FrancophonIA/ELRC3.0 huggingface dataset:
English: Nonfatal Stroke *Overall there were 153 subjects (5.7%) in the alogliptin group and 173 subjects (6.5%) in the placebo group who died (all-cause mortality).
Danish: Ikke-dødelig apopleksi *Samlet var der 153 forsøgspersoner (5,7 %) i alogliptin-gruppen og 173 forsøgspersoner (6,5 %) i placebogruppen, som døde (mortalitet af enhver årsag).
English: Skin and subcutaneous tissue disorders pruritus common rash common exfoliative skin conditions including Stevens-Johnson syndrome erythema multiforme not known not known angioedema not known urticaria not known
Danish: Hud og subkutane væv pruritus almindelig udslæt almindelig eksfoliative hudsygdomme, herunder Stevens-Johnsons syndrom erythema multiforme ikke kendt ikke kendt angioødem ikke kendt urticaria ikke kendt
English: However, as the distribution of AUC values for alogliptin in these patients was within the same range as control subjects, no dose adjustment for patients with mild renal impairment is necessary (see section 4.2).
Danish: Da distributionen af AUC-værdier for alogliptin hos disse patienter imidlertid var inden for det samme område som for kontrolpersonerne, er det ikke nødvendigt med dosisjustering hos patienter med let nedsat nyrefunktion (se pkt.
English: Vipidia is taken when your blood sugar cannot be adequately controlled by diet, exercise and one or more of these other oral anti-diabetic medicines.
Danish: Vipidia tages, når dit blodsukker ikke kan styres godt nok gennem kost, motion og din anden diabetesmedicin.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Vipidia in one or more subsets of the paediatric population in the treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Vipidia i en eller flere undergrupper af den pædiatriske population med type 2-diabetes mellitus (se pkt.
English: Shellac Iron oxide black (E172)
Danish: Shellac Sort jernoxid (E172)
English: A decision on whether to discontinue breast-feeding or to discontinue alogliptin therapy should be made taking into account the benefit of breast-feeding for the child and the benefit of alogliptin therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med alogliptin seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Two minor metabolites were detected following administration of an oral dose of [14C] alogliptin, N-demethylated alogliptin, M-I (< 1% of the parent compound), and N-acetylated alogliptin, M-II (< 6% of the parent compound).
Danish: Der blev fundet to mindre metabolitter efter administration af en oral dosis [14C]-alogliptin: N-demethyleret alogliptin, M-I (< 1 % af moderstoffet) og N-acetyleret alogliptin, M-II (< 6 % af moderstoffet).
English: (2-sided 95% CI)
Danish: (tosidet 95 %-KI)
English: If you stop taking Vipidia
Danish: Hvis du holder op med at tage Vipidia
English: The safety and efficacy of Vipidia in children and adolescents < 18 years old have not been established.
Danish: Sikkerheden ved og virkningen af Vipidia hos børn og unge under 18 år er endnu ikke klarlagt.
English: Vipidia is available in blister packs containing 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 tablets.
Danish: Vipidia fås i blisterpakninger med 10, 14, 28, 30, 56, 60, 84, 90, 98 eller 100 tabletter.
English: Primary Composite Endpoint [First Event of CV Death, Nonfatal MI and Nonfatal Stroke]
Danish: Primært sammensat endepunkt [første hændelse af KV- død, ikkedødeligt MI og ikke-dødelig apopleksi]
English: The studies included 5,744 patients with mild renal impairment, 1,290 patients with moderate renal impairment and 82 patients with severe renal impairment / end-stage renal disease treated with alogliptin.
Danish: Studierne omfattede 5.744 patienter med let nedsat nyrefunktion, 1.290 patienter med moderat nedsat nyrefunktion og 82 patienter med svært nedsat nyrefunktion/terminalt nyresvigt, der blev behandlet med alogliptin.
English: As a precautionary measure, it is preferable to avoid the use of alogliptin during pregnancy.
Danish: For en sikkerheds skyld bør alogliptin undgås under graviditet.
English: The no-observed-adverse-effect level (NOAEL) in the repeated dose toxicity studies in rats and dogs up to 26 and 39 weeks in duration, respectively, produced exposure margins that were approximately 147- and 227-fold, respectively, the exposure in humans at the recommended dose of 25 mg alogliptin.
Danish: Niveauet uden observeret negativ effekt (NOAEL) i toksicitetsstudier med gentagen dosering hos rotter og hunde, som varede op til henholdsvis 26 og 39 uger, viste eksponeringsmargener, der var henholdsvis ca. 147 og 227 gange større end eksponeringen hos mennesker, der tager den anbefalede daglige dosis på 25 mg alogliptin.
English: Vipidia has no or negligible influence on the ability to drive and use machines.
Danish: Vipidia påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: In a clinical study of alogliptin as mono-therapy, the incidence of hypoglycaemia was similar to that of placebo, and lower than placebo in another study as add-on to a sulphonylurea.
Danish: I et klinisk studie med alogliptin givet som enkeltstofbehandling var forekomsten af hypoglykæmi på samme niveau som for placebo, og den var lavere end for placebo i et andet studie med alogliptin som tillæg til sulfonylurinstof.
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):
English: Hypersensitivity reactions, including anaphylactic reactions, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome and erythema multiforme have been observed for DPP-4 inhibitors and have been spontaneously reported for alogliptin in the post-marketing setting.
Danish: Overfølsomhedsreaktioner, herunder anafylaktiske reaktioner, angioødem og eksfoliative hudreaktioner inklusive Stevens-Johnsons syndrom og erythema multiforme, er observeret for DPP-4hæmmere og er spontant indberettet for alogliptin efter markedsføring.
English: Vipidia is not known to affect your ability to drive and use machines.
Danish: Vipidia har ingen kendt virkning på evnen til at køre bil og betjene maskiner.
English: Results from studies with metformin, pioglitazone (thiazolidinedione), voglibose (alpha-glucosidase inhibitor) and glyburide (sulphonylurea) have shown no clinically relevant pharmacokinetic interactions.
Danish: Data fra studier med metformin, pioglitazon (thiazolidindion), voglibose (alfa-glukosidasehæmmer) og glyburid (sulfonylurinstof) har ikke påvist klinisk relevante farmakokinetiske interaktioner.
English: The pharmacokinetics of alogliptin in children and adolescents < 18 years old has not been established.
Danish: Alogliptins farmakokinetik hos børn og unge under 18 år er endnu ikke klarlagt.
English: In addition, a prospective randomised cardiovascular outcomes safety study was conducted with 5,380 patients with high underlying cardiovascular risk to examine the effect of alogliptin compared with placebo (when added to standard of care) on major adverse cardiovascular events (MACE) including time to the first occurrence of any event in the composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke in patients with a recent (15 to 90 days) acute coronary event.
Danish: Endvidere blev der udført et prospektivt, randomiseret, kardiovaskulært sikkerhedsendepunktsstudie med 5.380 patienter med høj underliggende kardiovaskulær risiko for at undersøge virkningen af alogliptin sammenlignet med placebo (i tillæg til standardbehandling) på større utilsigtede kardiovaskulære hændelser (MACE), herunder tid til den første forekomst af enhver hændelse i kombinationen af kardiovaskulær død, ikke-dødeligt myokardieinfarkt og ikke-dødelig apopleksi hos patienter med en nylig (15 til 90 dage) akut koronar hændelse.
English: The highest doses of alogliptin administered in clinical studies were single doses of 800 mg to healthy subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes mellitus (equivalent to 32 times and 16 times the recommended daily dose of 25 mg alogliptin, respectively).
Danish: De højeste doser alogliptin, der er givet i kliniske studier, er enkeltdoser på 800 mg til raske forsøgspersoner og doser på 400 mg én gang dagligt i 14 dage til patienter med type 2-diabetes mellitus (svarende til henholdsvis 32 gange og 16 gange den anbefalede daglige dosis på 25 mg alogliptin).
English: No adverse effects on fertility were observed in animal studies (see section 5.3).
Danish: Der blev ikke observeret nogen indvirkning på fertiliteten i dyrestudier (se pkt.
English: In studies in vitro, alogliptin was found to be neither a substrate nor an inhibitor of key transporters associated with disposition of the active substance in the kidney: organic anion transporter-1, organic anion transporter-3 or organic cationic transporter-2 (OCT2).
Danish: In vitro-studier påviste, at alogliptin hverken er et substrat eller en hæmmer af nøgle transportører af betydning for tilstedeværelse af det aktive stof i nyrerne: organisk aniontransporter-1, organisk aniontransporter-3 og organisk kationtransporter-2 (OCT2).
English: Based on mean dialysate concentrations, approximately 7% of the active substance was removed during a 3-hour haemodialysis session.)
Danish: Vurderet ud fra de gennemsnitlige dialysatkoncentrationer blev ca. 7 % af det aktive stof fjernet i løbet af en hæmodialyse af 3 timers varighed).
English: LOCF = last observation carried forward * Non inferiority and superiority statistically demonstrated † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values
Danish: LOCF = sidste observation fremført * Non-inferioritet og superioritet statistisk bevist †Mindste kvadraters gennemsnit justeret mht. tidligere antihyperglykæmisk behandlingsstatus og baselineværdier
English: - A severe allergic reaction: skin lesions or spots on your skin that can progress to a sore surrounded by pale or red rings, blistering and/or peeling of the skin possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores (Stevens-Johnson syndrome and Erythema multiforme).
Danish: • En alvorlig allergisk reaktion: hudlæsioner eller pletter på huden, der kan udvikle sig til et sår omgivet af blege eller røde ringe, blæredannelse og/eller afskalning af huden eventuelt med symptomer som kløe, feber, generel utilpashed, smertende led, synsforstyrrelser, brændende smertefuld eller kløende øjne og sår i munden (Stevens-Johnsons syndrome og erythema multiforme).
English: Patients should be observed closely for possible liver abnormalities.
Danish: Patienterne skal observeres nøje, så mulig leverpåvirkning opdages.
English: Polychlorotrifluoroethylene (PCTFE)/polyvinyl chloride (PVC) blisters with push through aluminium lidding foil.
Danish: Blisterkort af polychlorotrifluoroethylen (PCTFE)/polyvinylchlorid (PVC) med aluminiumsfolie, som tabletterne kan trykkes ud igennem.
English: In addition, a cardiovascular outcomes study with 5,380 patients with type 2 diabetes mellitus and a recent acute coronary syndrome event was conducted with 2,701 randomised to alogliptin and 2,679 randomised to placebo.
Danish: Endvidere blev der udført et kardiovaskulært endepunktsstudie hos 5.380 patienter med type 2-diabetes mellitus og en nylig hændelse af akut koronarsyndrom; 2.701 patienter var randomiseret til alogliptin og 2.679 randomiseret til placebo.
English: Metabolism and nutrition disorders hypoglycaemia common
Danish: Metabolisme og ernæring hypoglykæmi almindelig
English: If you forget to take Vipidia
Danish: Hvis du har glemt at tage Vipidia
English: Gastrointestinal disorders abdominal pain common gastroesophageal reflux disease common diarrhoea common acute pancreatitis not known
Danish: Mave-tarm-kanalen mavesmerter almindelig gastroøsofageal reflukssygsdom almindelig diarré almindelig akut pancreatitis ikke kendt
English: If you have mildly or moderately reduced liver function, the recommended dose of Vipidia is 25 mg once a day.
Danish: Hvis du har let til moderat nedsat leverfunktion, er den anbefalede dosis Vipidia 25 mg én gang dagligt.
English: When alogliptin is used in combination with metformin and/or a thiazolidinedione, the dose of metformin and/or the thiazolidinedione should be maintained, and Vipidia administered concomitantly.
Danish: Hvis alogliptin anvendes i kombination med metformin og/eller thiazolidindion, skal dosis af metformin og/eller thiazolidindion fastholdes og Vipidia administreres samtidigt.
English: The pharmacokinetics of alogliptin has been shown to be similar in healthy subjects and in patients with type 2 diabetes mellitus.
Danish: Alogliptins farmakokinetik er vist sig at være sammenlignelig hos raske forsøgspersoner og hos patienter med type 2-diabetes mellitus.
English: The efficacy and safety of the recommended doses of alogliptin were investigated separately in a subgroup of patients with type 2 diabetes mellitus and severe renal impairment/end-stage renal disease in a placebo-controlled study (59 patients on alogliptin and 56 patients on placebo for 6 months) and found to be consistent with the profile obtained in patients with normal renal function.
Danish: Virkningen af og sikkerheden ved administration af de anbefalede doser alogliptin til en undergruppe af patienter med type 2-diabetes mellitus og svært nedsat nyrefunktion/terminalt nyresvigt blev undersøgt hver for sig i et placebokontrolleret studie (59 patienter på alogliptin og 56 patienter på placebo i 6 måneder) og fundet i overensstemmelse med profilen for patienter med normal nyrefunktion.
English: This was determined by clinically relevant and statistically significant reductions in glycosylated haemoglobin (HbA1c) and fasting plasma glucose compared to control from baseline to study endpoint.
Danish: Dette blev fastlagt på grundlag af klinisk relevante og statistisk signifikante fald i glykosyleret hæmoglobin (HbA1c) og i fasteplasmaglucose sammenlignet med kontrol fra baseline og til endepunkt.
English: In the prospective randomised controlled cardiovascular outcomes study, investigator reported events of hypoglycemia were similar in patients receiving placebo (6.5%) and patients receiving alogliptin (6.7%) in addition to standard of care.
Danish: I det prospektive, randomiserede, kontrollerede, studie med kardiovaskulære endepunkter var investigatorindberettede tilfælde af hypoglykæmi på samme niveau hos patienter, der fik placebo (6,5 %), og patienter, der fik alogliptin (6,7 %), i tillæg til standardbehandling.
English: Vipidia contains the active substance alogliptin which belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) which are “oral anti-diabetics”.
Danish: Vipidia indeholder det aktive stof alogliptin, som hører til en gruppe lægemidler, der kaldes DPP-4hæmmere (dipeptyl peptidase 4-hæmmere), som er orale antidiabetika (diabetesmedicin, der indtages gennem munden).
English: Alogliptin may be administered without regard to the timing of dialysis.
Danish: Alogliptin kan gives uafhængigt af tidspunktet for dialyse.
English: In the pooled pivotal phase 3 controlled clinical studies of alogliptin as monotherapy and as add-on combination therapy involving 5,659 patients, the observed adverse reactions are listed below (Table 1).
Danish: I de samlede analyser af de pivotale, kontrollerede kliniske fase III-studier af alogliptin som enkeltstofbehandling og som tillæg i kombinationsbehandling, som omfattede 5.659 patienter, blev der observeret de bivirkninger, som er opført nedenfor (tabel 1).
English: If an abnormality is found and an alternative etiology is not established, consider discontinuation of alogliptin treatment.
Danish: Hvis der konstateres uregelmæssigheder, og anden ætiologi kan udelukkes, bør det overvejes at afbryde behandlingen med alogliptin.
English: The recommended dose of Vipidia is 25 mg once a day.
Danish: Den anbefalede dosis Vipidia er 1 tablet (25 mg) én gang dagligt.
English: Overall, treatment with the recommended daily dose of 25 mg alogliptin improved glycaemic control when given as monotherapy and as initial or add-on combination therapy.
Danish: Samlet set forbedrede administration af den anbefalede daglige dosis på 25 mg alogliptin den glykæmiske kontrol, når stoffet blev givet som enkeltstofsbehandling og som indledende kombinationsbehandling eller tillægsbehandling.
English: A single-dose of 50 mg alogliptin was administered to 4 groups of patients with varying degrees of renal impairment (CrCl using the Cockcroft-Gault formula): mild (CrCl = > 50 to ≤ 80 mL/min), moderate (CrCl = ≥ 30 to ≤ 50 mL/min), severe (CrCl = < 30 mL/min) and end-stage renal disease on haemodialysis.
Danish: En enkelt dosis 50 mg alogliptin blev givet til 4 grupper af patienter med forskellige grader af nedsat nyrefunktion (CrCl beregnet ud fra Cockcroft-Gault-formlen): let (CrCl = > 50 til ≤ 80 ml/min), moderat (CrCl = ≥ 30 til ≤ 50 ml/min), svært (CrCl = < 30 ml/min) eller hæmodialysekrævende terminal nyresygdom.
English: Alogliptin has not been studied in combination with sodium glucose co-transporter 2 (SGLT-2) inhibitors or glucagon like peptide 1 (GLP-1) analogues nor formally as triple therapy with metformin and a sulphonylurea.
Danish: Alogliptin er ikke undersøgt i kombination med natrium/glucose-co transporter-2 (SGLT-2)-hæmmere eller glukagon-lignende peptid-1-(GLP-1)-analoger og heller ikke formelt som trestofbehandling sammen med metformin og sulfonylurinstof.
English: Other medicines and Vipidia
Danish: Brug af anden medicin sammen med Vipidia
English: What you need to know before you take Vipidia
Danish: Det skal du vide, før du begynder at tage Vipidia
English: In the cardiovascular outcomes study the rates of pancreatitis reports in patients treated with alogliptin or placebo were 3 or 2 events per 1,000 patient years, respectively.
Danish: I studiet med kardiovaskulære endepunkter var hyppigheden af pancreatitis hos patienter, der blev behandlet med alogliptin eller placebo, henholdsvis 3 og 2 hændelser pr. 1.000 patientår.
English: Hypromellose Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Macrogol 8000
Danish: Hypromellose Titandioxid (E171) Rød jernoxid (E172) Gul jernoxid (E172) Macrogol 8000
English: There is no experience of using Vipidia in pregnant women or during breast-feeding.
Danish: Der er ingen erfaring med brug af Vipidia til gravide eller ammende kvinder.
English: (-infinity, 0.059)
Danish: (-uendelig, 0,059)
English: Postmarketing reports of hepatic dysfunction including hepatic failure have been received.
Danish: Der er modtaget indberetninger efter markedsføring om leverpåvirkning, herunder leversvigt.
English: LOCF = last observation carried forward † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values * p<0.001 compared to placebo or placebo+combination treatment
Danish: LOCF (last observation carried forward) = sidste observation ekstrapoleret † Gennemsnit beregnet ved mindste kvadraters metode justeret mht. tidligere antihyperglykæmisk behandlingsstatus og baselineværdier * p < 0,001 sammenlignet med placebo eller placebo + kombinationsbehandling
English: Therefore, in order to maintain systemic exposures to alogliptin that are similar to those observed in patients with normal renal function, lower doses of alogliptin should be used in patients with moderate or severe renal impairment, or end-stage renal disease requiring dialysis (see section 4.2).
Danish: For at opretholde en systemisk eksponering for alogliptin svarende til den, der er observeret hos patienter med normal nyrefunktion, bør der derfor gives lavere doser alogliptin til patienter med moderat til svært nedsat nyrefunktion eller dialysekrævende terminalnyresygdom (se pkt.
English: Animal studies have shown excretion of alogliptin in milk (see section 5.3).
Danish: Dyrestudier har vist, at alogliptin udskilles i mælk (se pkt.
English: 10 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 60 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets 100 film-coated tablets
Danish: 10 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 56 filmovertrukne tabletter 60 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 98 filmovertrukne tabletter 100 filmovertrukne tabletter
English: Higher rates of hypoglycaemia were observed with triple therapy with thiazolidinedione and metformin and in combination with insulin, as observed with other DPP-4 inhibitors.
Danish: Der blev observeret en hyppigere forekomst af hypoglykæmi ved trestofbehandling med thiazolidindion og metformin og i kombination med insulin, ligesom det er tilfældet med andre DPP4-hæmmere.
English: Minimal quantities of alogliptin are removed by haemodialysis (approximately 7% of the substance was removed during a 3-hour haemodialysis session).
Danish: Kun meget små mængder alogliptin kan fjernes ved hæmodialyse (ca. 7 % af stoffet blev fjernet i løbet af en tretimers-hæmodialysebehandling).
English: Administration of 25 mg alogliptin to patients with type 2 diabetes mellitus produced peak inhibition of DPP-4 within 1 to 2 hours and exceeded 93% both after a single 25 mg dose and after 14 days of once-daily dosing.
Danish: Administration af 25 mg alogliptin til patienter med type 2-diabetes mellitus medførte maksimal hæmning af DPP-4 efter 1 - 2 timer, og hæmningsgraden var på mere end 93 %, både efter administration af en enkeltdosis på 25 mg og efter administration af samme dosis én gang dagligt i 14 dage.
English: Importantly, despite alogliptin and glipizide having similar HbA1c and fasting plasma glucose changes from baseline, episodes of hypoglycaemia were notably less frequent in patients receiving 25 mg alogliptin (5.4%) compared to those receiving glipizide (26.0%).
Danish: Det er vigtigt at understrege, at selvom alogliptin og glipizid gav de samme ændringer i HbA1c og fasteplasmaglucose i forhold til baseline, var hypoglykæmiske episoder markant mindre hyppige hos patienter, der fik 25 mg alogliptin (5,4 %), end hos patienter, der fik glipizid (26,0 %).
English: However patients should be alerted to the risk of hypoglycaemia especially when combined with a sulphonylurea, insulin or combination therapy with thiazolidinedione plus metformin.
Danish: Patienter bør dog advares om risikoen for hypoglykæmi, især hvis Vipidia bruges i kombination med sulfonylurinstof eller insulin eller i kombinationsbehandling med thiazolidindion og metformin.
English: No adverse effects of alogliptin were observed upon fertility, reproductive performance, or early embryonic development in rats up to a systemic exposure far above the human exposure at the recommended dose.
Danish: Der blev ikke observeret bivirkninger af alogliptin, hvad angår fertilitet, reproduktionsevne eller tidlig embryonal udvikling hos rotter, op til en systemisk eksponering, som var langt højere end den humane eksponering ved den anbefalede dosis.
English: It must be taken together with other anti-diabetic medicines, which your doctor will have prescribed for you, such as sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide), metformin and/or thiazolidinediones (e.g. pioglitazone) and metformin and/or insulin.
Danish: Det skal tages sammen med anden diabetesmedicin, som din læge har ordineret til dig, såsom sulfonylurinstof (f.eks. glipizid, tolbutamid og glibenclamid), metformin og/eller thiazolidindioner (f.eks. pioglitazon) og metformin og/eller insulin.