FrancophonIA/ELRC3.0 huggingface dataset:
English: A clinical trial in approximately 15 000 patients comparing reteplase with the accelerated dose regimen of alteplase (GUSTO III) (2:1 randomisation reteplase: alteplase) did not show statistically different results for the primary endpoint of 30-day mortality (reteplase: 7.47 %, alteplase 7.23 %, p = 0.61) or for the combined endpoint of 30-day mortality and non-fatal disabling stroke (reteplase: 7.89 %, alteplase 7.88 %, p = 0.99).
Slovenian: (GUSTO III) (2 : 1 randomizacija reteplaza: alteplaza), ni pokazalo statistično različnih rezultatov za primarni cilj raziskave, 30-dnevno umrljivost, (reteplaza 7,47 %, alteplaza 7,23 %, p = 0,61) ali za kombinirani cilj raziskave, 30-dnevno umrljivost in onesposabljajočo kap brez smrtnega izida
English: There is no experience with Rapilysin in pregnant women.
Slovenian: Z uporabo zdravila Rapilysin pri nosečnicah ni izkušenj.
English: Intravenous use Read the package leaflet before use.
Slovenian: Pred uporabo preberite priloženo navodilo
English: Only clear, colourless solutions should be injected.
Slovenian: Injicirajo se lahko le bistre, brezbarvne raztopine.
English: Available evidence on reteplase does not indicate an antibody-mediated origin of these hypersensitivity reactions.
Slovenian: Razpoložljivi dokazi o reteplazi ne kažejo, da so preobčutljivostne reakcije posledice pojava protiteles.
English: No other medicines should be added to the injection solution.
Slovenian: Raztopini za injiciranje se ne sme dodajati nobenih drugih zdravil.
English: Do not use Rapilysin
Slovenian: Ne uporabljajte zdravila Rapilysin
English: • Damage to the heart or heart valves, or a blood clot in the lung, brain or other part of body mayoccur
Slovenian: • okvare srca ali srčnih zaklopk, krvi strdek v pljučih, možganih ali drugih delih telesa,
English: • Bleeding at the injection site, e.g. blood blister (haematoma)
Slovenian: • krvavitev na mestu injiciranja, npr. modrica (hematom),
English: In rabbits, vaginal bleedings and abortions possibly associated to prolonged haemostasis, but no foetal abnormalities were noted.
Slovenian: Pri kuncih so opažali krvavitve iz nožnice in splave, za katere je možna povezava s podaljšano hemostazo, a nobenih nenormalnosti ploda.
English: In cynomolgus monkeys, the sedative effect ranged from slight apathy to unconsciousness, caused by a reversible dose-related drop in blood pressure.
Slovenian: Pri opicah cynomolgus se je pomirjevalni učinek, ki ga je povzročil reverzibilen, od odmerka odvisen padec krvnega tlaka, kazal v razponu od rahle apatije do nezavesti.
English: Rapilysin is given as a 10 U injection followed by a second 10 U injection 30 minutes later (double bolus).
Slovenian: Zdravilo Rapilysin se daje kot injekcija 10 enot, ki ji sledi druga injekcija 10 enot 30 minut pozneje (dvojni bolus).
English: Heparin and Rapilysin cannot be mixed in the same solution.
Slovenian: Heparina in zdravila Rapilysin se ne sme mešati v skupno raztopino.
English: • Bleeding in the digestive tract (e.g. bloody or black vomit, or stools) in the gums or in the urinary or genital tract
Slovenian: • krvavitev v prebavilih (npr. krvavi ali črni izbljuvki, ali blato), iz dlesni, ali v sečilih ali spolovilih,
English: Heparin should be given for at least 24 hours, preferably for 48-72 hours, in order to keep aPTT values 1.5 to 2 times normal.
Slovenian: Heparin je treba dajati vsaj 24 ur, najbolje 48 do 72 ur, da se ohranja vrednosti aktiviranega parcialnega tromboplastinskega časa med 1,5- do 2-kratno normalno vrednostjo.
English: The reconstituted preparation results in a clear, colourless solution.
Slovenian: Pripravljeno zdravilo je bistra, brezbarvna raztopina.
English: The initial dose of acetylsalicylic acid prior to thrombolysis should be at least 250 mg (250 - 350 mg) followed by 75 - 150 mg/day at least until discharge.
Slovenian: Začetni odmerek acetilsalicilne kisline, dane pred trombolizo, naj bo vsaj 250 mg (250 do 350 mg),
English: At present there is no experience with repeated use of Rapilysin.
Slovenian: Trenutno ni izkušenj z večkratno uporabo zdravila Rapilysin, zato večkratna uporaba ni priporočena.
English: The most commonly reported adverse drug reaction associated with reteplase treatment is haemorrhage, predominantly at the injection site.
Slovenian: Neželeni učinek, o katerem so v povezavi z zdravljenjem z reteplazo poročali najpogosteje, je bila krvavitev, predvsem na mestu injiciranja.
English: Hypersensitivity reactions (e.g. allergic reactions)1
Slovenian: alergijske reakcije)1
English: - septic thrombophlebitis or occluded arteriovenous cannula at seriously infected site
Slovenian: - septični tromboflebitis ali zamašena arteriovenska kanila na resno okuženem mestu, - starost več kot 75 let,
English: A small amount of solution may remain in the vial due to overfill.
Slovenian: Morda bo zaradi prenapolnjenosti v viali ostala majhna količina raztopine.
English: Except in life-threatening situations, Rapilysin should not be used in pregnant women.
Slovenian: Zdravila Rapilysin naj se v nosečnosti ne uporablja, razen v življenje ogrožajočih primerih.
English: The half-life of reteplase was increased in patients with AMI as compared to healthy volunteers.
Slovenian: Pri bolnikih z akutnim miokardnim infarktom v primerjavi z zdravimi prostovoljci je bil razpolovni čas reteplaze podaljšan.
English: Suomi/Finland ratiopharm Oy Puh/Tel: +358 (0) 20 180 5900
Slovenian: Puh/Tel: +358 (0) 20 180 5900
English: Heparin and Rapilysin are incompatible when combined in solution.
Slovenian: Heparin in zdravilo Rapilysin, kombinirana v raztopini, nista kompatibilna.
English: • Burning sensation when Rapilysin is injected
Slovenian: • pekoči občutek pri injiciranju zdravila Rapilysin.
English: Treatment of children with Rapilysin is not recommended.
Slovenian: Zdravljenje z reteplazo pri otrocih ni priporočljivo.
English: As with other thrombolytic agents, recurrent ischaemia/angina, hypotension and heart failure/pulmonary oedema have been reported frequently as sequelae of myocardial infarction and/or thrombolytic administration.
Slovenian: Kot pri ostalih trombolitičnih učinkovinah so pogosto poročali o ponovitvi ishemije/angine pektoris, hipotenzije in srčnega popuščanja/pljučnega edema, kot posledicah miokardnega infarkta ali dajanja trombolitikov ali obojega.
English: Rapilysin is presented as a powder and a solvent for injection (0.56 g powder in a vial and 10 ml solvent in a pre-filled syringe with a reconstitution spike and a needle-pack of 2)
Slovenian: Zdravilo Rapilysin je na voljo kot prašek in vehikel za injiciranje v pakiranju po 2 (viali z 0,56 g praška, napolnjeni injekcijski brizgi z 10 ml vehikla, rekonstitucijska pripomočka in igli).
English: Rapilysin is administered as a 10 U bolus dose followed by a second 10 U bolus dose 30 minutes later (double bolus).
Slovenian: Zdravilo Rapilysin se daje kot bolus 10 enot, kateremu sledi drugi bolusni odmerek 10 enot 30 minut pozneje (dvojni bolus).
English: With the reconstitution spike and syringe still attached to the vial, swirl the vial gently to dissolve the Rapilysin 10 U powder.
Slovenian: S pripomočkom za rekonstitucijo in injekcijsko brizgo, še vedno pritrjenima na vialo, nežno zanihajte vialo, da raztopite prašek zdravila Rapilysin 10 enot.
English: Justification for not including Braille accepted
Slovenian: PODATKI V BRAILLOVI PISAVI <Sprejeta je utemeljitev, da Braillova pisava ni potrebna>
English: How to use Rapilysin
Slovenian: Kako uporabljati zdravilo Rapilysin
English: PUREN Pharma GmbH & Co. KG Tel: +49 (0)89 558909 0
Slovenian: KG Telefon: +49 (0)89 558909 0
English: The most frequent adverse drug reaction associated with reteplase treatment is haemorrhage.
Slovenian: Najpogostejši neželeni učinek zdravila, povezan z zdravljenjem z reteplazo, je krvavitev.
English: Withdraw 10 ml of Rapilysin 10 U solution back into the syringe.
Slovenian: Potegnite 10 ml zdravila Rapilysin 10 enot raztopine nazaj v injekcijsko brizgo.
English: 2 reconstitution spikes
Slovenian: 2 rekonstitucijska pripomočka
English: • high likelihood of a blood clot in the heart (e.g. as a result of narrowing of a heart valve or atrial fibrillation)
Slovenian: • krvavitev v prebavila, sečila ali spolovila v zadnjih 10 dneh, • visoko verjetnost za krvni strdek v srcu (npr. kot posledica zoženja srčne zaklopke ali atrijske fibrilacije),
English: Reteplase 10 U (recombinant plasminogen activator, thrombolytic agent)
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Reteplaza 10 enot (rekombinantni aktivator plazminogena, trombolitična učinkovina)
English: Remove the tip cap from the syringe.
Slovenian: S konice injekcijske brizge odstranite pokrovček.
English: Side effects of frequency not known (cannot be estimated from the available data) • Blockage of blood vessels due to cholesterol (fat)
Slovenian: Neželeni učinki neznane pogostnosti (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
English: Rapilysin 10 U powder and solvent for solution for injection Water for injections for Rapilysin 10 U solution for intravenous use
Slovenian: Rapilysin 10 enot prašek in vehikel za raztopino za injiciranje Voda za injekcije za zdravilo Rapilysin 10 enot raztopino za intravensko uporabo
English: Rapilysin contains the active substance reteplase(a recombinant plasminogen activator).
Slovenian: Kaj je zdravilo Rapilysin in za kaj ga uporabljamo Zdravilo Rapilysin vsebuje zdravilno učinkovino reteplazo (rekombinantni aktivator plazminogena).
English: Haemorrhage at the injection site (e.g. haematoma), a local reaction at injection site, for example a burning sensation
Slovenian: (npr. hematom); lokalna reakcija na mestu injiciranja, lahko se pojavi na primer občutek pekoče bolečine
English: Name and address of the manufacturers of the biological active substance
Slovenian: ZA SPROŠČANJE SERIJE Ime in naslov izdelovalca biološke zdravilne učinkovine
English: No other medicines should be injected through the line reserved for Rapilysin, neither at the same time, nor prior to, nor following Rapilysin injection.
Slovenian: Skozi kanal, rezerviran za zdravilo Rapilysin, naj se ne injicira nobenega drugega zdravila, ne sočasno, ne pred injiciranjem zdravila Rapilysin, ne po njem.
English: Remove the protective flip-cap from the vial of Rapilysin 10 U and clean the rubber closure with an alcohol wipe.
Slovenian: Z viale zdravila Rapilysin 10 enot odstranite zaščitni pokrovček, ki se sproži in z alkoholno blazinico očistite gumijast pokrov.
English: • systolic blood pressure higher than 160 mmHg
Slovenian: • bolezni krvnih žil v možganih, • sistolični krvni tlak, višji od 160 mmHg,
English: Reteplase is supplied as a freeze-dried substance in vials.
Slovenian: Reteplaza je v vialah v obliki liofilizata.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Voda za injekcije
English: Death or permanent disability are not uncommon in patients who have a stroke (including bleeding in the brain) or other serious bleeding problem.
Slovenian: Pri bolnikih, ki so doživeli možgansko kap (vključno z intrakranialno krvavitvijo) ali drugo resno krvavitev, smrt ali trajna nezmožnost nista redki.
English: Heparin and acetylsalicylic acid are given before and after Rapilysin to reduce the risk of new blood clots forming.
Slovenian: Heparin in acetilsalicilno kislino se za zmanjšanje tveganja za tvorbo novih krvnih strdkov daje pred zdravilom Rapilysin in po njem.
English: Protamine should be considered if heparin has been administered within 4 hours of the onset of bleeding.
Slovenian: Če je bolnik v 4 urah po nastanku krvavitve prejel heparin, je treba razmisliti o protaminu.
English: • if you have enlarged blood vessels in the gullet (oesophagus) (frequently caused by liver disease).
Slovenian: • če imate razjedo v želodcu ali tankem črevesu, • če imate razširjene krvne žile v požiralniku (pogosto povzročene z obolenjem jeter),
English: Events related to the nervous system (e.g. epileptic seizure, convulsion, aphasia, speech disorder, delirium, acute brain syndrome, agitation, confusion, depression, psychosis)
Slovenian: afazija, motnje govora, delirij, akutni organski psihosindrom, agitacija, zmedenost, depresija, psihoza)
English: Very common side effects (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov):
English: There was increased local haemorrhage at the injection site.
Slovenian: Na mestu injiciranja je prišlo do povečane lokalne krvavitve.
English: Marketing Authorisation Holder Actavis Group PTC ehf Reykjavíkurvegi 76-78
Slovenian: Reykjavikurvegur 76-78
English: Additional studies in human plasma samples in vitro suggest that complexation with C1-inactivator, α2-antiplasmin and α2-antitrypsin contributes to the inactivation of reteplase in plasma.
Slovenian: inaktivatorjem, α2-antiplazminom in α2-antitripsinom prispeva k inaktivaciji reteplaze v plazmi.
English: Therefore, be sure to tell the medical staff if you experience pain during the injection.
Slovenian: Če med injiciranjem čutite bolečine, o tem obvestite medicinsko osebje.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI)
English: In addition, the second bolus of reteplase should not be given if the serious bleeding occurs before it is administered.
Slovenian: Če se predhodno pojavi resna krvavitev pred dajanjem drugega bolusa reteplaze, se drugega odmerka ne sme dati.
English: or an infection of the heart muscle (bacterial endocarditis).
Slovenian: • če imate akutno vnetje trebušne slinavke ali osrčnika (vrečke, ki obdaja srce) ali okužbo srčne mišice (bakterijski endokarditis),
English: Take the 10 ml syringe out of the package.
Slovenian: Iz zavitka vzemite 10-ml injekcijsko brizgo.
English: Cerebral haemorrhage2
Slovenian: Bolezni živčevja občasni možganske krvavitve2
English: No other medicines should be injected through the line reserved for Rapilysin either at the same time, or prior to, or following Rapilysin injection.
Slovenian: Skozi kanal, rezerviran za zdravilo Rapilysin, naj se ne injicira nobenega drugega zdravila, ne sočasno, ne pred injiciranjem zdravila Rapilysin ali po njem.
English: Be sure to tell hospital staff immediately if any of these symptoms appear.
Slovenian: Če se pojavi kateri od teh simptomov, nemudoma povejte medicinskemu osebju.
English: given as a bolus injection prior to reteplase therapy followed by an infusion of 1000 I.U.
Slovenian: Priporočeni odmerek heparina je 5000 i.e., dan kot bolusna injekcija pred zdravljenjem z reteplazo, ki mu sledi infuzija 1000 i.e. na uro, ki začne teči po drugem bolusu reteplaze.
English: • Events related to the nervous system (e.g. epileptic seizure, convulsion, speech disorder,
Slovenian: zelo redki dogodki, povezani z živčevjem (npr. epileptični napad, krči,
English: Arrhythmias (e.g. AV block, atrial fibrillation/flutter, ventricular tachycardia/fibrillation, electromechanical dissociation (EMD)), cardiac arrest, cardiogenic shock and reinfarction
Slovenian: zelo pogosti ponovna ishemija/angina pektoris, hipotenzija in srčno popuščanje/pljučni edem pogosti aritmije (npr. AV-blok, atrijska fibrilacija/plapolanje, ventrikularna tahikardija/fibrilacija, elektromehanska disociacija
English: Heparin and acetylsalicylic acid should be administered before and following the administration of Rapilysin to reduce the risk of re-thrombosis.
Slovenian: Heparin in acetilsalicilno kislino naj se za zmanjšanje tveganja za ponovno trombozo da pred dajanjem zdravila Rapilysin in po njem.
English: Pharmacotherapeutic group: antithrombotic agent, ATC Code: B01AD07
Slovenian: Oznaka ATC: B01AD Mehanizem delovanja
English: Not relevant.
Slovenian: onesposabljajočih.
English: Discuss with your doctor when you can take up breast-feeding again.
Slovenian: O tem, kdaj lahko spet začnete dojiti, se pogovorite s svojim zdravnikom.
English: 1 vial contains 10 U* reteplase ** in 0.56 g powder 1 prefilled syringe contains 10 ml water for injections.
Slovenian: 1 viala vsebuje 10 enot* reteplaze** v 0,56 g praška.
English: coronary artery bypass graft, or surgery or injury to the head or spine), given birth, or had an organ biopsy or other medical / surgical procedure.
Slovenian: • če ste v zadnjih 3 mesecih hudo krvaveli, se hudo poškodovali ali imeli večji operacijski poseg (npr. vsaditev obvoda koronarne arterije ali operacija ali poškodba glave ali hrbtenice), če ste rodili ali imeli biopsijo organa ali drug medicinski/kirurški postopek.
English: Connect the syringe to the reconstitution spike and transfer the 10 ml of solvent into the vial of Rapilysin 10 U.
Slovenian: Injekcijsko brizgo pritrdite na pripomoček za rekonstitucijo in v vialo zdravila Rapilysin 10 enot prenesite 10 ml vehikla.
English: Adverse reactions seen with reteplase
Slovenian: Neželeni učinki opaženi pri zdravljenju z reteplazo
English: Fat embolism, which may lead to corresponding consequences in the complications organs concerned4
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih neznana maščobna embolija, ki ima lahko posledice v prizadetih organih
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL OF THE VIAL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: This applies to all medicines including heparin and acetylsalicylic acid, which are given before and after Rapilysin to reduce the risk of new blood clots forming.
Slovenian: To se nanaša na vsa zdravila, vključno s heparinom in acetilsalicilno kislino, ki se ju daje za zmanjšanje tveganja za tvorbo novih krvnih strdkov pred zdravilom Rapilysin in po njem.
English: • if you have had a stroke.
Slovenian: • če ste preboleli možgansko kap,
English: In those patients where the same line has to be used, this line (including Y-line) must be flushed thoroughly with a 0.9 % sodium chloride or 5 % glucose solution prior to and following the Rapilysin injection.
Slovenian: Pri bolnikih, kjer je nujno uporabiti isti kanal, je treba ta kanal (vključno z Y-kanalom) temeljito izprati z 0,9 % fiziološko raztopino ali 5 % raztopino glukoze pred injiciranjem zdravila Rapilysin in po njem.
English: given as a single injection before Rapilysin, followed by an infusion of 1000 I.U.
Slovenian: Odmerjanje heparina Priporočeni odmerek heparina je 5000 i.e., dan kot enkratna injekcija pred zdravilom Rapilysin, ki mu sledi infuzija 1000 i.e. na uro, ki začne teči po drugem injiciranju zdravila Rapilysin.
English: In those patients where the same line has to be used, this line (including Y-line) must be flushed thoroughly with 0.9 % sodium chloride or 5 % glucose solution prior to and following the Rapilysin injection.
Slovenian: Pri bolnikih, kjer je nujno uporabiti isti kanal, je treba ta kanal (vključno z Y-kanalom) temeljito izprati z 0,9-% fiziološko raztopino ali 5-% raztopino glukoze pred injiciranjem zdravila Rapilysin in po njem.
English: Dosage of Rapilysin
Slovenian: Odmerjanje zdravila Rapilysin
English: This applies to all products including heparin, and acetylsalicylic acid, which should be administered before and following the administration of reteplase to reduce the risk of re-thrombosis.
Slovenian: To se nanaša na vsa zdravila, vključno s heparinom in acetilsalicilno kislino, ki se dajejo pred dajanjem reteplaze in po tem za zmanjšanje tveganja ponovne tromboze.
English: Do not store above 25 °C Keep the vial in the outer carton in order to protect from light
Slovenian: Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
English: For the full list of excipients, see section 6.1.
Slovenian: Pripravljena raztopina vsebuje 1 enoto reteplaze na ml. Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: - recent gastrointestinal or genitourinary bleeding (within 10 days)
Slovenian: - sistolični krvni tlak, ob prihodu višji od 160 mmHg, - nedavna krvavitev v prebavila, sečila ali spolovila (v zadnjih 10 dneh),
English: Haemopericardium, retroperitoneal bleeding, cerebral haemorrhage, epistaxis, haemoptysis, eye haemorrhage and ecchymosis
Slovenian: Žilne bolezni pogosti krvavitve v prebavilih (hematemeza, melena), iz dlesni ali krvavitve v sečilh občasni hemoperikardij, retroperitonealna krvavitev, možganska krvavitev, krvavitev iz nosu, hemoptiza, krvavitev v očesu in ekhimoza
English: Incompatibility of some prefilled glass syringes (including Rapilysin) with certain needle free connectors has been reported.
Slovenian: Poročali so o inkompatibilnosti med nekaterimi napolnjenimi steklenimi injekcijskimi brizgami
English: Rapilysin 10 U powder and solvent for solution for injection.
Slovenian: IME ZDRAVILA Rapilysin 10 enot prašek in vehikel za raztopino za injiciranje
English: How to store Rapilysin
Slovenian: Shranjevanje zdravila Rapilysin
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 29. avgust 1996
English: In the event of overdosage there may be an increased risk of bleeding.
Slovenian: Če ste prejeli večji odmerek zdravila Rapilysin kot bi smeli: Pri prevelikem odmerjanju morda obstaja povečano tveganje za krvavitev.
English: Rapilysin 10 U powder and solvent for solution for injection Reteplase Intravenous use
Slovenian: Navodilo za uporabo Rapilysin 10 enot prašek in vehikel za raztopino za injiciranje reteplaza
English: Package leaflet: Information for the user Rapilysin 10 U powder and solvent for solution for injection reteplase
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Rapilysin 10 enot prašek in vehikel za raztopino za injiciranje reteplaza za intravensko uporabo
English: Readministration
Slovenian: Ponovno dajanje
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo
English: Contents of the pack and other information What Rapilysin contains
Slovenian: Shranjevanje zdravila Rapilysin Vsebina pakiranja in dodatne informacije
English: Powder and solvent for injection (contains 2x [0.56 g of powder in a vial and 10 ml solvent in a prefilled syringe with reconstitution spike and needle])
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Prašek in vehikel za injiciranje (vsebina: dve viali z 0,56 g praška, dve napolnjeni injekcijski brizgi z
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Poročali so o inkompatibilnosti med nekaterimi napolnjenimi steklenimi injekcijskimi brizgami
English: Cardiac disorders3
Slovenian: Srčne bolezni3
English: INFORMATION IN BRAILLE
Slovenian: OVOJNINAH Nalepka na viali
English: Because thrombolytic therapy increases the risk of bleeding, reteplase is contra-indicated in the following situations: - known haemorrhagic diathesis - patients with current concomitant therapy with oral anticoagulants (e.g. warfarin sodium) - intracranial neoplasm, arteriovenous malformation or aneurysm - neoplasm with increased bleeding risk - history of cerebrovascular accident - recent (< 10 days) prolonged and vigorous external heart massage - severe uncontrolled hypertension - active peptic ulceration - portal hypertension (oesophageal varices) - severe liver or renal dysfunction - acute pancreatitis, pericarditis, bacterial endocarditis
Slovenian: - cerebrovaskularni inzult v preteklosti, - nedavna (< 10 dni) podaljšana in intenzivna zunanja masaža srca, - huda nenadzorovana hipertenzija,
English: 1 vial + 1 ampoule l t o r
Slovenian: 1 viala + 1 ampula o ā
English: Fill volume (concentration)
Slovenian: Volumen polnjenja (koncentracija)
English: Package size
Slovenian: Velikost pakiranj
English: Invented name
Slovenian: Številka EMA Izmišljeno ime
English: 1 vial + 1 sachet
Slovenian: 1 viala + 1 vrečica
English: Immediate Packaging
Slovenian: Velikost pakiranja:
English: Strength Pharmaceutical Form
Slovenian: EU Številka Zaščiteno ime Jakost Farmacevtska oblika
English: --¹ Each dose of vaccine suspension (3 ml) contains:
Slovenian: Vsak odmerek suspenzije za cepljenje (3 ml) vsebuje: − skupaj 1.25x1011 bakterij naslednjih sevov: