FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are taking insulin or an antidiabetic medicine known as ‘sulphonylurea', your doctor may want to reduce your dose of insulin or the sulphonylurea when you take either of them together with this medicine, in order to avoid low blood sugar;
Danish: Din læge vil muligvis nedsætte din dosis af insulin eller sulfonylurinstof for at undgå, at du får for lavt blodsukker - hvis du har haft allergiske reaktioner over for andre lægemidler, som du tager for at kontrollere mængden af sukker i blodet
English: Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 1000 mg of metformin hydrochloride.
Danish: Hver tablet indeholder 2,5 mg saxagliptin (som hydrochlorid) og 1000 mg metforminhydrochlorid.
English: Komboglyze 2.5 mg/1,000 mg tablets saxagliptin/metformin HCl
Danish: Komboglyze 2,5 mg/1000 mg tabletter saxagliptin/metformin-HCl
English: Komboglyze 2.5 mg/850 mg tablets saxagliptin/metformin HCl
Danish: Komboglyze 2,5 mg/850 mg tabletter saxagliptin/metformin-HCl
English: CARTON Komboglyze 2.5 mg/1000 mg film-coated tablets
Danish: KARTON Komboglyze 2,5 mg/1000 mg filmovertrukne tabletter
English: Change from baseline (adjusted mean (95% Confidence interval [CI]) Difference from saxagliptin + metformin (adjusted mean (95% CI)
Danish: Forskel fra saxagliptin + metformin (justeret gennemsnit (95 % CI)
English: Komboglyze 2.5 mg/850 mg film-coated tablets saxagliptin/metformin
Danish: Komboglyze 2,5 mg/850 mg filmovertrukne tabletter saxagliptin/metformin
English: Komboglyze 2.5 mg/1,000 mg film-coated tablets saxagliptin/metformin
Danish: Komboglyze 2,5 mg/1000 mg filmovertrukne tabletter saxagliptin/metformin
English: Maximum daily dose is 1000 mg.
Danish: 30-44 Den maksimale daglige dosis er 1.000 mg
English: Pale yellow to light yellow, biconvex, oval shaped, film-coated tablets, with “2.5/1000” printed on one side and “4247” printed on the other side, in blue ink.
Danish: Komboglyze 2,5 mg/1.000 mg filmovertrukne tabletter Svagt gule til lysegule, bikonvekse, ovale filmovertrukne tabletter med "2.5/1000" trykt på den ene side og "4247" trykt på den anden side med blåt blæk.
English: Komboglyze 2.5 mg/850 mg film-coated tablets saxagliptin/metformin hydrochloride
Danish: Komboglyze 2,5 mg/850 mg filmovertrukne tabletter saxagliptin/metforminhydrochlorid
English: Komboglyze 2.5 mg/1,000 mg film-coated tablets saxagliptin/metformin hydrochloride
Danish: Komboglyze 2,5 mg/1000 mg filmovertrukne tabletter saxagliptin/metforminhydrochlorid
English: Maximum daily dose is 3000 mg.
Danish: 60-89 Den maksimale daglige dosis er 3.000 mg
English: Light brown to brown, biconvex, round, film-coated tablets, with “2.5/850” printed on one side and “4246” printed on the other side, in blue ink.
Danish: Komboglyze 2,5 mg/850 mg filmovertrukne tabletter Lysebrune til brune, bikonvekse, runde filmovertrukne tabletter med "2.5/850" trykt på den ene side og "4246" trykt på den anden side med blåt blæk.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Angioødem (se pkt.
English: Constipation
Danish: Hjertesvigt
English: Film coating
Danish: Filmovertræk
English: Package size l t o r
Danish: Pakningsstørrelse gem idlet er ikke ngere autoriseret til salg
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zonegran on 10 March 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zonegran den 10. marts 2005.
English: Zonegran zonisamide
Danish: Zonegran zonisamid
English: The full EPAR for Zonegran can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zonegran findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is available as capsules (25, 50 and 100 mg) and orodispersible tablets (25, 50, 100 and 300 mg).
Danish: Det fås som kapsler (25, 50 og 100 mg) og smeltetabletter (25, 50, 100 og 300 mg).
English: Other information about Zonegran:
Danish: Andre oplysninger om Zonegran:
English: This document is a summary of the European public assessment report (EPAR) for Zonegran.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zonegran.
English: This may help to stabilise electrical activity in the brain.
Danish: Dette kan medvirke til at stabilisere den elektriske aktivitet i hjernen.
English: These channels transmit electrical impulses between nerve cells.
Danish: Disse kanaler overfører de elektriske impulser mellem nervecellerne.
English: Zonegran can cause heatstroke and de-hydration, particularly in children, and these need to be treated promptly.
Danish: Zonegran kan forårsage hedeslag og dehydrering, navnlig hos børn, og disse skal behandles omgående.
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 Zonegran.
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 Zonegran.
English: Two other main studies, one involving 351 adults and one involving 207 children (between 6 and 17 years old), looked at Zonegran as an add-on to existing treatment.
Danish: To andre hovedundersøgelser - én med 351 voksne og én med 207 børn (i alderen seks til 17 år)vedrørte Zonegran som tillægsbehandling til eksisterende behandling.
English: Zonegran used on its own was shown to be beneficial in adults with partial seizures: 69.4% of patients on Zonegran were seizure-free for six months.
Danish: Zonegran anvendt alene viste sig at være gavnligt for voksne med partielle anfald: 69,4 % af patienterne på Zonegran var anfaldsfrie i seks måneder.
English: For more information about treatment with Zonegran, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zonegran, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Epileptic fits are caused by abnormal electrical activity in the brain.
Danish: Epileptiske anfald skyldes abnorm elektrisk aktivitet i hjernen.
English: Zonegran was more effective than placebo at reducing the frequency of seizures when used as an ‘addon' to existing treatment.
Danish: Zonegran var mere effektivt end placebo til at mindske hyppigheden af anfald, når det blev anvendt som tillægsbehandling til eksisterende behandling.
English: Before stopping Zonegran, the dose should be decreased gradually.
Danish: Hvis behandlingen med Zonegran afbrydes, bør dosis nedsættes gradvist.
English: These studies compared Zonegran with placebo (a dummy treatment).
Danish: I disse undersøgelser blev Zonegran sammenlignet med placebo (en virkningsløs behandling).
English: Zonegran used on its own was compared with carbamazepine, another anti-epileptic medicine, in a main study involving 583 adults newly diagnosed with partial epilepsy.
Danish: Zonegran anvendt alene blev sammenlignet med carbamazepin, et andet antieleptisk lægemiddel, i en hovedundersøgelse med 583 voksne, som for nylig havde fået stillet diagnosen partiel epilepsi.
English: Zonegran is a medicine that contains the active substance zonisamide.
Danish: Zonegran er et lægemiddel, der indeholder det aktive stof zonisamid.
English: By blocking these channels, zonisamide prevents the nerve cells from synchronising their activity and prevents abnormal electrical activity spreading through the brain.
Danish: Ved at blokere kanalerne forhindrer zonisamid nervecellerne i at synkronisere deres aktivitet, hvorved den abnorme elektriske aktivitet forhindres i at brede sig til hele hjernen.
English: Zonisamide works by blocking specific pores on the surface of nerve cells called sodium channels and calcium channels.
Danish: Zonisamid virker ved at blokere de særlige porer på nervecellernes overflade, der kaldes natriumkanaler og kalciumkanaler.
English: The active substance in Zonegran, zonisamide, is an anti-epileptic.
Danish: Det aktive stof i Zonegran, zonisamid, er et antiepileptisk lægemiddel.
English: The main measure of effectiveness was the proportion of patients who were seizure-free for a period of six months.
Danish: Det primære effektmål var andelen af patienterne, der var anfaldsfrie i seks måneder.
English: It is used on its own in newly diagnosed adults and as an ‘add-on' therapy in adults and children aged 6 years and above already receiving other antiepilepsy medicines.
Danish: Det anvendes alene hos nydiagnosticerede voksne eller som tillægsbehandling hos voksne og børn fra seksårsalderen, der i forvejen får andre epilepsilægemidler.
English: The CHMP decided that Zonegran's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Zonegran opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Zonegran.
English: The total dose must not exceed 500 mg a day.
Danish: Den samlede dosis må ikke overstige 500 mg om dagen.
English: The most common side effects with Zonegran (seen in more than 1 patient in 10) are loss of appetite, agitation, irritability, confusion, depression, ataxia (an inability to co-ordinate muscle movements), dizziness, memory impairment, somnolence (sleepiness), diplopia (double vision) and decreased blood bicarbonate levels; although the safety profile is similar in children and adults, some side effects are reported more frequently in children than in adults.
Danish: De hyppigste bivirkninger ved Zonegran (som optræder hos flere end 1 ud af 10 patienter) er appetitløshed, uro, irritabilitet, omtågethed, depression, ataksi (forstyrrelse i koordineringen af muskelbevægelserne), svimmelhed, hukommelsessvækkelse, somnolens (søvnighed), diplopi (dobbeltsyn) og mindsket indhold af bikarbonat i blodet.
English: After one week the dose may be increased to 50 mg twice a day and then further increased in steps of 100 mg every week, depending on the patient's response.
Danish: Efter en uge kan dosis sættes op til 50 mg to gange dagligt og derefter yderligere sættes op 100 mg ad gangen hver uge, afhængigt af patientens respons.
English: The percentage of patients on carbamazepine who were seizure-free for six months was 74.7%.
Danish: Af patienterne på carbamazepin var 74,7 % anfaldsfrie i seks måneder.
English: Zonegran is used to treat patients with partial seizures (epileptic fits starting in one part of the brain), including those who have secondary generalisation (where the seizure subsequently spreads to the whole brain).
Danish: Zonegran anvendes til behandling af patienter med partielle anfald (epileptiske anfald, der udløses i en del af hjernen), herunder patienter med sekundær generalisering (dvs. anfald, der efterfølgende breder sig til hele hjernen).
English: In children, the number of seizures was at least halved in 50% of the patients taking Zonegran, compared with 31% of those taking placebo.
Danish: Hos børn blev antallet af anfald mindst halveret hos 50 % af de patienter, der fik Zonegran, sammenlignet med 31 % hos dem, der fik placebo.
English: What is the risk associated with Zonegran?
Danish: Hvilken risiko er der forbundet med Zonegran?
English: Why has Zonegran been approved?
Danish: Hvorfor blev Zonegran godkendt?
English: Zonegran must not be used in people who are hypersensitive (allergic) to zonisamide, to any of the other ingredients, or to sulphonamides (such as some antibiotics).
Danish: Zonegran må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for zonisamid, over for andre af indholdsstofferne eller over for sulfonamider (såsom visse antibiotika).
English: After one or two weeks, the daily dose may be increased in steps of 1 mg per kg every one or two weeks until an appropriate dose is reached.
Danish: Efter én eller to uger kan den daglige dosis gradvist øges med 1 mg pr. kg legemsvægt hver uge eller hver anden uge, indtil en egnet dosis er nået.
English: Severe rashes have occurred in patients taking Zonegran, including cases of Stevens-Johnson syndrome (a severe, life-threatening type of allergic reaction affecting the skin and mucous membranes).
Danish: Der er forekommet alvorligt udslæt hos patienter, som fik Zonegran, herunder tilfælde af Stevens-Johnsons syndrom (en svær, livstruende allergisk hud- og slimhindereaktion).
English: Adults taking 500 mg Zonegran per day had an average reduction in seizure frequency of 51%, compared with 16% in those taking placebo.
Danish: Hyppigheden af anfald hos voksne, der fik 500 mg Zonegran dagligt, faldt i gennemsnit med 51 % sammenholdt med 16 % hos dem, der fik placebo.
English: What is Zonegran?
Danish: Hvad er Zonegran?
English: In the study involving adults, the main measure of effectiveness was the change in the frequency of partial seizures between the 12 weeks before treatment started and the 18-week period when a stable dose was used.
Danish: I voksenundersøgelsen var det primære effektmål ændringen i hyppigheden af partielle anfald i tidsrummet fra de 12 uger før behandlingens start til den 18-ugers periode, hvor patienterne fik en fast dosis.
English: For the full list of all side effects reported with Zonegran, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Zonegran fremgår af indlægssedlen.
English: When Zonegran is used as an ‘add-on' to existing treatment in adults, the recommended starting dose is 25 mg twice a day.
Danish: Når Zonegran anvendes som tillægsbehandling til voksne, der allerede er under behandling, er den anbefalede startdosis 25 mg to gange dagligt.
English: In the study in children, the main measure of effectiveness was the proportion of patients in whom the number of seizures was at least halved between the 8 weeks before treatment started and the 12-week period when a stable dose was used.
Danish: I børneundersøgelsen var det primære effektmål andelen af patienter, der som minimum oplevede et halvering i antallet af anfald i tidsrummet fra de otte uger før behandlingens start til den 12-ugers periode, hvor patienterne fik en fast dosis.
English: What benefit has Zonegran shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Zonegran?
English: When Zonegran is used on its own in newly diagnosed adults, the recommended starting dose is 100 mg once a day for two weeks, which may be increased by 100 mg at intervals of two weeks.
Danish: Når Zonegran anvendes alene hos nydiagnosticerede voksne, er den anbefalede startdosis 100 mg én gang dagligt i to uger.
English: Zonegran can be given once or twice a day after an appropriate dose is reached.
Danish: Når der er nået en egnet dosis, kan Zonegran gives én eller to gange dagligt.
English: How has Zonegran been studied?
Danish: Hvordan blev Zonegran undersøgt?
English: This reduces the chances of an epileptic fit. Zonegran also acts on the neurotransmitter gamma-aminobutyric acid (GABA, a chemical that allows nerve cells to communicate with each other).
Danish: Zonegran virker desuden på signalstoffet gammaaminosmørsyre (GABA, et kemisk stof, der anvendes af nervecellerne i deres indbyrdes kommunikation).
English: What is Zonegran used for?
Danish: Hvad anvendes Zonegran til?
English: How is Zonegran used?
Danish: Hvordan anvendes Zonegran?
English: When Zonegran is used as an ‘add-on' to existing treatment in children aged 6 years and above, the dose depends on body weight; the recommended starting dose is 1 mg per kg of body weight daily.
Danish: Når Zonegran anvendes som tillægsbehandling til børn fra seksårsalderen, der allerede er under behandling, afhænger dosis af legemsvægten.
English: How does Zonegran work?
Danish: Hvordan virker Zonegran?
English: 17 November 2011
Danish: Den 17. november 2011
English: How are they expected to work?
Danish: Hvordan forventes de at virke?
English: What were the medicines expected to be used for?
Danish: Hvad forventedes lægemidlerne anvendt til?
English: The company that applied for the change to the authorisation is Eli Lilly.
Danish: Virksomheden, der har indgivet ansøgningen, er Eli Lilly.
English: The full European Public Assessment Report for Ariclaim, Cymbalta and Xeristar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige europæiske offentlige vurderingsrapport for Ariclaim, Cymbalta og Xeristar findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It does not include pain from internal organs such as the stomach and intestines.
Danish: De omfatter ikke smerter fra indre organer som f.eks. mave og tarm.
English: There was also insufficient evidence that its effect could be maintained over time, which is important when treating a long-term condition.
Danish: Der var ligeledes ikke tilstrækkelig dokumentation for, at virkningen kunne opretholdes med tiden, som det er vigtigt ved langvarig sygdom.
English: There are no consequences on the use of these medicines in their approved indications, for which the balance of benefits and risks remains unchanged.
Danish: Der bliver ingen konsekvenser for anvendelsen af disse lægemidler til de godkendte indikationer, for hvilke der ikke er sket nogen ændring i benefit/risk-forholdet.
English: What did the company present to support its application?
Danish: Hvilken dokumentation fremlagde virksomheden til støtte for ansøgningen?
English: The medicines are expected to work in the same way they do in diabetic peripheral neuropathy.
Danish: Lægemidlerne forventes at virke på samme måde som de gør ved diabetisk perifer neuropati.
English: In addition, more information was needed on the effects of duloxetine in elderly patients and its safety in the intended patients including the elderly.
Danish: Desuden var der brug for flere oplysninger om duloxetins virkninger hos ældre patienter og dets sikkerhed ved anvendelse hos den tilsigtede patientgruppe, herunder ældre.
English: The CHMP noted that the studies had not proven that duloxetine would provide a relevant benefit in the indication applied for.
Danish: CHMP konstaterede, at undersøgelserne ikke havde bevist, at duloxetin ville have en relevant fordel ved den ansøgte indikation.
English: The Committee concluded however that its concerns had still not been adequately addressed and confirmed its initial negative opinion recommending the refusal of a change to the marketing authorisations.
Danish: Udvalget konkluderede imidlertid, at dets betænkeligheder fortsat ikke var tilstrækkeligt imødekommet, og fastholdt sin oprindelige negative udtalelse, som anbefalede afslag på ansøgningen om ændring af markedsføringstilladelserne.
English: Somatic pain is from the body surfaces (such as skin) or musculoskeletal tissues (such as skeletal muscles, bone and joints).
Danish: Somatiske smerter er smerter fra krop pens overflader (f.eks. huden) eller fra muskuloskeletalt væv (skeletmuskler, knogler og led).
English: What were the CHMP's main concerns that led to the refusal of the change to the marketing authorisations?
Danish: Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede at give afslag på ansøgningen om ændring af markedsføringstilladelserne?
English: The main measure of effectiveness was the change in the severity of pain, as recorded by the patients on an 11-point scale after 12 or 13 weeks of treatment.
Danish: Dette blev af patienterne registreret på en 11-punkts skala efter 12 eller 13 ugers behandling.
English: It works by preventing the neurotransmitters 5-hydroxytrypamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Danish: Det virker ved at forhindre, at neurotransmitterne 5-hydroxytryptamin (der også kaldes serotonin) og noradrenalin genoptages i nervecellerne i hjernen og rygmarven.
English: Ariclaim, Cymbalta and Xeristar are medicines containing the active substance duloxetine.
Danish: Ariclaim, Cymbalta og Xeristar er lægemidler, der indeholder det aktive stof duloxetin.
English: They are available as gastroresistant capsules.
Danish: De leveres som enterokapsler.
English: On 21 July 2011, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisations for the duloxetinecontaining medicines Ariclaim, Cymbalta and Xeristar.
Danish: Den 28. juli 2011 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om ændring af markedsføringstilladelsen for lægemidlerne Ariclaim, Cymbalta og Xeristar, der indeholder duloxetin.
English: The company informed the CHMP that there are currently no ongoing clinical trials with Ariclaim, Cymbalta and Xeristar in chronic somatic pain patients in Europe.
Danish: Virksomheden meddelte CHMP, at der på nuværende tidspunkt ikke gennemføres kliniske undersøgelser med Ariclaim, Cymbalta eller Xeristar hos patienter med kroniske somatiske smerter i Europa.
English: The company presented results of five main studies in 839 patients with chronic somatic pain: two studies in patients with knee pain caused by osteoarthritis (swelling and pain in the joints) and three in patients with chronic low back pain.
Danish: Virksomheden fremlagde resultater af fem hovedundersøgelser, der omfatter 839 patienter med kroniske somatiske smerter: To undersøgelser hos patienter med knæsmerter ved slidgigt (hævelse og smerter i leddene) og tre undersøgelser hos patienter med kroniske lændesmerter.
English: What are Ariclaim, Cymbalta and Xeristar?
Danish: Hvad er Ariclaim, Cymbalta and Xeristar?
English: Patients in the studies were treated with duloxetine or placebo (a dummy treatment) with some patients taking them in combination with NSAIDs.
Danish: Patienterne i undersøgelserne blev behandlet med duloxetin eller placebo (virkningsløs behandling), og hos nogle af patienterne blev behandlingen kombineret med NSAID.
English: In addition to pain due to diabetic peripheral neuropathy, Cymbalta and Xeristar are also used in major depression and generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Danish: Ud over smerter ved diabetisk perifer neuropati anvendes Cymbalta og Xeristar også ved svær depression og generaliseret angst (varig angst eller nervøsitet i forbindelse med dagligdags aktivitet).
English: After considering the grounds for this request, the CHMP re examined the initial opinion, and confirmed the refusal of the change to the marketing authorisations on 17 November 2011.
Danish: Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en revurdering af den første udtalelse og fastholdt den 17. november 2011 afslaget på ansøgningen om ændringen.
English: During the re-examination, the Committee considered the use of duloxetine in a smaller group of patients: patients with chronic low back pain or osteoarthritis (swelling and pain in the joints) of at least moderate severity who cannot use NSAIDS.
Danish: Som led i revurderingen tog udvalget stilling til anvendelsen af duloxetin hos en mindre gruppe af patienter: patienter, der har kroniske lændesmerter eller slidgigt (hævelse og smerter i leddene) af mindst moderat sværhed, og som ikke kan bruge NSAID.
English: Ariclaim is used to treat pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).
Danish: Ariclaim anvendes til smerter ved diabetisk perifer neuropati (beskadigelse af nerverne i arme og ben, hvilket kan forekomme hos patienter med diabetes).