FrancophonIA/ELRC3.0 huggingface dataset:
English: Othere a. Two patients without cirrhosis with undetermined genotype in the SOF/VEL/VOX group achieved SVR12.
Slovenian: Drugoe a. V skupini SOF/VEL/VOKS sta SVR12 dosegla dva bolnika brez ciroze z nedoločenim genotipom.
English: Renal impairment No dose adjustment of Vosevi is required for patients with mild or moderate renal impairment.
Slovenian: Ledvična okvara Pri bolnikih z blago ali zmerno ledvično okvaro prilagajanje odmerka zdravila Vosevi ni potrebno.
English: GT-3 (n = 78)
Slovenian: (n = 78)
English: Rifampicin (600 mg once daily) + voxilaprevir (100 mg single dose)f
Slovenian: Rifampicin (600 mg enkrat na dan) + voksilaprevir (100 mg enkratni odmerek)f
English: Suomi/Finland
Slovenian: Španci/Latinoameričani
English: Effect on velpatasvir or voxilaprevir exposure not studied.
Slovenian: velpatasvir ali voksilaprevir niso ugotovili.
English: Ciclosporin (600 mg single dose)e + voxilaprevir (100 mg single dose)f
Slovenian: Ciklosporin (600 mg enkratni odmerek)e + voksilaprevir (100 mg enkratni odmerek)f
English: Body weight did not have a clinically significant effect on sofosbuvir, velpatasvir or voxilaprevir exposure according to a population pharmacokinetic analysis.
Slovenian: Glede na analizo populacijske farmakokinetike telesna masa ni klinično pomembno vplivala na izpostavljenost sofosbuvirju, velpatasvirju ali voksilaprevirju.
English: The proportion of patients who permanently discontinued treatment due to adverse reactions was 0.1% for patients receiving sofosbuvir/velpatasvir/voxilaprevir for 8 weeks.
Slovenian: Pri bolnikih, ki so sofosbuvir/velpatasvir/voksilaprevir prejemali 8 tednov, je bil delež bolnikov, ki so zaradi neželenih učinkov trajno prekinili zdravljenje, 0,1 %.
English: Co-administration of Vosevi with efavirenz/emtricitabine/tenofovir disoproxil fumarate is not recommended (see section 4.4).
Slovenian: Vosevi z efavirenzom/emtricitabinom/ dizoproksiltenofovirijevim fumaratom ni priporočljiva
English: Effect of baseline HCV resistance-associated variants on treatment outcome
Slovenian: Učinki izhodiščnih različic HCV, povezanih z odpornostjo, na izid zdravljenja Študije pri bolnikih, ki so bili predhodno že zdravljeni z DAA
English: Voxilaprevir had no adverse effects on behavior, reproduction, or development of the offspring in the rat pre- and post-natal development study at AUC exposures approximately 238-times higher than the human exposure at the recommended clinical dose.
Slovenian: V študiji razvoja pri podganah pred kotitvijo in po njej pri izpostavljenosti vrednostim na podlagi AUC, ki so bile približno 238-krat večje od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, voksilaprevir ni povzročil nobenih neželenih učinkov na vedenje, razmnoževanje ali razvoj potomcev.
English: GT-6 (n = 6)
Slovenian: (n = 6)
English: Vosevi is contraindicated with phenobarbital and phenytoin (see section 4.3).
Slovenian: Uporaba zdravila Vosevi v kombinaciji s fenobarbitalom in fenitoinom je kontraindicirana (glejte poglavje 4.3).
English: Medicinal products that inhibit OATP1B, CYP2B6, CYP2C8, or CYP3A4 may increase plasma concentrations of velpatasvir or voxilaprevir.
Slovenian: Zdravila, ki zavirajo OATP1B, CYP2B6, CYP2C8 ali
English: Velpatasvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study at AUC exposures approximately 3-fold higher than the human exposure at the recommended clinical dose.
Slovenian: V študiji razvoja pri podganah pred kotitvijo in po njej pri izpostavljenosti vrednostim na podlagi AUC, ki so bile približno 3-krat večje od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, velpatasvir ni povzročil nobenih neželenih učinkov na vedenje, razmnoževanje ali razvoj potomcev.
English: No NS3 and NS5B NI RAVs emerged in any of these 3 patients.
Slovenian: Pri nobenem od teh 3 bolnikov ni prišlo do nobenih RAV NI NS3 in NS5B.
English: STIMULANTS Modafinil
Slovenian: STIMULANTI
English: (may affect more than 1 in 10 people) • headache
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: Without Cirrhosis
Slovenian: Brez ciroze
English: Rifampicin (600 mg single dose) + voxilaprevir (100 mg single dose)f
Slovenian: Rifampicin (600 mg enkratni odmerek) + voksilaprevir (100 mg enkratni odmerek)f
English: Gilead Sciences Ireland UC Carrigtohill
Slovenian: Gilead Sciences Ireland UC
English: POLARIS-2 (open label)
Slovenian: POLARIS-2
English: No NS3, NS5A, or NS5B nucleoside inhibitor (NI) RAVs emerged in the other 5 patients who relapsed.
Slovenian: NS5A ali NS5B, povezane z odpornostjo na nukleozidne zaviralce (RAV NI NS3, NS5A, NS5B; NInucleoside inhibitor).
English: Table 11: SVR12 by HCV genotype and virologic outcome in study POLARIS-4
Slovenian: V preglednici 11 sta predstavljena SVR12 po genotipu HCV in virološki izid za preskušanje POLARIS-4.
English: Vosevi [Outer packaging only]
Slovenian: PODATKI V BRAILLOVI PISAVI Vosevi [samo zunanja ovojnina]
English: Cimetidined Nizatidined Ranitidined
Slovenian: Blaga ledvična okvara
English: For velpatasvir in genotype 1-6 replicons, resistance-associated substitutions selected in 2 or more genotypes were L31I/V and Y93H.
Slovenian: Za velpatasvir v replikonih genotipa 1-6 so bile z odpornostjo povezane substitucije, selekcionirane v
English: • diarrhoea • feeling sick (nausea)
Slovenian: • glavobol • driska
English: Phenobarbital
Slovenian: Modafinil
English: Vosevi is contraindicated with rifampicin (see section 4.3).
Slovenian: Uporaba zdravila Vosevi v kombinaciji z rifampicinom je kontraindicirana (glejte poglavje 4.3).
English: Rifampicin (600 mg single dose) + velpatasvir (100 mg single dose)f
Slovenian: Rifampicin (600 mg enkratni odmerek) + velpatasvir (100 mg enkratni odmerek)f
English: Table 13 presents the SVR12 by HCV genotype by cirrhosis status for the POLARIS-2 trial.
Slovenian: V preglednici 12 sta predstavljena SVR12 po genotipu HCV in virološki izid za preskušanje POLARIS-2.
English: Colloidal anhydrous silica Copovidone
Slovenian: Dizoproksiltenofovirijev fumarat
English: United Kingdom
Slovenian: ZDA
English: Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 24 01 35 50
Slovenian: Tél/Tel: + 32 (0) 24 01 35 50
English: Age (years) median (range) Male Gender Race Black/African American 14% (60) White Hispanic/Latino Genotype Genotype 1a Genotype 1b Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6 IL28B CC HCV RNA ≥ 800,000 IU/mL 74% (306) Compensated cirrhosis Site US Non-US
Slovenian: Genotip 1a Genotip 1b Genotip 2 Genotip 3 Genotip 4 Genotip 5 Genotip 6 IL28B CC
English: DAA experienced patients* without cirrhosis or with compensated cirrhosis
Slovenian: Bolniki brez ciroze ali s kompenzirano cirozo, ki so bili predhodno že zdravljeni z DAA*
English: POLARIS-4 (open label)
Slovenian: POLARIS-4
English: tenofovir disoproxil fumarate (600/200/300 mg once daily)g + sofosbuvir/
Slovenian: (600/200/300 mg enkrat na dan)g + sofosbuvir/velpatasvir
English: Outcome for patients without SVR On-treatment virologic failurea
Slovenian: Izid za osebe brez SVR
English: Emtricitabine/rilpivirine/ tenofovir alafenamide (200/25/25 mg once daily)i + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg once daily) + voxilaprevir (100 mg once daily)f
Slovenian: Emtricitabin/rilpivirin/ tenofoviralafenamid (200/25/25 mg enkrat na dan)i
English: No dose adjustment of Vosevi is required for patients with mild hepatic impairment (Child-PughTurcotte [CPT] Class A).
Slovenian: Pri bolnikih z blago jetrno okvaro (stopnja A po Child-Pugh-Turcotteu [CPT]) odmerka zdravila Vosevi ni treba prilagajati.
English: Vosevi is contraindicated with carbamazepine (see section 4.3).
Slovenian: Uporaba zdravila Vosevi v kombinaciji s karbazepinom je kontraindicirana (glejte poglavje 4.3).
English: The monohydroxylated and desmethylated velpatasvir were the metabolites identified in human plasma.
Slovenian: Monohidroksilirani in demetilirani velpatasvir sta bila presnovka,
English: Macrogol
Slovenian: Metadon
English: Population pharmacokinetic analysis in HCV-infected patients indicated that patients with cirrhosis (CPT Class A) had 73% higher exposure of voxilaprevir than those without cirrhosis (see section 4.2).
Slovenian: Analiza populacijske farmakokinetike pri bolnikih, okuženih s HCV, je pokazala, da je bila pri bolnikih s cirozo (stopnja A
English: Vosevi contains lactose.
Slovenian: Zdravilo Vosevi vsebuje laktozo.
English: POLARIS-3 (open label)
Slovenian: POLARIS-3
English: ↔ Sofosbuvir ↓ Velpatasvir ↔ Voxilaprevir
Slovenian: ↓ Sofosbuvir ↓ Velpatasvir ↓ Voksilaprevir
English: ↓ Sofosbuvir ↓ Velpatasvir ↓ Voxilaprevir
Slovenian: ↔ Sofosbuvir ↓ Velpatasvir ↔ Voksilaprevir
English: NS5A inhibitor-experienced adults (POLARIS-1)
Slovenian: Odrasli bolniki, ki so bili predhodno že zdravljeni z DAA, vendar niso prejemali zaviralcev NS5A (POLARIS-4)
English: ANTIARRHYTHMICS Amiodarone
Slovenian: Antagonisti receptorjev H2
English: Outcome for patients without SVR Ontreatment virologic failurec
Slovenian: Virološki neuspeh med zdravljenjem 0/501 Relapsc
English: The pharmacokinetics of sofosbuvir, GS-331007, and velpatasvir were studied in HCV-infected patients with ESRD requiring dialysis treated with once daily sofosbuvir/velpatasvir 400/100 mg for
Slovenian: Farmakokinetiko sofosbuvirja, GS-331007 in velpatasvirja so preučili pri bolnikih, okuženih s HCV, z
English: Pravastatin (40 mg single dose) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg once daily) + voxilaprevir (100 mg once daily)f
Slovenian: voksilaprevir (400/100/100 mg enkrat na dan) + voksilaprevir (100 mg enkrat na dan)f (zaviranje OATP1B in
English: Relapsed
Slovenian: Posakonazold
English: Tablet core:
Slovenian: Bolezni živčevja:
English: e. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
Slovenian: e. Med drugo so bile vključene osebe z manjkajočimi podatki in tiste, ki so prekinile zdravljenje pred virološko supresijo.
English: Interaction only studied with sofosbuvir Expected:
Slovenian: Preučevane so bile samo interakcije s sofosbuvirjem.
English: Patients with GT2-6 infection were enrolled into the SOF/VEL/VOX 12 week group only.
Slovenian: Bolniki z okužbo GT 26 so bili vključeni samo v skupino za 12
English: Rosuvastatin (10 mg single dose) + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg once daily) + voxilaprevir (100 mg once daily)f
Slovenian: voksilaprevir (400/100/100 mg enkratni odmerek) + voksilaprevir (100 mg enkratni odmerek)f (zaviranje P-gp)
English: c. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
Slovenian: c. Med drugo so bile vključene osebe z manjkajočimi podatki in tiste, ki so prekinile zdravljenje pred virološko supresijo.
English: c. The denominator for relapse is the number of patients with HCV RNA <LLOQ at their last on-treatment assessment.
Slovenian: c. Denominator za relaps je število bolnikov s HCV RNK < LLOQ ob zadnji oceni med zdravljenjem.
English: • outer cartons containing 1 bottle of 28 film-coated tablets
Slovenian: • škatle, ki vsebujejo 1 plastenko z 28 filmsko obloženimi tabletami Imetnik dovoljenja za promet z zdravilom Gilead Sciences Ireland UC
English: Patients with GT1-3 infection were randomised in a 1:1 ratio to SOF/VEL/VOX or SOF/VEL for 12 weeks.
Slovenian: Bolniki z okužbo GT 1-3 so bili randomizirani v razmerju 1 : 1 za 12
English: b. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Slovenian: b. Denominator za relaps je število bolnikov s HCV RNK < LLOQ ob zadnji oceni med zdravljenjem.
English: Film-coating
Slovenian: ANTIKONVULZIVI
English: No dose adjustment of Vosevi or emtricitabine/rilpivirine/tenofovi r alafenamide is required.
Slovenian: Odmerka zdravila Vosevi ali emtricitabina/rilpivirina/ tenofoviralafenamida ni treba prilagajati.
English: b. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
Slovenian: b. Med drugo so bile vključene osebe z manjkajočimi podatki in tiste, ki so prekinili zdravljenje pred virološko supresijo.
English: Close monitoring of INR is recommended when Vosevi is co-administered with all vitamin K antagonists.
Slovenian: Ko se zdravilo Vosevi daje sočasno z antagonisti vitamina
English: d. Other includes patients with missing data and those who discontinued treatment prior to virologic suppression.
Slovenian: d. Med drugo so bile vključene osebe z manjkajočimi podatki in tiste, ki so prekinile zdravljenje pred virološko supresijo.
English: a. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Slovenian: a. Denominator za relaps je število bolnikov s HCV RNK < LLOQ ob zadnji oceni med zdravljenjem.
English: d. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Slovenian: d. Denominator za relaps je število bolnikov s HCV RNK < LLOQ ob zadnji oceni med zdravljenjem.
English: In the POLARIS-2 sofosbuvir/velpatasvir/voxilaprevir 8-week treatment group (see Table 12), a total of 21 of 501 (4%) patients (16 with genotype 1, 2 with genotype 2, 2 with genotype 4, and 1 with genotype 5) qualified for resistance analysis due to relapse.
Slovenian: bolnika (16 z genotipom 1, 2 z genotipom 2, 2 z genotipom 4 in 1 z genotipom 5) primernih za analizo odpornosti zaradi relapsa.
English: Overall SVR12a
Slovenian: Skupni SVR12 Genotip 1
English: No NS3 and NS5B NI RAVs emerged in any of these 21 patients at failure.
Slovenian: Pri nobenih od teh 21 bolnikov ni prišlo do nobenih RAV NS3 in
English: (Inhibition of OATP1B or
Slovenian: (zaviranje OATP1B,
English: Relative to healthy subjects (n = 137), velpatasvir AUC0-24 and Cmax were 41% lower and 39% lower, respectively, in HCV-infected patients.
Slovenian: primerjavi z zdravimi osebami (n = 137) sta bili pri bolnikih, okuženih s HCV, vrednosti AUC0-24 in
English: In vitro potential for sofosbuvir/velpatasvir/voxilaprevir drug-drug interactions
Slovenian: In vitro potencial za medsebojne interakcije med sofosbuvirjem, velpatasvirjem in voksilaprevirjem
English: Excipients
Slovenian: Elvitegravir
English: In its assessment, the HMPC also considered a few available clinical studies, including a study in patients suffering from sleep disorders, which suggested a positive effect on sleep.
Slovenian: V svoji oceni je odbor HMPC prav tako upošteval nekaj razpoložljivih kliničnih študij, vključno s študijo pri bolnikih z motnjami spanja, ki je pokazala pozitiven učinek na spanje.
English: The plant is cultivated or gathered when flowering to obtain the above-ground parts for medicinal use.
Slovenian: Rastlina se goji in nabira ob cvetenju za pridobivanje nadzemnih delov za medicinsko uporabo.
English: California poppy EMA/HMPC/334023/2015
Slovenian: Zel kalifornijskega zlatega maka EMA/HMPC/334023/2015
English: California poppy is the common name for the above-ground parts of the plant Eschscholzia californica Cham.
Slovenian: Zel kalifornijskega zlatega maka je splošno ime za nadzemne dele rastline Eschscholzia californica Cham.
English: California poppy preparations should only be used in adults.
Slovenian: Pripravki iz zeli kalifornijskega zlatega maka se smejo uporabljati samo pri odraslih.
English: Further information on the risks associated with California poppy medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo zel kalifornijskega zlatega maka, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This summary is not intended to provide practical advice on how to use medicines containing California poppy.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo zel kalifornijskega zlatega maka.
English: The HMPC concluded that, on the basis of its long-standing use, California poppy can be used for the relief of mild symptoms of mental stress and to aid sleep.
Slovenian: Odbor HMPC je zaključil, da se na podlagi njegove dolgotrajne uporabe zel kalifornijskega zlatega maka lahko uporablja za lajšanje blagih simptomov stresa in za pomoč pri spanju.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of California poppy.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo zeli zlatega kalifornijskega maka.
English: Any applications for the licensing of medicines containing California poppy have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo zel kalifornijskega zlatega maka, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: Further information on the HMPC assessment of California poppy medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo zel kalifornijskega zlatega maka, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions on the use of California poppy medicines to relieve mild symptoms of mental stress and to aid sleep are based on their ‘traditional use'.
Slovenian: Zaključki odbora HMPC glede uporabe zdravil, ki vsebujejo zel kalifornijskega zlatega maka, za lajšanje blagih simptomov stresa in kot pomoč pri spanju temeljijo na njihovi „tradicionalni uporabi“ pri teh stanjih.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing California poppy.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo zel kalifornijskega zlatega maka.
English: Information on the use and licensing of California poppy medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo zel kalifornijskega zlatega maka, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: Herbal medicines containing California poppy are usually available in solid forms to be taken by mouth.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo zel kalifornijskega zlatega maka, so navadno na voljo v trdnih oblikah za peroralno jemanje (zaužitje skozi usta).
English: Detailed instruction on how to take California poppy medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila o jemanju zdravil, ki vsebujejo zel kalifornijskega zlatega maka, in o tem, kdo lahko ta zdravila jemlje, so v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: California poppy preparations are obtained by powdering the dried above-ground parts of the plant.
Slovenian: Pripravki iz zeli kalifornijskega zlatega maka se pridobivajo z drobljenem suhih nadzemnih delov rastline v prašek.
English: The HMPC conclusions on the use of California poppy medicines are based on their long-standing use.
Slovenian: Zaključki HMPC v zvezi z uporabo zdravil, ki vsebujejo zel kalifornijskega zlatega maka, zato temeljijo na njihovi dolgotrajni uporabi.
English: For more information about treatment with California poppy medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo zel kalifornijskega zlatega maka, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: What evidence supports the use of California poppy medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo zel kalifornijskega zlatega maka?
English: What are the risks associated with California poppy medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo zel kalifornijskega zlatega maka?
English: What is California poppy?
Slovenian: Kaj je zel kalifornijskega zlatega maka?
English: Other information about California poppy medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo zel kalifornijskega zlatega maka
English: How are California poppy medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo zel kalifornijskega zlatega maka, odobrena v EU?
English: For practical information about using California poppy medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: California poppy
Slovenian: Zel kalifornijskega zlatega maka
English: It should be taken consistently either with or without food.
Slovenian: Jemati ga je treba dosledno, bodisi s hrano bodisi brez nje.
English: Further information on Epidyolex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/epidyolex.
Slovenian: Nadaljnje informacije o zdravilu Epidyolex so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/epidyolex.
English: This risk can be managed with restrictions and regular liver monitoring and is considered acceptable given the seriousness of the conditions and the lack of treatments.
Slovenian: To tveganje je mogoče obvladati z omejitvami in rednim spremljanjem delovanja jeter ter velja za sprejemljivo glede na resnost bolezni in pomanjkanje zdravljenj.
English: Further information on the orphan designations can be found on the European Medicines Agency's website: (Dravet syndrome: 15 October 2014; Lennox-Gastaut syndrome: 20 March 2017).
Slovenian: Nadaljnje informacije glede določitve zdravila sirote lahko najdete na spletni strani Evropske agencije za zdravila: (Dravetov sindrom: 15. oktobra 2014; Lennox-Gastautov sindrom: 20. marca 2017).
English: The European Medicines Agency therefore decided that Epidyolex's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Epidyolex večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The recommended starting dose is 2.5 mg per kilogram body weight given twice a day.
Slovenian: Priporočeni začetni odmerek je 2,5 mg na kilogram telesne mase dvakrat dnevno.
English: What measures are being taken to ensure the safe and effective use of Epidyolex?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Epidyolex?
English: Regarding safety, treatment with Epidyolex is associated with an increased risk of liver problems.
Slovenian: Z vidika varnosti je zdravljenje z zdravilom Epidyolex povezano s povečanim tveganjem za težave z jetri.
English: Epidyolex (cannabidiol)
Slovenian: Epidyolex (kanabidiol)
English: After one week, the dose should be increased to a maintenance dose of 5 mg/kg twice a day.
Slovenian: Po enem tednu je treba odmerek povečati do vzdrževalnega odmerka 5 mg/kg dvakrat dnevno.