FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the benefits and risks of Yargesa?
Danish: Hvilke fordele og risici er der forbundet med Yargesa?
English: Yargesa is available as 100 mg capsules to be taken by mouth.
Danish: Yargesa fås som kapsler a 100 mg, der tages gennem munden.
English: It is not intended to provide practical advice on how to use Yargesa.
Danish: Det er ikke en praktisk vejledning i, hvordan Yargesa bør anvendes.
English: Because Yargesa is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Yargesa er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: For more information about treatment with Yargesa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Yargesa, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Why is Yargesa approved?
Danish: Hvorfor blev Yargesa godkendt?
English: Yargesa is a medicine used to treat adults with mild to moderate type-1 Gaucher disease.
Danish: Yargesa er et lægemiddel, der anvendes til behandling af voksne med mild til moderat Gauchers sygdom, type 1.
English: Therefore, the CHMP's view was that, as for Zavesca, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Zavesca.
English: Patients with this disease lack an enzyme that breaks down a type of fat called glucosylceramide.
Danish: Patienter med denne sygdom mangler et enzym, der nedbryder en type fedt kaldet glucosylceramid.
English: The active substance in Yargesa, miglustat, prevents an enzyme called glucosylceramide synthase from working.
Danish: Det aktive stof i Yargesa, miglustat, forhindrer et enzym kaldet glucosylceramidsyntase i at virke.
English: For practical information about using Yargesa, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Yargesa, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Yargesa have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Yargesa.
English: How is Yargesa used?
Danish: Hvordan anvendes Yargesa?
English: How has Yargesa been studied?
Danish: Hvordan blev Yargesa undersøgt?
English: How does Yargesa work?
Danish: Hvordan virker Yargesa?
English: EU number Invented name Strength Pharmaceutical form Route of administration Packaging Content (concentration) Package size EU/1/02/235/001 Monotard
Danish: Emballage Indhold (koncentration) Pakningsstørrelse EU/1/02/235/001 Monotard 40 IE/ml Injektionsvæske, suspension Subkutan anvendelse Hætteglas 10 ml (1,4 mg/ml)
English: 31 July 2012
Danish: Den 31. juli 2012
English: The European Commission issued a decision on 31 July 2012.
Danish: Europa-Kommissionen traf en afgørelse den 31. juli 2012.
English: Tavanic is marketed in the following EU Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and United Kingdom.
Danish: Tavanic er godkendt i følgende EU-medlemsstater: Belgien, Bulgarien, Cypern, Estland, Finland, Frankrig, Det Forenede Kongerige, Grækenland, Irland, Italien, Litauen, Luxembourg, Malta, Nederlandene, Polen, Portugal, Slovakiet, Slovenien, Spanien, Sverige, Tjekkiet, Tyskland, Ungarn og Østrig.
English: Tavanic is authorised in the EU via national procedures.
Danish: Tavanic blev godkendt i EU via nationale procedurer.
English: What is Tavanic?
Danish: Hvad er Tavanic?
English: The company that markets these medicines is Sanofi.
Danish: Den virksomhed, der markedsfører disse lægemidler, er Sanofi.
English: Why was Tavanic reviewed?
Danish: Hvorfor blev Tavanic vurderet igen?
English: On 24 May 2012 the European Medicines Agency completed a review of Tavanic.
Danish: Den 24. maj 2012 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Tavanic.
English: Tavanic is an antibiotic that belongs to the group ‘fluoroquinolones'.
Danish: Tavanic er et antibiotikum, der tilhører gruppen af fluorquinoloner.
English: It works by blocking an enzyme that bacteria use to make copies of their DNA.
Danish: Det virker ved at blokere et enzym, som bakterierne anvender til at kopiere deres dna.
English: After reviewing the available data supporting the use of the medicine, the CHMP agreed that:
Danish: Efter gennemgang af de oplysninger, der underbygger lægemidlets anvendelse, fandt CHMP, at:
English: On 11 October 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Tavanic in the EU.
Danish: Den 11. oktober 2010 indbragte Europa-Kommissionen sagen for CHMP med henblik på at harmonisere markedsføringstilladelserne for Tavanic i EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the product information for Tavanic in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktoplysningerne for Tavanic i Den Europæiske Union (EU).
English: The CHMP also harmonised other sections of the SmPC including the addition of a new warning in section 4.4 recommending that an eye specialist should be consulted if vision becomes impaired or any effects on the eyes are experienced.
Danish: CHMP harmoniserede desuden andre afsnit af produktresuméet, bl.a. med tilføjelse af en ny advarsel i afsnit 4.4, hvor der anbefales konsultation hos øjenlæge i tilfælde af synsnedsættelse eller anden øjenpåvirkning.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: På grundlag af de forelagte data og den videnskabelige drøftelse i udvalget var CHMP af den opfattelse, at produktresuméer, etikettering og indlægssedler bør harmoniseres i EU.
English: Tavanic is currently used to treat various infections and is available as tablets or solution for infusion.
Danish: Tavanic anvendes på nuværende tidspunkt til behandling af forskellige infektioner og fås som tabletter og infusionsvæske, opløsning.
English: The amended information to doctors and patients is available here for solution for infusion and tablets.
Danish: De ændrede produktoplysninger til læger og patienter findes her for infusionsvæske, opløsning, og tabletter.
English: In addition, the Committee added new side effects in section 4.8 including ligament rupture, hypoglycaemic coma, benign intracranial hypertension, as well as palpitations and ventricular tachycardia, which may result in cardiac arrest.
Danish: Derudover tilføjede udvalget nye bivirkninger i afsnit 4.8, herunder ligamentruptur (bristning af ledbånd), hypoglykæmisk koma (bevidstløshed ved for lavt blodsukker), benign intrakraniel hypertension (godartet forhøjet hjernetryk) samt palpitationer (hjertebanken) og ventrikulær takykardi (ekstraslag, der er udløst fra hjertekammeret), som kan medføre hjertestop.
English: Based on the data reviewed, the CHMP decided a harmonisation of the contraindications of Tavanic in patients hypersensitive (allergic) to levofloxacin, any other quinolone or any of the excipients, in patients with epilepsy, in patients with history of tendon disorders related to fluoroquinolone administration, in children or growing adolescents, during pregnancy and in breast-feeding women.
Danish: På grundlag af de gennemgåede oplysninger fastlagde CHMP en harmoniseret ordlyd af kontraindikationerne for Tavanic hos patienter, der er overfølsomme for levofloxacin, for andre quinoloner eller for nogen af hjælpestofferne, hos patienter med tidligere senelidelser i forbindelse med anvendelse af fluorquinoloner, hos børn og unge i vækst, under graviditet og hos ammende kvinder.
English: By doing this, it stops the bacteria that are causing an infection from growing and multiplying.
Danish: Derved standser det væksten og formeringen af de bakterier, der bevirker infektionen.
English: Having harmonised the indications, the CHMP also harmonised the recommendations on the posology and frequency of administration of Tavanic, including the posology for acute exacerbations of chronic bronchitis and pyelonephritis.
Danish: Foruden indikationerne harmoniserede CHMP også anbefalingerne vedrørende dosis og behandlingshyppighed for Tavanic, herunder doseringen ved pludselig forværring af kronisk bronkitis og ved betændelse i nyrebækken og nyrer.
English: • Tavanic 250 mg and 500 mg film-coated tablets are indicated in acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia and complicated skin and soft tissue infections only when other commonly used antibacterial agents are not recommended.
Danish: • Tavanic, filmovertrukne tabletter, 250 mg og 500 mg, er indiceret til pludseligt indsættende bakte riel bihulebetændelse, pludselig forværring af kronisk bronkitis, samfundserhvervet lungebetæn delse og komplicerede infektioner i hud og underliggende væv, når brug af andre sædvanligt an vendte antibiotika frarådes.
English: • Tavanic 5mg/ml solution for infusion is indicated in community-acquired pneumonia and complicated skin and soft tissue infections only when other commonly used antibacterials are not recommended.
Danish: • Tavanic, infusionsvæske, opløsning 5 mg/ml, er indiceret til samfundserhvervet lungebetændelse og komplicerede infektioner i hud og underliggende væv, når brug af andre sædvanligt anvendte antibiotika frarådes.
English: Tavanic was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - lægemidler til mennesker (CMD(h)) fandt, at der er behov for harmonisering for Tavanic.
English: They are also indicated in pyelonephritis and complicated urinary tract infections (UTI), chronic bacterial prostatitis, uncomplicated cystitis and for the post-exposure prophylaxis and curative treatment of
Danish: Tabletterne er desuden indiceret ved betændelse i nyrebækken og ny rer, ved komplicerede urinvejsinfektioner, kronisk bakteriel blærehalskirtelbetændelse og ukompli ceret blærebetændelse samt til helbredende behandling af lungemiltbrand
English: chronic bacterial prostatitis, and for the post-exposure prophylaxis and curative treatment of
Danish: ved komplicerede urinvejsinfektioner og kronisk bakteriel blærehalskirtelbetændelse samt til fore byggende behandling efter udsættelse for smitte med lungemiltbrand og til helbredende behand ling heraf.
English: It is also indicated in pyelonephritis and complicated urinary tract infections (UTI),
Danish: Infusionsvæsken er desuden indiceret ved betændelse i nyrebækken og nyrer,
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zaltrap on 1 February 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zaltrap den 1. februar 2013.
English: This cycle of treatment is repeated every two weeks, until the disease gets worse or the patient cannot tolerate the treatment.
Danish: Denne procedure gentages hver anden uge, indtil sygdommen bliver værre, eller patienten ikke længere kan tåle behandlingen.
English: The full EPAR for Zaltrap can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zaltrap findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Zaltrap and what is it used for?
Danish: Hvad er Zaltrap, og hvad anvendes det til?
English: This is a summary of the European public assessment report (EPAR) for Zaltrap.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zaltrap.
English: Other information about Zaltrap
Danish: Andre oplysninger om Zaltrap
English: Why is Zaltrap approved?
Danish: Hvorfor blev Zaltrap godkendt?
English: Although medicines containing the same active substance are available for injection into the eye, Zaltrap must not be injected into the eye as it was not developed for such use and may cause local damage.
Danish: Selvom lægemidler med det samme aktive stof fås til injektion i øjet, må Zaltrap ikke injiceres i øjet, da det ikke er udviklet til det og kan forårsage lokale skader.
English: What measures are being taken to ensure the safe and effective use of Zaltrap?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zaltrap?
English: The main measure of effectiveness was the average length of time that patients survived after treatment.
Danish: Det primære mål for virkning var patienternes gennemsnitlige overlevelsestid efter behandlingen.
English: It is not intended to provide practical advice on how to use Zaltrap.
Danish: Det er ikke en praktisk vejledning i, hvordan Zaltrap bør anvendes.
English: As a result, the cancer cells cannot develop their own blood supply and are starved of oxygen and nutrients, so helping to slow down the growth of tumours.
Danish: Dette bevirker, at kræftcellerne ikke kan udvikle deres egen blodforsyning, og de får derfor mindre ilt og færre næringsstoffer, hvilket er med til at hæmme væksten af tumorer.
English: In this study, Zaltrap was more effective than placebo at increasing survival of patients: patients treated with Zaltrap plus FOLFIRI lived an average of 13.5 months, whereas patients treated with placebo and FOLFIRI lived an average of 12.1 months.
Danish: I denne undersøgelse var Zaltrap mere effektivt end placebo til at øge patienternes overlevelse: De patienter, der fik Zaltrap plus FOLFIRI, havde en gennemsnitlig overlevelse på 13,5 måneder, mens de patienter, der fik placebo plus FOLFIRI, havde en gennemsnitlig overlevelse på 12,1 måneder.
English: What are the risks associated with Zaltrap?
Danish: Hvilke risici er der forbundet med Zaltrap?
English: Zaltrap can only be obtained with a prescription and treatment should be supervised by a doctor who is experienced in using cancer medicines.
Danish: Zaltrap udleveres kun efter recept, og behandlingen bør overvåges af en læge med erfaring i brug af kræftmedicin.
English: Treatment should be discontinued, delayed, or the dose may have to be adjusted, in patients who develop certain side effects.
Danish: Behandlingen bør standses, udskydes eller dosisjusteres hos patienter, der får bestemte bivirkninger.
English: Although Zaltrap is associated with significant side effects, which can be severe enough to force treatment to be stopped, the results of the large main study show that there is a small but clinically significant benefit in prolonging the life of treated patients in whom previous treatment failed.
Danish: Selvom Zaltrap er forbundet med væsentlige bivirkninger, der kan være så svære, at man bliver nødt til at standse behandlingen, viser resultaterne fra den store hovedundersøgelse, at det har en lille, men klinisk væsentlig fordel ved at virke livsforlængende hos patienter, der tidligere har oplevet behandlingssvigt.
English: The medicine contains the active substance aflibercept.
Danish: Zaltrap indeholder det aktive stof aflibercept.
English: Overall, the European Medicines Agency decided that Zaltrap's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: CHMP konkluderede derfor, at fordelene ved Zaltrap overordnet set opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Zaltrap was investigated in one main study involving 1,226 adults with metastatic colorectal cancer that had not responded to oxaliplatin-based treatment.
Danish: Zaltrap er blevet vurderet i en hovedundersøgelse af 1.226 patienter med metastatisk kolorektal cancer, som ikke havde reageret på tidligere oxaliplatin-baseret behandling.
English: Zaltrap is given as an infusion (drip) into the vein over one hour, at a dose of 4 mg per kilogram body weight.
Danish: Zaltrap gives som infusion (drop) i en blodåre over 1 time i en dosis på 4 mg pr. kilo legemsvægt, hvorefter der gives FOLFIRI.
English: Zaltrap is used with FOLFIRI, which is a treatment combining the medicines irinotecan, 5-fluorouracil, and folinic acid.
Danish: Zaltrap anvendes sammen med FOLFIRI, der er en kombinationsbehandling bestående af midlerne irinotecan, 5-fluorouracil og folinsyre.
English: Zaltrap was compared with placebo (a dummy treatment) when added to FOLFIRI.
Danish: Zaltrap blev sammenlignet med placebo (et ikke-aktivt stof) som tillægsbehandling til FOLFIRI.
English: For more information about treatment with Zaltrap, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zaltrap, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: By binding to VEGF and PlGF, aflibercept stops them having an effect.
Danish: Når aflibercept binder til VEGF og PlGF, blokeres deres effekt.
English: Zaltrap is a cancer medicine used to treat adults with metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body) for whom treatment based on another medicine, oxaliplatin, has not worked or the cancer got worse.
Danish: Zaltrap er et kræftlægemiddel, der anvendes til behandling af voksne patienter med tyktarmskræft, der har spredt sig til andre dele af kroppen (metastatisk kolorektal cancer), og hos hvem der ved behandling med et andet kræftlægemiddel, oxaliplatin, er set behandlingssvigt eller forværring af kræftsygdommen.
English: For practical information about using Zaltrap, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Zaltrap, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The most common side effects with Zaltrap in combination with FOLFIRI (which may affect more than 20 patients in 100) are leucopenia and neutropenia (low levels of white cells in the blood, including the type that fight infections), diarrhoea, proteinuria (protein in the urine), increased blood levels of liver enzymes (aspartate and alanine transaminases), stomatitis (inflammation of the mouth), tiredness, thrombocytopenia (low blood platelet counts), hypertension (high blood pressure), weight loss, decreased appetite, epistaxis (nose bleeds), abdominal pain, dysphonia (speech disturbance), increases in creatinine in the blood (a marker of kidney problems), and headache.
Danish: De hyppigste bivirkninger ved Zaltrap i kombination med FOLFIRI (der kan forekomme hos mere end 20 ud af 100 patienter) er leukopeni og neutropeni (lavt antal hvide blodlegemer, herunder den type, der bekæmper infektion), diarré, protein i urinen (proteinuri), forhøjede leverenzymer (ASAT og ALAT), mundbetændelse, træthed, lavt antal blodplader (trombocytopeni), forhøjet blodtryk, vægttab, nedsat appetit, næseblod, mavesmerter, stemmesvigt (dysfoni), forhøjet kreatinin i blodet (tegn på nyreproblemer) og hovedpine.
English: What benefits of Zaltrap have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zaltrap?
English: How is Zaltrap used?
Danish: Hvordan anvendes Zaltrap?
English: The most common effects that led to treatment being permanently stopped were problems with the circulation including hypertension, infections, tiredness, diarrhoea, dehydration, stomatitis, neutropenia, proteinuria, and pulmonary embolism (a clot in a blood vessel supplying the lungs).
Danish: De hyppigste bivirkninger, der førte til permanent behandlingsstop, var problemer med kredsløbet, herunder forhøjet blodtryk, infektioner, træthed, diarré, dehydrering, mundbetændelse, lavt antal hvide blodlegemer (neutropeni), protein i urinen og lungeemboli (en blodprop i de kar, der forsyner lungerne med blod).
English: The active substance in Zaltrap, aflibercept, is a protein that attaches to vascular endothelial growth factor (VEGF) and placenta growth factor (PlGF), substances that circulate in the blood and make blood vessels grow.
Danish: Det aktive stof i Zaltrap, aflibercept, er et protein, som binder til stoffer i blodbanen, der stimulerer væksten af blodkar (såkaldt vaskulær endotel-vækstfaktor (VEGF) og placenta-vækstfaktor (PlGF)).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zaltrap have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Zaltrap.
English: For the full list of all side effects reported with Zaltrap, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Zaltrap fremgår af indlægssedlen.
English: How does Zaltrap work?
Danish: Hvordan virker Zaltrap?
English: For further details, see the package leaflet.
Danish: De nærmere oplysninger fremgår af indlægssedlen.
English: 1000 mg Granules for oral suspension Oral use
Danish: 1000 mg Granulat til oral suspension
English: EU Number
Danish: Paknings-størrelse
English: (Invented) nameStrength Pharmaceutical Form Route of AdministrationImmediate PackagingPack size
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
English: 21 January 2013
Danish: Den 21. januar 2013
English: Questions and answers on the review of tolperisonecontaining medicines
Danish: Spørgsmål og svar om gennemgangen af lægemidler indeholdende tolperison
English: The European Commission issued a decision on this opinion on 21 January 2013.
Danish: Europa-Kommissionen traf en afgørelse om denne udtalelse den 21. januar 2013.
English: The CHMP confirmed the above conclusions after re-examining its opinion.
Danish: CHMP bekræftede ovenstående konklusioner efter fornyet overvejelse af sin udtalelse.
English: After re-examination, the Committee confirmed these recommendations on 18 October 2012.
Danish: Efter fornyet gennemgang bekræftede udvalget disse anbefalinger den 18. oktober
English: What is tolperisone?
Danish: Hvad er tolperison?
English: Why were tolperisone-containing medicines reviewed?
Danish: Hvorfor blev lægemidler indeholdende tolperison gennemgået på ny?
English: On 21 June 2012, the European Medicines Agency completed a review of the safety and effectiveness of tolperisone.
Danish: Den 21. juni 2012 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af sikkerheden og virkningen af tolperison.
English: However, the study only included adults with post-stroke spasticity.
Danish: Undersøgelsen omfattede imidlertid kun voksne med postapoplektisk spasticitet.
English: If symptoms of hypersensitivity occur, treatment should be stopped immediately.
Danish: Hvis der optræder symptomer på hypersensitivitet, bør behandlingen seponeres øjeblikkelig.
English: The CHMP noted that most of the studies with oral tolperisone, performed in the 1960s and 1970s, were of a lower standard than that expected today.
Danish: CHMP bemærkede, at de fleste af undersøgelserne med oral indgift af tolperison var udført i 1960'erne og 1970'erne og var af lavere standard end den, der forventes i dag.