natgillin/translations-raw huggingface dataset:
The full EPAR for Ozempic 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 Ozempic je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
These are mild or moderate in severity and of short duration.
Ti neželeni učinki so blagi ali zmerni in so kratkotrajni.
The starting dose of Ozempic is 0.25 mg once a week.
Začetni odmerek zdravila Ozempic je 0,25 mg enkrat na teden.
This is a summary of the European public assessment report (EPAR) for Ozempic.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ozempic.
Other information about Ozempic
Druge informacije o zdravilu Ozempic
It acts in the same way as GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food.
To pomeni, da deluje enako kot GLP-1 (v črevesju proizvedeni hormon), in sicer tako, da povečuje količino insulina, ki ga kot odziv na zaužito hrano izloči trebušna slinavka.
What is Ozempic and what is it used for?
Kaj je zdravilo Ozempic in za kaj se uporablja?
The active substance in Ozempic, semaglutide, is a ‘GLP-1 receptor agonist'.
Zdravilna učinkovina v zdravilu Ozempic, semaglutid, je agonist receptorjev za GLP-1.
What benefits of Ozempic have been shown in studies?
Kakšne koristi je zdravilo Ozempic izkazalo v študijah?
What are the risks associated with Ozempic?
Kakšna tveganja so povezana z zdravilom Ozempic?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ozempic have 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 Ozempic upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Ozempic can be used on its own in patients who cannot take metformin (another diabetes medicine).
Zdravilo Ozempic se lahko uporablja kot samostojno zdravilo pri bolnikih, ki ne morejo jemati metformina (drugega zdravila za zdravljenje sladkorne bolezni).
Ozempic in these studies compared favourably with other treatments, sitagliptin, exenatide and insulin glargine (which led to reductions of 0.55, 0.92, 0.83 percentage points respectively) and placebo (reductions of up to 0.09 percentage points).
Izidi zdravljenja z zdravilom Ozempic so bili v teh študijah boljši od drugih zdravil - sitagliptina, eksenatida in insulina glargina (uporaba katerih je privedla do zmanjšanja za 0,55, 0,92 oz. 0,83 odstotne točke) - ter placeba (zmanjšanje za do 0,09 odstotne točke).
For more information about treatment with Ozempic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Ozempic preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The European Medicines Agency concluded that the benefits of Ozempic seen in studies outweighed its risk and recommended it be approved for use in the EU.
Evropska agencija za zdravila je zaključila, da so v študijah izkazane koristi zdravila Ozempic večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
It is not intended to provide practical advice on how to use Ozempic.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
If needed, the dose can be further increased up to a maximum of 1 mg once a week.
Ta odmerek je treba po štirih tednih povečati na 0,5 mg. Odmerek se po potrebi lahko dodatno poveča na največ 1 mg enkrat na teden.
A further study in over 3,000 diabetes patients at high risk of heart problems showed that overall, heart attack, stroke or death occurred less frequently in patients treated with Ozempic (6.6%) than with placebo (8.9%).
Še ena študija z več kot 3 000 bolniki s sladkorno boleznijo in velikim tveganjem za težave s srcem je pokazala, da je skupno do srčnega infarkta, možganske kapi ali smrti pri bolnikih, zdravljenih z zdravilom Ozempic, prišlo manj pogosto (6,6 %) kot pri bolnikih, zdravljenih s placebom (8,9 %).
Five studies in over 4,000 patients showed that Ozempic lowered levels of HbA1c (a measure of blood glucose) by between 1.2 and 1.8 percentage points over 10 to 13 months.
Pet študij z več kot 4 000 bolniki je pokazalo, da zdravilo Ozempic v 10- do 13-mesečnem obdobju zniža koncentracijo HbA1c (merilo za glukozo v krvi) za od 1,2 do 1,8 odstotne točke.
Ozempic is a diabetes medicine used with diet and exercise to treat adults whose type 2 diabetes is not satisfactorily controlled.
Ozempic je zdravilo za zdravljenje sladkorne bolezni, ki se uporablja skupaj z dieto in telesno vadbo za zdravljenje odraslih, pri katerih sladkorna bolezen tipa 2 ni zadovoljivo uravnana.
It is injected under the skin of the belly, the thigh or the upper arm.
Injicira se v podkožje, in sicer v trebuh, stegno ali nadlaket.
Studies showed that Ozempic is effective at lowering blood glucose levels and reducing the risk of health complications in patients with type 2 diabetes.
Študije so pokazale, da zdravilo Ozempic učinkovito znižuje koncentracijo glukoze v krvi in zmanjšuje tveganje za zdravstvene zaplete pri bolnikih s sladkorno boleznijo tipa 2.
Why is Ozempic approved?
Zakaj je bilo zdravilo Ozempic odobreno?
For practical information about using Ozempic, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Ozempic naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Ozempic is available as a solution for injection in prefilled pens and can only be obtained with a prescription.
Zdravilo Ozempic je na voljo v obliki raztopine za injiciranje v napolnjenih injekcijskih peresnikih, njegovo predpisovanje in izdaja pa je le na recept.
Ozempic was also shown to be effective at reducing the occurrence of serious health complications associated with diabetes such as heart attack and stroke.
Izkazalo se je tudi, da zdravilo Ozempic učinkovito zmanjšuje pojav resnih zdravstvenih zapletov, povezanih s sladkorno boleznijo, kot sta srčni infarkt in možganska kap.
This helps with the control of blood glucose levels.
To pomaga pri uravnavanju koncentracije glukoze v krvi.
The most common side effects with Ozempic (which may affect more than 1 in 10 people) include problems with the digestive system, such as diarrhoea, vomiting and nausea (feeling sick).
Najpogostejši neželeni učinki zdravila Ozempic (ki se lahko pojavijo pri več kot 1 bolniku od 10) so prebavne težave, kot so driska, bruhanje in navzea (siljenje na bruhanje).
For the full list of all side effects and restrictions with Ozempic, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Ozempic glejte navodilo za uporabo.
In addition, the results indicated that treatment with Ozempic was associated with a beneficial fall in body weight.
Poleg tega so rezultati pokazali, da je zdravljenje z zdravilom Ozempic povezano s koristnim zmanjšanjem telesne mase.
Side effects affecting the digestive system are considered to be manageable.
Neželeni učinki na prebavila naj bi bili obvladljivi.
When looking at the three ‘events' separately, fewer patients taking Ozempic had a heart attack or stroke, but rates of death from heart problems were similar in the two groups.
Ločena analiza teh treh „dogodkov“ je pokazala, da je do srčnega infarkta ali možganske kapi prišlo pri manj bolnikih, ki so jemali zdravilo Ozempic, umrljivost zaradi težav s srcem pa je bila v obeh skupinah podobna.
Treatment with Ozempic also led to weight loss, which is considered beneficial in patients with diabetes.
Zdravljenje z zdravilom Ozempic je privedlo tudi do zmanjšanja telesne mase, kar se pri bolnikih s sladkorno boleznijo šteje kot koristno.
Ozempic was shown to be effective at controlling blood glucose levels.
Zdravilo Ozempic se je izkazalo kot učinkovito pri uravnavanju koncentracije glukoze v krvi.
How is Ozempic used?
Kako se zdravilo Ozempic uporablja?
Ozempic contains the active substance semaglutide.
Zdravilo Ozempic vsebuje zdravilno učinkovino semaglutid.
Serious worsening of diabetic retinopathy (damage to the retina, the light sensitive membrane at the back of the eye) is common (it may affect up to 1 in 10 people).
Pogosto (pojavlja se pri največ 1 bolniku od 10) je resno poslabšanje diabetične retinopatije (poškodbe mrežnice, tj. na svetlobo občutljive membrane na očesnem ozadju).
How does Ozempic work?
Kako zdravilo Ozempic deluje?
720 ELISA Units
720 ELISA enot
1 pre-filled syringe +
1 napolnjena injekcijska brizga + 1 igla
1 dose (1 ml) contains: Hepatitis A virus (inactivated)1,2
Virus hepatitisa A (inaktivirani)
MA (EU) Number (Invented) name
(Izmišljeno) ime Jakost
What measures are being taken to ensure the safe and effective use of Glustin?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Glustin?
Further studies also looked at long-term use of Glustin.
V nadaljnjih študijah so proučevali tudi dolgoročno uporabo zdravila Glustin.
The full EPAR for Glustin 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 Glustin je na voljo na spletni strani agencije:ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The European Commission granted a marketing authorisation valid throughout the European Union, for Glustin on 11 October 2000.
Evropska komisija je dovoljenje za promet z zdravilom Glustin, veljavno po vsej Evropski uniji, izdala 11. oktobra 2000.
It is used in addition to diet and exercise as follows:
Uporablja se kot dodatek k ustrezni prehrani in telesni vadbi, in sicer:
Treatment with Glustin should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Zdravljenje z zdravilom Glustin je treba ponovno oceniti po treh do šest mesecih in ga pri bolnikih, ki od njega nimajo zadostne koristi, ukiniti.
Other information about Glustin:
Druge informacije o zdravilu Glustin:
This is a summary of the European public assessment report (EPAR) for Glustin.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Glustin.
Almost 7,000 patients received Glustin in all of the studies combined.
V vseh študijah skupaj je zdravilo Glustin prejemalo skoraj 7 000 bolnikov.
As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.
Posledično se raven glukoze v krvi zniža, kar pripomore k nadzoru sladkorne bolezni tipa 2.
It must also not be used in patients who have or have had bladder cancer or those with blood in the urine that has not yet been investigated.
Poleg tega ga ne smejo uporabljati bolniki, ki imajo ali so imeli raka sečnega mehurja, ali bolniki, ki imajo kri v urinu, vendar preiskave v zvezi s tem še niso bile opravljene.
What benefit has Glustin shown during the studies?
Kakšne koristi je zdravilo Glustin izkazalo med študijami?
What is the risk associated with Glustin?
Kakšna tveganja so povezana z zdravilom Glustin?
For more information about treatment with Glustin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Glustin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Glustin is a medicine that contains the active substance pioglitazone.
Glustin je zdravilo, ki vsebuje zdravilno učinkovino pioglitazon.
The most common side effects with Glustin (seen in between 1 and 10 patients in 100) are upper respiratory tract infection (colds), hypoaesthesia (reduced sense of touch), visual disturbance, bone fractures and increased weight.
Najpogostejši neželeni učinki zdravila Glustin (opaženi pri 1 do 10 bolnikih od 100) so okužba zgornjih dihal (prehladi), hipestezija (zmanjšan občutek za dotik), motnje vida, zlomi kosti in povečanje telesne mase.
The doses of Glustin may need to be adjusted when given with some other medicines such as gemfibrozil (used to lower cholesterol) or rifampicin (an antibiotic used to treat tuberculosis).
Odmerke zdravila Glustin bo morda treba prilagoditi, če se jemlje skupaj z nekaterimi drugimi zdravili, kot sta gemfibrozil (ki se uporablja za zniževanje holesterola) ali rifampicin (antibiotik, ki se uporablja za zdravljenje tuberkuloze).
The CHMP decided that Glustin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor CHMP je zaključil, da so koristi zdravila Glustin večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
If Glustin is used in combination with other diabetes medicines, other side effects may occur.
Če se zdravilo Glustin uporablja v kombinaciji z drugimi zdravili proti sladkorni bolezni, se lahko pojavijo še drugi neželeni učinki.
The active substance in Glustin, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Zdravilna učinkovina zdravila Glustin, pioglitazon, poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za uravnavanje ravni glukoze v krvi ali pri kateri ga telo ne more učinkovito izrabiti.
Glustin must not be used in patients who have problems with their liver, patients who have had heart failure (when the heart does not work as well as it should) or patients with diabetic ketoacidosis (a complication of diabetes).
Prav tako ga ne smejo uporabljati bolniki, ki imajo težave z jetri, bolniki s srčnim popuščanjem (pri katerih srce ne deluje, kot bi moralo) ali bolniki z diabetično ketoacidozo (zapletom pri sladkorni bolezni).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Glustin.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Glustin, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Glustin is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Zdravilo Glustin se uporablja za zdravljenje sladkorne bolezni tipa 2 pri odraslih (starejših od 18 let), zlasti tistih s prekomerno telesno maso.
The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
V študijah so merili raven snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je raven glukoze v krvi uravnana.
The company that markets Glustin will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
V njem bodo opisani možna tveganja za srčno popuščanje in raka sečnega mehurja pri zdravljenju s pioglitazonom, merila za izbiro bolnikov in potrebe po redni oceni zdravljenja ter prekinitev zdravljenja, če bolnikom ne koristi več.
This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Priporočeni začetni odmerek zdravila Glustin je 15 ali 30 mg enkrat na dan. Odmerek bo po enem ali dveh tednih morda treba povečati do 45 mg enkrat na dan, če je potrebno boljše uravnavanje glukoze (sladkorja) v krvi.
• on its own in patients for whom metformin (another diabetes medicine) is not suitable;
• kot samostojno zdravilo pri bolnikih, za katere metformin (drugo zdravilo za zdravljenje sladkorne bolezni) ni primeren;
Glustin also improved the glucose control obtained in type 2 diabetes when it was added to existing treatment with a sulphonylurea, insulin or metformin, or the combination of metformin and a sulphonylurea.
Zdravilo Glustin je izboljšalo tudi uravnavanje glukoze pri sladkorni bolezni tipa 2, če je bilo dodano obstoječemu zdravljenju s sulfonilsečnino, insulinom ali metforminom ali kombinaciji metformina in sulfonilsečnine.
• together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite treatment with two medicines by mouth;
• skupaj z metforminom in sulfonilsečnino pri bolnikih, pri katerih kljub peroralnemu zdravljenju z obema zdraviloma ni vzpostavljeno zadovoljivo uravnavanje;
Why has Glustin been approved?
Zakaj je bilo zdravilo Glustin odobreno?
Some studies also looked at combining Glustin with a sulphonylurea, insulin or metformin, or with the combination of metformin and a sulphonylurea.
V nekaterih študijah so proučevali tudi kombiniranje zdravila Glustin s sulfonilsečnino, insulinom ali metforminom ali s kombinacijo metformina in sulfonilsečnine.
For the full list of all side effects reported with Glustin, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Glustin, glejte navodilo za uporabo.
• in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of diabetes medicine) when metformin is not suitable in patients who are not satisfactorily controlled on a sulphonylurea alone;
• v kombinaciji z metforminom pri bolnikih, pri katerih zgolj z metforminom ni mogoče doseči zadovoljivega uravnavanja ali s sulfonilsečnino (drugo vrsto zdravila za zdravljenje sladkorne bolezni), če metformin ni primeren, pri bolnikih, pri katerih zgolj s sulfonilsečnino ni mogoče doseči zadovoljivega uravnavanja;
• together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
• skupaj z insulinom pri bolnikih, pri katerih bolezen ni zadostno uravnavana zgolj z insulinom in za katere metformin ni primeren.
At subsequent reviews prescribers should confirm that benefits to patients are maintained.
Pri nadaljnjih pregledih morajo zdravniki, ki zdravilo predpisujejo, preveriti, ali zdravilo še vedno zagotavlja enake koristi.
Glustin led to a decrease in the level of HbA1c, indicating that blood glucose levels had been reduced at doses of 15, 30 and 45 mg. Glustin on its own was shown to be as effective as metformin and gliclazide.
Zdravilo Glustin je povzročilo znižanje ravni HbA1c, kar pomeni, da so je raven glukoze v krvi znižala pri odmerkih 15 mg, 30 mg in 45 mg.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Glustin have also been included in the summary of product characteristics and the package leaflet.
V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bili vključeni priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo zdravila Glustin.
Glustin has been compared with placebo (a dummy treatment), metformin and gliclazide (a sulphonylurea) in a number of studies.
Zdravilo Glustin so v številnih študijah primerjali s placebom (zdravilom brez zdravilne učinkovine), metforminom ali gliklazidom (sulfonilsečnino).
What is Glustin used for?
Za kaj se zdravilo Glustin uporablja?
How has Glustin been studied?
Kako je bilo zdravilo Glustin raziskano?
What is Glustin?
Kaj je zdravilo Glustin?
How is Glustin used?
Kako se zdravilo Glustin uporablja?
How does Glustin work?
Kako zdravilo Glustin deluje?
Mean follow-up was 569 days.
Povprečno trajanje spremljanja je bilo 569 dni.
Adopted at the 8-11 April 2019 PRAC
Sprejeto na seji odbora PRAC od 8. do 11. aprila 2019
It is not known if your medicine may harm your unborn baby.
Ni znano, ali zdravilo škodi nerojenemu otroku.
[Product name] should not be used during pregnancy.
Zdravilo [ime zdravila] se ne sme uporabljati med nosečnostjo.
These may cause increased blood levels of [active substance].
Povečajo lahko ravni [učinkovine] v krvi.
As modafinil may reduce the effectiveness of oral contraception alternative additional methods of contraception are required (see sections 4.4 and 4.5).
Ker lahko modafinil zmanjša učinkovitost peroralne kontracepcije, so zahtevane dodatne alternativne kontracepcijske metode (glejte poglavji 4.4 in 4.5).
What you need to know before you take Eliquis/Lixiana/Roteas Warnings and precautions
Kaj morate vedeti, preden boste vzeli zdravilo Eliquis/Lixiana/Roteas Opozorila in previdnostni ukrepi
The trial was terminated prematurely after the enrolment of 120 patients due to an excess of events among patients in the rivaroxaban arm.
Preskušanje so po vključitvi 120 bolnikov predčasno prekinili zaradi prevelikega števila dogodkov pri bolnikih v skupini, ki je prejemala rivaroksaban.
59 patients were randomized to rivaroxaban 20 mg (15 mg for patients with creatinine clearance (CrCl) <50 mL/min) and 61 to warfarin (INR 2.0- 3.0).
59 bolnikov so randomizirali na rivaroksaban v jakosti 20 mg (15 mg pri bolnikih s kreatininskim očistkom (CrCl) < 50 ml/min), 61 pa na varfarin (INR 2,0-3,0).
Women of childbearing potential have to use effective contraception.
Ženske v rodni dobi morajo med zdravljenjem uporabljati učinkovito kontracepcijo.
Modafinil is not recommended for use during pregnancy or in women of childbearing potential unless they are using effective contraception.
Uporaba modafinila ni priporočljiva med nosečnostjo ali pri ženskah v rodni dobi, katere ne uporabljajo učinkovite kontracepcije.
Modafinil - Evaluation of data on foetal outcomes including congenital anomalies from a single observational study in the US (EPITT no 19367)
Modafinil - ovrednotenje podatkov o izidih pri plodu, vključno s prirojenimi nepravilnostmi, iz opazovalne študije v ZDA (št. EPITT 19367)
Based on limited human experience from a pregnancy registry and spontaneous reporting modafinil is suspected to cause congenital malformations when administered during pregnancy.
Na podlagi omejenih izkušenj pri človeku iz registra nosečnosti in spontanih poročil obstaja sum, da modafinil v primeru uporabe med nosečnostjo povzroča prirojene malformacije.
A reduction in the dose of [active substance] may be necessary based on monitoring of side-effects during concomitant treatment (see section 4.4).
Morda je na podlagi spremljanja neželenih učinkov med sočasnim zdravljenjem potrebno zmanjšanje odmerka [učinkovine] (glejte poglavje 4.4).
What you need to know before you take [product name] Pregnancy and breast-feeding
Kaj morate vedeti, preden boste vzeli zdravilo [ime zdravila] Nosečnost in dojenje
What you need to know before you take Xarelto/Pradaxa Take special care with Xarelto/Pradaxa - if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
Kaj morate vedeti, preden boste vzeli zdravilo Xarelto/Pradaxa Bodite posebno pozorni pri jemanju zdravila Xarelto/Pradaxa - če veste, da imate bolezen, imenovano antifosfolipidni sindrom (bolezen imunskega sistema, zaradi katere imate povečano tveganje za nastanek krvnih strdkov), o tem obvestite zdravnika, ki bo presodil, ali je treba zdravljenje spremeniti.
Rivaroxaban/dabigatran etexilate
Rivaroksaban/dabigatran eteksilat
Thromboembolic events occurred in 12% of patients randomized to rivaroxaban (4 ischaemic strokes and 3 myocardial infarctions).
Trombembolični dogodki so se pojavili pri 12 % bolnikov, randomiziranih na rivaroksaban (4 ishemične možganske kapi in 3 miokardni infarkti).