FrancophonIA/ELRC3.0 huggingface dataset:
English: These included hypoglycaemia (frequency very common with sulphonylurea or insulin), constipation (common with sulphonylurea), peripheral oedema (common with pioglitazone), and headache and dry mouth (uncommon with insulin).
Danish: obstipation (almindelig med sulfonylurinstoffer), perifert ødem (almindelig med pioglitazon) og hovedpine og mundtørhed (ikke almindelig med insulin).
English: EU/1/08/457/009 EU/1/08/457/010 EU/1/08/457/011 EU/1/08/457/012 EU/1/08/457/013 EU/1/08/457/014 EU/1/08/457/016 EU/1/08/457/018 EU/1/08/457/021 EU/1/08/457/022
Danish: EU/1/08/457/008 EU/1/08/457/009 EU/1/08/457/010 EU/1/08/457/011 EU/1/08/457/012 EU/1/08/457/013 EU/1/08/457/014 EU/1/08/457/016 EU/1/08/457/018 EU/1/08/457/021 EU/1/08/457/022
English: Efficib 50 mg/850 mg film-coated tablets
Danish: Efficib 50 mg/850 mg filmovertrukne tabletter.
English: Efficib 50 mg/1,000 mg film-coated tablets
Danish: Efficib 50 mg/1.000 mg filmovertrukne tabletter.
English: Study of sitagliptin in combination with metformin and insulin A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to insulin (at a stable dose for at least 10 weeks) with or without metformin (at least 1,500 mg).
Danish: Undersøgelse af sitagliptin i kombination med metformin og insulin En 24-ugers placebokontrolleret undersøgelse blev designet til at evaluere effekt og sikkerhed af sitagliptin (100 mg en gang dagligt) som supplement til insulin (ved stabil dosis i mindst 10 uger) med eller uden metformin (mindst 1.500 mg).
English: Efficib is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Danish: Efficib er indiceret som supplement til diæt og motion i kombination med et sulfonylurinstof (dvs. tripel kombinationsbehandling) hos patienter, der ikke er tilstrækkeligt kontrolleret på den maksimalt tolererede dosis metformin og sulfonylurinstof.
English: EU/1/08/457/008 14 film-coated tablets EU/1/08/457/009 28 film-coated tablets EU/1/08/457/010 56 film-coated tablets EU/1/08/457/021 60 film-coated tablets EU/1/08/457/011 112 film-coated tablets EU/1/08/457/012 168 film-coated tablets EU/1/08/457/022 180 film-coated tablets EU/1/08/457/013 196 film-coated tablets EU/1/08/457/014 50 x 1 film-coated tablets EU/1/08/457/016 196 (2 x 98) film-coated tablets EU/1/08/457/018 168 (2 x 84) film-coated tablets
Danish: EU/1/08/457/008 14 filmovertrukne tabletter EU/1/08/457/009 28 filmovertrukne tabletter EU/1/08/457/010 56 filmovertrukne tabletter EU/1/08/457/021 60 filmovertrukne tabletter EU/1/08/457/011 112 filmovertrukne tabletter EU/1/08/457/012 168 filmovertrukne tabletter EU/1/08/457/022 180 filmovertrukne tabletter EU/1/08/457/013 196 filmovertrukne tabletter EU/1/08/457/014 50 x 1 filmovertrukne tabletter EU/1/08/457/016 196 (2 x 98) filmovertrukne tabletter EU/1/08/457/018 168 (2 x 84) filmovertrukne tabletter
English: Metformin may act via three mechanisms: - by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis - in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation - by delaying intestinal glucose absorption.
Danish: Metformin virker via tre mekanismer: - ved reduktion af hepatisk glucoseproduktion gennem hæmning af glukoneogenese og glycogenolyse.
English: EU/1/08/457/001 14 film-coated tablets EU/1/08/457/002 28 film-coated tablets EU/1/08/457/003 56 film-coated tablets EU/1/08/457/019 60 film-coated tablets EU/1/08/457/004 112 film-coated tablets EU/1/08/457/005 168 film-coated tablets EU/1/08/457/020 180 film-coated tablets EU/1/08/457/006 196 film-coated tablets EU/1/08/457/007 50 x 1 film-coated tablets EU/1/08/457/015 196 (2 x 98) film-coated tablets EU/1/08/457/017 168 (2 x 84) film-coated tablets
Danish: EU/1/08/457/001 14 filmovertrukne tabletter EU/1/08/457/002 28 filmovertrukne tabletter EU/1/08/457/003 56 filmovertrukne tabletter EU/1/08/457/019 60 filmovertrukne tabletter EU/1/08/457/004 112 filmovertrukne tabletter EU/1/08/457/005 168 filmovertrukne tabletter EU/1/08/457/020 180 filmovertrukne tabletter EU/1/08/457/006 196 filmovertrukne tabletter EU/1/08/457/007 50 x 1 filmovertrukne tabletter EU/1/08/457/015 196 (2 x 98) filmovertrukne tabletter EU/1/08/457/017 168 (2 x 84) filmovertrukne tabletter
English: What Efficib is and what it is used for What you need to know before you take Efficib How to take Efficib
Danish: Det skal De vide, før De begynder at tage Efficib Sådan skal De tage Efficib Bivirkninger
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Efficib til Dem personligt.
English: This is sometimes called insulin-dependent diabetes - if you have or have had an allergic reaction to sitagliptin, metformin, or Efficib (see section 4) - if you are taking a sulphonylurea or insulin, diabetes medicines, together with Efficib, as you may experience low blood sugar levels (hypoglycaemia).
Danish: - Hvis De tager anden diabetesmedicin, sulfonylurinstof eller insulin, sammen med Efficib, da De så kan opleve lavt blodsukker (hypoglykæmi).
English: In patients taking non-pre-mixed (intermediate/long-acting) insulin, the mean daily dose was 44.3 U/day.
Danish: Hos patienter, der tog ikke-forblandet insulin (middellangtidsvirkende/langtidsvirkende), var den gennemsnitlige daglige dosis 44,3 E/dag.Data fra 73% af de patienter, som tog metformin, fremgår af tabel 2.
English: Efficib 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride
Danish: Efficib 50 mg/1.000 mg filmovertrukne tabletter sitagliptin/metforminhydrochlorid
English: Efficib 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride
Danish: Efficib 50 mg/850 mg filmovertrukne tabletter sitagliptin/metforminhydrochlorid
English: Do not take Efficib: - if you are allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6) - if you have severely reduced kidney function - if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Danish: - Hvis De har dårligt kontrolleret diabetes, der eksempelvis er ledsaget af alvorlig hyperglykæmi (højt blodsukker), kvalme, opkastning, diarré, hurtigt vægttab, laktacidose (se ”Risiko for laktacidose” nedenfor) eller ketoacidose.
English: Efficib 50 mg/1,000 mg tablets sitagliptin/metformin HCl
Danish: Efficib 50 mg/1000 mg tabletter sitagliptin/metforminhydrochlorid
English: What Efficib looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Efficib 50 mg/850 mg tablets sitagliptin/metformin HCl
Danish: Efficib 50 mg/850 mg tabletter sitagliptin/metforminhydrochlorid
English: If you take more Efficib than you should
Danish: Hvis De har taget for meget Efficib
English: Such decisions should instead be taken on a case by case basis, following an evaluation of the findings and their potential impact.
Danish: Sådanne afgørelser bør i stedet træffes i det enkelte tilfælde efter en vurdering af resultaterne og deres potentielle betydning.
English: Overall summary of the scientific evaluation of Tibocina and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Tibocina og relaterede navne (se bilag I)
English: A single bioequivalence study was conducted to support both applications.
Danish: Der blev udført en enkelt bioækvivalensundersøgelse til støtte for begge ansøgninger.
English: Tibolone is a synthetic steroid hormone drug which acts as an agonist, mainly on oestrogen receptors.
Danish: Tibolon er et syntetisk steroidt hormon, der navnlig virker agonistisk på østrogenreceptorer.
English: Two applications under the decentralised procedure were submitted for the generic products Tibolona Aristo and Tibocina, both 2.5 mg tablets with the indication “treatment of oestrogen deficiency symptoms in women, more than one year after the menopause”.
Danish: Der blev indgivet to ansøgninger under den decentrale procedure for de generiske produkter Tibolona Aristo og Tibocina, der begge er 2,5 mg tabletter med indikationen “symptomer på østrogenmangel hos kvinder, tidligst et år efter menopausen”.
English: These findings were classified as critical and one of the concerned member states therefore considered it impossible to conclude on the reliability of the bioequivalence study.
Danish: Disse resultater blev klassificeret som kritiske, og en af de berørte medlemsstater fandt det derfor umuligt at drage konklusioner om pålideligheden af bioækvivalensundersøgelsen.
English: A referral under Article 29(4) of Directive 2001/83/EC was triggered and the CHMP was requested to give its opinion on whether the proposed products Tibolona Aristo and Tibocina can be considered bioequivalent to the reference product.
Danish: Der blev indledt en indbringelse i medfør af artikel 29, stk. 4, af direktiv 2001/83/EF, og CHMP blev anmodet om at fremsætte en udtalelse om, hvorvidt de ansøgte produkter Tibolona Aristo og Tibocina kan anses for bioækvivalente med referenceproduktet.
English: • the CHMP reviewed the available data, including the Rapporteurs' assessment reports and the explanations submitted by the Applicant during the CMDh procedure
Danish: • CHMP gennemgik de foreliggende data, herunder rapportørernes vurderingsrapporter og ansøgerens redegørelser, der var forelagt under proceduren i CMDh,
English: Having reviewed the available data, the CHMP considered that there was sufficient additional evidence indicating that the study samples were not put at risks during the study and that these were maintained under adequate temperature conditions.
Danish: Efter gennemgang af de foreliggende data fandt CHMP, at der var tilstrækkelig supplerende dokumentation for, at prøverne fra undersøgelsen ikke blev udsat for risici under undersøgelsen, og at de blev opbevaret under tilfredsstillende temperaturbetingelser.
English: During the assessment of the application dossiers, a Good Clinical Practice (GCP) inspection of the clinical site identified a lack of evidence documenting the transfer date and time and the identification of pharmacokinetic samples from the dry ice box used for flash freezing to the freezer used at this site until the samples were transferred to the bioanalytical site.
Danish: Ved vurderingen af ansøgningernes dokumentation viste en GCP-inspektion (GCP = god klinisk praksis) af det kliniske forsøgssted, at der savnedes dokumentation for overførselsdato og -tidspunkt og identifikation af farmakogenetiske prøver fra den tørisboks, der blev anvendt til lynfrysning, til den fryser, der blev anvendt på forsøgsstedet, indtil prøverne blev overført til det bioanalytiske center.
English: The CHMP acknowledged that the findings are considered as a critical deficiency, however it did not consider that GCP inspection findings classified as critical should automatically invalidate the results of a bioequivalence study.
Danish: CHMP vedgik, at resultaterne anses for en kritisk mangel, men fandt ikke, at resultater af en GCPinspektion, der klassificeres som kritiske, automatisk bør afkræfte resultaterne af en bioækvivalensundersøgelse.
English: In addition, the bioequivalence study conducted demonstrated bioequivalence, with observed drug concentrations being comparable or superior to those reported in the literature and the CHMP considered that these results suggest that no significant degree of drug degradation occurred.
Danish: Den udførte undersøgelse viste desuden bioækvivalens, idet de iagttagne koncentrationer af lægemidlet var sammenlignelige med eller oversteg dem, der er beskrevet i i litteraturen, og CHMP fandt, at resultaterne tyder på, at der ikke har været tale om nævneværdig nedbrydning af lægemidlet.
English: The CHMP therefore reviewed the additional clinical evidence available, including the assessment carried out during the CMDh procedure and the evidence submitted by the Applicant.
Danish: CHMP gennemgik derfor den foreliggende supplerende kliniske dokumentation, herunder den vurdering, der blev foretaget under proceduren i CMDh (koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer (human)) og den dokumentation, der var forelagt af ansøgeren.
English: The CHMP therefore concluded that while deviations from GCP requirements were identified, the totality of the available evidence confirms that the results of the bioequivalence study are reliable and demonstrates the bioequivalence of the proposed products and the reference product.
Danish: CHMP konkluderede derfor, at den samlede dokumentation - uanset de fundne fravigelser af GCPkravene - bekræfter pålideligheden af resultaterne af bioækvivalensundersøgelsen og godtgør bioækvivalensen af de ansøgte produkter med referenceproduktet.
English: • the CHMP considered that the available data confirms that the results of the bioequivalence study are reliable and demonstrate the bioequivalence of the proposed products and the reference product the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Tibocina and associated names (see Annex I).
Danish: Produktresuméet, etiketteringen og indlægssedlen hertil forbliver uændrede og svarer til endelige version, der er fastlagt ved behandlingen i koordinationsgruppen, som anført i bilag III for Tibocina og relaterede navne (se bilag I).
English: Effects on human reproduction cannot be excluded.
Danish: Virkninger på human reproduktion kan ikke udelukkes.
English: All symptoms resolved completely within a few hours.
Danish: Alle symptomer forsvandt helt i løbet af nogle få timer.
English: • Allergic reactions which can, rarely, be serious
Danish: • Allergiske reaktioner, der i sjældne tilfælde kan være alvorlige
English: Careful monitoring.
Danish: Omhyggelig monitorering.
English: In case of long term treatment (more than 6 months):
Danish: Ved langvarig behandling (over 6 måneder):
English: Activated charcoal may be given if considered appropriate.
Danish: Aktivt kul kan gives, hvis det anses for hensigtsmæssigt.
English: Response rates varied between 43 and 80% depending on the studies and the criteria to define a response.
Danish: Responsraterne lå på mellem 43-80 % afhængigt af studierne og responskriterierne.
English: Improvement of clinical symptoms was noted in most patients after initiation of treatment.
Danish: Forbedring af de kliniske symptomer blev bemærket hos de fleste patienter efter initiering af behandling.
English: Cmax and AUC increase more than proportionally with dose.
Danish: Cmax og AUC øges mere end proportionalt med dosis.
English: Expected effect on drug levels
Danish: Forventet virkning på lægemiddelniveauer
English: In a retrospective study conducted in several French centres, 200 patients with Cushing's disease were followed between 1995 and 2012.
Danish: I et retrospektivt studie, der blev gennemført på flere franske centre, blev 200 patienter med Cushings sygdom fulgt i årene 1995-2012.
English: This medicine is not recommended for children under 12 years due to the lack of data in these patients.
Danish: Dette lægemiddel anbefales ikke til børn under 12 år, da der mangler data hos disse patienter.
English: Do not drive or operate machines if you experience these symptoms.
Danish: Du må ikke køre bil eller arbejde med maskiner, hvis du oplever disse symptomer.
English: Treatment of juvenile rats for 30 day beginning at 21 days of age delayed the puberty onset.
Danish: Behandling af unge rotter i 30 dage fra en alder på 21 dage forsinkede pubertetsstarten.
English: About 200 patients were treated for more than 6 months and some of them were treated for several years.
Danish: Cirka 200 patienter blev behandlet i mere end 6 måneder, og nogle i flere år.
English: Side effects with frequency not known (frequency cannot be estimated from the available data):
Danish: Bivirkninger, hvis hyppighed ikke er kendt (kan ikke vurderes ud fra tilgængelige data):
English: Table 1 Interactions and recommendations for co-administration.
Danish: Tabel 1 Interaktioner og anbefalinger vedrørende samtidig administration.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports (PSURs)
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Careful monitoring INR (international normalised ratio) monitoring recommended.
Danish: INR (International Normalised Ratio) bør monitoreres.
English: Then go on with regular schedule as prescribed.
Danish: Derefter fortsætter du som foreskrevet.
English: No studies were performed with albumin bound nanoparticules.
Danish: Der blev ikke udført studier med albuminbundne nanopartikler.
English: About 13% of the dose is excreted in the urine, of which 2 to 4% is unchanged medicinal product.
Danish: Ca. 13 % af dosis udskilles i urinen, hvoraf 2-4 % er uomdannet lægemiddel.
English: Associated with a decrease in corresponding values for the active metabolite
Danish: Forbundet med et fald i tilsvarende værdier for den aktive metabolit.
English: Monitoring of the QTc interval
Danish: Monitorering af QTc-intervallet
English: Plasma elimination is biphasic with a half-life of 2 hours during the first 10 hours and 8 hours thereafter.
Danish: Plasmaeliminationen er bifasisk med en halveringstid på 2 timer i de første 10 timer og 8 timer derefter.
English: Do not change the prescribed dose yourself.
Danish: Du må ikke selv ændre den foreskrevne dosis.
English: Dose reduction of indinavir to 600 mg every 8 hours should be considered.
Danish: Reduktion af indinavirdosis til 600 mg hver 8. time bør overvejes.
English: Not recommended unless necessary.
Danish: Bør ikke anvendes, medmindre det er påkrævet.
English: Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Courron d‘Auvergne France
Danish: Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Courron d'Auvergne Frankrig
English: The adverse reactions listed below in table 2 are classified according to System Organ Class.
Danish: Bivirkningerne anført herunder i tabel 2 er klassificeret efter systemorganklasse.
English: An ECG should be performed:
Danish: EKG skal foretages:
English: There are no data suggesting a need for a specific dose adjustment in this population.
Danish: Der er ingen data, der tyder på, at en specifik dosisjustering er nødvendig hos denne population.
English: The maximal dose that was used for treatment of Cushing's syndrome is 1,600 mg/day.
Danish: Den maksimale dosis, der er blevet anvendt til behandling af Cushings syndrom, er 1.600 mg/dag.
English: • Loss of appetite or increased appetite
Danish: • Appetitløshed eller øget appetit
English: In vitro, the plasma protein binding is about 99% mainly to the albumin fraction.
Danish: In vitro er plasmaproteinbindingen ca. 99 %, fortrinsvis til albuminfraktionen.
English: HRA Pharma Rare Diseases 200 avenue de Paris 92320 CHATILLON France
Danish: HRA Pharma Rare Diseases 200 avenue de Paris 92320 CHATILLON Frankrig
English: PVC/Alu blister of 10 tablets Pack sizes containing 60 tablets (6 blisters of 10 tablets).
Danish: PVC/Alu-blister med 10 tabletter Pakningsstørrelser med 60 tabletter (6 blistre med 10 tabletter).
English: Do not take this medicinal product during pregnancy.
Danish: Dette lægemiddel må ikke anvendes under graviditet.
English: Bone fragility and broken legs were reported in rats but were not observed in other species.
Danish: Knogleskørhed og brækkede ben blev rapporteret hos rotter, men blev ikke observeret hos andre arter.
English: Monitoring of QT-prolongation if used concomitantly.
Danish: Monitorering af QT-forlængelse, hvis anvendt på samme tid.
English: Frequency groupings are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known:
Danish: Hyppigheden er defineret i henhold til følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: However no modifications of ECG were recorded in dogs at daily doses up to 40 mg/kg administered for 12 months.
Danish: Der blev dog ikke registreret EKG-ændringer hos hunde ved daglige doser på op til 40 mg/kg i 12 måneder.
English: Careful monitoring as it may cause an earlier onset and/or an increased severity of side-effects.
Danish: Omhyggelig monitorering, da det kan forårsage tidligere forekomst af og/eller øget sværhedsgrad af bivirkninger.
English: If you forget to take one dose, take this dose as soon as you remember.
Danish: Hvis du glemmer at tage en dosis, skal du tage denne dosis hurtigst muligt.
English: Aripiprazole dose should be reduced to approximatively one-half of its prescribed dose.
Danish: Aripiprazol-dosis bør reduceres til ca. halvdelen af den oprindeligt ordinerede dosis.
English: Potential ↑in AUC of risperidone:
Danish: Potentiel ↑ i AUC af risperidon:
English: Maraviroc dose should be decreased to 150 mg twice daily.
Danish: Maraviroc-dosis bør nedsættes til 150 mg 2 gange dagligt.
English: In approximately 10 to 15 % of ketoconazole treated patients, an "escape phenomenon" is observed and reinforces the need for a long-term clinical and biochemical follow-up of these patients.
Danish: Hos cirka 10-15 % af de patienter, som behandles med ketoconazol, observeres et "undvigelsesfænomen", der forstærker behovet for langvarig klinisk og biokemisk opfølgning af disse patienter.
English: Serious hepatic toxicity caused by ketoconazole treatment is rare (1/15000).
Danish: Alvorlig hepatotoksicitet forårsaget af ketoconazolbehandling er sjælden (1/15.000).
English: In the event of accidental overdose, treatment consists of supportive measures.
Danish: I tilfælde af utilsigtet overdosering består behandlingen af understøttende forholdsregler.
English: Fatal cases have been reported particularly when treatment is continued despite liver enzyme elevation.
Danish: Der er rapporteret dødelige tilfælde, især når behandlingen fortsættes trods forhøjede leverenzymværdier.
English: Urticaria, alopecia
Danish: Urticaria, alopeci
English: Use in Cushing's disease
Danish: Anvendelse til Cushings sygdom
English: Frequency of hepatotoxicity could be higher in adolescents than in adults.
Danish: Hepatotoksicitet kan forekomme hyppigere hos unge end hos voksne.
English: Not recommended because of reboxetine narrow's therapeutic margin.
Danish: Bør ikke anvendes pga. reboxetins smalle terapeutiske margin.
English: Women must be provided with comprehensive information on pregnancy prevention.
Danish: Kvinder skal have omfattende oplysninger om anvendelse af kontraception.
English: Ketoconazole was stopped, but she deteriorated rapidly and died.
Danish: Ketoconazol blev seponeret, men hun fik det hurtigt værre og døde.
English: If such a phenomenon occurs, a further dose increase may be required to maintain cortisol levels within the normal range.
Danish: Hvis et sådant fænomen forekommer, kan yderligere dosisøgning være nødvendig for at opretholde et kortisolniveau i normalområdet.
English: This can result in an increase and/or prolongation of their effects, including adverse reactions.
Danish: Dette kan medføre en øget og/eller forlænget virkning af disse lægemidler, herunder af deres bivirkninger.
English: No change in plasma concentration were shown with paclitaxel concentrate.
Danish: Der blev ikke påvist nogen ændring i plasmakoncentrationen med paclitaxelkoncentrat.
English: Do not take Ketoconazole HRA if any of the above applies to you.
Danish: Tag ikke Ketoconazole HRA, hvis noget af ovennævnte gælder for dig.
English: • Change in laboratory markers
Danish: • Ændrede laboratoriemarkører
English: Potential interaction with medicinal products
Danish: Potentielle lægemiddelinteraktioner