FrancophonIA/ELRC3.0 huggingface dataset:
English: However patients should be alerted to the risk of hypoglycaemia especially when combined with sulphonylurea and/or insulin.
Danish: Patienterne bør advares om risikoen for hypoglykæmi, når Trajenta anvendes i kombination med sulfonylurinstof og/eller insulin.
English: Rifampicin: multiple co-administration of 5 mg linagliptin with rifampicin, a potent inductor of P-glycoprotein and CYP3A4, resulted in a 39.6% and 43.8% decreased linagliptin steady-state AUC and Cmax, respectively, and about 30% decreased DPP-4 inhibition at trough.
Danish: Rifampicin: Samtidig gentagen administration af 5 mg linagliptin og rifampicin, en potent Pglykoprotein og CYP3A4-inducer, resulterede i en reduktion af linagliptin steady state -AUC og Cmax på henholdvis 39,6 % og 43,8 % og en ca. 30 % lavere DPP-4-hæmning ved trough.
English: The pharmacokinetics of linagliptin has been extensively characterised in healthy subjects and patients with type 2 diabetes.
Danish: Linagliptins farmakokinetik er udførligt undersøgt hos raske frivillige og hos type 2-diabetes patienter.
English: Adverse reactions classified by system organ class and MedDRA preferred terms reported in patients who received 5 mg linagliptin in double-blind studies as monotherapy or as add-on therapy are presented in the table below (see table 1).
Danish: Bivirkninger opstillet i tabellen nedenfor er klassificeret efter systemorganklasser og foretrukken term i henhold til MedDRA, og indberettet for patienter i dobbeltblindede studier behandlet med 5 mg linagliptin som monoterapi eller kombinationsbehandling (se tabel 1).
English: The use of linagliptin has not been studied in pregnant women.
Danish: Linagliptin bør ikke anvendes under graviditeten.
English: No dosage adjustment is necessary based on gender.
Danish: Dosisjustering er ikke nødvendig på baggrund af køn.
English: Ritonavir: co-administration of a single 5 mg oral dose of linagliptin and multiple 200 mg oral doses of ritonavir, a potent inhibitor of P-glycoprotein and CYP3A4, increased the AUC and Cmax of linagliptin approximately twofold and threefold, respectively.
Danish: Ritonavir: Samtidig administration af en oral dosis af 5 mg linagliptin og multiple orale doser af 200 mg ritonavir, en potent inhibitor af P-glykoprotein og CYP3A4, gav en hhv. to- og trefoldig stigning i AUC og Cmax.
English: If you have symptoms of acute pancreatitis, like persistent, severe stomach ache (abdominal pain), you should consult your doctor.
Danish: Hvis du har vedvarende, svære mavesmerter, kan det være symptomer på akut pankreatitis, og du skal kontakte din læge.
English: Linagliptin also provided significant improvements in fasting plasma glucose (FPG), and a greater proportion of patients achieved a target HbA1c of < 7.0%, compared to placebo.
Danish: Linagliptin medførte desuden signifikant reduktion i faste-plasma-glucose (FPG), og en større andel af patienterne nåede det terapeutiske mål på HbA1c < 7,0 % sammenlignet med placebo.
English: A multiple-dose, open-label study was conducted to evaluate the pharmacokinetics of linagliptin (5 mg dose) in patients with varying degrees of chronic renal insufficiency compared to normal healthy control subjects.
Danish: I et åbent flerdosisstudie blev farmakokinetikken af linagliptin (5 mg dosis) undersøgt hos patienter med varierende grader af kronisk nedsat nyrefunktion og sammenlignet med raske frivillige.
English: Linagliptin as add-on therapy in elderly (age ≥ 70 years) with type 2 diabetes The efficacy and safety of linagliptin in elderly (age ≥ 70years) with type 2 diabetes was evaluated in a double-blind study of 24 weeks duration.
Danish: Linagliptin som tillægsbehandling til ældre (> 70 år) med type 2-diabetes I et dobbeltblindet 24-ugers studie blev virkningen og sikkerheden af linagliptin 5 mg evalueret hos ældre (> 70 år) med type 2-diabetes.
English: Linagliptin as add-on to a combination of metformin and sulphonylurea therapy A placebo-controlled study of 24 weeks in duration was conducted to evaluate the efficacy and safety of linagliptin 5 mg to placebo, in patients not sufficiently treated with a combination with metformin and a sulphonylurea.
Danish: Linagliptin som tillæg til metformin og et sulfonylurinstof I et 24-ugers placebokontrolleret studie blev virkningen og sikkerheden af linagliptin 5 mg undersøgt hos patienter, der ikke var tilstrækkeligt behandlet med en kombination af metformin og et sulfonylurinstof.
English: Sulphonylureas: co-administration of multiple oral doses of 5 mg linagliptin and a single oral dose of 1.75 mg glibenclamide (glyburide) resulted in clinically not relevant reduction of 14% of both AUC and Cmax of glibenclamide.
Danish: Sulfonylurinstoffer: Samtidig administration af en enkelt oral dosis på 1,75 mg glibenclamid (glyburid) og daglige doser på 5 mg linagliptin medførte en klinisk irrelevant reduktion på 14 % af både AUC og Cmax for glibenclamid.
English: Perforated alu/alu unit dose blisters in cartons containing 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 and 120 x 1 film-coated tablets.
Danish: Perforerede alu/alu-enkeltdosisblistere i æsker indeholdende 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 og 120 x 1 filmovertrukne tabletter.
English: EU/1/11/707/001 10 x 1 tablets EU/1/11/707/002 14 x 1 tablets EU/1/11/707/003 28 x 1 tablets EU/1/11/707/004 30 x 1 tablets EU/1/11/707/005 56 x 1 tablets EU/1/11/707/006 60 x 1 tablets EU/1/11/707/007 84 x 1 tablets EU/1/11/707/008 90 x 1 tablets EU/1/11/707/009 98 x 1 tablets EU/1/11/707/010 100 x 1 tablets EU/1/11/707/011 120 x 1 tablets
Danish: EU/1/11/707/001 10 x 1 tabletter EU/1/11/707/002 14 x 1 tabletter EU/1/11/707/003 28 x 1 tabletter EU/1/11/707/004 30 x 1 tabletter EU/1/11/707/005 56 x 1 tabletter EU/1/11/707/006 60 x 1 tabletter EU/1/11/707/007 84 x 1 tabletter EU/1/11/707/008 90 x 1 tabletter EU/1/11/707/009 98 x 1 tabletter EU/1/11/707/010 100 x 1 tabletter EU/1/11/707/011 120 x 1 tabletter
English: • Carbamazepine, phenobarbital or phenytoin.
Danish: • Carbamazepin, phenobarbital eller phenytoin, som er medicin, der bruges til at kontrollere krampeanfald eller mod kroniske smerter
English: Metformin: co-administration of multiple daily doses of 10 mg linagliptin with 850 mg metformin, an OCT substrate, had no relevant effect on the pharmacokinetics of metformin in healthy volunteers.
Danish: Metformin: Samtidig, gentagen administration af daglige doser på 10 mg linagliptin sammen med 850 mg metformin, et OCT-substrat, havde ingen relevant indvirkning på metformins farmakokinetik hos raske frivillige.
English: Effects on plasma lipids were negligible.
Danish: Der var ingen betydende ændringer i plasma-lipidniveauer.
English: Digoxin: co-administration of multiple daily doses of 5 mg linagliptin with multiple doses of 0.25 mg digoxin had no effect on the pharmacokinetics of digoxin in healthy volunteers.
Danish: Digoxin: Samtidig gentagen administration af 5 mg linagliptin og 0,25 mg digoxin dagligt havde ingen indvirkning på digoxins farmakokinetik hos raske frivillige.
English: In the pooled analysis of the placebo-controlled trials, the overall incidence of adverse events in patients treated with placebo was similar to linagliptin 5 mg (63.4% versus 59.1%).
Danish: I en puljet analyse af de placebokontrollerede studier var den overordnede bivirkningsfrekvens i gruppen, der fik placebo, sammenlignelig med bivirkningsfrekvensen i gruppen, der fik linagliptin 5 mg (63,4 % mod 59,1 %).
English: Treatment with once daily linagliptin at 5 mg provided a significant improvement in HbA1c (-0.69% change compared to placebo), in patients with baseline HbA1c of approximately 8%.
Danish: Behandling med linagliptin 5 mg én gang dagligt medførte en signifikant reduktion i HbA1c (ændring på -0,69 % sammenlignet med placebo) hos patienter med et baselineHbA1c på ca. 8 %.
English: Trajenta 5 mg film-coated tablets Linagliptin
Danish: Trajenta 5 mg filmovertrukne tabletter linagliptin
English: Film-coated tablet (tablet).
Danish: Filmovertrukken tablet
English: EU/1/11/707/006 (60 x 1 tablets) EU/1/11/707/007 (84 x 1 tablets) EU/1/11/707/008 (90 x 1 tablets) EU/1/11/707/009 (98 x 1 tablets) EU/1/11/707/010 (100 x 1 tablets) EU/1/11/707/011 (120 x 1 tablets)
Danish: EU/1/11/707/001 (10 x 1 tabletter) EU/1/11/707/002 (14 x 1 tabletter) EU/1/11/707/003 (28 x 1 tabletter) EU/1/11/707/004 (30 x 1 tabletter) EU/1/11/707/005 (56 x 1 tabletter) EU/1/11/707/006 (60 x 1 tabletter) EU/1/11/707/007 (84 x 1 tabletter) EU/1/11/707/008 (90 x 1 tabletter) EU/1/11/707/009 (98 x 1 tabletter) EU/1/11/707/010 (100 x 1 tabletter) EU/1/11/707/011 (120 x 1 tabletter)
English: It is not an inducer of CYP isozymes.
Danish: Linagliptin inducerer ikke CYPisozymer.
English: Discontinuation of therapy due to adverse events was higher in patients who received placebo as compared to linagliptin 5 mg (4.3% versus 3.4%).
Danish: Andelen af patienter, der seponerede behandlingen som følge af bivirkninger, var højere i placebogruppen end i linagliptin 5 mg gruppen (4,3 % mod 3,4 %).
English: How to take Trajenta
Danish: Sådan skal du tage Trajenta
English: In addition patients with T2DM and severe renal impairment (<30 ml/min) were compared to T2DM patients with normal renal function.
Danish: Desuden blev patienter med type 2-diabetes og svært nedsat nyrefunktion (< 30 ml/min.)
English: A decision must be made by your doctor whether to discontinue breast-feeding or to discontinue/abstain from Trajenta therapy.
Danish: Lægen vil beslutte, om enten amning eller behandling med Trajenta skal ophøre.
English: The observed incidence of hypoglycaemia in patients treated with linagliptin was similar to placebo.
Danish: Den observerede incidens af hypoglykæmi hos patienter behandlet med linagliptin, svarede til incidensen for placebo.
English: Metformin: co-administration of multiple three times daily doses of 850 mg metformin with 10 mg linagliptin once daily did not clinical meaningfully alter the pharmacokinetics of linagliptin in healthy volunteers.
Danish: Metformin: Samtidig, gentagen administration af 850 mg metformin tre gange dagligt og 10 mg linagliptin én gang dagligt gav ikke klinisk relevante ændringer i linagliptins farmakokinetik hos raske frivillige.
English: In clinical studies, as described below, linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glyburide, simvastatin, warfarin, digoxin or oral contraceptives providing in vivo evidence of a low propensity for causing medicinal product interactions with substrates of CYP3A4, CYP2C9, CYP2C8, P-glycoprotein, and organic cationic transporter (OCT).
Danish: I kliniske studier, som beskrevet nedenfor, havde linagliptin ingen klinisk relevant indvirkning på farmakokinetikken af metformin, glyburid, simvastatin, warfarin, digoxin eller orale kontraceptiva.
English: Linagliptin also showed significant improvements in fasting plasma glucose (FPG) compared to placebo.
Danish: Linagliptin viste sig desuden at medføre signifikante forbedringer i faste-plasma-glucose (FPG) sammenlignet med placebo.
English: Due to the concentration dependent binding of linagliptin to DPP-4, the pharmacokinetics of linagliptin based on total exposure is not linear; indeed total plasma AUC of linagliptin increased in a less than dose-proportional manner while unbound AUC increases in a roughly dose-proportional manner.
Danish: På grund af den koncentrationsafhængige binding af linagliptin til DPP-4 var linagliptins farmakokinetik ikke lineær vurderet på baggrund af total AUC.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of linagliptin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 5 mg linagliptin.
English: In the placebo-controlled studies 4.9% of patients experienced “hypoglycaemia” as an adverse reaction under linagliptin.
Danish: I de placebokontrollerede studier forekom bivirkningen hypoglykæmi hos 4,9 % af patienterne i behandling med linagliptin.
English: In non-diabetic patients with mild moderate and severe hepatic insufficiency (according to the ChildPugh classification), mean AUC and Cmax of linagliptin were similar to healthy matched controls following administration of multiple 5 mg doses of linagliptin.
Danish: Hos ikke-diabetiske patienter med let, moderat og svært nedsat leverfunktion (i henhold til ChildPugh-klassifikationen), var den gennemsnitlige AUC og Cmax sammenlignelig med raske, matchende frivillige efter indgivelse af gentagne doser af linagliptin 5 mg. Dosisjustering er ikke nødvendig hos diabetespatienter med let, moderat eller svært nedsat leverfunktion.
English: Some symptoms need immediate medical attention You should stop taking Trajenta and see your doctor immediately if you experience the following symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change or confusion (hypoglycaemia).
Danish: Ved symptomer på for lavt blodsukker (hypoglykæmi): Rysten, svedeture, angst, sløret syn, prikkende fornemmelse på læberne, bleghed, humørsvingninger eller forvirring, skal du stoppe med at tage Trajenta og straks kontakte en læge.
English: CrCl = (140 - age) x weight/72 x serum creatinine [x 0.85 for females], where age is in years, weight in kg, and serum creatinine is in mg/dl.
Danish: Kreatinin-clearance blev bestemt ud fra 24 timers urinopsamling eller ud fra serumkreatinin under anvendelse af Cockcroft-Gault-formlen: CrCl = (140alder) x vægt/72 x serumkreatinin [x 0,85 for kvinder], hvor alder er udtrykt i år, vægt i kg og serumkreatinin i mg/dl. Ved steady state var eksponeringen til linagliptin sammenlignelig hos patienter med let nedsat nyrefunktion og raske frivillige.
English: The effective half-life for accumulation of linagliptin, as determined from oral administration of multiple doses of 5 mg linagliptin, is approximately 12 hours.
Danish: Efter gentagen oral administration af linagliptin 5 mg var den effektive halveringstid for linagliptin ca. 12 timer ved steady state.
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Trajenta til dig personligt.
English: NAME OF THE MEDICINAL PRODUCT Trajenta 5 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Trajenta 5 mg filmovertrukne tabletter
English: Gastrointestinal disorders Pancreatitis rare #
Danish: Mave-tarm-kanalen Pankreatitis sjælden
English: The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to <80 ml/min), moderate (30 to <50 ml/min), and severe (<30 ml/min), as well as patients with ESRD on hemodialysis.
Danish: Studiet omfattede patienter med nedsat nyrefunktion, der ud fra kreatinin-clearance var klassificeret som let (50 til < 80 ml/min.
English: * Based on post-marketing experience ** Based on lipase elevations >3xULN observed in clinical trials Based on Linagliptin cardiovascular and renal safety study (CARMELINA), see also below Adverse reaction observed in combination with metformin plus sulphonylurea
Danish: * Baseret på post-marketing-erfaringer ** Baseret på lipase-stigninger på > 3 x den øvre normalgrænse set i kliniske forsøg
English: Therefore, no dosage adjustment of linagliptin is necessary in patients with any degree of renal insufficiency.
Danish: Dosisjustering af linagliptin er ikke nødvendig hos patienter med nedsat nyrefunktion, uanset sværhedsgrad.
English: Rash*
Danish: Udslæt*
English: Linagliptin as monotherapy in patients ineligible for metformin The efficacy and safety of linagliptin monotherapy was evaluated in a double-blind placebo-controlled study of 24 weeks duration.
Danish: Linagliptin som monoterapi til patienter, hvor metforminbehandling er uegnet I et 24-ugers dobbeltblindet placebokontrolleret studie blev effekt og sikkerhed af linagliptin, som monoterapi, undersøgt.
English: Linagliptin as add-on to a combination of metformin and empagliflozin therapy In patients inadequately controlled with metformin and empagliflozin (10 mg (n=247) or 25 mg (n=217)), 24-weeks treatment with add-on therapy of linagliptin 5 mg provided adjusted mean HbA1c reductions from baseline by -0.53% (significant difference to add-on placebo -0.32% (95% CI -0.52, -0.13) and -0.58% (significant difference to add-on placebo -0.47% (95% CI -0.66; -0.28), respectively.
Danish: Linagliptin som tillæg til metformin plus empagliflozin Hos patienter, der ikke var tilstrækkeligt reguleret med metformin og empagliflozin (10 mg (n = 247) eller 25 mg (n = 217)), medførte 24 ugers behandling med linagliptin 5 mg som tillæg, justerede gennemsnitlige fald i HbA1c i forhold til baseline på hhv. -0,53 % (signifikant forskel ift.
English: When linagliptin was added to a sulphonylurea (on a background of metformin), the incidence of hypoglycaemia was increased over that of placebo (see section 4.8).
Danish: Hypoglykæmi var hyppigere, når linagliptin blev givet i tillæg til et sulfonylurinstof (med metformin som basisbehandling) sammenlignet med placebo (se pkt.
English: In particular, you should tell your doctor if you are using medicines containing any of the following active substances:
Danish: Hvis du tager medicin, der indeholder nedenstående aktive stoffer, er det særligt vigtigt, at du taler med lægen:
English: NAME OF THE MEDICINAL PRODUCT Trajenta 5 mg film-coated tablets linagliptin
Danish: LÆGEMIDLETS NAVN Trajenta 5 mg filmovertrukne tabletter linagliptin
English: Linagliptin as add-on therapy in patients with severe renal impairment, 12 week placebo-controlled data (stable background) and 40 week placebo-controlled extension (adjustable background) The efficacy and safety of linagliptin was also evaluated in type 2 diabetes patients with severe renal impairment in a double-blind study versus placebo for 12 weeks duration, during which background glycaemic therapies were kept stable.
Danish: Linagliptin som tillægsbehandling til patienter med svært nedsat nyrefunktion, 12 ugers placebokontrollerede data (med uændret baggrundsbehandling) og 40 ugers placebokontrolleret forlængelse (justerbar baggrundsbehandling).
English: What Trajenta looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Secondary renal composite (renal death, ESRD, 40% sustained decrease in eGFR)
Danish: Antal patienter Primært sammensat kardiovaskulært (kardiovaskulær mortalitet, ikkedødeligt MI, ikkedødelig apopleksi) Sekundært sammensat renalt (nyredød, ESRD, 40 % vedvarende reduktion i eGFR) Mortalitet uanset årsag
English: The efficacy and safety of linagliptin monotherapy was also evaluated in patients for whom metformin therapy is inappropriate, due to intolerability or contraindicated due to renal impairment, in a doubleblind placebo-controlled study of 18 weeks duration.
Danish: I et 18-ugers dobbeltblindet placebokontrolleret studie blev effekt og sikkerhed af linagliptin som monoterapi desuden undersøgt hos patienter, som ikke var egnede til behandling med metformin på grund af intolerans eller kontraindikation på grund af nedsat nyrefunktion.
English: One main metabolite with a relative exposure of 13.3% of linagliptin at steady-state was detected which was found to be pharmacologically inactive and thus does not contribute to the plasma DPP-4 inhibitory activity of linagliptin.
Danish: En hovedmetabolit med en relativ eksponering på 13,3 % af linagliptin-dosis ved steady state blev påvist.
English: If a dose is missed, it should be taken as soon as the patient remembers.
Danish: En glemt dosis bør tages, når patienten kommer i tanker om dette - dog ikke som en dobbeltdosis.
English: Linagliptin also showed significant improvements in fasting plasma glucose (FPG), and 2-hour post-prandial glucose (PPG) compared to placebo.
Danish: Linagliptin viste sig desuden at medføre signifikant reduktion i faste-plasma-glucose (FPG) og 2timers postprandial glucose (PPG).
English: • are taking an anti-diabetic medicine known as a ‘sulphonylurea'(e.g. glimepiride, glipizide), your doctor may want to reduce your dose of sulphonylurea when you take it together with Trajenta in order to avoid your blood sugar going too low.
Danish: Lægen vil måske nedsætte dosis af sulfonylurinstof for at undgå, at dit blodsukker bliver for lavt.
English: Linagliptin provided significant improvements in HbA1c (-0.59 % change compared to placebo after 12 weeks), from a mean baseline HbA1c of 8.2%.
Danish: Linagliptin medførte signifikant reduktion i HbA1c (-0,59 % ændring sammenlignet med placebo efter 12 uger) i forhold til et gennemsnitligt baseline-HbA1c på 8,2 %.
English: Taking Trajenta in combination with medicines called sulphonylureas and/or insulin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines or work without safe foothold.
Danish: Trajenta kan i kombination med sulfonylurinstof og/eller insulin medføre for lavt blodsukker (hypoglykæmi).
English: No dosage adjustment is required based on age up to 80 years, as age did not have a clinically relevant impact on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Danish: Baseret på en farmakokinetisk populationsanalyse af fase I- og fase II-data, havde alder ikke nogen klinisk relevant indflydelse på linagliptins farmakokinetik.
English: had eGFR < 30 mL/min/1.73 m 2.
Danish: og svær (< 30 ml/min.)
English: No dosage adjustment is necessary based on race.
Danish: Dosisjustering er ikke nødvendig på baggrund af etnisk oprindelse.
English: Linagliptin provided significant improvements in HbA1c (-0.64 % change compared to placebo after 24 weeks), from a mean baseline HbA1c of 7.8%.
Danish: Linagliptin medførte signifikant reduktion i HbA1c, (ændring på -0,64 % sammenlignet med placebo efter 24 uger) i forhold til et gennemsnitligt HbA1c ved baseline på 7,8 %.
English: with a mean treatment difference of 0.20% (97.5% CI: 0.09, 0.299).
Danish: tillægsplacebo -0,32 % (95 %-CI: -0,52; -0,13)) og -0,58 % (signifikant forskel ift.
English: What Trajenta is and what it is used for What you need to know before you take Trajenta How to take Trajenta
Danish: Det skal du vide, før du begynder at tage Trajenta Sådan skal du tage Trajenta Bivirkninger
English: • in combination with other medicinal products for the treatment of diabetes, including insulin,
Danish: • i kombination med andre antidiabetika, herunder insulin, når disse ikke giver tilstrækkelig glykæmisk kontrol (se pkt.
English: • have had allergic reactions to any other medicines that you take to control the amount of sugar in your blood.
Danish: • har haft allergiske reaktioner over for anden diabetesmedicin
English: Linagliptin provided significant improvements in HbA1c, (-0.57% change compared to placebo), from a mean baseline HbA1c of 8.09%.
Danish: Linagliptin medførte signifikant reduktion i HbA1c, (ændring på -0,57 % sammenlignet med placebo) i forhold til et gennemsnitligt baseline-HbA1c på 8,09 %.
English: Linagliptin provided significant improvements in HbA1c (-0.62% change compared to placebo), from a mean baseline HbA1c of 8.14%.
Danish: Linagliptin medførte signifikant reduktion i HbA1c, (ændring på -0,62 % vs placebo) i forhold til et gennemsnitligt baseline-HbA1c på 8,14 %.
English: Hepatic impairment
Danish: Bulløs pemfigoid
English: BMI had no clinically relevant effect on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase
Danish: Baseret på en farmakokinetisk populationsanalyse af fase I- og fase II-data havde BMI ikke nogen klinisk relevant indvirkning på linagliptins farmakokinetik.
English: For patients with renal impairment, no dose adjustment for linagliptin is required.
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion.
English: The efficacy and safety of the addition of linagliptin 5 mg to insulin alone or in combination with metformin and/or pioglitazone has been evaluated in a double-blind placebo-controlled study of 24 weeks duration.
Danish: Et 24-ugers dobbeltblindet, placebokontrolleret studie evaluerede virkningen og sikkerheden af linagliptin 5 mg i kombination med insulin og til insulin i tillæg til metformin og/eller pioglitazon.