natgillin/translations-raw huggingface dataset:
The pharmacokinetic properties of bivalirudin have been evaluated and found to be linear in patients undergoing Percutaneous Coronary Intervention and in patients with ACS.
Farmakokinetične lastnosti bivalirudina so bile ovrednotene in so linearne pri bolnikih med perkutano koronarno intervencijo in pri bolnikih z akutnim koronarnim sindromom (AKS).
If you are breast-feeding, the doctor will decide whether Angiox should be used.
Če dojite, bo zdravnik odločil, ali lahko uporabljate zdravilo Angiox.
Medicinal products with dose concentration incompatibilities
Nezdružljiva zdravila glede na odmerek/koncentracijo incompatibilities
In the HORIZONS study both major and minor bleeding occurred commonly (1/100 and <1/10).
V študiji HORIZONS so se večje in manjše krvavitve pojavile pogosto (≥ 1/100 do < 1/10).
2Major bleeding was defined using the ACUITY bleeding scale.
Večja krvavitev je opredeljena na osnovi ACUITY lestvice krvavitev.
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.
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.
In vitro studies have indicated that bivalirudin inhibits both soluble (free) and clot-bound thrombin.
Študije in vitro kažejo, da bivalirudin inhibira tako topni (prosti) kot tudi na strdek vezani trombin.
A total of 55.1% of patients receiving bivalirudin experienced at least one adverse event and 8.7% experienced an adverse drug reaction.
55,1 % bolnikov, ki so prejemali bivalirudin, je izkusilo vsaj en neželen dogodek, 8,7 % bolnikov pa je izkusilo neželen učinek zdravila.
REPLACE-2 study results: 30-day endpoints (intent-to-treat and per-protocol populations
Rezultati študije REPLACE-2: opazovani dogodki (vključena populacija ("intent-to-treat") in populacija po protokolu) po 30 dneh
Interaction studies have been conducted with platelet inhibitors, including acetylsalicylic acid, ticlopidine, clopidogrel, abciximab, eptifibatide, or tirofiban.
Interakcijske študije so bile izvedene z inhibitorji krvnih ploščic, vključno z acetilsalicilno kislino, tiklopidinom, klopidogrelom, abciksimabom, eptifibatidom ali tirofibanom.
Such a reaction is uncommon (may affect up to 1 in 100 people).
Takšne reakcije so občasne (pojavijo se lahko pri največ 1 od 100 bolnikov)
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).
3.602 randomiziranih bolnikov je prejelo ali bivalirudin (1.800 bolnikov) ali nefrakcioniran heparin in zaviralec GP IIb/IIIa (1.802 bolnikov).
Per-protocol bivalirudin (N=2,994)
Po protokolu bivalirudin (N=2.994)
Medicinal products with dose concentration incompatibilities to bivalirudin.
Zdravila glede na odmerek/koncentracijo, ki niso združljiva z bivalirudinom.
Use with other anticoagulant therapy
Uporaba z drugimi antikoagulanti:
Do not use Angiox
Ne uporabljajte zdravila Angiox:
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.
Po subakutni trombozi stenta je bilo skupaj 17 smrtnih žrtev, 3 iz kraka z bivalirudinom in 14 pri UFH in GP IIb/IIIa.
Reconstituted solution: Store in a refrigerator (2 - 8
Rekonstituirana raztopina: Shranjujte v hladilniku (2
Two deaths occurred after acute stent thrombosis, 1 in each arm of the study.
Po akutni trombozi sta se pojavili dva smrtna primera, vsak iz enega kraka študije.
• Angiox must be administered as a bolus dose followed immediately by an intravenous infusion,
• Zdravilo Angiox je treba dati kot bolusni odmerek, ki mu takoj sledi intravenska infuzija, tudi
Healthcare providers are recommended to refer to the Angiox Summary of Product Characteristics for full information on dosing.
Zdravstvenim delavcem se priporoča, naj si za vse informacije o odmerjanju ogledajo povzetek glavnih značilnosti zdravila Angiox.
Angiox is contraindicated in patients with:
Angiox je kontraindiciran pri bolnikih z:
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.
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.
Uncommon side effects (may affect up to 1 in 100 people): • nausea (feeling sick) and/or vomiting (being sick)
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): • navzea (slabost) in/ali bruhanje
Patients undergoing PCI, including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI
Bolniki, ki bodo imeli PCI, vključno z bolniki z miokardnim infarktom z zvišanjem intervala ST (STEMI), pri katerih se bo izvedla primarna PCI
*clopidogrel pre-angiography or pre-PCI
*klopidogrel pred angiografijo ali pred PCI
Arm C bival alone (N=4,612)
Krak C samo bival (N=4.612)
Dose adjustments for this age group should be on the basis of renal function.
Prilagajanje odmerkov za to starostno skupino se naredi glede na stanje delovanja ledvic.
Rare (≥1/10,000 to
Občasni (≥ 1/1.000 do
ACUITY trial; bleeding events up to day 30 for the population of patients who received acetylsalicylic acid and clopidogrel as per protocol*
Študija ACUITY; krvavitve do dne 30 za vključeno populacijo in populacijo bolnikov, ki so prejemali acetililsalicilno kislino klopidogrel v skladu s protokolom*
Minor bleeding occurred very commonly (1/10) and major bleeding occurred commonly (1/100 and <1/10).
Manjša krvavitev je bila zelo pogosta (≥ 1/10), večja krvavitev pa pogosta (≥ 1/100 in < 1/10).
ACUITY trial; 30-day and 1-year risk differences for the composite ischaemic endpoint and its components for the overall population (ITT)
Študija ACUITY: razlike v tveganju za kompozito ishemije in njene komponente pri celotni populaciji (ITT) pri 30 dneh in 1 letu
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Za navodila glede rekonstitucije in redčenja zdravila pred dajanjem glejte poglavje 6.6. 4.3 Kontraindikacije
HORIZONS 30-day study results (intent-to-treat population)
Rezultati študije HORIZONS (Celotna populacija) po 30 dneh
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.
Bivalirudin je kot peptid podvržen katabolizmu na aminokisline, ki ga sestavljajo, s posledično ponovno uporabo aminokislin v telesu.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Predpisovanje in izdaja zdravila je le s posebnim režimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
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.
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.
Angiox contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”.
Pomožna snov Zdravilo Angiox vsebuje manj kot 1 mmol natrija (23 mg) na vialo, to dejansko pomeni »brez natrija«.
Approximately 23.3% of patients receiving bivalirudin experienced at least one adverse event and 2.1% experienced an adverse reaction.
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.
For further information regarding the use of bivalirudin with or without a GP IIb/IIIa inhibitor, please see section 5.1.
Za podrobne podatke glede uporabe bivalirudina z ali brez zaviralca GP IIb/IIIa glejte poglavje 5.1.
Angiox is a white to off-white powder in a glass vial.
Zdravilo Angiox je bel do belkast prašek v stekleni viali.
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.
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).
However, bivalirudin was not mutagenic or clastogenic in standard assays for such effects.
Bivalirudin se pri standardnih analizah za takšne učinke ni izkazal kot mutagen ali klastogen.
Powder for concentrate for solution for injection or infusion 10 vials
Prašek za koncentrat za raztopino za injiciranje ali infundiranje 10 vial
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.
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.
50 ml] of glucose solution or sodium chloride solution) 1 ml contains 5 mg bivalirudin.
ml] zmeša z raztopino glukoze ali natrijevega klorida)1 ml vsebuje 5 mg bivalirudina.
If the 5-minute ACT is less than 225 seconds, a second bolus dose of 0.3 mg/kg should be administered.
Če je 5-minutni ACT manjši od 225 sekund, bolniku odmerite drugi bolusni odmerek 0,3 mg/kg.
When bivalirudin is combined with a platelet inhibitor or an anti-coagulant medicine, clinical and biological parameters of haemostasis should be regularly monitored.
Če bivalirudin kombinirate z inhibitorjem trombocitov ali antikoagulacijskim zdravilom, morate redno spremljati klinične in biološke parametre hemostaze.
Bleeding definitions and outcomes from the REPLACE-2 trial are shown in Table 6.
Definicije krvavitev in rezultati študije REPLACE-2 so prikazani v preglednici 6.
Angiox is available in packs of 10 vials.
Zdravilo Angiox je pakirano v škatlah po 10 vial.
Bleeding definitions and outcomes from the HORIZONS trial are shown in Table 6.
Definicije krvavitev in rezultati preskušanja HORIZONS so prikazani v preglednici 6.
HOW TO STORE ANGIOX
Kako uporabljati zdravilo Angiox
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.
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.
White to off-white lyophilised powder.
Bel ali sivo bel liofiliziran prašek.
Lyophilised (freeze-dried) powder: Do not store above 25C.
Liofiliziran (sušen z zamrzovanjem) prašek: Shranjujte pri temperaturi do 25 ºC.
Platelets, bleeding and clotting
Trombociti, krvavitev in koagulacija
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).
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).
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.
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.
TIMI scale major bleeding *clopidogrel pre-angiography or pre-PCI
Večja krvavitev po lestvici TIMI *klopidogrel pred angiografijo ali pred PCI
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).
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).
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.
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.
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.
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.
Approximately 30% of patients receiving bivalirudin experienced at least one adverse event and 3% experienced an adverse reaction.
Približno 30 % bolnikov, ki so prejeli bivalirudin, je izkusilo vsaj en neželen dogodek, 3 % bolnikov pa je izkusilo neželen učinek povezan z zdravilom.
Administration errors may lead to fatal thrombosis.
Napake pri dajanju zdravila lahko privedejo do tromboze, ki se konča s smrtjo.
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.
Pri zdravih prostovoljcih in bolnikih bivalirudin kaže od odmerka in koncentracije odvisno antikoagulacijsko aktivnost, kar dokazuje podaljšanje ACT, aTČP, PČ, INR in TČ.
Diluted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25
Razredčena raztopina: kemična in fizikalna stabilnost ob uporabi je bila dokazana za 24 ur pri temperaturi 25
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.
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.
30-day Composite ischaemia
30 dni Kompozita ishemije Smrt
Angiox should be initially reconstituted to give a solution of 50 mg/ml bivalirudin.
Zdravilo Angiox je potrebno najprej rekonstituirati v raztopino s 50 mg/ml bivalirudina.
Anaphylaxis, including anaphylactic shock with fatal outcome has been reported very rarely (≤1/10,000) in post-marketing experience (see section 4.8).
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).
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.
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.
Hälsa Pharma GmbH, Nikolaus Dürkopp-Str. 4A, 33602 Bielefeld, GERMANY
Ime in naslov izdelovalca, odgovornega za sproščanje serij Hälsa Pharma GmbH, Nikolaus Dürkopp-Str. 4A, 33602 Bielefeld, Nemčija
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
• ko zapustite bolnišnico: takoj obvestite svojega zdravnika oziroma takoj obiščite urgentni
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*
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
There is no known antidote to bivalirudin, however, bivalirudin is haemo-dialysable.
Antidota za bivalirudin sicer ne poznamo, se pa bivalirudin lahko odstrani s hemodializo.
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)).
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)).
Angiox is a powder for concentrate for solution for injection or infusion (powder for concentrate).
Zdravilo Angiox je prašek za koncentrat za raztopino za injiciranje ali infundiranje (prašek za koncentrat).
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.
Večina teh bolnikov je prejela hkrati acetilsalicilno kislino in klopidogrel, 6 od 10 bolnikov je prejemalo tudi inhibitor GP IIb/IIIa.
All of these bivalirudintreated patients received concomitant acetylsalicylic acid, all but 1 received clopidogrel and 15 also received a GP IIb/IIIa inhibitor.
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.
Injection site reactions (Injection site discomfort, Injection site pain, Puncture site reaction)
Splošne težave in spremembe na mestu aplikacije reakcije na mestu injiciranja (nelagodje na mestu injiciranja, bolečine na mestu injiciranja, reakcije na mestu vboda)
The incidence of major bleeding is shown in Table 6.
Pogostnost manjših krvavitev je prikazana v preglednici 6.
Your doctor will decide how to treat you, including stopping the drug and monitoring for signs of ill effects.
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.
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.
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.
Other less frequently observed bleeding sites with greater than 0.1% (uncommon) bleeding included “other” puncture site, retroperitoneal, gastrointestinal, ear, nose or throat.
Druga, manj pogosta mesta krvavitve, s pogostnostjo krvavitve več kot 0,1 % (redko), so vključevala »druga« mesta vboda, retroperitonej, prebavila, ušesa, nos ali grlo.
The medicinal products incompatible with bivalirudin at higher concentrations are: dobutamine hydrochloride, famotidine, haloperidol lactate, labetalol hydrochloride, lorazepam and promethazine HCl.
Zdravila, ki so nezdružljiva z bivalirudinom pri višji koncentraciji, so: dobutaminijev klorid, famotidin haloperidolijev laktat, labetalolijev klorid, lorazepam in prometazinijev klorid.
The majority of these patients received concomitant acetylsalicylic acid and clopidogrel, and 10 out of 20 patients also received a GP IIb/IIIa inhibitor.
Večina teh bolnikov je prejela acetilsalicilno kislino in klopidogrel, 10 od 20 bolnikov pa je prejelo tudi zaviralec GP II/IIIa.
Powder for concentrate for solution for injection or infusion (powder for concentrate).
Prašek za koncentrat za raztopino za injiciranje ali infundiranje (prašek za koncentrat).
Intravenous use
Intravenska uporaba.
Other medicines and Angiox tell your doctor
Druga zdravila in zdravilo Angiox
Angiox should be used with caution during beta brachytherapy procedures.
Med beta brahiterapevtskimi postopki zdravilo Angiox uporabljajte previdno.
Warnings and precautions
4.4 Posebna opozorila in previdnostni ukrepi
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.
Pogostnost krvavitev po lestvici ACUITY in lestvici TIMI do 30. dne je za celotno populacijo predstavljena v tabeli 6.
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.
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.
Mannitol Sodium hydroxide 2% (for pH adjustment)
2 % raztopina natrijevega hidroksida (za uravnavanje pH).
Solutions containing particulate matter should not be used.
Ne uporabljajte raztopin, ki vsebujejo delce.
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).
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).
Adverse reactions for bivalirudin are listed by system organ class in Table 1.
Neželeni učinki za bivalirudin so našteti po organskih sistemih v preglednici 1.
The following six medicinal products show dose-concentration incompatibilities with bivalirudin.
Naslednjih šest zdravil je nezdružljivih z bivalirudinom glede na odmerek/koncentracijo.
Healthcare professionals should refer to the Summary of Product Characteristics for full prescribing information.
Za popolne informacije o predpisovanju naj zdravstveno osebje uporabi Povzetek glavnih značilnosti zdravila.
Aseptic procedures should be used for the preparation and administration of Angiox.
Za pripravo in dajanje zdravila Angiox uporabljajte aseptične postopke.
B - A Risk diff. (95% CI)
B - A Razlika tveganj (95 % CI)
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.
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.