indeholder det aktive stof telmisartan.
English: What measures are being taken to ensure the safe and effective use of Micardis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Micardis?
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 Micardis.
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, hvordan Micardis skal anvendes.
English: The CHMP decided that Micardis's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Micardis opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
English: Micardis is used to treat essential hypertension (high blood pressure) in adults.
Danish: Micardis anvendes til behandling af essentiel hypertension (for højt blodtryk) hos voksne.
English: The active substance in Micardis, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Det aktive stof i Micardis, telmisartan, er en "angiotensin II-receptorantagonist", hvilket betyder, at den blokerer virkningen af et hormon i kroppen, der kaldes angiotensin II.
English: It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.
Danish: Endvidere kan hjertet lettere pumpe blodet rundt, hvilket kan bidrage til at reducere risikoen for kardiovaskulære problemer i fremtiden.
English: The doctor should monitor the patient's blood pressure closely when starting Micardis, and may decide to adjust the patient's blood pressure-lowering medication.
Danish: Lægen bør overvåge patientens blodtryk nøje, når behandlingen med Micardis påbegyndes, og kan beslutte at justere patientens blodtrykssænkende medicin.
English: It is used in patients who have had problems due to blood clots in the past (such as heart disease, a stroke or artery disease) or who have type 2 diabetes that has damaged an organ (such as the eyes, heart or kidneys).
Danish: Det anvendes hos patienter, som tidligere har oplevet problemer som følge af blodpropper (såsom hjertesygdom, slagtilfælde eller arteriesygdom), eller som har type 2-diabetes, der har forårsaget beskadigelse af et organ (såsom øjnene, hjertet eller nyrerne).
English: Hypotension may be more common in patients receiving Micardis to prevent cardiovascular problems.
Danish: Hypotension kan forekomme oftere hos patienter, der får Micardis for at forebygge kardiovaskulære problemer.
English: By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Danish: Ved at blokere de receptorer, som angiotensin II normalt binder sig til, standser telmisartan virkningen af hormonet og gør det muligt for blodkarrene at udvide sig.
English: Micardis was compared with ramipril (another medicine to prevent cardiovascular problems), and with the combination of both medicines.
Danish: Micardis blev sammenlignet med ramipril (et andet lægemiddel til forebyggelse af kardiovaskulære problemer) og med kombinationen af begge lægemidler.
English: Various doses of Micardis were compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine).
Danish: Forskellige doseringer af Micardis blev sammenlignet med placebo (en virkningsløs behandling) og med andre lægemidler mod hypertension (atenolol, lisinopril, enalapril og amlodipin).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Micardis, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Micardis, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: What is the risk associated with Micardis?
Danish: Hvilken risiko er der forbundet med Micardis?
English: This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke.
Danish: Dette sænker blodtrykket og reducerer risiciene forbundet med højt blodtryk, såsom hjerteanfald og slagtilfælde.
English: Micardis must not be used in people who have severe liver problems or bile problems.
Danish: Micardis må ikke anvendes af personer, der har alvorlige leverproblemer eller galdeproblemer.
English: Micardis is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Danish: Micardis anvendes også til at forebygge kardiovaskulære problemer (problemer med hjertet og blodkarrene) såsom hjerteanfald eller slagtilfælde.
English: Micardis must not be used in women who are more than three months pregnant.
Danish: Det må ikke anvendes til gravide, som er længere end tre måneder henne i graviditeten.
English: In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, Micardis must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Danish: Hos patienter med type 2-diabetes eller moderat eller alvorlig nyresygdom må Kinzalmono desuden ikke anvendes i kombination med lægemidler, der indeholder aliskiren (som også anvendes til behandling af essentiel hypertension).
English: For the treatment of essential hypertension, the usual recommended dose of Micardis is 40 mg once a day, but some patients may benefit from using 20 mg once a day.
Danish: Til behandling af essentiel hypertension er den sædvanlige anbefalede dosis af Micardis 40 mg én gang dagligt, men visse patienter kan klare sig med 20 mg én gang dagligt.
English: For the treatment of essential hypertension, Micardis has been studied in 2,647 patients who took Micardis either alone or in combination with hydrochlorothiazide.
Danish: Micardis er, til behandling af essentiel hypertension, blevet undersøgt hos 2 647 patienter, der fik Micardis enten alene eller i kombination med hydrochlorothiazid.
English: The main measure of effectiveness was the reduction in the number of patients who died or were admitted to hospital, or who had a heart attack or stroke.
Danish: Virkningen blev hovedsageligt bedømt på reduktionen i antallet af patienter, der døde eller blev hospitalsindlagt, eller som fik et hjerteanfald eller slagtilfælde.
English: Why has Micardis been approved?
Danish: Hvorfor blev Micardis godkendt?
English: For the prevention of cardiovascular problems, 80 mg Micardis once a day has been studied in one main study involving almost 26,000 patients aged 55 years or over who had heart or artery disease, had had a stroke, or had diabetes and were at high risk of cardiovascular problems.
Danish: Til forebyggelse af kardiovaskulære problemer er Micardis 80 mg én gang dagligt blevet undersøgt i en hovedundersøgelse med deltagelse af knap 26 000 patienter i alderen 55 år eller derover, som havde hjerte- eller arteriesygdom, havde haft et slagtilfælde eller havde diabetes, og som havde stor risiko for kardiovaskulære problemer.
English: For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day.
Danish: Den anbefalede dosis til forebyggelse af kardiovaskulære problemer er 80 mg én gang dagligt.