natgillin/translations-raw huggingface dataset:
For ankylosing spondylitis, Simponi was compared with placebo over 24 weeks in one main study involving 356 patients who had not responded adequately to other treatments.
Pri ankilozirajočem spondilitisu so zdravilo Simponi 24 tednov primerjali s placebom v eni glavni študiji, v katero je bilo vključenih 356 bolnikov, pri katerih je bil odziv na druga zdravljenja neustrezen.
For ulcerative colitis, Simponi was compared with placebo in two main studies in patients who had not responded to or could not use other treatments.
Pri ulceroznemu kolitisu so zdravilo Simponi primerjali s placebom v dveh glavnih študijah pri bolnikih, ki se niso odzvali na druga zdravljenja ali za katere druga zdravljenja niso primerna.
For psoriatic arthritis, Simponi was compared with placebo over 24 weeks in one main study involving 405 patients who had not responded adequately to other treatments.
Pri psoriatičnem artritisu so zdravilo Simponi 24 tednov primerjali s placebom v eni glavni študiji, v katero je bilo vključenih 405 bolnikov, pri katerih je bil odziv na druga zdravljenja neustrezen.
In the second study, after 14 weeks, 35% of patients who received Simponi alone (54 out of 153) achieved 20% reductions in the number and severity of symptoms compared with 18% of patients who received placebo (28 out of 155).
V drugi študiji je po 14 tednih prišlo do 20-odstotnega zmanjšanja števila in resnosti simptomov pri 35 % (54 od 153) bolnikov, ki so prejemali zdravilo Simponi kot samostojno zdravilo, v primerjavi z 18 % (28 od 155) bolnikov, ki so prejemali placebo.
Of the patients who received Simponi, 59% (82 out of 138) had 20% reductions in the number and severity of symptoms after 14 weeks, compared with 22% of patients who were given placebo (17 out of 78).
Pri bolnikih, ki so jemali zdravilo Simponi, je po 14 tednih prišlo do 20-odstotnega zmanjšanja števila in resnosti simptomov pri 59% (82 od 138 bolnikov) v primerjavi z 22% (17 od 78) bolnikov, ki so jemali placebo.
Of the patients who received Simponi, 51% (74 out of 146) had 20% reductions in the number and severity of symptoms after 14 weeks, compared with 9% of patients who were given placebo (10 out of 113).
Pri bolnikih, ki so jemali zdravilo Simponi, je po 14 tednih prišlo do 20-odstotnega zmanjšanja števila in resnosti simptomov pri 51 % (74 od 146 bolnikov) v primerjavi z 9 % (10 od 113) bolnikov, ki so jemali placebo.
Of the patients who received Simponi, 71% (69 out of 97) had 20% reductions in the number and severity of symptoms after 16 weeks, compared with 40% of patients who were given placebo (40 out of 100).
Pri bolnikih, ki so jemali zdravilo Simponi, je po 16 tednih prišlo do 20-odstotnega zmanjšanja števila in resnosti simptomov pri 71 % (69 od 97 bolnikov) v primerjavi s 40 % (40 od 100) bolnikov, ki so jemali placebo.
The European Commission granted a marketing authorisation valid throughout the European Union for Xeplion on 4 March 2011.
Evropska komisija je dovoljenje za promet z zdravilom Xeplion, veljavno po vsej Evropski uniji, odobrila dne 4. marca 2011.
It is available as a prolongedrelease suspension for injection in pre-filled syringes (25, 50, 75, 100 and 150 mg).
Na voljo je kot suspenzija za injiciranje s podaljšanim sproščanjem v predhodno napolnjenih injekcijskih brizgah (25, 50, 75, 100 in 150 mg).
The full EPAR for Xeplion can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Xeplion je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
In the brain, it attaches to several different receptors on the surface of nerve cells.
V možganih se veže na različne receptorje na površini živčnih celic.
This is a summary of the European public assessment report (EPAR) for Xeplion.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xeplion.
The main measure of effectiveness in the studies was the change in the patients' symptoms after nine or 13 weeks assessed using a standard scale for schizophrenia.
Glavno merilo učinkovitosti v študijah je bila sprememba bolnikovih simptomov po devetih ali 13 tednih zdravljenja, ocenjena z uporabo standardne ocenjevalne lestvice za shizofrenijo
Because the medicine is a prolonged release suspension, it also has the advantage of being given at monthly intervals.
Ker je zdravilo v obliki suspenzije s podaljšanim sproščanjem, je njegova prednost tudi jemanje v mesečnih presledkih.
The most frequently reported side effects are insomnia (difficulty sleeping), headache, anxiety, upper respiratory tract infection (colds), reactions at the site of injection, parkinsonism (neurological symptoms including tremor and impaired muscular control), increased weight, akathisia (restlessness), agitation, somnolence (sleepiness), nausea, constipation, dizziness, muscle and bone pain, tachycardia (rapid heartbeat), tremor (shaking), abdominal pain (stomach ache), vomiting diarrhoea, fatigue (tiredness) and dystonia (involuntary muscle contractions).
Neželeni učinki, o katerih so najpogosteje poročali, so nespečnost, glavobol, anksioznost, okužbe zgornjih dihalnih poti (prehladi), reakcije na mestu injiciranja, parkinsonizem (nevrološki simptomi, vključno s tresavico in slabšim nadzorom nad mišicami), povečana telesna masa, akatizija (nemirnost), vznemirjenost, zaspanost, slabost, zaprtje, omotica, bolečine v mišicah in kosteh, tahikardija (zvišan srčni utrip), tresavica, bolečine v trebuhu, bruhanje, driska, utrujenost in distonija (nehoteni mišični krči).
What benefit has Xeplion shown during the studies?
Kakšne koristi je zdravilo Xeplion izkazalo med študijami?
In two other studies (one long- and one short-term), Xeplion was not proven to be as effective as risperidone.
Pri dveh drugih študijah (eni dolgoročni in ena kratkoročni) se zdravilo Xeplion ni izkazalo tako učinkovito kot risperidon.
This study looked at how well Xeplion prevented the relapse of severe symptoms.
V tej študiji so proučevali, kako dobro zdravilo Xeplion preprečuje ponovitev hudih simptomov.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xeplion.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Xeplion, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The injections on days 1 and 8 are into the upper part of the shoulder (deltoid muscle), while the maintenance doses can be given in the buttocks or the deltoid muscle.
Injekciji na prvi in osmi dan se injicirata v zgornji del ramena (deltoidno mišico), medtem ko se lahko vzdrževalni odmerki injicirajo v zadnjico ali deltoidno mišico.
The Committee decided that Xeplion's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Xeplion večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Six short-term studies were carried out with Xeplion.
Z zdravilom Xeplion je bilo izvedenih šest kratkoročnih študij.
What is the risk associated with Xeplion?
Kakšna tveganja so povezana z zdravilom Xeplion?
Because paliperidone has already been authorised in the EU as Invega, the company used some of the data from Invega to support the use of Xeplion.
Ker je paliperidon že odobren v EU kot zdravilo Invega, je družba v podporo uporabi zdravila Xeplion uporabila nekatere podatke o zdravilu Invega.
Other information about Xeplion
Druge informacije o zdravilu Xeplion:
For more information on the use of Xeplion including how to adjust the doses, see the summary of product characteristics (also part of the EPAR).
Za več informacij o uporabi zdravila Xeplion, vključno s prilagoditvijo odmerkov, glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Shizofrenija je duševna bolezen s številnimi simptomi, ki vključujejo neorganizirano mišljenje in govor, halucinacije (bolnik ima privide in prisluhe), sumničavost ter blodnje (zmotna prepričanja).
Xeplion treatment starts with two injections, one week apart, to bring the blood levels of paliperidone up, followed by monthly maintenance injections.
Zdravljenje z zdravilom Xeplion se prične z dvema injekcijama v presledku enega tedna, da se raven paliperidona v krvi dvigne, temu pa sledijo mesečne vzdrževalne injekcije.
The CHMP noted that the studies comparing Xeplion with placebo and risperidone showed that the medicine is beneficial to patients with schizophrenia.
CHMP je menil, da so študije, v katerih so primerjali zdravilo Xeplion s placebom in risperidonom, pokazale, da je zdravilo koristno za bolnike s shizofrenijo.
Two long-term studies lasting about a year were carried out with Xeplion.
Z zdravilom Xeplion sta bili izvedeni tudi dve dolgoročni študiji, ki sta trajali približno eno leto.
Paliperidone acts mainly by blocking receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin), which are involved in schizophrenia.
Paliperidon v glavnem zavira receptorje za živčna prenašalca dopamin in 5-hidroksitriptamin (imenovan tudi serotonin), ki sodelujeta pri shizofreniji.
This allows for the injection to have a long duration of action.
To omogoča dolgotrajno delovanje zdravila.
For more information about treatment with Xeplion, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Xeplion preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
In Xeplion, paliperidone has been attached to a fatty acid that allows it to be released slowly after being injected.
V zdravilu Xeplion je paliperidon vezan na maščobno kislino, ki omogoča njegovo počasno sproščanje po vbrizganju.
Paliperidone has been authorised in the European Union as Invega since 2007 as an oral treatment for schizophrenia.
Paliperidon je v Evropski uniji odobren od leta 2007 kot zdravilo Invega, peroralno zdravilo za shizofrenijo.
Why has Xeplion been approved?
Zakaj je bilo zdravilo Xeplion odobreno?
In four short-term studies the reductions in symptom scores were greater for patients receiving Xeplion than for those receiving placebo.
Pri štirih kratkoročnih študijah so bili rezultati zmanjšanja simptomov pri bolnikih, ki so prejemali zdravilo Xeplion, boljši kot pri bolnikih, ki so prejemali placebo.
Paliperidone is an active breakdown product (metabolite) of risperidone, another antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s.
Paliperidon je aktivni presnovek (metabolit) risperidona, drugega antipsihotika, ki se za zdravljenje shizofrenije uporablja od devetdesetih let prejšnjega stoletja.
Xeplion must not be given to people who are hypersensitive (allergic) to paliperidone or any of the other ingredients, or to risperidone.
Zdravila Xeplion ne smejo jemati bolniki, ki so preobčutljivi za (alergični na) paliperidon ali katero koli drugo sestavino zdravila ali risperidon.
Xeplion is used for the maintenance treatment of schizophrenia in adults whose disease has already been stabilised on treatment with paliperidone or risperidone.
Zdravilo Xeplion se uporablja za vzdrževalno zdravljenje shizofrenije pri odraslih, pri katerih je bila bolezen stabilizirana med zdravljenjem s paliperidonom ali risperidonom.
(day 1) followed by 100 mg on day 8.
Začetni injekciji znašata 150 mg na prvi dan zdravljenja (1. dan) in 100 mg na osmi dan (8. dan).
Some patients whose symptoms have not yet been stabilised may still be given Xeplion if they have responded well to oral paliperidone or risperidone in the past, their symptoms are mild to moderate and a long-acting injectable treatment is needed.
Zdravilo se lahko uporablja tudi pri določenih bolnikih s shizofrenijo, ki še niso bili stabilizirani, a so se v preteklosti dobro odzvali na zdravljenje s peroralnim paliperidonom ali risperidonom, če so njihovi simptomi blagi do zmerni in je potrebno zdravljenje z dolgo delujočim zdravilom.
The dose may be adjusted depending on the medicine's benefit to the patient and how the patient tolerates the treatment.
Mesečni vzdrževalni odmerek znaša 75 mg. Odmerek se lahko prilagodi glede na koristi zdravila pri posameznem bolniku in glede na to, kako bolnik prenaša zdravljenje.
The active substance in Xeplion, paliperidone, is an antipsychotic medicine.
Zdravilna učinkovina zdravila Xeplion, paliperidon, je antipsihotično zdravilo.
For the full list of all side effects reported with Xeplion, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Xeplion, glejte navodilo za uporabo.
Xeplion is a medicine that contains the active substance paliperidone.
Xeplion je zdravilo, ki vsebuje zdravilno učinkovino paliperidon.
The second study, involving 749 adults, compared Xeplion with risperidone long-acting injection (taken with oral risperidone supplements) and looked at the change in the patients' symptoms.
V drugi študiji, v kateri je sodelovalo 749 odraslih bolnikov, so zdravilo Xeplion primerjali z dolgo delujočo injekcijo risperidona (ki se jemlje s peroralnimi dodatki risperidona) in ugotavljali spremembe simptomov pri bolnikih.
Xeplion was more effective than placebo in reducing schizophrenia symptoms in the short-term.
Zdravilo Xeplion je bilo pri kratkoročnem izboljšanju simptomov shizofrenije učinkovitejše od placeba.
Prolonged-release means that the active substance is released slowly over a few weeks after being injected.
Podaljšano sproščanje pomeni, da se zdravilna učinkovina po injiciranju sprošča več tednov.
Xeplion was also shown to be effective in preventing relapses in the longterm, with fewer patients in the Xeplion group having a relapse compared with the placebo group.
Zdravilo Xeplion se je kot učinkovito izkazalo tudi pri dolgoročnem preprečevanju ponovitev, saj so se ponovitve pojavile pri manjšem številu bolnikov v skupini, ki je prejemala zdravilo Xeplion, v primerjavi s skupino, ki je prejemala placebo.
Two studies, involving 1,178 patients, compared Xeplion with risperidone long-acting injection (taken with oral risperidone supplements).
V dveh študijah, v katerih je sodelovalo 1 178 bolnikov, so primerjali zdravilo Xeplion z dolgo delujočo injekcijo risperidona (ki se jemlje s peroralnimi dodatki risperidona).
One of the studies, involving 410 adults, compared Xeplion with placebo.
V eni študiji, v kateri je sodelovalo 410 bolnikov, so zdravilo Xeplion primerjali s placebom.
What is Xeplion used for?
Za kaj se zdravilo Xeplion uporablja?
Four of the studies, involving 1,774 adults with schizophrenia, compared Xeplion with placebo (a dummy treatment).
V štirih študijah, v katerih je sodelovalo 1 774 odraslih s shizofrenijo, so primerjali zdravilo Xeplion s placebom (zdravilom brez zdravilne učinkovine).
Of these, akathisia and somnolence appear to be related to the dose.
Akatizija in zaspanost naj bi bili povezani z velikostjo odmerka.
What is Xeplion?
Kaj je zdravilo Xeplion?
How has Xeplion been studied?
Kako je bilo zdravilo Xeplion raziskano?
How does Xeplion work?
Kako zdravilo Xeplion deluje?
How is Xeplion used?
Kako se zdravilo Xeplion uporablja?
Xeplion was shown to be as effective as risperidone long-acting injection in reducing schizophrenia in one of the short-term studies.
Zdravilo Xeplion se je v eni kratkoročni študiji pri lajšanju shizofrenije izkazalo enako učinkovito kot dolgo delujoče injekcije risperidona.
16 October 2015
16. oktober 2015
Adoption of CMDh agreement:
Sprejetje sporazuma skupine CMDh:
17 June 2015
17. junij 2015
Implementation of the agreement by the Member States (submission of the variation type IB by the Marketing Authorisation Holder):
Izvajanje sporazuma s strani držav članic (predložitev spremembe tipa IB s strani imetnika dovoljenja za promet z zdravilom):
May 2015 CMDh meeting
Zasedanje skupine CMDh maja 2015
It is available as tablets (50 mg/850 mg and 50 mg/1,000 mg).
Na voljo je v obliki tablet (50 mg/850 mg in 50 mg/1 000 mg).
Vildagliptin on its own was approved by the European Union (EU) in September 2007 under the name Galvus, and metformin has been available in the EU since 1959.
Vildagliptin, uporabljen samostojno, je bil v Evropski uniji (EU) odobren septembra 2007 pod imenom Galvus, metformin pa je v EU na voljo od leta 1959.
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, druga pa zvečer.
Doses of vildagliptin above 100 mg are not recommended.
Odmerki vildagliptina nad 100 mg niso priporočljivi.
The European Commission granted a marketing authorisation valid throughout the EU for Eucreas on 14 November 2007.
Evropska komisija je dovoljenje za promet z zdravilom Eucreas, veljavno po vsej Evropski uniji, odobrila dne 14. novembra 2007.
Other information about Eucreas
Druge informacije o zdravilu Eucreas
The full EPAR for Eucreas can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Eucreas je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This is a summary of the European public assessment report (EPAR) for Eucreas.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Eucreas.
Therefore, the Committee decided that the benefits of Eucreas are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zato zaključil, da so koristi zdravila Eucreas večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
For more information about treatment with Eucreas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Eucreas preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Vildagliptin / metformin hydrochloride
Eucreas vildagliptin/metforminijev klorid
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 ga ne smejo uporabljati bolniki, ki imajo diabetično ketoacidozo (visoke koncentracije ketonov in kislin v krvi), diabetično predkomo, težave z ledvicami ali jetri, stanja, pri katerih obstaja možnost poslabšanja delovanja ledvic, ali bolezen, ki povzroči zmanjšanje pretoka kisika v tkiva, kot so srčna ali respiratorna odpoved ali nedavni srčni napad.
It should also not be used in patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, or during breastfeeding.
Prav tako se ne sme uporabljati pri bolnikih z akutno zastrupitvijo z alkoholom (prekomerno uživanje alkohola) ali v primeru alkoholizma oziroma med dojenjem.
What benefit has Eucreas shown during the studies?
Kakšne koristi je zdravilo Eucreas izkazalo med študijami?
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 predstavil tudi rezultate dveh študij, ki kažeta, da je telo zdravilni učinkovini v obeh jakostih zdravila Eucreas absorbiralo enako, kot pri njunem jemanju v obliki ločenih tablet.
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 teka.
• in patients who are already taking the combination of vildagliptin and metformin as separate tablets;
• pri bolnikih, ki že jemljejo kombinacijo vildagliptina in metformina v ločenih tabletah;
The choice of tablet strength to start with depends on the patient's current treatment and the expected effects of Eucreas, but it is recommended to provide a dose of metformin similar to the dose already being taken.
Izbira začetne jakosti tablete je odvisna od bolnikovega dotedanjega zdravljenja in pričakovanega učinka zdravila Eucreas, vendar je priporočljivo, da je odmerek metformina podoben odmerku, ki ga bolnik že jemlje.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Eucreas.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Eucreas, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Eucreas should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver.
Zdravilo Eucreas se ne sme uporabljati pri bolnikih, ki imajo zmerne ali hude težave z ledvicami ali imajo težave z jetri.
As a result of the action of both substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Kot posledica delovanja obeh zdravilnih učinkovin se koncentracija glukoze v krvi zniža, to pa prispeva k nadzoru sladkorne bolezni tipa 2.
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 zavira razgradnjo hormonov inkretinov v telesu.
Patients adding vildagliptin had falls in HbA1c levels of 0.88 percentage points after 24 weeks from a starting level of 8.38%.
Bolnikom, ki so kot dodatek prejemali vildagliptin, so se koncentracije HbA1c po 24 tednih zmanjšale za 0,88 odstotne točke glede na izhodiščno vrednost 8,38 %.
Eucreas should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients.
Zdravila Eucreas ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) vildagliptin, metformin ali katero koli drugo sestavino zdravila.
Elderly patients taking Eucreas should have their kidney function monitored regularly.
Pri starejših bolnikih, ki jemljejo zdravilo Eucreas, je treba redno spremljati delovanje ledvic.
Eucreas is used to treat adults with type 2 diabetes.
Zdravilo Eucreas se uporablja za zdravljenje odraslih, ki imajo sladkorno bolezen tipa 2.
The studies compared Galvus with placebo and 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 študijah so zdravilo Galvus primerjali s placebom in merili koncentracijo snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je glukoza v krvi nadzorovana.
The studies with Galvus as an add-on to metformin, metformin and a sulphonylurea, or metformin and insulin have been used to support the use of Eucreas in the same indications.
Študije zdravila Galvus kot dodatnega zdravila metforminu, metforminu in sulfonilsečnini ali metforminu, sulfonilsečnini in insulinu, so bile uporabljene v podporo zdravilu Eucreas za iste indikacije.
Vildagliptin can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Vildagliptin se lahko uporablja s metforminom pri bolnikih s sladkorno boleznijo tipa 2, pri katerih samo z metforminom ni mogoče doseči zadovoljivega nadzora.