FrancophonIA/ELRC3.0 huggingface dataset:
English: Target species Route of administration
Danish: Dyrearter, som læge-midlet er beregnet til
English: MA (EU) number (Invented) name
Danish: Markedsføringstilladelsesnummer (EU)
English: Immediate packaging
Danish: Indgivelsesvej Emballage Pakningsstørrelse
English: Strength Pharmaceutical form
Danish: Lægemiddelf orm
English: What is Egranli?
Danish: Hvad er Egranli?
English: The company withdrew before the European Commission had issued a decision on this opinion.
Danish: Virksomheden trak sin ansøgning tilbage, inden Europa-Kommissionen havde truffet en afgørelse på grundlag af denne udtalelse.
English: Egranli is a medicine that contains the active substance balugrastim.
Danish: Egranli er et lægemiddel, der indeholder det aktive stof balugrastim.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application on the basis of its marketing strategy, and that it wished to focus on other projects.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen begrundede virksomheden tilbagetrækningen i sin markedsføringsstrategi, idet virksomheden ønskede at koncentrere sig om andre projekter.
English: What was Egranli expected to be used for?
Danish: Hvad forventedes Egranli anvendt til?
English: Withdrawal of the marketing authorisation application for Egranli (balugrastim)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Egranli (balugrastim)
English: The company informed the CHMP that there is no impact on patients as there are no ongoing clinical trials or compassionate use programmes using Egranli.
Danish: Virksomheden har oplyst CHMP om, at beslutningen ikke vil få konsekvenser for patienter, da der ikke pågår kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Egranli.
English: 21 November 2014 EMA/705109/2014 EMEA/H/C/002637
Danish: Den 21. november 2014 EMA/30225/2015
English: How is Egranli expected to work?
Danish: Hvordan forventes Egranli at virke?
English: Based on the review of the data, at the time of the withdrawal the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Egranli for the reduction of the duration of neutropenia and of the occurrence of febrile neutropenia.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP afgivet en positiv udtalelse og anbefalede udstedelse af markedsføringstilladelse for Egranli til mindskelse af varigheden af neutropeni og forekomsten af febril neutropeni.
English: Withdrawal of the marketing authorisation application for Egranli (balugrastim) EMA/705109/2014
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Egranli (balugrastim) EMA/30225/2015
English: The active substance in Egranli, balugrastim, is made up of ‘granulocyte-colony-stimulating factor' (G-CSF), a naturally occurring protein in the body that promotes the production of white blood cells including neutrophils in the bone marrow.
Danish: Det aktive stof i Egranli, balugrastim, er granulocytkolonistimulerende faktor (G-CSF), et naturligt protein i kroppen, der fremmer produktionen af hvide blodlegemer, herunder neutrofile, i knoglemarven.
English: The main measure of effectiveness was the reduction in the duration of neutropenia and of the number of febrile neutropenia cases.
Danish: Virkningen blev hovedsagelig bedømt på mindskelsen af varigheden af neutropeni og af antallet af tilfælde med febril neutropeni.
English: Egranli was to be used to reduce the duration of neutropenia (abnormally low level of neutrophils, a type of white blood cell that fights infection) and the occurrence of febrile neutropenia (neutropenia with fever) in adult cancer patients receiving cytotoxic chemotherapy (medicines that treat cancer by killing cells).
Danish: Egranli forventedes anvendt til at mindske varigheden af for lavt indhold af hvide blodlegemer af typen neutrofile, der bekæmper infektioner, (neutropeni) og forekomsten af neutropeni med feber (febril neutropeni) hos voksne kræftpatienter, som får celledræbende kræftmedicin (cytotoksisk kemoterapi)
English: It was to be available as a solution for injection in prefilled syringes.
Danish: Det var meningen, at det skulle kunne fås som injektionsvæske, opløsning, i fyldte sprøjter.
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 Egranli eller i programmer for anvendelse af Egranli med særlig udleveringstilladelse?
English: On 4 November 2014, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Egranli, for reduction in the duration of neutropenia and the occurrence of febrile neutropenia in adult cancer patients.
Danish: officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Egranli til mindskelse af varigheden af neutropeni og forekomsten af febril neutropeni hos voksne kræftpatienter.
English: Egranli was investigated in a main study in 304 breast cancer patients receiving chemotherapy, in which it was compared with another medicine containing a different long-acting G-CSF called pegfilgrastim.
Danish: <X blev undersøgt i en hovedundersøgelse hos 304 brystkræftpatienter i behandling med kemoterapi.
English: Balugrastim acts in the same way as naturally produced G-CSF, increasing the production of neutrophils and thereby helping to reduce the duration of neutropenia and to prevent febrile neutropenia (a sign of infection) in patients undergoing chemotherapy.
Danish: Dette mindsker varigheden af neutropeni og forebygger febril neutropeni (et tegn på infektion) hos patienter i kemoterapi.
English: The G-CSF in Egranli is attached to another natural blood protein called albumin, which decreases the rate at which G-CSF is removed from the body and allows the medicine to have a longer duration of action and to be given less often.
Danish: G-CSF i Egranli er bundet til et andet naturligt blodprotein, albumin.
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: Det betyder, at selvom der ikke er tilstrækkelig dokumentation fra kliniske 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: Arctic root medicines should only be used in adults over the age of 18 years and should not be taken for longer than two weeks without seeking medical advice.
Danish: Lægemidler med rosenrod bør kun anvendes til voksne over 18 år og bør ikke tages længere end to uger uden at kontakte lægen.
English: Arctic root is the common name for the underground stem (or rhizome) and root of the plant Rhodiola rosea L. The plant is cultivated or gathered to obtain the underground organs (root and rhizome) for medicinal use.
Danish: Rosenrod er fællesnavnet for jordstænglen (eller rizomet) og roden af planten Rhodiola rosea L. Planten dyrkes eller indsamles for at høste de underjordiske dele (rod og jordstængel) til medicinsk anvendelse.
English: Arctic root EMA/HMPC/289537/2012
Danish: Rosenrod EMA/HMPC/289537/2012
English: Arctic root preparations are obtained from the dried extracts prepared by ethanol extraction (a technique used to extract compounds from plant material by dissolving them in ethanol).
Danish: Rosenrod forarbejdes ved at fremstille ekstrakter, der tilberedes ved ethanolekstraktion (en teknik, der anvendes til at udtrække forbindelser fra plantemateriale ved at opløse dem i ethanol).
English: Information on the use and licensing of arctic root medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om anvendelse og godkendelse i EU's medlemsstater af lægemidler, der indeholder rosenrod, skal indhentes fra de relevante nationale myndigheder.
English: Other information about arctic root medicines
Danish: Andre oplysninger om lægemidler, der indeholder rosenrod
English: Arctic root can also be found in combination with other herbal substances in some herbal medicines.
Danish: Rosenrod findes desuden kombineret med andre droger i visse plantelægemidler.
English: Any applications for the licensing of medicines containing arctic 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 rosenrod, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing arctic root.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder rosenrod.
English: Arctic root medicines are generally well tolerated.
Danish: Lægemidler, der indeholder rosenrod, er generelt veltolereret.
English: Further information on the HMPC assessment of arctic 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 rosenrod, herunder detaljerede oplysninger om udvalgets konklusioner, findes under "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 arctic 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 rosenrod, 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: Detailed instruction on how to take arctic root 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 rosenrod skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: The HMPC concluded that, on the basis of its long-standing use, arctic root can be used for the temporary relief of symptoms of stress, such as fatigue and sensation of weakness.
Danish: På baggrund af den mangeårige anvendelse, har HMPC konkluderet, at rosenrod kan anvendes til midlertidig lindring af stresssymptomer, såsom træthed og udmattelse.
English: This summary is not intended to provide practical advice on how to use medicines containing arctic root.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder rosenrod, anvendes.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of arctic root.
Danish: Dette er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af rosenrod.
English: Herbal medicines containing arctic root are usually available in solid forms to be taken by mouth.
Danish: Plantelægemidler med rosenrod fås normalt i fast form til indtagelse gennem munden.
English: How are arctic root medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder rosenrod, i EU?
English: What evidence supports the use of arctic root medicines?
Danish: Hvilken dokumentation underbygger anvendelsen af lægemidler med rosenrod?
English: The HMPC conclusions on the use of arctic root medicines are based on their ‘traditional use'.
Danish: HMPC's konklusioner vedrørende brugen af lægemidlermed rosenroder baseret på den "traditionelle anvendelse".
English: Arctic root
Danish: Rosenrod
English: EMA/HMPC/289537/2012
Danish: EMA/HMPC/289537/2012 Udvalget for Plantelægemidler (HMPC)
English: In its assessment, the HMPC also considered clinical studies of small size that have been carried out to investigate the effects of arctic root medicines in adults suffering from stress and fatigue as compared with placebo (a dummy treatment).
Danish: Under vurderingen har HMPC også taget hensyn til mindre kliniske studier, hvor virkningen af rosenrod blev sammenlignet med placebo (en virkningsløs behandling) hos voksne, der lider af stress og træthed,Selv om en mulig virkning i form af en midlertidig lindring af stresssymptomer blev observeret, er der konstateret adskillige mangler ved disse undersøgelser.
English: What are the risks associated with arctic root medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder rosenrod?
English: For more information about treatment with arctic 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 rosenrod, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: What is arctic root?
Danish: Hvad er rosenrod?
English: Therefore, the HMPC conclusions on the use of arctic root medicines are based on their long-standing use.
Danish: HMPC's konklusioner for anvendelsen af lægemidler med rosenrod bygger derfor på den traditionelle anvendelse.
English: For practical information about using arctic 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 lægemidler med rosenrod, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Wash your hands.
Danish: Vask dine hænder.
English: At the final analysis, 1653 deaths were reported.
Danish: Ved den endelige analyse var der blevet indberettet 1.653 dødsfald.
English: The symptoms are:
Danish: Symptomerne er:
English: Date of first authorisation: 28 August 2007 Date of latest renewal: 18 June 2012
Danish: Dato for første markedsføringstilladelse: 28. august 2007 Dato for seneste fornyelse: 18. juni 2012
English: It may affect other treatments or test results.
Danish: Det kan påvirke andre behandlinger eller testresultater.
English: This usually takes between 15 and 30 minutes.
Danish: Dette tager normalt 15 til 30 minutter.
English: Make the next injection as soon as you remember.
Danish: Udfør den næste indsprøjtning, så snart du husker på det.
English: Patients should only be switched from one ESA to another under appropriate supervision.
Danish: Patienter bør kun skiftes fra en ESA til en anden under hensigtsmæssig supervision.
English: Total (N)b
Danish: I alt (N)b
English: Do not use this medicine if you notice that
Danish: Brug ikke lægemidlet, hvis du bemærker, at
English: Thus, the volume of distribution is slightly greater than the plasma space.
Danish: Fordelingsvoluminet er således lidt større end plasmavoluminet.
English: Depending on your individual situation a blood transfusion may be preferable.
Danish: Afhængigt af din individuelle situation kan en blodtransfusion være at foretrække.
English: Administer over at least one to five minutes, depending on the total dose.
Danish: Administreres over minimum 1 til 5 minutter afhængigt af den totale dosis.
English: • Severe allergic reaction that may include:
Danish: • Alvorlig allergisk reaktion, der kan omfatte:
English: It is important to tell your doctor if any of the following apply to you.
Danish: Det er vigtigt at fortælle det til lægen, hvis noget af det følgende gælder for dig.
English: If you know you suffer, or have suffered, from:
Danish: Hvis du ved du lider af, eller har lidt af:
English: Your doctor will decide if it is right for you to take them.
Danish: Din læge vil bestemme, om det er korrekt, at du tager dem.
English: • if you are pregnant, or think you may be pregnant.
Danish: • hvis du er gravid eller har mistanke om, at du er gravid.
English: Administer the dose as per standard protocol.
Danish: Administrer dosis ifølge standardprotokollen.
English: • Allergic reaction.
Danish: • Allergisk reaktion.
English: Corresponding Presentations in Quantity/Volume for each Strength
Danish: Tilsvarende formuleringer i kvantitet/volumen for hver styrke
English: • porphyria (a rare blood disorder).
Danish: • porfyri (en sjælden blodsygdom).
English: Adults donating their own blood
Danish: Voksne patienter, som giver deres eget blod
English: • Or under the skin (subcutaneously).
Danish: • Eller under huden (subkutant).
English: Generally, children under 30 kg require higher maintenance doses than children over 30 kg and adults.
Danish: Børn under 30 kg har generelt brug for en højere vedligeholdelsesdosis end børn over 30 kg og voksne.
English: Your doctor will decide this.
Danish: Din læge vil beslutte dette.
English: • the seal is broken.
Danish: • forseglingen er brudt.
English: SI-1234 Menges Slovenia
Danish: SI-1234 Menges Slovenien
English: This does not affect normal operation of the syringe.
Danish: Det påvirker ikke sprøjtens normale funktion.
English: It may be necessary to add or increase anti-hypertensive treatment.
Danish: Det kan blive nødvendigt at begynde eller øge den antihypertensive behandling.
English: ESAs are not indicated for use in this patient population,
Danish: ESA'er er ikke indiceret til brug hos denne patientpopulation,
English: • anaemia from other causes;
Danish: • anæmi af andre årsager,
English: The cause of your anaemia is also a factor in your doctor deciding the correct dose.
Danish: Årsagen til din anæmi er også en faktor, når din læge bestemmer den korrekte dosis.
English: Overall, these studies have methodological limitations but treatment was associated with positive trends towards higher haemoglobin levels.
Danish: Generelt har disse studier metodologiske begrænsninger, men behandlingen blev forbundet med positive tendenser mod højere hæmoglobinniveauer.
English: If the medicinal product has not been used at the end of this period, it should be disposed of.
Danish: Hvis præparatet ikke er blevet anvendt ved slutningen af denne periode, skal det bortskaffes.
English: • if you know, or think that it may have been accidentally frozen, or
Danish: • hvis du ved, eller tror, at det utilsigtet kan have været nedfrosset, eller
English: The role of ESAs on tumour progression or reduced progression-free survival cannot be excluded.
Danish: ESA'ernes rolle i tumorprogression eller reduceret progressionsfri overlevelse kan ikke udelukkes.
English: After approximately two months of therapy, virtually all patients were transfusion-independent.
Danish: Efter ca. to måneders behandling var alle patienter praktisk talt transfusionsuafhængige.
English: Three were confirmed TVE and in the remaining case (sudden death), the thromboembolic event was not confirmed.
Danish: Tre blev bekræftet som TVE, og i det resterende tilfælde (pludselig død) blev den tromboemboliske hændelse ikke bekræftet.
English: Do not double up the injections to make up for a forgotten dose.
Danish: Du må ikke fordoble injektionerne som erstatning for den glemte dosis.
English: • Once your anaemia has been corrected, your doctor will continue to check your blood regularly.
Danish: • Når din anæmi er blevet korrigeret, vil din læge fortsætte med at kontrollere dit blod regelmæssigt.
English: This temperature range should be closely maintained until administration to the patient.
Danish: Dette temperaturinterval skal opretholdes nøje indtil patientadministration.
English: MedDRA System Organ Classification (SOC)
Danish: Systemorganklasser i henhold til MedDRA (SOC)
English: All special warnings and special precautions associated with autologous predonation programmes, especially routine volume replacement, should be respected.
Danish: Alle særlige advarsler og særlige forsigtighedsregler forbundet med autologe prædonationsprogrammer, særligt rutinemæssig erstatning af volumen, skal respekteres.
English: 3x/week for 4 weeks
Danish: 3 gange ugentligt i 4 uger
English: • have recently had a heart attack or stroke
Danish: • for nyligt har haft et hjerteanfald eller slagtilfælde
English: It is recommended that initial erythroid response be assessed 8 to 12 weeks following initiation of treatment.
Danish: Det anbefales, at indledende erythroidrespons vurderes 8 til 12 uger efter behandlingsstart.
English: In addition, special precaution should be taken in patients with predisposition for development of DVTs.
Danish: Der skal endvidere tages særlige forholdsregler hos patienter, som er disponeret for udvikling af DVT.
English: • the liquid is coloured or you can see particles floating in it,
Danish: • injektionsvæsken er farvet, eller du kan se partiker i den,
English: EPO is involved in all phases of erythroid development, and has its principal effect at the level of erythroid precursors.
Danish: EPO er involveret i alle faser af erytroidudviklingen, og det har sin primære virkning på niveauet for erytroidforstadier.
English: Once the target haematocrit was achieved, the maintenance dose was individualised for each patient.
Danish: Når målet for hæmatokrit var opnået, blev vedligeholdelsesdosis fastlagt individuelt for hver patient.
English: Use the syringe within 3 days of taking it out of the refrigerator.
Danish: Anvend sprøjten inden for 3 dage efter den tages ud af køleskabet.
English: A bone marrow examination should also be considered for diagnosis of PRCA.
Danish: Det bør også overvejes at foretage et knoglemarvsstudie med henblik på diagnosticering af PRCA.
English: Haemoglobin levels should be monitored regularly.
Danish: Hæmoglobinniveauer bør kontrolleres regelmæssigt.
English: Your doctor will check on this.
Danish: Din læge vil kontrollere dette.
English: • Problem with the blood that may cause pain, dark coloured urine or increased sensitivity of the skin to sunlight (porphyria).
Danish: • Problemer med blodet, der kan forårsage smerte, mørkfarvet urin eller øget følsomhed i huden over for sollys (porfyri).
English: Raised blood pressure may require treatment with medicines (or adjustment to any medicines you already take for high blood pressure).
Danish: Forhøjet blodtryk kan kræve behandling med medicin (eller justering af medicin, som du allerede tager for højt blodtryk).
English: The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
Danish: Erytropoietins tilsyneladende molekylevægt er 32.000-40.000 dalton.
English: These may be more common at the start of treatment.
Danish: Disse symptomer kan være mere almindelige ved starten af behandlingen.
English: Occlusion of the dialysis system is possible if heparinisation is not optimum.
Danish: Tillukning af dialysesystemet kan indtræffe, hvis hepariniseringen ikke er optimal.
English: • If blood tests show your haemoglobin is too high before the operation, the treatment will be stopped.
Danish: • Hvis blodprøverne viser, at dit hæmoglobin er for højt før operationen, vil behandlingen blive stoppet.
English: An inverse relationship between apparent clearance and dose was noted in healthy subjects.
Danish: Der blev bemærket et inverst forhold mellem den tilsyneladende clearance og dosis hos raske personer.