FrancophonIA/ELRC3.0 huggingface dataset:
English: o while you are in hospital: tell the doctor or nurse immediatelyo after you've left hospital: contact your doctor directly or go immediately to the Emergency
Slovenian: • ko zapustite bolnišnico: takoj obvestite svojega zdravnika oziroma takoj obiščite urgentni
English: ACUITY trial; 30-day and 1-year risk differences for the composite ischaemic endpoint and its components for patients that received acetylsalicylic acid and clopidogrel as per protocol*
Slovenian: Študija ACUITY; razlike v tveganju za kompozito ishemije in njene komponente pri bolnikih, ki so prejemali acetilsalicilno kislino in klopidogrel v skladu s protokolom*, pri 30 dneh in 1 letu
English: There is no known antidote to bivalirudin, however, bivalirudin is haemo-dialysable.
Slovenian: Antidota za bivalirudin sicer ne poznamo, se pa bivalirudin lahko odstrani s hemodializo.
English: The bolus dose remains 0.75 mg/kg (or 0.5 mg/kg in patients who proceed to PCI after receiving bivalirudin pre-cath lab (UA/NSTEMI)).
Slovenian: Bolusni odmerek ostane 0,75 mg/kg (ali 0,5 mg/kg pri bolnikih, ki so napoteni na PCI po prejemu bivalirudina v postopku priprave na kateterizacijo (UA/NSTEMI)).
English: Angiox is a powder for concentrate for solution for injection or infusion (powder for concentrate).
Slovenian: Zdravilo Angiox je prašek za koncentrat za raztopino za injiciranje ali infundiranje (prašek za koncentrat).
English: The majority of these patients received concomitant acetylsalicylic acid and clopidogrel, and 6 out of the 10 patients also received a GP IIb/IIIa inhibitor.
Slovenian: Večina teh bolnikov je prejela hkrati acetilsalicilno kislino in klopidogrel, 6 od 10 bolnikov je prejemalo tudi inhibitor GP IIb/IIIa.
English: All of these bivalirudintreated patients received concomitant acetylsalicylic acid, all but 1 received clopidogrel and 15 also received a GP IIb/IIIa inhibitor.
Slovenian: Vsi bolniki, ki so se zdravili z bivalirudinom, so prejeli hkrati acetisalicilno kislino, vsi razen 1 so prejeli klopidogrel, 15 pa jih je prejelo tudi zaviralec GP IIb/IIIa.
English: Injection site reactions (Injection site discomfort, Injection site pain, Puncture site reaction)
Slovenian: Splošne težave in spremembe na mestu aplikacije reakcije na mestu injiciranja (nelagodje na mestu injiciranja, bolečine na mestu injiciranja, reakcije na mestu vboda)
English: The incidence of major bleeding is shown in Table 6.
Slovenian: Pogostnost manjših krvavitev je prikazana v preglednici 6.
English: Your doctor will decide how to treat you, including stopping the drug and monitoring for signs of ill effects.
Slovenian: Če ste prejeli večji odmerek zdravila Angiox, kot bi smeli Vaš zdravnik bo odločil, kako vas zdraviti, kot tudi o prekinitvi dajanja zdravila in spremljanju znakov negativnih učinkov.
English: If you need to have a coronary artery bypass graft operation, treatment with bivalirudin will either be stopped one hour before the operation or an additional dose of 0.5 mg/kg body weight will be given by injection followed by an infusion of 1.75 mg/kg body weight per hour for the duration of surgery.
Slovenian: Če potrebujete operacijo srca, bo zdravljenje z bivalurinom prekinjeno eno uro pred operacijo ali se z injiciranjem doda dodatna doza 0,5 mg/kg telesne teže z infundiranjem 1,75 mg/kg telesne teže na uro, ki traja tako dolgo kot operacija.
English: Brachytherapy
Slovenian: Brahiterapija
English: Other less frequently observed bleeding sites with greater than 0.1% (uncommon) bleeding included “other” puncture site, retroperitoneal, gastrointestinal, ear, nose or throat.
Slovenian: Druga, manj pogosta mesta krvavitve, s pogostnostjo krvavitve več kot 0,1 % (redko), so vključevala »druga« mesta vboda, retroperitonej, prebavila, ušesa, nos ali grlo.
English: The medicinal products incompatible with bivalirudin at higher concentrations are: dobutamine hydrochloride, famotidine, haloperidol lactate, labetalol hydrochloride, lorazepam and promethazine HCl.
Slovenian: Zdravila, ki so nezdružljiva z bivalirudinom pri višji koncentraciji, so: dobutaminijev klorid, famotidin haloperidolijev laktat, labetalolijev klorid, lorazepam in prometazinijev klorid.
English: The majority of these patients received concomitant acetylsalicylic acid and clopidogrel, and 10 out of 20 patients also received a GP IIb/IIIa inhibitor.
Slovenian: Večina teh bolnikov je prejela acetilsalicilno kislino in klopidogrel, 10 od 20 bolnikov pa je prejelo tudi zaviralec GP II/IIIa.
English: Powder for concentrate for solution for injection or infusion (powder for concentrate).
Slovenian: Prašek za koncentrat za raztopino za injiciranje ali infundiranje (prašek za koncentrat).
English: Intravenous use
Slovenian: Intravenska uporaba.
English: Other medicines and Angiox tell your doctor
Slovenian: Druga zdravila in zdravilo Angiox
English: Angiox should be used with caution during beta brachytherapy procedures.
Slovenian: Med beta brahiterapevtskimi postopki zdravilo Angiox uporabljajte previdno.
English: Warnings and precautions
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi
English: The incidence of both ACUITY-scale and TIMI-scale bleeding events up to day 30 for the intent-totreat population is presented in Table 6.
Slovenian: Pogostnost krvavitev po lestvici ACUITY in lestvici TIMI do 30. dne je za celotno populacijo predstavljena v tabeli 6.
English: Adverse events were more frequent in females and in patients more than 65 years of age in both the bivalirudin and the heparin-treated comparator groups compared to male or younger patients.
Slovenian: Neželeni dogodki so bili pogostejši pri ženskah in bolnikih nad 65. letom starosti v primerjavi z moškimi in mlajšimi bolniki, tako v skupini zdravljeni z bivalirudinom kot v skupini zdravljeni s heparinom.
English: Mannitol Sodium hydroxide 2% (for pH adjustment)
Slovenian: 2 % raztopina natrijevega hidroksida (za uravnavanje pH).
English: Solutions containing particulate matter should not be used.
Slovenian: Ne uporabljajte raztopin, ki vsebujejo delce.
English: Adverse drug reactions for bivalirudin are listed by system organ class in Table 1.The incidence of stent thrombosis within the first 24 hours was 1.5% in patients receiving bivalirudin versus 0.3% in patients receiving UFH plus GP IIb/IIIa inhibitor (p=0.0002).
Slovenian: Neželeni učinki so našteti po organskih sistemih v preglednici 1.Tromboza stenta se je v 24-ih urah pojavila pri 1,5% bolnikih, ki so prejeli bivalirudin, pri bolnikih, ki so prejeli UFH in zaviralcem GP IIb/IIIa, pa le v 0,3% primerih (p=0,0002).
English: Adverse reactions for bivalirudin are listed by system organ class in Table 1.
Slovenian: Neželeni učinki za bivalirudin so našteti po organskih sistemih v preglednici 1.
English: The following six medicinal products show dose-concentration incompatibilities with bivalirudin.
Slovenian: Naslednjih šest zdravil je nezdružljivih z bivalirudinom glede na odmerek/koncentracijo.
English: Healthcare professionals should refer to the Summary of Product Characteristics for full prescribing information.
Slovenian: Za popolne informacije o predpisovanju naj zdravstveno osebje uporabi Povzetek glavnih značilnosti zdravila.
English: Aseptic procedures should be used for the preparation and administration of Angiox.
Slovenian: Za pripravo in dajanje zdravila Angiox uporabljajte aseptične postopke.
English: B - A Risk diff. (95% CI)
Slovenian: B - A Razlika tveganj (95 % CI)
English: In Arms B and C of the ACUITY trial, the recommended dose of bivalirudin was an initial postrandomisation intravenous bolus of 0.1 mg/kg followed by a continuous intravenous infusion of 0.25 mg/kg/h during angiography or as clinically warranted.
Slovenian: V krakih B in C študije ACUITY je bil priporočeni odmerek bivalirudina začetni intravenski bolus (po randomizaciji) 0,1 mg/kg, ki mu je sledila neprekinjena intravenska infuzija 0,25 mg/kg/h med angiografijo ali kot je bilo klinično utemeljeno.
English: Gastrointestinal haemorrhage (including haematemesis, melaena, oesophageal haemorrhage, anal haemorrhage), Retroperitoneal haemorrhage, Gingival haemorrhage, Nausea
Slovenian: Bolezni prebavil gastrointestinalna krvavitev (vključno s hematemezo, meleno, ezofagealno krvavitvijo, analno krvavitvijo), retroperitonealna krvavitev, gingivalna krvavitev, navzea peritonealna krvavitev, retroperitonealni hematom, bruhanje
English: - After reconstitution (addition of 5 ml water for injections to the vial to dissolve the powder),
Slovenian: - Po rekonstituciji (za raztopitev praška se v vialo doda 5 ml vode za injekcije) 1 ml vsebuje 50
English: Angiox contains sodium
Slovenian: Zdravilo Angiox vsebuje natrij
English: C - A Risk diff. (95% CI)
Slovenian: C - A Razlika tveganj (95 % CI)
English: Description of selected adverse reactions
Slovenian: Opis izbranih neželenih učinkov Krvavitev
English: Patients should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischaemia.
Slovenian: Bolniki po primarni PCI morajo biti pod strogim nadzorom glede kakršnih koli znakov in simptomov, ki bi kazali na srčno ishemijo.
English: In patients with mild or moderate renal insufficiency, the ACS dose (0.1 mg/kg bolus/0.25 mg/kg/h infusion) should not be adjusted.
Slovenian: Pri bolnikih z blago ali zmerno ledvično okvaro odmerka pri AKS (0,1 mg/kg za bolus/0,25 mg/kg/h za infuzijo) ni treba prilagajati.
English: Following PCI, the reduced infusion dose of 0.25 mg/kg/h may be resumed for 4 to 12 hours as clinically necessary.
Slovenian: Po PCI lahko nadaljujete z dajanjem zmanjšanega infuzijskega odmerka 0,25 mg/kg/h¸ v trajanju 4 do 12 ur, v skladu s kliničnimi potrebami.
English: The incidence of major and minor bleeding was significantly less in patients treated with bivalirudin versus patients treated with heparin plus a GP IIb/IIIa inhibitor.
Slovenian: Pogostnost večjih in manjših krvavitev je bila manjša pri bolnikih, zdravljenih z bivairudinom, kot pri bolnikih, zdravljenih s heparinom in zaviralcem GP IIb/IIIa.
English: What Angiox contains
Slovenian: Kaj vsebuje zdravilo Angiox
English: 1 vial contains 250 mg bivalirudin.
Slovenian: 1 viala vsebuje 250 mg bivalirudina.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, or toxicity to reproduction.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
English: - if you have, or have recently had, any bleeding from your stomach, intestines, bladder or other organs, for example, if you have noticed abnormal blood in your stools or urine (except from
Slovenian: - če ste alergični na bivalirudin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6) ali hirudine (druga zdravila za redčenje krvi), - če krvavite ali ste nedolgo tega krvaveli iz želodca, črevesja, sečnega mehurja ali drugih organov, kot na primer, če ste opazili nenormalno kri v blatu ali urinu (izjema so menstruacijske
English: Co-administration with platelet inhibitors or anti-coagulants
Slovenian: Sočasno dajanje z inhibitorji trombocitov ali drugimi antikoagulacijskimi zdravili
English: + GP IIb/IIIa inhibitor (%)
Slovenian: + zaviralec GP IIb/IIIa (%)
English: Major Adverse Cardiac/Ischaemic Events (MACE) was defined as the occurrence of any of the following; death, reinfarction, stroke or ischaemic target vessel revascularisation.
Slovenian: Events (MACE)) so opredeljeni kot pojav sledečih dogodkov: smrt, ponovni infarkt, možganska kap ali revaskularizacija ishemične žile .
English: Angiox should be administered with caution in breast-feeding mothers.
Slovenian: Zdravilo Angiox dajajte doječim materam previdno.
English: The incidence of both ACUITY-scale and TIMI-scale bleeding events to day 30 for the per protocol population are presented in Table 7.
Slovenian: Pogostnost krvavitev po lestvici ACUITY in lestvici TIMI do 30. dne je za bolnike v skladu s protokolom predstavljena v preglednici 7.
English: • Angiox is contraindicated in patients with severe renal insufficiency (glomerular filtration rate (GFR) < 30 ml/min) and in dialysis-dependent patients.
Slovenian: • Zdravilo Angiox je kontraindicirano pri bolnikih s hudo ledvično insuficienco (hitrost glomerulne filtracije (GFR) < 30 ml/min) in pri bolnikih, ki so odvisni od dialize.
English: Angiox is contraindicated in patients with severe renal insufficiency (GFR<30 ml/min) and also in dialysis-dependent patients (see section 4.3).
Slovenian: Angiox je kontraindiciran pri bolnikih s hudo ledvično okvaro (GFR < 30 ml/min) in dializnih bolnikih (glejte poglavje 4.3).
English: The analysis and results for the HORIZONS trial at 30 days for the overall (ITT) population is shown in Table 2.Results at 1 year were consistent with results at 30 days.
Slovenian: Analiza in rezultati 30-dnevnega preskušanja HORIZONS za celotno polulacijo (ITT) so prikazani v preglednici 2.
English: - Each vial contains 250 mg bivalirudin.
Slovenian: - Vsaka viala vsebuje 250 mg bivalirudina.
English: Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8C.
Slovenian: Rekonstituirana raztopina: kemična in fizikalna stabilnost ob uporabi je bila dokazana za 24 ur pri temperaturi 2
English: • 0.1 mg/kg body weight as an intravenous injection, followed by an infusion (drip) into vein of 0.25 mg/kg body weight per hour for up to 72 hours.
Slovenian: • 0,1 mg/kg telesne mase v obliki intravenske injekcije, ki ji sledi infundiranje (kapljično) v veno 0,25 mg/kg telesne mase na uro največ 72 ur.
English: For patients undergoing PCI, an additional intravenous bolus of 0.5 mg/kg bivalirudin was administered and the rate of intravenous infusion increased to 1.75 mg/kg/h.
Slovenian: Bolniki, ki so prestajali PCI, so prejeli dodaten intravenski bolus 0,5 mg/kg bivalirudina, hitrost intravenske infuzije pa se je povečala na 1,75 mg/kg/h.
English: There was no statistically significant difference in the rates of stent thrombosis between treatment arms at 30 days (p=0.3257) and 1 year (p=0.7754).
Slovenian: Pri 30-ih dneh (p=0,3257) in 1 letu (p=0,7754) ni bilo statistično značilnih razlik v deležih tromboze stenta med kraki zdravljenja.
English: 1-year Composite ischaemia
Slovenian: Kompozita ishemije
English: Coronary stent thrombosis including reports with fatal outcome c
Slovenian: Žilne bolezni hematom, hipotenzija tromboza koronarnega stenta, vključno s poročili o smrtnem izidu c,
English: Reconstituted material should then be further diluted in a total volume of 50 ml to give a solution of 5 mg/ml bivalirudin.
Slovenian: Rekonstituirano raztopino je potrebno nadalje razredčiti v skupno prostornino 50 ml, da je končna koncentracija bivalirudina 5 mg/ml.
English: Both minor and major bleeds were significantly less frequent with bivalirudin than the heparin plus GP IIb/IIIa inhibitor comparator group.
Slovenian: Tako manjše kot večje krvavitve so bile znatno redkejše pri uporabi bivalirudina kot v primerjalni skupini s heparinom in inhibitorjem GP IIb/IIIa.
English: Just prior to surgery, a 0.5 mg/kg bolus dose should be administered followed by a 1.75 mg/kg/h intravenous infusion for the duration of the surgery.
Slovenian: Tik pred izvedbo kirurškega posega je treba injicirati 0,5 mg/kg bolusni odmerek, čemur sledi intravensko infundiranje 1,75 mg/kg/h, ki poteka med posegom.
English: Ischaemic target vessel revascularisation Stroke
Slovenian: Komponente ishemije smrt ponovni infarkt revaskularizacija ishemične žile možganska kap
English: The recommended dose of bivalirudin for patients undergoing PCI is an intravenous bolus of 0.75 mg/kg body weight followed immediately by an intravenous infusion at a rate of 1.75 mg/kg body weight/hour for at least the duration of the procedure.
Slovenian: Priporočeni odmerek bivalirudina pri bolnikih, pri katerih se bo izvedla PCI, je intravenski bolus 0,75 mg/kg telesne mase, ki mu takoj sledi intravensko infundiranje s hitrostjo 1,75 mg/kg telesne mase/h vsaj v času trajanja postopka.
English: Arm C bival alone (N=2,911)
Slovenian: Krak C Samo bival (N=2.911)
English: Protocol defined major bleeding
Slovenian: Večje krvavitve glede na protokol Večje krvavitve TIMI (ne
English: The recommended starting dose of bivalirudin for medically managed patients with acute coronary syndrome (ACS) is an intravenous bolus of 0.1 mg/kg followed by an infusion of 0.25 mg/kg/h.
Slovenian: Priporočeni odmerek bivalirudina pri bolnikih z akutnim koronarnim sindromom (AKS), ki se zdravijo z zdravili, je 0,1 mg/kg kot intravenski bolus, ki mu sledi infundiranje 0,25 mg/kg/h.
English: • When this treatment is finished, the infusion may go back to 0.25 mg/kg body weight per hour
Slovenian: • Ko bo to zdravljenje končano, se bo odmerek za infundiranje zmanjšal nazaj na 0,25 mg/kg telesne mase na uro za dodatnih 4-12 ur.
English: If the medically managed patient proceeds to PCI, an additional bolus of 0.5 mg/kg of bivalirudin should be administered before the procedure and the infusion increased to 1.75 mg/kg/h for the duration of the procedure.
Slovenian: Če je bolnik, ki se zdravi z zdravili, napoten na PCI, je treba dati dodatni bolus 0,5 mg/kg bivalirudina pred postopkom, hitrost infundiranja pa čez celoten čas postopka povečati na 1,75 mg/kg/h.
English: Relative Risk [95% CI]
Slovenian: Opazovani dogodek Bivalirudin relativno tveganje [95% CI]
English: Renal Insufficiency
Slovenian: Ledvična insuficienca
English: pvalue*
Slovenian: p-vrednost*
English: After reconstitution 1 ml contains 50 mg bivalirudin.
Slovenian: Po rekonstituciji 1 ml vsebuje 50 mg bivalirudina.
English: Angiox 250 mg powder for concentrate for solution for injection or infusion.
Slovenian: Angiox 250 mg prašek za koncentrat za raztopino za injiciranje ali infundiranje.
English: 6%) of bivalirudin-treated patients and in 67 (3.9%) of patients treated with heparin plus a GP IIb/IIIa inhibitor.
Slovenian: O trombocitopeniji so pri bolnikih, ki so sodelovali pri študiji HORIZONS, poročali pri 26 bolnikih (1,6%), ki so jih zdravili z, ter pri 67 (3,9 %) bolnikih, ki so bili zdravljeni s heparinom in zaviralcem GP IIb/IIIa.
English: heparin  GP IIb/IIIa inhibitor (N=3,008)
Slovenian: heparin + inhibitor GP IIb/IIIa (N=3.008)
English: Coronary artery thrombosis and coronary stent thrombosis with myocardial infarction, and catheter thrombosis have each been reported rarely.
Slovenian: Redko so poročali o trombozi koronarne arterije in trombozi z miokardnim infarktom, ter trombozi katetra.
English: Both major and minor bleeds were significantly less frequent with bivalirudin alone than the heparin plus GP IIb/IIIa inhibitor and bivalirudin plus GP IIb/IIIa inhibitor groups.
Slovenian: V skupini, v kateri se je uporabil samo bivalirudin, so bile večje in manjše krvavitve znatno redkejše kot v skupini s heparinom in inhibitorjem GP IIb/IIIa, ter skupini z bivalirudinom in inhibitorjem GP IIb/IIIa.
English: Bival + GP IIb/IIIa inhibitor
Slovenian: Bival + zaviralec GP IIb/IIIa
English: 6.1 List of excipients
Slovenian: 6.1 Seznam pomožnih snovi Manitol
English: • Shortness of breath
Slovenian: • hitro bitje srca
English: Angiox 250 mg powder for concentrate bivalirudin
Slovenian: Angiox 250 mg prašek za koncentrat bivalirudin intravenozna uporaba
English: Unplanned revasc.
Slovenian: Neuporabljeno raztopino zavrzite.
English: heparin  GP IIb/IIIa inhibitor (N=2,882)
Slovenian: heparin + inhibitor GP IIb/IIIa (N=2.882)
English: • 0.5 mg/kg body weight for the intravenous injection, followed by an infusion into vein of 1.75 mg/kg body weight, per hour for the duration of the PCI.
Slovenian: • 0,5 mg/kg telesne mase za intravensko injekcijo, ki ji sledi infundiranje v veno 1,75 mg/kg telesne mase na uro za čas trajanja PCI.
English: Intravenous infusion lines should be primed with bivalirudin to ensure continuity of drug infusion after delivery of the bolus.
Slovenian: Da se zagotovi stalna infuzija zdravila po infuziji bolusa, morajo biti intravenske infuzijske linije napolnjene z bivalirudinom.
English: In STEMI patients the infusion of 1.75 mg/kg body weight/hour should be continued for up to 4 hours post-PCI and continued at a reduced dose of 0.25 mg/kg/h for an additional 4 - 12 hours as clinically necessary (see section 4.4).
Slovenian: Pri bolnikih s STEMI je treba infundiranje 1,75 mg/kg telesne mase/h nadaljevati še največ 4 ure po PCI in nato še, v skladu s kliničnimi potrebami, 4-12 ur z infundiranjem zmanjšanega odmerka 0,25 mg/kg/h (glejte poglavje 4.4).
English: • severe renal impairment (GFR<30 ml/min) and in dialysis-dependent patients.
Slovenian: • hudo ledvično okvaro (GFR < 30 ml/min) in dializnih bolnikih.
English: Intraocular haemorrhage
Slovenian: Očesne bolezni intraokularna krvavitev
English: • If you are taking blood thinners or medicines to prevent blood clots (anticoagulants or antithrombotics e.g. warfarin, dabigatran, apixaban, rivaroxaban, acetylsalicylic acid,
Slovenian: (antikoagulanti ali antitrombotiki npr. varfarin, dabigatran, apiksaban, rivaroksaban,
English: ACUITY major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site haemorrhage requiring radiological or surgical intervention, ≥5 cm diameter haematoma at puncture site, reduction in haemoglobin concentration of ≥4 g/dl without an overt source of bleeding, reduction in haemoglobin concentration of ≥3 g/dl with an overt source of bleeding, re-operation for bleeding, use of any blood product transfusion.
Slovenian: Večja krvavitev je bila v študiji ACUITY opredeljena kot: intrakranialna, retroperitonealna, intraokularna, krvavitev na mestu pristopa, ki zahteva radiološko ali kirurško intervencijo, hematom na mestu vboda s premerom 5 cm ali več, zmanjšanje koncentracije hemoglobina za 4 g/dl ali več brez očitnega vira krvavitve, zmanjšanje koncentracije hemoglobina za 3 g/dl ali več pri očitnem viru krvavitve, ponovna operacija zaradi krvavitve ali uporaba kakršne koli transfuzije krvnih proizvodov.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema znižane vrednosti hemoglobina trombocitopenija, anemija
English: Bival alone (N=2,911) %
Slovenian: Samo bival (N=2.911)
English: The approved adult weight-based intravenous bolus dose of 0.75 mg/kg followed by an infusion of 1.75 mg/kg/hour was studied and pharmacokinetic/pharmacodynamic analysis found a response similar to that of adults, although weight-normalized clearance (ml/min/kg) of bivalirudin was higher in neonates than in older children and decreased with increasing age.
Slovenian: Farmakokinetična/farmakodinamična analiza je pokazala, da je odziv podoben kot pri odraslih, čeprav je bil očistek bivalirudina, normaliziran glede na telesno maso (ml/min/kg), večji pri novorojenčkih kot pri starejših otrocih in se je s starostjo manjšal.
English: Haemorrhage
Slovenian: • zadihanost
English: • with chest pain due to heart disease (acute coronary syndromes - ACS)
Slovenian: o z bolečinami v prsih zaradi srčne bolezni (akutni koronarni sindrom - AKS) o ki imajo kirurški poseg za zdravljenje blokad v žilah (angioplastika ali perkutana koronarna
English: Quadruple endpoint Triple endpoint* Components: Death Myocardial Infarction Major bleeding** (based on nonTIMI criteria - see section 4.8) Urgent revascularisation * excludes major bleeding component.
Slovenian: Miokardni infarkt Večja krvavitev** (na osnovi ne-TIMI kriterijev - glejte poglavje
English: Bleeding has been observed in some reports of overdose.
Slovenian: Pri nekaterih primerih prevelikega odmerjanja so se pojavile krvavitve.
English: Ischaemic Components All cause death
Slovenian: Kompozita ishemije Smrt