natgillin/translations-raw huggingface dataset:
The rate of deterioration of HbA1c during the second year was less with pioglitazone than with gliclazide.
Stopa pogoršanja vrijednosti HbA1c tijekom druge godine bila je manja uz pioglitazon nego uz gliklazid.
When you take Tandemact, your blood sugar could fall below the normal level (hypoglycaemia).
Kad uzmete Tandemact, razina šećera u krvi može Vam se spustiti ispod normalne razine (hipoglikemija).
If patients report hypoglycaemia, the dose of Tandemact should be reduced or free combination therapy should be considered.
Ako bolesnici prijave hipoglikemiju, doza lijeka Tandemact se mora sniziti ili se mora razmotriti terapija slobodnom kombinacijom lijekova.
Animal studies have shown reproductive toxicity which was most likely related to the pharmacological action (hypoglycaemia) of glimepiride.
Ispitivanja na životinjama pokazala su reproduktivnu toksičnost, koja je najvjerojatnije povezana s farmakološkim djelovanjem (hipoglikemija) glimepirida.
After a single dose of radiolabelled glimepiride, 58% of the radioactivity was recovered in the urine, and 35% in the faeces.
Nakon primjene jednokratne doze radiološki označenog glimepirida, 58% radioaktivnosti otkrilo se u mokraći, a 35% u stolici.
A 24-month mechanistic study in male rats demonstrated that administration of pioglitazone resulted in an increased incidence of hyperplastic changes in the bladder.
Mehanističko ispitivanje u trajanju od 24 mjeseca u mužjaka štakora pokazalo je da je primjena pioglitazona rezultirala povećanom incidencijom hiperplastičnih promjena u mokraćnom mjehuru.
Linearity/non-linearity Single dose studies demonstrate linearity of pharmacokinetics in the therapeutic dose range.
Linearnost/nelinearnost Ispitivanja jednokratne doze pokazuju linearnost farmakokinetike u terapijskom rasponu doza.
Take care if you experience abnormal vision.
Budite oprezni ako imate poremećaj vida.
At two years, glycaemic control (defined as HbA1c < 8.0%) was sustained in 69% of patients treated with pioglitazone, compared with 50% of patients on gliclazide.
Nakon dvije godine, kontrola glikemije (definirane kao HbA1c 8,0%) bila je održana u 69% bolesnika liječenih pioglitazonom u usporedbi s 50% bolesnika liječenih gliklazidom.
Food intake has no relevant influence on absorption, only absorption rate is slightly diminished.
Uzimanje hrane nema važnog utjecaja na apsorpciju, samo je brzina apsorpcije blago smanjena.
Therapy with Tandemact should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 x upper limit of normal) or with any other evidence of liver disease.
Terapija lijekom Tandemact se ne smije započeti u bolesnika s povišenim razinama jetrenih enzima (ALT povišena više od 2,5 puta iznad gornje granice normale) ili nekim drugim dokazom bolesti jetre.
Risk related to pioglitazone
Rizik povezan s pioglitazonom
If you forget to take Tandemact
Ako ste zaboravili uzeti Tandemact
Blood and lymphatic system disorders changes in haematology1
Poremećaji krvi i limfnog sustava hematološke promjene1
The physiological response to acute physical exercise, reduction of insulin secretion, is still present under glimepiride.
Fiziološki odgovor na akutno fizičko opterećenje, smanjenje lučenja inzulina, još je prisutno pod utjecajem glimepirida.
Treatment of overdose of Tandemact primarily consists of preventing absorption of glimepiride by inducing vomiting and then drinking water or lemonade with activated charcoal (adsorbent) and sodium-sulphate (laxative).
Liječenje predoziranja lijekom Tandemact prvenstveno se sastoji od sprječavanja apsorpcije glimepirida izazivanjem povraćanja a potom ispijanja vode ili limunade s aktivnim ugljenom (adsorbens) i natrijevim sulfatom (laksativ).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Tandemact.
Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije nego što uzmete Tandemact.
Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure.
Pioglitazon može dovesti do zadržavanja tekućine, koje može pogoršati ili izazvati zatajenje srca.
4 Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic medicinal products.
4 Poremećaji vida zabilježeni su relativno rano u početku liječenja i povezani su s promjenama glukoze u krvi zbog privremeno promijenjenog turgora i indeksa refrakcije leće, kakvi se vide i uz druge hipoglikemijske lijekove.
Two metabolites - most probably resulting from hepatic metabolism (major enzyme is CYP2C9) - were identified both in urine and faeces: the hydroxy derivative and the carboxy derivative.
Dva metabolitanajvjerojatnije rezultat metabolizma u jetri (glavni enzim je CYP2C9) - pronađeni su i u mokraći i u stolici: hidroksi-derivat i karboksi-derivat.
There may be an increased possibility of becoming pregnant because you may ovulate again when you take Tandemact.
Postoji povećana mogućnost trudnoće, zato što Vam se za vrijeme uzimanja lijeka Tandemact može vratiti ovulacija.
In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
S obzirom na moguće rizike dugotrajnije terapije, liječnici koji propisuju lijek moraju naknadnim rutinskim procjenama potvrđivati da je korist od liječenja pioglitazonom održana (vidjeti dio 4.4).
When treating patients who have at least one risk factor for development of congestive heart failure (e.g. prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians should start with the lowest available dose of pioglitazone and increase the dose gradually.
Kod liječenja bolesnika s najmanje jednim čimbenikom rizika za razvoj kongestivnog zatajenja srca (npr. prethodni infarkt miokarda, simptomatska bolest koronarnih arterija ili starija dob), liječnici moraju započeti liječenje s najnižom dostupnom dozom pioglitazona i postupno je povećavati.
Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12,506 patients, 0.15%) than in control groups (7 cases from 10,212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, p=0.029).
U meta-analizi kontroliranih kliničkih ispitivanja, slučajevi karcinoma mokraćnog mjehura češće su zabilježeni u skupinama koje su primale pioglitazon (19 slučajeva na 12 506 bolesnika, 0,15%) nego u kontrolnim skupinama (7 slučajeva na 10 212 bolesnika, 0,07%) HR = 2,64 (95% CI 1,11-6,31, p = 0,029).
Tandemact contains pioglitazone and glimepiride which are anti-diabetic medicines, used to control blood sugar level.
Tandemact sadrži pioglitazon i glimepirid, koji su antidijabetički lijekovi i primjenjuju se za kontrolu razine šećera u krvi.
There is a linear relationship between dose and both Cmax and AUC (area under the time/concentration curve).
Linearnost/nelinearnost Postoji linearni odnos između doze i Cmax i AUC (površina ispod krivulje vrijeme-koncentracija).
Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers, and HMGCoA reductase inhibitors are not to be expected.
Ne treba očekivati interakcije s tvarima koje ovi enzimi metaboliziraju, npr. oralnim kontraceptivima, ciklosporinom, blokatorima kalcijevih kanala i inhibitorima reduktaze HMGCoA.
Sulphonylurea-derivatives like glimepiride pass into the breast milk.
Derivati sulfonilureje poput glimepirida prelaze u majčino mlijeko.
Maximum serum concentrations (Cmax) are reached approximately 2.5 hours after oral intake (mean 0.3 µg/mL during multiple dosing of 4 mg daily).
Najviše koncentracije u serumu (Cmax) postižu se približno 2,5 sata nakon peroralnog unosa (prosječno 0,3 µg/ml tijekom višekratne primjene doze od 4 mg na dan).
Close monitoring of glycaemic control should be considered (see section 4.4).
Potrebno je razmotriti pažljivo praćenje kontrole glikemije (vidjeti dio 4.4).
It is used in adults when metformin is not suitable to treat type 2 (non-insulin dependent) diabetes mellitus.
Tandemact se primjenjuje u odraslih kad metformin nije prikladan za liječenje šećerne bolesti tipa 2 (neovisne o inzulinu).
If glimepiride is taken simultaneously with certain other medicinal products, both undesired increases and decreases in the hypoglycaemic action of glimepiride can occur.
Ako se glimepirid uzme istovremeno s određenim lijekovima, mogu nastati i neželjena pojačanja i neželjena smanjenja hipoglikemijskog učinka glimepirida.
After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c).
Bolesnike se mora pregledati 3 do 6 mjeseci nakon početka terapije pioglitazonom kako bi se procijenila prikladnost odgovora na liječenje (npr. sniženje HbA1c).
After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were 7 cases (0.06%) on pioglitazone and 2 cases (0.02%) in control groups.
Nakon isključenja bolesnika koji su u vrijeme dijagnoze karcinoma mokraćnog mjehura bili izloženi ispitivanom lijeku kraće od godinu dana, zabilježeno je 7 slučajeva (0,06%) u skupinama koje su primale pioglitazon i 2 slučaja (0,02%) u kontrolnim skupinama.
If you experience symptoms of hypoglycaemia such as cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea, you should take some sugar to increase your blood sugar level again.
Ako iskusite simptome hipoglikemije poput hladnog znoja, umora, glavobolje, ubrzanih otkucaja srca, boli od gladi, razdražljivosti, nervoze ili mučnine, trebate uzeti malo šećera kako biste ponovno povećali svoju razinu šećera u krvi.
Treatment with Tandemact requires regular monitoring of glycaemic control.
Liječenje lijekom Tandemact zahtijeva redovito praćenje kontrole glikemije.
The hypoglycaemia may in general be accompanied by neurological symptoms like restlessness, tremor, visual disturbances, coordination problems, sleepiness, coma and convulsions.
Hipoglikemija može općenito biti praćena neurološkim simptomima poput nemira, tremora, poremećaja vida, otežane koordinacije, pospanosti, kome i konvulzija.
There are no adequate data from the use of pioglitazone in pregnant women.
Nema odgovarajućih podataka o primjeni pioglitazona u trudnica.
This may affect your ability to drive or use machines.
To može utjecati na Vašu sposobnost upravljanja vozilima i rada na strojevima.
Signs and symptoms include blood in your urine, pain when urinating or a sudden need to urinate.
Znakovi i simptomi uključuju krv u mokraći, bol pri mokrenju ili iznenadna potreba za mokrenjem.
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia from glimepiride or, for example, as a result of visual impairment.
Sposobnost bolesnika da se usredotoči i reagira može biti narušena zbog hipoglikemije ili hiperglikemije prouzročene glimepiridom ili, na primjer, zbog poremećaja vida.
In general observation in hospital is recommended.
Općenito se preporučuje hospitalizirati bolesnika zbog promatranja.
If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Ako slučajno uzmete previše tableta ili netko drugi ili dijete uzme
MAO-inhibitors quinolone antibiotics probenecid miconazole pentoxyfylline (high dose parenteral) tritoqualine fluconazole
MAO inhibitori kinolonski antibiotici probenecid mikonazol pentoksifilin (visoke parenteralne doze) tritokvalin flukonazol
The uptake of glucose from blood into peripheral muscle and fat tissues occurs via a special transport proteins, located in the cells membrane.
Unos glukoze iz krvi u periferne mišiće i masno tkivo odvija se putem posebnih transportnih proteina smještenih u staničnim membranama.
Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Ispitivanja u čovjeka ne sugeriraju da postoji indukcija glavnog inducibilnog citokroma P450, 1A, 2C8/9 i 3A4.
Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Iako ispitivanje nije uspjelo u pogledu primarnog ishoda, tj. kompozitne mjere sastavljene od mortaliteta svih uzroka, infarkta miokarda bez smrtnog ishoda, moždanog udara, akutnog koronarnog sindroma, velike amputacije noge, koronarne revaskularizacije i revaskularizacije noge, rezultati pokazuju da nije bilo dugotrajnih kardiovaskularnih rizika kod primjene pioglitazona.
Glycaemic control should be monitored closely.
Kontrolu glikemije je nužno pozorno pratiti.
Avoid alcohol while taking Tandemact since alcohol may increase or decrease the blood sugar lowering action of Tandemact in an unpredictable way.
Izbjegavajte piti alkohol dok uzimate Tandemact, jer alkohol može pojačati ili oslabiti učinak lijeka Tandemact na sniženje šećera u krvi na nepredvidljiv način.
Pioglitazone has been shown to be present in the milk of lactating rats.
Pokazalo se da je pioglitazon prisutan u mlijeku štakorica u vrijeme laktacije.
If you are following a special diet for diabetes, you should continue with this while you are taking Tandemact.
Ako ste na posebnoj dijeti zbog šećerne bolesti, za vrijeme uzimanja lijeka Tandemact morate nastaviti s dijetom.
You must tell your doctor if you are, you think you may be pregnant or are planning to have a baby.
Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku.
Following initiation of therapy with Tandemact, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
Nakon početka terapije lijekom Tandemact preporučuje se povremeno određivati jetrene enzime na temelju kliničke procjene.
Cross allergenicity with sulphonylureas, sulphonamides or related substances is possible.
Moguća je i križna alergija sa sulfonilurejama, sulfonamidima i sličnim tvarima.
An increased incidence of hyperplasia (males and females) and tumours (males) of the urinary bladder epithelium was apparent in rats treated with pioglitazone for up to 2 years.
Povećana incidencija hiperplazije (mužjaci i ženke) i tumora (mužjaci) epitela mokraćnog mjehura opažena je u štakora liječenih pioglitazonom u razdoblju do 2 godine.
Patients should be advised to adhere strictly to a calorie-controlled diet.
Bolesnicima se mora savjetovati da se strogo pridržavaju dijete s kontroliranim unosom kalorija.
Pioglitazone did not cause statistically significant increases in LDL-cholesterol levels compared with placebo, whilst reductions were observed with metformin and gliclazide.
Pioglitazon nije uzrokovao statistički značajna povišenja razine LDL-kolesterola u usporedbi s placebom, dok su sniženja bila opažena uz metformin i gliklazid.
The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Stope edema u skupinama liječenima komparatorom (sulfonilureja, metformin) iznosile su 2-5%.
No animal studies have been conducted with the combined products of Tandemact.
Nisu provedena ispitivanja kombiniranog lijeka Tandemact na životinjama.
In particular when treating hypoglycaemia due to accidental intake of Tandemact in infants and young children, the dose of glucose given must be carefully controlled to avoid the possibility of producing dangerous hyperglycaemia.
Kod liječenja hipoglikemije u dojenčadi i male djece zbog nehotičnog gutanja lijeka Tandemact, doza primijenjene glukoze mora se osobito pažljivo kontrolirati kako bi se izbjegao mogući razvoj opasne hiperglikemije.
There are no adequate data from the use of glimepiride in pregnant women.
Nema odgovarajućih podataka o primjeni glimepirida u trudnica.
This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser degree.
To se pretežno događa putem citokroma P450 2C8, iako mogu biti uključeni i drugi izoenzimi, ali u manjem stupnju.
Liver enzymes should be checked prior to the initiation of therapy with Tandemact in all patients.
Jetrene enzime se mora provjeriti u svih bolesnika prije početka terapije lijekom Tandemact.
Glimepiride may either potentiate or weaken the effects of coumarin derivatives.
Glimepirid može pojačati ili oslabiti učinke derivata kumarina.
The following statements reflect the pharmacokinetic properties of the individual active substances of Tandemact.
Sljedeće tvrdnje odnose se na farmakokinetička svojstva pojedine djelatne tvari u lijeku Tandemact.
The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator.
Izračunata incidencija prijeloma iznosila je 1,9 prijeloma na 100 bolesnik-godina u žena liječenih pioglitazonom i 1,1 prijeloma na 100 bolesnik-godina u žena liječenih komparatorom.
Some patients experienced the following side effects whilst taking pioglitazone and sulphonylureas, including glimepiride:
Neki su bolesnici razvili sljedeće nuspojave za vrijeme uzimanja pioglitazona i sulfonilureja, uključujući glimepirid:
In patients with low creatinine clearance, there was a tendency for glimepiride clearance to increase and for average serum concentrations to decrease, most probably resulting from a more rapid elimination because of lower protein binding.
U bolesnika s niskim klirensom kreatinina, klirens glimepirida naginjao je povećanju, a prosječne koncentracije u serumu smanjenju, što je najvjerojatnije rezultat brže eliminacije zbog nižeg vezanja za proteine.
Tandemact should not be used in patients with severe renal function disorders (creatinine clearance < 30 ml/min, see section 4.3).
Tandemact se ne smije primjenjivati u bolesnika s teškim poremećajem funkcije bubrega (klirens kreatinina < 30 ml/min, vidjeti dio 4.3).
Combination use with insulin should be considered with caution in the elderly because of increased risk of serious heart failure.
U starijih bolesnika treba s oprezom razmotriti kombiniranu primjenu s inzulinom zbog povišenog rizika od ozbiljnog zatajenja srca.
Clinical trials have been conducted with co-administered pioglitazone and glimepiride (see section 5.1).
Provedena su klinička ispitivanja sa istovremeno primijenjenim pioglitazonom i glimepiridom (vidjeti dio 5.1).
Tandemact is contraindicated during pregnancy (see section 4.3).
Tandemact je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA1c ≥ 8.0% after the first six months of therapy).
Kliničko ispitivanje pioglitazona u usporedbi s gliklazidom u obliku monoterapije bilo je produženo na dvije godine kako bi se procijenilo vrijeme do neuspjeha liječenja (definirano kao razvoj HbA1c  8,0% nakon prvih šest mjeseci terapije).
Mean dominant serum half-life, which is of relevance for the serum concentrations under multiple-dose conditions, is about 5 to 8 hours.
Prosječni poluvijek u serumu, koji je važan za koncentracije u serumu kod primjene višestrukih doza, pretežno iznosi oko 5 do 8 sati.
In animal fertility studies with pioglitazone, there was no effect on copulation, impregnation or fertility index.
U ispitivanjima utjecaja pioglitazona na plodnost u životinja nije bilo učinka na kopulaciju, oplodnju ili indeks plodnosti.
How to take Tandemact
Kako uzimati Tandemact
This is a serious reaction which may occur uncommonly (≥ 1/1,000 to < 1/100) (see section 4.4).
Hipoglikemija je ozbiljna reakcija koja može nastati manje često (≥ 1/1000 i < 1/100) (vidjeti dio 4.4).
Hypoglycaemic reactions mostly occur immediately due to the sulphonylurea component of Tandemact.
Hipoglikemijske reakcije uglavnom nastaju odmah, zbog toga što Tandemact sadrži sulfonilureju.
H2 antagonists, betablockers, clonidine and reserpine may lead to either potentiation or weakening of the blood glucose lowering effect.
H2 antagonisti, beta blokatori, klonidin i rezerpin mogu dovesti ili do pojačanja ili do slabljenja učinka snižavanja glukoze u krvi.
As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation.
Budući pojačava djelovanje inzulina, primjena pioglitazona u bolesnica sa sindromom policističnih jajnika može rezultirati ponovnom uspostavom ovulacije.
The tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption.
Ove tablete sadrže laktozu hidrat i stoga se ne smiju primjenjivati u bolesnika s rijetkim nasljednim poremećajima nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze.
Tandemact combines two antihyperglycaemic active substances with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes mellitus: pioglitazone, a member of the thiazolidinedione class and glimepiride, a member of the sulphonylurea class.
Tandemact je kombinacija dvije antihiperglikemijske djelatne tvari s komplementarnim mehanizmom djelovanja koje poboljšavaju kontrolu glikemije u bolesnika sa šećernom bolešću tipa 2: pioglitazonom, iz klase tiazolidindiona, i glimepiridom, iz klase sulfonilureja.
Pioglitazone or placebo was added to existing antidiabetic and cardiovascular therapy for up to 3.5 years.
Bolesnici su uzimali pioglitazon ili placebo uz postojeću antidijabetičku i kardiovaskularnu terapiju u trajanju do 3,5 godine.
Hepatobiliary disorders6 hepatitis very rare very rare impairment of liver function (with cholestasis and jaundice)
Poremećaji jetre i žuči6 hepatitis vrlo rijetko vrlo rijetko oštećenje funkcije jetre (s kolestazom i žuticom)
Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
Bolesnici koji su primali pioglitazon imali su prosječno sniženje vrijednosti HbA1c za 0,45% u usporedbi s onima koji su nastavili uzimati samo inzulin i doza inzulina bila je snižena u skupini liječenoj pioglitazonom.
Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea.
Čini se da istovremena primjena pioglitazona sa sulfonilurejama ne utječe na farmakokinetiku sulfonilureja.
Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Tandemact and have also been reported in male patients (frequency cannot be estimated from the available data) taking Tandemact.
Prijelomi kostiju su često prijavljivani (mogu se pojaviti u do 1 na 10 osoba) u žena koje su uzimale Tandemact, a također su prijavljivani i u muškaraca (učestalost se ne može procijeniti iz dostupnih podataka) koji su uzimali Tandemact.
Glimepiride binds with a high exchange rate to a beta cell membrane protein which is associated with the ATP-sensitive potassium channel but which is different from the usual sulphonylurea binding site.
Glimepirid se, uz visoku stopu razmjene, veže za protein na membrani beta stanica koji je povezan s ATP-osjetljivim kalijevim kanalima, ali koji se razlikuje od uobičajenog mjesta vezanja sulfonilureja.
In combination trials pioglitazone added to a sulphonylurea resulted in a mean weight increase over one year of 2.8 kg.
U kombiniranim ispitivanjima dodavanje pioglitazona sulfonilureji rezultiralo je prosječnim povećanjem tjelesne težine tijekom jedne godine za 2,8 kg.
Insulin release
Oslobađanje inzulina