FrancophonIA/ELRC3.0 huggingface dataset:
English: • newly diagnosed Ph+ CML in the ‘chronic' phase, or Ph+ CML when other treatments including imatinib cannot be given or have not worked;
Slovenian: • na novo diagnosticirane Ph+ KML v kroničnem obdobju ali Ph+ KML, kadar drugih zdravljenj, vključno z imatinibom, ni mogoče dati ali niso delovala;
English: 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.
Slovenian: Predpisovanje in izdaja zdravila Sprycel je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem levkemije.
English: 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.
Slovenian: 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.
English: Once- and twice-daily Sprycel had similar effectiveness, but the once-daily dose caused fewer side effects.
Slovenian: Odmerek, vzet enkrat ali dvakrat na dan, je podobno učinkovit, vendar pa odmerek, ki se vzame enkrat na dan, povzroči manj neželenih učinkov.
English: In children with ALL who are also receiving other cancer medicines, a fixed dose of Sprycel is used throughout their treatment.
Slovenian: Pri otrocih z ALL, ki prejemajo tudi druga zdravila, se uporablja enak odmerek zdravila Sprycel ves čas zdravljenja.
English: Sprycel is used when other treatments including imatinib (another cancer medicine) do not work or cause troublesome side effects;
Slovenian: Zdravilo Sprycel se uporablja, kadar druga zdravljenja, vključno z imatinibom (drugim zdravilom za zdravljenje raka), ne delujejo ali povzročajo hude neželene učinke;
English: In CML, granulocytes (a type of white blood cell) start growing out of control.
Slovenian: Pri KML začnejo granulociti (vrsta belih krvnih celic) nenadzorovano rasti.
English: 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.
Slovenian: 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.
English: By blocking Bcr-Abl kinase, as well as other kinases, Sprycel helps to reduce the number of leukaemia cells.
Slovenian: Zdravilo Sprycel z zaviranjem kinaze Bcr-Abl in drugih kinaz pomaga zmanjšati število levkemičnih celic.
English: Dasatinib acts mainly by blocking the Bcr-Abl protein kinase.
Slovenian: Dasatinib deluje v glavnem z zaviranjem proteinske kinaze Bcr-Abl.
English: How is Sprycel used?
Slovenian: Kako se zdravilo Sprycel uporablja?
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Sprycel is used when other treatments do not work or cause troublesome side effects.
Slovenian: Zdravilo Sprycel se uporablja, kadar druga zdravljenja ne delujejo ali povzročajo hude neželene učinke.
English: For the full list of side effects and restrictions with Sprycel, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Sprycel glejte navodilo za uporabo.
English: 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.
Slovenian: bolnikov, ki niso mogli prejemati imatiniba ali se niso odzivali nanj, in pri 94 % bolnikov z novo postavljeno diagnozo.
English: 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).
Slovenian: 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).
English: • Ph+ acute lymphoblastic leukaemia (ALL), where lymphocytes (another type of white blood cell) multiply too quickly, or in ‘lymphoid blast' CML.
Slovenian: • 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.
English: How does Sprycel work?
Slovenian: Kako zdravilo Sprycel deluje?
English: 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.
Slovenian: 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.
English: Sprycel is a cancer medicine.
Slovenian: Zdravilo Sprycel je zdravilo za zdravljenje raka.
English: 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.
Slovenian: Ph+ pomeni, da so se nekateri geni pri bolniku prerazporedili tako, da tvorijo poseben kromosom, imenovan kromosom Philadelphia.
English: • chronic myeloid leukaemia (CML) in the ‘chronic' phase in newly diagnosed patients who are ‘Philadelphia chromosome positive' (Ph+).
Slovenian: • z na novo diagnosticirano kronično mieloično levkemijo (KML) s prisotnostjo kromosoma Philadelphia (Ph+) v kroničnem obdobju.
English: • CML in ‘chronic', ‘accelerated' and ‘blast' phases.
Slovenian: • kronično mieloično levkemijo v kroničnem obdobju, obdobju pospešenega poteka in obdobju blastne preobrazbe.
English: Sprycel contains the active substance dasatinib.
Slovenian: Zdravilo Sprycel vsebuje učinkovino dasatinib.
English: Other incompatibilities may also exist.
Slovenian: Morda obstajajo tudi druge inkompatibilnosti.
English: Blood transfusions were rarely required.
Slovenian: Transfuzije krvi so bile le redko potrebne.
English: Each pack contains:
Slovenian: Vsako pakiranje vsebuje:
English: 20014 Nerviano (Milan) Italy
Slovenian: 20014 Nerviano (Milan) Italija
English: • if you have had external heart massage within the past 10 days.
Slovenian: • če so vam izvajali zunanjo masažo srca v zadnjih 10 dnevih,
English: Do not add any other medicines.
Slovenian: Ne dodajajte nobenih drugih zdravil.
English: - age over 75 years
Slovenian: • ste starejši od 75 let,
English: 2 needles 19 G1
Slovenian: 2 igli 19 G1
English: These events can be life-threatening and may lead to death.
Slovenian: Ti dogodki so lahko življenjsko ogrožujoči in lahko povzroči smrt.
English: Therefore it should not be used except in life-threatening situations.
Slovenian: Zato naj se ne uporablja, razen v primerih, ki ogrožajo življenje.
English: Chemical and physical in-use stability has been demonstrated for 8 hours between 2° and 30 °C after dissolving with water for injection.
Slovenian: Kemijska in fizikalna stabilnost je bila dokazana za 8 ur med 2 °C in 30 °C po raztapljanju z vodo za injekcije.
English: Each injection should be given slowly within 2 minutes.
Slovenian: Vsako injekcijo je treba dati počasi v 2 minutah.
English: It is given within 12 hours after the onset of symptoms.
Slovenian: Daje se ga v 12 urah po pojavu simptomov.
English: Date of first authorisation: 29 August 1996 Date of last renewal: 29 August 2006
Slovenian: Datum zadnjega podaljšanja: 29. avgust 2006
English: • severe allergic reaction, causing shock or collapse
Slovenian: • resna alergijska reakcija, ki povzroči šok ali kolaps.
English: In the patients who fail to respond to these conservative measures, judicious use of transfusion products may be indicated.
Slovenian: Pri bolnikih, ki se ne odzovejo na te konservativne ukrepe, je morda indicirana razumna uporaba transfuzijskih izdelkov.
English: From a microbiological point of view, the product should be used immediately.
Slovenian: Iz mikrobiološkega vidika se mora zdravilo uporabiti takoj.
English: Your doctor can tell you the risks and benefits of using Rapilysin during pregnancy.
Slovenian: Vaš zdravnik vam lahko pove o tveganjih in koristih uporabe zdravila Rapilysin med nosečnostjo.
English: For further information see section 4.4, section bleeding.
Slovenian: Za nadaljnje podatke glejte poglavje 4.4, odstavek Krvavitev.
English: Therefore tell the medical staff immediately if you
Slovenian: Zato nemudoma povejte medicinskemu osebju, če:
English: 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois France
Slovenian: 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois Francija
English: Rapilysin is usually given in a hospital.
Slovenian: Zdravilo Rapilysin se običajno daje v bolnišnici.
English: 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.
Slovenian: 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.
English: * 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.
Slovenian: *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.
English: This medicinal product should not be mixed with Heparin and/or acetylsalicylic acid.
Slovenian: To zdravilo se ne sme mešati s heparinom in/ali acetilsalicilno kislino.
English: Therefore, the compatibility of the glass syringe and intravenous access should be ensured before use.
Slovenian: Zato je treba kompatibilnost steklenih injekcijskih brizg in intravenskega dostopa zagotoviti pred uporabo.
English: Therefore Rapilysin must be given only in the presence and under the instructions of an emergency doctor.
Slovenian: Zato se sme zdravilo Rapilysin dajati samo v navzočnosti in po navodilih zdravnika urgentne medicine.
English: The risks of Rapilysin treatment may be increased if you have any of the following conditions:
Slovenian: Tveganje zdravljenja z zdravilom Rapilysin je lahko povečano, če imate katerega od naslednjih stanj:
English: • any other condition in which bleeding might be especially dangerous or might occur at a site where it would be difficult to control
Slovenian: • katero koli drugo stanje, ko bi bila krvavitev posebno nevarna ali bi se lahko pojavila na mestu, kjer bi jo bilo težko nadzorovati.
English: Each patient being considered for therapy with reteplase should be carefully evaluated.
Slovenian: Vsakega bolnika, pri katerem razmišljate o zdravljenju z reteplazo, je treba skrbno ovrednotiti.
English: • if you have severe uncontrolled high blood pressure (hypertension).
Slovenian: • če imate nenadziran hudo zvišan krvni tlak (hipertenzijo),
English: In the following conditions the risks of reteplase therapy may be increased and should be weighed against the anticipated benefits:
Slovenian: V naslednjih okoliščinah so lahko tveganja zdravljenja z reteplazo povečana in jih je treba pretehtati glede na pričakovane koristi:
English: Use aseptic technique throughout.
Slovenian: Vseskozi uporabljajte aseptične metode.
English: In the alteplase group 33.0 % were fatal and 39.8 % were disabling.
Slovenian: V skupini alteplaze je bilo 33,0 % smrtnih in 39,8 % onesposabljajočih.
English: Subacute toxicity studies did not reveal any unexpected adverse events.
Slovenian: Študije subakutne toksičnosti niso razkrile nepričakovanih neželenih učinkov.
English: Reconstituted product:
Slovenian: Rekonstituirano zdravilo:
English: Safety and effectiveness of Rapilysin in children have not been established.
Slovenian: Varnost in učinkovitost zdravila Rapilysin pri otrocih nista bili ugotovljeni.
English: • if you are allergic to reteplase or any of the other ingredients of this medicine (listed in section
Slovenian: • če ste alergični na reteplazo ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: • if you have other tumours associated with an increased risk of bleeding.
Slovenian: • če imate druge tumorje, povezane s povečanim tveganjem za krvavitev,
English: Genotoxicity of reteplase was excluded by a complete battery of tests at different genetic end points in vitro and in vivo.
Slovenian: Genotoksičnost reteplaze so izključili s popolnim sklopom testov različnih genetskih končnih točk in vitro in in vivo.
English: Since at present there is no experience with readministration of reteplase, the readministration is not recommended.
Slovenian: Ker trenutno ni izkušenj s ponovnim dajanjem reteplaze, se ponovno dajanje ne priporoča.
English: Exact data on the main elimination routes for reteplase in humans are not available and the consequences of hepatic or renal insufficiency are not known.
Slovenian: Točni podatki o poglavitnih poteh izločanja reteplaze pri ljudeh niso na razpolago in posledice jetrne ali ledvične insuficience niso znane.
English: Attention should be paid to this effect especially during periods of low plasma fibrinogen (up to about 2 days after fibrinolytic therapy of AMI).
Slovenian: 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).
English: The only relevant available animal data refer to studies performed in rabbits, which showed vaginal bleedings associated with abortions (see section 5.3).
Slovenian: 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).
English: Local reactions at injection site can also occur.
Slovenian: Pojavijo se lahko tudi lokalne reakcije na mestu injiciranja.
English: After reconstitution (“when dissolved”), the solution must be used immediately.
Slovenian: Po rekonstituciji (ko je raztopljena) je treba raztopino takoj uporabiti.
English: Reports of intracranial bleeding, many of which are fatal, are of particular concern.
Slovenian: Posebej zaskrbljujoča so poročila o intrakranialnih krvavitvah, od katerih so mnoge usodne.
English: 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.
Slovenian: V primeru prevelikega odmerjanja bi lahko pričakovali izčrpanje fibrinogena in drugih komponent strjevanja krvi (npr. koagulacijskega faktorja V) s posledičnim tveganjem za krvavitev.
English: This event has been reported for the therapeutic class of thrombolytic agents.
Slovenian: Ta dogodek je bil poročan za terapevtski razred trombolitikov.
English: The fibrinogen level normalises within 2 days.
Slovenian: Koncentracija fibrinogena se povrne na normalno vrednost v 2 dneh.
English: Overall stroke rates were 1.64 % in the reteplase and 1.79 % in the alteplase group.
Slovenian: Povprečni deleži kapi so bili 1,64 % pri reteplazi in 1,79 % v skupini alteplaze.
English: Other medicines may also not mix well with Rapilysin.
Slovenian: Tudi druga zdravila se z zdravilom Rapilysin morda ne mešajo dobro.
English: Reteplase (10+10 U) dose-dependently reduces plasma fibrinogen levels by about 60 to 80 %.
Slovenian: Reteplaza (10 + 10 enot) v odvisnosti od odmerka znižuje plazemske koncentracije fibrinogena za približno 60 do 80 %.
English: Coronary thrombolysis may result in arrhythmias associated with reperfusion.
Slovenian: Koronarna tromboliza lahko povzroči aritmije, povezane z reperfuzijo.
English: In dogs repeated dosing of the human peptide reteplase led to immunologic-allergic reactions.
Slovenian: Pri psih je večkratno odmerjanje človeške peptidne reteplaze povzročilo imunološke alergijske reakcije.
English: 220 Hafnarfjordur Iceland.
Slovenian: 220 Hafnarfjordur
English: The frequency of adverse reactions reported is listed in the following table.
Slovenian: Pogostnost poročanih neželenih učinkov je navedena v spodnji preglednici.
English: White powder and clear colourless liquid (water for injections).
Slovenian: Bel prašek in bistra brezbarvna tekočina (voda za injekcije).
English: See section 4.
Slovenian: glejte poglavje 3.
English: - any other condition in which bleeding constitutes a significant hazard or would be particularly difficult because of its location
Slovenian: - katero koli drugo stanje, ko bi bila krvavitev posebej nevarna ali bi bila posebno težavna za nadzor zaradi svoje lokacije.
English: In case of incompatibility an adaptor can be used and removed together with the glass syringe immediately after administration
Slovenian: V primeru inkompatibilnosti lahko uporabimo adapter, ki ga odstranimo skupaj s stekleno injekcijsko brizgo takoj po aplikaciji.
English: You should not breast-feed your baby during treatment with Rapilysin as it is not known whether Rapilysin is excreted into mother's milk.
Slovenian: Med zdravljenjem z zdravilom Rapilysin svojega dojenčka ne smete dojiti, ker ni znano, ali se zdravilo Rapilysin izloča v materino mleko.
English: • hypersensitivity (e.g. allergic reactions)
Slovenian: • preobčutljivost (npr. alergijske reakcije).
English: An additional increase of half-life of activity in patients with myocardial infarction and severely impaired liver and renal function cannot be excluded, but no clinical data of pharmacokinetics of reteplase in these patients are available.
Slovenian: Dodatnega podaljšanja razpolovnega časa aktivnosti pri bolnikih z miokardnim infarktom in hudo okvarjenim delovanjem jeter in ledvic ni mogoče izključiti, a klinični podatki farmakokinetike reteplaze pri teh bolnikih niso na voljo.
English: Teva Denmark A/S Tlf: +45 44985511
Slovenian: Danmark Teva Denmark A/S Tlf: +45 44985511
English: The injection must not be given mistakenly outside the vein.
Slovenian: Injekcije se ne sme pomotoma dati zunaj vene.
English: It is a thrombolytic medicine used to dissolve blood clots that have formed in certain blood vessels and to restore the blood flow in these blocked vessels (=thrombolysis).
Slovenian: Je trombolitično zdravilo, ki ga uporabljamo za raztapljanje krvnih strdkov, ki so se tvorili v nekaterih krvnih žilah, in za ponovno vzpostavitev pretoka krvi v teh zamašenih žilah (= tromboliza).
English: It is not known whether reteplase is excreted into breast milk.
Slovenian: Ni znano, ali se reteplaza izloča v materino mleko.
English: There are no adequate data on the use of reteplase in pregnant women.
Slovenian: O uporabi reteplaze pri nosečnicah ni zadostnih podatkov.
English: The risk of intracranial bleeding and fatal intracranial bleeding increases with increasing age.
Slovenian: Tveganje za intrakranialno krvavitev in smrtno intrakranialno krvavitev se povečuje s starostjo.
English: Plasminogen activator inhibitor 1 (PAI-1) activity can be reduced to around zero, but rapidly normalises within two hours showing a rebound phenomenon.
Slovenian: Aktivnost zaviralca 1 aktivatorja plazminogena (PAI-1) je lahko znižana na blizu nič, a se hitro povrne na normalno v dveh urah in izkazuje fenomen odboja.
English: Retrospective analyses of clinical studies did not reveal any clinically relevant interactions with medicinal product used concomitantly with reteplase in patients with acute myocardial infarction.
Slovenian: Retrospektivne analize kliničnih študij niso razkrile klinično pomembnih medsebojnih delovanj z zdravili, uporabljanimi sočasno z reteplazo pri bolnikih z akutnim miokardnim infarktom.
English: A large comparative mortality trial (INJECT) in approx. 6000 patients showed that reteplase reduced the incidence of heart failure (secondary efficacy criterion) in a significant manner and was at least equally effective in terms of reducing mortality (primary efficacy criterion) when compared to streptokinase.
Slovenian: Velika primerjalna študija umrljivosti (INJECT) pri približno 6.000 bolnikih je pokazala, da je reteplaza značilno znižala incidenco srčnega popuščanja (sekundarni kriterij učinkovitosti) in je bila vsaj enako učinkovita v smislu zniževanja umrljivosti (primarni kriterij učinkovitosti) v primerjavi s streptokinazo.
English: Experiments in rats indicate that the liver and the kidneys are the main organs of active uptake and lysosomal degradation.
Slovenian: Poskusi pri podganah kažejo, da so jetra in ledvice poglavitni organi aktivnega privzema in lizosomske razgradnje.
English: Cardiovascular events can be life-threatening or cause death.
Slovenian: Srčnožilni dogodki lahko ogrozijo življenje ali povzročijo smrt.
English: If an anaphylactoid reaction occurs, the injection should be discontinued immediately and appropriate therapy should be initiated.
Slovenian: Če se pojavi anafilaktoidna reakcija, je treba injiciranje takoj prekiniti in uvesti ustrezno zdravljenje.
English: Prothrombin activation fragment 1 levels and thrombin-antithrombin III-complexes increase during thrombolysis indicating thrombin production of which the clinical relevance is unknown.
Slovenian: Vrednosti fragmenta 1 aktivacije protrombina in kompleksov trombin-antitrombin III se med trombolizo povišajo, kar kaže na izdelovanje trombina, katerega klinični pomen ni znan.
English: In the reteplase group, 49.4 % of these strokes were fatal and 27.1 % were disabling.
Slovenian: V skupini reteplaze je bilo 49,4 % teh kapi smrtnih in 27,1 %
English: If the solution is not clear and colourless it should be thrown away.
Slovenian: Če raztopina ni bistra in brezbarvna, jo je treba zavreči.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če se ne uporabi takoj, je za rok uporabnosti in pogoje shranjenjevanja pripravljene raztopine odgovoren uporabnik.
English: The predominant acute symptom after single high doses of reteplase in rats and rabbits was transient apathy shortly after injection.
Slovenian: Poglavitni akutni simptom po enkratnih visokih odmerkih reteplaze pri podganah in kuncih je bila prehodna apatija kmalu po injiciranju.
English: No other medicines should be added to the injection solution (see below).
Slovenian: Raztopini za injiciranje se ne sme dodajati nobenih drugih zdravil (glejte spodaj).
English: A pre- and postnatal toxicity study was not performed with reteplase.
Slovenian: Študije pre- in postnatalne toksičnosti z reteplazo niso izvedli.
English: Abnormal heart beats (arrhythmias)
Slovenian: Nenormalni utripi srca (aritmije)
English: Each bolus is administered as a slow intravenous injection within 2 minutes.
Slovenian: Vsak bolus damo kot počasno intravensko injekcijo v 2 minutah.
English: delirium, agitation, confusion, depression, psychosis)
Slovenian: zmedenost, depresija, psihoza),
English: Before use, the powder for injection must be dissolved in the water for injection supplied in the prefilled syringe that is in the package.
Slovenian: Pred uporabo je treba prašek za injiciranje raztopiti v vodi za injekcije, ki je v napolnjeni injekcijski brizgi v pakiranju.