natgillin/translations-raw huggingface dataset:
Orfiril long 150 mg prolonged-release capsule 
Orfiril long 150 mg kapsula s podaljšanim sproščanjem
Ergenyl Chronosphere 250 mg Retardgranulat prolonged-release granules 
Ergenyl Chronosphere 250 mg Retardgranulat zrnca s podaljšanim sproščanjem
Depakine Chronosphere 250 mg - Retardgranulat in Beuteln prolonged-release granules 
Depakine Chronosphere 250 mg - Retardgranulat in Beuteln zrnca s podaljšanim sproščanjem
Valproat-neuraxpharm 600 600 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany 
Valproat-neuraxpharm 600 600 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Nemčija
CONVULEX 150 mg gastro-resistant capsule, soft 
CONVULEX 150 mg gastrorezistentna kapsula, mehka
Ergenyl Chronosphere 50 mg Retardgranulat prolonged-release granules 
Ergenyl Chronosphere 50 mg Retardgranulat zrnca s podaljšanim sproščanjem
Depakine Chronosphere 50 mg - Retardgranulat in Beuteln prolonged-release granules 
Depakine Chronosphere 50 mg - Retardgranulat in Beuteln zrnca s podaljšanim sproščanjem
CONVULEX 300 MG/ML 300mg/ml oral drops, solution 
CONVULEX 300 MG/ML 300mg/ml peroralne kapljice, raztopina
CONVULEX 500 mg gastro-resistant capsule, soft 
CONVULEX 500 mg gastrorezistentna kapsula, mehka
Ergenyl Chronosphere 500 mg Retardgranulat prolonged-release granules 
Ergenyl Chronosphere 500 mg Retardgranulat zrnca s podaljšanim sproščanjem
Valproat-neuraxpharm chrono 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany 
Valproat-neuraxpharm chrono 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Nemčija
Depakine Chronosphere 500 mg - Retardgranulat in Beuteln prolonged-release granules 
Depakine Chronosphere 500 mg - Retardgranulat in Beuteln zrnca s podaljšanim sproščanjem
CONVULEX 300 mg gastro-resistant capsule, soft 
CONVULEX 300 mg gastrorezistentna kapsula, mehka
200 mg/ml oral drops 
200 mg/ml peroralne kapljice
Valproat-neuraxpharm 300 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany 
Valproat-neuraxpharm 300 300 mg neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Nemčija
200 mg/ml oral drops, solution 
200 mg/ml peroralne kapljice, raztopina
Depakine Chronosphere modified-release granules 
Depakine Chronosphere zrnca s prirejenim sproščanjem
Depakine Retard modified-release tablet Oral Use 
Depakine Retard tableta s prirejenim sproščanjem
modified-release granules 
zrnca s prirejenim sproščanjem
Depakine Chronosphere 50350 mg/DosisRetardgranulat prolonged-release granules 
Depakine Chronosphere 50350 mg/DosisRetardgranulat zrnca s podaljšanim sproščanjem
Valproat-neuraxpharm 300 mg oral solution neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany 
Valproat-neuraxpharm 300 mg peroralna raztopina neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Nemčija
List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant(s) in the Member States 
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, predlagateljev, v državah članicah
Overall population (ITT) 
Celotna populacija (ITT)
Currently available data are described in sections 5.1 and 5.2. 
Trenutno razpoložljivi podatki so opisani v poglavjih 5.1 in 5.2
3.5 hours 
3,5 ur
An updated RMP should be submitted: 
Posodobljen RMP je treba predložiti :
• if you are a child (less than 18 years of age), this medicine is not appropriate for you. 
• če ste otrok (mlajši od 18 let), ker to zdravilo ni primerno za vas.
Date of first authorisation: 20.09.2004 Date of latest renewal: 23.06.2014 
Datum prve odobritve: 20.09.2004 Datum zadnjega podaljšanja: 23.06.2014
The majority of these cases were non-fatal. 
V večini teh primerov ni prišlo do smrtnega izida.
• before the start of the injection or infusion, the doctor will tell you about the signs of allergic reaction. 
• pred začetkom injiciranja ali infuzije vam bo zdravnik razložil znake alergijske reakcije.
All the undesirable effects, primary and secondary, resulting from excessive pharmacological activity were reversible. 
Vsi neželeni učinki, primarni in sekundarni, ki so bili posledica pretirane farmakološke aktivnosti, so bili reverzibilni.
However, the maximal ACT values for all groups (adults and all paediatric groups) converge at a similar level near an ACT of 400 seconds. 
Vendar pa se največje vrednosti ACT za vse skupine (odrasli in vse pediatrične skupine) približujejo na podobni ravni v bližini ACT 400 sekund.
In the case of shock, the current medical standards for shock treatment should be applied. 
V primeru šoka uporabite trenutno veljavne medicinske standarde za zdravljenje šoka.
This leaflet was last revised in: 
Navodilo je bilo nazadnje revidirano:
• if you are taking, or have recently taken or might take any other medicines. 
• če jemljete,ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo
Your doctor will decide whether or not this treatment is appropriate for you. 
Vaš zdravnik bo odločil, ali je ta način zdravljenja za vas primeren.
*Superiority p-value. 
*p-vrednosti za superiornost.
About 20% of bivalirudin is excreted unchanged in the urine. 
Približno 20 % bivalirudina se nespremenjenega izloči z urinom.
No dose adjustment is needed. 
Prilagoditev odmerkov ni potrebna.
The MAH shall agree on the dosing card together with a communication plan, with the National Competent Authority in each Member State prior to distribution in the Member State. 
MAH se mora o kartici za odmerjanje skupaj z načrtom komunikacije dogovoriti s pristojnim nacionalnim organom vsake države članice pred distribucijo zdravila v državi članici.
The doctor will decide for how long you should be treated. 
Zdravnik bo odločil, kako dolgo se morate zdraviti.
Comparison of the single and repeated dose studies revealed that toxicity was related primarily to duration of exposure. 
Primerjave med študijami z enim in ponavljajočimi odmerki kažejo, da je bila toksičnost povezana predvsem s trajanjem izpostavljenosti.
Approximately 66% of patients were pre-treated with unfractionated heparin. 
Približno 66 % bolnikov je bilo predhodno zdravljenih z nefrakcioniranim heparinom.
Clearance (ml/min/kg) 
Očistek (ml/min/kg)
There is currently no indication for the use of Angiox in children less than 18 years old and no recommendation on a posology can be made. 
Trenutno ni indikacij za uporabo zdravila Angiox pri otrocih, mlajših od 18 let, priporočil o odmerjanju pa ni mogoče dati.
If you cannot get access to your doctor go immediately to the Emergency Department of your nearest hospital 
Če do zdravnika ne morete doseči, takoj obiščite urgentni oddelek najbližje bolnišnice
The concentration-time profile following intravenous administration is well described by a twocompartment model. 
Profil koncentracija-čas po intravenskem dajanju je dobro opisan z dvokomponentnim modelom.
Mortality among these patients was nil. 
Smrtnosti med temi bolniki ni bilo.
The doctor will decide how much Angiox you receive, and will prepare the medicine. 
Zdravnik bo odločil, koliko zdravila Angiox boste dobili, in bo zdravilo tudi pripravil.
• Brief information on preparation and administration instructions. 
• Kratke informacije o pripravi in dajanju zdravila.
The results do not suggest pharmacodynamic interactions with these medicinal products. 
Rezultati ne nakazujejo farmakodinamičnih interakcij s temi zdravili.
Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP'. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake "EXP".
30 day Composite MACE 
30 dnevna kompozita MACE
There is no known antidote to bivalirudin but its effect wears off quickly (T½ is 25 ± 12 minutes). 
Antidota za bivalirudin ne poznamo, vendar njegovi učinki hitro popustijo (T½ je 25 ± 12 minut).
The ACT vs concentration data suggest a trend for a lower concentration response curve for adults as compared to older children (6 years to < 16 years) and younger children (2 years to <6 years), and for older children compared to infants (31 days to <24 months) and neonates (birth to 30 days). 
Podatki za ACT glede na koncentracijo kažejo trend nižje krivulje odziva na koncentracijo za odrasle v primerjavi s starejšimi otroki (6 let do < 16 let) in mlajšimi otroki (2 leti do < 6 let), in za starejše otroke v primerjavi z dojenčki (31 dni do < 24 mesecev) in novorojenčke (od rojstva do 30 dni).
The use of the Angiox dosing card is recommended as a quick reference guide. 
Uporaba kartice za odmerjanje zdravila Angiox je priporočena kot hiter referenčni vodnik.
The educational materials will be used in all member states for both initial training and re-education in the event of reports of bolus only dosing without subsequent infusion. 
Izobraževalni material se uporablja v vseh državah članicah za začetno usposabljanje in ponovno učenje v primeru poročil o odmerjanju samo bolusnega odmerka brez infuzije v nadaljevanju.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
• Do not use bivalirudin without first diluting it. 
• Bivalirudina ne uporabljajte, ne da bi ga najprej redčili.
Half-life (minutes) 
Razpolovna doba (minut)
Angiox is only given when a patient is in hospital. 
Zdravilo Angiox se daje le, kadar je bolnik v bolnišnici.
The clinical utility of ACT in neonates and children should be considered with caution considering their developmental haematological state. 
Glede klinične uporabnosti ACT pri novorojenčkih in otrocih je potrebna previdnost zaradi njihovega razvojnega hematološkega stanja.
Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). 
Študije na živalih niso zadostne z obzirom na učinke na nosečnost, razvoj zarodka/ploda, porod ali razvoj po rojstvu (glejte poglavje 5.3).
Enoxaparin was used as comparator in ACUITY only. 
Enoksaparin je bil uporabljen kot komparator samo pri študiji ACUITY.
Throughout your treatment, the doctor will check you for any signs of bleeding. 
času celotnega zdravljenja bo vaš zdravnik preverjal kakršnekoli znake krvavenja.
Educational material includes a slide deck presentation, dosing cards as described in the risk minimization measures in the RMP, and a copy of the SmPC. 
Izobraževalni material vključuje predstavitev z diapozotivi, kartice za odmerjanje, kot je opisano v ukrepih za zmanjšanje tveganj v RMP, in kopijo SmPC.
Undesirable effects that resulted from prolonged physiological stress in response to a non-homeostatic state of coagulation were not seen after short exposure comparable to that in clinical use, even at much higher doses. 
Neželeni učinki zaradi daljšega fiziološkega stresa, kot odziv na nehomeostatsko stanje koagulacije niso bili opaženi po krajši izpostavljenosti, primerljivi s tisto pri klinični uporabi, tudi pri precej večjih odmerkih.
After being treated with Angiox for a cardiac event, you should stay in the hospital for at least 24 hours and you should be monitored for any symptoms or signs similar to the ones that remind you of your cardiac event and resulted in your hospitalisation. 
Po zdravljenju z zdravilom Angiox zaradi srčnega dogodka morate ostati v bolnišnici najmanj 24 ur in morajo vas nadzorovati glede simptomov ali znakov podobnih tistim, ki vas spominjajo na srčni dogodek, zaradi katerega ste bili hospitalizirani.
Approximately 77% of patients had recurrent ischaemia, approximately 70% had dynamic ECG changes or elevated cardiac biomarkers, approximately 28% had diabetes and approximately 99% of patients underwent angiography within 72 hours. 
Približno 77 % bolnikov je imelo ponavljajočo ishemijo, približno 70 % je imelo dinamične spremembe EKG ali povišane srčne biološke označevalce, približno 28 % jih je imelo diabetes in približno 99 % bolnikov je prestalo angiografijo v 72 urah.
Bivalirudin is intended for short-term administration and therefore no data on the long-term carcinogenic potential of bivalirudin are available. 
Bivalirudin je namenjen kratkotrajnemu dajanju in zato ni podatkov o dolgotrajnem karcinogenem potencialu bivalirudina.
Clinical trials in a small number of patients have provided limited information about the use of Angiox in patients with HIT/HITTS. 
Klinična preskušanja na majhni skupini bolnikov nudijo omejene podatke o uporabi Angioxa pri bolnikih s HIT/HITTS.
If you get any of the following, potentially serious, side effects: 
Če opazite katerikoli izmed naslednjih, morebitno resnih, neželenih učinkov:
This dosing regimen is required to achieve and maintain the plasma concentration required for effective ischaemic protection during PCI. 
Ta režim odmerjanja je potreben za doseganje in vzdrževanje plazemske koncentracije, ki je potrebna za učinkovito ishemično zaščito med posegom PCI.
Bivalirudin does not bind to plasma proteins (other than thrombin) or to red blood cells. 
Bivalirudin se ne veže na beljakovine plazme (razen trombina) ali rdeče krvne celice.
Your treatment with Angiox will be supervised by a doctor. 
Vaše zdravljenje z zdravilom Angiox bo nadziral zdravnik.
See section 6.2 for the summary of compatible and incompatible concentrations of these compounds. 
Glejte poglavje 6.2 za povzetek združljivih in nezdružljivih koncentracij omenjenih učinkovin.
In order to ensure the correct use of Angiox and to avoid medication errors, the MAH shall ensure that all prescribers who are expected to prescribe/use Angiox are provided with training on dosing and administration. 
Da bi zagotovili pravilno uporabo zdravila Angiox in se izognili napakam pri zdravljenju, mora MAH poskrbeti, da bodo vsi zdravnikih, za katere se pričakuje da bodo predpisovali/uporabljali zdravila Angiox, usposobljeni za odmerjanje in dajanje.
• if bleeding occurs (if this happens, treatment with Angiox will be stopped). 
• če se pojavi krvavitev (v tem primeru je potrebno zdravljenje z zdravilom Angiox prekiniti).
Bleeding Definitions 
Definicije krvavitev
Angiox should not be used during pregnancy unless the clinical condition of the woman requires treatment with bivalirudin. 
Zdravila Angiox ne uporabljajte med nosečnostjo, razen če klinično stanje ženske zahteva zdravljenje z bivaluridinom.
The bioavailability of bivalirudin for intravenous use is complete and immediate. 
Biološka uporabnost bivalirudina, danega intravensko, je popolna in takojšnja.
• Allergic reactions,- are uncommon (may affect up to 1 in 100 people) and usually not serious but can become severe under some circumstances, and in rare cases may be fatal due to low blood pressure (shock). 
• Alergijske reakcije so občasne (pojavijo se lahko pri največ 1 od 100 bolnikov) in običajno niso resne, lahko pa postanejo resne v določenih pogojih, v redkih primerih so lahko smrtne zaradi nizkega krvnega tlaka (šok).
Acute cardiac events 
Akutni srčni dogodki
All 5 events were associated with additional cardiac procedures employing heparin anticoagulation (n=3) or with infections (n=2). 
Vseh 5 dogodkov je bilo povezanih z dodatnimi postopki na srcu z uporabo antikoagulacije s heparinom (n = 3) ali z okužbami (n = 2).
In all clinical studies bleeding data were collected separately from adverse reactions and are summarised in Table 6 together with the bleeding definitions used for each study. 
V vseh kliničnih študijah so bili podatki o krvavitvah pridobljeni ločeno od neželenih učinkov ter so predstavljeni v preglednici 6, skupaj z definicijami krvavitev uporabljenih pri vsaki študiji.
Where insufficient ACT increase is observed, the possibility of medication error should be considered, for example inadequate mixing of Angiox or intravenous equipment failures. 
Kjer ni opaziti zadostnega zvečanja ACT, je treba upoštevati možnosti napake pri dajanju zdravila, na primer nezadostno mešanje zdravila Angiox ali okvare na intravenski opremi.
Angiox should not be used during pregnancy, unless clearly necessary. 
Zdravila Angiox ne uporabljajte med nosečnostjo, razen če ni nujno potrebno.
• if you have been treated before with medicines similar to Angiox (e.g. lepirudin). 
• če ste se v preteklosti zdravili z zdravili, podobnimi zdravilu Angiox (npr. lepirudin)
Pharmacodynamic models indicated that this effect is due to a higher baseline ACT in neonates and infants than in older children. 
Farmakodinamični modeli kažejo, da je ta učinek posledica večje izhodiščne vrednosti ACT pri novorojenčkih in dojenčkih kot pri starejših otrocih.
In clinical study TMC-BIV-07-01, the pharmacodynamic response as measured by ACT was consistent with adult studies. 
V klinični študiji TMC-BIV-07-01 je bil farmakodinamični odziv, izmerjen s pomočjo ACT, skladen s študijami pri odraslih.
Instructions for preparation 
Navodila za pripravo
High risk patient characteristics of the ACUITY population that mandated angiography within 72 hours were balanced across the three treatment arms. 
Karakteristike bolnikov visokim tveganjem v populaciji študije ACUITY, zaradi katerih je bila potrebna angiografija v 72 urah, so bile proporcionalno razdeljene v vse tri krake zdravljenja.
The corresponding clearance is about 3.4  0.5 ml/min/kg. 
Ustrezen očistek je približno 3,4 ± 0,5 ml/min/kg.
ACT values 5 minutes after bivalirudin bolus average 365 +/- 100 seconds. 
Vrednost ACT 5 minut po bolusu bivalirudina je povprečno 365 +/- 100 sekund.
You can also report side effects directly via the national reporting system listed in Appendix V. 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V.
Reconstituted and diluted product should be thoroughly mixed prior to administration. 
Rekonstituirano in razredčeno zdravilo je treba pred uporabo temeljito zmešati.
• Haematoma (bruising) 
• hematom (modrica)
Antithrombotics are medicines which prevent the formation of blood clots (thrombosis). 
Antitrombotiki so zdravila, ki preprečujejo tvorjenje krvnih strdkov (tromboza).
Toxicity in animals upon repeated or continuous exposure (1 day to 4 weeks at exposure levels of up to 10 times the clinical steady state plasma concentration) was limited to exaggerated pharmacological effects. 
Toksičnost pri živalih po večkratni ali neprekinjeni izpostavljenosti (1 dan do 4 tedne pri stopnji izpostavljenosti do 10-kratne plazemske koncentracije v kliničnem stanju dinamičnega ravnovesja) je bila omejena na povečane farmakološke učinke.
• Reperfusion injury (no or slow reflow): impaired flow in the heart arteries after they have been reopened 
• reperfuzija (ni pretoka ali zmanjšan pretok): moten pretok v srčnih žilah potem, ko so bile
The ACT increased in all patients - from neonates to older children as well as adults- with increasing bivalirudin concentrations. 
ACT se je pri vseh bolnikih povečal, od novorojenčkov do starejših otrok ter odraslih, z večanjem koncentracij bivalirudina.
Elimination follows a first order process with a terminal half-life of 25  12 minutes in patients with normal renal function. 
Izločanje sledi procesu prve stopnje s končno razpolovno dobo 25 ± 12 minut pri bolnikih z normalno ledvično funkcijo.
If you have kidney problems, the dose of Angiox may need to be reduced. 
Če imate težave z ledvicami, bo morda treba odmerek zdravila Angiox zmanjšati.
• Anaemia (a low blood cell count) 
• anemija (majhno število krvnih celic)
• Bleeding and bruising at the puncture site (after PCI treatment) may be painful. 
• Krvavitev in podplutba na mestu aplikacije (po izvedeni PCI), ki je lahko boleča.
The bolus dose should not be changed from the posology described under ACS or PCI above. 
Bolusnega odmerka ne bi smeli spreminjati glede na odmerjanje, opisano pri AKS ali PCI zgoraj.
Thrombotic (9/110, 8.2%) and major bleeding events (2/110, 1.8%) were observed in the study. 
V študiji so opazili trombotične (9/110, 8,2 %) dogodke in dogodke večjih krvavitev (2/110, 1,8 %).
Angiox is used to treat patients: 
Zdravilo Angiox se uporablja za zdravljenje bolnikov:
Thus, bivalirudin initially acts as a complete non-competitive inhibitor of thrombin, but transitions over time to become a competitive inhibitor enabling initially inhibited thrombin molecules to interact with other clotting substrates and to coagulation if required. 
Zato bivalirudin sprva deluje kot popolni nekompetitivni inhibitor trombina, sčasoma pa postane kompetitivni inhibitor, s čimer omogoči sprva inhibiranim molekulam trombina, da medsebojno delujejo z drugimi substancami strjevanja in omogočijo koagulacijo, če je potrebno.
The dose given depends on your weight and on the kind of treatment you are being given. 
Odmerek, ki ga boste prejeli, je odvisen od vaše telesne mase in vrste zdravljenja, ki ste ga deležni.
Following angiographic assessment, patients were triaged to either medical management (33%), PCI (56%) or CABG (11%). 
Po angiografski oceni so bolnike triažirali v zdravljenje z zdravili (33 %), v skupino za PCI (56 %) ali CABG (11 %).
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh naslednjih sprejetih posodobitvah RMP.
If, after this, you then need percutaneous coronary intervention (PCI) treatment, the dosage will be increased to: 
Če bi po tem potrebovali zdravljenje s perkutano koronarno intervencijo (PCI), bo odmerek povečan na:
Pharmacokinetic studies indicate that hepatic metabolism of bivalirudin is limited, therefore the safety and efficacy of bivalirudin have not been specifically studied in patients with hepatic impairment. 
Farmakokinetične študije kažejo, da je jetrna presnova bivalirudina omejena, zato varnost in učinkovitost bivalirudina pri bolnikih z jetrno okvaro nista bili posebej preučeni.
Bivalirudin inhibits each of these thrombin effects. 
Bivalirudin inhibira vse te učinke trombina.
If you get any of the following, (potentially less serious), side effects: 
Če pride do naslednjih (potencialno manj resnih) neželenih učinkov:
Other frequently reported adverse events were decreased pedal pulse, catheter site haemorrhage, abnormal pulse, and nausea (8.2%, 7.3%, 6.4% and 5.5%, respectively). 
Drugi neželeni dogodki, o katerih so pogosto poročali, so bili oslabljen pulz na hrbtišču stopala, krvavitev na mestu vstavitve katetra, nenormalen pulz in slabost (8,2 %, 7,3 %, 6,4 % oz. 5,5 %).
(For full information on posology see section 4.2 of SmPC) 
(Za popolne informacije o odmerjanju glejte poglavje 4.2 SmPC)
For instructions for monitoring acute stent thrombosis, see section 4.4. d. Section 4.4 describes precautions for INR monitoring when bivalirudin is co-administered with warfarin. 
Za navodila glede spremljanja akutne tromboze stenta glejte tudi poglavje 4.4. d. Poglavje 4.4 opisuje previdnostne ukrepe za spremljanje INR, ko se bivalirudin daje sočasno z varfarinom.
Combined use of anti-coagulant medicinal products can be expected to increase the risk of bleeding (see section 4.5). 
Pri kombinirani uporabi zdravil proti koagulaciji se lahko pričakuje povečanje tveganja krvavitev (glejte poglavje 4.5).
A total of 92.9% of patients treated underwent primary PCI as their primary management strategy. 
Primarna PCI je bila za 92,9 % bolnikov primarna strategija zdravljenja.