FrancophonIA/ELRC3.0 huggingface dataset:
English: Since the interaction has not been established with dosages higher than 0.5 mg for repaglinide, the concomitant use of deferasirox with repaglinide should be avoided.
Danish: Da interaktionen ikke er blevet etableret med størrer doser end 0,5 mg for repaglinid, skal samtidig brug af deferasirox med repaglinid undgås.
English: As insulin sensitivity is increased in diabetic patients with renal impairment, caution is advised when titrating these patients.
Danish: Produktets totale plasmaclearance er reduceret i patienter med nedsat nyrefunktion, og da følsomheden for insulin er øget i diabetiske patienter med nedsat nyrefunktion, anbefales forsigtighed ved titrering af disse patienters dosis.
English: • Sympathomimetics (used to treat asthma).
Danish: • Sympatomimetika (mod astma)
English: Each tablet contains 0.5 mg, 1 mg, 2 mg repaglinide.
Danish: Hver tablet indeholder 0,5 mg, 1 mg eller 2 mg repaglinid.
English: Hepatic impairment No clinical studies have been conducted in patients with hepatic insufficiency.
Danish: Nedsat leverfunktion Der er ikke udført kliniske studier hos patienter med leverinsufficiens.
English: • Thiazides (diuretics or ‘water pills').
Danish: • Thiazider (vanddrivende tabletter)
English: - Hypersensitivity to repaglinide or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for repaglinid eller over for et eller flere af hjælpestofferne anført i pkt.
English: What you need to know before you take Enyglid
Danish: Det skal du vide, før du begynder at tage Enyglid
English: • Thyroid products (used to treat low levels of thyroid hormones).
Danish: • Thyreoideapræparater (mod lavt niveau af skjoldbruskkirtlens hormoner)
English: Busuttil Ltd. Tel: + 356 21 445 855
Danish: E.J. Busuttil Ltd. Tel: + 356 21 445 855
English: Repaglinide closes ATP-dependent potassium channels in the β-cell membrane via a target protein different from other secretagogues.
Danish: Repaglinid lukker de ATP afhængige kaliumkanaler i β-cellens membran ved at binde sig til bindingssteder, der er forskellige fra bindingssteder for andre β-celle stimulerende antidiabetika.
English: There are no studies of repaglinide in pregnant women.
Danish: Repaglinid er ikke klinisk undersøgt hos gravide kvinder.
English: Enyglid 0.5 mg tablets Enyglid 1 mg tablets Enyglid 2 mg tablets
Danish: Enyglid 0,5 mg tabletter Enyglid 1 mg tabletter Enyglid 2 mg tabletter
English: Talk to your doctor before taking Enyglid:
Danish: Advarsler og forsigtighedsregler Kontakt lægen før du tager Enyglid:
English: In an interaction study with healthy volunteers, co-administration of deferasirox (30 mg/kg/day, 4 days), a moderate inhibitor of CYP2C8 and CYP3A4, and repaglinide (single dose, 0.5 mg) resulted in an increase in repaglinide systemic exposure (AUC) to 2.3-fold (90% CI [2.03-2.63]) of control, a 1.6-fold (90% CI [1.42-1.84]) increase in Cmax, and a small, significant decrease in blood glucose values.
Danish: I et interaktionsstudie med frivillige raske personer, samtidig administration af deferasirox (30/mg/kg/dag, 4 dage), en moderat inhibitor af CYP2C8 og CYP3A4, og repaglinid (enkelt dosis, 0,5 mg) resulterede i en 2,3 gange øgning (90% CI [2,03-2,63]) af systemisk eksponeret (AUC) repaglinid i forhold til kontrol, en 1,6 gange (90% CI [1,42-1,84]) øgning af Cmax, og et mindre, signifikant fald af blodglucoseværdier.
English: When these medications are administered to or withdrawn from a patient receiving repaglinide, the patient should be observed closely for changes in glycaemic control.
Danish: Når patienter, der indtager repaglinid, starter eller ophører med at tage disse stoffer, skal de overvåges grundigt for ændring i blodglucoseregulering.
English: There are no studies in breast-feeding women.
Danish: Der er ikke udført studier hos ammende kvinder.
English: Since the interaction has not been established with dosages higher than 0.25 mg for repaglinide, the concomitant use of ciclosporin with repaglinide should be avoided.
Danish: Da interaktionen ikke er påvist ved doser af repaglinid, som er højere end 0,25 mg, skal samtidig brug af ciclosporin med repaglinid undgås.
English: Pharmaco-therapeutic group: Drugs used in diabetes, other blood glucose lowering drugs, excl. insulins, ATC code: A10BX02
Danish: Farmako-terapeutisk gruppe: Lægemidler anvendt mod diabetes, andre blodglucose sænkende lægemidler, ekskl.
English: Co-administration of 200 mg ketoconazole increased the repaglinide (AUC and Cmax) by 1.2-fold with profiles of blood glucose concentrations altered by less than 8% when administered concomitantly (a single dose of 4 mg repaglinide).
Danish: Samtidig administration af 200 mg ketoconazole øger repaglinidoptagelsen (AUC og Cmax) med 1,2 gange med ændring på mindre end 8% af blodglucoseprofilerne (en enkelt dosis på 4 mg repaglinid).
English: The use of repaglinide might be associated with an increased incidence of acute coronary syndrome (e.g. myocardial infarction), see sections 4.8 and 5.1.
Danish: Anvendelse af repaglinid kan være forbundet med en forhøjet incidens af akut koronarsyndrom (f.eks. myokardieinfarkt) se pkt.
English: In an interaction study with healthy volunteers, co-administration of clopidogrel (300 mg loading dose), a CYP2C8 inhibitor, increased repaglinide exposure (AUC0-∞) 5.1-fold and continued administration (75 mg daily dose) increased repaglinide exposure (AUC0-∞) 3.9-fold.
Danish: I et interaktionsstudie med frivillige raske personer, øgede samtidig administration af clopidogrel (300 mg opstartsdosis), en CYP2C8 inhibitor, eksponering af repaglinid (AUC0-∞) 5,1 gange, og ved kontinuerlig administration (75 mg daglig dosis) eksponering af repaglinid (AUC0-∞) 3,9 gange.
English: • if you have kidney problems.
Danish: • Hvis du har problemer med dine nyrer.
English: Enyglid 1 mg tablets
Danish: Enyglid 1 mg tabletter
English: Repaglinide, like other insulin secretagogues, is capable of producing hypoglycaemia.
Danish: Repaglinid kan, som andre β-cellestimulerende orale antidiabetika, forårsage hypoglykæmi.
English: In a study conducted in healthy volunteers, the concomitant administration of repaglinide (a single dose of 0.25 mg) and ciclosporin (repeated dose at 100 mg) increased repaglinide AUC and Cmax about 2.5-fold and 1.8-fold respectively.
Danish: I et studie udført på frivillige raske personer, øgede samtidig administration af repaglinid (en enkelt dosis på 0,25 mg) og ciclosporin (gentagen dosis på 100 mg) AUC og Cmax for repaglinid omkring 2,5 gange og 1,8 gange respektivt.
English: Enyglid 2 mg tablets
Danish: Enyglid 2 mg tabletter
English: Enyglid 0.5 mg tablets
Danish: Enyglid 0,5 mg tabletter
English: Very rare (may affect up to 1 in 10,000 people):
Danish: Meget sjældne bivirkninger (kan forekomme hos færre end 1 ud af 10.000 personer)
English: • If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl så spørg lægen eller på apoteket.
English: In an interaction study in healthy volunteers, co-administration of 250 mg clarithromycin, a potent mechanism-based inhibitor of CYP3A4, slightly increased the repaglinide (AUC) by 1.4-fold and Cmax by 1.7-fold and increased the mean incremental AUC of serum insulin by 1.5-fold and the maximum concentration by 1.6-fold.
Danish: I et interaktionsstudie med raske frivillige vistes, at samtidig administration af 250 mg clarithromycin, en potent mekanismebaseret CYP3A4-hæmmer, øgede repaglinidoptagelsen (AUC) 1,4 gange og Cmax 1,7 gange samt øgede den gennemsnitlige tilvækst i repaglinidoptagelsen AUC af serum insulin 1,5 gange og maksimumkoncentrationen 1,6 gange.
English: • have frequent hypos,
Danish: • Ofte har hypoglykæmi
English: Each tablet contains 0.5 mg repaglinide.
Danish: Hver tablet indeholder 0,5 mg repaglinid.
English: Repaglinide lowers the blood glucose levels acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning β-cells in the pancreatic islets.
Danish: Repaglinid, sænker øjeblikkeligt blodglucoseniveauerne ved at stimulere sekretionen af insulin fra pankreas.
English: • Beta blockers (used to treat high blood pressure orheart conditions).
Danish: • Betablokkere (mod forhøjet blodtryk eller hjertelidelser)
English: Repaglinide is a short-acting oral secretagogue.
Danish: Repaglinid er et oralt β-celle stimulerende korttidsvirkende antidiabeticum.
English: Co-administration of trimethoprim (160 mg twice daily), a moderate CYP2C8 inhibitor, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC, Cmax and t½ (1.6-fold, 1.4-fold and 1.2-fold respectively) with no statistically significant effects on the blood glucose levels.
Danish: Samtidig administration af trimetoprim (160 mg 2 gange dagligt), en moderat CYP2C8-hæmmer, og repaglinid (en enkelt dosis på 0,25 mg) øger repaglinid AUC, Cmax og t½ (henholdsvis 1,6, 1,4 og 1,2 gange) uden statistisk signifikans på blodglucoseniveauerne.
English: Enyglid 0.5 mg tablets Each tablet contains 0.5 mg repaglinide.
Danish: Enyglid 0,5 mg tabletter Hver tablet indeholder 0,5 mg repaglinid.
English: If the combination appears necessary, careful clinical and blood glucose monitoring should be performed (see section 4.4).
Danish: Hvis kombinationen synes nødvendig, skal der foretages omhyggelig klinisk overvågning og monitorering af blodglucosen (se pkt.
English: Repaglinide should only be prescribed if poor blood glucose control and symptoms of diabetes persist despite adequate attempts at dieting, exercise and weight reduction.
Danish: Repaglinid bør kun ordineres, hvis der efter behandling med diæt, motion og vægttab stadig er ringe blodglucosekontrol og symptomer på diabetes mellitus.
English: A number of medicinal products are known to influence repaglinide metabolism, possible interactions should therefore be taken into account by the physician:
Danish: Derfor bør lægen overveje mulige interaktioner:
English: Enyglid 1 mg tablets Each tablet contains 1 mg repaglinide.
Danish: Enyglid 1 mg tabletter Hver tablet indeholder 1 mg repaglinid.
English: • The other ingredients are: microcrystalline cellulose (E460); calcium hydrogen phosphate, anhydrous; croscarmellose sodium; povidone K25; glycerol; magnesium stearate; meglumine; poloxamer; yellow iron oxide (E172) only in the 1 mg tablets and red iron oxide (E172) only in the 2 mg tablets
Danish: croscarmellosenatrium, povidon K25, glycerol, magnesiumstearat, meglumin, poloxamerer, gul jernoxid (E172) kun i tabletter à 1 mg og rød jernoxid (E172) kun i tabletter à 2 mg.
English: Each tablet contains 1 mg repaglinide.
Danish: Hver tablet indeholder 1 mg repaglinid.
English: Enyglid 2 mg tablets Each tablet contains 2 mg repaglinide.
Danish: Enyglid 2 mg tabletter Hver tablet indeholder 2 mg repaglinid.
English: • Monoamine oxidase inhibitors (MAOI) (used to treat depression).
Danish: • Monoaminooxidasehæmmere eller (MAO-hæmmere) (mod depression)
English: • ACE-inhibitors (used to treat heart conditions).
Danish: • ACE-hæmmere (mod hjertelidelser)
English: How to take Enyglid
Danish: Sådan skal du tage Enyglid
English: Each tablet contains 2 mg repaglinide.
Danish: Hver tablet indeholder 2 mg repaglinid.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan forekomme hos mellem 1 og 10 ud af 100 personer)
English: Maintenance
Danish: Opbevaring
English: Co-administration of gemfibrozil (600 mg twice daily), an inhibitor of CYP2C8, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC 8.1-fold and Cmax 2.4-fold in healthy volunteers.
Danish: Samtidig administration af gemfibrozil (600 mg 2 gange dagligt), en CYP2C8-hæmmer, og repaglinid (en enkelt dosis på 0,25 mg) øgede repaglinidoptagelsen (AUC) med 8,1 gange og Cmax med 2,4 gange hos frivillige raske personer.
English: • Gemfibrozil (used to treat high blood fats).
Danish: • Gemfibrozil (mod kolesterol i blodet)
English: Eight percent of one dose of repaglinide is excreted through the kidneys and total plasma clearance of the product is decreased in patients with renal impairment.
Danish: Otte procent af en indgiven dosis af repaglinid udskilles gennem nyrerne.
English: Refraction disorder*
Danish: Synsforstyrrelser *
English: Abnormal hepatic function, increased liver enzymes Isolated cases of increased liver enzymes have been reported during treatment with repaglinide.
Danish: Der er rapporteret isolerede tilfælde af leverenzymstigning under behandling med repaglinid.
English: Use of repaglinide in case of secondary failure to insulin secretagogues has not been investigated in clinical trials.
Danish: Brugen af repaglinid til patienter med sekundært behandlingssvigt overfor andre β-celle stimulerende orale antidiabetika er ikke undersøgt i kliniske studier.
English: Check with your doctor if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: In the case of concomitant use with other active substances refer to sections 4.4 and 4.5 to assess the dosage.
Danish: 4.4 og 4.5 for at bestemme dosis.
English: If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed.
Danish: Hvis det er nødvendigt at give trimetoprim og repaglinid samtidig, skal blodglucosen måles omhyggeligt, og der skal være tæt klinisk observation.
English: Concomitant use
Danish: Samtidig anvendelse
English: • Vomiting
Danish: • Opkastning
English: • This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Enyglid til dig personligt.
English: Enyglid 1 mg tablets The tablets are pale brown-yellow, round, biconvex with bevelled edges and possible darker spots.
Danish: Enyglid 1 mg tabletter Tabletterne er svagt brun-gule, runde, bikonvekse med facetterede kanter og eventuelt mørkere pletter.
English: If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed (see section 4.4).
Danish: Hvis det er nødvendigt at bruge dem samtidig, skal blodglucosen måles omhyggeligt, og der skal være tæt klinisk observation (se pkt.
English: What Enyglid looks like and contents of the pack The 0.5 mg tablets are white, round and biconvex with bevelled edges.
Danish: Enyglid 0,5 mg tabletter Tabletterne er hvide, runde og bikonvekse med facetterede kanter.
English: The peak plasma level occurs within one hour post administration.
Danish: Maksimalt plasmaniveau indtræder en time efter indtagelsen.
English: The 2 mg tablets are pink, marbled, round, biconvex with bevelled edges and possible darker spots.
Danish: Tabletterne à 2 mg er lyserøde, marmorerede, runde, bikonvekse med facetterede kanter og muligvis mørkere pletter.
English: not affected by renal disorders (see section 5.2).
Danish: Repaglinid påvirkes ikke af nedsat nyrefunktion (se pkt.
English: Initial dose
Danish: Vedligeholdelsesdosis
English: Enyglid 1 mg tablets 30 tablets: EU/1/09/580/007 60 tablets: EU/1/09/580/008 90 tablets: EU/1/09/580/009 120 tablets: EU/1/09/580/010 180 tablets: EU/1/09/580/020 270 tablets: EU/1/09/580/011 360 tablets: EU/1/09/580/012
Danish: Enyglid 1 mg tabletter 30 tabletter: EU/1/09/580/007 60 tabletter: EU/1/09/580/008 90 tabletter: EU/1/09/580/009 120 tabletter: EU/1/09/580/010 180 tabletter: EU/1/09/580/020 270 tabletter: EU/1/09/580/011 360 tabletter: EU/1/09/580/012
English: 6.6 Special precautions for disposal
Danish: 6.6 Regler for destruktion og anden håndtering
English: 60 tablets: EU/1/09/580/014
Danish: 60 tabletter: EU/1/09/580/014
English: 30 tablets: EU/1/09/580/013
Danish: 30 tabletter: EU/1/09/580/013
English: The 1 mg tablets are pale brown-yellow, round, biconvex with bevelled edges and possible darker spots.
Danish: Tabletterne à 1 mg er svagt brun-gule, runde, bikonvekse med facetterede kanter og muligvis mørkere pletter.
English: 90 tablets: EU/1/09/580/015
Danish: 90 tabletter: EU/1/09/580/015
English: 30 tablets: EU/1/09/580/007
Danish: 30 tabletter: EU/1/09/580/007
English: Refraction disorders
Danish: Synsforstyrrelser
English: 30 tablets: EU/1/09/580/001
Danish: 30 tabletter: EU/1/09/580/001
English: What you need to know before you take Enyglid 3.
Danish: Det skal du vide, før du begynder at tage Enyglid Sådan skal du tage Enyglid Bivirkninger
English: 120 tablets: EU/1/09/580/004 180 tablets: EU/1/09/580/019 270 tablets: EU/1/09/580/005 360 tablets: EU/1/09/580/006
Danish: 120 tabletter: EU/1/09/580/004 180 tabletter: EU/1/09/580/019 270 tabletter: EU/1/09/580/005 360 tabletter: EU/1/09/580/006
English: Meglumine
Danish: Amning
English: • Stomach pain
Danish: • Mavesmerter
English: 60 tablets: EU/1/09/580/002
Danish: 60 tabletter: EU/1/09/580/002
English: Posology
Danish: Initialdosis
English: 120 tablets: EU/1/09/580/010 180 tablets: EU/1/09/580/020 270 tablets: EU/1/09/580/011 360 tablets: EU/1/09/580/012
Danish: 120 tabletter: EU/1/09/580/010 180 tabletter: EU/1/09/580/020 270 tabletter: EU/1/09/580/011 360 tabletter: EU/1/09/580/012
English: Enyglid 2 mg tablets 30 tablets: EU/1/09/580/013 60 tablets: EU/1/09/580/014 90 tablets: EU/1/09/580/015 120 tablets: EU/1/09/580/016 180 tablets: EU/1/09/580/021 270 tablets: EU/1/09/580/017 360 tablets: EU/1/09/580/018
Danish: Enyglid 0,5 mg tabletter 30 tabletter: EU/1/09/580/001 60 tabletter: EU/1/09/580/002 90 tabletter: EU/1/09/580/003 120 tabletter: EU/1/09/580/004 180 tabletter: EU/1/09/580/019 270 tabletter: EU/1/09/580/005 360 tabletter: EU/1/09/580/006
English: 120 tablets: EU/1/09/580/016 180 tablets: EU/1/09/580/021 270 tablets: EU/1/09/580/017 360 tablets: EU/1/09/580/018
Danish: 120 tabletter: EU/1/09/580/016 180 tabletter: EU/1/09/580/021 270 tabletter: EU/1/09/580/017 360 tabletter: EU/1/09/580/018
English: 60 tablets: EU/1/09/580/008
Danish: 60 tabletter: EU/1/09/580/008
English: 90 tablets: EU/1/09/580/003
Danish: 90 tabletter: EU/1/09/580/003
English: 90 tablets: EU/1/09/580/009
Danish: 90 tabletter: EU/1/09/580/009
English: Abdominal pain, diarrhoea Common Vomiting, constipation
Danish: Mavesmerter og diarré
English: The tablets are white, round and biconvex with bevelled edges.
Danish: Tabletterne à 0,5 mg er hvide, runde og bikonvekse med facetterede kanter.
English: Trials investigating the combination with other insulin secretagogues have not been performed.
Danish: Kombinationsbehandling med andre β-celle stimulerende orale antidiabetika er ikke undersøgt klinisk.
English: 1 Article 29(4) of Directive 2001/83/EC, as amended.
Danish: 1 Artikel 29, stk. 4 i direktiv 2001/83/EF, som ændret.
English: The Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, the Netherlands, Norway, Poland, Portugal, the Slovak Republic, Spain and Sweden.
Danish: Referencemedlemsstaten var Det Forenede Kongerige, og de berørte medlemsstater var Østrig, Belgien, Tjekkiet, Danmark, Finland, Frankrig, Tyskland, Ungarn, Irland, Nederlandene, Norge, Polen, Portugal, Slovakiet, Spanien og Sverige.
English: These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Danish: Disse medlemsstater kunne ikke nå til enighed om gensidig anerkendelse af den af referencemedlemsstaten udstedte markedsføringstilladelse.
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II.
English: The Czech Republic, Spain and Portugal referred the reasons for disagreement to the EMEA on 30 November 2006.
Danish: Tjekkiet, Spanien og Portugal fremsendte begrundelserne for uenigheden til EMEA den 30. november 2006.
English: Lansoprazole and associated names
Danish: Lansoprazol og tilknyttede navne
English: The Mutual Recognition Procedure started on 07 June 2006.
Danish: Proceduren for gensidig anerkendelse blev indledt den 7. juni 2006.
English: The arbitration procedure started on 14 December 2006 with the adoption of a list of questions.
Danish: Voldgiftsproceduren blev indledt den 14. december 2006 med vedtagelsen af en liste med spørgsmål.
English: International Non-Proprietary Name (INN): lansoprazole
Danish: Internationalt fællesnavn (INN): lansoprazol
English: The final opinion was converted into a Decision by the European Commission on 18 September 2007.
Danish: Den endelige udtalelse blev omdannet til en afgørelse truffet af Europa-Kommissionen den 18. september
English: London, 18 September 2007 EMEA/283378/2007
Danish: London, den 18. september 2007 EMEA/448438/2007
English: The Marketing Authorisation Holder provided written explanations on 30 March 2007.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 30. marts 2007.
English: A positive opinion was adopted by consensus on 21 June 2007.
Danish: Udvalget vedtog enstemmigt en positiv udtalelse den 21. juni 2007.
English: The reasons for disagreement were, that some Member States have raised public health objections on the grounds that while bioequivalence was proven in the fasting state, the same was not the case under fed conditions.
Danish: Grundene til uenigheden var, at nogle af medlemsstaterne havde gjort indsigelser i forbindelse med folkesundheden, fordi der var påvist bioækvivalens i fastende tilstand, men at dette ikke var tilfældet under ikke-fastende tilstande.
English: The Rapporteur was Dr. Frits Lekkerkerker and Co-Rapporteur was Dr. Ian Hudson.
Danish: Den udpegede rapportør og medrapportør var henholdsvis dr. Frits Lekkerkerker og dr. Ian Hudson.
English: Lansoprazole 15 & 30 mg gastro-resistant capsules, hard are generic preparations containing lansoprazole as the active substance.
Danish: Lansoprazol 15 & 30 mg gastro-resistente hårde kapsler er generiske præparater, der indeholder lansoprazol som det aktive stof.
English: TEVA UK Limited submitted applications for mutual recognition of Lansoprazole and associated names, 15 and 30 mg, gastro-resistant capsules, hard, on the basis of the marketing authorisation granted by the United Kingdom on 9 December 2005.
Danish: TEVA UK Limited indsendte ansøgninger om gensidig anerkendelse af Lansoprazol og tilknyttede navne, 15 og 30 mg, gastro-resistente kapsler, hårde, på baggrund af den markedsføringstilladelse, som blev udstedt af Det Forenede Kongerige den 9. december 2005.
English: Lansoprazole is a proton pump inhibitor that inhibits gastric acid secretion and is used for the treatment of duodenal and benign gastric ulcers, gastro-oesophageal reflux disease and associated conditions.
Danish: Lansoprazol er en protonpumpehæmmer, der hæmmer mavesyresekretion, og som anvendes til behandling af duodenale og godartede gastriske ulcera, gastroøsofageal reflukssygdom og associerede tilstande.
English: During their 18 - 21 June 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Lansoprazole and associated names, that the objections raised by the Czech Republic, Spain and Portugal should not prevent the granting of a Marketing Authorisation and that the valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: - 21. juni 2007 var CHMP på grundlag af de samlede forelagte oplysninger og de faglige drøftelser i udvalget af den opfattelse, at risk/benefit-forholdet var gunstigt for Lansoprazol og tilknyttede navne, at indvendingerne fra Tjekkiet, Spanien og Portugal ikke burde forhindre udstedelse af markedsføringstilladelse, og at det/den gældende produktresumé, etikettering og indlægsseddel er de endelige versioner, der er udarbejdet under koordineringsgruppens procedure.
English: OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 41
English: • If you have pain, redness, swelling or sores in your mouth (very common).
Danish: Hvis De har smerter, rødmen, hævelse eller sår i munden (meget almindelig).
English: The overall response rate was 14.1%.
Danish: Den samlede responsrate var 14,1 %.
English: Thirst and increased water consumption
Danish: Tørst og øget vandforbrug