FrancophonIA/ELRC3.0 huggingface dataset:
English: The cumulative review retrieved 187 cases out of which 57 were sufficiently documented, in 8 of these cases a causal relationship could not be ruled out.
Croatian: Kumulativni pregled obuhvatio je 187 slučajeva, od kojih je 57 bilo odgovarajuće dokumentirano, u 8 od tih slučajeva uzročno-posljedična veza nije se mogla isključiti.
English: If your blood pressure is not controlled after 4 to 6 weeks, your doctor may adjust your dose.
Croatian: Ako Vaš krvni tlak nije pod kontrolom nakon 4-6 tjedana, liječnik možda morati prilagoditi Vašu dozu.
English: A few patients have experienced these serious side effects.
Croatian: Nekoliko bolesnika je imalo ove ozbiljne nuspojave.
English: All three doses were well tolerated in both elderly and very elderly patients.
Croatian: Sve tri doze dobro su se podnosile među starim i među vrlo starim bolesnicima.
English: What you need to know before you take Rasilamlo
Croatian: Što morate znati prije nego počnete uzimati Rasilamlo
English: Dose should be individualised and adjusted according to the patient's clinical response.
Croatian: Dozu se mora individualizirati i prilagoditi prema kliničkom odgovoru bolesnika.
English: It reduces the amount of angiotensin II the body can make.
Croatian: Smanjuje količinu angiotenzina II koje tijelo može stvarati.
English: , peripheral neuropathy
Croatian: , periferna neuropatija
English: No mortality or significant toxicity was observed.
Croatian: Nije uočen mortalitet ili značajna toksičnost.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Second and third trimesters of pregnancy (see section 4.6).
Croatian: Drugo i treće tromjesečje trudnoće (vidjeti dio 4.6).
English: Aliskiren/amlodipine
Croatian: Aliskiren/amlodipin
English: Mechanisms responsible for deviation from linearity have not been identified.
Croatian: Nisu utvrđeni mehanizmi koji su odgovorni za odstupanje od linearnosti.
English: If you experience this symptom, do not drive or use tools or machines.
Croatian: Ako osjetite takav simptom, nemojte upravljati vozilima ili rukovati alatima ili strojevima.
English: What Rasilamlo is and what it is used for
Croatian: Što je Rasilamlo i za što se koristi
English: , dry mouth
Croatian: , suha usta
English: Rasilamlo is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.
Croatian: Rasilamlo se ne preporučuje u ranoj trudnoći te se ne smije uzimati ako ste trudni više od 3 mjeseca, jer može ozbiljno naštetiti Vašem djetetu ako se koristi nakon trećeg mjeseca trudnoće.
English: The blood pressure reductions with the combination were maintained throughout the entire 24-hour dose interval.
Croatian: Sniženja krvnog tlaka ostvarena kombinacijom lijekova održana su tijekom čitavog 24-satnog intervala doziranja.
English: Your doctor will normally advise you to stop taking Rasilamlo before you become pregnant and will advise you to take another medicine instead of Rasilamlo.
Croatian: Liječnik će Vas u pravilu savjetovati da prekinete uzimati Rasilamlo prije nego postanete trudni te će Vam savjetovati da uzmete drugi lijek umjesto lijeka Rasilamlo.
English: The adverse reactions are ranked by frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su poredane prema učestalosti, pri čemu su najčešće navedene prve, na sljedeći način: vrlo često (≥1/10), često (≥1/100 do <1/10), manje često (≥1/1000 do <1/100), rijetko (≥1/10 000 do <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Rasilamlo has been administered to more than 2,800 patients in completed clinical trials, including 372 patients for one year or more.
Croatian: Rasilamlo je primijenjen na više od 2800 bolesnika u završenim kliničkim ispitivanjima, uključujući 372 bolesnika najmanje jednu godinu ili dulje.
English: Therefore, because of the risk of therapeutic failure, fruit juice should not be taken together with Rasilamlo.
Croatian: Stoga se zbog rizika od terapijskog neuspjeha voćni sok ne bi smio uzimati zajedno s lijekom Rasilamlo.
English: • swelling mainly of the face and throat
Croatian: • oticanje uglavnom lica i grla
English: The safety of Rasilamlo has been evaluated in studies of up to one year duration.
Croatian: Sigurnost lijeka Rasilamlo ocjenjivana je u ispitivanjima do jedne godine trajanja.
English: As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Croatian: Kao i za bilo koju kombinaciju dviju djelatnih tvari, nuspojave povezane sa svakim pojedinim sastojkom ne mogu se isključiti.
English: In vitro studies with amlodipine have shown that approximately 97.5% of circulating amlodipine is bound to plasma proteins.
Croatian: In vitro ispitivanja s amlodipinom pokazala su da se otprilike 97,5% cirkulirajućeg amlodipina veže na proteine plazme.
English: A total of 33,357 hypertensive patients aged 55 or older were randomised and followed for a mean of 4.9 years.
Croatian: Randomizirano je ukupno 33 357 hipertenzivnih bolesnika u dobi od 55 godina ili starijih praćenih u prosjeku 4,9 godina.
English: Aliskiren is mainly eliminated as unchanged compound in the faeces (78%).
Croatian: Aliskiren se uglavnom eliminira kao nepromijenjeni lijek u stolici (78%).
English: Rasilamlo should not be used during the first trimester of pregnancy.
Croatian: Rasilamlo se ne smije primjenjivati tijekom prvog tromjesečja trudnoće.
English: Rasilamlo is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Croatian: Rasilamlo se ne preporučuje majkama koje doje, a ako želite dojiti liječnik Vam može odabrati drugo liječenje, posebno ako je Vaše dijete novorođenče ili je prijevremeno rođeno.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
English: Information on amlodipine interactions
Croatian: Informacije o interakcijama amolodipina
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: • 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.
Croatian: • Uoči svake izmjene sustava za upravljenje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: Hypotension was also uncommon (<1%) during combination therapy with other antihypertensive medicinal products.
Croatian: Hipotenzija je također bila manje česta (<1%) tijekom kombinirane terapije s drugim antihipertenzivnim lijekovima.
English: You should take this medicine with a light meal once a day, preferably at the same time each day.
Croatian: Ovaj lijek trebate uzimati s laganim obrokom jednom na dan, po mogućnosti svaki dan u isto vrijeme.
English: , arrhythmia (including bradycardia, ventricular tachycardia, and atrial fibrillation)
Croatian: , aritmija (uključujući bradikardiju, ventrikularnu tahikardiju, i fibrilaciju atrija)
English: , exfoliative dermatitis
Croatian: , eksfolijativni dermatitis
English: Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis).
Croatian: Opstrukcija istisnog dijela lijevog ventrikula (npr. aortalna stenoza visokog stupnja).
English: • skin rash (this may also be a sign of allergic reactions or angioedema - see “Rare” side effects
Croatian: • kožni osip (to može biti i znak alergijskih reakcija ili angioedema - pogledajte „Rijetke“
English: A possible mechanism is saturation of transporters at the absorption site or at the hepatobiliary clearance route.
Croatian: Mogući mehanizam je zasićenje transportera na mjestu apsorpcije ili na hepatobilijarnom putu klirensa.
English: For the surviving juvenile rats, no effects on behavioural or reproductive performance were observed.
Croatian: Kod preživjelih mladih štakora, nisu bili uočeni učinci na ponašanje ili sposobnost reprodukcije.
English: • increased sensitivity of the skin to sun
Croatian: • povećana osjetljivost kože na sunce.
English: Rasilamlo should be taken with a light meal once a day, preferably at the same time each day.
Croatian: Rasilamlo treba uzimati s laganim obrokom jednom na dan, po mogućnosti svaki dan u isto vrijeme.
English: difficulty breathing, dizziness (rare: may affect up to 1 in 1,000 people).
Croatian: teškoće pri disanju, omaglica (rijetko: mogu se javiti u do 1 na 1000 osoba).
English: Amlodipine belongs to a group of medicines known as calcium channel blockers, which help to control high blood pressure.
Croatian: Amlodipin pripada skupini lijekova koji se zovu blokatori kalcijevih kanala, koji pomažu kontrolirati povišeni krvni tlak.
English: The age at which the transporter system is mature cannot be determined.
Croatian: Dob u kojoj sazrijeva sustav prijenosa ne može se utvrditi.
English: • decreased skin sensitivity
Croatian: • smanjena osjetljivost kože
English: Carcinogenic potential was assessed in a 2-year rat study and a 6-month transgenic mouse study.
Croatian: Karcinogeni potencijal je određivan u 2-godišnjem ispitivanju na štakorima i 6-mjesečnom ispitivanju na transgeničnim miševima.
English: A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use.
Croatian: Vazokonstriktor može pomoći u uspostavljanju vaskularnog tonusa i krvnog tlaka, pod uvjetom da nema kontraindikacije za njegovu primjenu.
English: Additional information on individual components Adverse reactions previously reported with one of the individual components may occur with Rasilamlo even if not observed in clinical trials.
Croatian: Dodatne informacije o pojedinačnim komponentama Nuspojave ranije prijavljene s nekom od pojedinačnih komponenti mogu se pojaviti s Rasilamlom čak i ako nisu bile opažene u kliničkim ispitivanjima.
English: The ratio of lethal dose of 100 mg/kg/day and no-observed-adverse-effect-level (NOAEL) of 30 mg/kg/day is unexpectedly low.
Croatian: Omjer smrtonosne doze od 100 mg/kg/dan i razine bez uočenih štetnih učinaka (NOAEL) od 30 mg/kg/dan neočekivano je nizak.
English: Therefore aliskiren is not expected to affect the systemic exposure of substances that inhibit, induce or are metabolised by these enzymes.
Croatian: Zbog toga se ne očekuje da aliskiren utječe na sistemsku izloženost lijekovima koji te enzime inhibiraju, induciraju ili semetaboliziraju tim enzimima.
English: Other substances that act directly on the RAAS have been associated with serious foetal malformations and neonatal death.
Croatian: Drugi lijekovi koji djeluju direktno na RAAS povezane su s ozbiljnim malformacijama fetusa i neonatalnom smrću.
English: Similar reductions were found when aliskiren was combined with other antihypertensive medicinal products.
Croatian: Slična su sniženja nađena kada je aliskiren kombiniran s drugim antihipertenzivnim lijekovima.
English: • abnormal liver function test
Croatian: • abnormalni rezultati testa jetrene funkcije
English: Angiotensin II causes vasoconstriction and sodium and water reabsorption.
Croatian: Angiotenzin II uzrokuje vazokonstrikciju i reapsorpciju natrija i vode.
English: A single dose study was conducted in juvenile rats aged 14, 21, 24, 28, 31 or 36 days post-partum.
Croatian: Ispitivanje s jednom dozom provedeno je u mladih štakora u dobi od 14, 21, 24, 28, 31 ili 36 dana nakon okota.
English: Caution required with concomitant use - P-gp interactions
Croatian: Istodobna primjena zahtijeva oprez - P-gp interakcije
English: Findings during repeat-dose toxicity studies in animals were consistent with the known local 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 iritacijskim potencijalom ili s očekivanim farmakološkim učincima aliskirena.
English: A bioequivalence study under light meal conditions has not been conducted for Rasilamlo.
Croatian: Ispitivanje bioekvivalencije u uvjetima laganog obroka nije provedeno za Rasilamlo.
English: • severe allergic reaction (anaphylactic reaction)
Croatian: • teške alergijske reakcije (anafilaktička reakcija)
English: In patients with uncomplicated hypertension treated with Rasilamlo in short-term controlled trials, the incidence of hypotension was low (0.2%).
Croatian: U bolesnika s nekompliciranom hipertenzijom liječenom Rasilamlom u kratkotrajnim kontroliranim ispitivanjima incidencija hipotenzije bila je niska (0,2%).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Rasilamlo therapy taking into account the benefit of breast-feeding for the child and the benefit of
Croatian: Potrebno je odlučiti o tome treba li prekinuti dojenje ili prekinuti liječenje/suzdržati se od terapije Rasilamlom uzimajući u obzir korist dojenja za dijete i korist terapije za ženu.
English: If anaphylactic reactions or angioedema occur, Rasilamlo should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Croatian: Ako se pojavi anafilaktička reakcija ili angioedem, primjenu Rasilamlo treba odmah prekinuti i omogućiti odgovarajuću terapiju i praćenje dok ne dođe do potpunog i trajnog nestanka znakova i simptoma.
English: The use of combined treatment with aliskiren and amlodipine arises from the actions of these two medicinal products on different but complementary systems that regulate blood pressure.
Croatian: Primjena kombiniranog liječenja aliskirenom i amlodipinom proizlazi iz djelovanja ta dva lijeka na različite, ali komplementarne sustave koji reguliraju krvni tlak.
English: Do not take a double dose (two tablets at once) to make up for a
Croatian: Nemojte uzeti dvostruku dozu (dvije tablete odjednom) kako biste nadoknadili zaboravljenu tabletu.
English: If pregnancy is detected during therapy, Rasilamlo should be discontinued accordingly as soon as
Croatian: Ako se tijekom terapije utvrdi trudnoća, Rasilamlo se mora sukladno tome prekinuti čim je prije moguće.
English: 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.
Croatian: Ne bi se smio primjenjivati u djece u dobi od 2 do nenavršenih 6 godina i ne preporučuje se za rimjenu u djece i adolescenata u dobi od 6 do nenevršenih 18 godina.
English: Therefore, P-gp inhibitors may increase tissue levels more than plasma levels.
Croatian: P-gp inhibitori mogu povećati razine u tkivima više nego razine u plazmi.
English: Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit.
Croatian: Budući da se amlodipin u velikoj mjeri veže na proteine, dijaliza vjerojatno ne bi bila od koristi.
English: Women of child-bearing potential/contraception in males and females Healthcare professionals prescribing Rasilamlo should counsel women of childbearing potential about the potential risk during pregnancy.
Croatian: Žene u reproduktivnoj dobi/kontracepcija u muškaraca i žena Zdravstveni djelatnici koji propisuju Rasilamlo moraju savjetovati žene u reproduktivnoj dobi o mogućem riziku tijekom trudnoće.
English: Rasilamlo is contraindicated during the second and third trimesters (see section 4.3).
Croatian: Rasilamlo je kontraindiciran tijekom drugoga i trećeg tromjesečja (vidjeti dio 4.3).
English: You may need to stop Rasilamlo.
Croatian: Možda ćete morati prekinuti uzimanje Rasilamla.
English: Amlodipine is extensively (approximately 90%) metabolised in the liver to inactive metabolites, with 10% of the parent compound and 60% of the metabolites excreted in the urine.
Croatian: Amlodipin se u velikoj mjeri (približno 90%) metabolizira u jetri do inaktivnih metabolita, pri čemu se 10% nepromijenjenog lijeka i 60% metabolita izlučuje mokraćom.
English: If blood pressure remains uncontrolled after 4 to 6 weeks of therapy, the dose may be titrated up to a maximum of 300 mg aliskiren/10 mg amlodipine.
Croatian: Ako krvni tlak ostane nekontroliran nakon 4 do 6 tjedana terapije, dozu se može titrati do najviše 300 mg aliskirena/10 mg amlodipina.
English: The antihypertensive effect is manifested within 1 week and the effect is near maximal at around 4 weeks.
Croatian: Antihipertenzivni učinak se očituje unutar 1 tjedna, dok se gotovo maksimalni učinak postiže nakon otprilike 4 tjedna.
English: Safety pharmacology studies did not reveal any adverse effects on central nervous, respiratory or cardiovascular function.
Croatian: Ispitivanja sigurnosne farmakologije nisu otkrila bilo kakve nuspojave na centralnu nervnu, respiratornu ili kardiovaskularnu funkciju.
English: In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of
Croatian: U zdravih dobrovoljaca primjena aktivnog ugljena u roku do 2 sata nakon primjene 10 mg amlodipina dokazano smanjuje stopu apsorpcije amlodipina.
English: Thus, amlodipine directly inhibits vasoconstriction and reduces vascular resistance, while aliskiren, by controlling Ang II production, can also inhibit vasoconstriction but additionally shifts water and sodium balance toward levels necessary for normotensive conditions.
Croatian: Tako amlodipin direktno inhibira vazokonstrikciju i smanjuje vaskularnu rezistenciju, dok aliskiren, kontrolirajući stvaranje Ang II, također može inhibirati vazokonstrikciju, ali dodatno mijenja ravnotežu vode i natrija prema razinama potrebnim za normotenzivne uvjete.
English: Plasma concentrations correlate with effect in both young and elderly patients.
Croatian: Koncentracije u plazmi su u korelaciji s učinkom u mladih i u starih bolesnika.
English: Amlodipine can have minor or moderate influence on the ability to drive and use machines.
Croatian: Amlodipin može malo ili umjereno utjecati na sposobnost upravljanja vozilima i rada na strojevima.
English: Amlodipine elimination from plasma is biphasic with a terminal elimination half-life of approximately 30 to 50 hours.
Croatian: Eliminacija amlodipina iz plazme je bifazna poluvijekom eliminacije od približno 30 do 50 sati.
English: Therefore, information on interactions with other medicinal products that are known for the individual active substances is provided in this section.
Croatian: Stoga su u ovom dijelu prikazane informacije o poznatim interakcijama pojedinačnih djelatnih tvari s drugim lijekovima.
English: When driving vehicles or using machines it must be borne in mind that dizziness or drowsiness may occasionally occur when taking Rasilamlo.
Croatian: Prilikom upravljanja vozilima ili rada na strojevima, mora se imati na umu da se tijekom uzimanja lijeka Rasilamlo povremeno mogu javiti omaglica ili omamljenost.
English: Amlodipine does not change sinoatrial nodal function or atrioventricular conduction in intact animals or humans.
Croatian: Amlodipin ne mijenja funkciju sinoatrijskog čvora ili atrioventrikularno provođenje u intaktnih životinja ili ljudi.
English: Since there is insufficient/limited information on the excretion of aliskiren and amlodipine in human or animal breast milk, a risk to the newborns/infants cannot be excluded.
Croatian: Budući da su informacije o izlučivanju aliskirena i amlodipina u majčino mlijeko u ljudi ili životinja nedostatni/ograničeni, ne može se isključiti rizik za novorođenčad/dojenčad.
English: Rasilamlo 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 because of safety concerns due to potential aliskiren overexposure (see sections 4.3, 4.4, 5.2, and 5.3).
Croatian: Rasilamlo je 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 zbog sigurnosnih problema uzrokovanih potencijalnom prekomjernom izloženošću aliskirenu (vidjeti dijelove 4.3, 4.4, 5.2, i 5.3).
English: • vision disorder (including double vision)
Croatian: • poremećaj vida (uključujuči dvostruki vid)
English: As for any medicine that acts directly on the RAAS, aliskiren should not be used during the first trimester of pregnancy and is contraindicated during the second and third trimesters (see section 4.3).
Croatian: Kao i u slučaju bilo kojeg lijeka koji djeluje direktno na RAAS, aliskiren se ne smije primjenjivati tijekom prvog tromjesečja trudnoće te je kontraindiciran tijekom drugog i trećeg tromjesečja (vidjeti dio 4.3).
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 oralne primjene (vidjeti dio 5.2).
English: Slovenská republika Novartis Slovakia s.r.o.
Croatian: Česká republika Novartis s.r.o.
English: Patients with hepatic insufficiency have decreased clearance of amlodipine with resulting increase in AUC of approximately 40-60%.
Croatian: Bolesnici s insuficijencijom jetre imaju smanjeni klirens amlodipina s posljedičnim povećanjem AUC-a za približno 40-60%.
English: During the reporting a number of serious and non-serious adverse drug reactions (ADRs) from postmarketing data sources regarding “hyponatraemia” raised a concern that led to the submission of a cumulative review from the Marketing Authorisation Holder (MAH).
Croatian: Tijekom prijavljivanja niza ozbiljnih i ne-ozbiljnih nuspojava "hiponatrijemije" iz izvora podataka nakon stavljanja lijeka u promet pojavila se zabrinutost, zbog čega je nositelj odobrenja podnio kumulativni pregled.
English: Liver enzyme increased a, weight increase weight decrease
Croatian: Povišeni jetreni enzimi a, povećanje tjelesne težine
English: Linearity Amlodipine exhibits linear pharmacokinetics between the therapeutic dose range of 5 mg and 10 mg.
Croatian: Linearnost Amlodipin pokazuje linearnu farmakokinetiku u rasponu terapijskih doza od 5 mg i 10 mg.
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 pohranu različitih supstrata u tkiva i da P-gp inhibitori mogu povećati razine u tkivima više od razina u plazmi.
English: The age at which the transporter system is mature cannot be determined (see sections 5.2 and 5.3).
Croatian: Dob u kojoj sustav prijenosa sazrijeva ne može se utvrditi (vidjeti dijelove 5.2 i 5.3).
English: Experimental data suggest that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites.
Croatian: Eksperimentalni podaci ukazuju da se amlodipin veže na oba, dihidropiridinska i ne-dihidropiridinska vezna mjesta.