FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine after the expiry date which is stated on the carton and on the label of the vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici na bočici iza „EXP“.
English: Dosage of Acetylsalicylic Acid
Croatian: Doziranje acetilsalicilatne kiseline
English: In the reteplase group, 49.4 % of these strokes were fatal and 27.1 % were disabling.
Croatian: U skupini koja je primala reteplazu 49,4% moždanih udara bilo je smrtonosno, a 27,1% uzrokovalo je invalidnost.
English: Therefore, thrombolytic therapy requires careful attention to all possible bleeding sites (including catheter insertion sites, arterial and venous puncture sites, cut down sites and needle puncture sites).
Croatian: Stoga trombolitičko liječenje zahtijeva pažljivo nadziranje svih mjesta koja mogu početi krvariti (uključujući mjesta umetanja katetera, mjesta arterijskih i venskih punkcija, rezove i mjesta uboda iglom).
English: Heparin and Rapilysin cannot be mixed in the same solution.
Croatian: Heparin i Rapilysin ne smiju se miješati u istoj otopini.
English: A pre- and postnatal toxicity study was not performed with reteplase.
Croatian: Ispitivanja prenatalne i postnatalne toksičnosti s reteplazom nisu provedena.
English: Open the package containing the reconstitution spike, remove both protective caps from the reconstitution spike.
Croatian: Otvorite pakiranje s pomagalom za rekonstituciju, te s njega uklonite oba zaštitna zatvarača.
English: Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjordur Iceland.
Croatian: Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjordur Island
English: In rats, a species insensitive to the pharmacological effects of reteplase, there were no adverse effects on fertility, embryo-foetal development and offspring.
Croatian: Na štakorima, vrsti koja je neosjetljiva na farmakološke učinke reteplaze, nisu primijećene nuspojave vezane uz plodnost, razvoj embrija i fetusa te mladunaca.
English: Exact data on the main elimination routes for reteplase in humans are not available and the consequences of hepatic or renal insufficiency are not known.
Croatian: Točni podaci o glavnim putovima eliminacije reteplaze u ljudi nisu dostupni, a posljedice narušene funkcije jetre ili bubrega nisu poznate.
English: Therefore Rapilysin must be given only in the presence and under the instructions of an emergency doctor.
Croatian: Stoga se Rapilysin smije primjenjivati samo u nazočnosti i pod nadzorom liječnika.
English: Should serious bleeding, in particular cerebral haemorrhage, occur any concomitant heparin should be terminated immediately.
Croatian: Ako dođe do ozbiljnog krvarenja, posebno cerebralnog krvarenja, potrebno je odmah prestati s primjenom heparina.
English: Since at present there is no experience with readministration of reteplase, the readministration is not recommended.
Croatian: Trenutno nema iskustava u ponovnoj primjeni reteplaze, stoga se ponovna primjena ne preporučuje.
English: As fibrin is lysed during reteplase therapy, bleeding from recent puncture sites may occur.
Croatian: Kako se fibrin tijekom liječenja reteplazom razgrađuje, može doći do krvarenja na mjestu nedavnog uboda.
English: Coagulation factor V, clotting factor VIII, α2-macroglobulin, and C1-esterase inhibitor are only slightly reduced and normalise within 1 to 2 days.
Croatian: Vrijednosti koagulacijskog faktora V, faktora VIII, α2-makroglobulina i inhibitora C1-esteraze samo se blago smanjuju, a normaliziraju se tijekom 1 do 2 dana.
English: Mild impairment of renal function did not significantly affect the pharmacokinetic properties of reteplase.
Croatian: Blago oštećenje funkcije bubrega ne utječe znatno na farmakokinetička svojstva reteplaze.
English: Serious anaphylaxis/anaphylactoid reactions1
Croatian: Ozbiljne anafilaktičke/anafilaktoidne reakcije1
English: The reconstituted solution must be used immediately.
Croatian: Rekonstituirana otopina mora se odmah primijeniti.
English: For information on medicines that should not be physically mixed with Rapilysin solution for injection, see section 3.
Croatian: Za informacije o lijekovima koji se ne smiju fizički miješati s Rapilysin otopinom za injekciju,
English: • systolic blood pressure higher than 160 mmHg
Croatian: • sistolički krvni tlak viši od 160 mmHg
English: • Chest Pain / angina, low blood pressure and heart failure /shortness of breath may reappear
Croatian: • bol u prsima/angina, sniženi krvni tlak i zatajenje srca/nedostatak zraka mogu se ponovno pojaviti
English: Local reactions at injection site can also occur.
Croatian: Na tom se mjestu mogu pojaviti i lokalne reakcije.
English: Solvent: 10 ml Water for injection (prefilled syringe)
Croatian: Otapalo: 10 ml vode za injekciju (napunjena štrcaljka)
English: - The active substance is reteplase 10U/10 ml after reconstitution.
Croatian: - Djelatna tvar je reteplaza 10 U/10 ml nakon pripreme za primjenu.
English: • diseases of the blood vessels in the brain
Croatian: • bolesti krvnih žila u mozgu
English: Transfusions of cryoprecipitate, fibrinogen, fresh frozen plasma and platelets should be considered with clinical and laboratory reassessment after each administration.
Croatian: fibrinogena, svježe zamrznute plazme i trombocita s ponovnim kliničkim i laboratorijskim procjenama nakon svake primjene.
English: Genotoxicity of reteplase was excluded by a complete battery of tests at different genetic end points in vitro and in vivo.
Croatian: Genotoksičnost reteplaze isključena je nizom genetskih testova in vitro i in vivo.
English: Rapilysin contains the active substance reteplase(a recombinant plasminogen activator).
Croatian: Rapilysin sadrži djelatnu tvar reteplazu (rekombinantni aktivator plazminogena).
English: • Events related to the nervous system (e.g. epileptic seizure, convulsion, speech disorder,
Croatian: • događaji povezani sa živčanim sustavom (npr. epileptični napadaji, konvulzije, smetnje govora,
English: Shelf-life as package for sale: 3 years.
Croatian: Rok valjanosti lijeka u originalnom pakiranju: 3 godine.
English: No other medicines should be added to the injection solution (see below).
Croatian: U otopinu za injekciju se ne smiju dodavati drugi lijekovi (vidite niže).
English: Therefore, repeated use is not recommended.
Croatian: Stoga se višekratna primjena ne preporučuje.
English: The relative contribution of the inhibitors to inactivation of reteplase decreases as follows: C1-inactivator > α2antiplasmin > α2-antitrypsin.
Croatian: Relativni udio inhibitora u inaktivaciji reteplaze smanjuje se na sljedeći način: C1-inaktivator > α2
English: In the patients who fail to respond to these conservative measures, judicious use of transfusion products may be indicated.
Croatian: Za bolesnike koji ne reagiraju na takve uobičajene mjere treba razmisliti o opreznoj primjeni transfuzijskih pripravaka.
English: The concomitant use of heparin anticoagulation may contribute to bleeding.
Croatian: Istodobna primjena antikoagulacije heparinom može pojačati krvarenje.
English: Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 12 hours after the onset of acute myocardial infarction AMI symptoms.
Croatian: Rapilysin je indiciran za trombolitičko liječenje suspektnog infarkta miokarda s perzistentnom elevacijom ST segmenta ili nedavnim blokom lijeve grane unutar 12 sati nakon pojave simptoma akutnog infarkta miokarda.
English: Caution should be employed when used with other medicinal products affecting haemostasis such as heparin, low-molecular-weight heparins, heparinoids, oral anticoagulants and antiplatelet agents other than acetylsalicylic acid, such as dipyridamole, ticlopidine, clopidogrel or glycoprotein IIb/IIIa receptor antagonists.
Croatian: Potrebna je osobita pozornost pri primjeni s drugim lijekovima koji utječu na hemostazu, kao što su heparin, nisko molekularni heparini, heparionidi, oralni antikoagulansi i antitrombocitni lijekovi, osim acetilsalicilatne kiseline, npr. dipiridamol, tiklopidin, klopidogrel ili antagonisti receptora za glikoprotein IIb/IIIa.
English: Thrombolytic treatment may cause the heart to beat irregularly.
Croatian: Trombolitičko liječenje može uzrokovati nepravilne otkucaje srca.
English: At present, little data are available on the use of Rapilysin in patients with diastolic blood pressure higher than 100 mmHg.
Croatian: Trenutno je malo dostupnih podataka o primjeni lijeka Rapilysin u bolesnika s dijastoličkim krvnim tlakom višim od 100 mmHg.
English: Mitral regurgitation, pulmonary embolism, other systemic embolism/cerebral embolism and ventricular septal defect
Croatian: Mitralna regurgitacija, plućna embolija, druga sistemska embolija/cerebralna embolija i ventrikularni septalni defekt
English: • if you have enlarged blood vessels in the gullet (oesophagus) (frequently caused by liver disease).
Croatian: • ako imate proširene krvne žile u jednjaku (često uzrokovane bolestima jetre)
English: Reteplase activity is cleared from the plasma at a rate of 283±101 ml/min, resulting in a dominant half-life (t1/2α) of 14.6±6.7 min and a terminal half-life (t1/2ß) of 1.6 hours±39 min. Only minor amounts of reteplase were immunologically detected in the urine.
Croatian: Aktivnost reteplaze nestaje iz plazme brzinom od 283±101 ml/min, rezultirajući dominantnim poluvijekom (t1/2α) od 14,6±6,7 minuta i krajnjim poluvijekom (t1/2ß) od 1,6 sati±39 minuta.
English: A small amount of solution may remain in the vial due to overfill.
Croatian: Može se dogoditi da manja količina otopine ostane u bočici kao višak.
English: Ensure that the injection is not mistakenly given paravenously.
Croatian: Pazite da injekciju slučajno ne ubrizgate paravenski.
English: The half-life of reteplase was increased in patients with AMI as compared to healthy volunteers.
Croatian: Poluvijek reteplaze u bolesnika s akutnim infarktom miokarda bio je povećan u usporedbi sa zdravim dobrovoljcima.
English: Heparin and other medicines that thin the blood (anticoagulants) and acetylsalicylic acid (a substance used in many medicines used to relieve pain and lower fever) may increase the risk of bleeding.
Croatian: Heparin i drugi lijekovi koji razrjeđuju krv (antikoagulansi) te acetilsalicilatna kiselina (tvar koja se nalazi u mnogo lijekova za ublažavanje bolova i snižavanje temperature) mogu povećati rizik od krvarenja.
English: Cerebral haemorrhage2
Croatian: Cerebralno krvarenje2
English: Reports of intracranial bleeding, many of which are fatal, are of particular concern.
Croatian: Osobito su zabrinjavajuća izvješća o intrakranijalnim krvarenjima, koja su često smrtonosna.
English: The reconstituted preparation results in a clear, colourless solution.
Croatian: Rekonstituirani lijek je bistra, bezbojna otopina.
English: A target fibrinogen level of 1 g/l is desirable with cryoprecipitate or fibrinogen infusion.
Croatian: Pri infuziji krioprecipitata ili fibrinogena poželjna je ciljna razina fibrinogena od 1 g/l.
English: Haemorrhage at the injection site (e.g. haematoma), a local reaction at injection site, for example a burning sensation
Croatian: Krvarenje na mjestu injekcije (primjerice, hematom), lokalna reakcija na mjestu injekcije, primjerice osjećaj žarenja
English: Following intravenous bolus injection of 10 + 10 U in patients with acute myocardial infarction reteplase antigen is distributed in plasma with a dominant half-life (t1/2α) of 18±5 min and eliminated with a terminal half-life (t1/2ß) of 5.5 hours±12.5 min at a clearance rate of 121±25 ml/min.
Croatian: U bolesnika s akutnim infarktom miokarda nakon intravenske bolusne injekcije od 10 + 10 U, antigen reteplaze raspodjeljuje se u plazmi s dominantnim poluvijekom (t1/2α) od 18±5 minuta, a eliminira s krajnjim poluvijekom (t1/2ß) od 5,5 sati±12,5 minuta pri klirensu od 121±25 ml/minuta.
English: Events related to the nervous system (e.g. epileptic seizure, convulsion, aphasia, speech disorder, delirium, acute brain syndrome, agitation, confusion, depression, psychosis)
Croatian: Događaji povezani sa živčanim sustavom (primjerice, epileptički napadaj, konvulzija, afazija, poremećaj govora, delirij, akutni moždani sindrom, agitacija, konfuzija, depresija, psihoza)
English: Take the 10 ml syringe out of the package.
Croatian: Iz pakiranja izvadite napunjenu štrcaljku od 10 ml.
English: Patients with systolic blood pressure over 160 mmHg have a greater risk of bleeding in the brain.
Croatian: Bolesnici sa sistoličkim krvnim tlakom višim od 160 mmHg podložniji su riziku od krvarenja u mozgu.
English: Systolic blood pressure over 160 mmHg before thrombolysis with reteplase was associated with greater risk for cerebral bleeding.
Croatian: Sistolički krvni tlak veći od 160 mmHg prije trombolize s reteplazom bio je povezan s povećanim rizikom od cerebralnog krvarenja.
English: coronary artery bypass graft, or surgery or injury to the head or spine), given birth, or had an organ biopsy or other medical / surgical procedure.
Croatian: ugradnju premosnice koronarne arterije, operaciju ili ozljedu glave ili kralježnice), ako ste rodili ili bili podvrgnuti biopsiji organa ili drugim medicinskim/kirurškim zahvatima.
English: It is a thrombolytic medicine used to dissolve blood clots that have formed in certain blood vessels and to restore the blood flow in these blocked vessels (=thrombolysis).
Croatian: To je trombolitički lijek koji se koristi za otapanje krvnih ugrušaka koji su se stvorili u krvnim žilama te za ponovno uspostavljanje krvotoka u začepljenim krvnim žilama (=tromboliza).
English: The medicine is supplied in vials as a powder for injection.
Croatian: Lijek je dostupan u bočicama kao prašak za injekciju.
English: Marketing Authorisation Holder Actavis Group PTC ehf Reykjavíkurvegi 76-78
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Actavis Group PTC ehf Reykjavíkurvegi 76-78
English: • if you are taking medicine to thin your blood (oral anticoagulants, e.g. warfarin).
Croatian: • ako imate poremećaj zgrušavanja krvi • ako uzimate lijekove za sprječavanje zgrušavanja krvi (oralni antikoagulansi, npr. varfarin)
English: Dosage of Heparin
Croatian: Doziranje heparina
English: Heparin, vitamin K antagonists and medicinal product that alter platelet function (such as acetylsalicylic acid, dipyridamole and abciximab) may increase the risk of bleeding if administered prior to, during or after reteplase therapy.
Croatian: Heparin, antagonisti vitamina K i lijekovi koji mijenjaju funkciju trombocita (kao što su acetilsalicilatna kiselina, dipiridamol i abciksimab) mogu povećati rizik od krvarenja ako se primjenjuju prije, tijekom ili nakon liječenja reteplazom.
English: • feel palpitations or an irregular heart beat
Croatian: • osjetite lupanje srca ili nepravilne otkucaje srca.
English: Actavis Italy S.p.A. Nerviano Plant Via Pasteur 10
Croatian: Nerviano Plant Via Pasteur 10
English: In cynomolgus monkeys, the sedative effect ranged from slight apathy to unconsciousness, caused by a reversible dose-related drop in blood pressure.
Croatian: Sedacijski učinak primijećen u cynomolgulus majmuna bio je u rasponu od blage apatije do gubitka svijesti uzrokovane reverzibilnim padom tlaka povezanim s dozom.
English: Reteplase 10 U (recombinant plasminogen activator, thrombolytic agent)
Croatian: TVARI Reteplaza 10 U (rekombinantni aktivator plazminogena, trombolitički lijek)
English: • septic inflammation of a vein with blood clotting (septic thrombophlebitis) or blocked blood vessels at an infected site
Croatian: • septička upala vene sa zgrušavanjem krvi (septički tromboflebitis) ili začepljene krvne žile na mjestu infekcije
English: Death and permanent disability are not uncommonly reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.
Croatian: Smrt i trajna invalidnost nerijetko su prijavljivani u bolesnika s moždanim udarom (uključujući intrakranijalno krvarenje) i drugim teškim krvarenjima.
English: It is not known whether reteplase is excreted into breast milk.
Croatian: Nije poznato izlučuje li se reteplaza u majčino mlijeko.
English: As with other thrombolytic agents, recurrent ischaemia/angina, hypotension and heart failure/pulmonary oedema have been reported frequently as sequelae of myocardial infarction and/or thrombolytic administration.
Croatian: Kao i kod drugih trombolitičkih lijekova, ponavljajuća ishemija/angina, hipotenzija i zatajenje srca/plućni edem često su opaženi kao posljedica infarkta miokarda i/ili primjene trombolitika.
English: - systolic blood pressure at entry > 160 mmHg
Croatian: - sistolički krvni tlak na početku liječenja > 160 mmHg
English: The dose of acetylsalicylic acid given before Rapilysin should be at least 250 mg-350 mg and should be followed by 75-150 mg/day, at least until discharge from hospital.
Croatian: Doza acetilsalicilatne kiseline, dana prije lijeka Rapilysin, mora biti najmanje 250 mg - 350 mg, nakon koje slijedi 75 - 150 mg/dan, barem do otpuštanja iz bolnice.
English: • if you have severe liver or kidney disease.
Croatian: • ako imate tešku bolest jetre ili bubrega
English: Chemical and physical in-use stability has been demonstrated for 8 hours between 2° and 30 °C after dissolving with water for injection.
Croatian: Nakon otapanja s vodom za injekcije otopina je kemijski i fizikalno stabilna 8 sati na temperaturi od 2°C do 30°C.
English: As with other thrombolytic agents these cardiovascular events have been reported as sequelae of myocardial infarction and/or thrombolytic administration.
Croatian: Kao i s drugim trombolitičkim lijekovima ti kardiovaskularni događaji prijavljeni su kao posljedica infarkta miokarda i/ili primjene trombolitika.
English: Other medicines and Rapilysin:
Croatian: Drugi lijekovi i Rapilysin
English: Plasmin in turn degrades fibrin, which is the main component of the matrix of thrombi, thereby exerting its thrombolytic action.
Croatian: Plazmin razgrađuje fibrin, glavni sastojak osnove tromba, i pri tome djeluje trombolitički.
English: No other medicines should be added to the injection solution.
Croatian: Drugi se lijekovi ne smiju dodavati otopini za injekciju.
English: Most patients who have bleeding can be managed by interruption of thrombolytic and anticoagulant therapy, volume replacement and manual pressure applied to an incompetent vessel.
Croatian: Većinu bolesnika koji krvare moguće je zbrinuti prekidom liječenja tromboliticima i antikoagulansima, nadoknađivanjem tekućine i pritiskom rukom na oštećenu žilu.
English: Acute toxicity studies were performed in rats, rabbits and monkeys Subacute toxicity studies were performed in rats, dogs and monkeys.
Croatian: Ispitivanja subakutne toksičnosti provedena su na štakorima, psima i majmunima.
English: For information on product incompatibilities see section 4.2.
Croatian: Za informacije o inkompatibilnosti lijeka vidjeti dio 4.2.
English: Reteplase is supplied as a freeze-dried substance in vials.
Croatian: Reteplaza je dostupna kao smrzavanjem osušena tvar u bočicama.
English: The initial dose of acetylsalicylic acid prior to thrombolysis should be at least 250 mg (250 - 350 mg) followed by 75 - 150 mg/day at least until discharge.
Croatian: Početna doza acetilsalicilatne kiseline prije trombolize mora iznositi najmanje 250 mg (250 - 350 mg), nakon koje slijedi 75 - 150 mg/dan do otpuštanja iz bolnice.
English: There is no experience with Rapilysin in pregnant women.
Croatian: Nema iskustava o primjeni lijeka Rapilysin u trudnica.
English: The solution must be examined to ensure that only clear, colourless solution is injected.
Croatian: Potrebno je pregledati otopinu da bi se osiguralo ubrizgavanje samo bistre i bezbojne otopine.
English: • if you have an ulcer in the stomach or small intestine.
Croatian: • ako imate vrijed u želucu ili tankom crijevu
English: Only clear, colourless solutions should be injected.
Croatian: Samo se bistra, bezbojna otopina smije ubrizgati.
English: Visual inspection of the solution is necessary after reconstitution.
Croatian: Nakon rekonstitucije potrebno je vizualno pregledati otopinu.
English: • if you have a brain tumour or a malformed blood vessel or a vessel wall dilatation (aneurysm) in the brain.
Croatian: • ako imate tumor na mozgu, malformacije krvnih žila ili proširenje stijenke žila (aneurizme) u mozgu
English: 2 pre-filled glass syringes (borosilicate, type I) for single use, with a bromobutyl plunger stopper and a bromobutyl rubber tip cap, containing 10 ml of solvent.
Croatian: 2 napunjene staklene štrcaljke (borosilikat, tip I) za jednokratnu uporabu s bromobutilnim čepom klipa i bromobutilnim zatvaračem vrha koje sadrže 10 ml otapala.
English: Recurrent ischaemia/angina, hypotension and heart failure/pulmonary oedema
Croatian: Rekurentna ishemija/angina, hipotenzija i zatajenje srca/plućni edem
English: • bleeding in the gastrointestinal, urinary or genital tract within the past 10 days
Croatian: • krvarenje u probavnom, mokraćnom ili genitalnom sustavu u posljednjih 10 dana
English: The most commonly reported adverse drug reaction associated with reteplase treatment is haemorrhage, predominantly at the injection site.
Croatian: Najčešće prijavljivana nuspojava povezana s liječenjem reteplazom je krvarenje, pretežno na mjestu davanja injekcije.
English: 2 colourless glass vials (type I) with a rubber (butyl) closure and an aluminium flip-off cap, containing 0.56 mg of powder.
Croatian: 2 bezbojne staklene bočice (tip I) s gumenim (butil) čepom i aluminijskim zatvaračem, koje sadrže 0,56 mg praška.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I)
English: Antibody formation to the reteplase molecule has not been seen.
Croatian: Nije uočeno stvaranje antitijela na molekulu reteplaze.
English: Rapilysin should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor its use.
Croatian: Rapilysin smiju propisati samo liječnici s iskustvom u primjeni trombolitičkog liječenja te koji imaju na raspolaganju uređaj za praćenje učinka lijeka.
English: The most common side effect of Rapilysin is bleeding.
Croatian: Najčešća nuspojava lijeka Rapilysin je krvarenje.
English: Heparin, which is given together with Rapilysin, may also increase bleeding.
Croatian: koji se primjenjuje s lijekom Rapilysin, može također pojačati krvarenje.
English: • Abnormal heart beats (arrhythmias), cardiac arrest, circulatory collapse or another heart attack may occur
Croatian: • poremećeni otkucaji srca (aritmije), zastoj srca, kolaps cirkulacije ili ponovni srčani udar.
English: Rapilysin is given as a 10 U injection followed by a second 10 U injection 30 minutes later (double bolus).
Croatian: Rapilysin se primjenjuje kao injekcija od 10 U, nakon koje, 30 minuta kasnije, slijedi druga injekcija od 10 U (dvostruki bolus).
English: You must tell your doctor if you are pregnant or think you are pregnant.
Croatian: Ako ste trudni ili mislite da ste trudni, morate obavijestiti svog liječnika.
English: Arrhythmias (e.g. AV block, atrial fibrillation/flutter, ventricular tachycardia/fibrillation, electromechanical dissociation (EMD)), cardiac arrest, cardiogenic shock and reinfarction
Croatian: Aritmije (primjerice AV blok, fibrilacija/undulacija atrija, tahikardija/ fibrilacija ventrikula, elektromehanička disocijacija (EMD)), srčani zastoj,
English: Haemopericardium, retroperitoneal bleeding, cerebral haemorrhage, epistaxis, haemoptysis, eye haemorrhage and ecchymosis
Croatian: Hemoperikard, retroperitonealno krvarenje, cerebralno krvarenje, epistaksa, hemoptiza, krvarenje u oko i ekhimoza
English: At present, insufficient data in patients with a diastolic blood pressure > 100 mmHg prior to thrombolytic therapy are available for reteplase.
Croatian: Trenutno nema dovoljno podataka o primjeni retaplaze u bolesnika s dijastoličkim tlakom > 100 mmHg prije trombolitičkog liječenja.
English: Remove the protective flip-cap from the vial of Rapilysin 10 U and clean the rubber closure with an alcohol wipe.
Croatian: Uklonite zaštitni zatvarač s bočice lijeka Rapilysin 10 U i vatom namočenom u alkohol očistite gumeni čep.