FrancophonIA/ELRC3.0 huggingface dataset:
English: It must not be used in patients with urinary retention (difficulty in passing urine), severe gastro-intestinal conditions (problems with the stomach and gut), uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment) or myasthenia gravis (a disease of the nerves and muscles causing muscle weakness), or in patients at risk of these conditions.
Slovenian: Ne sme se uporabljati pri bolnikih z zastajanjem urina (težavami pri odvajanju urina), z resnimi želodčno-črevesnimi motnjami (težave s prebavili), neobvladanim glavkomom z zaprtim zakotjem (povišanim tlakom v očesu kljub zdravljenju), miastenijo gravis (boleznijo živčevja, ki povzroča šibkost mišic), ali pri bolnikih, pri katerih obstaja tveganje za te bolezni.
English: Kentera transdermal patches were studied in a total of 881 patients, mostly elderly women, with overactive bladders in two main studies.
Slovenian: Učinki transdermalnih obližev Kentera so bili raziskani v dveh glavnih študijah pri skupno 881 bolnikih, večinoma starejših ženskah s čezmerno aktivnim sečnim mehurjem.
English: After 12 weeks, the average number of incontinence episodes per week had decreased by 19 (about three per day) with Kentera patches, compared with a decrease of 15 episodes with placebo.
Slovenian: Po 12 tednih se je povprečno število inkontinenčnih epizod na teden ob uporabi obližev Kentera zmanjšalo za 19 (ali za približno 3 na dan), v primerjavi z zmanjšanjem za 15 epizod pri nanosu placeba.
English: It is available as a transdermal patch (a patch that delivers a medicine across the skin) and as a gel in a sachet or a metering pump.
Slovenian: Na voljo je v obliki transdermalnega obliža (obliža, ki dovaja zdravilo skozi kožo) in gela v vrečki ali gela za črpalko za odmerjanje.
English: Kentera is a medicine that contains the active substance oxybutynin.
Slovenian: Kentera je zdravilo, ki vsebuje zdravilno učinkovino oksibutinin.
English: The gel is applied to dry, intact skin on the abdomen, upper arm, shoulders or thighs.
Slovenian: nepoškodovano kožo trebuha, nadlakti, rame ali stegna.
English: In the bladder, this causes the muscles that push urine out of the bladder to relax.
Slovenian: Ta povzroča, da se mišice, ki iztiskajo urin iz sečnega mehurja, sprostijo.
English: The CHMP had first evaluated Kentera transdermal patches and concluded that their effectiveness was similar to that of the oxybutynin tablets already on the market and that the benefits outweighed the risks.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je najprej ocenil transdermalne obliže Kentera in sklenil, da je njihova učinkovitost primerljiva s tabletami oksibutinina, ki so že v prometu, in da koristi zdravila odtehtajo z njim povezana tveganja.
English: During its assessment of the application for Kentera gel, the CHMP concluded that its effectiveness was similar to that of the previously approved patches.
Slovenian: Med oceno nanosa gela Kentera je CHMP sklenil, da je njegova učinkovitost podobna učinkovitosti obližev, ki so bili že odobreni.
English: For the full list of all side effects reported with Kentera, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Kentera, glejte navodilo za uporabo.
English: Why has Kentera been approved?
Slovenian: Zakaj je bilo zdravilo Kentera odobreno?
English: The most common side effects with Kentera patches (seen in more than 1 patient in 10) are application site reactions (including itching around the site of patch application).
Slovenian: Najpogostejši neželeni učinki obližev Kentera (opaženi pri več kot 1 od 10 bolnikov) so reakcije na mestu nanosa (vključno s srbenjem okrog mesta nanosa obliža).
English: In one study, they were compared with placebo (a dummy treatment) in 520 patients.
Slovenian: V prvi študiji so učinke zdravila primerjali z učinki placeba (zdravila brez zdravilne učinkovine) pri 520 bolnikih.
English: This leads to an increase in the amount of urine that the bladder can hold, and to changes in the way the bladder muscles contract as the bladder fills up.
Slovenian: Zaradi tega se poveča zmogljivost sečnega mehurja in spremeni način krčenja mišic sečnega mehurja med njegovim polnjenjem.
English: What is Kentera used for?
Slovenian: Za kaj se zdravilo Kentera uporablja?
English: The patch should be applied to dry, intact skin on the abdomen (tummy), hip, or buttock immediately after it is removed from the protective sachet.
Slovenian: Obliž se namesti na suho, nepoškodovano kožo trebuha, boka ali zadnjice takoj, ko ga vzamemo iz ovojne vrečke.
English: Different application sites should be chosen, so that the same area of skin is not used on consecutive days.
Slovenian: Mesto nanosa je treba dnevno spreminjati, tako da se gel ne nanaša zaporedoma na isti predel kože.
English: How has Kentera been studied?
Slovenian: Kako je bilo zdravilo Kentera raziskano?
English: How is Kentera used?
Slovenian: Kako se zdravilo Kentera uporablja?
English: What is Kentera?
Slovenian: Kaj je zdravilo Kentera?
English: How does Kentera work?
Slovenian: Kako zdravilo Kentera deluje?
English: All active substances are authorised at the level of the Member States.
Slovenian: Vse zdravilne učinkovine so odobrene na ravni držav članic.
English: - Restriction of the maximum dose to 3 mg/day.
Slovenian: - Omejitev največjega odmerka na 3 mg/dan.
English: This has been subject to previous reviews leading to risk minimisation measures at national level.
Slovenian: To je bil predmet starejših pregledov, ki so privedli do ukrepov za zmanjšanje tveganja na državni ravni.
English: - The conditions of the marketing authorisations are set out in Annex IV.
Slovenian: - Pogoji dovoljenj za promet z zdravili so navedeni v Dodatku IV.
English: The stimulation of the 5-HT2B receptor agonists is considered the most plausible mechanism that induces cardiac valvulopathy, although other mechanisms may be involved.
Slovenian: Stimulacija agonistov receptorja 5-HT2B se smatra za najbolj verjeten mehanizem, ki sproži srčno valvulopatijo, čeprav so morda vpleteni tudi drugi mehanizmi.
English: The majority of reported fibrotic events were not completely reversible although symptomatic improvement occurs for various reasons and indeed occasionally fibrosis may regress.
Slovenian: Pri večini fibroznih dogodkov, o katerih se je poročalo, le-teh ni bilo mogoče popolnoma pozdraviti, čeprav je zaradi različnih razlogov prišlo do simptomatskih izboljšav, občasno celo do regresije fibroze.
English: - Strengthening of the contra-indications, warnings and precautions for use, outlining the necessity for patients to be monitored for signs of fibrosis with echocardiography before and during long-term treatment.
Slovenian: - Okrepitev kontraindikacij, opozoril in previdnostnih ukrepov pri uporabi, z opisom potrebe po opazovanju bolnikov glede prisotnosti znakov fibroze z ehokardiografijo pred in med dolgotrajnim zdravljenjem.
English: The mechanism of fibrotic reaction induced by ergot alkaloids has not been completely clarified yet.
Slovenian: Mehanizmi fibroznih reakcij, ki jih sprožijo alkaloidi rženega rožička, še niso povsem pojasnjeni.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CABERGOLINE AND PERGOLIDE AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA KABERGOLINA IN PERGOLIDA TER Z NJIMA POVEZANIH IMEN (GLEJTE DODATEK I)
English: Whether this mechanism also applies to the non-cardiac fibrotic events is unclear.
Slovenian: Ni jasno, ali ta mehanizem velja tudi za dogodke fibroze, ki niso povezani s srcem.
English: However, most trials did not include echocardiographic monitoring, thus preventing a reliable estimation of incidence rates.
Slovenian: Vendar pa pri večini preskušanj niso uporabili ehokardiografskega opazovanja, kar onemogoča zanesljivo oceno deležev pojavnosti.
English: Four main observational studies looked into the risk of cardiac valvulopathy in patients treated with dopamine agonists for Parkinson's disease (Zanettini et al., NEJM, 2007; Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006; Peralta et al., Movement Disorders 2006).
Slovenian: V štirih glavnih opazovalnih študijah so opazovali tveganje pojava srčne valvulopatije pri bolnikih, ki so jih zaradi Parkinsonove bolezni zdravili z agonisti dopamina (Zanettini et al., NEJM, 2007; Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006; Peralta et al., Movement Disorders 2006).
English: - In view of the available data, the Committee concluded that the risk of fibrosis, including cardiac valvulopathy, is well established for cabergoline and pergolide, and is higher at doses exceeding 3mg/day.
Slovenian: - Glede na razpoložljive podatke je Odbor odločil, da je tveganje fibroze, vključno s srčno valvulopatijo, dobro ugotovljeno za kabergolin in pergolid ter da je večje pri odmerkih, večjih od 3 mg/dan.
English: On 21 June 2007, the UK asked the CHMP, under article 31 of Directive 2001/83/EC, as amended, to review the risk of fibrosis and cardiac valvulopathy associated with the use of all ergot-derived dopamine agonists, and to provide an opinion on whether the marketing authorisations for all products of the class should be maintained, varied, suspended or withdrawn.
Slovenian: Dne 21. junija 2007 je Združeno kraljestvo skladno z 31. členom Direktive 2001/83/ES, kakor je bila spremenjena, zaprosilo CHMP, naj opravi pregled tveganja fibroze in srčne valvulopatije, povezanih z uporabo vseh iz rženega rožička pridobljenih agonistov dopamina, ter poda mnenje o tem, ali naj ostanejo dovoljenja za promet z vsemi zdravili te skupine še dalje veljavna, oziroma se spremenijo, začasno ukinejo ali umaknejo.
English: They are also used to treat conditions including hyperprolactinaemia and prolactinoma, and to prevent lactation and migraine.
Slovenian: Uporabljajo se tudi za zdravljenje stanj, med katerimi sta hiperprolaktinemija in prolaktinom, ter preprečevanje laktacije in migrene.
English: - The CHMP considered the referral made under Article 31 of Directive 2001/83/EC, as amended, for medicinal products containing bromocriptine, cabergoline dihydroergocryptine, lisuride and pergolide,
Slovenian: - CHMP je obravnaval napotitev, ki je bila sprožena v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo bromokriptin, kabergolin, dihidroergokriptin, lizurid in pergolid.
English: The CHMP also recommended that marketing authorisation holders provide a detailed protocol (e.g. drug utilisation studies or survey done by record linkage) for the long term follow-up on the adherence to and effectiveness of the changes to the product information.
Slovenian: CHMP je prav tako priporočil, da imetniki dovoljenj za promet z zdravilom priskrbijo podroben protokol (npr. študije uporabe zdravila ali oceno na podlagi povezovanja zapiskov) za dolgotrajno sledenje upoštevanja in učinkovitosti dopolnjenih informacij o zdravilu.
English: Ergot derived dopamine agonists are mainly used to treat Parkinson's disease, either on their own or in combination with other medicines.
Slovenian: Iz rženega rožička pridobljeni agonisti dopamina se v glavnem uporabljajo za zdravljenje Parkinsonove bolezni bodisi kot samostojna zdravila ali v kombinaciji z drugimi zdravili.
English: - Inclusion of cardiac valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial effusion) as “very common” undesirable effects.
Slovenian: - Vključitev srčne valvulopatije (vključno z regurgitacijo) in sorodnimi motnjami (perikarditis in iztekanje perikardialne tekočine) med „zelo pogoste“ neželene učinke.
English: For bromocriptine, dihydroergocryptine and lisuride an increased risk cannot be excluded based on the amount of evidence available.
Slovenian: Pri uporabi bromokriptina, dihidroergokriptina in lizurida pa povečanega tveganja, na osnovi dostopnih podatkov, ni mogoče izključiti.
English: For pergolide and cabergoline, the majority (about two thirds) of case reports of valvulopathy occurred with doses ≥ 3mg / day.
Slovenian: V primeru pergolida in kabergolina se je večina (približno dve tretjini) poročil o posameznih primerih valvulopatije nanašala na primere uporabe odmerkov, ki so bili enaki ali večji od 3 mg/dan.
English: At its June 2008 meeting, the CHMP concluded that the amount of evidence on the risk of fibrotic events, including valvulopathy, is not equal for all ergot-derived dopamine agonists.
Slovenian: Odbor za zdravila za uporabo v humani medicini je na svojem zasedanju junija 2008 menil, da dokazi o tveganju fibroznih dogodkov, vključno z boleznimi zaklopke, kažejo, da tveganje ni enako pri vseh agonistih dopamina, pridobjenih iz rženega rožička.
English: As a result, cabergoline and pergolide containing medicinal products are indicated only as 2nd line therapy in Parkinson's disease, and their use is contraindicated for patients with evidence of valve problems.
Slovenian: Zaradi tega so zdravila, ki vsebujejo kabergolin in pergolid, indicirana le kot zdravljenje druge izbire pri Parkinsonovi bolezni, njihova uporaba pa je kontraindicirana pri bolnikih z dokazanimi težavami s srčnimi zaklopkami.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLETS
Slovenian: PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
English: The Schade study reported higher adjusted incidence rate ratio (IRR) for symptomatic valvular regurgitation for cabergoline, and pergolide (in particular at doses > 3mg/day), compared to bromocriptine, lisuride, and non ergot derived dopamine agonists pramipexole and ropirinole for which no cases were reported.
Slovenian: Rezultati študije Schade so pokazali višje prilagojeno razmerje stopnje pojavnosti (IRR) simptomatske regurgitacije valvul za kabergolin in pergolid (še posebej pri odmerkih, ki presegajo 3 mg/dan), v primerjavi z bromokriptinom, lizuridom ter agonistoma dopamina pramipeksol ter ropirinol, ki nista pridobljena iz rženega rožička in za katera ni bilo poročil o takih primerih.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: The degree of 5-HT2B receptor agonism varies across ergot derived dopamine agonists and fits well with the difference in incidence rates of fibrotic events for the different ergot-products (C.Hofmann et al., Clin
Slovenian: Stopnja agonističnega delovanja na receptor 5-HT2B se razlikuje med posameznimi agonisti dopamina, ki so pridobljeni iz rženega rožička, in dobro ustreza razlikam v pojavnosti dogodkov fibroze v različnih skupinah zdravil, pridobljenih iz rženega rožička (C.Hofmann et al., Clin Neuropharmacol, 2006).
English: In view of the differences in the level risk amongst ergot derived dopamine agonists, the CHMP recommended that a separate opinion is issued for bromocriptine, dihydroergocryptine and lisuride.
Slovenian: Zaradi razlik v stopnji tveganja med agonisti dopamina, pridobljenimi iz rženega rožička, je CHMP predlagal, da se za bromokriptin, dihidroergokriptin in lizurid izda ločeno mnenje.
English: - The CHMP recommended amendments to the relevant sections of the Summary of product characteristics and Package leaflets of the medicinal products containing cabergoline and pergolide (see Annex III).
Slovenian: - CHMP je priporočil dopolnitve ustreznih poglavij povzetka glavnih značilnosti zdravila in navodil za uporabo zdravil, ki vsebujejo kabergolin in pergolid (glejte Prilogo III).
English: Data from spontaneous reports indicate that subjects using carbergoline and pergolide are more at risk for fibrotic events and valvulopathy than subjects using bromocriptine, lisuride or dihydroergocryptine.
Slovenian: Podatki spontanih poročil kažejo, da so osebe, ki uporabljajo kabergolin in pergolid, bolj izpostavljene tveganju fibroznih dogodkov in valvulopatiji kot osebe, ki uporabljajo bromokriptin, lizurid ali dihidroergokriptin.
English: In view of the above, the CHMP recommended the maintenance of the marketing authorisation for cabergoline and pergolide containing medicinal products with amendments to their product information (Summary of product characteristics and Package leaflet), as outlined below.
Slovenian: Zaradi tega je CHMP priporočil ohranitev dovoljenja za promet z zdravili, ki vsebujejo kabergolin in pergolid, s tem da se dopolnijo informacije o teh zdravilih (Povzetek glavnih značilnosti zdravila in navodilo za uporabo), kot je navedeno spodaj.
English: Ergot-derived dopamine agonists have been associated with an increased risk of fibrotic disorders and valvular heart disease.
Slovenian: Iz rženega rožička pridobljeni agonisti dopamina so povezani s povečanim tveganjem fibroznih motenj in obolenj srčnih zaklopk.
English: Cabergoline and pergolide belong to the class of ergot derived dopamine agonists, which also comprises bromocriptine, dihydroergocryptine and lisuride.
Slovenian: Kabergolin in pergolid spadata v skupino iz rženega rožička (ergot) pridobljenih agonistov dopamina, ki vključuje tudi bromokriptin, dihidroergokriptin in lizurid.
English: Comparative trials with non-ergot and ergot derived dopamine agonist are scarce.
Slovenian: Primerjalna preskušanja z agonisti dopamina, ki so pridobljeni iz rženega rožička, v primerjavi s tistimi, ki niso, so redka.
English: The CHMP reviewed all of the information made available by marketing authorisation holders (MAH) on the risk of fibrosis and cardiac valvulopathy from clinical trials, observational studies and spontaneous reports.
Slovenian: CHMP je pregledal vse podatke o tveganju pojava fibroze in srčne valvulopatije iz kliničnih preskušanj, opazovalnih študij ter spontanih poročil, ki so jih dali na voljo imetniki dovoljenj za promet z zdravilom.
English: Cases of fibrotic reactions and valvulopathy have been reported with cabergoline and pergolide during clinical trials (open label study and randomised controlled studies).
Slovenian: Med kliničnimi preskušanji (odprte študije in randomizirane nadzorovane študije) s kabergolinom in pergolidom so poročali o primerih fibroznih reakcij in valvulopatije.
English: 2nd line therapy in Parkinson's disease, and contraindicated for patients with evidence of valvulopathy.
Slovenian: CHMP je upošteval tudi, da so ta zdravila že indicirana samo kot zdravila za zdravljenje druge izbire pri Parkinsonovi bolezni in so kontraindicirana pri bolnikih z dokazano valvulopatijo.
English: For carbergoline and pergolide an increased risk of fibrotic events is considered well established.
Slovenian: Povečano tveganje fibroznih dogodkov je dobro potrjeno pri uporabi karbergolina in pergolida.
English: No cases were reported for bromocriptine, dihydroergocryptine and lisuride by MAHs.
Slovenian: Pri bromokriptinu, dihidroergokriptinu in lizuridu imetniki dovoljenj za promet z zdravilom niso poročali o takih primerih.
English: (Invented) name
Slovenian: (Izmisljeno) ime
English: 4 vials
Slovenian: 4 viale
English: Strength Pharmaceutical form
Slovenian: Farmacevtska oblik Pot uporabe Sticna ovojnina Vsebina
English: MA (EU) number
Slovenian: Stevilka (EU) dovoljenja za promet
English: This is not an exclusive list.
Slovenian: To ni izključni seznam.
English: The final study report shall be submitted by:
Slovenian: Končno poročilo o študiji se predloži do:
English: Date of first authorisation: 26th July 2017
Slovenian: Datum prve odobritve: 26. julij 2017
English: This allows the infection to be eliminated from the body.
Slovenian: To omogoči odstranitev okužbe iz telesa.
English: DORA (Part 1)
Slovenian: DORA (1. del)
English: Appropriate symptomatic treatment should be instituted immediately.
Slovenian: Takoj je treba uvesti ustrezno simptomatsko zdravljenje.
English: This is so that your doctor can decide if:
Slovenian: To je zato, da zdravnik lahko določi ali:
English: A risk to the suckling child cannot be excluded.
Slovenian: Tveganja za dojenega otroka ni mogoče izključiti.
English: Patients should be instructed not to take a double dose.
Slovenian: Bolnike je treba poučiti, naj ne vzamejo dvojnega odmerka.
English: f. VOYAGE-1 and VOYAGE-2 were Asian regional studies.
Slovenian: f. VOYAGE-1 in VOYAGE-2 sta bili azijski regionalni študiji.
English: Take the medicine pack with you so that you can show the doctor what you have taken.
Slovenian: Pakiranje zdravila vzemite s seboj, da boste zdravniku lahko pokazali, kaj ste vzeli.
English: 8017 JV Zwolle NETHERLANDS
Slovenian: 8017 JV Zwolle NIZOZEMSKA
English: Do not take a double dose (two doses too close together).
Slovenian: Ne vzemite dvojnega odmerka (dveh odmerkov v zelo kratkem časovnem razmaku).
English: How much to take
Slovenian: Koliko vzeti
English: Do not give this medicine to children under 12 years of age.
Slovenian: Tega zdravila ne dajajte otrokom, mlajšim od 12 let.
English: The doctor may need to change your dose of these medicines.
Slovenian: Možno je, da bo zdravnik moral spremeniti odmerek teh zdravil.
English: • you are taking the following medicines:
Slovenian: • jemljete naslednja zdravila:
English: • you should take Maviret and for how long
Slovenian: • morate jemati zdravilo Maviret in kako dolgo,
English: The risk of failure was, as expected, highest for those exposed to both classes.
Slovenian: Tveganje za neuspeh je bilo po pričakovanjih največje pri bolnikih, ki so bili izpostavljeni obema skupinama.
English: Number of clinical isolates
Slovenian: Število kliničnih izolatov
English: Then take the next dose at your usual time.
Slovenian: Naslednji odmerek vzemite ob običajni uri.
English: If the combination is unavoidable, use can be considered if the benefit outweighs the risk with a close clinical monitoring.
Slovenian: Če je kombinacija neizogibna, se o uporabi lahko razmisli, kadar koristi prevladajo nad tveganji, skupaj z natančnim kliničnim spremljanjem.
English: Talk to your doctor if you have the following because your doctor may want to check you more closely:
Slovenian: Posvetujte se z zdravnikom, če imate kaj od naštetega, ker vas bo zdravnik morda želel natančneje spremljati:
English: Iron oxide red (E172)
Slovenian: rdeči železov oksid (E172)
English: Caution is recommended.
Slovenian: Priporočljiva je previdnost.
English: The presence of HIV-1 coinfection did not impact efficacy.
Slovenian: Prisotnost sočasne okužbe s HIV-1 ni vplivala na učinkovitost.
English: Not known: cannot be estimated from the available data • itching
Slovenian: Neznana pogostnost: ni mogoče oceniti iz razpoložljivih podatkov • srbenje
English: ↔ ↔ ↔ No dose adjustment is required.
Slovenian: ↔ ↔ ↔ Prilagoditev odmerka ni potrebna.
English: Non-interventional post-authorisation safety study (PASS):
Slovenian: Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS):
English: b. Mean systemic exposure with moderate to high fat meals.
Slovenian: b. Povprečna sistemska izpostavljenost z zmerno do zelo mastnimi obroki.
English: • you are allergic to glecaprevir, pibrentasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Slovenian: • ste alergični na glekaprevir, pibrentasvir ali katero koli sestavino tega zdravila (navedeno v poglavju 6 tega navodila).
English: Adults and adolescents aged 12 to <18 years
Slovenian: Odrasli in mladostniki, stari od 12 do <18 let
English: Do not take Maviret if any of the above apply to you.
Slovenian: Ne jemljite zdravila Maviret, če kar koli od zgoraj naštetega velja za vas.
English: Your doctor will tell you how long you need to take Maviret for.
Slovenian: Vaš zdravnik vam bo povedal, koliko časa morate jemati zdravilo Maviret.
English: • feeling weak or lack of energy (asthenia)
Slovenian: • občutek šibkosti ali pomanjkanja energije (astenija)
English: Larger increases may be expected when unbound concentration is considered.
Slovenian: Ob upoštevanju nevezane koncentracije je mogoče pričakovati večja povečanja.