FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effect with Irbesartan Zentiva (seen in more than 1 patient in 10) is dizziness, hyperkalaemia (high blood potassium levels).
Croatian: Najčešća nuspojava s lijekom Irbesartan Zentiva (koja se može javiti u više od 1 na 10 osoba) je vrtoglavica, hiperkalemija (visoka razina kalija u krvi).
English: Irbesartan Zentiva is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
Croatian: Irbesartan Zentiva se također koristi za liječenje bolesti bubrega u odraslih s hipertenzijom i šećernom bolešću tipa
English: In the second kidney disease study, Irbesartan Zentiva reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo.
Croatian: U drugom ispitivanju bolesti bubrega Irbesartan Zentiva je tijekom ispitivanja smanjio relativan rizik od udvostručavanja razina kreatinina u krvi, koje zahtjeva transplantaciju bubrega ili dijalizu odnosno uzrokuju smrt, za 20% u usporedbi s placebom.
English: In the blood pressure studies, Irbesartan Zentiva was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Croatian: U ispitivanjima krvnoga tlaka Irbesartan Zentiva je bio djelotvorniji od placeba u smanjivanju dijastoličkog krvnog tlaka i imao je slično djelovanje kao drugi antihipertenzivi.
English: What is the risk associated with Irbesartan Zentiva?
Croatian: Koji su rizici povezani s lijekom Irbesartan Zentiva?
English: For the treatment of kidney disease, Irbesartan Zentiva was studied in two large studies involving a total of 2,326 patients with type 2 diabetes.
Croatian: Za liječenje bolesti bubrega Irbesartan Zentiva je ispitan u dva velika ispitivanja koja su obuhvatila ukupno 2.326 bolesnika sa šećernom bolešću tipa 2. Irbesartan Zentiva se primjenjivao tijekom dvije godine ili duže.
English: In the first kidney disease study, Irbesartan Zentiva was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
Croatian: U prvom ispitivanju bolesti bubrega Irbesartan Zentiva je bio djelotvorniji od placeba u smanjivanju rizika od nastanka oštećenja funkcije bubrega kako je izmjereno izlučivanjem proteina.
English: The CHMP decided that Irbesartan Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) odlučilo je da koristi od lijeka Irbesartan Zentiva nadmašuju s njim povezane rizike te je preporučilo izdavanje odobrenja za stavljanje lijeka u promet.
English: What is Irbesartan Zentiva?
Croatian: Što je Irbesartan Zentiva?
English: Why has Irbesartan Zentiva been approved?
Croatian: Zašto je Irbesartan Zentiva odobren?
English: For the full description of all side effects reported with Irbesartan Zentiva, see the package leaflet.
Croatian: Potpuni opis nuspojava koje su zabilježene s lijekom Irbesartan Zentiva potražite u uputi o lijeku.
English: What benefit has Irbesartan Zentiva shown during the studies?
Croatian: Koje koristi lijeka Irbesartan Zentiva su dokazane u ispitivanjima?
English: Irbesartan Zentiva was originally studied in 11 trials for its effects on blood pressure.
Croatian: Djelovanje lijeka Irbesartan Zentiva na krvni tlak izvorno je ispitano u 11 istraživanja.
English: How is Irbesartan Zentiva used?
Croatian: Kako se Irbesartan Zentiva koristi?
English: What is Irbesartan Zentiva used for?
Croatian: Za što se Irbesartan Zentiva koristi?
English: How has Irbesartan Zentiva been studied?
Croatian: Kako je Irbesartan Zentiva ispitan?
English: Irbesartan Zentiva is used in adults who have essential hypertension (high blood pressure).
Croatian: Irbesartan Zentiva se koristi za liječenje esencijalne hipertenzije (visokog krvnog tlaka) u odraslih osoba. „Esencijalna” znači da hipertenzija nema nekog očitog uzroka.
English: How does Irbesartan Zentiva work?
Croatian: Kako Irbesartan Zentiva djeluje?
English: Irbesartan Zentiva in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Croatian: U kombinaciji s lijekovima koji sadrže aliskiren (koristi se za liječenje esencijalne hipertenzije)
English: Date of first authorisation: 08 January 2014 Date of latest renewal: 20 November 2018
Croatian: Datum prvog odobrenja: 08 siječanj 2014 Datum posljednje obnove odobrenja: 20 studeni 2018
English: Elderly (65 years and older)
Croatian: Starije osobe (65 godina i stariji)
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno raspoloživi podaci su opisani u dijelovima 4.8, 5.1, i 5.2, ali ne mogu se napraviti preporuke vezane uz doziranje.
English: Read all of this leaflet carefully before you or your child start using this medicine because it contains important information for you.
Croatian: Pročitajte pažljivo cijelu uputu prije nego što Vi ili Vaše dijete počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: Height (cm) x ks
Croatian: Visina (cm) x ks
English: Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a reduction of its effect.
Croatian: Nemojte uzimati makrogol (lijek koji se koristi kao laksativ) jedan sat prije i jedan sat nakon uzimanja levetiracetama jer to može smanjiti učinak levetiracetama.
English: EXP Use immediately after dilution.
Croatian: EXP Upotrijebiti odmah nakon razrjeđivanja.
English: [140-age (years)] x weight (kg)
Croatian: [140-dob (godine)] x težina (kg)
English: If not used immediately, in-use storage time and conditions are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja odgovornost su korisnika.
English: Levetiracetam Hospira must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Croatian: Levetiracetam Hospira se mora primjenjivati dva puta na dan, jednom ujutro i jednom navečer, u približno isto vrijeme svaki dan.
English: This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy).
Croatian: To smanjenje koncentracije bilo je više izraženo tijekom trećeg trimestra (do 60% u odnosu na početnu koncentraciju prije trudnoće).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti i kancerogeni potencijal.
English: When you first start taking Levetiracetam Hospira, your doctor will prescribe you a lower dose for 2 weeks before giving you the lowest general dose.
Croatian: Kad prvi put počnete uzimati Levetiracetam Hospira, liječnik će Vam propisati manju dozu tijekom 2 tjedna prije davanja najmanje uobičajene doze.
English: You should not drive or use machines until it is established that your ability to perform such activities is not affected.
Croatian: Ne smijete voziti ili se koristiti strojevima dok se ne utvrdi da Vaša sposobnost za takve aktivnosti nije narušena.
English: This leaflet was last revised in month/YYYY.
Croatian: Ova uputa je zadnji puta revidirana u mjesec/GGGG.
English: The pharmacokinetic and safety profiles did not identify any safety concerns.
Croatian: Farmakokinetički i sigurnosni profil nije otkrio sigurnosne rizike.
English: Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins (< 10 %).
Croatian: Levetiracetam kao ni njegov primarni metabolit ne vežu se značajno za proteine plazme (<10%).
English: The major metabolic pathway (24% of the dose) is an enzymatic hydrolysis of the acetamide group.
Croatian: Glavni je metabolički put (24% doze) enzimska hidroliza acetamidne skupine.
English: This should be taken into consideration if you are on a controlled sodium diet.
Croatian: To treba uzeti u obzir ako ste na prehrani s kontroliranim unosom natrija.
English: No impact on fertility was detected in animal studies (see section 5.3).
Croatian: U studijama provedenim na životinjama nije utvrđen utjecaj na plodnost (vidjeti dio 5.3).
English: One was obtained by hydroxylation of the pyrrolidone ring (1.6 % of the dose) and the other one by opening of the pyrrolidone ring (0.9% of the dose).
Croatian: Jedan nastaje hidroksilacijom pirolidonskog prstena (1,6% doze), a drugi otvaranjem pirolidonskog prstena (0,9% doze).
English: Treatment with levetiracetam should be reviewed when a woman is planning to become pregnant.
Croatian: Liječenje levetiracetamom treba ponovno razmotriti kada žena planira trudnoću.
English: ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
Croatian: ks= 0,55 za djecu mlađu od 13 godina i za adolescente ženskog spola; ks= 0,7 za adolescente muškog spola
English: Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation).
Croatian: Levetiracetam se koristi za oblik epilepsije u kojem napadaj u početku utječe na samo jednu stranu mozga, ali bi se mogao nakon toga proširiti na veće područje, na obje strane mozga (parcijalni napadaj sa sekundarnom generalizacijom ili bez nje).
English: Dose recommendations for children and adolescents: Weight
Croatian: Preporučene doze za djecu i adolescente: Tjelesna težina
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14.
Croatian: Farmakoterapijska skupina: antiepileptici, ostali antiepileptici, ATK oznaka: N03AX14
English: Other unidentified components accounted only for 0.6% of the dose.
Croatian: Ostali neidentificirani metaboliti odgovaraju samo 0,6% doze.
English: To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed.
Croatian: Da biste mogli upotrijebiti ovu tablicu za doziranje, potrebna je procjena bolesnikova klirensa kretinina (CLcr) u ml/min.
English: Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m
Croatian: Stoga se preporučuje 50%-tno smanjenje dnevne doze održavanja ako je klirens kreatinina < 60 ml/min/1,73 m
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: 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) and very rare (<1/10,000).
Croatian: Nuspojave su prikazane u padajućem nizu prema ozbiljnosti i njihova učestalost je definirana na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000) i vrlo rijetko (<1/10 000).
English: Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase.
Croatian: Uslijed mogućih razlika u osjetljivosti među pojedincima u nekih bolesnika može se javiti somnolencija ili drugi simptomi vezani za središnji živčani sustav, osobito na početku liječenja ili nakon povećanja doze.
English: For doctors and nurses, more detailed direction for the proper use of Levetiracetam Hospira is provided in section 6.
Croatian: Za liječnike i medicinske sestre, detaljnija uputstva za pravilnu primjenu Levetiracetama Hospira se nalaze u dijelu 6.
English: Dose in adults and adolescents (from 16 years of age):
Croatian: Doza za odrasle i adolescente (od 16. godine života):
English: The pharmacokinetics in paediatric patients has not been investigated after intravenous administration.
Croatian: Farmakokinetika u pedijatrijskih bolesnika nije ispitivana nakon intravenske primjene.
English: CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Croatian: CLcr (ml/min) = ----------------------------------------- (x 0,85 za žene) 72 x kreatinin u serumu (mg/dl)
English: In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study.
Croatian: Dodatno, 101 dojenče u dobi manjoj od 12 mjeseci bilo je izloženo levetiracetamu u postmarketinškoj studiji o sigurnosti.
English: In addition, it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines.
Croatian: Također djelomično poništava smanjenje GABA- i glicin-posredovanih protoka, inducirano cinkom i β-karbolinima.
English: In both these paediatric age ranges, these data are supplemented with the post-marketing experience of the use of levetiracetam.
Croatian: U obje od tih pedijatrijskih dobnih skupina, ti podaci dopunjeni su postmarketinškim iskustvom primjene levetiracetama.
English: The dialyser extraction efficiency is 60% for levetiracetam and 74% for the primary metabolite.
Croatian: Ekstrakcijska učinkovitost dijalizatora je 60% za levetiracetam i 74% za njegov primarni metabolit.
English: If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
Croatian: • ako primijetite usporen rast ili neočekivan razvoj djeteta u pubertetu, obavijestite svog liječnika.
English: The apparent body weight adjusted clearance was approximately 30% higher than in epileptic adults.
Croatian: Prividni tjelesni klirens korigiran za tjelesnu težinu bio je približno 30% veći nego u odraslih s epilepsijom.
English: Chemical and physical in-use stability of the diluted product stored in PVC bags has been demonstrated for 24 hours at 30 °C and at 2-8 °C.
Croatian: Dokazana je kemijska i fizikalna stabilnost razrijeđenog lijeka koji se čuva u PVC vrećicama tijekom 24 sata pri temperaturi od 30°C i pri 2°C do 8°C.
English: • severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]);
Croatian: • teške alergijske reakcije (DRESS, anafilaktička reakcija [teška i ozbiljna alergijska reakcija], Quinckeov edem [oticanje lica, usana, jezika i grla]);
English: * Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
Croatian: * Prevalencija je značajno veća u japanskih bolesnika u usporedbi s bolesnicima koji nisu japanskog podrijetla
English: A large amount of post-marketing data on pregnant women exposed to levetiracetam monotherapy (more than 1800, among which in more than 1500 exposure occurred during the 1st trimester) do not suggest an increase in the risk for major congenital malformations.
Croatian: Velika količina podataka nakon stavljanja lijeka u promet o trudnicama koje su bile izložene monoterapiji levetiracetamom (više od njih 1800 od kojih su više od 1500 bile izložene levetiracetamu tijekom prvog trimestra trudnoće) ne ukazuje na povećanje rizika za teške kongenitalne malformacije.
English: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents (including levetiracetam).
Croatian: Samoubojstvo, pokušaj samoubojstva te samoubilačke ideje i ponašanje bili su prijavljivani kod bolesnika liječenih antiepileptičkim lijekovima (uključujući levetiracetam).
English: The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only.
Croatian: Bolesnici su morali imati spontane parcijalne napadaje ili samo generalizirane toničkokloničke napadaje.
English: Your total daily dose and frequency of administration remain identical.
Croatian: Vaša ukupna dnevna doza i učestalost primjene ostaju jednaki.
English: • a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
Croatian: • puno teži oblik osipa koji uzrokuje ljuštenje kože u više od 30% površine tijela (toksična epidermalna nekroliza)
English: If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).
Croatian: • ako ste alergični na levetiracetam, derivate pirolidona ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Conversion to or from oral to intravenous administration can be done directly without titration.
Croatian: Pretvorba u ili iz peroralne u intravensku primjenu može se napraviti izravno, bez titracije.
English: • encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms);
Croatian: • oštećenje mozga (encefalopatija, za detaljan opis simptoma pogledajte podnaslov „Recite odmah svom liječniku“)
English: Alopecia, eczema, pruritus
Croatian: Alopecija, ekcem, pruritus
English: • signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements.
Croatian: • znakove ozbiljnih mentalnih promjena ili ako netko oko Vas primijeti kod Vas znakove smetenosti, izrazitu pospanost, amneziju (gubitak pamćenja), slabljenje pamćenja (zaboravljivost), abnormalno ponašanje ili druge neurološke znakove uključujući nevoljne ili nekontrolirane pokrete.
English: A small number of people being treated with antiepileptics such as Levetiracetam Hospira have had thoughts of harming or killing themselves.
Croatian: • mali broj ljudi liječenih antiepilepticima kao što je Levetiracetam Hospira imali su misli o samoozljeđivanju ili samoubojstvu.
English: Epilepsy is a condition where the patients have repeated fits (seizures).
Croatian: Epilepsija je stanje u kojem bolesnici imaju ponavljajuće epileptične epizode (napadaje).
English: General dose: between 1,000 mg and 3,000 mg each day.
Croatian: Uobičajena doza: između 1000 mg i 3000 mg svaki dan.
English: These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience.
Croatian: Ti podaci dopunjeni su s podacima iz odgovarajućih ispitivanja otvorenog produžetka o primjeni levetiracetama, kao i postmarketinškim iskustvima.
English: Somnolence, headache
Croatian: Somnolencija, glavobolja
English: Package Leaflet: Information for the patient
Croatian: Uputa o lijeku: Informacije za korisnika
English: You can switch from the filmcoated tablets or from the oral solution to the intravenous formulation or reverse directly without dose adaptation.
Croatian: Možete se prebaciti s filmom obloženih tableta ili s oralne otopine na intravenski oblik ili obrnuto bez prilagodbe doze.
English: Levetiracetam has been given to you by your doctor to reduce the number of fits.
Croatian: Levetiracetam Vam je propisao Vaš liječnik s namjenom smanjivanja broja napadaja.
English: • swelling of the face, lips, tongue and throat (Quincke's oedema)
Croatian: • oticanje lica, usana, jezika i grla (Quinckeov edem)
English: Since there was limited exposure for levetiracetam intravenous use and since oral and intravenous formulations are bioequivalent, the safety information of levetiracetam intravenous will rely on levetiracetam oral use.
Croatian: Budući da je izloženost levetiracetamu za intravensku primjenu bila ograničena i budući da su peroralna i intravenska formulacija bioekvivalentne, sigurnosne informacije za intravenski levetiracetam se oslanjaju na levetiracetam za peroralnu primjenu.
English: Talk to your doctor before you are given Levetiracetam Hospira:
Croatian: Obratite se svom liječniku prije nego uzmete Levetiracetam Hospira:
English: Should your doctor decide to stop your Levetiracetam Hospira treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Hospira.
Croatian: Ako Vaš liječnik odluči prekinuti liječenje Levetiracetam Hospirom, pružiti će Vam informacije o postupnom prekidu liječenja Levetiracetam Hospirom.
English: • a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
Croatian: • kožni osip koji može tvoriti mjehure i izgledati poput malih meta (središnje tamne mrlje okružene svijetlim područjem, s tamnim prstenom oko ruba) (multiformni eritem)
English: What Levetiracetam Hospira is and what it is used for What you need to know before you are given Levetiracetam Hospira How Levetiracetam Hospira is given Possible side effects
Croatian: Što je Levetiracetam Hospira i za što se koristi Što morate znati prije nego počnete primjenjivati Levetiracetam Hospira Kako primjenjivati Levetiracetam Hospira Moguće nuspojave
English: A meta-analysis of randomized placebo-controlled trials of antiepileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour.
Croatian: Metaanaliza randomiziranih placebom kontroliranih studija antiepileptičkih lijekova pokazala je mali porast rizika od samoubilačkih misli i ponašanja.
English: This medicinal product is for single use only, any unused solution should be discarded.
Croatian: Ovaj lijek namijenjen je samo za jednokratnu uporabu, neupotrebljenu otopinu treba baciti.
English: • elevated/abnormal values in a liver function test;
Croatian: • povišeni/nenormalni nalazi funkcije jetre;
English: Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients;
Croatian: Prevalencija je značajno veća u japanskih bolesnika u usporedbi s bolesnicima koji nisu japanskog podrijetla.
English: nasopharyngitis (infection of the nose or throat); somnolence (sleepiness), headache.
Croatian: • nazofaringitis (infekcija nosa ili grla); • somnolencija (pospanost), glavobolja.
English: Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili druge pirolidonske derivate ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: No new safety concerns for levetiracetam were identified for infants less than 12 months of age with epilepsy.
Croatian: Nisu pronađena nikakva nova sigurnosna pitanja za levetiracetam u dojenčadi mlađoj od 12 mjeseci starosti s epilepsijom.
English: • Lactated Ringer's solution for injection
Croatian: • otopina Ringerovog laktata za injekciju
English: Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures (fits) in epilepsy).
Croatian: Levetiracetam je antiepileptik (lijek koji se koristi u liječenju epileptičkih napadaja).
English: The major route of excretion was via urine, accounting for a mean 95% of the dose (approximately 93% of the dose was excreted within 48 hours).
Croatian: Levetiracetam se uglavnom izlučuje putem urina, i to 95% doze (približno 93% doze izluči se za 48 sati).
English: Levetiracetam Hospira may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy.
Croatian: Levetiracetam Hospira može narušiti Vašu sposobnost upravljanja vozilima ili alatima ili strojevima jer može uzrokovati osjećaj pospanosti.
English: Box of 10 or 25 vials
Croatian: Kutija sa 10 ili 25 bočica
English: The cumulative urinary excretion of levetiracetam and its primary metabolite accounted for 66% and 24% of the dose, respectively during the first 48 hours.
Croatian: Kumulativno izlučivanje levetiracetama i njegovog glavnog metabolita urinom iznosi 66% odnosno 24% doze tijekom prvih 48 sati.
English: It is therefore recommended to adjust the maintenance daily dose of levetiracetam, based on creatinine clearance in patients with moderate and severe renal impairment (see section 4.2).
Croatian: Stoga se preporučuje prilagođavanje dnevne doze održavanja levetiracetama s obzirom na klirens kreatinina u bolesnika s umjerenim i teškim oštećenjem bubrega (vidjeti dio 4.2).