FrancophonIA/ELRC3.0 huggingface dataset:
English: Any applications for the licensing of medicines containing saw palmetto fruit 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 savpalmefrugt, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Information on the use and licensing of saw palmetto fruit medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder savpalmefrugt, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing saw palmetto fruit.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder savpalmefrugt.
English: In its assessment, the HMPC considered a number of clinical studies with saw palmetto fruit hexane extract some of which showed that it is as effective as finasteride and tamsulosin (other medicines approved to treat BPH) at treating BPH symptoms for periods up to 1 year.
Danish: HMPC har i sin vurdering lagt vægt på en række kliniske undersøgelser af hexanekstrakt af savpalmefrugt, hvoraf nogle har vist, at det er lige så effektivt som finasterid og tamsulosin (andre godkendte BPH-lægemidler) til behandling af BPH-symptomer i perioder på op til 1 år.
English: Further information on the HMPC assessment of saw palmetto fruit 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 savpalmefrugt, 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 saw palmetto fruit 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 savpalmefrugt, 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: BPH is a non-cancerous increase in size of the prostate gland which surrounds the urethra, the tube that carries urine from the bladder out of the body.
Danish: BPH er en godartet forstørrelse af blærehalskirtlen, der omkranser den øverste del af urinrøret, som transporterer urinen fra blæren og ud af kroppen.
English: Herbal medicines containing saw palmetto fruit are usually available in solid forms to be taken by mouth.
Danish: Plantelægemidler med savpalmefrugt fås normalt i fast form til anvendelse gennem munden.
English: How does saw palmetto fruit work as a medicine?
Danish: Hvordan virker savpalmefrugt som lægemiddel?
English: This summary is not intended to provide practical advice on how to use medicines containing saw palmetto fruit.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder savpalmefrugt, skal anvendes.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of saw palmetto fruit.
Danish: Dette dokument er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af savpalmefrugt.
English: In its assessment, the HMPC also considered clinical studies with saw palmetto fruit ethanol extract.
Danish: I sin vurdering har HMPC også lagt vægt på kliniske undersøgelser af ethanolekstrakt af savpalmefrugt.
English: Other information about saw palmetto fruit medicines
Danish: Andre oplysninger om lægemidler, der indeholder savpalmefrugt
English: How are saw palmetto fruit medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder savpalmefrugt, i EU?
English: What are the risks associated with saw palmetto fruit medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder savpalmefrugt?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom instructions on how to take saw palmetto fruit medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The way saw palmetto fruit acts is not fully known, but from laboratory studies it is thought to work by reducing the action of male sex hormones such as testosterone, which play a role in causing enlargement of the prostate gland in BPH; and it may also have anti-inflammatory effects.
Danish: Virkningsmekanismen for savpalmefrugt kendes ikke fuldstændigt, men på baggrund af laboratorieundersøgelser menes det, at savpalmefrugt reducerer aktiviteten af de mandlige kønshormoner, herunder testosteron, der har betydning for forstørrelsen af blærehalskirtlen i forbindelse med BPH.
English: For more information about treatment with saw palmetto fruit 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 savpalmefrugt, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Common side effects (seen between 1 and 10 patients in 100) reported with saw palmetto fruit are abdominal (belly) pain and headache.
Danish: Der er indberettet almindeligt forekommende bivirkninger ved savpalmefrugt (ses hos mellem 1 og 10 patienter ud af 100).
English: The HMPC also concluded that, on the basis of its long-standing use, saw palmetto fruit (extracted with ethanol) can be used for the relief of lower urinary tract symptoms (such as difficulty starting urination or a frequent need to urinate) related to BPH, after serious conditions have been excluded by a doctor.
Danish: På baggrund af den mangeårige anvendelse har HMPC desuden konkluderet, at ethanolekstraktaf savpalmefrugt kan anvendes til lindring af symptomer i de nedre urinveje (f.eks. vandladningsbesvær eller hyppig tissetrang), der er forbundet med BPH, når lægen har udelukket alvorlige lidelser.
English: Therefore, the HMPC conclusions on the use of saw palmetto medicines are based on their long-standing use.
Danish: HMPC's konklusioner vedrørende anvendelsen af lægemidler med savpalmefrugt er derfor baseret på den mangeårige traditionelle anvendelse.
English: What is saw palmetto fruit?
Danish: Hvad er savpalmefrugt?
English: The HMPC conclusions on the use of ethanol-extracted saw palmetto fruit medicines for the relief of lower urinary tract symptoms related to BPH are based on their ‘traditional use' in this condition.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med ethanolekstrakt af savpalmefrugt til lindring af symptomer i de nedre urinveje i forbindelse med BPH er baseret på den "traditionelle anvendelse" til denne tilstand.
English: What evidence supports the use of saw palmetto fruit medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af savpalmefrugt?
English: For practical information about using saw palmetto fruit 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 savpalmefrugt, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The HMPC conclusions on the use of hexane-extracted saw palmetto fruit medicines for the symptomatic treatment of BPH are based on their ‘well-established use' in this condition.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med hexanekstrakt af savpalmefrugt til behandling af symptomerne ved BPH er baseret på den "almindeligt anerkendte anvendelse" til denne tilstand.
English: The HMPC concluded that saw palmetto fruit (extracted with hexane) can be used to treat the symptoms of benign prostatic hyperplasia (BPH).
Danish: HMPC har konkluderet, at hexanekstrakt af savpalmefrugt kan anvendes til behandling af symptomerne på godartet forstørret prostata (BPH).
English: Saw palmetto fruit preparations may be obtained by using a technique to extract compounds from plant material by dissolving them in a solvent (hexane or ethanol), which is then partially evaporated to obtain a soft extract.
Danish: Savpalmefrugtekstrakterne fremstilles ved at udtrække stoffer fra plantematerialet i hexan eller ethanol.
English: 23 January 2015
Danish: Den 23. januar 2015
English: Teysuno has been authorised in the EU since March 2011.
Danish: Teysuno har været godkendt i EU siden marts 2011.
English: The full European Public Assessment Report for Teysuno can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige europæiske offentlige vurderingsrapport for Teysuno findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: As a result, it prevents the growth of cancer cells and eventually kills them.
Danish: Dette hæmmer kræftcellers vækst, så de til sidst dør.
English: Teysuno contains the active substances tegafur, gimeracil and oteracil.
Danish: Teysuno indeholder de aktive stoffer tegafur, gimeracil og oteracil.
English: On 6 January 2015, Nordic Group BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the indication for Teysuno.
Danish: Den 6. januar 2015 meddelte Nordic Group BV officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om ændring af anvendelsen af Teysuno.
English: 5-FU is similar to pyrimidine, a substance found in the genetic material of cells (DNA and RNA).
Danish: 5-FU ligner pyrimidin, som er et stof, der findes i cellernes genetiske materiale (DNA og RNA).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: There are no consequences on the use of Teysuno in its authorised indication.
Danish: Der er ingen konsekvenser ved brug af Teysuno til den godkendte anvendelse.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Danish: Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, som virksomheden oprindelig havde fremlagt, og udarbejdet en liste med spørgsmål.
English: What was Teysuno expected to be used for?
Danish: Hvad forventedes Teysuno anvendt til?
English: The two other active substances in Teysuno allow tegafur to be effective at lower doses and with fewer side effects: gimeracil by preventing the breakdown of 5-FU, and oteracil by reducing the activity of 5FU in normal, non-cancerous tissue in the gut.
Danish: De to andre aktive stoffer i Teysuno bevirker, at tegafur er effektivt ved lavere doser og har færre bivirkninger: gimeracil ved at forhindre nedbrydningen af 5-FU, og oteracil ved at nedsætte virkningen af 5-FU i det normale, kræftfrie væv i tarmen.
English: Tegafur is a ‘prodrug' that is converted in the body to another medicine called 5-fluorouracil (5-FU).
Danish: Tegafur er et lægemiddelforstadium (“prodrug”), der i kroppen omdannes til et andet lægemiddel, 5-fluoruracil (5-FU).
English: How is Teysuno expected to work?
Danish: Hvordan forventes Teysuno at virke?
English: The company presented data from two studies involving a total of 43 patients with advanced gastric cancer or other tumours, in which Teysuno was used in combination with oxaliplatin and other cancer medicines.
Danish: Virksomheden fremlagde data fra to andre undersøgelser med i alt 43 patienter med fremskreden mavekræft eller andre svulster, hvor Teysuno blev anvendt i kombination med oxaliplatin og andre kræftlægemidler.
English: In particular very limited data were provided on the combination of Teysuno with oxaliplatin and no data were provided on the use with carboplatin.
Danish: Der var således kun forelagt meget begrænsede data om kombination af Teysuno med oxaliplatin, og ingen om anvendelse i kombination med carboplatin.
English: Data from published studies on the use of Teysuno in combination with platinum-based medicines were also provided.
Danish: Desuden blev der fremlagt oplysninger fra offentliggjorte undersøgelser om anvendelse af Teysuno i kombination med platinbaserede lægemidler.
English: The main active substance in Teysuno, tegafur, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the ‘anti-metabolites' group.
Danish: Det vigtigste aktive stof i Teysuno, tegafur, er et vævsgiftigt stof (dvs. det dræber celler, der deler sig, såsom kræftceller).
English: Teysuno was also expected to be used in combination with platinum-based cancer medicines other than cisplatin, such as oxaliplatin.
Danish: Teysuno forventedes også anvendt i kombination med andre platinbaserede kræftlægemidler end cisplatin, såsom oxaliplatin.
English: It is used in combination with cisplatin (a platinum-based cancer medicine).
Danish: Det anvendes i kombination med cisplatin, der er et platinbaseret kræftlægemiddel.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it withdrew the application because, in its preliminary assessment report, the CHMP considered that the data provided were insufficient to conclude that the benefits outweigh the risks when Teysuno is used in combination with other platinum-based cancer medicines.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den trak ansøgningen tilbage, fordi CHMP i sin indledende vurderingsrapport fandt de forelagte data utilstrækkelige til at konkludere, at fordelene overstiger risiciene ved brug af Teysuno i kombination med andre platinbaserede kræftlægemidler.
English: What is happening with Teysuno for the treatment of patients with advanced gastric cancer in combination with cisplatin?
Danish: Hvad vil der ske med brugen af Teysuno til behandling af patienter med fremskreden mavekræft i kombination med cisplatin?
English: Teysuno is a cancer medicine that is used to treat adults with advanced gastric (stomach) cancer.
Danish: Teysuno er et lægemiddel til behandling af voksne med fremskreden mavekræft (kræft i mavesækken).
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Teysuno could not have been approved for the treatment of advanced gastric cancer in combination with platinumbased medicines other than cisplatin.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål havde CHMP på tidspunktet for tilbagetrækningen af ansøgningen visse betænkeligheder og var af den foreløbige opfattelse, at Teysuno ikke kunne være blevet godkendt til behandling af fremskreden mavekræft i kombination med andre platinbaserede lægemidler end cisplatin.
English: The change concerned extending the use of Teysuno to treat advanced gastric cancer in combination with platinum-based cancer medicines other than cisplatin.
Danish: Ændringen vedrørte udvidelse af anvendelsen af Teysuno til også at omfatte behandling af fremskreden mavekræft i kombination med andre platinbaserede kræftlægemidler end cisplatin.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the data provided were too scarce to allow adequate evaluation of the benefits and risks of Teysuno in combination with platinumbased medicines other than cisplatin in patients with advanced gastric cancer.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at de forelagte oplysninger ikke var tilstrækkelige til at vurdere fordele og risici ved Teysuno i kombination med andre platinbaserede lægemidler end cisplatin hos patienter med fremskreden mavekræft.
English: The company informed the CHMP that there are no consequences for patients in clinical trials or compassionate use programmes.
Danish: Virksomheden har til CHMP oplyst, at der ikke er konsekvenser for patienter, som deltager i kliniske undersøgelser med Teysuno eller i programmer for anvendelse af Teysuno med særlig udleveringstilladelse.
English: The data provided were too limited to allow a benefit-risk evaluation of Teysuno in combination with other platinum-based medicines in patients with advanced gastric cancer.
Danish: De forelagte data var for begrænsede til at vurdere forholdet mellem fordele og risici (benefit/riskforholdet) for Teysuno i kombination med andre platinbaserede lægemidler hos patienter med fremskreden mavekræft.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Teysuno eller i programmer for anvendelse af Teysuno med særlig udleveringstilladelse?
English: The withdrawal letter is available here.
Danish: Brevet fra virksomheden, hvori EMA underrettes om tilbagetrækningen af ansøgningen, kan ses her.
English: Send a question via our website www.ema.europa.eu/contact the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Danish: I kroppen indtager 5-FU pyrimidinets plads og griber derved ind i virkningen af de enzymer, der medvirker ved produktion af nyt DNA.
English: The marketing authorisation holder demonstrates bioequivalence in the fed state, in compliance with the guidance on the investigation of bioequivalence in place at the time of lifting the suspension.
Danish: Indehaveren af markedsføringstilladelsen skal påvise bioækvivalens i ikke-fastende tilstand i overensstemmelse med de retningslinjer for undersøgelse af bioækvivalens, der er gældende på tidspunktet for ophævelse af suspenderingen.
English: Conditions for the lifting of the marketing authorisations suspension
Danish: Betingelser for ophævelse af suspenderingen af markedsføringstilladelsen
English: Do not freeze
Danish: Må ikke nedfryses.
English: Long term effects are not yet known.
Danish: Langtidseffekterne er endnu ikke kendt.
English: Peri- and postnatal development has not been studied.
Danish: Peri- og postnatal udvikling er ikke blevet undersøgt.
English: Systemic exposure did not appear to increase with the dose.
Danish: Systemisk eksponering syntes ikke at øges med dosis.
English: The potential risk to the human embryo or foetus is unknown.
Danish: Den potentielle risiko for det humane embryo eller foster er ukendt.
English: Long term safety
Danish: Langtidssikkerhed
English: It is important to tell your doctor if you: - are pregnant; - think you may be pregnant; or - plan to have a baby.
Danish: Det er vigtigt at fortælle Deres læge, hvis De: - er gravid, - tror at De kan være gravid eller - planlægger at blive gravid.
English: Kepivance should only be used in adults over the age of 18 years.
Danish: Kepivance bør kun anvendes til voksne over 18 år.
English: 5550 Airport Boulevard Boulder, Colorado 80301 United States of America
Danish: 5550 Airport Boulevard Boulder, Colorado 80301 USA
English: These events were consistent with those observed at the recommended dose but were generally more severe.
Danish: Disse hændelser var overensstemmende med det, der blev observeret ved den anbefalede dosis, men var generelt mere alvorlige.
English: The long-term safety of Kepivance has not been fully evaluated with respect to overall survival, progression free survival and secondary malignancies.
Danish: Langtidssikkerheden for Kepivance er ikke fuldt ud evalueret med hensyn til generel overlevelse, progressionsfri overlevelse og sekundære maligniteter.
English: Neither of the two dosing regimens demonstrated statistically significant results versus placebo.
Danish: Ingen af de to dosisregimer viste statistisk signifikante resultater versus placebo.
English: Safety and efficacy has not been evaluated in older people.
Danish: Sikkerhed og virkning er ikke evalueret hos ældre personer.
English: These reactions were primarily mild to moderate in severity and were reversible.
Danish: Disse reaktioner var primært af let til moderat grad, og de var reversible.
English: Kepivance is not recommended in children (0 to 18 years).
Danish: Børn Kepivance anbefales ikke til børn (0 til 18 år).
English: The frequency listed below is defined using the following convention: very common (> 1/10), common (≥ 1/100 to < 1/10), not known (frequency cannot be estimated from available data).
Danish: Hyppighederne opført nedenfor er defineret ud fra følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Palifermin (60 micrograms/kg/day) n = 106
Danish: Palifermin (60 mikrogram/kg/dag) n = 106
English: Not known (frequency cannot be estimated from available data):
Danish: Ikke kendt (kan ikke vurderes ud fra tilgængelige data)
English: There are no adequate data from the use of Kepivance in pregnant women.
Danish: Der findes ingen adækvate data vedrørende anvendelse af Kepivance til gravide kvinder.
English: After reconstitution: 24 hours at 2 °C - 8 °C, protected from light.
Danish: Efter rekonstitution: 24 timer ved 2 °C - 8 °C, beskyttet mod lys.
English: Generally, dissolution of Kepivance takes less than 5 minutes.
Danish: Normalt tager opløsning af Kepivance mindre end 5 minutter.
English: Dysgeusia Paraesthesia oral
Danish: Dysgeusi paræstesi oral
English: If you are pregnant you should not use Kepivance unless clearly necessary.
Danish: Hvis De er gravid, bør De ikke få Kepivance, medmindre det tydeligt er nødvendigt.
English: Kepivance has not been tested in pregnant women.
Danish: Kepivance er ikke blevet testet på gravide kvinder.
English: There was an imbalance in age distribution with more elderly (> 65 years) patients in the palifermin group.
Danish: Der var en skævhed i aldersfordelingen med flest ældre (> 65 år) patienter i palifermin-gruppen.
English: A phase I dose escalation study was conducted in paediatric patients aged 1-16 years.
Danish: Et fase I-dosiseskaleringsstudie blev udført med pædiatriske patienter i alderen 1-16 år.
English: The contents should be swirled gently during dissolution.
Danish: Indholdet bør slynges forsigtigt under opløsningen.
English: Do not shake or vigorously agitate the vial.
Danish: Undgå at ryste eller bevæge hætteglasset voldsomt.
English: Date of latest renewal: 23 September 2010
Danish: Dato første markedsføringstilladelse: 25. oktober 2005 Dato seneste fornyelse: 23. september 2010
English: Please inform your doctor if you are receiving or have recently received heparin.
Danish: Fortæl det til lægen, hvis De får eller for nyligt har fået heparin.
English: Kepivance should not be administered subcutaneously due to poor local tolerability.
Danish: Administration Kepivance bør ikke indgives subkutant på grund af dårlig lokal tolerance.
English: In this study, 212 patients were randomised and received either palifermin or placebo.
Danish: I dette studie randomiseredes 212 patienter og modtog enten palifermin eller placebo.