natgillin/translations-raw huggingface dataset:
The risk of developing lactic acidosis is also increased with uncontrolled diabetes, prolonged fasting or alcohol intake, body fluid deficit (dehydration) due to severe diarrhoea or vomiting, liver problems and any medical conditions in which a region of the body is deprived with a lack of oxygen supply (such as acute severe heart diseases). 
Tveganje za nastanek laktacidoze je povečano tudi ob nenadzorovani sladkorni bolezni, dolgotrajnejšem postu ali uživanju alkohola, pomanjkanju telesnih tekočin (dehidracija) zaradi hude driske ali bruhanja, težavah z jetri in vsakem stanju, pri katerem ima del telesa pomanjkljivo oskrbo s kisikom (kot so akutna in huda obolenja srca).
Experience in New York Heart Association (NYHA) class I-II is limited, and there is no experience in clinical studies with empagliflozin in NYHA class III-IV. 
Heart Association) so omejene, izkušenj iz kliničnih študij z empagliflozinom z razredom III-IV po
At Week 18, empagliflozin provided statistically significant improvement in HbA1c compared with placebo (Table 4). 
V 18. tednu je pri empagliflozinu prišlo do statistično značilnega izboljšanja vrednosti HbA1c v primerjavi s placebom (preglednica 4).
Symptoms include rapid weight loss, feeling sick or being sick, stomach pain, fast and deep breathing, sleepiness or unusual fruity odour of the breath; 
Simptomi vključujejo hitro izgubo telesne mase, občutek slabosti ali bruhanje, trebušne bolečine, hitro in globoko dihanje, zaspanost ali nenavaden saden zadah.
Other associated risk factors should be considered to avoid lactic acidosis such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic impairment and any condition associated with hypoxia (such as decompensated cardiac failure, acute myocardial infarction) (see section 4.3). 
Da bi preprečili pojav laktacidoze, je treba upoštevati tudi druge povezane dejavnike tveganja, kot so slabo nadzorovana sladkorna bolezen, ketoza, dolgotrajnejši post, čezmerno uživanje alkohola, jetrna okvara in vsako stanje, ki je povezano s hipoksijo (kot je dekompenzirano srčno popuščanje, akutni miokardni infarkt) (glejte poglavje 4.3).
Stop taking Synjardy immediately and contact a doctor or the nearest hospital straight away. 
Takoj prenehajte jemati zdravilo Synjardy in se nemudoma posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico.
If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. 
Če se pri vas pojavijo ti simptomi, boste morda potrebovali takojšnje bolnišnično zdravljenje, saj lahko laktacidoza vodi v komo.
If you experience some of these symptoms, you should seek immediately medical attention, as lactic acidosis may lead to coma. 
Če opazite katerega izmed teh simptomov, nemudoma pokličite zdravnika, saj lahko laktacidoza vodi v komo.
Hypoglycaemia The frequency of hypoglycaemia depended on the background therapy in the respective studies. 
Hipoglikemija Pogostnost hipoglikemije je bila odvisna od sočasno uporabljenih zdravil v zadevnih študijah.
The efficacy and safety of empagliflozin as add on to basal insulin with concomitant metformin therapy was evaluated in a double-blind, placebo-controlled trial of 78 weeks duration. 
Učinkovitost in varnost empagliflozina kot dodatnega zdravljenja k bazalnemu insulinu s sočasnim metforminom so ocenili v dvojno slepem, s placebom nadzorovanem 78-tedenskem preskušanju.
Empagliflozin as add-on to metformin, sulphonylurea, pioglitazone Empagliflozin as add-on to metformin, metformin and a sulphonylurea, or pioglitazone and metformin resulted in statistically significant (p<0.0001) reductions in HbA1c and body weight compared to placebo (Table 2). 
Empagliflozin kot dodatno zdravljenje k metforminu, sulfonilsečnini, pioglitazonu Empagliflozin kot dodatno zdravljenje k metforminu, metforminu s sulfonilsečnino ali pioglitazonu z metforminom je povzročilo statistično značilno (p < 0,0001) zmanjšanje vrednosti HbA1c in telesne mase v primerjavi s placebom (preglednica 2).
Therefore, avoid consumption of alcohol and medicines containing alcohol when taking Synjardy (see section 4, ‘Possible side effects'). 
Če jemljete zdravilo Synjardy, ne uživajte alkohola in ne uporabljajte zdravil, ki ga vsebujejo (glejte poglavje 4 “Možni neželeni učinki”).
(95% CI) a Full analysis set (FAS) 
Razlika glede na placebo5 (95-odstotni IZ) a Niz celotne analize (FAS, full analysis set)
• difficulty breathing 
• huda utrujenost • težave z dihanjem
The intravascular administration of iodinated contrast agents in radiological studies may lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis. 
Intravaskularno dajanje jodiranih kontrastnih sredstev v radioloških študijah lahko pripelje do ledvične odpovedi, ki povzroči kopičenje metformina in s tem tveganje za pojav laktacidoze.
Placebo 
za placebo.
Special caution should be paid to situations where renal function may become impaired, for example in case of dehydration (severe diarrhoea or vomiting), or when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). 
Posebna previdnost je potrebna v razmerah, v katerih bi se lahko delovanje ledvic poslabšalo, na primer ob dehidraciji (huda driska ali bruhanje) ali ob začetku zdravljenja z antihipertenzivom, diuretikom ali nesteroidnim protivnetnim zdravilom (NSAID).
For patients inadequately controlled on metformin monotherapy or metformin in combination with other glucose-lowering medicinal products including insulin In patients not adequately controlled on metformin alone or in combination with other glucose-lowering medicinal products, including insulin, the recommended starting dose of Synjardy should provide empagliflozin 5 mg twice daily (10 mg daily dose) and the dose of metformin similar to the dose already being taken. 
Pri bolnikih z nezadostno urejeno boleznijo pri jemanju metformina v monoterapiji ali v kombinaciji z drugimi zdravili, ki nižajo raven glukoze, vključno z insulinom Priporočeni začetni odmerek zdravila Synjardy pri bolnikih z nezadostno urejeno boleznijo pri jemanju metformina v monoterapiji ali v kombinaciji z drugimi zdravili, ki nižajo raven glukoze, vključno z insulinom, je 5 mg empagliflozina dvakrat dnevno (dnevni odmerek je 10 mg) s podobnim odmerkom metformina, kot so ga že jemali.
The following statements reflect the pharmacokinetic properties of the individual active substances of Synjardy. 
Spodnje trditve temeljijo na farmakokinetičnih lastnostih posameznih zdravilnih učinkovin zdravila
SGLT2 prevents glucose (blood sugar) from being lost in urine by absorbing glucose back into the bloodstream as blood is being filtered in the kidneys. 
(krvnega sladkorja) v urinu, tako da absorbira glukozo nazaj v krvni obtok, medtem ko se kri filtrira v ledvicah.
In this analysis, AUC was estimated to be 5.82%, 10.4%, and 17.3% lower in subjects with BMI of 30, 35, and 45 kg/m2, respectively, compared to subjects with a body mass index of 25 kg/m2. 
10,4 % oz. 17,3 % nižja pri osebah z ITM 30, 35 oz. 45 kg/m2 v primerjavi z osebami z indeksom telesne mase 25 kg/m2.
An embryofetal development study in pregnant rats did not indicate a teratogenic effect attributed to the co-administration of empagliflozin and metformin at exposures of approximately 14-times the clinical AUC exposure of empagliflozin associated with the highest dose, and 4-times the clinical AUC exposure of metformin associated with the 2000 mg dose. 
Študija o učinkih na razvoj zarodka in plodu pri brejih podganah ni pokazala teratogenih učinkov sočasnega dajanja empagliflozina in metformina pri izpostavljenostih, ki so bile približno 14-krat večje od klinične izpostavljenosti empagliflozinu na podlagi vrednosti AUC, ki je povezana z največjim odmerkom, in 4-krat večje od klinične izpostavljenosti metforminu na podlagi vrednosti
In vitro studies suggested that the primary route of metabolism of empagliflozin in humans is glucuronidation by the uridine 5'-diphospho-glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8, and UGT1A9. 
Podatki in vitro kažejo, da je glavna presnovna pot empagliflozina pri ljudeh glukuronidacija z uridin 5‘-difosfo-glukuronoziltransferazami UGT1A3, UGT1A8, UGT1A9 in UGT2B7.
Due to the metformin component, co-administration of anaesthesia can increase the risk of side effects. 
Zaradi metformina lahko sočasno dajanje anestezije poveča tveganje neželenih učinkov.
Metformin is excreted into human milk. 
Dojenje Metformin se izloča v materino mleko.
Table 6 Efficacy results at 12 week in a placebo-controlled study of empagliflozin in patients with type 2 diabetes and uncontrolled blood pressurea 
Preglednica 6: Rezultati učinkovitosti v 12. tednu v s placebom nadzorovani študiji empagliflozina pri bolnikih s sladkorno boleznijo tipa 2 in nekontroliranim krvnim tlakoma placebo empagliflozin
In a prospective, pre-specified meta-analysis of independently adjudicated cardiovascular events from 12 phase 2 and 3 clinical studies involving 10,036 patients with type 2 diabetes, empagliflozin did not increase cardiovascular risk. 
12 kliničnih študijah 2. in 3. faze, ki so zajele 10.036 bolnikov s sladkorno boleznijo tipa 2,
2 Identified adverse reactions of empagliflozin monotherapy 3 Identified adverse reactions of metformin monotherapy 4 Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia) 
4 Dolgotrajno zdravljenje z metforminom so povezali z zmanjšano absorpcijo vitamina B12, kar lahko zelo redko pripelje do klinično pomembnega pomanjkanja tega vitamina (npr. megaloblastne anemije).
Empagliflozin 24 months data, as add-on to metformin in comparison to glimepiride In a study comparing the efficacy and safety of empagliflozin 25 mg versus glimepiride (up to 4 mg per day) in patients with inadequate glycaemic control on metformin alone, treatment with empagliflozin daily resulted in superior reduction in HbA1c (Table 3), and a clinically meaningful reduction in FPG, compared to glimepiride. 
V študiji, v kateri so primerjali učinkovitost in varnost empagliflozina 25 mg z glimepiridom (do 4 mg na dan) pri bolnikih z neustrezno urejeno glikemijo, ki so dobivali samo metformin, je dnevno zdravljenje z empagliflozinom povzročilo večje zmanjšanje vrednosti HbA1c (preglednica 3), in klinično pomembno zmanjšanje vrednosti FPG, v primerjavi z gimepiridom.
A total of 4704 patients with type 2 diabetes were treated in 7 double-blind, placebo or active-controlled clinical studies of at least 24 weeks duration, of which 1109 patients received empagliflozin 10 mg and 1863 received empagliflozin 25 mg as add-on to metformin therapy. 
Klinična učinkovitost in varnost V 7 dvojno slepih, s placebom ali zdravilno učinkovino nadzorovanih kliničnih študijah, je bilo zdravljenih skupaj 4.704 bolnikov s sladkorno boleznijo tipa 2 najmanj 24 tednov, od tega jih je 1.109 prejemalo empagliflozin 10 mg in 1.863 empagliflozin 25 mg kot dodatno zdravljenje k metforminu.
Table 4: Efficacy results at 18 and 52 weeks in a placebo-controlled study of empagliflozin as add-on to multiple daily doses of insulin with concomitant metformin therapy 
Preglednica 4: Rezultati učinkovitosti v 18. in 52. tednu v s placebom nadzorovani študiji z empagliflozinom kot dodatnim zdravljenjem k večkratnim dnevnim odmerkom insulina sočasno z metforminom placebo empagliflozin
A greater proportion of patients treated with empagliflozin and with a baseline HbA1c ≥7.0% achieved a target HbA1c of <7% compared to placebo (Table 5). 
V primerjavi s placebom je večji delež bolnikov, zdravljenih z empagliflozinom in z izhodiščno vrednostjo HbA1c ≥ 7,0 %, dosegel ciljno vrednost HbA1c < 7 % (preglednica 5).
Special caution should be exercised in situations where renal function may become impaired, for example in case of dehydration, or when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). 
Posebna previdnost je potrebna v razmerah, ko bi lahko prišlo do okvare v delovanju ledvic, na primer v primeru dehidracije ali na začetku zdravljenja z antihipertenzivom, diuretikom ali nesteroidnim protivnetnim zdravilom
An urge to pass urine or more frequent urination may be due to the way Synjardy works, but as they can also be signs of urinary tract infection. 
• bolečina v predelu medenice ali sredine hrbta (če so okužene ledvice) Nuja po uriniranju ali pogostejše uriniranje sta lahko posledica načina delovanja zdravila Synjardy, vendar sta lahko tudi znak okužbe sečil, zato se morate z zdravnikom posvetovati tudi, če se število teh simptomov poveča.
• feeling sick (nausea), vomiting 
Zelo pogosti • občutek slabosti (navzea), bruhanje
A total of 7052 patients with type 2 diabetes were treated in clinical studies to evaluate the safety of empagliflozin as add-on to metformin, of which 4740 patients were treated with empagliflozin as add-on to metformin. 
V klinične študije za ocenitev varnosti empagliflozina kot dodatnega zdravljenja k metforminu je bilo vključenih skupaj 7.052 bolnikov s sladkorno boleznijo tipa 2, od katerih se je 4.740 zdravilo z empagliflozinom kot dodatnim zdravljenjem k metforminu.
Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away. 
Takoj prenehajte jemati to zdravilo in se obrnite na zdravnika ali takoj pojdite v bolnišnico.
* p-value <0.0001 ** p-value <0.01 
* vrednost p < 0,0001 ** vrednost p < 0,001
The overall frequency of urinary tract infection reported as adverse event was higher in patients treated with empagliflozin 10 mg on a background of metformin compared to patients treated with placebo or empagliflozin 25 mg on a background of metformin (see section 4.8). 
Skupna pogostnost okužb sečil, o kateri so poročali kot o neželenem učinku, je bila pri bolnikih, zdravljenih z empagliflozinom 10 mg, večja v primerjavi z bolniki, ki so prejemali placebo ali empagliflozin 25 mg, pri čemer sta obe skupini zdravila prejemali skupaj z metforminom (glejte poglavje 4.8).
The risk of lactic acidosis must be considered in the event of non-specific signs such as muscle cramps, digestive disorders as abdominal pain and severe asthenia. 
Na možnost laktacidoze je treba premisliti, če se pojavijo nespecifični znaki, kot so mišični krči, prebavne motnje, kot so trebušne bolečine, in huda astenija.
Table 2: Efficacy results of 24 week placebo-controlled studies Add-on to metformin therapya 
Preglednica 2: Rezultati učinkovitosti 24-tedenskih s placebom nadzorovanih študij Dodatno zdravljenje k metforminua placebo empagliflozin
2 not evaluated for statistical significance as a part of the sequential confirmatory testing procedure 3 Week 19-40: treat-to-target regimen for insulin dose adjustment to achieve pre-defined glucose target levels (pre-prandial <100 mg/dl (5.5 mmol/l), post-prandial <140 mg/dl (7.8 mmol/l) * p-value ≤0.0005 
3 19.-40. teden: usmerjen (treat-to-target) režim prilagajanja odmerka insulina za doseganje vnaprej določenih ciljnih ravni glukoze (preprandialna < 100 mg/dl (5,5 mmol/l), postprandialna < 140 mg/dl (7,8 mmol/l)
What you need to know before you take Synjardy 
Kaj morate vedeti, preden boste vzeli zdravilo Synjardy Ne jemljite zdravila Synjardy:
• burning sensation when passing urine 
• pekoč občutek pri uriniranju • moten urin
Overall hypoglycaemia 
Skupna hipoglikemija
The active substances are empagliflozin and metformin. 
Zdravilni učinkovini sta empagliflozin in metformin.
The overall frequency of urinary tract infection adverse events was higher in metformin-treated patients who received empagliflozin 10 mg (8.8%) compared to empagliflozin 25 mg (6.6%) or placebo (7.8%). 
zdravljenih z metforminom, ki so prejemali empagliflozin 10 mg (8,8 %), višja kot pri bolnikih, ki so prejemali empagliflozin 25 mg (6,6 %) ali placebu (7,8 %).
Glimepirideb 
Laktacidoza
Therefore, this medicinal product must be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and has not deteriorated further (see section 4.4). 
Ponovno se ga sme uvesti šele po 48 urah in ponovni oceni delovanja ledvic, če se to ni dodatno poslabšalo (glejte poglavje 4.4).
Multiple-dose study: After repeated doses of 500 mg twice daily for 7 days in paediatric patients the peak plasma concentration (Cmax) and systemic exposure (AUC0-t) were approximately 33% and 40% lower, respectively, compared to diabetic adults who received repeated doses of 500 mg twice daily for 14 days. 
Študija z večkratnimi odmerki: Po ponavljajočih odmerkih 500 mg, ki so jih dvakrat dnevno 7 dni prejemali pediatrični bolniki, sta bili pri njih največja koncentracija v plazmi (Cmax) za približno 33 %
Placebo empagliflozin 
Empagliflozin Absorpcija
Add-on to metformin and a sulphonylurea therapya Placebo 
Dodatno zdravljenje k metforminu s sulfonilsečninoa placebo empagliflozin
Treatment with iodinated contrast agent can reduce your kidney function and increase the risk of side effects due to the metformin component. 
Izpostavljenost jodiranim kontrastnim sredstvom lahko poslabša delovanje ledvic in poveča tveganje neželenih učinkov zaradi metformina.
The steady state mean plasma AUC and Cmax were 1870 nmol.h and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h and 687 nmol/l with empagliflozin 25 mg once daily. 
enkratno dnevno uporabo empagliflozina so bile v stanju dinamičnega ravnovesja vrednosti v plazmi AUC 1.870 nmol.h in Cmax 259 nmol/l za empagliflozin 10 mg ter AUC 4.740 nmol.h in
Due to the metformin component, Synjardy may cause a very rare, but very serious complication called lactic acidosis, particularly if your kidneys are not working properly. 
Zaradi metformina lahko zdravilo Synjardy zlasti pri osebah z okvarjenim delovanjem ledvic povzroči zelo redek in resen zaplet, imenovan laktacidoza.
An increased frequency was noted when empagliflozin given as add-on to metformin and a sulfonylurea (empagliflozin 10 mg: 16.1%, empagliflozin 25 mg: 11.5% and placebo: 8.4%) or as add-on to metformin and insulin (empagliflozin 10 mg: 31.3%, empagliflozin 25 mg: 36.2% and placebo: 34.7%). 
25 mg: 11,5 %, placebo: 8,4 %) ali kot dodatnega zdravljenja k metforminu in insulinu (empagliflozin 10 mg: 31,3 %, empagliflozin 25 mg: 36,2 % in placebo: 34,7 %).
Administration of iodinated contrast agent 
Uporaba jodiranega kontrastnega sredstva
Empagliflozin does not inhibit human uptake transporters such as OAT3, OATP1B1, and OATP1B3 in vitro at clinically relevant plasma concentrations and, as such, drug-drug interactions with substrates of these uptake transporters are considered unlikely. 
OATP1B3 v klinično pomembnih plazemskih koncentracijah, zato medsebojno delovanje zdravila s substrati teh privzemnih prenašalcev ni verjetno.
Major hypoglycaemia (hypoglycaemia requiring assistance) The frequency of patients with major hypoglycaemic events was low (<1%) and similar for empagliflozin and placebo as add-on to metformin. 
Pogostnost bolnikov s hudimi hipoglikemičnimi dogodki je bila nizka (< 1 %) in podobna za empagliflozin in placebo kot dodatno zdravljenje k metforminu.
The dosage should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability using the recommended daily dose of 10 mg or 25 mg of empagliflozin, while not exceeding maximum recommended daily dose of metformin. 
Uporabljati je potrebno priporočeni dnevni odmerek empagliflozina po 10 mg ali 25 mg, ne da bi pri tem presegli največji priporočeni dnevni odmerek metformina.
Therefore, this medicinal product must be discontinued prior to, or at the time of the test and not be reinstituted until at least 48 hours afterwards, and only after renal function has been re-evaluated and has not deteriorated further (see section 4.5). 
Ponovno se ga sme uvesti šele po 48 urah in ponovni oceni delovanja ledvic, če se to ni dodatno poslabšalo (glejte poglavje 4.5).
• iodinated contrast agents (medicines used during an X-ray, see section 2 ‘Warnings and precautions'. 
• jodirana kontrastna sredstva (ki jih lahko prejmete pri rentgenskem slikanju, glejte poglavje 2
The most commonly reported adverse events in clinical trials were hypoglycaemia in combination with insulin and/or sulphonylurea, urinary tract infections, 
Najpogostejši neželeni učinki, o katerih so poročali v kliničnih preskušanjih, so bili hipoglikemija (pri kombinaciji z insulinom in/ali sulfonilsečnino), okužba sečil, okužba spolovil in pogostejše uriniranje (glejte opis izbranih neželenih učinkov).
Table 3: Efficacy results at 104 week in an active controlled study comparing empagliflozin to glimepiride as add on to metformina 
Preglednica 3: Rezultati učinkovitosti v 104. tednu v z zdravilno učinkovino nadzorovani študiji, v kateri so empagliflozin primerjali z glimepiridom kot dodatnim zdravljenjem k metforminua empagliflozin 25 mg glimepiridb
Volume depletion1, 2 
Žilne bolezni zmanjšanje volumna1, 2
At Week 52, treatment with empagliflozin resulted in a statistically significant decrease in HbA1c and insulin sparing compared with placebo and a reduction in body weight. 
HbA1c, varčevanje z insulinom v primerjavi s placebom in zmanjšanje telesne mase.
• redness of the skin (erythema) or an itchy rash (hives) 
• pordelost kože (eritem) ali srbeč izpuščaj (koprivnica) Poročanje o neželenih učinkih
Add-on to pioglitazone + metformin therapyb Placebo 
Dodatno zdravljenje k pioglitazonu z metforminomb placebo empagliflozin
Urinary tract infection1, 2 
okužbe sečil1, 2
An interaction study with gemfibrozil, an in vitro inhibitor of OAT3 and OATP1B1/1B3 transporters, showed that empagliflozin Cmax increased by 15% and AUC increased by 59% following co-administration. 
OATP1B1/1B3, je pokazala, da se je po sočasni uporabi Cmax empagliflozina povečal za 15 %, AUC pa za 59 %.
4 Mean adjusted for baseline SBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products 5 Mean adjusted for baseline DBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products * p-value <0.0001 
4 Povprečje, prilagojeno za vrednost sistoličnega krvnega tlaka ob izhodišču, vrednost HbA1c ob izhodišču, vrednost eGFR ob izhodišču, geografsko regijo in število antihipertenzivnih zdravil 5 Povprečje, prilagojeno za vrednost diastoličnega krvnega tlaka ob izhodišču, vrednost HbA1c ob izhodišču, vrednost eGFR ob izhodišču, geografsko regijo in število antihipertenzivnih zdravil
The onset of lactic acidosis can be subtle and the symptoms can be non-specific such as vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. 
Nastop laktacidoze je lahko skoraj nezaznaven z nespecifičnimi simptomi, kot so bruhanje, trebušne bolečine z mišičnimi krči, splošno slabo počutje z izrazito utrujenostjo in oteženo dihanje.
Synjardy 12.5 mg/850 mg and Synjardy 12.5 mg/1,000 mg tablets also contain iron oxide black (E172) and iron oxide red (E172). 
12,5 mg/1000 mg tablete vsebujejo tudi črni (E172) in rdeči železov oksid (E172).
2 Not evaluated for statistical significance as a part of the sequential confirmatory testing procedure 3 LOCF, values after antihypertensive rescue censored 
1 Povprečje, prilagojeno za izhodiščne vrednosti 2 Statistična značilnost ni bila ocenjena zaradi zaporednega potrditvenega postopka testiranja
N HbA1c (%) at week 52b 
Vrednost HbA1c (%) v 52. tednub
N HbA1c (%) at week 18a 
N Vrednost HbA1c (%) v 18. tednua
Synjardy 12.5 mg/1,000 mg film-coated tablets 
Synjardy 12,5 mg/1000 mg filmsko obložene tablete
** p-value <0.001 
* vrednost p < 0,0001
Increased urination1, 2 
Bolezni sečil pogostejše uriniranje1, 2
Following administration of a dose of 850 mg metformin hydrochloride, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 minute prolongation of the time to peak plasma concentration were observed. 
Po dajanju odmerka metforminijevega klorida 850 mg so izmerili za 40 % manjšo največjo koncentracijo v plazmi, za
Nervous system disorders 
Bolezni živčevja motnje okušanja3