natgillin/translations-raw huggingface dataset:
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
Ikke-dødeligt MI, N (%) Hazard ratio vs. placebo (95 % CI) p-værdi
Non-fatal stroke N (%) Hazard ratio vs. placebo (95% CI) p−value
Sammenligning med empagliflozin justeret middelværdi
Comparison vs. empagliflozin - adjusted mean
• Behandling med Glyxambi bør ikke initieres hos patienter med eGFR under 60 ml/min/1,73 m eller CrCl under 60 ml/min.
• In patients with an eGFR <60 mL/min/1.73 m 2 or CrCl <60 mL/min, Glyxambi should not be initiated.
Glyxambi 25 mg/5 mg filmovertrukne tabletter EU/1/16/1146/010 (7 x 1 filmovertrukne tabletter) EU/1/16/1146/011 (10 x 1 filmovertrukne tabletter) EU/1/16/1146/012 (14 x 1 filmovertrukne tabletter) EU/1/16/1146/013 (28 x 1 filmovertrukne tabletter) EU/1/16/1146/014 (30 x 1 filmovertrukne tabletter) EU/1/16/1146/015 (60 x 1 filmovertrukne tabletter) EU/1/16/1146/016 (70 x 1 filmovertrukne tabletter) EU/1/16/1146/017 (90 x 1 filmovertrukne tabletter) EU/1/16/1146/018 (100 x 1 filmovertrukne tabletter)
Glyxambi 25 mg/5 mg film-coated tablets EU/1/16/1146/010 (7 x 1 film-coated tablets) EU/1/16/1146/011 (10 x 1 film-coated tablets) EU/1/16/1146/012 (14 x 1 film-coated tablets) EU/1/16/1146/013 (28 x 1 film-coated tablets) EU/1/16/1146/014 (30 x 1 film-coated tablets) EU/1/16/1146/015 (60 x 1 film-coated tablets) EU/1/16/1146/016 (70 x 1 film-coated tablets) EU/1/16/1146/017 (90 x 1 film-coated tablets) EU/1/16/1146/018 (100 x 1 film-coated tablets)
Sammenlignet med placebo var alvorlig hypoglykæmi hyppigere hos patienter, der fik empagliflozin, når det blev givet som tillæg til basal insulin med eller uden metformin og med eller uden sulfonylurinstof (under de indledende 18 ugers behandling, hvor insulin ikke kunne justeres: empagliflozin 10 mg: 0 %; empagliflozin 25 mg: 1,3 %; placebo: 0 %.
The frequency of patients with major hypoglycaemic events was increased in patients treated with empagliflozin compared to placebo when given as add-on to basal insulin +/- metformin and +/sulphonylurea (empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1.3 %, placebo: 0 % during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1.3 %, placebo 0 % over the 78-week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 1.6 %, empagliflozin 25 mg: 0.5 %, placebo: 1.6 % during initial 18 weeks treatment when insulin could not be adjusted and over the 52-week trial).
# Se pkt.
Foot care
Baseret på en farmakokinetisk populationsanalyse havde køn ingen klinisk relevant indvirkning på empagliflozins eller linagliptins farmakokinetik.
Gender had no clinically relevant effect on the pharmacokinetics of empagliflozin or linagliptin based on population pharmacokinetic analysis.
EU/1/16/1146/010 7 x 1 filmovertrukne tabletter EU/1/16/1146/011 10 x 1 filmovertrukne tabletter EU/1/16/1146/012 14 x 1 filmovertrukne tabletter EU/1/16/1146/013 28 x 1 filmovertrukne tabletter EU/1/16/1146/014 30 x 1 filmovertrukne tabletter EU/1/16/1146/015 60 x 1 filmovertrukne tabletter EU/1/16/1146/016 70 x 1 filmovertrukne tabletter EU/1/16/1146/017 90 x 1 filmovertrukne tabletter EU/1/16/1146/018 100 x 1 filmovertrukne tabletter
EU/1/16/1146/010 7 x 1 film-coated tablets EU/1/16/1146/011 10 x 1 film-coated tablets EU/1/16/1146/012 14 x 1 film-coated tablets EU/1/16/1146/013 28 x 1 film-coated tablets EU/1/16/1146/014 30 x 1 film-coated tablets EU/1/16/1146/015 60 x 1 film-coated tablets EU/1/16/1146/016 70 x 1 film-coated tablets EU/1/16/1146/017 90 x 1 film-coated tablets EU/1/16/1146/018 100 x 1 film-coated tablets
EU/1/16/1146/001 7 x 1 filmovertrukne tabletter EU/1/16/1146/002 10 x 1 filmovertrukne tabletter EU/1/16/1146/003 14 x 1 filmovertrukne tabletter EU/1/16/1146/004 28 x 1 filmovertrukne tabletter EU/1/16/1146/005 30 x 1 filmovertrukne tabletter EU/1/16/1146/006 60 x 1 filmovertrukne tabletter EU/1/16/1146/007 70 x 1 filmovertrukne tabletter EU/1/16/1146/008 90 x 1 filmovertrukne tabletter EU/1/16/1146/009 100 x 1 filmovertrukne tabletter
EU/1/16/1146/001 7 x 1 film-coated tablets EU/1/16/1146/002 10 x 1 film-coated tablets EU/1/16/1146/003 14 x 1 film-coated tablets EU/1/16/1146/004 28 x 1 film-coated tablets EU/1/16/1146/005 30 x 1 film-coated tablets EU/1/16/1146/006 60 x 1 film-coated tablets EU/1/16/1146/007 70 x 1 film-coated tablets EU/1/16/1146/008 90 x 1 film-coated tablets EU/1/16/1146/009 100 x 1 film-coated tablets
Hvis du får de anførte symptomer hyppigere, skal du kontakte lægen.
If you take more of this medicine than you should, immediately talk to a doctor or go to a hospital.
LÆGEMIDLETS NAVN Glyxambi 10 mg/5 mg tabletter empagliflozin/linagliptin
NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg tablets empagliflozin/linagliptin
Glyxambi 10 mg/5 mg filmovertrukne tabletter EU/1/16/1146/001 (7 x 1 filmovertrukne tabletter) EU/1/16/1146/002 (10 x 1 filmovertrukne tabletter) EU/1/16/1146/003 (14 x 1 filmovertrukne tabletter) EU/1/16/1146/004 (28 x 1 filmovertrukne tabletter) EU/1/16/1146/005 (30 x 1 filmovertrukne tabletter) EU/1/16/1146/006 (60 x 1 filmovertrukne tabletter) EU/1/16/1146/007 (70 x 1 filmovertrukne tabletter) EU/1/16/1146/008 (90 x 1 filmovertrukne tabletter) EU/1/16/1146/009 (100 x 1 filmovertrukne tabletter)
Glyxambi 10 mg/5 mg film-coated tablets EU/1/16/1146/001 (7 x 1 film-coated tablets) EU/1/16/1146/002 (10 x 1 film-coated tablets) EU/1/16/1146/003 (14 x 1 film-coated tablets) EU/1/16/1146/004 (28 x 1 film-coated tablets) EU/1/16/1146/005 (30 x 1 film-coated tablets) EU/1/16/1146/006 (60 x 1 film-coated tablets) EU/1/16/1146/007 (70 x 1 film-coated tablets) EU/1/16/1146/008 (90 x 1 film-coated tablets) EU/1/16/1146/009 (100 x 1 film-coated tablets)
LÆGEMIDLETS NAVN Glyxambi 25 mg/5 mg tabletter empagliflozin/linagliptin
NAME OF THE MEDICINAL PRODUCT Glyxambi 25 mg/5 mg tablets empagliflozin/linagliptin
Blegrosa, trekantet filmovertrukken tablet på 8 mm, som er plan med buede sider og præget med "25/5" på den ene side og Boehringer Ingelheims firmalogo på den anden side.
One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with “25/5” (tablet dimensions: 8 mm each side).
Glyxambi 25 mg/5 mg er blegrosa, trekantede filmovertrukne tabletter på 8 mm, som er plane med buede sider og præget med "25/5" på den ene side og firmalogo på den anden.
Glyxambi 25 mg/5 mg film-coated tablets (tablets) are pale pink, arc triangular, flat faced and beveledged.
Mortalitet uanset årsag, N (%) Hazard ratio vs. placebo (95 % CI) p-værdi
All-cause mortality N (%) Hazard ratio vs. placebo (95% CI) p-value
Lysegul, trekantet filmovertrukken tablet på 8 mm, som er plan med buede sider og præget med "10/5" på den ene side og Boehringer Ingelheims firmalogo på den anden side.
One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with “10/5” (tablet dimensions: 8 mm each side).
Efter administration af gentagne doser linagliptin 5 mg var linagliptins middel-AUC og -Cmax sammenlignelige hos ikke-diabetiske patienter med let, moderat og svært nedsat leverfunktion (i henhold til Child-Pugh-klassifikation) og hos raske forsøgspersoner.
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 subjects following administration of multiple 5 mg doses of linagliptin.
Glyxambi 25 mg/5 mg filmovertrukne tabletter Tabletkerne:
Glyxambi 25 mg/5 mg film-coated tablets Tablet core
LÆGEMIDLETS NAVN Glyxambi 10 mg/5 mg filmovertrukne tabletter empagliflozin/linagliptin
NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg film-coated tablets empagliflozin/linagliptin
LÆGEMIDLETS NAVN Glyxambi 25 mg/5 mg filmovertrukne tabletter empagliflozin/linagliptin
NAME OF THE MEDICINAL PRODUCT Glyxambi 25 mg/5 mg film-coated tablets empagliflozin/linagliptin
Baseret på en farmakokinetisk populationsanalyse havde BMI ingen klinisk relevant indvirkning på empagliflozins eller linagliptins farmakokinetik.
Body mass index had no clinically relevant effect on the pharmacokinetics of empagliflozin or linagliptin based on population pharmacokinetic analysis.
Test for glucose i urinen vil være positiv på grund af empagliflozins virkningsmekanisme.
Due to the mechanism of action of empagliflozin, patients taking Glyxambi will test positive for glucose in their urine.
Glyxambi 10 mg/5 mg filmovertrukne tabletter Tabletkerne:
Glyxambi 10 mg/5 mg film-coated tablets Tablet core
Baseret på en farmakokinetisk populationsanalyse havde alder ingen klinisk relevant indvirkning på empagliflozins eller linagliptins farmakokinetik.
Age did not have a clinically meaningful impact on the pharmacokinetics of empagliflozin or linagliptin based on population pharmacokinetic analysis.
Glyxambi 10 mg/5 mg filmovertrukne tabletter Glyxambi 25 mg/5 mg filmovertrukne tabletter
Glyxambi 10 mg/5 mg film-coated tablets Glyxambi 25 mg/5 mg film-coated tablets empagliflozin/linagliptin
Sværhedsgraden (let, moderat, svær) af urinvejsinfektionerne var den samme som for placebo.
The intensity of urinary tract infections was similar to placebo for mild, moderate and severe intensity reports.
• uklar urin
• urine that appears cloudy
Glyxambi 10 mg/5 mg er lysegule, trekantede filmovertrukne tabletter på 8 mm, som er plane med buede sider og præget med "10/5" på den ene side og firmalogo på den anden.
Glyxambi 10 mg/5 mg film-coated tablets (tablets) are pale yellow, arc triangular, flat faced and bevel-edged.
Ved samtidig administration af lægemidler, der kan medføre volumendepletering (f.eks. diuretika, ACE-hæmmere), skal man derfor være særligt opmærksom på patientens væskeindtagelse.
Therefore, special attention should be given to their volume intake in case of co-administered medicinal products which may lead to volume depletion (e.g. diuretics, ACE inhibitors).
Hvis du har taget for meget Glyxambi
If you take more Glyxambi than you should
• Hvis eGFR vedvarende ligger under 45 ml/min/1,73 m2, eller CrCl vedvarende ligger under
• When eGFR is persistently below 45 mL/min/1.73 m2 or CrCl persistently below 45 mL/min, treatment should be discontinued (see sections 4.4, 4.8, 5.1, and 5.2).
Emballage Indhold Salgspakninger Tilbageholdelsestid
Packaging Content Package size
Eu Nummer
EU Number Tradename Strength
Dato for første tilladelse: 24. november 2011 Dato for seneste fornyelse: 8. august 2016
Date of first authorisation: 24 November 2011 Date of latest renewal: 8 August 2016