natgillin/translations-raw huggingface dataset:
Det anvendes som supplement til diæt og motion sammen med et eller flere antidiabetiske lægemidler: • i kombination med metformin til patienter, som ikke er tilfredsstillende kontrolleret med metformin alene • i kombination med et sulfonylurinstof til patienter, som ikke er tilfredsstillende kontrolleret med et sulfonylurinstof alene, eller når metformin ikke er velegnet • i kombination med både metformin og et sulfonylurinstof, når begge lægemidler ikke er tilstrækkelige til at holde patientens diabetes under kontrol • i kombination med en PPAR- gammaagonist, f. eks. et thiazolidindion, til patienter, som ikke er tilfredsstillende kontrolleret med PPAR- gammaagonisten alene.
It is used with diet and exercise, together with one or more antidiabetes medicines: • in combination with metformin, in patients who are not satisfactorily controlled on metformin alone; • in combination with a sulphonylurea in patients who are not satisfactorily controlled with a sulphonylurea alone and in whom metformin is not suitable; • in combination with both metformin and a sulphonylurea, when both medicines are not sufficient to give satisfactory control of the patient ’ s diabetes; • in combination with a PPAR gamma agonist, such as a thiazolidinedione, in patients who are not satisfactorily controlled on the PPAR gamma agonist alone.
Januvia tages som en dosis a 100 mg én gang dagligt med eller uden måltid.
Januvia is taken at a dose of 100 mg once a day, with or without food.
Det er ikke nødvendigt at ændre dosis af de andre lægemidler, som Januvia tages sammen med, undtagen når Januvia tages med et sulfonylurinstof.
There is no need to change the doses of the other medicines Januvia is taken with, except when Januvia is taken with a sulphonylurea.
I disse tilfælde kan dosis af sulfonylurinstoffet nedsættes for at mindske risikoen for hypoglykæmi (lave blodsukkerniveauer).
In such cases, the dose of the sulphonylurea may be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
Januvia anbefales ikke til patienter med moderate eller svære nyreproblemer eller til patienter under 18 år.
Januvia is not recommended for use in patients who have moderate or severe problems with their kidneys, or in patients aged less than 18 years.
Type 2- diabetes er en sygdom, hvor bugspytkirtlen ikke producerer tilstrækkeligt insulin til at regulere glukoseniveauet (sukker) i blodet, eller hvor kroppen ikke er i stand til at anvende insulinet effektivt.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Det aktive stof i Januvia, sitagliptin, er en dipeptidylpeptidase- 4- hæmmer (DPP- 4- hæmmer).
The active substance in Januvia, sitagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Det fungerer ved at blokere for nedbrydningen af 'inkretinhormoner' i kroppen.
It works by blocking the breakdown of ‘ incretin’ hormones in the body.
Ved at øge niveauet af inkretinhormoner i blodet stimulerer sitagliptin bugspytkirtlen til at producere mere insulin, når blodsukkerniveauet er højt.
By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood sugar levels are high.
Sitagliptin fungerer ikke, når blodsukkerniveauet er lavt.
Sitagliptin does not work when the blood sugar is low.
Sitagliptin reducerer også mængden af det sukker, leveren danner, ved at øge insulinniveauet og reducere 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. niveauet af hormonet glukagon.
Reproduction is authorised provided the source is acknowledged.
Virkningerne af Januvia blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Januvia were first tested in experimental models before being studied in humans.
Januvia blev undersøgt i fem hovedundersøgelser, der varede i op til et år og omfattede næsten 4 000 patienter med type 2- diabetes, hvis blodsukkerniveauer ikke var tilstrækkeligt reguleret.
Januvia was studied in five main studies lasting up to a year, involving almost 4,000 patients with type 2 diabetes whose blood sugar levels were not adequately controlled.
I fire af undersøgelserne sammenlignedes Januvia med placebo (en virkningsløs behandling), når det enten blev taget alene (to undersøgelser med 1 262 patienter) eller som et supplement til metformin (702 patienter) eller til PPAR- gammaagonisten pioglitazon (353 patienter).
Four of the studies compared Januvia to placebo (a dummy treatment), either taken alone (two studies involving 1,262 patients), or as an add-on to metformin (in 702 patients) or to the PPAR gamma agonist pioglitazone (in 353 patients).
I den femte undersøgelse sammenlignedes Januvia med glipizid (et sulfonylurinstof), når de blev givet som et supplement til metformin (1 172 patienter).
The fifth study compared Januvia to glipizide (a sulphonylurea), as an add-on to metformin in 1,172 patients.
I en yderligere undersøgelse blev Januvia sammenlignet med placebo, når de blev givet som et supplement til behandling med glimepirid (et andet sulfonylurinstof), med eller uden metformin, hos 441 patienter.
An additional study compared Januvia to placebo, when used as an add-on to treatment with glimepiride (another sulphonylurea), with or without metformin, in 441 patients.
I alle undersøgelser var det primære mål for effekten ændringen i niveauet af et stof i blodet, der kaldes glykosyleret hæmoglobin (HbA1c), som giver en indikation af, hvor godt blodglukoseniveauet er reguleret.
In all studies, the main measure of effectiveness was the change in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Januvia havde større effekt end placebo, når det blev taget alene eller i kombination med andre antidiabetiske lægemidler.
Januvia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines.
Når Januvia blev kombineret med metformin og givet i daglige doser på 100 mg, var HbA1c efter 24 uger reduceret med 0, 70% (fra 7, 96 til 7, 26%) sammenlignet med et fald på 0, 08% hos de patienter, der fik tilføjet placebo.
In combination with metformin, a daily dose of 100 mg Januvia reduced HbA1c by 0.70% (from 7.96 to 7.26%) after 24 weeks, compared to a fall of 0.08% in the patients adding placebo.
I kombination med pioglitazon havde 100 mg Januvia om dagen reduceret HbA1c- niveauet med 0, 88% efter 24 uger sammenlignet med 0, 18% hos patienter, som fik tilføjet placebo.
In combination with pioglitazone, 100 mg Januvia reduced HbA1c levels by 0.88% after 24 weeks, compared to 0.18% in the patients adding placebo.
I den undersøgelse, der sammenlignede Januvia med glipizid som et supplement til metformin, var glipizid i starten bedre til at reducere HbA1c- niveauet end Januvia.
In the study comparing Januvia and glipizide as an add-on to metformin, glipizide was initially more effective than Januvia in reducing HbA1c levels.
De to lægemidler havde dog nogenlunde samme effekt hos patienter, der fortsatte med at tage Januvia eller glipizid, efter et års behandling.
However, in patients continuing to take Januvia or glipizide, the two medicines had similar levels of effectiveness after a year of treatment.
Januvia var også mere effektivt end placebo, når det blev føjet til glimepirid (med eller uden metformin).
Januvia was also more effective than placebo when it was added to glimepiride (with and without metformin).
Dette reducerede HbA1c- niveauet med 0, 30% efter 24 uger hos patienter, som fik Januvia og glimepirid, og med 0, 60% hos de patienter, der ligeledes fik metformin i tillæg til Januvia og glimepirid.
This reduced HbA1c levels after 24 weeks by 0.30% in patients receiving Januvia and glimepiride, and by 0.60% in the patients who were also taking also taking metformin in addition to Januvia and glimepiride.
Den mest almindelige bivirkning ved Januvia, når det tages sammen med andre lægemidler, er hypoglæmi.
The most common side effect when taking Januvia with other medicines is hypoglycaemia.
Dette optræder hos flere end 1 ud af 10 patienter, når Januvia tages med et sulfonylurinstof (med eller uden metformin) og hos mellem 1 og 10 patienter ud af 100, når Januvia tages med en PPAR- gammaagonist.
This is seen in more than 1 patient in 10 when Januvia is taken with a sulphonylurea (with or without metformin) and in between 1 and 10 patients in 100 when Januvia is taken with a PPAR gamma agonist.
Når Januvia tages med metformin alene, er den hyppigste bivirkning (som optræder hos mellem 1 og 10 patienter ud af 100) kvalme.
When Januvia is taken with metformin only, the most common side effect (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
Den fuldstændige liste over de indberettede bivirkninger ved Januvia fremgår af indlægssedlen.
For the full list of all side effects reported with Januvia, see the Package Leaflet.
Januvia må ikke anvendes til personer, der kan være overfølsomme (allergiske) over for sitagliptin eller over for et eller flere af indholdsstofferne.
Januvia should not be used in people who may be hypersensitive (allergic) to sitagliptin or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Januvia er større end risiciene, når lægemidlet anvendes til behandling af patienter med type 2- diabetes mellitus for at forbedre den glykæmiske kontrol i kombination med metformin og/ eller et sulfonylurinstof eller en PPAR- gammaagonist, når diæt og motion plus de andre lægemidler ikke giver tilstrækkelig glykæmisk kontrol.
The Committee for Medicinal Products for Human Use (CHMP) decided that Januvia’ s benefits are greater than its risks for the treatment of patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin and/ or a sulphonylurea, or a PPAR gamma agonist, when diet and exercise plus the other medicines do not provide adequate glycaemic control.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Januvia.
The Committee recommended that Januvia be given marketing authorisation.
Andre oplysninger om Januvia:
Other information about Januvia:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Januvia til Merck Sharp & Dohme Ltd. den 21. marts 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Januvia to Merck Sharp & Dohme Ltd. on 21 March 2007.
Den fuldstændige EPAR om Januvia findes her.
The full EPAR for Januvia can be found here.
Januvia 25 mg filmovertrukne tabletter
NAME OF THE MEDICINAL PRODUCT
Hver tablet indeholder sitagliptin phosphatmonohydrat, svarende til 25 mg sitagliptin.
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
Rund, lyserød, filmovertrukken tablet mærket med ” 221 ” på den ene side.
Round, pink film-coated tablet with “ 221” on one side.
Januvia er indiceret:
For patients with type 2 diabetes mellitus, Januvia is indicated:
• til at forbedre den glykæmiske kontrol i kombination med metformin, i de tilfælde hvor diæt og motion plus metformin alene ikke giver tilstrækkelig glykæmisk kontrol.
• to improve glycaemic control in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
• til at forbedre den glykæmiske kontrol i kombination med et sulfonylurinstof, når diæt og motion plus maksimal tolereret dosis af et sulfonylurinstof alene ikke giver tilstrækkelig glykæmisk kontrol, og når metformin ikke er hensigtsmæssig p. g. a. af kontraindikationer eller intolerance.
• to improve glycaemic control in combination with a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
• til at forbedre den glykæmiske kontrol i kombination med et sulfonylurinstof og metformin, når diæt og motion plus dual behandling med disse lægemidler ikke giver tilstrækkelig glykæmisk kontrol.
• to improve glycaemic control in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.
Til patienter med type 2- diabetes mellitus, hvor anvendelse af en PPARγ- agonist (dvs. glitazoner) er hensigtsmæssig, er Januvia indiceret:
For patients with type 2 diabetes mellitus in whom use of a PPARγ agonist (i. e. a thiazolidinedione) is appropriate, Januvia is indicated:
• i kombination med PPARγ- agonisten, i de tilfælde hvor diæt og motion plus PPARγ- agonisten alene ikke giver tilstrækkelig glykæmisk kontrol.
• in combination with the PPARγ agonist when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.
Dosis for Januvia er 100 mg én gang dagligt.
The dose of Januvia is 100 mg once daily.
Doseringen af metformin eller PPARγ- agonist bør fortsættes, og sitagliptin administreres samtidigt.
The dosage of metformin or PPARγ agonist should be maintained, and sitagliptin administered concomitantly.
Når Januvia anvendes i kombination med et sulfonylurinstof, kan en lavere dosis af sulfonylurinstoffet overvejes for at reducere risikoen for hypoglykæmi (se pkt.
When Januvia is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
2 Patienter med nyreinsufficiens Til patienter med mild nyreinsufficiens (kreatinin- clearance [CrCl] ≥50 ml/ min), er dosisjustering for Januvia ikke nødvendig.
2 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for Januvia is required.
Erfaring fra kliniske undersøgelser af Januvia til patienter med moderat eller svær nyreinsufficiens er begrænset.
Clinical study experience with Januvia in patients with moderate or severe renal insufficiency is limited.
5. 2).
Therefore, use of Januvia is not recommended in this patient population (see section 5.2).
Patienter med leverinsufficiens Dosisjustering er ikke nødvendig til patienter med mild til moderat leverinsufficiens.
Patients with hepatic insufficiency No dosage adjustment is necessary for patients with mild to moderate hepatic insufficiency.
Januvia er ikke undersøgt hos patienter med svær leverinsufficiens.
Januvia has not been studied in patients with severe hepatic insufficiency.
Ældre Dosisjustering er ikke nødvendig på basis af alder.
Elderly No dosage adjustment is necessary based on age.
Der er begrænsede sikkerhedsdata for patienter ≥75 år, og der bør udvises forsigtighed i denne aldersklasse.
Limited safety data is available in patients ≥ 75 years of age and care should be exercised.
Børn Januvia bør ikke anvendes til børn under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning.
Paediatric population Januvia is not recommended for use in children below 18 years of age due to a lack of data on its safety and efficacy.
4. 4 og 4. 8).
Hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 4.8).
Generelt Januvia bør ikke anvendes til patienter med type 1- diabetes eller til behandling af diabetisk ketoacidose.
General Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Her var hyppigheden for hypoglykæmi, der er rapporteret for de patienter, der fik sitagliptin, den samme som hos de patienter, der fik placebo.
Hypoglycaemia when used in combination with other anti-hyperglycaemic agents In clinical trials of Januvia as monotherapy and as part of combination therapy with agents not known to cause hypoglycaemia (i. e. metformin or pioglitazone), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Når sitagliptin blev føjet til behandling med et sulfonylurinstof, øgedes incidensen af hypoglykæmi i forhold til placebo (se pkt.
When sitagliptin was added to a sulphonylurea, the incidence of hypoglycaemia was increased over that of placebo (see section 4.8).
4. 2).
Therefore, to reduce the risk of hypoglycaemia, a lower dose of sulphonylurea may be considered (see section 4.2).
Anvendelsen af sitagliptin sammen med insulin, er ikke undersøgt tilstrækkeligt.
The use of sitagliptin in combination with insulin has not been adequately studied.
5. 2).
Renal insufficiency As the experience is limited, patients with moderate to severe renal insufficiency should not be treated with Januvia (see section 5.2).
Hypersensitivitetsreaktioner Efter markedsføring er der rapporteret om alvorlige hypersensitivitetsreaktioner hos patienter, der er blevet behandlet med Januvia.
Hypersensitivity Reactions Postmarketing reports of serious hypersensitivity reactions in patients treated with Januvia have been reported.
Disse reaktioner er anafylaksi, angioødem og eksfoliative hudreaktioner, herunder Stevens- Johnsons syndrom.
These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
Disse reaktioner startede inden for de første 3 måneder efter initiering af behandling med Januvia, og nogle rapporter kom efter første dosis.
Onset of these reactions occurred within the first 3 months after initiation of treatment with Januvia, with some reports occurring after the first dose.
Hvis der er mistanke om en hypersensitivitetsreaktion, skal Januvia seponeres, og det skal vurderes, om der er andre potentielle årsager til hændelsen.
If a hypersensitivity reaction is suspected, discontinue Januvia, assess for other potential causes for the event, and institute alternative treatment for diabetes.
4. 8).
(See section 4.8).
Andre lægemidlers indvirkning på sitagliptin De kliniske data beskrevet nedenfor tyder på, at risikoen er lav for interaktioner af klinisk betydning mellem lægemidler, der administreres samtidigt.
Effects of other medicinal products on sitagliptin Clinical data described below suggest that the risk for clinically meaningful interactions by co- administered medicinal products is low.
Samtidig administration af multiple doser af 1. 000 mg metformin to gange om dagen og 50 mg sitagliptin ændrede ikke sitagliptins farmakokinetik betydeligt hos patienter med type 2 - diabetes.
Co-administration of multiple twice-daily doses of 1000 mg metformin with 50 mg sitagliptin did not meaningfully alter the pharmacokinetics of sitagliptin in patients with type 2 diabetes.
29% og 68%.
Coadministration of a single 100 mg oral dose of sitagliptin and a single 600 mg oral dose of cyclosporine increased the AUC and Cmax of sitagliptin by approximately 29% and 68%, respectively.
Der forventes derfor ingen klinisk betydende interaktioner med andre p- glykoproteinhæmmere.
Therefore, meaningful interactions would not be expected with other p-glycoprotein inhibitors.
In vitro- undersøgelser tyder på, at CYP3A4 primært er ansvarlig for sitagliptins begrænsede metabolisme, og at CYP2C8 medvirker hertil.
In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8.
Derfor kan potente CYP3A4- hæmmere (dvs. ketoconazol, itraconazol, ritonavir, clarithromycin) muligvis ændre sitagliptins farmakokinetik hos patienter med svær nyreinsufficiens eller ESRD.
For this reason, it is possible that potent CYP3A4 inhibitors (i. e. ketoconazole, itraconazole, ritonavir, clarithromycin) could alter the phamacokinetics of sitagliptin in patients with severe renal insufficiency or ESRD.
Virkningen af potente CYP3A4- hæmmere ved nyreinsufficiens har ikke været genstand for klinisk undersøgelse.
The effects of potent CYP3A4 inhibitors in the setting of renal insufficiency has not been assessed in a clinical study.
Dette giver in vivo evidens for lav tilbøjelighed til at forårsage interaktion med substrater for CYP3A4, CYP2C8, CYP2C9 og organisk kationtransportør.
In clinical studies, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptives, providing in vivo evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C8, CYP2C9, and organic cationic transporter (OCT).
Sitagliptin havde en lille effekt på digoxinkoncentrationen i plasma, og kan være en mild hæmmer af p- glycoprotein in vivo.
Sitagliptin had a small effect on plasma digoxin concentrations, and may be a mild inhibitor of p- glycoprotein in vivo.
Efter administration af 0, 25 mg digoxin samtidig med 100 mg Januvia dagligt i 10 dage, øgedes plasma AUC for digoxin gennemsnitligt med 11% og plasma Cmax med gennemsnitligt 18%.
Following administration of 0.25 mg digoxin concomitantly with 100 mg of Januvia daily for 10 days, the plasma AUC of digoxin was increased on average by 11%, and the plasma Cmax on average by 18%.
Der anbefales ingen dosisjustering af digoxin.
No dosage adjustment of digoxin is recommended.
Graviditet Der er ikke tilstrækkelige data for anvendelse af Januvia til gravide kvinder.
Pregnancy There are no adequate data from the use of Januvia in pregnant women.
Amning Det vides ikke, om sitagliptin udskilles i modermælk hos mennesker.
Lactation It is unknown whether sitagliptin is excreted in human breast milk.
Dyreundersøgelser har vist udskillelse af sitagliptin i modermælk.
Animal studies have shown excretion of sitagliptin in breast milk.
Ved bilkørsel og betjening af maskiner bør der dog tages hensyn til, at svimmelhed og søvnighed er rapporteret.
However, when driving or operating machines, it should be taken into account that dizziness and somnolence have been reported.
I 9 store kliniske undersøgelser af op til 2 års varighed er mere end 2. 700 patienter blevet behandlet med Januvia 100 mg dagligt, alene eller i kombination med metformin, et sulfonylurinstof (med eller uden metformin) eller en PPARγ agonist.
In 9 large clinical trials of up to 2 years in duration, over 2700 patients have received treatment with Januvia 100 mg per day alone or in combination with metformin, a sulphonylurea (with or without metformin) or a PPARγ agent.
I disse undersøgelser var incidensen af seponering på grund af hændelser, der blev anset som lægemiddelrelaterede, 0, 8% ved 100 mg dagligt og 1, 5% ved andre behandlinger.
In these trials, the rate of discontinuation due to adverse experiences considered drug-related was 0.8% with 100 mg per day and 1.5% with other treatments.
Bivirkningsfrekvens identificeret i placebo- kontrollerede kliniske undersøgelser
No adverse reactions considered as drug-related were reported in patients treated with sitagliptin occurring in excess (> 0.2% and difference > 1 patient) of that in patients treated with control.
Bivirkningsfrekvens i henhold til behandlingsregime Sitagliptin Sitagliptin Sitagliptin
Adverse reactions considered as drug-related reported in patients treated with sitagliptin occurring in excess (> 0.2% and difference > 1 patient) of that in patients treated with placebo are listed below (Table 1) by system organ class and frequency.
sammen med
Table 1.
sammen med et sammen med
Adverse Reaction
sammen med sammen med et sammen med
Frequency of adverse reaction by treatment regimen
sulfonylurinstof2
Sitagliptin with Sitagliptin with Sitagliptin with 1 2
metformin og et
Sitagliptin with
PPARγ -
Metformin
sulfonylurinstof3
a Sulfonylurea
lægemiddel
Metformin and a a PPARγ Agent Sulfonylurea3 (pioglitazone)4
Metabolisme og ernæring
hypoglycaemia*
Hypoglykæmi *
Very common
Diarré Kvalme Flatulens Forstoppelse Øvre abdominalsmerter
diarrhea nausea flatulence constipation upper abdominal pain
Almene symptomer
General disorders peripheral oedema
Nedsat blodglucose
Investigations blood glucose decreased *