natgillin/translations-raw huggingface dataset:
Incresync er indiceret som anden- eller tredjevalgsbehandling til voksne patienter på 18 år eller derover med type 2-diabetes mellitus:
Incresync is indicated as a second or third line treatment in adult patients aged 18 years and older with type 2 diabetes mellitus:
- hvis du lider af eller tidligere har haft blærecancer.
- if you have or have ever had bladder cancer.
Det er derfor ikke nødvendigt at justere dosis for alogliptin hos patienter med let til moderat nedsat leverfunktion (Child-Pugh-scorer på 5 til 9).
Therefore, no dose adjustment of alogliptin is necessary for patients with mild to moderate hepatic impairment (Child-Pugh scores of 5 to 9).
Efter 14 dages behandling var DPP-4-hæmningen fortsat over 81 % 24 timer efter sidste dosis.
Inhibition of DPP-4 remained above 81% at 24 hours after 14 days of dosing.
Ikke almindelige bivirkninger (forekommer hos op til 1 ud af 100 personer): - Symptomer på blærecancer, herunder blod i urinen, smerter ved vandladning og pludselig vandladningstrang.
Uncommon (may affect up to 1 in 100 people): - Symptoms of bladder cancer including blood in your urine, pain when urinating or a sudden need to urinate.
Da der er en risiko for stigning i dosisrelaterede bivirkninger, kan det være nødvendigt med en nedsættelse af dosis for pioglitazon, når gemfibrozil gives samtidigt.
Since there is a potential for an increase in dose-related adverse reactions, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Hypoglykæmi kan forekomme ved administration i kombination med sulfonylurinstof eller insulin.
Hypoglycaemia may occur in combination with sulphonylureas or insulin.
Data fra studier med alogliptin, metformin, pioglitazon (thiazolidindion), voglibose (alfaglukosidasehæmmer) og glyburid (sulfonylurinstof) har ikke påvist klinisk relevante farmakokinetiske interaktioner.
Results from alogliptin studies with metformin, pioglitazone (thiazolidinedione), voglibose (alphaglucosidase inhibitor) and glyburide (sulphonylurea) have shown no clinically relevant pharmacokinetic interactions.
Hvis ALAT-niveauerne øges til 3 gange den øvre normale grænse under behandling med Incresync-behandling, bør de vurderes igen så hurtigt som muligt.
If ALT levels are increased to 3 x upper limit of normal during therapy, liver enzyme levels should be reassessed as soon as possible.
Der bør dog fastlægges en konservativ dosering af alogliptin til ældre personer på grund af forhøjet risiko for nedsat nyrefunktion i denne aldersgruppe.
However, dosing of alogliptin should be conservative in patients with advanced age due to the potential for decreased renal function in this population.
Administration af Incresync sammen med mad resulterede ikke i nogen ændring i den samlede eksponering for alogliptin eller pioglitazon.
Administration of Incresync with food resulted in no change in overall exposure to alogliptin or pioglitazone.
Der var en lille reduktion i middelhæmoglobin (4 % relativ reduktion) og hæmatokrit (4,1 % relativ reduktion) under behandling med pioglitazon, foreneligt med blodfortynding.
There was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction) during therapy with pioglitazone, consistent with haemodilution.
I toksikologiske studier sås plasmavolumenforøgelse med fortynding af blodet, anæmi og reversibel, excentrisk hypertrofi af hjertet konsistent efter gentagen dosering til mus, rotter, hunde og aber.
In toxicology studies, plasma volume expansion with haemodilution, anaemia and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs and monkeys.
Ikke almindelige bivirkninger: - søvnbesvær.
Uncommon: - Difficulty sleeping
Intrinsic clearance reduceres derfor kombineret med en større ubundet fraktion af pioglitazon (se pkt.
Intrinsic clearance is, therefore, reduced coupled with a higher unbound fraction of pioglitazone (see section 4.2).
Indehaveren af markedsføringstilladelsen skal udarbejde informationsmateriale, som er målrettet alle læger, som forventes at ordinere/anvende alogliptin/pioglitazon.
The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use alogliptin/pioglitazone.
Selvom fertiliteten ikke blev påvirket, blev der observeret en lille, statistisk signifikant forøgelse i antallet af abnorme sædceller hos hanrotter ved en eksponering, som var langt højere end den humane eksponering ved den anbefalede dosis.
Although fertility was not affected, a slight, statistical increase in the number of abnormal sperm was observed in males at an exposure far above the human exposure at the recommended dose.
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.
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.
Interaktioner med pioglitazon
Interactions with pioglitazone
Brug af anden medicin sammen med Incresync
Other medicines and Incresync
I in vitro-studier viste alogliptin ingen hæmning af de renale transportere OAT1, OAT3 og OCT2.
In studies in vitro, alogliptin was not an inhibitor of the following renal transporters; OAT1, OAT3 and OCT2.
Et klinisk studie med alogliptin som tillæg til behandling med pioglitazon viste, at der ikke var nogen klinisk relevant stigning i hypoglykæmihyppigheden sammenlignet med placebo.
A clinical study of alogliptin as add-on therapy to pioglitazone demonstrated that there was no clinically relevant increase in hypoglycaemia rate compared to placebo.
En samlet analyse af data fra 13 studier viste, at den samlede forekomst af kardiovaskulær død, ikke-dødeligt myokardieinfarkt og ikke-dødelig apopleksi var sammenlignelig hos patienter behandlet med 25 mg alogliptin, aktiv kontrol eller placebo.
In a pooled analysis of the data from 13 studies, the overall incidences of cardiovascular death, non fatal myocardial infarction and non-fatal stroke were comparable in patients treated with 25 mg alogliptin, active control or placebo.
Det er muligt, at dosis for pioglitazon skal øges, hvis rifampicin gives samtidigt.
The pioglitazone dose may need to be increased when rifampicin is concomitantly administered.
Sikkerheden ved og virkningen af Incresync hos børn og unge under 18 år er ikke endnu klarlagt.
The safety and efficacy of Incresync in children and adolescents < 18 years old have not been established.
Du vil få kontrolleret blodsukkeret for at se, om du skal have ændret doseringen af Incresync.
Your blood sugar will be checked and your dose of Incresync may need to be changed.
10 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 56 filmovertrukne tabletter 60 filmovertrukne tabletter 90 filmovertrukne tabletter 98 filmovertrukne tabletter 100filmovertrukne tabletter
10 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 60 film-coated tablets 90 film-coated tablets 98 film-coated tablets 100 film-coated tablets
• i kombination med metformin (dvs. kombinationsbehandling med tre stoffer) som tillæg til diæt og motion med det formål at forbedre den glykæmiske kontrol hos voksne patienter (specielt overvægtige patienter), der er utilstrækkeligt reguleret på den maksimalt tolererede dosis metformin og pioglitazon.
• in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone.
Koncentrationen af frit (ubundet) pioglitazon er således uændret (se pkt.
Thus, free (unbound) pioglitazone concentration is unchanged (see section 4.2).
Undersøgelser hos mennesker tyder ikke på induktion af de vigtigste inducerbare cytokromer P450, 1A, 2C8/9 og 3A4.
Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
I et 20-ugers-studie reducerede pioglitazon såvel fastetriglycerider som postprandial hypertriglyceridæmi som følge af indvirkning på både absorberede og leversyntetiserede triglycerider.
In a 20-week study, as well as reducing fasting triglycerides, pioglitazone reduced postprandial hypertriglyceridaemia through an effect on both absorbed and hepatically synthesised triglycerides.
Et studie med kardiovaskulære endepunkter med pioglitazon er udført med patienter under 75 år med type 2-diabetes mellitus og betydende makrovaskulær sygdom.
A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
For at være egnede skulle patienterne have haft/gennemgået mindst 1 af følgende sygdomme/indgreb: myokardieinfarkt, apopleksi, perkutan koronarintervention eller koronar bypassoperation, akut koronarsyndrom, koronararteriesygdom eller perifer arteriel obstruktiv sygdom.
To be eligible, patients had to have had one or more of the following: myocardial infarction, stroke, percutaneous cardiac intervention or coronary artery bypass graft, acute coronary syndrome, coronary artery disease, or peripheral arterial obstructive disease.
Der er ingen data fra anvendelse af alogliptin til gravide kvinder.
There are no data from the use of alogliptin in pregnant women.
Forsinket fosterudvikling var tydelig i dyrestudie med pioglitazon.
Foetal growth restriction was apparent in animal studies with pioglitazone.
Dette blev fastlagt på grundlag af klinisk relevante og statistisk signifikante fald i glykosyleret hæmoglobin (HbA1c) og i fasteplasmaglucose sammenlignet med kontrol fra baseline til endepunkt.
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.
Alogliptin er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh-scorer > 9).
Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score > 9).
Generelt forbedrede behandlingen med den anbefalede daglige dosis på 25 mg alogliptin i kombination med pioglitazon den glykæmiske kontrol.
Overall, treatment with the recommended daily dose of 25 mg alogliptin in combination with pioglitazone improved glycaemic control.
Klinisk relevante reduktioner i HbA1c sammenlignet med placebo blev også observeret med 25 mg alogliptin, uanset om patienterne samtidig blev behandlet med metformin eller sulfonylurinstof.
Clinically meaningful reductions in HbA1c compared to placebo were also observed with 25 mg alogliptin regardless of whether patients were receiving concomitant metformin or sulphonylurea therapy.
Incresync kombinerer to antihyperglykæmiske lægemidler med komplementære og individuelle virkningsmekanismer med det formål at forbedre den glykæmiske kontrol hos patienter med type 2-diabetes mellitus: alogliptin, en dipeptidyl-peptidase-4 (DPP-4)-hæmmer og pioglitazon, der tilhører thiazolidindion-klassen.
Incresync combines two antihyperglycaemic medicinal products with complementary and distinct mechanisms of action to improve glycaemic control in patients with type 2 diabetes mellitus: alogliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor, and pioglitazone, a member of the thiazolidinedione class.
Der er ingen tilgængelige data (se pkt.
No data are available (see section 4.2).
Risikoen for frakturer skal tages i betragtning ved langtidsbehandling med Incresync (se pkt.
The risk of fractures should be considered in the long-term care of patients treated with Incresync (see section 4.8).
I kliniske studier med pioglitazon var der tegn på dosisrelateret vægtøgning, hvilket kan skyldes fedtophobning og i nogle tilfælde væskeretention.
In clinical studies with pioglitazone, there was evidence of dose-related weight gain, which may be due to fat accumulation and, in some cases, associated with fluid retention.
Overfølsomhedsreaktioner, herunder anafylaktiske reaktioner, angioødem og eksfoliative hudreaktioner, inklusive Stevens-Johnsons syndrom og erythema multiforme, er observeret for DPP-4-hæmmere og er spontant indberettet for alogliptin efter markedsføring.
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.
Blodprøverne kan vise små ændringer i dine blodværdier.
Slight changes in cell counts may show up in blood tests.
Pioglitazon forøgede ikke LDL-kolesterolniveauer statistisk signifikant sammenlignet med placebo, mens der sås reduktioner med metformin og gliclazid.
Pioglitazone did not cause statistically significant increases in LDL-cholesterol levels compared to placebo whilst reductions were observed with metformin and gliclazide.
Virkningen af og sikkerheden ved de anbefalede doser alogliptin og pioglitazon hos en undergruppe af patienter på 65 år og derover med type 2-diabetes mellitus blev vurderet, og data svarede til profilen for patienter under 65 år.
The efficacy and safety of the recommended doses of alogliptin and pioglitazone in a subgroup of patients with type 2 diabetes mellitus and ≥ 65 years old were reviewed and found to be consistent with the profile obtained in patients < 65 years old.
Maksimal daglig dosis Den højeste anbefalede daglige dosis på 25 mg alogliptin og 45 mg pioglitazon bør ikke overskrides.
The maximum recommended daily dose of 25 mg alogliptin and 45 mg pioglitazone should not be exceeded.
Der er ingen data fra anvendelse af Incresync til gravide kvinder.
There are no data from the use of Incresync in pregnant women.
I kontrollerede kliniske studier er forekomsten af rapporteret hjerteinsufficiens ved pioglitazonbehandling den samme som for placebo-, metformin- og sulfonylurinstof-grupperne, mens den er forøget ved kombinationsbehandling med insulin.
In controlled clinical studies, the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin.
Den forbedrede blodsukkerregulering hænger sammen med en reduktion af både fastende og postprandiale insulinkoncentrationer i plasma.
The improved glycaemic control is associated with a reduction in both fasting and postprandial plasma insulin concentrations.
Samtidig behandling med alogliptin og pioglitazon medførte ikke ny toksicitet og forværrede heller ikke de pioglitazon-relaterede fund.
Concomitant treatment with alogliptin and pioglitazone did not produce new toxicities, nor did it exacerbate any pioglitazone-related findings.
Der blev ikke observeret effekt på nogen af stoffernes toksikokinetik.
No effects on the toxicokinetics of either compound were observed.
Kombinationsbehandling af drægtige rotter med alogliptin og pioglitazon gav en let forøgelse af pioglitazon-relaterede føtale effekter i form af vækstretardering og viscerale forandringer, men inducerede ikke embryoføtal dødelighed eller teratogenicitet.
Combination treatment with alogliptin and pioglitazone to pregnant rats slightly augmented pioglitazone-related foetal effects of growth retardation and visceral variations, but did not induce embryo-foetal mortality or teratogenicity.
• Ordinationsvejledning.
• The Prescriber Guide
Der var også 1.269 patienter med let nedsat nyrefunktion og 161 patienter med moderat nedsat nyrefunktion, der alle blev behandlet med alogliptin/pioglitazon.
The studies included 1,269 patients with mild renal impairment and 161 patients with moderate renal impairment treated with alogliptin/pioglitazone.
Efter markedsføring er der også indberettet tilfælde af perifert ødem og hjerteinsufficiens hos patienter, der samtidigt fik pioglitazon og ikke-steroide antiinflamatoriske lægemidler (NSAID'er), herunder selektive COX-2-hæmmere.
Post marketing cases of peripheral oedema and cardiac failure have also been reported in patients with concomitant use of pioglitazone and nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors.
Ved baseline havde patienterne en gennemsnitsalder på 61 år, gennemsnitsvarighed af diabetes på 9,2 år og gennemsnitligt HbA1c på
At baseline, patients had a mean age of 61 years, mean duration of diabetes of 9.2 years, and mean HbA1c of 8.0%.
Synk tabletten hel sammen med vand.
Swallow your tablet(s) whole with water.
Alogliptin kan derfor tages med eller uden mad.
Alogliptin may, therefore, be administered with or without food.
Vurderet ud fra de gennemsnitlige dialysatkoncentrationer blev ca. 7 % af det aktive stof fjernet i løbet af en hæmodialyse af 3 timers varighed).
Based on mean dialysate concentrations, approximately 7% of the active substance was removed during a 3-hour haemodialysis session.
Interaktionsundersøgelser har vist, at pioglitazon ikke har nogen relevant effekt på hverken farmakokinetik eller farmakodynamik for digoxin, warfarin, phenprocoumon og metformin.
Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon or metformin.
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 nedsat (CrCl = > 50 til ≤ 80 ml/min), moderat nedsat (CrCl = ≥ 30 til ≤ 50 ml/min), svært nedsat (CrCl = < 30 ml/min) eller dialysekrævende terminal nyresygdom.
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.
Samtidig administration af 25 mg alogliptin én gang dagligt og 45 mg pioglitazon én gang dagligt i 12 dage hos raske forsøgspersoner havde ingen klinisk relevant effekt på farmakokinetikken for alogliptin, pioglitazon eller deres aktive metabolitter.
Co-administration of 25 mg alogliptin once daily and 45 mg pioglitazone once daily for 12 days in healthy subjects had no clinically relevant effects on the pharmacokinetics of alogliptin, pioglitazone or their active metabolites.
Type 2-diabetes kaldes også ikkeinsulinkrævende diabetes mellitus eller gammelmandssukkersyge.
Type 2 diabetes is also called non-insulin-dependent diabetes mellitus or NIDDM.
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.
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.
Patienter med moderat nedsat nyrefunktion (CrCl ≥ 30 til ≤ 50 ml/min) bør have dosis halveret til halvdelen af den anbefalede dosis alogliptin.
For patients with moderate renal impairment (CrCl ≥ 30 to ≤ 50 mL/min), one-half of the recommended dose of alogliptin should be administered.
Efter administration af orale enkeltdoser på op til 800 mg hos raske personer blev alogliptin hurtigt absorberet, og den højeste plasmakoncentration forekom 1 til 2 timer (median Tmaks) efter administration.
After administration of single, oral doses of up to 800 mg in healthy subjects, alogliptin was rapidly absorbed with peak plasma concentrations occurring 1 to 2 hours (median Tmax) after dosing.
- alogliptin tilhører en gruppe af lægemidler, der kaldes DPP-4-hæmmere (dipeptidyl peptidase-4-hæmmere).
- alogliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
Tabel 2: Ændring i HbA1c (%) fra baseline til uge 26 i placebokontrollerede studier med alogliptin 25 mg (FAS, LOCF) Studie
Table 2: Change in HbA1c (%) from baseline with alogliptin 25 mg at Week 26 by placebo-controlled study (FAS, LOCF)
In vitro-studier har vist, at alogliptin inducerer CYP3A4 i mindre grad, men stoffet har ikke vist sig at inducere CYP3A4 i in vivo-studier.
Studies in vitro have shown alogliptin to be a mild inducer of CYP3A4, but alogliptin has not been shown to induce CYP3A4 in studies in vivo.
Blisterkort af nylon/aluminium/polyvinylklorid (PVC) med aluminiumsfolie, som tabletterne kan trykkes ud igennem.
Nylon/aluminium/polyvinyl chloride (PVC) blisters with push through aluminium lidding foil.
I dyrestudie med pioglitazon er der ikke fundet nogen effekt på kopulation, befrugtning eller fertilitetsindeks.
In animal fertility studies conducted with pioglitazone there was no effect on copulation, impregnation or fertility index.
Incresyncs virkning og sikkerhed ved trestofbehandling sammen med sulfonylurinstof er ikke klarlagt, og derfor frarådes kombinationen.
The efficacy and safety of Incresync as triple therapy with a sulphonylurea has not been established and thus use is not recommended.
Der har været spontane bivirkningsindberetninger i form af akut pancreatitis efter markedsføring.
There have been spontaneously reported adverse reactions of acute pancreatitis in the post-marketing setting.
I studiet med kardiovaskulære endepunkter var hyppigheden af indberetning af pancreatitis hos patienter, der blev behandlet med alogliptin eller placebo, henholdsvis 3 eller 2 hændelser pr. 1.000 patientår.
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.
Klinisk relevante reduktioner i HbA1c sammenlignet med kontrol blev også observeret uanset lægemiddeldosis for baggrundsbehandling ved baseline.
Clinically meaningful reductions in HbA1c compared to control were also observed regardless of baseline background medicinal product dose.
- hvis du lider af en hjertesygdom eller af væskeophobning.
- if you suffer from heart disease or fluid retention.
Forekomsten af frakturer er beregnet til 1,9 frakturer pr. 100 patientår hos de kvinder, der blev behandlet med pioglitazon, og 1,1 frakturer pr. 100 patientår hos de kvinder, der blev behandlet med en komparator.
The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator.
Alogliptin udskilles primært uomdannet i urinen, og omsætning via cytokrom P450 (CYP)enzymsystemet er ubetydelig (se pkt.
Alogliptin is primarily excreted unchanged in the urine and metabolism by the cytochrome (CYP) P450 enzyme system is negligible (see section 5.2).
- 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 (Steven-Johnson syndrome og erythema multiforme).
- 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).
Tabel 3: Ændring i HbA1c (%) fra baseline i aktivt kontrollerede studier af alogliptin 25 mg (PPS, LOCF)
Table 3: Change in HbA1c (%) from baseline with alogliptin 25 mg by active-controlled study (PPS, LOCF)