natgillin/translations-raw huggingface dataset:
In clinical trials, patients who developed thyroid events were permitted to receive re-treatment with LEMTRADA.
V kliničnih preskušanjih so bolniki, pri katerih so se pojavile bolezni ščitnice, lahko prejeli ponovno zdravljenje z zdravilom LEMTRADA.
In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level < 1.2 IU/l as measured in a central laboratory.
V kliničnih preskušanjih so bile bolnice s hudim pomanjkanjem FSH in LH opredeljene na podlagi serumske ravni endogenega LH < 1,2 i.e./l, izmerjene v centralnem laboratoriju.
In clinical trials, Pegasys treatment was associated with decreases in both total white blood cell (WBC) count and absolute neutrophil count (ANC), usually starting within the first 2 weeks of treatment (see section 4.8).
Med kliničnimi preskušanji je bilo zdravljenje z zdravilom Pegasys povezano z zmanjšanjem celokupnega števila belih krvnih celic in zmanjšanjem absolutnega števila nevtrofilcev, ki se je običajno pojavilo v prvih 2 tednih zdravljenja (glejte poglavje 4.8).
In clinical trials, raloxifene did not stimulate the postmenopausal uterine endometrium.
V kliničnih preskušanjih raloksifen ni stimuliral postmenopavzalnega materničnega endometrija.
In clinical trials, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
V kliničnih preskušanjih so o izpuščaju poročali pri 4 % bolnikov in o pruritusu pri 1,5 % bolnikov.
In clinical trials, Repatha reduced unbound PCSK9, LDL-C, TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a), and increased HDL-C and ApoA1 in patients with primary hypercholesterolaemia and mixed dyslipidaemia.
V kliničnih preskušanjih je zdravilo Repatha bolnikom s primarno hiperholesterolemijo in mešano dislipidemijo znižalo nevezani PCSK9, LDL-H, TC, ApoB, ne-HDL-H, TC/HDL-H, ApoB/ApoA1, VLDL-H, trigliceride in Lp(a) ter zvišalo HDL-H in ApoA1.
In clinical trials, saline only was used for ear cleaning.
V kliničnih raziskavah so za čiščenje ušes uporabljali le fiziološko raztopino.
In clinical trials, scheduled dinutuximab doses of up to 120 mg/m2 (60 mg/m2/day) have been administered with an adverse reaction profile similar to that described in section 4.8. In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
V kliničnih preskušanjih so bili aplicirani odmerki dinutuksimaba do 120 mg/m2 (60 mg/m2/dan), s profilom neželenih učinkov, podobnem tistemu, ki je opisan v poglavju 4.8. V primeru prevelikega odmerjanja je treba pri bolnikih natančno spremljati znake ali simptome neželenih učinkov in izvesti primerno simptomatično terapijo.
In clinical trials, single doses of 1.0 mg of LeukoScan radiolabelled with 900 ± 200 MBq of 99mTc were administered to 11 patients with various types of infection and there were no adverse reactions at this dose.
V kliničnih študijah so bile posamezne doze 1,0 mg zdravila LeukoScan, ki je bil radiološko označen z 900  200 MBq 99mTc, aplicirane 11 bolnikom z različnimi tipi infekcij in pri teh odmerkih niso opazili neželenih učinkov.
In clinical trials, sixty seven percent (67 %) of the patients experienced at least one infusion- associated reaction (see section 4.8).
V kliničnih preskušanjih je sedeminšestdeset odstotkov (67 %) bolnikov imelo vsaj eno reakcijo, povezano z infuzijo (glejte poglavje 4.8).
In clinical trials, sixty seven percent (67%) of the patients experienced at least one infusion-associated reaction (see section 4.8).
V kliničnih preskušanjih je sedeminšestdeset odstotkov (67 %) bolnikov imelo vsaj eno reakcijo, povezano z infuzijo (glejte poglavje 4.8).
In clinical trials, smaller bleeding sites (< 10 cm2) used 0.5 g to 1 g on average.
V kliničnih preskušanjih so za manjše krvaveče predele (< 10 cm2) povprečno uporabili 0,5 g do 1 g.
In clinical trials, spinal/cervical cord compression (SCC) was observed both in patients receiving Vimizim and patients receiving placebo.
V kliničnih preskušanjih so o kompresiji hrbtenjače/vratne hrbtenice poročali pri bolnikih, ki so prejemali zdravilo Vimizim, in bolnikih, ki so prejemali placebo.
In clinical trials, switching from stavudine to other nucleosides (tenofovir or abacavir) resulted in increases in limb fat with modest to no improvements in clinical lipoatrophy.
V kliničnih preskušanjih je pri prehodu iz zdravljenja s stavudinom na zdravljenje z drugimi nukleozidi (tenofovir ali abakavir) prišlo do povečanja količine maščevja na okončinah, medtem ko se je klinična lipoatrofija izboljšala le malo ali pa sploh ne.
In clinical trials, the crude incidence rate of malignancy was the same in the Kineret-treated patients and the placebo-treated patients and did not differ from that in the general population.
V kliničnih preskušanjih je bila sama incidenca malignih bolezni pri bolnikih, ki so dobivali zdravilo Kineret in placebo, enaka in se ni razlikovala od tiste v splošni populaciji.
In clinical trials, the daily requirement for PRN opioids was significantly reduced when coadministered with parecoxib.
V kliničnih preskušanjih se je dnevna potreba po opioidih PP bistveno zmanjšala, če so bili uporabljeni sočasno s parekoksibom.
In clinical trials, the incidence rate for syncope is uncommon and did not differ between lacosamide treated epilepsy patients (0.1%) and placebo treated epilepsy patients (0.3%).
V kliničnih preskušanjih je bila glede na incidenco sinkopa opredeljena kot občasen neželeni učinek, incidenci pa se med bolniki z epilepsijo, ki se zdravijo z lakozamidom (0,1 %), in bolniki z epilepsijo, ki prejemajo placebo (0,3 %), nista razlikovali.
In clinical trials, the median time to onset of the first occurrence of left ventricular dysfunction, cardiac failure and LVEF decrease was between 2 and 5 months.
V kliničnih preskušanjih je bila mediana časa do prvega pojava disfunkcije levega prekata, srčnega popuščanja in zmanjšanja LVEF od 2 do 5 mesecev.
In clinical trials, the most common adverse reactions were blurred vision, eye irritation and eye pain, occurring in approximately 2% to 7% patients.
Najpogostejši neželeni učinki, ki so se v kliničnih študijah pojavili pri približno 2% do 7% bolnikov, so bili zamegljen vid, draženje očesa in očesna bolečina.
In clinical trials, the most frequent undesirable effects attributable to filgrastim at the recommended dose were mild or moderate musculoskeletal pain, occurring in 10 %, and severe musculoskeletal pain in 3 % of patients.
Blaga do zmerna mišičnoskeletna bolečina, ki se je pojavila pri 10% bolnikov, ter huda mišičnoskeletna bolečina, ki se je pojavila pri 3% bolnikov, sta bila najbolj pogosta neželena učinka, ki so ju v kliničnih preskušanjih pripisali filgrastimu v priporočenem odmerku.
In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43%) and vomiting (36%).
V kliničnih preskušanjih so bili neželeni učinki, ki so se med zdravljenjem najpogosteje pojavljali, prebavne motnje, in sicer navzeja (43 %) in bruhanje (36 %).
In clinical trials, the risk for hepatotoxicity was mitigated by exclusion of patients with baseline hepatitis or significant abnormalities of liver function tests.
V kliničnih študijah je bilo tveganje za hepatotoksičnost manjše, saj v študije niso vključevali bolnikov z že obstoječim hepatitisom ali značilnimi patološkimi izvidi jetrne funkcije.
In clinical trials, the use of Nimenrix as a booster following primary vaccination with Nimenrix or other meningococcal vaccines (quadrivalent meningococcal A, C, W and Y-DT conjugate vaccine or monovalent group C conjugate vaccines) was evaluated.
V kliničnih preskušanjih so ocenjevali uporabo cepiva Nimenrix kot obnovitvenega odmerka po osnovnem cepljenju s cepivom Nimenrix ali drugimi meningokoknimi cepivi (štirivalentno konjugirano cepivo proti meningokokom skupin A, C, W in Y-DT ali monovalentna konjugirana cepiva proti meningokokom skupine C).
In clinical trials, the use of Nimenrix as a booster following primary vaccination with Nimenrix or other meningococcal vaccines (quadrivalent meningococcal A, C, W, and Y-DT conjugate vaccine or monovalent group C conjugate vaccines) was evaluated.
V kliničnih preskušanjih so ocenjevali uporabo cepiva Nimenrix kot obnovitvenega odmerka po osnovnem cepljenju s cepivom Nimenrix ali drugimi meningokoknimi cepivi (štirivalentno konjugirano cepivo proti meningokokom skupin A, C, W in Y-DT ali monovalentna konjugirana cepiva proti meningokokom skupine C).
In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/l.
V kliničnih preskušanjih so te bolnice opredelili glede na serumsko raven endogenega LH < 1,2 i.e./l.
In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three years without evidence of continuous progression between relapses; AVONEX slows the progression of disability and decreases the frequency of relapses.
V kliničnih študijah so to opisali kot dva ali več akutnih poslabšanj (relapsov) v preteklih treh letih, brez dokazov o postopnem napredovanju med relapsi; zdravilo AVONEX upočasnjuje napredovanje prizadetosti in zmanjšuje pogostnost relapsov.
In clinical trials, this was characterised by two or more acute exacerbations in the previous two years (see section 5.1).
V kliničnih preskušanjih je bilo to opredeljeno z dvema ali več zagoni bolezni v obdobju zadnjih dveh let (glejte poglavje 5.1).
In clinical trials, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2 and a further dose reduction was required to manage adverse effects.
Med kliničnimi preskušanji so topotekan prenehali uporabljati, če je bil odmerek že zmanjšan na 1,0 mg/m2 in ga je bilo treba zaradi neželenih učinkov še dodatno zmanjšati.
In clinical trials, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2 and a further dose reduction was required to manage adverse effects.
V kliničnih preskušanjih so topotekan ukinili, če je bil odmerek že zmanjšan na 1,0 mg/m2 in bi bilo za odpravo neželenih učinkov potrebno dodatno zmanjšanje odmerka.
In clinical trials, topotecan was discontinued if the dose needed to be reduced below 1.5 mg/m2.
Med kliničnimi preskušanji so topotekan nehali uporabljati, če je bilo treba odmerek zmanjšati pod 1,5 mg/m2.
In clinical trials, transient or intermittent mild and moderate elevations of hepatic transaminases have been reported commonly with RoActemra treatment, without progression to hepatic injury (see section 4.8).
V kliničnih preskušanjih so med zdravljenjem z zdravilom RoActemra pogosto poročali o prehodnem ali intermitentnem blagem do zmernem zvišanju jetrnih transaminaz, brez napredovanja v poškodbo jeter (glejte poglavje 4.8).
In clinical trials, treated animals rapidly regained weight following cessation of treatment when diet was not restricted.
V kliničnih poskusih so zdravljene živali po prekinitvi zdravljenja hitro spet pridobile izgubljeno telesno maso, če prehrana ni bila omejena.
In clinical trials, treatment with bosutinib continued until disease progression or until it was no longer tolerated by the patient.
V kliničnih preskušanjih se je zdravljenje z bosutinibom nadaljevalo do napredovanja bolezni ali dokler bolnik zdravljenja ni več mogel prenašati.
In clinical trials, tumour haemorrhage occurred in approximately 2% of patients with GIST.
V kliničnih preskušanjih so se krvavitve tumorjev pojavile pri približno 2 % bolnikov z GIST.
In clinical trials, up to 3% of adult patients tested seropositive at least once during the study for antibodies capable of neutralising the biologic effects of anakinra.
V kliničnih preskušanjih je bilo do 3 % odraslih bolnikov vsaj enkrat med študijo seropozitivnih za protitelesa, ki lahko nevtralizirajo biološke učinke anakinre.
In clinical trials, weekly monitoring of the neutrophil count has been effective in identifying cases of neutropenia and agranulocytosis.
V kliničnih preskušanjih se je to izkazalo za učinkovito pri odkrivanju primerov nevtropenije in agranulocitoze.
In clinically stable patients, a switch to oral azole therapy was permitted after at least 10 days of study treatment.
Klinično stabilni bolniki so lahko po vsaj 10 dneh zdravljenja s preiskovanim zdravilom prešli na peroralno zdravljenje z azoli.
In clinically stable patients, a switch to oral azole therapy was permitted after at least 5 to 10 days of treatment with anidulafungin.
Klinično stabilni bolniki so lahko po vsaj 5 do 10dneh zdravljenja z anidulafunginom prešli na peroralno zdravljenje z azoli.
In CLL and FL, cancerous B-lymphocytes multiply too quickly and replace the normal cells in the bone marrow (where blood cells are made) and in lymph nodes.
Pri KLL se rakavi limfociti B prehitro razmnožujejo in nadomestijo normalne celice v kostnem mozgu (kjer krvne celice nastajajo) in v limfnih vozlih.
In CLL patients who received the combined measures for prevention of IRRs (adequate corticosteroid, oral analgesic/anti-histamine, omission of antihypertensive medicine in the morning of the first infusion, and the Cycle 1 Day 1 dose administered over 2 days) as described in section 4.2, a decreased incidence of IRRs of all grades was observed.
Pri bolnikih s KLL, ki so bili deležni kombiniranih ukrepov za preprečitev reakcij, povezanih z infuzijo (ustreznih kortikosteroidov, peroralnih analgetikov/antihistaminikov, neuporabe antihipertenzivov na jutro prvega infundiranja ter uporabe odmerka za 1. dan 1. ciklusa v 2 dneh), kot so opisani v poglavju 4.2, je bila incidenca z infuzijo povezanih reakcij vseh stopenj manjša.
In CLL patients, co-administration with MabThera did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide.
Sočasna uporaba zdravila MabThera pri bolnikih s KLL ni vplivala na farmakokinetiko fludarabina ali ciklofosfamida.
In CLL patients, if the previous infusion rate was not well tolerated, instructions for the Cycle 1, Day 1 and Day 2 infusion rate should be used for subsequent cycles (see Table 5 in section 4.2).
Če bolnik s KLL ni dobro prenašal predhodne hitrosti infundiranja, je treba za naslednje cikluse upoštevati navodila za hitrost infundiranja 1. in 2. dne 1. ciklusa (glejte preglednico 5 v poglavju 4.2).
In CLL Zydelig treatment is used in combination with another medicine (rituximab or ofatumumab) in patients who have certain high-risk factors or in patients whose cancer has come back after at least one previous treatment.
Pri KLL se zdravljenje z zdravilom Zydelig uporablja v kombinaciji z drugim zdravilom (rituksimab ali ofatumumab), pri bolnikih, ki imajo nekatere dejavnike velikega tveganja, ali pri bolnikih, pri katerih se je rak po vsaj enem predhodnem zdravljenju ponovil.
In CLL, Gazyvaro has been shown to significantly delay the disease getting worse in patients previously untreated who had other medical conditions and were therefore ineligible for fludarabine-based therapy.
Zdravilo Gazyvaro je znatno upočasnilo slabšanje KLL pri predhodno nezdravljenih bolnikih, ki so imeli tudi druge bolezni, zaradi katerih niso bili primerni za zdravljenje s fludarabinom.
In CLL, the overall incidence of grade 3 or 4 cardiac disorders was low both in the first-line study (4% R-FC, 3% FC) and in the relapsed/refractory study (4% R-FC, 4% FC).
Pri KLL je bila celokupna incidenca srčnih bolezni stopnje 3 ali 4 nizka, tako v študiji v prvi liniji zdravljenja (4 % R-FC, 3 % FC) kot tudi v študiji pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (4 % R- FC, 4 % FC).
In CLL, the overall incidence of grade 3 or 4 nervous system disorders was low both in the first-line study (4% R-FC, 4% FC) and in the relapsed/refractory study (3% R-FC, FC).
Pri KLL je bila celokupna incidenca bolezni živčevja stopnje 3 ali 4 nizka, tako v študiji v prvi liniji zdravljenja (4 % R-FC, 4 % FC) kot tudi v študiji pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (3 % R-FC, 3 % FC).
In CLL, Zydelig is used in combination with another medicine (rituximab or ofatumumab) in patients who have received at least one previous treatment and in patients who have genetic mutations in their cancer cells called 17p deletion or TP53 mutation who cannot be treated with any other therapy.
Pri kronični limfocitni levkemiji se zdravilo Zydelig uporablja v kombinaciji z drugim zdravilom (rituksimabom ali ofatumumabom) pri bolnikih, ki so pred tem prejeli vsaj eno zdravljenje, in pri bolnikih z genskimi mutacijami rakavih celic, imenovanimi delecija 17p ali mutacija TP53, ki ne morejo prejeti nobenega drugega zdravljenja.
In CML, cytopenias, particularly neutropenia and thrombocytopenia, have been a consistent finding in all studies, with the suggestion of a higher frequency at high doses  750 mg (phase I study).
Pri KML so v vseh študijah redno ugotavljali citopenije, posebno nevtropenijo in trombocitopenijo.
In colon cancer, Xeloda on its own has been compared with the combination of 5-FU and folinic acid (a medicine that enhances the effects of 5-FU) in 1,987 patients who had previously had surgery for their cancer.
Pri raku kolona so zdravilo Xeloda, kot samostojno zdravilo, primerjali s kombinacijo 5-FU in folne kisline (zdravila, ki poveča učinke 5-FU) pri 1 987 bolnikih, ki so bili predhodno operirani zaradi raka.
in combinatin with efavirenz
kombinaciji z efavirenzom
In combination studies of emtricitabine with protease inhibitors, nucleoside, nucleotide and non-nucleoside analogue inhibitors of HIV reverse transcriptase, additive to synergistic effects were observed.
V študijah kombinacije emtricitabina z zaviralci proteaz, z nukleozidnimi, nukleotidnimi in ne- nukleozidnimi analogi zaviralcev HIV reverzne transkriptaze so opazili aditivne ali celo sinergistične učinke.
In combination treatment, the recommended starting dose of capecitabine should be reduced to 800 – 1000 mg/m2 when administered twice daily for 14 days followed by a 7-day rest period, or to 625 mg/m2 twice daily when administered continuously (see section 5.1).
Pri zdravljenju s kombinacijo zdravil je treba priporočeni začetni odmerek kapecitabina zmanjšati na 800 do 1.000 mg/m2, kadar ga dajemo dvakrat na dan 14 dni, čemur sledi 7-dnevni premor, ali na 625 mg/m2 dvakrat na dan, če ga dajemo neprekinjeno (glejte poglavje 5.1).
in combination with a statin (other cholesterol-lowering medicines), or a statin plus other fat- lowering medicines, in patients who do not adequately respond to the maximum dose of the statin;
v kombinaciji s statinom (drugo vrsto zdravil, ki znižujejo raven holesterola) ali statinom z drugimi zdravili za zniževanje ravni maščob pri bolnikih, ki se nezadostno odzovejo na največji odmerek statina,
in combination with a statin (other cholesterol-lowering medicines), or a statin plus other fat- lowering medicines, in patients who do not adequately respond to the maximum tolerated dose of the statin; alone or in combination with other fat-lowering medicines in patients who cannot tolerate or cannot be given statins.
v kombinaciji s statinom (drugo vrsto zdravil, ki znižujejo raven holesterola) ali statinom in drugimi zdravili za zniževanje ravni maščob pri bolnikih, ki se nezadostno odzovejo na največji odmerek statina, ki ga še lahko prenašajo; samostojno ali v kombinaciji z drugimi zdravili za zniževanje ravni maščob pri bolnikih, ki ne prenašajo ali ne smejo prejemati statinov.
in combination with a sulphonylurea (another type of anti-diabetes medicine) together with diet and exercise, in patients whose diabetes is not satisfactorily controlled on metformin and a sulphonylurea. in combination with insulin together with diet and exercise, in patients whose diabetes is insufficiently controlled with insulin at a stable dose and metformin.
v kombinaciji s sulfonilsečnino (drugo vrsto zdravila proti sladkorni bolezni) skupaj z dieto in telesno vadbo pri bolnikih, pri katerih bolezen ni zadostno nadzorovana z metforminom in sulfonilsečnino; v kombinaciji z insulinom skupaj z dieto in telesno vadbo pri bolnikih, pri katerih bolezen ni zadostno nadzorovana z insulinom v ustaljenem odmerku in metforminom.
in combination with a sulphonylurea (another type of anti-diabetes medicine) together with diet and exercise, in patients whose diabetes is not satisfactorily controlled on metformin and a sulphonylurea; in combination with insulin together with diet and exercise, in patients whose diabetes is insufficiently controlled with insulin at a stable dose and metformin.
v kombinaciji s sulfonilsečnino (drugo vrsto zdravila proti sladkorni bolezni) skupaj z dieto in telesno vadbo pri bolnikih, pri katerih bolezen ni zadostno nadzorovana z metforminom in sulfonilsečnino; v kombinaciji z insulinom skupaj z dieto in telesno vadbo pri bolnikih, pri katerih bolezen ni zadostno nadzorovana z insulinom v ustaljenem odmerku in metforminom.
in combination with a sulphonylurea (another type of antidiabetes medicine) in patients who are not satisfactorily controlled with a sulphonylurea used on its own and in whom metformin is not suitable; in combination with both metformin and a sulphonylurea or a PPAR-gamma agonist, in patients who are not satisfactorily controlled on the two medicines;
v kombinaciji s sulfonilsečnino (vrsto zdravila proti sladkorni bolezni) pri bolnikih, pri katerih bolezen samo s sulfonilsečnino ni zadovoljivo nadzorovana, metformin pa zanje ni primeren; v kombinaciji z metforminom in sulfonilsečnino ali agonistom PPAR–gama pri bolnikih, pri katerih z obema zdraviloma ni vzpostavljen zadosten nadzor;
in combination with a sulphonylurea (another type of antidiabetes medicine) in patients who are not satisfactorily controlled with a sulphonylurea used on its own and in whom metformin is not suitable; in combination with both metformin, and a sulphonylurea or a PPAR-gamma agonist, in patients who are not satisfactorily controlled on the two medicines;
v kombinaciji s sulfonilsečnino (vrsto zdravila proti sladkorni bolezni) pri bolnikih, pri katerih bolezen samo s sulfonilsečnino ni zadovoljivo nadzorovana, metformin pa zanje ni primeren; v kombinaciji z metforminom in sulfonilsečnino ali agonistom PPAR–gama pri bolnikih, pri katerih z obema zdraviloma ni vzpostavljen zadosten nadzor;
in combination with a sulphonylurea (another type of antidiabetes medicine) in patients who are not satisfactorily controlled with a sulphonylurea used on its own and in whom metformin is not suitable; in combination with both metformin, and a sulphonylurea or a PPAR-gamma agonist, in patients who are not satisfactorily controlled on the two medicines;
v kombinaciji s sulfonilsečnino (vrsto zdravila proti sladkorni bolezni) pri bolnikih, pri katerih bolezen samo s sulfonilsečnino ni zadovoljivo nadzorovana, metformin pa zanje ni primeren; v kombinaciji z metforminom in sulfonilsečnino ali agonistom PPAR–gama pri bolnikih, pri katerih z obema zdraviloma ni vzpostavljen zadosten nadzor; v kombinaciji z insulinom z metforminom ali brez njega, pri bolnikih, pri katerih z ustaljenim odmerkom insulina ni vzpostavljen zadosten nadzor.
in combination with a sulphonylurea (another type of diabetes medicine) in patients who are not satisfactorily controlled with a sulphonylurea used on its own and in whom metformin is not suitable; in combination with both metformin, and a sulphonylurea or a PPAR-gamma agonist, in patients who are not satisfactorily controlled on the two medicines; in combination with insulin, with or without metformin, in patients who are not satisfactorily controlled on a stable dose of insulin.
v kombinaciji s sulfonilsečnino (drugo vrsto zdravila proti sladkorni bolezni) pri bolnikih, katerih nadzor na boleznijo s sulfonilsečnino, uporabljeno samostojno, ni zadosten in za katere zdravljenje z metforminom ni primerno; v kombinaciji z metforminom in sulfonilsečnino ali agonistom PPAR–gama pri bolnikih, pri katerih z obema zdraviloma ni vzpostavljen zadosten nadzor;