FrancophonIA/ELRC3.0 huggingface dataset:
English: Therapy with Incresync should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 x upper limit of normal) or with any other evidence of liver disease.
Danish: Behandling med Incresync bør ikke igangsættes hos patienter med forhøjede leverenzymtal (ALAT > 2,5 x øvre normalgrænse) eller med ethvert andet tegn på leversygdom.
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: Incresync is used to lower blood sugar levels in adults with type 2 diabetes.
Danish: Incresync sænker blodsukkeret hos voksne med type 2-diabetes.
English: Cardiovascular Safety
Danish: Kardiovaskulær sikkerhed
English: As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation.
Danish: Som en konsekvens af forøget insulinvirkning kan behandling med pioglitazon, hos patienter med polycystisk ovariesyndrom, resultere i en fornyet ovulation.
English: - if you have or have had a disease of the pancreas.
Danish: - hvis du har eller har haft sygdom i bugspytkirtlen.
English: Alogliptin is a potent and highly selective inhibitor of DPP-4, >10,000-fold more selective for DPP-4 than other related enzymes including DPP-8 and DPP-9.
Danish: Alogliptin er en potent og stærkt selektiv DPP-4-hæmmer, som er over 10.000 gange mere selektiv over for DPP-4 end over for andre beslægtede enzymer, herunder DPP-8 og DPP-9.
English: Higher doses of alogliptin decreased offspring body weight and exerted some developmental effects considered secondary to the low body weight.
Danish: Højere doser alogliptin medførte en lavere kropsvægt hos afkommet og havde en vis indvirkning på afkommets udvikling, som blev betragtet som en sekundær effekt af den lave kropsvægt.
English: What Incresync contains - The active substances are alogliptin and pioglitazone.
Danish: Incresync indeholder: - Aktive stoffer: alogliptin og pioglitazon.
English: Liver enzymes should be checked prior to the initiation of therapy in all patients.
Danish: Leverenzymerne bør kontrolleres forud for igangsættelse af en behandling med Incresync hos alle patienter.
English: Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Danish: Selvom studiet ikke indfriede sit primære endepunkt, der var en sammensætning af mortalitet uanset årsag, ikke-dødeligt myokardieinfarkt, apopleksi, akut koronarsyndrom, større benamputation, koronar revaskularisering og revaskularisering i benene, tyder resultaterne på, at der ikke er langtids-kardiovaskulære følgevirkninger ved brug af pioglitazon.
English: (1-sided CI)
Danish: (en-sidet KI)
English: The average renal clearance of alogliptin (170 mL/min) was greater than the average estimated glomerular filtration rate (approx. 120 mL/min), suggesting some active renal excretion.
Danish: Den gennemsnitlige renale clearance af alogliptin (170 ml/min) var højere end den gennemsnitlige anslåede glomerulære filtrationshastighed (ca. 120 ml/min), hvilket indikerer nogen aktivitet i renal udskillelse.
English: When the 4-hour postprandial glucose concentrations were averaged across breakfast, lunch and dinner, 14 days of treatment with 25 mg alogliptin resulted in a mean placebo-corrected reduction from baseline of -35.2 mg/dL.
Danish: Når gennemsnittet af de 4-timers postprandiale glucosekoncentrationer ved morgenmad, frokost og aftensmad blev beregnet, resulterede en 14-dages-behandling med 25 mg alogliptin i en placebokorrigeret gennemsnitlig reduktion i forhold til baseline på -35,2 mg/dl.
English: If ALT levels remain > 3 x the upper limit of normal, therapy should be discontinued.
Danish: Hvis ALAT-niveauerne forbliver højere end 3 gange den øvre normale grænse, bør behandlingen afbrydes.
English: However, as the distribution of AUC values for alogliptin in these patients was within the same range as control subjects, no dose adjustment of alogliptin for patients with mild renal impairment is necessary (see section 4.2).
Danish: Da fordelingen af AUC-værdier for alogliptin hos disse patienter imidlertid var inden for det samme interval som for kontrolpersonerne, er justering af alogliptindosis ikke nødvendig hos patienter med let nedsat nyrefunktion (se pkt.
English: Combination of alogliptin with other anti-diabetic medicinal products
Danish: Kombineret anvendelse af alogliptin og andre antidiabetiske lægemidler
English: When treating patients who have at least one risk factor for development of congestive heart failure (e.g. prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians should start pioglitazone therapy with the lowest available dose and increase the dose gradually.
Danish: Ved behandling af patienter, der har mindst én risikofaktor for udvikling af hjerteinsufficiens (f.eks. tidligere hjerteinfarkt eller symptomgivende koronararteriesygdom eller ældre patienter), bør lægen starte med den lavest tilgængelige dosis, som derefter øges gradvist.
English: In addition, Incresync can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type 2 diabetes mellitus already being treated with this combination.
Danish: Incresync kan desuden benyttes til at erstatte separate tabletter med alogliptin og pioglitazon hos voksne patienter på 18 år eller der over med type 2-diabetes mellitus, som allerede er i behandling med denne kombination.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Incresync in all 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 dispenseret fra kravet om at fremlægge resultaterne af studier med Incresync i alle undergrupper af den pædiatriske population med type 2-diabetes mellitus (se pkt.
English: Similar changes in body fat distribution on pioglitazone have been accompanied by an improvement in insulin sensitivity.
Danish: Lignende ændringer i fordelingen af kropsfedt ved behandling med pioglitazon har været fulgt af en forbedret insulinfølsomhed.
English: Pack sizes of 10, 14, 28, 30, 56, 60, 90, 98 or 100 film-coated tablets.
Danish: Pakninger med 10, 14, 28, 30, 56, 60, 90, 98 eller 100 filmovertrukne tabletter.
English: Acute pancreatitis is a serious adverse reaction and is attributed to the alogliptin component of Incresync (see section 4.4).
Danish: Akut pancreatitis er en alvorlig bivirkning og tilskrives alogliptin-komponenten i Incresync (se pkt.
English: In these studies, 312 alogliptin/pioglitazone-treated patients were ≥ 65 years old.
Danish: I disse studier var 312 af de patienter, der blev behandlet med alogliptin/pioglitazon, i alderen 65 år eller derover.
English: Both of these groups of medicines are “oral anti-diabetics”.
Danish: Begge disse grupper af lægemidler er såkaldte orale antidiabetika (diabetesmedicin til at indtage gennem munden).
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: Use with other antihyperglycaemic medicinal products and hypoglycaemia
Danish: Brug sammen med andre antihyperglykæmiske lægemidler og i forbindelse med hypoglykæmi
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 daily 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: Caution should be exercised in patients with a history of pancreatitis.
Danish: Der skal udvises forsigtighed hos patienter, der har pancreatitis i anamnesen.
English: Skin and subcutaneous tissue disorders pruritus common common rash common exfoliative skin conditions including StevensJohnson syndrome not known erythema multiforme not known angioedema not known urticaria not known
Danish: Hud og subkutane væv pruritus almindelig almindelig udslæt almindelig eksfoliative hudsygdomme, herunder Stevens-Johnsons syndrom ikke kendt erythema multiforme ikke kendt angioødem ikke kendt urticaria ikke kendt
English: Patients should be observed for signs and symptoms of heart failure, weight gain and oedema when pioglitazone is used in combination with insulin.
Danish: Patienter skal observeres for tegn og symptomer på hjerteinsufficiens, vægtøgning og ødem, når pioglitazon bruges i kombination med insulin.
English: In clinical studies of alogliptin, anaphylactic reactions were reported with a low incidence.
Danish: I kliniske studier med alogliptin blev anafylaktiske reaktioner indberettet med lav forekomst.
English: The decision whether to continue the patient on therapy with Incresync should be guided by clinical judgement pending laboratory evaluations.
Danish: Beslutningen om, hvorvidt patienten skal fortsætte med behandling med Incresync, bør afhænge af en løbende klinisk bedømmelse, indtil laboratorieværdierne foreligger.
English: It is not known if alogliptin is removed by peritoneal dialysis.
Danish: Det er ukendt, om alogliptin kan fjernes med peritonealdialyse.
English: In the alogliptin group, 12.7% (344 subjects) experienced an event within the secondary MACE composite endpoint, compared with 13.4% (359 subjects) in the placebo group [Hazard Ratio = 0.95; 1-sided 99% Confidence Interval: 0-1.14].
Danish: I alogliptin-gruppen oplevede 12,7 % (344 forsøgspersoner) en hændelse inden for det sekundære, sammensatte MACE-endepunkt, sammenlignet med 13,4 % (359 forsøgspersoner) i placebogruppen [hazard ratio = 0,95; en-sidet 99 % konfidensinterval: 0-1,14].
English: Steady-state pharmacokinetics is similar in patients aged 65 years and over and young subjects (see section 4.2).
Danish: Steady state-farmakokinetikken er ens hos patienter på 65 år og derover og unge forsøgspersoner (se pkt.
English: Effects of alogliptin on other medicinal products
Danish: Alogliptins indvirkning på andre lægemidler
English: Any macroscopic haematuria should be investigated before starting therapy.
Danish: Eventuel makroskopisk hæmaturi skal undersøges, inden behandlingen påbegyndes.
English: Generally, the effects of alogliptin on body weight and lipids were neutral.
Danish: Generelt havde alogliptin neutral effekt på kropsvægt og lipidkoncentration.
English: Risk related to pioglitazone
Danish: Risiko relateret til pioglitazon
English: In vitro studies suggest that alogliptin does not inhibit nor induce CYP 450 isoforms at concentrations achieved with the recommended dose of 25 mg alogliptin (see section 5.2).
Danish: In vitro-studier indikerer, at alogliptin hverken hæmmer eller inducerer CYP 450-isoformer ved de koncentrationer, der opstår ved den anbefalede dosis på 25 mg alogliptin (se pkt.
English: Alogliptin therefore improves glycaemic control via a glucose-dependent mechanism, whereby insulin release is enhanced and glucagon levels are suppressed when glucose levels are high.
Danish: Alogliptin forbedrer således den glykæmiske kontrol via en glucoseafhængig mekanisme, hvorved insulinfrigivelsen øges og glukagonmængden nedsættes, når glucosekoncentrationen er høj.
English: It is unclear whether or not there is a direct association between pioglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients on Incresync report disturbances in visual acuity; an appropriate ophthalmological referral should be considered.
Danish: Selvom det er uklart, om der er en direkte sammenhæng mellem pioglitazon og makulaødem, tilrådes læger at være opmærksomme på muligheden for makulaødem, hvis der for patienter, der tager Incresync, indberettes forstyrrelser i synsskarpheden.
English: In case of kidney disease, your doctor may reduce the dose of Incresync.
Danish: Hvis du har en nyresygdom, vil din læge muligvis nedsætte dosen af Incresync.
English: Incresync is taken when your blood sugar cannot be adequately controlled by diet, exercise and other oral anti-diabetic medicines such as pioglitazone; or pioglitazone and metformin taken together.
Danish: Du kan tage Incresync, hvis dit blodsukker ikke kan styres godt nok gennem kost, motion og andre orale antidiabetika såsom pioglitazon eller pioglitazon og metformin taget samtidigt.
English: If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked.
Danish: Enhver patient, der udvikler symptomer, der tyder på nedsat leverfunktion (disse kan omfatte uforklarlig kvalme, opkastninger, abdominalsmerter, træthed, anoreksi og/eller mørk urin), bør leverenzymerne tjekkes.
English: The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week study in type 2 diabetics.
Danish: Effekten af pioglitazon (45 mg monoterapi versus placebo) er undersøgt i et mindre 18-ugers klinisk studie af type 2-diabetikere.
English: Frequency of adverse reactions Alogliptin Pioglitazone Incresync
Danish: Bivirkningernes hyppighed Alogliptin Pioglitazon Incresync
English: - if you have a problem with your liver or kidneys.
Danish: - hvis du har problemer med lever eller nyrer.
English: What you need to know before you take Incresync
Danish: Det skal du vide, før du begynder at tage Incresync
English: Administration with a high-fat meal resulted in no change in total and peak exposure to alogliptin.
Danish: Administration sammen med et fedtholdigt måltid resulterede ikke i ændringer i den samlede og den højeste eksponering for alogliptin.
English: Following initiation of therapy with Incresync, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
Danish: Efter igangsættelse af behandling med Incresync anbefales det, at leverenzymniveauet monitoreres med jævne mellemrum baseret på en klinisk vurdering.
English: Appropriate assessment of renal function is recommended prior to initiation of Incresync and periodically thereafter (see section 4.4).
Danish: Det anbefales, at nyrefunktionen vurderes tilstrækkeligt inden igangsættelse af behandlingen med Incresync og regelmæssigt herefter (se pkt.
English: There is no induction of the main inducible P450 isoenzymes 1A, 2C8/9 and 3A4 in man.
Danish: Der sker ingen induktion af de vigtigste inducerbare P450-isoenzymer, 1A, 2C8/9 og 3A4, hos mennesket.
English: In a pre- and postnatal development study in rats, exposures far above the human exposure at the recommended dose did not harm the developing embryo or affect offspring growth and development.
Danish: I et studie af den prænatale og postnatale udvikling hos rotter blev disse udsat for eksponeringer, som var langt højere end den humane eksponering ved den anbefalede dosis, men dette skadede ikke den embryonale udvikling og påvirkede heller ikke afkommets vækst og udvikling.
English: In vitro studies indicate that alogliptin does not induce CYP1A2, CYP2B6 and CYP2C9 and does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 at concentrations achieved with the recommended dose of 25 mg alogliptin.
Danish: Data fra in vitro-studier indikerer, at alogliptin ikke inducerer CYP1A2, CYP2B6 og CYP2C9 og ikke hæmmer CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 eller CYP3A4 ved koncentrationer, der er opnået ved den anbefalede dosis på 25 mg alogliptin.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere information om Incresync findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Studies in animal models of diabetes showed that concomitant treatment with alogliptin and pioglitazone produced both additive and synergistic improvements in glycaemic control, increased pancreatic insulin content and normalised pancreatic beta-cell distribution.
Danish: Studier med dyremodeller for diabetes har vist, at samtidig behandling med alogliptin og pioglitazon giver både additive og synergistiske forbedringer i den glykæmiske kontrol, øget insulinindhold i pancreas og normaliseret betacellefordeling i pancreas.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Incresync therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Incresync seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: The (S)-enantiomer is not detectable at therapeutic doses.
Danish: (S)-enantiomeren kan ikke måles ved terapeutiske doser.
English: Other reactions such as upper respiratory tract infections, sinusitis, headache, hypoglycaemia, nausea, weight increase and oedema may occur commonly (≥ 1/100 to
Danish: Andre bivirkninger såsom infektioner i de øvre luftveje, sinusitis, hovedpine, hypoglykæmi, kvalme, vægtstigning og ødem kan forekomme almindeligt (≥ 1/100 til < 1/10).
English: Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea.
Danish: Samtidig administration af pioglitazon og sulfonylurinstoffer synes ikke at påvirke sulfonylurinstoffernes farmakokinetik.
English: • as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance.
Danish: • som supplement til diæt og motion med det formål at forbedre den glykæmiske kontrol hos voksne patienter (specielt overvægtige patienter), der er utilstrækkeligt reguleret med pioglitazon alene, og for hvem metformin ikke er velegnet på grund af kontraindikationer eller intolerans.
English: For patients intolerant to metformin or for whom metformin is contraindicated, inadequately controlled on pioglitazone alone, the recommended dose of Incresync is one tablet of 25 mg/30 mg or 25 mg/45 mg once daily, depending on the dose of pioglitazone already being taken.
Danish: For patienter, som ikke tåler metformin, eller for hvem metformin er kontraindiceret, og som er utilstrækkeligt reguleret med pioglitazon alene, er den anbefalede dosis Incresync én tablet a 25 mg/30 mg eller 25 mg/45 mg én gang dagligt, afhængigt af hvilken dosis pioglitazon der allerede tages.
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 involverede transportere af betydning for tilstedeværelse af det aktive stof i nyrerne: organisk aniontransporter-1, organisk aniontransporter-3 og organisk kationtransporter-2 (OCT2).
English: Total and peak exposure to alogliptin increased proportionately across single doses of 6.25 mg up to 100 mg alogliptin (covering the therapeutic dose range).
Danish: Den samlede og den højeste eksponering for alogliptin steg proportionalt ved stigende enkeltdoser fra 6,25 mg og op til 100 mg alogliptin (dækkende det terapeutiske dosisinterval).
English: Due to the increased risk of hypoglycaemia in combination with metformin, a lower dose of metformin or the pioglitazone component may be considered to reduce the risk of hypoglycaemia when this combination is used (see section 4.2).
Danish: På grund af den øgede risiko for hypoglykæmi ved kombinationsbehandling med metformin kan en lavere dosis af metformin- eller pioglitazon-komponenten overvejes for at mindske risikoen for hypoglykæmi, når denne kombination anvendes (se pkt.
English: What Incresync is Incresync contains two different medicines called alogliptin and pioglitazone in one tablet:
Danish: Hvad Incresync er Incresync indeholder to forskellige lægemidler, alogliptin og pioglitazon, i én tablet:
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, har været enkeltdoser a 800 mg til raske forsøgspersoner og doser på 400 mg én gang dagligt i 14 dage til patienter med type 2-diabetes mellitus (dette svarer til henholdsvis 32 og 16 gange den anbefalede daglige dosis på 25 mg alogliptin).
English: Close monitoring of glycaemic control should be considered (see section 4.4).
Danish: Nøje overvågning af den glykæmiske regulering bør overvejes (se pkt.
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 sikkerhedsendepunktstudie 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: In PROactive, a cardiovascular outcome study, 5,238 patients with type 2 diabetes mellitus and pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing anti-diabetic and cardiovascular therapy, for up to 3.5 years.
Danish: I PROactive, et studie med kardiovaskulære endepunkter, blev 5.238 patienter med type 2-diabetes mellitus og betydende makrovaskulær sygdom randomiseret til pioglitazon eller placebo i tillæg til eksisterende antidiabetisk og kardiovaskulær behandling i op til 3,5 år.
English: See leaflet for further information.
Danish: Indlægssedlen indeholder yderligere information.
English: In patients with renal impairment, serum concentrations of pioglitazone and its metabolites are lower than those seen in subjects with normal renal function, but oral clearance of parent substance is similar.
Danish: Hos patienter med nedsat nyrefunktion er plasmakoncentrationerne af pioglitazon og dets metabolitter lavere end dem, der ses hos forsøgspersoner med normal nyrefunktion, men den orale clearance af moderstoffet er den samme.