FrancophonIA/ELRC3.0 huggingface dataset:
English: For a 2.0 microgram/kg/min infusion, mean steady-state plasma eptifibatide concentrations range from 1.5 to 2.2 microgram/ml in patients with coronary artery disease.
Croatian: Kod infuzije od 2,0 mikrograma/kg/min koncentracije eptifibatida u plazmi u stanju dinamičke ravnoteže iznose od 1,5 do 2,2 mikrograma/kg u bolesnika s koronarnom bolesti srca.
English: In patients with moderate to severe renal insufficiency (creatinine clearance < 50 ml/min), the clearance of eptifibatide is reduced by approximately 50% and steady-state plasma levels are approximately doubled.
Croatian: U bolesnika s umjerenim do teškim oštećenjem bubrega (klirens kreatinina < 50 ml/min), klirens eptifibatida smanjuje se za oko 50 %, a razine u plazmi u stanju dinamičke ravnoteže su približno udvostručene.
English: If you notice any signs of bleeding, notify your doctor or hospital pharmacist or nurse immediately.
Croatian: Ako primijetite bilo kakav znak krvarenja, odmah obavijestite svog liječnika, bolničkog ljekarnika ili medicinsku sestru.
English: There was no consistent evidence that eptifibatide increased the risk of major or minor bleeding associated with tissue plasminogen activator in either a PCI or an acute myocardial infarction study.
Croatian: Nema konzistentnih dokaza da eptifibatid povećava rizik od većeg i manjeg krvarenja povezanog s primjenom tkivnog aktivatora plazminogena u ispitivanjima u bolesnicika podvrgnutih PCI ili s akutnim infarktom miokarda.
English: The pharmacokinetics of eptifibatide are linear and dose proportional for bolus doses ranging from 90 to 250 microgram/kg and infusion rates from 0.5 to 3.0 microgram/kg/min.
Croatian: Farmakokinetika eptifibatida je linearna i proporcionalna dozi za bolus doze od 90 do 250 mikrogramaa/kg i brzini infuzije od 0,5 do 3,0 mikrograma/kg/min.
English: If you develop severe allergic reaction or hives, notify your doctor or hospital pharmacist or nurse immediately.
Croatian: Ako nastupi jaka alergijska reakcija ili urtikarija, odmah o tome obavijestite svog liječnika, bolničkog ljekarnika ili medicinsku sestru.
English: No statistically significant benefit of early routine eptifibatide strategy was demonstrated in the subgroup of patients who were managed medically or during the medical management periods prior to PCI or CABG.
Croatian: Statistički se značajna dobrobit rane rutinske primjene eptifibatida nije pokazala u podskupini bolesnika koji su nekirurški liječeni ili tijekom liječenja u koronarnoj jedinici prije provedbe PCI ili
English: Thrombocytopaenia occurring after first exposure to a GPIIb/IIIa inhibitor may be explained by the fact that antibodies are naturally present in some normal individuals.
Croatian: GPIIb/IIIa može biti objašnjena činjenicom da se takva antitijela prirodno mogu naći u pojedinih, inače zdravih osoba.
English: In the eptifibatide arm of the trial, virtually all patients received aspirin (99.7 %), and 98.1 % received a thienopyridine, (clopidogrel in 95.4 % and ticlopidine in 2.7 %).
Croatian: U ispitivanoj skupini koja je primala eptifibatid, gotovo svi bolesnici primali su aspirin (99,7 %), a 98,1 % ih je primalo tienopiridin, (klopidogrel u 95,4 % i tiklopidin u 2,7 %).
English: MI could also be reported following CEC adjudication of an investigator report.
Croatian: Infarkt miokarda se također mogao prijaviti i nakon što je Povjerenstvo za kliničke događaje provjerilo ispitivačevo izvješće.
English: Incidence of Death/CEC-Assessed MI («Treated as Randomised» Population)
Croatian: Incidencija smrti/infarkta miokarda utvrđenog od strane Povjerenstva za kliničke događaje (populacija „liječena prema randomizaciji“)
English: Fatal bleeding (the majority involved central and peripheral nervous system disorders: cerebral or intracranial haemorrhages); pulmonary haemorrhage, acute profound thrombocytopenia, haematoma.
Croatian: Vrlo rijetko fatalno krvarenje (većina se odnosila na poremećaje središnjeg i perifernog živčanog sustava: cerebralna ili intrakranijalna krvarenja); plućna hemoragija,
English: Major bleeding was defined in the PURSUIT trial as either an intracranial haemorrhage or a decrease in haemoglobin concentrations of more than 5 g/dl.
Croatian: Veliko krvarenje definirano je u ispitivanju PURSUIT ili kao intrakranijalno krvarenje ili kao pad koncentracije hemoglobina za više od 5 g/dl.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection
Croatian: OBLIK I SADRŽAJ Otopina za injekcije
English: MARKETING AUTHORISATION NUMBER EU/1/99/109/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/109/001
English: − if you have or have had difficulty with your blood clotting or a low blood platelet count.
Croatian: − ako ste imali ili imate problema sa zgrušavanjem krvi ili nizak broj trombocita.
English: − severe hypertension (systolic blood pressure > 200 mm Hg or diastolic blood pressure
Croatian: − s protrombinskim vremenom > 1,2 puta u odnosu na kontrolnu vrijednost ili INR ≥ 2,0 − s teškom hipertenzijom (sistolički krvni tlak > 200 mm Hg ili dijastolički krvni tlak
English: Skin and subcutaneous tissue disorders Very rare
Croatian: Vrlo rijetko anafilaktičke reakcije Poremećaji kože i potkožnog tkiva
English: During treatment with Integrilin in this study, minor bleeding was a very common complication (>1/10, or 13.1% for Integrilin versus 7.6% for placebo).
Croatian: INTEGRILIN u ovom ispitivanju manje krvarenje je bilo vrlo česta komplikacija (>1/10 ili 13,1 % uz
English: − major surgery or severe trauma within past 6 weeks
Croatian: − koji su imali velik kirurški zahvat ili ozbiljnu ozljedu (traumu) tijekom posljednjih 6 tjedana
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 vial of 10 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: 72 hours, until initiation of coronary artery bypass graft (CABG) surgery, or until discharge from the hospital (whichever occurs first).
Croatian: 2 mikrograma/kg/min u trajanju do najviše 72 sata, do početka operacije ugradnje premosnice koronarne arterije (CABG) ili do otpusta iz bolnice (ovisno o tome što se dogodi prije).
English: MARKETING AUTHORISATION NUMBER EU/1/99/109/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/109/002
English: In patients with moderate renal impairment, (creatinine clearance 30 - 50mL/min) 100% inhibition was achieved at 24 hours following administration of 2 microgram/kg/min.
Croatian: U bolesnika s umjerenim oštećenjem bubrežne funkcije (klirens kreatinina 30 - 50 ml/min) postignuta je 100 % -tna inhibicija 24 sata nakon primjene 2 mikrograma/kg/min.
English: Protection of INTEGRILIN solution from light is not necessary during administration.
Croatian: Zaštita otopine lijeka Integrilin od svjetlosti nije potrebna tijekom primjene.
English: The recommended dosage is an intravenous bolus of 180 microgram/kg administered as soon as possible following diagnosis, followed by a continuous infusion of 2 microgram/kg/min for up to
Croatian: Preporučena doza je intravenski bolus od 180 mikrograma/kg koji se daje što je moguće ranije od trenutka postavljanja dijagnoze, a nakon kojeg se nastavlja kontinuirana infuzija od
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for injection contains 2 mg of eptifibatide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml otopine za injekcije sadržava 2 mg eptifibatida.
English: With delayed provisional eptifibatide administration, the TIMI major events were 1.4% vs 2.0% in patients who received reduced dose and standard dose respectively (p=0.54).
Croatian: Uz odgođenu privremenu primjenu eptifibatida, prema TIMI velika krvarenja su iznosila 1,4 % u bolesnika koji su primali smanjenu dozu naspram 2,0 % u bolesnika na standardnoj dozi (p=0,54).
English: Integrilin 2 mg/ml solution for injection eptifibatide
Croatian: INTEGRILIN 2 mg/ml otopina za injekcije eptifibatid
English: In patients with severe renal impairment (creatinine clearance <30mL/min) administered 1microgram/kg/min , 80% inhibition was achieved in more than 80% of patients at 24 hours.
Croatian: U bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min) u kojih je primijenjen lijek u dozi od 1 mikrogram/kg/min, nakon 24 sata postignuta je 80 % -tna inhibicija u više od 80 % bolesnika.
English: Uncommon Cerebral ischaemia.
Croatian: Poremećaji živčanog sustava Manje često cerebralna ishemija
English: These may affect up to 1 in 10,000 people
Croatian: Mogu se javiti u manje od 1 na 10 000 osoba
English: Patients were randomised to either placebo, eptifibatide 180 microgram/kg bolus followed by a 2.0 microgram/kg/min infusion (180/2.0), or eptifibatide 180 microgram/kg bolus followed by a 1.3 microgram/kg/min infusion (180/1.3).
Croatian: Bolesnici su randomizirani u skupinu koja je primala placebo ili u skupinu koja je primala eptifibatid 180 mikrograma/kg u bolusu, te nakon toga infuziju od 2,0 mikrograma/kg/min (180/2,0), ili u skupinu koja je primala eptifibatid 180 mikrograma/kg u bolusu, te nakon toga infuziju od 1,3 mikrograma/kg/min (180/1,3).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for infusion contains 0.75 mg of eptifibatide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml otopine za infuziju sadržava 0,75 mg eptifibatida.
English: The pivotal clinical trial for Unstable Angina (UA)/Non-Q Wave Myocardial Infarction (NQMI) was PURSUIT.
Croatian: PURSUIT je bilo ključno kliničko ispitivanje liječenja nestabilne angine (NA)/ infarkta miokarda bez Q-zupca (NQIM).
English: Integrilin 0.75 mg/ml solution for infusion eptifibatide
Croatian: INTEGRILIN 0,75 mg/ml otopina za infuziju eptifibatid
English: These may affect up to 1 in 100 people
Croatian: Mogu se javiti u manje od 1 na 100 osoba
English: − concomitant or planned administration of another parenteral glycoprotein (GP) IIb/IIIa inhibitor
Croatian: − kojima se istodobno daje ili se planira davati drugi parenteralni inhibitor glikoproteina (GP)
English: − medicines that prevent blood clots, including warfarin, dipyridamole, ticlopidine, aspirin (except those that you may be given as part of Integrilin treatment).
Croatian: tiklopidin, aspirin (osim onih koje Vam liječnik može dati kao dio liječenja lijekom Integrilin).
English: − history of stroke within 30 days or any history of haemorrhagic stroke
Croatian: − koji su imali moždani udar unutar 30 dana prije liječenja ili bilo kakav hemoragijski moždani udar u povijesti bolesti
English: Each ml of solution for injection contains 2 mg of eptifibatide.
Croatian: 1 ml otopine za injekcije sadrži 2 mg eptifibatida.
English: Do not use if particulate matter or discolouration is present.
Croatian: Nemojte koristiti ako su u bočici čestice ili je promijenjena boja.
English: Pharmacotherapeutic group: Antithrombotic agent (platelet aggregation inhibitors excl. heparin), ATC code: B01AC16
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Antitrombotički agens (inhibitor agregacije trombocita izuzev heparina),
English: NAME OF THE MEDICINAL PRODUCT INTEGRILIN 2 mg/ml solution for injection
Croatian: NAZIV LIJEKA INTEGRILIN 2 mg/ml otopina za injekcije
English: Early routine eptifibatide in this high-risk NSTE-ACS optimally-treated population who were managed with an invasive strategy did not result in a statistically significant reduction in the composite primary endpoint of rate of death, MI, RI-UR, and TBO within 96 hours compared with a regimen of delayed provisional eptifibatide (9.3% in early eptifibatide patients vs. 10.0% in patients assigned to delayed provisional eptifibatide; odds ratio=0.920; 95% CI=0.802-1.055; p=0.234).
Croatian: u bolesnika s ranom primjenom eptifibatida vs 10,0 % u bolesnika s odgođenom privremenom primjenom eptifibatida; omjer vjerojatnosti = 0,920; 95% CI = 0,802 - 1,055; p=0,234).
English: Patients could be medically managed, proceed to coronary artery bypass graft (CABG), or undergo percutaneous coronary intervention (PCI).
Croatian: Bolesnici su mogli biti liječenji lijekovima, proslijeđeni na ugradnju CABG ili podvrgnuti PCI-u.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION INTEGRILIN 0.75 mg/ml solution for infusion eptifibatide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA INTEGRILIN 0,75 mg/ml otopina za infuziju eptifibatid
English: Each ml of solution for infusion contains 0.75 mg of eptifibatide.
Croatian: 1 ml otopine za infuziju sadrži 0,75 mg eptifibatida.
English: − severe renal impairment (creatinine clearance < 30 ml/min) or dependency on renal dialysis
Croatian: − s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) ili oni koji ovise o dijalizi − s klinički značajnim oštećenjem jetre
English: TIMI major bleeding occurred in 2.7 % of patients who received a reduced dose (1microgram/kg/min) vs 4.2% of patients who received the standard dose (2microgram/kg/min) when eptifibatide was administered in the early routine fashion (p=0.36).
Croatian: TIMI veliko krvarenje je nastupilo u 2,7 % bolesnika koji su primali smanjenu dozu (1 mikrogram/kg/min) naspram 4,2 % bolesnika na standardnoj dozi
English: − clinically significant hepatic impairment
Croatian: akutna teška trombocitopenija, pojava hematoma
English: Keep this medicine out of the sight and reach of children Do not use this medicine after the expiry date (EXP) stated on the package and the vial.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza iznake EXP.
English: 6.3 Shelf life
Croatian: IIb/IIIa
English: Batch
Croatian: CABG.
English: UA/NQMI: For a patient who weighs ≥ 70 kg, it is recommended that a bolus dose of 5,000 units is given, followed by a constant intravenous infusion of 1,000 units/hr.
Croatian: Nestabilna angina ili Q infarkt miokarda bez Q-zupca: Za bolesnika koji teži ≥ 70 kg preporučuje se primjena bolus doze od 5000 jedinica, nakon koje treba uslijediti intravenska infuzija od 1000 jedinica/h.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION INTEGRILIN 2 mg/ml solution for injection eptifibatide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA INTEGRILIN 2 mg/ml otopina za injekcije eptifibatid
English: NAME OF THE MEDICINAL PRODUCT INTEGRILIN 0.75 mg/ml solution for infusion
Croatian: NAZIV LIJEKA INTEGRILIN 0,75 mg/ml otopina za infuziju
English: In a post hoc analysis of the EARLY ACS trial the risk benefit of dose reduction in patients with moderate renal impairment is inconclusive.
Croatian: ACS ne mogu se izvući zaključci o odnosu rizika i koristi primjene smanjene doze u bolesnika s umjerenim oštećenjem bubrežne funkcije.
English: − If you have any further questions, ask your doctor or hospital pharmacist or nurse.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku, bolničkom ljekarniku ili medicinskoj sestri.
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Croatian: GlaxoSmithKline d.o.o. Tel.: + 385 (0)1 605 19 99
English: Discard any unused medicinal product after opening.
Croatian: Nakon otvaranja, neupotrijebljeni lijek treba zbrinuti.
English: One vial of 100 ml of solution for infusion contains 75 mg of eptifibatide.
Croatian: Jedna bočica sa 100 ml otopine za infuziju sadrži 75 mg eptifibatida.
English: Eptifibatide reversibly inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor and other adhesive ligands to the glycoprotein (GP)IIb/IIIa receptors.
Croatian: Willebrandovog faktora i drugih adhezivnih liganada za receptore glikoproteina (GP) IIb/IIIa.
English: Common side effects These may affect up to 1 in 10 people
Croatian: Vrlo rijetke nuspojave Mogu se javiti u manje od 1 na 10 000 osoba
English: The clear, colourless solution is contained in a 10 ml glass vial, which is closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
Croatian: Bistra bezbojna otopina u staklenoj bočici od 10 ml, zatvorenoj s gumenim (butil guma) čepom i zapečaćenoj aluminijskom plombom.
English: One vial of 10 ml of solution for injection contains 20 mg of eptifibatide.
Croatian: Jedna bočica sa 10 ml otopine za injekcije sadrži 20 mg eptifibatida.
English: The clear, colourless solution is contained in a 100 ml glass vial, which is closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
Croatian: Bistra bezbojna otopina u staklenoj bočici od 100 ml, zatvorenoj s gumenim (butil guma) čepom i zapečaćenoj aluminijskom plombom.
English: − age
Croatian: − dob
English: If you have any further questions on the use of this product, ask your doctor or hospital pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku, bolničkom ljekarniku ili medicinskoj sestri.
English: With delayed provisional eptifibatide administration, the event rates were 10% vs 11.5% in patients who received reduced dose and standard dose respectively (p=0.61).
Croatian: Uz odgođenu privremenu primjenu eptifibatida, stope događaja su za bolesnike sa smanjenom dozom lijeka iznosile 10 % u odnosu na
English: − if you have had a stroke within the past 30 days or any haemorrhagic stroke (also, be sure your doctor knows if you ever had a stroke).
Croatian: (također, liječnik svakako mora znati ako ste ikada doživjeli moždani udar).
English: The incidence of severe or life threatening bleeding events with Integrilin was 1.9% compared to 1.1% with placebo.
Croatian: 1,9 % u usporedbi s 1,1 % bolesnika koji su dobivali placebo.
English: How to store Integrilin
Croatian: Moguće nuspojave Kako čuvati Integrilin
English: In patients with previous immune-mediated thrombocytopaenia from other parenteral GP IIb/IIIa inhibitors, there are no data with the use of INTEGRILIN.
Croatian: Nema podataka o primjeni lijeka INTEGRILIN u bolesnika koji su razvili imunološki posredovanu trombocitopeniju nakon primjene drugih parenteralnih inhibitora GP IIb/IIIa.
English: Thrombocytopenia and Immunogencity related to GP IIb/IIIa inhibitors INTEGRILIN inhibits platelet aggregation, but does not appear to affect the viability of platelets.
Croatian: Trombocitopenija i imunogenost vezana uz inhibitore GP IIb/IIIa
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution for injection contains 2 mg of eptifibatide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 ml otopine sadržava 2 mg eptifibatida.
English: One 100 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
Croatian: Jedna staklena bočica (staklo tipa I) sa 100 ml otopine, zatvorena gumenim čepom (butil guma) i aluminijskim prstenom.
English: Common
Croatian: Prema
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution for infusion contains 0.75 mg of eptifibatide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 ml otopine sadržava 0,75 mg eptifibatida.
English: One 10 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
Croatian: Jedna staklena bočica (staklo tipa I) s 10 ml otopine, zatvorena gumenim čepom (butil guma) i aluminijskim prstenom.
English: NAME OF THE MEDICINAL PRODUCT INTEGRILIN 2 mg/ml solution for injection eptifibatide
Croatian: Uputa o lijeku: Informacije za bolesnika Integrilin 2 mg/ml otopina za injekcije eptifibatid
English: NAME OF THE MEDICINAL PRODUCT INTEGRILIN 0.75 mg/ml solution for infusion eptifibatide
Croatian: Uputa o lijeku: Informacije za bolesnika Integrilin 0,75 mg/ml otopina za infuziju eptifibatid
English: Very common Bleeding (major and minor bleeding including femoral artery access, CABG
Croatian: Poremećaji krvi i limfnog sustava Vrlo često krvarenje (veliko i manje krvarenje uključujući i krvarenje na mjestu pristupa femoralnoj arteriji, vezana uz CABG, gastrointestinalno, urogenitalno, retroperitonealno, intrakranijalno krvarenje, hematemeza, hematurija, oralno/orofaringealno krvarenje, pad hemoglobina/hematokrita i drugo)
English: What Integrilin contains
Croatian: Sadržaj pakiranja i druge informacije Što Integrilin sadrži
English: Eptifibatide reversibly inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor and other adhesive ligands to the glycoprotein (GP) IIb/IIIa receptors.
Croatian: Eptifibatid reverzibilno inhibira agregaciju trombocita sprječavajući vezivanje fibrogena, von
English: If you get any side effects, talk to your doctor, hospital pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, bolničkog ljekarnika ili medicinsku sestru.
English: Iasibon is used in the following ways:
Croatian: Iasibon se primjenjuje u sljedećim situacijama:
English: The full EPAR for Iasibon can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Iasibon nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The patient must not lie down for one hour after taking the tablet.
Croatian: Bolesnik ne smije leći najmanje jedan sat nakon što je uzeo tablete.
English: The tablet should be taken while standing or sitting up, and it should not be chewed, sucked or crushed.
Croatian: Tabletu treba uzeti stojeći ili sjedeći, a tablete se ne smiju žvakati, cuclati niti drobiti.
English: They must be taken with a full glass of plain water (in areas with hard water, where tap water contains a lot of dissolved calcium, bottled water with a low mineral content should be used).
Croatian: Lijek treba uzeti s punom čašom obične vode (u područjima s tvrdom vodom, gdje tekuća voda sadrži veliku količinu otopljenog kalcija, može se koristiti flaširana voda s niskom koncentracijom minerala).
English: The infusion will normally bring the blood calcium level down to normal levels within a week.
Croatian: Infuzija najčešće snižava razine kalcija u krvi na normalne razine u roku od tjedan dana.
English: Iasibon is a ‘generic medicine'.
Croatian: Iasibon je „generički lijek”.
English: What measures are being taken to ensure the safe and effective use of Iasibon?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Iasibon?
English: This means that Iasibon is similar to a ‘reference medicine' already authorised in the European Union (EU) called Bondronat.
Croatian: To znači da je Iasibon sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Bondronat.
English: It is available as a concentrate that is made up into a solution for infusion (drip into a vein) and as tablets (50 mg).
Croatian: Dostupan je kao koncentrat za pripremu otopine za infuziju (drip) u venu i kao tablete (50 mg).
English: The tablets must always be taken after the patient has not eaten anything for at least six hours overnight and at least 30 minutes before the first food or drink of the day.
Croatian: Tablete se uvijek trebaju uzimati na prazan želudac, nakon što je bolesnik postio preko noći najmanje šest sati i najmanje 30 minuta prije prvog obroka ili pića tog dana.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Iasibon on 21 January 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Iasibon na snazi u Europskoj uniji od 21. siječnja 2011.
English: What are the benefits and risks of Iasibon?
Croatian: Koje su koristi i rizici lijeka Iasibon?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Iasibon.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Iasibon.
English: This is a summary of the European public assessment report (EPAR) for Iasibon.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Iasibon.
English: For more information about treatment with Iasibon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Iasibon pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.