natgillin/translations-raw huggingface dataset:
The marketing authorisation was renewed on 21 March 2007.
Dovoljenje za promet z zdravilom je bilo podaljšano 21. marca 2007.
For patients having surgery, the first dose should be given six hours after the end of the operation.
Bolnikom, ki so prestali operacijo, se začetni odmerek daje šest ur po zaključku operacije.
Other information about Quixidar:
Druge informacije o zdravilu Quixidar:
Blood clotting can be a problem when blood flow is disturbed in any way.
Strjevanje krvi lahko predstavlja resno težavo, če je pretok krvi na kakršen koli način oviran.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) QUIXIDAR EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) QUIXIDAR Povzetek EPAR za javnost
For the full list of restrictions, see the Package Leaflet.
Za celoten seznam omejitev glejte Navodilo za uporabo.
It can also be used in patients at high risk (because of their age or disease) when they have abdominal surgery, especially for cancer, or when they are forced to stay in bed because of an acute illness.
Prav tako se ga lahko uporablja pri bolnikih, pri katerih obstaja povečano tveganje (zaradi njihove starosti ali bolezni) pri kirurških posegih v trebušni votlini, še posebej v primeru raka, ali pri bolnikih, ki so primorani ostati v postelji zaradi akutne bolezni.
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 skupna stopnja trombotičnih dogodkov (zapletov zaradi krvnih strdkov).
The European Commission granted a marketing authorisation valid throughout the European Union for Quixidar on 21 March 2002.
Evropska komisija je dovoljenje za promet z zdravilom Quixidar, veljavno po celotni Evropski uniji, odobrila dne 21. marca 2002.
The main measure of effectiveness was the proportion of patients who died or had an ‘ischaemic event' (restriction of blood supply to an organ, including the heart).
Glavno merilo učinkovitosti je bil delež bolnikov, ki so umrli ali so imeli „ishemični dogodek“ (omejitev dotoka krvi do organov, vključno do srca).
Treatment should be continued until the risk of VTE has been reduced, usually at least five to nine days after surgery.
Z zdravljenjem je treba nadaljevati, dokler se tveganje za vensko tromboembolične dogodke ne zmanjša, navadno vsaj pet do devet dni po operaciji.
However, these results were insufficient to show whether Quixidar was more effective than unfractionated heparin or not.
Vendar ti rezultati niso bili zadostni, da bi pokazali, da je zdravilo Quixidar bilo bolj učinkovito kot nefrakcionirani heparin.
For patients who have kidney problems, Quixidar may not be suitable, or the lower 1.5-mg dose may be used.
Za bolnike, ki imajo težave s ledvicami, zdravilo Quixidar morda ni ustrezno, oziroma se lahko uporabi znižani, 1,5 mg odmerek.
The Committee recommended that Quixidar be given marketing authorisation.
Zato je odbor priporočil, da se za zdravilo Quixidar podeli dovoljenje za promet.
As with other antithrombotic medicines, the most common side effect of Quixidar is bleeding.
Kot pri vseh drugih antitrombotičnih zdravilih je najpogostejši neželeni učinek zdravila Quixidar krvavenje.
By using Quixidar after surgery, the risk of a blood clot forming is greatly reduced.
Z uporabo zdravila Quixidar po operaciji se tveganje za nastanek krvnih strdkov močno zmanjša.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Za več informacij glejte Povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
When this is blocked, no thrombin (another factor) can be produced, and no clot can be formed.
Če je ta blokiran, se trombin (drugi faktor) ne more več tvoriti, zaradi česar tudi krvni strdki ne morejo več nastajati.
What benefit has Quixidar shown during the studies?
Kakšne koristi je zdravilo Quixidar izkazalo med raziskavami?
What is the risk associated with Quixidar?
Kakšna tveganja so povezana z zdravilom Quixidar?
Quixidar contains the active substance fondaparinux sodium (1.5, 2.5, 5, 7.5 or 10 mg per syringe).
Quixidar vsebuje zdravilno učinkovino natrijev fondaparinuks (1,5 mg, 2,5 mg, 5 mg, 7,5 mg ali 10 mg na brizgo).
Quixidar is a solution for injection in a prefilled syringe.
Zdravilo Quixidar je raztopina za injiciranje v napolnjeni injekcijski brizgi.
Quixidar is not recommended in patients who are about to undergo certain types of PCI.
Zdravila Quixidar se ne priporoča bolnikom, ki so pred določenimi vrstami perkutane koronarne intervencije.
Quixidar is an anticoagulant; it prevents the blood from coagulating (clotting).
Zdravilo Quixidar je antikoagulant - preprečuje koagulacijo (strjevanje) krvi.
Quixidar 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 Quixidar 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 približno 5 % bolnikov v vsaki skupini umrlo ali imelo ishemični dogodek po devetih dneh.
For the full list of all side effects reported with Quixidar, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Quixidar, glejte Navodilo za uporabo.
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).
Prav tako so ga primerjali s placebom (zdravljenje 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).
The active ingredient in Quixidar, fondaparinux sodium, stops one of the substances (factors) that are involved in the clotting of blood, Factor Xa.
Zdravilna učinkovina natrijev fondaparinuks, ki se nahaja v zdravilu Quixidar, blokira eno od snovi (faktorjev), ki sodelujejo pri strjevanju krvi, in sicer faktor Xa.
In the study of myocardial infarction with ST segment elevation, Quixidar 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 Quixidar v primerjavi s standardnim zdravljenjem zmanjšalo tvaganje smrti ali ponovnega srčnega napada za 14 % po 30 dneh.
The effectiveness of Quixidar has been studied for the prevention of and in the treatment of VTE.
Učinkovitost zdravila Quixidar je bila preučevana z vidika preprečevanja in zdravljenja venskih tromboemboličnih dogodkov.
Why has Quixidar been approved?
Zakaj je bilo zdravilo Quixidar odobreno?
The 2.5 mg strength is also used to treat patients with unstable angina (a type of chest pain that changes in severity) or who are having a myocardial infarction (heart attack):
Odmerek jakosti 2,5 mg se uporablja tudi za zdravljenje bolnikov z nestabilno angino pektoris (vrsto bolečine v prsih, katere jakost se naglo spreminja) ali bolnikov, ki imajo miokardni infarkt (srčni napad):
Quixidar 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 Quixidar se ne sme uporabljati pri osebah, ki so preobčutljive za (alergične na) natrijev fondaparinuks ali katerokoli drugo sestavino zdravila, ter pri osebah, ki krvavijo ali imajo akutni bakterijski endokarditis (okužbo srca) ali hude težave z ledvicami.
Quixidar has also been studied in two main studies of patients with unstable angina or myocardial infarction.
Zdravilo Quixidar so raziskovali v dveh glavnih študijah bolnikov z nestabilno angino pektoris ali miokardnim infarktom.
By reducing blood clots, Quixidar 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 Quixidar pomaga bolnikom z angino pektoris ali bolnikom, ki imajo srčni napad, da ohranijo pretok krvi v srce.
In the prevention of VTEs, the recommended dose of Quixidar is 2.5 mg once a day by subcutaneous injection (under the skin).
Za preprečevanje tromboemboličnih dogodkov je priporočeni odmerek zdravila Quixidar 2,5 mg enkrat dnevno, ki se daje s subkutano injekcijo (pod kožo).
The overall rate of thrombotic events in patients treated with Quixidar 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 Quixidar, 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.
The Committee for Medicinal Products for Human Use (CHMP) decided that Quixidar's benefits are greater than its risks in both the prevention and the treatment of VTEs, unstable angina and myocardial infarction.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Quixidar tako pri preprečevanju kot zdravljenju venskih trombotičnih dogodkov, nestabilne angine pektoris in miokardnega infarkta večje od z njim povezanih tveganj.
In the prevention studies, Quixidar 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 Quixidar primerjali z drugimi antikoagulanti: enoksaparinom (pri operacijah kolka ali kolena; več kot 8000 bolnikov) ali z dalteparinom (pri operacijah v trebušni votlini; 2972 bolnikov).
• without ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) in patients who are not going to undergo urgent angioplasty (within two hours): angioplasty or
• brez „dviga spojnice ST“ (nenormalen izpis na elektrokardiogramu ali EKG) pri bolnikih, ki ne bodo prestali nujne angioplastike (v okviru dveh ur): angioplastika ali perkutana koronarna intervencija (PCI) je operacija za odpravo blokade srčnih krvnih žil,
At higher strengths (5, 7.5 and 10 mg), Quixidar is used to treat VTEs such as deep vein thrombosis (DVT, a blood clot in the leg) or pulmonary embolism (PE, blood clot in the lung).
Zdravilo Quixidar v večjih jakostih (5, 7,5 in 10 mg) je mogoče uporabljati za zdravljenje tromboemboličnih dogodkov, kot npr. globoke venske tromboze (DVT, krvni strdek v nogi) ali pljučne embolije (PE, krvni strdek v pljučih).
Quixidar (1.5 and 2.5 mg strengths) is used to prevent venous thromboembolic events (VTEs, problems caused by blood clots) in patients who are having major surgery to their legs, such as a hip replacement or surgery to repair a knee or hip fracture.
Zdravilo Quixidar (jakosti 1,5 in 2,5 mg) se uporablja za preprečevanje venskih tromboemboličnih dogodkov (VTE, zapletov, ki jih povzročajo krvni strdki) pri bolnikih po velikih operativnih posegih na nogah, kot so zamenjava kolka ali operativno zdravljenje kolena ali zloma kolka.
In the treatment of VTE, Quixidar was compared with enoxaparin (DVT: 2,192 patients) or with unfractionated heparin (PE: 2,184 patients).
Pri zdravljenju venskih tromboemboličnih dogodkov so zdravilo Quixidar primerjali z enoksaparinom (globoka vensko tromboza: 2192 bolnikov) ali z nefrakcioniranim heparinom (pljučna embolija: 2184 bolnikov).
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 zdravila Quixidar 7,5 mg enkrat dnevno, ki se daje s subkutano injekcijo navadno sedem dni.
The full EPAR for Quixidar can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Quixidar je na voljo tukaj.
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 dnevno 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. Z zdravljenjem se mora pričeti takoj po diagnozi in mora trajati do osem dni ali dokler bolnik ne odide iz bolnišnice.
How has Quixidar been studied?
Kako je bilo zdravilo Quixidar raziskano?
What is Quixidar used for?
Za kaj se zdravilo Quixidar uporablja?
How is Quixidar used?
Kako se zdravilo Quixidar uporablja?
• with ‘ST segment elevation' in patients who are receiving thrombolytic medicines (‘clot busters')
• z „dvigom spojnice ST“ pri bolnikih, ki prejemajo trombolitična zdravila („razkrojevalci strdkov clot busters“) ali ki niso pred prejemom katerega koli drugega zdravljenja za obnovitev krvnega pretoka v srce.
The first compared the effects of Quixidar with those of enoxaparin in over 20,000 patients with unstable angina or myocardial infarction without ST segment elevation, and the second compared Quixidar 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 Quixidar s standardnim zdravljenjem (nefrakcioniranim heparinom pri ustreznih bolnikih ali s placebom) pri več kot 12.000 bolnikih z miokardnim infarktom z dvigom spojnice ST.
What is Quixidar?
Kaj je zdravilo Quixidar?
Date of first authorisation: 17 January 2007 Date of latest renewal: 17 January 2012
Datum prve odobritve: 17. januar 2007 Datum zadnjega podaljšanja: 17. januar 2012
(It is also better to avoid Imprida in early pregnancy, see Pregnancy section).
(Zdravilu Imprida se je bolje izogibati tudi v zgodnji nosečnosti, glejte poglavje Nosečnost).
In two long-term follow-up studies the effect of Imprida was maintained for over one year.
V dveh dolgoročnih spremljevalnih študijah se je učinek zdravila Imprida ohranil več kot eno leto.
Imprida with food and drink
Zdravilo Imprida skupaj s hrano in pijačo
if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6).
če ste alergični na valsartan ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Your doctor will normally advise you to stop taking Imprida before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Imprida.
Zdravnik vam bo praviloma svetoval, da prenehate z jemanjem zdravila Imprida še preden zanosite oziroma takoj, ko ugotovite da ste noseči in vam bo svetoval jemanje drugega zdravila namesto zdravila Imprida.
It is recommended to take Imprida with some water.
Zdravilo Imprida je priporočljivo vzeti z malo vode.
Imprida and older people (age 65 years or over) Your doctor should exercise caution when increasing your dose.
Zdravilo Imprida in starejši ljudje (stari 65 let ali več) Zdravnik mora biti pri zviševanju vašega odmerka previden.
Children and adolescents The use of Imprida in children and adolescents is not recommended (aged below 18 years old).
Otroci in mladostniki Zdravila Imprida ni priporočljivo uporabljati pri otrocih in mladostnikih (starih manj kot 18 let).
Patients taking Imprida and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Bolniki, ki jemljejo zdravilo Imprida in vozijo motorna vozila ali uporabljajo stroje, morajo upoštevati, da se lahko občasno pojavi omotica ali utrujenost.
See also information under the heading “Do not take Imprida”.
Glejte tudi informacije pod naslovom “Ne jemljite zdravila Imprida”.
Imprida is not recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Jemanje zdravila Imprida v zgodnjem obdobju nosečnosti (v prvih 3 mesecih) ni priporočljivo, če pa ste noseči več kot 3 mesece, ga ne smete jemati, ker lahko uporaba po tretjem mesecu nosečnosti povzroči resno škodo vašemu otroku.
What Imprida is and what it is used for
Kaj je zdravilo Imprida in za kaj ga uporabljamo
Do not take Imprida if you are allergic to amlodipine or to any other calcium channel blockers.
Ne jemljite zdravila Imprida če ste alergični na amlodipin ali na katerikoli zaviralec kalcijevih kanalčkov.
The safety of Imprida has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Varnost zdravila Imprida so ocenjevali v petih kontroliranih kliničnih študijah s 5.175 bolniki, od katerih jih je 2.613 prejemalo valsartan v kombinaciji z amlodipinom.
Other medicines and Imprida
Druga zdravila in zdravilo Imprida
The safety and efficacy of Imprida in children aged below 18 years have not been established.
Varnost in učinkovitost zdravila Imprida pri otrocih, starih manj kot 18 let, nista bili dokazani.
What Imprida is and what it is used for What you need to know before you take Imprida
Kaj je zdravilo Imprida in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Imprida
• Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the
• Preobčutljivost na zdravilne učinkovine, na dihidropiridinske derivate ali katero koli pomožno
If you have taken too many tablets of Imprida, or if someone else has taken your tablets, consult a doctor immediately.
Če ste vzeli večji odmerek zdravila Imprida, kot bi smeli Če ste vzeli preveč tablet zdravila Imprida, ali je vaše tablete vzel kdo drug, se takoj posvetujte z zdravnikom.
The usual dose of Imprida is one tablet per day.
Običajni odmerek zdravila Imprida je ena tableta na dan.
You can take Imprida with or without food.
Zdravilo Imprida lahko vzamete s hrano ali brez nje.
If you think you may be allergic, talk to your doctor before taking Imprida.
Če domnevate, da bi lahko bili alergični, se posvetujte z zdravnikom, preden vzamete zdravilo Imprida.
For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Imprida containing the same component doses.
Zaradi praktičnosti je možno bolnike, ki dobivajo valsartan in amlodipin v ločenih tabletah/kapsulah, prevesti na zdravilo Imprida, ki vsebuje enaka odmerka sestavin.
To date there is no experience of the safe use of Imprida in patients who have had a recent kidney transplantation.
Doslej ni izkušenj glede varnosti uporabe zdravila Imprida pri bolnikih, ki jim je bila nedavno presajena ledvica.
What you need to know before you take Imprida
Kaj morate vedeti, preden boste vzeli zdravilo Imprida
Interactions common to the combination No drug-drug interaction studies have been performed with Imprida and other medicinal products.
Interakcije pogoste ob kombinaciji Študij medsebojnega delovanja z zdravilom Imprida in drugimi zdravili niso izvedli.
Stopping your treatment with Imprida may cause your disease to get worse.
Če prenehate jemati zdravilo Imprida, se lahko vaša bolezen poslabša.
If you stop taking Imprida
Če ste prenehali jemati zdravilo Imprida
If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with Imprida.
Če je uporabljen tudi diuretik, uporaba zdravila Imprida predvidoma poveča toksične učinke litija.
Talk to your doctor before taking Imprida: if you have been sick (vomiting or diarrhoea).
Pred začetkom jemanja zdravila Imprida se posvetujte s svojim zdravnikom: če vam je bilo slabo (bruhanje ali driska).
Abrupt withdrawal of Imprida has not been associated with a rapid increase in blood pressure.
Nenadna prekinitev zdravila Imprida ni povezana s hitrim zvišanjem krvnega tlaka.
If you get these symptoms, stop taking Imprida and contact your doctor straight away.
Če opazite navedene simptome, takoj prenehajte jemati zdravilo Imprida in obvestite svojega zdravnika.
The amlodipine component of Imprida inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Amlodipin v zdravilu Imprida zavira transmembranski vstop kalcijevih ionov v srčne in žilne gladke mišice.
Imprida is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets.
Zdravilo Imprida je na voljo v pakiranjih, ki vsebujejo 7, 14, 28, 30, 56, 90, 98 ali 280 tablet in v skupnih pakiranjih s 4 škatlami, od katerih vsaka vsebuje 70 tablet, ali z 20 škatlami, od katerih vsaka vsebuje 14 tablet.
Imprida has not been studied in any patient population other than hypertension.
Zdravilo Imprida ni raziskano pri nobeni drugi populaciji razen pri bolnikih s hipertenzijo.
if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za zniževanje krvnega tlaka, ki vsebuje aliskiren.
The rate and extent of absorption of Imprida are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Hitrost in obseg absorpcije zdravila Imprida sta enakovredna biološki uporabnosti valsartana in amlodipina, uporabljenih v ločenih tabletah.
Clinically significant hypotension due to Imprida overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Klinično značilna hipotenzija zaradi prevelikega odmerka zdravila Imprida zahteva srčnožilno podporo, vključno s pogostim nadziranjem delovanja srca in dihal, dviganjem udov ter kontrolo krožečega volumna tekočine in izločanja urina.
Imprida combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Zdravilo Imprida vsebuje dve antihipertenzivni učinkovini s komplementarnima mehanizmoma delovanja za obvladanje krvnega tlaka pri bolnikih z esencialno hipertenzijo: amlodipin spada med zaviralce kalcijevih kanalčkov, valsartan pa med antagoniste angiotenzina II.
If you forget to take Imprida
Če ste pozabili vzeti zdravilo Imprida
Additional information on the individual components Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with Imprida as well, even if not observed in clinical trials or during the post-marketing period.
Dodatne informacije o posameznih zdravilnih učinkovinah Neželeni učinki, opisani za katero od obeh zdravilnih učinkovin (za amlodipin ali valsartan), so lahko tudi neželeni učinki zdravila Imprida, tudi če niso bili ugotovljeni v kliničnih preskušanjih ali v obdobju po prihodu zdravila na trg.
Frequency Imprida Amlodipine Valsartan
Pogostnost Imprida Amlodipin Valsartan
Imprida was also studied in an active-controlled study of 130 hypertensive patients with mean sitting diastolic blood pressure ≥110 mmHg and <120 mmHg.
Zdravilo Imprida so raziskali tudi v študiji, kontrolirani z učinkovino, pri 130 bolnikih s hipertenzijo, ki so imeli srednji diastolični krvni tlak sede ≥110 mm Hg in <120 mm Hg.