natgillin/translations-raw huggingface dataset:
C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose is recovered in the faeces.
C] vildagliptina oko 85% doze se izlučuje u mokraću, a 15% doze pronađeno je u stolici.
Information on the likely symptoms of overdose was taken from a rising dose tolerability study in healthy subjects given Jalra for 10 days.
Informacije o mogućim simptomima predoziranja uzete su iz ispitivanja podnošljivosti povećanja doze u zdravih ispitanika koji su primali Jalru tijekom 10 dana.
OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
In vitro data in human kidney microsomes suggest that the kidney may be one of the major organs contributing to the hydrolysis of vildagliptin to its major inactive metabolite, LAY151.
In vitro podaci na humanim bubrežnim mikrosomima navode na zaključak da bubreg može biti jedan od glavnih organa koji doprinosi hidrolizi vildagliptina u njegov glavni neaktivni metabolit, LAY151.
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
MEĐUPAKIRANJE VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
Jalra is not recommended for use in children and adolescents (< 18 years).
Jalra se ne preporučuje za primjenu u djece i adolescenata (<18 godina).
Jalra contains lactose (milk sugar).
Jalra sadrži laktozu (mliječni šećer).
Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH02
Farmakoterapijska skupina: Lijekovi za liječenje šećerne bolesti, inhibitori dipeptidil peptidaze 4 (DPP-4), ATK oznaka: A10BH02
• if you have moderate or severe kidney disease (you will need to take a lower dose of Jalra).
• ako imate umjerenu do tešku bolest bubrega (trebat ćete uzeti nižu dozu Jalre).
• Do not use this medicine after the expiry date which is stated on the blister and the carton after
• Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza
What Jalra contains
Što Jalra sadrži
The active substance of Jalra, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.
Djelatna tvar Jalre, vildagliptin, pripada skupini lijekova koji se nazivaju „oralni antidijabetici“.
Vildagliptin is indicated in the treatment of type 2 diabetes mellitus in adults:
Vildagliptin je indiciran u liječenju šećerne bolesti tipa 2 u odraslih:
Use of vildagliptin has been associated with a risk of developing acute pancreatitis.
Primjena vildagliptina bila je povezana s rizikom od razvoja akutnog pankreatitisa.
Excipient with known effect: Each tablet contains 47.82 mg lactose (anhydrous).
Pomoćna tvar s poznatim učinkom: svaka tableta sadrži 47,82 mg laktoze (bezvodne).
How Jalra works
Kako Jalra djeluje
Jalra 50 mg tablets are round, white to light yellowish and flat, with “NVR” on one side and “FB” on the other.
Jalra 50 mg tablete su okrugle, bijele do svijetložućkaste i ravne, s oznakom „NVR“ na jednoj strani i „FB“ na drugoj strani.
* p< 0.05 for comparison versus placebo
* p< 0,05 za usporedbu naspram placeba
Oral use Jalra can be administered with or without a meal (see also section 5.2).
Jalra se može uzimati uz obrok ili bez obroka (vidjeti također dio 5.2).
• Store in the original package in order to protect from moisture.
• Čuvati u originalnom pakiranju radi zaštite od vlage.
LAY151 concentrations were approximately 2-3-fold higher than in patients with severe renal impairment.
Koncentracije LAY151 bile su otprilike 2-3 puta više nego u bolesnika s teškim oštećenjem bubrega.
A greater proportion of cases were reported when vildagliptin was administered in combination with an angiotensin converting enzyme inhibitor (ACE-Inhibitor).
Veći udio slučajeva je zabilježen kada se vildagliptin davao u kombinaciji s inhibitorom angiotenzin konvertirajućeg enzima (ACE-inhibitor).
White to light yellowish, round (8 mm diameter), flat-faced, bevelled-edge tablet.
Bijela do svijetložućkasta, okrugla (promjera 8 mm), ravna tableta sa zaobljenim rubovima.
7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 60 tablets 90 tablets 112 tablets 180 tablets 336 tablets
7 tableta 14 tableta 28 tableta 30 tableta 56 tableta 60 tableta 90 tableta 112 tableta 180 tableta 336 tableta
The European Medicines Agency has waived the obligation to submit the results of studies with vildagliptin in all subsets of the paediatric population with type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka vildagliptin u svim podskupinama pedijatrijske populacije za šećernu bolest tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Monotherapy placebo controlled studies
Ispitivanja monoterapije kontrolirane placebom
It helps to control the level of sugar in the blood.
Pomaže u kontroliranju razine šećera u krvi.
Patients who experience dizziness as an adverse reaction should avoid driving vehicles or using machines.
Bolesnici koji osjete omaglicu kao nuspojavu trebaju izbjegavati upravljanje vozilima ili rad na strojevima.
* p< 0.05 for comparison versus placebo + comparator
* p<0,05 za usporedbu naspram placebo + komparator
Glucagon is a substance which triggers the production of sugar by the liver, causing the blood sugar level to rise.
Glukagon je tvar koja potiče stvaranje šećera u jetri, što uzrokuje porast razine šećera u krvi.
Animal studies have shown excretion of vildagliptin in milk.
Ispitivanja na životinjama pokazala su da se vildagliptin izlučuje u mlijeko.
The increased incidence of these tumours in mice is considered not to represent a significant risk to humans based on the lack of genotoxicity of vildagliptin and its principal metabolite, the occurrence of tumours only in one species and the high systemic exposure ratios at which tumours were observed.
Smatra se da povećana incidencija tih tumora u miševa ne predstavlja značajan rizik za ljude na temelju nepostojanja genotoksičnosti vildagliptina i njegovog glavnog metabolita, zbog pojave tumora samo u jedne vrste te velikih omjera sustavne izloženosti kod kojih su tumori zapaženi.
Jalra should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Jalra se ne smije primjenjivati u bolesnika sa šećernom bolešću tipa 1 ili za liječenje dijabetičke ketoacidoze.
The safety and efficacy of vildagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established.
Nije ustanovljena sigurnost i djelotvornost vildagliptina kao trojne oralne terapije u kombinaciji s metforminom i tiazolidindionom.
The safety and efficacy of Jalra in children and adolescents (< 18 years) have not been established.
Sigurnost i djelotvornost Jalre u djece i adolescenata (<18 godina) nisu još ustanovljene.
Vildagliptin was not associated with a change in left-ventricular function or worsening of pre-existing CHF.
Vildagliptin nije bio povezan s promjenom u funkciji lijeve klijetke ili pogoršanjem već postojećeg KZS-a.
Vildagliptin was removed by haemodialysis to a limited extent (3% over a 3-4 hour haemodialysis session starting 4 hours post dose).
Vildagliptin je bio uklonjen hemodijalizom u ograničenoj mjeri (3% tijekom hemodijalize u trajanju od 3-4 sata, a koja je počela 4 sata nakon doziranja).
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), a koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality(ies) return(s) to normal.
Bolesnike u kojih se pojave povišene vrijednosti transaminaza treba pratiti provođenjem druge procjene jetrene funkcije s ciljem potvrđivanja nalaza te nakon toga kontrolirati čestim testovima jetrene funkcije sve dok se abnormalna(e) vrijednost(i) ne vrati(e) na normalu.
Following oral administration of [
Nakon peroralne primjene [
In the subgroup with NYHA class III, the decrease in HbA1c compared to placebo was lower (difference 0.3%) but this conclusion is limited by the small number of patients (n=44).
U podskupini s NYHA klasom III, smanjenje HbA1c u usporedbi s placebom bilo je manje (razlika 0,3%), ali taj je zaključak ograničen malim brojem bolesnika (n=44).
• Do not use any Jalra pack that is damaged or shows signs of tampering.
• Jalra se ne smije upotrijebiti ako je kutija oštećena ili postoje vidljivi znakovi otvaranja.
Therefore Jalra should be used with caution in these patients (see also sections 4.2, 5.1 and 5.2).
Zbog toga se u tih bolesnika Jalra treba primjenjivati s oprezom (vidjeti također dijelove 4.2, 5.1 i 5.2).
At 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), aspartate aminotransferase (AST), C-reactive protein (CRP) and myoglobin levels.
Pri dozi od 600 mg u jednog je ispitanika došlo do edema stopala i šaka te porasta razina kreatin fosfokinaze (CPK), aspartat aminotransferaze (AST), C-reaktivnog proteina (CRP) i mioglobina.
Do not take Jalra:
Nemojte uzimati Jalru:
• Angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulties breathing, sudden onset rash or hives, which may indicate a reaction called “angioedema”.
• Angioedem (rijetko: mogu se javiti u do 1 in 1000 osoba): simptomi uključuju otečeno lice, jezik ili grlo, otežano gutanje, otežano disanje, iznenadno izbijanje osipa ili koprivnjače, što može upućivati na reakciju zvanu „angioedem“.
Clinical experience in patients with NYHA functional class III treated with vildagliptin is still limited and results are inconclusive (see section 5.1).
Klinička iskustva u bolesnika s NYHA funkcionalnom klasom III liječenih vildagliptinom još uvijek su ograničena te se na temelju rezultata ne mogu donositi zaključci (vidjeti dio 5.1).
Ethnic group Limited data suggest that race does not have any major influence on vildagliptin pharmacokinetics.
Ograničeni podaci navode na zaključak da rasa nema nikakav značajniji utjecaj na farmakokinetiku vildagliptina.
Some patients have had the following side effects while taking Jalra, metformin and a sulphonylurea: • Common: Dizziness, tremor, weakness, low blood glucose, excessive sweating
Neki su bolesnici imali sljedeće nuspojave kada su uzimali Jalru, metformin i sulfonilureju: • Često: omaglica, tremor, slabost, niska razina glukoze u krvi, pojačano znojenje
No clinically relevant differences in the pharmacokinetics of vildagliptin were observed between male and female healthy subjects within a wide range of age and body mass index (BMI).
U farmakokinetici vildagliptina nisu zapažene klinički značajne razlike između zdravih ispitanika muškog i ženskog spola unutar širokog raspona dobi i indeksa tjelesne mase (BMI).
The major metabolite (LAY 151) is pharmacologically inactive and is the hydrolysis product of the cyano moiety, accounting for 57% of the dose, followed by the glucuronide (BQS867) and the amide hydrolysis products (4% of dose).
Glavni metabolit (LAY 151) je farmakološki neaktivan i produkt je hidrolize cijano dijela molekule, na što otpada 57% doze, nakon čega slijedi glukuronid (BQS867) i produkt hidrolize amida (4% doze).
There are no adequate data from the use of vildagliptin in pregnant women.
Nema odgovarajućih podataka o primjeni vildagliptina u trudnica.
There is no experience of vildagliptin use in clinical trials in patients with NYHA functional class IV and therefore use is not recommended in these patients.
Ne postoji iskustvo s primjenom vildagliptina u kliničkim ispitivanjima u bolesnika s IV. funkcijskim stupnjem prema NYHA pa se zbog toga primjena u tih bolesnika ne preporučuje.
If you forget to take Jalra
Ako ste zaboravili uzeti Jalru
Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Jalra.
U bolesnika koji razviju žuticu ili druge znakove koji upućuju na poremećaj jetrene funkcije treba prekinuti liječenje Jalrom.
• 50 mg daily in the morning if you have moderate or severe kidney disease or if you are on dialysis.
• 50 mg na dan, ujutro, ako imate umjerenu ili tešku bolest bubrega ili ako ste na dijalizi.
Some patients have had the following side effects while taking Jalra and insulin (with or without metformin):
Neki su bolesnici imali sljedeće nuspojave kada su uzimali Jalru i inzulin (sa ili bez metformina):
Of these patients, 2,264 patients received vildagliptin as monotherapy and 1,520 patients received vildagliptin in combination with another medicinal product.
Od tih je bolesnika njih 2264 primalo vildagliptin kao monoterapiju, a njih 1520 je primalo vildagliptin u kombinaciji s drugim lijekom.
Patients treated with vildagliptin reported significantly lower incidences of gastrointestinal adverse reactions versus those treated with metformin.
Bolesnici liječeni vildagliptinom prijavili su značajno niže incidencije gastrointestinalnih nuspojava u odnosu na one liječene metforminom.
You should not use Jalra during pregnancy.
Ne smijete uzimati Jalru tijekom trudnoće.
The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide).
Primjena vildagliptina rezultira brzom i potpunom inhibicijom aktivnosti DPP-4, koja dovodi do povišene endogene razine natašte i postprandijalno inkretinskih hormona GLP-1 (glukagonu sličan peptid 1) i GIP (inzulinotropni polipeptid ovisan o glukozi).
Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.
Vildagliptin je također indiciran za uporabu u kombinaciji s inzulinom (sa ili bez metformina) kad prehrana i tjelovježba povrh stabilne doze inzulina ne omogućuju odgovarajuću kontrolu glikemije.
Vildagliptin, a member of the islet enhancer class, is a potent and selective DPP-4 inhibitor.
Vildagliptin, pripadnik skupine stimulatora Langerhansovih otočića gušterače, jaki je i selektivni DPP-4 inhibitor.
No dose adjustments are necessary in elderly patients (see also sections 5.1 and 5.2).
U starijih bolesnika nije potrebno prilagođavati dozu (vidjeti također dijelove 5.1 i 5.2).
Your doctor will prescribe Jalra either alone or together with certain other antidiabetic medicines which you will already be taking, if these have not proved sufficiently effective to control diabetes.
Liječnik će Vam propisati Jalru bilo kao monoterapiju ili u kombinaciji s nekim drugim lijekovima za liječenje šećerne bolesti koje već uzimate ako se ti drugi lijekovi nisu pokazali dostatno djelotvornima u kontroli šećerne bolesti.
Combination with ACE-inhibitors
Kombinacija s ACE inhibitorima
Combination with pioglitazone, metformin and glyburide
Kombinacija s pioglitazonom, metforminom i gliburidom
Following oral administration in the fasting state, vildagliptin is rapidly absorbed, with peak plasma concentrations observed at 1.7 hours.
Nakon peroralne primjene natašte vildagliptin se brzo apsorbira pri čemu su vršne koncentracije u plazmi zapažene nakon 1,7 sati.
The exposure to vildagliptin after a single dose in patients with mild and moderate hepatic impairment was decreased (20% and 8%, respectively), while the exposure to vildagliptin for patients with severe impairment was increased by 22%.
Izloženost vildagliptinu nakon jednokratne doze u bolesnika s blagim i umjerenim oštećenjem jetre bila je smanjena (20%, odnosno 8%), dok je izloženost vildagliptinu u bolesnika s teškim oštećenjem bila povećana za 22%.
Jalra works by making the pancreas produce more insulin and less glucagon.
Jalra djeluje tako da gušterača stvara više inzulina, a manje glukagona.
In healthy elderly subjects (≥ 70 years), the overall exposure of vildagliptin (100 mg once daily) was increased by 32%, with an 18% increase in peak plasma concentration as compared to young healthy subjects (18-40 years).
U zdravih starijih ispitanika (≥70 godina) ukupna izloženost vildagliptinu (100 mg jedanput na dan) bila je povećana za 32%, uz 18%-tni porast vršne koncentracije u plazmi u usporedbi s mladim zdravim ispitanicima (18-40 godina).
Adverse reactions reported in patients who received Jalra in double-blind studies as monotherapy and add-on therapies are listed below for each indication by system organ class and absolute frequency.
Nuspojave zabilježene u bolesnika koji su primali Jalru u dvostruko slijepim ispitivanjima kao monoterapiju i kao dodatnu terapiju navedene su niže za svaku indikaciju prema klasifikaciji organskih sustava i apsolutnoj učestalosti.
• 50 mg daily taken as one dose in the morning if you are taking Jalra with another medicine called a sulphonylurea.
• 50 mg na dan, što se uzima kao jedna doza ujutro ako uzimate Jalru s drugim lijekom koji se zove sulfonilureja.
How long to take Jalra
Koliko dugo uzimati Jalru
Decreased blood glucose
niska razina glukoze u krvi
The pancreas makes both of these substances.
Obje te tvari stvara gušterača.
When used as monotherapy, in combination with metformin, in combination with thiazolidinedione, in combination with metformin and a sulphonylurea, or in combination with insulin (with or without metformin), the recommended daily dose of vildagliptin is 100 mg, administered as one dose of 50 mg in the morning and one dose of 50 mg in the evening.
Kada se primjenjuje kao monoterapija, u kombinaciji s metforminom, u kombinaciji s tiazolidindionom, u kombinaciji s metforminom i sulfonilurejom, ili u kombinaciji s inzulinom (sa ili bez metformina), preporučena dnevna doza vildagliptina je 100 mg, primijenjena kao jedna doza od 50 mg ujutro i jedna doza od 50 mg navečer.
A clinical trial of vildagliptin in patients with New York Heart Association NYHA functional class I-III showed that treatment with vildagliptin was not associated with a change in left-ventricular function or worsening of pre-existing congestive heart failure (CHF) versus placebo.
Kliničko ispitivanje vildagliptina u bolesnika s NYHA funkcionalnom klasom I-III pokazalo je da liječenje vildagliptinom nije povezano s promjenom u funkciji lijeve klijetke ili pogoršanjem već postojećeg kongestivnog zatajenja srca (KZS) u usporedbi s placebom.
AUC of the metabolites LAY151 and BQS867 increased on average about 1.5, 3 and 7-fold in patients with mild, moderate and severe renal impairment, respectively.
AUC metabolita LAY151 i BQS867 povećao se u prosjeku oko 1,5; 3 odnosno 7 puta u bolesnika s blagim, umjerenim odnosno teškim oštećenjem bubrega.
Jalra 50 mg tablets
Jalra 50 mg tablete
Another two-year carcinogenicity study was conducted in mice at oral doses up to 1,000 mg/kg.
Druga je dvogodišnja studija kancerogenosti provedena na miševima s oralnim dozama do 1000 mg/kg.
No studies on the effect on human fertility have been conducted for Jalra (see section 5.3).
Nisu provedena nikakva ispitivanja o učinku Jalre na plodnost u ljudi (vidjeti dio 5.3).
Results from studies conducted with these oral antidiabetics have shown no clinically relevant pharmacokinetic interactions.
Rezultati ispitivanja provedenih s ovim oralnim antidijabeticima nisu pokazali klinički značajne farmakokinetičke interakcije.
Liver function should be monitored during treatment with Jalra at three-month intervals during the first year and periodically thereafter.
Jetrenu funkciju treba pratiti tijekom liječenja Jalrom u razmacima od tri mjeseca tijekom prve godine liječenja te povremeno nakon toga.
Table 8 Key efficacy results of vildagliptin in placebo-controlled monotherapy trials and in add-on combination therapy trials (primary efficacy ITT population)
Tablica 8 Ključni rezultati djelotvornosti vildagliptina u placebo kontroliranim ispitivanjima monoterapije i u ispitivanjima kombinirane terapije kao dodatak drugom lijeku (primarna djelotvornost u populaciji svih randomiziranih ispitanika)
(type A) and magnesium stearate.
i magnezijev stearat.
Clinical studies performed with healthy subjects have shown no clinically relevant pharmacokinetic interactions.
Klinička ispitivanja provedena na zdravim ispitanicima nisu pokazala klinički značajne farmakokinetičke interakcije.
Jalra 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks comprising 3 cartons, each containing 112 tablets.
Jalra 50 mg tablete su dostupne u pakiranjima koja sadrže 7, 14, 28, 30, 56, 60, 90, 112, 180 ili 336 tableta i u višestrukim pakiranjima koja sadrže 3 kutije, a svaka sadrži 112 tableta.
Vildagliptin was associated with fewer hypoglycaemic events (0.7%) than gliclazide (1.7%).
Vildagliptin je bio povezan s manje hipoglikemijskih događaja (0,7%) nego gliklazid (1,7%).
As monotherapy - in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
Kao monoterapija - u bolesnika čija se bolest ne može kontrolirati samo dijetom i tjelovježbom i za koje je metformin neprikladan zbog kontraindikacija ili nepodnošenja.
In patients with moderate or severe renal impairment or with end-stage renal disease (ESRD), the recommended dose of Jalra is 50 mg once daily (see also sections 4.4, 5.1 and 5.2).
U bolesnika s umjerenim ili teškim oštećenjem bubrega ili u bolesnika u završnoj fazi bubrežne bolesti preporučena doza Jalre je 50 mg jedanput na dan (vidjeti također dijelove 4.4, 5.1 i 5.2).
It is not known if Jalra passes into breast milk.
Nije poznato prelazi li Jalra u majčino mlijeko.
This helps to control the blood sugar level.
To pomaže u kontroliranju razine šećera u krvi.
In this patient population, vildagliptin 100 mg daily was no more effective than vildagliptin 50 mg once daily.
U ovoj populaciji bolesnika, doza od 100 mg vildagliptina na dan nije bila učinkovitija od doze od 50 mg vildagliptina jedanput na dan.
Jalra 50 mg tablets vildagliptin
Jalra 50 mg tablete vildagliptin
Jalra should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN) (see also sections 4.4 and 5.2).
Jalra se ne smije primjenjivati u bolesnika s oštećenjem jetre, uključujući bolesnike u kojih su vrijednosti alanin aminotransferaze (ALT) ili aspartat aminotransferaze (AST) prije početka liječenja bile >3x vrijednosti gornje granice normale (GGN) (vidjeti također dijelove 4.4 i 5.2).
• Inflammation of the pancreas (pancreatitis) (frequency not known): Symptoms include severe and persistent pain in the abdomen (stomach area), which might reach through to your back, as well as nausea and vomiting.
• Upala gušterače (pankreatitis) (učestalost nepoznata): simptomi uključuju jaku i upornu bol utrbuhu (područje trbuha), koja bi se mogla proširiti do leđa te mučninu i povraćanje.
The majority of adverse reactions in these trials were mild and transient, not requiring treatment discontinuations.
U ovim je ispitivanjima većina nuspojava bila blaga i prolazna te nije bilo potrebno prekidati liječenje.
• 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Jalra alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulphonylurea, or with insulin.
• 100 na dan, što se uzima kao doza od 50 mg ujutro i 50 mg navečer ako uzimate Jalru sam ili s drugim lijekom koji se zove metformin ili glitazon, u kombinaciji s metforminom i sulfonilurejom ili inzulinom.
Placebo-corrected mean change in HbA1c (%) at week 24 (95% CI)
Placebo korigirana srednja promjena vrijednosti HbA1c (%) u 24. tjednu (95%CI)