FrancophonIA/ELRC3.0 huggingface dataset:
English: The company presented the results of three studies of Januvia/Xelevia to support the use of Janumet in patients who were not satisfactorily controlled on their existing metformin treatment.
Danish: Virksomheden fremlagde resultaterne af tre undersøgelser af Januvia/Xelevia til støtte for brugen af Janumet til patienter, som ikke kunne kontrolleres tilfredsstillende med den nuværende metforminbehandling.
English: CHMP decided that Janumet's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Janumet opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The most common side effect with Janumet (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
Danish: Den hyppigste bivikning ved Janumet (som optræder hos mellem 1 og 10 patienter ud af 100) er kvalme.
English: Janumet sitagliptin / metformin hydrochloride
Danish: Janumet sitagliptin/metforminhydrochlorid
English: What is the risk associated with Janumet?
Danish: Hvilken risiko er der forbundet med Janumet?
English: It is available as tablets (50 mg sitagliptin / 850 mg metformin hydrochloride; and 50 mg sitagliptin / 1,000 mg metformin hydrochloride).
Danish: Det fås som tabletter (50 mg sitagliptin/850 mg metforminhydrochlorid og 50 mg sitagliptin/1 000 mg metforminhydrochlorid).
English: In the first of the three further studies, Janumet was more effective than metformin or sitagliptin alone.
Danish: I den første af tre yderligere undersøgelser var Janumet mere effektivt end metformin eller sitagliptin alene.
English: It must not be used in patients who have diabetic ketoacidosis or pre-coma (dangerous conditions that can occur in diabetes), problems with the kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Danish: Det må ikke anvendes til patienter, som har diabetisk ketoacidose eller prækoma (alvorlig tilstand, der kan opstå hos sukkersygepatienter), nyre- eller leverproblemer, sygdomme, som kan påvirke nyrerne, eller en sygdom, som medfører dårlig iltforsyning til vævene, såsom hjerte- eller lungeinsufficiens eller et nyligt hjerteanfald.
English: Why has Janumet been approved?
Danish: Hvorfor er Janumet blevet godkendt?
English: As a result of the action of both active substances, blood glucose levels are reduced and this helps to control type 2 diabetes.
Danish: Som et resultat af begge aktive stoffers virkning sænkes blodsukkerniveauet, og dette medvirker til at kontrollere type 2-diabetes.
English: Janumet is a medicine that contains two active substances, sitagliptin and metformin hydrochloride.
Danish: Janumet er et lægemiddel, der indeholder de to aktive stoffer sitagliptin og metforminhydrochlorid.
English: If Janumet is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Danish: Hvis Janumet tages sammen med et sulfonylurinstof eller insulin, skal dosen af sulfonylurinstof eller insulin muligvis sænkes for at undgå hypoglykæmi (lavt blodsukkerniveau).
English: It must also not be used in patients who consume excessive amounts of alcohol or are alcoholic, or in women who are breast-feeding.
Danish: Det må heller ikke gives til patienter med overdrevet alkoholforbrug, alkoholikere eller ammende kvinder.
English: The active substances in Janumet, sitagliptin and metformin hydrochloride, each have a different mode of action.
Danish: De aktive stoffer i Janumet, sitagliptin og metforminhydrochlorid, virker hver især forskelligt.
English: Sitagliptin on its own as Januvia/Xelevia/Tesavel can be used with metformin, and with both metformin and a sulphonylurea, in type 2 diabetes patients.
Danish: Sitagliptin alene kan ligesom Januvia/Xelevia/Tesavel anvendes i kombination med metformin eller i kombination med både metformin og et sulfonylurinstof til patienter med type 2-diabetes.
English: Janumet is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels.
Danish: Janumet anvendes til patienter med type 2-diabetes til at forbedre reguleringen af blodglukoseniveauet (blodsukkerniveauet).
English: This study also compared the effects of adding sitagliptin or placebo.
Danish: I undersøgelsen blev virkningen af at tilføje sitagliptin eller placebo ligeledes sammenlignet.
English: The third included 641 patients who were not satisfactorily controlled on a stable dose of insulin, three-quarters of whom were also taking metformin.
Danish: Den tredje undersøgelse omfattede 641 patienter, som ikke kunne kontrolleres tilstrækkeligt med en fast dosis insulin, hvoraf tre fjerdedele også fik metformin.
English: Janumet must not be used in people who are hypersensitive (allergic) to sitagliptin, metformin or any of the other ingredients.
Danish: Janumet må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for sitagliptin, metformin eller andre af indholdsstofferne.
English: In all of the studies, the main measure of effectiveness was the change in the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Danish: I alle undersøgelserne blev virkningen hovedsagelig bedømt på ændringen i mængderne af et stof i blodet kaldet glykosyleret hæmoglobin (HbA1c), som viser, hvor godt blodsukkeret er reguleret.
English: • in patients who are not satisfactorily controlled on metformin (an antidiabetes medicine) used on its own;
Danish: • til patienter, som ikke er tilfredsstillende kontrolleret med metformin (et lægemiddel mod sukkersyge) alene
English: The effectiveness of adding sitagliptin to metformin was similar to that of adding glipizide.
Danish: Virkningen af at tilføje sitagliptin til metformin var den samme som ved tilføjelse af glipizid.
English: The second included 278 patients who were not satisfactorily controlled on the combination of metformin and rosiglitazone (a PPAR-gamma agonist) and compared the effects of adding sitagliptin or placebo.
Danish: Den anden omfattede 278 patienter, som ikke kunne kontrolleres tilstrækkeligt med kombinationen af metformin og rosiglitazon (en PPAR-gammaagonist), og sammenlignede virkningen af at tilføje sitagliptin eller placebo.
English: The first included 1,091 patients who were not satisfactorily controlled on diet and exercise alone and compared the effect of Janumet with that of metformin or sitagliptin alone.
Danish: Den første undersøgelse omfattede 1 091 patienter, som ikke kunne kontrolleres tilstrækkeligt med diæt og motion alene, og sammenlignede virkningen af Janumet med virkningen af metformin eller sitagliptin alene.
English: Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Danish: Sitagliptin reducerer også den mængde glukose, som leveren producerer, ved at øge insulinniveauet og mindske niveauet af hormonet glukagon.
English: What is Janumet?
Danish: Hvad er Janumet?
English: Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Danish: Metformin virker hovedsagelig ved at hæmme produktionen af glukose og mindske optagelsen af glukose i tarmen.
English: Two of the studies looked at sitagliptin as an add-on to metformin: the first compared it with placebo (a dummy treatment) in 701 patients, and the second compared it with glipizide (a sulphonylurea) in 1,172 patients.
Danish: I to af undersøgelserne så man nærmere på sitagliptin som tillægsbehandling til metformin: I den første undersøgelse blev det sammenlignet med placebo (en virkningsløs behandling) hos 701 patienter, og i den anden med glipizid (et sulfonylurinstof) hos 1 172 patienter.
English: There was no difference in this effect between the patients also taking metformin and those not taking it.
Danish: Virkningen var den samme hos patienter, der fik metformin som tillægsbehandling, og hos dem, som ikke fik det.
English: How has Janumet been studied?
Danish: Hvordan er Janumet blevet undersøgt?
English: For the full list of all side effects reported with Janumet, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Janumet fremgår af indlægssedlen.
English: In the second, HbA1c levels were reduced by 1.03% after 18 weeks in patients adding sitagliptin to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo.
Danish: I den anden var HbA1c-niveauerne faldet med 1,03 % efter 18 uger hos patienter, som fik tilføjet sitagliptin til metformin og rosiglitazon, sammenlignet med et fald på 0,31 % hos dem, som fik tilføjet placebo.
English: By increasing the levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Danish: Sitagliptin øger blodets indhold af inkretinhormoner og stimulerer dermed bugspytkirtlen til at producere mere insulin, når blodsukkerniveauet er højt.
English: What benefit has Janumet shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Janumet?
English: The third study compared sitagliptin with placebo, when used as an add-on to glimepiride (another sulphonylurea), with or without metformin, in 441 patients.
Danish: I den tredje undersøgelse hos 441 patienter sammenlignede man sitagliptin med placebo som tillægsbehandling til glimepirid (et andet sulfonylurinstof) sammen med eller uden metformin.
English: Adding 100 mg sitagliptin to metformin reduced HbA1c levels by 0.67% (from around 8.0%) after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Danish: Når der blev tilføjet 100 mg sitagliptin til metforminbehandlingen, var HbA1c-niveauerne faldet med 0,67 % (fra ca. 8,0 %) efter 24 uger sammenlignet med 0,02 % hos patienter, der fik placebo som tillægsbehandling.
English: In the study in which sitagliptin was added to glimepiride and metformin, the levels of HbA1c were reduced by 0.59% after 24 weeks, compared with an increase of 0.30% in the patients adding placebo.
Danish: I den undersøgelse, hvor sitagliptin var tillægsbehandling til glimepirid og metformin, faldt HbA1c-niveauerne med 0,59 % efter 24 uger sammenlignet med en stigning på 0,30 % hos patienter, der fik placebo som tillægsbehandling.
English: What is Janumet used for?
Danish: Hvad anvendes Janumet til?
English: Finally, they were reduced by 0.59% after 24 weeks in patients adding sitagliptin to insulin, compared with a fall of 0.03% in those adding placebo.
Danish: I den sidste var niveauerne faldet med 0,59 % efter 24 uger hos patienter, som fik sitagliptin som tillægsbehandling til insulin, sammenlignet med et fald på 0,03 % hos dem, som fik placebo som tillægsbehandling.
English: How does Janumet work?
Danish: Hvordan virker Janumet?
English: • in combination with a sulphonylurea, a PPAR-gamma agonist such as a thiazolidinedione, or insulin
Danish: • i kombination med et sulfonylurinstof, en PPAR-gammaagonist, som f.eks. et thiazolidindion, eller insulin (andre typer lægemidler mod sukkersyge) hos patienter, som ikke er tilfredsstillende kontrolleret med dette lægemiddel og metformin.
English: How is Janumet used?
Danish: Hvordan anvendes Janumet?
English: London, 15 October 2009 EMEA/608931/2009
Danish: London, den 15. oktober 2009 EMEA/608931/2009
English: Article 34 of Directive 2001/82/EC, as amended.
Danish: Artikel 34 i direktiv 2001/82/EF, med senere ændringer.
English: The final opinion was converted into a Decision by the European Commission on 15 October 2009.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 15. oktober 2009.
English: Marketing Authorisations for three different strengths (40g, 100g and 200g per kg) were granted in 19 Member States of the European Union via different authorisation procedures (mutual recognition procedures or national procedures).
Danish: Der er udstedt markedsføringstilladelser for tre forskellige styrker (40g, 100g og 200g pr. kg) i 19 af Den Europæiske Unions medlemsstater via forskellige godkendelsesprocedurer (gensidige anerkendelsesprocedurer eller nationale procedurer).
English: The Committee appointed Dr C. Rubio Montejano as rapporteur and Dr L. Jodkonis as co-rapporteur.
Danish: Rubio Montejano som rapportør og dr. L. Jodkonis som medrapportør.
English: The referral procedure started on 16 July 2008.
Danish: Proceduren for indbragte sager indledtes den 16. juli 2008.
English: A revised Opinion, necessitated by purely administrative changes, was adopted in July 2009.
Danish: Der blev vedtaget en revideret udtalelse, som var nødvendig på grund af de rent administrative ændringer, ved skriftlig procedure i juli 2009.
English: Written explanations were provided by the Marketing Authorisation Holders on 15 January 2009 and supplementary information was submitted on 16 March 2009.
Danish: Indehaverne af markedsføringstilladelsen fremsendte skriftlige redegørelser den 15. januar 2009 og yderligere oplysninger den 16. marts 2009.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics and labelling in the Annex III
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II, og det ændrede produktresumé og den ændrede etikettering findes i bilag III.
English: Oral explanations were given by the Marketing Authorisation Holders 15 April 2009.
Danish: Indehaveren af markedsføringstilladelsen afgav mundtlige redegørelser den 15. april 2009.
English: Based on evaluation of currently available data and the rapporteur's assessment report, the CVMP considered that the benefit/risk profile of Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names is positive subject to the recommended changes of the Summary of the Product Characteristics and product information and therefore adopted an Opinion in May 2009 recommending amendments of the Marketing Authorisations.
Danish: På grundlag af vurderingen af de aktuelt foreliggende oplysninger og evalueringsrapporten fra rapportøren var CHMP af den opfattelse, at risk/benefit-forholdet for Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix og tilknyttede navne var positivt under forudsætning af de anbefalede ændringer i produktresumeet og produktoplysningerne og vedtog derfor en udtalelse i maj 2009, hvori det anbefalede, at markedsføringstilladelserne ændres.
English: Due to divergences (i.e. indications for use, amount to be administered and withdrawal period) amongst the nationally authorised Summary of Product Characteristics for Pulmotil 40 VET Premix, Pulmotil 100 VET Premix and Pulmotil 200 VET Premix, Belgium referred the matter to the EMEA on 3 July 2008, under Article 34 of Directive 2001/82/EC.
Danish: På grund af forskelle mellem de nationalt godkendte produktresuméer (hvad angår indikationer for anvendelse, den mængde, der skal anvendes, og tilbagetrækkelsesperiode) for Pulmotil 40 VET Premix, Pulmotil 100 VET Premix og Pulmotil 200 VET Premix indbragte Belgien en sag for EMEA den 3. juli 2008 i henhold til artikel 34 i direktiv 2001/83/EF.
English: REFERRAL Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix og tilknyttede navne
English: Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names are premixes for medicated feeding stuff whose active ingredient is tilmicosin which is a chemically modified macrolide antibiotic with properties broadly similar to other macrolides.
Danish: Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix og tilknyttede navne er Premix til medicineret foderstof.
English: Strength Pharmaceutical Form Route of Administration Packaging
Danish: Styrke Lægemiddelform Indgivelsesvej
English: MA (EU) number (Invented) name
Danish: MA (EU)nummer
English: Immediate Packaging Pack size
Danish: Indre emballage
English: Frequency categories are as follows:
Danish: Kategorier for hyppighed er som følger:
English: Austria, Belgium, Bulgaria, Czech Republic, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom: Kytril Germany: Kevatril
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: Østrig, Belgien, Bulgarien, Tjekkiet, Estland, Finland, Frankrig, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Holland, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige, Storbritannien: Kytril
English: If changes do occur, they are generally without clinical significance.
Danish: Hvis der forekommer ændringer, er de generelt uden klinisk signifikans.
English: Your doctor will monitor your condition.
Danish: Din læge vil følge din tilstand.
English: Oral bioavailability is generally not influenced by food.
Danish: Oral biotilgængelighed bliver generelt ikke påvirket af føde.
English: {fax} {e-mail}
Danish: {fax} {email}
English: Plasma protein binding is approximately 65%.
Danish: Plasmaproteinbindingen er ca. 65 %.
English: If you do stop taking your medicine, your symptoms may return.
Danish: Hvis du stopper med at tage medicinen, kan symptomerne vende tilbage.
English: The dose of Kytril varies from one patient to another.
Danish: Dosis af Kytril varierer fra den ene patient til den anden.
English: Do not stop taking your medicine before the treatment is finished.
Danish: Stop ikke med at tage medicinen, før behandlingen er afsluttet.
English: There is limited amount of data from the use of granisetron in pregnant women.
Danish: Der er begrænsede data fra anvendelse af granisetron til gravide kvinder.
English: Children should not take these tablets.
Danish: Børn bør ikke tage disse tabletter.
English: There will be at least 10 minutes between each injection.
Danish: Der skal være mindst 10 minutter mellem hver injektion.
English: There is no specific antidote for Kytril.
Danish: Der findes ingen specifik antidot mod Kytril.
English: However, there is no modification of the cardiac frequency, blood pressure or the ECG trace.
Danish: Der er dog ingen ændring af hjertefrekvensen, blodtrykket eller ekg-optagelsen.
English: ATC code: A04AA02.
Danish: ATC-kode: A04AA02.
English: Treatment (acute nausea)
Danish: Behandling (akut kvalme)
English: Despite these changes, no dosage adjustment is necessary (see section 4.2).
Danish: Til trods for disse ændringer er dosisjustering ikke nødvendig (se pkt.
English: Total control of postoperative nausea and vomiting during the first 2 hours after surgery was observed in most patients.
Danish: Total kontrol af postoperativ kvalme og opkastning i de første 2 timer efter operationen blev observeret hos de fleste patienter.
English: The tablets should be swallowed whole with water.
Danish: Tabletterne skal sluges hele med et glas vand.
English: Keep container in the outer carton in order to protect from light.
Danish: Opbevar beholderen i den ydre karton for at beskytte mod lys.
English: Important information about some of the ingredients of Kytril
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Kytril
English: One additional dose may be administered within a 24 hour-period if required.
Danish: Om nødvendigt kan én yderligere dosis administreres inden for 24 timer.
English: Dexamethasone has been used concomitantly at doses up to 20 mg once a day orally.
Danish: Dexamethason er blevet anvendt samtidigt i doser på op til på 20 mg oralt én gang dagligt.
English: The safety and efficacy of granisetron tablets in children have not yet been established.
Danish: Sikkerheden og virkningen af granisetron-tabletter hos børn er ikke klarlagt.
English: The effect of the injection may be improved by the use of medicines called adrenocortical steroids.
Danish: Virkningen af injektionen kan forbedres ved at bruge medicin, som kaldes kortikosteroider.
English: • allergic reactions (anaphylaxis).
Danish: • allergiske reaktioner (anafylaksi).
English: This structure lacks an effective blood-brain barrier, and will detect emetic agents in both the systemic circulation and the cerebrospinal fluid.
Danish: Denne struktur mangler en effektiv blod-hjerne-barriere og vil opfange emetika både i det systemiske kredsløb og i cerebrospinalvæsken.
English: ATC code: A04AA02
Danish: ATC-kode: A04AA02
English: Always take Kytril exactly as your doctor has told you.
Danish: Tag altid Kytril nøjagtigt efter lægens anvisning.
English: Like all medicines, Kytril can cause side effects, although not everybody gets them.
Danish: Kytril kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Absorption of granisetron is rapid and complete, though oral bioavailability is reduced to about 60% as a result of first pass metabolism.
Danish: Granisetron absorberes hurtigt og fuldstændigt, men den orale biotilgængelighed er reduceret til omkring 60 % på grund af first pass metabolisme.
English: Carcinogenicity studies revealed no special hazard for humans when used in the recommended human dose.
Danish: Karcinogenicitetsstudier viste ingen særlig risiko for mennesker ved anvendelse af den anbefalede humane dosis.
English: The solution should be diluted to 5ml per mg.
Danish: Opløsningen skal fortyndes til 5 ml per mg.
English: There is insufficient clinical evidence to recommend administration of these tablets to children.
Danish: Der er utilstrækkelig klinisk erfaring til at kunne anbefale administration af disse tabletter til børn.
English: These tablets are only for use in adults.
Danish: Disse tabletter må kun bruges af voksne.
English: You will be treated depending on your symptoms.
Danish: Behandlingen afhænger af dine symptomer.
English: This additional dose should not be administered until at least 10 minutes after the initial infusion.
Danish: Denne ekstra dosis må først administreres mindst 10 minutter efter den første infusion.
English: No specific interaction studies have been conducted in anaesthetised patients.
Danish: Der er ikke udført specifikke interaktionsstudier hos bedøvede patienter.
English: Granisetron is extensively distributed, with a mean volume of distribution of approximately 3 l/kg.
Danish: Granisetron fordeles i stor udstrækning med et gennemsnitligt distributionsvolumen på ca. 3 l/kg.
English: Special populations
Danish: Særlige populationer:
English: Combination with steroids
Danish: Kombination med steroider
English: You may be given more injections to stop your sickness after the first dose.
Danish: Du kan få flere injektioner for at stoppe kvalme og opkastninger efter den første dosis.
English: The injection will be given to you by a doctor or nurse.
Danish: Du vil få injektionen af en læge eller sygeplejerske.
English: The maximum dose to be administered over 24 hours should not exceed 9 mg.
Danish: Den maksimale dosis i løbet af 24 timer bør ikke overstige 9 mg.
English: The solution for injection is a clear, colourless liquid.
Danish: Injektionsvæsken er en klar, farveløs væske.
English: This data helps to clarify the molecular mechanisms by which some of the ECG changes (particularly QT and QRS prolongation) associated with this class of agents occur.
Danish: Disse data er med til at klarlægge de molekylære mekanismer bag nogle af de ekg-ændringer (især QT- og QRSforlængelse), som forekommer ved anvendelse af denne lægemiddelklasse.
English: Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproductive toxicity and genotoxicity.
Danish: Prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, reproduktionstoksicitet og genotoksicitet.