natgillin/translations-raw huggingface dataset:
Liver, kidneys and gastrointestinal tract are the principal target organs of toxicity in mice and rats at repeat doses of linagliptin of more than 300 times the human exposure. 
Jetra, ledvice in prebavila so glavni ciljni organi za toksičnost pri miših in podganah pri ponavljajočem odmerjanju linagliptina preko 300-krat večjo izpostavljenostjo kot pri človeku.
Do not use this medicine after the expiry date which is stated on the blister, bottle and carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu, plastenki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
C] linagliptin oral 10 mg dose, approximately 5% of the radioactivity was excreted in urine. 
C] linagliptina se je približno 5 % radioaktivnosti izločilo s sečem.
- The other ingredients are: - Tablet core: arginine, copovidone, magnesium stearate, maize starch, silica, colloidal anhydrous. 
- Druge sestavine zdravila so: Jedro tablete: arginin, kopovidon, magnezijev stearat, koruzni škrob, brezvodni koloidni silicijev dioksid.
Some patients have experienced the following side effects while taking Jentadueto with insulin - Uncommon: liver function disorders, constipation 
Pri nekaterih bolnikih so se med jemanjem zdravila Jentadueto z insulinom pojavili naslednji neželeni učinki: - Občasni: motnje jetrnega delovanja, zaprtje
Patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin 
Bolniki z neustrezno urejeno boleznijo pri dvojno kombiniranem zdravljenju z insulinom in največjim odmerkom metformina, ki ga še prenašajo
90 x 1 film-coated tablets. 
90 x 1 filmsko obložena tableta.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 
Študije na živalih niso pokazale neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
In patients with mild moderate and severe hepatic impairment (according to the Child-Pugh classification), mean AUC and Cmax of linagliptin were similar to healthy matched controls following administration of multiple 5 mg doses of linagliptin. 
Pri bolnikih z blago, zmerno ali hudo jetrno okvaro (po Child-Pughovi klasifikaciji) sta bili srednji AUC in Cmax linagliptina po dajanju večkratnih odmerkov po 5 mg podobni kot pri ustreznih zdravih preizkušancih.
Nervous system disorders Taste disturbance common 
Bolezni živčevja motnje okušanja pogosto
Animal studies with metformin do not indicate harmful effects with respect to reproductive toxicity (see section 5.3). 
Študije na živalih ne kažejo škodljivih učinkov metformina na reprodukcijsko toksičnost (glejte poglavje 5.3).
Jentadueto combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class. 
Zdravilo Jentadueto vsebuje kombinacijo dveh antidiabetikov s komplementarnima mehanizmoma delovanja za boljšo urejenost glikemije pri bolnikih s sladkorno boleznijo tipa 2: linagliptin, zaviralec dipeptidil-peptidaze 4 (DPP-4), in metforminijev klorid, učinkovino iz skupine bigvanidov.
An embryofetal development study in pregnant rats did not indicate a teratogenic effect attributed to the co-administration of linagliptin and metformin at AUC exposure levels up to 4 and 30 times human exposure, respectively. 
Študija o učinkih na zarodek in plod pri brejih podganah ni kazala na teratogene učinke sočasnega dajanja linagliptina in metformina pri izpostavljenosti ravnem AUC, ki so bile do 4-krat oziroma do 30-krat večje kot pri človeku.
Pack sizes of 14, 60 and 180 film-coated tablets. 
Velikosti pakiranja po 14, 60 in 180 filmsko obloženih tablet.
The safety of linagliptin 2.5 mg twice daily (or its bioequivalent of 5 mg once daily) in combination with metformin has been evaluated in over 6800 patients with type 2 diabetes mellitus. 
Varnost linagliptina v odmerkih po 2,5 mg dvakrat na dan (ali bioekvivalentih po 5 mg enkrat na dan) v kombinaciji z metforminom so ocenili pri več kot 6800 bolnikih s sladkorno boleznijo tipa 2.
Symptoms of lactic acidosis include: - vomiting - stomach ache (abdominal pain) - muscle cramps - a general feeling of not being well with severe tiredness - difficulty in breathing - reduced body temperature and heartbeat 
Simptomi laktacidoze vključujejo: - bruhanje, - bolečino v trebuhu (abdominalna bolečina), - mišične krče, - splošno slabo počutje s hudo utrujenostjo, - težave z dihanjem, - znižano telesno temperaturo in počasen srčni utrip.
Plasma AUC of linagliptin increased approximately 33% following 5 mg doses at steady-state compared to the first dose. 
AUC linagliptina v plazmi se je v stanju dinamičnega ravnovesja po 5-mg odmerkih povečala za 33 % v primerjavi z njeno vrednostjo po prvem odmerku.
Intravascular administration of iodinated contrast agents may lead to contrast induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis. 
Intravaskularna aplikacija jodiranih kontrastnih sredstev lahko povzroči nefropatijo zaradi kontrastnega sredstva, ki povzroči kopičenje metformina in povečano tveganje laktacidoze.
It is not known whether linagliptin is excreted into human milk. 
Ni znano, ali se tudi linagliptin izloča v materino mleko.
Exposure in T2DM patients with severe RI was increased by about 1.4 fold compared to T2DM patients with normal renal function. 
Pri bolnikih s sladkorno boleznijo tipa 2 in hudo ledvično okvaro je bila izpostavljenost približno 1,4-krat večja kot pri bolnikih s sladkorno boleznijo tipa 2 z normalnim ledvičnim delovanjem.
Steady-state predictions for AUC of linagliptin in patients with ESRD indicated comparable exposure to that of patients with moderate or severe renal impairment. 
Napovedi za AUC linagliptina v stanju dinamičnega ravnovesja pri bolnikih s končno ledvično odpovedjo so kazale na primerljivo izpostavljenost kot pri tistih z zmerno ali hudo ledvično okvaro.
100 x 1 film-coated tablets. 
100 x 1 filmsko obložena tableta.
Metformin hydrochloride is excreted unchanged in the urine. 
Metforminijev klorid se nespremenjen izloči s sečem.
Among patients who were using insulin at baseline, the incidence of severe hypoglycaemia was 4.4% in linagliptin-treated patients and 4.9% in placebo treated patients. 
Med bolniki, ki so ob izhodišču jemali insulin, je bila pojavnost hude hipoglikemije 4,4 % pri bolnikih, ki so se zdravili z linagliptinom, in 4,9 % pri bolnikih, ki so se zdravili s placebom.
Food decreases the extent and slightly delays the absorption of metformin hydrochloride. 
Hrana zmanjša obseg absorpcije metforminijevega klorida in jo nekoliko upočasni.
These hormones are rapidly degraded by the enzyme DPP-4. 
Encim DPP-4 oba hormona hitro razgradi.
Linagliptin trough concentrations were also measured in elderly (age ≥ 70 years) with type 2 diabetes in a phase III study of 24 weeks duration. 
Najmanjše koncentracije linagliptina pred naslednjim odmerkom so merili tudi starejšim s sladkorno boleznijo tipa 2 (starost ≥ 70 let), in sicer v 24-tedenski študiji III. faze.
• Inhibitors of OCT1 (such as verapamil) may reduce efficacy of metformin. 
• zaviralci OCT1 (npr. verapamil) lahko zmanjša učinkovitost metformina;
When linagliptin and metformin were administered in combination with insulin, hypoglycaemia was the most frequently reported adverse event, but occurred at comparable rate when placebo and metformin were combined with insulin (linagliptin plus metformin plus insulin 29.5% and 30.9% in the placebo plus metformin plus insulin group) with a low rate of severe (requiring assistance) episodes (1.5% and 0.9%). 
Pri zdravljenju z linagliptinom in metforminom v kombinaciji z insulinom je bil najpogostejši neželeni dogodek, o katerem so poročali, hipoglikemija, vendar je do njega prišlo v primerljivem obsegu kot pri placebu in metforminom z insulinom (29,5 % za linagliptin + metformin + insulin in 30,9 % za skupino, ki je prejemala placebo + metformin + insulin); stopnja hudih epizod (kjer je bila potrebna pomoč) je bila nizka (1,5 % in 0,9 %).
- High-Density PolyEthylene (HDPE) bottle with plastic screw cap and a seal liner (aluminiumpolyester foil laminate) and a silica gel desiccant. 
- Plastenka iz polietilena visoke gostote (HDPE) s plastično navojno zaporko, podlogo tesnila (laminat iz aluminjasto poliesterske folije) in sredstvom za sušenje s silicijevim dioksidom.
When linagliptin plus metformin hydrochloride is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see section 4.4). 
Pri uporabi linagliptina in metforminijevega klorida v kombinaciji z insulinom je včasih potreben manjši odmerek insulina, da bi zmanjšali nevarnost hipoglikemije (glejte poglavje 4.4).
Linagliptin cardiovascular and renal safety study (CARMELINA) The CARMELINA study evaluated the cardiovascular and renal safety of linagliptin versus placebo in patients with type 2 diabetes and with increased CV risk evidenced by a history of established macrovascular or renal disease (see section 5.1). 
Študija o srčno-žilni in ledvični varnosti linagliptina (CARMELINA) Študija CARMELINA je ocenjevala srčno-žilno in ledvično varnost linagliptina v primerjavi s placebom pri bolnikih s sladkorno boleznijo tipa 2 in povečanim srčno-žilnim tveganjem, glede na anamnezo ugotovljenih makrovaskularnih ali ledvičnih bolezni (glejte poglavje 5.1).
Clinical experience with Jentadueto in patients with hepatic impairment is lacking. 
Z uporabo zdravila Jentadueto pri bolnikih z jetrno okvaro ni kliničnih izkušenj.
When linagliptin plus metformin hydrochloride is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4). 
Če jemljejo linagliptin in metformininjev klorid v kombinaciji s sulfonilsečnino, je včasih potreben manjši odmerek sulfonilsečnine, da bi zmanjšali nevarnost hipoglikemije (glejte poglavje 4.4).
The two active substances work together to control blood sugar levels in adult patients with a form of diabetes called ‘type 2 diabetes mellitus'. 
Dve zdravilni učinkovini urejata raven krvnega sladkorja pri odraslih bolnikih s sladkorno boleznijo tipa 2.
Following administration of a supratherapeutic dose of 10 mg linagliptin concomitantly with 40 mg of simvastatin daily for 6 days, the plasma AUC of simvastatin was increased by 34%, and the plasma Cmax by 10%. 
Po 6-dnevnem sočasnem dajanju supraterapevtskega odmerka linagliptina po 10 mg in 40 mg simvastatina na dan se je AUC simvastatina v plazmi povečala za 34 %, njegova Cmax v plazmi pa za
In clinical trials, the incidence rates of hypoglycemia were comparably low in patients taking linagliptin in combination with metformin or metformin alone. 
V kliničnih preskušanjih je bila stopnja pojavnosti hipoglikemije pri bolnikih, ki so jemali linagliptin v kombinaciji z metforminom in tistih, ki so jemali samo metformin, primerljivo nizka.
Jentadueto is also available in plastic bottles with plastic screw cap and a silica gel desiccant. 
Zdravilo Jentadueto je na voljo tudi v plastenkah s plastično navojno zaporko in sredstvom za sušenje s silicijevim dioksidom.
- Linagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 
- Linagliptin je zdravilna učinkovina iz skupine zaviralcev DPP-4 (zaviralci dipeptidil peptidaze-4).
In vivo assessment of interactions 
Ocena medsebojnega delovanja in vivo
Your doctor will decide when you must stop and when to restart your treatment with Jentadueto. 
Zdravnik se bo odločil, kdaj morate z jemanjem zdravila Jentadueto prenehati in kdaj lahko nadaljujete.
Jentadueto is not recommended in patients with hepatic impairment due to the active substance metformin (see sections 4.3 and 5.2). 
Zdravila Jentadueto zaradi zdravilne učinkovine metformina ne priporočajo za bolnike z jetrno okvaro (glejte poglavji 4.3 in 5.2).
All patients should continue their diet with an adequate distribution of carbohydrate intake during the day. 
Vsi bolniki morajo nadaljevati dieto z ustrezno porazdelitvijo vnosa ogljikovih hidratov čez dan. Bolniki s preveliko telesno maso morajo nadaljevati dieto z zmanjšano energijsko vrednostjo.
Linagliptin 5 mg once daily and 2.5 mg twice daily provided comparable (CI: -0.07; 0.19) significant HbA1c reductions of -0.80% (from baseline 7.98%), and -0.74% (from baseline 7.96%) compared to placebo. 
Linagliptin je v odmerkih po 5 mg enkrat na dan in 2,5 mg dvakrat na dan v primerjavi s placebom primerljivo (IZ: -0,07; 0,19) in pomembno znižal raven HbA1c, in sicer za -0,80 % (z izhodiščne ravni 7,98 %) in -0,74 % (z izhodiščne ravni 7,96 %).
Patients received metformin and/or sulphonylurea and/or insulin as background therapy. 
Za osnovno zdravljenje so bolniki jemali metformin in/ali sulfonilsečnino in/ali insulin.
Linagliptin cardiovascular safety study (CAROLINA) CAROLINA was a randomized study in 6033 patients with early type 2 diabetes and increased CV risk or established complications who were treated with linagliptin 5 mg (3023) or glimepiride 1-4mg (3010) added to standard of care (including background therapy with metformin in 83% of patients) targeting regional standards for HbA1c and CV risk factors. 
Študija o srčno-žilni varnosti linagliptina (CAROLINA) CAROLINA je bila randomizirana študija, v kateri je sodelovalo 6033 bolnikov s sladkorno boleznijo tipa 2 v zgodnji fazi in s povečanim srčno-žilnim tveganjem ali ugotovljenimi zapleti, ki so se zdravili z linagliptinom 5 mg (3023) ali glimepiridom 1-4 mg (3010), dodanima standardni terapiji (vključno z osnovnim zdravljenjem z metforminom pri 83 % bolnikov) na podlagi regionalnih standardov za vrednosti HbA1c in tveganja za srčno-žilne bolezni.
The mean HbA1c at baseline was 8.0%. 
Povprečna izhodiščna vrednost HbA1c je bila 8,0 %.
Cardiac function 
Delovanje srca
Frequency of adverse reaction 
Pogostnost neželenih učinkov
The overall incidence of adverse events and serious adverse events in patients receiving linagliptin was similar to that in patients receiving placebo. 
Pojavnost neželenih učinkov in resnih neželenih učinkov pri bolnikih, ki so jemali linagliptin, je bila podobna kot pri bolnikih, ki so jemali placebo.
Linagliptin plus metformin 
Linagliptin in metformin
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. 
Pri sočasnem dajanju enkratnega peroralnega odmerka linagliptina po 5 mg in večkratnih 200 mg peroralnih odmerkih ritonavirja, močnega zaviralca P-glikoproteina in CYP3A4, sta se povečali AUC in Cmax linagliptina, in sicer za približno dvakrat oziroma trikrat.
if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. 
- če imate hudo oslabljeno delovanje ledvic, - če imate nenadzorovano sladkorno bolezen, na primer s hudo hiperglikemijo (visoko ravnijo sladkorja v krvi), siljenjem na bruhanje, bruhanjem, drisko, hitro izgubo telesne mase, laktacidozo (glejte spodaj "Tveganje za laktacidozo") ali ketoacidozo.
Linagliptin binds selectively to DPP-4 and exhibits a > 10,000 fold selectivity versus DPP-8 or DPP-9 activity in vitro. 
Njegova selektivnost za DPP-4 je in vitro več kot 10.000-krat večja kot za DPP-8 ali DPP-9.
10 x 1 film-coated tablets 14 x 1 film-coated tablets 28 x 1 film-coated tablets 30 x 1 film-coated tablets 56 x 1 film-coated tablets 60 x 1 film-coated tablets 84 x 1 film-coated tablets 90 x 1 film-coated tablets 98 x 1 film-coated tablets 100 x 1 film-coated tablets 120 x 1 film-coated tablets 
10 x 1 filmsko obložena tableta 14 x 1 filmsko obložena tableta 28 x 1 filmsko obložena tableta 30 x 1 filmsko obložena tableta 56 x 1 filmsko obložena tableta 60 x 1 filmsko obložena tableta 84 x 1 filmsko obložena tableta 90 x 1 filmsko obložena tableta 98 x 1 filmsko obložena tableta 100 x 1 filmsko obložena tableta 120 x 1 filmsko obložena tableta
Total daily dose of linagliptin is equal to 5 mg 
Dnevni odmerek linagliptina je 5 mg.
Linagliptin cardiovascular and renal safety study (CARMELINA) CARMELINA was a randomized study in 6979 patients with type 2 diabetes with increased CV risk evidenced by a history of established macrovascular or renal disease who were treated with linagliptin 5 mg (3494) or placebo (3485) added to standard of care targeting regional standards for HbA1c, CV risk factors and renal disease. 
Študija o srčno-žilni in ledvični varnosti linagliptina (CARMELINA) Študija CARMELINA je bila randomizirana študija, v kateri je sodelovalo 6979 bolnikov s sladkorno boleznijo tipa 2 in povečanim srčno-žilnim tveganjem, glede na anamnezo ugotovljenih makrovaskularnih ali ledvičnih bolezni, ki so se zdravili z linagliptinom 5 mg (3494) ali placebom (3485), dodanima standardni terapiji na podlagi regionalnih standardov za vrednosti HbA1c, tveganja za srčno-žilne bolezni in ledvične bolezni.
There was no meaningful change from baseline in body weight in either group. 
Telesna masa se v nobeni od skupin ni pomembno spremenila glede na izhodiščno.
Difference from placebo (adjusted mean) (95% CI) Patients (n, %) achieving HbA1c 
Razlika v primerjavi s placebom (prilagojena srednja vrednost) (95-odstotni IZ) Bolniki (n, %), ki so dosegli HbA1c < 7 % Bolniki (%), ki so prejeli reševalno zdravilo
In controlled clinical trials, maximum metformin hydrochloride plasma levels (Cmax) did not exceed 5 microgram/ml, even at maximum doses. 
Največja koncentracija metforminijevega klorida v plazmi (Cmax) v kontroliranih kliničnih preskušanjih tudi ob največjih odmerkih ni presegla 5 μg/ml.
Symptoms of lactic acidosis are non-specific such as feeling or being very sick, vomiting, stomach ache with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. 
Simptomi laktacidoze so nespecifični, na primer močna slabost ali siljenje na bruhanje, bruhanje, trebušne bolečine z mišičnimi krči, splošno slabo počutje z izrazito utrujenostjo in oteženo dihanje.
You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse. 
Upoštevajte priporočila svojega zdravnika ali medicinske sestre o negi kože in stopal.
In a 24-week placebo-controlled factorial study of initial therapy, linagliptin 2.5 mg twice daily in combination with metformin (500 mg or 1,000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy as summarised in Table 3 (mean baseline HbA1c 8.65%). 
V 24-tedenski s placebom nadzorovani faktorski študiji začetnega zdravljenja je linagliptin v odmerkih po 2,5 mg dvakrat na dan v kombinaciji z metforminom (500 mg ali 1.000 mg dvakrat na dan) pomembno izboljšal glikemične parametre, in sicer v primerjavi z obema monoterapijama, kar je povzeto v preglednici 3 (srednja izhodiščna raven HbA1c 8,65 %).
The pharmacokinetics of linagliptin has been extensively characterised in healthy subjects and patients with type 2 diabetes. 
Farmakokinetiko linagliptina so obsežno proučevali pri zdravih preizkušancih in bolnikih s sladkorno boleznijo tipa 2.
• Inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib) may alter efficacy and renal elimination of metformin. 
• zaviralci OCT1 in OCT2 (npr. krizotinib, olaparib) lahko spremeni učinkovitost in izločanje metformina skozi ledvice.
Jentadueto must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.4. 
Metformin je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno, glejte poglavji 4.2 in 4.4.
When linagliptin and metformin were administered in combination with a sulphonylurea, hypoglycaemia was the most frequently reported adverse event (linagliptin plus metformin plus sulphonylurea 23.9% and 16.0% in placebo plus metformin plus sulphonylurea). 
Pri zdravljenju z linagliptinom in metforminom v kombinaciji s sulfonilsečnino je bil najpogostejši neželeni dogodek, o katerem so poročali, hipoglikemija (23,9 % za linagliptin + meformin + sulfonilsečnino in 16,0 % za placebo + meformin + sulfonilsečnino).
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. 
Linagliptin kot dodatno zdravilo h kombinaciji metformina in emagliflozina Pri bolnikih, neustrezno zdravljenih z metforminom in empagliflozinom (10 mg (n = 247) ali 25 mg (n = 217)), je 24-tedensko zdravljenje z linagliptinom 5 mg, kot dodatnim zdravilom, znižalo prilagojene povprečne vrednosti HbA1c od izhodišča za -0,53 % (pomembna razlika v primerjavi z dodatnim zdravljenjem s placebom -0,32 % (95 % IZ -0,52; -0,13) in -0,58 % (pomembna razlika v primerjavi z dodatnim zdravljenjem s placebom -0,47 % (95 % IZ -0,66; -0,28).
The pharmacokinetics of linagliptin was generally similar in healthy subjects and in patients with type 2 diabetes. 
Farmakokinetika linagliptina je bila pri zdravih preizkušancih in bolnikih s sladkorno boleznijo tipa 2 v glavnem podobna.
Metabolism plays a subordinate role in the elimination of linagliptin. 
Presnavljanje je pri izločanju linagliptina sekundarnega pomena.
Linagliptin also showed significant improvements in fasting plasma glucose (FPG) by -21.1 mg/dl and 2-hour postprandial glucose (PPG) by -67.1 mg/dl compared to placebo, as well as a greater portion of patients achieving a target HbA1c of < 7.0% (28.3% on linagliptin versus 11.4% on placebo). 
Hkrati je linagliptin pomembno izboljšal raven glukoze v plazmi na tešče, in sicer za -21,1 mg/dl, in raven glukoze 2 uri po jedi, za -67,1 mg/dl v primerjavi s placebom, poleg tega je večji delež bolnikov dosegel ciljno raven HbA1c, ki je < 7,0 % (28,3 % pri linagliptinu, v primerjavi z 11,4 % pri placebu).
Posology for renally impaired patients GFR ml/min Metformin 
Preglednica 1: Odmerjanje za bolnike z ledvično okvaro GFR ml/min Metformin
• a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034, 
• pomembno znižanje absolutnega tveganja za katerikoli s sladkorno boleznijo povezan zaplet v skupini z metforminom (29,8 dogodka/1000 bolnikovih let) v primerjavi s samo dieto (43,3 dogodka/1000 bolnikovih let), p = 0,0023, in v primerjavi z združenima skupinama na monoterapiji s sulfonilsečnino in insulinom (40,1 dogodka/1000 bolnikovih let), p = 0,0034;
INFORMATION IN BRAILLE Jentadueto 2.5 mg/850 mg 
PODATKI V BRAILLOVI PISAVI Jentadueto 2,5 mg/850 mg
Change in clinical status of patients with previously controlled type 2 diabetes As Jentadueto contains metformin, a patient with previously well controlled type 2 diabetes on Jentadueto who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis. 
Ker vsebuje zdravilo Jentadueto metformin, je treba stanje bolnika z dotlej dobro urejeno sladkorno boleznijo tipa 2 s tem zdravilom, nemudoma oceniti, kadar se pri njem pojavijo laboratorijske nepravilnosti ali klinična bolezen (zlasti nedoločena ali slabo opredeljena), da bi odkrili znake ketoacidoze ali laktacidoze.