FrancophonIA/ELRC3.0 huggingface dataset:
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, molimo obavijestite svog liječnika.
English: Your total daily dose and frequency of administration remain identical.
Croatian: Vaša ukupna dnevna doza i učestalost primjene će ostati ista.
English: Preparation and administration of Matever concentrate
Croatian: Priprema i primjena Matever koncentrata
English: Matever must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Croatian: Matever se mora primjeniti dva puta na dan, jednom ujutro i jednom navečer, u približno isto vrijeme svaki dan.
English: Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two medicinal products.
Croatian: Razine metotreksata i levetiracetama u krvi treba pažljivo pratiti u bolesnika istodobno liječenih s ova dva lijeka.
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: Other medicines and Matever
Croatian: Drugi lijekovi i Matever
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava :navedenog u Dodatku V.
English: Dose recommendations for children and adolescents:
Croatian: Preporučene doze za djecu i adolescente:
English: • elevated/abnormal values in a liver function test;
Croatian: • povišene/promijenjene vrijednosti testova jetrene funkcije ;
English: Swallow Matever tablets with a sufficient quantity of liquid (e.g. a glass of water).
Croatian: Progutajte Matever tablete s dovoljnom količinom tekućine (npr. s čašom vode).
English: If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti prije primjene su odgovornost korisnika i normalno ne bi smjeli biti dulji od 24 sata na 2 do 8°C, osim ako razrijeđivanje nije provedeno u kontroliranim i validiranim aseptičkim uvjetima.
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: Warnings and precautions Talk to your doctor before taking Matever
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete Matever
English: Matever concentrate for solution for infusion (Matever concentrate) is a clear, colorless, sterile liquid.
Croatian: Matever koncentrat za otopinu za infuziju (Matever koncentrat) je bistra, bezbojna, sterilna tekućina.
English: You can switch from the film-coated 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 direktno bez prilagođavanja doze.
English: Matever tablets are packaged in blister packs supplied in cardboard boxes containing:
Croatian: Matever tablete pakirane su u blister pakiranja unutar kartonskih kutija i sadrže:
English: What Matever contains
Croatian: Što Matever sadrži
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere (npr. laktozu), kontaktirajte svog liječnika prije uzimanja ovog lijeka.
English: • encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms;
Croatian: • encefalopatija ((detaljan opis simptoma vidjeti u dijelu „Recite odmah svom liječniku);
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 uzimanje Matevera ne utječe na Vaše sposobnosti za to.
English: This medicine contains 57.21 mg sodium (main component of cooking/table salt) in each maximum single dose.
Croatian: Ovaj lijek sadrži 57.21 mg natrija (glavni sastojak kuhinjske soli) u jednoj jedna najveća pojedinačna doza.
English: Aluminium/ PVC/PE/PVDC blister
Croatian: Aluminij/PVC/PE/PVDC blister
English: It is therefore recommended to adjust the maintenance daily dose of Matever, based on creatinine clearance in patients with moderate and severe renal impairment (see section 4.2).
Croatian: Stoga se preporučuje prilagođavanje dnevne doze održavanja Matevera s obzirom na klirens kreatinina u bolesnika s umjerenim i teškim oštećenjem bubrega (vidjeti dio 4.2).
English: Do not take macrogol (a medicine used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a reduction of its effect.
Croatian: Ne uzimajte makrogol (lijek koji se koristi kao laksativ) jedan sat prije i jedan sat nakon uzimanja levetiracetama zbog toga što se može smanjiti učinak levetiracetama.
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 bazičnu koncentraciju prije trudnoće).
English: • Matever is used as a chronic treatment.
Croatian: • Matever se koristi za dugotrajno liječenje.
English: Therefore, the interaction of Matever with other substances, or vice versa, is unlikely
Croatian: Iz toga proizlazi da interakcija Matevera s drugim tvarima, i obrnuto, nije vjerojatna.
English: Duration of treatment
Croatian: Trajanje liječenja:
English: The pharmacokinetic results indicated that half-life was shorter (5.3 h) than for adults (7.2 h) and apparent clearance was faster (1.5 ml/min/kg) than for adults (0.96 ml/min/kg).
Croatian: Farmakokinetički podaci ukazuju da je poluvrijeme života (5,3 h) kraće nego u odraslih (7,2 h), a prividni klirens (1,5 ml/min/kg) brži je nego u odraslih (0,96 ml/min/kg).
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: Epilepsija je stanje u kojem bolesnici imaju ponavljane epileptičke napadaje, Levetiracetam se koristi za oblik epilepsije u kojem napadaji započinju samo u jednoj strani mozga, ali se nakon toga mogu proširiti na veće područje u obje strane mozga (parcijalni napadaj sa ili bez sekundarne generalizacije).
English: A double-blind, placebo-controlled paediatric safety study with a non-inferiority design has assessed the cognitive and neuropsychological effects of levetiracetam in children 4 to 16 years of age with partial onset seizures.
Croatian: Dvostruko-slijepa i placebom kontrolirana pedijatrijska studija o sigurnosti s neinferiornim dizajnom ocijenila je kognitivne i neuropsihološke učinke levetiracetama u djece od 4 do 16 godina starosti s parcijalnim napadajima.
English: Box of 10 vials
Croatian: Kutija sa 10 bočica
English: The other strengths of Matever tablets do not contain this ingredient.
Croatian: Matever tableta ne sadrže ovaj sastojak.
English: Only limited evidence is available on the neurodevelopment of children exposed to levetiracetam monotherapy in utero.
Croatian: Dostupni su samo ograničeni podaci o neurološkom razvoju djece izložene monoterapiji lijekom levetiracetama in utero.
English: The adverse reaction profile presented below is based on the analysis of pooled placebo-controlled clinical trials with all indications studied, with a total of 3,416 patients treated with levetiracetam.
Croatian: Profil štetnog događaja opisan niže temelji se na analizi zbirnih placebom konroliranih kliničkih istraživanja za sve ispitivane indikacije, u kojima je liječeno s levetiracetamom ukupno 3416 bolesnika.
English: At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common.
Croatian: Na početku liječenja ili kod povećanja doze nuspojave poput pospanosti, umora i omaglice mogu se javiti češće.
English: Multipack: 200 (2 packs of 100) film-coated tablets
Croatian: Višestruko pakiranje: 200 (2 pakiranja od 100) filmom obloženih tableta
English: If you forget to take Matever Contact your doctor if you have missed one or more doses.
Croatian: Obavijestite liječnika ako ste zaboravili uzeti jednu ili više doza.
English: The dose level of 1800 mg/kg/day induced a marked maternal toxicity and a decrease in fetal weight associated with increased incidence of fetuses with cardiovascular/skeletal anomalies.
Croatian: Doza od 1800 mg/kg/dan izazvala je znatnu maternalnu toksičnost i smanjenje fetalne težine, povezane s povećanom pojavnošću fetusa s anomalijama srčano-žilnog sustava i kostura.
English: In the population pharmacokinetic analysis conducted in patients from 1 month to 16 years of age, body weight was significantly correlated to apparent clearance (clearance increased with an increase in body weight) and apparent volume of distribution.
Croatian: Farmakokinetička analiza populacije obavljena u bolesnika u dobi od 1 mjesec do 16 godina starosti pokazala je značajnu korelaciju tjelesne težine s prividnim klirensom (klirens se povećavao s porastom tjelesne težine) i s prividnim volumenom distribucije.
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: S obzirom na ograničenu izloženost pri intravenskoj primjeni levetiracetama i s obzirom da su oralni i intravenski oblici bioekvivalentni, sigurnosni podaci za levetiracetam primijenjen intravenski se oslanjaju na levetiracetam primijenjen oralno.
English: See Table 1 for the recommended preparation and administration of Matever concentrate to achieve a total daily dose of 500 mg, 1000 mg, 2000 mg, or 3000 mg in two divided doses.
Croatian: Vidjeti Tablicu 1 za preporučenu pripremu i primjenu Matever koncentrata kako bi se postigla ukupna dnevna doza od 500 mg, 1000 mg, 2000 mg, ili 3000 mg u dvije podijeljene doze.
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: • on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy.
Croatian: • samostalno u odraslih i adolescenata od navršene 16. godine života s novodijagnosticiranom epilepsijom, u liječenju određenog oblika epilepsije.
English: At 3600 mg/kg/day, in only one of the 2 EFD studies, there was a slight decrease in fetal weight associated with a marginal increase in skeletal variations/minor anomalies.
Croatian: Pri dozi od 3600 mg/kg/dan samo je u jednoj od dvije EFD studije uočeno blago smanjenje fetalne težine povezano s marginalnim porastom varijacija kostura/malih anomalija.
English: Drug reaction with eosinophilia and systemic symptoms (DRESS), Hypersensitivity (including angioedema and anaphylaxis)
Croatian: Reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS), preosjetljivost (uključujući angioedem i anafilaksiju)
English: Concomitant administration of levetiracetam and methotrexate has been reported to decrease methotrexate clearance, resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels.
Croatian: Pri istodobnoj primjeni levetiracetama i metotreksata prijavljeno je smanjenje klirensa metotreksata što uzrokuje povišenu/produljenu koncentraciju metotreksata u krvi do potencijalno toksičnih razina.
English: The plasma half-life in adults was 71 hours and did not vary either with dose, route of administration or repeated administration.
Croatian: Kod ljudi poluvijek levetiracetama u plazmi iznosi 7±1 sati i ne varira ovisno o dozi, putu primjene ili ponovljenoj primjeni.
English: The risk of anorexia is higher when levetiracetam is co-administered with topiramate.
Croatian: Rizik anoreksije veći je ako se levetiracetam uzima istodobno s topiramatom.
English: The pharmacokinetic profile has been characterized following oral administration.
Croatian: Farmakokinetički profil je okarakteriziran prema oralnoj primjeni.
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, derivati pirolidona ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Component of a multipack, can't be sold separately.
Croatian: 100 filmom obloženih tableta Sastavni dio višestrukog pakiranja, ne može se prodavati odvojeno.
English: In both population pharmacokinetic analyses, there was about a 20 % increase of apparent clearance of levetiracetam when it was co-administered with an enzyme-inducing antiepileptic medicinal product.
Croatian: U obje farmakokinetičke analize populacije prividni klirens levetiracetama se povećao za oko 20% kada se lijek davao istodobno s antiepileptikom koji inducira enzime.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14.
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: antiepileptici, ostali antiepileptici, ATK oznaka: N03AX14
English: Matever concentrate is an alternative for patients when oral administration is temporarily not feasible.
Croatian: Matever koncentrat je alternativa za bolesnike kod kojih oralna primjena privremeno nije moguća.
English: Example: if your daily dose is 1,000 mg, your reduced starting dose is 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Croatian: Na primjer: ako je Vaša dnevna doza 1000 mg, vaša smanjena početna doza je 2 tablete od 250 mg ujutro i 2 tablete od 250 mg navečer.
English: Add-on therapy for infants and children less than 4 years
Croatian: Dodatna terapija za dojenčad i djecu mlađu od 4 godine
English: If stopping treatment, as with other antiepileptic medicines, Matever should be discontinued gradually to avoid an increase of seizures.
Croatian: Ako prekidate liječenje Mateverom, kao i u slučaju drugih antiepileptika, prekid mora biti postupan kako bi se izbjeglo pojačanje napadaja.
English: Matever concentrate is for intravenous use only and the recommended dose must be diluted in at least 100 ml of a compatible diluent and administered intravenously as a 15-minute intravenous infusion (see section 6.6).
Croatian: Matever koncentrat je samo za intravensku primjenu i preporučena doza se mora razrijediti u najmanje 100 ml odgovarajuće otopine za razrjeđivanje i primjeniti intravenski kao 15-minutnu intravensku infuziju (vidjeti dio 6.6).
English: ks= 0.45 in Term infants to 1 year old; ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
Croatian: ks = 0,45 za dojenčad do 1. godine života rođene u terminu; ks = 0,55 za djecu mlađu od 13 godina i za adolescente ženskog spola; ks = 0,7 za adolescente muškog spola
English: This medicinal product contains 57.21 mg sodium per maximum single dose, equivalent to 2.86 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Ovaj lijek sadrži sadrži 57.21 mg natrija u najvećoj jednokratnoj dozi, što odgovara 2.86 % maksimalnog dnevnog unosa od 2g natrija prema preporukama SZO za odraslu osobu.
English: Should your doctor decide to stop your Matever treatment, he/she will instruct you about the gradual withdrawal of Matever.
Croatian: Ako Vaš liječnik odluči prekinuti Vaše liječenje Mateverom, uputit će Vas kako postupno prekinuti liječenje Mateverom.
English: Quincke's oedema [swelling of the face, lips, tongue and throat]);
Croatian: Quinckeov edem [angioedem oticanje lica, usana, jezika i grla]);
English: In infants and children aged 1 month to less than 4 years, irritability (very common, 11.7%) and coordination abnormal (common, 3.3%) were reported more frequently than in other age groups or in the overall safety profile.
Croatian: U dojenčadi i djece u dobi od 1 mjseca do manje od 4 godine, razdražljivost (vrlo često, 11,7%) i poremećaji koordinacije (često, 3,3%) bili su prijavljeni češće nego u drugim dobnim skupinama ili u cjelokupnom sigurnosnom profilu.
English: Toxic epidermal necrolysis, StevensJohnson syndrome, erythema multiforme
Croatian: Toksična epidermalna nekroliza, StevensJohnsonov sindrom, multiformni eritem
English: Matever therapy can be initiated with either intravenous or oral administration.
Croatian: Liječenje Mateverom može se započeti intravenskom ili peroralnom primjenom.
English: Intermediate packaging containing 100 tablets for multipack of 200 (2 x 100) tablets [without Blue Box]
Croatian: Srednje pakiranje koje sadrži 100 tableta za višestruko pakiranje od 200 (2 x 100) tableta [bez plavog okvira]
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 s obzirom na ozbiljnost 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: White opaque PVC/PE/PVDC-Aluminium foil blister in cardboard boxes.
Croatian: Bijeli, neprozirni blisteri od PVC/PE/PVDC-aluminijske folije u kartonskoj kutiji.
English: Peak plasma concentration (Cmax) observed in 17 subjects following a single intravenous dose of 1500 mg infused over 15 minutes was 51 ± 19 µg/ml (arithmetic average ± standard deviation).
Croatian: Vršna koncentracija u plazmi (Cmax) uočena u 17 ispitanika nakon jednokratne intravenske doze od 1500 mg infundirane tijekom 15 minuta bila je 51 ± μg/ml (aritmetička sredina ± standardna devijacija).
English: In use shelf life: from a microbiological point of view, the product should be used immediately after dilution.
Croatian: Rok valjanosti u primjeni: s mikrobiološkog stajališta lijek treba upotrijebiti odmah nakon razrjeđivanja.
English: One vial of Matever concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ml).
Croatian: Jedna bočica Matever koncentrata sadrži 500 mg levetiracetama (5 ml koncentrata od 100 mg/ml).
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: Dose and frequency Infants 1 to less than 6 months
Croatian: Doza i učestalost primjene Dojenčad od 1 do manje od 6 mjeseci
English: Levetiracetam 100mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescents (from 6 to 17 years) weighing less than 50 kg and when tablets don't allow accurate dose.
Croatian: Levetiracetam 100 mg/ml oralna otopina je prikladniji farmaceutski oblik za primjenu u dojenčadi i djece mlađe od 6 godina, djece i adolescenata (od 6-17 godina) tjelesne težine manje od 50 kg te kada se tabletama ne može postići točno doziranje.
English: The safety and efficacy of Matever concentrate for solution for infusion in infants and children less than 4 years have not been established.
Croatian: Sigurnost i djelotvornost Matever koncentrata za otopinu za infuziju u dojenčadi i djece mlađe od 4 godine nisu utvrđeni.
English: Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.
Croatian: Vi ili Vaše dijete počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Croatian: Djelatna tvar, levetiracetam, jest derivat pirolidona (S-enantiomer α-etil-2-okso-1-pirolidin-acetamida), kemijski različit od postojećih antiepileptičkih djelatnih tvari.
English: Contains glacial acetic acid, water for injections, sodium acetate trihydrate, sodium chloride - see leaflet for further information.
Croatian: Sadrži ledenu acetatnu kiselinu, vodu za injekcije, natrijev acetat trihidrat, natrijev klorid - za dodatne informacije vidjeti uputu o lijeku.
English: The time independent pharmacokinetic profile of levetiracetam was also confirmed following 1500 mg intravenous infusion for 4 days with twice daily dosing.
Croatian: Farmakokinetički profil levetiracetama neovisan o vremenu također je utvrđen prema intavenskoj infuziji 1500 mg tijekom 4 dana s doziranjem dva puta dnevno.
English: Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behavior as measured in a standardized and systematic way using a validated instrument (CBCL - Achenbach Child Behavior Checklist).
Croatian: Rezultati ocjene funkcioniranja ponašanja i emocionalnog funkcioniranja uputili su na pogoršanje u smislu agresivnijeg ponašanja u skupini koja je uzimala levetiracetam, ocijenjenog na standardiziran i sistematičan način koristeći validirani instrument (CBCL - Achenbach Child Behavior Checklist) na standardiziran i sistematičan način.
English: However, subjects who took levetiracetam in the long-term open label follow-up study, did not experience a worsening, on average, in their behavioural and emotional functioning; in particular measures of aggressive behavior were not worse than baseline.
Croatian: Međutim, u ispitanika koji su uzimali levetiracetam tijekom dugoročne, otvorene studije provedene praćenjem u prosjeku nije bilo pogoršanja bihevioralnog i emocionalnog funkcioniranja; osobito nije bilo pogoršanja pokazatelja agresivnog ponašanja u odnosu na početno stanje.
English: Clear, colourless concentrate.
Croatian: Bistri, bezbojni koncentrat.
English: CLcr (ml/min/1.73 m 2) = ---------------------------- x 1.73 BSA subject (m
Croatian: CLcr (ml/min/1,73 m 2) = ------------------------------ x 1,73 PT bolesnika (m2)
English: •Sodium chloride (0.9 %) injection
Croatian: • injekcija natrijeva klorida (0,9%)
English: Matever concentrate 5 ml vial is packed in a cardboard box of 10 vials.
Croatian: Bočica od 5 ml Matever koncentrata je pakirana u kartonsku kutiju sa 10 bočica.
English: 1500 mg twice daily Children 25 kg or less should preferably start the treatment with levetiracetam 100 mg/ml oral solution.
Croatian: 1500 mg dva puta na dan U djece od 25 kg ili manje liječenje je najbolje započeti s 100 mg/ml oralnom otopinom levetiracetama.
English: The intravenous administration of doses up to 4000 mg diluted in 100 ml of 0.9 % sodium chloride infused over 15 minutes and doses up to 2500 mg diluted in 100 ml of 0.9 % sodium chloride infused over 5 minutes was evaluated.
Croatian: Procjenjena je intravenska primjena doza do 4000 mg razrjeđenih u 100 ml 0,9 % natrijevog klorida infundiranog tijekom 15 minuta i doza do 2500 mg razrjeđenih u 100 ml 0,9 % natrijevog klorida infundiranog tijekom 5 minuta.