FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes.
Danish: Farmakoterapeutisk klassifikation: Andre midler til fordøjelsesorganer og stofskifte, enzymer.
English: For further instructions, see section 4.4.
Danish: For yderligere anvisninger se pkt.
English: Consequently hepatic and renal impairment are not expected to affect the pharmacokinetic of velmanase alfa.
Danish: Derfor forventes det ikke, at en nedsat lever- eller nyrefunktion påvirker farmakokinetikken af velmanase alfa.
English: Forcefully ejecting the water for injections from the syringe onto the powder should be avoided to minimise foaming.
Danish: Det bør undgås at uddrive vandet til injektionsvæsker med kraft fra sprøjten på pulveret for at minimere skumdannelse.
English: If you experience any side effect like these, please tell your doctor immediately.
Danish: Hvis du oplever nogle bivirkninger som disse, skal du straks fortælle det til lægen.
English: - The active substance is velmanase alfa.
Danish: - Aktivt stof: velmanase alfa.
English: d) The reconstituted solution is to be slowly withdrawn from each vial with caution to avoid foaming in the syringe.
Danish: d) Den rekonstituerede opløsning skal langsomt og forsigtigt trækkes ud af hvert hætteglas for at undgå skumdannelse i sprøjten.
English: Severe allergic reaction to the active substance or to any of the excipients listed in section 6.1.
Danish: Alvorlig allergisk reaktion over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: 3MSCT (steps/min)
Danish: 3MSCT (trin/min)
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLIGE VILKÅR
English: The metabolic pathway of velmanase alfa is predicted to be similar to other natural occurring proteins that degrade into small peptides and finally into amino acids.
Danish: Metabolismen af velmanase alfa forventes at svare til metabolismen af andre naturligt forekommende proteiner, der nedbrydes til små peptider, og til sidst til aminosyrer.
English: After reconstitution, one mL of the solution contains 2 mg of velmanase alfa (10 mg / 5 mL).
Danish: Efter rekonstitution indeholder 1 ml opløsning 2 mg velmanase alfa (10 mg / 5 ml).
English: After reconstitution, the medicine should be used immediately.
Danish: Efter rekonstitution skal lægemidlet straks bruges.
English: The reconstituted solution of Lamzede should be administered using an infusion set equipped with a pump and an in-line low protein-binding 0.22 µm filter.
Danish: Den rekonstituerede opløsning af Lamzede skal administreres med et infusionssæt udstyret med en pumpe og et in-line 0,22 µm filter med lav proteinbinding.
English: Table 4: Multiparametric responder analysis: MCID(1) Responders Rates by Endpoints and Domains (source data: rhLAMAN-05; rhLAMAN-10)
Danish: Tabel 4: Multiparametrisk analyse af personer, der responderede: MCID(1) rater for personer, der responderede efter endepunkter og domæner (kildedata: rhLAMAN-05; rhLAMAN-10)
English: e) The reconstituted solution should be administered using an infusion set equipped with a pump and an in-line low protein-binding 0.22 μm filter.
Danish: e) Den rekonstituerede opløsning skal administreres med et infusionssæt, udstyret med en pumpe og et in-line-filter på 0,22 μm med lav proteinbinding.
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosisenhed, dvs. den er i det væsentlige natrium-fri.
English: A 24 month multi-center, open label phase II trial investigating the safety and efficacy of repeated velmanase alfa (recombinant human alpha-mannosidase) treatment in paediatric patients <6 years of age with alpha-mannosidosis.
Danish: Et 24-måneders åbent, fase II-multicenterstudie, der undersøger sikkerheden og virkningen af gentagen behandling med velmanase alfa (rekombinant humant alfa-mannosidose) hos pædiatriske patienter under 6 år med alfa-mannosidose.
English: Table 2: Results from placebo-controlled clinical study rhLAMAN-05 (source data: rhLAMAN-05)
Danish: Tabel 2: Resultater fra det placebokontrollerede kliniske studie rhLAMAN-05 (kildedata: rhLAMAN-05)
English: Pyrexia(1)
Danish: Pyreksi(1)
English: Pharmacodynamic Domain Response
Danish: Farmakodynamisk domænerespons
English: Common side effects (may affect up to 1 in 10 people) - loss of consciousness (fainting, which may be preceded by feeling dizzy, lightheaded or confused) - acute renal insufficiency (kidney problems which can be recognised from fluid retention, swelling in legs, ankles or feet, drowsiness, shortness of breath or fatigue) - hypersensitivity and serious allergic reaction (symptoms including localised or diffuse skin itching, dizziness, difficulty breathing, chest pain, gastrointestinal symptoms such as nausea, vomiting, diarrhea or intestinal pain, swelling of the throat, face, lips or tongue)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) - bevidstløshed (besvimelse, hvor svimmelhed, omtågethed eller forvirring kan gå forud) - akut nedsat nyrefunktion (nyreproblemer, som kan genkendes fra væskeophobning, hævelse af ben, ankler eller fødder, døsighed, stakåndethed eller træthed) - overfølsomhed og alvorlig allergisk reaktion (symptomer omfatter lokaliseret eller diffus hudkløe, svimmelhed, vejrtrækningsbesvær, brystsmerter, symptomer fra mave-tarm-systemet såsom kvalme, opkastning, diarré eller tarmsmerter, hævelse af halsen, ansigtet, læber eller tunge)
English: Lamzede can be used during breastfeeding.
Danish: Lamzede kan anvendes under amning.
English: QoL Domain
Danish: QoL-domæne
English: General disorder and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet
English: For intravenous infusion use only.
Danish: Kun til intravenøs infusion.
English: Metabolism and nutrition disorders Increased appetite
Danish: Metabolisme og ernæring
English: In one patient, loss of consciousness considered related to the study treatment with recovery after a few seconds was reported.
Danish: Der blev rapporteret om bevidstløshed, anset for at være relateret til studiebehandlingen, og som forsvandt efter et par sekunder, hos én patient.
English: This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Danish: Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for lægemidlet, fordi det anvendes til en sjælden sygdom.
English: Functional
Danish: Funktionalitet
English: The maximum infusion rate is 25 mL/hour (see section 4.2).
Danish: Den maksimale infusionshastighed er 25 ml/time (se pkt.
English: Responders Rates rhLAMAN-05 study n=25
Danish: Rater for personer, der responderede rhLAMAN-05 studie n = 25
English: What Lamzede is and what it is used for What you need to know before Lamzede is used How Lamzede is used
Danish: Virkning og anvendelse Det skal du vide, før Lamzede bruges Sådan bruges Lamzede Bivirkninger
English: Renal failure acute(2)
Danish: Akut nyresvigt(2)
English: Lamzede 10 mg powder for solution for infusion
Danish: Lamzede 10 mg pulver til infusionsvæske, opløsning
English: Lamzede 10 mg powder for solution for infusion velmanase alfa
Danish: Lamzede 10 mg pulver til infusionsvæske, opløsning velmanase alfa
English: Elderly No data are available and no relevant use in elderly patients is described.
Danish: Ældre Der foreligger ingen data, og det er ikke relevant at anvende velmanase alfa til ældre patienter.
English: Criterion
Danish: Kriterie
English: Loss of consciousness(2)
Danish: Bevidstløshed(2)
English: Each mL of reconstituted solution contains 2 mg of velmanase alfa.
Danish: Hver ml rekonstitueret opløsning indeholder 2 mg velmanase alfa.
English: 10 vials
Danish: 10 hætteglas
English: Ocular hyperaemia
Danish: Okulær hyperæmi
English: It is not known whether velmanase alfa passes into breast milk.
Danish: Det er ukendt, om velmanase alfa udskilles i brystmælken.
English: Serum oligosaccharide concentration (μmol/l) Overall(1)
Danish: Oligosakkarid-koncentration i serum (μmol/l)
English: In both cases the patients recovered without sequelae.
Danish: I begge tilfælde forsvandt bivirkningerne uden følgevirkninger.
English: For infusion rate see section “Method of administration”.
Danish: Se pkt.”Administration” for infusionshastigheden.
English: For the management of adverse reactions, see sections 4.4 and 4.8.
Danish: 4.4 og 4.8 for behandling af bivirkninger.
English: Feeling hot(1)
Danish: Varmefølelse(1)
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum Næseblod
English: nausea, vomiting - pain at the site the infusion is given, chills, feeling hot, malaise, tiredness (fatigue) - skin rashes (urticaria), increased sweating (hyperhidrosis) - nosebleed - joint pain, back pain, joint stiffness, muscle pain, pain in extremity (hands, feet) - eye irritation, eyelid swelling (eyelid oedema), eye redness - increased appetite
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) - langsom puls (bradykardi) - psykotisk adfærd (psykisk sygdom med hallucinationer, problemer med at tænke klart og forstå virkeligheden, angst), indsovningsbesvær - forvirret tilstand, besvimelse, rysten, svimmelhed, hovedpine - mave-tarm-smerter, irriteret mave fra fordøjelsessyrer (refluks gastritis), kvalme, opkastning - smerter på det sted, hvor infusionen gives, kulderystelser, varmefølelse, utilpashed, træthed - hududslæt (urticaria), øget svedtendens (hyperhidrose) - næseblod - ledsmerter, rygsmerter, ledstivhed, muskelsmerter, smerter i ekstremiteter (hænder, fødder) - øjenirritation, hævede øjenlåg (øjenlågsødem), røde øjne - øget appetit
English: Abdominal pain
Danish: Øvre abdominalsmerter
English: [95% CI] p-value p=0.692
Danish: (95 % CI) p-værdi p = 0,692
English: [95% CI] p-value p<0.001
Danish: (95 % CI) p-værdi p < 0,001
English: Powder for solution for infusion 1 vial
Danish: Pulver til infusionsvæske, opløsning 1 hætteglas
English: [95% CI] p-value p=0.278
Danish: (95 % CI) p-værdi p = 0.278
English: Hypersensitivity(1)
Danish: Overfølsomhed(1)
English: [95% CI] p-value p=0.406
Danish: (95 % CI) p-værdi p = 0,406
English: Nausea(1)
Danish: Kvalme(1)
English: Statistically significant improvements were detected in serum oligosaccharide levels, 3MSCT, pulmonary function, serum IgG
Danish: Statistisk signifikante forbedringer i oligosakkarid-niveauer i serum, 3MSCT, lungefunktionen, serum IgG og EQ-5D-5L (euro quality of life-5 dimensioner) over tid blev påvist, op til den sidste observation (tabel 3).
English: Procedural headache
Danish: Hovedpine under indgrebet
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C.
Danish: Opbevaringstiden vil normalt ikke være længere end 24 timer ved 2 °C til 8 °C.
English: One vial contains 10 mg of velmanase alfa*.
Danish: Et hætteglas indeholder 10 mg velmanase alfa*.
English: <18 years(2) ≥18 years(2) 3MSCT (steps/min) Overall(1)
Danish: 3MSCT (trin/min) Samlet(1)
English: Each vial contains 10 mg of velmanase alfa.
Danish: Hvert hætteglas indeholder 10 mg velmanase alfa.
English: Anaphylactoid reaction(1)
Danish: Anafylaktoid reaktion(1)
English: One vial contains 10 mg of velmanase alfa.
Danish: Et hætteglas indeholder 10 mg velmanase alfa.
English: Domain
Danish: Domæne
English: Oligosaccharides 20.0% 100%
Danish: Ingen domæner 40,0% 0
English: Weight increase
Danish: Vægtøgning
English: Reconstituted solution for infusion
Danish: Rekonstitueret infusionsvæske, opløsning
English: What Lamzede looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Dizziness
Danish: Ledstivhed
English: Chiesi Pharmaceuticals B.V. Tel: + 31 88 501 64 00
Danish: Tel: + 31 88 501 64 00
English: <18 years(2) ≥18 years(2) FVC (% of predicted) Overall(1)
Danish: FVC (% af forventet) Samlet(1)
English: Malaise(1)
Danish: Utilpashed(1)
English: Renal or hepatic impairment
Danish: Nedsat nyre- eller leverfunktion
English: Catheter site pain
Danish: Smerter på kateterstedet
English: Teл.
Danish: Se pkt.
English: Strength Pharmaceutical Form Route of administration Packaging
Danish: Styrke Lægemiddelform Indgivelsesvej
English: Strength Pharmaceutical Form
Danish: Lægemiddelform
English: Packaging
Danish: Styrke
English: Route of Administration
Danish: Indgivelsesvej Emballage
English: They can be taken with or without food.
Danish: De kan indtages sammen med eller uden et måltid.
English: This summary was last updated in 09-2009.
Danish: Dette sammendrag blev sidst ajourført i 09-2009.
English: 1 Previously known as Latixa.
Danish: 1 Tidligere kendt som Latixa.
English: The marketing authorisation holder is Menarini International Operations Luxembourg S.A.
Danish: Indehaveren af markedsføringstilladelsen er Menarini International Operations Luxembourg S.A.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Latixa on 9 July 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Latixa den 9. juli 2008.
English: The name of the medicine was changed to Ranexa on 11 August 2008.
Danish: Lægemidlet ændrede navn til Ranexa den 11. august 2008.
English: ranolazine EPAR summary for the public
Danish: ranolazin EPAR - sammendrag for offentligheden
English: The main measure of effectiveness was how long patients could exercise after 12 weeks of treatment, compared with before treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor længe patienter kunne motionere efter 12 ugers behandling sammenlignet med før behandlingen.
English: It is available as oval prolongedrelease tablets (blue: 375 mg; orange: 500 mg; green: 750 mg).
Danish: Det leveres som ovale 'depottabletter' (blå: 375 mg; orange: 500 mg; grønne: 750 mg).
English: Other information about Ranexa:
Danish: Andre oplysninger om Ranexa:
English: Ranexa tablets should be swallowed whole and should not be broken, crushed or chewed.
Danish: Ranexa-tabletter skal sluges hele og må ikke knækkes over, knuses eller tygges.
English: Ranexa has been studied in one main study including a total of 823 patients with an average age of 64 years who had had angina pectoris for at least three months.
Danish: Ranexa blevet undersøgt i en hovedundersøgelse, som omfattede i alt 823 patienter med en gennemsnitsalder på 64 år, som havde haft angina pectoris i mindst tre måneder.
English: The Committee recommended that Ranexa be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Ranexa.
English: Ranexa is a medicine that contains the active substance ranolazine.
Danish: Ranexa er et lægemiddel, der indeholder det aktive stof ranolazin.
English: The full EPAR for Ranexa can be found here.
Danish: Den fuldstændige EPAR for Ranexa findes her.
English: The company that makes Ranexa will agree on the wording of the patient alert card in each Member State.
Danish: Virksomheden, der fremstiller Ranexa, skal nå til enighed om ordlyden af patientadvarselskortet i hver medlemsstat.
English: The card will be inserted in the boxes containing the tablets and will include information for patients and healthcare workers explaining how to use the medicine safely.
Danish: Kortet skal vedlægges i æsken med tabletterne og indeholde oplysninger til patienter og sundhedsmedarbejdere om, hvordan man sikrer risikofri anvendelse af lægemidlet.
English: This reduces the number of calcium ions that enter the cells.
Danish: Dette reducerer antallet af calciumioner, som trænger ind i cellerne.
English: After two to four weeks, the dose should be increased to 500 mg twice a day, and then to 750 mg twice a day, depending on the patient's response.
Danish: Efter to til fire uger øges dosen til 500 mg to gange dagligt og derefter til 750 mg to gange dagligt afhængigt af, hvordan patienten reagerer.
English: Dose increases should be carried out carefully in the elderly, in patients who weigh less than 60 kg, and in patients who have problems with their kidneys, liver or heart.
Danish: Der skal udvises forsigtig ved øgning af dosen hos ældre, hos patienter, der vejer under 60 kg og hos patienter, der har nyre-, lever- eller hjerteproblemer.
English: The recommended starting dose of Ranexa is 375 mg twice a day.
Danish: Den anbefalede startdosis af Ranexa er 375 mg to gang om dagen.
English: Which measures are being taken to ensure the safe use of Ranexa?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Ranexa?
English: The maximum dose is 750 mg twice a day.
Danish: Maksimal dosis er 750 mg to gange dagligt.
English: It must also not be used in patients who are taking other medicines that are broken down in the same way as ranolazine, or certain other medicines that are used to correct the heart rhythm.
Danish: Det bør heller ikke anvendes til patienter, som tager anden medicin, som nedbrydes på samme måde som ranolazin eller visse andre lægemidler, som anvendes til korrigering af hjerterytmen.
English: This interferes with the activity of special channels on the cell surface called ‘sodium-dependent calcium channels' through which calcium ions normally enter the cells.
Danish: Stoffet påvirker de særlige kanaler på celleoverfladen kaldet ‘natriumafhængige kalciumkanaler', hvorigennem calciumioner normalt strømmer ind i cellerne.
English: After 12 weeks, this increased by an average of 1 minute 56 seconds in the patients adding either dose of Ranexa, and by an average of 1 minute 32 seconds in those adding placebo.
Danish: Efter 12 uger steg det med 1 minut og 56 sekunder i gennemsnit hos de patienter, der havde fået en dosis Ranexa som tillægsbehandling, og med 1 minut og 32 sekunder i gennemsnit hos dem, der havde fået placebo som tillægsbehandling.
English: Ranexa should not be used in people who may be hypersensitive (allergic) to ranolazine or any of the other ingredients.
Danish: Ranexa må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for ranolazin eller nogen af indholdsstofferne.
English: Patients who take Ranexa must be given a ‘patient alert card' that summarises the key safety information on the medicine.
Danish: Patienter, der tager Ranexa, skal have udleveret et særligt informationskort, der sammenfatter de vigtigste sikkerhedsoplysninger om lægemidlet.
English: Two doses of Ranexa (750 and 1000 mg twice a day) were compared with placebo (a dummy treatment) as an add-on to commonly used medicines for angina pectoris (atenolol, amlodipine or diltiazem).
Danish: To doser af Ranexa (750 og 1000 mg to gange dagligt) blev sammenlignet med placebo (en virkningsløs behandling) som tillægsbehandling til de mest anvendte lægemidler til behandling af angina pectoris (atenolol, amlodipin eller diltiazem).
English: The most common side effects with Ranexa (seen in between 1 and 10 patients in 100) are dizziness, headache, constipation, vomiting, nausea (feeling sick) and asthenia (weakness).
Danish: De hyppigste bivirkninger ved Ranexa (som kunne observeres hos mellem 1 og 10 patienter ud af 100) er svimmelhed, hovedpine, forstoppelse, opkastning, kvalme og kraftesløshed.
English: For the full list of these medicines, see the Package Leaflet.
Danish: Den fuldstændige liste over disse lægemidler fremgår af indlægssedlen.
English: The Committee for Medicinal Products for Human Use (CHMP) noted that the effectiveness of Ranexa in improving the symptoms of patients with stable angina pectoris is modest but that it could be of value in patients who have not responded fully to other medicines.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konstaterede, at virkningen af Ranexa til forbedring af symptomerne for patienter med stabil angina pectoris er beskeden, men at den kan være gavnlig for patienter, som ikke har reageret fuldt ud på andre lægemidler.
English: ‘Prolonged release' means that ranolazine is released slowly from the tablet over a few hours.
Danish: At tabletterne kaldes depottabletter betyder, at stoffet ranolazin langsomt frigives fra tabletten over nogle få timer.
English: Doses may need to be lower in patients who have certain side effects.
Danish: I tilfælde af patienter med visse bivirkninger kan det være nødvendigt med en lavere dosis.
English: Ranexa is used to treat the symptoms of stable angina pectoris (chest pain caused by reduced blood flow to the heart).
Danish: Ranexa anvendes til behandling af symptomer på stabil angina pectoris (smerter i brystet forårsaget af reduceret blodtilførsel til hjertet).
English: It is used as an add-on to existing treatment in patients whose disease is not adequately controlled by other medicines for angina pectoris, such as beta-blockers or calcium antagonists, or in patients who cannot take these medicines.
Danish: Det anvendes som supplement til eksisterende behandling hos patienter, hvis sygdom ikke kan kontrolleres tilfredsstillende med andre lægemidler til behandling af angina pectoris, såsom betablokkere eller calciumantagonister, eller hos patienter, der ikke kan tage disse lægemidler.
English: By reducing the flow of calcium into the cells, ranolazine is thought to help the heart to relax, improving blood flow to the heart muscle and relieving the symptoms of angina pectoris.
Danish: Ved at reducere strømmen af calcium ind i cellerne hjælper ranolazin hjertet med at slappe af og forbedrer blodstrømmen til hjertemusklerne og afhjælper symptomerne på angina pectoris.
English: Ranexa was more effective than placebo at increasing the length of time the patients could exercise.
Danish: Ranexa var mere effektivt end placebo til at øge den tid, patienterne kunne motionere i. I begyndelsen af undersøgelsen kunne patienterne motionere i 7 minutter.
English: What is the risk associated with Ranexa?
Danish: Hvilken risiko er der forbundet med Ranexa?
English: Calcium ions normally cause the heart muscle to contract.
Danish: Calciumioner får normalt hjertemusklen til at trække sig
English: The active substance in Ranexa, ranolazine, is thought to work by reducing the flow of sodium ions into the heart muscle cells.
Danish: Det aktive stof i Ranexa, ranolazin, antages at reducere strømmen af natriumioner ind i hjertemuskelcellerne.
English: Why has Ranexa been approved?
Danish: Hvorfor blev Ranexa godkendt?
English: The Committee decided that Ranexa's benefits are greater than its risks as an add-on treatment of the symptoms of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal medicines (such as beta-blockers and/or calcium antagonists).
Danish: Udvalget besluttede, at fordelene ved Ranexa er større end risiciene som tillægsbehandling af symptomerne hos patienter med stabil angina pectoris, som er utilstrækkeligt kontrolleret med, eller som ikke tolerer de lægemidler, der anvendes i førstevalgsbehandling (såsom betablokkere og/eller calciumantagonister).
English: For the full list of all side effects reported with Ranexa, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Ranexa fremgår af indlægssedlen.
English: It must not be used in patients who have severe problems with their kidneys or moderate or severe problems with their liver.
Danish: Det må heller ikke anvendes til patienter, der lider af svære nyreproblemer eller moderate til svære leverproblemer.
English: What is Ranexa?
Danish: Hvad er Ranexa?
English: What is Ranexa used for?
Danish: Hvad anvendes Ranexa til?
English: How has Ranexa been studied?
Danish: Hvordan blev Ranexa undersøgt?
English: What benefit has Ranexa shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Ranexa?
English: How is Ranexa used?
Danish: Hvordan anvendes Ranexa?
English: Prazitel Plus was first launched in the EU market in May 2009.
Danish: Prazitel Plus blev første gang bragt på markedet i EU i maj 2009.