FrancophonIA/ELRC3.0 huggingface dataset:
English: Integrilin should not be used if it is noticed that particulate matter or discoloration is present.
Slovenian: Ne uporabljajte zdravila Integrilin, če ste opazili delce ali obarvanje vsebine.
English: − serious bleeding (for example, bleeding inside the abdomen, inside the brain, and into the lungs).
Slovenian: - hude krvavitve (na primer, krvavitve v trebušni votlini, možganih ali v pljuča);
English: Protection of INTEGRILIN solution from light is not necessary during administration.
Slovenian: Zaščita raztopine Integrilin pred svetlobo med uporabo ni potrebna.
English: Arterial sheaths may be removed when coagulation has returned to normal (e.g. when activated clotting time (ACT) is less than 180 seconds (usually 26 hours after discontinuation of heparin).
Slovenian: ko je aktivirani čas strjevanja (AČS) manjši od 180 sekund; ponavadi 2 do 6 ur po ukinitvi heparina).
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.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na viali poleg oznake »EXP«.
English: GlaxoSmithKline Manufacturing S.P.A. Strada Provinciale Asolana No. 90 San Polo di Torrile 43056 Parma
Slovenian: Strada Provinciale Asolana No. 90 San Polo di Torrile 43056 Parma
English: INTEGRILIN is intended for use with acetylsalicylic acid and unfractionated heparin.
Slovenian: 4.1 Terapevtske indikacije Zdravilo INTEGRILIN je namenjeno uporabi z acetilsalicilno kislino in nefrakcioniranim heparinom.
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).
Slovenian: UR) in reševanja tromboze (TBO)) v 96 urah v primerjavi s shemo odložene pomožne uporabe eptifibatida (9,3 % med bolniki z zgodnjo uporabo eptifibatida v primerjavi z 10,0 % med bolniki z odloženo pomožno uporabo; razmerje obetov = 0,920, 95% IZ = 0,802-1,055, p = 0,234).
English: Very common Bleeding (major and minor bleeding including femoral artery access, CABG
Slovenian: Zelo pogosti krvavitve (večje ali manjše krvavitve, vključujoč femoralni arterijski dostop, v povezavi s CABG, v prebavilih, v sečilih in spolnih organih, retroperitonealno,
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Irska 12.
English: − evidence of gastrointestinal bleeding, gross genitourinary bleeding or other active abnormal bleeding within the previous 30 days of treatment
Slovenian: - preobčutljivostjo na zdravilno učinkovino ali katerokoli pomožno snov navedeno v poglavju - znaki krvavitve v prebavilih, obilno krvavitvijo v sečilih ali spolnih organih ali kako drugo aktivno nenormalno krvavitvijo, ki nastopi v zadnjih 30 dneh pred zdravljenjem;
English: Shock, hypotension, phlebitis.
Slovenian: Žilne bolezni Pogosti šok, hipotenzija, flebitis
English: How to store Integrilin
Slovenian: Shranjevanje zdravila Integrilin
English: Similar differences were noted for TIMI major haemorrhage (118 [2.5%] in early routine use vs. 83 [1.8%] in delayed provisional use; p=0.016).
Slovenian: s 83 [1,8 %] med odloženo pomožno uporabo, p = 0,016).
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).
Slovenian: Večje krvavitve po TIMI so se pojavile pri 2,7 % prejemnikov nižjega odmerka (1 mikrogram/kg/min) in pri 4,2 % prejemnikov standardnega odmerka (2 mikrograma/kg/min), če je bil eptifibatid uporabljen v zgodnjem rutinskem načinu (p = 0,36).
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.
Slovenian: Pri bolnikih s hudo okvaro ledvic (kreatininski očistek < 30 ml/min), ki so prejeli 1 mikrogram/kg/min, je bila 80 % inhibicija po 24 urah dosežena pri več kot 80 % bolnikov.
English: Not relevant, as INTEGRILIN is intended for use only in hospitalised patients.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Podatek ni potreben, ker je zdravilo INTEGRILIN namenjeno samo zdravljenju hospitaliziranih bolnikov.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2)
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
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).
Slovenian: V primeru odložene pomožne uporabe eptifibatida je bil delež večjih dogodkov po TIMI med prejemniki nižjega odmerka 1,4 % in med prejemniki standardnega odmerka 2 % (p = 0,54).
English: − elevated heart rate or blood pressure
Slovenian: - zvišano srčno frekvenco ali krvnim tlakom, - trdovratno ali ponavljajočo se ishemično srčno bolečino,
English: haematuria, oral/oropharyngeal, haemoglobin/haematocrit decreased and other).
Slovenian: intrakranialno, hematemezo, hematurijo, oralno ali orofaringealno, zmanjšane vrednosti hemoglobina in hematokrita in druge)
English: Physical and chemical compatibility testing indicate that INTEGRILIN may be administered through an intravenous line with atropine sulfate, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, tissue plasminogen activator, or verapamil.
Slovenian: dajete po intravenski liniji skupaj z atropinijevim sulfatom, dobutaminom, heparinom, lidokainom, meperidinom, metoprololom, midazolamom, morfinom, nitroglicerinom, tkivnim aktivatorjem plazminogena in verapamilom.
English: Marketing Authorisation Holder:
Slovenian: Navodilo vsebuje:
English: What you need to know before you are given Integrilin
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Integrilin Zdravila Integrilin ne smete dobiti:
English: The primary endpoint event rate was 11.9 % in patients who received a reduced dose (1microgram/kg/min) vs 11.2% in patients who received the standard dose (2microgram/kg/min) when eptifibatide was administered in the early routine fashion (p=0.81).
Slovenian: Delež primarnih opazovanih dogodkov je bil 11,9 % pri prejemnikih nižjega odmerka (1 mikrogram/kg/min) in 11,2 % pri prejemnikih standardnega odmerka (2 mikrograma/kg/min), če je bil eptifibatid uporabljen v zgodnjem rutinskem načinu (p = 0,81).
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).
Slovenian: V primeru odložene pomožne uporabe eptifibatida pa je bil delež dogodkov med prejemniki nižjega odmerka 10 % in med prejemniki standardnega odmerka 11,5 % (p = 0,61).
English: INTEGRILIN solution for infusion must be used in conjunction with INTEGRILIN solution for injection.
Slovenian: Raztopino za infundiranje INTEGRILIN morate uporabljati skupaj z raztopino za injiciranje INTEGRILIN.
English: INTEGRILIN must not be used to treat patients with:
Slovenian: 4.3 Kontraindikacije Z zdravilom INTEGRILIN ne smete zdraviti bolnikov z/s:
English: 72 hours, until initiation of coronary artery bypass graft (CABG) surgery, or until discharge from the hospital (whichever occurs first).
Slovenian: Zdravljenje naj se nadaljuje s kontinuirano infuzijo 2 mikrograma/kg/min do 72 ur, bodisi do začetka koronarnega premostitvenega posega (CABG - Coronary Artery Bypass Graft) ali do odpusta iz bolnišnice (karkoli nastopi prej).
English: − heart failure
Slovenian: Srčne bolezni
English: Data are limited on the use of INTEGRILIN in patients receiving thrombolytic agents.
Slovenian: Zdravilo INTEGRILIN in trombolitična zdravila Podatki o uporabi zdravila INTEGRILIN pri bolnikih, zdravljenih s trombolitičnimi zdravili, so omejeni.
English: Integrilin 2 mg/ml solution for injection eptifibatide
Slovenian: INTEGRILIN 2 mg/ml raztopina za injiciranje eptifibatid
English: INTEGRILIN solution for injection must be used in conjunction with INTEGRILIN solution for infusion.
Slovenian: Raztopino za injiciranje INTEGRILIN morate uporabljati skupaj z raztopino za infundiranje INTEGRILIN.
English: Each ml of solution for injection contains 2 mg of eptifibatide.
Slovenian: Vsak ml raztopine za injiciranje vsebuje 2 mg eptifibatida.
English: An increased risk of bleeding may also be observed in patients who receive early administration of INTEGRILIN (e.g. upon diagnosis) compared to receiving it immediately prior to PCI, as seen in the Early ACS trial.
Slovenian: (npr. ob postavitvi diagnoze), v primerjavi s tistimi, ki ga prejmejo tik pred perkutanim koronarnim posegom, kot je pokazala študija Early ACS.
English: − skin rash (such as hives).
Slovenian: - kožni izpuščaj (kot je koprivnica);
English: Because INTEGRILIN inhibits platelet aggregation, caution must be employed when it is used with other medicinal products that affect haemostasis, including ticlopidine, clopidogrel, thrombolytics, oral anticoagulants, dextran solutions, adenosine, sulfinpyrazone, prostacyclin, non-steroidal antiinflammatory agents, or dypyridamole (see section 4.5).
Slovenian: peroralnimi antikoagulanti, raztopinami dekstrana, adenozinom, sulfinpirazonom, prostaciklinom, nesteroidnimi protivnetnimi zdravili ali dipiridamolom (glejte poglavje 4.5).
English: Uncommon Cerebral ischaemia.
Slovenian: Bolezni živčevja Občasni možganska ishemija
English: Vascular Disorders Common
Slovenian: Občasni trombocitopenija
English: Integrilin 0.75 mg/ml solution for infusion eptifibatide
Slovenian: INTEGRILIN 0,75 mg/ml raztopina za infundiranje eptifibatid
English: Patients most likely to benefit from INTEGRILIN treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA (Percutaneous Transluminal Coronary Angioplasty) (see section 5.1).
Slovenian: Verjetnost, da bo zdravljenje z zdravilom INTEGRILIN koristilo bolniku, je največja pri bolnikih z velikim tveganjem za nastanek miokardnega infarkta v prvih 3 do 4 dneh po pojavu akutnih simptomov angine pektoris.
English: NAME OF THE MEDICINAL PRODUCT INTEGRILIN 2 mg/ml solution for injection
Slovenian: IME ZDRAVILA INTEGRILIN 2 mg/ml, raztopina za injiciranje
English: − major surgery or severe trauma within past 6 weeks
Slovenian: - večjo operacijo ali hujšo poškodbo v zadnjih 6 tednih; - hemoragično diatezo v anamnezi;
English: There is no experience with INTEGRILIN and low molecular weight heparins.
Slovenian: Izkušenj s sočasno uporabo nizkomolekularnih heparinov in zdravila INTEGRILIN ni.
English: Skin and subcutaneous tissue disorders Very rare
Slovenian: Bolezni kože in podkožja Zelo redki težave na mestu aplikacije npr. urtikarija
English: Each ml of solution for infusion contains 0.75 mg of eptifibatide.
Slovenian: Vsak ml raztopine za injiciranje vsebuje 0,75 mg eptifibatida.
English: INTEGRILIN is an antithrombotic agent that acts by inhibition of platelet aggregation; therefore the patient must be observed carefully for indications of bleeding during treatment (see section 4.8).
Slovenian: Bolnika morate torej med zdravljenjem skrbno spremljati, da odkrijete znake krvavitve (glejte poglavje 4.8).
English: If you have any further questions on the use of this product, ask your doctor or hospital pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
English: What Integrilin looks like and contents of the pack Integrilin solution for injection: 10 ml vial, pack of one vial.
Slovenian: Integrilin raztopina za injiciranje: 10 ml viala, pakiranje po ena viala.
English: If Percutaneous Coronary Intervention (PCI) is performed during eptifibatide therapy, continue the infusion for 20-24 hours post-PCI for an overall maximum duration of therapy of 96 hours.
Slovenian: Percutaneous Coronary Intervention), morate nato z infuzijo nadaljevati še 20 do 24 ur po perkutanemkoronarnem posegu; povprečno najdaljše skupno trajanje zdravljenja je 96 ur.
English: NAME OF THE MEDICINAL PRODUCT INTEGRILIN 0.75 mg/ml solution for infusion
Slovenian: IME ZDRAVILA INTEGRILIN 0,75 mg/ml raztopina za infundiranje
English: Major bleeding was also very common and reported more frequently with Integrilin than with placebo in the PURSUIT study (>1/10 or 10.8% versus 9.3%), but it was infrequent in the vast majority of patients who did not undergo CABG within 30 days of inclusion in the study.
Slovenian: 10,8 % v primerjavi z 9,3 %), a niso bile pogoste pri veliki večini bolnikov, pri katerih ni bil narejen obvod koronarne arterije v 30 dneh od vključitve v študijo.
English: • either ST-segment changes: ST depression > 0.5 mm of less than 30 minutes or persistent ST
Slovenian: • bodisi spremembe spojnice ST: znižanje spojnice ST za > 0,5 mm za manj kot 30 minut ali trdovratno zvišanje spojnice ST za > 0,5 mm, ki ni zahtevalo reperfuzijske terapije ali trombolitičnih zdravil, inverzijo vala T (> 1 mm), • ali povečanje vrednosti CK-MB.
English: The pivotal clinical trial for Unstable Angina (UA)/Non-Q Wave Myocardial Infarction (NQMI) was PURSUIT.
Slovenian: Osrednja klinična študija nestabilne angine pektoris ali miokardnega infarkta brez zobca Q v EKG je bila študija PURSUIT.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION INTEGRILIN 0.75 mg/ml solution for infusion eptifibatide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE INTEGRILIN 0,75 mg/ml raztopina za infundiranje eptifibatid intravenska uporaba
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION INTEGRILIN 2 mg/ml solution for injection eptifibatide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE INTEGRILIN 2 mg/ml raztopina za injiciranje eptifibatid intravenska uporaba
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.
Slovenian: Willebrandovega faktorja in drugih adhezivnih ligandov na receptorje glikoproteina (GP) IIb/IIIa.
English: − medicines that prevent blood clots, including warfarin, dipyridamole, ticlopidine, aspirin (except those that you may be given as part of Integrilin treatment).
Slovenian: tiklopidinom in acetilsalicilno kislino (razen tistih, ki jih boste morda dobili v okviru zdravljenja z zdravilom Integrilin).
English: − If you have any further questions, ask your doctor or hospital pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
English: PURSUIT: This was a randomised, double-blind evaluation of the efficacy and safety of Integrilin versus placebo for reducing mortality and myocardial (re)infarction in patients with unstable angina or non-Q-wave myocardial infarction.
Slovenian: Integrilin v primerjavi s placebom za zmanjšanje umrljivosti in (ponovnega) miokardnega infarkta pri bolnikih z nestabilno angino pektoris ali miokardnim infarktom brez zobca Q v EKG.
English: For this diagnosis, within 24 hours after the index PCI procedure, there had to be at least two CK-MB values ≥ 3 x the upper limit of normal; thus, validation by the CEC was not required.
Slovenian: Miokardni infarkt so ugotavljali na podlagi osrednjih laboratorijskih meril za CK-MB. Za to diagnozo sta morali biti v obdobju 24 ur po zadevnem perkutanem koronarnem posegu najmanj dve vrednosti
English: INTEGRILIN did not appear to increase the risk of major and minor bleeding associated with concomitant use of warfarin and dipyridamole.
Slovenian: Pri sočasni uporabi z varfarinom in dipiridamolom ni bilo videti, da bi zdravilo INTEGRILIN povečalo tveganje za pojav večjih ali manjših krvavitev.
English: − severe renal impairment (creatinine clearance < 30 ml/min) or dependency on renal dialysis
Slovenian: - hudo okvaro ledvic (kreatininski očistek < 30 ml/min) ali odvisnost od dialize; - klinično pomembno jetrno okvaro; - sočasno ali predvideno uporabo kakega drugega parenteralnega zaviralca glikoproteina (GP)
English: One 100 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
Slovenian: Ena 100 ml viala iz stekla tipa I, zaprta z zamaškom iz butilne gume in zapečatena z aluminijasto zaporko.
English: If you get any side effects, talk to your doctor, hospital pharmacist or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, bolnišničnim farmacevtom ali medicinsko sestro.
English: One 10 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
Slovenian: Ena 10 ml viala iz stekla tipa I, zaprta z zamaškom iz butilne gume in zapečatena z aluminijasto zaporko.
English: These may affect up to 1 in 100 people
Slovenian: Pojavijo se pri 1 do 10 bolnikih od 100 bolnikov - vnetje ven.
English: Patients were managed according to the usual standards of the investigational site; frequencies of angiography, PCI and CABG therefore differed widely from site to site and from country to country.
Slovenian: perkutanih koronarnih posegov in koronarnih premostitvenih operacij se je zato zelo razlikovala med posameznimi mesti in državami.
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
Slovenian: Priporočeni odmerek je intravenski bolus 180 mikrogramov/kg čimprej po diagnozi.
English: Rash, application site disorders such as urticaria.
Slovenian: Bolezni kože in podkožja Zelo redki izpuščaj, težave na mestu aplikacije npr. urtikarija
English: Warfarin and dipyridamole
Slovenian: OVOJNINAH NALEPKA
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.
Slovenian: Bistra brezbarvna raztopina v 10-ml stekleni viali, ki je zaprta z zamaškom iz butilne gume in zapečatena z aluminijskim pokrovčkom.
English: − severe hypertension (systolic blood pressure > 200 mm Hg or diastolic blood pressure
Slovenian: - trombocitopenijo (< 100.000 celic/mm3); - protrombinskim časom > 1,2-krat večjim od kontrolne vrednosti ali mednarodnim normaliziranim količnikom (INR) ≥ 2,0; - hudo hipertenzijo (sistolični krvni tlak > 200 mm Hg ali diastolični krvni tlak > 110 mmHg ob antihipertenzivnem zdravljenju);
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.
Slovenian: Eptifibatid reverzibilno zavira agregacijo trombocitov, saj preprečuje vezavo fibrinogena, von
English: NAME OF THE MEDICINAL PRODUCT INTEGRILIN 2 mg/ml solution for injection eptifibatide
Slovenian: NAVODILO ZA UPORABO Integrilin 2 mg/ml raztopina za injiciranje eptifibatid
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.
Slovenian: Bistra brezbarvna raztopina v 100-ml stekleni viali, ki je zaprta z zamaškom iz butilne gume in zapečatena z aluminijskim pokrovčkom.
English: Integrilin is an inhibitor of platelet aggregation.
Slovenian: Zdravilo INTEGRILIN je antitrombotično zdravilo, ki deluje tako, da zavira agregacijo trombocitov.
English: NAME OF THE MEDICINAL PRODUCT INTEGRILIN 0.75 mg/ml solution for infusion eptifibatide
Slovenian: NAVODILO ZA UPORABO Integrilin 0,75 mg/ml raztopina za infundiranje eptifibatid
English: MARKETING AUTHORISATION NUMBER EU/1/99/109/001
Slovenian: ŠTEVILKA DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/99/109/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/109/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/99/109/001
English: − If you get any side effects talk to your doctor or hospital pharmacist or nurse.
Slovenian: - Če opazite katerikoli neželeni učinek se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/109/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/99/109/002
English: MARKETING AUTHORISATION NUMBER EU/1/99/109/002
Slovenian: ŠTEVILKA DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/99/109/002
English: − reduction in the number of platelets (blood cells necessary for blood clotting).
Slovenian: Pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov - zmanjšanje števila trombocitov (krvnih celic, ki so potrebne za strjevanje krvi);
English: PHARMACEUTICAL FORM AND CONTENTS Solution for infusion
Slovenian: Izgled zdravila Integrilin in vsebina pakiranja
English: Thrombocytopaenia, including acute profound thrombocytopaenia, has been observed with eptifibatide administration post-marketing (see section
Slovenian: Pri uporabi eptifibatida v obdobju trženja so opažali trombocitopenijo, vključno z akutno hudo trombocitopenijo (glejte poglavje 4.8).
English: − age
Slovenian: Lot
English: − concomitant or planned administration of another parenteral glycoprotein (GP) IIb/IIIa inhibitor
Slovenian: - klinično pomembno jetrno okvaro; - sočasno ali predvideno uporabo kakega drugega parenteralnega zaviralca glikoproteina (GP)
English: What measures are being taken to ensure the safe and effective use of Iasibon?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Iasibon?
English: Iasibon is used in the following ways:
Slovenian: Zdravilo Iasibon se uporablja na naslednje načine:
English: The tablet should be taken while standing or sitting up, and it should not be chewed, sucked or crushed.
Slovenian: Bolnik mora tableto vzeti v stoječem ali sedečem položaju, te pa ne sme žvečiti, lizati ali zdrobiti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Iasibon on 21 January 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Iasibon, veljavno po vsej Evropski uniji, izdala 21. januarja 2011.
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).
Slovenian: Tableto mora vzeti s polnim kozarcem navadne vode (na območjih s trdo vodo, kjer voda iz pipe vsebuje veliko raztopljenega kalcija, se lahko uporabi ustekleničena voda z nizko vsebnostjo mineralov).
English: What are the benefits and risks of Iasibon?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Iasibon?
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.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Iasibon je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This means that Iasibon is similar to a ‘reference medicine' already authorised in the European Union (EU) called Bondronat.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Bondronat.
English: Iasibon treatment should only be started by a doctor who has experience in the treatment of cancer.
Slovenian: Zdravljenje z zdravilom Iasibon lahko začne le zdravnik, ki ima izkušnje z zdravljenjem raka.