natgillin/translations-raw huggingface dataset:
Gemfibrozil, clarithromycin, itraconazole, ketokonazole, trimethoprim, ciclosporin, other antidiabetic agents, monoamine oxidase inhibitors (MAOI), non selective beta blocking agents, angiotensin converting enzyme (ACE)-inhibitors, salicylates, NSAIDs, octreotide, alcohol, and anabolic steroids.
Naslednje snovi lahko povečajo in/ ali podaljšajo hipoglikemični učinek repaglinida: gemfibrozil, klaritromicin, itrakonazol, ketokonazol, trimetoprim, ciklosporin, drugi antidiabetiki, zaviralci monoaminooksidaze (MAOI), neselektivni zaviralci beta, zaviralci angiotenzinske konvertaze (ACE), salicilati, nesteroidna protivnetna zdravila, oktreotid, alkohol in anabolni steroidi.
Co-administration of gemfibrozil, (600 mg twice daily), an inhibitor of CYP2C8, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC 8.1-fold and Cmax 2.4-fold in healthy volunteers.
Sočasna uporaba gemfibrozila (600 mg dvakrat dnevno), zaviralca CYP2C8, in repaglinida (enkratni odmerek 0, 25 mg), je pri zdravih prostovoljcih zvečala AUC repaglinida za 8, 1- krat in Cmax za 2, 4 - krat.
Half-life was prolonged from 1.3 hr to 3.7 hr, resulting in possibly enhanced and prolonged blood glucose-lowering effect of repaglinide, and plasma repaglinide concentration at 7 hr was increased 28.6-fold by gemfibrozil.
Z gemfibrozilom se je razpolovni čas podaljšal z 1, 3 na 3, 7 ure, kar bi lahko povečalo in podaljšalo učinek repaglinida na zniževanje glukoze v krvi, koncentracija repaglinida v plazmi po 7 urah pa je bila 28, 6- krat večja.
The concomitant use of gemfibrozil and repaglinide is contraindicated (see section 4.3).
Sočasna uporaba gemfibrozila in repaglinida je kontraindicirana (glejte poglavje 4. 3).
4 repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC, Cmax and t½ (1.6-fold, 1.4-fold and 1.2-fold respectively) with no statistically significant effects on the blood glucose levels.
4 Sočasna aplikacija trimetoprima (160 mg dvakrat dnevno), srednje močnega zaviralca CYP2C8, in repaglinida (v enkratnem odmerku 0, 25 mg) je povečala AUC, Cmax in t1/ 2 repaglinida (1, 6- krat, 1, 4 - krat in 1, 2- krat) brez statistično pomembnega učinka na vrednosti krvne glukoze.
Since the safety profile of this combination has not been established with dosages higher than 0.25 mg for repaglinide and 320 mg for trimethoprim, the concomitant use of trimethoprim with repaglinide should be avoided.
Ker varnostni profil te kombinacije zdravil še ni bil ugotovljen za odmerke višje od 0, 25 mg za repaglinid in 320 mg za trimetoprim, se je potrebno sočasni uporabi trimetoprima in repaglinida izogibati.
If concomitant use is necessary, careful monitoring of blood glucose and close clinical monitoring should be performed (see section 4.4).
Če je sočasna uporaba obeh zdravil nujna, je potrebno pazljivo spremljati vrednosti krvne glukoze in bolnika natančno klinično spremljati (glejte poglavje 4. 4).
Rifampicin, a potent inducer of CYP3A4, but also CYP2C8, acts both as an inducer and inhibitor of the metabolism of repaglinide.
Rifampicin, močan induktor CYP3A4, pa tudi CYP2C8, deluje kot induktor in inhibitor metabolizma repaglinida.
Seven days pre-treatment with rifampicin (600 mg), followed by co- administration of repaglinide (a single dose of 4 mg) at day seven resulted in a 50% lower AUC (effect of a combined induction and inhibition).
Pri sedemdnevnem pred- zdravljenju z rifampicinom (600 mg) in sledečemu dodatku repaglinida (v enkratnem odmerku 4 mg) sedmi dan, se je AUC znižala za 50% (učinek kombinacije indukcije in inhibicije).
When repaglinide was given 24 hours after the last rifampicin dose, an 80% reduction of the repaglinide AUC was observed (effect of induction alone). Concomitant use of rifampicin and repaglinide might therefore induce a need for repaglinide dose adjustment which should be based on carefully monitored blood glucose concentrations at both initiation of rifampicin treatment (acute inhibition), following dosing (mixed inhibition and induction), withdrawal (induction alone) and up to approximately two weeks after withdrawal of rifampicin where the inductive effect of rifampicin is no longer present.
Zaradi sočasne uporabe rifampicina in repaglinida lahko torej pride do potrebe po prilagajanju odmerka repaglinida, ki bi moralo temeljiti na pazljivem spremljanju vrednosti krvne glukoze tako ob uvedbi zdravljenja z rifampicinom (akutna inhibicija), ob nadaljnjem odmerjanju (mešana inhibicija in indukcija) kot tudi ob ukinitvi (samo indukcija) in še do približno dva tedna po ukinitvi rifampicina, ko indukcijskega učinka rifampicina ni več.
It can not be excluded that other inducers, e. g. phenytoin, carbamazepine, phenobarbital, St John’ s wort, may have a similar effect.
Ni mogoče izključiti, da imajo podoben učinek tudi drugi induktorji, kot so fenitoin, karbamazepin, fenobarbital in šentjanževka.
Co-administration of 200 mg ketoconazole increased the repaglinide (AUC and Cmax) by 1.2-fold with profiles of blood glucose concentrations altered by less than 8% when administered concomitantly (a single dose of 4 mg repaglinide).
Sočasna uporaba 200 mg ketokonazola je povečala AUC in Cmax repaglinida 1, 2- krat ob manj kot 8% spremenjenih profilih koncentracije krvne glukoze, če sta bila aplicirana hkrati (repaglinid v enkratnem odmerku 4 mg).
Co-administration of 100 mg itraconazole, an inhibitor of CYP3A4, has also been studied in healthy volunteers, and increased the AUC by 1.4-fold.
Pri zdravih prostovoljcih so raziskali tudi sočasno uporabo 100 mg itrakonazola, inhibitor CYP3A4; AUC je zvečal za 1, 4- krat.
In an interaction study in healthy volunteers, co-administration of 250 mg clarithromycin, a potent mechanism-based inhibitor of CYP3A4, slightly increased the repaglinide (AUC) by 1.4-fold and Cmax by 1.7-fold and increased the mean incremental AUC of serum insulin by 1.5-fold and the maximum concentration by 1.6-fold.
V študiji interakcij zdravih prostovoljcev je sočasna uporaba 250 mg klaritromicina, ki močno zavira encimski mehanizem CYP3A4, AUC repaglinida nekoliko zvečala za 1, 4- krat in Cmax za 1, 7- krat, povprečno inkrementalno AUC insulina v serumu za 1, 5- krat in največjo koncentracijo za 1, 6- krat.
In a study conducted in healthy volunteers, the concomitant administration of repaglinide (a single dose of 0.25 mg) and ciclosporin (repeated dose at 100 mg) increased repaglinide AUC and Cmax about 2.5-fold and 1.8-fold respectively.
V študiji pri zdravih prostovoljcih se je pri sočasni uporabi repaglinida (enkratni odmerek po 0, 25 mg) in ciklosporina (večkratni odmerki po 100 mg) AUC repaglinida zvečala za približno 2, 5- krat in njegova Cmax za približno 1, 8- krat.
Since the interaction has not been established with dosages higher than 0.25 mg for repaglinide, the concomitant use of ciclosporin with repaglinide should be avoided.
Ker to medsebojno delovanje ni ovrednoteno pri odmerkih, večjih od 0, 25 mg repaglinida, se je treba sočasni uporabi ciklosporina in repaglinida izogibati.
If the combination appears necessary, careful clinical and blood glucose monitoring should be performed (see section 4.4).
Če pa je uporaba te kombinacije nujna, sta potrebna natančen klinični nadzor in kontrola glukoze v krvi (glejte poglavje 4. 4).
β -blocking agents may mask the symptoms of hypoglycaemia.
Zaviralci β lahko prikrijejo simptome hipoglikemije.
Repaglinide had no clinically relevant effect on the pharmacokinetic properties of digoxin, theophylline or warfarin at steady state, when administered to healthy volunteers.
Repaglinid pri zdravih prostovoljcih ni klinično pomembno vplival na farmakokinetične lastnosti digoksina, teofilina ali varfarina v dinamičnem stanju ravnovesja.
Oral contraceptives, rifampicin, barbiturates, carbamazepine, thiazides, corticosteroids, danazol, thyroid hormones and sympathomimetics.
Naslednje snovi lahko zmanjšajo hipoglikemični učinek repaglinida: peroralni kontraceptivi, tiazidi, kortikosteroidi, danazol, ščitnični hormoni in simpatikomimetiki.
When these medications are administered to or withdrawn from a patient receiving repaglinide, the patient should be observed closely for changes in glycaemic control.
Ob uvedbi ali ukinitvi teh zdravil pri bolniku, ki jemlje repaglinid, je treba bolnika natančno spremljati, da bi odkrili spremembe v urejenosti glikemije.
When repaglinide is used together with other drugs that are mainly secreted by the bile, like repaglinide, any potential interaction should be considered.
Če se repaglinid uporablja z drugimi zdravili, ki se izločajo predvsem v žolču, tako kot repaglinid, je treba upoštevati morebitne interakcije.
5 4.6 Pregnancy and lactation
5 4. 6 Nosečnost in dojenje
There are no studies of repaglinide in pregnant or lactating women.
Študij o uporabi repaglinida pri nosečnicah ali doječih materah ni.
Therefore the safety of repaglinide in pregnant women cannot be assessed.
Zato varnosti repaglinida pri nosečnicah ni mogoče oceniti.
Up to now repaglinide showed not to be teratogenic in animal studies.
Doslej se repaglinid v študijah na živalih ni izkazal za teratogenega.
Embryotoxicity, abnormal limb development in foetuses and new born pups, was observed in rats exposed to high doses in the last stage of pregnancy and during the lactation period.
Pri podganah, ki so bile v zadnjem obdobju brejosti in med dojenjem izpostavljene velikim odmerkom, so opažali embriotoksične učinke in nenormalen razvoj udov pri plodovih in novoskotenih mladičih.
Repaglinide is detected in the milk of experimental animals.
Pri poskusnih živalih so repaglinid našli v mleku.
For that reason repaglinide should be avoided during pregnancy and should not be used in lactating women.
Zato se je treba repaglinidu med nosečnostjo izogibati, doječe ženske pa ga ne smejo uporabljati.
Common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000); not known (cannot be estimated from the available data).
Na podlagi izkušenj z repaglinidom in drugimi antidiabetiki so bili ugotovljeni naslednji neželeni učinki: opredelitev pogostnosti je: pogosto (≥ 1/ 100 do < 1/ 10); občasno (≥ 1/ 1, 000 do < 1/ 100); redko (≥ 1/ 10, 000 do < 1/ 1, 000); zelo redko (< 1/ 10, 000); ni znano (iz obstoječih podatkov ocena ni bila možna)
Allergy Generalised hypersensitivity reactions (e. g. anaphylactic reaction), or immunological reactions such as vasculitis.
Bolezni imunskega sistema Zelo redko: alergija Generalizirane preobčutljivostne reakcije (npr. anafilaktična reakcija) ali imunološke reakcije, npr. vaskulitis.
Hypoglycaemic coma and hypoglycaemic unconsciousness As with other hypoglycaemic agents, hypoglycaemic reactions have been observed after administration of repaglinide.
Presnovne in prehranske motnje Pogosto: hipoglikemija Ni znano: hipoglikemična koma in hipoglikemična nezavest Tako kot pri drugih antidiabetikih so tudi po uporabi repaglinida opažali hipoglikemične reakcije.
These reactions are mostly mild and easily handled through intake of carbohydrates.
Te reakcije so večinoma blage in jih je mogoče obvladati z zaužitjem ogljikovih hidratov.
If severe, requiring third party assistance, infusion of glucose may be necessary.
Če so hude (potrebna pomoč druge osebe), utegne biti potrebna infuzija glukoze.
The occurrence of such reactions depends, as for every diabetes therapy, on individual factors, such as dietary habits, dosage, exercise and stress (see section 4.4).
Pojav takšnih reakcij je, tako kot pri vsakem zdravilu za diabetes, odvisen od individualnih dejavnikov, npr. prehranskih navad, odmerka, telesne dejavnosti in stresa (glejte poglavje 4. 4).
Interactions with other medicinal products may increase the risk of hypoglycaemia (see section 4.5).
Medsebojno delovanje z drugimi zdravili lahko poveča tveganje za pojav hipoglikemije (glejte poglavje 4. 5).
During post marketing experience, cases of hypoglycaemia have been reported in patients treated with repaglinide in combination with metformin or thiazolidinedione.
Med pomarketinško uporabo so bili opisani primeri hipoglikemije pri bolnikih, ki so dobivali repaglinid v kombinaciji z metforminom ali tiazolidindionom.
Nausea Gastro-intestinal complaints such as abdominal pain, diarrhoea, nausea, vomiting and constipation have been reported in clinical trials.
Bolezni prebavil Pogosto: bolečine v trebuhu in diareja Zelo redko: bruhanje in zaprtje Ni znano: navzea V kliničnih preskušanjih so poročali o prebavnih težavah, npr. bolečinah v trebuhu, driski, navzeji, bruhanju in zaprtju.
The rate and severity of these symptoms did not differ from that seen with other oral insulin secretagogues.
Pogostnost in izrazitost teh simptomov se nista razlikovali od njihove pogostnosti in izrazitosti pri drugih peroralnih sekretagogih insulina.
Hypersensitivity Hypersensitivity reactions of the skin may occur as erythema, itching, rashes and urticaria.
Bolezni kože in podkožja Ni znano: preobčutljivost Preobčutljivostne kožne reakcije se lahko pojavijo kot eritem, srbenje, izpuščaj ali urtikarija.
There is no reason to suspect cross-allergenicity with sulphonylurea drugs due to the difference of the chemical structure.
Navzkrižne alergenosti z derivati sulfonilsečnine zaradi različne kemične zgradbe ni pričakovati.
Visual disturbances
Po začetku zdravljenja z repaglinidom so o takšnih motnjah poročali le v zelo
6 Changes in blood glucose levels have been known to result in transient visual disturbances, especially at the commencement of treatment.
6 redkih primerih.
Such disturbances have only been reported in very few cases after initiation of repaglinide treatment.
V kliničnih preskušanjih ni bilo treba v nobenem od teh primerov prekiniti zdravljenja z repaglinidom.
Cardiovascular disease Type 2 diabetes is associated with an increased risk for cardiovascular disease.
Srčne bolezni Redki: kardiovaskularne bolezni Diabetes tipa 2 je povezan z večjim tveganjem za kardiovaskularne bolezni.
However, the causality of the relationship remains uncertain (see sections 4.4 and 5.1).
V eni epidemiološki študiji so v skupini z repaglinidom zabeležili večjo pogostnost akutnega koronarnega sindroma, vendar vzročne povezanosti niso ugotovili (glejte poglavji 4. 4 in 5. 1).
However, a causal relationship with repaglinide has not been established.
Bolezni jeter, žolčnika in žolčevodov Zelo redki: nenormalno delovanje jeter V zelo redkih primerih je bilo opisano hudo moteno delovanje jeter, a vzročne povezanosti z repaglinidom niso ugotovili.
Increased liver enzymes Isolated cases of increase in liver enzymes have been reported during treatment with repaglinide.
Zelo redko: zvišanje jetrnih encimov Med zdravljenjem z repaglinidom so poročali o posameznih primerih zvišanja jetrnih encimov.
Most cases were mild and transient, and very few patients discontinued treatment due to increase in liver enzymes.
Večinoma je bilo zvišanje blago in prehodno; zelo malo bolnikov je moralo zaradi njega prekiniti zdravljenje.
Repaglinide has been given with weekly escalating doses from 4 - 20 mg four times daily in a 6 week period.
Repaglinid so dajali v tedensko naraščajočih odmerkih od 4 do 20 mg štirikrat na dan 6 tednov.
More severe hypoglycaemia with seizure, loss of consciousness or coma should be treated with IV glucose.
Hujšo hipoglikemijo s konvulzijami, izgubo zavesti ali komo je treba zdraviti z intravensko glukozo.
Carbamoylmethyl benzoic acid derivative, ATC code:
Farmakoterapevtska skupina: derivat karbamoilmetilbenzojeve kisline, oznaka ATC:
Repaglinide is a novel short-acting oral secretagogue.
Repaglinid je nov kratkodelujoči peroralni sekretagog.
Repaglinide lowers the blood glucose levels acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning β -cells in the pancreatic islets.
Koncentracijo glukoze v krvi hitro zmanjša tako, da stimulira sproščanje insulina iz trebušne slinavke; ta učinek je odvisen od obstoja delujočih celic β v pankreatičnih otočkih.
Repaglinide closes ATP-dependent potassium channels in the β -cell membrane via a target protein different from other secretagogues.
Repaglinid v membrani celic β zapre od ATP- odvisne kalijeve kanale, in sicer prek tarčne beljakovine, ki je druga kot pri ostalih sekretagogih.
This depolarises the β -cell and leads to an opening of the calcium channels.
To depolarizira celico β in povzroči odprtje kalcijevih kanalov.
The resulting increased calcium influx induces insulin secretion from the β -cell.
Vtok kalcija se zato zveča in to sproži izločanje insulina celice β.
In type 2 diabetic patients, the insulinotropic response to a meal occurred within 30 minutes after an oral dose of repaglinide.
Pri bolnikih z diabetesom tipa 2 se je insulinotropni odziv na obrok pojavil v 30 minutah po peroralnem odmerku repaglinida.
Plasma repaglinide levels decreased rapidly, and low drug concentrations were seen in the plasma of type 2 diabetic patients 4 hours post-administration.
Koncentracija repaglinida v plazmi se hitro zmanjša in nizko koncentracijo zdravila so v plazmi bolnikov z diabetesom tipa 2 ugotovili 4 ure po uporabi.
A dose-dependent decrease in blood glucose was demonstrated in type 2 diabetic patients when administered in doses from 0.5 to 4 mg repaglinide.
Pri bolnikih z diabetesom tipa 2 so med uporabo odmerkov od 0, 5 do 4 mg repaglinida dokazali od odmerka odvisno znižanje glukoze v krvi.
7 treated patients as compared to sulfonylurea treated patients (see sections 4.4 and 4.8).
Ena epidemiološka študija je nakazala večje tveganje za akutni koronarni sindrom pri bolnikih, zdravljenih z repaglinidom, v primerjavi z bolniki, zdravljenimi z derivati sulfonilsečnine (glejte poglavji 4. 4 in 4. 8).
Repaglinide is rapidly absorbed from the gastrointestinal tract, which leads to a rapid increase in the plasma concentration of the drug.
Repaglinid se hitro absorbira iz prebavil, zato se njegova koncentracija v plazmi hitro zveča.
After reaching a maximum, the plasma level decreases rapidly, and repaglinide is eliminated within 4 - 6 hours.
Potem, ko doseže največjo vrednost, se plazemska koncentracija hitro zmanjša in repaglinid se eliminira v 4 do 6 urah.
The plasma elimination half-life is approximately one hour.
Razpolovni čas plazemske eliminacije je približno ena ura.
Repaglinide pharmacokinetics are characterised by a mean absolute bioavailability of 63% (CV 11%), low volume of distribution, 30 L (consistent with distribution into intracellular fluid), and rapid elimination from the blood.
Za farmakokinetiko repaglinida so značilni 63% povprečna absolutna biološka uporabnost (CV 11%), majhen volumen porazdelitve 30 l (skladen s porazdelitvijo v znotrajcelični tekočini) in hitra eliminacija iz krvi.
A high interindividual variability (60%) in repaglinide plasma concentrations has been detected in the clinical trials.
V kliničnih preskušanjih so ugotovili veliko (60%) interindividualno variabilnost koncentracije repaglinida v plazmi.
Intraindividual variability is low to moderate (35%) and as repaglinide should be titrated against the clinical response, efficacy is not affected by interindividual variability.
Intraindividualna variabilnost je majhna do zmerna (35%); ker je odmerek repaglinida treba prilagajati kliničnemu odzivu, interindividualna variabilnost ne vpliva na učinkovitost.
Repaglinide exposure is increased in patients with hepatic insufficiency and in the elderly type 2 diabetic patients.
Izpostavljenost repaglinidu je zvečana pri bolnikih z insuficienco jeter in starejših bolnikih z diabetesom tipa 2.
The AUC (SD) after 2 mg single dose exposure (4 mg in patients with hepatic insufficiency) was 31.4 ng/ ml x hr (28.3) in healthy volunteers, 304.9 ng/ ml x hr (228.0) in patients with hepatic insufficiency, and 117.9 ng/ ml x hr (83.8) in the elderly type 2 diabetic patients.
AUC (SD) po posamičnem odmerku 2 mg (4 mg pri bolnikih z insuficienco jeter) je bila 31, 4 ng/ ml x ura (28, 3) pri zdravih prostovoljcih, 304, 9 ng/ ml x ura (228, 0) pri bolnikih z insuficienco jeter in 117, 9 ng/ ml x ura (83, 8) pri starejših bolnikih z diabetesom tipa 2.
After a 5 day treatment of repaglinide (2 mg x 3/ day) in patients with a severe impaired renal function (creatinine clearance:
Pri bolnikih s hudo okvaro delovanja ledvic (očistek kreatinina:
20-39 ml/ min.), the results showed a significant 2-fold increase of the exposure (AUC) and half-life (t1/ 2) as compared to subjects with normal renal function.
20– 39 ml/ min) so rezultati po 5 - dnevnem zdravljenju z repaglinidom (2 mg 3- krat na dan) pokazali pomembno 2- kratno zvečanje izpostavljenosti (AUC) in razpolovnega časa (t1/ 2) v primerjavi s preiskovanci z normalnim delovanjem ledvic.
Repaglinide is highly bound to plasma proteins in humans (greater than 98%).
Pri ljudeh se repaglinid izrazito veže na beljakovine v plazmi (več kot 98%).
No clinically relevant differences were seen in the pharmacokinetics of repaglinide, when repaglinide was administered 0, 15 or 30 minutes before a meal or in fasting state.
V farmakokinetiki repaglinida niso opažali klinično pomembnih razlik, če je bil uporabljen 0, 15 ali 30 minut pred obrokom ali na tešče.
Repaglinide is almost completely metabolised, and no metabolites with clinically relevant hypoglycaemic effect have been identified.
Repaglinid se skoraj popolnoma presnovi; ugotovili niso nobenih presnovkov s klinično pomembnim hipoglikemičnim delovanjem.
Repaglinide and its metabolites are excreted primarily via the bile.
Repaglinid in njegovi presnovki se pretežno izločajo v žolču.
A small fraction (less than 8%) of the administered dose appears in the urine, primarily as metabolites.
Majhen delež (manj kot 8%) uporabljenega odmerka se izloči v urinu, predvsem v obliki presnovkov.
Less than 1% of the parent drug is recovered in faeces.
Manj kot 1% matičnega zdravila je mogoče najti v blatu.
Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Maize starch Amberlite (polacrilin potassium) Povidone (polyvidone) Glycerol 85% Magnesium stearate Meglumine Poloxamer
mikrokristalna celuloza (E460) brezvodni kalcijev hidrogenfosfat koruzni škrob amberlit (polakrilin kalij) povidon (polividon) glicerol, 85 odstotni magnezijev stearat meglumin poloksamer
8 6.3 Shelf life
8 Navedba smiselno ni potrebna.
The blister pack (aluminium/ aluminium) contains 30, 90, 120 or 270 tablets, respectively.
Pretisni omot (aluminij/ aluminij) vsebuje 30, 90, 120 ali 270 tablet.
17 August 1998 Date of last renewal:
17. avgust 1998 Datum zadnjega podaljšanja dovoljenja za promet:
Repaglinide tablets are yellow, round and convex and engraved with Novo Nordisk logo (Apis bull).
Tablete repaglinida so rumene, okrogle, izbočene in imajo vrezan logo družbe Novo Nordisk (bika Apisa).
Repaglinide is also indicated in combination with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Repaglinid je indiciran tudi v kombinaciji z metforminom pri bolnikih z diabetesom mellitusom tipa 2, ki niso zadovoljivo urejeni samo z metforminom.
In the case of concomitant use with other active substances refer to sections 4.4 and 4.5 to assess dosage.
V primeru sočasne uporabe z drugimi zdravilnimi učinkovinami glejte poglavji 4. 4 in 4. 5 za oceno odmerjanja.
10 1 mg.
10 Če bolnik preide na repaglinid z drugega peroralnega antidiabetika, je priporočeni začetni odmerek repaglinida 1 mg.
11 performed.
11 Preskušanj, ki bi proučila kombinacijo z drugimi sekretagogi insulina in z akarbozo, ni bilo.
Co-administration of gemfibrozil (600 mg twice daily), an inhibitor of CYP2C8, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC 8.1-fold and Cmax 2.4-fold in healthy volunteers.
Sočasna uporaba gemfibrozila (600 mg dvakrat dnevno), zaviralca CYP2C8, in repaglinida (enkratni odmerek 0, 25 mg), je pri zdravih prostovoljcih zvečala AUC repaglinida za 8, 1- krat in Cmax za 2, 4 - krat.