FrancophonIA/ELRC3.0 huggingface dataset:
English: Warnings and precautions Talk to your doctor or pharmacist before taking Epidyolex or during treatment if: - you have or have had liver problems, as your doctor may need to change the dose of Epidyolex or may decide that Epidyolex is not appropriate for you.
Croatian: Upozorenja i mjere opreza Razgovarajte sa svojim liječnikom ili ljekarnikom prije uzimanja Epidyolexa ili tijekom liječenja ako: - imate ili iste imali problema s jetrom, jer će Vaš liječnik možda morati promijeniti dozu Epidyolexa, odnosno odlučiti da Epidyolex nije prikladan za Vas.
English: Contact your doctor if you are unsure of your dose or if you think your dose may need to be changed.
Croatian: Obratite se svom liječniku ako niste sigurni u svoju dozu ili ako smatrate da je treba promijeniti.
English: Do not use this medicine after the expiry date shown on the bottle.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci.
English: You should not breast-feed whilst taking Epidyolex, as Epidyolex is likely to be present in breast milk.
Croatian: Ne smijete dojiti dok uzimate Epidyolex, jer postoji vjerojatnost da će Epidyolex biti prisutan u mlijeku.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1389/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1389/001
English: The dose titration should be performed as detailed in section 4.2.
Croatian: Titraciju doze treba obaviti kako je navedeno u dijelu 4.2.
English: Patients and caregivers of patients should be advised to seek medical advice should any signs of suicidal behaviour and ideation emerge.
Croatian: Bolesnicima i njihovim njegovateljima treba savjetovati da potraže medicinski savjet ako se pojave bilo kakvi znakovi suicidalnog ponašanja i suicidalnih primisli.
English: UGT inhibitors
Croatian: Inhibitori UGT
English: Lethargy, Drooling, Tremor
Croatian: Letargija, slinjenje, tremor
English: Slowly pull back the plunger of the syringe, so the volume (number of ml) of solution needed is drawn into the syringe.
Croatian: Polako povucite klip iz štrcaljke, kako bi se potrebni volumen (broj ml) otopine povukao u štrcaljku.
English: When cannabidiol was combined with stiripentol there was a minor increase in stiripentol levels of 28% for Cmax and 55% for AUC.
Croatian: Kad se kanabidiol kombinirao sa stiripentolom, došlo je do malog povećanja razina stiripentola od 28% za Cmax i 55% za AUC.
English: The dose level of 125 mg/kg/day induced decreased foetal body weights and increased foetal structural variations associated with maternal toxicity.
Croatian: Doza od 125 mg/kg/dan dovela je do smanjenja tjelesne težine fetusa i povećanja strukturnih varijacija fetusa povezanih s maternalnom toksičnošću.
English: The maximum recommended single dose of Epidyolex (10 mg/kg) will increase the concentration of ethanol in the body by about 13 mg/l.
Croatian: Maksimalna preporučena jednostruka doza Epidyolexa (10 mg/kg) će povećati koncentraciju etanola u tijelu za oko 13 mg/l.
English: Elderly (65 years of age and above) The safety and efficacy of cannabidiol in patients ≥ 65 years of age have not been established.
Croatian: Starije osobe (65 godina i više) Sigurnost i djelotvornost kanabidiola u bolesnika u dobi od 65 godina i više nisu ustanovljene.
English: Cannabidiol also does not produce animal self-administration, suggesting it does not produce rewarding effects.
Croatian: Kanabidiol također ne uzrokuje samostalnu primjenu kod životinja, što znači da ne stvara učinke nagrade.
English: Your doctor may do blood tests to check your liver before you start taking this medicine and during treatment, as Epidyolex can cause liver problems.
Croatian: Vaš liječnik može obaviti i krvne pretrage kako bi provjerio Vašu jetru prije nego počnete uzimati ovaj lijek i tijekom liječenja, jer Epidyolex može uzrokovati probleme s jetrom.
English: 4.7 Effects on ability to drive and use machines Cannabidiol has major influence on the ability to drive and operate machines because it may cause somnolence and sedation (see section 4.4).
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Kanabidiol ima veliki utjecaj na sposobnost upravljanja vozilima i rukovanja strojevima jer može uzrokovati somnolenciju i sedaciju (vidjeti dio 4.4).
English: Concomitant Valproate and Clobazam
Croatian: Istovremeno uzimanje valproata i klobazama
English: There are no clinical data on the presence of cannabidiol or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
Croatian: Nema kliničkih podataka o prisutnosti kanabidiola u majčinom mlijeku, učincima na dojeno dijete ili učincima na proizvodnju mlijeka.
English: There were cases of transaminase elevations associated with hospitalisation in patients taking cannabidiol.
Croatian: Bilo je slučajeva povišenja transaminaza povezanih s hospitalizacijom bolesnika koji su uzimali kanabidiol.
English: The rapid achievement of steady state is related to the multiphasic elimination profile of the drug in which the terminal elimination represents only a small fraction of the drug's clearance.
Croatian: Brzo dostizanje stanja dinamičke ravnoteže je povezano s profilom višefazne eliminacije lijeka u kojem terminalna eliminacija predstavlja samo mali dio klirensa lijeka.
English: Concomitant use of clobazam also increased the incidence of transaminase elevations, although to a lesser extent than valproate.
Croatian: Istovremeno uzimanje klobazama je također povećalo incidenciju povišenih transaminaza, iako u manjoj mjeri nego valproat.
English: Common side effects (may affect more than 1 in 100 people):
Croatian: Česte nuspojave (mogu se pojaviti u više od 1 na 100 osoba):
English: Continuous weight loss/absence of weight gain should be periodically checked to evaluate if cannabidiol treatment should be continued.
Croatian: Kontinuirani gubitak težine/izostanak povećanja težine povremeno treba provjeravati kako bi se ocijenilo treba li nastaviti liječenje kanabidiolom.
English: In another study, cannabidiol was dosed to juvenile rats from PND 4-21 (as a subcutaneous injection) and from PND 22-50 (as an intravenous injection).
Croatian: U drugom je ispitivanju kanabidiol doziran mladim štakorima od PND 4-21 (kao supkutana injekcija) i od PND 22-50 (kao intravenska injekcija).
English: - High liver enzymes (transaminases elevations) seen in blood tests, which can be a sign of liver injury, have been reported in patients receiving Epidyolex - People taking this medicine can have thoughts of harming or killing themselves.
Croatian: - povišeni jetreni enzimi (povišenja transaminaza) uočeni u krvnim pretragama, što može biti znak oštećenja jetre, prijavljeni su u bolesnika koji primaju Epidyolex. - osobe koje uzimaju ovaj lijek mogu imati misli o ozljeđivanju ili samoubojstvu.
English: After single dosing, exposure over the range 750-6000 mg increases in a less than dose-proportional manner, indicating that absorption of cannabidiol may be saturable.
Croatian: Nakon jedne doze, izloženost se iznad raspona 750 - 6000 mg povećava manje nego proporcionalno dozi, što ukazuje da može doći do zasićenja apsorpcije kanabidiola.
English: It is important that you use the correct oral syringe to measure your dose.
Croatian: Važno je da upotrebljavate odgovarajuću štrcaljku za usta kako biste izmjerili svoju dozu.
English: For an adult weighing 70 kg, this is equivalent to 14 millilitres (ml) of beer, or 6 ml of wine per dose.
Croatian: Za odraslu osobu od 70 kg, to odgovara 14 mililitara (ml) piva ili 6 ml vina po dozi.
English: In a human abuse potential study, acute administration of cannabidiol to non-dependent adult recreational drug users at therapeutic and supratherapeutic doses produced small responses on positive subjective measures such as Drug Liking and Take Drug Again.
Croatian: U ispitivanju s mogućom zloporabom kod ljudi, akutna je primjena kanabidiola na neovisnim odraslim rekreativnim korisnicima lijeka u terapijskim i supraterapijskim dozama stvorila male odgovore na pozitivne subjektivne mjere, poput zadovoljstva lijekom i ponovnog uzimanja lijeka.
English: A small number of patients < 2 years with treatment-resistant epilepsy have been exposed to cannabidiol in an expanded access programme.
Croatian: Mali broj bolesnika mlađih od 2 godine s epilepsijom otpornom na liječenje je izložen kanabidiolu u programu s proširenim pristupom.
English: Open the bag containing the correct oral syringe to measure your dose.
Croatian: Otvorite vrećicu koja sadrži odgovarajuću štrcaljku za usta kako biste izmjerili svoju dozu.
English: Early identification of elevated transaminase may decrease the risk of a serious outcome.
Croatian: Rana identifikacija povišenih transaminaza može smanjiti rizik od ozbiljnog ishoda.
English: A slower or faster down titration may be required, as clinically indicated, at the discretion of the prescriber.
Croatian: Može biti potrebna sporija ili brža titracija, prema kliničkoj indikaciji i odluci osobe koja propisuje lijek.
English: In general, transaminase elevations of greater than 3 times the ULN in the presence of elevated bilirubin without an alternative explanation are an important predictor of severe liver injury.
Croatian: Općenito, povišenja razina transaminaza više od 3 puta GGN uz prisustvo povišenog bilirubina bez alternativnog objašnjenja važan su pokazatelj teškog oštećenja jetre.
English: Clear, colourless to yellow solution
Croatian: Bistra, bezbojna do žuta otopina
English: The precise mechanisms by which cannabidiol exerts its anticonvulsant effects in humans are unknown.
Croatian: Precizni mehanizam prema kojem kanabidiol pokazuje svoj antikonvulzivni učinak u ljudi nije poznat.
English: If the dose is more than 5 ml, repeat Steps 4 to 7 to give the remaining dose using the 5 ml oral syringe.
Croatian: Ako je doza veća od 5 ml, ponavljajte korake od 4 do 7 kako biste dali ostatak doze upotrebljavajući štrcaljku od 5 ml.
English: 3821AL Amersfoort, The Netherlands
Croatian: 3821AL Amersfoort, Nizozemska
English: Increases in creatinine
Croatian: Povišenja kreatinina
English: Dose adjustment may be necessary.
Croatian: Može biti potrebno prilagoditi dozu.
English: PK/PD analysis also demonstrated that systemic exposures to cannabidiol were correlated with some adverse events namely elevated ALT, AST, diarrhoea, fatigue, GGT, loss of appetite, rash, and somnolence (see section 4.8).
Croatian: PK/PD analiza također je pokazala da je sistemska izloženost kanabidiolu povezana s nekim štetnim događajima, odnosno povišeni ALT, AST, dijareja, umor, povišeni GGT, gubitak teka, osip i somnolencija (vidjeti dio 4.8).
English: Across both randomised DS studies, 97.7% of patients who completed the studies were enrolled into GWPCARE5.
Croatian: U oba randomizirana DS ispitivanja, 97,7% bolesnika koji su dovršili ispitivanja uključeno je u GWPCARE5.
English: Paediatric population There is no relevant use of cannabidiol in children aged below 6 months.
Croatian: Pedijatrijska populacija Nema relevantne primjene kanabidiola u djece u dobi mlađoj od 6 mjeseci.
English: There are only limited data from the use of cannabidiol in pregnant women.
Croatian: Postoje samo ograničeni podaci o primjeni kanabidiola u trudnica.
English: AST increased, ALT increased, GGT increased, Liver function test abnormal
Croatian: Povišen AST, povišen ALT, povišen GGT, testovi jetrene funkcije izvan normale
English: Of the patients that were not taking clobazam, the majority had previously taken and subsequently discontinued clobazam treatment.
Croatian: Od bolesnika koji nisu uzimali klobazam, većina je ranije uzimala i zatim prestala s liječenjem klobazamom.
English: Cannabidiol appears rapidly in plasma with a time to maximum plasma concentration of 2.5-5 hours at steady state.
Croatian: Kanabidiol se brzo pojavljuje u plazmi, uz vrijeme dostizanja maksimalne koncentracije u plazmi od 2,5-5 sati u stanju dinamičke ravnoteže.
English: Somnolence and sedation events have been observed in controlled trials with cannabidiol in LGS and DS.
Croatian: Događaji somnolencije i sedacije uočeni su u kontroliranim ispitivanjima s kanabidiolom u stanjima LGS i DS.
English: You should not take Epidyolex while you are pregnant unless the doctor decides the benefits outweigh the potential risks.
Croatian: Epidyolex ne smijete uzimati tijekom trudnoće, osim ako liječnik odluči kako su koristi veće od mogućih rizika.
English: Dose reduction should be considered for concomitant medicinal products that are sensitive CYP2C19 substrates or that have a narrow therapeutic index.
Croatian: Treba razmotriti smanjenje doze za istovremeno primijenjene lijekove koji su osjetljivi supstrati CYP2C19 ili koji imaju uski terapijski indeks.
English: Hypersensitivity to the active substance, to sesame oil, or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar, ulje sezama ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Effects of alcohol in children under the age of 6 years old may include sleepiness, behavioural changes, and problems with concentration and taking part in school activities.
Croatian: Učinci alkohola u djece mlađe od 6 godina mogu uključivati pospanost, promjene ponašanja, te probleme s koncentracijom i sudjelovanjem u školskim aktivnostima.
English: The plasma clearance of cannabidiol following a single 1500 mg dose of cannabidiol is about 1,111 L/h.
Croatian: Klirens kanabidiola iz plazme nakon jedne doze od 1500 mg kanabidiola je oko 1111 l/h.
English: Tell your doctor if you are taking any of the following medicines, as your dose may need to be adjusted: - other epilepsy medicines, such as carbamazepine, clobazam, lamotrigine, lorazepam,
Croatian: Recite svom liječniku ako uzimate neke od sljedećih lijekova, jer bi Vašu dozu možda trebalo prilagoditi: - drugi lijekovi za epilepsiju i liječenje napadaja, poput karbamazepina, klobazama, lamotrigina,
English: To minimise the variability in the bioavailability of cannabidiol in the individual patient, administration of cannabidiol should be standardised in relation to food intake including a ketogenic diet (high-fat meal).
Croatian: Kako bi se varijabilnost u biodostupnosti kanabidiola u pojedinog bolesnika svela na minimum, primjenu kanabidiola treba standardizirati u vezi unosa hrane, uključujući ketogenu prehranu (obroci bogati mastima).
English: Push the bottle adaptor firmly into the neck of the bottle, and make sure it is fully inserted.
Croatian: Čvrsto pritisnite adapter na vrat bočice, pazeći da je potpuno umetnut.
English: Epidyolex with food
Croatian: Epidyolex s hranom
English: Taking Epidyolex with certain other medicines may cause side effects, affect how the other medicines work, or affect how Epidyolex works.
Croatian: Uzimanje Epidyolexa s određenim lijekovima može uzrokovati nuspojave, utjecati na to kako ti lijekovi djeluju, odnosno kako djeluje Epidyolex.
English: No effect on clobazam levels.
Croatian: Nema utjecaja na razine klobazama.
English: Fill a cup with warm soapy water and clean the oral syringe by drawing water in and out using the plunger.
Croatian: Napunite čašu toplom sapunicom i vodom i očistite štrcaljku za usta uvlačenjem i izvlačenjem vode pomoću klipa.
English: Effects of alcohol in children less than 6 years old may include sleepiness, behavioural changes, and impaired ability to concentrate and participate in school activities.
Croatian: Učinci alkohola kod djece mlađe od 6 godina mogu uključivati pospanost, promjene ponašanja i smanjenu sposobnost koncentracije i sudjelovanja u školskim aktivnostima.
English: The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će prvi PSUR za ovaj lijek dostaviti unutar 6 mjeseci nakon dobivanja odobrenja.
English: Your doctor will calculate the dose according to your body weight.
Croatian: Vaš će liječnik izračunati dozu na temelju
English: Decreased growth, delayed sexual maturation, behavioural changes (decreased activity), and adverse effects on male reproductive organ development (small testes in adult offspring) and fertility were observed in the offspring at doses ≥ 150 mg/kg/day.
Croatian: Smanjen rast, kasnije spolno dozrijevanje, promjene ponašanja (smanjena aktivnost) i štetni učinci na razvoj muških reproduktivnih organa (mali testisi u odraslih potomaka) i plodnost kod potomaka uočeni su pri dozi od ≥ 150 mg/kg/dan.
English: Line up the end of the plunger with the volume marking required, as shown opposite.
Croatian: Poravnajte kraj klipa s oznakom za potrebnu količinu, kako je prikazano na slici.
English: Always take Epidyolex according to your doctor's instructions and consistently either with or without food including high-fat meals (such as ketogenic diet).
Croatian: Epidyolex uvijek uzimajte u skladu s uputama liječnika i dosljedno s hranom ili bez nje, uključujući obroke bogate mastima (poput ketogene prehrane).
English: The clinical relevance of this is unknown, but the patient should be closely monitored for adverse drug reactions.
Croatian: Klinička relevantnost tog povećanja nije poznata, ali bolesnika treba pomno pratiti zbog nuspojava.
English: - If your seizures happen more often, or if you experience a severe seizure while taking Epidyolex.
Croatian: - Ako Vam se češće događaju napadaji ili ako tijekom uzimanja lijeka Epidyolex imate jako težak napad.
English: Convulsive seizures were defined as atonic, tonic, clonic, and tonic-clonic seizures.
Croatian: Konvulzivni napadaji su definirani kao atonički, tonički, klonički i toničko-klonički napadaji.
English: Potential interactions between cannabidiol (750 mg twice daily in healthy volunteers and 20 mg/kg/day in patients) and other AEDs were investigated in drug-drug interaction studies in healthy volunteers and in patients and in a population pharmacokinetic analysis of plasma drug concentrations from placebo-controlled studies in the treatment of patients with LGS.
Croatian: Moguće interakcije između kanabidiola (750 mg dva puta dnevno u zdravih dobrovoljaca i 20 mg/kg/dan u bolesnika) i drugih antiepileptika su istraživane u ispitivanjima interakcija među lijekovima na zdravim dobrovoljcima i bolesnicima, te u analizi populacijske farmakokinetike za koncentracije lijeka u plazmi iz ispitivanja kontroliranih placebom u liječenju bolesnika koji imaju LGS.
English: In an uncontrolled study in patients in a different non-epilepsy indication, 2 elderly patients experienced elevations of alkaline phosphatase levels above 2 times the ULN in combination with transaminase elevations.
Croatian: U nekontroliranom ispitivanju u bolesnika u drugačijoj ne-epileptičnoj indikaciji 2 su starija bolesnika imala povišene razine alkalne fosfataze za oko 2 puta više od GGN u kombinaciji s povišenim razinama transaminaza.
English: Epidyolex should be initiated and supervised by physicians with experience in the treatment of epilepsy.
Croatian: Liječenje Epidyolexom trebaju započeti i pratiti liječnici iskusni u liječenju epilepsije.
English: The responder rate analysis also showed a correlation in the exposure-response relationship for the active metabolite of cannabidiol (7-OH-CBD).
Croatian: Analiza stope odgovora je također pokazala korelaciju u odnosu izloženost-odgovor za aktivni metabolit kanabidiola (7-OH-CBD).
English: The Cmax and AUC of cannabidiol are close to dose-proportional over the therapeutic dose range.
Croatian: Vrijednosti Cmax i AUC kanabidiola su blizu proporcionalnih dozi u terapijskom rasponu doza.
English: The alcohol content should be taken into account in pregnancy and high-risk groups such as patients with liver disease.
Croatian: Udio alkohola treba uzeti u obzir tijekom trudnoće i u grupama visokog rizika, poput bolesnika s bolesti jetre.
English: Twenty-seven percent (27%) of cannabidiol-treated patients developed a new laboratory-defined anaemia during the course of the study (defined as a normal haemoglobin concentration at baseline, with a reported value less than the lower limit of normal at a subsequent time point).
Croatian: Dvadeset sedam posto (27%) bolesnika koji su uzimali kanabidiol je razvilo novu laboratorijski potvrđenu anemiju tijekom ispitivanja (definirana kao normalna koncentracija hemoglobina na početku, uz prijavljenu vrijednost nižu od donje granice normalne vrijednosti na sljedećoj vremenskoj točci).
English: A meta-analysis of randomised placebo-controlled trials with AEDs has shown a small increased risk of suicidal behaviour and ideation.
Croatian: Meta-analiza randomiziranih ispitivanja kontroliranih placebom s antiepileptičnim lijekovima je pokazala malo povećani rizik od suicidalnog ponašanja i suicidalnih primisli.
English: Decreased appetite and weight loss may result in slightly reduced height gain.
Croatian: Smanjenje teka i gubitak težine mogu dovesti do blagog smanjenja porasta visine.
English: In about one-third of the cases, transaminase elevations resolved during continued treatment with cannabidiol, without dose reduction.
Croatian: U otprilike jednoj trećini slučajeva povišenja transaminaza povukla su se tijekom nastavka liječenja kanabidiolom, bez smanjenja doze.
English: Hepatocellular injury
Croatian: Hepatocelularna ozljeda
English: In controlled studies in healthy adults and in patients with LGS and DS, an increase in serum creatinine of approximately 10% was observed within 2 weeks of starting cannabidiol.
Croatian: U kontroliranim ispitivanjima u zdravih odraslih osoba i bolesnika koji imaju LGS i DS uočeno je povećanje serumskog kreatinina od oko 10% unutar 2 tjedna od početka uzimanja kanabidiola.
English: You may get the following side effects with this medicine.
Croatian: Uz ovaj lijek možete imati sljedeće nuspojave.
English: Pneumoniaa, Bronchitis, Nasopharyngitis, Urinary tract infection
Croatian: Upala plućaa, bronhitis, nazofaringitis, infekcije mokraćnoga sustava
English: Turn the bottle the right side up, and carefully remove the oral syringe from the adaptor.
Croatian: Okrenite bočicu uspravno, te pažljivo skinite štrcaljku za usta s adaptera.
English: Caution should be used in patients with moderate (Child-Pugh B) or severe hepatic impairment (Child-Pugh C).
Croatian: Treba biti oprezan kod primjene u bolesnika s umjerenim (Child-Pugh B) ili teškim oštećenjem funkcije jetre (Child-Pugh C).
English: In the phase 3 clinical trials, the observed frequency of status epilepticus was similar between the cannabidiol and placebo groups.
Croatian: U kliničkim ispitivanjima faze 3 primijećena učestalost epileptičnog statusa bila je slična u skupinama s kanabidiolom i placebom.
English: What Epidyolex is and what it is used for
Croatian: Što je Epidyolex i za što se koristi
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Across both randomised LGS studies, 99.5% of patients who completed the studies were enrolled into the long-term open-label extension study (GWPCARE5).
Croatian: U oba randomizirana LGS ispitivanja, 99,5% bolesnika koji su dovršili ispitivanja uključeno je u dugotrajni produžetak ispitivanja otvorenog tipa (GWPCARE5).
English: Patients with end-stage renal disease were not studied.
Croatian: Bolesnici sa završnom fazom bolesti bubrega nisu proučavani.
English: Less than 1% of cannabidiol-treated patients had ALT or AST levels greater than 20 times the ULN.
Croatian: Manje od 1% bolesnika liječenih kanabidiolom je imalo razine ALT-a ili AST-a više od 20 puta GGN.
English: Decreased weight
Croatian: Smanjena tjelesna težina
English: A corresponding decrease in haematocrit was also observed, with a mean change of −1.4% in cannabidiol-treated patients.
Croatian: Uočeno je i odgovarajuće smanjenje hematokrita, uz srednju vrijednost promjene od −1,4% u bolesnika koji su uzimali kanabidiol.