FrancophonIA/ELRC3.0 huggingface dataset:
English: Rasilez HCT may have been prescribed to you because your previous treatment with a medicine containing one of the active components of Rasilez HCT did not lower your blood pressure enough.
Croatian: Rasilez HCT Vam je možda propisan jer prethodno liječenje s lijekom koji sadrži samo jednu od djelatnih tvari lijeka Rasilez HCT nije dovoljno snizilo krvni tlak.
English: A possible mechanism is saturation of transporters at the absorption site or at the hepatobiliary clearance route.
Croatian: Mogući mehanizam je zasićenje prijenosnika na mjestu apsorpcije ili na hepatobilijarnom putu klirensa.
English: If symptomatic hypotension should occur, supportive treatment should be initiated.
Croatian: Ako se pojavi simptomatska hipotenzija, treba započeti potporno liječenje.
English: There are no data on the use of aliskiren in pregnant women.
Croatian: Nema podataka o primjeni aliskirena u trudnica.
English: Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of treatment initiation.
Croatian: Simptomi uključuju akutni nastup smanjenja oštrine vida ili bol oka i tipično se javlja unutar nekoliko sati do nekoliko tjedana nakon početka liječenja.
English: The combined rates of cardiovascular death, hospitalisation for heart failure, recurrent heart attack, stroke and resuscitated sudden death were similar in the aliskiren group and the placebo group.
Croatian: Kombinirane stope kardiovaskularne smrti, hospitalizacije zbog zatajenja srca, ponovljenog srčanog udara, moždanog udara i oživljavanja nakon iznenadne smrti bile su slične i u skupini na aliskirenu i u placebo skupini.
English: Findings during repeat-dose toxicity studies in animals were consistent with the known local (gastrointestinal tract) irritation potential or the expected pharmacological effects of aliskiren.
Croatian: Nalazi dobiveni tijekom ispitivanja toksičnosti ponovljenih doza u životinja bili su u skladu s već poznatim lokalnim (gastrointestinalni trakt) iritacijskim potencijalom ili s očekivanim farmakološkim učincima aliskirena.
English: The incidence of atrial fibrillation was 11.1%, 13.3%, and 11.0% in the combination, aliskiren, and enalapril groups, respectively.
Croatian: Incidencija atrijske fibrilacije je bila 11,1%, 13,3% i 11,0% u skupinama koje su primale kombinaciju, aliskiren odnosno enalapril.
English: Following intravenous administration, the mean volume of distribution at steady state is approximately 135 litres, indicating that aliskiren distributes extensively into the extravascular space.
Croatian: Nakon intravenske primjene, srednja vrijednost volumena distribucije u stanju dinamičke ravnoteže je približno 135 litara, što pokazuje da se aliskiren u velikoj mjeri distribuira u ekstravaskularni prostor.
English: The European Medicines Agency has waived the obligation to submit results of studies with Rasilez HCT in all subsets of the paediatric population in essential hypertension (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja Rasilez HCT-a u svim podskupinama pedijatrijske populacije za esencijalnu hipertenziju (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: This effect is also seen with other agents acting on the renin-angiotensin system, such as ACEIs and ARBs.
Croatian: Taj je učinak također viđen kod drugih lijekova koji djeluju na renin-angiotenzin sustav, kao što su ACEI-i i ARB-ovi.
English: • Skin rash (this may also be a sign of allergic reactions or angioedema - see “Rare” side effects below)
Croatian: • kožni osip (to može biti i znak alergijskih reakcija ili angioedema - pogledajte „Rijetke“
English: Similar reductions were found when aliskiren was combined with other antihypertensive agents.
Croatian: Slična su sniženja nađena kada je aliskiren kombiniran s drugim antihipertenzivnim lijekovima.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; renin inhibitor, ATC code: C09XA52
Croatian: Farmakoterapijska skupina: lijekovi koji djeluju na sustav renin-angiotenzin; inhibitor renina, ATK oznaka: C09XA52.
English: • Dizziness, fainting on standing up
Croatian: • omaglica, nesvjestica pri ustajanju
English: Your doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
Croatian: Liječnik Vam može provjeravati bubrežnu funkciju, krvni tlak i količinu elektrolita (npr. kalija) u krvi u redovitim intervalima.
English: The doses in rats and rabbits provided systemic exposures of 1 to 4 and 5 times higher, respectively, than the maximum recommended human dose (300 mg).
Croatian: Doze u štakora i kunića predstavljale su sistemsku izloženost koja je bila od 1 do 4, odnosno 5 puta viša od najviše preporučene doze za ljude (300 mg).
English: It is also better to avoid this medicine in early pregnancy - see section ‘Pregnancy'.
Croatian: Također, u ranoj je trudnoći bolje izbjegavati ovak lijekvidjeti dio „Trudnoća“.
English: The hyponatraemic effect of diuretics may be intensified by concomitant administration of medicinal products such as antidepressants, antipsychotics, antiepileptics, etc.
Croatian: Hiponatrijemijski učinak diuretika može se pojačati istodobnom primjenom lijekova kao što su antidepresivi, antipsihotici, antiepileptici, itd.
English: • Swelling of hands, ankles or feet (peripheral oedema)
Croatian: • oticanje šaka, gležnjeva ili stopala (periferni edem)
English: In addition, an increased incidence of adverse events was observed with aliskiren compared to placebo (38.2% versus 30.3%).
Croatian: Osim toga, s aliskirenom je u usporedbi s placebom opažena povećana incidencija štetnih događaja (38,2% naspram 30,3%).
English: Smaller changes in furosemide pharmacokinetics and efficacy were observed with aliskiren 150 mg/day.
Croatian: Manje promjene u farmakokinetici i djelotvornosti furosemida bile su opažene uz aliskiren 150 mg/dan.
English: Rasilez HCT has minor influence on the ability to drive and use machines.
Croatian: Rasilez HTC malo utječe na sposobnost upravljanja vozilima i strojevima.
English: The increase may be higher with higher aliskiren doses.
Croatian: Povećanje bi moglo biti više pri višim dozama aliskirena.
English: When driving vehicles or using machines, it must be borne in mind that dizziness or drowsiness may occasionally occur when taking Rasilez HCT.
Croatian: Prilikom upravljanja vozilima ili rada sa strojevima, mora se imati na umu da se tijekom uzimanja Rasilez HCT-a povremeno mogu javiti omaglica ili omamljenost.
English: You should consult your doctor prior to taking this medicine.
Croatian: Trebate se posavjetovati sa svojim liječnikom prije uzimanja ovog lijeka.
English: − Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulphonamide-derived substances.
Croatian: Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1, ili druge lijekove derivate sulfonamida.
English: However, staggering the dose of hydrochlorothiazide and resin such that hydrochlorothiazide is administered at least 4 hours before or 4-6 hours after the administration of resins would potentially minimise the interaction.
Croatian: Međutim, postupnim doziranjem hidroklorotiazida i smole tako da se hidroklorotiazid primjenjuje najmanje 4 sata prije ili 4-6 sati poslije primjene smola, moguće je svesti interakciju na najmanju moguću mjeru.
English: Although this has not been investigated for aliskiren, it is known that P-gp also controls tissue uptake of a variety of substrates and P-gp inhibitors can increase the tissue-to-plasma concentration ratios.
Croatian: Iako to nije ispitano kod aliskirena, poznato je da P-gp također kontrolira unos različitih supstrata u tkiva i da P-gp inhibitori mogu povećati omjer koncentracije u tkivima i koncentracije u plazmi.
English: You should establish a convenient daily schedule to take the medicine the same way each day, in a regular pattern with respect to the timing of your meals.
Croatian: Trebate uspostaviti pogodan dnevni raspored uzimanja lijeka na isti način svaki dan, u redovitim razmacima uzimajući u obzir vrijeme uzimanja obroka.
English: Ear and labyrinth disorders Not known
Croatian: Poremećaji uha i labirinta Nepoznato
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS (PVC/PCTFE OR PA/ALU/PVC) BLISTER (CALENDAR) (PVC/PCTFE OR PA/ALU/PVC)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI (PVC/PCTFE ILI PA/AL/PVC) BLISTER (KALENDAR) (PVC/PCTFE ILI PA/AL/PVC)
English: • Fever, sore throat or mouth ulcers, more frequent infections (lack or low level of white blood cells)
Croatian: • vrućica, grlobolja ili čirevi u ustima, češće infekcije (manjak ili niska razina bijelih krvnih stanica)
English: As a result no dose adjustment for aliskiren or these co-administered medicinal products is necessary.
Croatian: Kao rezultat toga, nije potrebna prilagodba doze aliskirena ili ovih istodobno primijenjenih lijekova.
English: The available clinical data did not indicate that higher doses of torasemide were used after coadministration with aliskiren.
Croatian: Dostupni klinički podaci nisu upućivali na to da su korištene više doze torasemida nakon istodobne primjene s aliskirenom.
English: Patients should be informed to report to the physician any signs suggestive of allergic reactions, in particular difficulties in breathing or swallowing, swelling of face, extremities, eyes, lips or tongue.
Croatian: Bolesnike je potrebno upozoriti da prijave liječniku sve znakove koji upućuju na alergijske reakcije, osobito teškoće pri disanju ili gutanju, oticanje lica, ekstremiteta, očiju, usnica ili jezika.
English: For adverse reactions observed with more than one component of a fixed-dose combination, the highest frequency is listed in the table below.
Croatian: Za nuspojave opažene s više od jedne komponente fiksne kombinacije doza, najviša učestalost je navedena u tablici u nastavku.
English: The effect of drinks containing plant extracts (including herbal teas) on the absorption of aliskiren has not been investigated.
Croatian: Učinak napitaka koji sadrže biljne ekstrakte (uključujući biljne čajeve) na apsorpciju aliskirena nije bio ispitivan.
English: Therefore, Rasilez HCT 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 section 4.2 and 4.3).
Croatian: Stoga je Rasilez HCT kontraindiciran u djece mlađe od 2 godine i ne bi se smio koristiti u djece u dobi od 2 do 6 godina (vidjeti dio 4.2 i 4.3).
English: Systemic lupus erythematosus
Croatian: Sistemski eritematozni lupus
English: Oral co-administration of aliskiren and furosemide had no effect on the pharmacokinetics of aliskiren but reduced exposure to furosemide by 20-30% (the effect of aliskiren on furosemide administered intramuscularly or intravenously has not been investigated).
Croatian: Istodobna peroralna primjena aliskirena i furosemida nije imala učinak na farmakokinetiku aliskirena, ali je smanjila izloženost furosemidu za 20-30% (učinak aliskirena na furosemid primijenjen intramuskularno ili intravenski nije bio ispitivan).
English: Dosing should be individualised and adjusted according to the patient's clinical response.
Croatian: Doziranje treba prilagoditi svakom pojedinom bolesniku u skladu s bolesnikovim kliničkim odgovorom.
English: Excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Croatian: Pretjerano sniženje krvnog tlaka u bolesnika s ishemijskom kardiopatijom ili ishemijskom kardiovaskularnom bolešću može rezultirati infarktom miokarda ili moždanim udarom.
English: There is no evidence that Rasilez HCT would reduce or prevent diuretic-induced hyponatraemia.
Croatian: Nema dokaza da bi Rasilez HCT smanjio ili spriječio hiponatrijemiju izazvanu diuretikom.
English: Increase of dose of probenecid or sulfinpyrazone may be necessary.
Croatian: Može biti potrebno povišenje doze probenecida ili sulfinpirazona.
English: No carcinogenic potential for aliskiren was detected in a 2-year rat study and a 6-month transgenic mouse study.
Croatian: Nije otkrivena kancerogenost aliskirena u 2-godišnjem ispitivanju na štakorima i 6-mjesečnom ispitivanju na transgeničnim miševima.
English: Extensive clinical data are available for hydrochlorothiazide and these are reflected in the relevant sections.
Croatian: Za hidroklorotiazid su dostupni opsežni klinički podaci, što se i vidi u odgovarajućim dijelovima.
English: Untreated acute angle-closure glaucoma can lead to permanent vision loss.
Croatian: Neliječeni akutni glaukom zatvorenog kuta može dovesti do trajnoga gubitka vida.
English: This helps to lower high blood pressure in adult patients.
Croatian: Time pomaže u snižavanju povišenog krvnog tlaka kod odraslih.
English: The most likely manifestation of overdose would be hypotension, related to the antihypertensive effect of aliskiren.
Croatian: Najvjerojatnija manifestacija predoziranja bila bi hipotenzija povezana s antihipertenzivnim učinkom aliskirena.
English: If you become pregnant while taking this medicine stop taking it immediately and talk to your doctor.
Croatian: Ako zatrudnite dok uzimate ovaj lijek, odmah ga prekinite uzimati i posavjetujte se sa svojim liječnikom.
English: Posology as substitution therapy
Croatian: Doziranje pri zamjenskoj terapiji
English: Digoxine or other digitalis glycosides
Croatian: Digoksin ili glikozidi digitalisa
English: − Children from birth to less than 2 years (see sections 4.2 and 5.3).
Croatian: Djeca mlađa od 2 godine (vidjeti dijelove 4.2 i 5.3).
English: Aliskiren is minimally excreted via the renal route, and only 0.6% of the aliskiren dose is recovered in urine following oral administration (see section 5.2).
Croatian: Aliskiren se minimalno izlučuje putem bubrega, a samo 0,6% doze aliskirena javlja se u mokraći nakon peroralne primjene (vidjeti dio 5.2).
English: • Nausea and vomiting
Croatian: • mučnina i povraćanje
English: Aliskiren was secreted in the milk of lactating rats.
Croatian: Aliskiren se izlučivao u mlijeko ženki štakora u laktaciji.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji e nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: Following oral absorption, peak plasma concentrations of aliskiren are reached after 1-3 hours.
Croatian: Nakon peroralne apsorpcije, vršne koncentracije aliskirena u plazmi se postižu nakon 1-3 sata.
English: Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association (NYHA) functional class III-IV) (see section 5.1).
Croatian: Aliskiren treba primjenjivati s oprezom u bolesnika s ozbiljnim kongestivnim zatajenjem srca (New York Heart Association (NYHA) funkcionalni stupanj III-IV) (vidjeti dio 5.1).
English: No relevant interactions with atenolol, digoxin, amlodipine or cimetidine have been observed.
Croatian: Nisu opažene značajne interakcije s atenololom, digoksinom, amlodipinom ili cimetidinom.
English: If you have wheat allergy (different from coeliac disease) you should not take this medicine.
Croatian: Ako imate alergiju na pšenicu (što je stanje koje je različito od celijakije), ne smijete uzimati ovaj lijek.
English: 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.
Croatian: Nadalje, zbog mogućnosti povećanja doze titracijom u slučaju medicinske potrebe radi kontroliranja srednje vrijednosti sistoličkog krvnog tlaka u sjedećem položaju, nije moguće izvesti zaključke o prikladnom doziranju aliskirena u bolesnika u dobi od 6 do 17 godina.
English: - cholestyramine, colestipol or other resins (substances used mainly to treat high levels of lipids in the blood).
Croatian: - kolestiramin, kolestipol ili druge smole (tvari koje se uglavnom koriste za liječenje povišenih razina masnoća u krvi).
English: If this continues for a long time, it can damage the blood vessels of the brain, heart and kidneys, and may result in a stroke, heart failure, heart attack or kidney failure.
Croatian: Ako to stanje dugo traje, može oštetiti krvne žile u mozgu, srcu i bubrezima te može rezultirati moždanim udarom, zatajenjem srca, srčanim udarom ili zatajenjem bubrega.
English: In the event that any signs of renal failure occur, aliskiren should be promptly discontinued.
Croatian: U slučaju pojave bilo kojih znakova zatajenja bubrega primjenu aliskirena treba odmah prekinuti.
English: • Low blood pressure
Croatian: • snižen krvni tlak
English: However, there is an increased risk of renal insufficiency, including acute renal failure, when patients with renal artery stenosis are treated with aliskiren.
Croatian: Međutim, postoji povećan rizik od insuficijencije bubrega, uključujući akutno zatajenje bubrega, kada se bolesnici sa stenozom bubrežne arterije liječe aliskirenom.
English: The risk of hypokalaemia is greater in patients with cirrhosis of the liver, patients experiencing brisk diuresis, patients with inadequate oral electrolyte intake and patients receiving concomitant therapy with corticosteroids or adrenocorticotropic hormone (ACTH) (see sections 4.5 and 4.8).
Croatian: Rizik od hipokalijemije je veći u bolesnika s cirozom jetre, bolesnika koji imaju brzu diurezu, bolesnika s neodgovarajućim peroralnim unosom elektrolita te u bolesnika koji primaju istodobnu terapiju kortikosteroidima ili adrenokortikotropnim hormonom (ACTH) (vidjeti dijelove 4.5 i 4.8).
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.
Croatian: Prestankom liječenja krvni se tlak tijekom razdoblja od nekoliko tjedana postupno vraćao prema početnim razinama, pri čemu nije bilo dokaza o postojanju povratnog učinka na krvni tlak ili ARP.
English: Hyponatraemia, accompanied by neurological symptoms (nausea, progressive disorientation, apathy) has been observed.
Croatian: Opažena je hiponatrijemija praćena neurološkim simptomima (mučnina, progresivna dezorijentiranost, apatija).
English: Aliskiren is an orally active, non-peptide, potent and selective direct inhibitor of human renin.
Croatian: Aliskiren je peroralno aktivan, nepeptidni, potentni i selektivni direktni inhibitor renina u ljudi.
English: The usual dose of Rasilez HCT is one tablet a day.
Croatian: Uobičajena doza Rasilez HCT-a je jedna tableta na dan.
English: Whereas other agents that inhibit the RAAS (angiotensin converting enzyme inhibitors (ACEI) and angiotension 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%.
Croatian: Dok drugi lijekovi koji inhibiraju RAAS (inhibitori angiotenzin-konvertirajućeg enzima (ACEI) i blokatori receptora angiotenzina II (ARB)) uzrokuju kompezatorni porast aktivnosti renina u plazmi (ARP), liječenje aliskirenom snižava ARP u hipertenzivnih bolesnika za približno 50 do 80%.
English: Non-steroidal anti-inflammatory drugs (NSAIDs)
Croatian: Nesteroidni protuupalni lijekovi (NSAIL-i)
English: Therefore, dialysis is not adequate to treat aliskiren over-exposure.
Croatian: Dijaliza stoga nije odgovarajuća za liječenje prekomjerne izloženosti aliskirenu.
English: Over 3,900 hypertensive patients received Rasilez HCT once daily in clinical study.
Croatian: U kliničkom je ispitivanju više od 3900 hipertenzivnih bolesnika primalo Rasilez HCT jednom dnevno.
English: Wheat starch in this medicine contains only very low levels of gluten (less than 100ppm) and is very unlikely to cause problems if you have coeliac disease.
Croatian: Pšenični škrob u ovom lijeku sadrži samo vrlo nisku razinu glutena (manje od 100 ppm) i malo je vjerojatno da će uzrokovati probleme ako imate celijakiju.
English: This medicine contains two active substances, called aliskiren and hydrochlorothiazide.
Croatian: Ovaj lijek sadrži dvije djelatne tvari koje se zovu aliskiren i hidroklorotiazid.
English: Other antihypertensive medicinal products
Croatian: Drugi antihipertenzivni lijekovi
English: No patients discontinued therapy due to anaemia.
Croatian: Niti jedan bolesnik nije prekinuo terapiju zbog anemije.
English: - amantadine (a medicine used to treat Parkinson's disease, also used to treat or prevent certain illnesses caused by viruses).
Croatian: Parkinsonove bolesti te kao pomoć uz anesteziju). - amantadin (lijek za liječenje Parkinsonove bolesti, također se koristi za liječenje ili sprječavanje pojedinih bolesti uzrokovanih virusima).
English: Similar food effect was observed for Rasilez HCT as for the individual monotherapies.
Croatian: Sličan utjecaj hrane opažen je za Rasilez HCT kao i za individualne monoterapije.
English: 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).
Croatian: Međutim, u narednoj 4-tjednoj randomiziranoj fazi ustezanja terapije u ispitivanju (2. faza), učinak aliskirena se preklapao s učincima zabilježenim u bolesnika koji su prešli na placebo u svim doznim skupinama (niska, p=0.8894; srednja, p=0.9511; visoka, p=0.0563).
English: The primary endpoint was a composite of cardiovascular death and first hospitalisation for heart failure.
Croatian: Primarna mjera ishoda bila je kompozitna i obuhvaćala je kardiovaskularnu smrt i prvu hospitalizaciju zbog zatajivanja srca.
English: In controlled clinical study, the incidence of diarrhoea in Rasilez HCT-treated patients was 1.3% compared to 1.4% for aliskiren- or 1.9% for hydrochlorothiazide-treated patients.
Croatian: U kontroliranim kliničkim ispitivanjima incidencija proljeva u bolesnika liječenih Rasilez HCT-om bila je 1,3% u usporedbi s 1,4% u bolesnika liječenih aliskirenom ili 1,9% u bolesnika liječenih hidroklorotiazidom.
English: Component of a multipack, can't be sold separately.90 film-coated tablets.
Croatian: Sastavni dio višestrukog pakiranja, ne može se prodavati zasebno. 90 filmom obloženih tableta.
English: Aliskiren is metabolised minimally by the cytochrome P450 enzymes.
Croatian: Aliskiren se minimalno metabolizira putem enzima citokroma P450.
English: Therefore, P-gp inhibitors may increase tissue levels more than plasma levels.
Croatian: Pgp inhibitori mogu povećati razine u tkivima više nego razine u plazmi.
English: Exposure to aliskiren increased slightly more than in proportion to the increase in dose.
Croatian: Izloženost aliskirenu povećala se nešto više nego razmjerno povećanju doze.
English: 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).
Croatian: 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).