natgillin/translations-raw huggingface dataset:
• a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patientyears (p=0.021),
• pomembno zmanjšanje absolutnega tveganja celokupne umrljivosti: metformin 13,5 dogodka/1000 bolnikovih let v primerjavi s samo dieto 20,6 dogodka/1000 bolnikovih let (p = 0,011), in v primerjavi z združenima skupinama na monoterapiji s sulfonilsečnino in insulinom, 18,9 dogodka/1000 bolnikovih let (p = 0,021).
• a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017,
• pomembno zmanjšanje absolutnega tveganja za katerikoli s sladkorno boleznijo povezan usodni izid: metformin 7,5 dogodka/1000 bolnik let, samo dieta 12,7 dogodka/1000 bolnikovih let, p = 0,017;
After a median follow up of 6.25 years, linagliptin, when added to standard of care, did not increase the risk of major adverse cardiovascular events (table 5) as compared to glimepiride.
Linagliptin, kadar je bil dodan standardni terapiji, v primerjavi z glimepiridinom ni povečal tveganja za hude neželene srčno-žilne dogodke po mediani spremljanja 6,25 let (glejte preglednico 5).
In a pooled analysis of elderly (age ≥ 70 years) patients with type 2 diabetes (n=183) who were taking both metformin and basal insulin as background therapy, linagliptin in combination with metformin plus insulin provided significant improvements in HbA1c parameters with -0.81% (CI: -1.01; -0.61) adjusted mean change from baseline (mean baseline HbA1c 8.13%) compared to placebo in combination with metformin plus insulin.
V analizi združenih podatkov o starejših bolnikih (starost ≥ 70 let) s sladkorno boleznijo tipa 2 (n = 183), ki so za osnovno zdravljenje jemali metformin in bazalni insulin, je linagliptin v kombinaciji z metforminom in insulinom v primerjavi s placebom v kombinaciji z metforminom in insulinom pomembno izboljšal parametre HbA1c, saj je bila prilagojena srednja sprememba v primerjavi z izhodiščno ravnijo (srednja izhodiščna raven HbA1c 8,13 %) -0,81 % (IZ: -1,01; -0,61).
Therefore, linagliptin is not an inhibitor of P-glycoprotein-mediated transport in vivo.
Torej linagliptin ne zavira s P-glikoproteinom posredovanega prenosa in vivo.
The dose of Jentadueto should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Z odmerkom zdravila Jentadueto morajo bolniki prejeti po 2,5 mg linagliptina dvakrat na dan (skupni dnevni odmerek je 5 mg) in podoben odmerek metformina, kot so ga že jemali.
Maximum daily dose is 1000 mg.
30 do 44 Največji dnevni odmerek je 1.000 mg.
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 subjects.
Sočasno dajanje večkratnih dnevnih odmerkov linagliptina po 5 mg in večkratnih odmerkov digoksina po 0,25 mg pri zdravih prostovoljcih ni vplivalo na farmakokinetiko digoksina.
• a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
• pomembno zmanjšanje absolutnega tveganja pojava miokardnega infarkta: metformin 11 dogodkov/1000 bolnikovih let, sama dieta 18 dogodkov/1000 bolnikovih let, (p = 0,01).
Co-administration of multiple daily doses of 10 mg linagliptin with 850 mg metformin hydrochloride, an OCT substrate, had no relevant effect on the pharmacokinetics of metformin in healthy subjects.
Sočasno dajanje večkratnih dnevnih odmerkov linagliptina po 10 mg z 850 mg metforminijevega klorida, substrata za OCT, pri zdravih prostovoljcih ni relevantno vplivalo na farmakokinetiko metformina.
Risk of lactic acidosis.
Tveganje za laktacidozo
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.
Po večkratnem sočasnem dajanju linagliptina po 5 mg in rifampicina, močnega induktorja P-glikoproteina in CYP3A4, sta se za 39,6 % in 43,8 % zmanjšali AUC in Cmax linagliptina v stanju dinamičnega ravnovesja ter za približno 30 % zaviralni učinek na DPP-4 pri najmanjši koncentraciji v plazmi.
Oval, biconvex, light pink, film-coated tablet of 21.1 mm x 9.7 mm debossed with ”D2/1000" on one side and the company logo on the other.
Jentadueto 2,5 mg/1000 mg filmsko obložene tablete Podolgovata, obojestransko izbočena, svetlo rožnata filmsko obložena tableta velikosti 21,1 mm x 9,7 mm, z vtisnjeno oznako “D2/1000” na eni strani in logotipom podjetja na drugi strani.
What Jentadueto contains
Kaj vsebuje zdravilo Jentadueto
Description of selected adverse reactions
Opis določenih neželenih učinkov
Jentadueto is available in perforated unit dose blisters with 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 and multipacks containing 120 x 1 (2 packs of 60 x 1), 180 x 1 (2 packs of 90 x 1) and 200 x 1 (2 packs of 100 x 1) film-coated tablets.
Zdravilo Jentadueto je na voljo v perforiranih, enoodmernih pretisnih omotih po 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 in 120 x 1 filmsko obložena tableta in večkratnih pakiranjih po 120 x 1 (2 enoti po 60 x 1), 180 x 1 (2 enoti po 90 x 1) in 200 x 1 (2 enoti po 100 x 1) filmsko obložena tableta.
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.
Pri sočasnem dajanju večkratnih peroralnih odmerkov linagliptina po 5 mg in enkratnega peroralnega odmerka glibenklamida (gliburida) po 1,75 mg sta se za 14 % zmanjšali AUC in Cmax glibenklamida, kar ni veljalo za klinično pomembno.
A NOAEL of 78 times human exposure was derived for embryo-fetal toxicity in rabbits, and for maternal toxicity the NOAEL was 2.1 times human exposure.
Odmerek, pri katerem še ni opaziti toksičnega delovanja (NOAEL), so pri kuncih na podlagi toksičnosti za zarodke in plodove določili pri izpostavljenosti, ki 78-krat presega izpostavljenost za človeka, pri samicah pa 2,1-krat.
Co-administration of multiple three-times-daily doses of 850 mg metformin hydrochloride with 10 mg linagliptin once daily did not clinical meaningfully alter the pharmacokinetics of linagliptin in healthy subjects.
Pri sočasnem dajanju večkratnih odmerkov metforminijevega klorida po 850 mg, trikrat na dan, in 10 mg linagliptina, enkrat na dan, pri zdravih prostovoljcih ni bilo klinično pomembnih sprememb farmakokinetike linagliptina.
This has been shown at therapeutic doses in controlled, medium-term or longterm clinical studies: metformin hydrochloride reduces total cholesterol, LDL cholesterol and triglyceride levels.
Neodvisno od učinka na glikemijo, metforminijev klorid pri ljudeh ugodno vpliva na presnovo lipidov, kar je bilo dokazano z nadzorovanimi, srednje dolgimi in dolgotrajnimi kliničnimi študijami terapevtskih odmerkov: metforminijev klorid znižuje ravni skupnega holesterola, holesterola LDL in trigliceridov.
System organ class Adverse reaction
Organski sistem Neželeni učinki
Linagliptin provided significant improvements in HbA1c (-0.64% change compared to placebo after 24 weeks), from a mean baseline HbA1c of 7.8%.
Linagliptin je pomembno izboljšal HbA1c (-0,64-odstotna sprememba v primerjavi s placebom po 24 tednih), in sicer z izhodiščne ravni HbA1c 7,8 %.
Maximum daily dose is 3000 mg.
60 do 89 Največji dnevni odmerek je 3.000 mg.
Oval, biconvex, light orange, film-coated tablet of 19.2 mm x 9.4 mm debossed with "D2/850" on one side and the company logo on the other.
Jentadueto 2,5 mg/850 mg filmsko obložene tablete Podolgovata, obojestransko izbočena, svetlo oranžna filmsko obložena tableta velikosti 19,2 mm x 9,4 mm, z vtisnjeno oznako “D2/850” na eni strani in logotipom podjetja na drugi strani.
Investigations Amylase increased uncommon
Preiskave povečana raven amilaze občasni povečana raven lipaze*
Factors that may increase the risk of lactic acidosis (see 4.4) should be reviewed before considering initiation of metformin in patients with GFR<60 ml/min.
Pri bolnikih z GFR < 60 ml/min je treba pred uvedbo metformina pregledati dejavnike, ki lahko povečajo tveganje za laktacidozo (glejte poglavje 4.4).
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.
Starost ni klinično pomembno vplivala na farmakokinetiko linagliptina, kar je pokazala populacijska farmakokinetična analiza podatkov I. in II faze.
Jentadueto 2.5 mg/850 mg are oval, biconvex, light orange, film-coated tablets (tablets).
Zdravilo Jentadueto 2,5 mg/850 mg so ovalne, obojestransko izbočene, svetlo oranžne, filmsko obložene tablete (tablete).
Jentadueto 2.5 mg/1,000 mg film-coated tablets also contains iron oxide red (E172).
Zdravilo Jentadueto 2,5 mg/1000 mg filmsko obložene tablete vsebuje tudi rdeči železov oksid (E172).
• in patients inadequately controlled on their maximally tolerated dose of metformin alone
• pri bolnikih z nezadostno urejeno boleznijo pri jemanju največjega odmerka metformina, ki ga še prenašajo;
Jentadueto should not be used during pregnancy.
Zdravila Jentadueto nosečnice ne smejo jemati.
Infections and infestations Nasopharyngitis uncommon
Infekcijske in parazitske bolezni nazofaringitis občasno
Urticaria rare
zelo redko
Effects of other medicinal products on linagliptin Clinical data described below suggest that the risk for clinically meaningful interactions by coadministered medicinal products is low.
Navedeni klinični podatki kažejo na majhno tveganje klinično pomembnih interakcij s sočasno danimi zdravili.
How to take this medicine - one tablet twice daily by mouth in the dose prescribed by your doctor.
- zaužijte eno tableto dvakrat na dan v odmerku, ki vam ga je predpisal vaš zdravnik; - ob jedi, kar zmanjša možnost pojava želodčnih težav.
Talk to your doctor, pharmacist or nurse before taking Jentadueto - if you have type 1 diabetes (your body does not produce any insulin).
Pred začetkom jemanja zdravila Jentadueto se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro: - če imate sladkorno bolezen tipa 1 (vaše telo ne izdeluje insulina); zdravila Jentadueto ni dovoljeno uporabljati za zdravljenje tega stanja; - če jemljete insulin ali antidiabetik sulfonilsečnino, vam bo zdravnik morda zmanjšal vaš odmerek insulina ali sulfonilsečnine, če boste katerega od njiju jemali hkrati z zdravilom
PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 2 packs, each containing 60 x 1 film-coated tablets Multipack comprising 2 packs, each containing 90 x 1 film-coated tablets Multipack comprising 2 packs, each containing 100 x 1 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA Večkratno pakiranje z 2 enotama, ki vsebujeta po 60 x 1 filmsko obloženo tableto.
A delayed time to peak serum concentrations by 2 hours was observed for metformin under fed conditions.
Pri jemanju s hrano so zasledili tudi podaljšan čas do največje koncentracije v serumu, in sicer za 2 uri.
How Jentadueto works
Kako deluje zdravilo Jentadueto
Jentadueto 2.5 mg/850 mg film-coated tablets also contains iron oxide red (E172) and iron oxide yellow (E172).
Zdravilo Jentadueto 2,5 mg/850 mg filmsko obložene tablete vsebuje tudi rdeči (E172) in rumeni železov oksid (E172).
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.
Linagliptin kot dodatno zdravilo ob kombinaciji metformina in sulfonilsečnine Učinkovitost in varnost linagliptina po 5 mg v primerjavi s placebom so ocenili v s placebom nadzorovani 24-tedenski študiji pri bolnikih z nezadostno urejeno boleznijo ob zdravljenju s kombinacijo metformina in sulfonilsečnine.
Body mass index had no clinically relevant effect on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Indeks telesne mase ni klinično pomembno vplival na farmakokinetiko linagliptina, kar je pokazala populacijska farmakokinetična analiza podatkov I. in II.
Cardiovascular and renal outcomes by treatment group in the CARMELINA study Linagliptin 5mg
Preglednica 5 Pomembni neželeni srčno-žilni dogodki (MACE) in umrljivost po skupinah zdravljenja v študiji CAROLINA linagliptin 5 mg glimepiridin (1-4 mg)
During treatment with Jentadueto, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Med zdravljenjem z zdravilom Jentadueto bo zdravnik vsaj enkrat letno preveril delovanje ledvic.
Linagliptin provided significant improvements in HbA1c (-0.62% change compared to placebo), from a mean baseline HbA1c of 8.14%.
Linagliptin je pomembno izboljšal raven HbA1c (-0,62 % v primerjavi s placebom), in sicer s srednje izhodiščne ravni HbA1c 8,14 %.
The NOAEL for fertility, early embryonic development and teratogenicity in rats was set at > 900 times the human exposure.
Odmerek, pri katerem še ni opaziti toksičnega učinka (NOAEL) na plodnost, zgodnji razvoj zarodka in teratogenost pri podganah, več kot 900-krat presega mejo izpostavljenosti za človeka.
For the different doses of metformin, Jentadueto is available in strengths of 2.5 mg linagliptin plus 850 mg metformin hydrochloride and 2.5 mg linagliptin plus 1,000 mg metformin hydrochloride.
Zaradi potrebe po različnih odmerkih metformina je zdravilo Jentadueto na voljo v jakostih 2,5 mg linagliptina in 850 mg metforminijevega klorida ali 2,5 mg linagliptina in1000 mg metforminijevega klorida.
In the CARMELINA study, bullous pemphigoid was reported in 0.2% of patients treated with linagliptin and in no patient treated with placebo.
V študiji CARMELINA so o buloznem pemfigoidu poročali pri 0,2 % bolnikov, ki so se zdravili z linagliptinom, in pri nobenem bolniku, ki se je zdravil s placebom.
Gender had no clinically relevant effect on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Spol ni klinično pomembno vplival na farmakokinetiko linagliptina, kar je pokazala populacijska farmakokinetična analiza podatkov I. in II.
Linagliptin in combination with metformin plus insulin provided significant improvements in HbA1c in this subgroup with -0.68% (CI: -0.78; -0,57) adjusted mean change from baseline (mean baseline HbA1c 8.28%) compared to placebo in combination with metformin plus insulin.
Linagliptin v kombinaciji z metforminom in insulinom je v tej podskupini pomembno izboljšal raven HbA1c v primerjavi s placebom v kombinaciji z meforminom in insulinom, saj je bila prilagojena srednja sprememba v primerjavi z izhodiščno ravnijo HbA1c (srednja izhodiščna raven HbA1c 8,28 %) -0,68 % (IZ: -0,78; -0,57).
No adverse effects of linagliptin on fertility were observed in male or female rats (see section 5.3).
Pri podganjih samcih ali samicah niso ugotovili neželenih učinkov linagliptina na plodnost (glejte poglavje 5.3).
Jentadueto in order to avoid low blood sugar (hypoglycaemia).
Jentadueto, da bi tako preprečil pojav nizke ravni krvnega sladkorja (hipoglikemije); - če imate ali ste imeli bolezen trebušne slinavke.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS
PODATKI NA ZUNANJI OVOJNINI ŠKATLA S PRETISNIMI OMOTI
Linagliptin also showed significant improvements in fasting plasma glucose (FPG) compared to placebo.
Poleg tega je v primerjavi s placebom pomembno izboljšal raven glukoze na tešče.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - WRAPPED IN TRANSPARENT FOILINCLUDING THE BLUE BOX - 2.5 mg/850 mg FILM-COATED TABLETS
ZUNANJA OVOJNA NALEPKA NA VEČKRATNEM PAKIRANJU- OVITA V PROZORNO FOLIJO-VKLJUČUJE MODRO OKENCE- 2,5 MG/850 MG FILMSKO OBLOŽENE TABLETE
Due to the concentration dependent binding of linagliptin to DPPIV, 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.
Skupna AUC linagliptina v plazmi se je povečevala manj kot bi sicer bilo sorazmerno z odmerkom, medtem ko se AUC nevezane učinkovine povečuje približno sorazmerno z odmerkom.
Therefore, linagliptin is not an inhibitor of OCT-mediated transport.
Linagliptin ne zavira z OCT posredovanega prenosa.
Table 3:
Preglednica 3.
Linagliptin as add-on to metformin therapy
Linagliptin kot dodatno zdravilo ob metforminu
Patients inadequately controlled on maximal tolerated dose of metformin monotherapy For patients not adequately controlled on metformin alone, the usual starting dose of Jentadueto should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) plus the dose of metformin already being taken.
Bolniki z neustrezno urejeno boleznijo med zdravljenjem z dvojno kombinacijo, ki vsebuje največji odmerek metformina, ki ga še prenašajo, in sulfonilsečnino Z odmerkom zdravila Jentadueto morajo bolniki prejeti po 2,5 mg linagliptina dvakrat na dan (skupni dnevni odmerek je 5 mg) in podoben odmerek metformina, kot so ga že jemali.
A slow increase in dose of metformin hydrochloride may also improve gastrointestinal tolerability.
Prenašanje zdravila v prebavilih je možno izboljšati tudi s počasnim povečevanjem odmerka metformina hidroklorida.
PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 14 filmsko obloženih tablet 60 filmsko obloženih tablet 180 filmsko obloženih tablet
As the dose is individually titrated based on glycaemic control, this is of limited clinical relevance.
Ta izsledek je manjšega kliničnega pomena, ker odmerke titriramo individualno na podlagi urejenosti glikemije.
Vitamin B12 deficiency very rare
Presnovne in prehranske motnje hipoglikemija zelo pogosto laktična acidoza zelo redko pomanjkanje vitamina B12
Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.
Simptomi vključujejo bolečine v trebuhu, hitro in globoko dihanje, zaspanost ali zadah z nenavadnim sadnim vonjem; - če ste kadar koli v preteklosti imeli diabetično predkomo, - če imate hudo okužbo, kot je okužba, ki prizadene pljuča, bronhije ali ledvice.
Number of patients Primary CV composite (Cardiovascular death, non-fatal MI, non-fatal stroke)
število bolnikov primarni sestavljeni srčno-žilni izid (srčno-žilna smrt, neusodni MI, neusodna možganska kap) umrljivost zaradi vseh vzrokov srčno-žilna smrt hospitalizacija zaradi srčnega popuščanja
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - WRAPPED IN TRANSPARENT FOILINCLUDING THE BLUE BOX - 2.5 mg/1,000 mg FILM-COATED TABLETS
ZUNANJA OVOJNA NALEPKA NA VEČKRATNEM PAKIRANJU- OVITA V PROZORNO FOLIJO-VKLJUČUJE MODRO OKENCE- 2,5 MG/1000 MG FILMSKO OBLOŽENE TABLETE
Blister Store in the original package in order to protect from moisture.
Pretisni omot Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
The decrease in body weight with the combination of linagliptin and metformin was similar to that observed for metformin alone or placebo; there was no change in weight from baseline for patients on linagliptin alone.
Telesna masa se je med zdravljenjem s kombinacijo linagliptina in metformina podobno zmanjšala kot pri jemanju samega metformina ali placeba.
Twice Daily Metformin HCl 500 mg
Linagliptin 2,5 mg dvakrat na dan metformin HCl
Jentadueto 2.5 mg / 850 mg film-coated tablets Jentadueto 2.5 mg / 1,000 mg film-coated tablets linagliptin/metformin hydrochloride
Jentadueto 2,5 mg/850 mg filmsko obložene tablete Jentadueto 2,5 mg/1000 mg filmsko obložene tablete linagliptin/metforminijev klorid
MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/032 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/033 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/034 (200 (2 x 100 x 1) film-coated tablets)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/780/032 (120 (2 x 60 x 1) filmsko obloženih tablet) EU/1/12/780/033 (180 (2 x 90 x 1) filmsko obloženih tablet) EU/1/12/780/034 (200 (2 x 100 x 1) filmsko obloženih tablet)
Table 2:
Preglednica 2.
MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/029 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/030 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/031 (200 (2 x 100 x 1) film-coated tablets)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/780/029 (120 (2 x 60 x 1) filmsko obloženih tablet) EU/1/12/780/030 (180 (2 x 90 x 1) filmsko obloženih tablet) EU/1/12/780/031 (200 (2 x 100 x 1) filmsko obloženih tablet)
In the CARMELINA study, bullous pemphigoid was reported in 0.2% of patients on treatment with linagliptin and in no patient on placebo.
V študiji CARMELINA so o buloznem pemfigoidu poročali pri 0,2 % bolnikov, zdravljenih z linagliptinom, in pri nobenem bolniku, ki je jemal placebo.
shock.
faze.
Refer to Summary of Product Characteristics for metformin for additional information Adverse reaction observed in combination of Jentadueto with sulphonylurea Adverse reaction observed in combination of Jentadueto with insulin
Neželeni učinek opažen v kombinaciji zdravila Jentadueto in sulfonilsečnine 2 Neželeni učinek opažen v kombinaciji zdravila Jentadueto in insulina
Jentadueto 2.5 mg/850 mg film-coated tablets Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
Jentadueto 2,5 mg/850 mg filmsko obložene tablete Ena tableta vsebuje 2,5 mg linagliptina in 850 mg metforminijevega klorida.
When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin hydrochloride in plasma.
Če je delovanje ledvic okvarjeno, se ledvični očistek zmanjša sorazmerno z očistkom kreatinina.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 2.5 mg/850 mg FILM-COATED TABLETS
VEČKRATNO PAKIRANJE- VMESNA ŠKATLA BREZ MODREGA OKENCA2,5 MG/850 MG FILMSKO OBLOŽENE TABLETE
However, such studies have been conducted with the individual active substances, i.e. linagliptin and metformin.
Študij o interakcijah niso izvedli, opravili pa so jih z njegovima posamičnima zdravilnima učinkovinama, linagliptinom in metforminom.
Jentadueto 2.5 mg/1,000 mg are oval, biconvex light pink film-coated tablets (tablets).
Zdravilo Jentadueto 2,5 mg/1000 mg so ovalne, obojestransko izbočene, rožnate, filmsko obložene tablete (tablete).
NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/850 mg film-coated tablets Jentadueto 2.5 mg/1,000 mg film-coated tablets
Jentadueto 2,5 mg/850 mg filmsko obložene tablete Jentadueto 2,5 mg/1000 mg filmsko obložene tablete
Jentadueto 2.5 mg/1,000 mg film-coated tablets Each tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
Jentadueto 2,5 mg/1000 mg filmsko obložene tablete Ena tableta vsebuje 2,5 mg linagliptina in 1000 mg metforminijevega klorida.
- Each Jentadueto 2.5 mg/850 mg film-coated tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
- Ena filmsko obložena tableta Jentadueto 2,5 mg/850 mg vsebuje 2,5 mg linagliptina in 850 mg metforminijevega klorida.
High overdose of metformin hydrochloride or concomitant risks may lead to lactic acidosis.
Močno preveliki odmerki metforminijevega klorida ali sočasni dejavniki tveganja lahko povzročijo laktacidozo, ki je nujno medicinsko stanje in jo je treba zdraviti v bolnišnici.
How to store Jentadueto
Shranjevanje zdravila Jentadueto