natgillin/translations-raw huggingface dataset:
Limited data from patients with end stage renal disease (ESRD) indicate that vildagliptin exposure is similar to that in patients with severe renal impairment.
Ograničeni podaci dobiveni od bolesnika koji su u završnoj fazi bubrežne bolesti upućuju da je izloženost vildagliptinu slična onoj u bolesnika s teškim oštećenjem bubrega.
Study 2301: Vildagliptin 50 mg twice daily (N=90) Study 2384: Vildagliptin 50 mg twice daily (N=79)
Ispitivanje 2301: vildagliptin 50 mg dvaput na dan (N=90) Ispitivanje 2384: vildagliptin 50 mg dvaput na dan (N=79)
Children and adolescents The use of Jalra in children and adolescents up to 18 years of age is not recommended.
Djeca i adolescenti Jalra se ne preporučuje za primjenu u djece i adolescenata ispod 18 godina.
Mean baseline HbA1c (%)
Srednja početna vrijednost HbA1c (%)
Overall, vildagliptin improved glycaemic control when given as monotherapy or when used in combination with metformin, a sulphonylurea, and a thiazolidinedione, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 8).
Sveukupno, vildagliptin je poboljšao kontrolu glikemije kada je davan kao monoterapija, ili kada je primjenjivan u kombinaciji s metforminom, sulfonilurejom te tiazolidindionom, što je u ishodu ispitivanja izmjereno klinički značajnim smanjenjima vrijednosti HbA1c u odnosu na početne vrijednosti (vidjeti Tablicu 8).
• Common: Weight increase, swollen hands, ankle or feet (oedema)
• Često: porast tjelesne težine, otečene šake, gležnjevi ili stopala (edem)
Combination with amlodipine, ramipril, valsartan or simvastatin
Kombinacija s amlodipinom, ramiprilom, valsartanom ili simvastatinom
The effect of impaired hepatic function on the pharmacokinetics of vildagliptin was studied in patients with mild, moderate and severe hepatic impairment based on the Child-Pugh scores (ranging from 6 for mild to 12 for severe) in comparison with healthy subjects.
Učinak oštećene jetrene funkcije na farmakokinetiku vildagliptina ispitivan je u bolesnika s blagim, umjerenim i teškim oštećenjem jetre, na temelju bodova prema Child-Pugh klasifikaciji (u rasponu od 6 za blagi do 12 za teški oblik) u usporedbi sa zdravim ispitanicima.
Vildagliptin is not metabolised by CYP 450 enzymes to any quantifiable extent.
Vildagliptin se ne metabolizira enzimima CYP 450 do bilo kojeg mjerljivog opsega.
Should an increase in AST or ALT of 3x ULN or greater persist, withdrawal of Jalra therapy is recommended.
Potraju li povišene vrijednosti AST-a ili ALT-a na razini 3x vrijednosti GGN-e ili većoj, preporučuje se prekinuti terapiju Jalrom.
As dual oral therapy in combination with - metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin, - a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance, - a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate.
Kao dvojna oralna terapija u kombinaciji s - metforminom, u bolesnika u kojih je kontrola glikemije nedostatna usprkos maksimalno podnošljivoj dozi metformina u monoterapiji, - sulfonilurejom, u bolesnika u kojih je kontrola glikemije nedostatna usprkos maksimalno podnošljivoj dozi sulfonilureje i za koje je metformin neprikladan zbog kontraindikacija ili nepodnošenja, - tiazolidindionom, u bolesnika u kojih je kontrola glikemije nedostatna i za koje je primjena tiazolidindiona prikladna.
When used in dual combination with a sulphonylurea, the recommended dose of vildagliptin is 50 mg once daily administered in the morning.
Kada se primjenjuje u dvojnoj kombinaciji sa sulfonilurejom, preporučena doza vildagliptina iznosi 50 mg jedanput na dan, a daje se ujutro.
CARTON OF UNIT PACK
KUTIJA ZA JEDINIČNO PAKIRANJE
Jalra contains lactose
Jalra sadrži laktozu
In clinical trials, the magnitude of HbA1c reductions with vildagliptin was greater in patients with higher baseline HbA1c.
U kliničkim je ispitivanjima stupanj redukcije HbA1c s vildagliptinom bio veći u bolesnika s većom početnom vrijednosti HbA1c.
• Very rare: Sore throat, runny nose, fever
• Vrlo rijetko: grlobolja, curenje iz nosa, vrućica
• if you are taking an anti-diabetic medicine known as a sulphonylurea (your doctor may want to reduce your dose of the sulphonylurea when you take it together with Jalra in order to avoid low blood glucose [hypoglycaemia]).
• ako uzimate lijek protiv šećerne bolesti iz skupine sulfonilureja (kako bi se izbjegle niske vrijednosti glukoze u krvi [hipoglikemija], Vaš će Vam liječnik možda smanjiti dozu sulfonilureje kad je uzimate zajedno s Jalrom).
There was no correlation between the severity of the hepatic disease and changes in the exposure to vildagliptin.
Između težine bolesti jetre i promjena u izloženosti vildagliptinu nije bilo korelacije.
If a dose of Jalra is missed, it should be taken as soon as the patient remembers.
Ako je bolesnik zaboravio uzeti dozu Jalre, treba je uzeti čim se sjeti.
When used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
Kada se primjenjuje u kombinaciji sa sulfonilurejom, niža doza sulfonilureje se može razmotriti kako bi se smanjio rizik od hipoglikemije.
A multiple-dose, open-label trial was conducted to evaluate the pharmacokinetics of the lower therapeutic dose of vildagliptin (50 mg once daily) in patients with varying degrees of chronic renal impairment defined by creatinine clearance (mild: 50 to <80 ml/min, moderate: 30 to <50 ml/min and severe: <30 ml/min) compared to normal healthy control subjects.
Otvoreno ispitivanje s višestrukim dozama bilo je provedeno kako bi se ocijenila farmakokinetika niže terapijske doze vildagliptina (50 mg jedanput na dan) u bolesnika s različitim stupnjevima kroničnog oštećenja bubrega definiranog klirensom kreatinina (blago: 50 do <80 ml/min, umjereno: 30 do <50 ml/min i teško: <30 ml/min) u usporedbi s normalnim zdravim kontrolnim ispitanicima.
Each tablet contains 50 mg vildagliptin.
Svaka tableta sadrži 50 mg vildagliptina.
Liver function tests should be performed prior to the initiation of treatment with Jalra in order to know the patient's baseline value.
Testove jetrene funkcije treba napraviti prije početka liječenja Jalrom kako bi se utvrdile početne vrijednosti.
In these cases, the patients were generally asymptomatic without clinical sequelae and liver function test results returned to normal after discontinuation of treatment.
U tim slučajevima bolesnici su općenito bili bez simptoma i kliničkih posljedica, a testovi jetrene funkcije su se vratili na normalu nakon prekida liječenja.
• Frequency not known (cannot be estimated from the available data): Itchy rash, inflammation of the pancreas, localised peeling of skin or blisters, muscle pain
• Učestalost nije poznata (učestalost se ne može procijeniti iz dostupnih podataka): osip koji svrbi, upala gušterače, lokalizirano ljuštenje kože ili mjehurići, bol u mišiću.
Driving and using machines If you feel dizzy while taking Jalra, do not drive or use machines.
Ako osjećate omaglicu dok uzimate Jalru, nemojte upravljati vozilima niti raditi sa strojevima.
Accordingly, the metabolic clearance of vildagliptin is not anticipated to be affected by co-medications that are CYP 450 inhibitors and/or inducers.
Zbog toga se ne očekuje da na metabolički klirens vildagliptina utječe istodobna primjena lijekova koji su inhibitori i/ili induktori CYP 450.
68.8% and 80.5% of the patients with moderate and severe renal impairment respectively were treated with insulin (mean daily dose of 56 units and 51.6 units respectively) at baseline.
68,8% odnosno 80,5% bolesnika s umjerenim odnosno teškim oštećenjem bubrega bilo je liječeno inzulinom (srednja dnevna doza od 56 odnosno 51,6 jedinica) na početku.
Safety data were obtained from a total of 3,784 patients exposed to vildagliptin at a daily dose of 50 mg (once daily) or 100 mg (50 mg twice daily or 100 mg once daily) in controlled trials of at least 12 weeks duration.
Podaci o sigurnosti dobiveni su na ukupno 3784 bolesnika koji su bili izloženi vildagliptinu u dnevnoj dozi od 50 mg (jedanput na dan) ili 100 mg (50 mg dvaput na dan ili 100 mg jedanput na dan) u kontroliranim kliničkim ispitivanjima koja su trajala najmanje 12 tjedana.
In the subgroups treated with insulin with or without concomitant metformin the placebo-adjusted mean reduction in HbA1c was -0.63% and -0.84%, respectively.
U podskupinama liječenim inzulinom sa ili bez istodobne primjene metformina srednje sniženje HbA1c, prilagođeno s obzirom na placebo, bilo je -0,63% odnosno -0,84%.
There were more cardiac events in vildagliptin treated patients with NYHA class III heart failure compared to placebo.
Bilo je više srčanih događaja u bolesnika sa zatajenjem srca NYHA klase III liječenih vildagliptinom u usporedbi s placebom.
• Common (may affect up to 1 in 10 people): Trembling, headache, dizziness, nausea, low blood glucose
• Često (mogu se javiti u do 1 na 10 osoba): drhtanje, glavobolja, omaglica, mučnina, niska razina glukoze u krvi
In these trials, vildagliptin was administered as monotherapy in drugnaïve patients with type 2 diabetes or in combination in patients not adequately controlled by other antidiabetic medicinal products.
U tim je ispitivanjima vildagliptin primjenjivan kao monoterapija u bolesnika sa šećernom bolešću tipa 2 koji još nisu primali lijekove za šećernu bolest, ili u kombinaciji u bolesnika u kojih nije bila postignuta odgovarajuća kontrola s drugim antidijabeticima.
Add-on / Combination studies Vildagliptin 50 mg twice daily + metformin (N=143) Vildagliptin 50 mg daily + glimepiride (N=132) Vildagliptin 50 mg twice daily + pioglitazone (N=136) Vildagliptin 50 mg twice daily + metformin + glimepiride (N=152)
Ispitivanja lijeka kao dodatne terapije/kombinacije lijekova Vildagliptin 50 mg dvaput na dan + metformin (N=143) Vildagliptin 50 mg na dan + glimepirid (N=132) Vildagliptin 50 mg dvaput na dan + pioglitazon (N=136) Vildagliptin 50 mg dvaput na dan + metformin + glimepiridin (N=152)
Jalra should not be used during breast-feeding.
Jalra se ne smije primjenjivati tijekom dojenja.
In these studies, vildagliptin was administered to more than 9,000 patients at daily doses of 50 mg once daily, 50 mg twice daily or 100 mg once daily.
U tim je ispitivanjima vildagliptin primjenjivan u više od 9000 bolesnika u dnevnim dozama od 50 mg jedanput na dan, 50 mg dvaput na dan ili 100 mg jedanput na dan.
It is unknown whether vildagliptin is excreted in human milk.
Nije poznato izlučuje li se vildagliptin u majčino mlijeko u ljudi.
Mean reductions were -1.20% with vildagliptin and -1.48% with rosiglitazone in patients with mean baseline HbA1c of 8.7%.
Srednje vrijednosti sniženja bile su -1,20% za vildagliptin i -1,48% za roziglitazon u bolesnika sa srednjom početnom vrijednošću HbA1c od 8,7%.
How to take Jalra • Swallow the tablets whole with some water.
• Tablete progutajte cijele s malo vode.
There may be an increased risk of angioedema in patients concomitantly taking ACE-inhibitors.
Može postojati povećani rizik od angioedema u bolesnika koji istodobno uzimaju ACE inhibitore (vidjeti dio 4.8).
In a 52-week double-blind controlled trial, vildagliptin (50 mg twice daily) reduced baseline HbA1c by -1% compared to -1.6% for metformin (titrated to 2 g/day) statistical non-inferiority was not achieved.
U dvostruko slijepom kontroliranom ispitivanju u trajanju od 52 tjedna, vildagliptin (50 mg dvaput na dan) je smanjio početnu HbA1c vrijednost za -1% u usporedbi s -1,6% kod metformina (titriranog do 2 g/dan), pri čemu statistička ne-inferiornost nije postignuta.
2,682 patients were treated with vildagliptin 100 mg daily (either 50 mg twice daily or 100 mg once daily) and 1,102 patients were treated with vildagliptin 50 mg once daily.
2682 bolesnika liječena su vildagliptinom u dozi od 100 mg na dan (ili 50 mg dvaput na dan ili 100 mg jedanput na dan), a 1102 bolesnika liječena su vildagliptinom u dozi od 50 mg jedanput na dan.
Table 7 Post-marketing adverse reactions
Tablica 7 Nuspojave nakon stavljanja lijeka u promet
In another 24-week study in patients with more advanced type 2 diabetes not adequately controlled on insulin (short and longer acting, average insulin dose 80 IU/day), the mean reduction in HbA1c when vildagliptin (50 mg twice daily) was added to insulin was statistically significantly greater than with placebo plus insulin (0.5% vs. 0.2%).
U drugom 24-tjednom ispitivanju s bolesnicima s uznapredovalom šećernom bolešću tipa 2 u kojih terapijom inzulinom nije postignuta odgovarajuća kontrola (prosječna doza inzulina kratkog ili dugog djelovanja 80 IU/dan), srednje sniženje HbA1c kad je vildagliptin (50 mg dvaput na dan) bio pridodan inzulinu bilo je statistički značajno veće nego kad je inzulinu bio pridodan placebo (0,5% u odnosu na 0,2%).
In data from controlled monotherapy and add-on therapy trials of up to 24 weeks in duration, the incidence of ALT or AST elevations  3x ULN (classified as present on at least 2 consecutive measurements or at the final on-treatment visit) was 0.2%, 0.3% and 0.2% for vildagliptin 50 mg once daily, vildagliptin 50 mg twice daily and all comparators, respectively.
U podacima iz kontroliranih ispitivanja monoterapije i ispitivanja lijeka kao dodatne terapije u trajanju do 24 tjedna incidencija povećanja ALT-a ili AST-a 3x GGN (klasificirano kao prisutnost u najmanje 2 uzastopna mjerenja ili na završnoj posjeti tijekom liječenja) bila je 0,2% za 50 mg vildagliptina jedanput dnevno, 0,3% za 50 mg vildagliptina dvaput dnevno i 0,2% za sve lijekove usporedbe.
In controlled clinical trials with the combination of vildagliptin 50 mg + a sulphonylurea, the overall incidence of withdrawals due to adverse reactions was 0.6% in the vildagliptin 50 mg + sulphonylurea vs 0% in the placebo + sulphonylurea treatment group.
U kontroliranim kliničkim ispitivanjima s kombinacijom 50 mg vildagliptina i sulfonilureje, ukupna incidencija povlačenja iz ispitivanja zbog nuspojava je bila 0,6% u skupini liječenoj sa 50 mg vildagliptina uz sulfonilureju, u odnosu na 0% u skupini placeba uz sulfonilureju.
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Nakon dobivanja odobrenja lijeka, važno je za prijavljivanje sumnji na njegove nuspojave.
Combination with a thiazolidinedione
Kombinacija s tiazolidindionom
Vildagliptin AUC increased on average 1.4, 1.7 and 2-fold in patients with mild, moderate and severe renal impairment, respectively, compared to normal healthy subjects.
AUC vildagliptina povećao se u prosjeku 1,4; 1,7 odnosno 2 puta u bolesnika s blagim, umjerenim odnosno teškim oštećenjem bubrega, u usporedbi s normalnim zdravim ispitanicima.
In addition, in controlled monotherapy trials with vildagliptin the overall incidence of withdrawals due to adverse reactions was no greater for patients treated with vildagliptin at doses of 100 mg daily (0.3%) than for placebo (0.6%) or comparators (0.5%).
Osim toga, u kontroliranim kliničkim ispitivanjima monoterapije vildagliptinom ukupna incidencija povlačenja iz ispitivanja zbog nuspojava nije bila veća u bolesnika koji su liječeni vildagliptinom u dozama od 100 mg na dan (0,3%), u odnosu na bolesnike koji su primali placebo (0,6%) ili lijekove usporedbe (0,5%).
In a 24-week double-blind controlled trial, vildagliptin (50 mg twice daily) was compared to rosiglitazone (8 mg once daily).
U dvostruko slijepom kontroliranom ispitivanju u trajanju od 24 tjedna, vildagliptin (50 mg dvaput na dan) je uspoređivan s roziglitazonom (8 mg jedanput na dan).
Mean change from baseline in HbA1c (%) at week 24
Srednja promjena od početne vrijednosti za HbA1c (%) u 24. tjednu
No dose adjustment is required in patients with mild renal impairment (creatinine clearance ≥ 50 ml/min).
U bolesnika s blagim oštećenjem bubrega (klirens kreatinina ≥50 ml/min) nije potrebno prilagođavati dozu.
Vildagliptin significantly decreased HbA1c compared with placebo (difference of 0.6%) from a mean baseline of 7.8% at week 16.
Vildagliptin je značajno smanjio HbA1c u usporedbi s placebom (razlika 0,6%) od srednje početne vrijednosti od 7,8% nakon 16 tjedana.
Patients receiving rosiglitazone experienced a mean increase in weight (+1.6 kg) while those receiving vildagliptin experienced no weight gain (-0.3 kg).
U bolesnika koji su primali roziglitazon došlo je do povećanja srednje vrijednosti tjelesne težine (+1,6 kg), dok oni koji su primali vildagliptin nisu dobili na tjelesnoj težini (-0,3 kg).
After two years, mean reduction in HbA1c was -0.5% for vildagliptin and -0.6% for gliclazide, from a mean baseline HBA1c of 8.6%.
Nakon dvije godine, srednje sniženje HbA1c bilo je -0,5% za vildagliptin i -0,6% za gliklazid, uz srednju početnu vrijednost HbA1c od 8,6%.
A test to determine your liver function will be performed before the start of Jalra treatment, at threemonth intervals for the first year and periodically thereafter.
Testovi jetrene funkcije će se napraviti prije početka liječenja Jalrom, potom tijekom prve godine u razmacima od tri mjeseca te poslije toga periodički.
The incidence of peripheral oedema when vildagliptin 100 mg daily was added to a maximum dose of background pioglitazone (45 mg once daily) was 7.0%, compared to 2.5% for background pioglitazone alone.
Incidencija perifernog edema bila je 7,0% kada je 100 mg vildagliptina na dan dodavano maksimalnoj dozi osnovne terapije pioglitazonom (45 mg jedanput na dan), u odnosu na 2,5% za samo osnovnu terapiju pioglitazonom.
In clinical trials, the incidence of hypoglycaemia was uncommon in patients receiving vildagliptin + pioglitazone (0.6%) but common in patients receiving placebo + pioglitazone (1.9%).
U kliničkim je ispitivanjima incidencija hipoglikemije bila manje česta u bolesnika koji su primali vildagliptin + pioglitazon (0,6%), ali je bila česta u bolesnika koji su primali placebo + pioglitazon (1,9%).
Combination with metformin and a sulphonylurea
Kombinacija s metforminom i sulfonilurejom
A 52-week multi-centre, randomised, double-blind trial was conducted in patients with type 2 diabetes and congestive heart failure (NYHA functional class I-III) to evaluate the effect of vildagliptin 50 mg twice daily (N=128) compared to placebo (N=126) on left-ventricular ejection fraction (LVEF).
Multicentrično, randomizirano, dvostruko slijepo ispitivanje u trajanju od 52 tjedna provedeno je u bolesnika sa šećernom bolešću tipa 2 i kongestivnim zatajenjem srca (NYHA funkcionalna klasa I-III) da bi se ocijenio učinak vildagliptina 50 mg dvaput na dan (N=128) u usporedbi s placebom (N=126) na ejekcijsku frakciju lijeve klijetke (eng. left-ventricular ejection fraction, LVEF).
Jalra is used to treat adult patients with type 2 diabetes.
Jalra se primjenjuje za liječenje bolesnika sa šećernom bolešću tipa
Jalra should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST > 3x ULN (see also sections 4.2 and 5.2).
Jalra se ne smije primjenjivati u bolesnika s oštećenjem funkcije jetre, uključujući bolesnike u kojih su ALT ili AST prije početka liječenja bili >3x vrijednosti GGN (vidjeti također dijelove 4.2 i 5.2).
DPP-4 inhibition by vildagliptin is not affected by age.
Dob ne utječe na inhibiciju DPP-4 vildagliptinom.
The incidence of peripheral oedema was lower in the vildagliptin group than in the rosiglitazone group (2.1% vs. 4.1% respectively).
Incidencija perifernog edema bila je niža u skupini koja je primala vildagliptin, nego u skupini koja je primala roziglitazon (2,1%, u odnosu na 4,1%).
Aluminium/Aluminium (PA/Al/PVC//Al) blister Available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks containing 336 (3 packs of 112) tablets.
Dostupno u pakiranjima koja sadrže 7, 14, 28, 30, 56, 60, 90, 112, 180 ili 336 tableta i u višestrukim pakiranjima koja sadrže 336 (3 pakiranja od 112) tableta.
A 24-week, multi-centre, randomised, double-blind, placebo-controlled trial was conducted to evaluate the treatment effect of vildagliptin 50 mg once daily compared to placebo in 515 patients with type 2 diabetes and moderate renal impairment (N=294) or severe renal impairment (N=221).
24-tjedno multicentrično, randomizirano, dvostruko slijepo, placebo kontrolirano ispitivanje bilo je provedeno kako bi se ocijenio učinak terapije vildagliptinom od 50 mg jedanput na dan u usporedbi s placebom, u 515 bolesnika sa šećernom bolesti tipa 2 i umjerenim oštećenjem bubrega (N=294) ili teškim oštećenjem bubrega (N=221).
In the overall population, the placebo-adjusted mean reduction from a mean baseline HbA1c 8.8% was -0.72%.
U sveukupnoj populaciji srednje sniženje, prilagođeno s obzirom na placebo, u odnosu na srednju početnu vrijednost HbA1c 8,8% bilo je -0,72%.
Following withdrawal of treatment with Jalra and LFT normalisation, treatment with Jalra should not be reinitiated.
Nakon prekida liječenja Jalrom i normalizacije testova jetrene funkcije ne smije se ponovno započeti primjena Jalre.
Table 5 Adverse reactions reported in patients who received Jalra 50 mg twice daily in combination with metformin and a sulphonylurea (N=157)
Tablica 5 Nuspojave zabilježene u bolesnika koji su primali Jalru 50 mg dva puta na dan u kombinaciji s metforminom i sulfonilurejom (N=157)
The incidence of hypoglycaemia in the overall population was 4.7% and 5.6% in the vildagliptin and placebo groups, respectively.
Incidencija hipoglikemije u cjelokupnoj populaciji bila je 4,7% u skupini koja je primala vildagliptin i 5,6% u skupini koja je primala placebo.
Lactose, anhydrous Cellulose, microcrystalline Sodium starch glycolate (type A) Magnesium stearate
6.1 Popis pomoćnih tvari laktoza, bezvodna celuloza, mikrokristalična natrijev škroboglikolat (vrste A) magnezijev stearat
In clinical trials, the incidence of hypoglycaemia was common in patients receiving vildagliptin 100 mg daily in combination with metformin (1%) and uncommon in patients receiving placebo + metformin (0.4%).
U kliničkim je ispitivanjima incidencija hipoglikemije bila česta u bolesnika koji su primali 100 mg vildagliptina na dan u kombinaciji s metforminom (1%) te manje česta u bolesnika koji su primali placebo uz metformin (0,4%).
In a clinical trial of 2 years' duration, vildagliptin (50 mg twice daily) was compared to gliclazide (up to 320 mg/day).
U kliničkom ispitivanju koje je trajalo 2 godine, uspoređivan je vildagliptin (50 mg dva puta na dan) s gliklazidom (do 320 mg/dan).
More than 15,000 patients with type 2 diabetes participated in double-blind placebo- or activecontrolled clinical trials of up to more than 2 years' treatment duration.
U dvostruko slijepim placebo ili aktivno kontroliranim kliničkim ispitivanjima u trajanju više od 2 godine sudjelovalo je više od 15 000 bolesnika sa šećernom bolešću tipa 2.
• The other ingredients are lactose anhydrous, microcrystalline cellulose, sodium starch glycolate
• Drugi sastojci su bezvodna laktoza, mikrokristalična celuloza, natrijev škroboglikolat (vrste A)
In clinical trials, the incidence of hypoglycaemia when vildagliptin 50 mg once daily was added to glimepiride was 1.2% versus 0.6% for placebo + glimepiride.
U kliničkim je ispitivanjima incidencija hipoglikemije bila 1,2% kada je 50 mg vildagliptina jedanput na dan dodano glimepiridu, u odnosu na 0,6% za placebo uz glimepirid.
In patients with moderate renal impairment vildagliptin significantly decreased HbA1c compared with placebo (difference of -0.53%) from a mean baseline of 7.9%.
U bolesnika s umjerenim oštećenjem bubrega vildagliptin je značajno smanjio HbA1c u usporedbi s placebom (razlika od -0,53%) u odnosu na srednju početnu vrijednost od 7,9%.
Table 6 Adverse reactions reported in patients who received Jalra 100 mg daily in combination with insulin (with or without metformin) in double-blind studies (N=371)
Tablica 6 Nuspojave zabilježene u bolesnika koji su primali Jalru 100 mg na dan u kombinaciji s inzulinom (s ili bez metformina) u dvostruko slijepim ispitivanjima (N=371)
How to take Jalra
Kako uzimati Jalru
Some patients have had the following side effects while taking Jalra alone:
Neki su bolesnici imali sljedeće nuspojave kada su uzimali samo Jalru: