natgillin/translations-raw huggingface dataset:
abdominal pain, malaise, back pain and increased inflammatory markers.
Simptomi lahko vključujejo povišano telesno temperaturo, bolečine v trebuhu, slabo počutje, bolečine v hrbtu in povišane vrednosti vnetnih označevalcev.
Summary of product characteristics (SPC)
Povzetek glavnih značilnosti zdravila
Hydroxycarbamide - Cutaneous lupus erythematosus (EPITT no 18939)
Hidroksikarbamid - kožni eritematozni lupus (št. EPITT
This means that each pack contains:
To pomeni, da vsako pakiranje vsebuje:
Secondary mortality was observed 1-2 days later.
Sekundarno umrljivost so zasledili 1 do 2 dni pozneje.
This is also supported by animal data.
Tako kažejo tudi podatki iz raziskav na živalih.
Elderly ( 75 years)
Starejši (> 75 let)
STREAM study
Študija STREAM
This significant difference between the groups for the primary endpoint at 90 days was already present in-hospital and at 30 days.
Ta pomembna razlika med skupinama glede na primarni opazovani dogodek po 90 dneh je bila prisotna že v bolnišnici in po 30 dneh.
Ecchymoses are observed commonly but usually do not require any specific action.
Ekhimoze so pogoste, vendar zaradi njih običajno niso potrebni posebni ukrepi.
In the few patients who fail to respond to these conservative measures, judicious use of transfusion products may be indicated.
Pri redkih bolnikih, ki se na te konservativne ukrepe ne odzovejo, je indicirana razumna uporaba transfuzijskih pripravkov.
OTHER SPECIAL WARNING(S), IF NECESSARY Please follow accurately the instructions for use.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Natančno upoštevajte navodila za uporabo.
The study population consisted of 1,892 patients randomised by means of an interactive voice response system.
Obravnavano populacijo je sestavljalo 1892 bolnikov, ki so bili naključno razvrščeni po sistemu interaktivnega glasovnega odziva.
These medicines help to dissolve blood clots.
Ta zdravila raztapljajo krvne strdke.
Adverse reactions listed below are classified according to frequency and system organ class.
Spodaj navedeni neželeni učinki so razvrščeni po pogostnosti in organskih sistemih.
From a microbiological point of view, the reconstituted solution should be used immediately.
Iz mikrobiološkega vidika je treba rekonstituirano raztopino takoj uporabiti.
Table 1 displays the frequency of adverse reactions.
Preglednica 1 navaja podatke o pogostnosti neželenih učinkov.
Primary PCI (n=948)
Primarna PKI (n = 948)
This observation is consistent with the intended effect of plasminogen activation.
To opažanje je v skladu s predvidenim učinkom aktivacije plazminogena.
This helps to prevent the damage caused by heart attacks and has been shown to save lives.
Prepreči poškodbe, ki nastanejo pri srčnem napadu in pokazalo se je, da rešuje življenja.
The terminal half-life is 129 ± 87 min, and plasma clearance is 119 ± 49 ml/min.
Končna razpolovna doba je 129 ± 87 minut, očistek iz plazme pa 119 ± 49 ml/min.
if you have, or have recently had, an illness that increases your risk of bleeding (haemorrhage), including:
če imate ali ste nedavno imeli eno od naslednjih bolezni, ki povečajo nevarnost krvavitve (hemoragije):
Tenecteplase is not considered to be teratogenic (please see section 5.3).
Tenekteplaza ne velja za teratogeno učinkovino (glejte poglavje 5.3).
Antifibrinolytic agents are available as a last alternative.
Kot zadnja možnost so na voljo antifibrinolitiki.
It is not known whether and to which extent tenecteplase binds to plasma proteins in humans.
Ni znano, če in v kakšnem obsegu se tenekteplaza pri človeku veže na beljakovine v plazmi.
The volume required to administer the correct dose can be calculated from the following scheme:
Volumen, ki je potreben za pravilen odmerek, lahko izračunamo po naslednji shemi:
The main organ to which tenecteplase distributed was the liver.
Poglavitni organ, v katerega se je razporejala tenekteplaza, so bila jetra.
Metalyse (U)
Metalyse (E)
Mutagenicity and carcinogenicity are not expected for this class of recombinant proteins and genotoxicity and carcinogenicity testing were not necessary.
Mutagenosti in kancerogenosti pri tej skupini rekombinantnih proteinov ne pričakujemo, zato raziskave o genotoksičnosti in kancerogenosti niso bile potrebne.
Frequency groupings are defined according to the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Skupine bolezni so po pogostnosti opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
What Metalyse is and what it is used for
Kaj je zdravilo Metalyse in za kaj ga uporabljamo
Pharmacotherapeutic group: Antithrombotic agents, enzymes; ATC code: B01A D11
Farmakoterapevtska skupina: antitrombotiki, encimi; oznaka ATC: B01A D11
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli po znaku EXP.
Should serious bleeding occur, in particular cerebral haemorrhage, concomitant heparin administration should be terminated immediately.
Če se pojavi resna krvavitev, zlasti možganska, moramo nemudoma ukiniti sočasno zdravljenje s heparinom.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 2001
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 23. februar 2001 Datum zadnjega podaljšanja: 23. februar 2006
Systolic blood pressure > 160 mm Hg
• sistolični krvni tlak > 160 mm Hg,
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Oneželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V.S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
Sterile needle for single use.
Sterilna igla za enkratno uporabo.
Acetylsalicylic acid should be initiated as soon as possible after symptom onset and continued with lifelong treatment unless it is contraindicated.
Acetilsalicilno kislino je treba začeti dajati čim prej po pojavu simptomov in z dajanjem nadaljevati doživljenjsko, razen če je kontraindicirano.
The distribution phase represents 31% ± 22% to 69% ± 15% (mean ± SD) of the total AUC following the administration of doses ranges from 5 to 50 mg.
Faza porazdelitve je 31 % ± 22 % do 69 % ± 15 % (srednja vrednost ± SD) skupne AUC po dajanju odmerkov v razponu 5 do 50 mg.
Women exhibit in general lower clearance than men, but this can be explained by the generally lower body weight of women.
Pri ženskah je očistek na splošno manjši kot pri moških, kar lahko pojasnimo z njihovo manjšo telesno maso.
This translates into a significantly lower need of transfusions (4.3% vs. 5.5%, p=0.0002).
To pomeni, da je pri zdravljenju s tenekteplazo potreba po transfuzijah pomembno manjša (4,3 % proti 5,5 %; p = 0,0002).
The powder is white to off-white.
Prašek je bele do skoraj bele barve.
The trial was prematurely terminated with 1667 randomised patients due to a numerically higher mortality in the facilitated PCI group receiving tenecteplase.
Preskušanje so predčasno končali pri 1667 naključno izbranih bolnikih, ker je bila umrljivost številčno večja v skupini s PKI, ki je prejemala tenekteplazo.
GPIIb/IIIa antagonists
Antagonisti GPIIb/IIIa
For any information about this medicine please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
No other medicinal product should be added to the injection solution.
V raztopino za injiciranje ne smemo dodajati drugih zdravil.
Potency of tenecteplase is expressed in units (U) by using a reference standard which is specific for tenecteplase and is not comparable with units used for other thrombolytic agents.
Jakost tenekteplaze je izražena v enotah (E), ki so določene s specifičnim referenčnim standardom za tenekteplazo in niso primerljive z enotami, ki jih uporabljamo za druge trombolitike.
Furthermore, Metalyse is contraindicated in the following situations because thrombolytic therapy is associated with a higher risk of bleeding:
Zdravilo Metalyse je kontraindicirano še pri naslednjih stanjih, saj je trombolitično zdravljenje povezano s tveganjem krvavitve;
Gentamicin is contained as trace residue from the manufacturing process
Gentamicin je ostanek v sledeh iz proizvodnega postopka.
What do you need to know before you receive Metalyse
Kaj morate vedeti, preden boste prejeli zdravilo Metalyse
Reperfusion arrhythmias may lead to cardiac arrest, can be life threatening and may require the use of conventional antiarrhythmic therapies.
Reperfuzijske aritmije lahko povzročijo srčni zastoj, ogrozijo življenje in zahtevajo uvedbo konvencionalnih antiaritmikov.
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
Kaj je zdravilo Metalyse in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Metalyse Kako boste prejeli zdravilo Metalyse Možni neželeni učinki
Metalyse is not recommended for use in children (below 18 years) due to a lack of data on safety and efficacy.
Uporabe zdravila Metalyse pri otrocih (mlajših od 18 let) ne priporočamo, ker je na voljo premalo podatkov o varnosti in učinkovitosti.
Invert vial/syringe and transfer the appropriate volume of the solution into syringe according to the dosing instructions.
Obrnemo vialo/brizgo in prenesemo ustrezen volumen raztopine v brizgo v skladu z navodili za odmerjanje.
Metalyse should be administered with caution in the elderly ( 75 years) due to a higher bleeding risk (see information on bleeding in section 4.4 and on the STREAM study in section 5.1).
Starejšim (> 75 let) je treba zdravilo Metalyse zaradi večjega tveganja za pojav krvavitve dajati previdno (glejte podatke o krvavitvah v poglavju 4.4 in o študiji STREAM v poglavju 5.1).
PARTICULARS TO APPEAR ON THE INNER SIDE OF THE LID OF THE CARTON IN FORM OF A PICTOGRAMM
PODATKI, KI MORAJO BITI NAVEDENI NA NOTRANJI STRANI ROBNEGA DELA ŠKATLE V OBLIKI PIKTOGRAMA
However, the effect of renal and hepatic dysfunction on pharmacokinetics of tenecteplase in humans has not been specifically investigated.
Toda specifičnega vpliva ledvične in jetrne disfunkcije na farmakokinetiko tenekteplaze pri ljudeh niso raziskali.
Data on tissue distribution were obtained in studies with radioactively labelled tenecteplase in rats.
Podatki o tkivni porazdelitvi izvirajo iz raziskav z radioaktivno označeno tenekteplazo pri podganah.
Cerebrovascular disease
• cerebrovaskularna bolezen,
In any case, tenecteplase should not be readministered before assessment of haemostatic factors like fibrinogen, plasminogen and alpha2antiplasmin.
Tenekteplaze ne smemo ponovno dajati, ne da bi prej določili hemostatske faktorje, kot so fibrinogen, plazminogen in antiplazmin alfa2.
Because elimination of tenecteplase is through the liver, it is not expected that renal dysfunction will affect its the pharmacokinetics.
Ker se tenekteplaza izloča skozi jetra, ledvična disfunkcija predvidoma ne vpliva na njeno farmakokinetiko.
Coronary thrombolysis may result in arrhythmias associated with reperfusion.
Koronarna tromboliza lahko povzroči aritmijo, ki jo spremlja reperfuzija.
However there is no systematic experience with re-administration of tenecteplase.
Vendar s ponovnim dajanjem tenekteplaze ni sistematičnih izkušenj.
 60 to < 70  70 to < 80  80 to < 90
 60 do < 70  70 do < 80  80 do < 90
Active peptic ulceration
• aktivni peptični ulkus,
If primary percutaneous coronary intervention (PCI) is scheduled according to the current relevant treatment guidelines, tenecteplase (see section 5.1 ASSENT-4 study) should not be given.
Če je perkutana koronarna intervencija (PKI) načrtovana v skladu z veljavnimi smernicami za zdravljenje, tenekteplaze (glejte poglavje 5.1 študija ASSENT-4) ne smete dajati.
Any unused solution should be discarded.
Neporabljeno raztopino moramo zavreči.
The required dose should be administered as a single intravenous bolus over approximately 10 seconds.
Potreben odmerek vnesemo z enim intravenskim bolusom v približno 10 sekundah.
In the following conditions, the risk of tenecteplase therapy may be increased and should be weighed against the anticipated benefits:
Pri naštetih stanjih je lahko tveganost zdravljenja s tenekteplazo povečana, zato moramo o njegovi uvedbi presoditi glede na pričakovano korist:
Treatment with Metalyse should be initiated as soon as possible after onset of symptoms.
Zdravljenje z zdravilom Metalyse moramo začeti čimprej po pojavu simptomov.
The dose linearity analysis based on AUC suggested that tenecteplase exhibits non-linear pharmacokinetics in the dose range studied, i.e. 5 to 50 mg.
Analiza linearnosti odmerka, ki je temeljila na AUC, je kazala, da ima tenekteplaza nelinearno farmarmakokinetiko v preskušanem razponu odmerkov, to je 5 do 50 mg.
If an anaphylactoid reaction occurs, the injection should be discontinued immediately and appropriate therapy should be initiated.
Če se pojavi anafilaktoidna reakcija, moramo injiciranje takoj prekiniti in uvesti ustrezno zdravljenje.
Severe uncontrolled hypertension
• huda nenadzorovana hipertenzija,
Unfractionated heparin and enoxaparin have been used as antithrombotic adjunctive therapy in clinical studies with Metalyse.
Nefrakcionirani heparin in enoksaparin so že uporabili kot dodatno protitrombotično zdravilo v kliničnih preskušanjih zdravila Metalyse.
Concomitant use of GPIIb/IIIa antagonists increases bleeding risk.
Sočasna uporaba antagonistov GPIIb/IIIa poveča tveganje krvavitve.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and 8 hours at 30°C.
Kemična in fizikalna stabilnost med uporabo je preverjena za čas do 24 ur pri 2-8 °C in do 8 ur pri 30 °C.
** the incidence in the pharmaco-invasive group is as expected for fibrinolysis with tenecteplase (as observed in previous studies).
** V skupini s farmakoinvazivno strategiijo je pojavnost takšna, kot je pri fibrinolizi s tenekteplazo pričakovana (po podatkih iz prejšnjih študij).
Failure to do so may lead to greater than the required dose of Metalyse being administered.
Zaradi neupoštevanja navodil se lahko zgodi, da boste odmerili večji odmerek Metalysa, kot je potreben.
METHOD OF ADMINISTRATION Reconstituted solution, for patients of body weight (kg):
POSTOPEK UPORABE Pripravljena raztopina, za bolnika telesne mase (kg):
The doctor calculates your dose of Metalyseaccording to your bodyweight, based on the following scheme:
Zdravnik izračuna za vas ustrezen odmerek zdravila Metalysena podlagi vaše telesne mase po naslednji shemi:
Open the top of the vial-adapter.
Odpremo zgornji del nastavka za vialo.
For details see section 6.6: Special precautions for disposal and other handling
Glejte poglavje 6.6: Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
The ASSENT-4 PCI study was designed to show if in 4000 patients with large myocardial infarctions pre-treatment with full dose tenecteplase and concomitant single bolus of up to 4,000 IU unfractionated heparin administered prior to primary PCI to be performed within 60 to 180 minutes leads to better outcomes than primary PCI alone.
Raziskava ASSENT-4 PCI je bila načrtovana tako, da bi pokazala, ali bo izid zdravljenja pri 4000 bolnikih z obsežnim miokardnim infarktom ob predzdravljenju s polnimi odmerki tenekteplaze in sočasni enkratni bolusni injekciji do 4000 i.e. nefrakcioniranega heparina pred primarno PKI, ki bo opravljena v 60 do 180 minutah, boljši kot ob sami primarni PKI.
Transfusion of cryoprecipitate, fresh frozen plasma, and platelets should be considered with clinical and laboratory reassessment after each administration.
Presoditi je treba o transfuziji krioprecipitata, sveže zamrznjene plazme in trombocitov in po vsaki transfuziji bolnikovo stanje ponovno oceniti s klinično in laboratorijsko preiskavo.
less than 6060 to 7070 to 8080 to 90above 90
manj kot 6060 do 7070 do 8080 do 90več kot 90
There is limited amount of data from the use of Metalyse in pregnant women.
Podatkov o uporabi zdravila Metalyse pri nosečnicah je malo.
It is not known if tenecteplase is excreted in human milk.
Ni znano ali se tenektoplaza izloča v materino mleko.
As fibrin is lysed during tenecteplase therapy, bleeding from recent puncture site may occur.
Ker se med zdravljenjem s tenekteplazo fibrin raztaplja, lahko pride do krvavitve na mestu nedavne punkcije.
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).
Intrakranialna krvavitev po spremembi protokola na polovični odmerek pri bolnikih, starih ≥ 75 let: * Pojavnost v obeh skupinah je bila takšna, kot je pričakovana za bolnike z miokardnim infarktom z dvigom spojnice ST, ki se zdravijo s fibrinolitiki ali primarno PKI (po podatkih iz prejšnjih študij).
In comparative studies a less than 15% reduction in fibrinogen and a less than 25% reduction in plasminogen were observed in subjects treated with the maximum dose of tenecteplase (10,000 U, corresponding to 50 mg), whereas alteplase caused an approximately 50% decrease in fibrinogen and plasminogen levels.
V primerjalnih raziskavah se je pri bolnikih, ki so jih zdravili z največjim odmerkom tenekteplaze (10.000 E, kar ustreza 50 mg), raven fibrinogena zmanjšala za manj kot 15 % in plazminogena za manj kot 25 %, alteplaza pa je povzročila približno 50-odstotno zmanjšanje ravni fibrinogena in plazminogena.
Metalyse should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor that use.
Zdravilo Metalyse morajo predpisati zdravniki, ki imajo izkušnje s trombolitičnim zdravljenjem in na voljo opremo za njegovo spremljanje.
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).
Neklinični podatki o tenekteplazi so pokazali krvavitev in sekundarno umrljivost samic zaradi znanega farmakološkega delovanja zdravilne učinkovine ter v nekaj primerih splav in resorpcijo plodu (te učinke so opazili samo pri ponovljenih odmerkih).
These cardiovascular events can be life-threatening and may lead to death.
Našteti srčnožilni dogodki so lahko življenjsko nevarni in lahko povzročijo smrt.
The mean residence time (MRT) in the body is approximately 1 h and the mean (± SD) volume of distribution at the steady-state (Vss) ranged from 6.3 ± 2 L to 15 ± 7 L.
Srednji čas zadrževanja v telesu je približno 1 ura, srednja (± SD) prostornina porazdelitve v stanju dinamičnega ravnovesja (Vss) pa 6,3 ± 2 l do 15 ± 7 l.
In both groups the bounds of the confidence interval of the observed incidences prior and post dose reduction are overlapping.
V obeh skupinah se meje intervala zaupanja pri pojavnosti pred zmanjšanjem odmerka in po njem prekrivajo.
Tenecteplase (U)
Tenekteplaza (E)
Very common (may affect more than 1 in 10 people): bleeding
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): krvavitev.
cardiac tamponade, myocardial rupture - rare: pulmonary embolism
tamponada srca, ruptura miokardija, - redki: pljučna embolija.
Accordingly, there is no guidance for the adjustment to tenecteplase dose in patients with hepatic and severe renal insufficiency.
Zato o prilagoditvi odmerka tenekteplaze za bolnike z jetrno ali hudo ledvično insuficienco ni priporočil.
Children and adolescents The use of Metalyse in children and adolescents up to the age of 18 years is not recommended.
Otroci in mladostniki Uporaba zdravila Metalyse pri otrocih do 18.leta starosti ni priporočena.
Tell your doctor or pharmacist if you are taking,have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete,ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
The other ingredients are L-arginine, phosphoric acid and polysorbate 20.
Pomožne snovi so L-arginin, fosforjeva kislina in polisorbat 20.
Patients who cannot undergo primary PCI within one hour as recommended by guidelines and receive tenecteplase as primary coronary recanalization treatment should be transferred without delay to a coronary intervention capable facility for angiography and timely adjunctive coronary intervention within 6-24 hours or earlier if medically indicated (see section 5.1 STREAM study).
Bolnike, pri katerih primarne perkutane koronarne intervencije ni mogoče opraviti v eni uri, kot priporočajo smernice, in prejemajo tenekteplazo za primarno koronarno rekanalizacijo, je treba brez odlašanja premestiti v enoto, ki je opremljena za izvajanje koronarnih intervencij, opraviti angiografijo in pravočasno izvesti dodatno koronarno intervencijo v 6 do 24 urah ali prej, če je medicinsko indicirano (glejte poglavje 5.1 študija STREAM).
The initial, dominant half-life is 24 ± 5.5 (mean ±SD) min, which is 5 times longer than native t-PA.
Začetna, prevladujoča razpolovna doba je 24 ± 5,5 (srednja vrednost ± SD) minut, kar je petkrat dlje kot pri naravnem t-PA.
Most frequently haemorrhage at the injection site, and occasionally genitourinary and gingival bleeding were observed.
Najpogosteje so zasledili krvavitev na mestu injekcije, občasno pa urogenitalno krvavitev in krvavitev dlesni.
SPECIAL STORAGE CONDITIONS Keep the container in the outer carton.
POSEBNA NAVODILA ZA SHRANJEVANJE Vsebnik shranjujte v zunanji ovojnini.
Metalyse is to be administered to the patient, intravenously in about 10 seconds.
Zdravilo Metalyse injiciramo bolniku intravensko v 10 sekundah.
Safety pharmacology data in cynomolgus monkeys revealed reduction of blood pressure followed by changes of ECG, but these occurred at exposures that were considerably higher than the clinical exposure.
Farmakološki podatki o varnosti pri opicah vrste cynomolgus so pokazali zmanjšanje krvnega tlaka in prehodne motnje na izvidu EKG, ki pa so se pojavili samo ob odmerkih, veliko večjih od klinično uporabljanih.
Metalyse belongs to a group of medicines called thrombolytic agents.
Zdravilo Metalyse sodi v skupino zdravil, ki jih imenujemo trombolitiki.
If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev,se posvetujte z zdravnikom, preden prejmete zdraviloMetalyse.
The pharmaco-invasive strategy consisted of early fibrinolytic treatment with bolus tenecteplase and additional antiplatelet and anticoagulant therapy followed by angiography within 6-24 hours or rescue coronary intervention.
Farmakoinvazivna strategija je zajemala zgodnje fibrinolitično zdravljenje s tenekteplazo v bolusu ter dodatno protitrombocitno in antikoagulacijsko zdravljenje, zatem so v 6 do 24 urah izvedli angiografijo ali opravili reševalno koronarno intervencijo.
Tenecteplase induced total litter deaths during the mid-embryonal period.
Tenekteplaza je povzročila pogin celotnega zaroda v sredini embrionalnega razvoja.
Incidence of total strokes and intracranial haemorrhage
Pojavnost vseh možganskih kapi in intrakranialnih krvavitev
Total stroke (all types)
Skupno možganska kap (vse oblike)
When tenecteplase was given during the mid- or late-embryonal period maternal animals showed vaginal bleeding on the day after the first dose.
Če so tenekteplazo dajali v srednjem in poznem obdobju embrionalnega razvoja, se je pri samicah dan po prvem odmerku pojavila krvavitev iz nožnice.