FrancophonIA/ELRC3.0 huggingface dataset:
English: Gefitinib Mylan contains the active substance gefitinib and is a ‘generic medicine'.
Danish: Gefitinib Mylan indeholder det aktive stof gefitinib og er et "generisk lægemiddel".
English: Therefore, the Agency's view was that, as for Iressa, the benefit of Gefitinib Mylan outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Gefitinib Mylan opvejer de identificerede risici som for Iressa, og at det kan godkendes til anvendelse i EU.
English: Why is Gefitinib Mylan authorised in the EU?
Danish: Hvorfor blev Gefitinib Mylan godkendt i EU?
English: These enzymes can be found on the surface of cancer cells, such as EGFR on the surface of non-small cell lung cancer cells.
Danish: EGFR findes på overfladen af kræftcellerne ved ikke-småcellet lungekræft.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gefitinib Mylan 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 Gefitinib Mylan.
English: How is Gefitinib Mylan used?
Danish: Hvordan anvendes Gefitinib Mylan?
English: How has Gefitinib Mylan been studied?
Danish: Hvordan blev Gefitinib Mylan undersøgt?
English: How does Gefitinib Mylan work?
Danish: Hvordan virker Gefitinib Mylan?
English: Content (concentration)
Danish: Post (plastik)
English: Subcutaneous use Type I glass bottle with a chlorobutyl rubber stopper and aluminium cap
Danish: Subkutan injektion Type I glasflaske med klorbutyl gummiprop og aluminiumshætte
English: EMEA Number Invented name
Danish: EU-nummer Særnavn
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Dyrearter, som lægemidlet er beregnet til
English: Target Species
Danish: Kvæg Får
English: * Equivalent to titre prior to inactivation (log10)
Danish: EU/2/09/094/001 BTVPUR Alsap 8 ≥ 7.1 CCID50*
English: placebo.
Danish: fik placebo.
English: Adopted at the 6-9 June 2016 PRAC
Danish: Vedtaget på PRAC's møde 6.-9. juni 2016
English: The available data do not indicate a clinically significant benefit from riociguat treatment in these patients.
Danish: Tilgængelige data viser ikke en klinisk signifikant fordel ved riociguatsbehandling hos disse patienter.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/400813/2016
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger om signaler EMA/PRAC/424169/2016
English: Interim results showed an increased risk of mortality and serious adverse events in subjects receiving riociguat compared to those receiving
Danish: De foreløbige resultater viste en øget risiko for død og alvorlige hændelser hos patienter, der fik riociguat, sammenlignet med patienter, der
English: Section 2 - What you need to know before you take Adempas Do NOT take Adempas: - If you have increased pressure in your pulmonary circulation associated with scarring of the lungs, of unknown cause (idiopathic pulmonary pneumonia).
Danish: Punkt 2 - Det skal du vide, før du begynder at tage Adempas Tag IKKE Adempas: - Hvis du har for højt tryk i lungekredsløbet i forbindelse med dannelse af arvæv i lungerne af ukendt årsag (idiopatisk pulmonal pneumonitis).
English: A randomised, double blind, placebo-controlled phase II study (RISE-IIP) to evaluate the efficacy and safety of riociguat in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) was terminated early.
Danish: Et randomiseret, dobbeltblindt placebo-kontrolleret fase II-studie (RISE-IPP) til evaluering af riociguats virkning og sikkerhed hos patienter med symptomatisk pulmonal hypertension associeret med idiopatisk interstitiel pneumonitis (PH-IIP) blev afsluttet tidligt.
English: Riociguat - Increased mortality and serious adverse events (SAEs) in patients with pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) in a single clinical trial (EPITT no 18681)
Danish: Riociguat - Øget mortalitet og alvorlige hændelser r hos patienter med pulmonal hypertension associeret med idiopatisk interstitiel pneumonitis (PH-IIP) i et enkelt klinisk forsøg (EPITT nr. 18681)
English: Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP)
Danish: Patienter med pulmonal hypertension associeret med idiopatisk interstitiel pneumonitis (PH-IIP)
English: Section 4.3 - Contraindications - Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) (see Section 5.1)
Danish: Punkt 4.3 - Kontraindikationer - Patienter med pulmonal hypertension associeret med idiopatisk interstitiel pneumonitis (PH-IIP) (se pkt.
English: Riociguat is therefore contraindicated in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (see section 4.3).
Danish: Riociguat er derfor kontraindikeret til patienter med pulmonal hypertension associeret med idiopatisk interstitiel pneumonitis (se pkt.
English: It may be risky for you to have sex.
Danish: Det kan være risikabelt for Dem at have sex.
English: Date of first authorisation: 6 March 2003 Date of latest renewal: 6 March 2008
Danish: Dato for første markedsføringstilladelse: 6. marts 2003 Dato for seneste fornyelse: 6. marts 2008
English: When using the individual correction formulae, none of the values were out of the limit.
Danish: Når den individuelle korrektionsformel blev anvendt var ingen af værdierne udenfor grænsen.
English: - If you have or have had low blood pressure.
Danish: - Hvis De har eller har haft lavt blodtryk.
English: The mean absolute oral bioavailability is 15%.
Danish: Den gennemsnitlige absolutte orale biotilgængelighed er 15%.
English: Levitra with food, drink and alcohol
Danish: Brug af Levitra sammen med mad, drikke og alkohol
English: Do not take Levitra more than once a day.
Danish: De må ikke tage Levitra mere end én gang i løbet af døgnet.
English: Most of the effects are mild or moderate.
Danish: De fleste af bivirkningerne er som regel milde eller moderate.
English: There are no fertility data available.
Danish: Der foreligger ingen fertilitetsdata.
English: The safety and efficacy of vardenafil was maintained in long-term studies.
Danish: Sikkerheden og effekten af vardenafil var opretholdt i langtidsstudier.
English: Most of the men who experienced these side effects had heart problems before taking this medicine.
Danish: De fleste af de mænd, som oplevede disse bivirkninger, havde hjerteproblemer, før de tog denne medicin.
English: It is not possible to determine whether these events were directly related to vardenafil.
Danish: Det er ikke muligt at afgøre, om disse hændelser var direkte relateret til vardenafil.
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter ”EXP”.
English: There are no studies of vardenafil in pregnant women.
Danish: Der findes ingen studier med vardenafil hos gravide kvinder.
English: The clinical relevance of this finding is unknown and cannot be generalised to all patients under all circumstances, as it will depend on the individual risk factors and susceptibilities that may be present at any time in any given patient.
Danish: Den kliniske relevans heraf er ukendt og kan ikke generaliseres til alle patienter under alle forhold, da det vil afhænge af individuelle risikofaktorer og modtagelighed som kan være til stede på hvilket som helst tidspunkt hos enhver given patient.
English: Use in adult men
Danish: Anvendelse hos voksne mænd
English: Moxifloxacin (400 mg) was included as an active internal control.
Danish: Moxifloxacin (400 mg) var inkluderet som aktiv intern kontrol.
English: Of these, 900 patients have been treated for one year or longer.
Danish: Heraf havde flere end 900 patienter været behandlet i et år eller længere.
English: Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
Danish: Hos de fleste af de patienter, hvor disse hændelser er blevet rapporteret, var der allerede eksisterende kardiovaskulære risikofaktorer.
English: Sudden death
Danish: Pludselig død
English: - Alcoholic drink can make erection difficulties worse.
Danish: - Alkoholiske drikke kan forværre erektionsproblemer.
English: There was no evidence of favourable clinical effect of the combination in the population studied.
Danish: Der var ingen evidens for en gunstig klinisk virkning af kombinationen i den undersøgte population.
English: Very rare or not known:
Danish: Meget sjældne eller ikke kendte bivirkninger:
English: The actual clinical impact of these QT changes is unknown.
Danish: Den faktiske kliniske virkning af disse QT-ændringer kendes ikke.
English: At least one in ten men has trouble getting or keeping an erection at some time.
Danish: Mindst 1 ud af 10 mænd har problemer med at opnå eller vedligeholde en erektion over et givent tidsrum.
English: Effect on QTc interval
Danish: Virkning på QTc-intervallet
English: Therefore, the current information of section 4.8 should be revised to highlight the temporal association with vardenafil.
Danish: Derfor bør de nuværende informationer i sektion 4.8 ændres for at fremhæve den tidsmæssige relation til vardenafil.
English: This was not associated with any muscle or neurological toxicity.
Danish: Dette var ikke associeret med muskel- eller neurologisk toksicitet.
English: However, it is not possible to definitively determine whether these events are related directly to these risk factors, to vardenafil, to sexual activity, or to a combination of these or other factors.
Danish: Det er imidlertid ikke muligt endeligt at afgøre, om disse hændelser er direkte relateret til disse risikofaktorer, til vardenafil, til seksuel aktivitet eller til en kombination af disse eller andre faktorer.
English: In order for Levitra to be effective, sexual stimulation is required.
Danish: For at Levitra kan være effektiv, er seksuel stimulation nødvendig.
English: Hypotension Hypertension
Danish: Hypertension Hypotension
English: Men who take too much Levitra may experience more side effects or may get severe back pain.
Danish: Mænd, som tager for meget Levitra, kan opleve flere bivirkninger eller få alvorlige rygsmerter.
English: There may be physical or psychological causes, or a mixture of both.
Danish: Dette kan skyldes fysiske eller psykologiske årsager, eller mest sandsynligt en kombination af begge dele.
English: Due to the nitrate component it has the potential to have serious interaction with vardenafil.
Danish: På grund af nitratkomponenten kan det potentielt have alvorlige interaktioner med vardenafil.
English: Parts of M1 are in the form of the glucuronide in systemic circulation.
Danish: En del af M1 er på glukuronid-form i den systemiske cirkulation.
English: Further information on clinical trials
Danish: Yderligere information om kliniske studier
English: Stop taking Levitra and contact your doctor immediately.
Danish: Stop med at tage Levitra og kontakt øjeblikkeligt Deres læge.
English: - You can take Levitra with or without food but preferably not after a heavy or high-fat meal as this may delay the effect.
Danish: - De kan tage Levitra uafhængigt af måltider, men helst ikke efter et massivt måltid eller et meget fedtholdigt måltid, da det kan forsinke virkningen.
English: In addition, in line with the product information of other PDE5s, a warning should also be included in section 4.4 to highlight these events, and reflect that it is not possible to definitively determine whether these events are related directly to any risk factors, to vardenafil, to sexual activity, or to a combination of these or other factors.
Danish: I overensstemmelse med produktinformationen for andre PDE5er skal der derudover også inkluderes en advarsel i sektion 4.4 for fremhæve disse hændelser og afspejle at det ikke har været muligt endeligt at afgøre, om disse tilfælde er direkte relateret til eventuelle risikofaktorer, til vardenafil, til seksuel aktivitet eller til en kombination af disse eller andre faktorer.
English: Based on tolerability and efficacy, the dose may subsequently be increased.
Danish: Vurderet ud fra tolerance og effekt kan dosis efterfølgende øges.
English: The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of the paediatric population in the treatment of the erectile dysfunction.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier i alle undergrupper af den pædiatriske population ved behandlingen af erektil dysfunktion.
English: During sexual stimulation, nitric oxide is released.
Danish: Ved seksuel stimulation frigives nitrogenoxid.
English: The maximum recommended dosing frequency is once per day.
Danish: Den anbefalede maksimale dosisfrekvens er én gang i døgnet.
English: Effect on vision
Danish: Virkning på synet
English: Talk to a doctor without taking Levitra.
Danish: Tal med en læge uden at tage Levitra.
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Danish: CHMP tilslutter sig PRACs videnskabelige konklusioner.
English: Treatment of erectile dysfunction in adult men.
Danish: Behandling af erektil dysfunktion hos voksne mænd.
English: For vardenafil as well as M1, protein binding is independent of total drug concentrations.
Danish: For vardenafil såvel som for M1 er proteinbindingen uafhængig af de totale stofkoncentrationer.
English: Vardenafil AUC is not affected.
Danish: AUC for vardenafil påvirkes ikke.
English: - Don't drink grapefruit juice when you use Levitra.
Danish: - Drik ikke grapefrugtjuice, når De bruger Levitra.
English: The most commonly reported adverse drug reaction occurring in ≥ 10% of patients is headache.
Danish: Den hyppigst indberettede bivirkning, som forekom hos ≥ 10% af patienterne, er hovedpine.
English: The combination should be avoided (see section 4.5).
Danish: Kombinationen bør undgås (se pkt.
English: - If you have recently had a stroke or heart attack.
Danish: - Hvis De for nylig har haft et slagtilfælde eller hjertetilfælde.
English: The chance of having a side effect is described by the following categories:
Danish: Risikoen for at få en bivirkning er beskrevet med følgende hyppigheder:
English: Sudden decrease or loss of hearing has been reported.
Danish: Der er rapporteret pludseligt nedsat hørelse eller høretab.
English: Store in the original package in order to protect from humidity and light.
Danish: Opbevares i den originale pakning for at beskytte mod fugt og lys.
English: Renal dialysis is not expected to accelerate clearance, as vardenafil is highly bound to plasma proteins and not significantly eliminated in the urine.
Danish: Renal dialyse forventes ikke at øge clearance, da vardenafil i høj grad er bundet til plasmaproteiner og ikke udskilles af betydning i urinen.
English: The mean steady state volume of distribution for vardenafil is 208 l, indicating distribution into the tissues.
Danish: Det gennemsnitlige steady-state fordelingsvolumen for vardenafil er 208 l, hvilket tyder på fordeling ind i vævene.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: De eller deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: - If your family has a history of degenerative eye diseases (such as retinitis pigmentosa).
Danish: - Hvis der i Deres familie har været tilfælde af degenerative øjensygdomme (som f.eks. retinitis pigmentosa).
English: Elderly (≥65 years old)
Danish: Anvendelse hos ældre (≥65 år)
English: Dissolve in the mouth
Danish: Opløses i munden.
English: Tell your doctor if you think Levitra is too strong or too weak.
Danish: Tal med Deres læge, hvis De mener, at Levitra er for kraftige eller for svage.
English: Therefore vardenafil should be administered to these patients only after careful benefit-risk assessment.
Danish: Derfor bør vardenafil kun gives til disse patienter efter omhyggeligt at have vurderet fordele over for risici.
English: - Swallow one tablet with a glass of water
Danish: - En tablet synkes med et glas vand
English: An additional analysis, including data from clinical trials, post marketing experience and literature showed that some occurred with a close temporal association (the two first weeks) after the intake of vardenafil.
Danish: En yderligere analyse, som inkluderer data fra kliniske forsøg, erfaring efter marketingsføring og litteratur, viste, at nogle forekom med en tidsmæssigt tæt relation (de to første uger) efter indtagelsen af vardenafil.
English: Concomitant intake of grapefruit or grapefruit juice is expected to increase the plasma concentrations of vardenafil.
Danish: Samtidig indtagelse af grapefrugt eller grapefrugtjuice forventes at øge plasmakoncentrationen af vardenafil.
English: Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC code: G04BE09.
Danish: Farmakoterapeutisk klassifikation: Urologika, lægemidler anvendt ved erektil dysfunktion, ATC-kode: G04BE09.
English: - The active substance is vardenafil.
Danish: - Aktivt stof: vardenafil.
English: Levitra allows an erection to last long enough for you to satisfactorily complete sexual activity.
Danish: Levitra lader en erektion vare længe nok til, at De på tilfredsstillende måde kan gennemføre en seksuel aktivitet.
English: Over 2,500 patients have been treated with vardenafil for six months or longer.
Danish: Flere end 2.500 patienter havde været behandlet med vardenafil i seks måneder eller længere.
English: - Swallow one tablet with a glass of water.
Danish: - En tablet synkes med et glas vand.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for vardenafil, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRACs vurderingsrapport om PSUR'erne for vardenafil er CHMP nået frem til følgende videnskabelige konklusioner:
English: With sexual stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Levitra.
Danish: I forbindelse med seksuel stimulation kan De opnå en erektion i tidsrummet fra 25 minutter op til 4-5 timer efter at have taget Levitra.
English: The tablets are provided in blister packs containing 2, 4, 8, 12 or 20 tablets.
Danish: Tabletterne findes i blisterpakninger, som indeholder 2, 4, 8, 12, eller 20 tabletter.
English: Effects on the QT interval were measured one hour post-dose (average tmax for vardenafil).
Danish: Påvirkninger af QTintervallet blev målt en time efter dosering (gennemsnitlig tmax for vardenafil).
English: - If you are taking riociguat.
Danish: - Hvis De tager riociguat.
English: Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been experienced by patients.
Danish: Nogle patienter har oplevet delvist, pludseligt, midlertidigt eller permanent nedsat syn eller synstab på det ene eller begge øjne.
English: The elimination half-life of the metabolite M1 is between 3 to 5 hours, similar to parent drug.
Danish: Elimineringshalveringstiden for metabolitten M1 er mellem 3 og 5 timer, svarende til moderstoffet.
English: However, 90% of the time, maximum plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Danish: I 90% af tilfældene blev den maksimale plasmakoncentration imidlertid nået inden for 30 til 120 minutter (median 60 minutter) efter oral indgift i fastende tilstand.
English: It reduces the action of the natural chemical in your body which makes erections go away.
Danish: Det nedsætter funktionen af det naturlige stof i kroppen, der fjerner en erektion.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale repporteringssystem anført i Appendiks V.
English: (cannot be estimated from the available data)
Danish: Ikke kendte (kan ikke estimeres ud fra forhåndenværende data)
English: Nicorandil is a hybrid of potassium channel opener and nitrate.
Danish: Nicorandil er en hybrid bestående af en kaliumkanalåbner og nitrat.
English: Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
Danish: Erektil dysfunktion er manglende evne til at opnå eller vedligeholde en erektion af penis, som er tilstrækkelig til tilfredsstillende seksuel aktivitet.
English: In general, the incidence of adverse reactions (especially “dizziness”) has been shown to be slightly higher in patients with a history of hypertension.
Danish: Generelt er det vist, at bivirkninger (især ”svimmelhed”) forekommer lidt hyppigere hos patienter med hypertension i anamnesen.
English: At 24 hours, the plasma levels of vardenafil had fallen to approximately 4% of the maximum vardenafil plasma level (Cmax).
Danish: Efter 24 timer var plasmaniveauet af vardenafil faldet til 4% af det maksimale vardenafil plasmaniveau (Cmax).
English: In vitro studies have shown that vardenafil is more potent on PDE5 than on other known phosphodiesterases (>15-fold relative to PDE6, >130-fold relative to PDE1, >300-fold relative to PDE11, and >1000-fold relative to PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 and PDE10).
Danish: In vitro-undersøgelser har vist, at vardenafil er mere potent overfor PDE5 end andre kendte phosphodiesteraser (> 15 gange i forhold til PDE6, > 130 gange i forhold til PDE1, > 300 gange i forhold til PDE11, og > 1000 gange i forhold til PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 og PDE10).
English: The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Danish: CHMP anbefaler, at betingelserne i markedsføringstilladelsen/-tilladelserne ændres.
English: The following groups were not well represented in clinical trials: elderly (>75 years, 2.4%), and patients with certain cardiovascular conditions (see section 4.3).
Danish: De følgende grupper var ikke velrepræsenterede i kliniske studier: Ældre (>75 år, 2,4%) og patienter med visse kardiovaskulære tilstande (se pkt.
English: - If you have a physical condition affecting the shape of the penis.
Danish: - Hvis De har en fysisk tilstand, som påvirker formen af penis.
English: Among subjects treated with terazosin, hypotension was observed more frequently when vardenafil and terazosin were given simultaneously than when the dosing was separated by a time interval of 6 hours.
Danish: Blandt personer behandlet med terazosin blev hypotension observeret hyppigere, når vardenafil og terazosin blev givet samtidig, end når doseringerne var separeret med et tidsinterval på 6 timer.
English: - Ritonavir or indinavir, medicines for HIV.
Danish: - Ritonavir eller indinavir, medicin for HIV.
English: If you have a physical condition affecting the shape of the penis.
Danish: Hvis De har en fysisk tilstand, som påvirker formen af penis.
English: On the basis of the scientific conclusions for vardenafil the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing vardenafil is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for vardenafil er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder vardenafil, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Vardenafil and its major circulating metabolite (M1) are highly bound to plasma proteins (approximately 95% for vardenafil or M1).
Danish: Vardenafil og dets væsentligste cirkulerende metabolit (M1) er i høj grad bundet til plasmaproteiner (ca. 95% for både vardenafil og M1).