natgillin/translations-raw huggingface dataset:
The active substance in Zoledronic acid medac, zoledronic acid, is a bisphosphonate. 
Zdravilna učinkovina zdravila Zoledronska kislina medac, zoledronska kislina, je difosfonat.
Why has Zoledronic acid medac been approved? 
Zakaj je bilo zdravilo Zoledronska kislina medac odobreno?
No additional studies were needed as Zoledronic acid medac is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa. 
Ker je zdravilo Zoledronska kislina medac generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Zometa, niso bile potrebne nobene dodatne študije.
How has Zoledronic acid medac been studied? 
Kako je bilo zdravilo Zoledronska kislina medac raziskano?
How does Zoledronic acid medac work? 
Kako zdravilo Zoledronska kislina medac deluje?
What is Zoledronic acid medac? 
Kaj je zdravilo Zoledronska kislina medac?
What is Zoledronic acid medac used for? 
Za kaj se zdravilo Zoledronska kislina medac uporablja?
How is Zoledronic acid medac used? 
Kako se zdravilo Zoledronska kislina medac uporablja?
Further information on Sprycel can be found on the Agency's website ema.europa.eu/medicines/human/EPAR/Sprycel. 
Nadaljnje informacije za zdravilo Sprycel so na voljo na spletni strani agencije ema.europa.eu/medicines/human/EPAR/Sprycel.
The dose is then gradually increased until the disease is controlled well enough. 
Odmerek se nato postopoma povečuje, dokler ni bolezen zadovoljivo nadzorovana.
The doses for Sprycel tablets and suspension are not the same. 
Odmerki za tablete in suspenzijo niso enaki.
It is taken once a day, consistently either in the morning or in the evening. 
Zdravilo Sprycel se jemlje enkrat na dan, bodisi vedno zjutraj ali vedno zvečer.
The main measure of effectiveness was the proportion of patients who did not have an unwanted event within 3 years of treatment. 
Glavno merilo učinkovitosti je bil delež bolnikov, ki niso imeli neželenega dogodka v treh letih zdravljenja.
Such events were: any sign of the disease in bone marrow, return of the disease anywhere in the body, a second cancer or death. 
Tovrstni dogodki vključujejo: kakršen koli znak bolezni v kostnem mozgu, vrnitev bolezni kjer koli v telesu, drugi rak ali smrt.
What measures are being taken to ensure the safe and effective use of Sprycel? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Sprycel?
The European Medicines Agency decided that Sprycel's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Sprycel večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Sprycel is also used in children to treat: 
Zdravilo Sprycel se uporablja tudi pri otrocih za zdravljenje:
What benefits of Sprycel have been shown in studies? 
Kakšne koristi zdravila Sprycel so se pokazale v študijah?
Why is Sprycel authorised in the EU? 
Zakaj je zdravilo Sprycel odobreno v EU?
What are the risks associated with Sprycel? 
Kakšna tveganja so povezana z zdravilom Sprycel?
Other information about Sprycel 
Druge informacije o zdravilu Sprycel
None of these studies compared Sprycel with another medicine. 
V nobeni študiji niso zdravila Sprycel primerjali z drugim zdravilom.
Sprycel received a marketing authorisation valid throughout the European Union on 20 November 
Za zdravilo Sprycel je bilo 20. novembra 2006 izdano dovoljenje za promet, veljavno po vsej EU.
An overview of Sprycel and why it is authorised in the EU 
Pregled zdravila Sprycel in zakaj je odobreno v EU
As for all medicines, data on the use of Sprycel are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Sprycel stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sprycel have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Sprycel upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Among patients treated with Sprycel and chemotherapy, 66% did not have an unwanted event. 
Med bolniki, zdravljeni z zdravilom Sprycel in kemoterapijo, jih 66 % ni imelo neželenega dogodka.
The most common side effects with Sprycel (seen in more than 1 patient in 10) are infection, suppression of the bone marrow (decreasing numbers of blood cells), headache, haemorrhage (bleeding), pleural effusion (fluid around the lungs), dyspnoea (difficulty breathing), diarrhoea, vomiting, nausea (feeling sick), abdominal pain (belly ache), skin rash, musculoskeletal pain, tiredness, swelling in the legs and arms and in the face, fever. 
Najpogostejši neželeni učinki zdravila Sprycel (opaženi pri več kot 1 bolniku od 10) so okužbe, supresija kostnega mozga (zmanjšano število krvnih celic), glavobol, hemoragija (krvavitev), plevralni izliv (tekočina v pljučih), dispneja (oteženo dihanje), driska, bruhanje, navzeja (siljenje na bruhanje), bolečine v trebuhu, kožni izpuščaj, mišično-skeletne bolečine, utrujenost, otekanje nog in rok ter obraza, povišana telesna temperatura.
What is Sprycel and what is it used for? 
Kaj je zdravilo Sprycel in za kaj se uporablja?
The doctor may reduce the dose or interrupt treatment if blood cell counts are too low or certain side effects occur. 
Zdravnik lahko zmanjša odmerek ali prekine zdravljenje, če je število krvnih celic prenizko ali če pride do nekaterih neželenih učinkov.
Sprycel is available as tablets (20, 50, 70, 80, 100 and 140 mg) and a powder to make up a suspension (10 mg/ml) to be taken by mouth. 
Zdravilo Sprycel je na voljo v obliki tablet (20, 50, 70, 80, 100 in 140 mg) in praška za pripravo suspenzije (10 mg/ml) za peroralno uporabo.
Most of these studies assessed how well the leukaemia responded to treatment by measuring the levels of white cells and platelets in the blood, to see if they were returning to within normal levels, and by measuring the number of white blood cells that contained the Philadelphia chromosome, to see if it was decreasing. 
V večini študij so ocenjevali, kako dobro se levkemija odziva na zdravljenje, z merjenjem ravni belih krvnih celic in trombocitov v krvi, da bi ugotovili, ali so se te vrnile na normalne ravni, in merjenjem deleža belih krvnih celic, ki vsebujejo kromosom Philadelphia, da bi ugotovili, ali se je ta znižal.
Side effects reported with Sprycel are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Sprycel, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The five main studies of Sprycel in adults involved 515 patients, all of whom had received treatment with imatinib, which had not worked or had stopped working. 
V pet glavnih študij zdravila Sprycel pri odraslih je bilo vključenih 515 bolnikov, od katerih so se vsi zdravili z imatinibom, ki ni deloval ali je prenehal delovati.
Treatment is stopped if the medicine no longer controls the condition or if the patient cannot take the medicine because of side effects. 
Zdravljenje se ustavi, če zdravilo ne nadzoruje več bolezni ali če bolnik ne more jemati zdravila zaradi neželenih učinkov.
For more information about using Sprycel, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Sprycel glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
• newly diagnosed Ph+ ALL in combination with chemotherapy (cancer medicines). 
• na novo diagnosticirane Ph+ ALL v kombinaciji s kemoterapijo (zdravili za zdravljenje raka).
The starting dose depends on the condition being treated and, for children, their body weight. 
Začetni odmerek je odvisen od obravnavane bolezni in pri otrocih tudi telesne mase.
In comparison, using results of previous studies, the figure was 49% in patients who had received chemotherapy alone and 59% in patients who had received imatinib and chemotherapy. 
V primerjavi z rezultati prejšnjih študij je bila ta številka 49 % pri bolnikih, ki so prejemali samo kemoterapijo, in 59 % pri bolnikih, ki so prejemali imatinib in kemoterapijo.
Sprycel was more effective than imatinib: within one year, 77% of patients receiving Sprycel no longer had the Philadelphia chromosome in their blood cells, compared with 66% of patients receiving imatinib. 
Zdravilo Sprycel je bilo učinkovitejše od imatiniba: 77 % bolnikov, ki so prejemali zdravilo Sprycel, po enem letu v krvi ni več imelo kromosoma Philadelphia, v primerjavi s 66 % bolnikov, ki so prejemali imatinib.
The active substance in Sprycel, dasatinib, belongs to a group of medicines that block enzymes known as protein kinases. 
Učinkovina zdravila Sprycel, dasatinib, spada v skupino zdravil, ki zavirajo encime, znane kot proteinske kinaze.
In addition, the number of white blood cells containing the Philadelphia chromosome was reduced in around 33 to 66% of treated patients in the five main studies. 
Poleg tega se je v petih glavnih študijah število belih krvnih celic, ki vsebujejo kromosom Philadelphia, zmanjšalo pri približno 33 do 66 % zdravljenih bolnikov.
This enzyme is produced by leukaemia cells, and causes them to multiply uncontrollably. 
Ta encim tvorijo levkemične celice, povzroča pa njihovo nenadzorovano razmnoževanje.
In a study involving 106 children and adolescents with newly diagnosed Ph+ ALL, patients were treated with Sprycel and chemotherapy. 
V študiji, ki je vključevala 106 otrok in mladostnikov z na novo diagnosticirano Ph+ ALL, so bolniki prejemali zdravilo Sprycel in kemoterapijo.
• newly diagnosed Ph+ CML in the ‘chronic' phase, or Ph+ CML when other treatments including imatinib cannot be given or have not worked; 
• na novo diagnosticirane Ph+ KML v kroničnem obdobju ali Ph+ KML, kadar drugih zdravljenj, vključno z imatinibom, ni mogoče dati ali niso delovala;
Sprycel can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of leukaemia. 
Predpisovanje in izdaja zdravila Sprycel je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem levkemije.
In patients with CML in other phases (accelerated, myeloid blast and lymphoid blast) and in ALL, around 25 to 33% of the patients had complete response. 
Pri bolnikih s KML v drugih obdobjih (obdobju pospešene rasti, mieloblastne preobrazbe in limfoblastne preobrazbe) in bolnikih z ALL se je na zdravljenje v celoti odzvalo 25 do 33 % bolnikov.
Once- and twice-daily Sprycel had similar effectiveness, but the once-daily dose caused fewer side effects. 
Odmerek, vzet enkrat ali dvakrat na dan, je podobno učinkovit, vendar pa odmerek, ki se vzame enkrat na dan, povzroči manj neželenih učinkov.
In children with ALL who are also receiving other cancer medicines, a fixed dose of Sprycel is used throughout their treatment. 
Pri otrocih z ALL, ki prejemajo tudi druga zdravila, se uporablja enak odmerek zdravila Sprycel ves čas zdravljenja.
Sprycel is used when other treatments including imatinib (another cancer medicine) do not work or cause troublesome side effects; 
Zdravilo Sprycel se uporablja, kadar druga zdravljenja, vključno z imatinibom (drugim zdravilom za zdravljenje raka), ne delujejo ali povzročajo hude neželene učinke;
In CML, granulocytes (a type of white blood cell) start growing out of control. 
Pri KML začnejo granulociti (vrsta belih krvnih celic) nenadzorovano rasti.
Two further studies compared the effects of Sprycel taken once or twice a day, one in 670 patients with chronic phase CML and the other in 611 patients with advanced phase CML or Ph+ ALL. 
V dveh nadaljnjih študijah so primerjali učinke zdravila Sprycel, vzetega enkrat ali dvakrat na dan, pri čemer je v eni študiji sodelovalo 670 bolnikov s KML v kroničnem obdobju, v drugi pa 611 bolnikov s KML v napredovalem obdobju ali Ph+ ALL.
By blocking Bcr-Abl kinase, as well as other kinases, Sprycel helps to reduce the number of leukaemia cells. 
Zdravilo Sprycel z zaviranjem kinaze Bcr-Abl in drugih kinaz pomaga zmanjšati število levkemičnih celic.
Dasatinib acts mainly by blocking the Bcr-Abl protein kinase. 
Dasatinib deluje v glavnem z zaviranjem proteinske kinaze Bcr-Abl.
How is Sprycel used? 
Kako se zdravilo Sprycel uporablja?
In the larger main study of patients with chronic phase CML, blood levels of platelets and white blood cells returned to within normal values in 90% of the patients. 
V večji glavni študiji z bolniki s KML v kroničnem obdobju so se pri 90 % bolnikov ravni trombocitov in belih krvnih celic vrnile na normalne vrednosti.
Another main study looked at the effectiveness of Sprycel in 113 children with Ph+ chronic phase CML, including 29 patients who could not use imatinib or it had not worked, as well as 84 newly diagnosed children who had not been previously treated. 
V drugi glavni študiji so proučevali učinkovitost zdravila Sprycel pri 113 otrocih s Ph+ KML v kroničnem obdobju, vključno z 29 bolniki, ki niso mogli uporabljati imatiniba ali se nanj niso odzvali, ter 84 otroki z novo postavljeno diagnozo, ki niso bili predhodno zdravljeni.
Sprycel is used when other treatments do not work or cause troublesome side effects. 
Zdravilo Sprycel se uporablja, kadar druga zdravljenja ne delujejo ali povzročajo hude neželene učinke.
For the full list of side effects and restrictions with Sprycel, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Sprycel glejte navodilo za uporabo.
A response was seen in around 90% of patients who could not use imatinib or it had not worked, and in 94% of newly diagnosed patients. 
bolnikov, ki niso mogli prejemati imatiniba ali se niso odzivali nanj, in pri 94 % bolnikov z novo postavljeno diagnozo.
Two studies were in patients with chronic CML (198 and 36 patients), one was in accelerated CML (120 patients), one was in myeloid blast CML (80 patients), and one was in Ph+ ALL and lymphoid blast CML (81 patients). 
Dve študiji sta vključevali bolnike s KML v kroničnem obdobju (198 in 36 bolnikov), v eni študiji so proučevali KML v obdobju pospešenega poteka (pri 120 bolnikih), v eni KML v obdobju mieloblastne preobrazbe (pri 80 bolnikih), v zadnji študiji pa Ph+ ALL in KML v fazi limfoblastne preobrazbe (pri 81 bolnikih).
• Ph+ acute lymphoblastic leukaemia (ALL), where lymphocytes (another type of white blood cell) multiply too quickly, or in ‘lymphoid blast' CML. 
• akutno limfoblastno levkemijo (ALL) s prisotnim kromosomom Philadelphia (Ph+), pri kateri se limfociti (druga vrsta belih krvnih celic) razmnožujejo prehitro, ali kronično mieloično levkemijo v obdobju limfoblastne preobrazbe.
How does Sprycel work? 
Kako zdravilo Sprycel deluje?
A further study involving 519 patients compared Sprycel with imatinib in treating newly diagnosed Ph+ patients with chronic phase CML who had not received any previous treatment. 
V dodatni študiji, ki je vključevala 519 bolnikov, so zdravilo Sprycel pri zdravljenju bolnikov z na novo diagnosticirano Ph+ KML v kroničnem obdobju, ki se pred tem še niso zdravili, primerjali z imatinibom.
Sprycel is a cancer medicine. 
Zdravilo Sprycel je zdravilo za zdravljenje raka.
Ph+ means that some of the patient's genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome which produces an enzyme, Bcr-Abl kinase that leads to the development of leukaemia. 
Ph+ pomeni, da so se nekateri geni pri bolniku prerazporedili tako, da tvorijo poseben kromosom, imenovan kromosom Philadelphia.
• chronic myeloid leukaemia (CML) in the ‘chronic' phase in newly diagnosed patients who are ‘Philadelphia chromosome positive' (Ph+). 
• z na novo diagnosticirano kronično mieloično levkemijo (KML) s prisotnostjo kromosoma Philadelphia (Ph+) v kroničnem obdobju.
• CML in ‘chronic', ‘accelerated' and ‘blast' phases. 
• kronično mieloično levkemijo v kroničnem obdobju, obdobju pospešenega poteka in obdobju blastne preobrazbe.
Sprycel contains the active substance dasatinib. 
Zdravilo Sprycel vsebuje učinkovino dasatinib.
Other incompatibilities may also exist. 
Morda obstajajo tudi druge inkompatibilnosti.
Blood transfusions were rarely required. 
Transfuzije krvi so bile le redko potrebne.
Each pack contains: 
Vsako pakiranje vsebuje:
• if you have had external heart massage within the past 10 days. 
• če so vam izvajali zunanjo masažo srca v zadnjih 10 dnevih,
Do not add any other medicines. 
Ne dodajajte nobenih drugih zdravil.
- age over 75 years 
• ste starejši od 75 let,
2 needles 19 G1 
2 igli 19 G1
These events can be life-threatening and may lead to death. 
Ti dogodki so lahko življenjsko ogrožujoči in lahko povzroči smrt.
Therefore it should not be used except in life-threatening situations. 
Zato naj se ne uporablja, razen v primerih, ki ogrožajo življenje.
Chemical and physical in-use stability has been demonstrated for 8 hours between 2° and 30 °C after dissolving with water for injection. 
Kemijska in fizikalna stabilnost je bila dokazana za 8 ur med 2 °C in 30 °C po raztapljanju z vodo za injekcije.
Each injection should be given slowly within 2 minutes. 
Vsako injekcijo je treba dati počasi v 2 minutah.
It is given within 12 hours after the onset of symptoms. 
Daje se ga v 12 urah po pojavu simptomov.
Date of first authorisation: 29 August 1996 Date of last renewal: 29 August 2006 
Datum zadnjega podaljšanja: 29. avgust 2006
• severe allergic reaction, causing shock or collapse 
• resna alergijska reakcija, ki povzroči šok ali kolaps.
In the patients who fail to respond to these conservative measures, judicious use of transfusion products may be indicated. 
Pri bolnikih, ki se ne odzovejo na te konservativne ukrepe, je morda indicirana razumna uporaba transfuzijskih izdelkov.
From a microbiological point of view, the product should be used immediately. 
Iz mikrobiološkega vidika se mora zdravilo uporabiti takoj.
Your doctor can tell you the risks and benefits of using Rapilysin during pregnancy. 
Vaš zdravnik vam lahko pove o tveganjih in koristih uporabe zdravila Rapilysin med nosečnostjo.
For further information see section 4.4, section bleeding. 
Za nadaljnje podatke glejte poglavje 4.4, odstavek Krvavitev.
Therefore tell the medical staff immediately if you 
Zato nemudoma povejte medicinskemu osebju, če:
52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois France 
52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois Francija
Rapilysin is usually given in a hospital. 
Zdravilo Rapilysin se običajno daje v bolnišnici.
As with other plasminogen activators a rebound phenomenon then occurs during which fibrinogen levels reach a maximum within 9 days and remain elevated for up to 18 days. 
Kot pri drugih aktivatorjih plazminogena se nato pojavi fenomen odboja; med njegovim potekom koncentracije fibrinogena dosežejo maksimum v 9 dneh in ostanejo povišane do 18 dni.
* Potency of reteplase is expressed in units (U) by using a reference standard which is specific for reteplase and is not comparable with units used for other thrombolytic agents. 
*Jakost reteplaze se izraža v enotah (U) z uporabo referenčnega standarda, ki je specifičen za reteplazo in ni primerljiv z enotami, uporabljenimi za druge trombolitične učinkovine.
This medicinal product should not be mixed with Heparin and/or acetylsalicylic acid. 
To zdravilo se ne sme mešati s heparinom in/ali acetilsalicilno kislino.
Therefore, the compatibility of the glass syringe and intravenous access should be ensured before use. 
Zato je treba kompatibilnost steklenih injekcijskih brizg in intravenskega dostopa zagotoviti pred uporabo.
Therefore Rapilysin must be given only in the presence and under the instructions of an emergency doctor. 
Zato se sme zdravilo Rapilysin dajati samo v navzočnosti in po navodilih zdravnika urgentne medicine.
The risks of Rapilysin treatment may be increased if you have any of the following conditions: 
Tveganje zdravljenja z zdravilom Rapilysin je lahko povečano, če imate katerega od naslednjih stanj:
• any other condition in which bleeding might be especially dangerous or might occur at a site where it would be difficult to control 
• katero koli drugo stanje, ko bi bila krvavitev posebno nevarna ali bi se lahko pojavila na mestu, kjer bi jo bilo težko nadzorovati.
Each patient being considered for therapy with reteplase should be carefully evaluated. 
Vsakega bolnika, pri katerem razmišljate o zdravljenju z reteplazo, je treba skrbno ovrednotiti.
• if you have severe uncontrolled high blood pressure (hypertension). 
• če imate nenadziran hudo zvišan krvni tlak (hipertenzijo),
In the following conditions the risks of reteplase therapy may be increased and should be weighed against the anticipated benefits: 
V naslednjih okoliščinah so lahko tveganja zdravljenja z reteplazo povečana in jih je treba pretehtati glede na pričakovane koristi:
Use aseptic technique throughout. 
Vseskozi uporabljajte aseptične metode.
In the alteplase group 33.0 % were fatal and 39.8 % were disabling. 
V skupini alteplaze je bilo 33,0 % smrtnih in 39,8 % onesposabljajočih.
Subacute toxicity studies did not reveal any unexpected adverse events. 
Študije subakutne toksičnosti niso razkrile nepričakovanih neželenih učinkov.
Reconstituted product: 
Rekonstituirano zdravilo:
Safety and effectiveness of Rapilysin in children have not been established. 
Varnost in učinkovitost zdravila Rapilysin pri otrocih nista bili ugotovljeni.
• if you are allergic to reteplase or any of the other ingredients of this medicine (listed in section 
• če ste alergični na reteplazo ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
• if you have other tumours associated with an increased risk of bleeding. 
• če imate druge tumorje, povezane s povečanim tveganjem za krvavitev,
Genotoxicity of reteplase was excluded by a complete battery of tests at different genetic end points in vitro and in vivo. 
Genotoksičnost reteplaze so izključili s popolnim sklopom testov različnih genetskih končnih točk in vitro in in vivo.
Since at present there is no experience with readministration of reteplase, the readministration is not recommended. 
Ker trenutno ni izkušenj s ponovnim dajanjem reteplaze, se ponovno dajanje ne priporoča.
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. 
Točni podatki o poglavitnih poteh izločanja reteplaze pri ljudeh niso na razpolago in posledice jetrne ali ledvične insuficience niso znane.
Attention should be paid to this effect especially during periods of low plasma fibrinogen (up to about 2 days after fibrinolytic therapy of AMI). 
Na ta učinek je treba biti pozoren, še posebno v obdobjih nizkih plazemskih koncentracij fibrinogena (do približno 2 dni po fibrinolitičnem zdravljenju akutnega miokardnega infarkta).
The only relevant available animal data refer to studies performed in rabbits, which showed vaginal bleedings associated with abortions (see section 5.3). 
Edini razpoložljivi relevantni podatki iz študij na živalih se nanašajo na študije, izvajane na kuncih, kjer so se pokazale krvavitve iz nožnice, povezane s splavi (glejte poglavje 5.3).
Local reactions at injection site can also occur. 
Pojavijo se lahko tudi lokalne reakcije na mestu injiciranja.
After reconstitution (“when dissolved”), the solution must be used immediately. 
Po rekonstituciji (ko je raztopljena) je treba raztopino takoj uporabiti.
Reports of intracranial bleeding, many of which are fatal, are of particular concern. 
Posebej zaskrbljujoča so poročila o intrakranialnih krvavitvah, od katerih so mnoge usodne.
In the event of overdosage one might expect depletion of fibrinogen and other blood coagulation components (e.g. coagulation factor V) with a consequent risk of bleeding. 
V primeru prevelikega odmerjanja bi lahko pričakovali izčrpanje fibrinogena in drugih komponent strjevanja krvi (npr. koagulacijskega faktorja V) s posledičnim tveganjem za krvavitev.
This event has been reported for the therapeutic class of thrombolytic agents. 
Ta dogodek je bil poročan za terapevtski razred trombolitikov.