FrancophonIA/ELRC3.0 huggingface dataset:
English: Alternatively the reconstitution can be performed with the included needle.
Croatian: Rekonstitucija se još može izvesti i uz pomoć priložene igle.
English: Before use, the solvent (water for injections) is added to the powder to form a solution that is given by injection.
Croatian: Prije primjene, otapalo (voda za injekcije) se dodaje prašku kako bi se napravila otopina koja se daje putem injekcije.
English: Metalyse is incompatible with glucose infusion solutions.
Croatian: Metalyse nije kompatibilan s infuzijskim otopinama glukoze.
English: In both groups the bounds of the confidence interval of the observed incidences prior and post dose reduction are overlapping.
Croatian: U obje skupine granice intervala pouzdanosti primijećenih incidencija, prije i poslije snižavanja doze, se preklapaju.
English: Coronary patency and limited clinical outcome data showed that AMI patients have been successfully treated later than 6 hours after symptom onset.
Croatian: Koronarna prohodnost i ograničeni klinički podaci pokazali su da su bolesnici koji su doživjeli akutni infarkt miokarda bili uspješno liječeni i nakon 6 sati od pojave simptoma.
English: No other medicinal product should be added to the injection solution.
Croatian: Otopini za injekciju ne smiju se dodavati nikakvi drugi lijekovi.
English: All-cause mortality Cardiogenic shock Congestive heart failure Re-infarction Cardiac mortality
Croatian: Smrtnost svih uzroka Kardiogeni šok Kongestivno zatajenje srca Ponovni infarkt Kardijalna smrtnost
English: How to store Metalyse
Croatian: Kako čuvati Metalyse
English: Metalyse is incompatible with glucose solution.
Croatian: Metalyse nije kompatibilan s otopinom glukoze.
English: 20 ml glass vial type I, with a coated (B2-42) grey rubber stopper and a flip-off cap filled with powder for solution for injection.
Croatian: I od 20 ml, s obloženim (B2-42) sivim gumenim čepom i «flip-off» poklopcem, napunjena praškom za otopinu za injekciju.
English: Pulmonary haemorrhage
Croatian: Plućno krvarenje
English: However, the analysis of data from more than 12,000 patients treated during phase I, II and III did not reveal any clinically relevant interactions with medicinal products commonly used in patients with AMI and concomitantly used with tenecteplase.
Croatian: Međutim, analiza podataka na više od 12 000 bolesnika, liječenih tijekom I, II i III faze, nije otkrila relevantne kliničke interakcije s lijekovi koji se najčešće primjenjuju kod bolesnika s akutnim infarktom miokarda, i istovremenoj primjene tenekteplaze.
English: A target fibrinogen level of 1 g/l is desirable with cryoprecipitate infusion.
Croatian: Kod infuzije krioprecipitata poželjna je vrijednost fibrinogena od 1 g/l.
English: Investigations Rare
Croatian: Pretrage Rijetko
English: After the dose reduction of tenecteplase by half in patients ≥ 75 years there was no further intracranial hemorrhage (0 of 97 patients) (95% CI: 0.0-3.7) versus 8.1% (3 of 37 patients) (95% CI: 1.7-21.9) prior to dose reduction.
Croatian: Nakon sniženja doze tenekteplaze za polovinu za bolesnike ≥ 75 godina nije bilo daljnjih intrakranijalnih krvarenja (0 od 97 bolesnika) (95% CI: 0,0-3,7) naspram 8,1% (3 od 37 bolesnika) (95% CI: 1,7-21,9) prije snižavanja doze.
English: Hypersensitivity/Re-administration
Croatian: Preosjetljivost/ponovljena primjena
English: Heart failure
Croatian: Srčani poremećaji
English: No local irritation of the blood vessel was observed after intravenous, intra-arterial or paravenous administration of the final formulation of tenecteplase.
Croatian: Nisu primijećene lokalne iritacije krvih žila nakon intravenske, intraarterijske, ili paravenske primjene finalnog oblika tenekteplaze.
English: Pharmaco-invasive (n=944)
Croatian: Farmakoinvazivna metoda (n=944)
English: Directly before the solution will be administered, invert the vial with the syringe still attached, so that the syringe is below the vial.
Croatian: Izravno prije primjene otopine, preokrenite bočicu s još uvijek pričvršćenom štrcaljkom, tako da štrcaljka stoji ispod bočice.
English: A large scale mortality trial (ASSENT-2) in approx. 17,000 patients showed that tenecteplase is therapeutically equivalent to alteplase in reducing mortality (6.2% for both treatments, at 30 days, upper limit of the 95% CI for the relative risk ratio 1.124) and that the use of tenecteplase is associated with a significantly lower incidence of non-intracranial bleedings (26.4% vs. 28.9%, p=0.0003).
Croatian: Ispitivanje smrtnosti u velikom istraživanju (ASSENT-2) na otprilike 17 000 bolesnika pokazalo je da je tenekteplaza terapijski ekvivalentna alteplazi u smanjenju smrtnosti (6,2% za oba načina liječenja, tijekom 30 dana, gornja granica od 95% CI za relativnu stopu rizika od 1,124) te da je primjena tenekteplaze povezana sa značajno nižom incidencijom neintrakranijalnih krvarenja (26,4% prema 28,9%, p=0,0003).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove (EMA): http://www.ema.europa.eu
English: It binds to the fibrin component of the thrombus (blood clot) and selectively converts thrombus-bound plasminogen to plasmin, which degrades the fibrin matrix of the thrombus.
Croatian: Tenekteplaza se veže za fibrinsku komponentu tromba (krvni ugrušak) i selektivno pretvara plazminogen, koji je vezan za tromb, u plazmin, koji razgrađuje fibrinski matriks tromba.
English: Nonclinical data performed with tenecteplase have shown bleeding with secondary mortality of dams due to the known pharmacological activity of the active substance and in a few cases abortion and resorption of the foetus occurred (effects only have been observed with repeated dose administration).
Croatian: Podaci iz nekliničkih ispitivanja provedenih s tenekteplazom pokazali su krvarenje uz sekundarnu smrtnost ženki zbog poznate farmakološke aktivnosti djelatne tvari, kao i nekoliko slučajeva prekida trudnoće i resorpcije fetusa (ovi učinci su primijećeni isključivo uz primjenu ponovljenih doza).
English: The STREAM study was designed to evaluate the efficacy and safety of a pharmaco-invasive strategy versus a strategy of standard primary PCI in patients presenting with ST elevation acute myocardial infarction within 3 hours of onset of symptoms not able to undergo primary PCI within one hour of first medical contact.
Croatian: Ispitivanje STREAM osmišljeno je za ocjenu djelotvornosti i sigurnosti farmakoinvazivne strategije naspram strategije standardnog primarnog PCI-a, u bolesnika s akutnim infarktom miokarda s elevacijom ST spojnice unutar 3 sata od nastupa simptoma, koji nisu mogli biti podvrgnuti primarnom PCI-u unutar jednog sata od prvog javljanja liječniku.
English: Only clear solution without particles should be used.
Croatian: Smije se primijeniti isključivo bistra otopina, bez vidljivih čestica.
English: Transfusion of cryoprecipitate, fresh frozen plasma, and platelets should be considered with clinical and laboratory reassessment after each administration.
Croatian: Potrebno je nakon svake primjene transfuzije krioprecipitata, svježe zamrznute plazme i trombocita, učiniti kliničku i laboratorijsku procjenu.
English: Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija
English: Antithrombotic adjunctive therapy with platelet inhibitors and anticoagulants should be administered according to the current relevant treatment guidelines for the management of patients with ST-elevation myocardial infarction.
Croatian: Dodatnu antitrombotičku terapiju s inhibitorima trombocita i antikoagulansima potrebno je primjenjivati prema trenutno važećim smjernicama za liječenje bolesnika s infarktom miokarda s elevacijom ST spojnice.
English: Volume of reconstituted solution (ml)
Croatian: Volumen rekonstituirane otopine (ml)
English: Following intravenous bolus administration of 30 mg tenecteplase in patients with acute myocardial infarction, the initially estimated tenecteplase plasma concentration was 6.45 ± 3.60 µg/mL (mean ± SD).
Croatian: Nakon intravenske primjene bolusa od 30 mg tenekteplaze kod bolesnika s akutnim infarktom miokarda, početna procjena koncentracije tenekteplaze u plazmi bila je 6,45 ± 3,60 µg/mL (srednja vrijednost ± SD).
English: Adverse reactions listed below are classified according to frequency and system organ class.
Croatian: U nastavku navedene nuspojave se klasificiraju prema učestalosti i organskim sustavima.
English: Acetylsalicylic acid should be initiated as soon as possible after symptom onset and continued with lifelong treatment unless it is contraindicated.
Croatian: Nakon nastupa simptoma nužno je što ranije početi s primjenom acetilsalicilatne kiseline te nastaviti s doživotnim liječenjem, osim u slučaju kontraindikacija.
English: Metalyse will not be prescribed and given by your doctor:
Croatian: Liječnik Vam neće propisati i dati Metalyse :
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 ml water for injections
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 10 ml vode za injekcije
English: What Metalyse is and what it is used for What you need to know before you receive Metalyse How is Metalyse administered Possible side effects
Croatian: Što je Metalyse i za što se koristi Što morate znati prije nego primite Metalyse
English: Intracranial haemorrhage after protocol amendment to half dose in patients ≥ 75 years : * the incidences in both groups are those expected in STEMI patients treated by fibrinolytics or primary PCI (as observed in previous studies).
Croatian: Intrakranijalno krvarenje nakon promjene protokolna smanjenjem doze na polovinu kod bolesnika ≥ 75 years : * incidencije u obje skupine su očekivane za bolesnike s infarktom miokarda s elevacijom ST spojnice koji se liječe fibrinoliticima ili primarnim PCI-om (prema zapažanjima u prethodnim ispitivanjima).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 8 ml water for injections
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 8 ml vode za injekcije
English: Excipients: L-Arginine, Phosphoric Acid, Polysorbate 20 Trace residue from manufacturing process: Gentamicin The solvent is water for injections.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: L-arginin, fosfatna kiselina, polisorbat 20 Ostatak u tragovima iz proizvodnog procesa: gentamicin Otapalo je voda za injekcije.
English: Intracranial haemorrhage (such as cerebral haemorrhage, cerebral haematoma, haemorrhagic stroke, haemorrhagic transformation stroke, intracranial haematoma, subarachnoid haemorrhage) including associated symptoms as somnolence, aphasia, hemiparesis, convulsion
Croatian: Intrakranijalna krvarenja (kao što je cerebralna hemoragija, cerebralni hematom, hemoragijski moždani udar, transformacija u hemoragijski moždani udar, intrakranijski hematom, subarahnoidalna hemoragija), uključujući s time povezane simptome kao što su somnolencija, afazija, hemipareza, konvulzije
English: Metalyse is indicated in adults for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 6 hours after the onset of acute myocardial infarction (AMI) symptoms.
Croatian: Metalyse je indiciran u trombolitičkom liječenju odraslih u slučaju suspektnog infarkta miokarda, sa trajnom elevacijom ST spojnice ili novonastalim blokom lijeve grane unutar 6 sati od nastupa simptoma akutnog infarkta miokarda.
English: Uncommon (may affect up to 1 in 100 people): irregular heart beat (reperfusion arrhythmias), sometimes leading to cardiac arrest.
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba): - nepravilni otkucaji srca (reperfuzijske aritmije), koje mogu dovesti do zastoja srca.
English: Death or permanent disability may occur following bleeding in the brain or other serious bleeding events bleeding in the eyes (eye haemorrhage)
Croatian: Može doći do smrti ili trajnog invaliditeta nakon krvarenja u mozgu, kao i nakon drugih teških epizoda krvarenja - krvarenje u očima (hemoragija oka)
English: Patency data from the phase I and II angiographic studies suggest that tenecteplase, administered as a single intravenous bolus, is effective in dissolving blood clots in the infarct-related artery of subjects experiencing an AMI on a dose related basis.
Croatian: Dostupni podaci iz faze I i II angiografskih ispitivanja ukazuju da je tenekteplaza, primijenjena u obliku jednokratnog intravenskog bolusa, učinkovita u razgradnji krvnih ugrušaka u arteriji odgovornoj za infarkt kod ispitanika s akutnim infarktom miokarda, zavisno od doze.
English: The secondary endpoints re-infarction and repeat target vessel revascularisation were significantly increased in the group pre-treated with tenecteplase: reinfarction: 6.1% vs. 3.7% p=0.0279; repeat target vessel revascularisation: 6.6% vs. 3.4% p=0.0041.
Croatian: Sekundarni ishodi ispitivanja, tj. ponovljeni infarkt i ponovljena revaskularizacija ciljne žile bili su značajno povećani u skupini koja je bila na liječenju tenekteplazom: ponovljeni infarkt: 6,1% prema 3,7% p=0,0279; ponovljena revaskularizacija ciljne žile: 6,6% prema 3,4% p=0,0041.
English: Tenecteplase is a recombinant fibrin-specific plasminogen activator that is derived from native t-PA by modifications at three sites of the protein structure.
Croatian: Tenekteplaza je rekombinirani fibrin-specifični aktivator plazminogena, koji se derivira iz fiziološkog t-PA putem modifikacija njezine proteinske strukture na tri mjesta.
English: In patients ≥ 75 years the observed incidence of the primary efficacy composite end point for the pharmaco-invasive strategy and primary PCI were as follows: before dose reduction 11/37 (29.7%) (95% CI: 15.9- 47.0) versus 10/32 (31.3%) (95% CI: 16.1-50.0), after dose reduction: 25/97 (25.8%) (95% CI: 17.4-35.7) versus 25/88 (24.8%) (95% CI: 19.3-39.0).
Croatian: Kod bolesnika ≥ 75 godina primijećene incidencije primarnog kompozitnog ishoda djelotvornosti za farmakoinvazivnu strategiju i primarni PCI bile su sljedeće: prije sniženja doze 11/37 (29,7%) (95% CI: 15,9-47,0) naspram 10/32 (31,3%) (95% CI: 16,1-50,0), nakon sniženja doze: 25/97 (25,8%) (95% CI: 17,4-35,7) naspram 25/88 (24,8%) (95% CI: 19,3-39,0).
English: Your doctor will give Metalyse as soon as possible after your chest pain starts as a single dose.
Croatian: Liječnik će Vam dati Metalyse što je prije moguće nakon nastanka boli u prsnom košu u obliku jednokratne doze.
English: Your doctor will give you the medicinal product to prevent blood clotting in addition to Metalyse, as soon as possible after your chest pain starts.
Croatian: Liječnik će Vam propisati lijek za sprječavanje zgrušavanja krvi kao dodatak METALYSEU, što je prije moguće nakonnastanka boli u prsnom košu.
English: Reconstitute by swirling gently.
Croatian: Rekonstituirajte nježnim okretanjem.
English: The reconstituted preparation results in a colourless to pale yellow, clear solution.
Croatian: Rekonstituirani pripravak je bezbojna do blijedožuta, bistra otopina.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL FOR SOLVENT
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA ŠTRCALJKI ZA OTAPALO
English: Numerically all of the components of the clinical composite endpoint were in favour of the PCI only regimen: death: 6.7% vs. 4.9% p=0.14; cardiogenic shock: 6.3% vs. 4.8% p=0.19; congestive heart failure: 12.0% vs. 9.2% p=0.06 respectively.
Croatian: Brojčano, sve komponente klinički kompozitnih ishoda ispitivanja išle su u prilog liječenju samo perkutnom koronarnom intervencijom (PCI): smrt: 6,7% prema 4,9% p=0,14; kardiogeni šok: 6,3% prema 4,8% p=0,19; kongestivno zatajenje srca: 12,0% prema 9,2% p=0,06.
English: As with other thrombolytic agents, the following events have been reported as sequelae of myocardial infarction and/or thrombolytic administration:
Croatian: Kao i uz druge trombolitike, prijavljeni su sljedeći događaji kao posljedica infarkta miokarda i/ili primjene trombolitika:
English: The following adverse events occurred more frequently with tenecteplase prior to PCI: intracranial haemorrhage: 1% vs. 0% p=0.0037; stroke: 1.8% vs. 0% p<0.0001; major bleeds: 5.6% vs. 4.4% p=0.3118; minor bleeds: 25.3% vs. 19.0% p= 0.0021; blood transfusions: 6.2% vs. 4.2% p=0.0873; abrupt vessel closure: 1.9% vs. 0.1% p=0.0001.
Croatian: Sljedeći štetni događaji bili su učestaliji uz tenekteplazu prije PCI: intrakranijalno krvarenje: 1% prema 0% p=0,0037; moždani udar: 1,8% prema 0% p<0,0001; velika krvarenja: 5,6% prema 4,4% p=0,3118; manja krvarenja: 25,3% prema 19,0% p=0,0021; transfuzije krvi: 6,2% prema 4,2% p=0,0873; naglo zatvaranje krvnih žila: 1,9% prema 0,1% p=0,0001.
English: Metalyse should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor that use.
Croatian: Metalyse mogu propisivati liječnici koji imaju iskustva u primjeni trombolitičkih lijekova i mogućnosti praćenja njegove primjene.
English: The primary endpoint, a composite of death or cardiogenic shock or congestive heart failure or re-infarction within 30 days, was observed in 12.4% (116/939) of the pharmaco-invasive arm versus 14.3% (135/943) in the primary PCI arm (relative risk 0.86 (0.68-1.09)).
Croatian: Primarni ishod, kompozit smrti ili kardiogenog šoka ili kongestivnog zatajenja srca ili ponovnog infarkta u roku 30 dana, primijećen je kod 12,4% (116/939) bolesnika u skupini na farmakoinvazivnoj metodi naspram 14,3% (135/943) bolesnika u skupini podvrgnutoj primarnom PCI-u (relativni rizik 0,86 (0,68-1,09)).
English: Each vial 40 mg tenecteplase.
Croatian: Svaka bočica 40 mg tenekteplaze.
English: if you have previously had a sudden life-threatening allergic reaction (severe hypersensitivity) to the active ingredient tenecteplase, to gentamicin (a trace residue from the manufacturing process) or any of the other ingredients of Metalyse.
Croatian: - ako ste prethodno imali iznenadnu, po život opasnu alergijsku reakciju (teška preosjetljivost) na djelatnu tvar tenekteplazu, na gentamicin (ostatak iz proizvodnog procesa u tragovima), ili neku od pomoćnih tvari Metalysea.
English: Caution is needed when administering tenecteplase to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, or to gentamicin (a residue from the manufacturing process).
Croatian: Potreban je oprez u primjeni tenekteplaze kod osoba s poznatom preosjetljivošću (osim anafilaktičke reakcije) na djelatnu tvar, neku od pomoćnih tvari, ili na gentamicin (ostatak iz proizvodnog procesa).
English: Metalyse must not be administered to patients with a history of an anaphylactic (i.e. life-threatening) reaction to any of the constituents (i.e. tenecteplase or any excipient) or gentamicin (a trace residue from the manufacturing process).
Croatian: Metalyse se ne smije primjenjivati kod bolesnika s anamnezom anafilaktičke (tj. po život opasne) reakcije na bilo koji sastojak (tj. tenekteplazu ili neku pomoćnu tvar) ili gentamicin (ostatak iz proizvodnog procesa u tragovima).
English: The active substance is tenecteplase.
Croatian: - Djelatna tvar je tenekteplaza.
English: Rare (may affect up to 1 in 1,000 people): Blood clot in the lung (pulmonary embolism)
Croatian: Rijetko (može se javiti u do 1 na 1000 osoba): - krvni ugrušak u plućima (embolija pluća)
English: Remove the flip-off cap from the vial.
Croatian: Uklonite «flip-off» poklopac s bočice.
English: Tenecteplase is a fibrin-specific plasminogen activator produced in a Chinese hamster ovary cell line by recombinant DNA technology.
Croatian: Tenekteplaza je fibrin-specifični aktivator plazminogena proizveden na staničnoj liniji jajnika kineskog hrčka tehnologijom rekombinantne DNA.
English: As with other thrombolytic agents, the following events have been reported as sequelae of myocardial infarction and/or thrombolytic administration: - very common: hypotension, heart rate and rhythm disorders, angina pectoris - common: recurrent ischaemia, cardiac failure, myocardial infarction, cardiogenic shock,
Croatian: Kao i uz ostale trombolitičke lijekove, sljedeći događaji zabilježeni su kao posljedica infarkta miokarda i/ili primjene trombolitika: - vrlo često: hipotenzija, poremećaji srčane frekvencije i ritma, angina pektoris - često: recidivirajuća ishemija, zatajenje srca, infarkt miokarda, kardiogeni šok, perikarditis,
English: Add the water for injections into the vial by pushing the syringe plunger down slowly to avoid foaming.
Croatian: Dodajte vodu za injekcije polaganim potiskivanjem klipa štrcaljke prema dolje kako biste izbjegli pjenjenje.
English: The occurrence of the primary endpoint, a composite of death or cardiogenic shock or congestive heart failure within 90 days, was significantly higher in the group receiving the exploratory regimen of tenecteplase followed by routine immediate PCI: 18.6% (151/810) compared to 13.4% (110/819) in the PCI only group, p=0.0045.
Croatian: Pojava primarnih kombiniranih ishoda, tj. smrti ili kardiogenog šoka ili kongestivnog zatajenja srca unutar 90 dana, bila je znatno učestalija u skupini koja je primala tenekteplazu, prema eksplorcijskom režimu, nakon kojeg je odmah slijedila rutinska PCI: 18,6% (151/810) u usporedbi s 13,4% (110/819) u skupini koja je bila podvrgnuta samo PCI, p=0,0045.
English: Then immediately screw the pre-filled syringe on the vial adapter and penetrate the vial stopper in the middle with the spike of the vial adapter.
Croatian: Zatim odmah pričvrstite napunjenu štrcaljku na nastavak bočice i probijte čep bočice u sredini sa šiljkom nastavka bočice.
English:  60 to < 70  70 to < 80  80 to < 90
Croatian: ≥ 60 do < 70 ≥ 70 do < 80 ≥ 80 do < 90
English: The observed incidence of major and of minor non-ICH bleeds were similar in both groups: Pharmaco-invasive (n=944)
Croatian: Primijećena incidencija velikih i malih neintrakranijalnih krvarenja bila je slična u obje skupine:
English: Common (may affect up to 1 in 10 people): bleeding at the injection or puncture site nosebleeds genitourinary bleeding (you may notice blood in your urine) bruising gastro-intestinal bleeding (e.g. bleeding from the stomach or bowel)
Croatian: Često (mogu se javiti u do 1 na 10 osoba): - krvarenje na mjestu uboda injekcije ili punkcije - krvarenje iz nosa - genitourinarno krvarenje (možete primijetiti krv u mokraći) - stvaranje modrica - gastrointestinalno krvarenje (npr. krvarenje iz želuca ili crijeva)
English: Furthermore, Metalyse is contraindicated in the following situations because thrombolytic therapy is associated with a higher risk of bleeding:
Croatian: Nadalje, Metalyse je kontraindiciran u sljedećim situacijama, jer je trombolitičko liječenje povezano s povećanim rizikom od krvarenja: - značajni poremećaj krvarenja, bilo da je trenutno prisutan ili je bio prisutan u proteklih 6
English: Common (may affect up to 1 in 10 people): Further chest pain/angina (recurrent ischaemia) Heart attack
Croatian: Često (može se javiti u do 1 na 10 osoba): - ponovljena bol u prsnom košu/angina (rekurentna ishemija)
English: The type of haemorrhage is predominantly superficial at the injection site.
Croatian: Na mjestu primjene injekcije tip krvarenja je uglavnom površinski.
English: one vial of 8,000 units Metalyse powder and one pre-filled syringe containing 8 ml water for injections
Croatian: - jednu bočicu od 8000 jedinica Metalyse praška i - jednu napunjenu štrcaljku koja sadržava 8 ml vode za injekcije
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/169/006
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/169/006
English: When reconstituted with 8 ml solvent each ml contains 1,000 U tenecteplase.
Croatian: Nakon rekonstitucije s 8 ml otapala svaki ml sadržava 1000 U tenekteplaze.
English: The use of rigid catheters as well as intramuscular injections and non-essential handling of the patient should be avoided during treatment with tenecteplase.
Croatian: Tijekom liječenja tenekteplazom, potrebno je izbjegavati uporabu krutih katetera kao i intramuskularnih injekcija te nebitne postupke na bolesnicima.