FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, patients should be advised that their physical and/ or mental abilities needed for operating machinery or driving may be impaired and they are recommended not to do so until it has been established that their ability to perform such activities is not affected.
Slovenian: Zato je treba bolnike obvestiti, da so lahko njihove fizične in/ali mentalne sposobnosti, ki so potrebne za upravljanje strojev ali vožnjo, zmanjšane, in jim priporočiti, da se tem dejavnostim izogibajo, dokler se ne ugotovi, da ni vpliva na njihovo zmožnost opravljanja teh dejavnosti.
English: However, due to interindividual variability, the effect may be clinically relevant in some individuals.
Slovenian: Vendar je lahko zaradi velikih razlik med posamezniki ta učinek pri nekaterih posameznih klinično pomemben.
English: • Increased urine production during night time
Slovenian: • zvečana tvorba urina ponoči,
English: The safety and efficacy of Exalief in children below 18 years has not yet been established.
Slovenian: Varnost in učinkovitost zdravila Exalief pri otrocih starih do 18 let še nista bili dokazani.
English: These could be signs of an allergic reaction.
Slovenian: To so lahko znaki alergijske reakcije.
English: • Increased or decreased appetite
Slovenian: • zvečan ali zmanjšan apetit,
English: Dose when you start treatment
Slovenian: Odmerek ob začetku zdravljenja
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Slovenian: V skladu s smernicamo CHMP o sistemih za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
English: • High or low blood pressure or a fall in blood pressure on standing up
Slovenian: • visok ali nizek krvni tlak ali padec krvnega tlaka ob vstajanju,
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21.04.2009
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 21.04.2009
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for eslicarbazepine acetate.
Slovenian: Mehanizem tveganja še ni znan, vendar razpoložljivi podatki ne izključujejo možnosti povečanega tveganja za eslikarbazepinacetat.
English: Pharmacotherapeutic group: Antiepileptics, Carboxamide derivatives, ATC code: N03AF04
Slovenian: Farmakoterapevtska skupina: antiepileptiki, derivati karboksamida, oznaka ATC: N03AF04
English: Risk Management plan
Slovenian: Načrt za obvladovanje tveganja (RMP)
English: • Difficulty in concentration
Slovenian: • težave pri koncentraciji,
English: These could be signs of an allergic reaction
Slovenian: To so lahko znaki alergijske reakcije;
English: In patients with CLCR <30 ml/min use is not recommended due to insufficient data.
Slovenian: Pri bolnikih, pri katerih je CLCR < 30 ml/min, uporaba ni priporočena zaradi nezadostnih podatkov.
English: • Tell your doctor if you are taking hormonal/oral contraceptives.
Slovenian: • Povejte zdravniku, če jemljete hormonske/peroralne kontraceptive.
English: Do not take Exalief if:
Slovenian: Ne jemljite zdravila Exalief, če:
English: Apart from this, sodium levels should be determined during routine laboratory examination.
Slovenian: Poleg tega je treba ravni natrija določiti tudi pri rutinskih laboratorijskih preiskavah.
English: When initiating or discontinuing treatment with Exalief or changing the dose, it may take 2 to 3 weeks to reach the new level of enzyme activity.
Slovenian: Ob začetku ali prenehanju zdravljenja z zdravilom Exalief, ali pri spreminjanju njegovega odmerka, lahko doseganje nove ravni encimske aktivnosti traja 2 do 3 tedne.
English: Symptomatic and supportive treatment should be administered as appropriate.
Slovenian: Po potrebi je treba uporabiti simptomatsko in podporno zdravljenje.
English: The presence of HLA-B*1502 allele in other ethnicities is negligible.
Slovenian: Prisotnost alela HLA-B*1502 pri drugih narodnostih je zanemarljiva.
English: Minimum effective doses should be given, and monotherapy whenever possible should be preferred at least during the first three months of pregnancy.
Slovenian: Kadar koli je mogoče, je treba uporabiti najmanjše učinkovite odmerke in samostojno zdravljenje, vsaj v prvih treh mesecih nosečnosti.
English: Based on individual response, the dose may be increased to 1200 mg once daily (see section 5.1).
Slovenian: Glede na odziv posameznika se odmerek lahko zveča do 1.200 mg enkrat na dan (glejte poglavje 5.1).
English: Safety margins based on comparative exposure have thus not been established.
Slovenian: Zato glede na primerjalno izpostavljenost meje varnosti niso bile ugotovljene.
English: • Feeling numb in any part of your body
Slovenian: • občutek otrplosti v kateremkoli delu telesa,
English: • Ear pain or ringing in the ears
Slovenian: • bolečine ali zvenenje v ušesih,
English: Your doctor may need to adjust the dose.
Slovenian: Zdravnik vam bo morda prilagodil odmerek zdravila.
English: • you suffer from a heart disease such as heart failure or heart attack.
Slovenian: • imate bolezen srca, kot sta srčno popuščanje ali srčna kap.
English: The usual maintenance dose is 800 mg once daily.
Slovenian: Običajni vzdrževalni odmerek je 800 mg enkrat na dan.
English: Biotransformation
Slovenian: Biološka transformacija
English: Valproate and levetiracetam
Slovenian: Valproat in levetiracetam
English: • you suffer from a certain type of heart rhythm disorder (second or third degree atrioventricular (AV) block)
Slovenian: • imate določeno vrsto okvare srčnega ritma (atrioventrikularni (AV) blok druge ali tretje stopnje)
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA
English: • Tell your doctor if you are taking tricyclic antidepressants e.g. amitriptyline.
Slovenian: • Povejte zdravniku, če jemljete triciklične antidepresive, npr. amitriptilin.
English: If they happen to you stop taking Exalief and tell a doctor or go to a hospital immediately, as you may need urgent medical treatment:
Slovenian: Če se pojavijo, nehajte jemati zdravilo Exalief in takoj povejte zdravniku ali pojdite v bolnišnico, saj morda potrebujete nujno zdravniško pomoč:
English: Your doctor will decide how long you should take Exalief for.
Slovenian: Zdravnik se bo odločil, koliko časa morate jemati zdravilo Exalief.
English: Children Exalief is not to be given to children and adolescents.
Slovenian: Otroci Zdravilo Exalief se ne sme dajati otrokom ali mladostnikom.
English: • Weight loss and general ill health (Cachexia)
Slovenian: • izguba telesne mase in splošno slabo zdravje (kaheksija),
English: Risk related to epilepsy and antiepileptic medicinal products in general It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3 % in the general population.
Slovenian: Tveganja, povezana z epilepsijo in antiepileptiki na splošno Raziskave so pokazale, da je pri potomcih žensk z epilepsijo razširjenost malformacij dve- do trikrat večja kot pri splošni populaciji, kjer je 3-odstotna.
English: • Difficulty in speaking
Slovenian: • težave pri govoru,
English: • Poor memory or forgetfulness
Slovenian: • slab spomin ali pozabljivost,
English: Therefore, whenever possible, subjects of Han Chinese and Thai origin should be screened for this allele before starting treatment with carbamazepine or chemically-related compounds.
Slovenian: Zato je treba, kadar koli je mogoče, pri posameznikih kitajske ali tajske narodnosti pregledati prisotnost tega alela pred začetkom zdravljenja s karbamazepinom ali sorodnimi kemijskimi spojinami.
English: The binding of eslicarbazepine to plasma proteins is relatively low (<40%) and independent from concentration.
Slovenian: Sorazmerno malo eslikarbazepina se veže na beljakovine v plazmi (< 40 %), vezava pa je neodvisna od koncentracije.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Slovenian: Bolnikom (in njihovim skrbnikom) je treba svetovati, da poiščejo zdravniško pomoč, če se pojavijo znaki samomorilnih misli in vedenja.
English: • Do not take oxcarbazepine (a medicine used to treat epilepsy) with Exalief, as it is not known whether it is safe to take these medicines together.
Slovenian: • Ne jemljite okskarbazepina (zdravila za zdravljenje epilepsije) skupaj z zdravilom Exalief, saj ni znano, ali je sočasno jemanje teh dveh zdravil varno.
English: • you suffer from confusion, worsening of seizures or decreased consciousness which can be signs of low blood salt levels
Slovenian: • se pojavijo zmedenost, poslabšanje epileptičnih napadov ali zmanjšana zavest, kar so lahko znaki nizkih ravni soli v krvi.
English: • Nail or skin changes (e.g. red skin)
Slovenian: • spremembe na nohtih ali koži (npr. rdeča koža),
English: Taking Exalief with food and drink Exalief tablets may be taken with or without food.
Slovenian: Jemanje zdravila Exalief skupaj s hrano in pijačo Tablete Exalief lahko jemljete s hrano ali brez nje.
English: It is not known whether it passes into breast milk.
Slovenian: Ni znano, ali zdravilo prehaja v materino mleko.
English: On the other hand effective anti-epileptic therapy must not be interrupted since the worsening of the disease is harmful to both the mother and the unborn child.
Slovenian: Po drugi strani se zdravljenje z antiepileptiki ne sme prekiniti, saj je poslabšanje bolezni lahko škodljivo za mater in nerojenega otroka.
English: WHAT EXALIEF IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO EXALIEF IN ZA KAJ GA UPORABLJAMO
English: Therefore, their occurrence after treatment with Exalief cannot be excluded.
Slovenian: Zato njihovega pojava po zdravljenju z zdravilom Exalief ni mogoče izključiti.
English: Caution should be exercised in the treatment of elderly patients as there is limited safety information on the use of Exalief in these patients.
Slovenian: Pri zdravljenju starejših bolnikov je potrebna previdnost, saj so informacije o varnosti uporabe zdravila Exalief pri njih omejene.
English: No effects on F1 fertility parameters were observed in rats and mice.
Slovenian: Učinkov na parametre plodnosti pri F1 generaciji pa pri podganah in miših niso opazili.
English: Known second or third degree atrioventricular (AV) block.
Slovenian: Znan atrioventrikularni (AV) blok druge ali tretje stopnje.
English: • Seeing double or blurred vision
Slovenian: • dvojni ali zamegljen vid,
English: • Reduction in white blood cells which makes infections more likely
Slovenian: • zmanjšanje števila levkocitov, zaradi katerega so okužbe verjetnejše.
English: • Blood tests showing that you have low levels of salts or sodium in your blood or a reduction in red blood cells
Slovenian: • krvne preiskave, ki kažejo, da imate nizke ravni soli ali natrija v krvi ali zmanjšano število eritrocitov,
English: However, due to inter-individual variability in the interaction, special attention on monitoring of INR should be performed the first weeks after initiation or ending concomitant treatment of warfarin and eslicarbazepine acetate.
Slovenian: Vendar je zaradi velikih razlik med posamezniki pri interakcijah potrebna posebna pozornost pri spremljanju vrednosti INR v prvih tednih po začetku ali prekinitvi sočasnega zdravljenja z varfarinom in eslikarbazepinacetatom.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
English: There are no data from the use of eslicarbazepine acetate in pregnant women.
Slovenian: Ni podatkov o uporabi eslikarbazepinacetata pri nosečnicah.
English: Hyponatraemia is asymptomatic in most cases, however, it may be accompanied by clinical symptoms like worsening of seizures, confusion, decreased consciousness.
Slovenian: Hiponatriemija je v večini primerov asimptomatska, vendar jo lahko spremljajo tudi klinični simptomi, kot so poslabšanje epileptičnih napadov, zmedenost in zmanjšana zavest.
English: Exalief may decrease the effectiveness of hormonal contraceptives.
Slovenian: Zdravilo Exalief lahko zmanjša učinkovitost hormonskih kontraceptivov.
English: You must only take Exalief during pregnancy if your doctor tells you.
Slovenian: Zdravilo Exalief lahko jemljete med nosečnostjo samo, če vam tako naroči zdravnik.
English: FURTHER INFORMATION What Exalief contains
Slovenian: DODATNE INFORMACIJE Kaj vsebuje zdravilo Exalief
English: Monoamino Oxidase Inhibitors (MAOIs)
Slovenian: Zaviralci monoamin-oksidaze (zaviralci MAO)
English: In total, eslicarbazepine and its glucuronide correspond to more than 90% of total metabolites excreted in urine, approximately two thirds in the unchanged form and one third as glucuronide conjugate.
Slovenian: Eslikarbazepin in njegov glukuronid tvorita skupaj več kot 90 % vseh presnovkov, ki se izločajo z urinom, približno dve tretjini v nespremenjeni obliki in ena tretjina kot glukuronidni konjugat.
English: A study in patients with mild to severe renal impairment showed that clearance is dependent on renal function.
Slovenian: Študija pri bolnikih z blago do hudo ledvično okvaro je pokazala, da je očistek odvisen od delovanja ledvic.
English: If women receiving eslicarbazepine acetate become pregnant or plan to become pregnant, the use of Exalief should be carefully re-evaluated.
Slovenian: Če ženska, ki prejema eslikarbazepinacetat, zanosi, ali če načrtuje zanositev, je treba uporabo zdravila Exalief znova pozorno oceniti.
English: Exalief is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.
Slovenian: Zdravilo Exalief je indicirano kot dodatno zdravljenje pri odraslih s parcialnimi epileptičnimi napadi s sekundarno generalizacijo ali brez nje.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 4.0 načrta za obvladovanje tveganja (RMP), predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
English: Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines.
Slovenian: Raziskave so pokazale zvečano tveganje za okvare ploda pri otrocih žensk, ki jemljejo zdravila za zdravljenje epilepsije.
English: Antiepileptic medicinal products may contribute to folic acid deficiency, a possible contributory cause of foetal abnormality.
Slovenian: Antiepileptiki lahko prispevajo k pomanjkanju folne kisline, ki je lahko možen prispevajoči vzrok fetalnih nenormalnosti.
English: Therefore, women of childbearing potential must use adequate contraception during treatment with Exalief, and up to the end of the current menstruation cycle after the treatment has been discontinued (see section 4.4 and 4.6).
Slovenian: Zato morajo ženske v rodni dobi med zdravljenjem z zdravilom Exalief in do konca trenutnega menstrualnega cikla po prekinitvi zdravljenja uporabljati ustrezno kontracepcijo (glejte poglavji 4.4 in 4.6).
English: • you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram) called increased PR interval.
Slovenian: • jemljete katero koli zdravilo, ki lahko povzroči spremembe elektrokardiograma (EKG), imenovane podaljšanje intervala PR.
English: • you suffer from seizures that begin with a widespread electric discharge that involves both sides of the brain
Slovenian: • če imate epileptične napade, ki se začnejo z razširjenim razelektrenjem, ki zajame obe polovici možganov.
English: As the efficacy of this supplementation is not proven, a specific antenatal diagnosis can be offered even for women with a supplementary treatment of folic acid.
Slovenian: Učinkovitost te nadomestne terapije ni dokazana, zato se lahko posebna antenatalna diagnostika ponudi tudi ženskam, ki uporabljajo nadomestno zdravljenje s folno kislino.
English: Exalief is used in adult patients who are already taking other anti-epileptic medicines and are still experiencing seizures that affect one part of the brain (partial seizure).
Slovenian: Zdravilo Exalief se uporablja pri odraslih bolnikih, ki že jemljejo druga zdravila proti epilepsiji in imajo še vedno epileptične napade, ki prizadenejo en del možganov (parcialne epileptične napade).
English: Patients should be counselled regarding the possibility of an increased risk of malformations and given the opportunity to antenatal screening.
Slovenian: Bolnice je treba seznaniti z možnostjo povečanega tveganja za malformacije in jim dati priložnost za prenatalne presejalne preglede.
English: Take special care when taking Exalief to avoid accidental injury (fall).
Slovenian: Med jemanjem zdravila Exalief bodite posebno previdni, da preprečite nezgodne poškodbe (padce).
English: Adverse reactions were usually mild to moderate in intensity and occurred predominantly during the first weeks of treatment with eslicarbazepine acetate.
Slovenian: Neželene reakcije so bile ponavadi blage do zmerne, pojavljale pa so se predvsem v prvih tednih zdravljenja z eslikarbazepinacetatom.
English: There was no effect on the R-warfarin pharmacokinetics or on coagulation.
Slovenian: Učinka na farmakokinetiko R-varfarina ali na koagulacijo ni bilo.
English: Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects.
Slovenian: Najpogostejše okvare so razcepljena ustnica, kardiovaskularne malformacije in okvare nevralne cevi.
English: Your doctor will work out the correct dose for you.
Slovenian: Zdravnik bo določil odmerek, ki je ustrezen za vas.
English: No sudden discontinuation of antiepileptic therapy should be undertaken as this may lead to breakthrough seizures which could have serious consequences for both mother and child.
Slovenian: Zdravljenje z antiepileptiki se ne sme prekiniti nenadoma, saj to lahko povzroči prebojne epileptične napade, ki imajo lahko resne posledice za mater in otroka.
English: • Faster, slower or irregular heart beat
Slovenian: • hitrejši, počasnejši ali nereden srčni utrip,
English: However, they have been reported with oxcarbazepine.
Slovenian: Vendar so o njih poročali pri okskarbazepinu.
English: Method and route of administration Swallow the tablet with a glass of water.
Slovenian: Način in pot uporabe Tablete pogoltnite cele, s kozarcem vode.
English: The efficacy and safety of eslicarbazepine acetate has been demonstrated in three phase III double-blind placebo-controlled studies in 1,049 adult patients with partial epilepsy refractory to treatment with one to three concomitant anti-epileptic medicinal products.
Slovenian: Učinkovitost in varnost eslikarbazepinacetata so pokazali v treh dvojno slepih, s placebom nadzorovanih študijah III. faze pri 1.049 odraslih bolnikih s parcialno epilepsijo, ki se odziva na zdravljenje z enim do tremi antiepileptiki.
English: Very common side effects are: • Feeling dizzy or sleepy
Slovenian: Zelo pogosti neželeni učinki so: • občutek omotice ali zaspanosti.
English: Genotoxicity studies with eslicarbazepine acetate indicate no special hazards for humans.
Slovenian: Študije genotoksičnosti z eslikarbazepinacetatom ne kažejo posebnega tveganja za človeka.
English: • Severe pain in the back and stomach
Slovenian: • hude bolečine v hrbtu ali trebuhu,
English: • The other ingredients are povidone K29/32, croscarmellose sodium and magnesium stearate.
Slovenian: • Pomožne snovi so povidon K 29/32, premreženi natrijev karmelozat in magnezijev stearat.
English: Take special care with Exalief Contact your doctor immediately if:
Slovenian: Bodite posebno pozorni pri uporabi zdravila Exalief Takoj se posvetujte z zdravnikom, če:
English: Based on a structural relationship of eslicarbazepine acetate to tricyclic antidepressants, an interaction between eslicarbazepine acetate and MAOIs is theoretically possible.
Slovenian: Na podlagi strukturne povezave med eslikarbazepinacetatom in tricikličnimi antidepresivi so interakcije med eslikarbazepinacetatom in zaviralci MAO teoretično mogoče.
English: • Feeling low in energy or tired
Slovenian: • občutek pomanjkanja energije ali utrujenosti,
English: The precise mechanisms of action of eslicarbazepine acetate are unknown.
Slovenian: Natančni mehanizmi delovanja eslikarbazepinacetata niso znani.
English: Exalief must be added to existing anticonvulsant therapy.
Slovenian: Zdravilo Exalief je treba dodati k obstoječemu zdravljenju z antiepileptiki.
English: The pharmacokinetic profile of eslicarbazepine acetate is unaffected in the elderly patients with creatinine clearance >60 ml/min (see section 4.2).
Slovenian: Farmakokinetični profil eslikarbazepinacetata je nespremenjen pri starejših bolnikih s kreatininskim očistkom > 60 ml/min (glejte poglavje 4.2).
English: Studies in animals have shown reproductive toxicity (see Fertility).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje Plodnost).
English: However, in vitro electrophysiological studies indicate that both eslicarbazepine acetate and its metabolites stabilise the inactivated state of voltage-gated sodium channels, preventing their return to the activated state and thereby sustaining repetitive neuronal firing.
Slovenian: Vendar elektrofiziološke študije in vitro kažejo, da eslikarbazepinacetat in njegovi presnovki stabilizirajo neaktivirano stanje natrijevih napetostnih kanalčkov, pri čemer preprečujejo, da bi se vrnili v aktivirano stanje in posledično vzdržujejo ponavljajoče se sprožanje nevronov.
English: Palpitations, bradycardia, sinus bradycardia
Slovenian: Srčne bolezni palpitacije, bradikardija, sinusna bradikardija
English: Eslicarbazepine acetate was tested at doses of 400 mg, 800 mg and 1200 mg, once daily.
Slovenian: Eslikarbazepinacetat so preizkusili pri odmerkih 400 mg, 800 mg in 1.200 mg enkrat na dan.
English: Within each frequency category, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: Should your doctor decide to stop your treatment with Exalief your dose will usually be reduced gradually.
Slovenian: Če se zdravnik odloči, da morate prekiniti zdravljenje z zdravilom Exalief, bo odmerek postopoma zmanjšal.
English: POSSIBLE SIDE EFFECTS Like all medicines, Exalief can cause side effects, although not everybody gets them.
Slovenian: MOŽNI NEŽELENI UČINKI Kot vsa zdravila ima lahko tudi zdravilo Exalief neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Multiple antiepileptic medicinal product therapy may be associated with a higher risk of congenital malformations than monotherapy, therefore it is important that monotherapy is practised whenever possible.
Slovenian: Kombinirano zdravljenje z antiepileptiki je lahko povezano z večjim tveganjem za kongenitalne malformacije kot samostojno zdravljenje, zato je pomembno uporabiti samostojno zdravljenje, kadar koli je mogoče.