FrancophonIA/ELRC3.0 huggingface dataset:
English: At present, little data are available on the use of Rapilysin in patients with diastolic blood pressure higher than 100 mmHg.
Slovenian: Trenutno je na voljo le malo podatkov o uporabi zdravila Rapilysin pri bolnikih z diastoličnim krvnim tlakom, višjim od 100 mmHg.
English: Teva Gyógyszergyár Zrt Tel.: +36 1 288 6400
Slovenian: Magyarország Teva Gyógyszergyár Zrt Tel.: +36 1 288 6400
English: In rats, a species insensitive to the pharmacological effects of reteplase, there were no adverse effects on fertility, embryo-foetal development and offspring.
Slovenian: Pri podganah, živalski vrsti, neobčutljivi za farmakološke učinke reteplaze, ni bilo neželenih učinkov na plodnost, razvoj zarodka in ploda ter leglo.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥
Slovenian: Kategorije pogostnosti so opredeljene z naslednjim dogovorom: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Rapilysin should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor its use.
Slovenian: Zdravilo Rapilysin naj predpisujejo zdravniki z izkušnjami pri uporabi trombolitičnega zdravljenja in z zmožnostjo spremljanja tega zdravljenja.
English: Use the solution immediately after reconstitution
Slovenian: Raztopino uporabite takoj po rekonstituciji
English: Reteplase is a recombinant plasminogen activator that catalyzes the cleavage of endogenous plasminogen to generate plasmin.
Slovenian: Reteplaza je rekombinantni aktivator plazminogena, ki katalizira cepljenje endogenega plazminogena za tvorbo plazmina.
English: Transfusions of cryoprecipitate, fibrinogen, fresh frozen plasma and platelets should be considered with clinical and laboratory reassessment after each administration.
Slovenian: Razmisli naj se o transfuzijah krioprecipitata, fibrinogena, sveže zmrznjene plazme in trombocitov, s ponovnim kliničnim in laboratorijskim vrednotenjem po vsakem dajanju.
English: The concomitant use of heparin anticoagulation may contribute to bleeding.
Slovenian: Sočasna uporaba antikoagulacije s heparinom lahko prispeva h krvavitvi.
English: DO NOT SHAKE.
Slovenian: NE STRESAJTE.
English: The relative contribution of the inhibitors to inactivation of reteplase decreases as follows: C1-inactivator > α2antiplasmin > α2-antitrypsin.
Slovenian: Relativni prispevki zaviralcev k inaktivaciji reteplaze se nižajo v naslednjem vrstnem redu: C1inaktivator > α2-antiplazmin > α2-antitripsin.
English: Animal data show that in case of severely impaired renal function with a pronounced increase in serum creatinine and serum urea an increase in half-life of reteplase has to be expected.
Slovenian: Podatki iz proučevanja pri živalih kažejo, da gre v primeru hudo okvarjenega delovanja ledvic z izraženim povišanjem serumskih koncentracij kreatinina in sečnine pričakovati podaljšanje razpolovnega časa reteplaze.
English: The dose is now ready for intravenous administration.
Slovenian: Odmerek je zdaj pripravljen za intravensko dajanje.
English: In two clinical trials aiming primarily at coronary artery patency (RAPID I and II) reteplase was associated with higher early patency rates (primary efficacy criterion), as well as with a lower incidence of heart failure (secondary efficacy criterion) than alteplase (3 hour and "accelerated" dosage regimens).
Slovenian: V dveh kliničnih preskušanjih, v katerih so proučevali predvsem prehodnost koronarnih arterij (RAPID I in II), je bila reteplaza povezana z višjimi stopnjami zgodnje prehodnosti (primarni kriterij učinkovitosti), kot tudi z nižjo pojavnostjo srčnega popuščanja (sekundarni kriterij učinkovitosti) kot alteplaza (3-urni in “pospešeni” režimi odmerjanja).
English: ** Recombinant plasminogen activator produced in Escherichia coli by recombinant DNA technology.
Slovenian: **Rekombinantni aktivator plazminogena pridobljen s tehnologijo rekombinantne DNA iz bakterije Escherichia coli.
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).
Slovenian: Zato trombolitično zdravljenje zahteva pozorno spremljanje vseh možnih mest krvavitve (vključujoč mesta vstavitve katetrov, mesta arterijskih in venskih punkcij, mesta odrezanja in mesta zbadanja).
English: Should serious bleeding, in particular cerebral haemorrhage, occur any concomitant heparin should be terminated immediately.
Slovenian: Pri pojavu resne krvavitve, posebno možganske krvavitve, je treba nemudoma ukiniti kakršno koli sočasno zdravljenje s heparinom.
English: • if you have a bleeding disorder.
Slovenian: • če imate motnjo strjevanja krvi,
English: - cerebrovascular disease
Slovenian: - cerebrovaskularno obolenje,
English: Ischaemic or haemorrhagic cerebrovascular events may be contributing or underlying conditions.
Slovenian: Ishemični ali hemoragični cerebrovaskularni dogodki so lahko prispevajoča ali že prej obstajajoča stanja.
English: Treatment with Rapilysin 10 U should be started as soon as possible after the symptoms of heart attack begin.
Slovenian: Zdravljenje z zdravilom Rapilysin 10 enot je treba začeti čimprej po nastanku simptomov srčnega infarkta.
English: Pay careful attention to all possible bleeding sites (e.g. injection sites).
Slovenian: Bodite posebno pozorni na vsa možna mesta krvavitve (npr. mesta injiciranja).
English: Patients with systolic blood pressure over 160 mmHg have a greater risk of bleeding in the brain.
Slovenian: Bolniki s sistoličnim krvnim tlakom prek 160 mmHg imajo večje tveganje za krvavitev v možgane.
English: As fibrin is lysed during reteplase therapy, bleeding from recent puncture sites may occur.
Slovenian: Ko se fibrin med zdravljenjem z reteplazo razgrajuje, se lahko pojavi krvavitev z mest nedavnega zbadanja.
English: What Rapilysin is and what it is used for What you need to know before Rapilysin is given to you How to use Rapilysin
Slovenian: Kaj je zdravilo Rapilysin in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Rapilysin Kako uporabljati zdravilo Rapilysin
English: • Chest Pain / angina, low blood pressure and heart failure /shortness of breath may reappear
Slovenian: • bolečina v prsnem košu/angina pektoris, nizek krvni tlak in srčno popuščanje/zadihanost, ki se lahko pojavijo ponovno,
English: Rapilysin is used after an acute myocardial infarction (heart attack) in order to dissolve the blood clot causing the heart attack.
Slovenian: Zdravilo Rapilysin se uporablja po akutnem miokardnem infarktu (srčna kap), da bi raztopili krvni strdek, ki je povzročil srčni infarkt.
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.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki viale poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Solvent: 10 ml Water for injection (prefilled syringe)
Slovenian: Vehikel: 10 ml vode za injekcije (napolnjena injekcijska brizga)
English: Plasmin in turn degrades fibrin, which is the main component of the matrix of thrombi, thereby exerting its thrombolytic action.
Slovenian: Plazmin nato razgradi fibrin, ki je poglavitna sestavina matriksa trombov, in tako izvaja svoje trombolitično delovanje.
English: Coagulation factor V, clotting factor VIII, α2-macroglobulin, and C1-esterase inhibitor are only slightly reduced and normalise within 1 to 2 days.
Slovenian: Vrednosti koagulacijskega faktorja V, faktorja strjevanja krvi VIII, α2makroglobulina in zaviralca C1-esteraze so samo rahlo znižane in se povrnejo na normalno stopnjo v 1 do 2 dnevih.
English: Mild impairment of renal function did not significantly affect the pharmacokinetic properties of reteplase.
Slovenian: Blago okvarjeno delovanje ledvic ni značilno vplivalo na farmakokinetične lastnosti reteplaze.
English: Heparin, which is given together with Rapilysin, may also increase bleeding.
Slovenian: Heparin, ki se ga daje sočasno z zdravilom Rapilysin, tudi lahko poveča krvavitev.
English: This plasminogenolysis occurs preferentially in the presence of fibrin.
Slovenian: Do plazminogenolize najraje pride v prisotnosti fibrina.
English: Reductions of plasma levels of plasminogen and α2-antiplasmin normalise within 1 to 3 days.
Slovenian: Znižanja plazemskih koncentracij plazminogena in α2-antiplazmina se povrnejo na normalne vrednosti v 1 do 3 dnevih.
English: In general, however, it is not necessary to replace the coagulation factors because of the relatively short half-life of reteplase.
Slovenian: V splošnem faktorjev strjevanja krvi zaradi relativno kratkega razpolovnega časa reteplaze ni nujno nadomeščati.
English: Open the package containing the reconstitution spike, remove both protective caps from the reconstitution spike.
Slovenian: Odprite zavitek, ki vsebuje pripomoček za pripravo, in z njega odstranite oba zaščitna pokrovčka.
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.
Slovenian: Večino bolnikov, ki krvavijo, se lahko nadzoruje s prekinitvijo trombolitičnega in antikoagulantnega zdravljenja, nadomeščanjem tekočin in ročnim pritiskom na poškodovano žilo.
English: • Bleeding around the heart, in the abdomen, the brain or the eyes, under the skin, from the nose or as coughed up blood
Slovenian: • krvavitev okrog srca, v trebušno votlino, možgane ali oči, pod kožo, iz nosu, izkašljevanje krvi,
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.
Slovenian: Po intravenskem bolusnem injiciranju 10 + 10 enot bolnikom z akutnim miokardnim infarktom se antigen reteplaze v plazmi porazdeljuje s prevladujočim razpolovnim časom (t1/2α) 18 ± 5 minut in se izloča s končnim razpolovnim časom (t1/2ß) 5,5 ur ± 12,5 minut in očistkom 121 ± 25 ml/minuto.
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.
Slovenian: Zdravilo Rapilysin je indicirano za trombolitično zdravljenje domnevnega miokardnega infarkta s trajno povišanim intervalom ST ali nedavnim levokračnim blokom v 12 urah po pojavu simptomov akutnega miokardnega infarkta.
English: - The active substance is reteplase 10U/10 ml after reconstitution.
Slovenian: - Učinkovina je reteplaza 10 enot/10 ml po rekonstituciji.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske Agencije za Zdravila http://www.ema.europa.eu.
English: The doctor will ask you questions before giving you Rapilysin, to find out if you have an increased risk of bleeding.
Slovenian: Kaj morate vedeti, preden vam zdravnik da zdravilo Rapilysin Zdravnik vam bo postavil nekaj vprašanj, preden vam bo dal zdravilo Rapilysin, da bi ugotovil, ali imate povečano tveganje za krvavitev.
English: The medicine is supplied in vials as a powder for injection.
Slovenian: Zdravilo je na voljo v vialah kot prašek za injiciranje.
English: Reproductive toxicity studies were performed in rats (fertility and embryo-foetotoxicity study including a littering phase) and in rabbits (embryo-foetotoxicity study, dose-range finding only).
Slovenian: Študije reproduktivne toksičnosti so izvajali pri podganah (študija plodnosti in toksičnosti za zarodek in plod, vključujoč stopnjo legla) in pri kuncih (študija toksičnosti za zarodek in plod, samo z najdbami v razponu odmerkov).
English: • if you are taking medicine to thin your blood (oral anticoagulants, e.g. warfarin).
Slovenian: • če jemljete zdravilo za redčenje krvi (peroralne antikoagulante, npr. varfarin),
English: For information on medicines that should not be physically mixed with Rapilysin solution for injection, see section 3.
Slovenian: Za podatke o zdravilih, ki se jih ne sme fizično mešati z raztopino za injiciranje zdravila Rapilysin,
English: Actavis Italy S.p.A. Nerviano Plant Via Pasteur 10
Slovenian: Nerviano Plant Via Pasteur 10
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.
Slovenian: Heparin in druga zdravila, ki redčijo kri (antikoagulanti), ter acetilsalicilna kislina (snov v mnogih zdravilih za lajšanje bolečin in nižanje zvišane telesne temperature) lahko povečajo tveganje za krvavitev.
English: Repeated use
Slovenian: Večkratna uporaba
English: Mitral regurgitation, pulmonary embolism, other systemic embolism/cerebral embolism and ventricular septal defect
Slovenian: občasni mitralna regurgitacija, pljučna embolija, druga sistemska embolija/možganska embolija in ventrikularni septalni defekt
English: Mother's milk should be thrown away during the first 24 hours after thrombolytic treatment.
Slovenian: V prvih 24 urah po trombolitičnem zdravljenju je treba materino mleko zavreči.
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.
Slovenian: Odmerek acetilsalicilne kisline, dane pred zdravilom Rapilysin, naj bo vsaj 250 do 350 mg, sledi pa naj mu 75 do 150 mg/dan, vsaj do odpusta iz bolnišnice.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: Dosage of Acetylsalicylic Acid
Slovenian: Odmerjanje acetilsalicilne kisline
English: The lyophilisate is reconstituted with the contents of the accompanying syringe.
Slovenian: Liofilizat rekonstituiramo z vsebino priložene injekcijske brizge.
English: • septic inflammation of a vein with blood clotting (septic thrombophlebitis) or blocked blood vessels at an infected site
Slovenian: • septično vnetje vene s strjevanjem krvi (septični tromboflebitis) ali zamašene krvne žile na okuženem mestu,
English: Dosage of Heparin
Slovenian: Odmerjanje heparina
English: Acute toxicity studies were performed in rats, rabbits and monkeys Subacute toxicity studies were performed in rats, dogs and monkeys.
Slovenian: Študije subakutne toksičnosti so izvajali pri podganah, psih in opicah.
English: Other medicines and Rapilysin:
Slovenian: Druga zdravila in zdravilo Rapilysin:
English: At present, insufficient data in patients with a diastolic blood pressure > 100 mmHg prior to thrombolytic therapy are available for reteplase.
Slovenian: Trenutno za reteplazo ni na voljo zadostnih podatkov pri bolnikih z diastoličnim krvnim tlakom > 100 mmHg pred trombolitičnim zdravljenjem.
English: • feel palpitations or an irregular heart beat
Slovenian: • čutite palpitacije ali neredno bitje srca.
English: Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjordur Iceland.
Slovenian: Reykjavikurvegur 76-78 220 Hafnarfjordur Islandija
English: Tranexamic acid di-potassium-hydrogen phosphate phosphoric acid sucrose polysorbate 80
Slovenian: Prašek: traneksaminska kislina kalijev hidrogenfosfat fosforna kislina saharoza polisorbat 80
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.
Slovenian: Reteplaza izginja iz plazme s hitrostjo 283 ± 101 ml/minuto, kar ima za posledico prevladujoči razpolovni čas (t1/2α) 14,6 ± 6,7 minut in končni razpolovni čas (t1/2ß) 1,6 ure ± 39 minut.
English: Thrombolytic treatment may cause the heart to beat irregularly.
Slovenian: Trombolitično zdravljenje lahko povzroči neredno bitje srca.
English: The solution must be examined to ensure that only clear, colourless solution is injected.
Slovenian: Pregledati je treba videz raztopine, da zagotovite, da se injicira samo bistra, brezbarvna raztopina.
English: EU/1/96/018/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/96/018/001
English: Systolic blood pressure over 160 mmHg before thrombolysis with reteplase was associated with greater risk for cerebral bleeding.
Slovenian: Sistolični krvni tlak prek 160 mmHg pred trombolizo z reteplazo je bil povezan z višjim tveganjem za možgansko krvavitev.
English: • if you have severe liver or kidney disease.
Slovenian: • če imate hudo obolenje jeter ali ledvic,
English: A target fibrinogen level of 1 g/l is desirable with cryoprecipitate or fibrinogen infusion.
Slovenian: Pri infuziji krioprecipitata ali fibrinogena je zaželena tarčna koncentracija fibrinogena 1 g/l.
English: The most common side effect of Rapilysin is bleeding.
Slovenian: Najpogostejši neželeni učinek zdravila Rapilysin je krvavitev.
English: - within 3 months of severe bleeding, major trauma or major surgery (e.g. coronary artery bypass graft, intracranial or intraspinal surgery or trauma), obstetrical delivery, organ biopsy, previous puncture of non-compressible vessels.
Slovenian: - v zadnjih 3 mesecih hude krvavitve, obsežne poškodbe ali obsežni operacijski poseg (npr. vsaditev obvoda koronarne arterije, intrakranialna ali intraspinalna operacija ali poškodba), porod, biopsija organa, predhodna punkcija nekompresibilnih žil.
English: Serious anaphylaxis/anaphylactoid reactions1
Slovenian: zelo redki resne anafilaksijske/anafilaktoidne reakcije1
English: - high likelihood of left heart thrombus, e.g. mitral stenosis with atrial fibrillation
Slovenian: - visoka verjetnost za krvni strdek v levem srcu, npr. mitralna stenoza z atrijsko fibrilacijo,
English: Warnings and precautions
Slovenian: Opozorila in previdnostni ukrepi Krvavitev
English: Shelf-life as package for sale: 3 years.
Slovenian: Rok uporabnosti zdravila v originalnem pakiranju: 3 leta
English: Antibody formation to the reteplase molecule has not been seen.
Slovenian: Tvorbe protiteles proti molekuli reteplaze niso opazili.
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.
Slovenian: Heparin, antagonisti vitamina K in zdravila, ki spreminjajo delovanje trombocitov (kot so acetilsalicilna kislina, dipiridamol in abciksimab), lahko povečajo tveganje za krvavitev, če se jih daje pred zdravljenjem z reteplazo, med njim ali po njem.
English: As with other thrombolytic agents these cardiovascular events have been reported as sequelae of myocardial infarction and/or thrombolytic administration.
Slovenian: Kot pri drugih trombolitičnih učinkovinah so bili ti kardiovaskularni dogodki posledica miokardnega infarkta in/ali dajanja trombolitikov.
English: TEVA Pharmaceuticals Slovakia s.r.o Tel: +421 2 57 26 79 11
Slovenian: Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o Tel: +421 2 57 26 79 11
English: However, no antibody formation to the reteplase molecule has been observed.
Slovenian: Vendar pa tvorbe protiteles proti molekuli reteplaze niso opazili.
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.
Slovenian: 2 napolnjeni stekleni injekcijski brizgi (borosilikat, tip I) za enkratno uporabo z brombutilnim batnim zamaškom in zaporko iz brombutilne gume, ki vsebujeta 10 ml vehikla.
English: Treatment with reteplase should be initiated as soon as possible after the onset of AMI symptoms.
Slovenian: Zdravljenje z reteplazo je treba začeti čim prej po pojavu simptomov akutnega miokardnega infarkta.
English: Ensure that the injection is not mistakenly given paravenously.
Slovenian: Paziti moramo, da pomotoma ne injiciramo paravensko.
English: • if you have a brain tumour or a malformed blood vessel or a vessel wall dilatation (aneurysm) in the brain.
Slovenian: • če imate možganski tumor ali nepravilno oblikovano krvno žilo v možganih ali razširjenje stene krvne žile (anevrizmo) v možganih,
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.
Slovenian: Pri uporabi z drugimi zdravili, ki vplivajo na hemostazo, kot so heparin, nizkomolekularni heparini, heparinoidi, peroralni antikoagulanti in anitrombotiki, razen acetilsalicilne kisline, kot so dipiridamol, tiklopidin, klopidogrel ali antagonisti receptorjev za glikoprotein IIb/IIIa, je potrebna previdnost.
English: Rapilysin should be injected preferably through an intravenous line that is used only for the injection of Rapilysin.
Slovenian: Zdravilo Rapilysin je najbolje injicirati skozi intravenski kanal, ki se uporablja samo za injiciranje zdravila Rapilysin.
English: What Rapilysin looks like and contents of the pack
Slovenian: Izgled zdravila Rapilysin in vsebina pakiranja
English: You must tell your doctor if you are pregnant or think you are pregnant.
Slovenian: Če ste noseči ali mislite, da ste noseči, obvestite svojega zdravnika.
English: The resulting solution must be used immediately.
Slovenian: Pripravljeno raztopino je potrebno takoj uporabiti.
English: • Abnormal heart beats (arrhythmias), cardiac arrest, circulatory collapse or another heart attack may occur
Slovenian: • nenormalno utripanje srca (aritmije), srčni zastoj, cirkulatorni kolaps ali ponovitev srčne kapi.
English: For information on product incompatibilities see section 6.2.
Slovenian: Za podatke o inkompatibilnosti zdravil glejte poglavje 6.2.
English: Instructions for use/handling
Slovenian: Navodila za uporabo/ravnanje z zdravilom
English: The most common complication encountered during reteplase therapy is bleeding.
Slovenian: Najpogostejši zaplet, na katerega naletimo med zdravljenjem z reteplazo, je krvavitev.
English: 2 colourless glass vials (type I) with a rubber (butyl) closure and an aluminium flip-off cap, containing 0.56 mg of powder.
Slovenian: 2 brezbarvni stekleni viali (tip I) z gumijastim (butilnim) pokrovom in aluminjasto zaporko, ki vsebujeta 0,56 mg praška.
English: For information on product incompatibilities see section 4.2.
Slovenian: Za podatke o inkompatibilnostih zdravil, glejte poglavje 4.2.
English: It is strongly recommended that antiarrhythmic therapy for bradycardia and/or ventricular tachyarrhythmias (e.g. ventricular tachycardia or fibrillation) be available when reteplase is administered.
Slovenian: Ob dajanju reteplaze je zelo priporočljivo, da je na razpolago antiaritmično zdravljenje za bradikardijo in/ali ventrikularne tahiaritmije (npr. ventrikularna tahikardija ali fibrilacija).
English: The use of rigid catheter as well as intramuscular injections and nonessential handling of the patient should be avoided during treatment with reteplase.
Slovenian: Med zdravljenjem z reteplazo se je treba izogibati uporabi rigidnih katetrov in intramuskularnih injekcij ter postopkov pri bolniku, ki niso nujno potrebni.