natgillin/translations-raw huggingface dataset:
Velmetia should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis.
Zdravila Velmetia se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 in za zdravljenje diabetične ketoacidoze.
Other medicines and Velmetia
Druga zdravila in zdravilo Velmetia
Velmetia with alcohol
Zdravilo Velmetia skupaj z alkoholom
STOP taking Velmetia and contact a doctor immediately if you notice any of the following serious side effects:
Zdravilo Velmetia takoj PRENEHAJTE jemati in se posvetujte z zdravnikom, če opazite katerega koli od naslednjih resnih neželenih učinkov:
What you need to know before you take Velmetia
Kaj morate vedeti, preden boste vzeli zdravilo Velmetia
The dose of antihyperglycaemic therapy with Velmetia should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.
Odmerek zdravila Velmetia pri antidiabetičnem zdravljenju je treba prilagoditi na podlagi bolnikovega trenutnega režima zdravljenja, učinkovitosti in tolerabilnosti, pri tem pa se ne sme preseči največjega dovoljenega dnevnega odmerka 100 mg sitagliptina.
Velmetia may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Zdravilo Velmetia lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza, zlasti če ledvice ne delujejo pravilno.
Velmetia contains two different medicines called sitagliptin and metformin.
Zdravilo Velmetia vsebuje dve različni učinkovini, imenovani sitagliptin in metformin.
Pharmacokinetic drug interaction studies with Velmetia have not been performed; however, such studies have been conducted with the individual active substances, sitagliptin and metformin.
Študije farmakokinetičnih interakcij z zdravilom Velmetia niso bile izvedene, vendar pa so take študije opravili s posameznima učinkovinama, sitagliptinom in metforminom.
You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Velmetia.
Morda boste morali pogosteje opravljati preiskave glukoze v krvi in delovanja ledvic, zdravnik pa bo morda moral prilagoditi odmerek zdravila Velmetia.
Velmetia may cause a very rare (may affect up to 1 in 10,000 people), but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Zdravilo Velmetia lahko povzroči zelo redek (pojavi se lahko pri največ 1 od 10.000 bolnikov), a zelo resen neželeni učinek, imenovan laktacidoza (glejte poglavje "Opozorila in previdnostni ukrepi").
Avoid excessive alcohol intake while taking Velmetia since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Med jemanjem zdravila Velmetia ne uživajte čezmernih količin alkohola, saj lahko to poveča tveganje za laktacidozo (glejte poglavje "Opozorila in previdnostni ukrepi").
No animal studies have been conducted with Velmetia.
Študij na živalih z zdravilom Velmetia niso opravili.
What Velmetia is and what it is used for What you need to know before you take Velmetia How to take Velmetia
Kaj je zdravilo Velmetia in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Velmetia Kako jemati zdravilo Velmetia Možni neželeni učinki
Stop taking Velmetia for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Za kratek čas prenehajte jemati zdravilo Velmetia, če imate stanje, ki je lahko povezano z dehidracijo (znatna izguba telesnih tekočin), kot je hudo bruhanje, driska, zvišana telesna temperatura, izpostavljenost vročini ali če pijete manj tekočine, kot običajno.
If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you must stop taking Velmetia before or at the time of the injection.
Če vam bodo v krvni obtok injicirali kontrastno sredstvo, ki vsebuje jod, na primer zaradi rentgenskega ali drugega slikanja, morate pred časom injiciranja ali v tem času prenehati z jemanjem zdravila Velmetia.
What Velmetia looks like and contents of the pack
Izgled zdravila Velmetia in vsebina pakiranja
The following statements reflect the pharmacokinetic properties of the individual active substances of Velmetia.
V nadaljevanju so naštete farmakokinetične lastnosti posameznih učinkovin v zdravilu Velmetia.
Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Velmetia who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Spremembe kliničnega statusa pri bolnikih s predhodno nadzorovano sladkorno boleznijo tipa 2 Pri bolnikih s sladkorno boleznijo tipa 2, predhodno dobro nadzorovano z jemanjem zdravila Velmetia, pri katerih se pojavijo nenormalni izvidi laboratorijskih preiskav ali klinične bolezni (zlasti nejasne ali slabo opredeljene bolezni), je treba čim prej ugotoviti, če imajo ketoacidozo ali laktacidozo.
Velmetia should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Zdravilo Velmetia je treba jemati dvakrat na dan s hrano, da se zmanjšajo neželeni učinki metformina na prebavila.
If this happens, you must stop taking Velmetia and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
V tem primeru morate prenehati jemati zdravilo Velmetia in se takoj obrniti na zdravnika ali najbližjo bolnišnico, saj lahko laktacidoza vodi v komo.
Velmetia is contraindicated in patients with GFR < 30 mL/min and should be temporarily discontinued during conditions with the potential to alter renal function (see section 4.3).
Zdravilo Velmetia je kontraindicirano pri bolnikih z GFR < 30 ml/min in ga je treba začasno ukiniti, če se pojavijo stanja, ki spremenijo delovanje ledvic (glejte poglavje 4.3).
Stop taking Velmetia and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Takoj prenehajte jemati zdravilo Velmetia in se obrnite na zdravnika ali najbližjo bolnišnico, če se pojavijo nekateri od simptomov laktacidoze, saj lahko to stanje vodi v komo.
For patients switching from co-administration of sitagliptin and metformin For patients switching from co-administration of sitagliptin and metformin, Velmetia should be initiated at the dose of sitagliptin and metformin already being taken.
Pri bolnikih, ki prehajajo s sočasnega jemanja sitagliptina in metformina Pri bolnikih, ki prehajajo s sočasnega jemanja sitagliptina in metformina, je treba zdravljenje z zdravilom Velmetia začeti z odmerkom sitagliptina in metformina, ki ga že jemljejo.
A bioequivalence study in healthy subjects demonstrated that the Velmetia (sitagliptin/metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets.
V bioekvivalenčni študiji pri zdravih osebah so pokazali, da so kombinirane tablete Velmetia (sitagliptin/metforminijev klorid) bioekvivalentne sočasni uporabi sitagliptinijevega fosfata in metforminijevega klorida v obliki posameznih tablet.
Hepatic impairment Velmetia must not be used in patients with hepatic impairment (see section 5.2).
Jetrna okvara Zdravila Velmetia se pri bolnikih z okvaro jeter ne sme uporabljati (glejte poglavje 5.2).
If you need to have major surgery you must stop taking Velmetia during and for some time after the procedure.
Če morate na večji kirurški poseg, morate v času posega in še nekaj časa po tem prenehati z jemanjem zdravila Velmetia.
If you forget to take Velmetia
Če ste pozabili vzeti zdravilo Velmetia
Your doctor will decide when you must stop and when to restart your treatment with Velmetia.
Zdravnik se bo odločil, kdaj morate z jemanjem zdravila Velmetia prenehati in kdaj lahko nadaljujete.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Velmetia.
Če niste prepričani, če kar koli od navedenega velja za vas, se pred začetkom jemanja zdravila Velmetia, posvetujte z zdravnikom ali farmacevtom.
Velmetia has no or negligible influence on the ability to drive and use machines.
Zdravilo Velmetia nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
Če ste vzeli večji odmerek zdravila Velmetia, kot bi smeli Če ste vzeli večji odmerek tega zdravila od predpisanega, se takoj posvetujte z zdravnikom.
If you stop taking Velmetia
Če ste prenehali jemati zdravilo Velmetia
When Velmetia is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see section 4.4).
Kadar se zdravilo Velmetia uporablja v kombinaciji z insulinom, bo morda potreben manjši odmerek insulina za zmanjšanje tveganja za hipoglikemijo (glejte poglavje 4.4).
Patients receiving Velmetia in combination with a sulphonylurea or with insulin may be at risk for hypoglycaemia.
Pri bolnikih, ki prejemajo zdravilo Velmetia v kombinaciji s sulfonilsečnino ali z insulinom, se lahko pojavi tveganje za hipoglikemijo.
When Velmetia is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Kadar se zdravilo Velmetia uporablja v kombinaciji s sulfonilsečnino, bo morda potreben manjši odmerek sulfonilsečnine za zmanjšanje tveganja za hipoglikemijo (glejte poglavje 4.4).
As metformin and sitagliptin are excreted by the kidney, Velmetia should be used with caution as age increases.
Metformin in sitagliptin se izločata skozi ledvice, zato je pri uporabi zdravila Velmetia pri starejših potrebna previdnost.
There have been no therapeutic clinical trials conducted with Velmetia tablets however bioequivalence of Velmetia with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).
Kliničnih terapevtskih preskušanj z zdravilom Velmetia niso izvedli, vendar pa so dokazali bioekvivalenco zdravila Velmetia in sočasne uporabe sitagliptina in metformina (glejte poglavje 5.2).
Velmetia must therefore not be used in women who are breast-feeding (see section 4.3).
Zato ženske, ki dojijo, zdravila Velmetia ne smejo jemati (glejte poglavje 4.3).
If a hypersensitivity reaction is suspected, Velmetia should be discontinued, other potential causes of the event should be assessed, and alternative treatment for diabetes should be instituted (see section 4.8).
Pri sumu na preobčutljivostne reakcije morate zdravljenje z zdravilom Velmetia prekiniti, oceniti druge morebitne vzroke za ta neželeni učinek in začeti zdraviti sladkorno bolezen z drugimi zdravili (glejte poglavje 4.8).
Velmetia should not be used during pregnancy.
Bolnice med nosečnostjo ne smejo jemati zdravila Velmetia.
Velmetia is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
Zdravilo Velmetia je indicirano kot dodatek dieti in telesni aktivnosti za izboljšanje urejenosti glikemije pri bolnikih z neustrezno nadzorovano sladkorno boleznijo pri jemanju največjega odmerka samega metformina, ki ga prenašajo, ali pri bolnikih, ki že prejemajo kombinacijo sitagliptina in metformina.
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Velmetia (see section 4).
Pri bolnikih, ki so prejemali zdravilo Velmetia, so poročali o primerih vnetja trebušne slinavke (pankreatitisa) (glejte poglavje 4).
You will need to stop taking Velmetia at the time of the X-ray and for 2 or more days after as directed by your doctor,
Zdravilo Velmetia morate prenehati jemati na dan rentgenskega pregleda in ga ne smete jemati še 2 ali več dni po njem, kot vam je naročil zdravnik, odvisno od delovanja vaših ledvic.
How to take Velmetia
Kako jemati zdravilo Velmetia
Velmetia is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist.
Zdravilo Velmetia je indicirano za trojno kombinirano zdravljenje z agonistom receptorja gama, aktiviranega s peroksisomskim proliferatorjem (PPAR - peroxisome proliferator-activated receptor gamma) (tj. s tiazolidindionom) kot dodatek dieti in telesni aktivnosti pri bolnikih z neustrezno nadzorovano sladkorno boleznijo pri jemanju največjega odmerka metformina, ki ga prenašajo, in agonista PPAR.
For the different doses on metformin, Velmetia is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
Za različne odmerke metformina je zdravilo Velmetia na voljo v jakostih po 50 mg sitagliptina in 850 mg metforminijevega klorida ali 1.000 mg metforminijevega klorida.
Velmetia is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Zdravilo Velmetia je indicirano tudi kot dodatno zdravljenje k insulinu (tj. trojno kombinirano zdravljenje) kot dodatek dieti in telesni aktivnosti za izboljšanje urejenosti glikemije pri bolnikih, pri katerih s stabilnim odmerkom insulina in samim metforminom urejenost glikemije ni zadostna.
The level of digoxin in your blood may need to be checked if taking with Velmetia.
Med sočasnim jemanjem z zdravilom Velmetia vam bodo morda morali preveriti vrednosti digoksina v krvi.
What Velmetia contains
Kaj vsebuje zdravilo Velmetia
Velmetia must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.3 and 4.4).
Zdravilo Velmetia je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno (glejte poglavji 4.3 in 4.4).
Do not take Velmetia if any of the above apply to you and talk with your doctor about other ways of managing your diabetes.
Zdravila Velmetia ne jemljite in se z zdravnikom posvetujte o drugih možnostih za nadzor sladkorne bolezni, če kar koli od navedenega velja za vas.
Velmetia is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Zdravilo Velmetia je indicirano v kombinaciji s sulfonilsečnino (tj. trojno kombinirano zdravljenje) kot dodatek dieti in telesni aktivnosti pri bolnikih z neustrezno nadzorovano sladkorno boleznijo pri jemanju največjega odmerka metformina, ki ga prenašajo, in sulfonilsečnine.
Talk to your doctor or pharmacist before taking Velmetia: - if you have or have had a disease of the pancreas (such as pancreatitis) - if you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.
Pred začetkom jemanja zdravila Velmetia se posvetujte z zdravnikom ali farmacevtom: - če imate ali ste kdaj imeli bolezen trebušne slinavke (kot je pankreatitis).
If you are not sure, talk to your doctor, pharmacist or nurse before taking Velmetia.
Če niste prepričani, se pred začetkom jemanja zdravila Velmetia, posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
EU/1/08/456/008 14 film-coated tablets EU/1/08/456/009 28 film-coated tablets EU/1/08/456/010 56 film-coated tablets EU/1/08/456/021 60 film-coated tablets EU/1/08/456/011 112 film-coated tablets EU/1/08/456/012 168 film-coated tablets EU/1/08/456/022 180 film-coated tablets EU/1/08/456/013 196 film-coated tablets EU/1/08/456/014 50 x 1 film-coated tablets EU/1/08/456/016 196 (2 x 98) film-coated tablets EU/1/08/456/018 168 (2 x 84) film-coated tablets
EU/1/08/456/008 14 filmsko obloženih tablet EU/1/08/456/009 28 filmsko obloženih tablet EU/1/08/456/010 56 filmsko obloženih tablet EU/1/08/456/021 60 filmsko obloženih tablet EU/1/08/456/011 112 filmsko obloženih tablet EU/1/08/456/012 168 filmsko obloženih tablet EU/1/08/456/022 180 filmsko obloženih tablet EU/1/08/456/013 196 filmsko obloženih tablet EU/1/08/456/014 50 x 1 filmsko obložena tableta EU/1/08/456/016 196 (2 x 98) filmsko obloženih tablet EU/1/08/456/018 168 (2 x 84) filmsko obloženih tablet
If pancreatitis is suspected, Velmetia and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Velmetia should not be restarted.
Ob sumu na pankreatitis je treba prenehati z jemanjem zdravila Velmetia in drugih zdravil, ki bi lahko povzročila pankreatitis.
EU/1/08/456/001 14 film-coated tablets EU/1/08/456/002 28 film-coated tablets EU/1/08/456/003 56 film-coated tablets EU/1/08/456/019 60 film-coated tablets EU/1/08/456/004 112 film-coated tablets EU/1/08/456/005 168 film-coated tablets EU/1/08/456/020 180 film-coated tablets EU/1/08/456/006 196 film-coated tablets EU/1/08/456/007 50 x 1 film-coated tablets EU/1/08/456/015 196 (2 x 98) film-coated tablets EU/1/08/456/017 168 (2 x 84) film-coated tablets
EU/1/08/456/001 14 filmsko obloženih tablet EU/1/08/456/002 28 filmsko obloženih tablet EU/1/08/456/003 56 filmsko obloženih tablet EU/1/08/456/019 60 filmsko obloženih tablet EU/1/08/456/004 112 filmsko obloženih tablet EU/1/08/456/005 168 filmsko obloženih tablet EU/1/08/456/020 180 filmsko obloženih tablet EU/1/08/456/006 196 filmsko obloženih tablet EU/1/08/456/007 50 x 1 filmsko obložena tableta EU/1/08/456/015 196 (2 x 98) filmsko obloženih tablet EU/1/08/456/017 168 (2 x 84) filmsko obloženih tablet
Velmetia 50 mg/850 mg film-coated tablets
Velmetia 50 mg/850 mg filmsko obložene tablete
Velmetia 50 mg/1,000 mg film-coated tablets
Velmetia 50 mg/1.000 mg filmsko obložene tablete
EU/1/08/456/010 EU/1/08/456/011 EU/1/08/456/012 EU/1/08/456/013 EU/1/08/456/014 EU/1/08/456/016 EU/1/08/456/018 EU/1/08/456/021 EU/1/08/456/022
EU/1/08/456/008 EU/1/08/456/009 EU/1/08/456/010 EU/1/08/456/011 EU/1/08/456/012 EU/1/08/456/013 EU/1/08/456/014 EU/1/08/456/016
If bullous pemphigoid is suspected, Velmetia should be discontinued.
Ob sumu na bulozni pemfigoid je treba zdravljenje z zdravilom Velmetia prekiniti.
Velmetia 50 mg/1,000 mg tablets sitagliptin/metformin HCl
Velmetia 50 mg/1.000 mg tablete sitagliptin/metformin HCl
Velmetia 50 mg/850 mg tablets sitagliptin/metformin HCl
Velmetia 50 mg/850 mg tablete sitagliptin/metformin HCl
How to store Velmetia
Shranjevanje zdravila Velmetia
In addition, patients should be alerted to the risk of hypoglycaemia when Velmetia is used in combination with a sulphonylurea or with insulin.
Poleg tega je treba bolnike, ki jemljejo zdravilo Velmetia skupaj s sulfonilsečnino ali z insulinom, opozoriti na tveganje za pojav hipoglikemije.
Velmetia 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride
Velmetia 50 mg/1.000 mg filmsko obložene tablete sitagliptin/metforminijev klorid
Velmetia 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride
Velmetia 50 mg/850 mg filmsko obložene tablete sitagliptin/metforminijev klorid
This is sometimes called insulin-dependent diabetes - if you have or have had an allergic reaction to sitagliptin, metformin, or Velmetia (see section 4) - if you are taking a sulphonylurea or insulin, diabetes medicines, together with Velmetia, as you may experience low blood sugar levels (hypoglycaemia).
- če imate ali ste imeli alergijsko reakcijo na sitagliptin, metformin ali zdravilo Velmetia (glejte poglavje 4).
Velmetia combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Vsebuje sitagliptinijev fosfat, ki je zaviralec dipeptidil-peptidaze 4 (DPP-4), in metforminijev klorid, ki spada med bigvanide.
Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines in Velmetia) or during post-approval use of Velmetia or sitagliptin alone or with other diabetes medicines:
Pri nekaterih bolnikih, ki so v kliničnih študijah jemali samo sitagliptin (eno od učinkovin v zdravilu Velmetia) ali so v obdobju trženja jemali zdravilo Velmetia ali sitagliptin, sam ali z drugimi zdravili za zdravljenje sladkorne bolezni, so se pojavili naslednji neželeni učinki: Pogosti: nizek krvni sladkor, glavobol, okužba zgornjih dihal, zamašen nos ali izcedek iz nosu in vnetje grla, osteoartritis, bolečine v rokah ali nogah Občasni: omotica, zaprtje, srbenje
Furthermore, the data provided, including some data on reduced bleeding, were considered promising.
Poleg tega so bili predloženi podatki, vključno z nekaterimi podatki o zmanjšani krvavitvi, obravnavani kot obetavni.
As a result, the excessive bleeding caused by the anticoagulants is reduced.
Posledično se zmanjša čezmerna krvavitev, ki jo povzročijo antikoagulanti.
Further information on Ondexxya can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ondexxya.
Nadaljnje informacije o zdravilu Ondexxya so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/ondexxya.
The dose depends on what the last dose of the anticoagulant was and when the patient took it.
Odmerek je odvisen od zadnjega odmerka antikoagulanta in tega, kdaj ga je bolnik vzel.
The Agency therefore decided that Ondexxya's benefits are greater than its risks and it can be authorised for use in the EU.
Agencija je zato zaključila, da so koristi zdravila Ondexxya večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Patients treated with Ondexxya, especially those aged over 75 years, may be at a higher risk of thromboembolism.
Pri bolnikih, zdravljenih z zdravilom Ondexxya, zlasti tistih, starejših od 75 let, je lahko tveganje za trombembolijo večje.
What measures are being taken to ensure the safe and effective use of Ondexxya?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ondexxya?
The company will also carry out studies to gain more information on the effects and blood levels of Ondexxya and to confirm the dosage recommendations.
Prav tako bo izvedlo študije, s katerimi bo pridobilo več informacij o učinkih zdravila Ondexxya in njegovih ravneh v krvi ter potrdilo priporočila glede odmerjanja.
However, the Agency also noted the unmet medical need to stop life-threatening or uncontrolled bleeding caused by factor Xa inhibitors.
Agencija pa je opozorila tudi na neizpolnjeno zdravstveno potrebo po zaustavitvi življenjsko nevarne ali neobvladane krvavitve, ki jo povzročajo zaviralci faktorja Xa.
These anticoagulants work by blocking factor Xa, a natural protein that helps the blood to clot.
Ti antikoagulanti delujejo tako, da zavirajo faktor Xa, tj. naravno beljakovino, ki pomaga pri strjevanju krvi.
The main measure of effectiveness was the reduction in 'antifactor Xa activity' (a measure of how well natural factor Xa is blocked by an anticoagulant).
Glavno merilo učinkovitosti je bilo zmanjšanje „delovanja antifaktorja Xa“ (merilo, ki pove, kako uspešno antikoagulant zavira naravni faktor Xa).
In patients who were bleeding, the most common side effects (affecting around 1 in 10 people) were thromboembolism (problems due to clots in blood vessels such as blocked veins, heart attack and stroke) and fever.
Pri bolnikih s krvavitvami sta bila najpogostejša neželena učinka (ki se lahko pojavita pri približno 1 bolniku od 10) trombembolija (težave zaradi strdkov v krvnih žilah, kot so zamašene žile, srčni infarkt in možganska kap) in zvišana telesna temperatura.