FrancophonIA/ELRC3.0 huggingface dataset:
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Incresync, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Do not take Incresync: - if you are allergic to alogliptin, pioglitazone or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Incresync: - hvis du er allergisk over for alogliptin, pioglitazon eller et af de øvrige indholdsstoffer i Incresync (angivet i punkt 6).
English: - if you have cysts on your ovaries (polycystic ovarian syndrome).
Danish: - hvis du har cyster på æggestokkene (polycystisk ovariesyndrom).
English: The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
Danish: Den højeste rapporterede dosis på 120 mg om dagen i fire dage og derefter 180 mg om dagen i syv dage medførte ikke nogen symptomer.
English: Patients should be advised to adhere strictly to a calorie-controlled diet.
Danish: Patienter bør rådes til nøje at overholde en kaloriekontrolleret diæt.
English: Incresync should not be used in patients with type 1 diabetes mellitus.
Danish: Incresync må ikke gives til patienter med type 1-diabetes mellitus.
English: Change at Week 52 (n=303)
Danish: Ændring i uge 52 (n =
English: No alogliptin-related effects were observed in juvenile rats following repeat-dose administration for 4 and 8 weeks.
Danish: Ingen alogliptin-relaterede virkninger blev observeret hos unge rotter efter gentagne doseringer i 4 og 8 uger.
English: Interaction with substrates of CYP 450 isoforms are thus not expected and have not been shown.
Danish: Interaktion med substrater af CYP 450-isoformer er derfor ikke forventet og er ikke påvist.
English: Immune system disorders hypersensitivity not known hypersensitivity and allergic reactions not known
Danish: Immunsystemet overfølsomhed ikke kendt overfølsomhed og allergiske reaktioner ikke kendt
English: • Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure).
Danish: • Forsigtighed ved brug hos ældre i lyset af aldersbetingede risici (især blærecancer, knoglebrud og hjerteinsufficiens).
English: Incresync should not be used during pregnancy.
Danish: Incresync må ikke anvendes under graviditet.
English: The mean serum elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Danish: Den gennemsnitlige serumhalveringstid for uomdannet pioglitazon er hos mennesket 5-6 timer og for dets samlede, aktive metabolitter 16-23 timer.
English: Manufacturer Takeda Ireland Limited Bray Business Park Kilruddery
Danish: Fremstiller Takeda Ireland Limited Bray Business Park Kilruddery
English: Alogliptin does not undergo extensive metabolism, 60-70% of the dose is excreted as unchanged active substance in the urine.
Danish: Alogliptin gennemgår ikke en omfattende metabolisering; 60-70 % af en dosis udskilles i urinen som uomdannet aktivt stof.
English: Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Danish: Brugen af DPP-4-hæmmere er sat i forbindelse med en risiko for udvikling af akut pancreatitis.
English: Incresync is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Danish: Incresync anbefales ikke til børn og unge under 18 år, da der ikke foreligger tilstrækkelige data for denne aldersgruppe.
English: Your blood sugar levels may increase when you stop taking Incresync.
Danish: Dit blodsukker kan blive højere, når du holder op med at tage Incresync.
English: Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers and HMGCoA reductase inhibitors, are not to be expected.
Danish: Interaktion med stoffer, der omsættes af disse enzymer, f.eks. orale kontraceptiva, ciclosporin, calciumkanalblokkere og HMGCoA-reduktasehæmmere, kan ikke forventes.
English: Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Danish: Efter oral administration af radioaktivt mærket pioglitazon hos mennesker genfandtes den mærkede del hovedsagelig i fæces (55 %) og i en mindre mængde i urin (45 %).
English: Elimination Alogliptin was eliminated with a mean terminal half-life (T1/2) of approximately 21 hours.
Danish: Elimination Alogliptin blev elimineret med en gennemsnitlig terminal halveringstid (T1/2) på ca. 21 timer.
English: Furthermore, clinical data do not suggest interaction with p-glycoprotein inhibitors or substrates.
Danish: Endvidere antyder de kliniske data ingen interaktion med p-glykoproteinhæmmere eller -substrater.
English: This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level.
Danish: Informationsmaterialet har til formål at skærpe opmærksomheden omkring vigtige identificerede risici for blærecancer og hjerteinsufficiens, og de overordnede anbefalinger har til formål at optimere riskbenefit-balancen på patientniveau.
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and toxicology.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi og toksicitet.
English: The physician educational pack should contain:
Danish: Informationsmaterialet til lægen bør omfatte:
English: Placental transfer of alogliptin occurs in rats.
Danish: Placentaoverførsel af alogliptin er set hos rotter.
English: Adults (≥ 18 years old) The dose should be individualised on the basis of the patient's current treatment regimen
Danish: Voksne (≥ 18 år) Dosis skal tilpasses den enkelte patient ud fra dennes aktuelle behandling.
English: Time-dependency
Danish: Tidsafhængighed
English: Total exposure (AUC(0-inf)) to alogliptin following administration of a single dose was similar to exposure during one dose interval (AUC(0-24)) after 6 days of once daily dosing.
Danish: Den samlede eksponering (AUC(0-inf)) for alogliptin efter administration af en enkeltdosis svarede til eksponeringen i løbet af et dosisinterval (AUC(0-24)) efter 6 dage med administration én gang dagligt.
English: Pioglitazone or placebo was added to existing anti-diabetic and cardiovascular therapy for up to 3.5 years.
Danish: Behandling med pioglitazon eller placebo blev tilføjet til en eksisterende antidiabetisk og kardiovaskulær behandling i op til 3,5 år.
English: The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.
Danish: De indberettede tilfælde med ødemer var generelt lette til moderate og krævede sædvanligvis ikke afbrydelse af behandling.
English: If you stop taking Incresync
Danish: Hvis du holder op med at tage Incresync
English: Minimal to mild simple transitional cell hyperplasia was seen in the urinary bladder of male rats at the lowest dose used (27 times the human exposure) without establishment of a clear NOEL (no observed effect level).
Danish: Minimal til let simpel overgangsepitelhyperplasi sås i blæren hos hanrotter ved den laveste anvendte dosis (27 gange større end den humane eksponering), uden at et klart NOEL (niveau uden observeret effekt) blev fastlagt.
English: In particular tell your doctor or pharmacist if you are taking any of the following: - gemfibrozil (used to lower cholesterol) - rifampicin (used to treat tuberculosis and other infections)
Danish: Det er især vigtigt, at du fortæller det til lægen, hvis du i forvejen tager et af disse lægemidler: - gemfibrozil (bruges til at sænke kolesterol) - rifampicin (bruges til at behandle tuberkulose og andre infektionssygdomme).
English: In the event of an overdose, appropriate supportive measures should be employed as dictated by the patient's clinical status.
Danish: I tilfælde af overdosering skal der gives tilstrækkelig understøttende behandling, der afhænger af patientens kliniske status.
English: Interactions with CYP inhibitors are thus not expected and have not been shown.
Danish: Interaktion med CYP-hæmmere forventes derfor ikke og er ikke påvist.
English: In light of age-related risks (especially bladder cancer, fractures and heart failure associated with the pioglitazone component), the balance of benefits and risks should be considered carefully both before and during Incresync treatment in the elderly.
Danish: Set i lyset af de aldersrelaterede risici (især blærecancer, frakturer og hjerteinsufficiens relateret til pioglitazonkomponenten) bør forholdet mellem fordele og risici overvejes nøje både før og under behandling af ældre personer med Incresync.
English: No environmental impact is anticipated from the clinical use of pioglitazone.
Danish: Der forventes ingen virkninger på miljøet ved klinisk anvendelse af pioglitazon.
English: ATC code: A10BD09.
Danish: af orale blodglucosesænkende midler, ATC-kode: A10BD09.
English: If jaundice is observed, the medicinal product should be discontinued.
Danish: Hvis der observeres gulsot, bør behandlingen med lægemidlet afbrydes.
English: In healthy subjects, alogliptin had no effect on prothrombin time or International Normalised Ratio (INR) when administered concomitantly with warfarin.
Danish: Hos raske forsøgspersoner havde alogliptin ingen indvirkning på prothrombin-tid eller International Normalised Ratio (INR), når det blev administreret samtidigt med warfarin.
English: Taking Incresync in combination with other anti-diabetic medicines can cause low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines.
Danish: Hvis du tager Incresync samtidig med anden diabetesmedicin, kan du få for lavt blodsukker (hypoglykæmi), hvilket kan påvirke din evne til at køre bil og betjene maskiner.
English: Common (may affect up to 1 in 10 people): - Sudden and severe bone pain or immobility (particularly in women).
Danish: Almindelige bivirkninger (forekommer hos op til 1 ud af 10 personer): - Pludselige og stærke knoglesmerter eller ubevægelighed (særligt hos kvinder).
English: In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
Danish: I kliniske studier har patienter taget pioglitazon i højere doser end den anbefalede maksimale dosis på 45 mg dagligt.
English: Studies in lactating rats indicate that alogliptin is excreted in milk.
Danish: Studier af diegivende rotter tyder på, at alogliptin udskilles i mælken.
English: It is recommended that you carry some sugar lumps, sweets,
Danish: Det anbefales, at du altid medbringer lidt sukkerknalder, slik, kiks eller sukkerholdig frugtjuice.
English: After initiation of therapy with Incresync, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c).
Danish: 3 til 6 måneder efter påbegyndelsen af behandlingen med Incresync skal patienten tilses, så det kan vurderes, om behandlingen har tilstrækkelig effekt (f.eks. fald i HbA1c).
English: Visceral fat was significantly decreased while there was an increase in extra-abdominal fat mass.
Danish: Mængden af visceralt fedtvæv blev signifikant reduceret, mens der sås en stigning i den ekstraabdominale fedtmasse.
English: It is unknown whether alogliptin and pioglitazone are excreted in human milk.
Danish: Det er ukendt, om alogliptin og pioglitazon bliver udskilt i human mælk.
English: Incresync should be discontinued if any deterioration in cardiac status occurs.
Danish: Behandling med Incresync bør afbrydes, hvis der opstår en forværring i hjertestatus.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 September 2013
Danish: Dato for første markedsføringstilladelse: 19. september 2013 Dato for seneste fornyelse:
English: In an animal model of familial adenomatous polyposis, treatment with two other thiazolidinediones increased tumour multiplicity in the colon.
Danish: I en dyremodel af familiær adenomatøs polypose behandlet med to andre thiazolidindioner øgedes tumormangfoldigheden i kolon.
English: Alogliptin exists predominantly as the (R)-enantiomer (> 99%) and undergoes little or no chiral conversion in vivo to the (S)-enantiomer.
Danish: Alogliptin findes primært som (R)-enantiomeren (> 99 %) og gennemgår ingen eller kun meget begrænset kiral konvertering til (S)-enantiomeren in vivo.
English: Patients should be alerted to the risk of hypoglycaemia when Incresync is used in combination with other anti-diabetic medicinal products known to cause hypoglycaemia.
Danish: Patienterne bør dog advares om risikoen for hypoglykæmi, hvis Incresync bruges i kombination med andre antidiabetiske lægemidler, som kan forårsage hypoglykæmi.
English: However, the incidences of oedema, weight gain and heart failure were increased.
Danish: Forekomsten af ødemer, vægtforøgelse og hjertesvigt var dog øget.
English: Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical studies.
Danish: Der er indberettet ødemer hos 6-9 % af de patienter, der blev behandlet over 1 år med pioglitazon i kontrollerede kliniske studier.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Takeda
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Takeda
English: (-infinity, -0.28)
Danish: (-uendelig, -0,35) (-uendelig, -0,28)
English: Risk factors for bladder cancer should be assessed before initiating Incresync treatment (risks include age, smoking history, exposure to some occupational or chemotherapy medicinal products e.g. cyclophosphamide or prior radiation treatment in the pelvic region).
Danish: Risikofaktorer, der er relateret til blærecancer, skal vurderes inden igangsættelsen af behandling med Incresync (disse risici omfatter alder, rygehistorik, eksponering for visse arbejdsrelaterede stoffer eller kemoterapeutiske lægemidler, f.eks. cyclofosfamid, eller tidligere strålebehandling af bækkenregionen).
English: No data are available with regard to overdose of Incresync.
Danish: Der findes ingen data om overdosering af Incresync.
English: In case of hypoglycaemia, a lower dose of the thiazolidinedione or metformin may be considered.
Danish: I tilfælde af hypoglykæmi kan en lavere thiazolidindion- eller metformin-dosis overvejes.
English: - pioglitazone belongs to a group of medicines called thiazolidinediones.
Danish: - pioglitazon tilhører en gruppe af lægemidler, der kaldes thiazolidindioner.
English: Before you start taking this medicine you will have a blood sample taken to check your liver and kidney function.
Danish: Før du begynder at tage Incresync, vil du få taget en blodprøve til kontrol af lever- og nyrefunktion.
English: Alogliptin works to increase the levels of insulin in the body after a meal and decrease the amount of sugar in the body.
Danish: Alogliptin virker ved at øge insulinniveauet i kroppen efter et måltid og sænke mængden af sukker i kroppen.
English: If you forget to take Incresync
Danish: Hvis du har glemt at tage Incresync
English: Following oral administration, pioglitazone is rapidly absorbed and peak serum concentrations of unchanged pioglitazone are usually achieved 2 hours after administration.
Danish: Pioglitazon absorberes hurtigt efter oral indgivelse, og maksimale serumkoncentrationer af uomdannet pioglitazon opnås som regel 2 timer efter administration.
English: Incresync is not a substitute for insulin in insulin-requiring patients.
Danish: Incresync kan ikke erstatte insulin hos patienter med insulinkrævende diabetes.
English: Following administration of an oral dose of [14C] alogliptin, 76% of total radioactivity was eliminated in the urine and 13% was recovered in the faeces.
Danish: Efter administration af en oral dosis [14C]-alogliptin blev 76 % af den samlede radioaktivitet udskilt i urinen, og 13 % blev udskilt i fæces.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyrestudie indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår reproduktionstoksicitet (se pkt.
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: If you are already taking both alogliptin and pioglitazone as single tablets, Incresync can replace them in one tablet.
Danish: Hvis du allerede tager både alogliptin og pioglitazon som separate tabletter, kan Incresync erstatte dem begge.
English: (Patients with end-stage renal disease underwent haemodialysis immediately after alogliptin dosing.
Danish: (Patienter med terminal nyresygdom fik hæmodialyse umiddelbart efter dosis med alogliptin.
English: In vitro data indicate that CYP2D6 and CYP3A4 contribute to the limited metabolism of alogliptin.
Danish: In vitro-data indikerer, at CYP2D6 og CYP3A4 bidrager til alogliptins begrænsede metabolisering.
English: There were 703 patients who experienced an event within the secondary MACE composite endpoint (first event of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke and urgent revascularization due to unstable angina).
Danish: Der var 703 patienter, som oplevede en hændelse inden for det sekundære, sammensatte MACE-endepunkt (første hændelse af kardiovaskulær død, ikke-dødeligt myokardieinfarkt, ikke-dødelig apopleksi og akut revaskularisering på grund af ustabil angina).
English: After excluding patients in whom exposure to the medicinal product was less than one year at the time of diagnosis of bladder cancer, there were 7 cases (0.06%) on pioglitazone and 2 cases (0.02%) in control groups.
Danish: Efter eksklusion af patienter, som kun havde været eksponeret for lægemidlet kortere end 1 år ved diagnosticering af blærecancer, var der 7 tilfælde (0,06 %) tilbage, som fik pioglitazon, og 2 tilfælde (0,02 %) i kontrolgruppen.
English: This indicates no time-dependency in the kinetics of alogliptin after multiple dosing.
Danish: Dette indikerer, at der ikke er nogen tidsafhængighed i alogliptins kinetik efter gentagne doseringer.
English: In studies performed with the individual active substances, both alogliptin and pioglitazone were excreted in the milk of lactating rats.
Danish: I studier udført med de enkelte aktive stoffer blev både alogliptin og pioglitazon udskilt i mælken hos diegivende rotter.
English: If you take more tablets than you should, or if someone else or a child takes your medicine, contact or go to your nearest emergency centre straight away.
Danish: Hvis du har taget for mange Incresync-tabletter Hvis du har taget flere tabletter, end du skulle, eller hvis en anden person, f.eks. et barn, tager dine tabletter, skal du kontakte læge eller søge til den nærmeste skadestue med det samme.
English: Total exposure to alogliptin was approximately 10% lower and peak exposure was approximately 8% lower in patients with moderate hepatic impairment compared to control subjects.
Danish: Den samlede eksponering for alogliptin var ca. 10 % lavere og den højeste eksponering var ca. 8 % lavere hos patienter med moderat nedsat leverfunktion sammenlignet med raske forsøgspersoner.
English: Patients (≥ 65 years old) with type 2 diabetes mellitus are considered more susceptible to episodes of hypoglycaemia than patients < 65 years old.
Danish: Patienter (≥ 65 år) med type 2-diabetes mellitus vurderes at have større risiko for hypoglykæmi end patienter under 65 år.
English: GLP-1 and GIP increases insulin biosynthesis and secretion from pancreatic beta cells, while GLP-1 also inhibits glucagon secretion and hepatic glucose production.
Danish: GLP-1 og GIP øger insulinbiosyntesen og -sekretionen fra bugspytkirtlens betaceller, mens GLP-1 også hæmmer glukagonsekretionen og leverens glucoseproduktion.
English: HOMA analysis shows that pioglitazone improves beta-cell function as well as increasing insulin sensitivity.
Danish: En HOMA-analyse viser, at pioglitazon forbedrer beta-cellefunktionen og øger insulinfølsomheden.
English: A 24-month mechanistic study in male rats demonstrated that administration of pioglitazone resulted in an increased incidence of hyperplastic changes in the bladder.
Danish: Et 24-måneders mekanistisk forsøg med hanrotter viste, at administration af pioglitazon medførte en øget forekomst af hyperplastiske forandringer i blæren.
English: Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups.
Danish: Pioglitazon gennemgår en omfattende metabolisering i leveren ved hydroxylering af alifatiske methylengrupper.
English: The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Danish: Hyppigheden af ødemer i de sammenlignede grupper (sulfonylurinstof, metformin) var 2-5 %.
English: Since insulin and pioglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema.
Danish: Da både insulin og pioglitazon er forbundet med væskeretention, kan samtidig administration øge risikoen for ødemer.
English: Incresync is available in blister packs containing 10, 14, 28, 30, 56, 60, 90, 98 or 100 tablets.
Danish: Incresync fås i blisterpakninger indeholdende 10, 14, 28, 30, 56, 60, 90, 98 eller 100 tabletter.
English: Following a single intravenous dose of 12.5 mg alogliptin to healthy subjects, the volume of distribution during the terminal phase was 417 L indicating that the active substance is well distributed into tissues.
Danish: Efter at raske forsøgspersoner havde fået en intravenøs enkeltdosis på 12,5 mg alogliptin, var fordelingsvolumenet i den terminale fase 417 l, hvilket indikerer, at det aktive stof fordeles godt i vævene.
English: If you have kidney problems your doctor may prescribe you a reduced dose.
Danish: Hvis du har nyreproblemer, vil din læge muligvis ordinere en lavere dosis til dig.
English: Risk related to alogliptin
Danish: Risiko relateret til alogliptin
English: If pancreatitis is suspected, Incresync should be discontinued; if acute pancreatitis is confirmed, Incresync should not be restarted.
Danish: Hvis der er mistanke om akut pancreatitis, skal behandlingen med Incresync afbrydes, og hvis mistanken bekræftes, må behandlingen med Incresync ikke genoptages.
English: Higher doses of alogliptin were not teratogenic but resulted in maternal toxicity, and were associated with delayed and/or lack of ossification of bones and decreased foetal body weights.
Danish: Højere doser alogliptin var ikke teratogene, men resulterede i toksicitet hos moderen og blev forbundet med forsinket og/eller manglende knogledannelse og nedsat føtal kropsvægt.
English: The following data are findings from studies performed with alogliptin or pioglitazone individually.
Danish: Følgende data er resultater af studier udført med alogliptin og pioglitazon hver for sig.
English: Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals.
Danish: Pioglitazon synes at virke via aktivering af specifikke kernereceptorer (peroxisomproliferator-aktiveret receptorgamma), der medfører øget insulinfølsomhed i lever-, fedt- og skeletmuskelceller hos dyr.
English: The observed excess risk of fractures for women in this dataset on pioglitazone is, therefore, 0.8 fractures per 100 patient years of use.
Danish: Den observerede overhyppighed af frakturer hos pioglitazonbehandlede kvinder i dette datasæt er derfor 0,8 frakturer pr. 100 patientår.
English: Therefore, haemodialysis is of little clinical benefit in overdose.
Danish: Hæmodialyse gør således kun begrænset klinisk gavn ved overdosering.