FrancophonIA/ELRC3.0 huggingface dataset:
English: Information on the use and licensing of primula flower medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder primulablomst, 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 primula flower.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder primulablomst.
English: Primula flower medicines must not be used in patients who are allergic to primula flower or to other plants of the primula species.
Danish: Lægemidler med primulablomst må ikke anvendes til patienter, der er allergiske over for primulablomst eller andre primula arter.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of primula flower.
Danish: Dette dokument er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af primulablomst.
English: Primula flower preparations may also be found in combination with other herbal substances in some herbal medicines.
Danish: Tilberedninger af primulablomst findes desuden kombineret med andre droger i visse plantelægemidler.
English: Detailed instructions on how to take primula flower 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 primulablomst bør anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: Further information on the HMPC assessment of primula flower 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 primulablomst, 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 these primula flower 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 primulablomst, 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: What is primula flower?
Danish: Hvad er primulablomst?
English: This summary is not intended to provide practical advice on how to use medicines containing primula flower.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder primulablomst, skal anvendes.
English: How are primula flower medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder primulablomst, i EU?
English: The HMPC conclusions on the use of these primula flower medicines for coughs are based on their ‘traditional use' .
Danish: HMPC's konklusioner om anvendelsen af lægemidler med primulablomst er baseret på disse lægemidlers "traditionelle anvendelse" til hoste.
English: Herbal medicines containing these primula flower preparations are usually available as herbal tea to be drunk and in liquid forms to be taken by mouth.
Danish: Plantelægemidler med primulablomst i disse tilberedninger fås normalt som urtete beregnet til at drikke eller i flydende form til anvendelse gennem munden.
English: Other information about primula flower medicines
Danish: Andre oplysninger om lægemidler, der indeholder primulablomst
English: What are the risks associated with primula flower medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder primulablomst?
English: The HMPC conclusions only cover primula flower preparations which are obtained by comminuting (reducing into tiny pieces) the flowers or using a technique to extract compounds by putting the plant material in a solvent (such as ethanol) to dissolve compounds and form a liquid extract.
Danish: HMPC's konklusioner omfatter kun tilberedninger af primulablomst, som fremstilles ved tørring og findeling af blomsterne eller ved at udtrække stoffer fra plantematerialet i et opløsningsmiddel (såsom ethanol ).
English: Primula flower
Danish: Primulablomst
English: What evidence supports the use of primula flower medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af primulablomst?
English: For more information about treatment with primula flower 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 primulablomst, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: In its assessment, the HMPC considered laboratory studies which showed primula flower increased production of airway secretions, making phlegm less thick and easier to expel.
Danish: HMPC har vurderet laboratorieundersøgelser, der viste, at primulablomst øgede mængden af sekret i luftvejene, således at slimen blev mindre tyk og lettere at hoste op. Der er ingen kliniske undersøgelser med tilberedninger, der kun indeholder primulablomst.
English: The HMPC concluded that, on the basis of its long-standing use, these primula flower primula flower preparations can be used as an expectorant (a medicine that helps bring up phlegm) for coughs associated with colds.
Danish: På baggrund af den mangeårige anvendelse har HMPC konkluderet, at primulablomst i disse tilberedninger kan anvendes som slimløsnende middel (ekspektorans) ved hoste i forbindelse med forkølelse.
English: For practical information about using primula flower 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 primulablomst, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Danish: Virksomheden kan anmode om, at udtalelsen bliver revurderet, inden for 15 dage efter modtagelsen af meddelelsen om denne negative udtalelse.
English: To support this claim, the company referred to published data and provided an expert opinion.
Danish: Til støtte for denne påstand henviste virksomheden til offentliggjorte data og fremlagde en ekspertudtalelse.
English: Data from clinical studies also showed differences in the safety profile of the two active substances.
Danish: Data fra kliniske undersøgelser har også vist forskelle i sikkerhedsprofilen for de to aktive stoffer.
English: What consequences does this refusal have for patients in clinical trials?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske forsøg?
English: The company that applied for authorisation is Teva B.V.
Danish: Virksomheden, som ansøgte om tilladelse, er Teva B.V.
English: The company informed the CHMP that there are no ongoing clinical trials with Cabazitaxel Teva in the EU.
Danish: Virksomheden har oplyst CHMP om, at der i øjeblikket ikke gennemføres kliniske forsøg med Cabazitaxel Teva i EU.
English: The applicant also made reference to another medicine, Taxotere, which contains docetaxel.
Danish: Ansøgeren henviste også til et andet lægemiddel, Taxotere, der indeholder docetaxel.
English: Refusal of the marketing authorisation for Cabazitaxel Teva (cabazitaxel)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Cabazitaxel Teva (cabazitaxel)
English: The CHMP did not agree that the data presented by the company were sufficient to support the claim that cabazitaxel and docetaxel should be considered the same active substance.
Danish: CHMP var ikke enig i, at de data, som virksomheden havde fremlagt, var tilstrækkelige til at støtte den påstand, at cabazitaxel og docetaxel burde anses for at være det samme aktive stof.
English: Although cabazitaxel is a derivative of docetaxel, laboratory studies have shown that cabazitaxel and docetaxel have different properties, for example cabazitaxel can cross the blood-brain barrier while docetaxel cannot.
Danish: Selvom cabazitaxel er et derivat af docetaxel, har laboratorieundersøgelser vist, at cabazitaxel og docetaxel har forskellige egenskaber; f.eks. kan cabazitaxel passere blod-hjerne-barrieren, mens docetaxel ikke kan.
English: On 26 April 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Cabazitaxel Teva, intended for the treatment of prostate cancer.
Danish: Den 26. april 2019 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse om anbefaling af afslag på ansøgningen om markedsføringstilladelse for lægemidlet Cabazitaxel Teva, der er beregnet til behandling af prostatakræft.
English: The company made reference to two medicines, Jevtana (containing cabazitaxel) and Taxotere (containing docetaxel, see below for more details).
Danish: Virksomheden henviste til to lægemidler, Jevtana (der indeholder cabazitaxel) og Taxotere (der indeholder docetaxel; se yderligere oplysninger nedenfor).
English: There was no need for ‘bioequivalence' studies to investigate whether Cabazitaxel Teva is absorbed similarly to Jevtana to produce the same level of the active substance in the blood.
Danish: Der var ikke behov for "bioækvivalensstudier" af, hvorvidt Cabazitaxel Teva absorberes på samme måde som Jevtana for at producere samme niveau af det aktive stof i blodet.
English: Because Cabazitaxel Teva was developed as a hybrid medicine, the company presented data from the published literature to demonstrate that it is similar to Jevtana.
Danish: Eftersom Cabazitaxel Teva blev udviklet som et "hybridlægemiddel", har virksomheden fremlagt data fra den offentliggjorte litteratur for at påvise, at det svarer til Jevtana.
English: Cabazitaxel Teva was developed as a ‘hybrid medicine'.
Danish: Cabazitaxel Teva blev udviklet som et "hybridlægemiddel".
English: Additionally, laboratory data suggest that cabazitaxel can be effective at treating cancer that is resistant to docetaxel.
Danish: Desuden tyder laboratoriedata på, at cabazitaxel kan være effektiv til behandling af kræft, der er resistent over for docetaxel.
English: This means that Cabazitaxel Teva was intended to be similar to a ‘reference medicine' containing the same active substance and already authorised in the European Union.
Danish: Det vil sige, at det var hensigten, at Cabazitaxel Teva skulle svare til et referencelægemiddel, der indeholder det samme aktive stof, og som allerede er godkendt i Den Europæiske Union.
English: The company claimed that cabazitaxel is a derivative of docetaxel, and that the active substances do not differ significantly in their safety and effectiveness.
Danish: Virksomheden hævdede, at cabazitaxel er et derivat af docetaxel, og at de aktive stoffer ikke er signifikant forskellige med hensyn til sikkerhed og virkning.
English: Thus Taxotere cannot be used to support the application for Cabazitaxel Teva and the CHMP recommended that Cabazitaxel Teva be refused marketing authorisation.
Danish: Taxotere kan derfor ikke anvendes som støtte for ansøgningen vedrørende Cabazitaxel Teva, og CHMP anbefalede at give afslag på ansøgningen om markedsføringstilladelse for Cabazitaxel Teva.
English: Cabazitaxel also affects non-cancer cells, such as blood and nerve cells, which can cause side effects.
Danish: Cabazitaxel påvirker også andre celler end kræftceller, f.eks. blod- og nerveceller, hvilket kan medføre bivirkninger.
English: Cabazitaxel Teva was to be used when the cancer had spread to other parts of the body (metastatic) despite treatments to prevent the production of testosterone or after surgical removal of the testes (castration).
Danish: Cabazitaxel Teva skulle anvendes, når kræften har bredt sig til andre dele af kroppen (metastatisk kræft) trods behandlinger til forebyggelse af produktion af testosteron eller efter kirurgisk fjernelse af testiklerne (kastrering).
English: Based on these findings, the CHMP was of the opinion that it cannot be concluded that cabazitaxel and docetaxel do not differ significantly with regard to safety and effectiveness.
Danish: På dette grundlag var CHMP af den opfattelse, at det ikke kunne konkluderes, at cabazitaxel og docetaxel ikke adskiller sig væsentligt fra hinanden med hensyn til sikkerhed og virkning.
English: Cabazitaxel belongs to the group of cancer medicines known as ‘taxanes'.
Danish: Cabazitaxel hører til den gruppe kræftlægemidler, der kaldes "taxaner".
English: Furthermore, patients receiving cabazitaxel are exposed to the unchanged substance plus two active breakdown products, which are not formed when docetaxel is given.
Danish: Patienter, der får cabazitaxel, er desuden eksponeret for det uomdannede stof samt to nedbrydningsprodukter, som ikke dannes ved behandling med docetaxel.
English: This is because Cabazitaxel Teva is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Danish: Dette skyldes, at Cabazitaxel Teva gives ved infusion i en blodåre, så det aktive stof ledes direkte ind i blodbanen.
English: Cabazitaxel Teva is expected to work in the same way as the reference medicine, Jevtana.
Danish: Cabazitaxel Teva forventes at virke på samme måde som referencelægemidlet Jevtana.
English: It was to be available as a concentrate to be made into a solution for infusion (drip) into a vein.
Danish: Det skulle have kunnet fås som et koncentrat til infusionsvæske, opløsning, (drop) i en vene.
English: Cabazitaxel Teva is a cancer medicine that contains the active substance cabazitaxel.
Danish: Cabazitaxel Teva er et kræftlægemiddel, der indeholder det aktive stof cabazitaxel.
English: What was Cabazitaxel Teva expected to be used for?
Danish: Hvad forventedes Cabazitaxel Teva anvendt til?
English: Cabazitaxel Teva was to be used in combination with prednisone or prednisolone (anti-inflammatory medicines) in patients who have previously been treated with docetaxel (another cancer medicine).
Danish: Det skulle anvendes i kombination med prednison eller prednisolon (antiinflammatoriske lægemidler) hos patienter, der tidligere er blevet behandlet med docetaxel (et andet kræftlægemiddel).
English: What is Cabazitaxel Teva?
Danish: Hvad er Cabazitaxel Teva?
English: Cabazitaxel Teva was expected to be used to treat men with prostate cancer, a cancer that affects the prostate gland (which produces the liquid in semen).
Danish: Cabazitaxel Teva forventedes anvendt til at behandle mænd med prostatakræft, dvs. kræft i prostatakirtlen (der producerer sædvæsken).
English: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26.
English: How does Cabazitaxel Teva work?
Danish: Hvordan virker Cabazitaxel Teva?
English: Egg production may also be affected.
Danish: Ægproduktionen kan også være berørt.
English: If another course of treatment is required, the interval between the two courses of treatment should be at least 3 months.
Danish: Hvis et nyt behandlingsforløb er nødvendigt, bør intervallet mellem de to behandlingsforløb være på mindst 3 måneder.
English: While handling the product people must not eat, drink or smoke.
Danish: Under håndtering af produktet må personer ikke spise, drikke eller ryge.
English: The European Commission granted a marketing authorisation valid throughout the EU for Exzolt on 18 August 2017.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Exzolt den 18/08/2017.
English: This is a summary of the European public assessment report (EPAR) for Exzolt.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Exzolt.
English: The full EPAR for Exzolt can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Exzolt findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: One of the houses on each of the farms was treated with Exzolt, the other house was left untreated.
Danish: Et af husene på hver bedrift blev behandlet med Exzolt, mens det andet hus blev ikke behandlet.
English: The duration of effectiveness was between 6 weeks and 8 months, depending on the length of the production cycle and how effectively the farms prevented re-introduction of new mites into their houses.
Danish: Virkningen holdt i mellem 6 uger og 8 måneder, afhængigt af produktionscyklussens længde, og hvor effektivt bedrifterne forhindrede forekomst af nye mider i deres huse.
English: Hands and contacted skin should be washed after use of the medicine.
Danish: Hænder og berørt hud bør vaskes efter brug af lægemidlet.
English: What is Exzolt and what is it used for?
Danish: Hvad er Exzolt, og hvad anvendes det til?
English: The withdrawal period for meat from chickens treated with Exzolt is 14 days.
Danish: Tilbageholdelsestiden for kød fra kyllinger, der behandles med Exzolt, er 14 dage.
English: The withdrawal period for eggs from chickens treated with Exzolt is ‘zero' days, which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for æg fra kyllinger, der behandles med Exzolt, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: Exzolt has been studied in a field study involving 9 farms with poultry red mite infestation, each with two similar houses with 550 to 100,000 chickens per house.
Danish: Exzolt er blevet undersøgt i en feltundersøgelse, der omfattede 9 bedrifter med kyllingemideangreb, hver med to lignende huse med 550 til 100 000 kyllinger pr. hus.
English: This means it kills parasites such as mites that feed on the skin of animals.
Danish: Det betyder, at det dræber parasitter, såsom mider, der lever af dyrs hud.
English: Why is Exzolt approved?
Danish: Hvorfor blev Exzolt godkendt?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Exzolt's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Exzolt opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Exzolt is added to drinking water on two occasions, seven days apart.
Danish: Exzolt tilsættes til drikkevand i to omgange, med syv dages mellemrum.
English: Exzolt reduced the number of mites by more than 99% in pullets and breeders and more than 98% in layers.
Danish: Exzolt reducerede antallet af mider med mere end 99 % hos unge høner og avlshøner, og mere end 98 % hos læggehøner.
English: It is not intended to provide practical advice on how to use Exzolt.
Danish: Det er ikke en praktisk vejledning i, hvordan Exzolt bør anvendes.
English: Exzolt contains the active substance fluralaner.
Danish: Exzolt indeholder det aktive stof fluralaner.
English: What are the risks associated with Exzolt?
Danish: Hvilke risici er der forbundet med Exzolt?
English: Since the veterinary medicine may be slightly irritating to skin and/or eyes, contact with skin, eyes and mucous membranes (moist body surfaces, such as the lining of the mouth) should be avoided.
Danish: Da veterinærlægemidlet kan være let irriterende for huden og/eller øjnene, bør der udgås kontakt med hud, øjne og slimhinder (fugtige legemsoverflader, såsom mundens indvendige overflade).
English: Fluralaner kills mites by acting on their nervous system after they have ingested the chicken's blood.
Danish: Fluralaner dræber mider ved at indvirke på deres nervesystem, når de har indtaget kyllingens blod.
English: Sufficient Exzolt is added to ensure the required dose is present in the volume of water that the chickens will consume in one day.
Danish: Der tilsættes tilstrækkeligt Exzolt til at sikre, at den mængde vand, som kyllingerne vil drikke på én dag, indeholder den krævede dosis.
English: Exzolt is a veterinary medicine used to treat poultry red mite (Dermanyssus gallinae) infestation in pullets (young female chickens), breeders and layer hens.
Danish: Exzolt er et veterinærlægemiddel, der anvendes til at behandle kyllingemide- (Dermanyssus gallinae) angreb på unge høner (unge kyllinger af hunkøn), avlshøner og læggehøner.
English: Exzolt is available as a solution for use in drinking water and can only be obtained with a prescription.
Danish: Exzolt fås som opløsning til anvendelse i drikkevand og udleveres kun efter recept.
English: It works by interfering with the way that signals are passed between nerve cells (neurotransmission) in the nervous system of parasites, resulting in paralysis and death of the mites.
Danish: Det virker ved at forstyrre overførslen af signaler mellem nerveceller (neurotransmission) i parasitternes nervesystem, så miderne lammes og dør.
English: Red mite infestations can cause irritation and restlessness of the bird, feather pecking and anaemia (low red blood cell counts).
Danish: Kyllingemideangreb kan forårsage irritation og rastløshed hos fuglen, fjerpilning og anæmi (lavt antal røde blodlegemer).
English: The active substance in Exzolt, fluralaner, acts as an ‘ectoparasiticide'.
Danish: Det aktive stof i Exzolt, fluralaner, er et ektoparasitdræbende middel.
English: The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter indgivelse af et lægemiddel, før et dyr kan slagtes, og kødet kan anvendes til menneskeligt konsum.
English: Other information about Exzolt?
Danish: Andre oplysninger om Exzolt
English: Poultry red mite is a parasite that feeds on the blood of hens.
Danish: Kyllingemiden er en parasit, der lever af høners blod.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Exzolt, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Exzolt, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: What benefits of Exzolt have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Exzolt?
English: How is Exzolt used?
Danish: Hvordan anvendes Exzolt?
English: For more information about treatment with Exzolt, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Exzolt, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Exzolt, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Exzolt, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How does Exzolt work?
Danish: Hvordan virker Exzolt?
English: This usually disappears within one to four weeks.
Danish: Den forsvinder normalt i løbet af en til fire uger.
English: This summary was last updated on 24 October 2007.
Danish: Dette sammendrag blev sidst ajourført den 24. oktober 2007.