natgillin/translations-raw huggingface dataset:
The European Commission granted a marketing authorisation valid throughout the European Union for Arixtra on 21 March 2002.
Evropska komisija je dovoljenje za promet z zdravilom Arixtra, veljavno po vsej Evropski uniji, odobrila dne 21. marca 2002.
The dose may be adjusted depending on body weight.
Odmerek se lahko prilagodi, odvisno od telesne mase.
Other information about Arixtra:
Druge informacije o zdravilu Arixtra:
For patients having surgery, the first dose should be given six hours after the end of the operation.
Bolnikom po operaciji se začetni odmerek da šest ur po koncu operacije.
Arixtra fondaparinux sodium
Arixtra natrijev fondaparinuks
This document is a summary of the European public assessment report (EPAR) for Arixtra.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Arixtra.
Blood clotting can be a problem when blood flow is disturbed in any way.
Strjevanje krvi lahko predstavlja resno težavo, če je pretok krvi kakor koli oviran.
The CHMP decided that Arixtra's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Arixtra večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
What benefit has Arixtra shown during the studies?
Kakšne koristi je zdravilo Arixtra izkazalo med študijami?
In all studies, the main measure of effectiveness was the overall rate of thrombotic events (problems caused by blood clots).
V vseh študijah je bilo glavno merilo učinkovitosti celokupna stopnja trombotičnih dogodkov (zapletov zaradi krvnih strdkov).
Treatment should be started as soon as possible following exclusion of DVT, and should be continued for between 30 and 45 days.
Zdravljenje je treba začeti čim prej po izključitvi možnosti nastanka globoke venske tromboze in ga je treba nadaljevati od 30 do 45 dni.
For patients who have kidney problems, Arixtra may not be suitable, or the 1.5-mg dose may be used.
Za bolnike, ki imajo težave s ledvicami, zdravilo Arixtra morda ni ustrezno oziroma se lahko uporabi 1,5-miligramski odmerek.
It can also be used in adults at high risk (because of their age or disease) when they are having abdominal surgery or are forced to stay in bed because of an acute illness.
Prav tako se lahko uporablja pri bolnikih, pri katerih obstaja povečano tveganje (zaradi njihove starosti ali bolezni) pri kirurških posegih v trebušni votlini ali pri bolnikih, ki so morajo ostati v postelji zaradi akutne 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 Arixtra.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Arixtra, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
For more information about treatment with Arixtra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Arixtra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
However, these results were insufficient to show whether Arixtra was more effective than unfractionated heparin or not.
Vendar ti rezultati niso bili zadostni, da bi pokazali, da je zdravilo Arixtra učinkovitejše od nefrakcioniranega heparina.
As with other anticoagulant medicines, the most common side effect of Arixtra is bleeding.
Kot pri vseh drugih antikoagulacijskih zdravilih je najpogostejši neželeni učinek zdravila Arixtra krvavenje.
Treatment should be continued until the risk of VTE has been reduced, usually at least five to nine days after surgery.
Zdravljenje je treba nadaljevati, dokler se tveganje za vensko tromboembolične dogodke ne zmanjša, navadno vsaj pet do devet dni po operaciji.
By using Arixtra after surgery, the risk of a blood clot forming is greatly reduced.
Z uporabo zdravila Arixtra po operaciji se tveganje za nastanek krvnih strdkov močno zmanjša.
When this is blocked, no thrombin (another factor) can be produced, and no clot can be formed.
Če je ta zaviran, se trombin (drugi faktor) ne more več tvoriti, zaradi česar tudi krvni strdki ne morejo več nastajati.
What is the risk associated with Arixtra?
Kakšna tveganja so povezana z zdravilom Arixtra?
Arixtra is a solution for injection in a prefilled syringe.
Zdravilo Arixtra je raztopina za injiciranje v napolnjeni injekcijski brizgi.
Arixtra is an anticoagulant: it prevents the blood from coagulating (clotting).
Zdravilo Arixtra je antikoagulant: preprečuje koagulacijo (strjevanje) krvi.
Arixtra has also been studied in two main studies of patients with unstable angina or myocardial infarction.
Zdravilo Arixtra so tudi raziskovali v dveh glavnih študijah bolnikov z nestabilno angino pektoris ali miokardnim infarktom.
For the full list of all side effects reported with Arixtra, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Arixtra, glejte navodilo za uporabo.
The active ingredient in Arixtra, fondaparinux sodium, stops one of the substances (factors) that are involved in the clotting of blood, factor Xa.
Zdravilna učinkovina zdravila Arixtra, natrijev fondaparinuks, zavira eno od snovi (faktorjev), ki sodelujejo pri strjevanju krvi, in sicer faktor Xa.
In the study of myocardial infarction with ST segment elevation, Arixtra reduced the risk of death or another heart attack by 14% after 30 days, compared to standard care.
Pri študiji miokardnega infarkta z dvigom spojnice ST je zdravilo Arixtra v primerjavi s standardnim zdravljenjem po 30 dneh zmanjšalo tveganje smrti ali ponovnega srčnega napada za 14 %.
Arixtra was at least as effective as enoxaparin in preventing death or an ischaemic event in patients with unstable angina or myocardial infarction without ST segment elevation, with around 5% of the patients in each group had died or had an ischaemic event after nine days.
Zdravilo Arixtra je bilo vsaj toliko učinkovito kot enoksaparin pri preprečevanju smrti ali ishemičnih dogodkov pri bolnikih z nestabilno angino pektoris ali miokardnim infarktom z dvigom spojnice ST, pri čemer je po devetih dneh približno 5 % bolnikov v vsaki skupini umrlo ali imelo ishemični dogodek.
Why has Arixtra been approved?
Zakaj je bilo zdravilo Arixtra odobreno?
Arixtra is not recommended in patients who are about to undergo certain types of operations to unblock the heart's blood vessels.
Zdravilo Arixtra se ne priporoča bolnikom, pri katerih bodo izvedene določene vrste kirurških posegov za odmašitev srčnih krvnih žil.
Arixtra contains the active substance fondaparinux sodium (1.5, 2.5, 5, 7.5 or 10 mg per syringe).
Zdravilo vsebuje zdravilno učinkovino natrijev fondaparinuks (1,5 mg, 2,5 mg, 5 mg, 7,5 mg ali 10 mg na brizgo).
By reducing blood clots, Arixtra can also help the flow of blood to the heart to be maintained in patients with angina or who are having a heart attack.
Poleg zmanjševanja nastanka krvnih strdkov lahko zdravilo Arixtra pomaga bolnikom z angino pektoris ali bolnikom, ki imajo srčni napad, da ohranijo enak pretok krvi v srce.
The main measure of effectiveness of this study was the overall occurrence of VTE or death.
Glavno merilo učinkovitosti študije je bil celokupni pojav venskih tromboemboličnih dogodkov ali smrti.
Arixtra should not be used in people who may be hypersensitive (allergic) to fondaparinux sodium or any of the other ingredients, who might be bleeding already, who have acute bacterial endocarditis (an infection of the heart) or have severe kidney problems.
Zdravila Arixtra ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) natrijev fondaparinuks ali katero koli drugo sestavino zdravila, ter osebe, ki krvavijo ali imajo akutni bakterijski endokarditis (okužbo srca) ali hude težave z ledvicami.
The 2.5 mg strength is also used to treat adults with unstable angina (a type of chest pain that changes in severity due to reduced blood flow to the heart) or who are having a myocardial infarction (heart attack) with or without ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG).
2,5-miligramski odmerek se uporablja tudi za zdravljenje odraslih ljudi z nestabilno angino pektoris (vrsto bolečine v prsih, katere jakost se spreminja zaradi zmanjšanega dotoka krvi v srce) ali miokardnim infarktom (srčnim napadom) z „dvigom spojnice ST“ (nenormalnim izpisom na elektrokardiogramu ali EKG-ju) ali brez njega.
In the prevention studies, Arixtra was compared with other anticoagulants: enoxaparin (in hip or knee surgery; over 8,000 patients) or dalteparin (in abdominal surgery; 2,927 patients).
V študijah za preprečevanje bolezni so zdravilo Arixtra primerjali z drugimi antikoagulanti: enoksaparinom (pri operacijah kolka ali kolena; več kot 8 000 bolnikov) ali dalteparinom (pri operacijah v trebušni votlini; 2 972 bolnikov).
The overall rate of thrombotic events in patients treated with Arixtra was significantly less than in patients treated with placebo or enoxaparin (for patients undergoing leg surgery), and was similar to that seen with enoxaparin (treatment of DVT), dalteparin or unfractionated heparin.
Skupna stopnja trombotičnih dogodkov pri bolnikih, zdravljenih z zdravilom Arixtra, je bila znatno manjša kot pri bolnikih, zdravljenih s placebom ali enoksaparinom (pri bolnikih, operiranih na nogah), oziroma je bila podobna tisti, ugotovljeni pri uporabi enoksaparina (pri zdravljenju globoke venske tromboze), dalteparina ali nefrakcioniranega heparina.
It was also compared with placebo (a dummy treatment) when looking at patients with an acute illness (839 patients) and patients treated for an additional 24 days following hip fracture surgery (656 patients).In the treatment of VTE such as DVT and PE, Arixtra was compared with enoxaparin (DVT: 2,192 patients) or with unfractionated heparin (PE: 2,184 patients).
Prav tako so ga primerjali s placebom (zdravljenjem brez zdravilne učinkovine), in sicer pri bolnikih z akutno boleznijo (839 bolnikov) in pri bolnikih, ki so bili zdravljeni nadaljnjih 24 dni po operaciji zloma kolka (656 bolnikov).Pri zdravljenju venskih tromboemboličnih dogodkov, kot sta globoka venska tromboza in pljučna embolija, so zdravilo Arixtra primerjali z enoksaparinom (globoka venska tromboza: 2 192 bolnikov) ali z nefrakcioniranim heparinom (pljučna embolija: 2 184 bolnikov).
In the treatment of superficial vein thrombosis, Arixtra was compared with placebo in one study of 3,000 patients with superficial vein thrombosis of the legs, without DVT.
Pri zdravljenju površinske venske tromboze so zdravilo Arixtra primerjali s placebo v eni študiji s 3 000 bolniki s površinsko vensko trombozo nog brez globoke venske tromboze.
While there was one VTE or death for every 100 patients taking Arixtra, there were six for every hundred taking placebo.
Venski tromboembolični dogodek ali smrt sta se pojavila pri enem bolniku od 100, ki so jemali zdravilo Arixtra, v primerjavi s šestimi bolniki od 100, ki so jemali placebo.
Arixtra was more effective than placebo in reducing the overall occurrence of VTE or death in patients with superficial vein thrombosis.
Zdravilo Arixtra je bilo pri zmanjševanju celokupnega pojava venskih tromboemboličnih dogodkov ali smrti pri bolnikih s površinsko vensko trombozo učinkovitejše od placeba.
The full EPAR for Arixtra can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Arixtra je na voljo tukaj.
Arixtra (1.5 and 2.5 mg strengths) is also used to treat adults who have blood clots in the superficial veins of the legs (superficial venous thrombosis) but not in their deep veins (deep vein thrombosis, DVT).
Zdravilo Arixtra (v 1,5 in 2,5 mg) je mogoče uporabljati tudi za zdravljenje odraslih, ki imajo krvne strdke in površinskih venah nog (površinska venska tromboza), a ne v globokih venah (globoka venska tromboza, DVT).
At higher strengths (5, 7.5 and 10 mg), Arixtra is used to treat DVT or pulmonary embolism (PE, clot in a blood vessel supplying the lungs).
Zdravilo Arixtra v večjih jakostih (5 mg, 7,5 mg in 10 mg) se uporablja za zdravljenje globoke venske tromboze ali pljučne embolije (PE, tj. strdkov v krvnih žilah, ki oskrbujejo pljuča).
Arixtra has been studied for the prevention of and in the treatment of VTE.
Zdravilo Arixtra so proučevali z vidika preprečevanja in zdravljenja venskih tromboemboličnih dogodkov.
In the prevention of VTEs, the recommended dose of Arixtra is 2.5 mg once a day by subcutaneous injection (under the skin).
Za preprečevanje tromboemboličnih dogodkov je priporočeni odmerek zdravila Arixtra 2,5 mg enkrat na dan, ki se daje s subkutano injekcijo (pod kožo).
In the treatment of DVT or PE, the recommended dose is 7.5 mg once a day by subcutaneous injection, usually for seven days.
Pri zdravljenju globoke venske tromboze ali pljučne embolije je priporočeni odmerek 7,5 mg enkrat na dan, ki se daje s subkutano injekcijo, navadno sedem dni.
Arixtra (1.5 and 2.5 mg strengths) is used to prevent venous thromboembolic events (VTEs, problems due to the formation of blood clots in the veins) in adults (aged 18 years or over) who are having major surgery to their legs, such as a hip or knee surgery.
Zdravilo Arixtra (jakosti 1,5 mg in 2,5 mg) se uporablja za preprečevanje venskih tromboemboličnih dogodkov (VTE, tj. zapletov, ki jih povzročajo krvni strdki) pri bolnikih (starejših od 18 let) po velikih operativnih posegih na nogah, kot so operativno zdravljenje kolka ali kolena.
How does Arixtra work?
Kako zdravilo Arixtra deluje?
What is Arixtra used for?
Za kaj se zdravilo Arixtra uporablja?
For patients with unstable angina or myocardial infarction, the recommended dose is 2.5 mg once daily by subcutaneous injection, but the first dose is given intravenously (into a vein) through an existing line or as an infusion (drip) in patients with ST segment elevation.
Za bolnike z nestabilno angino pektoris ali miokardnim infarktom je priporočeni odmerek 2,5 mg enkrat na dan s subkutano injekcijo, pri čemer se prvi odmerek daje intravensko (v veno) skozi obstoječo cevko ali kot infuzijo (kapalno infuzijo) pri bolnikih z dvigom spojnice ST. Zdravljenje se mora pričeti takoj po diagnozi in mora trajati do osem dni ali do odpusta bolnika iz bolnišnice.
In the treatment of superficial vein thrombosis, the recommended dose is 2.5 mg once a day by subcutaneous injection.
Pri zdravljenju površinske venske tromboze znaša priporočeni odmerek zdravila Arixtra 2,5 mg enkrat, ki se daje s subkutano injekcijo.
How has Arixtra been studied?
Kako je bilo zdravilo Arixtra raziskano?
What is Arixtra?
Kaj je zdravilo Arixtra?
How is Arixtra used?
Kako se zdravilo Arixtra uporablja?
The first compared the effects of Arixtra with those of enoxaparin in over 20,000 patients with unstable angina or myocardial infarction without ST segment elevation, and the second compared Arixtra with standard care (unfractionated heparin in eligible patients, or placebo) in over 12,000 patients with myocardial infarction with ST segment elevation.
V drugi študiji pa so primerjali učinke zdravila Arixtra s standardnim zdravljenjem (nefrakcioniranim heparinom pri ustreznih bolnikih ali s placebom) pri več kot 12 000 bolnikih s miokardnim infarktom z dvigom spojnice ST.
Arixtra was at least as effective as the comparators in all of the studies that looked at the prevention of VTE and treatment of DVT and PE.
Zdravilo Arixtra je bilo v vseh študijah, v katerih so proučevali preprečevanje venskih tromboemboličnih dogodkov in zdravljenje globoke venske tromboze in pljučne embolije, vsaj tako učinkovito kot primerjalna zdravila.
It is important to tell your doctor if you are taking:
Pomembno je, da zdravniku poveste, če jemljete:
• if you are going to have an operation under anaesthesia.
• če boste imeli operacijo v anesteziji.
• at least two to four times a year in patients with serum creatinine levels at the upper limit of normal and in elderly subjects
• vsaj dva- do štirikrat letno pri bolnikih z ravnjo kreatinina v serumu na zgornji meji normalne vrednosti in pri starejših bolnikih.
Make sure to ask your doctor for advice regarding when you can start your treatment again;
Zdravnika morate vprašati za nasvet, kdaj se lahko ponovno začnete zdraviti;
Signs of ‘lactic acidosis' are:
Znaki “laktacidoze” so:
Erythema3 Urticaria3
eritem3 urtikarija3
• if you have problems with your liver;
• če imate težave z ledvicami;
• Renal failure or renal dysfunction (creatinine clearance <60 ml/min).
• Ledvična odpoved ali ledvična disfunkcija (kreatininski očistek < 60 ml/min).
Consumption of alcohol and medicinal products containing alcohol should be avoided.
Pitje alkohola in jemanje zdravil, ki vsebujejo alkohol, se odsvetujeta.
Follow your doctor's instructions about stopping and re-starting your medicine.
Upoštevajte priporočila zdravnika o prekinitvi in ponovnem začetku jemanja zdravila.
This is a build-up of lactic acid in the blood that can cause death.
To je kopičenje mlečne kisline v krvi, ki lahko povzroči smrt.
Further symptoms are reduced body temperature and heart beat.
Dodatna simptoma sta znižana telesna temperatura in zmanjšan srčni utrip.
Due to the mechanism of action, decreased renal function will result in reduced efficacy of empagliflozin.
Zaradi mehanizma delovanja bo zmanjšano delovanje ledvic povzročilo zmanjšano učinkovitost empagliflozina.
This helps to lower blood sugar levels, which are too high in patients with type 2 diabetes.
To pripomore k zniževanju ravni krvnega sladkorja, ki so pri bolnikih s sladkorno boleznijo tipa 2 previsoke.
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), or very rare (<1/10,000), and not known (cannot be estimated from the available data).
Pogostnosti so opredeljene kot zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥ 1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000) in zelo redki (<1/10.000) ali neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Synjardy should be discontinued, at least temporarily, until the situation is clarified.
Jemanje zdravila Synjardy je treba vsaj začasno prekiniti, dokler se stanje ne razjasni.
Ketoacidosis is a condition in which substances called ‘ketone bodies' accumulate in the blood and which can lead to diabetic precoma.
Ketoacidoza je stanje, v katerem se snovi, imenovane ‘ketonska telesa', nakopičijo v krvi, in lahko privede do diabetične predkome.
As this medicinal product contains metformin, the treatment must be discontinued 48 hours before elective surgery with general, spinal or peridural anaesthesia.
Ker to zdravilo vsebuje metformin, je treba zdravljenje z njim prekiniti 48 ur pred elektivnim kirurškim posegom v splošni, spinalni ali epiduralni anesteziji.
Patients should be instructed to notify these signs immediately to their physicians if they occur, notably if patients had a good tolerance to Synjardy before.
Bolnikom naročite, da ob pojavu navedenih znakov nemudoma obvestijo svojega zdravnika, zlasti, če so bolniki pred tem dobro prenašali zdravilo Synjardy.
By blocking this protein, the medicine causes blood sugar to be removed via the urine.
Z zaviranjem te beljakovine zdravilo povzroča izločanje krvnega sladkorja z urinom.
Stop taking Synjardy and see a doctor as soon as possible if you notice any of the following serious or potentially serious side effects:
Takoj prenehajte jemati zdravilo Synjardy in se posvetujte z zdravnikom, če opazite katerega od naslednjih resnih ali potencialno resnih neželenih učinkov:
Physicians should alert the patients on the risk and on the symptoms of lactic acidosis.
Zdravniki morajo bolnike opozoriti o tveganju in simptomih laktacidoze.
Reintroduction of Synjardy should then be discussed taking into account the benefit/risk ratio in an individual basis as well as renal function.
O ponovni uvedbi zdravila Synjardy se je treba pogovoriti ob upoštevanju razmerja med koristjo in tveganjem pri posamezniku ter delovanja ledvic.
If necessary, the dose of the anti-hyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Po potrebi je treba med zdravljenjem z drugim zdravilom ali ob njegovi ukinitvi prilagoditi odmerek antihiperglikemičnega zdravila.
In these cases, it is also recommended to check renal function before initiating treatment with Synjardy.
V tovrstnih primerih je priporočljivo tudi preveriti delovanje ledvic pred pričetkom zdravljenja z zdravilom Synjardy.
Your doctor may ask you to stop taking Synjardy until you recover to prevent loss of too much body fluid;
Vaš zdravnik vam bo morda naročil, da zdravilo Synjardy prenehate jemati, dokler ne okrevate, da preprečite izgubo prevelike količine telesnih tekočin;
Please note the following particular risk of lactic acidosis.
Bodite pozorni predvsem na naslednja tveganja za laktacidozo.
Possible signs of losing too much fluid from your body are listed in section 4 ‘Possible side effects'.
Možni znaki pretirane izgube tekočine iz telesa so našteti v poglavju 4, “Možni neželeni učinki”;
This medicinal product must not be used in patients with moderate or severe renal impairment (creatinine clearance <60 ml/min) (see sections 4.3 and 4.4).
To zdravilo se ne sme uporabljati pri bolnikih z zmerno ali hudo ledvično okvaro (kreatininski očistek < 60 ml/min) (glejte poglavji 4.3 in 4.4).
Patients (%) achieving
Bolniki (%) z izhodiščno vrednostjo
Body Weight (kg) at week 52b
Telesna masa (kg) v 52. tednu b
In the acute conditions listed, metformin should be temporarily discontinued.
Ob navedenih akutnih stanjih je treba začasno prekiniti zdravljenje z metforminom.
You will need to tell your doctor and stop taking this medicine before, or at the time of the X-ray and for 2 or more days after depending on how your kidneys are working.
O tem boste morali obvestiti zdravnika in prenehati jemati to zdravilo pred ali na dan rentgenskega slikanja ter še 2 ali več dni po preiskavi, odvisno od delovanja ledvic.
It is important to you to comply with your medication intake, dietary instructions and regular exercise program because this can reduce the risk of lactic acidosis.
Pomembno je, da pravilno jemljete zdravilo in upoštevate navodila glede prehrane ter program redne telesne vadbe, saj lahko s tem zmanjšate tveganje za nastanek laktacidoze.
N SBP (mmHg)3
N Vrednost SBP (mmHg)2
• a medicine used to remove water from the body (diuretic), as Synjardy may increase the risk of losing too much fluid.
• zdravilo, ki iz telesa odvaja tekočino (diuretik), saj lahko zdravilo Synjardy poveča tveganje za pretirano izgubo tekočine.
The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Bolnika je treba s tem seznaniti in zlasti na začetku zdravljenja s temi zdravili pogosteje spremljati njegovo raven glukoze v krvi.
Lactic acidosis is a very rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation.
Laktacidoza je zelo redek, ampak resen presnovni zaplet (zaradi visoke umrljivosti, če ni takojšnjega zdravljenja), ki ga lahko povzroči kopičenje metformina.
It particularly affects patients whose kidneys are not working properly.
Zlasti prizadene bolnike, ki imajo težave z delovanjem ledvic.
In case of lactic acidosis, the patient should be hospitalised immediately (see section 4.9).
Ob pojavu laktacidoze je treba bolnika nemudoma sprejeti v bolnišnico (glejte poglavje 4.9).
Synjardy can also be combined with other medicines.
Zdravilo Synjardy se lahko uporablja tudi v kombinaciji z drugimi zdravili.
Decreased renal function in elderly patients is frequent and asymptomatic.
Zmanjšano delovanje ledvic je pri starejših ljudeh pogosto in asimptomatično.
a derived from postmarketing experience b see section 4.4
a Izhaja iz izkušenj v obdobju trženja b