natgillin/translations-raw huggingface dataset:
What Pioglitazone Teva is and what it is used for What you need to know before you take Pioglitazone Teva How to take Pioglitazone Teva Possible side effects
Što je Pioglitazon Teva i za što se koristi Što morate znati prije nego počnete uzimati Pioglitazon Teva Kako uzimati Pioglitazon Teva
Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins; ATC code: A10BG03.
Farmakoterapijska skupina: Pripravci za liječenje šećerne bolesti, lijekovi za snižavanje glukoze u krvi, osim inzulina; ATK oznaka: A10BG03.
Close monitoring of glycaemic control should be considered (see section 4.4).
Preporučuje se pozorno praćenje kontrole glikemije (vidjeti dio 4.4).
If you are following a special diet for diabetes, you should continue with this while you are taking Pioglitazone Teva.
Ako se pridržavate posebne dijete za šećernu bolest, trebate nastaviti s dijetom dok uzimate Pioglitazon Teva.
- The other ingredients are mannitol, carmellose calcium, hydroxypropylcellulose and magnesium stearate.
- Ostali sastojci su manitol, karmelozakalcij hidroksipropilceluloza i magnezijev stearat.
Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
primali kardiovaskularne lijekove (beta blokatore, ACE inhibitore, antagoniste angiotenzina II, blokatore kalcijevih kanala, nitrate, diuretike, aspirin, statine, fibrate).
Some epidemiological studies have suggested a similarly increased risk of fracture in both men and women.
Neka epidemiološka ispitivanja ukazuju na jednako povećani rizik od lomova i kod muškaraca i kod žena
Therapy with pioglitazone 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 pioglitazonom ne smije se započeti u bolesnika s povišenim početnim razinama jetrenih enzima (ALT više od 2,5 puta iznad gornje granice normale) ili nekim drugim dokazom bolesti jetre.
Pioglitazone has been shown to be present in the milk of lactating rats.
Pokazalo se da je pioglitazon prisutan u mlijeku štakorica tijekom laktacije.
Pioglitazone Teva may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar.
Pioglitazon Teva se može primjenjivati sam u bolesnika koji ne mogu uzimati metformin, a kod kojih se liječenjem dijetom i tjelovježbom nije uspjela postići kontrola šećera u krvi, ili se može dodati drugim lijekovima (kao što su metformin, sulfonilureja ili insulin) koji nisu uspjeli osigurati dostatnu kontrolu šećera u krvi.
In light of age- related risks (especially bladder cancer, fractures and heart failure), the balance of benefits and risks should be considered carefully both before and during treatment in the elderly.
U svjetlu rizika povezanih sa životnom dobi (osobito karcinoma mokraćnog mjehura, prijeloma i zatajenja srca), potrebno je pažljivo razmotriti ravnotežu između koristi i rizika kako prije, tako i tijekom liječenja starijih bolesnika.
Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals.
Pioglitazon vjerojatno djeluje putem aktivacije posebnih receptora u jezgri (receptor gama aktiviran peroksizomskim proliferatorom), što u životinja dovodi do povećane osjetljivosti jetre, masnog tkiva i skeletnih mišića na inzulin.
• Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure)
• Oprez kod primjene u starijih s obzirom na rizike povezane s dobi (osobito karcinom mokraćnog mjehura, prijelome i zatajenje srca).
Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.
U svakoj klasi organskih sustava nuspojave su prikazane slijedom prema sve manjoj incidenciji te sve manjoj ozbiljnosti.
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 i iznenadnu potreba za mokrenjem.
Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets
Aluminij/aluminij blisteri, pakiranja sa 14, 28, 30, 50, 56, 84, 90, 98, 112 i 196 tableta.
- The tablets are supplied in blisters in packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets.
- Tablete se isporučuju u blisterima u pakiranjima sa 14, 28, 30, 50, 56, 84, 90, 98, 112 ili 196 tableta.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Učestalost je navedena kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000
However, the incidences of oedema, weight gain and heart failure were increased.
Međutim, incidencija edema, povećanja tjelesne težine i zatajenja srca bila je povišena.
Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea.
Istodobna primjena pioglitazona sa sulfonilurejama čini se da ne utječe na farmakokinetiku sulfonilureje.
Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza “Rok valjanosti”.
In an animal model of familial adenomatous polyposis (FAP), treatment with two other thiazolidinediones increased tumour multiplicity in the colon.
Na životinjskom modelu obiteljske adenomatozne polipoze, liječenje s dva druga tiazolidindiona povećala je brojnost tumora u debelom crijevu.
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 kompozitnog primarnog ishoda, koji je obuhvaćao smrtnost svih uzroka, infarkt miokarda bez smrtnog ishoda, moždani udar, akutni koronarni sindrom, veća amputacija noge, koronarna revaskularizacija i revaskularizacija noge, rezultati pokazuju da primjena pioglitazona nije nosila dugoročne kardiovaskularne rizike.
The pioglitazone dose may need to be increased when rifampicin is concomitantly administered.
Dozu pioglitazona možda će trebati povisiti kad se istodobno primjenjuje rifampicin.
• This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level.
• Svrha ovog edukacijskog paketa jest povisiti svijest o važnosti utvrđenih rizika od karcinoma mokraćnog mjehura i zatajenja srca te opće preporuke namijenjene optimizaciji raspona koristi u odnosu na rizik na razini bolesnika.
If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked.
Ako neki bolesnik razvije simptome koji ukazuju na poremećaj funkcije jetre, koji mogu uključivati neobjašnjenu mučninu, povraćanje, bol u abdomenu, umor, anoreksiju i/ili tamnu boju mokraće, potrebno je provjeriti jetrene enzime.
This medicinal product does not require any special storage conditions.
Ovaj lijek ne zahtjeva posebne uvjete čuvanja.
It is an anti-diabetic medicine used to treat type 2 (noninsulin dependent) diabetes mellitus in adults, when metformin is not suitable or has failed to work adequately.
To je antidijabetički lijek koji se primjenjuje za liječenje šećerne bolesti tipa 2 (neovisne o inzulinu) kod odraslih, kada metformin nije pogodan ili nije imao odgovarajuće djelovanje.
Intrinsic clearance is therefore reduced, coupled with a higher unbound fraction of pioglitazone.
Intrinzički klirens stoga je smanjen, povezan s većim udjelom nevezanog pioglitazona.
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, u skupinama koje su primale pioglitazon bilo je 7 slučajeva (0,06%), a u kontrolnim skupinama 2 slučaja (0,02%).
Foetal growth restriction was apparent in animal studies with pioglitazone.
Ograničenje fetalnog rasta bilo je očigledno u ispitivanjima pioglitazona na životinjama.
Pioglitazone should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Pioglitazon se ne smije primjenjivati u bolesnika s oštećenjem jetre (vidjeti dio 4.3 i 4.4).
Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible.
Ako ste već prije imali zamagljen vid i taj se simptom pogoršava, čim prije razgovarajte sa svojim liječnikom.
If patients report hypoglycaemia, the dose of insulin should be decreased.
Ako bolesnici prijave hipoglikemiju, doza inzulina mora se sniziti.
This check may be repeated at intervals.
Ta će se pretraga ponavljati u redovitim razmacima.
A 24-month mechanistic study in male rats demonstrated that administration of pioglitazone resulted in an increased incidence of hyperplastic changes in the bladder.
Ispitivanjem u trajanju od 24 mjeseca u mužjaka štakora pokazalo se da primjena pioglitazona rezultira povećanom incidencijom hiperplastičkih promjena u mokraćnom mjehuru.
Since insulin and pioglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema.
Budući da su i inzulin i pioglitazon povezani sa zadržavanjem tekućine, njihova istovremena primjena može povećati rizik od edema.
Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12506 patients, 0.15%) than in control groups (7 cases from 10212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, P=0.029).
U meta-analizi kontroliranih kliničkih ispitivanja češće su zabilježeni slučajevi karcinoma mokraćnog mjehura 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,
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 smanjenja opažena uz metformin i gliklazid.
In combination with insulin, the current insulin dose can be continued upon initiation of pioglitazone therapy.
Kod kombinacije s inzulinom, može se nastaviti s postojećom dozom inzulina nakon što se započne terapija pioglitazonom.
To be eligible patients had to have had one or more of the following: myocardial infarction, stroke, percutaneous cardiac intervention or coronary artery bypass graft, acute coronary syndrome, coronary artery disease, or peripheral arterial obstructive disease.
Da bi bili pogodni za ispitivanje, bolesnici su morali imati jedno ili više od sljedećeg: infarkt miokarda, moždani udar, perkutanu srčanu intervenciju ili premosnicu koronarne arterije, akutni koronarni sindrom, bolest koronarnih arterija ili opstruktivnu bolest perifernih arterija.
Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Treba razmotriti prilagodbu doze pioglitazona unutar preporučenog doziranja ili promjene u liječenju šećerne bolesti (vidjeti dio 4.5).
Hypoglycaemia may occur in combination with sulphonylureas or insulin.
Hipoglikemija može nastati u kombinaciji sa sulfonilurejom ili inzulinom.
Allergic reactions have been reported (frequency cannot be estimated from the available data) in patients taking pioglitazone.
Zabilježene su alergijske reakcije (učestalost se ne može procijeniti iz dostupnih podataka) kod bolesnika koji uzimaju pioglitazone.
If you take more Pioglitazone Teva than you should
Ako uzmete više Pioglitazon Teva tableta nego što ste trebali
Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Ispitivanja u čovjeka sugeriraju da nema indukcije glavnih inducibilnih citokroma P450, 1A, 2C8/9 i 3A4.
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 ako neka druga osoba ili dijete uzmu
These reactions include anaphylaxis, angioedema, and urticaria.
Takva reakcija uključuje anafilaksiju, angioedem i urtikariju.
This is similar to that seen in a sulphonylurea active comparator group.
To je slično onome opaženom u skupini koja je primala sulfonilureju kao aktivni usporedni lijek.
No information is available from dialysed patients therefore pioglitazone should not be used in such patients.
Nema dostupnih informacija o bolesnicima na dijalizi pa se pioglitazon ne smije primjenjivati u tih bolesnika.
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 (definirana kao HbA1c < 8,0%) bila je održana u 69% bolesnika liječenih pioglitazonom u odnosu na
Pioglitazone treatment may be initiated at 15 mg or 30 mg once daily.
Liječenje pioglitazonom može se započeti dozom od 15 mg ili 30 mg jedanput na dan.
As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation.
Zbog pojačanog djelovanja inzulina, liječenje pioglitazonom u bolesnica sa sindromom policističnih jajnika može rezultirati povratkom ovulacije.
common common uncommon macular oedema not known not known not known not known not known
manje često makularni edem nepoznato nepoznato nepoznato nepoznato nepoznato
In patients on insulin with no pioglitazone the incidence of heart failure was 8.2% in those ≥65 years compared to 4.0% in patients less than 65 years.
U bolesnika na inzulinu bez pioglitazona, incidencija srčanog zatajenja bila je 8,2% kod osoba u dobi ≥65 godina, u odnosu na 4,0% u bolesnika mlađih od 65 godina.
Mean levels of liver enzymes decreased with treatment with pioglitazone.
Prosječne razine jetrenih enzima smanjivale su se s liječenjem pioglitazonom.
• The risk of heart failure and relevant risk minimisation advice.
• Rizik od zatajenja srca i odgovarajuće savjete o smanjivanju rizika.
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 primijećena je u štakora liječenih pioglitazonom u razdoblju do 2 godine.
Patients should be advised to adhere strictly to a calorie-controlled diet.
Bolesnicima treba savjetovati da se strogo pridržavaju dijete s ograničenim unosom kalorija.
Visceral fat was significantly decreased, while there was an increase in extra-abdominal fat mass.
Visceralno masno tkivo bilo je značajno smanjeno, dok se masa izvanabdominalnog masnog tkiva povećala.
Your doctor will take this into account when treating your diabetes.
Liječnik koji Vas liječi zbog šećerne bolesti će to uzeti u obzir.
- Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
- Pioglitazon je također indiciran u kombinaciji s inzulinom u odraslih bolesnika sa šećernom bolešću tipa 2 i nedostatnom kontrolom glikemije pomoću inzulina u kojih je metformin neprikladan zbog kontraindikacija ili nepodnošljivosti (vidjeti dio 4.4).
Patients should be observed for signs and symptoms of heart failure, weight gain or oedema; particularly those with reduced cardiac reserve.
Bolesnici trebaju biti pod nadzorom zbog znakova i simptoma zatajenja srca, povećanja tjelesne težine ili pojave edema, osobito oni sa smanjenom srčanom rezervom.
Since there is a potential for an increase in doserelated adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Budući da postoji mogućnost povećanja nuspojava povezanih s dozom, možda bude potrebno sniziti dozu pioglitazona kod istodobne primjene gemfibrozila.
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).
Bolesnicima treba napraviti pretrage 3 do 6 mjeseci nakon početka terapije pioglitazonom, kako bi se procijenilo imaju li primjereni odgovor na liječenje (npr. smanjenje HbA1c).
Package leaflet: Information for the user Pioglitazone Teva 15 mg tablets
Uputa o lijeku: Informacija za korisnika Pioglitazon Teva 15 mg tablete
Any macroscopic haematuria should be investigated before starting pioglitazone therapy.
Svaku makroskopsku hematuriju treba provjeriti prije početka terapije pioglitazonom.
A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
Ispitivanje kardiovaskularnog ishoda kod primjene pioglitazona provedeno je u bolesnika mlađih od 75 godina sa šećernom bolešću tipa 2 i postojećom teškom makrovaskularnom bolešću.
In patients with renal impairment, plasma concentrations of pioglitazone and its metabolites are lower than those seen in subjects with normal renal function, but oral clearance of parent substance is similar.
U bolesnika s oštećenjem funkcije bubrega, koncentracije pioglitazona i njegovih metabolita u plazmi niže su od onih opaženih u ispitanika s normalnom funkcijom bubrega, ali oralni klirens prekursora je sličan.
This was attributable to the action of pioglitazone in diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during pregnancy thereby reducing the availability of metabolic substrates for foetal growth.
To se moglo pripisati djelovanju pioglitazona na smanjenje hiperinzulinemije u majke i povećanje inzulinske rezistencije koje nastaje tijekom trudnoće i tako smanjuje raspoloživost metaboličkih supstrata za fetalni rast.
The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Stope edema u skupinama koje su primale usporedni lijek (sulfonilureju, metformin) iznosile su 2-5%.
Pioglitazone Teva should be used every day to work properly.
Da bi Pioglitazon Teva ispravno djelovao, treba ga uzimati svaki dan.
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 monoterapijom gliklazidom bilo je produljeno na dvije godine kako bi se procijenilo vrijeme do prestanka odgovora na terapiju (definirano kao nastanak HbA1c ≥ 8,0% nakon prvih šest mjeseci terapije).
In this study in patients receiving pioglitazone and insulin, a higher percentage of patients with heart failure was observed in patients aged ≥65 years compared with those less than 65 years (9.7% compared to 4.0%).
U ovom ispitivanju, u bolesnika koji su primali pioglitazon i inzulin zabilježen je veći postotak bolesnika sa zatajenjem srca u skupini bolesnika u dobi od ≥65 godina u odnosu na one mlađe od 65 godina (9,7% u odnosu na 4,0%).
Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin
Kombinacija s metforminom sa sulfonilurejom s metforminom i sulfonilurejom s inzulinom
Investigations weight increased6 common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon alanine aminotransferase increased7
Povišena kreatin fosfokinaza u krvi povišena laktična dehidrogenaza manje često povišena alanin aminotransferaza7
Patients should be advised to promptly seek the attention of their physician if macroscopic haematuria or other symptoms such as dysuria or urinary urgency develop during treatment.
Bolesnicima treba savjetovati da odmah potraže liječničku pomoć ako tijekom liječenja razviju makroskopsku hematuriju ili druge simptome, kao što su dizurija ili neodgodiva potreba za mokrenjem.
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 smanjenje HbA1c za 0,45% u usporedbi s onima koji su nastavili primati samo inzulin, a u skupini koja je liječena pioglitazonom smanjena je doza inzulina.
You may also experience a reduction in blood count (anaemia).
Može Vam se pogoršati i krvna slika (anemija).
Your blood sugar will be checked, and your dose of Pioglitazone Teva may need to be changed.
Provjerit će Vam šećer u krvi i nakon toga će možda biti potrebno promijeniti dozu lijeka Pioglitazon Teva Pioglitazon Teva s hranom i pićem
Environmental Risk Assessment (ERA): No environmental impact is anticipated from the clinical use of pioglitazone.
Procjena rizika za okoliš: ne očekuje se utjecaj na okoliš tijekom kliničke primjene pioglitazona.
• The risk of bladder cancer risk and relevant risk minimisation advice.
• Rizik od karcinoma mokraćnog mjehura i odgovarajuće savjete o smanjivanju rizika.
Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking pioglitazone and have also been reported in male patients (frequency cannot be estimated from the available data) taking pioglitazone.
Prijelomi kostiju su često prijavljivani (mogu se javiti do 1 od 10 osoba) u žena koje su uzimale pioglitazon, a također su prijavljivani i u muškaraca (učestalost se ne može procijeniti iz dostupnih podataka) koji su uzimali pioglitazon.
Following initiation of therapy with pioglitazone, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
Nakon početka terapije pioglitazonom preporučuje se povremeno određivati jetrene enzime na temelju kliničke procjene.
Blood and lymphatic system disorders anaemia common
Poremećaji krvi i limfnog sustava anemija
In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/creatinine ratio compared to baseline.
U kliničkim ispitivanjima u trajanju od jedne godine, pioglitazon je dosljedno pokazivao statistički značajno sniženje omjera albumina i kreatinina u usporedbi s početnim omjerom.
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 produljene terapije, liječnici koji propisuju lijek trebaju i dalje rutinski procjenjivati nastavak koristi od liječenja pioglitazonom (vidjeti dio 4.4).
Reproductive system and breast disorders erectile dysfunction common
Poremećaji reproduktivnog sustava i dojki erektilna disfunkcija