natgillin/translations-raw huggingface dataset:
Aliskiren is an effective once-a-day antihypertensive treatment in adult patients, regardless of gender, age, body mass index and ethnicity.
Aliskiren je učinkovita antihipertenzivna terapija koja se uzima jedanput na dan u odraslih bolesnika, bez obzira na spol, dob, indeks tjelesne mase i etničku pripadnost.
How to take Rasilez
Kako uzimati Rasilez
**Including one case of ‘liver failure fulminant' reported in the post-marketing experience, for which a causal relationship with aliskiren cannot be excluded.
**Uključujući jedan slučaj ‘fulminantnog zatajenja jetre' prijavljen nakon stavljanja lijeka u promet, za kojeg se uzročna veza s aliskirenom ne može isključiti.
NSAIDs may reduce the anti-hypertensive effect of aliskiren.
NSAIL-ovi mogu smanjiti antihipertenzivni učinak aliskirena.
No carcinogenic potential for aliskiren was detected in a 2-year rat study and a 6-month transgenic mouse study.
Nije otkriven kancerogeni potencijal aliskirena u 2-godišnjem ispitivanju na štakorima i 6-mjesečnom ispitivanju na transgeničnim miševima.
The volume or salt depletion should be corrected prior to administration of Rasilez, or the treatment should start under close medical supervision.
Volumen tekućine ili razina natrija se treba ispraviti prije primjene Rasileza, ili liječenje treba započeti uz pomni nadzor liječnika.
Talk to your doctor before taking Rasilez: - if you are taking a diuretic (a type of medicine also known as “water” tablets which increases the amount of urine you produce).
Obratite se svom liječniku prije nego uzmete Rasilez: - ako uzimate diuretik (vrstu lijeka također poznatu kao „tablete za mokrenje“ koje povećavaju količinu mokraće koju stvarate).
The most likely manifestations of overdosage would be hypotension, related to the antihypertensive effect of aliskiren.
Najvjerojatnija manifestacija predoziranja bila bi hipotenzija povezana s antihipertenzivnim učinkom aliskirena.
The usual starting dose is one 150 mg tablet once daily.
Uobičajena početna doza je jedna tableta od 150 mg jednom dnevno.
This medicine must not be used in babies from birth to less than 2 years of age.
Ovaj lijek se ne smije primjenjivati u male djece od rođenja do nenavršene 2 godine.
In addition, due to the possibility of up-titration if medically necessary to control the msSBP, no conclusion can be drawn on the appropriate posology of aliskiren in patients aged 6 to 17 years.
Dodatno, zbog mogućnosti povećanja doze u slučaju medicinski neophodnog kontroliranja srednje vrijednosti sistoličkog krvnog tlaka u sjedećem položaju, ne može se izvući zaključak o odgovarajućem doziranju aliskirena u bolesnika u dobi od 6 do 17 godina.
Aliskiren has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Sigurnost aliskirena ispitivana je u više od 7800 bolesnika uključujući više od 2300 bolesnika liječenih duže od 6 mjeseci te više od 1200 bolesnika liječenih duže od 1 godine.
Do not take Rasilez - if you are allergic to aliskiren or any of the other ingredients of this medicine (listed in section 6).
- ako ste alergični na aliskiren ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
- certain types of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
- određene vrste lijekova protiv bolova koji se zovu nesteroidni protuupalni lijekovi (NSAIL).
Aliskiren has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Aliskiren je ispitivan u 1864 bolesnika u dobi od 65 godina ili starijih te u 426 bolesnika u dobi od 75 godina ili starijih.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 August 2007
Datum prvog odobrenja: 22. kolovoza 2007.
The available clinical data did not indicate that higher doses of torasemide were used after co-administration with aliskiren.
Dostupni klinički podaci nisu upućivali na to da su korištene više doze torasemida nakon istodobne primjene s aliskirenom.
The change in plasma levels of aliskiren in the presence of ketoconazole or verapamil is expected to be within the range that would be achieved if the dose of aliskiren were doubled; aliskiren doses of up to 600 mg, or twice the highest recommended therapeutic dose, have been found to be well tolerated in controlled clinical studies.
Očekuje se da bi promjena u razinama aliskirena u plazmi u prisutnosti ketokonazola ili verapamila bila unutar raspona koji bi se postigao kada bi se doza aliskirena udvostručila; u kontroliranim kliničkim ispitivanjima je otkriveno da se doze aliskirena do 600 mg, ili dvostruko više od najviše preporučene terapijske doze, dobro podnose.
In a 36-week study involving 820 patients with ischaemic left ventricular dysfunction, no changes in ventricular re-modelling as assessed by left ventricular end systolic volume were detected with aliskiren compared to placebo on top of background therapy.
U 36-tjednom ispitivanju u koje je bilo uključeno 820 bolesnika s ishemijskom disfunkcijom lijevog ventrikula nisu otkrivene nikakve promjene u ventrikularnom remodeliranju prema volumenu lijevog ventrikula na kraju sistole s aliskirenom u usporedbi s placebom dodanom osnovnoj terapiji.
It is unknown whether aliskiren/metabolites are excreted in human milk.
Nije poznato izlučuju li se aliskiren/metaboliti u majčino mlijeko.
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%.
Dok drugi lijekovi koji inhibiraju RAAS (ACEI i blokatori receptora angiotenzina II (ARB)), uzrokuju kompenzatorni porast aktivnosti renina u plazmi (ARP), liječenje aliskirenom snižava ARP u hipertenzivnih bolesnika za približno 50 do 80%.
Hyponatraemia *Isolated cases of liver disorder with clinical symptoms and laboratory evidence of more marked hepatic dysfunction.
*Izolirani slučajevi poremećaja jetre s kliničkim simptomima i laboratorijski dokaz izraženije jetrene disfunkcije.
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).
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).
Therefore, Rasilez is contraindicated in children from birth to less than 2 years and should not be used in children aged 2 to less than 6 years (see sections 4.2 and 4.3).
Stoga je Rasilez kontraindiciran u djece od rođenja do nenavršene 2 godine i ne bi se smio koristiti u djece u dobi od 2 do nenavršenih 6 godina (vidjeti dijelove 4.2 i 4.3).
Aliskiren should not be used during breast-feeding.
Aliskiren se ne smije primjenjivati tijekom dojenja.
Haemoglobin decreased, haematocrit decreased, blood creatinine increased
Sniženi hemoglobin, sniženi hematokrit, povišeni kreatinin u krvi
Rasilez should be taken once a day, always with or always without food, preferably at the same time each day.
Rasilez treba uzimati jednom na dan, uvijek sa ili uvijek bez hrane, po mogućnosti svaki dan u isto vrijeme.
Symptomatic hypotension could occur after initiation of treatment with aliskiren in the following cases: - Patients with marked volume depletion or patients with salt depletion (e.g. those receiving high doses of diuretics) or - Combined use of aliskiren with other agents acting on the RAAS.
Simptomatska hipotenzija se može pojaviti nakon početka liječenja aliskirenom u sljedećim slučajevima: - u bolesnika sa izrazito smanjenim volumenom tekućine ili bolesnika sa sniženom razinom natrija (npr. u onih koji primaju visoke doze diuretika) ili - istodobna primjena aliskirena s drugim lijekovima koji djeluju na RAAS.
In some patients with compromised renal function (dehydrated patients or elderly patients) aliskiren given concomitantly with NSAIDs may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
U nekih bolesnika s kompromitiranom funkcijom bubrega (dehidrirani ili stariji bolesnici) aliskiren dan istodobno s NSAIL-ovima može rezultirati dodatnim pogoršanjem funkcije bubrega, uključujući moguće akutno zatajenje bubrega koje je obično reverzibilno.
- History of angioedema with aliskiren.
- Anamneza angioedema s aliskirenom.
Rasilez should not be used in children aged 2 to less than 6 years because of safety concerns due to potential aliskiren overexposure (see sections 4.3, 4.4, 5.2, and 5.3).
Rasilez se ne smije koristiti u djece u dobi od 2 do nenavršenih 6 godina zbog razloga sigurnosti uzrokovanih potencijalnom prekomjernom izloženošću aliskirenu (vidjeti dijelove 4.3, 4.4, 5.2, i 5.3).
The antihypertensive effect is substantially present within two weeks (85-90%) after initiating therapy with 150 mg once daily.
Antihipertenzivni učinak je značajno prisutan unutar dva tjedna (85-90%) nakon početka terapije sa
Rare (may affect up to 1 in 1,000 people): increased level of creatinine in the blood, decreased level of haemoglobin in the blood (anaemia), decreased level of red blood cells, red skin (erythema).
Rijetko (mogu se javiti u do 1 na 1000 osoba): povišena razina kreatinina u krvi, snižena razina hemoglobina u krvi (anemija), snižena razina crvenih krvnih stanica, crvena koža (eritem).
Aliskiren is an orally active, non-peptide, potent and selective direct inhibitor of human renin.
Mehanizam djelovanja Aliskiren je peroralno aktivan, nepeptidni, potentni i selektivni direktni inhibitor renina u ljudi.
Therefore, drinks containing plant extracts, including herbal teas, should not be taken together with aliskiren (see section 4.2)
Stoga se napitci koji sadrže biljne ekstrakte, uključujući biljne čajeve, ne smiju uzimati zajedno s aliskirenom (vidjeti dio 4.2).
Angiotensin II causes blood vessels to tighten, which increases the blood pressure.
Angiotenzin II uzrokuje sužavanje krvnih žila što povisuje krvni tlak.
In general, dual blockade of the RAAS by combining aliskiren with an ACEI or an ARB is not recommended (see section “Dual blockade of the renin-angiotensin-aldosterone system (RAAS)” above and also sections 4.5 and 4.8).
Općenito, ne preporučuje se dvostruka blokada RAAS-a kombiniranjem aliskirena s ACEI-om ili ARB-om (vidjeti dio“Dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS)” iznad u tekstu i također dijelove 4.5 i 4.8).
Reducing the amount of angiotensin II allows the blood vessels to relax, which lowers blood pressure.
Smanjujući količinu angiotenzina II krvnim se žilama omogućava da se opuste što snižava krvni tlak.
Gender, weight and ethnicity have no clinically relevant influence on aliskiren pharmacokinetics.
Spol, tjelesna težina i etnička pripadnost nisu imali klinički značajan utjecaj na farmakokinetiku aliskirena.
The treatment with aliskiren was well tolerated in this study.
U ovom ispitivanju liječenje aliskirenom se dobro podnosilo.
It should not be used in children from 2 to less than 6 years of age, and is not recommended for use in children and adolescents from 6 to less than 18 years of age.
Ne bi se smio primjenjivati u djece u dobi od 2 do nenavršenih 6 godina i ne preporučuje se za primjenu u djece i adolescenata u dobi od 6 do nenavršenih 18 godina, jer sigurnost i koristi ovog lijeka nisu poznate u ovoj populaciji.
The starting doses for aliskiren were 37.5/75/150 mg in the low, mid and high weight groups, respectively.
Početne doze aliskirena su bile 37,5/75/150 mg u grupama male, srednje odnosno velike tjelesne težine.
You should avoid taking this medicine together with fruit juice and/or drinks containing plant extracts (including herbal teas), as it could cause a decrease in the effectiveness of this medicine.
Izbjegavajte uzimanje ovog lijeka zajedno s voćnim sokom i/ili napitcima koji sadrže biljne ekstrakte (uključujući biljne čajeve) jer to može uzrokovati smanjenje učinkovitosti ovog lijeka.
In the event of severe and persistent diarrhoea, Rasilez therapy should be stopped (see section 4.8).
Općenito U slučaju teškog i ustrajnog proljeva potrebno je prekinuti terapiju Rasilezom (vidjeti dio 4.8).
The other ingredients are crospovidone type A, hypromellose substitution type 2910 (3 mPa s), magnesium stearate, macrogol 4000, microcrystalline cellulose, povidone K-30, colloidal anhydrous silica, talc, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).
Drugi sastojci su krospovidon tip A, hipromeloza supstitucijski tip 2910 (3 mPa s), magnezijev stearat, makrogol 4000, mikrokristalična celuloza, povidon K-30, koloidni bezvodni silicijev dioksid, talk, titanijev dioksid (E 171), crni željezov oksid (E 172), crveni željezov oksid (E 172).
The recommended dose of Rasilez is 150 mg once daily.
Doziranje Preporučena doza Rasileza iznosi 150 mg jednom dnevno.
Severe cutaneous adverse reactions (SCARs) including Stevens Johnson syndrome, toxic epidermal necrolysis (TEN) and oral mucosal reactions, rash, pruritus, urticaria
Teške kožne nuspojave (SCAR) uključujući Stevens-Johnsonov sindrom, toksičnu epidermalnu nekrolizu (TEN) i reakcije oralne sluznice, osip, pruritus, urtikarija
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• prilikom svake izmjene sustava za upravljenje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
Aliskiren monotherapy studies have shown blood pressure lowering effects comparable to other classes of antihypertensive agents including ACEI and ARB.
Ispitivanja monoterapije aliskirenom pokazala su učinke snižavanja krvnoga tlaka koji se mogu usporediti s drugim skupinama antihipertenzivnih lijekova, uključujući ACEI-e i ARB-ove.
Not known (frequency cannot be estimated from the available data): spinning sensation, low level of sodium in the blood, shortness of breath, nausea, vomiting, signs of liver disorder (nausea, loss of appetite, dark coloured urine or yellowing of skin and eyes).
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): osjećaj vrtnje, niska razina natrija u krvi, nedostatak zraka, mučnina, povraćanje, znakovi poremećaja jetre (mučnina, gubitak apetita, tamno obojani urin ili žuto obojana koža i oči).
In clinical studies in hypertensive patients, Rasilez had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
U kliničkim ispitivanjima hipertenzivnih bolesnika Rasilez nije imao klinički značajnih učinaka na ukupni kolesterol, HDLkolesterol (HDL-C), trigliceride natašte, glukozu natašte ili mokraćnu kiselinu.
However, in the subsequent 4 week randomised withdrawal phase of the study (Phase 2), the effect of aliskiren overlapped with the effects observed in patients switched to placebo in all dose groups (low, p=0.8894; mid, p=0.9511; high, p=0.0563).
(ispitivanje faze 2), učinak aliskirena se podudarao s učincima uočenim u bolesnika prebačenih na placebo u svim doznim skupinama (niska, p=0,8894; srednja, p=0,9511; visoka, p=0,0563).
In a study conducted in patients with end stage renal disease (ESRD) receiving haemodialysis, dialysis clearance of aliskiren was low (< 2% of oral clearance).
U ispitivanju provedenom na bolesnicima u završnom stadiju bubrežne bolesti (ESRD) na hemodijalizi klirens aliskirena dijalizom bio je nizak (<2% peroralnog klirensa).
Uncommon (may affect up to 1 in 100 people): Skin rash (this may also be a sign of allergic reactions or angioedema - see “Rare” side effects below), kidney problems including acute renal failure (severely decreased urine output), swelling of hands, ankles or feet (peripheral oedema), severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin, blistering of the lips, eyes or mouth, skin peeling, fever), low blood pressure, palpitations, cough, itching, itchy rash (urticaria), increased liver enzymes.
Manje često (mogu se javiti u do 1 na 100 osoba): Kožni osip (to može biti i znak alergijskih reakcija ili angioedema - pogledajte „Rijetke“ nuspojave u nastavku), problemi s bubrezima, uključujući akutno zatajenje bubrega (jako smanjeno izlučivanje mokraće), oticanje ruku, gležnjeva ili stopala (periferni edem), teške kožne reakcije (toksična epidermalna nekroliza i/ili reakcije oralne sluznicecrvena koža, stvaranje mjehurića na usnicama, očima ili ustima, guljenje kože, vrućica), snižen krvni tlak, palpitacije, kašalj, svrbež, osip praćen svrbežom (urtikarija), povišeni jetreni enzimi.
The starting doses for enalapril were 2.5/5/10 mg in the low, mid and high weight groups, respectively.
Početne doze enalaprila su bile 2,5/5/10 mg u grupama male, srednje odnosno velike tjelesne težine.
- an angiotensin II receptor blocker or an angiotensin converting enzyme inhibitor (see sections
- blokator angiotenzina II receptora (ARB) ili inhibitor angiotenzin - konvertirajućeg enzima, (vidjeti dijelove
Liver disorder*, jaundice, hepatitis, liver failure** Skin and subcutaneous tissue disorders Uncommon:
Poremećaji jetre*, žutica, hepatitis, zatajenje jetre** Poremećaji kože i potkožnog tkiva Manje često:
- if you have diabetes or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure: an angiotensin converting enzyme inhibitor such as enalapril, lisinopril, ramipril or an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan.
- ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se bilo kojom od skupina lijekova navedenih u nastavku, koje se koriste za liječenje visokog krvnog tlaka: inhibitorom angiotenzin konvertirajućeg enzima kao što je enalapril, lizinopril, ramipril ili blokatorom angiotenzin II receptora, kao što je valsartan, telmisartan, irbesartan.
Do not use this medicine after the expiry date which is stated on the carton and blister.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti“ ili „EXP“.
This study was extended with a 52-week double-blind, randomised study to evaluate the safety, tolerability and efficacy of aliskiren compared to enalapril in 208 paediatric hypertensive patients aged 6 to 17 years (at baseline in the previous study).
Ovo ispitivanje se nastavilo s 52-tjednim dvostruko-slijepim, randomiziranim ispitivanjem da se procijeni sigurnost, podnošljivost i djelotvornost aliskirena u usporedbi s enalaprilom u 208 pedijatrijskih hipertenzivnih bolesnika u dobi od 6 do 17 godina (na početku prethodnog ispitivanja).
INFORMATION IN BRAILLE Rasilez 300 mg
16. PODACI NA BRAILLEOVOM PISMU Rasilez 300 mg
Small decreases in haemoglobin and haematocrit (mean decreases of approximately 0.05 mmol/l and 0.16 volume percent, respectively) were observed.
Opažena su mala sniženja hemoglobina i hematokrita (srednja vrijednost sniženja od približno 0,05 mmol/l, odnosno 0,16 volumnog postotka).
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.
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.
- The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-glycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated (see section 4.5).
- Kontraindicirana je istodobna primjena aliskirena s ciklosporinom i itrakonazolom, dva visoko potentna inhibitora P-glikoproteina (P-gp), i drugim potentnim P-gp inhibitorima (npr. kinidin) (vidjeti dio 4.5).
No controlled clinical data are available on the use of aliskiren in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Nisu dostupni kontrolirani klinički podaci o primjeni aliskirena u bolesnika s jednostranom ili obostranom stenozom bubrežne arterije, ili stenozom bubrežne arterije kod postojanja samo jednog bubrega.
There were no statistically significant differences in the mean changes in weight, height, or BMI between the treatment groups from Baseline to LT Visit 18 (Week 104) (primary analysis).
Nije bilo statistički značajnih razlika u promjenama srednjih vrijednosti težine,visine ili BMI-a između liječenih skupina od početnih vrijednosti do onih u 18. posjetu provedenom u sklopu procjene dugoročne sigurnosti (104. tjedan) (primarna analiza).
Rasilez 300 mg film-coated tablets EU/1/07/405/011-020
Rasilez 300 mg filmom obložene tablete EU/1/07/405/011-020
Compared to a diuretic (hydrochlorothiazide - HCTZ), Rasilez 300 mg lowered systolic/diastolic blood pressure by 17.0/12.3 mmHg, compared to 14.4/10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
usporedbi s diuretikom (hidroklorotiazid - HCTZ), Rasilez je u dozi od 300 mg snizio sistolički/dijastolički krvni tlak za 17,0/12,3 mmHg, u usporedbi s 14,4/10,5 mmHg za HCTZ u dozi od 25 mg nakon 12 tjedana liječenja.
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.
Relativni AUC i Cmax aliskirena u ispitanika s oštećenjem bubrežne funkcije bili su u rasponu između 0,8 do 2 puta veći od razina u zdravih ispitanika nakon primjene jednokratne doze u stanju dinamičke ravnoteže.
The usual recommended starting dose of aliskiren in elderly patients aged 65 years or older is 150 mg.
Uobičajena početna doza aliskirena koja se preporučuje u starijih bolesnika u dobi od 65 godina ili starijih iznosi 150 mg.
An additional 52 to 104 week non-interventional observational extension study in 106 patients (no study treatment administered) was conducted with the objective to evaluate the long-term safety in terms of growth and development of children 6-17 years of age with hypertension (primary or secondary) at baseline in the core study, previously treated with aliskiren.
Provedeno je dodatnih 52 do 104 tjedna neintervencijskog opservacijskog nastavka ispitivanja na 106 bolesnika (bez primjene ispitivanog liječenja) s ciljem procjene dugoročne sigurnosti u pogledu rasta i razvoja djece u dobi od 6 do 17 godina s hipertenzijom (primarnom ili sekundarnom) na početku osnovnog ispitivanja, prethodno liječenih aliskirenom.
Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of Rasilez.
Induktori P-gp-a (Gospina trava, rifampicin) stoga bi mogli smanjiti bioraspoloživost Rasileza.