natgillin/translations-raw huggingface dataset:
Detailed instructions for your doctor or your nurse on how to prepare the Erbitux infusion are included at the end of this package leaflet (see'Handling instructions').
60 Na koncu tega navodila so dodana podrobna navodila za zdravnika ali medicinsko sestro o tem, kako pripraviti infuzijo zdravila Erbitux (glejte poglavje "Navodila za pripravo").
59 Duration of treatment
Trajanje zdravljenja
Side effects concerning the skin
61 Neželeni učinki, povezani s kožo, so:
60 Main side effects concerning the skin include: • acne-like skin alterations • itching • dry skin • scaling • excessive growth of hair • nail disorders, for example inflammation of the nail bed
Glavni neželeni učinki, povezani s kožo, so • aknam podobne kožne spremembe • srbenje • suha koža • luščenje • prekomerna rast dlak • bolezni nohtov, na primer vnetje podnohtja
If you receive Erbitux in combination with anticancer medicines including platinum, it is more likely that your white blood cell count may be reduced.
62 Če zdravilo Erbitux prejemate v kombinaciji z zdravili proti raku, ki vsebujejo platino, obstaja večja verjetnost, da se bo število belih krvničk zmanjšalo.
61 If you receive Erbitux in combination with an anticancer medicine containing 5-fluorouracil, it is more likely that you experience the following side effects of this other medicine: • chest pain • heart attack • heart failure • redness and swelling of the palms of the hands or the soles of the feet which may cause the skin to peel (hand-foot syndrome)
Če zdravilo Erbitux prejemate v kombinaciji z zdravilom proti raku, ki vsebuje 5- fluorouracil, je verjetneje, da boste imeli naslednje neželene učinke, povezane z drugim zdravilom: • bolečine v prsnem košu • srčna kap • srčno popuščanje • rdečica in otekanje dlani ali podplatov, ki lahko povzroči luščenje kože (sindrom dlani in stopal)
Each ml of the solution for infusion contains 5 mg cetuximab. • The other ingredients are sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide and water for injections.
Vsak mililiter raztopine za infundiranje vsebuje 5 mg cetuksimaba. • Pomožne snovi so natrijev klorid, glicin, polisorbat 80, monohidrat citronske kisline, natrijev hidroksid in voda za injekcije.
What Erbitux looks like and contents of the pack Erbitux 5 mg/ ml solution for infusion is supplied in vials containing 10 ml, 20 ml, 50 ml or 100 ml.
Izgled zdravila Erbitux in vsebina pakiranja Erbitux 5 mg/ ml raztopina za infundiranje je na voljo v vialah po 10 ml, 20 ml, 50 ml ali 100 ml raztopine.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
63 Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
62 The following information is intended for medical or healthcare professionals only:
Naslednje informacije so namenjene samo zdravstvenemu osebju:
Since Erbitux is only compatible with sterile sodium chloride 9 mg/ ml (0.9%) solution for injection, it must not be mixed with other intravenously applied medicinal products.
Ker je zdravilo Erbitux združljivo samo s sterilno raztopino natrijevega klorida 9 mg/ ml (0, 9%) za injiciranje, ga ne smete mešati z drugimi zdravili za intravensko uporabo.
Erbitux 5 mg/ ml is compatible • with polyethylene (PE), ethyl vinyl acetate (EVA) or polyvinyl chloride (PVC) bags, • with polyethylene (PE), polyurethane (PUR), ethyl vinyl acetate (EVA), polyolefine thermoplastic (TP) or polyvinyl chloride (PVC) infusion sets, • with polypropylene (PP) syringes for syringe pump.
Zdravilo Erbitux 5 mg/ ml je združljivo • s polietilenskimi (PE), etilvinilacetatnimi (EVA) ali polivinilkloridnimi (PVC) vrečkami, • s polietilenskimi (PE), poliuretanskimi (PUR), etilvinilacetatnimi (EVA), poliolefinskimi termoplastičnimi (TP) ali polivinilkloridnimi (PVC) infuzijskimi sistemi, • s polipropilenskimi (PP) brizgami za črpalko za brizgo.
Erbitux 5 mg/ ml is chemically and physically stable for up to 48 hours at 25°C, if the solution is prepared as described hereafter.
Zdravilo Erbitux 5 mg/ ml je kemično in fizikalno stabilno do 48 ur pri temperaturi 25 °C, če je raztopina pripravljena, kot je opisano v nadaljevanju.
• For administration with infusion pump or gravity drip (diluted with sterile sodium chloride 9 mg/ ml (0.9%) solution):
• Za uporabo z infuzijsko črpalko ali s težnostno kapalno infuzijo (razredčeno s sterilno raztopino natrijevega klorida 9 mg/ ml, (0, 9%)):
• For administration with infusion pump or gravity drip (undiluted):
• Za uporabo z infuzijsko črpalko ali težnostno kapalno infuzijo (nerazredčeno):
• For administration with a syringe pump:
64 • Za uporabo s črpalko za brizgo:
Eucreas is a medicine containing the active substances vildagliptin and metformin hydrochloride.
Zdravilo Eucreas vsebuje zdravilni učinkovini vildagliptin in metforminijev klorid.
It is available as oval tablets (dark yellow:
Na voljo je v ovalnih tabletah (v temno rumeni barvi:
50 mg/ 850 mg; light yellow:
50 mg/ 850 mg; v svetlo rumeni barvi:
Eucreas is used to treat type 2 diabetes (non insulin-dependent diabetes).
Zdravilo Eucreas se uporablja za zdravljenje sladkorne bolezni tipa 2 (od insulina neodvisna sladkorna bolezen).
It is used in patients whose disease is insufficiently controlled with the maximum tolerated dose of metformin taken alone or who are already taking the combination of vildagliptin and metformin as separate tablets.
Uporablja se ga pri bolnikih, pri katerih se bolezni ne da zadostno nadzorovati z največjim dovoljenim odmerkom metformina, uporabljenega samostojno, ali ki že jemljejo kombinacijo vildagliptina in metformina v obliki ločenih tablet.
The recommended dose of Eucreas is one tablet twice a day, with one tablet taken in the morning and one in the evening.
Priporočeni odmerek zdravila Eucreas je ena tableta dvakrat dnevno, pri čemer se ena tableta vzame zjutraj in druga zvečer.
The choice of tablet strength to start with depends on the dose of metformin the patient is currently taking, but the recommended dose is 50 mg vildagliptin and 1,000-mg metformin twice a day.
Izbira jakosti tablete je odvisna od odmerka metformina, ki ga bolnik trenutno jemlje, vendar je priporočeni odmerek 50 mg vildagliptina in 1000 my metformina dvakrat dnevno.
Patients already taking vildagliptin and metformin should switch to Eucreas containing the same amounts of each active substance.
Bolniki, ki že jemljejo vildagliptin in metformin morajo preiti na zdravilo Eucreas, v katerem sta ti dve zdravilni učinkovini zastopani v enaki količini.
Eucreas should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver.
Zdravila Eucreas se ne sme uporabljati pri bolnikih, ki imajo zmerne ali hude težave z ledvicami ali imajo težave z jetri.
Eucreas is not recommended for use in patients aged over 75 years.
Zdravilo Eucreas ni priporočljivo za uporabo pri bolnikih, starih več kot 75 let.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za uravnavanje ravni glukoze (sladkorja) v krvi ali kadar telo ne more učinkovito izrabiti insulina.
Vildagliptin, which is a dipeptidyl peptidase 4 (DPP-4) inhibitor, works by blocking the breakdown of ‘ incretin’ hormones in the body.
Vildagliptin, ki je zaviralec dipeptidil peptidaze 4 (DPP- 4), deluje tako, da blokira razgradnjo hormonov inkretinov v telesu.
These hormones are released after a meal and stimulate the pancreas to produce insulin.
Ti hormoni, ki jih telo sprošča po obroku, spodbujajo trebušno slinavko k tvorjenju insulina.
By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Vildagliptin s povečanjem koncentracije hormonov inkretinov v krvi spodbudi trebušno slinavko k tvorjenju večjih količin insulina, ko so koncentracije glukoze v krvi visoke.
Vildagliptin does not work when the blood glucose is low.
Vildagliptin nima učinka, kadar je koncentracija glukoze v krvi nizka.
Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Vildagliptin tudi zmanjša količino glukoze, ki jo tvorijo jetra, tako da poviša koncentracije insulina in zniža koncentracije hormona glukagona.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Kot 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Eucreas been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged posledica delovanja obeh zdravilnih učinkovin se koncentracija glukoze v krvi zniža, to pa prispeva k nadzoru sladkorne bolezni tipa 2.
The studies of Galvus as an add-on to metformin were used to support the use of Eucreas in the same indication.
Študije zdravila Galvus kot dodatek metfominu so bile uporabljene v podporo uporabi zdravila Eucreas za isto indikaciji.
The studies measured the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
V okviru študij so merili koncentracijo snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je glukoza v krvi nadzorovana.
The applicant also presented the results of two studies showing that the active substances in the two strengths of Eucreas were absorbed in the body in the same way as when they were taken as separate tablets.
Predlagatelj je tudi predstavil rezultate dveh študij, ki prikazujeta, da sta bili zdravilni učinkovini v obeh jakostih zdravila Eucreas absorbirani v telo na enak način, kot pri njunem jemanju v obliki ločenih tablet.
What benefit has Eucreas shown during the studies?
Kakšne koristi je zdravilo Eucreas izkazalo med raziskavami?
Vildagliptin was more effective than placebo (a dummy treatment) at reducing HbA1c levels when it was added to metformin.
Vildagliptin je bil, kot dodatek metforminu, bolj učinkovit od placeba (zdravila brez zdravilne učinkovine) pri zmanjševanju koncentracij HbA1c.
Patients adding vildagliptin had falls in HbA1c levels of 0.88% after 24 weeks from a starting level of 8.38%.
Bolnikom, katerim so dodajali vildagliptin, so se koncentracije HbA1c po 24 tednih zmanjšale za 0, 88% glede na izhodiščno vrednost 8, 38%.
In contrast, patients adding placebo had smaller changes in HbA1c levels, with a rise of 0.23% from a starting level of 8.30%.
Bolniki, katerim so dodajali placebo, pa so imeli manjše spremembe koncentracij HbA1c, in sicer dvig v višini 0, 23% glede na izhodiščno vrednost 8, 30%.
The most common side effects with Eucreas (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
Najpogostejši neželeni učinki zdravila Eucreas (opaženi pri več kot 1 bolniku od 10) so slabost, bruhanje, driska, bolečina v trebuhu in izguba apetita.
For the full list of all side effects reported with Eucreas, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Eucreas, glejte Navodilo za uporabo.
Eucreas should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients.
Zdravila Eucreas se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) vildagliptin, metformin ali katerokoli drugo sestavino zdravila.
It should also not be used in patients who have diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic pre-coma, problems with their kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Prav tako se ga ne sme uporabljati pri bolnikih, ki imajo diabetično ketoacidozo (visoke koncentracije ketonov in kislin v krvi), diabetično predkomo, težave z ledvicami in jetri, bolezni, ki lahko vplivajo na ledvice, ali bolezen, ki povzroči zmanjšanje pretoka kisika v tkiva, kot je srčno popuščanje ali oteženo delovanje pljuč ali nedavni srčni napad.
It should also not be used in patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, or during breast- feeding.
Prav tako se ga ne sme uporabljati pri bolnikih, ki so zastrupljeni z alkoholom (prekomerno uživanje alkohola), ali alkoholizmom ali med dojenjem.
The Committee for Medicinal Products for Human Use (CHMP) concluded that vildagliptin taken with metformin reduces blood glucose levels and the combination of the two active substances in one tablet may help patients to stick to their treatment.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da jemanje vildagliptina skupaj s metfominom znižuje koncentracije glukoze v krvi in da kombinacija obeh zdravilnih učinkovin v eni tableti lahko pomaga bolnikom, da ostanejo pri predvidenem zdravljenju.
Therefore, the Committee decided that the benefits of Eucreas are greater than its risks for the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Zato je odbor odločil, da so koristi zdravila Eucreas pri zdravljenju bolnikov s sladkorno boleznijo tipa 2, pri katerih sladkorna bolezen ni mogoče urediti samo z metforminom v največjem peroralnem odmerku, ki ga še prenašajo, ali pri tistih, ki že prejemajo zdravljenje z vildagliptinom in metforminom v obliki ločenih tablet, večje od z njim povezanih tveganj.
The Committee recommended that Eucreas be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Eucreas odobri dovoljenje za promet.
Other information about Eucreas:
Druge informacije o zdravilu Eucreas:
The European Commission granted a marketing authorisation valid throughout the EU for Eucreas to Novartis Europharm Limited on 14 November 2007.
Evropska komisija je dovoljenje za promet z zdravilom Eucreas, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 14. novembra 2007.
The full EPAR for Eucreas can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Eucreas je na voljo tukaj.
Eucreas 50 mg/ 850 mg film-coated tablets
Eucreas 50 mg/ 850 mg filmsko obložene tablete
Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin).
Vsaka filmsko obložena tableta vsebuje 50 mg vildagliptina in 850 mg metforminijevega klorida (kar ustreza 660 mg metformina).
Yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “ NVR” on one side and “ SEH” on the other side.
Rumena ovalna filmsko obložena tableta z zaobljenim robom in vtisnjeno oznako “ NVR ” na eni strani in “ SEH ” na drugi.
Eucreas is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Zdravilo Eucreas je indicirano za zdravljenje bolnikov z diabetesom tipa 2, pri katerih diabetesa ni mogoče urediti samo z metforminom v največjem peroralnem odmerku, ki ga še prenašajo, ali pri tistih, ki že prejemajo zdravljenje z vildagliptinom in metforminom v obliki ločenih tablet.
Adults Based on the patient’ s current dose of metformin, Eucreas may be initiated at either the 50 mg/ 850 mg or 50 mg/ 1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.
Odrasli Glede na odmerek metformina, ki ga je bolnik uporabljal do tedaj, je mogoče začeti z uporabo zdravila Eucreas bodisi jakosti 50 mg/ 850 mg ali 50 mg/ 1000 mg dvakrat dnevno in sicer eno tableto zjutraj, drugo pa zvečer.
The recommended daily dose is 100 mg vildagliptin plus 2000 mg metformin hydrochloride.
Priporočeni dnevni odmerek je 100 mg vildagliptina in 2000 mg metforminijevega klorida.
Patients receiving vildagliptin and metformin from separate tablets may be switched to Eucreas containing the same doses of each component.
Bolniki, ki prejemajo vildagliptin in metformin v ločenih tabletah, lahko preidejo na zdravljenje z zdravilom Eucreas, ki vsebuje enake odmerke posameznih zdravilnih učinkovin.
Doses higher than 100 mg of vildagliptin are not recommended.
Odmerki vildagliptina nad 100 mg niso priporočeni.
There is no clinical experience of vildagliptin and metformin in triple combination with other antidiabetic agents.
O uporabi vildagliptina in metformina v trojni kombinaciji z drugimi antidiabetičnimi zdravili ni nobenih kliničnih izkušenj.
Taking Eucreas with or just after food may reduce gastrointestinal symptoms associated with metformin (see also section 5.2).
Jemanje zdravila Eucreas s hrano ali takoj po njej lahko ublaži gastrointestinalne simptome, ki so povezani z jemanjem metformina (glejte tudi poglavje 5. 2).
Additional information on special populations Renal impairment Eucreas should not be used in patients with creatinine clearance < 60 ml/ min (see sections 4.3, 4.4 and 5.2).
Dodatni podatki o posebnih skupinah bolnikov Okvara ledvic Bolniki z očistkom kreatinina < 60 ml/ min ne smejo uporabljati zdravila Eucreas (glejte poglavja 4. 3, 4. 4 in 5. 2).
Hepatic impairment Eucreas should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see sections 4.3, 4.4 and 4.8).
2 3- kratno zgornjo mejo normalnih vrednosti (upper limit of normal - ULN) (glejte poglavja 4. 3, 4. 4 in 4. 8).
2 Elderly (≥ 65 years) As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Eucreas should have their renal function monitored regularly (see section 4.4).
Starejši (≥ 65 let) Metformin se izloča preko ledvic, pri starejših bolnikih pa je delovanje ledvic pogosto zmanjšano, zato je treba starješim bolnikom, ki jemljejo zdravilo Eucreas, redno pregledovati delovanje ledvic (glejte poglavje 4. 4).
Eucreas has not been studied in patients older than 75 years.
Uporaba zdravila Eucreas pri bolnikih, starejših od 75 let, ni bila proučena.
Therefore the use of Eucreas is not recommended in this population.
Zato uporaba zdravila Eucreas pri tej skupini bolnikov ni priporočena.
Paediatric population (< 18 years) Eucreas is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Pediatrična populacija (< 18 let) Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Eucreas pri otrocih in mladostnikih ni priporočljiva.
− Hypersensitivity to the active substances or to any of the excipients − Diabetic ketoacidosis or diabetic pre-coma − Renal failure or renal dysfunction defined as creatinine clearance < 60 ml/ min (see section 4.4) − Acute conditions with the potential to alter renal function, such as:
- akutna stanja, ki bi lahko vplivala na delovanje ledvic, kot so:
dehydration, severe infection, shock, intravascular administration of iodinated contrast agents (see section 4.4).
dehidracija, huda okužba, šok, intravaskularna aplikacija jodiranih kontrastnih sredstev (glejte poglavje 4. 4);
−
- akutna ali kronična bolezen, ki lahko povzroča tkivno hipoksijo, kot je:
or chronic disease which may cause tissue hypoxia, such as: cardiac or respiratory failure, recent myocardial infarction, shock.
srčno popuščanje ali odpoved dihanja, nedaven miokardni infarkt, šok;
− Hepatic impairment (see sections 4.2, 4.4 and 4.8) − Acute alcohol intoxication, alcoholism − Lactation (see section 4.6)
- okvara jeter (glejte poglavja 4. 2, 4. 4 in 4. 8);
4.4 Special warnings and precautions for use
- akutna zastrupitev z alkoholom, alkoholizem;
General Eucreas is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
Splošno Zdravilo Eucreas ne more nadomestiti zdravljenja z insulinom pri bolnikih, ki potrebujejo insulin, in se ga ne sme uporabljati pri bolnikih z diabetesom tipa 1.
Lactic acidosis Lactic acidosis is a very rare but serious metabolic complication that can occur due to metformin accumulation.
Laktacidoza Laktacidoza je zelo redek, a resen presnovni zaplet, do katerega lahko pride zaradi kopičenja metformina.
The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors, such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any conditions associated with hypoxia (see also sections 4.3 and 4.5).
Pogostnost laktacidoze je mogoče in tudi potrebno zmanjšati s presojo drugih sočasnih dejavnikov tveganja, kot so slabo urejen diabetes, ketoza, dolgotrajno stradanje, prekomerno uživanje alkohola, jetrna insuficienca in katerakoli s hipoksijo povezana bolezen (glejte tudi poglavji 4. 3 in 4. 5).
Diagnosis of lactic acidosis Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain and hypothermia followed by coma.
Diagnostika laktacidoze Za laktacidozo so značilne acidotična dispneja, bolečine v trebuhu in hipotermija, ki ji sledi koma.
Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l and increased anion gap and lactate/pyruvate ratio.
Diagnostični laboratorijski izvidi so znižan pH krvi, koncentracije laktata v plazmi nad 5 mmol/ l ter povečana anionska vrzel in zvišano razmerje laktat/ piruvat.
If metabolic acidosis is suspected, treatment with the medicinal product should be discontinued and the patient hospitalised immediately (see section 4.9).
Pri sumu na metabolično acidozo je treba zdravljenje s tem zdravilom prekiniti, bolnika pa takoj hospitalizirati (glejte poglavje 4. 9).
Renal impairment As metformin is excreted by the kidney, serum creatinine concentrations should be monitored regularly:
Okvara ledvic Metformin se izloča preko ledvic, zato je treba koncentracije kreatinina v serumu redno spremljati:
- at least two to four times a year in patients with serum creatinine levels at the upper limit of
- vsaj enkrat na leto pri bolnikih z normalnih delovanjem ledvic,
3 Renal impairment in elderly patients is frequent and asymptomatic.
3
Hepatic impairment Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Eucreas (see sections 4.2, 4.3 and 4.8).
Okvara jeter Zdravilo Eucreas se ne sme uporabljati pri bolnikih z okvaro jeter, vključno z bolniki, ki imajo pred zdravljenjem vrednosti ALT ali AST nad 3- kratno zgornjo mejo normalnih vrednosti (glejte poglavja 4. 2, 4. 3 in 4. 8).
Liver enzyme monitoring Rare cases of hepatic dysfunction (including hepatitis) have been reported with vildagliptin.
Spremljanje jetrnih testov Pri zdravljenju z vildagliptinom so poročali o redkih primerih motenega delovanja jeter (vključno s hepatitisom).
Liver function should be monitored during treatment with Eucreas at three-month intervals during the first year and periodically thereafter.
Delovanje jeter je treba v prvem letu zdravljenja z zdravilom Eucreas spremljati vsake 3 mesece in občasno tudi kasneje.