natgillin/translations-raw huggingface dataset:
De fleste patienter (80,5 %) fik insulin som baggrundsbehandling enten alene eller i kombination med orale antidiabetika såsom sulfonylurinstof, glinid eller pioglitazon. 
Most patients (80.5%) received insulin as background therapy, alone or in combination with other oral anti-diabetics such as sulphonylurea, glinide and pioglitazone.
Hvis du holder op med at tage Trajenta 
If you stop taking Trajenta
Linagliptin givet én gang dagligt medførte klinisk signifikante forbedringer i glykæmisk kontrol uden klinisk relevant ændring af kropsvægten. 
Linagliptin once daily produced clinically significant improvements in glycaemic control, with no clinically relevant change in body weight.
Hvis du ønsker yderligere oplysninger om Trajenta, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen: 
For any information about this medicine, please contact the local representatives of the Marketing Authorisation Holder:
Linagliptin er derfor ikke en inhibitor af OCT-medieret transport. 
Therefore, linagliptin is not an inhibitor of OCT-mediated transport.
• Ikke almindelige: Betændelse i næse eller svælg (nasofaryngit), hoste, forstoppelse (i kombination med insulin), forhøjet indhold af amylase i blodet. 
• Uncommon: inflamed nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), level of amylase in the blood increased.
Tabel 2 Kardiovaskulære og renale endepunkter pr. behandlingsgruppe i CARMELINA-studiet 
Table 2 Cardiovascular and renal outcomes by treatment group in the CARMELINA study
"D5" på den ene side og firmalogo på den anden. 
“D5” on one side and the Boehringer Ingelheim logo on the other.
Pædiatrisk population Linagliptins sikkerhed og virkning hos børn og unge er endnu ikke klarlagt. 
The safety and efficacy of linagliptin in children and adolescents has not yet been established.
Tabletkerne: Mannitol, pregelatineret stivelse (majs), majsstivelse, copovidon, magnesiumstearat 
Tablet core: Mannitol, pregelatinised starch (maize), maize starch, copovidone, magnesium stearate
Hvis du har glemt at tage Trajenta 
If you forget to take Trajenta
Simulationer af steady state-plasmakoncentrationer af linagliptin, med og uden samtidig administration af ritonavir, tydede på, at øget eksponering ikke er forbundet med øget akkumulering. 
Simulations of steady-state plasma concentrations of linagliptin with and without ritonavir indicated that the increase in exposure will be not associated with an increased accumulation.
Dosis af linagliptin er 5 mg én gang dagligt. 
The dose of linagliptin is 5 mg once daily.
De tilgængelige farmakokinetiske data fra dyrestudier viser, at linagliptin/metabolitter udskilles i mælk. 
Available pharmacokinetic data in animals have shown excretion of linagliptin/metabolites in milk.
Det vides ikke, om Trajenta går over i mælk. 
It is not known if Trajenta passes into human breast milk.
Efter en median opfølgning på 6,25 år øgede linagliptin ikke risikoen for større kardiovaskulære hændelser (se tabel 3), sammenlignet med glimepirid. 
After a median follow up of 6.25 years, linagliptin did not increase the risk of major adverse cardiovascular events (see table 3) as compared to glimepiride.
• Rifampicin - et antibiotikum, der bruges til behandling af infektioner såsom tuberkulose. 
This is an antibiotic used to treat infections such as tuberculosis.
Trajenta bruges ved type 2-diabetes hos voksne, når sygdommen ikke kan kontrolleres tilstrækkeligt med et oralt diabeteslægemiddel (metformin eller sulfonylurinstof) eller udelukkende med diæt og motion. 
Trajenta is used for ‘type 2 diabetes' in adults, if the disease cannot be adequately controlled with one oral anti-diabetic medicine (metformin or sulphonylureas) or diet and exercise alone.
I en yderligere opfølgningsperiode på 40 uger var dosisjustering af den antidiabetiske baggrundsbehandling tilladt. 
There was a further follow up 40 week treatment period during which dose adjustments in antidiabetes background therapies were allowed.
Hud og subkutane væv Angioødem* 
Skin and subcutaneous tissue disorders Angioedema*
Farmakokinetiske studier tyder på, at dosisjustering ikke er nødvendig hos patienter med nedsat leverfunktion, men der mangler klinisk erfaring. 
Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking.
Der er ikke gennemført studier af linagliptins virkning på human fertilitet. 
No studies on the effect on human fertility have been conducted for linagliptin.
2-årige, orale karcinogenicitetsstudier i rotter og mus viste ikke nogen evidens for karcinogenicitet hos rotter eller hanmus. 
Oral 2 year carcinogenicity studies in rats and mice revealed no evidence of carcinogenicity in rats or male mice.
Efter en median opfølgning på 2,2 år øgede linagliptin, når det blev tilføjet til den sædvanlige behandling, ikke risikoen for større uønskede kardiovaskulære hændelser eller renale hændelser. 
After a median follow up of 2.2 years, linagliptin, when added to usual care, did not increase the risk of major adverse cardiovascular events or renal outcome events.
Desuden blev 1.238 patienter med let nedsat nyrefunktion og 143 patienter med moderat nedsat nyrefunktion behandlet med linagliptin. 
There were also 1,238 patients with mild renal impairment, and 143 patients with moderate renal impairment on linagliptin.
Ældre (65 til 80 år, de ældste patienter var 78 år) og yngre havde sammenlignelige plasmakoncentrationer af linagliptin. 
Older subjects (65 to 80, oldest patient was 78 years) had comparable plasma concentrations of linagliptin compared to younger subjects.
C]-linagliptin 10 mg dosis blev ca. 5 % af radioaktiviteten udskilt med urinen. 
C] linagliptin oral 10 mg dose, approximately 5% of the radioactivity was excreted in urine.
Filmovertræk: Hypromellose, titandioxid (E171), talcum, macrogol (6.000), rød jernoxid (E172) 
Film coating: Hypromellose, titanium dioxide (E171), talc, macrogol (6000), iron oxide red (E172)
Du skal fortsat følge de råd om diæt og motion, som lægen eller sygeplejersken har givet. 
It is important to keep following the advice about diet and exercise that you have been given by your doctor or nurse.
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med linagliptin i en eller flere undergrupper af den pædiatriske population ved type 2-diabetes (se pkt. 
The European Medicines Agency has deferred the obligation to submit the results of studies with linagliptin in one or more subsets of the paediatric population in Type 2 diabetes (see section 4.2 for information on paediatric use).
Incidensen af hypoglykæmi i linagliptingruppen (7,5 %) var signifikant lavere end incidensen i glimepiridgruppen (36,1 %). 
The incidence of hypoglycaemia in the linagliptin group (7.5%) was significantly lower than that in the glimepiride group (36.1%).
Ca. 19 % af populationen havde eGFR ≥ 45 til < 60 ml/min/1,73 m2, 28 % af populationen havde eGFR ≥ 30 til < 45 ml/min/1,73 m 2, og 15 % havde eGFR < 30 ml/min/1,73 m 
Approximately 19% of the population had eGFR ≥45 to <60 mL/min/1.73 m2, 28% of the population had eGFR ≥30 to <45 mL/min/1.73 m2 and 15%
Der forventes ikke klinisk betydningsfulde interaktioner med andre sulfonylurinstoffer (f.eks. glipizid, tolbutamid og glimepirid), der som glibenclamid primært elimineres af CYP2C9. 
Clinically meaningful interactions would not be expected with other sulphonylureas (e.g., glipizide, tolbutamide, and glimepiride) which, like glibenclamide, are primarily eliminated by CYP2C9.
Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger på fertiliteten (se pkt. 
Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Det skal besluttes, om amning eller behandling med linagliptin skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen. 
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from linagliptin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
INFORMATION I BRAILLESKRIFT Trajenta 5 mg 
INFORMATION IN BRAILLE Trajenta 5 mg
Linagliptin hæmmer enzymet DPP-4 (dipeptidylpeptidase 4, EC 3.4.14.5), et enzym, der er involveret i inaktiveringen af inkretinhormonerne GLP-1 og GIP (glucagon-lignende peptid-1, glucoseafhængigt insulintropt polypeptid). 
Linagliptin is an inhibitor of the enzyme DPP-4 (dipeptidyl peptidase 4, EC 3.4.14.5) an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide1, glucose-dependent insulinotropic polypeptide).
Ved høje koncentrationer, hvor DPP-4 er fuldt mættet, var 70-80 % af linagliptin bundet til andre plasmaproteiner end DPP-4, og 30-20 % var ubundet. 
At high concentrations, where DPP-4 is fully saturated, 70-80% of linagliptin was bound to other plasma proteins than DPP-4, hence 30-20% were unbound in plasma.
Din læge kan ordinere Trajenta sammen med andre diabeteslægemidler. 
Your doctor may prescribe Trajenta together with another oral anti-diabetic medicine.
• når metformin ikke er hensigtsmæssig pga. intolerans eller kontraindiceret pga. nedsat nyrefunktion som kombinationsterapi 
• when metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.
Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger på reproduktionstoksicitet (se pkt. 
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Macrogol (6000) Jernoxid, rød (E172) 
Macrogol (6000) Iron oxide red (E172)
Den anbefalede dosis af Trajenta er 5 mg som 1 tablet én gang dagligt. 
The recommended dose of Trajenta is one 5 mg tablet once a day.
• Svære og vedvarende smerter i maven, som kan stråle ud til ryggen, samt kvalme og opkastning, 
• Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas
Linagliptin påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner. 
Linagliptin has no or negligible influence on the ability to drive and use machines.
Hvis der er mistanke om bulløs pemfigoid, skal Trajenta seponeres. 
If bullous pemphigoid is suspected, Trajenta should be discontinued.
Trajenta er indiceret til behandling af voksne patienter med type 2-diabetes mellitus som tillæg til diæt og motion for at forbedre den glykæmiske kontrol: som monoterapi 
Trajenta is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as: monotherapy
Samtidig administration af andre potente P-glykoprotein- og CYP3A4induktorer, såsom carbamazepin, phenobarbital og phenytoin, er ikke undersøgt. 
Co-administration with other potent inducers of P-glycoprotein and CYP3A4, such as carbamazepine, phenobarbital and phenytoin has not been studied.
Trajenta indeholder: - Aktivt stof: Linagliptin 
What Trajenta contains - The active substance is linagliptin
Koncentrationen af ubundet linagliptin, der normalt er mindre end 1 % ved terapeutisk dosis, blev forøget 4-5 gange efter samtidig administration med ritanovir. 
The unbound concentrations, which are usually less than 1% at the therapeutic dose of linagliptin, were increased 4-5-fold after coadministration with ritonavir.
sjælden 
rare
Patienter behandlet med linagliptin havde en signifikant gennemsnitlig reduktion i kropsvægt i forhold til baseline sammenlignet med en signifikant vægtstigning hos patienter, der fik glimepirid (-1,39 vs +1,29 kg). 
Patients treated with linagliptin exhibited a significant mean decrease from baseline in body weight compared to a significant weight gain in patients administered glimepiride (-1.39 vs +1.29 kg).
Efter oral administration af en 5 mg dosis til enten raske frivillige eller patienter absorberes linagliptin hurtigt og maksimal plasmakoncentration (median Tmax) blev opnået 1,5 time efter indtagelsen. 
After oral administration of a 5 mg dose to healthy volunteers or patients, linagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1.5 hours post-dose.
I de placebokontrollerede studier blev linagliptin givet som: 
The placebo-controlled studies included studies where linagliptin was given as
Orale antidiabetika bruges til at behandle for højt blodsukker, idet det medvirker til at sænke indholdet af sukker i blodet. 
Oral anti-diabetics are used to treat high blood sugar levels.
Farmakoterapeutisk klassifikation: Antidiabetika, dipeptidylpeptidase-4 (DPP-4)-hæmmere, ATCkode: A10BH05 
Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH05
Samtidig indtagelse af et måltid med højt fedtindhold og linagliptin forlængede tiden til at opnå Cmax med 2 timer og sænkede Cmax med 15 %, men der blev ikke observeret nogen påvirkning af AUC0-72t. 
Co-administration of a high-fat meal with linagliptin prolonged the time to reach Cmax by 2 hours and lowered Cmax by 15% but no influence on AUC 0-72h was observed.
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Trajenta, hvis du: 
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Trajenta if you:
Der forventes derfor ikke klinisk relevante interaktioner med andre P-glykoprotein/CYP3A4-hæmmere. 
Therefore, clinically relevant interactions would not be expected with other Pglycoprotein/CYP3A4 inhibitors.
• Trajenta fås i perforerede enkeltdosisblistere i aluminium/aluminium. 
• Trajenta is available in perforated aluminium/aluminium unit dose blisters.
Dosisreduktion af sulfonylurinstof eller insulin kan overvejes (se pkt. 
A dose reduction of the sulphonylurea or insulin may be considered (see section 4.2).
Desuden fandt man i fase I-studier, at linagliptins farmakokinetiske karakteristika var ens hos japanske, kinesiske og kaukasiske raske frivillige. 
In addition the pharmacokinetic characteristics of linagliptin were found to be similar in dedicated phase I studies in Japanese, Chinese and Caucasian healthy volunteers.
Plasmaproteinbindingen af linagliptin var koncentrationsafhængig og faldt fra ca. 99 % ved 1 nmol/l til 75-89 % ved ≥ 30 nmol/l, hvilket afspejler, at bindingen til DPP-4 blev mættet med stigende koncentrationer af linagliptin. 
Plasma protein binding of linagliptin is concentration-dependent, decreasing from about 99% at 1 nmol/l to 75-89% at ≥30 nmol/l, reflecting saturation of binding to DPP-4 with increasing concentration of linagliptin.
Når linagliptin anvendes i kombination med et sulfonylurinstof eller med insulin, kan en lavere dosis sulfonylurinstof eller insulin overvejes for at reducere risikoen for hypoglykæmi (se pkt. 
When linagliptin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin, may be considered to reduce the risk of hypoglycaemia (see section 4.4)
Pankreatitis blev rapporteret hyppigere hos patienter randomiseret til linagliptin (7 tilfælde ud af 6.580 linagliptin-behandlede patienter mod 2 tilfælde ud af 4.383 placebobehandlede). 
Pancreatitis was reported more often in patients randomized to linagliptin (7 events in 6,580 patients receiving linagliptin versus 2 events in 4,383 patients receiving placebo).
Derfor bør der udvises forsigtighed, når linagliptin bruges i kombination med et sulfonylurinstof og/eller insulin. 
Therefore, caution is advised when linagliptin is used in combination with a sulphonylurea and/or insulin.
Pregelatineret stivelse (majs) Majsstivelse 
Pregelatinised starch (maize) Maize starch
Tabel 3 Større kardiovaskulære bivirkninger (MACE) og mortalitet pr. behandlingsgruppe i CAROLINA-studiet 
Table 3 Major adverse cardiovascular events (MACE) and mortality by treatment group in the
Som et resultat af vævsbindingen var det gennemsnitlige fordelingsvolumen ved steady state efter en enkelt intravenøs dosis på 5 mg linagliptin hos raske frivillige ca. 1.110 liter, hvilket antyder, at linagliptin har en udtalt vævsfordeling. 
As a result of tissue binding, the mean apparent volume of distribution at steady-state following a single 5 mg intravenous dose of linagliptin to healthy subjects is approximately 1,110 litres, indicating that linagliptin extensively distributes to the tissues.
Hos patienter med moderat nedsat nyrefunktion sås en moderat øget eksponeringen på ca. 1,7 gange sammenlignet med kontrolgruppen. 
In moderate renal impairment, a moderate increase in exposure of about 1.7 fold was observed compared with control.
Incidensen af hypoglykæmi hos patienter behandlet med linagliptin var højere end for placebo på grund af en øget incidens af asymptomatiske hypoglykæmiske hændelser. 
The observed incidence of hypoglycaemia in patients treated with linagliptin was higher than placebo, due to an increase in asymptomatic hypoglycaemic events.
Plasmakoncentrationen af linagliptin aftog tre-fasisk med en lang terminal halveringstid (længere end 100 timer), der overvejende var relateret til linagliptins mættede, tætte binding til DPP-4, uden at bidrage til lægemiddelakkumuleringen. 
Plasma concentrations of linagliptin decline in a triphasic manner with a long terminal half-life (terminal half-life for linagliptin more than 100 hours), that is mostly related to the saturable, tight binding of linagliptin to DPP-4 and does not contribute to the accumulation of the medicinal product.
Efter administration af 5 mg linagliptin én gang dagligt opnåedes steady state-plasmakoncentrationerne efter tredje dosis. 
After once daily dosing of 5 mg linagliptin, steady-state plasma concentrations are reached by the third dose.
Dosisjustering er ikke nødvendig på baggrund af BMI. 
No dosage adjustment is necessary based on BMI.
Simvastatin: Daglige doser af linagliptin havde hos raske frivillige en minimal indvirkning på steady state-farmakokinetikken af simvastatin, et sensitivt CYP3A4-substrat. 
Simvastatin: multiple daily doses of linagliptin had a minimal effect on the steady-state pharmacokinetics of simvastatin, a sensitive CYP3A4 substrate, in healthy volunteers.
Trajenta har ingen eller kun ubetydelig indvirkning på evnen til at føre motorkøretøj og betjene maskiner. 
Driving and using machines Trajenta has no or negligible influence on the ability to drive and use machines.
Rund, lyserød, filmovertrukket 8 mm tablet præget med D5 på den ene side og firmalogo på den anden. 
8 mm diameter round, light red film-coated tablet debossed with "D5" on one side and the Boehringer Ingelheim logo on the other.
Den observerede forskel i HbA1c i forhold til placebo var -0,72 % efter 52 uger. 
The observed difference in HbA1c over placebo was0.72% after 52 weeks.
Brug af anden medicin sammen med Trajenta 
Other medicines and Trajenta
For daglige supraterapeutiske doser på 10 mg linagliptin og 40 mg simvastatin i 6 dage, var simvastatins plasma-AUC øget med 34 % og plasma-Cmax var øget med 10 %. 
Following administration of a supratherapeutic dose of 10 mg linagliptin concomitantly with 40 mg of simvastatin daily for 6 days, the plasma AUC of simvastatin was increased by 34%, and the plasma Cmax by 10%.
Linagliptin er substrat for P-glykoprotein og hæmmer P-glykoproteinmedieret transport af digoxin med lav potens. 
Linagliptin is a P-glycoprotein substrate, and inhibits P-glycoprotein mediated transport of digoxin with low potency.
- monoterapi i op til 4 uger - monoterapi i ≥ 12 uger - kombinationsbehandling med metformin - kombinationsbehandling med metformin + sulfonylurinstof - kombinationsbehandling med metformin og empagliflozin - kombinationsbehandling med insulin, med eller uden metformin 
- monotherapy with short-term duration of up to 4 weeks - monotherapy with ≥ 12 week duration - add-on to metformin - add-on to metformin + sulphonylurea - add on to metformin and empagliflozin - add-on to insulin with or without metformin
Det kan være hensigtsmæssigt at teste blodsukkeret hyppigere for at minimere risikoen for for lavt blodsukker, især når Trajenta kombineres med sulfonylurinstof og/eller insulin. 
However, more frequent blood glucose testing might be recommended to minimise the risk for hypoglycaemia, especially when Trajenta is combined with sulphonylurea and/or insulin.
I rotter blev der set påvirkning af kønsorganerne, thyroidea og lymfoide organer ved en eksponering på mere end 1.500 gange den humane eksponering. 
In rats effects on reproductive organs, thyroid and the lymphoid organs were seen at more than 1,500 times human exposure.
Trajenta kan bruges sammen med anden diabetesmedicin, f.eks. metformin, sulfonylurinstof (f.eks. glimepirid eller glipizid), empagliflozin eller insulin. 
Trajenta may be used together with other anti-diabetic medicines e.g. metformin, sulphonylureas (e.g. glimepiride, glipizide), empagliflozin, or insulin.
Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk 
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Tag ikke Trajenta - hvis du er allergisk over for linagliptin eller et af de øvrige indholdsstoffer (angivet i afsnit 6). 
What you need to know before you take Trajenta Do not take Trajenta - if you are allergic to linagliptin or any of the other ingredients of this medicine (listed in section
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 5 mg linagliptin. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of linagliptin.
Den observerede incidens af hypoglykæmi hos linagliptin-behandlede patienter svarede til incidensen i placebo-gruppen (22,2 % linagliptin; 21,2 % placebo). 
The observed incidence of hypoglycaemia in patients treated with linagliptin was similar to placebo (22.2% linagliptin; 21.2% placebo).
Tabel 1 Bivirkninger rapporteret hos patienter i behandling med linagliptin 5 mg dagligt som monoterapi eller i kombinationsbehandling i kliniske studier og fra postmarketing erfaring. 
Table 1 Adverse reactions reported in patients who received linagliptin 5 mg daily as monotherapy or as add-on therapies in clinical trial and from post-marketing experience
4.4, 4.5 og 5.1 for de tilgængelige oplysninger om forskellige kombinationer). 
when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Nogle patienter fik udslæt (hyppighed ikke almindelig), nældefeber (urticaria; hyppigheden er sjælden (kan forekomme hos op til 1 ud af 1.000 personer)) samt hævelse af ansigt, læber, tunge og svælg, hvilket kan forårsage problemer med at trække vejret eller synke (angioødem; hyppighed sjælden). 
Some patients experienced rash (frequency uncommon), hives (urticaria; frequency rare, may affect up to 1 in 1000 people), and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing (angioedema; frequency rare).
Med henblik på at evaluere effekt og sikkerhed er der gennemført 8 randomiserede, kontrollerede fase III-studier med 5.239 type 2-diabetespatienter, hvoraf 3.319 blev behandlet med linagliptin. 
8 phase III randomised controlled trials involving 5,239 patients with type 2 diabetes, of which 3,319 were treated with linagliptin were conducted to evaluate efficacy and safety.
I kliniske studier, hvor linagliptin blev givet i kombination med lægemidler, der ikke er kendt for at medføre hypoglykæmi (metformin), rapporteredes hypoglykæmirater for linagliptin, der var sammenlignelige med raterne for patienter, der fik placebo. 
In clinical trials of linagliptin as part of combination therapy with medicinal products not known to cause hypoglycaemia (metformin), rates of hypoglycaemia reported with linagliptin were similar to rates in patients taking placebo.