natgillin/translations-raw huggingface dataset:
Symptomerne inkluderer hævet ansigt, tunge eller hals, synkebesvær, vejrtrækningsbesvær, pludselig optræden af udslæt eller nældefeber, som kan tyde på en reaktion kaldet ” angioødem ”  Leversygdom (hepatitis) (sjælden):
Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulties breathing, sudden onset rash or hives, which may indicate a reaction called “ angioedema”.  Liver disease (hepatitis) (rare):
Andre bivirkninger Nogle patienter har oplevet følgende bivirkninger, mens de tog Jalra og metformin:  Almindelige:
Other side effects Some patients have had the following side effects while taking Jalra and metformin:  Common:
Rysten, hovedpine, svimmelhed, kvalme, lavt blodsukker  Ikke almindelig:
Trembling, headache, dizziness, nausea, low blood glucose  Uncommon:
Nogle patienter har oplevet følgende bivirkninger, mens de tog Jalra og et sulfonylurea:  Almindelige:
Some patients have had the following side effects while taking Jalra and a sulphonylurea:  Common:
Rysten, hovedpine, svimmelhed, svækkelse, lavt blodsukker  Ikke almindelig:
Trembling, headache, dizziness, weakness, low blood glucose  Uncommon:
Forstoppelse  Meget sjældne:
Constipation  Very rare:
Ondt i halsen, løbende næse 27 Nogle patienter har oplevet følgende bivirkninger, mens de tog Jalra og et glitazon:  Almindelige:
27 Some patients have had the following side effects while taking Jalra and a glitazone:  Common:
Vægtøgning, hævede hænder, ankler eller fødder (ødem)  Ikke almindelige:
Weight increase, swollen hands, ankle or feet (oedema)  Uncommon:
Nogle patienter har oplevet følgende bivirkninger, mens de tog Jalra alene:  Almindelig:
Some patients have had the following side effects while taking Jalra alone:  Common:
Svimmelhed  Ikke almindelige:
Dizziness  Uncommon:
Hovedpine, forstoppelse, hævede hænder, ankler eller fødder (ødem), ledsmerter, lavt blodsukker  Meget sjældne:
Headache, constipation, swollen hands, ankle or feet (oedema), joint pain, low blood glucose  Very rare:
OPBEVARING
HOW TO STORE JALRA
 Opbevares utilgængeligt for børn.  Brug ikke Jalra efter den udløbsdato, der står på blisterkortet og pakningen.
 Keep out of the reach and sight of children.  Do not use Jalra after the expiry date which is stated on the blister and the carton.
Udløbsdatoen er den sidste dag i den nævnte måned.  Opbevares i den originale pakning for at beskytte mod fugt.  Brug ikke Jalra, hvis emballagen er beskadiget eller viser tegn på, at nogen har forsøgt at åbne den.
The expiry date refers to the last day of that month.  Store in the original package in order to protect from moisture.  Do not use any Jalra pack that is damaged or shows signs of tampering.
Jalra indeholder:  Aktivt stof: vildagliptin.
What Jalra contains  The active substance is vildagliptin.
Hver tablet indeholder 50 mg vildagliptin.  Øvrige indholdsstoffer: vandfri lactose, mikrokrystallinsk cellulose, natriumstivelseglycoat (type A) og magnesiumstearat.
Each tablet contains 50 mg vildagliptin.  The other ingredients are lactose anhydrous, microcrystalline cellulose, sodium starch glycolate (type A) and magnesium stearate.
Jalras udseende og pakningsstørrelse Jalra 50 mg tabletter er runde, hvide til svagt lysegule og flade præget med ” NVR ” på den ene side og ” FB ” på den anden side.
What Jalra looks like and contents of the pack Jalra 50 mg tablets are round, white to light yellowish and flat, with “ NVR” on one side and “ FB” on the other.
Jalra 50 mg tabletter fås i pakninger med 7, 14, 28, 30, 56, 60, 90, 112, 180 eller 336 tabletter i multipakninger, der indeholder 336 (3x112) tabletter.
Jalra 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks containing 336 (3x112) tablets.
Hvis du vil have yderligere oplysninger om Jalra, skal du henvende dig til den lokale repræsentant:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
28 België/ Belgique/ Belgien Novartis Pharma N. V.
28 België/ Belgique/ Belgien Novartis Pharma N. V.
Janumet er et lægemiddel, der indeholder de to aktive stoffer sitagliptin og metforminhydrochlorid.
Janumet is a medicine containing two active substances, sitagliptin and metformin hydrochloride.
Janumet anvendes til behandling af patienter med type 2- diabetes (sukkersyge) med henblik på at forbedre reguleringen af blodsukkerniveauet.
Janumet is used to treat patients with type 2 diabetes, to improve control of blood sugar levels.
Patienter, der allerede tager metformin, med eller uden sulfonylurin, skal tage Janumet, der indeholder samme dosis metformin.
Patients already taking metformin, with or without a sulphonylurea, should take Janumet containing the same dose of metformin.
Patienter, der allerede tager sitagliptin og metformin som separate tabletter skal skifte til Janumet, som indeholder de samme doser af begge aktive stoffer.
Patients already taking sitagliptin and metformin as separate tablets should switch to Janumet containing the same doses of both active substances.
Hvis Janumet tages sammen med et et sulfonylurinstof, skal dosen af sulfonylurinstof eventuelt sænkes for at undgå hypoglykæmi (lave blodsukkerniveauer).
If Janumet is taken with a sulphonylurea, the dose of the sulphonylurea may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Janumet anbefales ikke til børn under 18 år på grund af manglende data om sikkerhed og effekt hos denne aldersgruppe.
Janumet is not recommended for use in children under 18 years of age because of a lack of information on safety and effectiveness in this group.
De aktive stoffer i Janumet, sitagliptin og metformin hydrochlorid, virker hver især forskelligt.
Reproduction is authorised provided the source is acknowledged. ‘ incretin’ hormones in the body.
Hvordan blev Janumet undersøgt?
How has Janumet been studied?
Tre undersøgelser af Januvia hos patienter med type 2- sukkersyge, hvis blodsukkerniveauer ikke kunne kontrolleres tilstrækkeligt med metformin alene, blev anvendt til at underbygge brugen af Janumet til de samme indikationer.
Three studies of Januvia, in patients with type 2 diabetes whose blood glucose levels were not adequately controlled on metformin alone, were used to support the use of Janumet in the same indications.
Der blev også foretaget to ’ bioækvivalens ’ - undersøgelser, der viser, at de aktive stoffer i de to styrker af Janumet blev optaget i kroppen på samme måde, som når de blev taget hver for sig i to tabletter.
Two ‘ bioequivalence’ studies were also carried out, showing that the active substances in the two strengths of Janumet were absorbed in the body in the same way as when they were taken as separate tablets.
Hvilken fordel viser undersøgelserne, der er ved Janumet?
What benefit has Janumet shown during the studies?
Den hyppigste bivikning ved Janumet (som kunne observeres hos mellem 1 og 10 patienter ud af 100) er kvalme.
The most common side effect with Janumet (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
Den fuldstændige liste over de indberettede bivirkninger ved Janumet fremgår af indlægssedlen.
For the full list of all side effects reported with Janumet, see the Package Leaflet.
Janumet bør ikke anvendes til personer, som kan være overfølsomme (allergiske) over for sitagliptin, metformin eller nogen af indholdsstofferne.
Janumet should not be used in people who may be hypersensitive (allergic) to sitagliptin, metformin or any of the other ingredients.
Hvorfor blev Janumet godkendt?
Why has Janumet been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Janumet er større end risiciene ved behandling af type 2 - diabetes mellitus.
The Committee for Medicinal Products for Human Use (CHMP) decided that Janumet’ s benefits are greater than its risks for the treatment of patients with type 2 diabetes mellitus.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Janumet.
The Committee recommended that Janumet be given marketing authorisation.
2/ 3 Andre oplysninger om:
2/ 3 The full EPAR for Janumet can be found here.
Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu)
Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu)
14 tabletter 28 tabletter 56 tabletter 112 tabletter 168 tabletter 196 tabletter 50x1 tabletter 14 tabletter 28 tabletter 56 tabletter 112 tabletter 168 tabletter 196 tabletter 50x1 tabletter
14 tablets 28 tablets 56 tablets 112 tablets 168 tablets 196 tablets 50x1 tablets 14 tablets 28 tablets 56 tablets 112 tablets 168 tablets 196 tablets 50x1 tablets
Janumet 50 mg/ 850 mg filmovertrukne tabletter.
Janumet 50 mg/ 850 mg film-coated tablets
Janumet er også indiceret som supplement til diæt og motion i kombination med et sulfonylurinstof (dvs. tripel kombinationsbehandling) hos patienter, der ikke er tilstrækkeligt kontrolleret på den maksimalt tolererede dosis metformin og sulfonylurinstof.
Janumet is also indicated in combination with a sulphonylurea (i. e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Doseringen af antihyperglykæmisk behandling med Janumet bør individualiseres på basis af patientens aktuelle regime, effektivitet og tolerabilitet, uden at den maksimale anbefalede daglige dosis på 100 mg sitagliptin overskrides.
The dose of antihyperglycaemic therapy with Janumet should be individualised on the basis of the patient’ s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.
Til patienter, der ikke er tilstrækkeligt kontrolleret på maksimal tolereret dosis af metformin - monoterapi Til patienter, der ikke er tilstrækkeligt kontrolleret på metformin alene, bør den normale startdosis for Janumet doseres som 50 mg sitagliptin to gange dagligt (100 mg i alt pr. dag) plus den dosis metformin, som allerede tages.
For patients inadequately controlled on maximal tolerated dose of metformin monotherapy For patients not adequately controlled on metformin alone, the usual starting dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
Til patienter, der ikke er tilstrækkeligt kontrolleret på dual kombinationsbehandling med den maksimale tolererede dosis af metformin og et sulfonylurinstof Janumet bør doseres som sitagliptin 50 mg to gange dagligt (100 mg i alt pr. dag), og metformin bør gives i en dosis svarende til den, som allerede tages.
For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea The dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
4. 4).
When Janumet is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
2 Til de forskellige metformindoser findes Janumet i styrker på 50 mg sitagliptin og 850 mg metforminhydrochlorid eller 1. 000 mg metforminhydrochlorid.
2 For the different doses on metformin, Janumet is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1000 mg metformin hydrochloride.
Janumet bør gives to gange dagligt sammen med et måltid for at reducere de gastrointestinale bivirkninger, der er forbundet med metformin.
Janumet should be given twice daily with meals to reduce the gastrointestinal undesirable effects associated with metformin.
4. 3 og 4. 4).
Patients with renal insufficiency Janumet should not be used in patients with moderate or severe renal impairment (creatinine clearance < 60 ml/ min) (see sections 4.3 and 4.4).
4. 3 og 5. 2).
Patients with hepatic insufficiency Janumet should not be used in patients with hepatic impairment (see sections 4.3 and 5.2).
Ældre Da metformin og sitagliptin udskilles via nyrerne, bør Janumet anvendes med forsigtighed efterhånden som alderen stiger.
Elderly As metformin and sitagliptin are excreted by the kidney, Janumet should be used with caution as age increases.
Børn Janumet bør ikke anvendes til børn under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning hos denne gruppe.
Paediatric population Janumet is not recommended for use in children below 18 years of age due to a lack of data on its safety and efficacy in this population.
Generelt Janumet bør ikke anvendes til patienter med type 1- diabetes og må ikke anvendes til behandling af diabetisk ketoacidose.
General Janumet should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis.
Hypoglykæmi Patienter, der får Janumet sammen med et sulfonylurinstof, har øget risiko for at få hypoglykæmi.
Hypoglycaemia Patients receiving Janumet in combination with a sulphonylurea may be at risk for hypoglycaemia.
Anvendelse af Janumet sammen med insulin er ikke blevet tilstrækkeligt undersøgt.
The use of Janumet in combination with insulin has not been adequately studied.
4. 8).
If a hypersensitivity reaction is suspected, discontinue Janumet, assess for other potential causes of the event, and institute alternative treatment for diabetes (see section 4.8).
Operation Da Janumet indeholder metforminhydrochlorid, bør behandlingen seponeres 48 timer før elektiv operation med generel, spinal eller epidural anæstesi.
Surgery As Janumet contains metformin hydrochloride, the treatment should be discontinued 48 hours before elective surgery with general, spinal or epidural anaesthesia.
Behandling med Janumet bør sædvanligvis ikke genoptages tidligere end 48 timer herefter og kun efter, at nyrefunktionen er blevet revurderet og fundet normal.
Janumet should not usually be resumed earlier than 48 hours afterwards and only after renal function has been re-evaluated and found to be normal.
4. 5).
Therefore, Janumet should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Ændring i klinisk status hos patienter med tidligere velbehandlet type 2- diabetes En patient med type 2- diabetes, der tidligere var velbehandlet på Janumet, og som udvikler unormale laboratorieværdier eller klinisk sygdom (især vagt eller uklart defineret sygdom) bør vurderes hurtigt med henblik på tegn på ketoacidose eller laktacidose.
4 Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Janumet who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Vurderingen bør inkludere måling af serumelektrolytter og ketoner, blodglucose og hvis indiceret, blod- pH, laktat, pyruvat og
Evaluation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels.
Hvis acidose i en eller anden form forekommer, skal Janumet stoppes omgående, og andre hensigtsmæssige og korrigerende handlinger initieres.
If acidosis of either form occurs, Janumet must be stopped immediately and other appropriate corrective measures initiated.
Der er ikke udført farmakokinetiske interaktionsundersøgelser med Janumet, men sådanne undersøgelser er udført med de enkelte aktive stoffer i Janumet, sitagliptin og metformin.
Pharmacokinetic drug interaction studies with Janumet have not been performed; however, such studies have been conducted with the individual active substances of Janumet, sitagliptin and metformin.
Der er øget risiko for laktacidose ved akut alkoholforgiftning (især i tilfælde af faste, dårlig ernæringstilstand eller leverinsufficiens) på grund af den aktive metforminsubstans i Janumet (se pkt.
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Janumet (see section 4.4).
4. 4).
Therefore, Janumet should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.4).
Hvis en patient ønsker at blive gravid eller bliver gravid, bør behandling med Janumet seponeres, og der bør skiftes til insulinbehandling så snart som muligt.
If a patient wishes to become pregnant or if a pregnancy occurs, treatment with Janumet should be discontinued and switched to insulin treatment as soon as possible.
Der er ikke udført undersøgelser på diegivende dyr med de kombinerede aktive stoffer i Janumet.
No studies in lactating animals have been conducted with the combined active substances of Janumet.
4. 3).
Janumet must therefore not be used in women who are breast-feeding (see section 4.3).
Der er ikke foretaget undersøgelser af virkningen af Janumet på evnen til at føre motorkøretøj eller betjene maskiner.
No studies on the effects on the ability to drive and use machines have been performed with Janumet.
Desuden bør patienter advares om risikoen for hypoglykæmi, når Janumet anvendes sammen med andre sulfonylurinstoffer.
In addition, patients should be alerted to the risk of hypoglycaemia when Janumet is used in combination with other sulfonylurea agents.
5. 2).
There have been no therapeutic clinical trials conducted with Janumet tablets however bioequivalence of Janumet with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).
Diarré Kvalme Obstipation Øvre abdominalsmerter
diarrhoea nausea constipation upper abdominal pain
1 I denne placebo- kontrollerede 24- ugers- undersøgelse af sitagliptin 100 mg, én gang dagligt i kombination med metformin, var incidensen af formodede bivirkninger 9, 3% hos de patienter, der blev behandlet med sitagliptin/ metformin sammenlignet med 10, 1% hos de patienter, der fik placebo/ metformin.
1 In this placebo-controlled 24-week study of sitagliptin 100 mg once daily added to ongoing metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin added to ongoing metformin compared to treatment with placebo added to ongoing metformin was 9.3% and 10.1%, respectively.
2 I denne 24- ugers placebokontrollerede undersøgelse af sitagliptin 100 mg én gang dagligt sammen med kombinationsbehandling med glimepirid og metformin var den bivirkningsincidens, som blev anset for at være lægemiddelrelateret, 18, 1% hos de patienter, der blev behandlet med glimepirid og metformin.
2 In this 24-week placebo-controlled study of sitagliptin 100 mg once daily added to ongoing combination treatment with glimepiride and metformin, the overall incidence of adverse reactions
I en 24- ugers undersøgelse af initial kombinationsbehandling med sitagliptin og metformin to gange dagligt (sitagliptin/ metformin 50 mg/ 500 mg eller 50 mg/ 1. 000 mg) var den totale
7 considered as drug-related in patients treated with the addition of sitagliptin to the ongoing treatment with glimepiride and metformin was 18.1% compared to treatment with the addition of placebo to the ongoing treatment with glimepiride and metformin which was 7.1%.
7 bivirkningsincidens, som blev anset for at være lægemiddelrelateret, henholdsvis 14, 0% og 9, 7% hos de patienter, der blev behandlet med en kombination af sitagliptin og metformin sammenlignet med de patienter, der fik placebo.
In a 24-week study of initial combination therapy with sitagliptin and metformin administered twice daily (sitagliptin/ metformin 50 mg/ 500 mg or 50 mg/ 1,000 mg), the overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin compared to patients treated with placebo was 14.0% and 9.7%, respectively.
4. 4).
During post-marketing experience of Janumet or sitagliptin, one of the active substances of Janumet, the following additional adverse reactions have been reported (frequency not known): hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and exfoliative skin conditions including Stevens-Johnson syndrome (see section 4.4).
Metallisk smag i munden
8 Adverse reaction metallic taste
Urticaria, erythema, pruritus
Skin and subcutaneous disorders urticaria, erythema, pruritis
Metabolisme og ernæring Laktacidose B12- vitaminmangelb
Metabolism and nutrition disorders
Der findes ingen tilgængelige data vedrørende overdosering af Janumet.
No data are available with regard to overdose of Janumet.
9 Farmakoterapeutisk klassifikation:
Pharmacotherapeutic group:
Sitagliptinphosphat, en dipeptylpeptidase- 4- hæmmer (DPP- 4), og metforminhydrochlorid, der tilhører biguanidklassen.
Janumet combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Undersøgelse af sitagliptin i kombination med metformin og et sulfonylurinstof En 24- ugers placebo- kontrolleret undersøgelse blev designet til at vurdere effekt og sikkerhed af sitagliptin (100 mg én gang dagligt) som supplement til glimepirid (alene eller i kombination med metformin).
Study of sitagliptin in combination with metformin and a sulphonylurea A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to glimepiride (alone or in combination with metformin).
Sitagliptin som supplement til glimepirid og metformin gav signifikante forbedringer af
The addition of sitagliptin to glimepiride and metformin provided significant improvements in glycaemic parameters.
11 Hos mennesker har metformin, uafhængigt af dets indvirkning på hyperglykæmi, gunstig indvirkning på lipidmetabolismen.
In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Janumet En bioækvivalensundersøgelse med raske forsøgspersoner viste, at Janumet (sitagliptin/ metforminhydrochlorid) kombinationstabletter er bioækvivalente med samtidig administration af sitagliptinphosphat og metforminhydrochlorid som individuelle tabletter.
Janumet A bioequivalence study in healthy subjects demonstrated that the Janumet (sitagliptin/ metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets.
Metabolisme Sitagliptin metaboliseres i mindre grad og elimineres primært uændret i urinen.
Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Seks metabolitter blev påvist på sporstofniveau og forventes ikke at bidrage til sitagliptins DPP- 4 - hæmmende aktivitet i plasma.
Six metabolites were detected at trace levels and are not expected to contribute to the plasma DPP-4 inhibitory activity of sitagliptin.
12 In vitro- data viste, at sitagliptin ikke er en hæmmer af CYP- isozymerne CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 eller 2B6, og det inducerer ikke CYP3A4 og CYP1A2.
In vitro data showed that sitagliptin is not an inhibitor of CYP isoenzymes CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 or 2B6, and is not an inducer of CYP3A4 and CYP1A2.
Børn Der er ikke udført undersøgelser med anvendelse af sitagliptin til børn.
Paediatric No studies with sitagliptin have been performed in paediatric patients.