natgillin/translations-raw huggingface dataset:
Patienter, som får synsforstyrrelser, skal dog udvise forsigtighed, når de færdes i trafikken eller betjener maskiner.
However, patients who experience visual disturbance should be cautious when driving or using machines.
Absorption Alogliptins absolutte biotilgængelighed er ca. 100 %.
Absorption The absolute bioavailability of alogliptin is approximately 100%.
Incresync påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
Incresync has no or negligible influence on the ability to drive and use machines.
Mange af disse patienter indberettede samtidige perifere ødemer.
Many of these patients reported concurrent peripheral oedema.
Studiet påviste, at alogliptin ikke øgede risikoen for at få en MACE sammenlignet med placebo [hazard ratio: 0,96; en-sidet 99 % konfidensinterval: 0-1,16].
The study demonstrated that alogliptin did not increase the risk of having a MACE compared to placebo [Hazard Ratio: 0.96; 1-sided 99% Confidence Interval: 0-1.16].
Den totale plasmakoncentration af pioglitazon er uændret, men med øget fordelingsvolumen.
Total serum concentration of pioglitazone is unchanged, but with an increased volume of distribution.
Dette studie viste et øget antal indberetninger om hjerteinsufficiens, uden dog at føre til en øget dødelighed i dette studie.
This study showed an increase in reports of heart failure, however this did not lead to an increase in mortality in this study.
En stigning på ca. 1,7 gange i AUC for alogliptin blev observeret hos patienter med let nedsat nyrefunktion.
An approximate 1.7-fold increase in AUC for alogliptin was observed in patients with mild renal impairment.
Kardiovaskulær død*
Cardiovascular Death*
Alogliptin var ikke karcinogent i de to-årige karcinogenicitetsstudier, der blev udført på rotter og mus.
Alogliptin was not carcinogenic in 2-year carcinogenicity studies conducted in rats and mice.
Alogliptin har en plasmaproteinbinding på 20-30 %.
Alogliptin is 20-30% bound to plasma proteins.
Proportionale stigninger i serumkoncentrationen sås for doser fra 2 til 60 mg. Steady-state opnås efter 4-7 dages administration.
Proportional increases of the serum concentration were observed for doses from 2-60 mg. Steady-state is achieved after 4-7 days of dosing.
Patienter skal oplyses om det karakteristiske symptom på akut pancreatitis: vedholdende, svære abdominalsmerter, som kan stråle ud i ryggen.
Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain, which may radiate to the back.
Se punkt 2 "Incresync indeholder lactose".
See section 2 “Incresync contains lactose”.
Ændring i uge 26 (n =
Change at Week 26 (n=303)
Højere HbA1c ved baseline var forbundet med større reduktion i HbA1c.
Higher baseline HbA1c was associated with a greater reduction in HbA1c.
Hvis du ønsker yderligere oplysninger om Incresync, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Tag ikke Incresync: - hvis du er allergisk over for alogliptin, pioglitazon eller et af de øvrige indholdsstoffer i Incresync (angivet i punkt 6).
Do not take Incresync: - if you are allergic to alogliptin, pioglitazone or any of the other ingredients of this medicine (listed in section 6).
- hvis du har cyster på æggestokkene (polycystisk ovariesyndrom).
- if you have cysts on your ovaries (polycystic ovarian syndrome).
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.
The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
Patienter bør rådes til nøje at overholde en kaloriekontrolleret diæt.
Patients should be advised to adhere strictly to a calorie-controlled diet.
Incresync må ikke gives til patienter med type 1-diabetes mellitus.
Incresync should not be used in patients with type 1 diabetes mellitus.
Ændring i uge 52 (n =
Change at Week 52 (n=303)
Ingen alogliptin-relaterede virkninger blev observeret hos unge rotter efter gentagne doseringer i 4 og 8 uger.
No alogliptin-related effects were observed in juvenile rats following repeat-dose administration for 4 and 8 weeks.
Interaktion med substrater af CYP 450-isoformer er derfor ikke forventet og er ikke påvist.
Interaction with substrates of CYP 450 isoforms are thus not expected and have not been shown.
Immunsystemet overfølsomhed ikke kendt overfølsomhed og allergiske reaktioner ikke kendt
Immune system disorders hypersensitivity not known hypersensitivity and allergic reactions not known
• Forsigtighed ved brug hos ældre i lyset af aldersbetingede risici (især blærecancer, knoglebrud og hjerteinsufficiens).
• Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure).
Incresync må ikke anvendes under graviditet.
Incresync should not be used during pregnancy.
Den gennemsnitlige serumhalveringstid for uomdannet pioglitazon er hos mennesket 5-6 timer og for dets samlede, aktive metabolitter 16-23 timer.
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.
Fremstiller Takeda Ireland Limited Bray Business Park Kilruddery
Manufacturer Takeda Ireland Limited Bray Business Park Kilruddery
Alogliptin gennemgår ikke en omfattende metabolisering; 60-70 % af en dosis udskilles i urinen som uomdannet aktivt stof.
Alogliptin does not undergo extensive metabolism, 60-70% of the dose is excreted as unchanged active substance in the urine.
Brugen af DPP-4-hæmmere er sat i forbindelse med en risiko for udvikling af akut pancreatitis.
Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Incresync anbefales ikke til børn og unge under 18 år, da der ikke foreligger tilstrækkelige data for denne aldersgruppe.
Incresync is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Dit blodsukker kan blive højere, når du holder op med at tage Incresync.
Your blood sugar levels may increase when you stop taking Incresync.
Interaktion med stoffer, der omsættes af disse enzymer, f.eks. orale kontraceptiva, ciclosporin, calciumkanalblokkere og HMGCoA-reduktasehæmmere, kan ikke forventes.
Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers and HMGCoA reductase inhibitors, are not to be expected.
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 %).
Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Elimination Alogliptin blev elimineret med en gennemsnitlig terminal halveringstid (T1/2) på ca. 21 timer.
Elimination Alogliptin was eliminated with a mean terminal half-life (T1/2) of approximately 21 hours.
Endvidere antyder de kliniske data ingen interaktion med p-glykoproteinhæmmere eller -substrater.
Furthermore, clinical data do not suggest interaction with p-glycoprotein inhibitors or substrates.
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.
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.
Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi og toksicitet.
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and toxicology.
Informationsmaterialet til lægen bør omfatte:
The physician educational pack should contain:
Placentaoverførsel af alogliptin er set hos rotter.
Placental transfer of alogliptin occurs in rats.
Voksne (≥ 18 år) Dosis skal tilpasses den enkelte patient ud fra dennes aktuelle behandling.
Adults (≥ 18 years old) The dose should be individualised on the basis of the patient's current treatment regimen
Tidsafhængighed
Time-dependency
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.
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.
Behandling med pioglitazon eller placebo blev tilføjet til en eksisterende antidiabetisk og kardiovaskulær behandling i op til 3,5 år.
Pioglitazone or placebo was added to existing anti-diabetic and cardiovascular therapy for up to 3.5 years.
De indberettede tilfælde med ødemer var generelt lette til moderate og krævede sædvanligvis ikke afbrydelse af behandling.
The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.
Hvis du holder op med at tage Incresync
If you stop taking Incresync
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.
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).
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).
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)
I tilfælde af overdosering skal der gives tilstrækkelig understøttende behandling, der afhænger af patientens kliniske status.
In the event of an overdose, appropriate supportive measures should be employed as dictated by the patient's clinical status.
Interaktion med CYP-hæmmere forventes derfor ikke og er ikke påvist.
Interactions with CYP inhibitors are thus not expected and have not been shown.
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.
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.
Der forventes ingen virkninger på miljøet ved klinisk anvendelse af pioglitazon.
No environmental impact is anticipated from the clinical use of pioglitazone.
af orale blodglucosesænkende midler, ATC-kode: A10BD09.
ATC code: A10BD09.
Hvis der observeres gulsot, bør behandlingen med lægemidlet afbrydes.
If jaundice is observed, the medicinal product should be discontinued.
Hos raske forsøgspersoner havde alogliptin ingen indvirkning på prothrombin-tid eller International Normalised Ratio (INR), når det blev administreret samtidigt med warfarin.
In healthy subjects, alogliptin had no effect on prothrombin time or International Normalised Ratio (INR) when administered concomitantly with warfarin.
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.
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.
Almindelige bivirkninger (forekommer hos op til 1 ud af 10 personer): - Pludselige og stærke knoglesmerter eller ubevægelighed (særligt hos kvinder).
Common (may affect up to 1 in 10 people): - Sudden and severe bone pain or immobility (particularly in women).
I kliniske studier har patienter taget pioglitazon i højere doser end den anbefalede maksimale dosis på 45 mg dagligt.
In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
Studier af diegivende rotter tyder på, at alogliptin udskilles i mælken.
Studies in lactating rats indicate that alogliptin is excreted in milk.
Det anbefales, at du altid medbringer lidt sukkerknalder, slik, kiks eller sukkerholdig frugtjuice.
It is recommended that you carry some sugar lumps, sweets,
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).
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).
Mængden af visceralt fedtvæv blev signifikant reduceret, mens der sås en stigning i den ekstraabdominale fedtmasse.
Visceral fat was significantly decreased while there was an increase in extra-abdominal fat mass.
Det er ukendt, om alogliptin og pioglitazon bliver udskilt i human mælk.
It is unknown whether alogliptin and pioglitazone are excreted in human milk.
Behandling med Incresync bør afbrydes, hvis der opstår en forværring i hjertestatus.
Incresync should be discontinued if any deterioration in cardiac status occurs.
Dato for første markedsføringstilladelse: 19. september 2013 Dato for seneste fornyelse:
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 September 2013
I en dyremodel af familiær adenomatøs polypose behandlet med to andre thiazolidindioner øgedes tumormangfoldigheden i kolon.
In an animal model of familial adenomatous polyposis, treatment with two other thiazolidinediones increased tumour multiplicity in the colon.
Alogliptin findes primært som (R)-enantiomeren (> 99 %) og gennemgår ingen eller kun meget begrænset kiral konvertering til (S)-enantiomeren in vivo.
Alogliptin exists predominantly as the (R)-enantiomer (> 99%) and undergoes little or no chiral conversion in vivo to the (S)-enantiomer.
Patienterne bør dog advares om risikoen for hypoglykæmi, hvis Incresync bruges i kombination med andre antidiabetiske lægemidler, som kan forårsage hypoglykæmi.
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.
Forekomsten af ødemer, vægtforøgelse og hjertesvigt var dog øget.
However, the incidences of oedema, weight gain and heart failure were increased.
Der er indberettet ødemer hos 6-9 % af de patienter, der blev behandlet over 1 år med pioglitazon i kontrollerede kliniske studier.
Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical studies.
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Takeda
NAME OF THE MARKETING AUTHORISATION HOLDER Takeda
(-uendelig, -0,35) (-uendelig, -0,28)
(-infinity, -0.28)
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).
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).
Der findes ingen data om overdosering af Incresync.
No data are available with regard to overdose of Incresync.
I tilfælde af hypoglykæmi kan en lavere thiazolidindion- eller metformin-dosis overvejes.
In case of hypoglycaemia, a lower dose of the thiazolidinedione or metformin may be considered.
- pioglitazon tilhører en gruppe af lægemidler, der kaldes thiazolidindioner.
- pioglitazone belongs to a group of medicines called thiazolidinediones.
Før du begynder at tage Incresync, vil du få taget en blodprøve til kontrol af lever- og nyrefunktion.
Before you start taking this medicine you will have a blood sample taken to check your liver and kidney function.
Alogliptin virker ved at øge insulinniveauet i kroppen efter et måltid og sænke mængden af sukker i kroppen.
Alogliptin works to increase the levels of insulin in the body after a meal and decrease the amount of sugar in the body.
Hvis du har glemt at tage Incresync
If you forget to take Incresync
Pioglitazon absorberes hurtigt efter oral indgivelse, og maksimale serumkoncentrationer af uomdannet pioglitazon opnås som regel 2 timer efter administration.
Following oral administration, pioglitazone is rapidly absorbed and peak serum concentrations of unchanged pioglitazone are usually achieved 2 hours after administration.
Incresync kan ikke erstatte insulin hos patienter med insulinkrævende diabetes.
Incresync is not a substitute for insulin in insulin-requiring patients.
Efter administration af en oral dosis [14C]-alogliptin blev 76 % af den samlede radioaktivitet udskilt i urinen, og 13 % blev udskilt i fæces.
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.
Dyrestudie indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår reproduktionstoksicitet (se pkt.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
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).
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)
Hvis du allerede tager både alogliptin og pioglitazon som separate tabletter, kan Incresync erstatte dem begge.
If you are already taking both alogliptin and pioglitazone as single tablets, Incresync can replace them in one tablet.
(Patienter med terminal nyresygdom fik hæmodialyse umiddelbart efter dosis med alogliptin.
(Patients with end-stage renal disease underwent haemodialysis immediately after alogliptin dosing.
In vitro-data indikerer, at CYP2D6 og CYP3A4 bidrager til alogliptins begrænsede metabolisering.
In vitro data indicate that CYP2D6 and CYP3A4 contribute to the limited metabolism of alogliptin.
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).
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).
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.
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.
Dette indikerer, at der ikke er nogen tidsafhængighed i alogliptins kinetik efter gentagne doseringer.
This indicates no time-dependency in the kinetics of alogliptin after multiple dosing.
I studier udført med de enkelte aktive stoffer blev både alogliptin og pioglitazon udskilt i mælken hos diegivende rotter.
In studies performed with the individual active substances, both alogliptin and pioglitazone were excreted in the milk of lactating rats.
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.
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.
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.
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.
Patienter (≥ 65 år) med type 2-diabetes mellitus vurderes at have større risiko for hypoglykæmi end patienter under 65 år.
Patients (≥ 65 years old) with type 2 diabetes mellitus are considered more susceptible to episodes of hypoglycaemia than patients < 65 years old.
GLP-1 og GIP øger insulinbiosyntesen og -sekretionen fra bugspytkirtlens betaceller, mens GLP-1 også hæmmer glukagonsekretionen og leverens glucoseproduktion.
GLP-1 and GIP increases insulin biosynthesis and secretion from pancreatic beta cells, while GLP-1 also inhibits glucagon secretion and hepatic glucose production.
En HOMA-analyse viser, at pioglitazon forbedrer beta-cellefunktionen og øger insulinfølsomheden.
HOMA analysis shows that pioglitazone improves beta-cell function as well as increasing insulin sensitivity.
Et 24-måneders mekanistisk forsøg med hanrotter viste, at administration af pioglitazon medførte en øget forekomst af hyperplastiske forandringer i blæren.
A 24-month mechanistic study in male rats demonstrated that administration of pioglitazone resulted in an increased incidence of hyperplastic changes in the bladder.
Pioglitazon gennemgår en omfattende metabolisering i leveren ved hydroxylering af alifatiske methylengrupper.
Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups.
Hyppigheden af ødemer i de sammenlignede grupper (sulfonylurinstof, metformin) var 2-5 %.
The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Da både insulin og pioglitazon er forbundet med væskeretention, kan samtidig administration øge risikoen for ødemer.
Since insulin and pioglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema.
Incresync fås i blisterpakninger indeholdende 10, 14, 28, 30, 56, 60, 90, 98 eller 100 tabletter.
Incresync is available in blister packs containing 10, 14, 28, 30, 56, 60, 90, 98 or 100 tablets.
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.
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.
Hvis du har nyreproblemer, vil din læge muligvis ordinere en lavere dosis til dig.
If you have kidney problems your doctor may prescribe you a reduced dose.
Risiko relateret til alogliptin
Risk related to alogliptin
Hvis der er mistanke om akut pancreatitis, skal behandlingen med Incresync afbrydes, og hvis mistanken bekræftes, må behandlingen med Incresync ikke genoptages.
If pancreatitis is suspected, Incresync should be discontinued; if acute pancreatitis is confirmed, Incresync should not be restarted.
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.
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.