FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies in hypertensive patients, Sprimeo had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Slovenian: V kliničnih študijah s hipertenzivnimi bolniki zdravilo Sprimeo ni klinično pomembno vplivalo na vrednosti celokupnega holesterola, holesterola lipoproteinov visoke gostote (HDL holesterola), trigliceridov na tešče, glukoze na tešče in sečne kisline.
English: Aliskiren was devoid of any mutagenic potential in the in vitro and in vivo mutagenicity studies.
Slovenian: Aliskiren ni izražal mutagenega potenciala niti v študijah mutagenosti in vitro niti in vivo.
English: Similar reductions were found when aliskiren was combined with other antihypertensive agents.
Slovenian: Do podobnega znižanja pride tudi pri uporabi aliskirena v kombinaciji z drugimi antihipertenzivnimi zdravili.
English: The incidence of adverse reactions showed no association with gender, age, body mass index, race or ethnicity.
Slovenian: Incidenca neželenih učinkov ni kazala nobene povezanosti s spolom, starostjo, indeksom telesne mase ter z rasno ali etnično pripadnostjo.
English: Its use is therefore not recommended in women who are breast-feeding.
Slovenian: Iz tega razloga uporaba zdravila Sprimeo ni priporočena za matere, ki dojijo.
English: Although aliskiren has known irritation potential, safety margins obtained in humans at the dose of 300 mg during a study in healthy volunteers were considered to be appropriate at 9-11-fold based on faecal concentrations or 6-fold based on mucosa concentrations in comparison with 250 mg/kg/day in the rat carcinogenicity study.
Slovenian: Čeprav je znano, da aliskiren lahko povzroča draženje, so v študiji z zdravimi prostovoljci, ki so prejemali odmerke 300 mg, ugotovili, da obsega okvir še varnih odmerkov 9 do 11-kratne vrednosti glede na koncentracije v blatu oziroma 6-kratne vrednosti glede na koncentracije v sluznici v primerjavi z odmerkom 250 mg/kg/dan v študiji karcinogenosti na podganah.
English: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Sprimeo.
Slovenian: V kontroliranih kliničnih preskušanjih je bila uporaba zdravila Sprimeo občasno povezana s klinično pomembnimi spremembami standardnih laboratorijskih parametrov.
English: Sprimeo is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Slovenian: Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Sprimeo pri otrocih in mladostnikih pod 18 let ni priporočljiva (glejte poglavje 5.2).
English: This condition should be corrected prior to administration of Sprimeo, or the treatment should start under close medical supervision.
Slovenian: Pomanjkanje natrija in/ali hipovolemijo je treba odpraviti pred dajanjem zdravila Sprimeo ali pa je treba zdravljenje uvajati pod strogim zdravniškim nadzorom.
English: As for any medicine that acts directly on the RAAS, Sprimeo should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Slovenian: Tako kot velja za katerokoli drugo zdravilo, ki deluje neposredno na sistem renin-angiotenzin-aldosteron, tudi zdravila Sprimeo ne smete uporabljati v prvem trimesečju nosečnosti oziroma pri ženskah, ki načrtujejo nosečnost, poleg tega je kontraindiciran v drugem in tretjem trimesečju nosečnosti (glejte poglavje 4.3).
English: There have also been reports of peripheral oedema, increase in blood creatinine and severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN) and oral mucosal reactions.
Slovenian: Poročali so tudi o perifernih edemih, zvišanju vrednosti kreatinina v krvi in o hudih kožnih neželenih reakcijah (angl. severe cutaneous adverse reactions, SCAR), vključno s toksično epidermalno nekrolizo (TEN) in reakcijami ustne sluznice.
English: In a 36-week study involving 820 patients with ischaemic left ventricular dysfunction, no changes in ventricular remodelling as assessed by left ventricular end systolic volume were detected with aliskiren compared to placebo on top of background therapy.
Slovenian: V 36-tedenski študiji pri 820 bolnikih z ishemično disfunkcijo levega prekata niso ugotovili sprememb prekatnega remodeliranja (ocenjenega s končnim sistoličnim volumnom v levem prekatu) z aliskirenom v primerjavi s placebom, dodanima osnovnemu zdravljenju.
English: HOW TO TAKE SPRIMEO
Slovenian: KAKO JEMATI ZDRAVILO SPRIMEO
English: If you have accidentally taken too many Sprimeo tablets, consult a doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Sprimeo, kot bi smeli Če ste pomotoma vzeli več tablet zdravila Sprimeo, kot bi smeli, se takoj posvetujte z zdravnikom.
English: Rifampicin, which is an inducer of P-gp, reduced aliskiren bioavailability by approximately 50% in a clinical study.
Slovenian: V klinični študiji je rifampicin, ki je induktor P-gp, zmanjšal biološko uporabnost aliskirena za približno 50 %.
English: If pregnancy is detected during therapy, Sprimeo should be discontinued accordingly.
Slovenian: V primeru, da se med zdravljenjem z zdravilom Sprimeo izkaže, da je ženska noseča, je treba zdravljenje v skladu s tem prekiniti.
English: Grapefruit juice
Slovenian: Grenivkin sok
English: In this study, aliskiren 300 mg was compared to placebo when added to standard of care which included either an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker.
Slovenian: V tej študiji so primerjali aliskiren 300 mg s placebom, pri čemer so enega ali drugega dodajali standardnemu zdravljenju, ki je vključevalo bodisi zaviralec encima angiotenzinske konvertaze ali zaviralec angiotenzinskih receptorjev.
English: Common (affecting less than 1 in 10 patients): Diarrhoea, joint pain (arthralgia), high level of potassium in the blood, dizziness.
Slovenian: Pogosti (pojavijo se pri manj kot 1 od 10 bolnikov): driska, bolečine v sklepih (artralgija), zvišana raven kalija v krvi, omotičnost.
English: Aliskiren is metabolised minimally by the cytochrome P450 enzymes.
Slovenian: Aliskiren se v zelo majhni meri presnavlja z encimi s citokromom P450.
English: Warfarin The effects of Sprimeo on warfarin pharmacokinetics have not been evaluated.
Slovenian: Varfarin Učinkov zdravila Sprimeo na farmakokinetične lastnosti varfarina niso ocenjevali.
English: Therefore the combination of aliskiren with an NSAID requires caution, especially in elderly patients.
Slovenian: Zato je pri uporabi aliskirena z nesteroidnimi protivnetnimi zdravili, posebno pri starejših bolnikih, potrebna previdnost.
English: However, in patients receiving aliskiren there was a significantly higher rate of hyperkalaemia, hypotension and kidney dysfunction when compared to the placebo group.
Slovenian: Vendar je bil med bolniki, ki so prejemali aliskiren, delež hiperkaliemije, hipotenzije in motenega delovanja ledvic značilno večji kot v skupini, ki je prejemala placebo.
English: The recommended dose of Sprimeo is 150 mg once daily.
Slovenian: Priporočeni odmerek zdravila Sprimeo je 150 mg enkrat dnevno.
English: Increased aliskiren exposure during co-administration of CYP3A4 inhibitors that also inhibit P-gp can therefore be expected (see P-glycoprotein interactions below).
Slovenian: Zato je mogoče pričakovati povečano izpostavljenost aliskirenu v času sočasne uporabe tistih zaviralcev CYP3A4, ki zavirajo tudi P-gp (glejte spodaj Medsebojno delovanje s P-glikoproteinom).
English: Relative AUC and Cmax of aliskiren in subjects with renal impairment ranged between 0.8 to 2 times the levels in healthy subjects following single dose administration and at steady state.
Slovenian: Relativne AUC in Cmax aliskirena pri bolnikih z okvaro ledvic so se gibale med 0,8 do 2-kratnimi vrednostmi zdravih oseb po enkratnem odmerku in v stanju dinamičnega ravnovesja.
English: With cessation of treatment, blood pressure gradually returned towards baseline levels over a period of several weeks, with no evidence of a rebound effect for blood pressure or PRA.
Slovenian: Po prenehanju zdravljenja se je krvni tlak v obdobju nekaj tednov postopoma vrnil na izhodiščne vrednosti, pri tem ni bilo nobenih znakov za povratni učinek niti glede krvnega tlaka niti glede delovanja renina v plazmi.
English: 98 film-coated tablets (2x49) (perforated unit-dose blister)
Slovenian: 98 filmsko obloženih tablet (2x49) (perforirani pretisni omoti z
English: The pharmacokinetics of aliskiren were evaluated in patients with varying degrees of renal insufficiency.
Slovenian: Farmakokinetične lastnosti aliskirena so ocenjevali pri bolnikih z različnimi stopnjami ledvične insuficience.
English: MDR1/Mdr1a/1b (P-gp) was found to be the major efflux system involved in intestinal absorption and biliary excretion of aliskiren in preclinical studies.
Slovenian: V predkliničnih študijah so ugotovili, da predstavlja MDR1/Mdr1a/1b (P-gp) najpomembnejši izlivni sistem pri absorpciji aliskirena v črevesju in njegovem izločanju z žolčem.
English: In the event of any signs suggesting a hypersensitivity reaction/angioedema (in particular difficulties in breathing or swallowing, rash, itching, hives or swelling of the face, extremities, eyes, lips and/or tongue, dizziness) patients should discontinue treatment and contact the physician (see section 4.4).
Slovenian: V primeru znakov, ki bi nakazovali preobčutljivostno reakcijo/angioedem (še posebno, če gre za težave z dihanjem ali pri požiranju, izpuščaj, srbenje, koprivnico ali otekanje obraza, okončin, oči, ustnic in/ali jezika, omotico), mora bolnik prekiniti zdravljenje in se obrniti na zdravnika (glejte poglavje 4.4).
English: History of angioedema with aliskiren.
Slovenian: Anamneza angioedema zaradi aliskirena.
English: The most likely manifestations of overdosage would be hypotension, related to the antihypertensive effect of aliskiren.
Slovenian: Najbolj verjetna posledica prevelikega odmerjanja bi bila glede na antihipertenziven učinek aliskirena lahko hipotenzija.
English: P-glycoprotein interactions
Slovenian: Medsebojno delovanje s P-glikoproteinom
English: In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with Sprimeo 300 mg provided additional blood pressure reduction that was comparable to add-on treatment with irbesartan 300 mg or amlodipine 10 mg.
Slovenian: Pri debelih bolnikih s hipertenzijo, ki se niso zadostno odzvali na zdravljenje s hidroklorotiazidom 25 mg, je dodatek zdravila Sprimeo 300 mg povzročil dodatno znižanje krvnega tlaka, ki je bilo primerljivo z dodatkom irbesartana 300 mg ali amlodipina 10 mg.
English: A single dose drug interaction study in healthy subjects has shown that ciclosporin (200 and 600 mg) increases Cmax of aliskiren 75 mg approximately 2.5-fold and AUC approximately 5-fold.
Slovenian: V študiji medsebojnega delovanja zdravil z enkratnim odmerjanjem pri zdravih osebah se je pokazalo, da ciklosporin (200 in 600 mg) zviša Cmax aliskirena (75 mg) približno 2,5-krat, AUC pa približno 5krat.
English: Tolerability was comparable in both treatment arms, however cough was more often reported with the ramipril regimen than the aliskiren regimen (14.2% vs. 4.4%), whilst diarrhoea was more common with the aliskiren regimen than for the ramipril regimen (6.6% vs. 5.0%).
Slovenian: Prenašanje zdravila je bilo v obeh terapevtskih krakih primerljivo, vendar so o kašlju bolj pogosto poročali pri shemi z ramiprilom kot pri shemi z aliskirenom (14,2 % v primerjavi s 4,4 %), medtem ko je bila diareja bolj pogosta pri shemi z aliskirenom kot pri shemi z ramiprilom (6,6 % v primerjavi s 5,0 %).
English: Approximately 0.6% of the dose is recovered in urine following oral administration.
Slovenian: Po peroralni aplikaciji je približno 0,6 % odmerka možno zaslediti v urinu.
English: In patients with marked volume- and/or salt-depletion (e.g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Sprimeo.
Slovenian: Bolniki s pomanjkanjem natrija in/ali hipovolemijo Pri bolnikih s hudim pomanjkanjem natrija in/ali hipovolemijo (na primer pri tistih, ki prejemajo velike odmerke diuretikov) lahko po uvedbi zdravljenja z zdravilom Sprimeo pride do simptomatske hipotenzije.
English: As with other agents acting on the renin-angiotensin system, NSAIDs may reduce the antihypertensive effect of aliskiren.
Slovenian: Tako kot druga zdravila, ki vplivajo na sistem renin-angiotenzin, lahko nesteroidna protivnetna zdravila zmanjšajo antihipertenzivno delovanje aliskirena.
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).
Slovenian: Vsaka filmsko obložena tableta vsebuje 300 mg aliskirena (v obliki hemifumarata).
English: Whereas other agents that inhibit the RAAS (ACEI and angiotensin II receptor blockers (ARB)) cause a compensatory rise in plasma renin activity (PRA), treatment with aliskiren decreases PRA in hypertensive patients by approximately 50 to 80%.
Slovenian: V nasprotju z drugimi učinkovinami, ki zavirajo sistem renin-angiotenzin-aldosteron (zaviralci ACE in antagonisti angiotenzina II) in povzročajo kompenzacijsko zvišanje delovanja renina v plazmi, pa zdravljenje z aliskirenom zniža delovanje renina v plazmi pri hipertenzivnih bolnikih za približno 50 do 80 %.
English: or an “angiotensin 2 receptor blocker” such as valsartan, telmisartan, irbesartan etc.
Slovenian: “zaviralci angiotenzinskih receptorjev 2”, kot so valsartan, telmisartan, irbesartan in podobno.
English: Hypotension was also uncommon (<1%) during combination therapy with other antihypertensive agents.
Slovenian: Hipotenzijo so občasno (pri manj kot 1 %) opažali tudi med zdravljenjem v kombinaciji z drugimi antihipertenzivnimi zdravili.
English: an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.
Slovenian: “zaviralci encima angiotenzinske konvertaze” kot so enalapril, lizinopril, ramipril in podobno,
English: Sprimeo belongs to a new class of medicines called renin inhibitors.
Slovenian: Zdravilo Sprimeo sodi v novo skupino zdravil z imenom zaviralci renina.
English: If co-medication with an agent affecting the level of serum potassium is considered necessary, caution is advisable.
Slovenian: Če je sočasna uporaba zdravila, ki vpliva na koncentracijo kalija v serumu neizogibna, je priporočena previdnost.
English: Healthcare professionals prescribing any agents acting on the RAAS should counsel women of childbearing potential about the potential risk of these agents during pregnancy.
Slovenian: Zdravstveni delavci, ki predpisujejo katerokoli učinkovino, ki deluje na sistem renin-angiotenzin-aldosteron, morajo ženskam v rodni dobi razložiti možna tveganja uporabe teh učinkovin med nosečnostjo.
English: Cases of angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have also been reported in post-marketing experience.
Slovenian: Primere angioedema oziroma simptome, ki kažejo na angioedem, (otekanje obraza, ustnic, grla oziroma žrela in/ali jezika) so opisovali tudi na podlagi izkušenj po prihodu zdravila na trg.
English: Therefore, concomitant use of aliskiren and P-gp potent inhibitors is contraindicated (see section 4.3).
Slovenian: Zato je sočasna uporaba aliskirena in močnih zaviralcev P-gp kontraindicirana (glejte poglavje 4.3).
English: As a result no dose adjustment for Sprimeo or these co-administered medicinal products is necessary.
Slovenian: Iz tega razloga pri sočasni uporabi ni treba prilagajati odmerkov zdravila Sprimeo oziroma navedenih zdravil.
English: Aliskiren 150 mg or 300 mg per day or ramipril 5 mg or 10 mg per day were administered for 36 weeks with optional add-on therapy of hydrochlorothiazide (12.5 mg or 25 mg) at week 12, and amlodipine (5 mg or 10 mg) at week 22.
Slovenian: Bolnikom so 36 tednov dajali aliskiren v odmerku 150 mg ali 300 mg na dan oziroma ramipril v odmerku 5 mg ali 10 mg na dan z možnostjo dodajanja hidroklorotiazida (v odmerku 12,5 mg ali 25 mg) od 12. tedna dalje in amlodipina (v odmerku 5 mg ali 10 mg) od 22. tedna dalje.
English: In healthy subjects, itraconazole (100 mg) increases AUC and Cmax of aliskiren (150 mg) by 6.5-fold and 5.8-fold, respectively.
Slovenian: Pri zdravih osebah itrakonazol (100 mg) zviša AUC in Cmax aliskirena (150 mg) za 6,5-krat oziroma 5,8-krat.
English: P-gp substrates or weak inhibitors
Slovenian: Substrati P-gp ali šibki zaviralci P-gp
English: By inhibiting the enzyme renin, aliskiren inhibits the RAAS at the point of activation, blocking the conversion of angiotensinogen to angiotensin I and decreasing levels of angiotensin I and angiotensin II.
Slovenian: Z zaviranjem encima renina aliskiren zavre delovanje sistema renin-angiotenzin-aldosteron na točki aktivacije, saj zavre pretvorbo angiotenzinogena v angiotenzin I in tako zniža ravni angiotenzina I in angiotenzina II.
English: The assays included in vitro assays in bacterial and mammalian cells and in vivo assessments in rats.
Slovenian: Pri tem so izvajali tako in vitro teste z bakterijskimi in sesalskimi celicami, kot tudi ocenjevanje podgan in vivo.
English: In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of Sprimeo 150 mg had a blood-pressure-lowering effect similar to that obtained by increasing amlodipine dose to 10 mg, but had a lower incidence of oedema (aliskiren 150 mg/amlodipine 5 mg 2.1% vs. amlodipine 10 mg 11.2%).
Slovenian: Pri bolnikih, ki se niso zadostno odzvali na zdravljenje z zaviralcem kalcijevih kanalčkov amlodipinom v odmerku 5 mg, je dodatek zdravila Sprimeo v odmerku 150 mg povzročil učinek zniževanja krvnega tlaka, ki je bil podoben, kot če bi zvišali odmerek amlodipina na 10 mg, vendar je bila incidenca edemov pri tem nižja (aliskiren 150 mg/amlodipin 5 mg: 2,1 %; v primerjavi z amlodipinom 10 mg: 11,2 %).
English: Administration of a single oral dose of 300 mg aliskiren was associated with very minor changes in the pharmacokinetics of aliskiren (change in Cmax of less than 1.2 fold; increase in AUC of up to 1.6 fold) compared to matched healthy subjects.
Slovenian: Pri odmerjanju enkratnega peroralnega odmerka 300 mg aliskirena so bile razlike v farmakokinetiki aliskirena zelo majhne (razlika vrednosti Cmax je bila manj kot 1,2-kratna, povečanje vrednosti AUC pa največ 1,6-kratno) v primerjavi z ustreznimi zdravimi osebami.
English: The most common adverse drug reaction is diarrhoea.
Slovenian: Najpogostejši neželeni učinek zdravila je driska.
English: Preclinical studies indicate that aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion.
Slovenian: Predklinične študije kažejo, da sočasna uporaba aliskirena in ketokonazola zveča absorpcijo aliskirena v prebavilih in zmanjša izločanje z žolčem.
English: In post-marketing experience, renal dysfunction and cases of acute renal failure have been reported in patients at risk (see section 4.4).
Slovenian: Na podlagi izkušenj po prihodu zdravila na trg so pri bolnikih s povečanim tveganjem opisovali ledvično disfunkcijo in primere akutne ledvične odpovedi (glejte poglavje 4.4).
English: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).
Slovenian: Vsaka filmsko obložena tableta vsebuje 150 mg aliskirena (v obliki hemifumarata).
English: Administration of grapefruit juice with aliskiren resulted in a decrease in AUC and Cmax of aliskiren.
Slovenian: Uživanje grenivkinega soka z aliskirenom je zmanjšalo AUC in znižalo Cmax aliskirena.
English: In most patients arterial blood pressure was well controlled at baseline.
Slovenian: Večina bolnikov je imela ob izhodišču urejen krvni tlak.
English: Caution should therefore be exercised when prescribing aliskiren to patients with a history of angioedema, and such patients should be closely monitored during treatment (see section 4.8) especially at the beginning of the treatment.
Slovenian: Poleg tega je treba take bolnike med zdravljenjem skrbno spremljati (glejte poglavje 4.8), zlasti na začetku zdravljenja.
English: Dual blockade of the renin-angiotensin-aldosterone system by combining aliskiren with an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB) is therefore not recommended.
Slovenian: Iz tega razloga dvojno zaviranje sistema renin-angiotenzin-aldosteron s kombinirano uporabo aliskirena z zaviralcem ACE ali z zaviralcem angiotenzinskih receptorjev II ni priporočeno.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) Hypotension, syncope, stroke, hyperkalaemia, and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system (see section 5.1).
Slovenian: Dvojno zaviranje sistema renin-angiotenzin-aldosteron (RAAS, renin-angiotensin-aldosterone system) Pri dovzetnejših osebah so poročali o hipotenziji, sinkopi, možganski kapi, hiperkaliemiji in spremembah ledvične funkcije (vključno z akutno odpovedjo ledvic), zlasti pri uporabi kombinacije zdravil, ki vplivajo na sistem renin-angiotenzin-aldosteron (glejte poglavje 5.1).
English: Treatment with Sprimeo resulted in an overall incidence of adverse reactions similar to placebo up to 300 mg.
Slovenian: Pri zdravljenju z zdravilom Sprimeo je bila pri odmerkih do 300 mg incidenca vseh neželenih učinkov skupaj podobna kot pri placebu.
English: Co-administration of aliskiren with either metformin (↓28%), amlodipine (↑29%) or cimetidine (↑19%) resulted in between 20% and 30% change in Cmax or AUC of Sprimeo.
Slovenian: Ob sočasni uporabi aliskirena z metforminom (↓28 %), amlodipinom (↑29 %) ali s cimetidinom (↑19 %) sta se Cmax ali AUC zdravila Sprimeo spremenila za 20 % do 30 %.
English: Combination therapy studies are available for Sprimeo added to the diuretic hydrochlorothiazide, the calcium channel blocker amlodipine and the beta blocker atenolol.
Slovenian: Izvajali so študije kombiniranega zdravljenja z dodajanjem zdravila Sprimeo diuretiku hidroklorotiazidu, zaviralcu kalcijevih kanalčkov amlodipinu in zaviralcu andrenergičnih receptorjev beta atenololu.
English: Co-administration with aliskiren 150 mg resulted in a 61% decrease in aliskiren AUC and coadministration with aliskiren 300 mg resulted in a 38% decrease in aliskiren AUC.
Slovenian: Sočasna uporaba z aliskirenom v odmerku 150 mg je zmanjšala AUC aliskirena za 61 %, sočasna uporaba z aliskirenom v odmerku 300 mg pa je zmanjšala AUC aliskirena za 38 %.
English: No relevant interactions with atenolol, digoxin, amlodipine or cimetidine have been observed.
Slovenian: Z atenololom, z digoksinom, z amlodipinom in s cimetidinom niso opažali pomembnega medsebojnega delovanja.
English: The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated (see section 4.5).
Slovenian: Sočasna uporaba aliskirena s ciklosporinom in itrakonazolom, ki sta zelo močna zaviralca P-gp, in drugih močnih zaviralcev P-gp (na primer kinidina) je kontraindicirana (glejte poglavje 4.5).
English: In clinical studies Sprimeo has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated GFR < 30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
Slovenian: V kliničnih študijah zdravila Sprimeo niso raziskovali pri hipertenzivnih bolnikih s hudo okvaro ledvic (kreatinin v serumu ≥ 150 μmol/l oziroma 1,70 mg/dl pri ženskah in ≥ 177 μmol/l oziroma 2,00 mg/dl pri moških in/ali ocenjeno GFR < 30 ml/min/1,73 m2), pri bolnikih, ki so se že zdravili z dializo, pri bolnikih z nefrotskim sindromom ali z renovaskularno hipertenzijo.