FrancophonIA/ELRC3.0 huggingface dataset:
English: International non-proprietary name (INN): lacosamide
Danish: Internationalt fællesnavn (INN): lacosamid
English: The application was at day 181 when the company withdrew.
Danish: Ansøgningsproceduren var ved dag 181, da virksomheden trak sin ansøgning tilbage.
English: The main measure of effectiveness was the change in pain levels between the start of the study and the last four weeks on the stable dose.
Danish: Det vigtigste mål for virkningen var ændringen i smerteniveauet mellem undersøgelsens start og de sidste fire uger med den faste dosis.
English: Lacosamide has been authorised in the European Union (EU) as an anti-epileptic medicine under the trade name Vimpat since August 2008.
Danish: Lacosamid har været godkendt i Den Europæiske Union som lægemiddel mod epilepsi under handelsnavnet Vimpat siden august 2008.
English: This withdrawal has no consequences on Vimpat, for which the balance of benefits and risks remains unchanged.
Danish: Tilbagetrækningen har ingen konsekvenser for Vimpat, da benefit/risk-forholdet for Vimpat forbliver uændret.
English: The effectiveness of three doses of Lacosamide Pain UCB Pharma (200, 400 and 600 mg per day) was compared with that of placebo (a dummy treatment) in a total of 1,724 patients in four main studies.
Danish: Virkningen af tre forskellige doser af Lacosamid Pain UCB Pharma (200, 400 og 600 mg dagligt) blev sammenlignet med virkningen af placebo (en virkningsløs behandling) hos i alt 1 724 patienter i fire hovedundersøgelser.
English: What is happening with Vimpat used for the treatment of epilepsy?
Danish: Hvad sker der med Vimpat, som anvendes til behandling af andre sygdomme?
English: The medicine can also cause side effects affecting the heart and central nervous system (such as dizziness), which are of concern in patients with diabetes.
Danish: Lægemidlet kan også medføre bivirkninger, der påvirker hjertet og centralnervesystemet (f.eks. svimmelhed), hvilket kan være til bekymring for patienter med diabetes.
English: It was to be available as tablets.
Danish: Det skulle have været leveret som kapsler.
English: The effects of Lacosamide Pain UCB Pharma were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Lacosamid Pain UCB Pharma blev først undersøgt i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The exact way in which lacosamide works is still unclear, but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells.
Danish: Det vides endnu ikke nøjagtigt, hvordan lacosamid virker, men det menes at nedsætte natriumkanalernes (porer på nervecellernes overflade) aktivitet, hvilket gør det muligt at sende elektriske impulser mellem nerveceller.
English: Together, these actions are expected to prevent abnormal electrical activity in nerve cells, reducing pain due to nerve damage.
Danish: Tilsammen forventes disse virkningsmåder at forebygge unormal høj elektrisk aktivitet i nervecellerne og derved mindske smerter, som er forårsaget af nervebeskadigelser.
English: Lacosamide Pain UCB Pharma contains the active substance lacosamide.
Danish: Lacosamid Pain UCB Pharma indeholder det aktive stof lacosamid.
English: Lacosamide is also thought to be involved in the development of nerve cells that have been damaged.
Danish: Lacosamid menes desuden at medvirke ved gendannelsen af nerveceller, som er blevet beskadiget.
English: In all four studies, the dose of Lacosamide Pain UCB Pharma was increased gradually over a few weeks before being maintained at a stable dose for 12 weeks.
Danish: I alle fire undersøgelser blev dosen af Lacosamid Pain UCB Pharma gradvist forøget over nogle få uger og var herefter fast i 12 uger.
English: Questions and answers on the withdrawal of the marketing application for Lacosamide Pain UCB Pharma
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Lacosamid Pain UCB Pharma
English: Lacosamide Pain UCB Pharma was expected to be used in adults to treat pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Danish: Lacosamid Pain UCB Pharma forventedes anvendt til voksne til behandling af smerter forårsaget af diabetisk perifer neuropati (beskadigelse af nerverne i arme og ben, som kan forekomme hos patienter med diabetes).
English: On 25 September 2008, UCB Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Lacosamide Pain UCB Pharma, for the treatment of diabetic neuropathic pain in adults.
Danish: Den 25. september 2008 meddelte UCB Pharma S.A. officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Lacosamid Pain UCB Pharma til behandling af diabetiske neuropatiske smerter hos voksne.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Lacosamide Pain UCB Pharma had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Lacosamid Pain UCB Pharma ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Lacosamide Pain UCB Pharma could not have been approved for the treatment of diabetic neuropathic pain in adults.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Lacosamid Pain UCB Pharma ikke kunne være blevet godkendt til behandling af diabetiske neuropatiske smerter hos voksne.
English: The CHMP was concerned that the studies had not shown a meaningful benefit of Lacosamide Pain UCB Pharma.
Danish: CHMP var betænkelig ved, at undersøgelserne ikke havde vist nogen betydelige fordele ved Lacosamid Pain UCB Pharma.
English: What is Lacosamide Pain UCB Pharma?
Danish: Hvad er Lacosamid Pain UCB Pharma?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Lacosamide Pain UCB Pharma.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som for øjeblikket deltager i kliniske undersøgelser med Lacosamid Pain UCB Pharma eller i programmer for anvendelse af Lacosamid Pain UCB Pharma med særlig udleveringstilladelse.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Lacosamide Pain UCB Pharma?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Lacosamid Pain UCB Pharma eller i programmer for anvendelse med særlig udleveringstilladelse?
English: What was Lacosamide Pain UCB Pharma expected to be used for?
Danish: Hvad forventedes Lacosamid Pain UCB Pharma anvendt til?
English: How is Lacosamide Pain UCB Pharma expected to work?
Danish: Hvordan forventedes Lacosamid Pain UCB Pharma at virke?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: Subcutaneous use pre-filled pen 1.0 ml (150 mg/ml) 3 (3 x 1) pre-filled pens (multipack)
Danish: Forfyldt pen 1,0 ml (150 mg/ml) 3 (3 x 1) forfyldt pen (multipakke)
English: Subcutaneous use pre-filled pen 1.0 ml (150 mg/ml) 1 pre-filled pen
Danish: Forfyldt pen 1,0 ml (150 mg/ml) 1 forfyldt pen
English: Subcutaneous use pre-filled syringe 1.0 ml (150 mg/ml) 3 (3 x 1) pre-filled syringes (multipack)
Danish: Forfyldt sprøjte 1,0 ml (150 mg/ml) 3 (3 x 1) forfyldt sprøjte (multipakke)
English: Subcutaneous use pre-filled syringe 1.0 ml (150 mg/ml) 1 pre-filled syringe
Danish: Forfyldt sprøjte 1,0 ml (150 mg/ml) 1 forfyldt sprøjte
English: Treatment should not be stopped abruptly.
Danish: Behandlingen bør ikke standses brat.
English: This is a summary of the European public assessment report (EPAR) for INOmax.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for INOmax.
English: In children and adults undergoing heart surgery, treatment usually lasts for 24 to 48 hours.
Danish: Hos børn og voksne, som undergår en hjerteoperation, varer behandlingen almindeligvis mellem 24 og 48 timer.
English: INOmax nitric oxide
Danish: INOmax nitrogenoxid
English: The maximum starting dose of INOmax is 20 ppm for children up to 18 years of age, and 40 ppm for adults.
Danish: Den maksimale startdosis af INOmax er 20 ppm til børn op til 18 år og 40 ppm til voksne.
English: The full EPAR for INOmax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for INOmax findes ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for INOmax on 1 August 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for INOmax til Linde Healthcare AB den 1. august 2001.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that INOmax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved INOmax er større end risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
English: • patients of all ages who are undergoing or have undergone heart surgery and develop pulmonary hypertension.
Danish: • Patienter i alle aldre, som undergår eller har undergået en hjerteoperation og udvikler pulmonal hypertension.
English: This was mainly due to a reduction in the need for ECMO, rather than a reduction in death rates.
Danish: Forskellen skyldtes i højere grad mindsket behov for ECMO end mindsket dødelighed.
English: The company must put in place an educational programme to ensure that doctors who are going to use INOmax for the treatment of patients undergoing heart surgery are aware of the risks and the precautions necessary when using the medicine.
Danish: Virksomheden skal indføre et uddannelsesprogram for at sikre, at læger, som skal anvende INOmax til behandling af patienter, der undergår en hjerteoperation, altid er bekendt med risiciene og de nødvendige forholdsregler i forbindelse med anvendelse af lægemidlet.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for INOmax.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for INOmax.
English: What measures are being taken to ensure the safe use of INOmax?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af INOmax?
English: INOmax should only be used in units where staff have been trained in the use of a nitric oxide delivery system.
Danish: INOmax bør kun anvendes på afdelinger, hvor personalet er oplært i brugen af systemer til indgift af nitrogenoxid.
English: INOmax treatment should be supervised by a doctor who has experience in intensive care or neonatal intensive care if the patient is a newborn baby.
Danish: Behandlingen med INOmax bør overvåges af en læge med erfaring i intensiv behandling eller intensiv behandling af nyfødte, hvis patienten er en nyfødt.
English: INOmax should not be used in babies who may be hypersensitive (allergic) to nitric oxide or the other ingredient (nitrogen).
Danish: INOmax bør ikke anvendes hos spædbørn, der kan være overfølsomme (allergiske) over for nitrogenoxid eller det andet indholdsstof (nitrogen).
English: In newborn babies with breathing problems, treatment can be continued at this dose until there is improvement in oxygen levels, for a maximum of four days.
Danish: Hos nyfødte med vejrtrækningsproblemer kan behandlingen fortsættes ved denne dosis, indtil der ses en forbedring af iltindholdet, dog højst i fire dage.
English: This should then be reduced to 5 ppm, provided the blood in the arteries contains enough oxygen.
Danish: Koncentrationen bør derefter nedsættes til 5 ppm, forudsat at iltindholdet i arterieblodet er tilstrækkelig højt.
English: INOmax is used in patients who are undergoing artificial ventilation, once the ventilation is optimised.
Danish: INOmax anvendes til patienter i kunstig ventilering, efter at ventileringen er optimeret.
English: INOmax is used in combination with artificial ventilation and other medicines to help improve blood oxygen levels in the following groups of patients:
Danish: INOmax anvendes i kombination med kunstig ventilering og andre lægemidler til at øge iltindholdet i blodet hos følgende patientgrupper:
English: The most common side effect with INOmax (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), hypokalaemia (low blood potassium levels), hypotension (low blood pressure), atelectasis (collapse of the whole, or part of a, lung), and hyperbilirubinaemia (high blood levels of bilirubin).
Danish: De hyppigste bivirkninger ved INOmax (som optræder hos flere end 1 ud af 10 patienter) er trombocytopeni (lavt antal blodplader), hypokaliæmi (lavt kaliumindhold i blodet), hypotension (lavt blodtryk), atelektase (sammenfald af hele eller en del af lungen) og hyperbilirubinæmi (høje niveauer af bilirubin i blodet).
English: • newborn babies (born after 34 weeks of gestation) with breathing problems associated with pulmonary hypertension (high blood pressure in the lungs).
Danish: • Nyfødte (født efter graviditetens 34. uge) med vejrtrækningsproblemer i forbindelse med pulmonal hypertension (højt blodtryk i lungerne).
English: Other information about INOmax
Danish: Andre oplysninger om INOmax:
English: For the full list of all side effects reported with INOmax, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved INOmax fremgår af indlægssedlen.
English: INOmax is a gas for inhalation that contains the active substance nitric oxide diluted in nitrogen gas at 400 or 800 parts per million (ppm).
Danish: INOmax er en inhalationsgas, der indeholder det aktive stof nitrogenoxid (kvælstofilte), fortyndet i nitrogengas i koncentrationen 400 eller 800 ppm (parts per million).
English: In the two main studies in newborn babies with breathing problems, INOmax was more effective than placebo at reducing the need of ECMO.
Danish: I de to hovedundersøgelser af nyfødte med vejrtrækningsproblemer var INOmax mere effektivt end placebo til at nedbringe behovet for ECMO.
English: It also helps to decrease inflammation in the lungs.
Danish: Det bidrager også til at dæmpe betændelsestilstande i lungerne.
English: INOmax is given after being diluted in an oxygen/air mixture supplied to the patient through the ventilator.
Danish: INOmax gives efter at være blevet fortyndet i den ilt/luftblanding, som patienten får gennem ventilatoren.
English: For more information about treatment with INOmax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist..
Danish: De nærmere oplysninger om behandling med INOmax fremgår af indlægssedlen (også en del af EPAR) eller kan fås hos lægen eller på apoteket.
English: In these patients INOmax is used to help improve heart function and reduce blood pressure in the lungs.
Danish: Hos disse patienter anvendes INOmax til at forbedre hjertefunktionen og nedbringe blodtrykket i lungerne.
English: The main measure of effectiveness was the proportion of neonates who died or needed ECMO over the first 120 days in hospital.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor stor en del af de nyfødte der døde eller måtte have ECMO i løbet af de første 120 dage på hospitalet.
English: In the second main study, 30 (31%) of the neonates receiving INOmax needed ECMO, compared with 51 (57%) of the 89 receiving placebo.
Danish: I den anden hovedundersøgelse måtte 30 (31 %) af de nyfødte, der fik INOmax, have ECMO, sammenholdt med 51 (57 %) af de 89, der fik placebo.
English: INOmax has also been studied in 421 neonates from 34 weeks gestation with pulmonary hypertension in two main studies.
Danish: INOmax blev desuden undersøgt i to hovedundersøgelser af 421 nyfødte med gestationsalder fra 34 uger med pulmonal hypertension.
English: Because nitric oxide is a well-known chemical, the company used data from the published literature to support INOmax's use in newborn babies with pulmonary hypertension, and in adults and children undergoing heart surgery.
Danish: Da nitrogenoxid er et velkendt stof, fremlagde virksomheden oplysninger fra den videnskabelige litteratur til at underbygge anvendelsen af INOmax til nyfødte med pulmonal hypertension samt voksne og børn, der undergår en hjerteoperation.
English: INOmax is used in these babies to improve oxygen supply levels and to reduce the need for extracorporeal membrane oxygenation (ECMO, a technique to oxygenate the blood outside the body using a device similar to a heart-lung machine).
Danish: INOmax anvendes hos disse spædbørn til at øge iltindholdet og mindske behovet for ekstrakorporal membranoxygenering (ECMO, der er en teknik til iltning af blodet uden for kroppen med et apparat svarende til en hjerte-lungemaskine).
English: It must not be used in babies who have right-to-left or significant left-to-right shunting of blood (abnormal circulation of blood in the heart).
Danish: Det må desuden ikke anvendes hos spædbørn, der har højre-venstre shunt eller betydende venstre-højre shunt (unormal blodpassage mellem hjertehalvdelene).
English: In the published literature, INOmax treatment was shown to reduce the blood pressure in the lungs and improve heart function when used during or after heart surgery.
Danish: I den offentliggjorte litteratur har INOmax vist sig at nedbringe blodtrykket i lungerne og forbedre hjertefunktionen, når det anvendes under eller efter en hjerteoperation.
English: What is the risk associated with INOmax?
Danish: Hvilken risiko er der forbundet med INOmax?
English: The active substance in INOmax, nitric oxide, is a naturally-occurring chemical in the body, which causes the muscles in the lining of the blood vessels to relax.
Danish: Det aktive stof i INOmax, nitrogenoxid, er et stof, der findes naturligt i kroppen og får musklerne i karvæggene til at afslappes.
English: Why has INOmax been approved?
Danish: Hvorfor blev INOmax godkendt?
English: In the first main study, 52 (46%) of the 114 neonates receiving INOmax died or needed ECMO, compared with 77 (64%) of the 121 receiving placebo.
Danish: I den første hovedundersøgelse fik 114 nyfødte INOmax, hvoraf 52 (46 %) døde eller måtte have ECMO, sammenholdt med 77 (64 %) af de 121, der fik placebo.
English: In the second study, 186 neonates with respiratory failure received either INOmax or placebo.
Danish: I den anden undersøgelse indgik 186 nyfødte, der havde åndedrætssvigt og enten fik INOmax eller placebo.
English: In the first study, 235 neonates with respiratory failure received either INOmax or placebo (a dummy treatment).
Danish: I den første undersøgelse indgik 235 nyfødte, der havde åndedrætssvigt og enten fik INOmax eller placebo (en virkningsløs behandling).
English: What is INOmax?
Danish: Hvad er INOmax?
English: The main measure of effectiveness was the proportion of neonates who needed ECMO.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor stor en del af de nyfødte der måtte have ECMO.
English: What benefit has INOmax shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved INOmax?
English: What is INOmax used for?
Danish: Hvad anvendes INOmax til?
English: When inhaled, it causes the vessels in the lungs to dilate (widen); this allows blood to flow more easily in the lungs to supply oxygen to the rest of the body and remove carbon dioxide, reducing pulmonary hypertension.
Danish: Derved flyder blodet lettere i lungerne og forsyner resten af kroppen med ilt og fjerner kuldioxid, hvorved den pulmonale hypertension mindskes.
English: How has INOmax been studied?
Danish: Hvordan blev INOmax undersøgt?
English: How is INOmax used?
Danish: Hvordan anvendes INOmax?
English: How does INOmax work?
Danish: Hvordan virker INOmax?
English: Date of first authorisation: 30 October 2009 Date of latest renewal: 18 July 2014
Danish: Dato for første markedsføringstilladelse: 30. oktober 2009 Dato for seneste forlængelse: 18. juli 2014
English: You can take Irbesartan Teva with or without food.
Danish: Du kan tage Irbesartan Teva med eller uden mad.
English: This medicinal product should not be given to children under 18 years of age because the safety and efficacy have not yet been fully established.
Danish: Dette lægemiddel bør ikke anvendes til børn under 18 år, da sikkerhed og virkning ikke er blevet fuldstændig klarlagt.
English: Such conditions should be corrected before the administration of irbesartan.
Danish: Sådanne tilstande skal korrigeres før administration af irbesartan.
English: Swensweg 5, Postbus 552 2003 RN Haarlem The Netherlands
Danish: Swensweg 5, Postbus 552 2003 RN Haarlem Holland
English: Patients with high blood pressure
Danish: • Patienter med højt blodtryk
English: Plasma protein binding is approximately 96 %, with negligible binding to cellular blood components.
Danish: Plasmaproteinbindingen er ca. 96 % med ubetydelig binding til cellulære blodkomponenter.
English: The combination should be administered with caution, especially in the elderly.
Danish: Der skal udvises forsigtighed når denne kombination anvendes, især hos de ældre.
English: If you suffer from heart problems
Danish: • hvis du lider af hjerteproblemer.
English: After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80 %.
Danish: Efter oral administration absorberes irbesartan godt: studier af absolut biotilgængelighed gav værdier på ca. 60-80 %.
English: ATC code: C09C A04
Danish: ATC-kode: C09C A04.
English: No specific information is available on the treatment of overdose with irbesartan.
Danish: Der foreligger ikke specifikke oplysninger om behandling af overdosering med irbesartan.
English: However, there was no difference in the half-life and accumulation of irbesartan.
Danish: Der var dog ingen forskel på halveringstid og akkumulering af irbesartan.
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Danish: Hyppigheden af bivirkninger anført nedenfor defineres i henhold til følgende konventioner: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000).
English: PVC/PVdC white opaque - aluminium blisters.
Danish: PVC/PVdC hvide uigennemsigtige - aluminiumblistere.
English: The efficacy of irbesartan is not influenced by age or gender.
Danish: Virkningen af irbesartan afhænger ikke af alder eller køn.
English: The total body and renal clearance are 157-176 and 3-3.5 ml/min, respectively.
Danish: Total krops- og nyreclearance er henholdsvis 157-176 og 3-3,5 ml/min.
English: The safety and efficacy of Irbesartan Teva in children aged 0 to 18 has not been established.
Danish: Irbesartan Tevas sikkerhed og virkning hos børn i alderen 0 til 18 år er ikke fastlagt.
English: Rebound hypertension has not been observed.
Danish: Der er ikke observeret rebound-hypertension.