natgillin/translations-raw huggingface dataset:
Food had no effect on the AUC and Cmax of pioglitazone when Competact was administered to healthy volunteers. 
Hrana nije utjecala na AUC i Cmax pioglitazona kad se Competact primijenio u zdravih dobrovoljaca.
Competact has no or negligible influence on the ability to drive and use machines. 
Competact ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
The safety and efficacy of Competact in children and adolescents under 18 years of age have not been established. 
Sigurnost i djelotvornost lijeka Competact u djece i adolescenata starosti do 18 godina nisu još ustanovljene.
If you take Competact with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia). 
Ako uzimate Competact s drugim lijekovima za šećernu bolest, veća je vjerojatnost da će Vam šećer u krvi pasti na vrijednosti ispod normalne razine (hipoglikemija).
If no adequate strength of Competact is available, individual monocomponents should be used instead of the fixed dose combination. 
Ako nije dostupna odgovarajuća jačina lijeka Competact, potrebno je primijeniti pojedinačne komponente zasebno umjesto fiksne kombinacije.
Taking Competact with, or just after food, may reduce gastrointestinal symptoms associated with metformin. 
Uzimanje lijeka Competact s hranom ili neposredno nakon obroka može smanjiti gastrointestinalne simptome povezane s metforminom.
Not known (frequency can not be estimated from the available data) - inflammation of the liver (hepatitis) - liver does not work as well as it should (changes in liver enzymes) 
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) - upala jetre (hepatitis) - jetra ne funkcionira onako dobro kako bi trebala (promjene jetrenih enzima)
If you have a serious allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing, stop taking this medicine and talk to your doctor immediately. 
Ako imate ozbiljnu alergijsku reakciju, uključujući koprivnjaču, oticanje lica, usana, jezika ili grla, to može uzrokovati probleme s disanjem ili gutanjem pa prestanite uzimati ovaj lijek i obratite se odmah svom liječniku.
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 “EXP”.
As Competact contains metformin hydrochloride,it must be discontinued at the time of surgery under general, spinal or epidural anesthesia. 
Budući da Competact sadrži metformin hidroklorid, njegovu primjenu treba prekinuti u vrijeme kirurških zahvata pod općom, spinalnom ili epiduralnom anestezijom.
There have been no formal interaction studies for Competact. 
Nisu provedena službena ispitivanja interakcija lijeka Competact.
Competact helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces. 
Competact pomaže kontrolirati razinu šećera u krvi kod šećerne bolesti tipa 2, tako što pomaže Vašem tijelu da bolje iskoristi inzulin koji se u tijelu proizvodi.
Small clinical trials have not revealed metformin to have malformative effects. 
Mala klinička ispitivanja nisu pokazala da metformin ima malformacijske učinke.
Also, if you already have blurred vision and the symptoms get worse, talk to your doctor as soon as possible. 
Također, ako već imate zamagljen vid i simptomi se pogoršavaju, što prije obavijestite svog liječnika.
- if you have a problem with your heart. 
- ako imate tegobe sa srcem.
Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland Delpharm Novara S.r.l., Via Crosa, 86, I-28065 Cerano (NO), Italy Lilly S.A., Avda. 
Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Irska Delpharm Novara S.r.l., Via Crosa, 86, I-28065 Cerano (NO), Italija Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Španjolska
- do not use Competact if you are breastfeeding or are planning to breast-feed (see section “Do not take Competact”). 
- Nemojte uzimati Competact ako dojite ili planirate dojiti (vidjeti dio „Nemojte uzimati Competact“).
You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Competact. 
Možda ćete češće morati raditi pretrage glukoze u krvi ili testove funkcije bubrega ili će Vam liječnik trebati prilagoditi dozu lijeka Competact.
The European Medicines Agency has waived the obligation to submit the results of studies with Competact in all subsets of the paediatric population in type 2 diabetes mellitus. 
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Competact u svim podskupinama pedijatrijske populacije u tipu 2 šećerne bolesti.
Risk related to metformin 
Rizik povezan s metforminom
Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu. 
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu
There may be an increased possibility of becoming pregnant because you may ovulate again when you take Competact. 
Mogućnost trudnoće može biti povećana zato što Vam se, dok uzimate Competact, može vratiti ovulacija.
3 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. 
3 Poremećaj vida zabilježen je uglavnom na početku liječenja i povezan je s promjenama glukoze u krvi zbog privremene promjene turgidnosti i indeksa refrakcije leće.
- if you are going to have a certain type of X-ray with an injectable dye, talk to your doctor as you must stop taking Competact for a certain period of time before and after the examination. 
- ako idete na određenu vrstu rendgenskog snimanja s ubrizgavanjem kontrastnog sredstva razgovarajte sa svojim liječnikom jer ćete morati prestati uzimati Competact na određeno vrijeme prije i nakon pregleda.
Animal studies have not revealed teratogenic effects. 
Ispitivanja na životinjama nisu pokazala teratogene učinke.
Lactic acidosis is a serious reaction which may occur very rarely (< 1/10,000) (see section 4.4) and other reactions such as bone fracture, weight increase and oedema may occur commonly (≥ 1/100 to < 1/10) (see section 4.4). 
Laktacidoza je ozbiljna reakcija koja može nastati vrlo rijetko (< 1/10 000) (vidjeti dio 4.4), a druge reakcije kao što su prijelomi kostiju, povećanje tjelesne težine i edemi mogu nastati često (≥ 1/100 do < 1/10) (vidjeti dio 4.4).
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/mL, even at maximum doses. 
U kontroliranim kliničkim ispitivanjima, maksimalne razine metformina u plazmi (Cmax) nisu prelazile 4 µg/ml, čak i kod najviših doza.
Tablets should be swallowed with a glass of water. 
Način primjene Tablete se trebaju progutati uz čašu vode.
At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/mL. 
Kod uobičajenih doza metformina i rasporeda doziranja, dinamička ravnoteža koncentracije u plazmi postiže se u roku od 24-48 sati i općenito je manja od 1 µg/ml.
If you are following a special diet for diabetes, you should continue with this while you are taking Competact. 
Ako se pridržavate posebne dijete za šećernu bolest, nastavite s takvom prehranom dok uzimate Competact.
Your doctor will decide when you must stop and when to restart your treatment with Competact. 
Liječnik će odlučiti kada morate prekinuti i kada ćete nastaviti s liječenjem lijekom Competact.
Dose titration with pioglitazone (added to the optimal dose of metformin) should be considered before the patient is switched to Competact. 
Titraciju doze pioglitazona (pridodanog optimalnoj dozi metformina) treba razmotriti prije nego što se bolesnika prebaci na Competact.
60 x 1 tablets 
60 x 1 tableta
Stop taking Competact for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. 
Prestanite nakratko uzimati Competact ako imate stanje koje može biti povezano s dehidracijom (značajan gubitak tjelesnih tekućina) kao što je jako povraćanje, proljev, vrućica, izloženost toplini ili ako pijete manje tekućine nego obično.
When starting or using such products in combination with Competact, close monitoring of renal function is necessary. 
Kad se takvi lijekovi uvode ili primjenjuju u kombinaciji s Competact, potrebno je pažljivo praćenje funkcije bubrega.
If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heart-beating, vision disorders or difficulty in concentration, you should take some sugar to increase your blood sugar level again. 
Ako iskusite simptome hipoglikemije poput slabosti, omaglice, pojačanog znojenja, ubrzanih otkucaja srca, smetnji vida ili poteškoća u koncentraciji, morate uzeti malo šećera kako biste ponovno povećali svoju razinu šećera u krvi.
If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Competact before or at the time of the injection. 
Ako trebate dobiti injekciju kontrastnog sredstva koje sadrži jod u krvnu žilu, na primjer, u sklopu rendgenskog snimanja ili skeniranja, morate prestati uzimati lijek Competact prije ili u vrijeme injekcije.
Renal clearance of metformin is > 400 mL/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion. 
Bubrežni klirens metformina je >400 ml/min, što pokazuje da se metformin eliminira glomerularnom filtracijom i tubularnom sekrecijom.
In case of dehydration (severe diarrhoea or vomiting, fever, heat, reduced fluid intake), Competact should be temporarily discontinued and contact with a health care professional is recommended. 
U slučaju dehidracije (teški proljev ili povraćanje, vrućica ili smanjen unos tekućine), potrebno je privremeno prekinuti primjenu Competact i preporučuje se obratiti se zdravstvenom radniku.
FOR CALENDARISED PACKS: 7 Tablet blister 
ZA KALENDARSKA PAKIRANJA: blister sa 7 tableta blister sa 14 tableta
common common alanine aminotransferase increased9 
često često povišena alanin aminotransferaza9
Eye disorders visual disturbance3 
Poremećaji oka poremećaj vida3
They are supplied in aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, multipacks of 196 (2 packs of 98) tablets or in aluminium/aluminium perforated unit dose blisters in packs of 60 x 1 tablets. 
Isporučuju se u aluminij/aluminij blisterima u pakiranjima od 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, višestrukim pakiranjima od 196 (2 pakiranja od 98) tableta ili u aluminij/aluminij perforiranim blisterima djeljivim na jedinične doze u pakiranjima od 60 x 1 tableta.
Multipack: 196 (2 packs of 98) film-coated tablets. 
Višestruko pakiranje: 196 (2 pakiranja od 98) filmom obloženih tableta.
It is an anti-diabetic medicine used in adults to treat type 2 (non-insulin dependent) diabetes mellitus when treatment with metformin alone is not sufficient. 
To je antidijabetički lijek koji se primjenjuje u odraslih za liječenje šećerne bolesti tipa 2 (neovisne o inzulinu) kad liječenje samo metforminom nije dovoljno.
ACE inhibitors may decrease the blood glucose levels. 
ACE-inhibitori mogu sniziti razinu glukoze u krvi.
Some epidemiological studies have suggested a similarly increased risk of fracture in both men and women. 
Neka epidemiološka ispitivanja ukazuju na jednako povećni rizik od lomova i kod muškaraca i kod žena.
You may take your tablets with or just after food to reduce the chance of an upset stomach. 
Tablete možete uzeti uz obrok ili neposredno nakon obroka, jer to smanjuje mogućnost želučanih smetnji.
Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. 
Neklinički podaci za metformin ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti i reproduktivne toksičnosti.
If you stop taking Competact 
Ako prestanete uzimati Competact,
Competact should not be used during pregnancy. 
Competact se ne smije primjenjivati tijekom trudnoće.
Both pioglitazone and metformin have been shown to be present in the milk of lactating rats. 
Pokazalo se da su i pioglitazon i metformin prisutni u mlijeku ženki štakora tijekom laktacije.
Blurred vision due to swelling (or fluid) at the back of the eye (macular oedema) has been reported (frequency cannot be estimated from available data). 
Zabilježen je zamagljen vid zbog oticanja (ili nakupljanja tekućine) u stražnjem segmentu oka (makularni edem) (učestalost se ne može procijeniti iz dostupnih podataka).
The recommended dose of Competact is 30 mg/day pioglitazone plus 1,700 mg/day of metformin hydrochloride (this dose is achievable with one tablet of Competact 15 mg/850 mg, taken twice a day). 
Preporučena doza lijeka Competact je 30 mg pioglitazona na dan plus 1700 mg metforminklorida na dan (ova se doza može postići jednom tabletom lijeka Competact 15 mg/850 mg, koja se uzima dvaput na dan).
These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure. 
Ovi su nalazi opaženi u svih životinjskih vrsta kod koncentracije u plazmi koja je ≤ 4 puta veća od izloženosti kod kliničke primjene.
common common macular oedema not known not known 
često često makularni edem nepoznato nepoznato
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.
4 Gastrointestinal disorders occur most frequently during initiation of therapy and resolve spontaneously in most cases. 
4 Poremećaji probavnog sustava češće nastaju u početku liječenja i u većine se slučajeva spontano povlače.
EU/1/06/354/001 14 tablets EU/1/06/354/002 28 tablets EU/1/06/354/003 30 tablets EU/1/06/354/004 50 tablets EU/1/06/354/005 56 tablets EU/1/06/354/006 60 tablets EU/1/06/354/007 90 tablets EU/1/06/354/008 98 tablets EU/1/06/354/010 112 tablets EU/1/06/354/009 180 tablets EU/1/06/354/012 60 x 1 tablets 
EU/1/06/354/001 14 tableta EU/1/06/354/002 28 tableta EU/1/06/354/003 30 tableta EU/1/06/354/004 50 tableta EU/1/06/354/005 56 tableta EU/1/06/354/006 60 tableta EU/1/06/354/007 90 tableta EU/1/06/354/008 98 tableta EU/1/06/354/010 112 tableta EU/1/06/354/009 180 tableta EU/1/06/354/012 60 x 1 tableta
A large overdose of metformin (or coexisting risks of lactic acidosis) may lead to lactic acidosis which is a medical emergency and must be treated in hospital. 
Teško predoziranje metforminom (ili istovremeno prisutnim rizikom od laktacidoze) može dovesti do laktacidoze, koja je hitno medicinsko stanje i mora se liječiti u bolnici.
If you need to have major surgery you must stop taking Competact during and for some time after the procedure. 
Ako se morate podvrgnuti velikom kirurškom zahvatu, morate prestati uzimati lijek Competact tijekom i još neko vrijeme nakon zahvata.
Stop taking Competact and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma. 
Prestanite uzimati Competact i odmah se obratite liječniku ili otiđite u najbližu bolnicu ako osjetite neke od simptoma laktacidoze, jer to stanje može dovesti do kome.
However, the incidence of oedema, weight gain and heart failure were increased. 
Ipak, incidencija edema, porasta tjelesne težine i zatajenja srca je bila povećana.
Multipack of 196 (2 packs of 98) tablets and aluminium/aluminium perforated unit dose blisters in pack of 60 x 1 tablets. 
Višestruko pakiranje od 196 (2 pakiranja od 98) tableta i aluminij/aluminij perforirani blisteri djeljivi na jedinične doze u pakiranju od 60 x 1 tablete.
Skin and subcutaneous tissue disorders erythema very rare very rare pruritis very rare very rare urticaria very rare very rare 
Poremećai kože i potkožnog tkiva eritem vrlo rijetko vrlo rijetko pruritis vrlo rijetko vrlo rijetko urtikarija vrlo rijetko vrlo rijetko
Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Competact and have also been reported in male patients (frequency cannot be estimated from the available data) taking Competact. 
Prijelomi kostiju su često prijavljivani (mogu se pojaviti u do 1 na 10 osoba) u žena koje su uzimale Competact, a također su prijavljivani i u muškaraca (učestalost se ne može procijeniti iz dostupnih podataka) koji su uzimali Competact.
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 studija nije uspjela u pogledu njene primarne mjere ishoda, koja je bila kompozitna mjera sastavljena od mortaliteta svih uzroka; ne-fatalnog infarkta miokarda, moždanog udara, akutnog koronarnog sindroma, amputacije noge, koronarne revaskularizacije i revaskularizacije noge, rezultati ukazuju da nema kardiovaskularne opasnosti pri dugotrajnoj primjeni pioglitazona.
The following statements reflect the pharmacokinetic properties of the individual active substances of Competact. 
Sljedeće tvrdnje odnose se na farmakokinetička svojstva pojedine djelatne tvari u lijeku Competact.
- if you are allergic to pioglitazone, metformin or any of the other ingredients of this medicine (listed in section 6). 
- ako ste alergični na pioglitazon, metformin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako imate ili ste ranije imali zatajenje srca.
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). 
< 1/100); rijetko (≥ 1/10000 i < 1/1000); vrlo rijetko (< 1/10000); nepoznato (ne može se procijeniti iz dostupnih podataka).
Bioequivalence studies in healthy volunteers have shown Competact to be bioequivalent to the administration of pioglitazone and metformin given as separate tablets. 
Ispitivanja bioekvivalencije u zdravih dobrovoljaca pokazala su da je Competact bioekvivalentan primjeni pioglitazona i metformina kad se daju kao zasebne tablete.
- The other ingredients are microcrystalline cellulose, povidone (K30), croscarmellose sodium magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide (E171). 
- Drugi sastojci su mikrokristalična celuloza, povidon (K 30), umrežena karmelozanatrij, magnezijev stearat, hipromeloza, makrogol 8000, talk i titanijev dioksid (E171).
If this happens you must stop taking Competact and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma. 
Ako Vam se to dogodi, morate prestati uzimati lijek Competact i odmah se obratiti liječniku ili otići u najbližu bolnicu, jer laktacidoza može dovesti do kome.
Avoid excessive alcohol intake while taking Competact since this may increase the risk of lactic acidosis (see section “Risk of lactic acidosis”). 
Izbjegavajte prekomjerni unos alkohola dok uzimate lijek Competact jer to može povećati rizik od laktacidoze (vidjeti dio “Rizik od laktacidoze”).
An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions of bone fracture from randomised, controlled, double blind clinical trials (see section 4.8) 
Povećana incidencija prijeloma kostiju u žena opažena je u analizi objedinjenih podataka o prijelomima kostiju kao nuspojava u randomiziranim, kontroliranim, dvostruko slijepim kliničkim ispitivanjima (vidjeti dio 4.8).
As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Competact should have their renal function monitored regularly (see sections 4.3 and 4.4). 
Budući da se metformin izlučuje putem bubrega, a funkcija bubrega u starijih bolesnika može biti smanjena, potrebno je redovito provjeravati funkciju bubrega u starijih bolesnika koji uzimaju Competact (vidjeti dijelove 4.3 i 4.4).
In combination trials pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg. 
U kombiniranim ispitivanjima dodavanje pioglitazona metforminu rezultiralo je prosječnim povećanjem tjelesne težine tijekom jedne godine za 1,5 kg.
Date of first authorisation: 28/07/2006 Date of latest renewal: 25/04/2016 
Datum prvog odobrenja: 28.07.2006.
This study showed an increase in reports of heart failure; however this did not lead to an increase in mortality in this study. 
U ovom je ispitivanju zabilježen povećani broj slučajeva zatajenja srca; ali bez povećanja smrtnosti.
If a patient wishes to become pregnant, treatment with Competact should be discontinued. 
Ako bolesnica želi zatrudnjeti, liječenje lijekom Competact treba prekinuti.
If you have taken more Competact that you should have, you may experience lactic acidosis (see section “Risk of lactic acidosis”). 
Ako uzmete više lijeka Competact nego što ste trebali možete iskusiti laktacidozu (vidjeti dio “Rizik od laktacidoze”).
Following initiation of therapy with Competact, it is recommended that liver enzymes be monitored periodically according to clinical judgement. 
Nakon početka terapije lijekom Competact preporučuje se povremeno određivati jetrene enzime na temelju kliničke procjene.
comprising 2 packs, each containing 98 film-coated tablets. 
Sastavni dio višestrukog pakiranja koje se sastoji od 2 pakiranja, od kojih svako sadrži 98 filmom obloženih tableta.
Competact is indicated as second line treatment of type 2 diabetes mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone. 
Competact je indiciran kao druga linija liječenja šećerne bolesti tipa 2 u odraslih bolesnika, osobito onih s prekomjernom tjelesnom težinom, koji ne mogu postići zadovoljavajuću kontrolu glikemije samo peroralnim metforminom u najvišim podnošljivim dozama.
No animal studies have been conducted with the combined products in Competact. 
Nisu provedena ispitivanja na životinjama kombinacije lijekova u lijeku Competact.
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 vrijednosti HbA1c ≥ 8,0% nakon prvih šest mjeseci terapije).
Competact 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 metformin hydrochloride, a member of the biguanide class. 
Competact 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 metforminkloridom iz klase bigvanida.