natgillin/translations-raw huggingface dataset:
Protein C slows down the production of thrombin, and therefore slows down clotting.
Protein C usporava stvaranje trombina, i stoga usporava grušanje krvi.
An injection of Ceprotin produces an immediate but temporary increase in levels of protein C, controlling clotting problems in protein C-deficient patients.
Injekcija lijeka Ceprotin stvara neposredno, no privremeno povećanje u koncentraciji proteina C, kontrolirajući probleme s grušanjem u bolesnika s deficijencijom proteina C.
What is happening with Ceprotin for the treatment of patients with severe congenital protein C deficiency?
Što se događa s lijekom Ceprotin za liječenje bolesnika s ozbiljnom deficijencijom kongenitalnog proteina C?
How is Ceprotin expected to work?
Kako je Ceprotin trebao djelovati?
Ceprotin is a medicine that is used to treat patients with severe congenital (hereditary) protein C deficiency and for the short-term prevention of blood clotting in patients with severe congenital protein C deficiency.
Ceprotin je lijek koji se koristi za liječenje bolesnika s ozbiljnom kongenijalnom (nasljednom) deficijencijom proteina C is toga za kratkoročnu prevenciju grušanja krvi u bolesnika s ozbiljnom kongenijalnom deficijencijom proteina C.
‘Acquired' means that the disease is not inherited but develops during the patient's life and may occur for different reasons such as severe infection, liver disease or vitamin K deficiency.
Ceprotin se trebao koristiti u bolesnika sa „stečenom“ deficijencijom proteina C. „Stečeno“ označava da bolest nije nasljedna, već da se razvila tijekom života bolesnika i može nastupiti uslijed različitih uzroka, poput ozbiljne infekcije, bolesti jetre ili deficijencije vitamina K.
Ceprotin contains the active substance human protein C. It has been authorised in the EU since July
Odobren je na razini EU-a od srpnja 2001.
Pack size syringes (multipack)
6 (3 x 2) napunjenih brizgalica (višestruko pakiranje)
Immediate Packaging
Vel i čina pakovanja
1 pre-filled pen pens (multipack)
1 napunjena brizgalica
<Content (concentration)>
<Sastav (koncentracija)>
(Invented) name Strength Pharmaceutical form
Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik
Your body's response to Repaglinide Accord may change if you take other medicines, especially these:
Reakcija tijela na Repaglinid Accord može se promijeniti ako uzimate druge lijekove, posebice ove:
• If you are about to have major surgery or you have recently suffered a severe illness or infection.
• Ako se spremate na veći operativni zahvat ili ste nedavno preboljeli tešku bolest ili infekciju.
Manufacturer Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow,
Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow,
• If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death.
• Ako se teška hipoglikemija ne liječi, ona može uzrokovati oštećenje mozga (privremeno ili trajno) pa čak i smrt.
Debilitated or malnourished patients
Oslabljeni ili pothranjenih bolesnici
Be aware that the desired effect is not achieved if you stop taking Repaglinide Accord.
Imajte na umu da željeni učinak nije postignut ako prestanete uzimati Repaglinid Accord.
Date of latest renewal: 19th September 2016
Datum prvog odobrenja: 22. prosinac 2011. godine Datum posljednje obnove: 19. rujan 2016
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se neće razviti kod svakoga.
Repaglinide Accord may not be suitable for you.
Repaglinid Accord Vam možda neće odgovarati.
In case a Risk Management Plan is submitted to any regulatory authority the MAH must inform the Rapporteur.
U slučaju da je Plan upravljanja rizicima predan bilo kojem regulatornom tijelu, nositelj odobrenja mora o tome obavijestiti izvjestitelja.
Do not take more Repaglinide Accord than your doctor has recommended.
Nemojte uzeti više lijeka Repaglinid Accord nego što Vam je preporučio liječnik.
If you miss a dose, take the next dose as usual - do not double the dose.
Ako ste zaboravili uzeti Repaglinid Accord Ako zaboravite uzeti dozu, uzmite sljedeću dozu kao obično - nemojte uzeti dvostruku dozu.
You should not take Repaglinide Accord if you are pregnant or you are planning to become pregnant.
Ne smijete uzimati Repaglinid Accord ako ste trudni ili planirate trudnoću.
Repaglinide Accord with alcohol
Repaglinid Accord s alkoholom
• If you take other medicines or suffer from liver or kidney problems (see other sections of 2.
• ako uzimate druge lijekove ili imate problema s jetrom ili bubrezima (pogledajte ostale odjeljke dijela 2.
What Repaglinide Accord is and what it is used for
Što je Repaglinid Accord i za što se koristi
30 tablets 90 tablets 120 tablets 180 tablets 270 tablets
30 tableta 90 tableta 120 tableta 180 tableta 270 tableta
Diabetes mellitus type 1, C-peptide negative.
• Šećerna bolest tipa 1, C-peptid negativan.
Middlesex, HA1 4HF United Kingdom
Middlesex, HA1 4HF
• If you are allergic to repaglinide or any of the other ingredients in this medicine (listed in section
• ako ste alergični na repaglinid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
100 tablets in a HDPE bottle.
100 tableta u HDPE bočici.
What Repaglinide Accord is and what it is used for What you need to know before you take Repaglinide Accord How to take Repaglinide Accord Possible side effects
Što je Repaglinid Accord i za što se koristi Što morate znati prije nego počnete uzimati Repaglinid Accord Kako uzimati Repaglinid Accord Moguće nuspojave
The most frequent side effect is hypoglycaemia which may affect up to 1 in 10 patients (see If you get a hypo in section 2).
Najčešća nuspojava je hipoglikemija koja se može javiti u manje od 1 na 10 bolesnika (pogledajte dio Ako dobijete hipoglikemiju u dijelu 2).
If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take Repaglinide Accord.
Ako uzimate gemfibrozil (koristi se za snižavanje povišene razine masnoća u krvi) ne smijete uzimati Repaglinid Accord.
Repaglinide has been given with weekly escalating doses from 4 - 20 mg four times daily in a 6 week period.
Repaglinid je primjenjivan u tjedno povećavanim dozama od 4 do 20 mg četiri puta dnevno u razdoblju od 6 tjedana.
Other medicines and Repaglinide Accord
Drugi lijekovi i Repaglinid Accord
How to store Repaglinide Accord Contents of the pack and other information
Kako čuvati Repaglinid Accord Sadržaj pakovanja i druge informacije
If you take more Repaglinide Accord than you should
Ako uzmete više lijeka Repaglinid Accord nego što ste trebali
Vomiting, constipation
Povraćanje, opstipacija
Based on the experience with repaglinide and with other hypoglycaemic medicinal products the following adverse reactions have been seen: Frequencies are defined as: 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) and not known (cannot be estimated from the available data).
Učestalost je definirana kao: često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti na temelju dostupnih podataka).
Alcohol can change the ability of Repaglinide Accord to reduce the blood sugar.
Alkohol može izmijeniti učinkovitost lijeka Repaglinid Accord u snižavanju razine šećera u krvi.
Immune system disorders Allergic reactions*
Poremećaji imunološkog sustava Alergijske reakcije*
This phenomenon is known as secondary failure, to distinguish it from primary failure, where the medicinal product is ineffective in an individual patient when first given.
Ta pojava se naziva sekundarno zatajivanje, za razliku od primarnoga zatajivanja kada su lijekovi u pojedinih bolesnika neučinkoviti već pri prvoj primjeni.
What Repaglinide Accord contains
Što Repaglinid Accord sadrži
Symptoms such as swelling, difficulty in breathing, rapid heartbeat, feeling dizzy and sweating could be signs of anaphylactic reaction.
Simptomi kao što su oticanje, poteškoće s disanjem, ubrzani otkucaji srca, omaglica i znojenje mogu biti znakovi anafilaktičke reakcije.
• Deferasirox (used to reduce chronic iron overload)
• deferasiroks (koristi se za snižavanje kroničnog preopterećenja željezom)
Risk Management Plan (RMP)
• Plan upravljanja rizikom (RMP) Nije primjenjivo.
4.4 Special warnings and precautions for use General
4.4 Posebna upozorenja i mjere opreza pri uporabi
The total maximum daily dose should not exceed 16 mg. Special populations
Ukupna maksimalna dnevna doza ne smije biti veća od 16 mg.
Do not use Repaglinide Accord after the expiry date which is stated on the carton bottle label and blister after “EXP”.
Repaglinid Accord se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kartonskom pakovanju bočice i blisteru iza oznake ‘Rok valjanosti'.
This medicinal product does not require any special storage conditions.
Ovaj medicinski proizvod ne zahtijeva posebne uvjete čuvanja.
The active substance is repaglinide.
Djelatna tvar je repaglinid.
What you need to know before you take Repaglinide Accord).
Što morate znati prije nego počnete uzimati Repaglinid Accord).
4.7 Effects on ability to drive and use machines Repaglinide Accord has no direct influence on the ability to drive and use machines but may cause hypoglycaemia.
Repaglinid Accord nema izravnog učinka na sposobnost upravljanja vozilima i rada na strojevima, ali može uzrokovati hipoglikemiju.
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.
Istodobna primjena rifampicina i repaglinida stoga može zahtijevati prilagodbu doze repaglinida, što treba činiti na osnovi pomnog praćenja koncentracije glukoze u krvi pri uvođenju terapije rifampicinom (akutna inhibicija), pri daljnjem doziranju (miješano indukcija i inhibicija), pri prestanku terapije (indukcija) te do približno dva tjedna nakon prestanka uzimanja rifampicina kada inducirajući učinak rifampicina više nije prisutan.
When symptoms of hypoglycaemia have disappeared or when blood sugar levels are stabilised continue Repaglinide Accord treatment.
Kad simptomi hipoglikemije nestanu ili Vam se stabilizira razina šećera u krvi, nastavite terapiju lijekom Repaglinid Accord.
• Clopidogrel (prevents blood clots)
• klopidogrel (sprječava zgrušavanje krvi)
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Znakovi koji upozoravaju na hipoglikemiju mogu nastupiti iznenada i mogu obuhvaćati: hladan znoj, hladnu blijedu kožu, glavobolju, ubrzane otkucaje srca, mučninu, osjećaj jake gladi, privremene promjene vida, pospanost, neuobičajen umor i slabost, nervozu ili nevoljno drhtanje, osjećaj tjeskobe, osjećaj smetenosti, poteškoće s koncentracijom.
Please see If you get a hypo on what a hypo is and how to treat it.
Molimo pogledajte dio Ako dobijete hipoglikemiju kako biste znali što je hipoglikemija i kako se liječi.
The amount of Repaglinide Accord, food or exercise may need to be adjusted.
Možda će biti potrebno uskladiti dozu lijeka Repaglinid Accord, hranu ili tjelovježbu.
North Harrow, Middx HA1 4HF United Kingdom
319 Pinner Road North Harrow, Middx HA1 4HF Velika Britanija
CONDITIONS OR RESTRICTIONS WITH REGARDS TO SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
The following substances may enhance and/or prolong the hypoglycaemic effect of repaglinide: Gemfibrozil, clarithromycin, itraconazole, ketoconazole, trimethoprim, ciclosporin, deferasirox, clopidogrel, other antidiabetic substances, monoamine oxidase inhibitors (MAOI), non selective beta blocking substances, angiotensin converting enzyme (ACE)-inhibitors, salicylates, NSAIDs, octreotide, alcohol, and anabolic steroids.
Sljedeće tvari mogu pojačati i/ili produljiti hipoglikemijski učinak repaglinida: gemfibrozil, klaritromicin, itrakonazol, ketokonazol, trimetoprim, ciklosporin, deferasiroks, klopidogrel, drugi oralni antidijabetici, inhibitori monoamino oksidaze (MAO inhibitori), neselektivni beta-blokatori, inhibitori angiotenzin konvertirajućeg enzima (ACE inhibitori), salicilati, NSAIL, oktreotid, alkohol i anabolički steroidi.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Time se omogućuje kontinuirani praćenje omjera koristi i rizika lijeka.
• Danazol (used to treat breast cysts and endometriosis)
• danazol (koristi se za liječenje cista na dojci i endometrioze)
• Thiazides (diuretics or ‘water pills')
• tiazide (diuretici ili 'lijekovi za izmokravanje')
Allergy is very rare (may affect up to 1 in 10,000 patients).
Alergija se javlja vrlo rijetko (može se javiti u manje od 1 na 10 000 bolesnika).
If you stop taking Repaglinide Accord
Ako prestanete uzimati Repaglinid Accord
Repaglinide is given preprandially and is titrated individually to optimise glycaemic control.
Repaglinid se uzima preprandijalno uz individualnu titraciju doze kako bi se postigla optimalna regulacija glikemije.
Repaglinide is also indicated in combination with metformin in adults with type 2 diabetes mellitus who are not satisfactorily controlled on metformin alone.
Repaglinid je također indiciran u kombinaciji s metforminom u odraslih sa šećernom bolešću tipa 2 koja nije primjereno regulirana samim metforminom.
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).
Prethodna terapija rifampicinom (600 mg) tijekom 7 dana, a potom dodavanje repaglinida (pojedinačna doza od 4 mg) sedmoga je dana rezultirala 50% nižom AUC (učinak je kombinacija indukcije i inhibicije).
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.
Budući da sigurnosni profil ove kombinacije nije utvrđen za doze repaglinida veće od 0,25 mg i 320 mg trimetoprima, istodobnu primjenu trimetoprima s repaglinidom treba izbjegavati.
Patients receiving other oral hypoglycaemic medicinal products
Bolesnici koji uzimaju druge oralne antidijabetike
Repaglinide Accord is an oral antidiabetic medicine containing repaglinide which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose).
Repaglinid Accord je lijek protiv šećerne bolesti za primjenu kroz usta, a sadrži repaglinid koji pomaže gušterači da stvori više inzulina te tako snizi razinu šećera (glukoze) u krvi.
Use of repaglinide in case of secondary failure to insulin secretagogues has not been investigated in clinical trials.
Primjena repaglinida u slučaju sekundarnog zatajivanja lijekova koji potiču lučenje inzulina nije bila ispitivana u kliničkim ispitivanjima.
You can take Repaglinide Accord with metformin, another medicine for diabetes, if your doctor prescribes it.
Repaglinid Accord možete uzimati u kombinaciji s metforminom, drugim lijekom protiv šećerne bolesti, ako ga liječnik propiše.
Repaglinide Accord has been shown to lower the blood sugar, which helps to prevent complications from your diabetes.
Repaglinid Accord snižava razinu šećera u krvi i time pomaže u sprječavanju komplikacija šećerne bolesti.
Repaglinide Accord is available in the following pack sizes: 30, 90, 120, 180 or 270 tablets in blisters
Repaglinid Accord je dostupan u sljedećim veličinama pakovanja: 30, 90, 120, 180 ili 270 tableta u blisterima
When a patient stabilised on any oral hypoglycaemic agent is exposed to stress such as fever, trauma, infection or surgery, a loss of glycaemic control may occur.
Kada je bolesnik, u kojega se stanje stabiliziralo primjenom bilo kojeg oralnog antidijabetika, izložen stresu kao što je vrućica, trauma, infekcija ili operativni zahvat, može doći do poremećaja regulacije glikemije.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 December 2011
DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
No clinical studies have been conducted in patients with hepatic insufficiency.
Nisu provedena klinička ispitivanja u bolesnika s insuficijencijom jetre.
How to take Repaglinide Accord
Kako uzimati Repaglinid Accord
Co-administration of cimetidine, nifedipine, oestrogen, or simvastatin with repaglinide, all CYP3A4 substrates, did not significantly alter the pharmacokinetic parameters of repaglinide.
Istodobna primjena supstrata CYP3A4, kao što su cimetidin, nifedipin, estrogen ili simvastatin, s repaglinidom nije značajno izmijenila farmakokinetičke parametre repaglinida.
• Hypersensitivity (such as rash, itchy skin, redening of the skin, swelling of the skin)
Nepoznata učestalost • preosjetljivost (kao što je osip, svrbež kože, crvenilo kože, oticanje kože)
Aluminium/aluminium blister in packs containing 30, 90, 120, 180 or 270 tablets.
Aluminij/aluminijski blister u pakovanjima koja sadrže 30, 90, 120, 180 ili 270 tableta.
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
• fenitoin, karbamazepin, fenobarbital (koriste se za liječenje epilepsije)
Repaglinide Accord is not recommended in patients with moderate liver disease.
Repaglinid Accord se ne preporučuje u bolesnika koji imaju srednje tešku bolest jetre.
Repaglinide Accord can also be given with metformin, another medicine for diabetes.
Repaglinid Accord se može primjenjivati i u kombinaciji s metforminom, drugim lijekom protiv šećerne bolesti.
• The dose may be adjusted by your doctor by up to 4 mg to be taken immediately before or up to
• Liječnik Vam može povećati dozu do 4 mg koju treba uzeti neposredno prije ili do 30 minuta prije svakog glavnog obroka.
Repaglinide closes ATP-dependent potassium channels in the β-cell membrane via a target protein different from other secretagogues.
Repaglinid zatvara o ATP-u ovisne kalijeve kanale u membrani β-stanica vezanjem za protein koji je različit od proteina na koji se vezuju drugi lijekovi koji potiču lučenje inzulina.
Abnormal hepatic function, increased liver enzymes
Poremećaji funkcije jetre, porast jetrenih enzima
Combination with Neutral Protamine Hagedorn (NPH) insulin or thiazolidinediones Trials of combination therapy with NPH insulin or thiazolidinediones have been performed.
Kombinacija s Neutralnim Protamin Hagedorn (NPH) inzulinom ili tiazolidindionima
HDPE bottle containing 100 tablets in packs of 1 bottle.
Jedna HDPE plastična bočica u pakiranju od 100 tableta.
Patients can be transferred directly from other oral hypoglycaemic medicinal products to repaglinide.
Bolesnici mogu izravno prijeći na repaglinid s nekog drugog oralnog antidijabetika.
PARTICULARS TO APPEAR ONTHE IMMEDIATE PACKAGING HDPE BOTTLE
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU HDPE BOČICA
Isolated cases of increased liver enzymes have been reported during treatment with repaglinide.
Tijekom liječenja repaglinidom zabilježeni su pojedinačni slučajevi porasta jetrenih enzima.
Tablet 100 tablets
120 tableta
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.
U bolesnika sa šećernom bolešću tipa 2, sniženje razine glukoze u krvi ovisno o dozi lijeka potvrđeno je pri dozama repaglinida od 0,5 do 4 mg.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg of repaglinide.
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Svaka tableta sadrži 1 mg repaglinida.
The recommended starting dose is 0.5 mg. One to two weeks should elapse between titration steps (as determined by blood glucose response).
Između svakog koraka titracije doze trebalo bi proći jedan do dva tjedna (na temelju mjerenja razine glukoze u krvi).
• If you take too little Repaglinide Accord
• ako uzmete premalo lijeka Repaglinid Accord
What you need to know before you take Repaglinide Accord Do not take Repaglinide Accord
Što morate znati prije nego počnete uzimati Repaglinid Accord
You should not take Repaglinide Accord if you are breast-feeding.
Ne smijete uzimati Repaglinid Accord ako dojite.
Very rare (may affect up to 1 in 10,000 patients)
Vrlo rijetko (mogu se javiti u manje od 1 na 10 000 bolesnika)
Gastrointestinal disorders Abdominal pain, diarrhoea
Poremećaji probavnog sustava Bol u trbuhu, proljev
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
Repaglinide pharmacokinetics are characterised by low volume of distribution, 30 L (consistent with distribution into intracellular fluid), and is highly bound to plasma proteins in humans (greater than
Farmakokinetika repaglinida karakterizirana je malim volumenom distribucije, 30 l (što je sukladno s distribucijom u unutarstaničnoj tekućini) i u velikom se postotku veže za proteine plazme u ljudi (više od 98%), te se brzo eliminira iz krvi.
• Thyroid products (used to treat low levels of thyroid hormones)
• hormone štitnjače (koriste se za liječenje niske razine hormona štitnjače)
Repaglinide Accord 0.5 mg tablets Repaglinide Accord 1 mg tablets Repaglinide Accord 2 mg tablets Repaglinide
Repaglinid Accord 0,5 mg tablete Repaglinid Accord 1 mg tablete
No clinical studies have been conducted in patients >75 years of age.
Nisu provedena klinička ispitivanja u bolesnika u dobi
Talk to your doctor before taking Repaglinide Accord
Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete Repaglinid Accord:
Your blood sugar may get too high (hyperglycaemia).
Ako razina šećera u krvi postane previsoka Razina šećera u krvi može biti previsoka (hiperglikemija).
Repaglinide, like other insulin secretagogues, is capable of producing hypoglycaemia.
Repaglinid, kao i drugi lijekovi koji potiču lučenje inzulina, može izazvati hipoglikemiju.
Marketing authorisation holder and manufacturer Marketing authorisation holder Accord Healthcare S.L.U.
Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet
• If you take too much Repaglinide Accord
• ako uzmete previše lijeka Repaglinid Accord
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.
Poluvijek je produljen s 1,3 na 3,7 sati, rezultirajući mogućim pojačanim i produljenim učinkom repaglinida na snižavanje razine glukoze u krvi.
In an interaction study with healthy volunteers, co-administration of deferasirox (30 mg/kg/day, 4 days), a moderate inhibitor of CYP2C8 and CYP3A4, and repaglinide (single dose, 0.5 mg) resulted in an increase in repaglinide systemic exposure (AUC) to 2.3-fold (90% CI [2.03-2.63]) of control, a 1.6-fold (90% CI [1.42-1.84])an increase in Cmax of 62%,, and a small, significant decrease in blood glucose values.
U ispitivanju interakcija u zdravih dobrovoljaca, istodobna primjena deferasiroksa (30 mg/kg/dan, 4 dana), slabije umjerenog inhibitora CYP2C8 i CYP3A4 i repaglinida (pojedinačna doza od 0,5 mg) rezultirala je povećanjem sistemske izloženosti repaglinidu (AUC) za 2,3 puta (90% CI [2,03-2,63]) u odnosu na kontrolnu skupinu, povećanjem Cmax za 1,6 puta (90% CI [1,42-1,84]), što je 62%, te malim, ali značajnim sniženjem razine glukoze u krvi.
White to off white, round, biconvex with beveled edge, uncoated tablets, with inscription “R” on one side and plain on other side.
Bijele do bjelkaste, okrugle, bikonveksne, neobložene tablete s ukošenim rubovima, s utisnutom oznakom „R“ na jednoj strani te bez oznaka na drugoj strani.
Repaglinide Accord should not be taken if you have a severe liver disease (see Do not take Repaglinide Accord).
Repaglinid Accord ne smijete uzimati ako imate tešku bolest jetre