FrancophonIA/ELRC3.0 huggingface dataset:
English: Takeda Pharma A/S Dybendal Alle 10 2630 Taastrup Denmark
Croatian: Takeda Pharma A/S Dybendal Alle 10 2630 Taastrup Danska
English: Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible.
Croatian: Također, ako već imate zamagljen vid i simptomi se pogoršavaju, obratite se čim prije liječniku.
English: Animal studies have not revealed teratogenic effects or do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama nisu otkrila teratogene učinke niti ukazuju na izravne ili neizravne štetne učinke s obzirom na reproduktivnu toksičnost (vidjeti dio 5.3).
English: Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood and which can lead to diabetic pre-coma.
Croatian: Ketoacidoza je stanje u kojem se tvari koje se nazivaju „ketonska tijela“ nakupljaju u krvi i mogu dovesti do dijabetičke predkome.
English: Ask your doctor or pharmacist for more information if you are not sure how to recognise this.
Croatian: Od svog liječnika ili ljekarnika zatražite više informacija ako niste sigurni kako prepoznati simptome.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza “EXP“.
English: This medicine will not affect your ability to drive or use machines but take care if you experience abnormal vision.
Croatian: Ovaj lijek neće utjecati na Vašu sposobnost upravljanja vozilima i rukovanja strojevima, ali budite oprezni ako osjetite poremećaje vida.
English: What Glubrava is and what it is used for What you need to know before you take Glubrava How to take Glubrava
Croatian: Što je Glubrava i za što se koristi Što morate znati prije nego počnete uzimati lijek Glubrava
English: 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.
Croatian: 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 odmah se obratite svom liječniku.
English: Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke.
Croatian: Gotovo je polovica bolesnika prethodno imala infarkt miokarda, a približno 20% bolesnika je imalo moždani udar.
English: The most effective method to remove lactate and metformin is haemodialysis.
Croatian: Najučinkovitiji način uklanjanja laktata i metformina je hemodijaliza.
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Croatian: Nakon peroralne doze, neapsorbirani udio otkriven u stolici iznosio je 20-30%.
English: EU/1/07/421/001 EU/1/07/421/002 EU/1/07/421/003 EU/1/07/421/004 EU/1/07/421/005 EU/1/07/421/006 EU/1/07/421/007 EU/1/07/421/008 EU/1/07/421/009
Croatian: EU/1/07/421/001 EU/1/07/421/002 EU/1/07/421/003 EU/1/07/421/004 EU/1/07/421/005 EU/1/07/421/006 EU/1/07/421/007
English: No dose adjustment.
Croatian: Bez prilagodbe doze.
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Glubrava.
Croatian: Mogućnost trudnoće može biti povećana zato što Vam se, dok uzimate Glubrava, može vratiti ovulacija.
English: In animals, only a small amount of unchanged pioglitazone can be detected in either urine or faeces.
Croatian: U životinja se samo mala količina neizmijenjenog pioglitazona može otkriti u mokraći ili izmetu.
English: The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.
Croatian: Edemi su u zabilježenim slučajevima bili blagi do umjereni i obično nisu zahtijevali prekid liječenja.
English: Combinations requiring precautions for use
Croatian: Kombinacije čija primjena zahtijeva mjere opreza
English: 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).
Croatian: Nakon početka terapije pioglitazonom, bolesnike treba kontrolirati nakon 3 do 6 mjeseci kako bi se procijenio odgovor na liječenje (npr. sniženje HbA1c).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Glubrava in all subsets of the paediatric population in type 2 diabetes mellitus.
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Glubrava u svim podskupinama pedijatrijske populacije u šećernoj bolesti tipa 2.
English: Approximately one third of patients were receiving insulin in combination with metformin and/or a sulphonylurea.
Croatian: Približno je jedna trećina bolesnika primala inzulin u kombinaciji s metforminom i/ili sulfonilurejom.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment.
Croatian: Bolesnika treba o tome obavijestiti i češće pratiti glukozu u krvi, osobito na početku liječenja.
English: 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.
Croatian: Kod uobičajenih doza metformina i rasporeda doziranja, koncentracije u plazmi u stanju dinamičke ravnoteže postižu se u roku od 24-48 sati i općenito su manje od 1 g/ml.
English: Glycaemic control should be monitored closely.
Croatian: Potrebne su pažljive kontrole glikemije.
English: The relevance to humans of the tumourigenic findings in the male rat cannot be excluded.
Croatian: Važnost ovih tumorogenih nalaza u mužjaka štakora za ljude ne može se isključiti.
English: The safety profile seen in this study reflected the known adverse reactions seen with the individual products and did not suggest any new safety issues.
Croatian: Sigurnosni profil opažen u ovom ispitivanju odgovarao je poznatim nuspojavama pojedinačnih lijekova i nije ukazivao na nove probleme u sigurnosti primjene.
English: A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Croatian: Ispitivanje provedeno u sedam normalnih zdravih dobrovoljaca pokazalo je da je cimetidin, primijenjen u dozi od 400 mg dvaput na dan, povećao sistemsku izloženost (AUC) metforminu za 50% i Cmax metformina za 81%.
English: Non-clinical 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.
Croatian: 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.
English: Patients should be aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, the treatment should be discontinued (see section 4.6).
Croatian: Bolesnice moraju znati da postoji rizik od trudnoće i liječenje treba prekinuti ako bolesnica želi zatrudnjeti ili ako nastupi trudnoća (vidjeti dio 4.6).
English: if you have a problem with your liver.
Croatian: - ako imate tegobe s jetrom.
English: very rare very rare lactic acidosis very rare very rare
Croatian: vrlo rijetko vrlo rijetko laktacidoza vrlo rijetko vrlo rijetko
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: The rate of deterioration of HbA1c during the second year was less with pioglitazone than with gliclazide.
Croatian: Postotak pogoršanja vrijednosti HbA1c tijekom druge godine bio je manji uz pioglitazon nego uz gliklazid.
English: If you have reduced kidney function, your doctor may prescribe a lower dose, which may need to be given as separate tablets of pioglitazone and metformin.
Croatian: Ako imate smanjenu funkciju bubrega liječnik Vam može propisati nižu dozu, koju ćete možda morati uzimati kao zasebne tablete pioglitazona i metformina.
English: This type 2 diabetes usually develops in adulthood particularly as a result of the person being overweight and where the body either does not produce enough insulin (a hormone that controls blood sugar levels), or cannot effectively use the insulin it produces.
Croatian: Tip 2 šećerne bolesti obično nastaje u odrasloj dobi, osobito kao posljedica prekomjerne tjelesne težine i kad tijelo ne proizvodi dovoljno inzulina (hormona koji kontrolira razinu šećera u krvi) ili ne može učinkovito iskoristiti inzulin koji proizvodi.
English: In an animal model of familial adenomatous polyposis (FAP), treatment with two other thiazolidinediones increased tumour multiplicity in the colon.
Croatian: U životinjskom modelu obiteljske adenomatozne polipoze (FAP), liječenje s druga dva tiazolidindiona je povećalo brojnost tumora u debelom crijevu.
English: Repeated dosing does not result in accumulation of the compound or metabolites.
Croatian: Ponovljene doze ne rezultiraju nakupljanjem glavnog spoja ili metabolita.
English: It is used in adults to treat type 2 (non-insulin dependent) diabetes mellitus when treatment with metformin alone is not sufficient.
Croatian: Primjenjuje se u odraslih za liječenje šećerne bolesti tipa 2 (neovisne o inzulinu) kad liječenje samo metforminom nije dovoljno.
English: In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
Croatian: U kliničkim su ispitivanjima bolesnici uzimali pioglitazon u dozama koje su bile više od najviše preporučene doze od 45 mg na dan.
English: 5 How to store Glubrava Contents of the pack and other information
Croatian: Kako čuvati lijek Glubrava Sadržaj pakiranja i druge informacije
English: If you take Glubrava with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
Croatian: Ako uzimate lijek Glubrava s drugim lijekovima za šećernu bolest, veća je vjerojatnost da bi Vam vrijednosti šećera u krvi mogle pasti ispod normalne razine (hipolikemija).
English: Maximum daily dose is 45 mg
Croatian: Maksimalna dnevna doza iznosi 45 mg
English: A higher number of bone fractures was seen in patients, particularly women taking pioglitazone.
Croatian: Veći broj prijeloma opažen je u bolesnika, naročito u žena koje uzimaju pioglitazon.
English: However, in the case of metformin, in the fed state the mean AUC and Cmax were lower (13% and 28% respectively).
Croatian: Međutim, AUC i Cmax metformina su u sitom stanju bili niži (13% odnosno 28%).
English: What you need to know before you take Glubrava
Croatian: Što morate znati prije nego počnete uzimati lijek Glubrava
English: EU/1/07/421/001 14 tablets EU/1/07/421/002 28 tablets EU/1/07/421/003 30 tablets EU/1/07/421/004 50 tablets EU/1/07/421/005 56 tablets EU/1/07/421/006 60 tablets EU/1/07/421/007 90 tablets EU/1/07/421/008 98 tablets EU/1/07/421/009 180 tablets
Croatian: EU/1/07/421/001 14 tableta EU/1/07/421/002 28 tableta EU/1/07/421/003 30 tableta EU/1/07/421/004 50 tableta EU/1/07/421/005 56 tableta EU/1/07/421/006 60 tableta EU/1/07/421/007 90 tableta EU/1/07/421/008 98 tableta EU/1/07/421/009 180 tableta
English: Glucocorticoids (given by systemic and local routes), beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Croatian: Glukokortikoidi (primijenjeni sistemski ili lokalno), beta-2-agonisti i diuretici imaju intrinzičko hiperglikemijsko djelovanje.
English: There is no clinical experience of pioglitazone in triple combination with other oral antidiabetic medicinal products.
Croatian: Nema kliničkog iskustva s primjenom pioglitazona u trostrukoj kombinaciji s drugim peroralnim antidijabeticima.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/mL, even at maximum doses.
Croatian: U kontroliranim kliničkim ispitivanjima, maksimalne razine metformina u plazmi (Cmax) nisu prelazile 4 g/ml, čak i kod najviših doza.
English: Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.
Croatian: Metformin nije utjecao na plodnost u mužjaka i ženki štakora kad se primjenjivao u dozama od čak 600 mg/kg na dan, što približno odgovara trostrukoj maksimalnoj dnevnoj dozi u ljudi na temelju usporedbe površine tijela.
English: HOMA analysis shows that pioglitazone improves beta cell function as well as increasing insulin sensitivity.
Croatian: Analiza HOMA pokazala je da pioglitazon poboljšava funkciju beta stanica, kao i da povećava osjetljivost na inzulin.
English: 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 and increase the dose gradually.
Croatian: 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 trebaju započeti s najnižom dostupnom dozom i postupno je povećavati.
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Glubrava.
Croatian: Možda ćete češće morati raditi pretrage glukoze u krvi ili testove funkcije bubrega ili će Vam liječnik trebati prilagoditi dozu lijeka Glubrava.
English: 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 Glubrava before or at the time of the injection.
Croatian: Ako trebate dobiti injekciju kontrastnog sredstva koje sadrži jod u krvnu žilu, na primjer, u sklopu rendgenskog snimanja ili skeniranja, morate prestati uzimati lijek Glubrava prije ili u vrijeme injekcije.
English: Medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib).
Croatian: Lijekove koji se primjenjuju za liječenje boli i upale (NSAIL i COX-2-inhibitori, kao što su ibuprofen i celekoksib).
English: Taking Glubrava with, or just after food, may reduce gastrointestinal symptoms associated with metformin.
Croatian: Uzimanje lijeka Glubrava s hranom ili neposredno nakon obroka može smanjiti gastrointestinalne simptome povezane s metforminom.
English: Glubrava should not be used during pregnancy.
Croatian: Glubrava se ne smije primjenjivati tijekom trudnoće.
English: There are no adequate human data from the use of pioglitazone in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni pioglitazona u trudnica.
English: In patients who fail to show an adequate response, pioglitazone should be discontinued.
Croatian: U bolesnika koji nisu adekvatno odgovorili na liječenje primjenu pioglitazona treba prekinuti.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu
English: 2 Long term treatment of metformin has been associated with a decrease of vitamin B12 absorption with decrease of serum levels.
Croatian: 2 Dugotrajno liječenje metforminom povezano je sa smanjenom apsorpcijom vitamina B12 uz sniženje njegove razine u serumu.
English: Tmax was delayed by food by approximately 1.9 h for pioglitazone and 0.8 h for metformin.
Croatian: Hrana je produljila Tmax pioglitazona za približno 1,9 sati, a metformina za 0,8 sati.
English: Avoid excessive alcohol intake while taking Glubrava since this may increase the risk of lactic acidosis (see section “Risk of lactic acidosis”).
Croatian: Izbjegavajte prekomjerni unos alkohola dok uzimate lijek Glubrava jer to može povećati rizik od laktacidoze (vidjeti dio “Rizik od laktacidoze ”).
English: These findings were observed across species at plasma concentrations ≤4 times the clinical exposure.
Croatian: Ovi su nalazi opaženi u svih životinjskih vrsta kod koncentracije u plazmi koja je  4 puta veća od izloženosti kod kliničke primjene.
English: Some epidemiological studies have suggested a similarly increased risk of fracture in both men and women.
Croatian: Neka epidemiološka ispitivanja ukazuju na jednako povećani rizik od lomova i kod muškaraca i kod žena.
English: Pioglitazone and metformin combination
Croatian: Kombinacija pioglitazona i metformina
English: if you have liver disease.
Croatian: - ako imate bolest jetre.
English: Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin in patients with GFR < 60 mL/min.
Croatian: Čimbenike koji mogu povećati rizik od laktacidoze (vidjeti dio 4.4) potrebno je provjeriti prije nego što se počne razmatrati uvođenje metformina u bolesnika s GFR < 60 ml/min.
English: If no adequate strength of Glubrava is available, individual monocomponents should be used instead of the fixed dose combination.
Croatian: Ako nije dostupna odgovarajuća jačina lijeka Glubrava, potrebno je primijeniti pojedinačne komponente zasebno umjesto fiksne kombinacije.
English: It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.
Croatian: Ne potiče izlučivanje inzulina i stoga ne izaziva hipoglikemiju.
English: It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Croatian: Pretpostavlja se da je farmakokinetika apsorpcije metformina nelinearna.
English: 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.
Croatian: Ako imate simptome hipoglikemije kao što su slabost, omaglica, pojačano znojenje, ubrzan rad srca, poremećaje vida ili poteškoće u koncentraciji, trebate uzeti šećer kako biste ponovo povećali razinu šećera u krvi.
English: Very common (may affect more than 1 in 10 people) - stomach ache - feeling sick (nausea) - vomiting - diarrhoea - loss of appetite
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba) - bol u trbuhu - mučnina - povraćanje - proljev - gubitak apetita
English: This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser degree.
Croatian: To se pretežno događa putem citokroma P450 2C8, iako i drugi izoenzimi mogu biti uključeni u manjem stupnju.
English: The safety and efficacy of Glubrava in children and adolescents under 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Glubrava u djece i adolescenata starosti do 18 godina nisu još ustanovljene.
English: Glubrava has no or negligible influence on the ability to drive and use machines.
Croatian: Glubrava ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: You may take your tablets with or just after food to reduce the chance of an upset stomach.
Croatian: Tablete možete uzeti uz obrok ili neposredno nakon obroka, jer to smanjuje mogućnost nadražaja želuca.
English: A 24-month mechanistic study in male rats demonstrated that administration of pioglitazone resulted in an increased incidence of hyperplastic changes in the bladder.
Croatian: Mehanističko ispitivanje u trajanju od 24 mjeseca u mužjaka štakora pokazalo je da je primjena pioglitazona rezultirala povećanom incidencijom hiperplastičkih promjena u mokraćnom mjehuru.
English: Total plasma concentration of pioglitazone is unchanged, but with an increased volume of distribution.
Croatian: Ukupna koncentracija pioglitazona u plazmi nije izmijenjena, ali volumen raspodjele je povećan.
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (> 5 mmol/L) and an increased anion gap and lactate/pyruvate ratio.
Croatian: Dijagnostički laboratorijski nalazi pokazuju snižen pH krvi (< 7,35), povišene razine laktata u plazmi (> 5 mmol/l) i povećan anionski procjep te omjer laktata i piruvata.
English: Your doctor may take blood tests to monitor your blood cell levels and liver function.
Croatian: Liječnik će Vam napraviti krvne pretrage kako bi pratio razine krvnih stanica i funkciju jetre.
English: If you stop using Glubrava, your blood sugar may go up.
Croatian: Ako prestanete uzimati lijek Glubrava, šećer u krvi Vam se može povisiti.
English: 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.
Croatian: Poremećaj vida zabilježen je uglavnom na početku liječenja i povezan je s promjenama glukoze u krvi zbog privremene promjene turgidnosti i indeksa refrakcije leće.
English: The MAH provided updates on new information related to the important identified and important potential risks as listed in the summary of safety concerns.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet dostavio je nadopune novih informacija vezanih uz važne identificirane i potencijalne rizike, kako je navedeno u sažetku sigurnosnih pitanja.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Glubrava (also see section 4) if you have a problem with your heart.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Glubrava (također pogledajte dio 4) - ako imate tegobe sa srcem.
English: Following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 min prolongation of time to peak plasma concentration was observed.
Croatian: Nakon primjene doze od 850 mg, opažena je 40% niža vršna koncentracija u plazmi, 25% smanjeni AUC i za 35 minuta produljeno vrijeme do postizanja vršne koncentracije u plazmi.
English: It is unclear whether or not there is a direct association between pioglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity; an appropriate ophthalmological referral should be considered.
Croatian: Nije jasno postoji li izravna veza između pioglitazona i makularnog edema, ali liječnici trebaju imati na umu mogućnost makularnog edema ako bolesnici prijave pogoršanje oštrine vida; potrebno je razmotriti upućivanje bolesnika na odgovarajući oftalmološki pregled.
English: Glubrava 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.
Croatian: Glubrava 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.
English: Consideration of such aetiology is recommended if a patient presents with megaloplastic anaemia.
Croatian: Potrebno je uzeti u obzir tu etiologiju ako bolesnik razvije megaloblastičnu anemiju.
English: Pioglitazone or placebo was added to existing antidiabetic and cardiovascular therapy for up to 3.5 years.
Croatian: Bolesnici su uzimali pioglitazon ili placebo kao dodatak postojećoj antidijabetičkoj i kardiovaskularnoj terapiji u trajanju do 3,5 godina.
English: Before you start taking Glubrava you will have a blood sample taken to check your liver function.
Croatian: Prije nego počnete uzimati lijek Glubrava uzet će Vam uzorak krvi za provjeru funkcije jetre.