FrancophonIA/ELRC3.0 huggingface dataset:
English: GIAPREZA will be given to you at the lowest dose that helps you to achieve or maintain your blood pressure.
Slovenian: Zdravilo GIAPREZA boste prejemali v najmanjšem odmerku, ki vam bo pomagal doseči ali ohranjati ustrezen krvni tlak.
English: The plasma half-life of angiotensin II administered intravenously is less than one minute.
Slovenian: Razpolovna doba intravensko danega angiotenzina II v plazmi je manj kot ena minuta.
English: It makes the blood vessels tighten and become narrower, thus increasing blood pressure.
Slovenian: Povzroči stiskanje in oženje krvnih žil, s čimer povzroči zvišanje krvnega tlaka.
English: It is unknown whether angiotensin II or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se angiotenzin II ali njegovi presnovki izločajo v materino mleko.
English: GIAPREZA should only be administered by continuous intravenous infusion under close monitoring of haemodynamics and end-organ perfusion.
Slovenian: Zdravilo GIAPREZA se sme dajati samo z neprekinjeno intravensko infuzijo ob skrbnem spremljanju hemodinamike in perfuzije tarčnih organov.
English: Once an infusion has been established, the dose may be titrated as frequently as every 5 minutes in steps of up to 15 ng/kg per minute, as needed, depending on the patient's condition and target mean arterial pressure.
Slovenian: Po vzpostavitvi infuzije se odmerek lahko titrira tudi na vsakih 5 minut po korakih do 15 ng/kg na minuto, kot je potrebno glede na bolnikovo stanje in ciljni povprečni arterijski tlak.
English: The safety and efficacy of GIAPREZA in children less than 18 years old has not yet been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila GIAPREZA pri otrocih, mlajših od 18 let, še nista dokazani.
English: LIST OF EXCIPIENTS Excipients: mannitol, water for injections, sodium hydroxide, hydrochloric acid
Slovenian: Pomožne snovi: manitol, voda za injekcije, natrijev hidroksid, klorovodikova kislina
English: Concomitant administration of GIAPREZA and other vasopressors may have an additive effect on mean arterial pressure (MAP).
Slovenian: Sočasno dajanje zdravila GIAPREZA in drugih vazopresorjev ima lahko aditiven učinek na povprečni arterijski tlak (MAP - mean arterial pressure).
English: It is not known whether GIAPREZA can affect fertility.
Slovenian: Ni znano, ali zdravilo GIAPREZA vpliva na plodnost.
English: What GIAPREZA looks like and contents of the pack GIAPREZA is presented as a concentrate for solution for infusion (sterile concentrate).
Slovenian: Izgled zdravila GIAPREZA in vsebina pakiranja Zdravilo GIAPREZA je na voljo v obliki koncentrata za raztopino za infundiranje (sterilnega koncentrata).
English: For their inclusion in the study, patients had to have clinical features of high-output shock defined as a cardiac index > 2.3 L/min/m2 or the sum of central venous oxygen saturation > 70% with central venous pressure (CVP) > 8 mmHg.
Slovenian: Da so bili bolniki lahko vključeni v študijo, so morali imeti klinične značilnosti šoka s povečanim minutnim volumnom srca, ki je opredeljen kot srčni indeks 2,3 l/min/m2 ali vsota nasičenosti krvi v centralnih venah s kisikom > 70 % s centralnim venskim tlakom (CVP - central venous pressure) > 8 mmHg.
English: Table 2 lists the adverse reactions recorded in clinical studies in the total safety population treated with GIAPREZA by MedDRA system organ class and frequency.
Slovenian: Preglednica neželenih učinkov V preglednici 2 so neželeni učinki, zabeleženi v kliničnih študijah v celotni populaciji za ocenjevanje varnosti, zdravljeni z zdravilom GIAPREZA, navedeni po organskem sistemu MedDRA in pogostnosti.
English: The solution is a clear, colourless solution free of any visible particles.
Slovenian: Raztopina je bistra in brezbarvna ter ne vsebuje vidnih delcev.
English: There is a limited amount of data from the use of angiotensin II in pregnant women.
Slovenian: Podatki o uporabi angiotenzina II pri nosečnicah so omejeni.
English: In the GIAPREZA-treated group, the median time to reach the target MAP endpoint was 5 minutes.
Slovenian: V skupini, zdravljeni z zdravilom GIAPREZA, je bil mediani čas do ciljne vrednosti MAP 5 minut.
English: GIAPREZA is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies (see section 5.1).
Slovenian: Zdravilo GIAPREZA je indicirano za zdravljenje neodzivne hipotenzije pri odraslih s septičnim ali drugačnim distribucijskim šokom, ki ostajajo hipotenzivni kljub ustrezni restituciji volumna ter dajanju kateholaminov in drugih razpoložljivih vazopresorskih zdravil (glejte poglavje 5.1).
English: Other medicines and GIAPREZA
Slovenian: Druga zdravila in zdravilo GIAPREZA
English: 37/158 patients
Slovenian: 37/158 bolnikov
English: Patients with active bleeding, mesenteric ischaemia, liver failure and MELD score of ≥ 30, CV SOFA score ≤ 3 and patients with extensive burns were also excluded.
Slovenian: Izključeni so bili tudi bolniki z aktivno krvavitvijo, mezenterično ishemijo, odpovedjo jeter in rezultatom po lestvici MELD ≥ 30, rezultatom srčno-žilne komponente po lestvici SOFA ≤ 3 in bolniki z obsežnimi opeklinami.
English: GIAPREZA has only been tested in people with septic and distributive shock.
Slovenian: Zdravilo GIAPREZA so preskušali samo pri bolnikih s septičnim in distribucijskim šokom.
English: GIAPREZA is supplied in a carton as a 1 x 1 ml or 1 x 2 ml single use vial.
Slovenian: Zdravilo GIAPREZA je na voljo v škatli kot 1 x 1 ml ali 1 x 2 ml viala za enkratno uporabo.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 2.5 mg/ml, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na 2,5 mg/ml, kar v bistvu pomeni „brez natrija“.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mg/ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2,5 mg/ml
English: The addition of GIAPREZA may require a reduction in doses of other vasopressors.
Slovenian: Dodajanje zdravila GIAPREZA lahko zahteva zmanjšanje odmerkov drugih vazopresorjev.
English: When you are first given GIAPREZA, it is expected that your blood pressure will increase.
Slovenian: Ko boste prvič prejeli zdravilo GIAPREZA, naj bi se vaš krvni tlak zvišal.
English: Doses as low as 1.25 ng/kg per minute may be used.
Slovenian: Lahko se uporabi tudi tako majhne odmerke, kot je 1,25 ng/kg na minuto.
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede redčenja zdravila pred dajanjem glejte poglavje 6.6.
English: It is important to administer GIAPREZA at the lowest compatible dose to achieve or maintain adequate arterial blood pressure and tissue perfusion (see section 4.4).
Slovenian: Pomembno je, da se zdravilo GIAPREZA daje v najmanjšem združljivem odmerku za doseganje ali vzdrževanje ustreznega arterijskega krvnega tlaka in perfuzije tkiva (glejte poglavje 4.4).
English: 28/52 patients
Slovenian: 28/52 bolnikov
English: Plasma levels of angiotensin II were evaluated at baseline and hour 3 of infusion in the phase 3 pivotal study.
Slovenian: Ravni angiotenzina II v plazmi so ovrednotili v ključni študiji 3. faze ob izhodišču in po treh urah infundiranja.
English: If GIAPREZA is stopped suddenly or stopped too early, you may experience a decrease in your blood pressure or your condition may worsen.
Slovenian: Če zdravilo GIAPREZA odtegnemo nenadoma ali prezgodaj, se vam krvni tlak lahko zniža oziroma se vam stanje poslabša.
English: If you have too much GIAPREZA, you may experience high blood pressure.
Slovenian: Če ste prejeli prevelik odmerek zdravila GIAPREZA, boste morda imeli visok krvni tlak.
English: GIAPREZA will be given to you in a hospital by a doctor or a nurse.
Slovenian: Kako uporabljati zdravilo GIAPREZA Zdravilo GIAPREZA vam bo v bolnišnici dal zdravnik ali medicinska sestra.
English: Patients also had to have catecholamine refractory hypotension (CRH) defined as requiring a total sum vasopressor dose of > 0.2 mcg/kg/min for 6 to 48 hours, to maintain a mean arterial pressure (MAP) between 55-70 mmHg and receiving at least 25 mL/kg of crystalloid or colloid equivalent over the previous 24-hour period and be adequately volume resuscitated in the opinion of the treating investigator.
Slovenian: Bolniki so morali imeti tudi hipotenzijo, neodzivno na zdravljenje s kateholamini (CRHcatecholamine refractory hypotension), opredeljeno kot hipotenzija, pri kateri je potreben skupen odmerek vazopresorjev > 0,2 μg/kg/min v obdobju od 6 do 48 ur za vzdrževanje povprečnega arterijskega tlaka (MAP) med 55 in 70 mmHg in prejemanje ekvivalenta vsaj 25 ml kristaloidov ali koloidov na kg v predhodnem 24-urnem obdobju; po mnenju lečečega raziskovalca so morali biti ustrezno zdravljeni z nadomeščanjem volumna.
English: Of them, 5 cases (3.1%) in the GIAPREZA arm and 3 (1.9%) cases in the placebo arm were considered serious.
Slovenian: Med njimi je bilo kot resnih ocenjenih 5 primerov (3,1 %) v skupini, ki je prejemala zdravilo GIAPREZA, in 3 primeri (1,9 %) v skupini, ki je prejemala placebo.
English: GIAPREZA is titrated to effect for each individual patient.
Slovenian: Zdravilo GIAPREZA pri vsakem bolniku posebej titriramo do učinka.
English: Your doctor should be told if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby before this medicine is given.
Slovenian: Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, obvestite zdravnika,
English: In a 48-hour continuous intravenous administration of angiotensin II in neonatal lambs, the nominal dose rates of 4, 12 and 40 ng/kg/min were well tolerated.
Slovenian: Pri neprekinjenem 48-urnem intravenskem dajanju angiotenzina II novorojenim jagenjčkom so ti nazivne odmerke 4, 12 in 40 ng/kg/min dobro prenašali.
English: Transient hypertension may be promptly mitigated by dose down-titration (see section 4.2).
Slovenian: Prehodno hipertenzijo je mogoče hitro odpraviti z zmanjšanjem odmerka (glejte poglavje 4.2).
English: Non-pharmacologic VTE prophylaxis may be considered where pharmacologic prophylaxis is contraindicated.
Slovenian: Kadar je farmakološka profilaksa kontraindicirana, pride v poštev nefarmakološka profilaksa VTE.
English: The recommended starting dosage of GIAPREZA is 20 nanograms (ng)/kg per minute via continuous intravenous infusion.
Slovenian: Priporočeni začetni odmerek zdravila GIAPREZA je 20 nanogramov (ng)/kg na minuto z neprekinjeno intravensko infuzijo.
English: The recommended starting rate of GIAPREZA is 20 nanograms (ng) per kilogram of your body weight per minute.
Slovenian: Priporočeni začetni odmerek zdravila GIAPREZA je 20 nanogramov (ng) na kilogram telesne mase na minuto.
English: Water for injections Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Slovenian: 6.1 Seznam pomožnih snovi manitol voda za injekcije natrijev hidroksid (za prilagoditev pH) klorovodikova kislina (za prilagoditev pH)
English: There is limited information about the effects of GIAPREZA during pregnancy.
Slovenian: Informacije o učinkih zdravila GIAPREZA med nosečnostjo so omejene.
English: The Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) was a Phase 3 randomised, placebo-controlled, double-blind, international, multi-centre safety and efficacy study in which 321 adults with septic or other distributive shock who remained hypotensive despite fluid and vasopressor therapy were randomised 1:1 to GIAPREZA or placebo.
Slovenian: Študija z naslovom Angiotenzin II za zdravljenje šoka s povečanim minutnim volumnom srca (ATHOS-3) je bila s placebom nadzorovana, dvojno slepa, mednarodna, multicentrična študija varnosti in učinkovitosti 3. faze, v kateri so 321 odraslih s septičnim ali drugačnim distribucijskim šokom, ki so kljub tekočinskemu in vazopresorskemu zdravljenju ostali hipotenzivni, v razmerju 1 : 1
English: GIAPREZA is recommended to be administered via a central venous line.
Slovenian: Zdravilo GIAPREZA je priporočljivo dajati po centralnem venskem katetru.
English: How GIAPREZA is stored 6.
Slovenian: Shranjevanje zdravila GIAPREZA 6.
English: Adding GIAPREZA to these medicines may require that the doses of the other medicines be lowered.
Slovenian: Zaradi dodajanja zdravila GIAPREZA tem zdravilom bo morda treba zmanjšati odmerke teh drugih zdravil.
English: Concentrate for solution for infusion (sterile concentrate).
Slovenian: koncentrat za raztopino za infundiranje (sterilni koncentrat) Bistra in brezbarvna raztopina.
English: What GIAPREZA is and what it is used for
Slovenian: Kaj je zdravilo GIAPREZA in za kaj ga uporabljamo
English: Hypertensive effects are expected to be brief because the half-life of angiotensin II is less than one minute.
Slovenian: Hipertenzivni učinki naj bi bili kratkotrajni, saj je razpolovna doba angiotenzina II
English: Doses of GIAPREZA or placebo were titrated to a target mean arterial pressure (MAP) of ≥ 75 mmHg during the first 3 hours of treatment while doses of other vasopressors were maintained.
Slovenian: Odmerek zdravila GIAPREZA ali placeba so titrirali do ciljnega povprečnega arterijskega tlaka (MAP) ≥ 75 mmHg v prvih treh urah zdravljenja,
English: The primary endpoint was achieved by 70% of patients randomised to GIAPREZA compared to 23% of placebo subjects; p < 0.0001 (a treatment effect of 47%).
Slovenian: Primarni opazovani dogodek je doseglo 70 % bolnikov, randomiziranih na zdravilo GIAPREZA, in 23 % preiskovancev, randomiziranih na placebo; p < 0,0001 (47-odstotni učinek zdravljenja).
English: Therefore, once underlying shock is sufficiently improved, a slow down-titration is recommended by gradual decrements of up to 15 ng/kg per minute, as needed, based on blood pressure (see sections 4.2 and 4.4).
Slovenian: Ko se osnovni šok dovolj izboljša, se zato priporoča počasno zmanjševanje odmerka v korakih po največ 15 ng/kg na minuto, kot je potrebno glede na krvni tlak (glejte poglavji 4.2 in 4.4).
English: Dilute 1 or 2 ml of GIAPREZA in sodium chloride 9 mg/ml (0.9%) solution for injection to achieve a final concentration of 5,000 ng/ml or 10,000 ng/ml.
Slovenian: Razredčite 1 ali 2 ml zdravila GIAPREZA v raztopini natrijevega klorida 9 mg/ml (0,9 %) za injiciranje, da dobite končno koncentracijo 5.000 ng/ml ali 10.000 ng/ml.
English: ACE inhibitors may increase to the effect of GIAPREZA.
Slovenian: Zaviralci ACE lahko povečajo učinek zdravila GIAPREZA;
English: Pack size of one vial per carton.
Slovenian: Velikost pakiranja je ena viala v škatli.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER La Jolla Pharmaceutical II B.V.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM La Jolla Pharmaceutical II B.V.
English: Of the 321 patients, 227 (71%) were receiving a baseline norepinephrine equivalent dose (NED) < 0.5 mcg/kg/min, 73 patients (23%) were receiving baseline NED ≥ 0.5 to
Slovenian: 227 (71 %) ob izhodišču prejemalo norepinefrinu enakovreden odmerek (NED - norepinephrine equivalent dose) < 0,5 μg/kg/min, 73 bolnikov (23 %) je ob izhodišču prejemalo NED ≥ 0,5 do
English: Patients who have recently received angiotensin converting enzyme (ACE) inhibitors may be more sensitive to GIAPREZA's action with an increased response.
Slovenian: Bolniki, ki so nedavno prejeli zaviralce angiotenzinske konvertaze (ACE - angiotensin converting enzyme), so lahko dovzetnejši za delovanje zdravila GIAPREZA in se odzovejo močneje.
English: Use during pregnancy should be avoided if possible and the potential benefit to the patient weighed against any possible risk to the foetus.
Slovenian: Če je le mogoče, se je treba uporabi med nosečnostjo izogibati ter pretehtati korist za bolnico in tveganje za plod.
English: must be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection prior to use.
Slovenian: Zdravilo je treba pred uporabo razredčiti v raztopini natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: It is important to administer GIAPREZA at the lowest compatible dose to achieve or maintain adequate mean arterial pressure and tissue perfusion.
Slovenian: Pomembno je, da se zdravilo GIAPREZA daje v najmanjšem združljivem odmerku za doseganje ali vzdrževanje ustreznega povprečnega arterijskega tlaka in perfuzije tkiva.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Single-dose.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Enkratni odmerek.
English: Peripheral ischaemia has been reported with the use of angiotensin II (see section 4.8).
Slovenian: Pri uporabi angiotenzina II v kliničnih preskušanjih so poročali o periferni ishemiji (glejte poglavje 4.8).
English: No specific studies have been conducted to investigate the distribution of GIAPREZA.
Slovenian: Za preučitev porazdelitve zdravila GIAPREZA niso izvedli posebnih študij.
English: Breast-feeding should be discontinued during treatment with GIAPREZA.
Slovenian: Med zdravljenjem z zdravilom GIAPREZA je treba prenehati z dojenjem.
English: Dilute before use.
Slovenian: Pred uporabo razredčite.
English: to < 1/1,000), and very rare (< 1/10,000).
Slovenian: občasni (≥ 1/10.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
English: There are limited efficacy and safety data of GIAPREZA in patients > 75 years.
Slovenian: Podatki o učinkovitosti in varnosti zdravila GIAPREZA pri bolnikih, starejših od 75 let, so omejeni.
English: Patients were not necessarily on maximum doses of other vasopressors at the time of randomisation.
Slovenian: Bolniki ob randomizaciji niso nujno prejemali največjih odmerkov drugih vazopresorjev.
English: No special dose adjustment is required in patients with renal insufficiency or those with hepatic impairment (see section 5.2).
Slovenian: Pri bolnikih z okvaro ledvic ali okvaro jeter posebno prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: Animal studies are insufficient with respect to reproductive toxicity.
Slovenian: Ni dovolj študij na živalih o vplivu zdravila na sposobnost razmnoževanja.
English: Patients who have recently received angiotensin II receptor blockers (ARBs) may be less sensitive to GIAPREZA's actions with a reduced response.
Slovenian: Bolniki, ki so nedavno prejeli zaviralce receptorja angiotenzina II (ARB - angiotensin II receptor blocker), so lahko manj dovzetni za delovanje zdravila GIAPREZA in se odzovejo slabše.
English: Discard the vial and any unused portion of the medicinal product after use.
Slovenian: Vialo in neuporabljeno zdravilo po uporabi zavrzite.
English: No special dose adjustment is required in patients over 75 years.
Slovenian: Posebno prilagajanje odmerka pri bolnikih, starejših od 75 let, ni potrebno.
English: Discard prepared solution after 24 hours at room temperature or under refrigeration.
Slovenian: Pripravljeno raztopino po 24 urah shranjevanja pri sobni temperaturi ali v hladilniku zavrzite.
English: In order to minimise adverse events derived from prolonged vasoconstriction, treatment should be withdrawn as soon as the underlying shock is sufficiently improved (see sections 4.2 and 4.4).
Slovenian: Za zmanjšanje neželenih učinkov zaradi dolgotrajne vazokonstrikcije je treba zdravljenje z zdravilom GIAPREZA ukiniti takoj, ko se osnovni šok dovolj izboljša (glejte poglavji 4.2 in 4.4).
English: Impairment of liver or kidneys
Slovenian: Okvara ledvic ali jeter
English: It is not known whether GIAPREZA can pass into breast milk.
Slovenian: Ni še znano, ali se zdravilo GIAPREZA izloča v materino mleko.
English: Frequency of adverse reactions MedDRA System Organ Class Very common
Slovenian: Organski sistem MedDRA Zelo pogosti
English: GIAPREZA should be gradually decreased since patients may experience hypotension or worsening of the underlying diagnosis of shock on abrupt withdrawal or premature discontinuation.
Slovenian: Ukinitev zdravljenja Odmerek zdravila GIAPREZA je treba zmanjševati postopoma, saj se pri nekaterih bolnikih ob nenadni odtegnitvi ali predčasni prekinitvi zdravljenja lahko pojavi hipotenzija ali poslabšanje osnovne diagnoze šoka.
English: Very common side effects (may affect more than 1 in 10 people) are: - Too high blood pressure
Slovenian: Drugi neželeni učinki so: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) so:
English: GIAPREZA may be co-administered with norepinephrine, epinephrine, vasopressin, terlipressin, dopamine, and/or phenylephrine.
Slovenian: Zdravilo GIAPREZA se lahko daje sočasno z norepinefrinom, epinefrinom, vazopresinom,
English: No trials have been conducted to investigate the pharmacokinetics of angiotensin II in renally impaired patients since the kidneys are not a major organ for angiotensin II metabolism or excretion.
Slovenian: Preskušanj za preučevanje farmakokinetike angiotenzina II pri bolnikih z okvaro ledvic niso izvedli, ker ledvice niso glavni organ za presnovo ali izločanje angiotenzina II.
English: If you are given more GIAPREZA than you should GIAPREZA will be given to you by a doctor or a nurse, so it is unlikely you will be given the wrong dose.
Slovenian: Zdravilo GIAPREZA vam bo dal zdravnik ali medicinska sestra, zato ni verjetno, da bi prejeli napačen odmerek.
English: In order to minimise the risk of side effects to this medicine, GIAPREZA will be withdrawn as soon as your condition improves.
Slovenian: Da bi zmanjšali tveganje za neželene učinke zdravila, bo zdravilo GIAPREZA
English: In order to minimise the risk of adverse events derived from prolonged vasoconstriction, treatment with GIAPREZA should be withdrawn once underlying shock is sufficiently improved (see section 4.4 and 4.8).
Slovenian: Za zmanjšanje tveganja neželenih učinkov zaradi dolgotrajne vazokonstrikcije je treba zdravljenje z zdravilom GIAPREZA ukiniti, ko se osnovni šok dovolj izboljša (glejte poglavji 4.4 in 4.8).
English: Baseline APACHE II > 30 17/65 patients
Slovenian: APACHE II > 30
English: More patients experienced venous and arterial thromboembolic events in the GIAPREZA arm compared to placebo arm in the Phase 3 (ATHOS-3) study (21 [12.9%] vs 8 [5.1%]).
Slovenian: Trombembolični dogodki V študiji 3. faze (ATHOS-3) so se arterijski trombembolični dogodki pojavili pri več bolnikih iz skupine, ki je prejemala zdravilo GIAPREZA (21 [12,9 %]), kot pri bolnikih iz skupine, ki je prejemala placebo (8 [5,1 %]).
English: Thromboembolic events have been reported with the use of angiotensin II in clinical trials.
Slovenian: Pri uporabi angiotenzina II v kliničnih preskušanjih so poročali o trombemboličnih dogodkih.
English: No trials have been conducted to investigate the pharmacokinetics of angiotensin II in patients with hepatic impairment since the liver is not a major organ for angiotensin II metabolism or excretion.
Slovenian: Preskušanj za preučevanje farmakokinetike angiotenzina II pri bolnikih z okvaro jeter niso izvedli, ker jetra niso glavni organ za presnovo ali izločanje angiotenzina II.
English: < 1 mcg/kg/min and 21 (6%) patients were receiving high doses of vasopressors (NED ≥ 1.0 mcg/kg/min).
Slovenian: < 1 μg/kg/min, 21 (6 %) bolnikov pa je prejemalo velike odmerke vazopresorjev
English: In a cardiovascular safety pharmacology study in normotensive dogs, GIAPREZA elicited increased heart rate, systemic vascular resistance, left ventricular systolic pressure and left ventricular diastolic pressure, and PR interval prolongation.
Slovenian: povzročilo povečano srčno frekvenco, sistemsko žilno upornost, zvišan sistolični tlak levega prekata in zvišan diastolični tlak levega prekata ter podaljšanje intervala PR.
English: A total of 37 patients (23%) experienced transient hypertension with the angiotensin II 20 ng/kg/min starting dose.
Slovenian: Prehodna hipertenzija Prehodna hipertenzija se je pojavila pri skupaj 37 bolnikih (23 %), ki so prejeli začetni odmerek angiotenzina II 20 ng/kg/min.
English: No specific studies have been conducted to investigate the metabolism and excretion of GIAPREZA.
Slovenian: Za preučitev presnove in izločanja zdravila GIAPREZA niso izvedli posebnih študij.