FrancophonIA/ELRC3.0 huggingface dataset:
English: Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly (see sections 4.3 and 4.4).
Danish: Monitorering af nyrefunktionen er nødvendig for at forhindre metforminassocieret laktacidose, især hos ældre (se pkt.
English: Post-marketing reports of serious hypersensitivity reactions in patients treated with sitagliptin have been reported.
Danish: Efter markedsføring er der blevet rapporteret om alvorlige overfølsomhedsreaktioner hos patienter, der er blevet behandlet med sitagliptin.
English: • certain medicines used to treat stomach problems such as cimetidine
Danish: • Visse typer medicin, der anvendes til at behandle maveproblemer, fx cimetidin.
English: Among patients taking metformin, baseline HbA1c was 8.70 % and baseline insulin dose was 37 IU/day.
Danish: Blandt de patienter, som tog metformin, var HbA1c ved baseline 8,70%, og insulindosis ved baseline var 37 IE/dag.
English: Among patients taking metformin, at Week 24, the increase in daily insulin dose was 19 IU/day in patients treated with sitagliptin and 24 IU/day in patients treated with placebo.
Danish: Blandt de patienter, som tog metformin, var stigningen i uge 24 i daglig insulindosis 19 IE/dag hos de patienter, der blev behandlet med sitagliptin, og 24 IE/dag hos de patienter, der blev behandlet med placebo.
English: When blood glucose levels are low, insulin release is not enhanced and glucagon secretion is not suppressed.
Danish: Når blodglucosekoncentrationen er lav, ses der ikke en stimulering af insulinfrigørelse og hæmning af glucagonsekretionen.
English: Following administration of a dose of 850 mg, a 40 % lower plasma peak concentration, a 25 % decrease in AUC and a 35 min prolongation of time to peak plasma concentration was observed.
Danish: Efter administration af en dosis på 850 mg sås en 40% lavere plasma peakkoncentration, 25% fald i AUC og en forlængelse af tiden op til plasma peakkoncentration på 35 minutter.
English: • sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
Danish: • Sitagliptin tilhører en klasse af medicin, som kaldes DPP-4-hæmmere (dipeptidylpeptidase-4
English: Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma.
Danish: Laktacidose er kendetegnet ved acidotisk dyspnø, abdominalsmerter, muskelkramper, asteni og hypotermi efterfulgt af koma.
English: Body weight did not increase from baseline with sitagliptin therapy.
Danish: Kropsvægten steg ikke i forhold til baseline ved behandling med sitagliptin.
English: No dose adjustment for sitagliptin is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Danish: Dosisjustering af sitagliptin er ikke nødvendig hos patienter med let eller moderat leverinsufficiens (Child-Pugh score ≤9).
English: Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in cases of fasting, malnutrition or hepatic impairment.
Danish: Alkoholintoksikation er forbundet med en øget risiko for laktacidose, især i tilfælde af faste, fejlernæring eller leverinsufficiens.
English: When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells.
Danish: Når blodglucosekoncentrationen er normal eller forhøjet, bevirker GLP-1 og GIP en øget insulinsyntese og frigørelse af insulin fra de pankreatiske betaceller.
English: Ristfor is contraindicated in patients with GFR < 30 mL/min and should be temporarily discontinued during conditions with the potential to alter renal function (see section 4.3).
Danish: Ristfor er kontraindiceret hos patienter med GFR < 30 ml/min, og behandlingen skal afbrydes midlertidigt ved tilstedeværelse af tilstande, der påvirker nyrefunktionen (se pkt.
English: Pack of 50 x 1 film-coated tablets in perforated unit dose blisters.
Danish: Pakning med 50 x 1 filmovertrukne tabletter i perforerede enkeltdosisblistre.
English: You will need to stop taking Ristfor at the time of the X-ray and for 2 or more days after as directed by your doctor,
Danish: Det vil være nødvendigt at stoppe med Ristfor på tidspunktet for røntgenundersøgelsen og i 2 dage eller mere som foreskrevet af lægen, afhængigt af hvordan Deres nyrer fungerer.
English: Adverse reactions were identified through post-marketing surveillance.
Danish: Bivirkninger identificeret ved bivirkningsovervågning efter markedsføring.
English: Studies in animals have shown reproductive toxicity at high doses of sitagliptin (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet ved høje doser (se pkt.
English: Some patients have experienced diarrhoea, nausea, flatulence, constipation, stomach ache or vomiting when starting the combination of sitagliptin and metformin together (frequency is common).
Danish: Nogle patienter har oplevet diarré, kvalme, øget luftafgang fra tarmen, forstoppelse, mavesmerter eller opkastning, når de er startet med at tage sitagliptin og metformin sammen (hyppighed: almindelig).
English: A no-effect level for these findings was found at an exposure 6-fold the clinical exposure level.
Danish: No-effect-niveauet for disse fund var til stede ved en eksponering, der var 6 gange højere end den kliniske eksponering.
English: Pharmacotherapeutic group: Drugs used in diabetes, Combinations of oral blood glucose lowering drugs, ATC code: A10BD07
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, kombinationer af orale blodglucosesænkende midler, ATC-kode: A10BD07
English: The most effective method to remove lactate and metformin is haemodialysis.
Danish: Den mest effektive måde at fjerne laktat og metformin på er ved hæmodialyse.
English: Risk of lactic acidosis
Danish: Risiko for laktacidose
English: In addition, patients should be alerted to the risk of hypoglycaemia when Ristfor is used in combination with a sulphonylurea or with insulin.
Danish: Desuden bør patienter advares om risikoen for hypoglykæmi, når Ristfor anvendes sammen med et sulfonylurinstof eller sammen med insulin.
English: The reduction in HbA1c for patients treated with sitagliptin, metformin, and insulin was -1.35 % compared to -0.90 % for patients treated with placebo, metformin, and insulin, a difference of -0.45 % [95 % CI: -0.62, -0.29].
Danish: Reduktionen i HbA1c for de patienter, der blev behandlet med sitagliptin, metformin og insulin, var -1,35% sammenlignet med -0,90% for de patienter, der blev behandlet med placebo, metformin og insulin, en forskel på -0,45% [95% konfidensinterval: -0,62; -0,29].
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Ristfor.
Danish: De skal eventuelt have kontrolleret Deres blodsukker eller Deres nyrefunktion hyppigere, eller lægen kan ændre Deres dosis af Ristfor.
English: If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Ristfor.
Danish: Hvis De er i tvivl om noget af ovenstående passer på Dem, skal De tale med lægen eller apotekspersonalet, før De tager Ristfor.
English: When this medicine is used with a sulphonylurea medicine or with insulin, low blood sugar can occur and your doctor may reduce the dose of your sulphonylurea or insulin.
Danish: Når lægemidlet tages sammen med et sulfonylurinstof eller insulin, kan lavt blodsukker forekomme, og Deres læge vil måske nedsætte dosis af sulfonylurinstof eller insulin.
English: In addition, very slight to slight skeletal muscle degeneration was also observed histologically at doses resulting in systemic exposure levels of approximately 23 times the human exposure level.
Danish: Histologisk blev der desuden observeret en meget let til let degeneration af skeletmuskulaturen ved doser svarende til en systemisk eksponering, der var ca. 23 gange højere end hos mennesker.
English: In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions observed with sitagliptin with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for periods of up to 28 days.
Danish: I fase-I flerdosisstudier blev der ikke observeret dosisrelaterede kliniske bivirkninger med sitagliptin med doser op til 600 mg/dag i perioder op til 10 dage og 400 mg/dag i perioder op til 28 dage.
English: Renal and liver toxicity were observed in rodents at systemic exposure values 58 times the human exposure level, while the no-effect level was found at 19 times the human exposure level.
Danish: Der blev observeret nyre- og levertoksicitet hos gnavere ved systemiske eksponeringsniveauer, der var 58 gange højere end eksponeringsniveauet hos mennesker, mens no-effect-niveauet fandtes ved et niveau, der var 19 gange højere end eksponeringsniveauet hos mennesker.
English: Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Danish: Symptomer fra mave-tarm-kanalen som kvalme, opkastning, diarré, mavesmerter og appetitløshed forekommer hyppigst i forbindelse med initiering af behandlingen og forsvinder spontant i de fleste tilfælde.
English: Evaluation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels.
Danish: Vurderingen bør inkludere måling af serumelektrolytter og ketoner, blodglucose og, hvis indiceret, blod-pH, laktat, pyruvat og metforminkoncentration.
English: Multi-pack containing 196 (2 packs of 98) film-coated tablets Multi-pack containing 168 (2 packs of 84) film-coated tablets
Danish: Multipakning indeholdende 196 (2 x 98) filmovertrukne tabletter Multipakning indeholdende 168 (2 x 84) filmovertrukne tabletter
English: Co-administration of multiple doses of sitagliptin (50 mg twice daily) and metformin (1,000 mg twice daily) did not meaningfully alter the pharmacokinetics of either sitagliptin or metformin in patients with type 2 diabetes.
Danish: Samtidig administration af multiple doser af sitagliptin (50 mg to gange dagligt) og metformin (1.000 mg to gange dagligt) ændrede ikke hverken sitagliptins eller metformins farmakokinetik betydeligt hos patienter med type 2-diabetes.
English: Packs of 14, 28, 56, 60, 112, 168, 180, 196 film-coated tablets, multi-packs containing 196 (2 packs of 98) and 168 (2 packs of 84) film-coated tablets.
Danish: Pakninger med 14, 28, 56, 60, 112, 168, 180, 196 filmovertrukne tabletter, multipakning indeholdende 196 (2 x 98) og 168 (2 x 84) filmovertrukne tabletter.
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Danish: Hos mennesker har metformin, uafhængigt af dets indvirkning på hyperglykæmi, gunstig indvirkning på lipidmetabolismen.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ristfor in all subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Ristfor hos alle undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt.
English: Additional adverse reactions associated with metformin include metallic taste (common); lactic acidosis, liver function disorders, hepatitis, urticaria, erythema, and pruritus (very rare).
Danish: Yderligere bivirkninger, der er associeret med metformin, omfatter metallisk smag i munden (almindelig); laktacidose, leverinsufficiens, hepatitis, urticaria, erythema og pruritus (meget sjælden).
English: Ristfor has no or negligible influence on the ability to drive and use machines.
Danish: Ristfor påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: A bioequivalence study in healthy subjects demonstrated that the Ristfor (sitagliptin/metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets.
Danish: En bioækvivalensundersøgelse med raske forsøgspersoner viste, at Ristfor (sitagliptin/metforminhydrochlorid) kombinationstabletter er bioækvivalente med samtidig administration af sitagliptinphosphat og metforminhydrochlorid som individuelle tabletter.
English: Patients treated with sitagliptin had a modest increase in body weight (+1.1 kg) compared to those given placebo.
Danish: Patienter, der blev behandlet med sitagliptin, havde en moderat vægtøgning (+1,1 kg) sammenlignet med de patienter, der fik placebo.
English: In a 52-week study, comparing the efficacy and safety of the addition of sitagliptin 100 mg once daily or glipizide (a sulphonylurea) in patients with inadequate glycaemic control on metformin monotherapy, sitagliptin was similar to glipizide in reducing HbA1c (-0.7 % mean change from baselines at week 52, with baseline HbA1c of approximately 7.5 % in both groups).
Danish: I en 52-ugers undersøgelse af effekt og sikkerhed af tillægsbehandling med sitagliptin 100 mg en gang dagligt eller glipizid (et sulfonylurinstof) til patienter med utilstrækkelig glykæmisk kontrol i metforminmonoterapi, var sitagliptin sammenlignelig med glipizid mht. reduktion af HbA1c (-0,7% gennemsnitlig ændring i forhold til baseline i uge 52, med baseline-HbA1c på ca. 7,5% i begge grupper).
English: If bullous pemphigoid is suspected, Ristfor should be discontinued.
Danish: Hvis der er mistanke om bulløs pemfigoid, skal Ristfor seponeres.
English: Sitagliptin differs in chemical structure and pharmacological action from GLP-1 analogues, insulin, sulphonylureas or meglitinides, biguanides, peroxisome proliferator-activated receptor gamma (PPAR) agonists, alpha-glucosidase inhibitors, and amylin analogues.
Danish: Sitagliptin adskiller sig i kemisk struktur og farmakologisk virkning fra GLP-1-analoger, insulin, sulfonylurinstoffer eller meglitinider, biguanider, peroxisom-proliferatoraktiverede receptorgammaagonister (PPARγ), alfaglucosidasehæmmere og amylinanaloger.
English: In monotherapy studies of sitagliptin 100 mg once daily alone compared to placebo, adverse reactions reported were headache, hypoglycaemia, constipation, and dizziness.
Danish: I monoterapiundersøgelser af sitagliptin 100 mg en gang dagligt alene sammenlignet med placebo er der rapporteret om følgende bivirkninger: Hovedpine, hypoglykæmi, obstipation og svimmelhed.
English: Table 1: The frequency of adverse reactions identified from placebo-controlled clinical studies of sitagliptin and metformin alone, and post-marketing experience
Danish: Tabel 1: Bivirkningsfrekvens identificeret i placebokontrollerede kliniske undersøgelser med sitagliptin og metformin-monoterapi og efter markedsføring
English: The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
Danish: Risikoen for at udvikle laktacidose er også forhøjet ved dårligt kontrolleret diabetes, alvorlige infektioner, længerevarende faste eller alkoholindtagelse, dehydrering (væskemangel se yderligere oplysninger nedenfor), leverproblemer og enhver tilstand med nedsat iltforsyning til en legemsdel (såsom akut alvorlig hjertesygdom).
English: Other medicines and Ristfor
Danish: Brug af anden medicin sammen med Ristfor
English: They work together to control blood sugar levels in adult patients with a form of diabetes called ‘type 2 diabetes mellitus'.
Danish: Sammen kontrollerer de blodsukkeret hos voksne patienter med type 2-diabetes mellitus.
English: Go to the hospital if you have symptoms of lactic acidosis such as feeling cold or uncomfortable, severe nausea or vomiting, stomach ache, unexplained weight loss, muscular cramps, or rapid breathing (see section “Warnings and precautions”).
Danish: Tag på hospitalet, hvis De får symptomer på laktacidose, fx hvis De fryser eller føler Dem utilpas, får svær kvalme eller opkastning, mavesmerter, uforklarligt vægttab, muskelkramper eller hurtig vejrtrækning (se punktet ”Advarsler og forsigtighedsregler”).
English: The NOEL in these studies was observed at exposures to sitagliptin of approximately 6 times the human exposure and to metformin of approximately 2.5 times the human exposure.
Danish: No-effectniveauet i disse undersøgelser blev observeret ved eksponeringer over for sitagliptin og metformin, der var henholdsvis ca. 6 og 2,5 gange højere end hos mennesker.
English: Ristfor must therefore not be used in women who are breast-feeding (see section 4.3).
Danish: Ristfor må derfor ikke anvendes til kvinder, der ammer (se pkt.
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.
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 - i musklerne, ved let øgning af følsomheden over for insulin, ved forbedring af perifer glucoseoptagelse og ved udnyttelse af glucose.
English: Sitagliptin was modestly removed by haemodialysis (13.5 % over a 3- to 4-hour haemodialysis session starting 4 hours post-dose).
Danish: Sitagliptin elimineredes moderat ved hæmodialyse (13,5% over en 3-4 timers hæmodialysesession med start 4 timer efter dosering).
English: Common: low blood sugar, headache, upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain
Danish: Almindelige: Lavt blodsukker, hovedpine, infektion i øvre luftveje, stoppet næse eller snue og ondt i halsen, betændelse i led og de tilgrænsende knogler, smerter i arme eller ben.
English: • medicines (taken by mouth, inhalation, or injection) used to treat diseases that involve inflammation, like asthma and arthritis (corticosteroids)
Danish: • Medicin (der tages gennem munden, som inhalation eller injektion), som anvendes til behandling af sygdomme, der kan medføre betændelsestilstande, som astma og gigt
English: Sitagliptin phosphate is an orally-active, potent, and highly selective inhibitor of the dipeptidyl peptidase 4 (DPP-4) enzyme for the treatment of type 2 diabetes.
Danish: Sitagliptinphosphat er en oralt aktiv, potent og højselektiv hæmmer af DPP-4-enzymet til behandling af type 2-diabetes.
English: In case of dehydration (severe vomiting, diarrhoea, fever or reduced fluid intake), metformin should be temporarily discontinued and contact with a health care professional is recommended.
Danish: Patienterne skal informeres om, at i tilfælde af dehydrering (alvorlig opkastning, diarré, feber eller nedsat væskeindtagelse) skal metforminbehandlingen afbrydes midlertidigt, og at det anbefales, at de kontakter en læge.
English: By inhibiting the DPP-4 enzyme, sitagliptin increases the levels of two known active incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
Danish: Ved at hæmme DPP-4-enzymet øger sitagliptin niveauerne for de to kendte aktive inkretinhormoner, glucagonlignende peptid 1 (GLP-1) og glucoseafhængigt insulinotropt polypeptid (GIP).
English: Very common (may affect more than 1 in 10 people): low blood sugar Common: constipation
Danish: Meget almindelig (kan berøre flere end 1 ud af 10 behandlede): Lavt blodsukker.
English: Animal data do not suggest an effect of treatment with sitagliptin on male and female fertility.
Danish: Data fra dyrestudier viser ingen virkning af sitagliptinbehandling på fertiliteten hos hanner og hunner.
English: Tablet core microcrystalline cellulose (E460) povidone K29/32 (E1201) sodium lauril sulfate sodium stearyl fumarate
Danish: Mikrokrystallinsk cellulose (E460) Povidon K29/32 (E1201) Natriumlaurilsulfat Natriumstearylfumarat
English: Patients receiving Ristfor in combination with a sulphonylurea or with insulin may be at risk for hypoglycaemia.
Danish: Patienter, der får Ristfor sammen med et sulfonylurinstof eller sammen med insulin, har øget risiko for at få hypoglykæmi.
English: Gastrointestinal symptoms were reported very commonly in clinical studies and post-marketing use of metformin.
Danish: Symptomer fra mave-tarm-kanalen blev rapporteret med frekvensen meget almindelig i kliniske undersøgelser og ved brug af metformin efter markedsføring.
English: In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8.
Danish: In vitro-undersøgelser indikerede, at det enzym, der primært er ansvarligt for sitagliptins begrænsede metabolisering, er CYP3A4, med medvirken fra CYP2C8.
English: 50 x 1 film-coated tablets
Danish: 50 x 1 filmovertrukne tabletter
English: Analysis in the Intention-to-Treat Population Number of patients
Danish: Analyse i Intention to treat-populationen
English: Other risk factors for lactic acidosis are excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting and any conditions associated with hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis (see sections 4.3 and 4.5).
Danish: Andre risikofaktorer for laktacidose omfatter stort alkoholforbrug, leverinsufficiens, utilstrækkeligt kontrolleret diabetes, ketose, langvarig faste og enhver tilstand forbundet med hypoksi samt samtidig brug af lægemidler, der kan forårsage laktacidose (se pkt.
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Danish: Metformin stimulerer intracellulær glykogensyntese ved at indvirke på glykogensyntasen.
English: The Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) included 7,332 patients treated with sitagliptin, 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 mL/min/1.73 m2), and 7,339 patients treated with placebo in the intention-to-treat population.
Danish: TECOS-studiet (The Trial Evaluating Cardiovascular Outcomes with Sitagliptin) inkluderede 7.332 patienter, som blev behandlet med sitagliptin 100 mg dagligt (eller 50 mg dagligt, hvis eGFR ved baseline var ≥ 30 og < 50 ml/min/1,73 m2), og 7.339 patienter, som fik placebo, i intention to treat-populationen.
English: Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)
Danish: Hyppighed ikke kendt: Nyreproblemer (som kan kræve dialyse), opkastning, ledsmerter, muskelsmerter, rygsmerter, interstitiel lungesygdom, bulløs pemfigoid (en type blærer på huden).
English: For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin
Danish: Til patienter, der ikke er tilstrækkeligt kontrolleret på dual kombinationsbehandling med insulin og den maksimalt tolererede dosis af metformin
English: Your doctor may reduce the dose of your sulphonylurea or insulin
Danish: Lægen kan nedsætte Deres dosis af sulfonylurinstof eller insulin.
English: Do not take a double dose of this medicine.
Danish: De må ikke tage en dobbeltdosis som erstatning for den glemte dosis af dette lægemiddel.
English: INTERMEDIATE CARTON for Multi-packs 2 packs - without blue box - 50 mg/1,000 mg film-coated tablets
Danish: INDRE KARTON til multipakninger (2 pakninger) - uden Blue Box 50 mg/1.000 mg filmovertrukne tabletter
English: Some patients have experienced the following side effects while taking this medicine in combination with insulin:
Danish: Nogle patienter har oplevet følgende bivirkninger, når de har taget dette lægemiddel sammen med insulin:
English: Nervous system disorders somnolence
Danish: Nervesystemet Døsighed