natgillin/translations-raw huggingface dataset:
The efficacy and safety of aliskiren-based therapy were compared to ramipril-based therapy in a 9month non-inferiority study in 901 elderly patients (≥ 65 years) with essential systolic hypertension.
Djelotvornost i sigurnost terapije temeljene na aliskirenu uspoređivana je s terapijom temeljenom na ramiprilu u 9-mjesečnom ispitivanju neinferiornosti u kojem je sudjelovao 901 stariji bolesnik (≥65 godina) s esencijalnom sistoličkom hipertenzijom.
Single-packs containing 7, 14, 28, 30, 50 or 56 tablets.
Pojedinačna pakiranja sadrže 7, 14, 28, 30, 50 ili 56 tableta.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Not known
Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Nepoznata
Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to hydrochlorothiazide.
Metformin treba primjenjivati s oprezom zbog rizika od laktacidoze izazvane mogućim funkcionalnim zatajenjem bubrega povezanim s hidroklorotiazidom.
Diarrhoeac,a,h, decreased appetiteh, nausea and vomitinga,h
Proljevc,a,h, smanjen apetith, mučnina i povraćanjea,h
The combination of aliskiren and hydrochlorothiazide neutralised the reactive increase of PRA caused by hydrochlorothiazide.
Kombinacija aliskirena i hidroklorotiazida neutralizirala je reaktivno povećanje ARP uzrokovano hidroklorotiazidom.
Special caution is necessary in patients with a hypersensitivity predisposition.
Potreban je poseban oprez u bolesnika sa sklonošću preosjetljivosti.
The antihypertensive effect of Rasilez HCT may be increased with the concomitant use of other antihypertensive agents.
Antihipertenzivni učinak Rasilez HCT-a može se povećati istodobnom primjenom drugih antihipertenzivnih lijekova.
- medicines to increase blood pressure, such as noradrenaline or adrenaline.
Rasilez HCT“ i „Upozorenja i mjere opreza“). - lijekove koji povisuju krvni tlak kao što su noradrenalin ili adrenalin.
Aliskiren plasma protein binding is moderate (47-51%) and independent of the concentration.
Aliskiren se umjereno veže na proteine plazme (47-51%) i vezanje ne ovisi o koncentraciji.
Conversely, it is anticipated that prokinetic substances such as cisapride may decrease the bioavailability of thiazide-type diuretics.
Nasuprot tome, predviđa se da prokinetički lijekovi kao što je cisaprid mogu smanjiti bioraspoloživost tiazidnih diuretika.
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.
Stoga je nužan oprez pri propisivanju aliskirena bolesnicima s angioedemom u anamnezi i te bolesnike je potrebno vrlo pozorno pratiti tijekom liječenja (vidjeti dio 4.8), a osobito na početku liječenja.
Psychiatric disorders Rare
Psihijatrijski poremećaji Rijetko
If this combination proves essential, careful monitoring of serum lithium level is recommended during concomitant use.
Ako je ova kombinacija neophodna, preporučuje se pažljivo praćenje razine litija u serumu tijekom istodobne primjene.
Single-packs containing 7, 14, 28, 30, 50, 56, 90 or 98 tablets.
Pojedinačna pakiranja sadrže 7, 14, 28, 30, 50, 56, 90 ili 98 tableta.
However, in patients receiving aliskiren there was a significantly higher rate of hyperkalaemia, hypotension and kidney dysfunction when compared to the placebo group.
Međutim, u bolesnika koji su primali aliskiren stopa hiperkalijemije, hipotenzije i disfunkcije bubrega bila je značajno viša u usporedbi s placebo skupinom.
Other medicines and Rasilez HCT
Drugi lijekovi i Rasilez HCT
In controlled clinical study, angioedema and hypersensitivity reactions occurred rarely during treatment with aliskiren with rates comparable to treatment with placebo or comparators.
U kontroliranim kliničkim ispitivanjima angioedem i reakcije preosjetljivosti javljali su se rijetko tijekom liječenja aliskirenom uz stope koje se mogu usporediti s liječenjem placebom ili komparatorima.
• Liver disorders which can occur together with yellow skin and eyes
• poremećaj jetre koji može biti popraćen žutilom kože i očiju
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti” i „EXP”.
- if the level of calcium in your blood is too high.
- ako je razina kalcija u Vašoj krvi previsoka.
The mode of action of thiazides is through inhibition of the Na+Cl- symporter by competing for the Cl- site, thereby affecting electrolyte reabsorption mechanisms: directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly by this diuretic action reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.
Način djelovanja tiazida je kroz inhibiciju Na+Cl- simportera nadmetanjem za mjesto vezanja Cl-, čime se utječe na mehanizme reapsorpcije elektrolita: direktno povećanjem izlučivanja natrija i klorida u otprilike jednakoj mjeri, a indirektno smanjenjem volumena plazme putem ovog diuretskog djelovanja, s posljedičnim povećanjima aktivnosti renina u plazmi, izlučivanja aldosterona i gubitka kalija mokraćom te sniženja kalija u serumu.
Rasilez HCT combines two antihypertensive active substances to control blood pressure in patients with essential hypertension: Aliskiren belongs to the class of direct renin inhibitors and hydrochlorothiazide to the class of thiazide diuretics.
Rasilez HCT je kombinacija dvaju antihipertenzivnih djelatnih tvari za kontrolu krvnog tlaka u bolesnika s esencijalnom hipertenzijom: aliskiren pripada skupini direktnih inhibitora renina, a hidroklorotiazid skupini tiazidnih diuretika.
Increased aliskiren exposure during co-administration of CYP3A4 inhibitors that also inhibit P-gp can therefore be expected (see other P-gp references in section 4.5).
Stoga se može očekivati povećana izloženost aliskirenu tijekom istodobne primjene s CYP3A4 inhibitorima koji također inhibiraju P-gp (vidjeti ostale reference za P-gp u dijelu 4.5).
PVC/polychlorotrifluoroethylene (PCTFE) - Alu blisters:
PVC/poliklorotrifluoroetilen (PCTFE) - Al blisteri:
Fertility, pre-natal development and post-natal development were unaffected in rats at doses up to 250 mg/kg/day.
prenatalni razvoj i postnatalni razvoj nije bilo utjecaja u štakora pri dozama do 250 mg/kg/dan.
However, compounds potentially inhibiting organic anion transporting polypeptide-mediated uptake of aliskiren are widely present in fruits, vegetables, and many other plant products.
Međutim, spojevi koji mogu inhibirati unos aliskirena posredovan polipeptidnim prijenosnikom organskih aniona vrlo su rasprostanjeni u voću, povrću, i mnogim drugim biljnim proizvodima.
However, this effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, corticosteroids, laxatives, adrenocorticotropic hormone (ACTH), amphotericin, carbenoxolone, penicillin G, salicylic acid derivatives).
Međutim, može se očekivati da ovaj učinak hidroklorotiazida na kalij u serumu bude pojačan drugim lijekovima povezanim s gubitkom kalija i hipokalijemijom (npr. drugi diuretici koji pojačavaju izlučivanje kalija mokraćom, kortikosteroidi, laksativi, adrenokortikotropni hormon (ACTH), amfotericin, karbenoksolon, penicilin G, derivati salicilatne kiseline).
• Itchy rash (urticarial)
• osip praćen svrbežom (urtikarija)
The study also evaluated the combination of aliskiren and enalapril.
Ispitivanje je također procjenjivalo kombinaciju aliskirena i enalaprila.
In a post-authorisation observational study, the co-administration of aliskiren with ACEIs or ARBs has been associated with an increased risk of angioedema.
U opservacijskom ispitivanju nakon davanja odobrenja, istodobna primjena aliskirena s ACEI-ima ili ARB-ima bila je povezana s povećanim rizikom od angioedema.
The volume or salt depletion should be corrected prior to administration of Rasilez HCT, or the treatment should start under close medical supervision.
Volumen tekućine ili razina natrija se treba ispraviti prije primjene Rasilez HCT, ili liječenje treba započeti uz pomni nadzor liječnika.
Rasilez HCT has been shown to be effective as a once-a-day antihypertensive treatment in adult patients, regardless of gender, age, body mass index and ethnicity.
Rasilez HCT se pokazao učinkovitom antihipertenzivnom terapijom koja se uzima jedanput na dan u odraslih bolesnika, bez obzira na spol, dob, indeks tjelesne mase i etničku pripadnost.
The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
P-gp-a će vjerojatno ovisiti o stupnju inhibicije ovog prijenosnika.
• Combined use of aliskiren with other agents acting on the RAAS.
• istodobna primjena aliskirena s drugim lijekovima koji djeluju na RAAS.
No pharmacokinetic data on Rasilez HCT are available in the paediatric population.
Nisu dostupni farmakokinetički podaci za Rasilez HCT u pedijatrijskoj populaciji.
Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or pre-eclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease.
Hidroklorotiazid se ne smije primjenjivati u liječenju gestacijskog edema, gestacijske hipertenzije ili preeklampsije zbog rizika od smanjenja volumena plazme i hipoperfuzije placente, bez korisnog učinka na tijek bolesti.
P-gp substrates or weak inhibitors
P-gp supstrati ili slabi inhibitori
Therefore, drinks containing plant extracts, including herbal teas, should not be taken together with Rasilez HCT.
Stoga se napitci koji sadrže biljne ekstrakte, uključujući biljne čajeve, ne smiju uzimati zajedno s Rasilez HCT-om.
Wheat starch in this medicine contains only very low levels of gluten and is very unlikely to cause problems if you have coeliac disease.
Pšenični škrob u ovom lijeku sadrži samo vrlo nisku razinu glutena i malo je vjerojatno da će uzrokovati probleme ako imate celijakiju.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) Hypotension, syncope, stroke, hyperkalaemia, and decreased 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).
Dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS) Hipotenzija, sinkopa, moždani udar, hiperkalijemija i smanjena bubrežna funkcija (uključujući akutno zatajenje bubrega) zabilježeni su u osjetljivih pojedinaca, osobito ako su se kombinirali lijekovi koji utječu na taj sustav (vidjeti dio 5.1).
Hypokalaemia may result in muscle spasms and/or accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain antiarrhythmic medicinal products.
Hipokalijemija može rezultirati spazmom mišića i/ili pojačati srčane aritmije povezane s istodobnom primjenom glikozida digitalisa ili određenih antiaritmijskih lijekova.
Hyperkalaemiaa, hyponatraemia c, a, h
Hiperkalijemijaa, hiponatrijemija c, a, h
− Severe renal impairment (GFR < 30 ml/min/1.73 m2).
Teško oštećenje bubrežne funkcije (GFR <30 ml/min/1,73 m2).
Therefore, caution should be exercised when aliskiren is administered with ketoconazole, verapamil or other moderate P-gp inhibitors (clarithromycin, telithromycin, erythromycin, amiodarone).
Stoga je nužan oprez kada se aliskiren primjenjuje s ketokonazolom, verapamilom ili drugim umjerenim P-gp inhibitorima (klaritromicin, telitromicin, eritromicin, amiodaron).
Caution required with concomitant use
Istodobna primjena zahtijeva oprez
Anticholinergic agents and other medicinal products affecting gastric motility The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Antikolinergički lijekovi i drugi lijekovi koji utječu na motilitet želuca Bioraspoloživost tiazidnih diuretika može se povećati antikolinergičkim lijekovima (npr. atropin, biperiden), vjerojatno zbog smanjenja gastrointestinalnog motiliteta i brzine pražnjenja želuca.
Due to the hydrochlorothiazide component, Rasilez HCT is contraindicated in symptomatic hyperuricaemia (see section 4.3).
Zbog hidroklortiazidne komponente, Rasilez HCT je kontraindiciran u simptomatskoj hiperuricemiji (vidjeti dio 4.3).
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).
U slučaju bilo kakvih znakova koji ukazuju na reakciju preosjetljivosti/angioedem (osobito teškoće pri disanju ili gutanju, osip, svrbež, koprivnjača ili oticanje lica, ekstremiteta, očiju, usnica i/ili jezika, omaglica), bolesnici trebaju prekinuti liječenje i obratiti se liječniku (vidjeti dio 4.4).
The rate and extent of absorption of Rasilez HCT are equivalent to the bioavailability of aliskiren and hydrochlorothiazide when administered as individual monotherapies.
Brzina i opseg apsorpcije Rasilez HCT-a ekvivalentni su bioraspoloživosti aliskirena i hidroklorotiazida kada se primjenjuju kao individualne monoterapije.
Not all pack sizes or strengths may be available in your country.
Na tržištu u Vašoj zemlji se ne moraju nalaziti sve veličine pakiranja ili jačine.
Combination therapy studies are available for aliskiren added to the diuretic hydrochlorothiazide, the calcium channel blocker amlodipine and the beta blocker atenolol.
Dostupna su klinička ispitivanja kombinirane terapije aliskirena dodanog diuretiku hidroklorotiazidu, blokatoru kalcijevih kanala amlodipinu and beta-blokatoru atenololu.
Patients with a history of angioedema may be at increased risk of experiencing angioedema during treatment with aliskiren (see sections 4.3 and 4.8).
Bolesnici s angioedemom u anamnezi mogli bi imati povećani rizik pojave angioedema tijekom liječenja aliskirenom (vidjeti dijelove 4.3 i 4.8).
The renal clearance is composed of passive filtration and active secretion into the renal tubule.
Bubrežni klirens se odvija pasivnom filtracijom i aktivnom sekrecijom u bubrežne tubule.
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.
Peroralna primjena jednokratne doze aliskirena od 300 mg bila je povezana s vrlo malim promjenama u farmakokinetici aliskirena (promjena Cmax-a za manje od 1,2 puta, povećanje AUC-a do najviše 1,6 puta) u usporedbi s usporedivim zdravim ispitanicima.
All patients receiving thiazide diuretics should be periodically monitored for imbalances in electrolytes, particularly potassium, sodium and magnesium.
Sve bolesnike koji primaju tiazidne diuretike potrebno je periodički pratiti radi neravnoteže elektrolita, osobito kalija, natrija i magnezija.
If Rasilez HCT is used during breast-feeding, doses should be kept as low as possible.
Ako se Rasilez HCT primjenjuje tijekom dojenja, doze moraju biti najmanje moguće.
The safety and efficacy of Rasilez HCT in children below 18 years have not yet been established.
Sigurnost i djelotvornost Rasilez HCT-a u djece mlađe od 18 godina nije još ustanovljena.
• Skin and lip cancer (Non-melanoma skin cancer)
• rak kože i usana (nemelanomski rak kože)
Although aliskiren has known local (gastrointestinal tract) 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.
Iako aliskiren ima poznat lokalni (gastrointestinalni trakt) iritacijski potencijal, smatra se da sigurnosne granice, koje su tijekom ispitivanja na zdravim dobrovoljcima dobivene u ljudi pri dozi od 300 mg, odgovaraju 9-11 puta većoj dozi na temelju koncentracija u stolici, ili 6 puta većoj dozi na temelju koncentracija u sluznici, u usporedbi s 250 mg/kg/dan u ispitivanju kancerogenosti u štakora.
Organic anion transporting polypeptide (OATP) inhibitors Preclinical studies indicate that aliskiren might be a substrate of organic anion transporting polypeptides.
Inhibitori polipeptidnih prijenosnika organskih aniona (OATP) Pretklinička ispitivanja pokazuju da bi aliskiren mogao biti supstrat polipeptidnih prijenosnika organskih aniona.
Therefore, the use of Rasilez HCT with an NSAID requires caution, especially in elderly patients.
Stoga primjena Rasilez HCT-a s NSAIL-ovima zahtijeva oprez, posebno u starijih bolesnika.
In a pharmacokinetic study of aliskiren treatment in 39 paediatric hypertensive patients aged 6 to 17 years given daily doses of 2 mg/kg or 6 mg/kg aliskiren administered as granules (3.125 mg/tablet), pharmacokinetic parameters were similar to those in adults.
U farmakokinetičkom ispitivanju liječenja aliskirenom u 39 pedijatrijskih hipertenzivnih bolesnika u dobi od 6 do 17 godina koji su dobivali dnevne doze od 2 mg/kg ili 6 mg/kg aliskirena primijenjenog u obliku granula (3,125 mg/tableta), farmakokinetički parametri bili su slični onima u odraslih osoba.
A cumulative doseresponse relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Povezanost odgovora i kumulativne doze dokazan je s prilagođenim OR 2,1 (95% CI: 1,7-2,6) s povećanjem na OR 3,9 (3,0-4,9) za veliku primjenu hidroklorotiazida (~25 000 mg) i OR 7,7 (5,7-10,5) za najvišu kumulativnu dozu (~100 000 mg) (vidjeti i dio 4.4).
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 aliskiren.
Istodobna primjena aliskirena bilo s metforminom (↓28%), amlodipinom (↑29%) ili cimetidinom (↑19%) rezultirala je promjenom Cmax ili AUC-a aliskirena između 20% i 30%.
Rifampicin, which is an inducer of P-gp, reduced aliskiren bioavailability by approximately 50% in a clinical study.
Rifampicin, induktor P-gp-a, u kliničkom je ispitivanju smanjio bioraspoloživost aliskirena za približno 50%.
If blood pressure remains uncontrolled after 2-4 weeks of therapy, the dose may be titrated up to a maximum of Rasilez HCT 300 mg/25 mg daily.
Ako nakon 2-4 tjedna terapije krvni tlak i dalje nije kontroliran, doza se može titrirati do najviše 300 mg/25 mg Rasilez HCT-a dnevno.
At the end of this extension study, changes in msSBP from baseline were similar with aliskiren compared to enalapril (-7.63 mmHg vs. -7.94 mmHg) in the full analysis set.
Na kraju ovog produženog ispitivanja, promjene u srednjoj vrijednosti sistoličkog krvnog tlaka u sjedećem položaju u odnosu na početak bile su slične kod aliskirena i kod enalaprila (-7,63 mmHg u odnosu na -7,94 mmHg) u potpunom skupu podataka za analizu.
- if you have gout (uric acid crystals in the joints).
- ako imate giht (kristali mokraćne kiseline u zglobovima).
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.
U ovom ispitivanju aliskiren 300 mg bio je uspoređivan s placebom kad su aliskiren odnosno placebo dodani standardnoj terapiji koja je uključivala ili neki inhibitor angiotenzin konvertirajućeg enzima ili blokator receptora angiotenzin.
The incidence of adverse events tended to be higher in patients with diabetes, or with GFR <60 ml/min/1.73 m², or with age ≥ 65 years; however, there was no difference between patients treated with aliskiren and those treated with enalapril.
Incidencija štetnih događaja imala je tendenciju povećanja u bolesnika s dijabetesom ili s GFR <60 ml/min/1,73 m2 ili s dobi ≥ 65 godina; međutim, nije bilo razlike između bolesnika liječenih aliskirenom i onih liječenih enalaprilom.
If hypokalaemia develops during hydrochlorothiazide therapy Rasilez HCT should be discontinued until stable correction of the potassium balance.
Ako se hipokalijemija razvije tijekom terapije hidroklorotiazidom, potrebno je prekinuti primjenu lijeka Rasilez HCT-a sve dok se postigne stabilna korekcija ravnoteže kalija.
The final study results indicated a hazard ratio for the primary endpoint of 1.097 in favour of placebo (95.4% Confidence Interval: 0.987, 1.218, 2-sided p=0.0787).
Završni rezultati ispitivanja pokazali su omjer hazarda za primarni ishod od 1,097 u korist placeba (95,4% interval pouzdanosti: 0,987, 1,218, 2-strani p=0,0787).
Therefore, the combination of aliskiren with an NSAID requires caution, especially in elderly patients.
Stoga primjena aliskirena s NSAIL-ima zahtijeva oprez, posebno u starijih bolesnika.
Medicinal products used in the treatment of gout
Lijekovi koji se koriste za liječenje gihta
Co-administration of lithium and hydrochlorothiazide is not recommended.
Ne preporučuje se istodobna primjena litija i hidroklorotiazida.
Hypersensitivity reactions to hydrochlorothiazide may occur in patients, but are more likely in patients with allergy and asthma.
U bolesnika se mogu javiti reakcije preosjetljivosti na hidroklorotiazid, ali veća je vjerojatnost njihove pojave u bolesnika s alergijom i astmom.
- if you have serious liver or serious kidney problems.
- ako imate ozbiljnih problema s jetrom ili bubrezima.
In the subgroup of patients with diabetes mellitus the hazard ratio was 1.64 in favour of placebo (95% Confidence Interval: 1.15-2.33), whereas the hazard ratio in the subgroup of patients without diabetes was 0.69 in favour of aliskiren (95% Confidence Interval: 0.50-0.94); p-value for interaction = 0.0003.
U podskupini bolesnika sa šećernom bolesti omjer hazarda bio je 1,64 u korist placeba (95% interval pouzdanosti: 1,15-2,33), dok je omjer hazarda u podskupini bolesnika bez šećerne bolesti bio 0,69 u korist aliskirena (95% interval pouzdanosti: 0,50-0,94); p-vrijednost za interakciju = 0,0003.
Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with aliskiren may reduce diuretic-induced hypokalaemia.
Premda se hipokalijemija može razviti kada se uzimaju tiazidni diuretici, istodobna terapija aliskirenom može smanjiti hipokalijemiju izazvanu diuretikom.
• Sugar in the urine
• šećer u mokraći
The increased incidence of stroke was greater in patients with renal insufficiency.
Povećana incidencija moždanog udara bila je veća u bolesnika s insuficijencijom bubrega.
Concomitant intake with fruit juice and/or drinks containing plant extracts (including herbal teas) should be avoided (see section 4.5).
Treba izbjegavati istodobno uzimanje voćnog soka i/ili napitaka koji sadrže biljne ekstrakte (uključujući biljne čajeve) (vidjeti dio 4.5).
The final results of the study did not demonstrate statistically that aliskiren was non-inferior to enalapril on the primary endpoint, however there was essentially no difference in the observed incidence rates between aliskiren and enalapril (hazard ratio of 0.99 with 95% Confidence Interval: 0.90-1.10).
Konačni rezultati ispitivanja nisu statistički pokazali da je aliskiren ne-inferioran u odnosu na enalapril u primarnoj mjeri ishoda, međutim u osnovi nije bilo razlike u zabilježenim stopama incidencije između aliskirena i enalaprila (omjer hazarda od 0,99; 95% interval pouzdanosti: 0,90-1,10).
Via Provinciale Schito 131 IT-80058 Torre Annunziata/NA Italy
Novartis Farma S.p.A. Via Provinciale Schito 131 IT-80058 Torre Annunziata/NA
• Difficulty breathing with fever, coughing, wheezing, breathlessness (respiratory distress including pneumonitis and pulmonary oedema)
• teškoće pri disanju s vrućicom, kašljem, zviždanjem u plućima, nedostatkom zraka (respiratorni distres uključujući pneumonitis i plućni edem)