natgillin/translations-raw huggingface dataset:
Hos patienter, der var utilstrækkeligt kontrolleret på maksimalt tolerable doser metformin, blev ikke-blindet empagliflozin 10 mg eller empagliflozin 25 mg tilføjet behandlingen i 16 uger. 
In patients inadequately controlled on maximally tolerated doses of metformin, open label empagliflozin 10 mg or empagliflozin 25 mg was added for 16 weeks.
I længerevarende toksicitetsstudier hos gnavere og hunde blev der observeret tegn på toksicitet ved eksponeringer svarende til ≥ 10 gange den kliniske dosis empagliflozin. 
In long-term toxicity studies in rodents and dogs, signs of toxicity were observed at exposures greater than or equal to 10-times the clinical dose of empagliflozin.
I kliniske studier med empagliflozin blev øget vandladning (herunder de prædefinerede betegnelser pollakisuri, polyuri og nocturi) observeret hyppigere hos patienter, der blev behandlet med empagliflozin (empagliflozin 10 mg: 3,5 %; empagliflozin 25 mg: 3,3 %), sammenlignet med placebo (1,4 %). 
In clinical trials with empagliflozin, increased urination (including the predefined terms pollakiuria, polyuria, nocturia) was observed at higher frequencies in patients treated with empagliflozin (empagliflozin 10 mg: 3.5 %, empagliflozin 25 mg: 3.3 %) compared to placebo (1.4 %).
Empagliflozin øgede ikke forekomsten af tumorer hos hunmus ved doser på op til 1.000 mg/kg/dag, hvilket svarer til ca. 62 gange den maksimale kliniske eksponering for empagliflozin. 
Empagliflozin did not increase the incidence of tumours in female mice at doses up to 1,000 mg/kg/day, which corresponds to approximately 62-times the maximal clinical exposure to empagliflozin.
Den anbefalede startdosis er 1 Glyxambi-tablet 10 mg/5 mg (10 mg empagliflozin plus 5 mg linagliptin) én gang dagligt. 
The recommended starting dose is 1 film-coated tablet of Glyxambi 10 mg/5 mg (10 mg empagliflozin plus 5 mg linagliptin) once daily.
Der er ikke gennemført studier af Glyxambis eller af de enkelte aktive stoffers indvirkning på human fertilitet. 
No studies on the effect on human fertility have been conducted with Glyxambi or with the individual active substances.
Patienter, der var utilstrækkeligt kontrolleret efter denne 16-ugers periode, fik dobbeltblindet behandling med enten empagliflozin 10 mg, empagliflozin 25 mg eller placebo i 24 uger. 
In patients inadequately controlled after this 16 week period, patients received double-blind treatment with either empagliglozin 10 mg, empagliflozin 25 mg or placebo for 24-weeks.
Overfølsomhed over for de aktive stoffer, over for natrium-glucose-co-transportprotein-2 (SGLT2)hæmmere, over for dipeptidyl-peptidase-4 (DPP-4)-hæmmere eller over for et eller flere af hjælpestofferne anført i pkt. 
Hypersensitivity to the active substances, to any other Sodium-Glucose-Co-Transporter-2 (SGLT2) inhibitor, to any other Dipeptidyl-Peptidase-4 (DPP-4) inhibitor, or to any of the excipients listed in section 6.1.
Lægen kan beslutte, om din dosis skal øges til én Glyxambi-tablet 25 mg/5 mg (25 mg empagliflozin plus 5 mg linagliptin) én gang dagligt. 
Your doctor will decide whether you need to increase your dose to one film-coated tablet of Glyxambi 25 mg/5 mg (25 mg empagliflozin plus 5 mg linagliptin) once a day.
Din læge kan beslutte, at du skal holde pause med at tage Glyxambi, indtil du er rask. 
Your doctor may ask you to stop taking Glyxambi until you have recovered.
Ved steady state var estimeret AUC for linagliptin sammenligneligt hos patienter med terminal nyreinsufficiens og patienter med moderat eller svært nedsat nyrefunktion. 
Steady-state predictions for AUC of linagliptin in patients with ESRD indicated comparable exposure to that of patients with moderate or severe renal impairment.
Virkningen var svækket i uge 94 med en justeret gennemsnitlig (SE) forbedring af HbA1c på hhv. 0,50 % (0,02) og 0,55 % (0,02) i empagliflozin 10- og 25 mg-grupperne sammenholdt med 0,08 % (0,02) i placebogruppen. 
Therefore the effect was attenuated at week 94, with an adjusted mean (SE) improvement in HbA1c of 0.08 % (0.02) in the placebo group, 0.50 % (0.02) and 0.55 % (0.02) in the empagliflozin 10 and 25 mg groups.
Hos hanrotter blev der observeret behandlingsrelaterede benigne vaskulære proliferative læsioner (hæmangiomer) i den mesenteriske lymfekirtel ved den højeste dosis, men ikke ved 300 mg/kg/dag, hvilket svarer til ca. 26 gange den maksimale kliniske eksponering for empagliflozin. 
In male rats, treatment related benign vascular proliferative lesions (haemangiomas) of the mesenteric lymph node were observed at the highest dose, but not at 300 mg/kg/day, which corresponds to approximately 26 times the maximal clinical exposure to empagliflozin.
Empagliflozin var superiort i forhold til placebo med hensyn til at forhindre det primære sammensatte endepunkt (kardiovaskulær død, ikke-dødeligt myokardieinfarkt eller ikke-dødelig apopleksi). 
Empagliflozin was superior in preventing the primary combined endpoint of cardiovascular death, nonfatal myocardial infarction, or non-fatal stroke, as compared with placebo.
I uge 12 blev der observeret en justeret gennemsnitlig (SE) forbedring af HbA1c i forhold til baseline på hhv. 0,65 % (0,02) og 0,71 % (0,02) i empagliflozin 10- og 25 mg-grupperne sammenholdt med 0,11 % (0,02) i placebogruppen. 
At week 12, an adjusted mean (SE) improvement in HbA1c when compared to baseline of 0.11 % (0.02) in the placebo group, 0.65 % (0.02) and 0.71 % (0.02) in the empagliflozin 10 and 25 mg groups was observed.
Hyppighederne var sammenlignelige med dem, der er rapporteret fra de kliniske studier med empagliflozin (se også pkt. 
The frequencies have been comparable to those reported from the empagliflozin clinical trials (see also section 4.4).
Det er vigtigt, at du overholder det diæt- og motionsprogram, som din læge har anbefalet, mens du tager Glyxambi. 
It is important to stay on the diet and exercise program recommended by your doctor during treatment with this medicine.
Effektparametre i kliniske studier, der sammenlignede Glyxambi 10 mg/5 mg med empagliflozin 10 mg og Glyxambi 25 mg/5 mg med empagliflozin 25 mg som tillægsbehandling hos patienter, der var utilstrækkeligt kontrolleret på empagliflozin 10 mg/25 mg og metformin 
Table 4 Efficacy parameters in clinical studies comparing Glyxambi 10 mg/5 mg to empagliflozin 10 mg as well as Glyxambi 25 mg/5 mg to empagliflozin 25 mg as add-on therapy in patients inadequately controlled on empagliflozin 10 mg/25 mg and metformin
Hypoglykæmi ved linagliptin 
Hypoglycaemia with linagliptin
Passende monitorering af volumenstatus (f.eks. objektiv undersøgelse, blodtryksmålinger, laboratorietest, herunder hæmatokrit) og elektrolytter anbefales hos patienter med tilstande med risiko for væsketab (f.eks. mave-tarmsygdom), der behandles med empagliflozin. 
In case of conditions that may lead to fluid loss (e.g. gastrointestinal illness), careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended for patients receiving empagliflozin.
60 ml/min/1,73 m2, eller CrCl er under 60 ml/min, bør Glyxambi-dosis justeres til eller fastholdes på 10 mg empagliflozin plus 5 mg linagliptin én gang dagligt. 
• In patients tolerating Glyxambi whose eGFR falls persistently below 60 mL/min/1.73 m2 or CrCl below 60 mL/min, the dose of Glyxambi should be adjusted to or maintained at 10 mg empagliflozin plus 5 mg linagliptin once daily.
I en præspecificeret patientundergruppe med baseline HbA1c ≥ 8,5 % var reduktionen i HbA1c ved uge 24 -1,3 % fra baseline med empagliflozin 25 mg/linagliptin 5 mg (p < 0,0001 versus placebo og linagliptin 5 mg) og -1,3 % med empagliflozin 10 mg/linagliptin 5 mg (p < 0,0001 versus placebo og linagliptin 5 mg). 
In a pre-specified subgroup of patients with baseline HbA1c greater or equal than 8.5 % the reduction from baseline in HbA1c with empagliflozin 25 mg/linagliptin 5 mg was -1.3 % at 24 weeks (p<0.0001 versus placebo and linagliptin 5 mg) and with empagliflozin 10 mg/ linagliptin 5 mg -1.3 % at 24 weeks (p<0.0001 versus placebo and linagliptin 5 mg).
Hastigheden og omfanget af absorption af empagliflozin og linagliptin i Glyxambi svarer til biotilgængeligheden af empagliflozin og linagliptin, når de indgives separat i tabletter. 
The rate and extent of absorption of empagliflozin and linagliptin in Glyxambi are equivalent to the bioavailability of empagliflozin and linagliptin when administered as individual tablets.The pharmacokinetics of empagliflozin and linagliptin as single agents have been extensively characterized in healthy subjects and patients with type 2 diabetes.
Hvis du tager følgende lægemidler, er det særligt vigtigt, at du fortæller det til lægen: 
In particular, you should tell your doctor if you are using the following medicines:
Efter denne dobbeltblindede periode gav behandling med linagliptin 5 mg statistisk signifikante forbedringer i HbA1c i begge populationer (metformin + empagliflozin 10 mg og metformin + empagliflozin 25 mg) sammenlignet med placebo; alle patienter fortsatte behandling med metformin og empagliflozin under studiet. 
After this double-blind period, treatment in both populations (metformin + empagliflozin 10 mg and metformin + empagliflozin 25 mg) linagliptin 5 mg provided statistically significant improvements in HbA1c compared to placebo; all patients continued treatment with metformin and empagliflozin during the study.
Glyxambi 10 mg/5 mg filmovertrukne tabletter Hver tablet indeholder 10 mg empagliflozin og 5 mg linagliptin. 
Glyxambi 10 mg/5 mg film-coated tablets Each film-coated tablet contains 10 mg empagliflozin and 5 mg linagliptin.
Efter gentagen oral administration af linagliptin 5 mg er linagliptins effektive halveringstid ca. 12 timer ved steady state. 
The effective half-life for accumulation of linagliptin, as determined from oral administration of multiple doses of 5 mg linagliptin, is approximately 12 hours.
Glyxambi 25 mg/5 mg filmovertrukne tabletter Hver tablet indeholder 25 mg empagliflozin og 5 mg linagliptin. 
Glyxambi 25 mg/5 mg film-coated tablets Each film-coated tablet contains 25 mg empagliflozin and 5 mg linagliptin.
Linagliptin binder meget effektivt, men reversibelt til DPP-4. 
Linagliptin binds very effectively to DPP-4 in a reversible manner and thus leads to a sustained increase and a prolongation of active incretin levels.
Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Boehringer Ingelheim Pharma GmbH & Co. 
Name and address of the manufacturer responsible for batch release Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173
Sammenligning med placebo (oddsratio) (95 % CI) 
Comparison vs. placebo (odds ratio) (95 % CI)
I en præspecificeret patientundergruppe med baseline-HbA1c ≥ 8,5 % var reduktionen i HbA1c ved uge 24 -1,8 % fra baseline med Glyxambi 25 mg/5 mg (p < 0,0001 versus linagliptin 5 mg; p < 0,001 versus empagliflozin 25 mg) og -1,6 % med Glyxambi 10 mg/5 mg (p < 0,01 versus linagliptin 5 mg og ikke-signifikant versus empagliflozin 10 mg). 
In a pre-specified subgroup of patients with baseline HbA1c greater or equal than 8.5 %, the reduction from baseline in HbA1c at 24 weeks with Glyxambi 25 mg/5 mg was -1.8 % (p<0.0001 versus linagliptin 5 mg, p<0.001 versus empagliflozin 25 mg) and with Glyxambi 10 mg/ 5 mg -1.6 % (p<0.01 versus linagliptin 5 mg, n.s. versus empagliflozin 10 mg).
Hazard ratio vs. placebo (95 % CI) p-værdi 
Hazard ratio vs. placebo (95% CI) p-value
Linagliptins total-plasma-AUC steg på en mindre end dosisproportional måde, mens stigningen i AUC for ubundet linagliptin stort set var dosisproportional. 
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.
Ca. halvdelen af patienterne (52,2 %) havde eGFR 60-90 ml/min/1,73 m 17,8 % havde eGFR 45-60 ml/min/1,73 m2, og 7,7 % havde eGFR 30-45 ml/min/1,73 m 
About half of the patients (52.2 %) had an eGFR of 60-90 ml/min/1.73 m2, 17.8 % of
Pankreatitis Mundsår 
Pancreatitis Mouth ulceration
Forhøjet amylase Forhøjet lipase 
Amylase increased
• Vanddrivende medicin (diuretika). 
• medicines used to remove water from your body (diuretics).
Ikke-CV mortalitet, N (%) Hazard ratio vs. placebo (95 % CI) 
Non-CV mortality N (%) Hazard ratio vs. placebo (95% CI)
Lægen vil kontrollere, hvordan dine nyrer virker, før du begynder behandling med Glyxambi og regelmæssigt under behandlingen. 
Before you start treatment with Glyxambi and regularly during treatment, your doctor will check how well your kidneys are working.
INFORMATION I BRAILLESKRIFT Glyxambi 10 mg/5 mg 
INFORMATION IN BRAILLE Glyxambi 10 mg/5 mg
I kliniske studier med empagliflozin var den overordnede hyppighed af forhøjet serumkreatinin og nedsat glomerulær filtrationshastighed sammenlignelig i empagliflozin-gruppen og placebogruppen (forhøjet serumkreatinin: empagliflozin 10 mg 0,6 %; empagliflozin 25 mg 0,1 %; placebo 0,5 %. 
In clinical trials with empagliflozin, the overall frequency of patients with increased blood creatinine and decreased glomerular filtration rate were similar between empagliflozin and placebo (blood creatinine increased: empagliflozin 10 mg 0.6%, empagliflozin 25 mg 0.1%, placebo 0.5%; glomerular filtration rate decreased: empagliflozin 10 mg 0.1%, empagliflozin 25 mg 0%, placebo 0.3%).
En glemt dosis bør tages snarest efter, patienten bliver opmærksom på dette - dog ikke, hvis der er mindre end 12 timer til næste dosis. 
If a dose is missed, and it is less than 12 hours until the next dose, the dose should be skipped and the next dose should be taken at the usual time.
INFORMATION I BRAILLESKRIFT Glyxambi 25 mg/5 mg 
INFORMATION IN BRAILLE Glyxambi 25 mg/5 mg
Blandede effekt-modeller for gentagne målinger (MMRM) på FAS (OC) omfatter baseline-HbA1c, baseline-eGFR (MDRD), geografisk område, ambulant behandling samt behandling ved besøgsinteraktion. 
Patients randomized to the placebo group were receiving the placebo plus linagliptin 5 mg with background metformin Mixed-effects models for repeated measurements (MMRM) on FAS (OC) includes baseline HbA1c, baseline eGFR (MDRD), geographical region, visit treatment,and treatment by visit interaction.
Sammenlignet med placebo opnåede et statistisk signifikant større antal patienter med baseline-HbA1c ≥ 7,0 %, behandlet med enten 10 mg eller 25 mg empagliflozin, mål-HbA1c < 7 % (se tabel 3). 
A statistically significant greater number of patients with a baseline HbA1c ≥7.0 % treated with both doses of empagliflozin achieved a target HbA1c of <7 % compared to placebo (see Table 3).
Hver filmovertrukken tablet indeholder 10 mg empagliflozin og 5 mg linagliptin. 
Each film-coated tablet contains 10 mg empagliflozin and 5 mg linagliptin.
Sammenligning med linagliptin 5 mg justeret middelværdi 
Comparison vs. linagliptin 5 mg - adjusted mean
Diabetisk ketoacidose, en sjælden bivirkning (kan forekomme hos op til 1 ud af 1.000 patienter) Følgende symptomer er tegn på diabetisk ketoacidose (se også afsnit 2, 'Advarsler og forsigtighedsregler'): - forhøjet indhold af ketonstoffer i urinen eller blodet - hurtigt vægttab 
Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2, ‘Warnings and precautions'): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Hver filmovertrukken tablet indeholder 25 mg empagliflozin og 5 mg linagliptin. 
Each film-coated tablet contains 25 mg empagliflozin and 5 mg linagliptin.
På grund af virkningsmekanismen afhænger empagliflozins glykæmiske virkning af nyrefunktionen (se pkt. 
Due to the mechanism of action, the glycaemic efficacy of empagliflozin is dependent on renal function (see sections 4.2, 5.1 and 5.2).
Sammenligning med placebo (justeret middelværdi) (95 % CI) 
Comparison vs. placebo (adjusted mean) (95 % CI)
Hvis du tager Glyxambi sammen med andre lægemidler, som for eksempel et sulfonylurinstof eller insulin, kan du få for lavt blodsukker (hypoglykæmi). 
Low blood sugar (hypoglycaemia), seen commonly (may affect up to 1 in 10 people) If you take Glyxambi with another medicine that can cause low blood sugar, such as a sulphonylurea or insulin, you are at risk of getting too low blood sugar (hypoglycaemia).
(eGFR) ≥ 60 ml/min/1,73 m2 eller kreatinin-clearance (CrCl) ≥ 60 ml/min. 
• In patients with an estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 or creatinine clearance (CrCl) ≥60 mL/min, no dose adjustment is required.
Glyxambi 10 mg/5 mg filmovertrukne tabletter 
Glyxambi 10 mg/5 mg film-coated tablets
Glukose (sukker) i urinen 
Urine glucose
Det skal du vide, før du begynder at tage Glyxambi Sådan skal du tage Glyxambi Bivirkninger 
What Glyxambi is and what it is used for What you need to know before you take Glyxambi How to take Glyxambi
Hypoglykæmi var hyppigere hos patienter, der fik empagliflozin, sammenlignet med placebo, når det blev givet som tillæg til metformin og sulfonylurinstof (empagliflozin 10 mg: 16,1 %; empagliflozin 25 mg: 11,5 %; placebo: 8,4 %), tillæg til basal insulin med eller uden metformin og med eller uden et sulfonylurinstof (under de indledende 18 ugers behandling, hvor insulin ikke kunne justeres: empagliflozin 10 mg: 19,5 %; empagliflozin 25 mg: 28,4 %; placebo: 20,6 %. 
The frequency of patients with hypoglycaemia was increased in patients treated with empagliflozin compared to placebo when given as add-on to metformin plus sulphonylurea (empagliflozin 10 mg: 16.1 %, empagliflozin 25 mg: 11.5 %, placebo: 8.4 %), add-on to basal insulin +/- metformin and +/-sulphonylurea (empagliflozin 10 mg: 19.5 %, empagliflozin 25 mg: 28.4 %, placebo: 20.6 % during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg and 25 mg: 36.1 %, placebo 35.3 % over the 78 week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 39.8 %, empagliflozin 25 mg: 41.3 %, placebo: 37.2 % during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 51.1 %, empagliflozin 25 mg: 57.7 %, placebo: 58 % over the 52-week trial).
I kliniske studier med Glyxambi var der ingen særlig forskel på hyppigheden af volumendepletering hos patienter, der blev behandlet med Glyxambi (Glyxambi 25 mg/5 mg: 0,4 %; Glyxambi 10 mg/5 mg: 0,8 %), sammenlignet med patienter, der blev behandlet med empagliflozin og linagliptin. 
In clinical trials with Glyxambi, there was no notable difference in the frequency of volume depletion in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 0.4 %; Glyxambi 10 mg/5 mg: 0.8 %) compared to the patients treated with empagliflozin and linagliptin.
I kliniske studier med Glyxambi blev forhøjet serumkreatinin (Glyxambi 25 mg/5 mg: 0,4 %; Glyxambi 10 mg/5 mg: 0 %) og nedsat glomerulær filtrationshastighed (Glyxambi 25 mg/5 mg: 0,4 %; Glyxambi 10 mg/5 mg: 0,6 %) rapporteret med samme hyppighed som i de kliniske studier med empagliflozin. 
In clinical trials with Glyxambi, the frequency of patients with increased blood creatinine (Glyxambi 25 mg/5 mg: 0.4%; Glyxambi 10 mg/5 mg: 0%) and decreased glomerular filtration rate (Glyxambi 25 mg/5 mg: 0.4%; Glyxambi 10 mg/5 mg: 0.6%) has been comparable to those reported from the empagliflozin clinical trials.
Empagliflozin skal straks seponeres hos patienter med formodet eller verificeret DKA. 
In patients where DKA is suspected or diagnosed, treatment with empagliflozin should be discontinued immediately.
ANGIVELSE AF AKTIVE STOFFER Hver tablet indeholder 25 mg empagliflozin og 5 mg linagliptin. 
STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 25 mg empagliflozin and 5 mg linagliptin.
Glyxambi 25 mg/5 mg filmovertrukne tabletter 
Glyxambi 25 mg/5 mg film-coated tablets
Tid til første hændelse af CV-død, ikke-dødeligt MI eller ikke-dødelig apopleksi, N (%) Hazard ratio. 
Time to first event of CV death, non-fatal MI, or non-fatal stroke N (%) Hazard ratio vs. placebo (95.02% CI) p−value for superiority
I kliniske studier med Glyxambi sås ingen særlig forskel på hyppigheden af urinvejsinfektioner hos patienter, der fik Glyxambi (Glyxambi 25 mg/5 mg: 8,5 %; Glyxambi 10 mg/5 mg: 7,5 %), sammenlignet med patienter, der fik empagliflozin og linagliptin. 
In clinical trials with Glyxambi, there was no notable difference of the frequency of urinary tract infections in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 8.5 %; Glyxambi 10 mg/5 mg: 7.5 %) compared to the patients treated with empagliflozin and linagliptin.
Det vides ikke, om Glyxambi er skadeligt for det ufødte barn. 
It is not known whether Glyxambi is harmful to the unborn child. As a precautionary measure it is preferrable to avoid the use of this medicine during pregnancy.
Dette giver in vivo-evidens for lav tilbøjelighed til at forårsage lægemiddelinteraktioner med substrater for CYP3A4, CYP2C9, CYP2C8, P-gp og organisk kationtransporter (OCT). 
Linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glibenclamide, simvastatin, pioglitazone, warfarin, digoxin, empagliflozin or oral contraceptives providing in vivo evidence of a low propensity for causing drug interactions with substrates of CYP3A4, CYP2C9, CYP2C8, P-gp and organic cationic transporter (OCT).
Sådan skal du tage Glyxambi 
How to take Glyxambi
I kliniske studier med Glyxambi blev øget vandladning rapporteret hyppigere for patienter behandlet med Glyxambi (Glyxambi 25 mg/5 mg: 2,6 %; Glyxambi 10 mg/5 mg: 1,4 %) end for linagliptin og med samme hyppighed som for empagliflozin. 
In clinical trials with Glyxambi, increased urination in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 2.6 %; Glyxambi 10 mg/5 mg: 1.4 %) was reported more frequently than for linagliptin and with similar frequency than for empagliflozin.
En hovedmetabolit med en relativ eksponering på 13,3 % af linagliptin-dosis ved steady state blev påvist. 
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 to not contribute to the plasma DPP-4 inhibitory activity of linagliptin.
5.1) blev bulløs pemfigoid rapporteret hos 0,2 % af patienterne behandlet med linagliptin, og hos ingen af de patienter, der fik placebo. 
In the CARMELINA study (see section 5.1), bullous pemphigoid was reported in 0.2% patients treated with linagliptin and in no patients treated with placebo.
I kliniske studier med Glyxambi blev genitale infektioner rapporteret hyppigere hos patienter, der blev behandlet med Glyxambi (Glyxambi 25 mg/5 mg: 3,0 %; Glyxambi 10 mg/5 mg: 2,5 %), sammenlignet med linagliptin, men mindre hyppigt end for empagliflozin. 
In clinical trials with Glyxambi, genital infections in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 3.0 %; Glyxambi 10 mg/5 mg: 2.5 %) were reported more frequently than for linagliptin but less freqeuntly than for empagliflozin.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg empagliflozin og 5 mg linagliptin. 
STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 10 mg empagliflozin and 5 mg linagliptin.
Dosisjustering er ikke nødvendig på baggrund af alder. Nyrefunktion og risiko for volumendepletering skal dog tages i betragtning hos ældre patienter (se pkt. 
However, renal function and risk of volume depletion should be taken into account in elderly patients (see sections 4.4 and 4.8).
Patienter, der blev randomiseret til empagliflozin 10 mg- eller 25 mg-grupperne, fik Glyxambi 10 mg/5 mg eller 25 mg/5 mg sammen med metformin som baggrundsbehandling Patienter, der blev randomiseret til placebo-gruppen, fik placebo plus linagliptin 5 mg sammen med metformin som baggrundsbehandling 
Patients randomized to the empagliflozin 10 mg or 25 mg groups were receiving Glyxambi 10 mg/5 mg or 25 mg/5 mg with background metformin