FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP agreed that the indications for the injectable form of Losec should be the same as for the tablets, but that the injection should only be used when the administration of the tablets or capsules is not possible.
Danish: CHMP besluttede, at indikationerne for den injicerbare form for Losec skulle være de samme som for tabletterne, men at der udelukkende bør anvendes injektion, når indgivelse af tabletter eller kapsler ikke er mulig.
English: The CHMP also noted that there was some interaction with clopidogrel, but the clinical implications of this is not clear.
Danish: CHMP bemærkede ligeledes, at der var en vis interaktion med clopidogrel, men den kliniske betydning heraf er ikke fastlagt.
English: The company that markets these medicines is AstraZeneca.
Danish: Disse lægemidler markedsføres af virksomheden AstraZeneca.
English: It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining that pump acid into the stomach.
Danish: Det virker ved at blokere for "protonpumperne", som er proteiner i særlige celler i mavesækkens slimhinde, der pumper syren ind i maven.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Losec and associated names in the European Union (EU).
Danish: EMA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at der er behov for at harmonisere ordinationsoplysningerne for Losec og relaterede navne i Den Europæiske Union (EU).
English: The CHMP harmonised the SmPC sections on pregnancy and lactation, the ability to drive and use machines, undesirable effects and overdose.
Danish: CHMP harmoniserede produktresuméets punkter om graviditet og amning, virkning på evnen til at føre motorkøretøj eller betjene maskiner, bivirkninger og overdosering.
English: The CHMP also agreed on a harmonised wording for the contra-indications (situations where the medicine must not be used).
Danish: CHMP godkendte også en harmoniseret formulering af kontraindikationer (situationer, hvor lægemidlet ikke må anvendes).
English: This has led to divergences among Member States in the way the medicine can be used, as seen in the differences in the Summaries of Product Characteristics (SmPCs), labelling and package leaflets in the countries where the product is marketed.
Danish: Dette har medført, at lægemidlet anvendes på forskellige måder i medlemsstaterne, sådan som det fremgår af forskellene i produktresuméerne, etiketteringen og indlægssedlerne i de lande, hvor lægemidlet bliver markedsført.
English: Losec can also be used for the prevention and treatment of the stomach ulcers that are caused by medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment.
Danish: Losec kan ligeledes anvendes til forebyggelse og behandling af mavesår, der skyldes medicin, som anvendes til behandling af smerter og betændelse, kaldet non-selektive, non-steroide antiinflammatoriske lægemidler (NSAID'er), når patienten har brug for fortsat NSAID-behandling.
English: Losec is used to treat diseases where the stomach produces too much acid.
Danish: Losec anvendes til at behandle sygdomme, hvor der produceres for meget mavesyre.
English: Together with antibiotics, it can be used to help rid the stomach of a bacterium called Helicobacter pylori (H. pylori), which is known to cause stomach ulcers.
Danish: Sammen med antibiotika kan det anvendes til at fjerne en bakterie i maven, der kaldes Helicobacter pylori (H. pylori), og som er kendt for at forårsage mavesår.
English: The Committee also recommended that, as a precaution, use of Losec in patients receiving clopidogrel should be discouraged.
Danish: Udvalget anbefalede ligeledes, at man af forsigtighedsgrunde begrænser brugen af Losec hos patienter, der får clopidogrel.
English: These include:
Danish: Disse sygdomme omfatter:
English: However, if the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended while high doses of PPI should be avoided.
Danish: Hvis kombinationen af atazanavir og en protonpumpehæmmer anses for at være uundgåelig, anbefales det dog at foretage en nøje klinisk overvågning (f.eks. af virusmængden), og høje doser af protonpumpehæmmeren skal undgås.
English: The CHMP also included a warning that treatment with Losec and other PPIs may lead to an increase in infections of the gut.
Danish: CHMP medtog ligeledes en advarsel om, at behandling med Losec og andre protonpumpehæmmere kan medføre en stigning i antallet af infektioner i tarmene.
English: Losec was also indicated for use before surgery to prevent acid aspiration (acid moving from the gullet into the lungs during anaesthesia, causing pneumonia).
Danish: Losec var ligeledes indiceret til anvendelse før kirurgi for at forebygge syreaspiration (syre, der løber fra spiserøret og ind i lungerne under anæstesi, og som medfører lungebetændelse).
English: • H. pylori eradication in stomach and duodenum ulcer disease in combination with antibiotics,
Danish: • udryddelse af H. pylori ved mavesår og duodenal ulcus, i kombination med antibiotika,
English: When used as an OTC medicine, the CHMP recommended that the indication be the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Danish: Anvendt som håndkøbsmedicin anbefalede CHMP, at indikationen var behandling af reflukssymptomer (f.eks. halsbrand og sure opstød) hos voksne.
English: • symptomatic gastro-oesophageal reflux disease,
Danish: • symptomatisk gastroøsofageal reflukssygdom,
English: • reflux oesophagitis (treatment, including long-term management after healing),
Danish: • refluksøsofagitis (behandling, herunder langvarig behandling efter helbredelse),
English: • NSAID associated ulcers (treatment and prevention),
Danish: • NSAID-associeret ulcus (behandling og forebyggelse),
English: Losec must not be used in people who are allergic to omeprazole or to any other ingredients in the medicine, and in people being treated with nelfinavir.
Danish: Losec må ikke anvendes til personer, som er allergiske over for omeprazol eller over for et eller flere af hjælpestofferne, og det må ikke anvendes til personer, som behandles med nelfinavir.
English: The CHMP noted that, due to interactions, the concomitant use of PPIs may affect the efficacy of atazanavir and other HIV medications whose absorption is pH-dependent.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion CHMP bemærkede, at på grund af interaktioner kan samtidig brug af protonpumpehæmmere have indflydelse på virkningen af atazanavir og andre hiv-lægemidler, hvis absorption er pH-afhængig.
English: Losec has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Det blev bestemt af den humanmedicinske koordineringsgruppe for gensidig anerkendelse og decentrale procedurer (CMD(h)), at Losec skulle harmoniseres.
English: • Zollinger-Ellison syndrome (a condition caused by oversecretion of acid in the stomach).
Danish: • Zollinger-Ellisons syndrom (en tilstand, der skyldes for stor produktion af mavesyre).
English: • duodenal ulcers (treatment and prevention of relapse),
Danish: • duodenal ulcus (behandling og forebyggelse af tilbagefald),
English: • reflux oesophagitis (inflammation of the gullet, due to acid),
Danish: • refluksøsofagitis (betændelse i spiserøret forårsaget af syre),
English: • In combination with antibiotics in the treatment of duodenal ulcer caused by H. pylori.
Danish: • behandling af duodenal ulcus forårsaget af H. pylori, i kombination med antibiotika.
English: • reflux disease, to treat symptoms such as heartburns and acid regurgitation (acid flowing up in the mouth),
Danish: • reflukssygdom, hvor det behandler symptomer såsom halsbrand og sure opstød,
English: • stomach or duodenal ulcer, including preventing the ulcer from coming back (relapse),
Danish: • mavesår eller sår på tolvfingertarmen, herunder forebyggelse af sårets tilbagevenden (tilbagefald),
English: • stomach ulcers (treatment and prevention of relapse),
Danish: • mavesår (behandling og forebyggelse af tilbagefald),
English: • heartburn and acid regurgitation in gastro-oesophageal reflux disease.
Danish: • halsbrand og sure opstød ved gastroøsofageal reflukssygdom,
English: Co-administration of atazanavir with a PPI such as Losec is not recommended.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Samtidig indgivelse af atazanavir og en protonpumpehæmmer som Losec anbefales ikke.
English: • reflux oesophagitis,
Danish: • refluksøsofagitis,
English: PPS = per protocol set
Danish: PPS = pr. protokolsæt
English: Combinations not studied
Danish: Kombinationer, der ikke er undersøgt
English: The magnitude of these reductions was not considered to be clinically relevant.
Danish: Størrelsen af disse reduktioner blev ikke anset for at være klinisk relevant.
English: - if you have blood in your urine that your doctor has not checked.
Danish: - hvis du har blod i urinen, som din læge ikke har undersøgt.
English: The majority of these episodes were mild to moderate in intensity.
Danish: Størstedelen af disse episoder var lette til moderate i intensitet.
English: Age, gender, race, body weight
Danish: Alder, køn, race, kropsvægt
English: Incresync should be taken once daily.
Danish: Incresync skal tages én gang dagligt.
English: Distribution The estimated volume of distribution in humans is 19 L.
Danish: Fordeling Det beregnede fordelingsvolumen hos mennesker er 19 l.
English: Your doctor will tell you how much Incresync you need to take and if you need to change the amount of other medicines you take.
Danish: Lægen fortæller dig, hvor meget Incresync du skal tage, og om du skal ændre mængden af andre lægemidler, du tager.
English: It is important that you continue to follow the advice on diet and exercise that your nurse or doctor has given you.
Danish: Det er vigtigt, at du bliver ved med at følge de råd om kost og motion, som din læge eller sygeplejerske har givet dig.
English: Your doctor will check whether Incresync is working 3 to 6 months after you start taking it.
Danish: Din læge tjekker, om Incresync virker tilfredsstillende, 3 til 6 måneder efter du er startet med at tage det.
English: Do not stop taking Incresync without consulting your doctor first.
Danish: Hold ikke op med at tage Incresync uden at tale med din læge først.
English: The relevance of such a mechanism in humans is unclear.
Danish: Relevansen af en sådan mekanisme hos mennesker er uklar.
English: - if you have had a serious allergic reaction to any other similar medicines that you take to control your blood sugar.
Danish: - hvis du har haft en alvorlig allergisk reaktion over for andre lignende lægemidler, som du tager for at styre dit blodsukker.
English: Do not take Incresync and get your doctor to check your urine as soon as possible.
Danish: Undlad at tage Incresync, og få din læge til at tjekke din urin hurtigst muligt.
English: What Incresync is used for
Danish: Hvad Incresync bruges til
English: If you forget to take a dose, take it as soon as you remember it. Do not take a double dose to make up for a forgotten dose.
Danish: Hvis du har glemt at tage en dosis, skal du tage den så snart, du kommer i tanke om det. Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: If you are following a diabetic diet, you should continue with this while you are taking Incresync.
Danish: Hvis du følger en diabetesdiæt, skal du fortsætte med denne, mens du tager Incresync.
English: A double dose should not be taken on the same day.
Danish: Patienten må ikke tage en dobbelt dosis på samme dag.
English: Take this leaflet or some tablets with you so that your doctor knows exactly what you have taken.
Danish: Tag denne indlægsseddel eller nogle tabletter med, så lægen nøjagtigt ved, hvad der er indtaget.
English: Approximately half of the study population had at least two of the cardiovascular history entry criteria.
Danish: Omkring halvdelen af studiepopulationen opfyldte mindst to af de kardiovaskulære inklusionskriterier.
English: Some epidemiological studies have suggested a similarly increased risk of fracture in both men and women.
Danish: Nogle epidemiologiske studier indikerer, at der er samme øgede risiko for frakturer hos både mænd og kvinder.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/842/001-036
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/842/001-036
English: Co. Wicklow Ireland
Danish: Co. Wicklow Irland
English: Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%).
Danish: Pioglitazon og alle aktive metabolitter er stærkt bundet til plasmaprotein (> 99 %).
English: Animal studies of up to 13-weeks duration have been conducted with the combined substances in Incresync.
Danish: Der er blevet udført dyrestudier af op til 13 ugers varighed med kombinationen af stoffer i Incresync.
English: This has also been observed with other DPP-4 inhibitors.
Danish: Dette er også observeret i forbindelse med andre DPP-4-hæmmere.
English: However, this did not lead to an increase in mortality in this study.
Danish: Dette førte dog ikke til en forøget dødelighed i studiet.
English: Frequencies are defined as 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 (cannot be estimated from available data).
Danish: Hyppigheder defineres som 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Your weight should be checked at regular intervals; if your weight increases, tell your doctor.
Danish: Din vægt bør tjekkes med jævne mellemrum, og hvis den stiger, skal du kontakte din læge.
English: The adverse reactions are listed by system organ class and frequency.
Danish: Bivirkningerne er opstillet efter systemorganklasse og hyppighed.
English: Your blood sugar could fall below the normal level, but can be increased again by taking sugar.
Danish: Blodsukkeret kan falde til under det normale niveau, men kan bringes til at stige igen, hvis du indtager sukker.
English: STOP taking Incresync and contact a doctor immediately if you notice any of the following serious side effects:
Danish: STOP med at tage Incresync, og kontakt lægen med det samme, hvis du får en eller flere af de følgende alvorlige bivirkninger:
English: Not known (frequency cannot be estimated from the available data): - An allergic reaction.
Danish: Bivirkninger med ukendt hyppighed (hyppigheden kan ikke bestemmes ud fra de foreliggende data): - En allergisk reaktion.
English: The tablets should be swallowed whole with water.
Danish: Tabletterne skal synkes hele med vand.
English: In some cases, weight increase may be a symptom of cardiac failure, therefore weight should be closely monitored.
Danish: I nogle tilfælde kan vægtøgning være et symptom på hjertesvigt, så derfor bør vægten overvåges nøje.
English: The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Danish: Studiepopulationen havde en gennemsnitsalder på 62 år, og den gennemsnitlige varighed af diabetes var 9,5 år.
English: Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke.
Danish: Næsten halvdelen af patienterne havde tidligere haft et myokardieinfarkt, og omkring 20 % havde haft et apopleksi.
English: Investigations weight increased common alanine aminotransferase increased not known
Danish: Undersøgelser øget vægt almindelig øget alaninaminotransferase ikke kendt
English: (2-sided 95% CI)
Danish: (to-sidet 95 %-KI)
English: These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure.
Danish: Disse fund blev observeret i forskellige dyrearter ved plasmakoncentrationer ≤ 4 gange den kliniske eksponering.
English: - if you have diabetic ketoacidosis (a serious complication of poorly controlled diabetes).
Danish: - hvis du lider af diabetisk ketoacidose (en alvorlig komplikation ved dårligt reguleret diabetes).
English: Incresync should not be used in combination with insulin, as the safety and efficacy of this combination have not been established.
Danish: Incresync bør ikke anvendes sammen med insulin, da sikkerheden ved og virkningen af denne kombination ikke er klarlagt.
English: On this basis, M-IV contribution to efficacy is approximately 3-fold that of pioglitazone whilst the relative efficacy of M-II is minimal.
Danish: Med udgangspunkt i dette er M-IV's bidrag til effekten omkring tre gange pioglitazons, mens den relative effekt af M-II er minimal.
English: Although in very rare cases, fatal outcome has been reported, causal relationship has not been established.
Danish: Selvom der i meget sjældne tilfælde har været rapporteret tilfælde med dødelig udgang, er der ikke fundet nogen kausal sammenhæng.
English: mood change or feeling confused.
Danish: humørsvingninger eller forvirring.
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Incresync.
Danish: Der kan være større sandsynlighed for at blive gravid, fordi du kan få ægløsning igen, når du tager Incresync.
English: You should also discuss with your doctor if you experience the following side effects:
Danish: Du skal også fortælle din læge, hvis du får følgende bivirkninger:
English: The relevance of this finding is unknown.
Danish: Relevansen af dette fund er ukendt.
English: The inter-subject coefficient of variation for alogliptin AUC was small (17%).
Danish: Forsøgspersonernes intervariationskoefficient for alogliptins AUC var lav (17 %).
English: Age (65-81 years old), gender, race (white, black and Asian) and body weight did not have any clinically relevant effect on the pharmacokinetics of alogliptin.
Danish: Alder (65-81 år), køn, race (hvid, sort eller asiatisk) og kropsvægt havde ingen klinisk relevant indvirkning på alogliptins farmakokinetik.
English: Your doctor may discuss the results with you.
Danish: Din læge vil muligvis tale med dig om det.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Incresync: - if you have type 1 diabetes (your body does not produce insulin).
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Incresync: - hvis du har type 1-diabetes (din krop kan ikke producere insulin).
English: Specific pharmacokinetic drug interaction studies have not been performed with Incresync.
Danish: Der er ikke udført farmakokinetiske lægemiddelinteraktionsundersøgelser med Incresync.
English: A risk to the suckling child cannot be excluded.
Danish: En risiko for børn, der ammes, kan ikke udelukkes.
English: In the alogliptin group, 11.3% of patients experienced a MACE compared to 11.8% of patients in the placebo group.
Danish: I alogliptin-gruppen oplevede 11,3 % af patienterne en MACE sammenlignet med 11,8 % af patienterne i placebogruppen.
English: The effect of Incresync on fertility in humans has not been studied.
Danish: Incresyncs indvirkning på fertiliteten hos mennesker er ikke undersøgt.
English: Patients should, therefore, be made aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, Incresync treatment should be discontinued (see section 4.6).
Danish: Patienter skal derfor gøres opmærksomme på risikoen for graviditet, og hvis en patient ønsker at blive gravid, eller hvis graviditet forekommer, bør behandlingen afbrydes (se pkt.
English: It helps your body make better use of the insulin it produces.
Danish: Pioglitazon hjælper din krop med bedre at udnytte den insulin, den producerer.
English: Prior to distribution of the prescriber guide in each Member State, the MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority.
Danish: Forud for udlevering af ordinationsvejledningen i hver enkelt medlemsstat skal indehaveren af markedsføringstilladelsen og den relevante nationale myndighed blive enige om indholdet og formatet af informationsmaterialet samt en kommunikationsplan.
English: A higher number of bone fractures was seen in patients, particularly women taking pioglitazone.
Danish: Der er set et øget antal knoglebrud hos patienter, især kvinder, der tager pioglitazon.
English: Reductions in HbA1c were similar across different subgroups including renal impairment, age, gender and body mass index, while differences between races (e.g. White and non-White) were small.
Danish: Reduktionerne i HbA1c var på samme niveau i de forskellige undergrupper, herunder nedsat nyrefunktion, alder, køn, og body mass index (BMI), mens forskellene mellem racer (f.eks. hvide og ikke-hvide) var mindre.
English: However, patients who experience visual disturbance should be cautious when driving or using machines.
Danish: Patienter, som får synsforstyrrelser, skal dog udvise forsigtighed, når de færdes i trafikken eller betjener maskiner.
English: Absorption The absolute bioavailability of alogliptin is approximately 100%.
Danish: Absorption Alogliptins absolutte biotilgængelighed er ca. 100 %.
English: Incresync has no or negligible influence on the ability to drive and use machines.
Danish: Incresync påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Many of these patients reported concurrent peripheral oedema.
Danish: Mange af disse patienter indberettede samtidige perifere ødemer.
English: The study demonstrated that alogliptin did not increase the risk of having a MACE compared to placebo [Hazard Ratio: 0.96; 1-sided 99% Confidence Interval: 0-1.16].
Danish: Studiet påviste, at alogliptin ikke øgede risikoen for at få en MACE sammenlignet med placebo [hazard ratio: 0,96; en-sidet 99 % konfidensinterval: 0-1,16].
English: Total serum concentration of pioglitazone is unchanged, but with an increased volume of distribution.
Danish: Den totale plasmakoncentration af pioglitazon er uændret, men med øget fordelingsvolumen.
English: This study showed an increase in reports of heart failure, however this did not lead to an increase in mortality in this study.
Danish: Dette studie viste et øget antal indberetninger om hjerteinsufficiens, uden dog at føre til en øget dødelighed i dette studie.
English: An approximate 1.7-fold increase in AUC for alogliptin was observed in patients with mild renal impairment.
Danish: En stigning på ca. 1,7 gange i AUC for alogliptin blev observeret hos patienter med let nedsat nyrefunktion.
English: Cardiovascular Death*
Danish: Kardiovaskulær død*
English: Alogliptin was not carcinogenic in 2-year carcinogenicity studies conducted in rats and mice.
Danish: Alogliptin var ikke karcinogent i de to-årige karcinogenicitetsstudier, der blev udført på rotter og mus.
English: Alogliptin is 20-30% bound to plasma proteins.
Danish: Alogliptin har en plasmaproteinbinding på 20-30 %.
English: Proportional increases of the serum concentration were observed for doses from 2-60 mg. Steady-state is achieved after 4-7 days of dosing.
Danish: Proportionale stigninger i serumkoncentrationen sås for doser fra 2 til 60 mg. Steady-state opnås efter 4-7 dages administration.
English: Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain, which may radiate to the back.
Danish: Patienter skal oplyses om det karakteristiske symptom på akut pancreatitis: vedholdende, svære abdominalsmerter, som kan stråle ud i ryggen.
English: See section 2 “Incresync contains lactose”.
Danish: Se punkt 2 "Incresync indeholder lactose".
English: Change at Week 26 (n=303)
Danish: Ændring i uge 26 (n =
English: Higher baseline HbA1c was associated with a greater reduction in HbA1c.
Danish: Højere HbA1c ved baseline var forbundet med større reduktion i HbA1c.