FrancophonIA/ELRC3.0 huggingface dataset:
English: What is in this leaflet:
Danish: Det kan omfatte:
English: No particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency, therefore Stalevo therapy should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy (see section 5.2).
Danish: Der bør derfor udvises forsigtighed ved behandling af patienter med alvorlig nedsat nyrefunktion, inklusive dialysepatienter, med Stalevo (se pkt.
English: London, 11 July 2007 EMEA/CHMP/75066/2007
Danish: London, den 11. juli 2007 EMEA/CHMP/75066/2007
English: The Reference Member State was the Netherlands and the Concerned Member States were Austria, Germany, Ireland, Italy, and United Kingdom.
Danish: Referencemedlemsstaten var Nederlandene, og de berørte medlemsstater var Østrig, Tyskland, Irland, Italien og Det Forenede Kongerige.
English: A positive opinion was adopted by on 24 January 2007.
Danish: Den 24. januar 2007 blev der vedtaget en positiv udtalelse.
English: The Netherlands referred the reasons for disagreement to the EMEA on 7 July 2006.
Danish: Nederlandene indbragte grundene til uenigheden for EMEA den 7. juli 2006.
English: The Mutual Recognition Procedure started on 28 January 2006.
Danish: Den gensidige anerkendelsesprocedure blev indledt den 28. januar 2006.
English: Significant differences have been identified with regard to dose in urinary tract infections and of the maximum adult daily dose.
Danish: Der blev påpeget væsentlige forskelle vedrørende doseringen ved urinvejsinfektioner og vedrørende den maksimale daglige dosis til voksne.
English: The Rapporteur was Dr Ian Hudson and Co-Rapporteur was Dr Bengt Ljungberg.
Danish: Dr. Ian Hudson var rapportør, og dr. Bengt Ljungberg var medrapportør.
English: The final opinion was converted into a Decision by the European Commission on 11 July 2007.
Danish: Den endelige udtalelse blev den 11. juli 2007 omarbejdet til en beslutning af Europa-Kommissionen.
English: The Marketing Authorisation Holder provided written explanations on 20 October 2006.
Danish: Indehaveren af markedsføringstilladelsen indsendte skriftlige redegørelser den 20. oktober 2006.
English: The arbitration procedure started on 27 July 2006 with the adoption of a list of questions.
Danish: Voldgiftsproceduren blev indledt den 27. juli 2006 med vedtagelsen af en række spørgsmål.
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Danish: Listen over de berørte produktnavne findes i bilag I. De faglige konklusioner fremgår af bilag II, produktresuméet af bilag III.
English: During their January 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 Ciprofloxacin Hikma and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: På sit møde i januar 2007 fandt CHMP på baggrund af alle de forelagte oplysninger og den faglige drøftelse i udvalget, at benefit-risk forholdet er gunstigt for Ciprofloxacin Hikma og tilknyttede navne, at de rejste indvendinger ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
English: submitted applications for mutual recognition of Ciprofloxacin Hikma and associated names, 2 mg/ml solution for infusion on the basis of the marketing authorisation granted by the Netherlands on 12 April 2005.
Danish: har indgivet ansøgninger om gensidig anerkendelse af Ciprofloxacin Hikma og tilknyttede navne, infusionsvæske, opløsning, 2 mg/ml, baseret på den markedsføringstilladelse, der blev udstedt af Nederlandene den 12. april 2005.
English: In addition, it was considered that the applicant should include in the Summary of Product Characteristics (point 5.1) the organisms listed in the breakpoints and susceptibility table relevant to the indications, as per the Note for Guidance on Evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev.1).
Danish: 5.1 burde medtage de organismer, der er anført i forbindelse med tærskelværdierne og i følsomhedstabellen for indikationerne, i overensstemmelse med "Note for Guidance on Evaluation of medicinal products indicated for treatment of bacterial infections" (CPMP/EWP/558/95 rev.1).
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Ciprofloxacin Hikma and associated names International Non-Proprietary Name (INN): Ciprofloxacin BACKGROUND INFORMATION Ciprofloxacin Hikma and associated names, 2 mg/ml solution for infusion, is an antibiotic belonging to the quinolone family, effective in vitro against a large number of Gram-negative aerobic bacteria as well as against some Gram-positive organisms.
Danish: Ciprofloxacin, infusionsvæske, opløsning, 2 mg/ml, og tilknyttede navne er et antibiotikum, der tilhører quinolongruppen og er effektivt in vitro mod en lang række gramnegative aerobe bakterier foruden visse grampositive organismer.
English: Other information about Januvia
Danish: Andre oplysninger om Januvia
English: The European Commission granted a marketing authorisation valid throughout the European Union for Januvia on 21 March 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Januvia den 21. marts 2007.
English: This is a summary of the European public assessment report (EPAR) for Januvia.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Januvia.
English: The full EPAR for Januvia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Januvia findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Januvia is taken at a dose of 100 mg once a day.
Danish: Januvia tages i en dosis a 100 mg én gang dagligt.
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 Januvia.
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 Januvia.
English: Januvia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines.
Danish: Januvia havde større effekt end placebo, når det blev taget alene eller i kombination med andre lægemidler mod diabetes.
English: Januvia is a medicine that contains the active substance sitagliptin.
Danish: Januvia er et lægemiddel, der indeholder det aktive stof sitagliptin.
English: For more information about treatment with Januvia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Januvia, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In patients with moderately or severely reduced kidney function the dose of Januvia should be reduced.
Danish: Hos patienter med moderat eller svært nedsat nyrefunktion skal dosis af Januvia nedsættes.
English: The CHMP decided that Januvia's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Januvia opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The active substance in Januvia, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Danish: Det aktive stof i Januvia, sitagliptin, er en dipeptidylpeptidase-4 (DPP-4)-hæmmer.
English: What is the risk associated with Januvia?
Danish: Hvilken risiko er der forbundet med Januvia?
English: • four of the studies compared Januvia with placebo (a dummy treatment).
Danish: • I fire af undersøgelserne sammenlignedes Januvia med placebo (en virkningsløs behandling).
English: • two studies compared Januvia with other antidiabetes medicines.
Danish: • I to undersøgelser sammenlignedes Januvia med andre lægemidler mod diabetes.
English: Januvia must not be used in people who are hypersensitive (allergic) to sitagliptin or any of the other ingredients.
Danish: Januvia må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for sitagliptin eller andre af indholdsstofferne.
English: Januvia was studied in nine studies involving almost 6,000 patients with type 2 diabetes whose blood glucose levels were not adequately controlled:
Danish: Januvia blev undersøgt i ni undersøgelser, som omfattede næsten 6 000 patienter med type 2diabetes, hvis blodglukoseniveauer ikke var tilstrækkeligt reguleret:
English: Serious side effects reported with Januvia include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions).
Danish: Alvorlige indberettede bivirkninger ved Januvia omfatter pankreatitis (betændelse i bugspytkirtlen) og overfølsomhed (allergiske reaktioner).
English: If Januvia is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
Danish: Hvis Januvia tages sammen med et sulfonylurinstof eller insulin, er det muligvis nødvendigt at nedsætte dosis af sulfonylurinstoffet for at mindske risikoen for hypoglykæmi (lave blodsukkerniveauer).
English: Why has Januvia been approved?
Danish: Hvorfor blev Januvia godkendt?
English: What is Januvia?
Danish: Hvad er Januvia?
English: Januvia is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels.
Danish: Januvia anvendes til patienter med type 2-diabetes til at forbedre reguleringen af blodglukoseniveauerne (sukker).
English: When taken on their own, Januvia and metformin produced similar reductions in HbA1c levels, but the effectiveness of Januvia seemed to be slightly lower than that of metformin.
Danish: Når de blev taget hver for sig, bevirkede Januvia og metformin tilsvarende fald i HbA1c-niveauer, men effekten af Januvia var tilsyneladende en anelse lavere end effekten af metformin.
English: In the studies comparing Januvia with other medicines, the effectiveness of adding Januvia to metformin was similar to that of adding glipizide.
Danish: I de undersøgelser, hvor Januvia blev sammenlignet med andre lægemidler, svarede effekten af at tilføje Januvia til metformin til effekten af at tilføje glipizid.
English: Januvia or placebo were used on their own in two studies involving 1,262 patients, as an add-on to metformin in one study involving 701 patients, and as an add-on to pioglitazone (a PPAR-gamma agonist) in one study involving 353 patients;
Danish: Januvia eller placebo blev anvendt hver for sig i to undersøgelser, der omfattede 1 262 patienter, som en tillægsbehandling til metformin i en undersøgelse, der omfattede 701 patienter, og som tillægsbehandling til pioglitazon (en PPAR-gammaagonist) i en undersøgelse, der omfattede 353 patienter.
English: For the full list of all side effects reported with Januvia, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Januvia fremgår af indlægssedlen.
English: • three additional studies compared Januvia with placebo when they were added to other antidiabetes medicines: glimepiride (another sulphonylurea), with or without metformin, in 441 patients; the combination of metformin and rosiglitazone (a PPAR-gamma agonist) in 278 patients; and a stable dose of insulin, with or without metformin, in 641 patients.
Danish: • I tre yderligere undersøgelser blev Januvia sammenlignet med placebo, når disse blev anvendt som tillægsbehandling til andre lægemidler mod diabetes: glimepirid (et andet sulfonylurinstof), med eller uden metformin, hos 441 patienter, en kombination af metformin og rosiglitazon (en PPAR-gamma-agonist) hos 278 patienter og en stabil dosis insulin, med eller uden metformin, hos 641 patienter.
English: 0.12% and 0.18%, respectively, in the patients taking placebo.
Danish: Til gengæld steg de med henholdsvis 0,12 % og 0,18 % hos patienter, der tog placebo.
English: One study compared Januvia with glipizide (a sulphonylurea), when they were used as an add-on to metformin in 1,172 patients.
Danish: I en undersøgelse sammenlignedes Januvia med glipizid (et sulfonylurinstof), hvor de blev anvendt som en tillægsbehandling til metformin hos 1 172 patienter.
English: In patients taking Januvia on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% after 24 weeks.
Danish: Hos patienter, som fik Januvia alene, faldt HbA1c-niveauerne fra ca. 8,0 % i starten af undersøgelserne med 0,48 % efter 18 uger og med 0,61 % efter 24 uger.
English: The other study compared Januvia with metformin, used on their own, in 1,058 patients;
Danish: I den anden undersøgelse sammenlignedes Januvia med metformin anvendt hver for sig hos 1 058 patienter.
English: What is Januvia used for?
Danish: Hvad anvendes Januvia til?
English: Finally, they were reduced by 0.59% in patients adding Januvia to insulin (with or without metformin), compared with a fall of 0.03% in those adding placebo.
Danish: Niveauerne blev endelig reduceret med 0,59 % hos patienter, som fik tilføjet Januvia til insulin (med eller uden metformin), sammenlignet med et fald på 0,03 % hos dem, der fik tilføjet placebo.
English: • in combination with metformin or a PPAR-gamma agonist (a type of antidiabetes medicine) such as a thiazolidinedione, in patients who are not satisfactorily controlled on metformin or the PPARgamma agonist used on its own;
Danish: • i kombination med metformin eller en PPAR-gammaagonist (en type lægemiddel mod diabetes) såsom et thiazolidindion hos patienter, som ikke reguleres tilfredsstillende med metformin eller PPAR-gammaagonisten anvendt alene
English: How has Januvia been studied?
Danish: Hvordan blev Januvia undersøgt?
English: HbA1c levels were reduced by 1.03% after 18 weeks in patients adding Januvia to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo.
Danish: HbA1c-niveauerne blev reduceret med 1,03 % efter 18 uger hos patienter, som fik tilføjet Januvia til metformin og rosiglitazon, sammenlignet med et fald på 0,31 % hos dem, som fik tilføjet placebo.
English: What benefit has Januvia shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Januvia?
English: Hypoglycaemia has been reported in combination with a sulphonylurea in 4.7-13.8% of patients and with insulin in 9.6% of patients.
Danish: Hypoglykæmi blev indberettet hos 4,7 til 13,8 % af patienterne, der fik Januvia i kombination med et sulfonylurinstof, og hos 9,6 % af patienterne, som fik Januvia med insulin.
English: In the additional studies, adding Januvia to glimepiride (with or without metformin) led to a reduction in HbA1c levels of 0.45% after 24 weeks, compared with an increase of 0.28% in the patients adding placebo.
Danish: I de yderligere undersøgelser bevirkede tilføjelsen af Januvia til glimepirid (med eller uden metformin) et fald i HbA1c-niveauerne på 0,45 % efter 24 uger sammenlignet med en stigning på 0,28 % hos patienter, som fik tilføjet placebo.
English: How is Januvia used?
Danish: Hvordan anvendes Januvia?
English: How does Januvia work?
Danish: Hvordan virker Januvia?
English: Adding Januvia to metformin reduced HbA1c levels by 0.67% after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Danish: Ved at tilføje Januvia til metformin reduceredes HbA1c-niveauerne med 0,67 % efter 24 uger sammenlignet med et fald på 0,02 % hos patienter, som fik tilføjet placebo.
English: When added to pioglitazone, Januvia reduced HbA1c levels by 0.85% after 24 weeks, compared with a fall of 0.15% in the patients adding placebo.
Danish: Ved at tilføje Januvia til pioglitazon reduceredes HbA1cniveauerne med 0,85 % efter 24 uger sammenlignet med et fald på 0,15 % hos patienter, som fik tilføjet placebo.
English: Two of these studies included children.
Danish: To af undersøgelserne omfattede børn.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Opatanol on 17 May 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Opatanol den 17. maj 2002.
English: Opatanol has been studied in 688 patients in four main studies lasting between six and 14 weeks.
Danish: Opatanol blev undersøgt hos 688 patienter i fire hovedundersøgelser, der varede mellem seks og 14 uger.
English: The full EPAR for Opatanol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Opatanol findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: At lower pollen counts, there were no differences between the two treatments.
Danish: Ved lavere pollental var der ingen forskel mellem de to behandlinger.
English: This is a summary of the European public assessment report (EPAR) for Opatanol.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Opatanol.
English: Opatanol is used in adults and children aged three years and older.
Danish: Opatanol anvendes til voksne og børn i alderen tre år og derover.
English: Therefore care should be taken by people who wear soft contact lenses.
Danish: Forsigtighed bør derfor udvises af patienter, der bruger bløde kontaktlinser.
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 Opatanol.
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 Opatanol.
English: Other information about Opatanol
Danish: Andre oplysninger om Opatanol
English: Opatanol olopatadine
Danish: Opatanol olopatadin
English: If another eye treatment is also being used, there should be a gap of five minutes between treatments; eye ointments should be administered last.
Danish: Hvis der også anvendes en anden øjenbehandling, skal der være et interval på fem til 10 minutter mellem behandlingerne.
English: The most common side effects with Opatanol (seen in between 1 and 10 patients in 100) are headache, dysgeusia (taste disturbances), eye pain, eye irritation, dry eyes, abnormal sensations in the eye, dry nose and fatigue (tiredness).
Danish: De hyppigste bivirkninger ved Opatanol (som optræder hos mellem 1 og 10 patienter ud af 100) er hovedpine, smagsforstyrrelser, øjensmerter, øjenirritation, øjentørhed, unormale fornemmelser i øjet, næsetørhed og træthed.
English: For more information about treatment with Opatanol, read the package leaflet (also part of the EPAR) or contact your doctor of pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Opatanol, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Opatanol can be used for up to four months, if needed.
Danish: Om nødvendigt kan patienten fortsætte med Opatanol i indtil fire måneder.
English: It is given as one drop into the affected eye(s) twice a day, given eight hours apart.
Danish: Der gives én dråbe i det eller de pågældende øjne to gange dagligt med otte timers mellemrum.
English: Opatanol was as effective as cromolyn sodium and as levocabastine.
Danish: Opatanol var lige så effektivt som natriumcromoglicat og som levocabastin.
English: The active substance in Opatanol, olopatadine, is an antihistamine.
Danish: Det aktive stof i Opatanol, olopatadin, er et antihistaminikum.
English: Opatanol was compared with cromolyn sodium (another anti-allergy medicine), with levocabastine (another antihistamine) and, in two studies, with placebo (a dummy treatment).
Danish: Opatanol blev sammenlignet med natriumcromoglicat (et andet antiallergisk lægemiddel), med levocabastin (et andet antihistaminikum) og desuden i to undersøgelser med placebo (en virkningsløs behandling).
English: Opatanol contains benzalkonium chloride, which is known to discolour soft contact lenses.
Danish: Opatanol indeholder benzalkoniumchlorid, der vides at blege bløde kontaktlinser.
English: What is the risk associated with Opatanol?
Danish: Hvilken risiko er der forbundet med Opatanol?
English: For the full list of all side effects reported with Opatanol, see the Package Leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Opatanol fremgår af indlægssedlen.
English: The CHMP decided that Opatanol's benefits are greater than its risks for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Opatanol opvejer risiciene ved behandling af øjensymptomer ved sæsonbundet allergisk betændelse i øjets bindehinde (konjunktivitis), og anbefalede udstedelse af en markedsføringstilladelse for Opatanol.
English: Why has Opatanol been approved?
Danish: Hvorfor blev Opatanol godkendt?
English: Opatanol is a clear eye drop solution, which contains the active substance olopatadine.
Danish: Opatanol er øjendråber (en klar opløsning), der indeholder det aktive stof olopatadin.
English: Opatanol is used to treat the eye symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever).
Danish: Opatanol anvendes til behandling af symptomerne på sæsonbundet allergisk betændelse i øjets bindehinde (konjunktivitis), som forårsages af pollen hos patienter med høfeber.
English: When compared with placebo, Opatanol was more effective only when pollen counts were taken into account, showing that the higher the level of pollen in the air, the greater the difference between the effects of Opatanol and those of placebo.
Danish: Jo større pollental, desto større forskel var der mellem virkningen af Opatanol og af placebo.
English: What is Opatanol?
Danish: Hvad er Opatanol?
English: Olopatadine works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
Danish: Olopatadin virker ved at blokere de receptorer, som histamin normalt binder sig til.
English: How has Opatanol been studied?
Danish: Hvordan blev Opatanol undersøgt?
English: What is Opatanol used for?
Danish: Hvad anvendes Opatanol til?
English: In all of the studies, the main measure of effectiveness was based on the degree of itching and redness in the eye. One of the placebo studies also looked at these symptoms in relation to pollen counts.
Danish: I en af undersøgelserne med placebo blev disse symptomer også bragt i sammenhæng med pollental.
English: How is Opatanol used?
Danish: Hvordan anvendes Opatanol?
English: What benefit has Opatanol shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Opatanol?
English: These include itching, redness and swelling.
Danish: Symptomerne er kløe, røde øjne og hævelse.
English: How does Opatanol work?
Danish: Hvordan virker Opatanol?
English: 183 11 Täby Sweden
Danish: 183 11 Täby Sverige
English: 0667 Oslo Norway
Danish: 0667 Oslo Norge
English: Novartis Hellas Aebe National Road a, 12 th Km Metamorphosi Attikis
Danish: Grækenland Novartis Hellas Aebe National Road a, 12 th Km Metamorphosi Attikis
English: 6824 DP Arnhem Nederland
Danish: 6824 DP Arnhem Holland