natgillin/translations-raw huggingface dataset:
The usual starting dose of Besremi is 100 microgram every 2 weeks.
Običajni začetni odmerek zdravila Besremi je 100 mikrogramov vsaka 2 tedna.
Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Bolniki si morajo dvakrat na dan temeljito umiti zobe in hoditi na redne zobozdravstvene kontrolne preglede.
You will see the figures in the window change, and you will hear clicks when the button moves.
Oznake v okencu se bodo spremenile, ko se gumb premika, pa boste zaslišali klikajoče zvoke.
Titration phase
Obdobje titracije
The needle should be inserted into the skin.
Iglo morate vstaviti v kožo.
• Carefully remove the needle from the skin.
• Iglo pazljivo izvlecite iz kože.
The safety and efficacy of Besremi in children and adolescents has not been established.
Pediatrična populacija Varnost in učinkovitost zdravila Besremi pri otrocih in mladostnikih nista bili dokazani.
If adverse events develop during therapy, the administered dose should be reduced or treatment discontinued temporarily until adverse events abate; further, treatment should be re-initiated with a lower dose than the dose that caused adverse events.
Če se med zdravljenjem pojavijo neželeni učinki, je treba dani odmerek zmanjšati oziroma začasno prekiniti zdravljenje, dokler neželeni učinki ne izzvenijo; nato je treba zdravljenje ponovno uvesti z manjšim odmerkom od tistega, ki je povzročil neželene učinke.
Do not use Besremi if you are taking telbivudine (for treating hepatitis B) since the combination of these medicines increases the risk of peripheral neuropathy (numbness, tingling, or burning sensations in the arms and legs).
Ne uporabljajte zdravila Besremi, če jemljete telbivudin (za zdravljenje hepatitisa B), saj kombinacija teh zdravil povečuje tveganje za periferno nevropatijo (odrevenelost, mravljinčenje ali pekoč občutek v rokah in nogah).
You will need the following supplies for your injection:
Za injiciranje boste potrebovali naslednje pripomočke:
High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).
Velike volumne je treba uporabljati previdno in le, če je to nujno potrebno, še zlasti pri bolnikih z okvaro jeter ali ledvic, saj obstaja tveganje za akumulacijo in toksičnost (presnovna acidoza).
The medicinal product is intended for long-term treatment and can be administered by a physician, nurse, family member or patient when trained in the administration of subcutaneous injections with the pre-filled pen.
Zdravilo je namenjeno dolgoročnemu zdravljenju in ga lahko bolniku da zdravnik, medicinska sestra, družinski član ali pa si ga bolnik da sam, če je bil poučen o dajanju subkutanih injekcij z napolnjenim injekcijskim peresnikom.
When the increase in liver enzyme levels is progressive and persistent, the dose should be reduced.
Kadar je zvišanje jetrnih encimov napredujoče in vztrajno, je treba odmerek zmanjšati.
Besremi has minor influence on the ability to drive and use machines.
Zdravilo Besremi ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Details on how to prepare and inject Besremi are given in the Instructions for Use.
Podrobnosti glede priprave in injiciranja zdravila Besremi so navedene v Navodilu za uporabo.
Apply an adhesive plaster if needed.
Če je treba, namestite samolepilni obliž.
• If you need two pens, use a different injection site for each pen (e. g., right and left side of belly or right and left thigh).
• Če potrebujete dva peresnika, za vsakega od njiju uporabite drugo mesto injiciranja (npr. leva in desna stran popka ali levo in desno stegno).
- if you have changes in your vision − you must tell your doctor and have an immediate eye examination.
- če se vam pojavijo spremembe vida - posvetujte se z zdravnikom in nemudoma pojdite na očesni pregled.
If you have health problems which may lead to eye problems such as diabetes or high blood pressure, you doctor should check your vision also during treatment.
Če imate zdravstvene težave, ki lahko vodijo do težav z očmi, kot sta sladkorna bolezen in visok krvni tlak, vam mora zdravnik vid pregledovati tudi med zdravljenjem.
Your doctor or pharmacist will show you how to use the pen.
Zdravnik ali farmacevt vam bo pokazal, kako uporabljati peresnik.
If an increase of haematological parameters (haematocrit, platelets, leukocytes) is observed, the dose and/or dosing interval needs to be adapted individually.
Če se pojavi zvečanje hematoloških parametrov (hematokrit, trombociti, levkociti), je treba odmerek in/ali interval odmerjanja individualno prilagoditi.
If a certain dose cannot be set, an insufficient quantity of medicinal product may be left in the pen and a new pen must be used.
Če določenega odmerka ne morete nastaviti, je lahko v peresniku ostala nezadostna količina zdravila in uporabiti je treba nov peresnik.
Pharmacotherapeutic group: Immunostimulants, interferons, ATC code: L03AB15
Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, interferoni, oznaka ATC: L03AB15
Tell your doctor if you are being treated with telbivudine.
Obvestite zdravnika, če se zdravite s telbivudinom.
Binding to IFNAR initiates a downstream signalling cascade through the activation of kinases, in particular Janus kinase 1 (JAK1) and tyrosine kinase 2 (TYK2) and activator of transcription (STAT) proteins.
Vezava na IFNAR sproži kaskado potovanja signalov navzdol prek aktivacije kinaz, še zlasti Janusove kinaze 1 (JAK1) in tirozin kinaze 2 (TYK2), ter beljakovin, ki aktivirajo transkripcije (STAT).
very rare myocardial ischemia#
zelo redki miokardna ishemija#
In case of an overdose, close monitoring of the patient and symptomatic treatment, if necessary, are recommended.
V primeru prevelikega odmerjanja je priporočljivo bolnika skrbno spremljati in uvesti simptomatsko zdravljenje, če je to potrebno.
In this case, place the pen back into the outer carton and store it in the refrigerator for the next use.
V tem primeru peresnik shranite nazaj v zunanjo ovojnino in ga do naslednje uporabe shranjujte v hladilniku.
Any patient reporting a decrease or loss of vision or reporting other eye symptoms should have an immediate eye examination.
ki navaja zmanjšanje ali izgubo vida ali druge očesne simptome, je treba nemudoma pregledati oči.
Patients were stratified by previous exposure to hydroxycarbamide, age at screening (≤60 or >60 years) and presence of thromboembolic events in the past.
Bolnike so stratificirali glede na predhodno izpostavljenost hidroksikarbamidu, starost ob presejanju (≤ 60 ali > 60 let) in prisotnost trombemboličnih dogodkov v anamnezi.
Your doctor or pharmacist will explain to you how to use the two pens.
Zdravnik ali farmacevt vam bo pojasnil, kako uporabiti dva peresnika.
It is unknown if the active substance of the medicinal product is excreted into experimental animal or human milk (see section 4.6).
Ni znano, ali se učinkovina v tem zdravilu izloča v mleko pri eksperimentalnih živalih ali materino mleko pri človeku (glejte poglavje 4.6).
If the increase in liver enzymes is progressive and clinically significant despite dose reduction, or if there is evidence of hepatic decompensation, therapy should be discontinued (see section 4.4).
Če je zvišanje jetrnih encimov kljub zmanjšanju odmerka napredujoče in klinično pomembno ali so prisotni dokazi dekompenzacije jeter, je treba zdravljenje prekiniti (glejte poglavje 4.4).
The pre-filled pen may not be used more than twice, and must be discarded 30 days after the first use, regardless of any medicinal product remaining in the pre-filled pen.
Napolnjenega injekcijskega peresnika se ne sme uporabiti več kot dvakrat in ga je treba 30 dni po prvi uporabi zavreči, ne glede na to, ali je v napolnjenem injekcijskem peresniku ostalo še kaj zdravila.
• Click the needle onto the pen and make sure that it is firmly attached.
• Iglo namestite na peresnik in se prepričajte, da je dobro pritrjena.
It may only be used if the solution is clear, colourless to pale yellow, with no particles visible.
Uporabiti se sme le, če je raztopina bistra, brezbarvna do bledo rumena in brez vidnih delcev.
If at any time during the use of the pen, you feel you may have damaged it (e. g. by dropping it or using excessive force), do not use the pen further.
Če imate med uporabo peresnika kadar koli občutek, da ste ga poškodovali (npr. da vam je padel ali ste uporabili pretirano silo), ga prenehajte uporabljati.
• Decompensated cirrhosis of the liver (Child-Pugh B or C)
• dekompenzirana ciroza jeter (Child-Pugh B ali C),
AOP Orphan Pharmaceuticals AG Wilhelminenstrasse 91/II f 1160 Vienna
AOP Orphan Pharmaceuticals AG Wilhelminenstrasse 91/II f 1160 Dunaj
• Hold the push button down and wait for at least 10 seconds before removing the needle.
• Potisni gumb držite pritisnjen navzdol in počakajte najmanj 10 sekund, preden umaknete iglo.
The most common adverse reactions (including number of patients, incidence rate, severity grade, necessity for dose adaptation and outcome) reported during the ropeginterferon alfa-2b clinical development program are summarised in Table 1.
Najpogostejši neželeni učinki (vključno s številom bolnikov, stopnjo incidence, stopnjo resnosti, potrebo po prilagajanju odmerka in izidu), o katerih so poročali v programu kliničnega razvoja ropeginterferona alfa-2b, so povzeti v Preglednici 1.
As ropeginterferon alfa-2b may have the same effect, this medicinal product is not recommended during pregnancy.
Ker ima lahko ropeginterferon alfa-2b enak učinek, tega zdravila ni priporočljivo uporabljati med nosečnostjo.
To prevent possible transmission of disease or any kind of contamination, the use of Besremi pre-filled pen should remain strictly for a single patient, even when the needle is changed.
Za preprečevanje morebitnega prenosa bolezni ali kakršne koli kontaminacije mora biti uporaba napolnjenega injekcijskega peresnika zdravila Besremi strogo omejena na enega bolnika, tudi če je igla zamenjana.
What you need to know before you use Besremi Do not use Besremi:
Kaj morate vedeti, preden boste uporabili zdravilo Besremi Ne uporabljajte zdravila Besremi:
The maximum recommended single dose is 500 micrograms injected every two weeks.
Največji priporočeni posamični odmerek je 500 mikrogramov, injiciran vsaka dva tedna.
• End stage renal disease (GFR <15 mL/min)
• končna ledvična odpoved (GFR < 15 ml/min).
The effect of Besremi during pregnancy is not known.
Učinek zdravila Besremi med nosečnostjo ni znan.
Years*
Leta*
Complete haematological responsea Complete haematological responsea and improvement in disease burdenb
Popoln hematološki odziva Popoln hematološki odziva in izboljšanje bremena boleznib
- if you have psoriasis or other skin problems because they may get worse during treatment with Besremi.
- če imate luskavico ali druge težave s kožo, ker se lahko med zdravljenjem z zdravilom Besremi poslabšajo.
Polycythaemia vera is a type of cancer in which the bone marrow produces too many red blood cells, white blood cells and platelets (cells that help the blood to clot).
Prava policitemija je vrsta raka, pri katerem kostni mozeg izdeluje preveč rdečih krvnih celic, belih krvnih celic in trombocitov (celic, ki pomagajo pri strjevanju krvi).
Once you have started Besremi treatment, talk to your doctor: - if you develop symptoms of depression (such as feelings of sadness, dejection, and suicidal thoughts).
Po začetku zdravljenja z zdravilom Besremi se posvetujte z zdravnikom: - če se vam pojavijo simptomi depresije (kot so občutek žalosti, potrtost in samomorilne misli);
Do not stop using Besremi before you have talked to your doctor.
Ne prenehajte uporabljati zdravila Besremi, ne da bi se prej pogovorili z zdravnikom.
Inter-subject variability for ropeginterferon alfa-2b was 35% (Cmax) and 25% (AUC).
Razlike med preskušanci za ropeginterferon alfa-2b so bile 35 % (Cmax) in 25 % (AUC).
Phlebotomy as rescue treatment to normalise blood hyperviscosity may be necessary.
Morda bo kot rešilno zdravljenje za normalizacijo hiperviskoznosti krvi potrebna flebotomija.
For benzyl alcohol and sodium, see section 2 “Besremi contains benzyl alcohol” and “Besremi contains sodium”.
Za benzialkohol in natrij glejte poglavje 2 »Zdravilo Besremi vsebuje benzilalkohol« in »Zdravilo Besremi vsebuje natrij«.
Other medicines and Besremi
Druga zdravila in zdravilo Besremi
Do not use the pen later than 30 days.
Po preteku 30 dni peresnika ne uporabljajte več.
Note: You may see a small droplet of liquid sitting on your skin after you remove the needle.
Opomba: na koži lahko po odstranitvi igle opazite majhno kapljo tekočine.
JAK2V617F allele burden (%)* 41.9±23.49
Breme alela JAK2V617F (%)* 41,9±23,49
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na ml, kar v bistvu pomeni »brez natrija«.
• Optional: adhesive plaster
• izbirno: samolepilni obliž.
Responder % (n/N)
Odzivni % (n/N)
CTCAE intensity grade ≥3 N (%)
Stopnja jakosti po CTCAE ≥ 3 n (%)
• Alcohol wipe
• alkoholni zloženec,
The dose will be set individually for you by your doctor for your condition.
Zdravnik vam bo odmerek določil individualno glede na vašo bolezen.
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from ropeginterferon alfa-2b therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba ali prenehati z dojenjem ali prenehati oz. vzdržati se zdravljenja z ropeginterferonom alfa-2b, pri čemer je treba upoštevati koristi dojenja za otroka in koristi zdravljenja za mater.
Side effects with frequency not known (cannot be estimated from the available data): - detachment of the retina (you may experience eye problems including changes in vision)
Neželeni učinki neznane pogostnosti (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): - odstop mrežnice (pojavijo se vam lahko težave z očmi, vključno s spremembami vida).
If you are a woman of childbearing potential, your doctor will discuss with you if effective birth control should be used during your treatment with Besremi.
Če ste ženska v rodni dobi, se bo zdravnik z vami pogovoril glede uporabe učinkovite metode kontracepcije med zdravljenjem z zdravilom Besremi.
Interferons are produced by your immune system to block the growth of cancer cells.
Interferone izdeluje vaš imunski sistem za onemogočanje rasti rakavih celic.
The dose should be gradually increased by 50 micrograms every two weeks (in parallel, other cytoreductive therapy should be decreased gradually, as appropriate) until stabilisation of the haematological parameters is achieved (haematocrit <45%, platelets <400 x 109/L and leukocytes <10 x 109/L).
Odmerek je treba postopno zvečevati po 50 mikrogramov vsaka dva tedna (vzporedno je treba postopno zmanjševati drugo citoreduktivno zdravljenje, če je to primerno), dokler ni dosežena stabilizacija hematoloških parametrov (hematokrit < 45 %, trombociti < 400 x 109/l in levkociti < 10 x 109/l).
Read them before you start using Besremi.
Preberite jih pred začetkom uporabe zdravila Besremi.
Treatment should be initiated under supervision of a physician experienced in the management of the disease.
Zdravljenje mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s to boleznijo.
*Class label for interferon medicinal products, see below pulmonary arterial hypertension.
*Velja za skupino zdravil, ki vsebujejo interferone, glejte pljučno arterijsko hipertenzijo spodaj.
Ropeginterferon alfa-2b treatment was continued and the patients received appropriate medicinal products to treat these events.
Zdravljenje z ropeginterferonom alfa-2b so nadaljevali, bolniki pa so za zdravljenje teh dogodkov prejeli ustrezna zdravila.
• Unscrew the needle and dispose of it appropriately.
• Iglo odvijte in jo primerno odstranite.
To prevent passing on infectious diseases, you should never share Besremi pre-filled pen with anyone else, even when the needle is changed.
Za preprečevanje morebitnega prenosa okužb ne smete peresnika zdravila Besremi nikoli deliti s katero koli drugo osebo, tudi če je bila igla zamenjana.
• Immunosuppressed transplant recipients
• prejemniki presadka na imunosupresivnem zdravljenju,
• If you are unable to reach the required dose setting by turning the dose knob, your pen may not have sufficient medicine left.
• Če z vrtenjem odmernega gumba ne morete doseči zahtevane nastavitve odmerka, v vašem peresniku morda ni več dovolj zdravila.
Patients who experience dizziness, somnolence or hallucination (see section 4.8) during Besremi therapy should avoid driving or using machines.
Bolniki, ki se jim med zdravljenjem z zdravilom Besremi pojavijo omotica, somnolenca ali halucinacije (glejte poglavje 4.8), se morajo izogibati vožnji in upravljanju strojev.
• Do not touch the needle tip at any time.
• V nobenem primeru se ne dotikajte konice igle.
Interferon alfa belongs to the class of type I interferons which exhibit their cellular effects by binding to a transmembrane receptor termed interferon alfa receptor (IFNAR).
Interferon alfa spada v skupino interferonov tipa I, ki svoje učinke na celice izražajo z vezavo na transmembranske receptorje, imenovane interferon alfa receptorji (IFNAR).
Ropeginterferon alfa-2b may inhibit the activity of CYP1A2 and CYP2D6 and thus may increase the blood concentrations of these medicinal products.
Ropeginterferon alfa-2b lahko zavira aktivnost CYP1A2 in CYP2D6 in tako povzroči zvečano koncentracijo teh zdravil v krvi.
If you stop using Besremi
Če ste prenehali uporabljati zdravilo Besremi
- if you develop signs of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while using Besremi - if this is the case you will need to seek medical help immediately.
- če se vam med uporabo zdravila Besremi pojavijo znaki hude alergijske reakcije (kot so oteženo dihanje, piskajoče dihanje ali koprivnica) - v tem primeru morate nemudoma poiskati zdravniško pomoč;
Cases of pulmonary arterial hypertension (PAH) have been reported with interferon alfa, notably in patients with risk factors for PAH (such as portal hypertension, HIV infection, cirrhosis).
Pri interferonu alfa so poročali o primerih pljučne arterijske hipertenzije (PAH), predvsem pri bolnikih z dejavniki tveganja za PAH (kot je portalna hipertenzija, okužba s HIV, ciroza).
Raynaud's phenomenon, hypertension, haematoma, flushing
Raynaudov fenomen, hipertenzija, hematom, zardevanje
Before use, the pre-filled pen should be brought to room temperature (15 °C - 25 °C) for up to 15 minutes.
Pred uporabo pustite napolnjen injekcijski peresnik do 15 minut na sobni temperaturi (15 °C - 25 °C).
Patients should be closely monitored for any symptoms of psychiatric disorders and therapeutic management should be considered by the treating physician if such symptoms emerge.
Bolnike je treba skrbno spremljati glede pojava kakršnih koli simptomov psihiatričnih bolezni, če pa se taki simptomi pojavijo, mora lečeči zdravnik razmisliti o njihovem zdravljenju.
Basedow's disease, sarcoidosis very rare idiopathic or thrombotic thrombocytopenic purpura#
Basedowova bolezen, sarkoidoza zelo redki idiopatska ali trombotična trombocitopenična purpura#
If you forget to use Besremi
Če ste pozabili uporabiti zdravilo Besremi
not known retinal detachment#
neznana odstop mrežnice#
The disease response (defined as haematocrit <45% without phlebotomy [at least 3 months since last phlebotomy], platelets <400 x 109/L and leukocytes <10 x 109/L after 12 months of treatment) was 43.1% [53/123 of patients] in the ropeginterferon alfa-2b arm after 12 months of treatment.
Odziv bolezni (določen kot hematokrit < 45 % brez flebotomije [najmanj 3 mesece od zadnje flebotomije], trombociti < 400 x 109/l in levkociti < 10 x 109/l po 12 mesecih zdravljenja) je bil 43,1 % [53/123 bolnikov] v skupini z ropeginterferonom alfa-2b po 12 mesecih zdravljenja.
Interferon alfa therapy has been associated with hepatotoxicity characterized by potentially significant increases in liver enzymes.
Zdravljenje z interferonom alfa je bilo povezano s hepatotoksičnostjo, za katero so značilna potencialno pomembna zvišanja jetrnih encimov.
What Besremi is and what it is used for
Kaj je zdravilo Besremi in za kaj ga uporabljamo
These actions may be involved in the therapeutic effects of interferon alfa in polycythaemia vera.
Ta delovanja so lahko vpletena v terapevtske učinke interferona alfa pri pravi policitemiji.
This droplet is normal and does not mean that you underdosed.
To je normalno in ne pomeni, da ste prejeli premajhen odmerek.
Once a droplet of liquid appears at the needle tip, the pre-filled pen and the needle are working properly.
Ko se na konici igle pojavi kapljica tekočine, napolnjen injekcijski peresnik in igla delujeta pravilno.
• If you are using this pen for the first time, continue with preparation of the pen in step 5.
• Če ta peresnik uporabljate prvič, nadaljujte s pripravo peresnika, kot opisuje korak 5.
How to use Besremi
Kako uporabljati zdravilo Besremi
• Hold the pen so that the display window and the label are visible during the injection.
• Peresnik držite tako, da sta okence in nalepka med injiciranjem vidna.
not known pulmonary fibrosis#, pneumonia#, pulmonary arterial hypertension#*
neznana pljučna fibroza#, pljučnica#, pljučna arterijska hipertenzija#*
Contact your doctor immediately if you notice any of the following serious side effects during your treatment with Besremi:
Nemudoma obvestite zdravnika, če med zdravljenjem z zdravilom Besremi opazite katerega koli od naslednjih resnih neželenih učinkov:
250 μg, 300 μg, 350 μg, 400 μg, 450 μg and 500 μg.
200 μg in 250 μg, 300 μg, 350 μg, 400 μg, 450 μg in 500 μg.
One patient who experienced serious acute stress disorder (0.6%; incidence rate: 0.2 events/100 patients per year) with moderate intensity recovered completely after the dose of ropeginterferon alfa-2b was reduced.
En bolnik, ki je doživel resno akutno stresno reakcijo (0,6 %; stopnja incidence: 0,2 dogodkov/100 bolnikov na leto) zmerne jakosti, je po zmanjšanju odmerka ropeginterferona alfa-2b popolnoma okreval.
Each pre-filled pen contains a cartridge (type 1 colourless glass) with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (bromobutyl rubber).
En napolnjen injekcijski peresnik vsebuje vložek (brezbarvno steklo tipa I) s sivim batom (bromobutilna guma) in prirobljeno zaporko (aluminij) z zamaškom (bromobutilna guma).
Obese or underweighted patients
Prekomerno prehranjeni ali podhranjeni bolniki
Based on data in monkeys, it is approx. 80%, similar to that seen for pegylated interferon alfa-2a.
Glede na podatke pri opicah je približno 80 %, podobno kot so opažali pri pegiliranem interferonu alfa-2a.
The pharmacokinetic profile in patients with moderate or severe renal impairment and in patients with end stage renal disease (ESRD) has been evaluated only for other pegylated interferon alfa medicinal products.
Farmakokinetični profil pri bolnikih z zmerno ali hudo okvaro ledvic in pri bolnikih s končno ledvično odpovedjo so ovrednotili le za druga zdravila s pegiliranim interferonom alfa.
The dose can be set in steps of 50 micrograms by rotating the dose knob.
Odmerek lahko nastavljate v korakih po 50 mikrogramov z vrtenjem odmernega gumba.
In a clinical study in polycythaemia vera, the end of the mean individual titration phase for ropeginterferon alfa-2b was reached after approximately 3.7 months, for hydroxycarbamide after approximately 2.6 months of treatment.
V klinični študiji prave policitemije je bil konec povprečne individualne faze titracije za ropeginterferon alfa-2b dosežen po približno 3,7 mesecih, za hidroksikarbamid pa po približno 2,6 mesecih zdravljenja.
This medicinal product is contraindicated in patients with severe preexisting cardiovascular disease or patients who had recently suffered from a stroke or myocardial infarction (see section 4.3).
To zdravilo je kontraindicirano pri bolnikih s hudo obstoječo srčno-žilno boleznijo ali pri bolnikih z nedavno možgansko kapjo ali miokardnim infarktom (glejte poglavje 4.3).