FrancophonIA/ELRC3.0 huggingface dataset:
English: Thrombosis includes coronary artery thrombosis (blood clot in the heart arteries or within a stent being felt as a heart attack which can also be fatal) and/or thrombosis in the catheter, both of which are rare (may affect up
Slovenian: Tromboza vključuje trombozo koronarne arterije (krvni strdek v srčni arteriji ali znotraj stenta, kar se čuti kot srčni napad, ki je prav tako lahko smrten) in/ali trombozo v katetru, oba pojava sta redka (pojavita se lahko pri največ 1 od 1.000 bolnikov).
English: There are no gender effects in the pharmacokinetics of bivalirudin.
Slovenian: Spol ne vpliva na farmakokinetiko bivalirudina.
English: The mean steadystate concentration of bivalirudin following a constant intravenous infusion of 2.5 mg/kg/h is 12.4 µg/ml.
Slovenian: Povprečna koncentracija bivalirudina v stanju dinamičnega ravnovesja po konstantni intravenski infuziji 2,5 mg/kg/h je 12,4 µg/ml.
English: The HORIZONS Trial (Patients with STEMI undergoing primary PCI)
Slovenian: Preskušanje HORIZONS (Bolniki s STEMI pri katerih se izvede primarna PCI)
English: • In patients with moderate renal impairment (GFR 30-59 ml/ min) the infusion rate should be reduced to 1.4 mg/kg/h.
Slovenian: • Pri bolnikih z zmerno ledvično insuficienco (GFR 30-59 ml/min) je treba hitrost infuzije zmanjšati na 1,4 mg/kg/h.
English: Compatible concentrations Incompatible concentrations
Slovenian: Združljive koncentracije
English: Patients with moderate renal impairment (GFR 30-59 ml/min) undergoing PCI (whether being treated with bivalirudin for ACS or not) should receive a lower infusion rate of 1.4 mg/kg/h.
Slovenian: Bolniki z zmerno okvaro ledvic (GFR 30-59 ml/min), ki prestajajo PCI (ne glede na to, ali se zaradi AKS zdravijo z bivalirudinom ali ne), bi morali prejemati nižji infuzijski odmerek, ki je 1,4 mg/kg/h.
English: The following data are based on a clinical study of bivalirudin in 13,819 patients with ACS; 4,612 were randomised to bivalirudin alone, 4,604 were randomised to bivalirudin plus GP IIb/IIIa inhibitor and 4,603 were randomised to either unfractionated heparin or enoxaparin plus GP IIb/IIIa inhibitor.
Slovenian: Naslednji podatki temeljijo na klinični študiji z bivalirudinom pri 13.819 bolnikih z AKS, od katerih so jih 4.612 randomizirali v skupino, ki je prejemala le bivalirudin, 4.604 jih je bilo randomiziranih v skupino, ki je prejemala bivalirudin skupaj z inhibitorjem GP IIb/IIIa, 4.603 pa jih je bilo randomiziranih v skupino z nefrakcioniranim heparinom ali enoksaparinom in inhibitorjem GP IIb/IIIa.
English: • For patients undergoing PCI, bivalirudin MUST be administered initially as an intravenous bolus followed immediately by an infusion.
Slovenian: • Bolnikom med PCI je treba bivalirudin najprej dati kot intravenski bolus, ki mu takoj sledi infuzija.
English: This is administered and supervised by a doctor experienced in caring for patients with heart disease.
Slovenian: Zdravilo vam bo dal in zdravljenje nadzoroval zdravnik z izkušnjami z zdravljenem srčnih bolnikov.
English: Major bleeding rates are shown in Table 6 for the IIT population and Table 7 for the per protocol population (patients receiving clopidogrel and acetylsalicylic acid).
Slovenian: Deleži večjih krvavitev so prikazani v preglednici 6 za populacijo, ki predhodno še ni bila zdravljena (ITT) in v preglednici 7 za bolnike po protokolu (bolniki, ki prejemajo klopidogrel in acetilsalicilno kislino).
English: Bivalirudin is metabolized by proteases, including thrombin.
Slovenian: Bivalirudin presnavljajo proteaze, vključno s trombinom.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8C unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Ne shranjujte dlje kot 24 ur pri temperaturi med oC in 8 °C, razen če rekonstitucija in redčenje nista bila opravljena v nadzorovanih in preverjeno aseptičnih pogojih.
English: For patients with acute coronary syndromes (ACS) who are treated medically the recommended starting dose is:
Slovenian: Za bolnike z akutnim koronarnim sindromom (AKS), ki se zdravijo je priporočen začetni odmerek:
English: 3, representing a ≥50% decrease in platelets from baseline.
Slovenian: 3, kar predstavlja ≥ 50 % zmanjšanje števila trombocitov glede na izhodišče.
English: In REPLACE-2 thrombocytopenia occurred in 20 bivalirudin-treated patients (0.7%).
Slovenian: Pri študiji REPLACE-2 se je trombocitopenija pojavila pri 20 bolnikih, ki so bili zdravljeni z bivalirudinom (0,7%).
English: For patients who proceed to CABG surgery on pump, the intravenous infusion of bivalirudin should be continued until 1 hour prior to surgery after which the infusion should be discontinued and the patient treated with unfractionated heparin (UFH).
Slovenian: Pri bolnikih, ki bodo deležni kirurškega postopka CABG ob uporabi črpalke, morate z intravensko infuzijo bivalirudina nadaljevati do 1 ure pred operacijo, po postopku pa infuzijo prekiniti in bolnika zdraviti z nefrakcioniranim heparinom (UFH).
English: Patients who are to be medically managed may continue the infusion of 0.25 mg/kg/h for up to 72 hours.
Slovenian: Pri bolnikih, ki bodo v nadaljnji zdravstveni obdelavi, lahko nadaljujete z infuzijo 0,25 mg/kg/h, do 72 ur.
English: The ACUITY trial was a prospective, randomised open-label, trial of bivalirudin with or without GP IIb/IIIa inhibitor (Arms B and C respectively) versus unfractionated heparin or enoxaparin with GP IIb/IIIa inhibitor (Arm A) in 13,819 high risk ACS patients.
Slovenian: Študija ACUITY je bila prospektivna, odprta, randomizirana študija bivalirudina z ali brez inhibitorja GP IIb/IIIa (krak B in krak C v istem vrstnem redu) v primerjavi z nefrakcioniranim heparinom ali enoksaparinom z inhibitorjem GP IIb/IIIa (krak A) pri 13.819 bolnikih z visokim tveganjem za AKS.
English: Five patients had a post-baseline nadir platelet count of <150,000 cells/mm
Slovenian: Pet bolnikov je imelo po izhodišču najnižje število trombocitov < 150.000 celic/mm
English: The pharmacokinetic properties of bivalirudin have been evaluated and found to be linear in patients undergoing Percutaneous Coronary Intervention and in patients with ACS.
Slovenian: Farmakokinetične lastnosti bivalirudina so bile ovrednotene in so linearne pri bolnikih med perkutano koronarno intervencijo in pri bolnikih z akutnim koronarnim sindromom (AKS).
English: If you are breast-feeding, the doctor will decide whether Angiox should be used.
Slovenian: Če dojite, bo zdravnik odločil, ali lahko uporabljate zdravilo Angiox.
English: Medicinal products with dose concentration incompatibilities
Slovenian: Nezdružljiva zdravila glede na odmerek/koncentracijo incompatibilities
English: In the HORIZONS study both major and minor bleeding occurred commonly (1/100 and <1/10).
Slovenian: V študiji HORIZONS so se večje in manjše krvavitve pojavile pogosto (≥ 1/100 do < 1/10).
English: 2Major bleeding was defined using the ACUITY bleeding scale.
Slovenian: Večja krvavitev je opredeljena na osnovi ACUITY lestvice krvavitev.
English: The following medicinal products should not be administered in the same intravenous line as bivalirudin since they result in haze formation, micro-particulate formation or gross precipitation; alteplase, amiodarone HCl, amphotericin B, chlorpromazine hydrochloride (HCl), diazepam, prochlorperazine edisylate, reteplase, streptokinase and vancomycin HCl.
Slovenian: Naslednjih zdravil ne dajajte po isti intravenski poti kot bivalirudin, ker ima to lahko za posledico tvorbo razpršenih kapljic, mikrodelcev ali močno precipitacijo; alteplas, amiodaronijev klorid, amfotericin B, klorpromazinijev klorid, diazepam, proklorperazin edisilat, reteplas, streptokinaza in vankomicinijev klorid.
English: In vitro studies have indicated that bivalirudin inhibits both soluble (free) and clot-bound thrombin.
Slovenian: Študije in vitro kažejo, da bivalirudin inhibira tako topni (prosti) kot tudi na strdek vezani trombin.
English: A total of 55.1% of patients receiving bivalirudin experienced at least one adverse event and 8.7% experienced an adverse drug reaction.
Slovenian: 55,1 % bolnikov, ki so prejemali bivalirudin, je izkusilo vsaj en neželen dogodek, 8,7 % bolnikov pa je izkusilo neželen učinek zdravila.
English: REPLACE-2 study results: 30-day endpoints (intent-to-treat and per-protocol populations
Slovenian: Rezultati študije REPLACE-2: opazovani dogodki (vključena populacija ("intent-to-treat") in populacija po protokolu) po 30 dneh
English: Interaction studies have been conducted with platelet inhibitors, including acetylsalicylic acid, ticlopidine, clopidogrel, abciximab, eptifibatide, or tirofiban.
Slovenian: Interakcijske študije so bile izvedene z inhibitorji krvnih ploščic, vključno z acetilsalicilno kislino, tiklopidinom, klopidogrelom, abciksimabom, eptifibatidom ali tirofibanom.
English: Such a reaction is uncommon (may affect up to 1 in 100 people).
Slovenian: Takšne reakcije so občasne (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: A total of 3,602 patients were randomised to receive either bivalirudin (1,800 patients) or unfractionated heparin plus a GP IIb/IIIa inhibitor (1,802 patients).
Slovenian: 3.602 randomiziranih bolnikov je prejelo ali bivalirudin (1.800 bolnikov) ali nefrakcioniran heparin in zaviralec GP IIb/IIIa (1.802 bolnikov).
English: Per-protocol bivalirudin (N=2,994)
Slovenian: Po protokolu bivalirudin (N=2.994)
English: Medicinal products with dose concentration incompatibilities to bivalirudin.
Slovenian: Zdravila glede na odmerek/koncentracijo, ki niso združljiva z bivalirudinom.
English: Use with other anticoagulant therapy
Slovenian: Uporaba z drugimi antikoagulanti:
English: Do not use Angiox
Slovenian: Ne uporabljajte zdravila Angiox:
English: A total of 17 deaths occurred after subacute stent thrombosis, 3 in the bivalirudin arm and 14 in the UFH plus GP IIb/IIIa arm.
Slovenian: Po subakutni trombozi stenta je bilo skupaj 17 smrtnih žrtev, 3 iz kraka z bivalirudinom in 14 pri UFH in GP IIb/IIIa.
English: Reconstituted solution: Store in a refrigerator (2 - 8
Slovenian: Rekonstituirana raztopina: Shranjujte v hladilniku (2
English: Two deaths occurred after acute stent thrombosis, 1 in each arm of the study.
Slovenian: Po akutni trombozi sta se pojavili dva smrtna primera, vsak iz enega kraka študije.
English: • Angiox must be administered as a bolus dose followed immediately by an intravenous infusion,
Slovenian: • Zdravilo Angiox je treba dati kot bolusni odmerek, ki mu takoj sledi intravenska infuzija, tudi
English: Healthcare providers are recommended to refer to the Angiox Summary of Product Characteristics for full information on dosing.
Slovenian: Zdravstvenim delavcem se priporoča, naj si za vse informacije o odmerjanju ogledajo povzetek glavnih značilnosti zdravila Angiox.
English: Angiox is contraindicated in patients with:
Slovenian: Angiox je kontraindiciran pri bolnikih z:
English: Swelling or pain in the groin or the arm, back pain, bruising, headache, coughing blood, pink or red urine, sweating, feeling faint or sick or dizzy due to low blood pressure may be signs of internal bleeding.
Slovenian: Znaki notranje krvavitve so lahko otekanje ali bolečina v dimljah ali roki, bolečina v križu, modrice, glavobol, izkašljevanje krvi, roza ali rdeč urin, potenje, občutek omedlevice, slabosti ali omotičnosti zaradi nizkega krvnega tlaka.
English: Uncommon side effects (may affect up to 1 in 100 people): • nausea (feeling sick) and/or vomiting (being sick)
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): • navzea (slabost) in/ali bruhanje
English: Patients undergoing PCI, including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI
Slovenian: Bolniki, ki bodo imeli PCI, vključno z bolniki z miokardnim infarktom z zvišanjem intervala ST (STEMI), pri katerih se bo izvedla primarna PCI
English: *clopidogrel pre-angiography or pre-PCI
Slovenian: *klopidogrel pred angiografijo ali pred PCI
English: Arm C bival alone (N=4,612)
Slovenian: Krak C samo bival (N=4.612)
English: Dose adjustments for this age group should be on the basis of renal function.
Slovenian: Prilagajanje odmerkov za to starostno skupino se naredi glede na stanje delovanja ledvic.
English: Rare (≥1/10,000 to
Slovenian: Občasni (≥ 1/1.000 do
English: ACUITY trial; bleeding events up to day 30 for the population of patients who received acetylsalicylic acid and clopidogrel as per protocol*
Slovenian: Študija ACUITY; krvavitve do dne 30 za vključeno populacijo in populacijo bolnikov, ki so prejemali acetililsalicilno kislino klopidogrel v skladu s protokolom*
English: Minor bleeding occurred very commonly (1/10) and major bleeding occurred commonly (1/100 and <1/10).
Slovenian: Manjša krvavitev je bila zelo pogosta (≥ 1/10), večja krvavitev pa pogosta (≥ 1/100 in < 1/10).
English: ACUITY trial; 30-day and 1-year risk differences for the composite ischaemic endpoint and its components for the overall population (ITT)
Slovenian: Študija ACUITY: razlike v tveganju za kompozito ishemije in njene komponente pri celotni populaciji (ITT) pri 30 dneh in 1 letu
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije in redčenja zdravila pred dajanjem glejte poglavje 6.6. 4.3 Kontraindikacije
English: HORIZONS 30-day study results (intent-to-treat population)
Slovenian: Rezultati študije HORIZONS (Celotna populacija) po 30 dneh
English: As a peptide, bivalirudin is expected to undergo catabolism to its constituent amino acids, with subsequent recycling of the amino acid in the body pool.
Slovenian: Bivalirudin je kot peptid podvržen katabolizmu na aminokisline, ki ga sestavljajo, s posledično ponovno uporabo aminokislin v telesu.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: The advantage of bivalirudin over UFH/enoxaparin plus GP IIb/IIIa inhibitor in terms of bleeding events was only observed in the bivalirudin monotherapy arm.
Slovenian: Prednost bivalirudina pred UFH/ enoksaparinom in zaviralcem GP IIb/IIIa, kar zadeva krvavitve, je bila opažena samo pri skupini, ki je prejemala monoterapijo z bivalirudinom.
English: Angiox contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”.
Slovenian: Pomožna snov Zdravilo Angiox vsebuje manj kot 1 mmol natrija (23 mg) na vialo, to dejansko pomeni »brez natrija«.
English: Approximately 23.3% of patients receiving bivalirudin experienced at least one adverse event and 2.1% experienced an adverse reaction.
Slovenian: Približno 23,3 % bolnikov, ki so prejeli bivalirudin, je izkusilo vsaj en neželen dogodek, 2,1 % bolnikov pa je izkusilo neželen učinek, povezan z zdravilom.
English: For further information regarding the use of bivalirudin with or without a GP IIb/IIIa inhibitor, please see section 5.1.
Slovenian: Za podrobne podatke glede uporabe bivalirudina z ali brez zaviralca GP IIb/IIIa glejte poglavje 5.1.
English: Angiox is a white to off-white powder in a glass vial.
Slovenian: Zdravilo Angiox je bel do belkast prašek v stekleni viali.
English: In patients taking warfarin who are treated with bivalirudin, International Normalised Ratio (INR) monitoring should be considered to ensure that it returns to pre-treatment levels following discontinuation of bivalirudin treatment.
Slovenian: Pri bolnikih, ki jemljejo varfarin in jih zdravite z bivalirudinom, morate po koncu zdravljenja za zagotovitev povratka bivalirudina na ravni pred zdravljenjem razmisliti o opazovanju po mednarodno umerjenemu razmerju (INR).
English: However, bivalirudin was not mutagenic or clastogenic in standard assays for such effects.
Slovenian: Bivalirudin se pri standardnih analizah za takšne učinke ni izkazal kot mutagen ali klastogen.
English: Powder for concentrate for solution for injection or infusion 10 vials
Slovenian: Prašek za koncentrat za raztopino za injiciranje ali infundiranje 10 vial
English: In Arm A of the ACUITY trial, UFH or enoxaparin was administered in accordance with the relevant guidelines for the management of ACS in patients with UA and NSTEMI.
Slovenian: Bolniki v kraku A študije ACUITY so prejemali nefrakcionirani heparin ali enoksaparin, ki so ga dajali v skladu z veljavnimi smernicami za vodenje AKS pri bolnikih z UA in NSTEMI.
English: 50 ml] of glucose solution or sodium chloride solution) 1 ml contains 5 mg bivalirudin.
Slovenian: ml] zmeša z raztopino glukoze ali natrijevega klorida)1 ml vsebuje 5 mg bivalirudina.
English: If the 5-minute ACT is less than 225 seconds, a second bolus dose of 0.3 mg/kg should be administered.
Slovenian: Če je 5-minutni ACT manjši od 225 sekund, bolniku odmerite drugi bolusni odmerek 0,3 mg/kg.
English: When bivalirudin is combined with a platelet inhibitor or an anti-coagulant medicine, clinical and biological parameters of haemostasis should be regularly monitored.
Slovenian: Če bivalirudin kombinirate z inhibitorjem trombocitov ali antikoagulacijskim zdravilom, morate redno spremljati klinične in biološke parametre hemostaze.
English: Bleeding definitions and outcomes from the REPLACE-2 trial are shown in Table 6.
Slovenian: Definicije krvavitev in rezultati študije REPLACE-2 so prikazani v preglednici 6.
English: Angiox is available in packs of 10 vials.
Slovenian: Zdravilo Angiox je pakirano v škatlah po 10 vial.
English: Bleeding definitions and outcomes from the HORIZONS trial are shown in Table 6.
Slovenian: Definicije krvavitev in rezultati preskušanja HORIZONS so prikazani v preglednici 6.
English: HOW TO STORE ANGIOX
Slovenian: Kako uporabljati zdravilo Angiox
English: For patients who proceed to coronary artery bypass graft (CABG) surgery off pump, the intravenous infusion of bivalirudin should be continued until the time of surgery.
Slovenian: Pri bolnikih, ki bodo deležni kirurškega postopka koronarne arterijske premostitve (CABG»coronary artery bypass graft«) brez uporabe črpalke, je treba uporabljati intravensko infuzijo bivalirudina do začetka kirurškega posega.
English: White to off-white lyophilised powder.
Slovenian: Bel ali sivo bel liofiliziran prašek.
English: Lyophilised (freeze-dried) powder: Do not store above 25C.
Slovenian: Liofiliziran (sušen z zamrzovanjem) prašek: Shranjujte pri temperaturi do 25 ºC.
English: Platelets, bleeding and clotting
Slovenian: Trombociti, krvavitev in koagulacija
English: Reperfusion injury (no or slow reflow), Contusion a. ADRs identified in post-marketing experience b. Compartment syndrome has been reported as a complication of forearm haematoma following administration of bivalirudin via the radial access route in post-marketing experience c. Further detail regarding stent thrombosis is provided in section 4.8: The HORIZONS Trial (Patients with STEMI undergoing primary PCI).
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih reperfuzijska poškodba (brez ponovne vzpostavitve pretoka ali počasna ponovna vzpostavitev pretoka), kontuzija a. Neželeni učinki, opaženi v okviru izkušenj v obdobju trženja b. O utesnitvenem sindromu so poročali kot o komplikaciji hematoma podlakti, do katere je prišlo po aplikaciji bivalirudina po radialni poti v okviru izkušenj v obdobju trženja c. Dodatne informacije glede tromboze stenta najdete v poglavju 4.8: Preskušanje HORIZONS (zdravljenja bolnikov s STEMI, pri katerih je bila izvedena PCI).
English: Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.
Slovenian: Zdravilo Angiox je indicirano kot antikoagulant pri odraslih bolnikih, pri katerih se bo izvedla perkutana koronarna intervencija (PCI), vključno z bolniki z miokardnim infarktom z zvišanim intervalom ST (STEMI), pri katerih se bo izvedla PCI.
English: TIMI scale major bleeding *clopidogrel pre-angiography or pre-PCI
Slovenian: Večja krvavitev po lestvici TIMI *klopidogrel pred angiografijo ali pred PCI
English: The dose of bivalirudin used in HORIZONS was the same as that used in the REPLACE-2 study (0.75 mg/kg bolus followed by a 1.75 mg/kg body weight/hour infusion).
Slovenian: Odmerek bivalirudina v preskušanju HORIZONS je bil enak kot pri študiji REPLACE-2 (0,75 mg/kg, bolus ki mu je sledila infuzija 1,75 mg/kg telesne mase/h).
English: Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) planned for urgent or early intervention.
Slovenian: Zdravilo Angiox se uporablja tudi za za zdravljenje bolnikov z nestabilno angino (UA) / miokardnim infarktom brez zvišanja intervala ST (NSTEMI), pri katerih je načrtovana urgentna ali zgodnja intervencija.
English: If the 5-minute ACT is less than 225 seconds, a second bolus dose of 0.3 mg/kg should be administered and the ACT re-checked 5 minutes after the administration of the second bolus dose.
Slovenian: Če je 5-minutni ACT manj kot 225 sekund, bolniku dajte drugi bolusni odmerek 0,3 mg/kg in 5 minut po drugem bolusnem odmerku ponovno preverite ACT.
English: Approximately 30% of patients receiving bivalirudin experienced at least one adverse event and 3% experienced an adverse reaction.
Slovenian: Približno 30 % bolnikov, ki so prejeli bivalirudin, je izkusilo vsaj en neželen dogodek, 3 % bolnikov pa je izkusilo neželen učinek povezan z zdravilom.
English: Administration errors may lead to fatal thrombosis.
Slovenian: Napake pri dajanju zdravila lahko privedejo do tromboze, ki se konča s smrtjo.
English: In healthy volunteers and patients, bivalirudin exhibits dose- and concentration-dependent anticoagulant activity as evidenced as prolongation of the ACT, aPTT, PT, INR and TT. Intravenous administration of bivalirudin produces measurable anticoagulation within minutes.
Slovenian: Pri zdravih prostovoljcih in bolnikih bivalirudin kaže od odmerka in koncentracije odvisno antikoagulacijsko aktivnost, kar dokazuje podaljšanje ACT, aTČP, PČ, INR in TČ.
English: Diluted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25
Slovenian: Razredčena raztopina: kemična in fizikalna stabilnost ob uporabi je bila dokazana za 24 ur pri temperaturi 25
English: The following data are based on a clinical study of bivalirudin in patients with STEMI undergoing primary PCI; 1,800 patients were randomised to bivalirudin alone, 1,802 were randomised to heparin plus GP IIb/IIIa inhibitor.
Slovenian: Sledeči podatki temeljijo na klinični študiji zdravljenja bolnikov s STEMI, pri katerih je bila izvedena PCI z bivalirudinom; 1.800 bolnikov je bilo zdravljenih samo z bivalirudinom, 1.802 pa s heparinom in zaviralcem GP IIbIIIa.
English: 30-day Composite ischaemia
Slovenian: 30 dni Kompozita ishemije Smrt
English: Angiox should be initially reconstituted to give a solution of 50 mg/ml bivalirudin.
Slovenian: Zdravilo Angiox je potrebno najprej rekonstituirati v raztopino s 50 mg/ml bivalirudina.
English: Anaphylaxis, including anaphylactic shock with fatal outcome has been reported very rarely (≤1/10,000) in post-marketing experience (see section 4.8).
Slovenian: V izkušnjah v obdobju trženja so zelo redko poročali o primerih anafilaksije (< 1/10.000), vključno z anafilaktičnim šokom s smrtnim izidom (glejte poglavje 4.8).
English: Withdraw 5 ml from the vial, and further dilute in a total volume of 50 ml of glucose 5% solution for injection, or sodium chloride 9 mg/ml (0.9%) solution for injection to give a final bivalirudin concentration of 5 mg/ml.
Slovenian: Nato vzemite 5 ml iz viale in dodatno razredčite na celotni volumen 50 ml s5 % raztopino za injiciranje ali o 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje, da je končna koncentracija bivalirudina 5 mg/ml.
English: Hälsa Pharma GmbH, Nikolaus Dürkopp-Str. 4A, 33602 Bielefeld, GERMANY
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij Hälsa Pharma GmbH, Nikolaus Dürkopp-Str. 4A, 33602 Bielefeld, Nemčija