natgillin/translations-raw huggingface dataset:
The full EPAR for Roteas can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Roteas je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Roteas
Druge informacije o zdravilu Roteas
This is a summary of the European public assessment report (EPAR) for Roteas.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Roteas.
It must also not be used in pregnant or breastfeeding women or together with another anticoagulant.
Prav tako se ne sme uporabljati pri nosečnicah in doječih materah ter skupaj z drugim antikoagulantom.
The effects were studied in one main study, which involved over 21,000 patients for an average of 2.5 years.
Njegove učinke so proučevali v eni glavni študiji z več kot 21 000 bolniki, ki so v njej v povprečju sodelovali 2,5 leta.
It is not intended to provide practical advice on how to use Roteas.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Roteas's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Roteas večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Roteas is available as tablets (15, 30 and 60 mg) and can only be obtained with a prescription.
Zdravilo Roteas je na voljo v obliki tablet (15, 30 in 60 mg), njegovo predpisovanje in izdaja pa je le na recept.
Although there was greater a risk of bleeding from the mucosa (tissues lining body cavities such as the nose, gut and vagina), the Committee considered that the risk could be managed with appropriate measures.
Čeprav so opazili večje tveganje krvavitve iz sluznice (tkiv, ki obdajajo telesne odprtine, kot so nos, črevo in nožnica), je Odbor menil, da je tveganje mogoče obvladati z ustreznimi ukrepi.
This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin.
To pomeni, da zavira faktor Xa, tj. encim, ki sodeluje pri tvorbi trombina.
With respect to safety, overall the risk of serious bleeding such as bleeding into the brain was reduced compared with warfarin, although there may be less difference where warfarin treatment is well managed.
Kar zadeva varnost, je bilo na splošno tveganje za resno krvavitev, kot je krvavitev v možganih, manjše kot pri uporabi varfarina, čeprav so lahko razlike manjše, kadar je zdravljenje z varfarinom dobro vodeno.
Roteas is an anticoagulant medicine (a medicine that prevents blood clotting) used in adults:
Zdravilo Roteas je antikoagulacijsko zdravilo (zdravilo za preprečevanje strjevanja krvi), ki se uporablja pri odraslih:
It is used in patients who have one or more risk factors, such as having had a previous stroke, high blood pressure, diabetes, heart failure or being 75 years old or over;
Uporablja se pri bolnikih z enim ali več dejavniki tveganja, kot so možganska kap v preteklosti, visok krvni tlak, sladkorna bolezen, srčno popuščanje ali starost 75 let ali več;
Further episodes were seen in 130 of 4,118 patients given edoxaban (3.2%) and in 146 of 4,122 given warfarin (3.5%).
Njun ponoven pojav so opazili pri 130 od 4 118 bolnikov, ki so prejemali edoksaban (3,2 %), in pri 146 od 4 122 bolnikov, ki so prejemali varfarin (3,5 %).
The company that markets Roteas will provide educational materials for doctors prescribing the medicine and an alert card for patients, explaining the risks of bleeding with the medicine and how to manage them.
Družba, ki trži zdravilo Roteas, bo zagotovila izobraževalno gradivo za zdravnike, ki bodo predpisovali zdravilo, in opozorilno kartico za bolnike, na kateri bodo pojasnjena tveganja krvavitve pri uporabi zdravila in navodila za njihovo obvladovanje.
What is Roteas and what is it used for?
Kaj je zdravilo Roteas in za kaj se uporablja?
What benefits of Roteas have been shown in studies?
Kakšne koristi je zdravilo Roteas izkazalo v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Roteas have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Roteas upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
It will also carry out a study of the effects of the medicine in patients with atrial fibrillation and good kidney function.
Prav tako bo izvedla študijo o učinkih zdravila pri bolnikih z atrijsko fibrilacijo, katerih ledvice dobro delujejo.
What are the risks associated with Roteas?
Kakšna tveganja so povezana z zdravilom Roteas?
Why is Roteas approved?
Zakaj je bilo zdravilo Roteas odobreno?
For more information about treatment with Roteas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Roteas preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The company that makes Lixiana has agreed that its scientific data can be used for Roteas (‘informed consent').
Družba, ki proizvaja zdravilo Lixiana, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Roteas („uporaba dokumentacije s soglasjem“).
• to prevent stroke (caused by blood clots in the brain) and systemic embolism (blood clots in other organs) in patients with non-valvular atrial fibrillation (irregular rapid contractions of the upper chambers of the heart).
• za preprečevanje možganske kapi (ki jo povzročajo krvni strdki v možganih) in sistemske embolije (krvnih strdkov v drugih organih) pri bolnikih z nevalvularno atrijsko fibrilacijo (hitrim nepravilnim krčenjem preddvorov srca).
Roteas must not be used in patients who are actively bleeding, have liver diseases that affect blood clotting, have severe uncontrolled high blood pressure or who have a condition putting them at significant risk of major bleeding.
Zdravilo Roteas se ne sme uporabljati pri bolnikih z aktivno krvavitvijo, boleznijo jeter, ki vpliva na strjevanje krvi, nenadzorovanim zelo visokim krvnim tlakom ali boleznijo, zaradi katere pri njih obstaja veliko tveganje za hude krvavitve.
Other common side effects are anaemia (low levels of red blood cells), rash and abnormal results in tests of liver function.
Drugi neželeni učinki so anemija (nizke ravni rdečih krvnih celic), izpuščaji in nenormalni izvidi preiskav delovanja jeter.
When another recommended definition of the type of stroke was used, embolism or stroke due to blood clots was seen in 143 patients given Roteas (0.9%) and 157 given warfarin (1%).
Ko so uporabili drugo priporočeno opredelitev vrste možganske kapi, so embolijo ali možgansko kap zaradi krvnih strdkov zabeležili pri 143 bolnikih, ki so prejemali zdravilo Roteas (0,9 %), in 157 bolnikih, ki so prejemali varfarin (1 %).
The most common side effects with Roteas (which may affect up to 1 in 10 people) are bleeding from skin and soft tissues, nose (epistaxis) and the vagina.
Najpogostejši neželeni učinki zdravila Roteas (ki se lahko pojavijo pri več kot 1 bolniku od 10) so krvavitev iz kože in mehkih tkiv ter krvavitve iz nosu (epistaksa) in nožnice.
The main measure of effectiveness was the rate of stroke or systemic embolism among the patients each year.
Glavno merilo učinkovitosti je bil delež možganske kapi ali sistemske embolije, ki so jo vsako leto zabeležili pri bolnikih.
By blocking factor Xa, the medicine reduces the levels of thrombin in the blood, which helps treat clots and reduce the risk of them forming in the arteries and veins and leading to DVT, pulmonary embolism, stroke or other organ damage.
Z zaviranjem faktorja Xa zdravilo Roteas zniža ravni trombina v krvi, s čimer pomaga odpraviti strdke in zmanjša tveganje, da bi se ti tvorili v arterijah in venah ter povzročili globoko vensko trombozo, pljučno embolijo, možgansko kap ali poškodbo drugih organov.
A first systemic embolism or stroke occurred in 182 patients given standard doses of Roteas and in 232 of those given warfarin, corresponding to annual rates for these events of around 1.2% and 1.5% respectively.
Prvi pojav sistemske embolije ali možganske kapi so zabeležili pri 182 bolnikih, ki so prejemali standardne odmerke zdravila Roteas, in 232 bolnikih, ki so prejemali varfarin, kar pomeni, da je bil letni delež teh dogodkov približno 1,2 % oziroma 1,5 %.
Dose adjustments may also need to be made in patients who are switched between Roteas and other anticoagulant medicines.
Odmerek je včasih treba prilagoditi tudi pri bolnikih, ki preidejo na zdravilo Roteas z drugih antikoagulantov in obratno.
For practical information about using Roteas, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Roteas naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
For the full list of all side effects reported with Roteas, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Roteas, glejte navodilo za uporabo.
• to treat deep-vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (a clot in a blood vessel supplying the lungs), and to prevent DVT and pulmonary embolism from re-occurring.
• za zdravljenje globoke venske tromboze (GVT, tj. krvnega strdka v globoki veni, običajno v nogi) in pljučne embolije (strdka v krvni žili, ki oskrbuje pljuča) ter za preprečevanje njune ponovitve.
The active substance in Roteas, edoxaban, is a ‘factor Xa inhibitor'.
Zdravilna učinkovina v zdravilu Roteas, edoksaban, je zaviralec faktorja Xa.
Doses should be halved in patients with moderately or severely reduced kidney function, or low body weight or in those who are also taking certain medicines (known as P-gp inhibitors) that can interfere with the removal of edoxaban from the body.
Bolniki z zmerno ali hudo okvaro delovanja ledvic, bolniki z majhno telesno maso ali bolniki, ki sočasno jemljejo nekatera druga zdravila (imenovana zaviralci P-glikoproteina), ki lahko vplivajo na izločanje edoksabana iz telesa, morajo jemati polovične odmerke.
The main measure of effectiveness was the number of patients who had another episode of DVT or pulmonary embolism during the study period.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je v času trajanja študije ponovno pojavila globoka venska tromboza ali pljučna embolija.
Treatment is continued while the benefit outweighs the risk of bleeding, which depends on the condition being treated and any existing risk factors.
Običajni odmerek je 60 mg enkrat na dan. Zdravljenje traja, dokler so njegove koristi večje od tveganja krvavitve, kar je odvisno od zdravljene bolezni in morebitnih obstoječih dejavnikov tveganja.
There was a trend for better results in patients with reduced kidney function than those whose kidney function was normal.
Izkazalo se je, da so bili rezultati boljši pri bolnikih z okvarjenim delovanjem ledvic kot pri bolnikih z normalnim delovanjem ledvic.
The medicine has been shown to be at least as effective as warfarin in reducing stroke rates in patients with atrial fibrillation and in preventing further episodes of DVT or pulmonary embolism.
Dokazali so, da je zdravilo vsaj tako učinkovito kot varfarin pri zmanjševanju deleža možganske kapi pri bolnikih z atrijsko fibrilacijo in pri preprečevanju nadaljnjih ponovitev globoke venske tromboze ali pljučne embolije.
How is Roteas used?
Kako se zdravilo Roteas uporablja?
Roteas contains the active substance edoxaban.
Zdravilo Roteas vsebuje zdravilno učinkovino edoksaban.
Roteas has been shown to be as effective as the standard anticoagulant warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation.
Izkazalo se je, da je zdravilo Roteas pri preprečevanju možganske kapi in sistemske embolije pri bolnikih z atrijsko fibrilacijo enako učinkovito kot standardni antikoagulant varfarin.
How does Roteas work?
Kako zdravilo Roteas deluje?
In the treatment and prevention of blood clots in patients with DVT or pulmonary embolism, Roteas was also found to be as effective as warfarin, in a study involving over 8,200 patients.
V študiji, v kateri je sodelovalo več kot 8 200 bolnikov, so ugotovili, da je zdravilo Roteas enako učinkovito kot varfarin tudi pri zdravljenju in preprečevanju krvnih strdkov pri bolnikih z globoko vensko trombozo ali pljučno embolijo.
or vice versa.
in obratno.
per day as described above.
na dan, kot je opisano zgoraj.
Very rare, not known*
Zelo redki, neznani*
Thus, the results from this subset are in line with the overall trial results.
Rezultati te podskupine se torej ujemajo s celotnimi rezultati preizkušanja.
The median follow-up for both groups was 359 days.
Mediano spremljanje je v obeh skupinah trajalo 359 dni.
Children and adolescents Do not give this medicine to children because it does not work.
Otroci in mladostniki Ne dajajte tega zdravila otrokom ali mladostnikom, ker ne deluje.
Do not stop the treatment unless your doctor tells you so.
Ne prekinite zdravljenja razen, če tako odloči zdravnik.
• You should tell your doctor if a surgery (including dental) is planned.
: - morate zdravniku povedati, če imate predvideno kakšno operacijo (tudi zobozdravstveni poseg).
Date of first authorisation: 21 September 2009 Date of latest renewal: 3 June 2014
Datum prve odobritve: 21. september 2009 Datum zadnjega podaljšanja:
The characteristics of the studied cohort were similar in the 2 groups.
Značilnosti proučevane kohorte so bile v obeh skupinah podobne.
• Your doctor may order blood tests.
- lahko vaš zdravnik naroči krvne preiskave.
The requirements for submission of (PSURs) reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
• If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na klopidogrel ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
An occasional use of acetylsalicylic acid (no more than 1000 mg in any 24 hour period), should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Priložnostna uporaba acetilsalicilne kisline (ne več kot 1000 mg v kateremkoli 24-urnem obdobju) na splošno ne bi smela povzročati težav,vendar pa se morate o daljši uporabi v drugih okoliščinah posvetovati s svojim zdravnikom.
The patient population included 41.8 % women.
V populaciji bolnikov je bilo 41,8 % žensk.
Clopidogrel has been evaluated for safety in more than 44,000 patients who have participated in clinical studies, including over 12,000 patients treated for 1 year or more.
Varnost klopidogrela so vrednotili pri več kot 44.000 bolnikih, ki so sodelovali v kliničnih študijah, vključno z več kot 12.000 bolniki, ki so se zdravili 1 leto ali več.
Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg.
Ker so veliki odmerki ASA povezani s povečanim tveganjem za krvavitve, se priporoča, da odmerek ASA ni večji od 100 mg.
Do not take a double dose to make up for a forgotten tablet.
Ne jemljite dvojnega odmerka, da bi nadomestili posamezno izpuščeno tableto.
9/l); requirement for clopidogrel or oral anticoagulants (OAC); or intolerance to any of the two compounds.
9/l), potreba po klopidogrelu ali peroralnih antikoagulantih ali intoleranca za katero od obeh snovi.
for as long as your doctor continues to prescribe it.
morate jemati, dokler vam ga vaš zdravnik predpisuje.
Clopidogrel has no or negligible influence on the ability to drive and use machines.
Klopidogrel nima ali ima zanemarljiv vpliv na sposobnost za vožnjo in upravljanje strojev.
The ACTIVE-A study included patients who could not receive VKA therapy because they were unable or unwilling to receive the treatment.
Študija ACTIVE-A pa je vključila bolnike, ki niso mogli prejemati zdravljenja z VKA, ker zanj niso bili primerni ali ga niso želeli.
No special requirements for disposal.
Ni posebnih zahtev.
may be taken with or without food.
lahko jemljete s hrano ali brez nje.
Although the ischaemic benefit was consistent throughout the first year, greater reduction in ischaemic recurrence after ACS was observed during the initial days following the treatment initiation.
Čeprav je bila korist glede ishemije stalna v celotnem prvem letu, so večje zmanjšanje ishemičnih ponovitev po AKS opažali v prvih dneh po začetku zdravljenja.
The mean CHADS2 score was 2.0 (range 0-6).
Povprečna ocena CHADS2 je bila 2,0 (razpon: od 0 do 6).
Secondary prevention of atherothrombotic events Clopidogrel is indicated in:
Sekundarno preprečevanje aterotrombotičnih dogodkov Klopidogrel je indiciran pri:
Medicinal products associated with bleeding risk: There is an increased risk of bleeding due to the potential additive effect.
Zdravila, povezana s tveganjem za krvavitve: Obstaja večje tveganje za krvavitve zaradi možnega aditivnega učinka.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Pred začetkom jemanja zdravilanatančno preberite navodilo, ker vsebuje za vas pomembne podatke!
is and what it is used for
in za kaj ga uporabljamo
Patients were treated for up to one year.
Zdravili so se do eno leto.
A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
Številne druge klinične študije so izvedli s klopidogrelom in drugimi sočasno danimi zdravili, da bi proučili potencial za farmakodinamične in farmakokinetične interakcije.
All patients were continued on aspirin and were followed for one year.
Vsi bolniki so še naprej jemali acetilsalicilno kislino in spremljali so jih eno leto.
(1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Njihova pogostnost je navedena po naslednjem dogovoru: pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
TOPIC and TROPICAL-ACS were designed to study how to mitigate the bleeding events while maintaining efficacy.
Študiji TOPIC in TROPICAL-ACS sta bili načrtovani za proučitev, kako ublažiti krvavitve in ohraniti učinkovitost.
• Adults and elderly
Odmerjanje - Odrasli in starejši bolniki
The mean age was 71 years, 41.6% of patients were ≥75 years.
Povprečna starost je bila 71 let, 41,6 % bolnikov je bilo starih ≥ 75 let.
In cases of confirmed isolated activated Partial Thromboplastin Time (aPTT) prolongation with or without bleeding, acquired haemophilia should be considered.
V primeru potrjenega izoliranega podaljšanja aktiviranega parcialnega tromboplastičnega časa (aPTČ) s krvavitvami ali brez njih, je treba pomisliti na pridobljeno hemofilijo.
7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets
7 filmsko obloženih tablet 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 56 filmsko obloženih tablet 84 filmsko obloženih tablet 90 filmsko obloženih tablet 100 filmsko obloženih tablet
7 film-coated tablets: EU/1/09/562/001 14 film-coated tablets: EU/1/09/562/002 28 film-coated tablets: EU/1/09/562/003 30 film-coated tablets: EU/1/09/562/004 50 film-coated tablets: EU/1/09/562/005 56 film-coated tablets: EU/1/09/562/006 84 film-coated tablets: EU/1/09/562/007 90 film-coated tablets: EU/1/09/562/008 100 film-coated tablets: EU/1/09/562/009
7 filmsko obloženih tablet: EU/1/09/562/001 14 filmsko obloženih tablet: EU/1/09/562/002 28 filmsko obloženih tablet: EU/1/09/562/003 30 filmsko obloženih tablet: EU/1/09/562/004 50 filmsko obloženih tablet: EU/1/09/562/005 56 filmsko obloženih tablet: EU/1/09/562/006 84 filmsko obloženih tablet: EU/1/09/562/007 90 filmsko obloženih tablet: EU/1/09/562/008 100 filmsko obloženih tablet: EU/1/09/562/009
The results obtained in populations with different characteristics (e.g. unstable angina or non-Q-wave MI, low to high risk levels, diabetes, need for revascularisation, age, gender, etc.) were consistent with the results of the primary analysis.
Rezultati, pridobljeni pri populacijah z različnimi karakteristikami (npr. nestabilna angina, MI brez Qzobca, veliko do majhno tveganje, sladkorna bolezen, potreba po revaskularizaciji, spol, starost, itd.), so skladni z rezultati primarne analize.
Cross-reactions among thienopyridines
Navzkrižne reakcije med tienopiridini
You should not breast-feed while taking this medicine.
Med jemanjem tega zdravila ne smete dojiti.
The prasugrel-only patients were continued on prasugrel for 11.5 months.
Bolniki, ki so prejemali le prasugrel, so nadaljevali jemanje prasugrela v obdobju 11,5 meseca.
Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (see section 5.1).
Podatki iz kliničnih preizkušanj kažejo, da je primerna uporaba do 12 mesecev, največjo korist pa so opazili po 3 mesecih (glejte poglavje 5.1).
Therapeutic experience with clopidogrel is limited in patients with renal impairment.
Terapevtske izkušnje s klopidogrelom so omejene pri bolnikih z ledvično okvaro.
In addition, a subgroup analysis by age suggested that the benefitof clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.
Poleg tega analiza podskupin glede na starost nakazuje, da so koristi od zdravljenja s klopidogrelom pri bolnikih, starejših od 75 let, manjše od tistih, ki so jih opazili pri bolnikih starih 75 let ali manj.
Patients who had developed a previous allergic reaction and/or haematological reaction to one thienopyridine may have an increased risk of developing the same or another reaction to another thienopyridine.
Bolniki, ki so kdaj imeli alergijsko in/ali hematološko reakcijo na enega od tienopiridinov, imajo lahko večje tveganje za pojav enake ali druge reakcije na drug tienopiridin.
The ACTIVE-W and ACTIVE-A studies, separate trials in the ACTIVE program, included patients with atrial fibrillation (AF) who had at least one risk factor for vascular events.
Študiji ACTIVE-W in ACTIVE-A, ločeni preskušanji v programu ACTIVE, sta vključili bolnike z atrijsko fibrilacijo (AF), ki so imeli vsaj en dejavnik tveganja za žilne dogodke.
The elimination half-life of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Razpolovni čas izločanja glavnega (neaktivnega) krožečega metabolita je bil 8 ur po enkratnem in večkratnem dajanju.
to help prevent blood clots and reduce the risk of these severe events because: - You have a condition of hardening of arteries (also known as atherosclerosis), and - You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease.
vam je predpisano za pomoč pri preprečevanju nastajanja krvnih strdkov in za zmanjšanje tveganja teh hudih dogodkov, ker: - imate otrdele arterije (znano tudi kot ateroskleroza) in - ste predhodno doživeli srčni napad, kap ali imeli stanje, ki je znano kot periferna arterijska bolezen.