natgillin/translations-raw huggingface dataset:
Zomarist is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes. 
Zdravilo Zomarist ne more nadomestiti zdravljenja z insulinom pri bolnikih, ki potrebujejo insulin, in se ga ne sme uporabljati pri bolnikih z diabetesom tipa 1.
The mean volume of distribution of vildagliptin at steady-state after intravenous administration (Vss) is 71 litres, suggesting extravascular distribution. 
Povprečen volumen porazdelitve vildagliptina v stanju dinamičnega ravnovesja po intravenski aplikaciji (Vss) je 71 litrov, kar kaže ne ekstravaskularno porazdelitev.
- Do not use Zomarist if you are pregnant or breast-feeding (see also “Do not take Zomarist”). 
- Če ste noseči ali dojite, ne smete uporabljati zdravila Zomarist (glejte tudi “Ne jemljite zdravila Zomarist”).
Your doctor will test your blood and urine for sugar regularly. 
Poleg tega vam bo zdravnik redno pregledoval vsebnost sladkorja v krvi in urinu.
Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion. 
Ledvični očistek metformina je > 400 ml/min, kar nakazuje, da se metformin izloča z glomerulno filtracijo in tubulno sekrecijo.
The Cmax for vildagliptin and the area under the plasma concentrations versus time curves (AUC) increased in an approximately dose proportional manner over the therapeutic dose range. 
Cmax vildagliptina in površina pod krivuljo časovne porazdelitve koncentracij v plazmi (AUC) sta se v okviru terapevtskih odmerkov povečevali približno sorazmerno z velikostjo odmerka.
Zomarist may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. 
Zdravilo Zomarist lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza, zlasti če ledvice ne delujejo pravilno.
This medicine has been shown to reduce blood sugar, which may help to prevent complications from your diabetes. 
Dokazano je bilo, da to zdravilo znižuje koncentracijo sladkorja v krvi in tako pomaga preprečevati zaplete sladkorne bolezni.
If you take too many Zomarist tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately. 
Če ste vzeli večji odmerek zdravila Zomarist, kot bi smeli Če ste vzeli preveč tablet zdravila Zomarist ali če kdo drug vzame vaše tablete, se takoj obrnite na zdravnika ali farmacevta.
60 film-coated tablets. 
60 filmsko obloženih tablet.
Renal impairment: In subjects with mild, moderate, or severe renal impairment, systemic exposure to vildagliptin was increased (Cmax 8-66%; AUC 32-134%) and total body clearance was reduced compared to subjects with normal renal function. 
Okvara ledvic: Pri bolnikih z blago, zmerno ali hudo okvaro ledvic je bila izpostavljenost vildagliptinu večja (Cmax 8-66 %; AUC 32-134 %), celotni telesni očistek pa je bil manjši v primerjavi z osebami z normalnim delovanjem ledvic.
However, vildagliptin cannot be removed by haemodialysis, although the major hydrolysis metabolite (LAY 151) can. 
Vendar pa vildagliptina ni mogoče odstraniti s hemodializo, je pa mogoče s hemodializo odstraniti njegov glavni presnovek (LAY 151).
Vildagliptin Information regarding overdose with vildagliptin is limited. 
Podatki o prevelikem odmerjanju vildagliptina so omejeni.
Studies in animals have shown excretion of both metformin and vildagliptin in milk. 
Študije na živalih kažejo na izločanje metformina in vildagliptina v mleko.
If you have reduced kidney function, your doctor may prescribe a lower dose. 
Če imate zmanjšano delovanje ledvic, vam bo zdravnik morda predpisal nižji odmerek.
If you forget to take Zomarist 
Če ste pozabili vzeti zdravilo Zomarist
You should stop taking Zomarist and see your doctor immediately if you experience the following side effects: 
Prenehajte jemati zdravilo Zomarist in takoj obiščite zdravnika, če se pri vas pojavijo naslednji neželeni učinki:
- Do not store above 30C. 
- Shranjujte pri temperaturi do 30 C.
Following administration of a dose of 850 mg, the plasma peak concentration was 40% lower, AUC was decreased by 25% and time to peak plasma concentration was prolonged by 35 minutes. 
Po aplikaciji odmerka 850 mg je bila najvišja koncentracija v plazmi 40 % nižja, AUC manjša za 25 %, čas do najvišje koncentracije v plazmi pa daljši za 35 minut.
The increased incidence of these tumours in mice is considered not to represent a significant risk to humans based on the lack of genotoxicity of vildagliptin and its principal metabolite, the occurrence of tumours only in one species, and the high systemic exposure ratios at which tumours were observed. 
Ocenjeno je, da zvišana incidenca teh tumorjev pri miših ne predstavlja pomembnega tveganja za ljudi glede na to, da vildagliptin in njegov glavni presnovek nista genotoksična, da je do tumorjev prišlo le pri eni živalski vrsti in glede na visoka razmerja med izpostavljenostmi, pri katerih so tumorje opažali.
Another two-year carcinogenicity study was conducted in mice at oral doses up to 1000 mg/kg. 
Drugo dvoletno študijo karcinogenosti so opravili na miših s peroralnimi odmerki do 1.000 mg/kg.
Embryofoetal toxicity was evaluated in rats and rabbits. 
Toksičnost za zarodek in plod so ocenjevali pri podganah in kuncih.
Both active substances, vildagliptin and metformin, help to control the level of sugar in the blood. 
Obe učinkovini, vildagliptin in metformin, pomagata uravnavati koncentracijo sladkorja v krvi.
**Isolated cases of liver function test abnormalities or hepatitis resolving upon metformin discontinuation have been reported. 
**Poročali so o posameznih primerih nenormalnih vrednosti jetrnih testov ali hepatitisa, ki so izzveneli po ukinitvi metformina.
Driving and using machines If you feel dizzy while taking Zomarist, do not drive or use any tools or machines. 
Vpliv na sposobnost upravljanja vozil in strojev Če ste med jemanjem zdravila Zomarist omotični, ne vozite avtomobila in ne upravljajte z orodji in stroji.
Vildagliptin has a low potential for interactions with co-administered medicinal products. 
Vildagliptin ima le majhno možnost medsebojnega delovanja z drugimi sočasno uporabljenimi zdravili.
Stop taking Zomarist for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. 
Za kratek čas prenehajte jemati zdravilo Zomarist, če imate stanje, ki je lahko povezano z dehidracijo (znatna izguba telesnih tekočin), kot je hudo bruhanje, driska, zvišana telesna temperatura, izpostavljenost vročini ali če pijete manj tekočine, kot običajno.
Furthermore, there have been post-marketing reports of bullous and exfoliative skin lesions. 
Poleg tega so v obdobju trženja zdravila poročali o mehurčastih in eksfoliacijskih kožnih spremembah.
It is unknown whether vildagliptin is excreted in human milk, but metformin is excreted in human milk in low amounts. 
Ni znano, ali se vildagliptin izloča v materino mleko, se pa v materino mleko v majhnih količinah izloča metformin.
At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ml. 
Pri običajnih odmerkih in shemah odmerjanja se plazemske koncentracije v stanju dinamičnega ravnovesja dosežejo v 24-48 urah, večinoma pa so nižje od 1 µg/ml.
If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Zomarist before or at the time of the injection. 
Če vam bodo v krvni obtok injicirali kontrastno sredstvo, ki vsebuje jod, na primer zaradi rentgenskega ali drugega slikanja, morate pred časom injiciranja ali v tem času prenehati z jemanjem zdravila Zomarist.
At study endpoint (2 years), the HbA1c was similar to baseline values in both treatment groups and the body weight changes and hypoglycaemia differences were maintained. 
Po določenem času v študiji (po 2 letih) je bila v obeh skupinah vrednost HbA1c podobna izhodiščni, medtem ko je telesna masa ostala spremenjena, obdržale pa so se tudi spremembe glede hipoglikemij.
Hydroxypropylcellulose Magnesium stearate 
Jedro tablete hidroksipropilceluloza magnezijev stearat
Table 5 Adverse reactions for metformin component 
Preglednica 5 Neželeni učinki metformina
In case of dehydration (severe diarrhoea or vomiting, fever, or reduced fluid intake), metformin should be temporarily discontinued and contact with a healthcare professional is recommended. 
V primeru dehidracije (huda driska ali bruhanje, zvišana telesna temperatura ali zmanjšan vnos tekočine) je treba jemanje metformina začasno prekiniti; priporoča se posvet z zdravstvenim delavcem.
Children and adolescents The use of Zomarist in children and adolescents up to 18 years of age is not recommended. 
Otroci in mladostniki Pri otrocih in mladostnikih do 18. leta starosti uporaba zdravila Zomarist ni priporočena.
Metformin is contraindicated in patients with GFR <30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3). 
Metformin je kontraindiciran pri bolnikih z GFR< 30 ml/min in ga je treba začasno ukiniti, če se pojavijo stanja, ki spremenijo delovanje ledvic (glejte poglavje 4.3).
Stop taking Zomarist and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma. 
Takoj prenehajte jemati zdravilo Zomarist in se obrnite na zdravnika ali najbližjo bolnišnico, če se pojavijo nekateri od simptomov laktacidoze, saj lahko to stanje vodi v komo.
The major metabolite (LAY 151) is pharmacologically inactive and is the hydrolysis product of the cyano moiety, accounting for 57% of the dose, followed by the amide hydrolysis product (4% of dose). 
Glavni presnovek (LAY 151) nima farmakološkega učinka in nastane s hidrolizo ciano skupine ter predstavlja 57 % odmerka, sledi pa mu produkt hidrolize amida (4 % odmerka).
Although skin lesions were not observed at an increased incidence in clinical trials, there was limited experience in patients with diabetic skin complications. 
V kliničnih preskušanjih niso opažali zvišane incidence kožnih sprememb, vendar je pri bolnikih s kožnimi obolenji kot diabetičnim zapletom obseg izkušenj omejen.
Both insulin and glucagon are made in the pancreas. 
Tako insulin kot glukagon nastajata v trebušni slinavki.
It can also develop if the body produces too much glucagon. 
Diabetes se razvije tudi v primeru, ko organizem tvori preveč glukagona.
Adverse reactions listed in Table 5 are based on information available from the metformin Summary of Product Characteristics available in the EU. 
Neželeni učinki, ki so navedeni v preglednici 5, temeljijo na podatkih iz Povzetka glavnih značilnosti zdravila, ki se za metformin uporablja v Evropski skupnosti.
Continue to take this medicine as long as your doctor prescribes it so that it can continue to control your blood sugar. 
Z jemanjem zdravila nadaljujte, dokler vam ga zdravnik predpisuje, tako da boste lahko v tem času z zdravilom uravnavali raven sladkorja v krvi.
Administration of vildagliptin with food resulted in a decreased Cmax (19%) compared to dosing in the fasting state. 
Zaradi uživanja vildagliptina skupaj s hrano se je znižala Cmax (19 %) v primerjavi z odmerjanjem na tešče.
Zomarist should not be used during pregnancy. 
Zdravila Zomarist ne smete uporabljati pri nosečnicah.
Assessment of each individual MACE component showed no increased risk (similar M-H RR). 
Pri ocenjevanju posameznih kategorij pomembnih neželenih kardiovaskularnih dogodkov pri nobeni niso odkrili povečanja tveganja (razmerje M-H RR je bilo podobno).
Metabolism is the major elimination pathway for vildagliptin in humans, accounting for 69% of the dose. 
Glavna pot izločanja vildagliptina pri človeku je njegova presnova, ki odstrani 69 % odmerka.
Animal studies of up to 13-week duration have been conducted with the combined substances in Zomarist. 
Na živalih so opravili 13 tednov trajajoče študije s kombinacijo učinkovin v zdravilu Zomarist.
If this happens you must stop taking Zomarist and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma. 
V tem primeru morate prenehati jemati zdravilo Zomarist in se takoj obrniti na zdravnika ali najbližjo bolnišnico, saj lahko laktacidoza vodi v komo;
A large overdose of metformin (or co-existing risk of lactic acidosis) may lead to lactic acidosis, which is a medical emergency and must be treated in hospital. 
Zaradi znatno prevelikega odmerjanja metformina (ali sočasnega tveganja za laktacidozo) lahko pride do laktacidoze, ki je urgentno stanje in zahteva bolnišnično zdravljenje.
- The other ingredients are: Hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 4000 and talc. 
- Druge sestavine zdravila so: hidroksipropilceluloza, magnezijev stearat, hipromeloza, titanov dioksid (E 171), rumeni železov oksid (E 172), makrogol 4000 in smukec.
Vildagliptin, a member of the islet enhancer class, is a potent and selective dipeptidyl-peptidase-4 (DPP-4) inhibitor. 
Vildagliptin iz skupine spodbujevalcev Langerhansovih otočkov je močan in selektiven zaviralec dipeptidil peptidaze 4 (DPP-4).
• Liver disease (hepatitis) (rare): Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis). 
• bolezen jeter (hepatitis) (redek): simptomi vključujejo rumena koža in oči, slabost, izguba apetita ali temno obarvan urin, kar lahko kaže na bolezen jeter (hepatitis) ;
If you stop taking Zomarist 
Če ste prenehali jemati zdravilo Zomarist
Avoid excessive alcohol intake while taking Zomarist since this may increase the risk of lactic acidosis (please see section “Warnings and precautions”). 
Med jemanjem zdravila Zomarist ne uživajte čezmernih količin alkohola, sajlahko to poveča tveganje za laktacidozo (glejte poglavje “Opozorila in previdnostni ukrepi”).
Food slightly delays and decreases the extent of the absorption of metformin. 
Hrana nekoliko upočasni absorpcijo metfomina in zmanjša njen obseg.
Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent LFTs until the abnormality(ies) return(s) to normal. 
Bolnikom, pri katerih pride do zvišanja vrednosti aminotransferaz, je treba za potrditev opraviti še drugo preiskavo delovanja jeter, nato pa jih je treba spremljati s pogostimi pregledi jetrnih testov, dokler se nenormalni izvid(i) ne normalizira(jo).
The rate and extent of absorption of metformin from Zomarist 50 mg/1000 mg were decreased when given with food as reflected by the decrease in Cmax by 26%, AUC by 7% and delayed Tmax (2.0 to 4.0 h). 
Hitrost in obseg absorpcije metformina iz zdravila Zomarist 50 mg/1000 mg pa sta bili pri jemanju s hrano zmanjšani, kar se je odražalo na znižanju Cmax za 26 %, zmanjšanju AUC za 7 % in na podaljšanem Tmax (2,0 do 4,0 ure).
Results from clinical trials conducted with the oral antidiabetics pioglitazone, metformin and glyburide in combination with vildagliptin have shown no clinically relevant pharmacokinetic interactions in the target population. 
Rezultati kliničnih preskušanj s peroralnimi antidiabetiki pioglitazonom, metforminom in gliburidom v kombinaciji z vildagliptinom niso pokazali nobenih klinično pomembnih farmakokinetičnih interakcij pri ciljni populaciji.
A fertility and early embryonic development study in rats revealed no evidence of impaired fertility, reproductive performance or early embryonic development due to vildagliptin. 
V študijah plodnosti in zgodnjega razvoja zarodka pri podganah ni bilo nobenih znakov slabše plodnosti, motene sposobnosti razmnoževanja ali motenj zgodnjega razvoja zarodka zaradi vildagliptina.
Other risk factors for lactic acidosis are excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting and any conditions associated with hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis (see also sections 4.3 and 4.5). 
Drugi dejavniki tveganja za laktacidozo so pretirano uživanje alkohola, jetrna insuficienca, neustrezno nadzorovana sladkorna bolezen, ketoza, dolgotrajno postenje in vsa stanja, povezana s hipoksijo, ter sočasna uporaba zdravil, ki lahko povzročijo laktacidozo (glejte poglavji 4.3 in 4.5).
The active substances of Zomarist, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”. 
Zdravilni učinkovini v zdravilu Zomarist, vildagliptin in metformin, sodita v skupino zdravil, ki se imenujejo “peroralni antidiabetiki”.
- Do not use this medicine after the expiry date which is stated on the blister and carton after 
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake “EXP”.
If pancreatitis is suspected, vildagliptin should be discontinued if acute pancreatitis is confirmed, vildagliptin should not be restarted. 
Če obstaja sum na pankreatitis, je potrebno prenehati z jemanjem vildagliptina, če pa je diagnoza akutnega pankreatitisa potrjena, bolnik ne sme ponovno začeti z jemanjem vildagliptina.
Hypromellose Titanium dioxide (E 171) Iron oxide, yellow (E 172) Macrogol 4000 
Filmska obloga hipromeloza titanov dioksid (E 171) železov oksid, rumeni (E 172) makrogol 4000 smukec
Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, Zomarist should not be used during breast-feeding (see section 4.3). 
Tako zaradi potencialnega tveganja, da bi pri novorojenčku zaradi metformina prišlo do hipoglikemije, kot tudi zaradi pomanjkanja podatkov o vildagliptinu pri ljudeh, se zdravila Zomarist med dojenjem ne sme uporabljati (glejte poglavje 4.3).
Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering or ulceration, is recommended. 
Zato je v okviru rutinske oskrbe diabetikov priporočeno opazovanje kože glede kožnih sprememb, kot so mehurčast izpuščaj ali razjede na koži.
At 5 mg/kg/day (approximately equivalent to human AUC exposure at the 100 mg dose), only blisters were observed. 
Pri odmerku 5 mg/kg/dan (kar približno ustreza izpostavljenosti AUC pri človeku pri odmerku 100 mg) so opažali samo mehurčke.
A MACE occurred in 83 out of 9,599 (0.86%) vildagliptin-treated patients and in 85 out of 7,102 (1.20%) comparator-treated patients. 
Do pomembnega neželenega kardiovaskularnega dogodka je prišlo pri 83 od 9.599 (0,86 %) bolnikov, ki so prejemali vildagliptin, in pri 85 od 7.102 (1,20 %) bolnikov, ki so prejemali katero od primerjalnih zdravil.
A two-year carcinogenicity study was conducted in rats at oral doses up to 900 mg/kg (approximately 200 times human exposure at the maximum recommended dose). 
Dvoletno študijo karcinogenosti so opravili na podganah s peroralnimi odmerki do 900 mg/kg (kar pomeni izpostavljenost, ki je približno 200-krat večja od izpostavljenosti pri človeku pri največjih priporočenih odmerkih).
Patients who may experience dizziness as an adverse reaction should avoid driving vehicles or using machines. 
Bolniki, pri katerih prihaja do neželenega učinka v obliki omotičnosti, naj se izogibajo vožnji ali upravljanju s stroji.
At 400 mg, there were three cases of muscle pain, and individual cases of mild and transient paraesthesia, fever, oedema and a transient increase in lipase levels. 
Pri 400 mg je v treh primerih prišlo do bolečin v mišicah in v posameznih primerih do blage in prehodne parestezije, zvišane telesne temperature, edemov in prehodnega zvišanja koncentracije lipaz.
Drug-drug interaction studies in healthy subjects were conducted with amlodipine, ramipril, valsartan and simvastatin. 
Na zdravih prostovoljcih so izvajali klinične študije medsebojnega delovanja z amlodipinom, ramiprilom, valsartanom in s simvastatinom.
Metformin may exert its glucose-lowering effect via three mechanisms: - by reduction of hepatic glucose production through inhibition of gluconeogenesis and glycogenolysis; - in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation; - by delaying intestinal glucose absorption. 
Metformin lahko deluje na zniževanje glukoze v krvi na tri načine: - zmanjšuje tvorbo glukoze v jetrih, tako da zavira glukoneogenezo in glikogenolizo; - v mišicah nekoliko poveča občutljivost za insulin, izboljša periferni privzem in koriščenje glukoze; - upočasni absorpcijo glukoze v črevesju.
The plasma protein binding of vildagliptin is low (9.3%) and vildagliptin distributes equally between plasma and red blood cells. 
Vildagliptin se v majhni meri veže na proteine v plazmi (9,3 %) in se enakomerno porazdeli med plazmo in eritrocite.
In particular, if you are following a diabetic weight control diet, continue with this while you are taking Zomarist. 
Še posebno če se držite diete za uravnavanje telesne mase za diabetike, z dieto nadaljujte tudi v obdobju jemanja zdravila Zomarist.
What Zomarist is and what it is used for What you need to know before you take Zomarist How to take Zomarist 
Kaj je zdravilo Zomarist in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Zomarist Kako jemati zdravilo Zomarist Možni neželeni učinki
There have been no therapeutic clinical trials conducted with Zomarist. 
Terapevtskih kliničnih preskušanj z zdravilom Zomarist niso izvajali.
Adverse reactions reported in patients who received vildagliptin in double-blind studies as monotherapy and add-on therapies are listed below by system organ class and absolute frequency. 
Neželeni učinki, o katerih so poročali pri bolnikih, ki so v dvojno slepih študijah prejemali vildagliptin v monoterapiji ali kot dodatno terapijo, so navedeni po organskih sistemih in po absolutni pogostnosti.
Studies in animals performed with vildagliptin and metformin have not shown evidence of teratogenicity, but foetotoxic effects at maternotoxic doses (see section 5.3). 
Študije na živalih, ki so jih izvajali z vildagliptinom in metforminom, niso pokazale teratogenosti, pokazali pa so se toksični učinki za plod pri odmerkih, ki so bili toksični za mater (glejte poglavje 5.3).
Angiotensin converting enzyme (ACE) inhibitors may decrease the blood glucose levels. 
Zaviralci angiotenzinske konvertaze (zaviralci ACE) lahko znižujejo koncentracije glukoze v krvi.
Vildagliptin/metformin 50 mg/1000 mg twice daily reduced HbA1c by -1.82%, vildagliptin/metformin 50 mg/500 mg twice daily by -1.61%, metformin 1000 mg twice daily by -1.36% and vildagliptin 50 mg twice daily by -1.09% from a mean baseline HbA1c of 8.6%. 
Odmerek kombinacije vildagliptin/metformin 50 mg/1000 mg dvakrat na dan je znižal vrednost HbA1c za 1,82 %, odmerek kombinacije vildagliptin/metformin 50 mg/500 mg dvakrat na dan za 1,61 %, metformin 1000 mg dvakrat na dan za 1,36 % in vildagliptin 50 mg dvakrat na dan za 1,09 % od povprečne izhodiščne vrednosti HbA1c 8,6 %.
• Lactic acidosis (very rare: may affect up to 1 user in 10,000): Zomarist may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”). 
• laktacidoza (zelo redek: pojavi se lahko pri do 1 od 10.000 bolnikov) Zdravilo Zomarist lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza (glejte poglavje "Opozorila in previdnostni ukrepi").
Following withdrawal of treatment with Zomarist and LFT normalisation, treatment with Zomarist should not be re-initiated. 
Po prekinitvi zdravljenja z zdravilom Zomarist in normalizaciji vrednosti jetrnih testov se zdravljenja z zdravilom Zomarist ne sme ponovno uvesti.
Clinical trials of up to more than 2 years' duration did not show any additional safety signals or unforeseen risks when vildagliptin was added on to metformin. 
Klinična preskušanja, ki so trajala tudi več kot 2 leti, niso pokazala nobenih dodatnih signalov glede varnosti ali nepredvidenega tveganja, če so vildagliptin dodali metforminu.