FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose of the film-coated tablets may be increased to a maximum of 20 mg or decreased to 5 mg, depending on the effectiveness of treatment and any side effects.
Croatian: Doza filmom obloženih tableta može se povećati na maksimalno 20 mg ili smanjiti na 5 mg, ovisno o djelotvornosti liječenja i nuspojavama.
English: It is available as film-coated tablets (5, 10 and 20 mg) and as orodispersible tablets (10 mg).
Croatian: Lijek je dostupan u obliku filmom obloženih tableta (5, 10 i 20 mg) i u obliku raspadljivih tableta za usta (10 mg).
English: A risk management plan has been developed to ensure that Levitra is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Levitra.
English: • patients with unstable angina and hereditary eye problems known as ‘retinal degenerative disorders'.
Croatian: • bolesnici s nestabilnom anginom ili nasljednim očnim problemima poznatima kao „degenerativni poremećaji mrežnice”.
English: For more information about treatment with Levitra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Levitra pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Levitra must not be taken with nitrates (medicines used to treat angina).
Croatian: Levitra se ne smije primjenjivati s nitratima (lijekovima koji se koriste za liječenje angine).
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax.
Croatian: Tijekom normalne seksualne stimulacije u penisu se proizvodi cGMP, gdje uzrokuje opuštanje mišića u spužvastom tkivu penisa (kavernoznom tijelu).
English: Levitra is a medicine that contains the active substance vardenafil.
Croatian: Levitra je lijek koji sadrži djelatnu tvar vardenafil.
English: By blocking the breakdown of cGMP, Levitra restores erectile function.
Croatian: Blokadom razgradnje cGMP-a Levitra ponovno uspostavlja erektilnu funkciju.
English: The maximum recommended dosing frequency is one film-coated tablet or orodispersible tablet per day.
Croatian: Maksimalna preporučena učestalost doziranja jest jedna filmom obložena tableta ili tableta raspadljiva u ustima na dan.
English: Levitra is used to treat adult men (aged 18 years or over) with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Croatian: Lijek Levitra koristi se za liječenje erektilne disfunkcije (koja se ponekad naziva i impotencija) u odraslih muškaraca (u dobi od 18 godina i više), u slučajevima kada ne mogu postići ili zadržati ukrućeni penis (erekciju) dovoljno dugo za zadovoljavajuću seksualnu aktivnost.
English: Orodispersible tablets are tablets that dissolve in the mouth.
Croatian: Raspadljive tablete za usta jesu tablete koje se otapaju u ustima.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Levitra, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Levitra nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Levitra must not be used in people who are hypersensitive (allergic) to vardenafil or any of the other ingredients.
Croatian: Lijek Levitra ne smiju koristiti osobe koje su preosjetljive (alergične) na vardenafil ili bilo koji drugi sastojak lijeka.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom uzimaju druge lijekove koji blokiraju enzime potrebne za razgradnju lijeka Levitra.
English: For Levitra to be effective, sexual stimulation is required.
Croatian: Da bi lijek Levitra djelovao, potrebna je seksualna stimulacija.
English: Why has Levitra been approved?
Croatian: Zašto je lijek Levitra odobren?
English: Levitra tablets were compared with placebo (a dummy treatment) in four main studies including a total of 2,431 men with erectile dysfunction aged 20 to 83 years.
Croatian: Tablete lijeka Levitra uspoređivane su s placebom (lažno liječenje) u okviru četiriju glavnih ispitivanja koja su obuhvaćala 2 431 muškarca s erektilnom disfukncijom u dobi od 20 do 83 godine.
English: The CHMP decided that Levitra's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Levitra nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje u promet lijeka.
English: Levitra must not be taken with ketoconazole and itraconazole (used to treat fungal infections) in men over 75 years of age, or with medicines called ‘HIV protease inhibitors' such as ritonavir or indinavir (used to treat HIV infection).
Croatian: Levitra se ne smije primjenjivati s nekim lijekovima poput ketokonazola i itrakonazola (za liječenje gljivičnih infekcija) u muškaraca starijih od 75 godina ili s lijekovima zvanima „inhibitori proteaze HIVa” poput ritonavira ili indinavira (za liječenje infekcije HIV-om).
English: What benefit has Levitra shown during the studies?
Croatian: Koje su koristi lijeka Levitra dokazane u ispitivanjima?
English: Levitra tablets and orodispersible tablets were significantly more effective than placebo for all measures in all of the studies.
Croatian: Lijek Levitra u obliku tableta i tableta raspadljivih u ustima prema svim se mjerilima te u svim ispitivanjima pokazao znatno učinkovitijim od placeba.
English: One of these studies was carried out in diabetic men and another in men who had had their prostate gland removed.
Croatian: Jedno ispitivanje provedeno je na muškarcima sa šećernom bolesti, a drugo na muškarcima kojima je odstranjena prostata.
English: In addition, Levitra must not be taken with medicines known as guanylate cyclase stimulators, including riociguat (used to treat pulmonary hypertension [high blood pressure in the lungs]).
Croatian: Osim toga, Levitra se ne smije primjenjivati s lijekovima poznatima kao stimulatori gvanilat ciklaze, uključujući riocigvat (koristi se za liječenje plućne hipertenzije [visokog krvnog tlaka u plućima]).
English: It must also not be used in patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy or NAION).
Croatian: Lijek također ne smiju uzimati bolesnici koji su doživjeli gubitak vida zbog problema s dotokom krvi u očni živac (nearteritička prednja ishemička neuropatija ili NAION).
English: What is Levitra used for?
Croatian: Za što se Levitra koristi?
English: How does Levitra work?
Croatian: Kako Levitra djeluje?
English: The dose may need to be adjusted in patients taking other medicines that block enzymes that break down Levitra.
Croatian: Možda će biti potrebno prilagoditi dozu u bolesnika koji
English: How is Levitra used?
Croatian: Kako se Levitra koristi?
English: A starting dose of 5 mg should be considered for patients with mild and moderate liver problems or severe kidney problems.
Croatian: U bolesnika s blagim i umjerenim problemima u radu jetre i ozbiljnim problemima u radu bubrega, potrebno je razmotriti početnu dozu od 5 mg.
English: For the full list of all side effects reported with Levitra, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Levitra potražite u uputi o lijeku.
English: How has Levitra been studied?
Croatian: Kako je lijek Levitra ispitivan?
English: BLISTER (CALENDAR)
Croatian: BLISTER (KALENDAR)
English: Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Croatian: Ponedjeljak Utorak Srijeda
English: (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Rasilez with food and drink
Croatian: Rasilez s hranom i pićem
English: “Do not take Rasilez” and “Warnings and precautions”).
Croatian: “Nemojte uzimati Rasilez” i “Upozorenja i mjere opreza”).
English: If you take more Rasilez than you should
Croatian: Ako uzmete više Rasileza nego što ste trebali
English: See also section “Do not take Rasilez”.
Croatian: Vidjeti također dio “Nemojte uzimati Rasilez”.
English: Some side effects can be serious (frequency not known):
Croatian: Neke nuspojave mogu biti ozbiljne (učestalost nepoznata):
English: The AUC is 50% higher in elderly (> 65 years) than in young subjects.
Croatian: AUC je 50% viši u starijih osoba (>65 godina) nego u mladih ispitanika.
English: It 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 used after the third month of pregnancy.
Croatian: Ne preporučuje se 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: Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of this medicine.
Croatian: Prije nego započnete upravljati vozilom, raditi sa strojevima ili obavljati druge aktivnosti koje zahtijevaju koncentraciju, svakako morate znati kako reagirate na učinke ovog lijeka.
English: What Rasilez is and what it is used for
Croatian: Što je Rasilez i za što se koristi
English: - Second and third trimesters of pregnancy (see section 4.6).
Croatian: - Drugo i treće tromjesečje trudnoće (vidjeti dio 4.6).
English: What you need to know before you take Rasilez
Croatian: Što morate znati prije nego počnete uzimati Rasilez
English: - during the last 6 months of pregnancy or if you are breast-feeding, see section “Pregnancy and breastfeeding”.
Croatian: - tijekom zadnjih 6 mjeseci trudnoće ili ako dojite, vidite dio „Trudnoća i dojenje“.
English: Do not take this medicine if you are pregnant (see section “Do not take Rasilez”).
Croatian: Nemojte uzimati ovaj lijek ako ste trudni (pogledajte dio Nemojte uzimati Rasilez).
English: However, if it is almost time for your next dose you should simply take the next tablet at the usual time.
Croatian: Međutim, ako je uskoro vrijeme za Vašu sljedeću dozu, onda jednostavno u uobičajeno vrijeme uzmite sljedeću dozu.
English: This helps to lower high blood pressure in adult patients.
Croatian: To pomaže u snižavanju povišenog krvnog tlaka u odraslih bolesnika.
English: If any of the following occur, tell your doctor straight away:
Croatian: Ako se dogodi nešto od sljedećeg, odmah obavijestite svog liječnika:
English: This medicine may make you feel dizzy and this can affect your ability to concentrate.
Croatian: Uz ovaj lijek možete osjetiti omaglicu, a to može utjecati na vašu sposobnost koncentracije.
English: The average differences between aliskiren and placebo for the low and mid dose groups were <0.2 mmHg.
Croatian: Prosječna razlika između aliskirena i placeba za skupine s niskom i srednjom dozom bila je <0,2 mmHg.
English: - if you have impaired kidney function, your doctor will carefully consider whether this medicine is suitable for you and may wish to monitor you carefully.
Croatian: - ako imate oštećenu funkciju bubrega, Vaš će liječnik pažljivo razmotriti je li ovaj lijek primjeren za Vas i vjerojatno će Vas htjeti pozornije pratiti.
English: You may need to stop Rasilez.
Croatian: Možda ćete morati prekinuti uzimanje Rasileza.
English: However, CYP3A4 inhibitors often also affect P-gp.
Croatian: Međutim, CYP3A4 inhibitori također često utječu na P-gp.
English: Your doctor may need to change your dose and/or to take other precautions if you are taking one of the following medicines: - medicines that increase the amount of potassium in your blood.
Croatian: Liječnik će Vam možda morati promijeniti dozu i/ili poduzeti druge mjere opreza, ako uzimate neki od sljedećih lijekova: - lijekove koji povećavaju količinu kalija u Vašoj krvi.
English: People who have high blood pressure often do not notice any signs of the problem.
Croatian: Osobe koje imaju povišeni krvni tlak često ne osjećaju nikakve znakove probleme.
English: Via Provinciale Schito 131 80058 Torre Annunziata (NA) Italy
Croatian: Novartis Farma S.p.A. Via Provinciale Schito 131 80058 Torre Annunziata (NA) Italija
English: - if you are taking either of the following classes of medicines used to treat high blood pressure:
Croatian: - ako uzimate bilo koju od skupina lijekova navedenih u nastavku, koje se koriste za liječenje visokog krvnog tlaka:
English: Therefore, because of the risk of therapeutic failure, fruit juice should not be taken together with aliskiren.
Croatian: Stoga se zbog rizika od terapijskog neuspjeha voćni sok ne bi smio uzimati zajedno s aliskirenom.
English: The blood pressure lowering effect is present within two weeks after beginning treatment.
Croatian: Učinak snižavanja krvnog tlaka prisutan je unutar dva tjedna nakon početka liječenja.
English: Your doctor may prescribe this medicine together with other medicines used to treat high blood pressure.
Croatian: Liječnik Vam može propisati ovaj lijek zajedno s drugim lijekovima koji se koriste za liječenje povišenog krvnog tlaka.
English: If you have severe and persistent diarrhoea you should stop taking Rasilez.
Croatian: Ako imate težak i ustrajan proljev potrebno je prestati uzimati Rasilez.
English: Depending on how you respond to the treatment your doctor may prescribe a higher dose of one 300 mg tablet once daily.
Croatian: Ovisno o tome kako odgovarate na liječenje, liječnik Vam može propisati višu dozu od jedne tablete od 300 mg jednom dnevno.
English: Elderly patients aged 65 years and over
Croatian: Stariji bolesnici u dobi od 65 godina i više
English: Use of Rasilez is not recommended in this population.
Croatian: Ne preporučuje se koristiti lijek Rasilez u ovoj populaciji.
English: Palpitations, oedema peripheral
Croatian: Palpitacije, periferni edem
English: Rasilez is contraindicated in children from birth to less than 2 years.
Croatian: Rasilez je kontraindiciran u djece od rođenja do nenavršene 2 godine.
English: Limited data are available related to overdose in humans.
Croatian: Dostupni podaci povezani s predoziranjem u ljudi su ograničeni.
English: However, the efficacy of aliskiren was similar when taken with a light meal or under fasted state.
Croatian: Međutim, djelotvornost aliskirena bila je slična kad se uzimao s laganim obrokom ili natašte.
English: Therefore the combination of aliskiren with an NSAID requires caution, especially in elderly patients.
Croatian: Stoga kombinacija aliskirena s NSAIL-ovima zahtijeva oprez, posebno u starijih bolesnika.
English: Liver enzyme increased
Croatian: Povišeni jetreni enzimi
English: Hypotension was also uncommon (<1%) during combination therapy with other antihypertensive agents.
Croatian: Hipotenzija je također bila manje česta (<1%) tijekom kombinirane terapije s drugim antihipertenzivnim lijekovima.
English: Aliskiren belongs to a class of medicines called renin inhibitors.
Croatian: Aliskiren pripada skupini lijekova koji se zovu inhibitori renina.
English: In patients whose blood pressure is not adequately controlled, the dose may be increased to 300 mg once daily.
Croatian: U bolesnika u kojih krvni tlak nije odgovarajuće kontroliran, doza se može povećati na 300 mg jedanput dnevno.
English: Other medicines and Rasilez
Croatian: Drugi lijekovi i Rasilez
English: Renin inhibitors reduce the amount of angiotensin II the body can produce.
Croatian: Inhibitori renina smanjuju količinu angiotenzina II koji tijelo može stvarati.
English: When driving vehicles or using machines it must be borne in mind that dizziness or drowsiness may occasionally occur when taking Rasilez.
Croatian: Prilikom upravljanja vozilima ili rada sa strojevima, mora se imati na umu da se tijekom uzimanja Rasileza povremeno mogu javiti omaglica ili omamljenost.
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 povezani su s ozbiljnim malformacijama fetusa i neonatalnom smrću.
English: The starting dose in each group was assigned depending on weight with three groups: ≥20 to <50 kg, ≥50 to <80 kg, and ≥80 to ≤150 kg.
Croatian: Početna doza u svakoj grupi je dodijeljena ovisno o tjelesnoj težini u tri grupe: ≥20 do <50 kg, ≥50 do <80 kg i ≥80 do ≤150 kg.
English: The safety and efficacy of Rasilez in children aged 6 to 17 years have not yet been established.
Croatian: Sigurnost i djelotvornost Rasileza u djece u dobi od 6 do 17 godina nisu još ustanovljene.
English: - Hereditary or idiopathic angioedema.
Croatian: - Nasljedni ili idiopatski angioedem.
English: If you have accidentally taken too many tablets of this medicine, consult a doctor immediately.
Croatian: Ako ste slučajno uzeli previše tableta ovog lijeka, odmah se obratite svom liječniku.
English: It induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide.
Croatian: Izazvao je dodatni učinak na snižavanje krvnoga tlaka, kada je dodan hidroklorotiazidu.
English: As a result no dose adjustment for Rasilez or these co-administered medicinal products is necessary.
Croatian: Kao rezultat toga, nije potrebna prilagodba doze Rasileza ili ovih istodobno primijenjenih lijekova.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with aliskiren in one or more subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka aliskirena u jednoj ili više podskupina pedijatrijske populacije u hipertenziji (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If you forget to take Rasilez
Croatian: Ako ste zaboravili uzeti Rasilez
English: This medicine contains an active substance called aliskiren.
Croatian: Ovaj lijek sadrži djelatnu tvar koja se zove aliskiren.
English: Rasilez has minor influence on the ability to drive and use machines.
Croatian: Rasilez malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: difficulty breathing, dizziness.
Croatian: teškoće pri disanju, omaglica.
English: If anaphylactic reactions or angioedema occur, treatment 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 treba odmah prekinuti i omogućiti odgovarajuću terapiju i praćenje dok ne dođe do potpunog i trajnog nestanka znakova i simptoma.
English: As for any medicine that acts directly on the RAAS, alsikiren should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Croatian: Kao i u slučaju bilo kojeg lijeka koji djeluje direktno na RAAS, aliskiren se ne smije primjenjivati tijekom prvog tromjesečja trudnoće ili u žena koje planiraju zatrudnjeti te je kontraindiciran tijekom drugog i trećeg tromjesečja (vidjeti dio 4.3).
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; renin inhibitor, ATC code: C09XA02
Croatian: Farmakoterapijska skupina: lijekovi koji djeluju na sustav renin-angiotenzin; inhibitor renina, ATK oznaka: C09XA02
English: If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Croatian: Ako se terapija dvostrukom blokadom smatra apsolutno nužnom smije se samo provoditi pod nadzorom specijalista i uz pažljivo praćenje bubrežne funkcije, elektrolita i krvnog tlaka.
English: In experimental animals, it has been shown that P-gp is a major determinant of Rasilez bioavailability.
Croatian: U eksperimentalnih se životinja pokazalo da je P-gp glavna odrednica bioraspoloživosti Rasileza.
English: Healthcare professionals prescribing any agents acting on the RAAS should counsel women of childbearing potential about the potential risk of these agents during pregnancy.
Croatian: Zdravstveni djelatnici koji propisuju lijekove koji djeluju na RAAS trebaju ženama u reproduktivnoj dobi objasniti mogući rizik tih lijekova tijekom trudnoće.
English: Safety pharmacology studies did not reveal any adverse effects on central nervous, respiratory or cardiovascular function.
Croatian: Ispitivanja sigurnosne farmakologije nisu otkrila nikakve nuspojave na središnju živčanu, respiratornu ili kardiovaskularnu funkciju.
English: • Severe allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue,
Croatian: • Teška alergijska reakcija sa simptomima poput osipa, svrbeža, oticanja lica ili usnica ili jezika,
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 APR.
English: Serious adverse reactions include anaphylactic reaction and angioedema which have been reported in post-marketing experience and may occur rarely (less than 1 case per 1,000 patients).
Croatian: Ozbiljne nuspojave uključuju anafilaktičku reakciju i angioedem, koji su prijavljeni nakon stavljanja lijeka u promet, a pojavljuju se rijetko (manje od 1 slučaja na 1000 bolesnika).
English: Aliskiren is an effective once-a-day antihypertensive treatment in adult patients, regardless of gender, age, body mass index and ethnicity.
Croatian: 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.
English: How to take Rasilez
Croatian: Kako uzimati Rasilez
English: **Including one case of ‘liver failure fulminant' reported in the post-marketing experience, for which a causal relationship with aliskiren cannot be excluded.
Croatian: **Uključujući jedan slučaj ‘fulminantnog zatajenja jetre' prijavljen nakon stavljanja lijeka u promet, za kojeg se uzročna veza s aliskirenom ne može isključiti.
English: NSAIDs may reduce the anti-hypertensive effect of aliskiren.
Croatian: NSAIL-ovi mogu smanjiti antihipertenzivni učinak aliskirena.
English: No carcinogenic potential for aliskiren was detected in a 2-year rat study and a 6-month transgenic mouse study.
Croatian: Nije otkriven kancerogeni potencijal aliskirena u 2-godišnjem ispitivanju na štakorima i 6-mjesečnom ispitivanju na transgeničnim miševima.
English: The volume or salt depletion should be corrected prior to administration of Rasilez, or the treatment should start under close medical supervision.
Croatian: Volumen tekućine ili razina natrija se treba ispraviti prije primjene Rasileza, ili liječenje treba započeti uz pomni nadzor liječnika.
English: 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).
Croatian: 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).
English: The most likely manifestations of overdosage would be hypotension, related to the antihypertensive effect of aliskiren.
Croatian: Najvjerojatnija manifestacija predoziranja bila bi hipotenzija povezana s antihipertenzivnim učinkom aliskirena.
English: The usual starting dose is one 150 mg tablet once daily.
Croatian: Uobičajena početna doza je jedna tableta od 150 mg jednom dnevno.