FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor and pharmacist will tell you how much (number of ml) Epidyolex to take each day, how many times a day you should take it and which syringe you should use for your dose (1 ml or 5 ml).
Slovenian: Zdravnik in farmacevt vam bosta povedala, koliko (število mililitrov) zdravila Epidyolex morate vzeti vsak dan, kolikokrat na dan ga morate vzeti in katero brizgo morate uporabiti za vaš odmerek (1- ali 5-mililitrsko).
English: Do not take Epidyolex - if you are allergic to cannabidiol or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Epidyolex - če ste alergični na kanabidiol ali katero koli sestavino tega zdravila (navedene v poglavju 6).
English: Compared to dronabinol (synthetic THC) and alprazolam, cannabidiol has low abuse potential.
Slovenian: V primerjavi z dronabinolom (sintetični THC) in alprazolamom ima kanabidiol majhen potencial za zlorabo.
English: There was a significant positive correlation between the derived AUC of cannabidiol and the probability of a ≥ 50% response.
Slovenian: Ugotovljena je bila pomembna pozitivna korelacija med izpeljano AUC kanabidiola in verjetnostjo ≥ 50-odstotnega odziva.
English: Each study consisted of a 4-week baseline period, a 2-week titration period and a 12-week maintenance period.
Slovenian: Posamezna študija je bila sestavljena iz 4-tedenskega uvajalnega obdobja, 2-tedenskega obdobja titriranja in 12-tedenskega obdobja vzdrževalnega zdravljenja.
English: There have not been any clinical studies formally investigating this interaction.
Slovenian: Kliničnih študij, ki bi formalno raziskale to interakcijo, niso opravili.
English: If the solution in the bottle has turned cloudy, this doesn't change how well it works.
Slovenian: Če raztopina v steklenici postane motna, to ne vpliva na njeno učinkovitost.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics; ATC code: N03AX24
Slovenian: Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki; oznaka ATC: N03AX24
English: The apparent volume of distribution was high in healthy volunteers at 20,963 L to 42,849 L and greater than total body water, suggesting a wide distribution of cannabidiol.
Slovenian: Pri zdravih prostovoljcih je bil navidezni volumen porazdelitve velik, tj. od 20.963 l do 42.849 l, in večji od skupne količine vode v telesu, kar kaže na obsežno porazdelitev kanabidiola.
English: - Epidyolex makes you feel sleepy.
Slovenian: - zdravilo Epidyolex povzroči, da se počutite zaspani.
English: (See also section 3, How to take Epidyolex).
Slovenian: (Glejte tudi poglavje 3, Kako jemati zdravilo Epidyolex).
English: Increased systemic levels of these active substances may lead to enhanced pharmacological effects and to an increase in adverse drug reactions.
Slovenian: Zvišane sistemske ravni teh učinkovin lahko vodijo do povečanih farmakoloških učinkov in povečanja neželenih učinkov zdravil.
English: Cannabidiol also does not produce animal self-administration, suggesting it does not produce rewarding effects.
Slovenian: Poleg tega kanabidiol pri živalih ne povzroči samoaplikacije, kar kaže na to, da ne povzroča nagrajujočih učinkov.
English: Irritability, Insomnia, Aggression, Abnormal behaviour, Agitation
Slovenian: Razdražljivost, nespečnost, agresija, nenormalno vedenje, agitacija
English: Shake off any water from both parts and allow them to dry in the air until the next use.
Slovenian: Z obeh delov brizge otresite morebitne ostanke vode, nato pa pustite, da se do naslednje uporabe posušita na zraku.
English: Potential for cannabidiol to affect other medicinal products
Slovenian: Možnost vpliva kanabidiola na druga zdravila
English: In the event of overdose the patient should be observed and appropriate symptomatic treatment given, including monitoring of vital signs.
Slovenian: V primeru zaužitja prevelikega odmerka je treba bolnika opazovati in poskrbeti za ustrezno simptomatsko zdravljenje, vključno s spremljanjem bolnikovih vitalnih znakov.
English: The calculated dose should be rounded to the nearest graduated increment.
Slovenian: Izračunani odmerek je treba zaokrožiti na najbližji merilni korak.
English: Genotoxicity studies have not detected any mutagenic or clastogenic activity.
Slovenian: Pri študijah genotoksičnosti niso odkrili nobene mutagene ali klastogene aktivnosti.
English: Epidyolex contains refined sesame oil which may rarely cause severe allergic reactions.
Slovenian: Zdravilo Epidyolex vsebuje rafinirano sezamovo olje, ki v redkih primerih lahko izzove hude alergijske reakcije.
English: Reproductive toxicity
Slovenian: Reproduktivna toksičnost
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.
Slovenian: Hitro doseganje stanja dinamičnega ravnovesja je povezano z večfaznim eliminacijskim profilom zdravila, pri katerem končno izločanje predstavlja samo majhen delež očistka zdravila.
English: Special populations
Slovenian: Posebna populacija
English: One 100 ml bottle
Slovenian: Ena 100-mililitrska steklenica
English: Do not throw away any medicine in the wastewater or household waste.
Slovenian: Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: The precise mechanisms by which cannabidiol exerts its anticonvulsant effects in humans are unknown.
Slovenian: Natančni mehanizmi, preko katerih kanabidiol doseže svoj antikonvulzivni učinek pri ljudeh, niso znani.
English: Do not push the plunger forcefully or direct the medicine to the back of the mouth or throat.
Slovenian: Bata ne pritiskajte silovito in zdravila ne usmerite v zadnji del ustne votline ali grlo.
English: The elevations typically occur in the first two months of treatment initiation; however, there were cases observed up to 18 months after initiation of treatment, particularly in patients taking concomitant valproate.
Slovenian: Zvišanje se običajno pojavi v prvih dveh mesecih po uvedbi zdravljenja, zabeleženi pa so tudi primeri zvišanja do 18 mesecev po uvedbi zdravljenja, predvsem pri bolnikih, ki so sočasno jemali valproat.
English: Contact your doctor or go to a hospital straight away (See section 4).
Slovenian: Nemudoma se posvetujte s svojim zdravnikom ali poiščite pomoč v najbližji bolnišnici (glejte poglavje 4).
English: The mechanism of this interaction remains unknown.
Slovenian: Mehanizem te interakcije ostaja neznan.
English: Pharmacokinetics in special patient groups
Slovenian: Farmakokinetika in posebne skupine bolnikov
English: If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: In clinical trials, cannabidiol discontinuation was achieved by reducing the dose by approximately 10% per day for 10 days (see section 4.4).
Slovenian: V kliničnih preskušanjih so prekinitev zdravljenja s kanabidiolom dosegli tako, da so odmerek 10 dni zmanjševali za približno 10 % na dan (glejte poglavje 4.4).
English: Epidyolex must not be given to children under the age of 2 years, since there is no information on use in children below this age.
Slovenian: Zdravila Epidyolex ne smete dajati otrokom, mlajšim od 2 let, saj za to starostno skupino ni na voljo informacij o uporabi.
English: For any information about this medicine, please contact the medical information representative of the Marketing Authorisation Holder:
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: Do not reduce the dose or stop this medicine unless the doctor tells you to.
Slovenian: Ne zmanjšajte odmerka oziroma ne prenehajte jemati tega zdravila, razen če vam to naroči zdravnik.
English: a average increases of 47% in AUC and 73% in Cmax b based on Cmax and AUC
Slovenian: a AUC se je v povprečju povečala za 47 %, Cmax pa za 73 % b glede na Cmax in AUC
English: In vitro, > 94% of cannabidiol and its phase I metabolites were bound to plasma proteins, with preferential binding to human serum albumin.
Slovenian: In vitro se > 94 % kanabidiola in njegovih presnovkov faze I veže na beljakovine v plazmi s preferenčno vezavo na humani serumski albumin.
English: The mechanism has not been determined.
Slovenian: Mehanizma še niso ugotovili.
English: Push the bottle adaptor firmly into the neck of the bottle, and make sure it is fully inserted.
Slovenian: Nastavek za steklenico močno potisnite v vrat steklenice in se prepričajte, da je popolnoma vstavljen.
English: Upon changes in cannabidiol dose above 10 mg/kg/day or changes in medicinal products (dose change or additions) that are known to impact the liver, this monitoring schedule should be restarted.
Slovenian: Po spremembah odmerka kanabidiola nad 10 mg/kg/dan ali spremembah zdravil (sprememba ali dodajanje odmerkov), za katera je znano, da vplivajo na jetra, je treba ponovno izvesti to shemo spremljanja.
English: The mechanism of this interaction is unknown.
Slovenian: Mehanizem te interakcije ni znan.
English: Tell your doctor if you have liver problems because the doctor may need to adjust the dose.
Slovenian: Obvestite zdravnika, če imate težave z jetri, ker vam bo morda moral prilagoditi odmerek.
English: Results of the subgroup analysis of patients treated with clobazam compared to patients treated without clobazam, indicated that there is residual statistical uncertainty regarding the treatment effect of cannabidiol in patients not taking clobazam.
Slovenian: Rezultati analize podskupin pri bolnikih, zdravljenih s klobazamom, v primerjavi z bolniki, ki so se zdravili brez klobazama, so pokazali, da obstaja statistična negotovost glede učinka zdravljenja s kanabidiolom pri bolnikih, ki ne jemljejo klobazama.
English: The safety and efficacy of cannabidiol in children aged 6 months to 2 years have not yet been established.
Slovenian: Varnost in učinkovitost kanabidiola pri bolnikih, starih od 6 mesecev do 2 let, še nista bili dokazani.
English: A no-effect dose was not established.
Slovenian: Odmerka brez učinka niso ugotovili.
English: Interaction resulting in an approximate 28% increase in Cmax and 55% increase in AUC.
Slovenian: Interakcija je povzročila približno 28odstotno povečanje Cmax in 55-odstotno povečanje AUC.
English: Patients should be advised not to drive or operate machinery until they have gained sufficient experience to gauge whether it adversely affects their abilities (see section 4.8).
Slovenian: Bolnikom je treba odsvetovati vožnjo ali upravljanje strojev, dokler z zdravilom ne pridobijo zadostnih izkušenj, da znajo presoditi, ali negativno vpliva na njihove sposobnosti (glejte poglavje 4.8).
English: The doctor will explain how to gradually stop taking Epidyolex.
Slovenian: Zdravnik vam bo razložil, kako postopoma prenehati z jemanjem zdravila Epidyolex.
English: If there is an air bubble in the syringe, push the liquid back into the bottle whilst keeping the bottle upside down, and repeat Step 5 until the bubble has gone.
Slovenian: Če je v brizgi zračni mehurček, potisnite tekočino nazaj v steklenico, ki jo držite obrnjeno navzdol, nato pa ponovite korak 5, da mehurček izgine.
English: The dose titration should be performed as detailed in section 4.2.
Slovenian: Titriranje odmerka je treba izvesti, kakor je podrobneje opisano v poglavju 4.2.
English: A corresponding decrease in haematocrit was also observed, with a mean change of −1.4% in cannabidiol-treated patients.
Slovenian: Primerljivo znižanje so opazili tudi pri vrednostih hematokrita, in sicer s povprečno spremembo −1,4 % pri bolnikih, zdravljenih s kanabidiolom.
English: Although no formal drug-drug interaction studies have been performed for other AEDs, phenytoin and lamotrigine are addressed based on in vitro data.
Slovenian: Čeprav niso bile izvedene nobene formalne študije medsebojnega delovanja zdravil za druge AED, sta fenitoin in lamotrigin obravnavana na podlagi podatkov in vitro.
English: Lethargy, Drooling, Tremor
Slovenian: Letargija, slinjenje, tremor
English: Elderly (65 years of age and above) The safety and efficacy of cannabidiol in patients ≥ 65 years of age have not been established.
Slovenian: Starejši bolniki (stari 65 let in več) Varnost in učinkovitost kanabidiola pri bolnikih, starih ≥ 65 let, nista bili dokazani.
English: Your doctor will calculate the dose according to your body weight.
Slovenian: Zdravnik vam bo izračunal ustrezen odmerek na osnovi vaše telesne mase.
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.
Slovenian: Največji priporočeni enkratni odmerek zdravila Epidyolex (10 mg/kg) poveča koncentracijo etanola v telesu za približno 13 mg/l.
English: Clear, colourless to yellow solution
Slovenian: Bistra, brezbarvna do rumena raztopina
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila, http://www.ema.europa.eu.
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).
Slovenian: Za zmanjšanje variabilnosti v biološki uporabnosti kanabidiola pri posameznem bolniku je treba dajanje kanabidiola standardizirati glede na vnos hrane, vključno s ketogeno dieto (obroki z veliko maščobe).
English: Decreased appetite and weight loss may result in slightly reduced height gain.
Slovenian: Zmanjšan apetit in izguba telesne mase lahko povzročita nekoliko zmanjšano pridobivanje telesne višine.
English: The alcohol content should be taken into account in pregnancy and high-risk groups such as patients with liver disease.
Slovenian: Vsebnost alkohola je treba upoštevati pri nosečnicah in skupinah z visokim tveganjem, kot so bolniki z jetrnimi obolenji.
English: Other CNS depressants, including alcohol, can potentiate the somnolence and sedation effect.
Slovenian: Drugi zaviralci centralnega živčnega sistema, vključno z alkoholom, lahko ojačajo učinek somnolence in sedacije.
English: The clinical relevance of this is unknown, but the patient should be closely monitored for adverse drug reactions.
Slovenian: Klinična pomembnost tega ni znana, bolnika pa je treba skrbno spremljati glede pojava neželenih učinkov zdravila.
English: The DS population in studies GWPCARE2 and GWPCARE1 was predominantly paediatric patients, with only 5 adult patients who were 18 years old (1.6%), and therefore limited efficacy and safety data were obtained in the adult DS population.
Slovenian: Populacijo bolnikov z DS v študijah GWPCARE2 in GWPCARE1 so sestavljali pretežno pediatrični bolniki in samo 5 odraslih bolnikov, starih 18 let (1,6 %), zato je bilo v odrasli populaciji bolnikov z DS pridobljenih le malo podatkov o učinkovitosti in varnosti zdravila.
English: The dose level of 125 mg/kg/day induced decreased foetal body weights and increased foetal structural variations associated with maternal toxicity.
Slovenian: Odmerek 125 mg/kg/dan je povzročil zmanjšanje telesne mase ploda in povečane strukturne spremembe ploda, povezane s toksičnostjo pri materi.
English: Therefore, dose adjustments of cannabidiol or clobazam may be required.
Slovenian: Zato so lahko potrebne prilagoditve odmerka kanabidiola ali klobazama.
English: Hypersensitivity to the active substance, to sesame oil, or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino, sezamovo olje ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Of the patients that were not taking clobazam, the majority had previously taken and subsequently discontinued clobazam treatment.
Slovenian: Od bolnikov, ki niso jemali klobazama, se je večina bolnikov predhodno zdravila s klobazamom in je zdravljenje s klobazamom kasneje prekinila.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with cannabidiol in one or more subsets of the paediatric population in treatment of seizures associated with DS and LGS.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s kanabidiolom za eno ali več podskupin pediatrične populacije pri zdravljenju epileptičnih napadov, povezanih z DS in LGS.
English: Animal abuse-related studies show that cannabidiol does not produce cannabinoid-like behavioural responses, including generalisation to delta-9-tetrahydrocannabinol (THC) in a drug discrimination study.
Slovenian: Študije na živalih, povezane z zlorabo, kažejo, da kanabidiol ne povzroča kanabinoidnih vedenjskih odzivov, kar vključuje generalizacijo na delta-9-tetrahidrokanabinol (THC) v študiji razlikovanja zdravil.
English: Open the bag containing the correct oral syringe to measure your dose.
Slovenian: Odprite vrečko, ki vsebuje ustrezno brizgo za peroralno dajanje, da boste lahko odmerili odmerek.
English: Cannabidiol can cause somnolence and sedation, which occur more commonly early in treatment and may diminish with continued treatment.
Slovenian: Kanabidiol lahko povzroči somnolenco in sedacijo, ki se pogosteje pojavita v zgodnjem obdobju zdravljenja in se lahko med nadaljevanjem zdravljenja zmanjšata.
English: Concomitant use of clobazam also increased the incidence of transaminase elevations, although to a lesser extent than valproate.
Slovenian: Tudi sočasna uporaba klobazama je povečala incidenco zvišanja transaminaz, vendar v manjši meri kot valproat.
English: 3821AL Amersfoort, The Netherlands
Slovenian: 3821AL Amersfoort, Nizozemska
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.
Slovenian: Klinični podatki o prisotnosti kanabidiola ali njegovih presnovkov v materinem mleku, učinkih na dojenega dojenčka ali učinkih na nastajanje mleka niso na voljo.
English: Given that cannabidiol is highly protein bound and will likely pass freely from plasma into milk, as a precaution, breast-feeding should be discontinued during treatment.
Slovenian: Glede na to, da se kanabidiol močno veže na beljakovine in prosto prehaja iz plazme v mleko, je treba med zdravljenjem prenehati z dojenjem.
English: Drop seizures were defined as atonic, tonic, or tonic-clonic seizures that led or could have led to a fall or injury.
Slovenian: Akinetični napadi so bili opredeljeni kot atonični, tonični ali tonično-klonični epileptični napadi, ki so povzročili ali bi lahko povzročili padec ali poškodbo.
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.
Slovenian: Učinki alkohola pri otrocih, mlajših od 6 let, lahko vključujejo zaspanost, vedenjske spremembe in težave s koncentracijo ter sodelovanjem pri šolskih dejavnostih.
English: If cannabidiol has to be discontinued, the dose should be decreased gradually.
Slovenian: Če je treba zdravljenje s kanabidiolom prekiniti, je odmerek priporočljivo zmanjševati postopoma.
English: Taking Epidyolex with certain other medicines may cause side effects, affect how the other medicines work, or affect how Epidyolex works.
Slovenian: Jemanje zdravila Epidyolex z nekaterimi drugimi zdravili lahko povzroči neželene učinke, vpliva na delovanje teh drugih zdravil ali vpliva na delovanje zdravila Epidyolex.
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.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Epidyolex ali med zdravljenjem se posvetujte z zdravnikom ali farmacevtom, če: - imate ali ste kdaj imeli težave z jetri, saj bo zdravnik morda moral spremeniti odmerek zdravila Epidyolex oziroma lahko presodi, da zdravilo Epidyolex za vas ni primerno.
English: This leaflet was last revised in .
Slovenian: Navodilo je bilo nazadnje revidirano dne
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.
Slovenian: Učinki alkohola pri otrocih, starih manj kot 6 let, lahko vključujejo zaspanost, vedenjske spremembe ter zmanjšano sposobnost koncentracije in sodelovanja pri šolskih dejavnostih.
English: In the case of more than 7 days' missed doses, re-titration to the therapeutic dose should be made.
Slovenian: Če so bili odmerki izpuščeni v obdobju več kot 7 dni, je potrebno ponovno titriranje odmerka nazaj na terapevtski odmerek.
English: The alcohol content should be taken into account in pregnant women, children and high-risk groups such as patients with liver disease.
Slovenian: Vsebnost alkohola je treba upoštevati pri nosečnicah, otrocih in skupinah z visokim tveganjem, kot so bolniki z jetrnimi obolenji.
English: Epidyolex should be initiated and supervised by physicians with experience in the treatment of epilepsy.
Slovenian: Zdravilo Epidyolex mora uvesti in nadzorovati zdravnik z izkušnjami z zdravljenjem epilepsije.
English: Insufficient data are available to assess the risk of concomitant administration of other hepatotoxic medicinal products and cannabidiol (see section 4.4).
Slovenian: Na voljo ni dovolj podatkov, da bi lahko ocenili tveganje sočasnega dajanja drugih hepatotoksičnih zdravil in kanabidiola (glejte poglavje 4.4).
English: Signs of taking more Epidyolex than you should include diarrhoea and sleepiness.
Slovenian: Znaki, da ste vzeli večji odmerek zdravila Epidyolex, kot bi smeli, vključujejo drisko in zaspanost.
English: Concomitant AED treatments
Slovenian: Sočasno zdravljenje z AED
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.
Slovenian: Možne interakcije med kanabidiolom (v odmerku 750 mg dvakrat na dan pri zdravih prostovoljcih in 20 mg/kg/dan pri bolnikih) in drugimi AED so proučevali v študijah medsebojnega delovanja zdravil pri zdravih prostovoljcih in bolnikih ter v okviru analiz populacijske farmakokinetike koncentracij zdravila v plazmi iz študij, kontroliranih s placebom, pri zdravljenju bolnikov z LGS.
English: Do not place the oral syringe in a dishwasher.
Slovenian: Brizge za peroralno dajanje ne perite v pomivalnem stroju.
English: Dose adjustment may be necessary.
Slovenian: Morda bo potrebno prilagoditi odmerek.
English: Patients should be monitored for signs of suicidal behaviour and ideation and appropriate treatment should be considered.
Slovenian: Zato je treba bolnike spremljati glede znakov samomorilnega vedenja in razmišljanja ter razmisliti o ustreznem zdravljenju.
English: cannabidiol and/or concomitant AED treatment should therefore be adjusted during regular medical supervision and the patient should be closely monitored for adverse drug reactions.
Slovenian: Zdravljenje s kanabidiolom in/ali sočasnim(i) AED je zato treba med rednim zdravniškim nadzorom prilagoditi, bolnika pa je treba skrbno spremljati glede pojava neželenih učinkov zdravila.
English: Cannabidiol appears rapidly in plasma with a time to maximum plasma concentration of 2.5-5 hours at steady state.
Slovenian: Kanabidiol se hitro pojavi v plazmi, pri čemer je čas do največje plazemske koncentracije v stanju dinamičnega ravnovesja 2,5-5 ur.
English: - If your seizures happen more often, or if you experience a severe seizure while taking Epidyolex.
Slovenian: - če imate pogostejše epileptične napade ali če doživite hud epileptični napad med jemanjem zdravila Epidyolex.