FrancophonIA/ELRC3.0 huggingface dataset:
English: Blood and lymphatic system disorders leukopenia, neutropenia, anaemia pancytopenia, thrombocytopenia, eosinophilia, hypoalbuminaemia haemolytic anaemia, haemolysis (see section disseminated intravascular coagulation
Danish: Blod og lymfesystem leukopeni, neutropeni, anæmi pancytopeni trombocytopeni, eosinofili, hypoalbuminæmi hæmolytisk anæmi, hæmolyse (se pkt.
English: 1 vial contains 50 mg or 100 mg micafungin (as sodium).
Danish: 1 hætteglas indeholder 50 mg eller 100 mg micafungin (som natriumsalt).
English: - The dose to treat a Candida infection of the oesophagus is 150 mg for patients weighing more than 40 kg and 3 mg/kg per day for patients weighing 40 kg or less.
Danish: - Dosis til behandling af en Candida-infektion i spiserøret er 150 mg for patienter, der vejer mere end 40 kg, og 3 mg/kg per dag for patienter, der vejer 40 kg eller mindre.
English: MIC breakpoint (mg/L)
Danish: MIC-grænseværdi (mg/l) ≤S (Følsom)
English: 2 mg/kg/day*
Danish: 2 mg/kg/dag*
English: Nervous system disorders headache somnolence, tremor, dizziness, dysgeusia
Danish: Nervesystemet hovedpine døsighed, tremor,
English: Population PK modeling demonstrated that a dose of 10 mg/kg in children less than 4 month of age would be sufficient to achieve the target exposure for the treatment of CNS Candida infections.
Danish: mg/kg til børn under 4 måneder vil være tilstrækkelig til at opnå måleksponeringen til behandling af Candida-infektioner i CNS.
English: 5 ml approx. 10 ml
Danish: 5 ml ca. 10 ml
English: In the following table adverse reactions are listed by system organ class and MedDRA preferred term.
Danish: I nedenstående tabel er bivirkningerne opstillet efter organklassificering i henhold til MedDRA.
English: In both studies increased incidences/numbers of hepatocellular tumours were observed after the 18 and 20 month treatment free period in the high dose group of 32 mg/kg/day as well as in a lower dose group (although not statistically significant).
Danish: I begge studier blev der set stigende forekomster/antal af hepatocellulære tumorer efter henholdsvis 18 og 20 måneder, som udgjorde den behandlingsfrie periode.
English: Therefore, no dose adjustment is necessary for patients with mild to moderate hepatic impairment.
Danish: Dosisjustering af patienter med mild til moderat nedsat leverfunktion er derfor ikke nødvendig.
English: 5 ml approx. 5 ml (20 mg/ml)
Danish: 5 ml ca. 5 ml (20 mg/ml)
English: Renal and urinary disorders blood creatinine increased, blood urea increased, renal failure aggravated renal impairment (see section 4.4), acute renal failure
Danish: Nyrer og urinveje forhøjet serumkreatinin, forhøjet urinstof i blodet, forværret nyresvigt nedsat nyrefunktion (se pkt.
English: Candida species
Danish: EUCAST-grænseværdier Candida arter
English: In dog, liver effects consisted of increased weight and centrilobular hypertrophy, no degenerative changes of hepatocytes were observed.
Danish: Hos hunde viste leverpåvirkningerne sig ved vægtøgning og centrilobulær hypertrofi.
English: (hyperkalaemia); decreased phosphates in the blood (hypophosphataemia); anorexia (eating disorder) - insomnia (difficulty in sleeping); anxiety; confusion - feeling lethargic (somnolence); trembling; dizziness; disturbed taste - increased heart rate; stronger heartbeat; irregular heartbeat - high or low blood pressure; skin flushing
Danish: (thrombocytopeni), forhøjet antal af visse typer hvide blodlegemer, som kaldes eosinofile, nedsat albuminindhold i blodet (hypoalbuminæmi) - overfølsomhed - øget svedproduktion - nedsat natriumindhold i blodet (hyponatræmi), øget kaliumindhold i blodet (hyperkalæmi), nedsat fosfatindhold i blodet (hypofosfatæmi), anoreksi (spiseforstyrrelser) - søvnbesvær (insomni), angst, forvirring - søvnighed (døsighed), rysten, svimmelhed, smagsforstyrrelser - øget puls, kraftigere hjertebanken, uregelmæssig hjerterytme - højt eller lavt blodtryk, hudrødme - kortåndethed - fordøjelsesbesvær, forstoppelse
English: Male rats treated intravenously for 9 weeks showed vacuolation of the epididymal ductal epithelial cells, increased epididymis weights and reduced number of sperm cells (by 15%), however, in studies of 13 and 26 weeks duration these changes did not occur.
Danish: Hanrotter i intravenøs behandling i 9 uger viste vakuolisering i bitestiklernes duktale epitelceller, forøget bitestikkelvægt og reduceret antal sædceller (med 15 %).
English: The following reactions have been reported more often in paediatric patients than in adult patients: Common (may affect up to 1 in 10 people) - decreased blood platelets (thrombocytopenia) - increased heart rate (tachycardia) - high or low blood pressure - increased bile pigment in the blood (hyperbilirubinaemia); enlarged liver - acute kidney failure; increased urea in the blood
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer) - nedsat antal blodplader (trombocytopeni) - forøget hjertefrekvens (takykardi) - højt eller lavt blodtryk - øget indhold af galdefarvestof i blodet (hyperbilirubinæmi), forstørret lever - akut nyresvigt, øget indhold af urinstof i blodet
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret
English: The solution must not be used if it is cloudy or has precipitated.
Danish: Brug ikke opløsningen, hvis den er uklar eller har bundfald.
English: 5 ml approx. 5 ml (10 mg/ml)
Danish: 5 ml ca. 5 ml (10 mg/ml)
English: Mycamine 100 mg powder for solution for infusion micafungin
Danish: Mycamine 100 mg pulver til infusionsvæske, opløsning micafungin
English: Prescriber checklist
Danish: Tjekliste for ordinerende læger
English: (hypomagnesaemia); decreased calcium in the blood (hypocalcaemia) - headache - inflammation of the vein wall (at injection-site) - nausea (feeling sick); vomiting (being sick); diarrhoea; abdominal pain - abnormal liver function tests (increased alkaline phosphatase; increased aspartate aminotransferase, increased alanine aminotransferase) - increased bile pigment in the blood (hyperbilirubinaemia) - rash - fever - rigors (shivering)
Danish: (hypomagnesæmi), nedsat calciumindhold i blodet (hypocalcæmi) - hovedpine - betændelse af venevæggen (ved injektionsstedet) - kvalme, opkastning, diarré, mavesmerter - unormale leverfunktionstest (forhøjet alkalisk fosfatase, forhøjet aspartat aminotransferase,
English: 150 1 x 100 + 1 x
Danish: 150 1 x 100 + 1 x 50 5 ml ca. 10 ml
English: Mycamine 50 mg powder for solution for infusion Mycamine 100 mg powder for solution for infusion
Danish: Mycamine 50 mg pulver til infusionsvæske, opløsning Mycamine 100 mg pulver til infusionsvæske, opløsning
English: Mycamine 50 mg powder for solution for infusion micafungin
Danish: Mycamine 50 mg pulver til infusionsvæske, opløsning micafungin
English: Immune system disorders anaphylactic / anaphylactoid reaction (see section 4.4), hypersensitivity anaphylactic and anaphylactoid shock (see section 4.4)
Danish: 4.4), overfølsomhed anafylaktisk og anafylaktoid shock (se pkt.
English: Hepatobiliary disorders blood alkaline phosphatase increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased (including hyperbilirubinaemia), liver function test abnormal hepatic failure (see section 4.4), gammaglutamyltransferase increased, jaundice, cholestasis, hepatomegaly, hepatitis hepatocellular damage including fatal cases (see section 4.4)
Danish: Lever og galdeveje forhøjet alkalisk fosfatase i blodet, forhøjet aspartataminotransferase (ASAT), forhøjet alaninaminotransferase (ALAT), forhøjet blodbilirubin (inklusive hyperbilirubinæmi) unormal leverfunktionstest leversvigt (se pkt.
English: After reconstitution each ml contains 20 mg micafungin (as sodium).
Danish: Efter rekonstitution indeholder hver ml 20 mg micafungin (som natriumsalt).
English: After reconstitution each ml contains 10 mg micafungin (as sodium).
Danish: Efter rekonstitution indeholder hver ml 10 mg micafungin (som natriumsalt).
English: No dose adjustment of micafungin is required based on gender or race.
Danish: Dosisjustering er ikke nødvendig for patienter af bestemt køn eller race.
English: Haemolysis
Danish: Amning
English: Astellas Pharma B.V. Tel: +31 (0)71 5455745
Danish: Tlf: +31 (0)71 5455745
English: Each vial contains 50 mg micafungin (as sodium).
Danish: Hvert hætteglas indeholder 50 mg micafungin (som natriumsalt).
English: Each vial contains 100 mg micafungin (as sodium).
Danish: Hvert hætteglas indeholder 100 mg micafungin (som natriumsalt).
English: Diluted infusion solution
Danish: dissemineret intravaskulær koagulation
English: • Caution must be demonstrated if the patient: - has severe liver function impairment - has chronic liver diseases known to represent preneoplastic conditions (e.g. advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects) - is receiving a concomitant therapy including hepatotoxic and/or genotoxic properties
Danish: fremskreden leverfibrose, cirrose, viral hepatitis, neonatal leversygdom eller kongenitte enzymdefekter) - får samtidig behandling med hepatotoksiske og/eller genotoksiske egenskaber - har anamnese med hæmolyse, hæmolytisk anæmi eller nedsat nyrefunktion.
English: decreased albumin in the blood (hypoalbuminaemia) - hypersensitivity - increased sweating - decreased sodium in the blood (hyponatraemia); increased potassium in the blood
Danish: forhøjet alanin aminotransferase) - øget indhold af galdefarvestof i blodet (hyperbilirubinæmi) - udslæt - feber - kulderystelser (rysteture)
English: Astellas Pharma S.p.A. Tel: +39 02 921381
Danish: Tel: +39 0 2 921381
English: If you use Mycamine you should not breast-feed.
Danish: De bør ikke amme, når De er i behandling med Mycamine.
English: As Mycamine is given intravenously (into a vein), no restrictions on food or drink are required.
Danish: Der er derfor ingen begrænsninger af mad og drikke.
English: - shortness of breath - indigestion; constipation - liver failure; increased liver enzymes (gamma-glutamyltransferase); jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems); reduced bile reaching the intestine
Danish: - leversvigt, forhøjede leverenzymer (gamma-glutamyltransferase), gulsot (gulfarvning af hud eller det hvide i øjnene forårsaget af lever- eller blodproblemer), en nedsat galdemængde, der når tarmen (kolestase), forstørret lever, leverbetændelse - kløende udslæt (urtikaria), hudkløe, hudrødme (erytem) - unormale nyrefunktionstests (forhøjet serum-kreatinin, øget indhold af urinstof i blodet), forværret nyresvigt - øget indhold af et enzym kaldet laktat dehydrogenase - blodstørkning i venen ved injektionsstedet, betændelse på injektionsstedet, smerter ved injektionsstedet, væskeophobning i kroppen
English: 31 May 2016 EMA/270540/2016
Danish: 31. maj 2016 EMA/270540/2016
English: Knotgrass herb medicines should only be used in adults and adolescents over the age of 12 years.
Danish: Lægemidler med vejpileurt bør kun anvendes til voksne og børn over 12 år.
English: Any applications for the licensing of medicines containing knotgrass herb 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 vejpileurt, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: However, because of the limitations with the available data, the HMPC conclusions on the use of these knotgrass herb medicines are based on their long-standing use.
Danish: Men på grund af begrænsninger i de tilgængelige data er HMPC's konklusioner vedrørende anvendelsen af lægemidler med vejpileurt derfor baseret på den mangeårige traditionelle anvendelse.
English: Information on the use and licensing of knotgrass herb medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder vejpileurt, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: If symptoms last longer than two weeks or worsen during the use of the medicine for minor urinary tract problems a doctor or qualified healthcare practitioner should be consulted.
Danish: Hvis symptomerne varer længere end to uger eller forværres under brug af lægemidlet til behandling af mindre urinvejsproblemer, bør der søges råd hos en læge eller en kvalificeret sundhedsperson.
English: Although a possible effect in decreasing gingivitis was observed, information on how the study was conducted is incomplete, so firm conclusions could not be drawn.
Danish: Selvom en mulig virkning i form af lindring af tandkødsbetændelse blev observeret, foreligger der ikke tilstrækkelige oplysninger om, hvordan undersøgelsen er blevet gennemført.
English: The HMPC also considered studies in laboratory tests which support anti-inflammatory and antibacterial effects of knotgrass herb medicines.
Danish: HMPC har også vurderet laboratorieundersøgelser, der understøtter en antiinflammatorisk og antibakteriel virkning af lægemidler med vejpileurt.
English: Further information on the HMPC assessment of knotgrass herb 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 vejpileurt, 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 conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing knotgrass herb.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder vejpileurt.
English: Further information on the risks associated with knotgrass herb 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 vejpileurt, 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: This summary is not intended to provide practical advice on how to use medicines containing knotgrass herb.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder vejpileurt, skal anvendes.
English: Detailed instructions on how to take knotgrass herb 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 vejpileurt bør anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: Knotgrass herb EMA/270540/2016
Danish: Vejpileurt EMA/270540/2016
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of knotgrass herb.
Danish: Dette dokument er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af vejpileurt.
English: The HMPC conclusions on the use of these knotgrass herb medicines for common colds, minor mouth or throat inflammation and minor problems affecting the urinary tract are based on their ‘traditional use'.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med vejpileurt til behandling af forkølelse, mindre mund- og halsbetændelse og mindre urinvejsproblemer er baseret på lægemidlernes "traditionelle anvendelse".
English: Knotgrass herb is the common name for the flowering aerial parts of the plant Polygonum aviculare L. The HMPC conclusions only cover knotgrass herb preparations which are obtained by drying and comminuting (reducing into tiny pieces) the flowering aerial parts.
Danish: Vejpileurt er fællesnavnet for de blomstrende overjordiske dele af planten Polygonum aviculare L. HMPC's konklusioner omfatter kun tilberedninger af vejpileurt, som fremstilles ved tørring og findeling af blomsterne på de overjordiske dele.
English: How are knotgrass herb medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder vejpileurt, i EU?
English: Knotgrass herb preparations may also be found in combination with other herbal substances in some herbal medicines.
Danish: Tilberedninger af vejpileurt findes desuden kombineret med andre droger i visse plantelægemidler.
English: Herbal medicines containing these knotgrass herb preparations are usually available as herbal material that is used to make herbal teas to be drunk or added to water to produce a liquid (decoction) to be applied to the lining of the mouth.
Danish: Plantelægemidler med vejpileurt i disse tilberedninger fås normalt som en droge, der anvendes til at lave urtete beregnet til at drikke eller som tilsætning til vand, så der opnås et afkog, til anvendelse på mundslimhinden.
English: For more information about treatment with knotgrass herb 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 vejpileurt, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The HMPC concluded, that on the basis of its long-standing use, these knotgrass herb preparations can be used for the relief of symptoms of common cold, for treating symptoms of minor mouth or throat inflammation and for minor problems affecting the urinary tract (structures that carry urine) to increase the production of urine in order to achieve flushing of the urinary tract.
Danish: På baggrund af den mangeårige anvendelse har HMPC konkluderet, at vejpileurt i disse tilberedninger kan anvendes til behandling af forkølelsessymptomer, lettere symptomer på mund- og halsbetændelse samt for at øge urinproduktionen og opnå en bedre gennemskylning af urinvejene ved lettere uringvejsproblemer.
English: In its assessment, the HMPC considered a clinical study in men with gingivitis (inflammation of the gum).
Danish: HMPC har i sin vurdering lagt vægt på en klinisk undersøgelse af mænd med tandkødsbetændelse.
English: For practical information about using knotgrass herb 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 vejpileurt, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: What evidence supports the use of knotgrass herb medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af vejpileurt?
English: If symptoms last longer than one week or worsen during the use of the medicine for common cold symptoms or for minor mouth or throat inflammation, a doctor or qualified healthcare practitioner
Danish: Hvis symptomerne varer længere end én uge eller forværres under brug af lægemidlet til behandling af forkølelsessymptomer
English: What are the risks associated with knotgrass herb medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder vejpileurt?
English: Other information about knotgrass herb medicines
Danish: Andre oplysninger om lægemidler, der indeholder vejpileurt
English: What is knotgrass herb?
Danish: Hvad er vejpileurt?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Neupro on 15 February 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Neupro den 15. februar 2006.
English: Neupro is applied once a day at about the same time every day.
Danish: Neupro påsættes én gang dagligt på omtrent samme tidspunkt hver dag.
English: Neupro rotigotine
Danish: Neupro rotigotin
English: This is a summary of the European public assessment report (EPAR) for Neupro.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Neupro.
English: The full EPAR for Neupro can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Neupro findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Neupro
Danish: Andre oplysninger om Neupro
English: Neupro is used to treat the symptoms of the following diseases in adults:
Danish: Neupro anvendes til behandling af symptomerne på følgende sygdomme hos voksne:
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 Neupro.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Neupro.
English: Neupro is used when a specific cause for the disorder cannot be identified.
Danish: Neupro anvendes, når det ikke er muligt at fastslå en bestemt årsag til sygdommen.
English: Neupro was more effective than placebo in treating Parkinson's disease.
Danish: Neupro var mere effektivt end placebo til behandling af Parkinsons sygdom.
English: For more information about treatment with Neupro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Neupro, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The backing layer of Neupro contains aluminium.
Danish: Det yderste lag af Neupro indeholder aluminium.
English: To avoid skin burns, Neupro must be removed if the patient has to have magnetic resonance imaging (MRI) or cardioversion (a process that restores the heart's normal rhythm).
Danish: For at undgå forbrænding af huden skal Neupro fjernes, hvis patienten skal have foretaget en magnetisk resonans billeddannelse (MRI-scanning) eller kardioversion (en proces, der genetablerer normal hjerterytme).
English: The CHMP decided that Neupro's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Neupro opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Neupro delivers a constant supply of rotigotine through the skin into the bloodstream.
Danish: Neupro giver en konstant tilførsel af rotigotin gennem huden til blodbanen.
English: The active substance in Neupro, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine.
Danish: Det aktive stof i Neupro, rotigotin, er en dopaminagonist, hvilket vil sige, at den efterligner virkningen af dopamin.
English: Neupro was less effective than ropinirole: an improvement was seen in 70% of the patients receiving ropinirole.
Danish: Neupro var mindre effektivt end ropinirol: 70 % af de patienter, som fik ropinirol, oplevede en forbedring.
English: In the smaller studies completed later, the effectiveness of Neupro was found to be comparable with ropinirole.
Danish: I de mindre undersøgelser, der senere blev gennemført, blev virkningen af Neupro påvist at være sammenlignelig med ropinirol.
English: Neupro is a range of transdermal patches (patches that deliver a medicine across the skin).
Danish: Neupro er en serie af forskellige depotplastre (plastre, der afgiver et lægemiddel gennem huden).