FrancophonIA/ELRC3.0 huggingface dataset:
English: VIAGRA 25 mg film-coated tablets Sildenafil
Danish: VIAGRA 25 mg filmovertrukne tabletter Sildenafil
English: mouth
Danish: Hjerte
English: VIAGRA 100 mg film-coated tablets Sildenafil
Danish: VIAGRA 100 mg filmovertrukne tabletter Sildenafil
English: EU/1/98/077/013 (2 film-coated tablets) EU/1/98/077/002 (4 film-coated tablets) EU/1/98/077/003 (8 film-coated tablets) EU/1/98/077/004 (12 film-coated tablets)
Danish: EU/1/98/077/013 (2 filmovertrukne tabletter) EU/1/98/077/002 (4 filmovertrukne tabletter) EU/1/98/077/003 (8 filmovertrukne tabletter) EU/1/98/077/004 (12 filmovertrukne tabletter)
English: EU/1/98/077/014 (2 film-coated tablets) EU/1/98/077/006 (4 film-coated tablets) EU/1/98/077/007 (8 film-coated tablets) EU/1/98/077/008 (12 film-coated tablets) EU/1/98/077/024 (24 film-coated tablets)
Danish: EU/1/98/077/014 (2 filmovertrukne tabletter) EU/1/98/077/006 (4 filmovertrukne tabletter) EU/1/98/077/007 (8 filmovertrukne tabletter) EU/1/98/077/008 (12 filmovertrukne tabletter) EU/1/98/077/024 (24 filmovertrukne tabletter)
English: Use in patients taking other medicinal products With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).
Danish: 4.4 ), bør en startdosis på 25 mg overvejes til patienter i samtidig behandling med andre CYP3A4-hæmmere (se pkt.
English: Use in patients taking other medicinal products With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4), a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).
Danish: 4.4), bør en startdosis på 25 mg overvejes til patienter i samtidig behandling med andre CYP3A4-hæmmere (se pkt.
English: Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil
Danish: Hver tablet indeholder sildenafilcitrat svarende til 50 mg sildenafil
English: VIAGRA 50 mg film-coated tablets Sildenafil
Danish: VIAGRA 50 mg filmovertrukne tabletter Sildenafil
English: oC.
Danish: C.
English: EU Number Invented Name Strength Pharmaceutical Form
Danish: EU-nummer Særnavn Styrke Lægemiddelform
English: Content Package size Withdrawal period
Danish: Indgivelsesvej Emballage IndholdPakningsstørrelseTilbageholdelsestid
English: This was assessed by measuring the number of letters they could see on a standard vision chart: a fall of 15 letters or more over six months was considered to be a loss of vision.
Danish: Dette blev vurderet ved at måle antallet af bogstaver, som de kunne se på en standard synstavle: Et fald på 15 bogstaver eller mere over seks måneder ansås for at være et synstab.
English: London, 22 March 2007 Doc.
Danish: London, den 22. marts 2007 Ref.-dok.
English: What is ARXXANT?
Danish: Hvad er ARXXANT?
English: International non-proprietary name (INN): ruboxistaurin
Danish: Internationalt fællesnavn (INN): ruboxistaurin
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for ARXXANT
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNING AF ANSØGNING OM MARKEDSFØRINGSTILLADELSE for ARXXANT
English: Ref. EMEA/117441/2007
Danish: EMEA/44517/2008
English: Retinopathy can eventually lead to a loss of vision and even blindness.
Danish: Retinopati kan i sidste ende medføre tab af syn og endda blindhed.
English: ‘Non-proliferative' means that the disease is an early stage, during which the patient may not notice any change in vision.
Danish: 'Non-proliferativ' betyder, at sygdommen er på et tidligt stadium, hvor patienten måske endnu ikke har bemærket nogen forandringer i synet.
English: The committee also had concerns over the medicine's side effects, particularly disturbances of the heart rhythm.
Danish: Udvalget var også betænkelig ved lægemidlets bivirkninger, især med hensyn til forstyrrelser af hjerterytmen.
English: The main measure of effectiveness was the proportion of patients in each group who experienced a loss of vision at the end of the study.
Danish: Det primære mål for virkning var andelen af patienter i hver gruppe med et synstab ved afslutningen af undersøgelsen.
English: The effects of ARXXANT were first tested in experimental models before being studied in humans.
Danish: Virkningerne af ARXXANT blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: What documentation did the company present to support its application to the CHMP?
Danish: Hvilken dokumentation fremlagde virksomheden som støtte for sin ansøgning til CHMP?
English: ARXXANT is a medicine that contains the active substance ruboxistaurin (as 32 mg tablets).
Danish: ARXXANT er et lægemiddel, der indeholder det aktive stof ruboxistaurin (som 32 mg tabletter).
English: What was ARXXANT expected to be used for?
Danish: Hvad forventes ARXXANT anvendt til?
English: The study compared the effects of ARXXANT and placebo (a dummy treatment) over three years.
Danish: I undersøgelsen sammenlignedes virkningen af ARXXANT med placebo (uvirksomhed behandling) over tre år.
English: The application was at day 120 when the company withdrew.
Danish: Ansøgningen var nået til dag 120 i ansøgningsprocessen, da virksomheden trak den tilbage.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with ARXXANT?
Danish: Hvilke konsekvenser får tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med ARXXANT?
English: How is ARXXANT expected to work?
Danish: Hvordan forventes ARXXANT at virke?
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Danish: Når virksomheden har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, inden det afgiver en udtalelse, stille eventuelle supplerende spørgsmål (omkring dag 180) til
English: What was the recommendation of the CHMP at that time?
Danish: Hvad anbefalede CHMP på det tidspunkt?
English: The company presented the results of one main study involving 685 patients with moderately severe to very severe non-proliferative diabetic retinopathy.
Danish: Virksomheden fremlagde resultaterne af en hovedundersøgelse med 685 patienter med moderat svær til meget svær non-proliferativ diabetisk retinopati.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of ARXXANT had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: Derfor var det CHMP's opfattelse på tilbagetrækningstidspunktet, at fordelene ved ARXXANT ikke var blevet tilstrækkeligt påvist, og at eventuelle fordele ikke opvejede de identificerede risici.
English: The active substance in ARXXANT, ruboxistaurin, blocks the activity of the enzyme protein kinase C (PKC) beta.
Danish: Det aktive stof i ARXXANT, ruboxistaurin, blokerer aktiviteten af enzymet PKC-beta (proteinkinase C).
English: Retinopathy is damage to the blood vessels within the retina, the light-sensitive surface at the back of the eye.
Danish: Retinopati er skader på blodkarrene i nethinden, dvs. den lysfølsomme overflade bagerst i øjet.
English: The CHMP was concerned that the effectiveness of ARXXANT had not been proven adequately in the clinical study.
Danish: CHMP's betænkeligheder var, at virkningen af ARXXANT ikke var blevet tilstrækkeligt påvist i den kliniske undersøgelse af lægemidlet.
English: This is a naturally-occurring enzyme that is responsible for regulating the activity of blood vessels in the retina.
Danish: Det er et naturligt forekommende enzym, der regulerer aktiviteten i nethindens blodkar.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with ARXXANT.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som nu deltager i kliniske undersøgelser med ARXXANT.
English: ARXXANT was expected to be used to treat adult patients who have moderate to severe non-proliferative retinopathy as a complication of diabetes.
Danish: ARXXANT skulle have været anvendt til behandling af voksne patienter, der lider af moderat til svær non-proliferativ retinopati som følgevirkning af diabetes.
English: In patients with diabetes, high levels of glucose (sugar) in the blood may cause this enzyme to become overactivated, leading to damage to the blood vessels.
Danish: Et højt blodsukkerniveau kan få dette enzym til at blive overaktivt hos patienter med diabetes, og det kan medføre skader på blodkarrene.
English: Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that ARXXANT could not have been approved for the treatment of diabetic retinopathy in adult patients with moderate to severe non-proliferative retinopathy.
Danish: Efter gennemgang af de foreliggende oplysninger på tidspunktet for tilbagetrækningen havde CHMP betænkeligheder, og udvalgets foreløbige holdning var, at ARXXANT ikke kunne godkendes til behandling af diabetisk retinopati hos voksne patienter med moderat til svær non-proliferativ retinopati.
English: This damage causes the blood vessels to leak fluid, leading to swelling in the retina.
Danish: Disse skader får blodkarrene til at lække væske, og det fører til opsvulmen af nethinden.
English: By blocking PKC beta, ruboxistaurin is expected to prevent damage to the blood vessels and loss of vision.
Danish: Ruboxistaurin forventes at kunne forebygge skader på blodkarrene og tab af synet ved at blokere PKC-beta.
English: On 13 March 2007, Eli Lilly Nederland 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 ARXXANT, for the treatment of diabetic retinopathy in adult patients with moderate to severe non-proliferative retinopathy.
Danish: en officiel meddelelse til Udvalget for Humanmedicinske Lægemidler (CHMP) om, at virksomheden ønskede at tilbagetrække ansøgningen om markedsføringstilladelse for ARXXANT til behandling af diabetisk retinopati hos voksne patienter med moderat til svær non-proliferativ retinopati.
English: 49 x 1 tablets (unit dose)
Danish: 49x1 tabletter (enkeltdosis)
English: EU/1/17/1213/001
Danish: EU/1/17/1213/001 Maviret
English: 84 (4 x 21) tablets (multipack)
Danish: 84 (4 x 21) tabletter (multipakning)
English: Film-coated tablet Oral use blister (PVC/PE/PCTFE/alu)
Danish: Oral anvendelse blister (PVC/PE/PCTFE/aluminiumsfolie)
English: EU Number
Danish: MF (EU)- nummer
English: Maviret
Danish: Pakningsstørrelse
English: Route of Administration
Danish: Filmovertrukken tablet
English: Investigator's global assessments of efficacy also showed significant improvement.
Danish: Forskernes globale vurderinger af effekt viste også signifikant forbedring.
English: Your doctor will advise you what to do.
Danish: Lægen vil fortælle dig, hvad du skal gøre.
English: Tasmar is administered orally three times daily.
Danish: Tasmar administreres oralt tre gange dagligt.
English: Increases were approximately two times more likely in females.
Danish: Forhøjelserne var ca. to gange hyppigere hos kvinder.
English: frequency cannot be estimated from the available data
Danish: Frekvensen kan ikke angives ud fra tilgængelige data
English: However clinical circumstances of these cases were so diverse, that no general conclusions can be drawn from the cases.
Danish: De kliniske omstændigheder ved disse tilfælde var imidlertid så forskellige, at der ikke kan trækkes generelle konklusioner.
English: Management of overdose: Hospitalisation is advised.
Danish: Behandling af overdosis: Hospitalisering anbefales.
English: Your doctor may need to review your treatments.
Danish: Din læge kan være nødt til at revurdere din behandling.
English: Number (proportion) with moderate or marked improvement
Danish: Antallet (procentdelen) med moderat eller markant forbedring
English: The absolute bioavailability of an oral administration is around 65 %.
Danish: Den absolutte biotilgængelighed af en oral indgift er ca. 65 %.
English: Any other yellow urine discolouring is usually harmless.
Danish: Alle andre gulfarvninger af urinen er som regel harmløse.
English: Do not use Tasmar if you notice that the tablets are damaged.
Danish: Brug ikke Tasmar, hvis du bemærker, at tabletterne er beskadiget.
English: Tasmar may be taken with or without food (see section 5.2).
Danish: Tasmar kan indtages sammen med eller uden mad (se afsnit 5.2).
English: Number (proportion) improved on both primary and secondary outcome
Danish: Antallet (procentdelen) forbedret på både primært og sekundært resultat
English: Distribution: The volume of distribution (Vss) of tolcapone is small (9 l).
Danish: Distribution: Tolcapons distributionsvolumen (Vss) er lille (9 l).
English: Tolcapone does not distribute widely into tissues due to its high plasma protein binding (>99.9 %).
Danish: Tolcapon er ikke vidt fordelt i vævene på grund af sin høje plasmaproteinbinding (> 99,9 %).
English: Before beginning treatment:
Danish: Før behandlingen påbegyndes:
English: The primary outcome was the proportion of patients with a 1 or more hour increase in ON time (see Table 1).
Danish: Det primære resultat var procentdelen af patienter med en stigning i ON-tiden på 1 eller flere timer (se tabel 1).
English: The onset of effect occurs after the first administration.
Danish: Effekten forekommer efter første indgift.
English: Periodic monitoring of liver enzymes cannot reliably predict the occurrence of fulminant hepatitis.
Danish: Periodisk kontrol af leverenzymer kan ikke pålideligt forudsige fulminant hepatitis.
English: The increases usually appeared within 6 to 12 weeks of starting treatment, and were not associated with any clinical signs or symptoms.
Danish: Forhøjelserne forekom oftest indenfor 6 til 12 uger efter behandlingens start og var ikke forbundet med nogen form for kliniske tegn eller symptomer.
English: In this case your doctor may perform regular blood tests to monitor how easily your blood clots.
Danish: Lægen vil måske tage regelmæssige blodprøver for at kontrollere, hvor let blodet størkner.
English: Additionally late onset hepatitis after approximately 18 months of treatment has been reported rarely.
Danish: Endvidere er der i sjældne tilfælde rapporteret sent forekommende hepatitis efter ca. 18 måneders behandling.
English: There is no relevant indication for use in children and adolescents.
Danish: Der er ingen relevant indikation for brug til børn og teenagere.
English: Tolcapon e N=75
Danish: Tolcapon N = 75
English: General supportive care is indicated.
Danish: Almindelig støttende behandling er indicereret.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: If this happens notify your doctor.
Danish: Hvis det sker, skal du informere din læge.
English: Absorption: Tolcapone is rapidly absorbed with a tmax of approximately 2 hours.
Danish: Absorption: Tolcapon absorberes hurtigt med et tmax på ca. 2 timer.
English: Tasmar should be taken with 1 glass of water.
Danish: Tasmar skal tages med 1 glas vand.
English: Marketing Authorisation Holder: Meda AB
Danish: Indehaveren af markedsføringstilladelsen: Meda AB
English: if you develop persistent or severe diarrhoea
Danish: - hvis du får vedvarende eller svær diarre
English: Muscle injury can sometimes cause dark urine.
Danish: Muskelskader kan nogle gange medføre mørk urin.
English: Lactose intolerance: Tasmar contains lactose.
Danish: Lactoseintolerans: Tasmar indeholder lactose.
English: o Uncontrolled excessive shopping or spending.
Danish: o Ukontrollabelt overdrevne indkøb eller stort forbrug.
English: The following suggestions are based on pharmacological considerations and have not been evaluated in clinical trials.
Danish: De følgende forslag er baseret på farmakologiske overvejelser, og de er ikke undersøgt i kliniske studier.
English: Food delays and decreases the absorption of tolcapone, but the relative bioavailability of a dose of tolcapone taken with a meal is still 80 % to 90 %.
Danish: Mad forsinker og nedsætter absorbtionen af tolcapon, men den relative biotilgængelighed af en dosis tolcapon indtaget sammen med mad er stadig 80 % til 90 %.
English: Review of treatment is recommended if such symptoms develop.
Danish: Revurdering af patientens behandling anbefales, hvis patienten udvikler sådanne symptomer.
English: Under such a diagnosis Tasmar should be immediately discontinued and the patient should be followed up closely.
Danish: Ved sådan en diagnose skal Tasmar øjeblikkelig seponeres, og patienten skal følges nøje.
English: In vitro experiments have shown that tolcapone binds mainly to serum albumin.
Danish: In vitro forsøg har vist, at tolcapon hovedsageligt bindes til serum-albumin.
English: Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely.
Danish: Episoder med pludselig falden i søvn under daglige gøremål og i nogle tilfælde uden forudgående advarselssignaler er i meget sjældne tilfælde blevet rapporteret.
English: After oral administration, 60 % of drug-related material is excreted into urine and 40 % into faeces.
Danish: Efter oral indgift udskilles 60 % af lægemiddelrelateret substans i urinen og 40 % i fæces.
English: Tasmar has an effect on the symptoms of your Parkinson's disease.
Danish: Tasmar har en virkning på dine symptomer fra din Parkinsons sygdom.
English: Impulse control disorders: Patients should be regularly monitored for the development of impulse control disorders.
Danish: Manglende impulskontrol: Patienter bør kontrolleres regelmæssigt for udvikling af manglende impulskontrol.
English: Overall, the frequency of adverse reactions increased slightly.
Danish: Som helhed øgedes frekvensen af bivirkninger imidlertid let.
English: Studies in healthy volunteers and parkinsonian patients have confirmed that the maximum effect occurs with 100 - 200 mg tolcapone.
Danish: Undersøgelser på raske frivillige og på parkinsonpatienter har bekræftet, at den maksimale effekt forekommer efter 100-200 mg tolcapon.
English: It should also be noted that female patients may have a higher risk of liver injury (see section 4.8).
Danish: Det skal også bemærkes, at kvindelige patienter kan have større risiko for leverskader (se afsnit 4.8).
English: The magnitude of the effect was dependent on the dose of benserazide.
Danish: Størrelsen af effekten var afhængig af benseraziddosis.
English: Tasmar is not recommended for use in children below the age of 18 due to insufficient data on safety or efficacy.
Danish: Tasmar anbefales ikke til børn under 18 år, da der ikke foreligger tilstrækkelig data for sikkerhed og effekt.
English: However, no evidence of renal toxicity was observed in the low-dose group.
Danish: Der var imidlertid ingen evidens for renal toksicitet i lavdosisgruppen.
English: Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than needed to satisfy your hunger).
Danish: o Overspisning (spise store mængder mad på kort tid) eller tvangsspisning (spise mere mad end normalt og mere end nødvendigt for at stille sulten).
English: The average reduction in daily levodopa dose was about 30 % in those patients requiring a levodopa dose reduction.
Danish: Den gennemsnitlige reduktion af den daglige levodopadosis var ca. 30 % hos de patienter, som krævede reduktion af levodopadosis.
English: This reduction may increase the average concentration of unbound drug two-fold.
Danish: Denne reduktion kan muligvis øge den gennemsnitlige koncentration af ubundet lægemiddel til det dobbelte.
English: Tasmar should not be prescribed until there has been a complete informative discussion of the risks with the patient.
Danish: Tasmar må ikke ordineres, før en fyldestgørende information af alle risici er blevet diskuteret med patienten.
English: It should also be noted that female patients may have a higher risk of liver injury.
Danish: Det skal bemærkes, at kvinder kan have større risiko for leverskade.
English: An interaction was observed with benserazide, which may lead to increased levels of benserazide and its active metabolite.
Danish: Der observeredes en interaktion med benserazid, som kunne medføre øgede koncentrationer af benserazid og dets aktive metabolit.
English: Since your ability to drive a car or operate machinery may be affected by Parkinson's disease, you should discuss this with your doctor.
Danish: Da dine evner til at køre bil eller betjene maskiner kan påvirkes af Parkinsons sygdom, skal du tale med lægen herom.
English: A diagnosis of NMS should be considered even if not all the above findings are present.
Danish: Diagnosen malignt neuroleptikasyndrom bør overvejes selvom ikke alle ovennævnte symptomer er til stede.
English: Therefore, clinically relevant interactions involving cytochrome CYP2C9 appear unlikely.
Danish: Derfor er det ikke sandsynligt, at der vil forekomme klinisk relevante interaktioner med involvering af cytochrom CYP2C9.
English: Do not break or crush the tablets.
Danish: Du må ikke brække eller knuse tabletterne.
English: Tolcapone is a low-extraction-ratio drug (extraction ratio = 0.15), with a moderate systemic clearance of about 7 L/h.
Danish: Tolcapon er et low-extraction-ratio lægemiddel (ekstraktionsratio = 0,15) med en moderat systemisk clearance på ca. 7 l/time.
English: There are no adequate data from the use of tolcapone in pregnant women.
Danish: Graviditet Der foreligger ikke tilstrækkelig data om brugen af tolcapon hos gravide kvinder.
English: other important symptoms are high fever and mental confusion.
Danish: - andre vigtige symptomer er høj feber og forvirring.
English: In clinical trials, more than 70 % of patients required a decrease in their daily levodopa dose if their daily dose of levodopa was >600 mg or if patients had moderate or severe dyskinesias before beginning treatment.
Danish: I de kliniske studier behøvede over 70 % af patienterne en reduktion af deres daglige levodopadosis, hvis den daglige levodopadosis var > 600 mg, eller hvis patienterne havde moderate eller svære dyskinesier før behandlingen blev påbegyndt.
English: However, in patients with moderate cirrhotic liver disease, clearance of unbound tolcapone was reduced by almost 50 %.
Danish: Hos patienter med moderat cirrhotisk leverlidelse reduceredes clearance af ubundet tolcapon imidlertid med næsten 50 %.
English: However, it is generally believed that early detection of medicine-induced hepatic injury along with immediate withdrawal of the suspect medication enhances the likelihood for recovery.
Danish: Det er dog den generelle opfattelse, at tidlig opdagelse af lægemiddelinducerede leverskader sammen med øjeblikkelig seponering af den pågældende medicinske behandling øger muligheden for helbredelse.
English: The maximum therapeutic dose of 200 mg three times daily should not be exceeded, as there is no evidence of additional efficacy at higher doses.
Danish: Den maksimale terapeutiske dosis på 200 mg tre gange daglig bør ikke overskrides, da der ikke er evidens for yderligere effekt af højere doser.
English: These adverse reactions were predictable based on the known adverse reactions to each of the three drugs individually.
Danish: Disse bivirkninger var forudsigelige med kendskab til bivirkningerne af hvert af de tre lægemidler.
English: Elderly patients No dose adjustment of Tasmar is recommended for elderly patients.
Danish: Ældre patienter Det anbefales ikke at justere Tasmar dosis hos ældre patienter.