FrancophonIA/ELRC3.0 huggingface dataset:
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Slovenian: Pri nekaterih bolnikih z napredovalo okužbo z virusom HIV (AIDS), ki so v preteklosti imeli oportunistične okužbe, se lahko znaki in simptomi vnetja predhodnih okužb pojavijo kmalu po začetku zdravljenja okužbe z virusom HIV.
English: Efavirenz is an in vivo inducer of CYP3A4, CYP2B6 and UGT1A1.
Slovenian: Efavirenz in vivo inducira encime CYP3A4, CYP2B6 in UGT1A1.
English: The combination of efavirenz, emtricitabine and tenofovir disoproxil has been studied in 460 patients either as the fixed-dose combination tablet Atripla (study AI266073) or as the component products (study GS-01-934).
Slovenian: Kombinacijo efavirenza, emtricitabina in dizoproksiltenofovirataso preučevali pri 460 bolnikih bodisi kot kombinacijo tablet Atripla s fiksnim odmerkom (študija AI266073) ali kot posamične učinkovine v zdravilu (študija GS-01-934).
English: Table 5: Maintenance of pure virologic response (Kaplan Meier % (Standard Error) [95%CI]) at week 48 for treatment-experienced patients with baseline HIV-1 RNA < 75 copies/ml who had therapy switched to Atripla according to the type of prior antiretroviral regimen (Kaiser Permanente patient database)
Slovenian: Tabela 5: Ohranjanje čistega virološkega odziva (% po metodi Kaplan Meier (standardna napaka) [95 % IZ]) po 48. tednih za predhodno zdravljene bolnike z začetnim HIV-1 RNA < 75 kopij/ml, ki so prešli na zdravljenje z zdravilom Atripla glede na vrsto predhodnega protiretrovirusnega zdravljenja (zbirka podatkov bolnikov Kaiser Permanente)
English: In HIV infected patients, peak efavirenz plasma concentrations were attained by 5 hours and steady-state concentrations reached in 6 to 7 days.
Slovenian: Pri bolnikih, okuženih z virusom HIV, so bile največje koncentracije efavirenza v plazmi dosežene v 5 urah, dinamično ravnovesje koncentracije pa v 6 do 7 dneh.
English: • inflammation of the kidney, passing a lot of urine and feeling thirsty
Slovenian: • vnetje ledvic, izločanje velike količine urina in občutek žeje;
English: Adults The recommended dose of Atripla is one tablet taken orally once daily.
Slovenian: Priporočeni odmerek zdravila Atripla je ena tableta peroralno enkrat na dan.
English: If overdose occurs, the patient must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary.
Slovenian: Če pride do prevelikega odmerjanja, je treba pri bolniku nadzorovati znake toksičnosti (glejte poglavje 4.8) in mu nuditi standardno podporno zdravljenje.
English: Studies in humans and in vitro studies using human liver microsomes have demonstrated that efavirenz is principally metabolised by the CYP system to hydroxylated metabolites with subsequent glucuronidation of these hydroxylated metabolites.
Slovenian: Študije pri ljudeh in študije in vitro z uporabo človeških jetrnih mikrosomov so pokazale, da se efavirenz presnavlja predvsem s sistemom CYP, in sicer v hidroksilirane presnovke, z nadaljnjo glukuronidacijo teh hidroksiliranih presnovkov.
English: Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Slovenian: Znaki osteonekroze so otrdelost sklepov, bolečine v sklepih (zlasti v kolku, kolenu in rami) in težave pri gibanju.
English: Since decreased concentrations of artemether, dihydroartemisinin, or lumefantrine may result in a decrease of antimalarial efficacy, caution is recommended when Atripla and artemether/lumefantrine tablets are co-administered.
Slovenian: Ker lahko zmanjšane koncentracije artemetra, dihidroartemizinina ali lumefantrina povzročijo zmanjšanje učinkovitosti proti malariji, je potrebna previdnost ob sočasnem dajanju zdravila Atripla in tablet artemetra/lumefantrina.
English: In vitro studies have shown that both emtricitabine and tenofovir can be fully phosphorylated when combined together in cells.
Slovenian: Študije in vitro so pokazale, da se lahko tako emtricitabin kot tenofovir popolnoma fosforilirata v celicah, ko se uporabita v kombinaciji.
English: Emtricitabine-resistant viruses with the M184V/I mutation were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir and zidovudine.
Slovenian: Virusi, odporni na emtricitabin, z mutacijo M184V/I so bili navzkrižno odporni na lamivudin, vendar so ohranili občutljivost za didanozin, stavudin, tenofovir in zidovudin.
English: Psychiatric side effects in addition to those listed above include delusions (false beliefs), neurosis.
Slovenian: Poleg zgoraj navedenih psihiatrični neželeni učinki vključujejo tudi blodnje (zmotna prepričanja) in nevrozo.
English: Atripla should be avoided in patients with HIV-1 harbouring the K65R, M184V/I or K103N mutation (see sections 4.1 and 5.1).
Slovenian: Uporabi zdravila Atripla se je treba izogibati pri bolnikih, ki so okuženi z virusom HIV-1 z mutacijami K65R, M184V/I ali K103N (glejte poglavji 4.1 in 5.1).
English: In both studies, plasma progesterone levels for subjects receiving efavirenz and DMPA remained low consistent with suppression of ovulation.
Slovenian: V obeh študijah so koncentracije progesterona v plazmi preiskovancev, ki so prejemali efavirenz in DMPA, ostale nizke skladno s supresijo ovulacije.
English: - Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) - Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) - Tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI)
Slovenian: - efavirenz je nenukleozidni zaviralec reverzne transkriptaze (non-nucleoside reverse transcriptase inhibitor - NNRTI), - emtricitabin je nukleozidni zaviralec reverzne transkriptaze (nucleoside reverse transcriptase inhibitor - NRTI), - tenofovir je nukleotidni zaviralec reverzne transkriptaze (nucleotide reverse transcriptase inhibitorNtRTI).
English: The apparent clearance of tenofovir averaged approximately 307 ml/min.
Slovenian: Povprečni navidezni očistek tenofovirja je znašal približno 307 ml/min.
English: If therapy with Atripla is discontinued, consideration should be given to the long half-life of efavirenz (see section 5.2) and long intracellular half-lives of emtricitabine and tenofovir.
Slovenian: Ob prekinitvi zdravljenja z zdravilom Atripla je treba upoštevati dolgi razpolovni čas efavirenza (glejte poglavje 5.2) ter dolgi znotrajcelični razpolovni čas tenofovirja in emtricitabina.
English: Reproductive toxicity studies showed increased foetal resorptions in rats.
Slovenian: Študije vpliva na sposobnost razmnoževanja so pokazale povečano resorpcijo zarodkov v podganah.
English: When efavirenz was given with ritonavir 500 mg or 600 mg twice daily, the combination was not well tolerated (for example, dizziness, nausea, paraesthesia and elevated liver enzymes occurred).
Slovenian: Kadar so efavirenz dajali skupaj s 500 mg ali 600 mg ritonavirja dvakrat na dan, bolniki te kombinacije niso dobro prenašali (pojavili so se na primer omotica, navzea, parestezija in povečane vrednosti jetrnih encimov).
English: Cannabinoid test interaction
Slovenian: Interakcije s kanabinoidnimi testi
English: If you accidentally take too many Atripla tablets you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Slovenian: Če ste pomotoma zaužili preveč tablet zdravila Atripla, ste lahko izpostavljeni povečanemu tveganju za pojav morebitnih neželenih učinkov tega zdravila (glejte poglavje 4, Možni neželeni učinki).
English: Emtricitabine and tenofovir disoproxil: A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicates no malformations or foetal/neonatal toxicity associated with emtricitabine and tenofovir disoproxil.
Slovenian: Emtricitabin in dizoproksiltenofovirat: Večje število podatkov o uporabi pri nosečnicah (več kot 1000 izpostavljenih nosečnosti) kaže, da ni povezave med uporabo emtricitabina in dizoproksiltenofoviratain malformacijsko ali feto-/neonatalno toksičnostjo.
English: They include some common medicines and some herbal preparations (including St. John's wort) which can cause serious interactions.
Slovenian: Med temi zdravili so nekatera pogosto uporabljana zdravila in nekateri zeliščni pripravki (vključno s šentjanževko), ki lahko povzročijo resne interakcije.
English: Also, emtricitabine did not inhibit uridine 5'-diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Slovenian: Emtricitabin prav tako ni zaviral uridin-5'difosfoglukuronil-transferaze, encima, ki je odgovoren za glukuronidacijo.
English: - Other medicines used for HIV infection: The following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or ritonavir boosted atazanavir or saquinavir.
Slovenian: - Druga zdravila proti okužbi z virusom HIV: Naslednji zaviralci proteaze: darunavir, indinavir, lopinavir/ritonavir, ritonavir ali z ritonavirjem okrepljen atazanavir ali sakvinavir.
English: Magnesium stearate (E572) Microcrystalline cellulose (E460) Sodium laurilsulfate
Slovenian: Jedro tablete premreženi natrijev karmelozat hiproloza magnezijev stearat (E572) mikrokristalna celuloza (E460) natrijev lavrilsulfat
English: If you take more Atripla than you should
Slovenian: Če ste vzeli večji odmerek zdravila Atripla, kot bi smeli
English: [outer packaging only]
Slovenian: [samo zunanja ovojnina]
English: Atripla should not be taken with any of these medicines.
Slovenian: Zdravila Atripla ne smete jemati sočasno z nobenim od teh zdravil.
English: If you are pregnant, you should take Atripla only if you and your doctor decide it is clearly needed.
Slovenian: Če ste noseči, smete jemati zdravilo Atripla samo, če se zdravnik odloči, da je nujno.
English: This medicinal product contains 23.6 mg sodium per dose, equivalent to 1.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: To zdravilo vsebuje 23,6 mg natrija na odmerek, kar je enako 1,2 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
English: The adverse reactions from clinical study and post-marketing experience with Atripla and the individual components of Atripla in antiretroviral combination therapy are listed in Table 2 below by body system organ class, frequency and the component(s) of Atripla to which the adverse reactions are attributable.
Slovenian: Neželeni učinki iz klinične študije in postmarketinških izkušenj z zdravilom Atripla in s posameznimi učinkovinami zdravila Atripla v protiretrovirusnem kombiniranem zdravljenju so razvrščeni v tabeli 2 spodaj, glede na organske sisteme, pogostnost in sestavino/-e zdravila Atripla, ki se ji/-m neželeni dogodek pripisuje.
English: Tenofovir pharmacokinetics were not substantially altered in subjects with hepatic impairment suggesting that no dose adjustment of tenofovir disoproxil is required in these subjects.
Slovenian: Farmakokinetika tenofovirja se pri osebah z jetrno okvaro ni bistveno spremenila, kar nakazuje, da pri teh osebah ni treba prilagoditi odmerjanja dizoproksiltenofovirata.
English: Patients who completed 144 weeks of treatment with either treatment arm in study GS-01-934 were given the option to continue in an open-label extended phase of the study with Atripla on an empty stomach.
Slovenian: Bolnikom, ki so končali 144-tedensko zdravljenje v eni od obeh skupin v študiji GS-01-934, so ponudili možnost udeležbe v odprti podaljšani fazi študije z zdravilom Atripla, jemanim na tešče.
English: Metabolism and nutrition disorders: Very common hypophosphataemia2
Slovenian: Presnovne in prehranske motnje: Zelo pogosti hipofosfatemija2
English: The most frequently reported adverse reactions considered possibly or probably related to Atripla among patients treated up to 48 weeks in study AI266073 were psychiatric disorders (16%), nervous system disorders (13%), and gastrointestinal disorders (7%).
Slovenian: Najpogosteje poročani neželeni učinki, ki se štejejo kot možno ali verjetno povezani z zdravilom Atripla, med bolniki, zdravljenimi do 48 tednov v študiji AI266073, so bili psihiatrične motnje (16 %), bolezni živčevja (13 %), in bolezni prebavil (7 %).
English: Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects).
Slovenian: Težave s kostmi (pri katerih včasih pride do zlomov) se lahko pojavijo zaradi poškodbe tubularnih celic ledvic (glejte poglavje 4, Možni neželeni učinki).
English: Efavirenz: There have been seven retrospective reports of findings consistent with neural tube defects, including meningomyelocele, all in mothers exposed to efavirenz-containing regimens (excluding any efavirenz-containing fixed-dose combination tablets) in the first trimester.
Slovenian: Efavirenz: Na voljo je sedem retrospektivnih poročil, ki kažejo na okvare nevralne cevi, vključno z meningomielokelo, vsa pri materah, ki so bile v prvem trimesečju nosečnosti izpostavljene režimu zdravljenja z efavirenzem (katere koli tablete s fiksno kombinacijo odmerkov efavirenza niso vključene).
English: Contact your doctor or nearest emergency department for advice.
Slovenian: Posvetujte se z zdravnikom ali oddelkom za nujno zdravniško pomoč.
English: They may occur more frequently when Atripla is taken concomitantly with meals possibly due to increased efavirenz plasma levels (see section 5.2).
Slovenian: Lahko se pojavijo pogosteje, kadar se zdravilo Atripla jemlje skupaj s hrano, verjetno zaradi povečane koncentracije efavirenza v plazmi (glejte poglavje 5.2).
English: Uncommon suicide attempt3, suicide ideation3, psychosis3, mania3, paranoia3, hallucination3, euphoric mood3, affect lability3, confusional state3, aggression3, catatonia3
Slovenian: Občasni poskus samomora3, samomorilske misli3, psihoza3, manija3, paranoja3, halucinacije3, evforično razpoloženje3, afektivna labilnost3, stanje zmedenosti3, agresivnost3, katatonija3
English: Severe skin reactions such as Stevens-Johnson syndrome and erythema multiforme; neuropsychiatric adverse reactions (including severe depression, death by suicide, psychosis-like behaviour, seizures); severe hepatic events; pancreatitis and lactic acidosis (sometimes fatal) have been reported.
Slovenian: Poročali so o hudih kožnih reakcijah, kot je Stevens-Johnsonov sindrom in multiformni eritem; nevropsihiatričnih neželenih učinkih (vključno s hudo depresijo, smrtjo zaradi samomora, psihozi podobno vedenje, epileptični napadi); hudih jetrnih dogodkih, pankreatitisu in laktacidozi (včasih s smrtnim izidom).
English: Carbamazepine plasma levels should be monitored periodically.
Slovenian: Občasno je treba nadzorovati koncentracije karbamazepina v plazmi.
English: If you are taking any of these medicines, tell your doctor immediately.
Slovenian: Če jemljete katerokoli od teh zdravil, takoj obvestite svojega zdravnika.
English: Carcinogenicity studies showed an increased incidence of hepatic and pulmonary tumours in female mice, but not in male mice.
Slovenian: Študije kancerogenosti so pokazale povečano incidenco jetrnih in pljučnih tumorjev pri mišjih samicah, ne pa tudi pri samcih.
English: Animal studies do not indicate harmful effects of efavirenz, emtricitabine or tenofovir disoproxil on fertility.
Slovenian: Študije na živalih niso pokazale škodjivih učinkov učinkovin efavirenz, emtricitabin ali dizoproksiltenofovirata na plodnost.
English: Dosing at bedtime seems to improve the tolerability of these symptoms (see section 4.2).
Slovenian: Kaže, da odmerjanje pred spanjem izboljša prenašanje teh simptomov (glejte poglavje 4.2).
English: Two additional cases (1 prospective and 1 retrospective) including events consistent with neural tube defects have been reported with the fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil.
Slovenian: O dveh dodatnih primerih (1 prospektiven in 1 retrospektiven), ki vključujeta dogodke, ki kažejo na okvare nevralne cevi, so poročali pri uporabi tablet s fiksno kombinacijo odmerkov efavirenza, emtricitabina in dizoproksiltenofovirat.
English: Contains sodium, see leaflet for further information.
Slovenian: SEZNAM POMOŽNIH SNOVI Zdravilo vsebuje natrija, za dodatne informacije glejte navodilo za uporabo.
English: • problems with digestion resulting in discomfort after meals, feeling bloated, wind (flatulence)
Slovenian: • težave s prebavo, ki povzročajo neugodje po obrokih, občutek napihnjenosti, vetrove;
English: Although in vitro data suggest that efavirenz inhibits CYP2C9 and CYP2C19, there have been contradictory reports of both increased and decreased exposures to substrates of these enzymes when co-administered with efavirenz in vivo.
Slovenian: Čeprav podatki in vitro nakazujejo, da efavirenz zavira CYP2C9 in CYP2C19, obstajajo protislovna poročila o povečanju in zmanjšanju izpostavljenosti substratom teh encimov ob sočasni uporabi z efavirenzom in vivo.
English: When you start or stop taking Atripla your doctor will closely monitor your plasma levels of the immunosuppressant and may need to adjust its dose.
Slovenian: Ob začetku ali prekinitvi jemanja zdravila Atripla bo vaš zdravnik natančno spremljal koncentracijo imunosupresivov v krvi in po potrebi prilagodil odmerek.
English: • yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver
Slovenian: • porumenelost kože ali oči, srbenje ali bolečina v trebuhu (želodcu), ki jo povzroča vnetje jeter;
English: If you think that you may have any of these serious side effects, talk to your doctor.
Slovenian: Če menite, da imate katerega koli od teh resnih neželenih učinkov, se posvetujte s svojim zdravnikom.
English: Atripla film-coated tablets are pink, capsule shaped tablets, engraved on one side with the number “123” and plain on the other side.
Slovenian: Atripla filmsko obložene tablete so rožnate barve, v obliki kapsule, z vtisnjeno oznako „123“ na eni strani in brez oznake na drugi strani.
English: Methadone:
Slovenian: metadon:
English: Tenofovir disoproxil is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate.
Slovenian: Dizoproksiltenofovirat se in vivo pretvori v tenofovir, nukleozidni monofosfatni (nukleotidni) analog adenozinmonofosfata.
English: In combination studies evaluating the in vitro antiviral activity of efavirenz and emtricitabine together, efavirenz and tenofovir together, and emtricitabine and tenofovir together, additive to synergistic antiviral effects were observed.
Slovenian: V študijah kombinacij in vitro, pri katerih so ocenjevali protivirusno aktivnost efavirenza in emtricitabina skupaj, efavirenza in tenofovirja skupaj ter emtricitabina in tenofovirja skupaj, so opazili sinergistične protivirusne učinke.
English: Efavirenz has been shown to induce CYP3A4 and CYP2B6, resulting in the induction of its own metabolism, which may be clinically relevant in some patients.
Slovenian: Pokazalo se je, da efavirenz inducira encima CYP3A4 in CYP2B6, s čimer povzroči indukcijo svoje lastne presnove, kar je lahko klinično pomembno za nekatere bolnike.
English: Co-administration of tenofovir disoproxil and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i.e. active) didanosine.
Slovenian: Sočasna uporaba dizoproksiltenofovirata in didanozina v odmerku 400 mg na dan je bila povezana s pomembnim zmanjšanjem števila celic CD4, morda zaradi znotrajceličnih interakcij, ki so povečale količino fosforiliranega (tj. aktivnega) didanozina.
English: Atripla is not recommended in this population (see section 4.2).
Slovenian: Zdravilo Atripla se ne priporoča v tej populaciji (glejte poglavje 4.2).
English: Since fluoxetine shares a similar metabolic profile with paroxetine, i.e. a strong CYP2D6 inhibitory effect, a similar lack of interaction would be expected for fluoxetine.
Slovenian: Ker ima fluoksetin podobni presnovni profil kot paroksetin, tj. močno zavira CYP2D6, tudi pri fluoksetinu ni pričakovati interakcij.
English: • back pain caused by kidney problems, including kidney failure.
Slovenian: • bolečina v hrbtu, ki jo povzročajo ledvične težave, vključno z levično odpovedjo.
English: After oral administration, tenofovir is widely distributed throughout the body.
Slovenian: Po peroralni uporabi se tenofovir porazdeli po vsem telesu.
English: However, tenofovir disoproxil reduced the viability index and weight of pups in peri-postnatal toxicity studies at maternally toxic doses.
Slovenian: Vendar pa je dizoproksiltenofovirat zmanjšal indeks preživetja in telesno maso mladičev v peri- in postnatalnih študijah toksičnosti pri odmerkih, ki so bili toksični za mater.
English: elevated serum AST and/or elevated serum ALT, hyperbilirubinaemia increased transaminases
Slovenian: povišanje serumske ravni AST in/ali povišanje serumske ravni ALT, hiperbilirubinemija povišanje transaminaz
English: Skin and subcutaneous tissue disorders: Very common rash (moderate-severe, 11.6%, all grades, 18%)3
Slovenian: Bolezni kože in podkožja: Zelo pogosti izpuščaj (zmeren do hud, 11,6 %; (vseh stopenj,
English: Efavirenz non-competitively inhibits HIV-1 reverse transcriptase (RT) and does not significantly inhibit human immunodeficiency virus-2 (HIV-2) RT or cellular deoxyribonucleic acid (DNA) polymerases (α, β, γ, and δ).
Slovenian: Efavirenz je nekompetitivni zaviralec reverzne transkriptaze (RT) HIV-1 in ne zavira pomembno RT virusa humane imunske pomanjkljivosti (HIV-2) ali celičnih polimeraz (α, β, γ, in δ) deoksiribonukleinske kisline (DNA).
English: Each film-coated tablet contains 1 mmol (23.6 mg) of sodium.
Slovenian: Ena filmsko obložena tableta vsebuje 1 mmol (23,6 mg) natrija.
English: Renally eliminated medicinal products: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of Atripla with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Slovenian: Zdravila, ki se izločajo skozi ledvice: Emtricitabin in tenofovir se izločata predvsem skozi ledvice, zato sočasna uporaba zdravila Atripla in zdravil, ki zmanjšujejo delovanje ledvic ali tekmujejo za aktivno tubularno sekrecijo (npr. cidofovir), lahko zviša serumske koncentracije emtricitabina, tenofovirja in/ali sočasno uporabljenih zdravil.
English: While the clinical significance of decreased indinavir concentrations has not been established, the magnitude of the observed pharmacokinetic interaction should be taken into consideration when choosing a regimen containing both efavirenz, a component of Atripla, and indinavir.
Slovenian: Kliničnega pomena zmanjšanih koncentracij indinavirja niso ugotovili, vendar je treba stopnjo opažene farmakokinetične interakcije upoštevati pri izbiri režima zdravljenja, pri katerem se uporabljata oba - efavirenz, učinkovina zdravila Atripla, in indinavir.
English: Atripla is not recommended if you have moderate to severe kidney disease.
Slovenian: Uporabe zdravila Atripla ne priporočamo, če imate zmerno do hudo bolezen ledvic.
English: - Medicines used to lower blood fats (also called statins): Atorvastatin, pravastatin,
Slovenian: - Zdravila za znižanje količine maščob v krvi (imenovana tudi statini): Atorvastatin, pravastatin, simvastatin.
English: Ethinyloestradiol:
Slovenian: etinilestradiol:
English: Test: single fixed-dose combination tablet taken under fasted conditions.
Slovenian: Test: kombinirana tableta z enkratnim fiksnim odmerkom na tešče.
English: Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels.
Slovenian: Pri bolnikih, ki sočasno prejemajo antikonvulzive, ki se primarno presnavljajo v jetrih, kot so fenitoin, karbamazepin in fenobarbital, bo morda treba občasno spremljati plazemske koncentracije.